Q1 2025 Performance - ICU Medical's total revenue for Q1 2025 was $599 million[7] - Consumables revenue in Q1 2025 reached $266 million, with a year-over-year growth of 9% (10% FXN)[7] - Systems revenue for Q1 2025 was $166 million, showing a year-over-year growth of 6% (8% FXN)[7] - Vital Care revenue in Q1 2025 amounted to $167 million, reflecting a year-over-year growth of 10% (11% FXN)[7] 2025 Guidance (Post JV Transaction) - Adjusted EBITDA is projected to be between $380 million and $405 million[8] - Adjusted EPS is expected to be in the range of $655 to $725[8] - Vital Care revenue is expected to decline by approximately 35% FXN, but remain flat organically[8] - Capital Expenditures are estimated to be between $75 million and $95 million[8] 2025 Guidance Assumptions - Gross Margin percentage is projected to be between 39% and 40%[8] - SG&A and R&D expenses are expected to be approximately 26% of revenue[8] - Net interest expense is estimated to be around $87 million[8]

[PART I. Financial Information](index=5&type=section&id=PART%20I.%20Financial%20Information) [Item 1. Financial Statements (Unaudited)](index=5&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) This section presents ICU Medical, Inc.'s unaudited condensed consolidated financial statements for Q1 2025, including balance sheets, income, equity, and cash flow statements, with detailed notes on accounting policies and financial activities Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Total Current Assets** | $1,423,915 | $1,441,983 | | **Total Assets** | $4,184,581 | $4,203,931 | | **Total Current Liabilities** | $549,024 | $556,182 | | **Long-Term Debt** | $1,488,565 | $1,531,858 | | **Total Liabilities** | $2,196,892 | $2,238,696 | | **Total Stockholders' Equity** | $1,987,689 | $1,965,235 | Condensed Consolidated Statements of Operations Highlights (in thousands) | Account | Three months ended March 31, 2025 | Three months ended March 31, 2024 | | :--- | :--- | :--- | | **Total Revenues** | $604,702 | $566,655 | | **Gross Profit** | $210,109 | $185,244 | | **Income (Loss) from Operations** | $12,888 | $(10,655) | | **Net Loss** | $(15,476) | $(39,471) | | **Net Loss Per Share (Basic & Diluted)** | $(0.63) | $(1.63) | Condensed Consolidated Statements of Cash Flows Highlights (in thousands) | Cash Flow Activity | Three months ended March 31, 2025 | Three months ended March 31, 2024 | | :--- | :--- | :--- | | **Net cash provided by operating activities** | $51,327 | $45,791 | | **Net cash used in investing activities** | $(16,811) | $(17,862) | | **Net cash used in financing activities** | $(56,336) | $(26,845) | | **Net Decrease in Cash and Cash Equivalents** | $(18,862) | $(2,799) | | **Cash and Cash Equivalents, end of period** | $289,704 | $251,423 | [Note 4: Assets Held For Sale](index=13&type=section&id=Note%204%3A%20Assets%20Held%20For%20Sale) The company agreed to sell a 60% equity interest in its IV Solutions product line to OPF for approximately $209.5 million in cash, with the transaction closing on April 24, 2025, and net assets held for sale valued at $256.5 million as of March 31, 2025 - The company agreed to sell a 60% stake in its IV Solutions business to OPF for approximately **$209.5 million** in cash plus potential milestone payments. The transaction closed subsequent to the quarter end, on April 24, 2025[44](index=44&type=chunk)[160](index=160&type=chunk) Assets and Liabilities Held for Sale (in thousands) | Category | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Total assets held for sale** | $286,122 | $284,382 | | **Total liabilities held for sale** | $29,664 | $32,911 | | **Net assets held for sale** | $256,458 | $251,471 | [Note 5: Revenue](index=14&type=section&id=Note%205%3A%20Revenue) Total revenues for the three months ended March 31, 2025, increased to $604.7 million from $566.7 million in the prior-year period, with growth across all product lines and the United States remaining the largest market Revenues by Product Line (in thousands) | Product line | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Consumables | $266,226 | $244,039 | | Infusion Systems | $166,300 | $157,338 | | Vital Care | $172,176 | $165,278 | | **Total Revenues** | **$604,702** | **$566,655** | Revenues by Geography (in thousands) | Geography | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | United States | $388,245 | $366,155 | | Europe, the Middle East and Africa | $95,688 | $98,389 | | APAC | $59,411 | $51,853 | | Other Foreign | $61,358 | $50,258 | | **Total Revenues** | **$604,702** | **$566,655** | [Note 18: Long-Term Debt](index=32&type=section&id=Note%2018%3A%20Long-Term%20Debt) The company's long-term debt totaled $1.54 billion as of March 31, 2025, primarily consisting of Term Loan A and Term Loan B, with $47.8 million in principal repayments made during Q1 2025, and the company remaining in compliance with all financial covenants Carrying Value of Long-Term Debt (in thousands) | Debt Component | March 31, 2025 | | :--- | :--- | | Term Loan A — principal | $759,688 | | Term Loan B — principal | $789,500 | | Less unamortized debt issuance costs | $(12,810) | | **Total carrying value of long-term debt** | **$1,536,378** | - Total principal payments on term loans were **$47.8 million** for Q1 2025, which included an additional prepayment of **$35.0 million** on Term Loan B[131](index=131&type=chunk) - The company was in compliance with all financial covenants, including the Senior Secured Leverage Ratio and the Interest Coverage Ratio, as of March 31, 2025[140](index=140&type=chunk) [Note 20: Commitments and Contingencies](index=36&type=section&id=Note%2020%3A%20Commitments%20and%20Contingencies) The company faces FDA Warning Letters, including a new one in April 2025 regarding infusion pumps, and has accrued liabilities for corrective actions and Italy's Medical Device Payback legislation - In April 2025, the company received a new warning letter from the FDA regarding changes to its MedFusion™ Model 4000 and CADD™ Solis VIP infusion pumps that may require new 510(k) clearance. The financial impact is not yet predictable[154](index=154&type=chunk) - As of March 31, 2025, the accrued liability for field service corrective actions, primarily related to the 2021 FDA Warning Letter, was **$37.6 million**[152](index=152&type=chunk) - The company has accrued **$25.5 million** for potential payments related to the Italy Medical Device Payback (IMDP) legislation, though the ultimate resolution remains unknown[153](index=153&type=chunk)[110](index=110&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=39&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management reports a 6.7% increase in total revenue to $604.7 million for Q1 2025, driven by growth across all product segments and improved gross margin, while highlighting risks from new U.S. tariffs and strong liquidity supported by cash from operations and debt paydown from the IV Solutions business sale Revenue Change by Segment (in millions) | Segment | Q1 2025 Revenue (GAAP) | YoY % Change (GAAP) | YoY % Change (Constant Currency) | | :--- | :--- | :--- | :--- | | Consumables | $266.2 | 9.1% | 10.3% | | Infusion Systems | $166.3 | 5.7% | 7.6% | | Vital Care | $172.2 | 4.2% | 5.1% | - Gross margin increased to **34.8%** in Q1 2025 from **32.7%** in Q1 2024, primarily due to price increases, higher production levels, favorable foreign exchange impact, lower supply chain costs, and integration synergies[199](index=199&type=chunk) - The company highlights risks from new U.S. tariffs imposed in early 2025, which could materially impact business due to a significant portion of products being manufactured in Mexico and Costa Rica and imported into the U.S[188](index=188&type=chunk)[249](index=249&type=chunk) - Cash and cash equivalents decreased by **$18.9 million** during the quarter to **$289.7 million**, primarily due to debt principal payments of **$47.8 million**[215](index=215&type=chunk) - Subsequent to the quarter, the company received **$209.5 million** from the sale of 60% of its IV Solutions business and used approximately **$200.0 million** to prepay a portion of its Term Loan A debt[160](index=160&type=chunk)[224](index=224&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=52&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company manages interest rate risk on its $2.2 billion variable-rate debt through swaps, with a 1% SOFR change impacting annual interest expense by $15.5 million, and mitigates foreign currency risk, where a 10% weakening would decrease derivative fair value by $4.3 million - The company is exposed to interest rate risk on its variable-rate term loans. A **1%** increase or decrease in the SOFR rate would result in an approximate **$15.5 million** change in annual interest expense[239](index=239&type=chunk) - To manage interest rate risk, the company has entered into three interest rate swaps, effectively converting portions of its floating-rate term loans to fixed rates[240](index=240&type=chunk) - The company is exposed to foreign currency risk. A sensitivity analysis showed that a hypothetical **10%** weakening in foreign currency exchange rates would result in an estimated **$4.3 million** decrease in the fair value of its outstanding derivative contracts[243](index=243&type=chunk) [Controls and Procedures](index=53&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, including the CEO and CFO, concluded that the company's disclosure controls and procedures were effective as of March 31, 2025, with no material changes to internal control over financial reporting during the quarter - Management, including the principal executive and financial officers, concluded that as of March 31, 2025, the company's disclosure controls and procedures were effective at the reasonable assurance level[245](index=245&type=chunk) - There were no material changes to the company's internal control over financial reporting during the first quarter of 2025[246](index=246&type=chunk) [PART II. Other Information](index=53&type=section&id=PART%20II.%20Other%20Information) [Legal Proceedings](index=53&type=section&id=Item%201.%20Legal%20Proceedings) The company is involved in routine legal proceedings not expected to materially impact its financial position or results of operations, with further details referenced in Note 20 of the financial statements - The company is involved in routine legal proceedings which are not expected to have a material adverse impact on its financial position or operations[148](index=148&type=chunk)[247](index=247&type=chunk) [Risk Factors](index=54&type=section&id=Item1A.%20Risk%20Factors) The company highlights new U.S. tariffs as a material risk, potentially increasing costs and impacting financial results, given a significant portion of revenue comes from products manufactured in Costa Rica and Mexico and imported into the U.S - A key risk is the imposition of U.S. tariffs and foreign retaliatory measures, as a significant portion of revenues are from products manufactured in Costa Rica and Mexico and imported to the U.S[249](index=249&type=chunk)[251](index=251&type=chunk) - Tariffs imposed in January and April 2025 are likely to have a material impact on the business, financial condition, and results of operations by increasing costs[249](index=249&type=chunk)[252](index=252&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=54&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) During Q1 2025, ICU Medical did not repurchase any common stock, with its $100.0 million share purchase plan remaining fully available but currently limited by Credit Agreement terms Stock Repurchase Activity - Q1 2025 | Period | Total number of shares purchased | Average price paid per share | Approximate dollar value that may yet be purchased under the program | | :--- | :--- | :--- | :--- | | Q1 2025 Total | 0 | $0 | $100,000,000 | - The company's ability to repurchase shares is limited by the terms and conditions of its Credit Agreement[255](index=255&type=chunk) [Other Information](index=55&type=section&id=Item%205.%20Other%20Information) During the three months ended March 31, 2025, no directors or officers adopted, modified, or terminated any Rule 10b5-1 or non-Rule 10b5-1 trading arrangements - No directors or officers adopted, modified, or terminated a Rule 10b5-1 trading arrangement or non-Rule 10b5-1 trading arrangement in Q1 2025[256](index=256&type=chunk) [Exhibits](index=55&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including the Purchase Agreement with Otsuka, CEO and CFO certifications, and XBRL data files - The report includes a list of all exhibits filed, such as various agreements and required CEO/CFO certifications[259](index=259&type=chunk)

[First Quarter 2025 Financial Highlights](index=1&type=section&id=First%20Quarter%202025%20Financial%20Highlights) ICU Medical reported strong Q1 2025 results, with revenue at **$604.7 million**, a narrowed GAAP net loss, and increased adjusted diluted EPS and EBITDA, reflecting improved profitability Q1 2025 vs. Q1 2024 Key Financial Metrics | Metric | Q1 2025 (in millions) | Q1 2024 (in millions) | Change | | :--- | :--- | :--- | :--- | | **Revenue** | $604.7 | $566.7 | +6.7% | | **GAAP Gross Profit** | $210.1 | $185.2 | +13.4% | | **GAAP Gross Margin** | 35% | 33% | +2 p.p. | | **GAAP Net Loss** | $(15.5) | $(39.5) | N/A | | **GAAP Diluted EPS** | $(0.63) | $(1.63) | N/A | | **Adjusted Diluted EPS** | $1.72 | $0.96 | +79.2% | | **Adjusted EBITDA** | $99.4 | $78.8 | +26.1% | - CEO Vivek Jain stated that the first quarter results were generally in line with the company's expectations[5](index=5&type=chunk) [Revenue by Product Line](index=1&type=section&id=Revenue%20by%20Product%20Line) All product lines demonstrated year-over-year revenue growth in Q1 2025, with Consumables being the largest contributor and total revenue increasing by **$38.0 million** Revenue by Product Line (in millions) | Product Line | Q1 2025 Revenue (in millions) | Q1 2024 Revenue (in millions) | $ Change (in millions) | | :--- | :--- | :--- | :--- | | Consumables | $266.2 | $244.1 | $22.1 | | Infusion Systems | $166.3 | $157.3 | $9.0 | | Vital Care* | $172.2 | $165.3 | $6.9 | | **Total** | **$604.7** | **$566.7** | **$38.0** | - The Vital Care product line includes Pfizer contract manufacturing revenue, which decreased to **$5.2 million** in Q1 2025 from **$14.1 million** in Q1 2024[5](index=5&type=chunk) [Consolidated Financial Statements](index=4&type=section&id=Consolidated%20Financial%20Statements) This section provides a detailed view of the company's financial position and performance through its unaudited condensed consolidated financial statements for Q1 2025 [Condensed Consolidated Statements of Operations](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) The Q1 2025 statement of operations showed a significant turnaround, shifting from an operating loss to an operating income of **$12.9 million**, leading to a substantially reduced net loss Q1 Statement of Operations Highlights (in thousands) | Line Item | Q1 2025 (in thousands) | Q1 2024 (in thousands) | | :--- | :--- | :--- | | Total Revenues | $604,702 | $566,655 | | Gross Profit | $210,109 | $185,244 | | Total Operating Expenses | $197,221 | $195,899 | | Income (Loss) from Operations | $12,888 | $(10,655) | | Net Loss | $(15,476) | $(39,471) | | Diluted Net Loss Per Share | $(0.63) | $(1.63) | [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of March 31, 2025, ICU Medical's balance sheet showed total assets of **$4.18 billion**, reduced long-term debt, and increased total stockholders' equity Balance Sheet Highlights (in thousands) | Account | March 31, 2025 (in thousands) | December 31, 2024 (in thousands) | | :--- | :--- | :--- | | Cash and cash equivalents | $289,704 | $308,566 | | Total Current Assets | $1,423,915 | $1,441,983 | | Total Assets | $4,184,581 | $4,203,931 | | Long-Term Debt | $1,488,565 | $1,531,858 | | Total Liabilities | $2,196,892 | $2,238,696 | | Total Stockholders' Equity | $1,987,689 | $1,965,235 | [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) In Q1 2025, the company generated **$51.3 million** in net cash from operating activities, resulting in a net decrease in cash and cash equivalents of **$18.9 million** for the quarter Q1 Statement of Cash Flows Highlights (in thousands) | Cash Flow Activity | Q1 2025 (in thousands) | Q1 2024 (in thousands) | | :--- | :--- | :--- | | Net cash provided by operating activities | $51,327 | $45,791 | | Purchase of property, plant and equipment | (14,621) | (15,915) | | Net cash used in financing activities | $(56,336) | $(26,845) | | **Net Decrease in Cash** | **$(18,862)** | **$(2,799)** | [Non-GAAP Financial Measures and Reconciliations](index=8&type=section&id=Non-GAAP%20Financial%20Measures%20and%20Reconciliations) This section details the company's use of non-GAAP financial measures, including Adjusted EBITDA, Adjusted Diluted EPS, and Free Cash Flow, with detailed reconciliation tables [Use of Non-GAAP Financial Information](index=8&type=section&id=Use%20of%20Non-GAAP%20Financial%20Information) The company justifies using non-GAAP measures to assess business performance by excluding unusual or non-core operational items like contract manufacturing revenue and restructuring costs - Management uses non-GAAP measures to facilitate more meaningful period-over-period comparisons of operational results[16](index=16&type=chunk) - Special items excluded from non-GAAP calculations include: contract manufacturing revenue, stock compensation expense, intangible asset amortization, restructuring and integration costs, and quality system remediation charges[18](index=18&type=chunk)[19](index=19&type=chunk)[20](index=20&type=chunk) - Free cash flow is presented as a measure of the company's ability to generate additional cash from business operations and is calculated as net cash from operations less capital expenditures, plus proceeds from asset sales[30](index=30&type=chunk)[39](index=39&type=chunk) [Reconciliation of GAAP to Non-GAAP Measures](index=10&type=section&id=Reconciliation%20of%20GAAP%20to%20Non-GAAP%20Measures) Reconciliation tables show Q1 2025 GAAP net loss of **$(15.5) million** adjusted to non-GAAP Adjusted EBITDA of **$99.4 million** and diluted EPS of **$1.72** Reconciliation of GAAP Net Loss to Adjusted EBITDA (in thousands) | Line Item | Q1 2025 (in thousands) | Q1 2024 (in thousands) | | :--- | :--- | :--- | | **GAAP net loss** | **$ (15,476)** | **$ (39,471)** | | Total non-GAAP adjustments | 114,902 | 118,278 | | **Adjusted EBITDA** | **$ 99,426** | **$ 78,807** | Reconciliation of GAAP to Non-GAAP Diluted EPS | Per Share Data | Q1 2025 (per share) | Q1 2024 (per share) | | :--- | :--- | :--- | | **Reported (GAAP) diluted loss per share** | **$ (0.63)** | **$ (1.63)** | | Total adjustments | $ 2.35 | $ 2.59 | | **Adjusted (Non-GAAP) diluted earnings per share** | **$ 1.72** | **$ 0.96** | Reconciliation to Free Cash Flow (in thousands) | Line Item | Q1 2025 (in thousands) | Q1 2024 (in thousands) | | :--- | :--- | :--- | | Net cash provided by operating activities | $ 51,327 | $ 45,791 | | Purchase of property, plant and equipment | (14,621) | (15,915) | | **Free cash flow** | **$ 36,748** | **$ 30,383** | [Other Information](index=1&type=section&id=Other%20Information) This section provides logistical details for the investor conference call and the standard safe harbor statement regarding forward-looking statements and risks [Conference Call](index=1&type=section&id=Conference%20Call) The company scheduled a conference call and webcast for May 8, 2025, at 4:30 p.m. ET to discuss its Q1 2025 financial results - A conference call to discuss Q1 2025 financial results was scheduled for May 8, 2025, at 4:30 p.m. ET (1:30 p.m. PT)[6](index=6&type=chunk) [Forward-Looking Statements](index=1&type=section&id=Forward-Looking%20Statements) The press release contains forward-looking statements regarding the company's 2025 outlook, subject to various risks and uncertainties detailed in SEC filings - The report contains forward-looking statements about the company's expectations for 2025 and the anticipated impacts from the IV Solutions joint venture[9](index=9&type=chunk) - Key risks that could affect future results include international trade barriers, competition, raw material costs, inflation, geopolitical conditions, and regulatory disruptions[9](index=9&type=chunk)

Core Viewpoint - ICU Medical, Inc. reported a revenue increase of 6.7% year-over-year for Q1 2025, reaching $604.7 million, while also showing improvements in gross profit and adjusted earnings per share [2][3][4]. Financial Performance - Revenue for Q1 2025 was $604.7 million, compared to $566.7 million in Q1 2024, marking a $38 million increase [2][4]. - GAAP gross profit for Q1 2025 was $210.1 million, up from $185.2 million in Q1 2024, resulting in a gross margin of 35% compared to 33% in the prior year [2][4]. - The GAAP net loss for Q1 2025 was $(15.5) million, or $(0.63) per diluted share, an improvement from a net loss of $(39.5) million, or $(1.63) per diluted share, in Q1 2024 [2][4][13]. - Adjusted diluted earnings per share for Q1 2025 was $1.72, compared to $0.96 in Q1 2024 [2][4]. Revenue Breakdown - Revenue by product line for Q1 2025 included: - Consumables: $266.2 million, up from $244.1 million in Q1 2024, a change of $22.1 million [4]. - Infusion Systems: $166.3 million, an increase of $9 million from $157.3 million in Q1 2024 [4]. - Vital Care: $172.2 million, up by $6.9 million from $165.3 million in Q1 2024 [4]. Cash Flow and Liquidity - Net cash provided by operating activities for Q1 2025 was $51.3 million, compared to $45.8 million in Q1 2024 [36]. - Free cash flow for Q1 2025 was $36.7 million, an increase from $30.4 million in Q1 2024 [36]. Conference Call - The company hosted a conference call to discuss its Q1 2025 financial results, providing insights into its performance and future expectations [6]. Company Overview - ICU Medical is a global leader in infusion systems and high-value critical care products, focusing on quality, innovation, and value for clinical customers worldwide [7].

Core Viewpoint - ICU Medical, Inc. is under investigation for potential securities fraud and unlawful business practices following a warning letter from the FDA regarding unauthorized changes to its infusion pump products [1][3]. Group 1: FDA Warning and Impact - On April 22, 2025, ICU disclosed that it received a warning letter from the FDA, which cited unauthorized modifications to two of its infusion pump products, labeling them as "adulterated" and "misbranded" [3]. - The FDA's letter indicated that these modifications could significantly affect the functionality of the devices, particularly concerning the infusion delivery profile and alarm functionality, raising safety and efficacy concerns [3]. - Following the news of the FDA warning, ICU's stock price dropped by $6.04 per share, or 4.42%, closing at $130.68 per share on the same day [4]. Group 2: Legal Investigation - Pomerantz LLP is investigating claims on behalf of ICU investors regarding potential securities fraud or other unlawful business practices by the company and its officers or directors [1]. - Investors are encouraged to contact Pomerantz LLP for more information about the class action [2]. Group 3: Pomerantz LLP Background - Pomerantz LLP is recognized as a leading firm in corporate, securities, and antitrust class litigation, with a history of recovering significant damages for victims of securities fraud and corporate misconduct [5].

Core Viewpoint - The formation of Otsuka ICU Medical LLC represents a significant partnership aimed at enhancing the IV solutions supply chain in North America, with an estimated combined production capacity of 1.4 billion annual units, thereby increasing supply chain resiliency and fostering innovation in the market [1][2][3]. Company Overview - ICU Medical, Inc. is a leader in the development and sale of innovative medical devices, focusing on providing clinically essential medical devices that enhance patient care [6]. - Otsuka Pharmaceutical Factory, Inc. has over 75 years of experience in developing, manufacturing, and selling IV solutions, positioning itself as a key player in clinical nutrition [5]. Joint Venture Details - The joint venture, Otsuka ICU Medical LLC, combines OPF's extensive manufacturing capabilities across 16 production sites in Asia with ICU Medical's strong presence in North America, particularly in Austin, Texas [3]. - The partnership aims to introduce new PVC-free technologies to the North American market, enhancing the product offerings available to customers [3]. Market Impact - The collaboration is expected to provide increased stability and choice in the North American IV solutions market, delivering enhanced economic and clinical value to customers [3]. - The joint venture is positioned to improve global supply resiliency, which is critical in the healthcare sector [3].

Core Viewpoint - ICU Medical, Inc. is under investigation for potential securities fraud and unlawful business practices following a warning from the FDA regarding unauthorized changes to its infusion pump products [1][2]. Group 1: FDA Warning and Product Issues - On April 22, 2025, ICU disclosed that it received a warning letter from the FDA, which cited unauthorized modifications to two of its infusion pump products [2]. - The FDA's letter described the pumps as "adulterated" and "misbranded," indicating that the changes could significantly affect the functionality of the devices, particularly their delivery profile and alarm functionality [2]. - Concerns were raised about the safety and efficacy of the devices due to these modifications, questioning the adequacy of ICU's regulatory disclosures [2]. Group 2: Stock Market Reaction - Following the FDA warning, ICU's stock price dropped by $6.04 per share, or 4.42%, closing at $130.68 per share on April 22, 2025 [3]. Group 3: Legal Investigation - Pomerantz LLP is investigating claims on behalf of ICU investors regarding potential securities fraud or other unlawful business practices by the company and its officers or directors [1].

Core Viewpoint - The Schall Law Firm is investigating ICU Medical, Inc. for potential violations of securities laws related to misleading statements and undisclosed information affecting investors [1][2]. Group 1: Investigation Details - The investigation centers on whether ICU Medical issued false or misleading statements and failed to disclose critical information to investors [2]. - An FDA warning letter dated April 22, 2025, highlighted that ICU Medical made multiple changes to its Medfusion Model 4000 Syringe Infusion Pump and CADD Solis VIP Ambulatory Infusion Pump, which could significantly impact the safety and effectiveness of these devices [2]. - The FDA classified the pumps as "adulterated" and "misbranded," indicating that modifications could significantly affect functionality, including infusion delivery profiles and alarm functionality, thereby altering the risk profile of the devices [2].

Core Points - ICU Medical, Inc. will release its first quarter 2025 earnings results on May 8, 2025, at approximately 4:00 p.m. ET [2] - A conference call to discuss the results will take place on the same day at 4:30 p.m. ET [2] - The conference call can be accessed via phone and will also be available through a webcast on the company's website [2] Company Overview - ICU Medical is a global leader in infusion systems, infusion consumables, and high-value critical care products [3] - The company focuses on providing quality, innovation, and value to clinical customers worldwide [3] - ICU Medical is headquartered in San Clemente, California [3]

ICU Medical (ICUI) announced at the 24th Annual Needham Virtual Healthcare Conference that it has developed a proactive strategy to mitigate the potential financial ramifications of the newly imposed tariffs announced by the Trump Administration. These tariffs, part of a broader trade policy shift, have already led to a notable decline in MedTech stocks and introduced uncertainty within the medical device industry. Despite these challenges, ICU Medical remains cautiously optimistic about its position, under ...