[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 ...

ICU Medical, Inc. (ICUI) , yesterday, announced the FDA’s 510(k) clearance for the Plum Solo precision IV pump, a single-channel complement to the dual-channel Plum Duo. The company also received the 510(k) clearance for updated versions of the Plum Duo precision IV pump and LifeShield infusion safety software, completing the initial launch of the ICU Medical IV Performance Platform.The Plum Solo expands the capabilities of the IV Performance Platform by offering a single-channel pump designed to work along ...

New devices address infusion delivery variability and expand the ICU Medical IV Performance Platform. SAN CLEMENTE, Calif., April 7, 2025 /PRNewswire/ -- ICU Medical Inc. (NASDAQ:ICUI), a worldwide leader in the development, manufacture and sale of innovative medical devices, has announced 510(k) regulatory clearance from the U.S. Food and Drug Administration (FDA) for the Plum Solo™ precision IV pump, a single-channel complement to the dual-channel Plum Duo™. ICU Medical also received 510(k) clearance for ...