Core Insights - ICU Medical, Inc. reported a revenue of $537.0 million for Q3 2025, a decrease from $589.1 million in Q3 2024, indicating a year-over-year decline of approximately 8.8% [2] - The company achieved a GAAP gross profit of $200.9 million with a gross margin of 37%, an improvement from 35% in the same period last year [2] - The net loss for Q3 2025 was $(3.4) million, significantly reduced from a net loss of $(33.0) million in Q3 2024, translating to a loss per diluted share of $(0.14) compared to $(1.35) [2][12] - Adjusted diluted earnings per share rose to $2.03 from $1.59 year-over-year, while adjusted EBITDA increased to $105.9 million from $94.8 million [2][3] Financial Performance - Revenue breakdown for Q3 2025 by product line showed: - Consumables: $285.1 million, up from $264.9 million (increase of $20.2 million) - Infusion Systems: $173.9 million, up from $159.8 million (increase of $14.1 million) - Vital Care: $78.0 million, down from $164.5 million (decrease of $86.5 million) [3] - For the nine months ended September 30, 2025, total revenue was $1,690.5 million, down from $1,752.2 million in the same period of 2024 [3] Fiscal Year Guidance - The company updated its fiscal year 2025 guidance for GAAP net loss to a range of $(8) million to $0 million, an improvement from the previous range of $(43) million to $(35) million [4] - Adjusted EBITDA guidance for the full year was revised to a range of $395 million to $405 million, up from $380 million to $390 million [4] - Diluted earnings per share guidance was also increased to a range of $7.35 to $7.65 from $6.85 to $7.15 [4] Conference Call - A conference call to discuss the third quarter 2025 financial results was scheduled for today at 4:30 p.m. ET, accessible via phone and webcast [5] 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 [6]

Core Points - ICU Medical, Inc. will release its third quarter 2025 earnings results on November 6, 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, accessible via phone and webcast [2] - ICU Medical is a global leader in infusion systems and critical care products, focusing on quality and innovation for clinical customers [3]

Group 1 - The company has shown evolving dynamics in its story, indicating a positive shift in its operational strategy [2] - The recent personal stock purchase by Vivek Jain suggests increased confidence and enthusiasm in the company's future prospects [2] - The restructuring and integration of Smiths has been a significant focus for the company, reflecting its commitment to enhancing operational efficiency [2]

Summary of ICU Medical Conference Call Company Overview - **Company**: ICU Medical - **Industry**: Medical Devices, specifically focusing on infusion systems and consumables Key Points Business Segments Performance - **Consumables Segment**: - Grew 4% in Q2, with expectations of mid-single digit growth for the year [4] - Historical growth rate of 5-6% annually over the past five years [4] - Drivers include strong end-market demand, demographic trends, and a national shortage of IV solutions [4][5] - Incremental innovations and FDA clearances are expected to enhance competitive advantage [6][8] - **IV Systems**: - Double-digit growth in LVP (Large Volume Pump) revenue [10] - Market growth is estimated at 3-4%, with ICU Medical outpacing this due to market refresh from competitors' device issues [12] - Focus on integrating various pumping modalities into a single software platform for improved user experience [10][11] - **Vital Care Division**: - Approximately $600 million division, now reduced to $300 million post joint venture with Otsuka Pharmaceutical [24][25] - Experienced a decline of 4% in Q2, with expectations of flat growth moving forward [29] Regulatory Landscape - Regulatory scrutiny is high, which is seen as a necessary barrier to ensure safety in drug delivery systems [15] - The company is focused on maintaining compliance and improving product standards to avoid setbacks [45] Innovation and Product Development - Recent FDA approvals for new products are expected to drive growth in both consumables and IV systems [16][17] - The company is investing in R&D to enhance product offerings and maintain competitive edge [42] Financial Guidance and Market Outlook - Updated guidance reflects a $17 million EBITDA loss from divestiture and $30 million in tariffs impacting the second half of the year [35][36] - Anticipated growth in 2026 is supported by innovation in consumables and a potential increase in average selling prices (ASP) for new pump technologies [40][46] - The company aims for mid-single digit growth while improving gross margins and generating cash flow for shareholder returns [42][57] Strategic Focus - Emphasis on home care as a growth area, leveraging existing market share and technology [22][20] - The company is cautious about pursuing new M&A opportunities unless they are compelling [57] Competitive Landscape - ICU Medical is positioned well against competitors by offering integrated solutions that enhance user experience and operational efficiency [18][19] - The company is focused on differentiating its offerings in the home care market, which is fragmented and competitive [21] Conclusion - ICU Medical is at a pivotal point with ongoing innovations and strategic initiatives aimed at sustaining growth and enhancing shareholder value. The focus remains on executing current opportunities while navigating regulatory challenges and market dynamics [61]

Financial Data and Key Metrics Changes - The company reported a 4% organic growth in the consumables business for the second quarter and expects sequential sales growth to average mid-single digits for the year [4][5] - The guidance for 2025 was updated, with the high end of the range adjusted from $425 million to $408 million due to the divestment of solutions and unexpected tariffs amounting to $30 million [41][42] Business Segment Data and Key Metrics Changes - The consumables business has compounded growth at 5% to 7% annually for over five years, driven by good clinical outcomes, brand inertia, and market share gains due to industry shortages [5][6] - The LVP (Large Volume Pump) revenue experienced double-digit growth, attributed to increased utilization and competitive wins, with a new product, Plum Duo, recently installed at customers [10][12] - The Vital Care segment saw a negative 4% organic growth in the second quarter, with expectations for flat sales in 2025 [33] Market Data and Key Metrics Changes - The overall market for infusion pumps has been abnormal, with significant catch-up growth due to actions taken by other manufacturers [10] - The competitive environment is shifting, with recalls and sales pauses affecting market dynamics, leading to a need for hospitals to decide on infusion pump platforms in the next 18 to 24 months [18][19] Company Strategy and Development Direction - The company is focused on maintaining competitive advantages through product innovation and integration of all pumps on a single platform, which enhances operational efficiency for customers [30] - The joint venture with Otsuka Pharmaceutical is seen as a strategic move to align with a leading innovator in the market, enhancing the company's product offerings without the capital intensity of traditional manufacturing [39] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the utilization rates across geographies, indicating a stable operating environment despite some challenges [3] - The company anticipates that the replacement cycle for its pump products will begin towards the end of next year, which could drive future revenue growth [16][17] Other Important Information - The company is navigating a complex regulatory environment, with ongoing scrutiny and multiple product approvals in the pipeline, which are critical for future growth [23][24] - Management highlighted the importance of not annualizing the impact of tariffs, as they are actively working on mitigating their effects through various strategies [56] Q&A Session Summary Question: What are the drivers of the consumables business growth? - Management identified good clinical outcomes, brand inertia, and market share gains from industry shortages as key drivers [5][6] Question: How does the company view the competitive environment for LVP? - Management noted that the competitive landscape is changing due to recalls and the need for hospitals to make decisions on infusion pump platforms [18][19] Question: What is the expectation for the approval of new devices? - Management expects a minimum of nine months for the approval of new devices, with ongoing efforts to streamline the process [26] Question: How does the company plan to address the Vital Care segment's performance? - Management indicated they are exploring the right solutions for the Vital Care segment, acknowledging its different growth rates compared to other segments [33][34] Question: What is the company's strategy for capital deployment once leverage ratios improve? - Management stated that they are focused on organic growth and do not feel pressured to pursue M&A, emphasizing the importance of R&D investments [61][62]

Financial Data and Key Metrics Changes - The company reported 4% organic growth in the consumables business for Q2 and expects mid-single digit sequential sales growth for the year [4][5] - The guidance for 2025 was updated, with the high end of the range adjusted from $425 million to $408 million due to tariffs and divestiture of the solutions business [42][43] Business Segment Data and Key Metrics Changes - The consumables business has compounded growth of 5% to 7% annually for over five years, driven by good clinical outcomes, brand inertia, and market share gains due to industry shortages [5][6] - The LVP (Large Volume Pump) revenue experienced double-digit growth, attributed to strong volume, competitive wins, and improvements in software and service [11][12] - The Vital Care segment saw a negative 4% organic growth in Q2, with expectations for flat sales in 2025 [34] Market Data and Key Metrics Changes - The infusion pump market has been abnormal for years, with current growth driven by catch-up from competitors and the company's competitive pipeline [11][19] - The competitive environment is influenced by recalls and sales pauses from other manufacturers, creating opportunities for market share gains [19][20] Company Strategy and Development Direction - The company is focused on integrating all pumps onto a single platform to enhance operational efficiency and customer experience [30][31] - The joint venture with Otsuka Pharmaceutical is seen as a strategic move to align with a leading innovator and improve product offerings in IV solutions [40][41] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the utilization rates across geographies, indicating a stable operating environment [3] - The company anticipates that the replacement cycle for pumps will begin towards the end of next year, which could drive future growth [17][18] Other Important Information - The company is navigating challenges related to tariffs, which are expected to impact gross margins by 200 to 300 basis points [49] - Management emphasized the importance of maintaining high regulatory standards in the infusion pump market, which they view as a competitive advantage [24] Q&A Session Summary Question: Why did the CEO buy back stock personally? - The CEO felt the market was missing the earnings opportunity and believed it was a good time to act [2] Question: What are the growth drivers for the consumables business? - Key drivers include good clinical outcomes, brand inertia, and market share gains from industry shortages [5][6] Question: How does the company view the competitive environment for LVP? - The company sees opportunities due to competitors facing recalls and the need for market remediation [19][20] Question: What is the expectation for the approval of new devices? - The company expects approvals for new devices like Plum Duo and Plum Solo within nine months [27] Question: How are tariffs impacting the financial outlook? - Tariffs are expected to have a $30 million impact, but the company is confident in mitigating some of these effects through cost-saving measures [43][45]

Company Overview - ICU Medical's 2024 revenues reached $2.35 billion[8] - The company's revenue mix includes 44% from consumables and 28% from systems pre-JV, which shifts to 52% and 33% post-JV respectively[6] - Vital Care accounts for 28% of revenue pre-JV and 16% post-JV[7] - Geographically, 64% of revenue comes from the US & Canada, and 36% from OUS post-JV[11] - Single-use consumables make up 88% of revenue, while hardware accounts for 12% post-JV[11] Financial Highlights - The company's diluted equity value is $3.2 billion, with a net debt of $1.0 billion, resulting in an enterprise value of $4.2 billion[11] Growth and Strategy - The industry is experiencing pump replacement cycle acceleration due to distinct circumstances[14] - The company is focused on improving its quality system and FDA warning letter remediation[37] - The company aims to achieve gross margin expansion, targeting 42-43% in the near-med term and 45% in the longer term[34] - The company is working towards a fully stable supply chain, production, and distribution network[37] - The company is focused on contract renewals of a significant portion of L-ICU US sales in late 2024[37]

Core Insights - ICU Medical (ICUI) is facing a recall notice from the FDA for its Plum Duo Infusion System due to software issues, but the recall does not require the device to be removed from use [1][5][8] FDA Recall Details - The FDA has classified the recall as the most serious type, warning that the affected Plum Duo Infusion System with software version 1.1.3 or earlier may cause the pump to stop responding, potentially leading to serious injury or death if not corrected [2][8] - The affected devices are identified by Unique Device Identifier 400020401 and Model M335400021, with the software version of 1.13 or earlier [6][9] Device Usage and Impact - The Plum Duo Infusion System is designed for delivering parenteral fluids and medications through intravenous, intra-arterial, and subcutaneous routes in various patient populations [3] - ICU Medical has advised users to quarantine the affected pumps until a software patch is available, emphasizing that if removing the device could harm patient care, users should monitor the 'CONFIRM STOP' message to prevent unintended interruptions [10][9] Company Response and Market Performance - ICU Medical is actively working on software corrections and has issued an Urgent Medical Device Correction notice to all affected users [4] - Despite the recall, ICU Medical's shares have remained steady, with a year-to-date decline of 17.7%, compared to a 7.7% gain in the industry and a 10.1% increase in the S&P 500 Index [5]

Financial Data and Key Metrics Changes - Revenue for Q2 was $544 million, reflecting a 2% organic growth but a reported decline of 6% due to the impact of the joint venture [5][6] - Adjusted EBITDA was $100 million, with EPS at $2.1, and gross margins improved due to the joint venture [6][14] - Adjusted gross margin for Q2 was 40%, showing a three percentage point expansion year-over-year and sequentially [14][15] - Free cash flow was a net outflow of $8 million, influenced by higher tax payments and tariff payments [17][18] Business Line Data and Key Metrics Changes - Consumables business grew 4% organically and 3% reported, achieving record sales levels [7][8] - IV Systems business grew 2% organically and reported, driven by double-digit growth in LVP [9][10] - Vital Care segment reported a decline of 434% due to the deconsolidation of IV Solutions revenues [12][13] Market Data and Key Metrics Changes - The demand and utilization environment in Q2 remained attractive across most geographies, although growth rates were not as high as the previous year [6][24] - The capital environment is stable, with customers proceeding with necessary investments [6] Company Strategy and Development Direction - The company aims to build a comprehensive infusion therapy company, focusing on innovation and optimizing its portfolio [5][26] - The strategy includes enhancing patient safety and workflow efficiencies through new product developments and regulatory approvals [8][11] - The company is focused on mitigating tariff impacts and optimizing its manufacturing network to improve profitability [30][31] Management's Comments on Operating Environment and Future Outlook - Management acknowledged the challenges posed by tariffs and their impact on profitability, emphasizing the need for cost controls and price increases [20][30] - The outlook for Q3 and Q4 is positive, with expectations for sequential growth in consumables and IV systems [24][51] - The company is cautious about the evolving tariff landscape and its potential long-term implications [58] Other Important Information - The company has made significant progress in integrating its IT systems and consolidating its manufacturing network [15][31] - The joint venture is expected to continue benefiting the balance sheet and income statement [31] Q&A Session Summary Question: What assumptions have been made regarding tariffs, particularly for China? - The current guidance assumes tariffs at existing rates, with some benefits from pauses in tariff increases [38] Question: Is there anything outside of tariffs impacting the EBITDA outlook? - The primary impact on the EBITDA outlook is from tariffs, with no other significant factors affecting the guidance [39] Question: What is the demand profile for Duo and the infusion systems segment? - There is a positive outlook for both consumables and infusion systems, with installations of Duo underway [42][44] Question: How does the suspension of Baxter's no room pump sales affect the company? - While it may create some opportunities, the long-term view remains that all competitors will eventually return to the market [53] Question: What is the status of ongoing planning consolidation? - The move of infusion pumps to Costa Rica is complete, with other consolidations expected to be finalized within the next six to nine months [64] Question: Is the replacement cycle starting to contribute to revenue? - The replacement cycle is not yet significant, but discussions are beginning, with expectations for next year [71][72]

In $Millions 1 Disclosures 2 > Any statement concerning Management's expectation with respect to future results is a forward-looking statement based upon the best information currently available to Management and assumptions Management believes are reasonable, but Management does not intend the statement to be a representation as to future results. > Future results are subject to risks and uncertainties, including the risk factors described in the Company's filings with the Securities and Exchange Commissio ...