ICU Medical (ICUI) Q2 2025 Earnings Call August 07, 2025 04:30 PM ET Speaker0Please stand by. We're about to begin. Good afternoon, everyone, and welcome to today's ICU Medical Second Quarter twenty twenty five Earnings Conference Call.All participants will be in a listen only mode. After today's presentation, there will be an opportunity to ask questions. To ask a question at that time, please press 1. Also, note that today's event is being recorded. I would now like to turn the conference over to Mr.John ...

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 ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended: June 30, 2025 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from: to Commission File No.: 001-34634 ICU MEDICAL, INC. (Exact name of registrant as specified in its charter) Delaware 33-0022692 (State or other jurisdiction of (I.R.S. E ...

Exhibit 99.1 ICU Medical Announces Second Quarter 2025 Results and Updates its Fiscal Year 2025 Guidance SAN CLEMENTE, Calif., August 7, 2025 (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 ended June 30, 2025. Second Quarter 2025 Results Second quarter 2025 revenue was $548.9 million, as compared to $596.5 million in the same period in the prior year. GAAP gross ...

Core Insights - The chest drainage catheters market is projected to grow at a CAGR of 4.78% from 2025 to 2032, driven by the increasing prevalence of chronic conditions such as cancer and cardiovascular diseases, along with advancements in catheter technology and improved healthcare access [2][6]. Market Dynamics - In 2022, there were 2,480,675 reported cases of lung-related cancers, predominantly in Asia, which significantly boosts the demand for thoracic drainage interventions using chest drainage catheters [3]. - Approximately 620 million people globally are living with heart and circulatory diseases, further driving the need for interventions like pericardial effusions management through chest drainage catheters [4]. Technological Advancements - The adoption of minimally invasive procedures is enhancing the chest drainage catheter market by improving procedural precision and patient outcomes, with innovations such as image-guided catheter placements and smart catheters enabling real-time monitoring [5]. Challenges - The market faces challenges including catheter complexity and stringent regulatory requirements, which may limit growth; however, the demand for safe and effective thoracic drainage solutions continues to rise due to the increasing global burden of cancer and cardiovascular diseases [6]. Segment Analysis - Pleural drainage catheters are expected to lead the market in 2024, driven by the rise in pleural diseases associated with lung cancer and heart failure, with features like tunneled indwelling pleural catheters offering less invasive alternatives [7]. Manufacturer Innovations - Manufacturers are advancing catheter designs by incorporating features such as smaller diameters, anti-microbial coatings, and integration with digital drainage systems, enhancing safety and clinical outcomes [8]. Regional Outlook - North America is anticipated to dominate the chest drainage catheters market in 2024, supported by an increasing number of cancer patients, advanced healthcare infrastructure, and the presence of key market players like BD, Teleflex Incorporated, and Cook [9][10]. Key Players - Leading companies in the chest drainage catheters market include BD, Teleflex Incorporated, Cook, ICU Medical, and Redax S.p.A., among others [10][12]. Recent Developments - In June 2021, BD received FDA 510(k) clearance for its PeritXT Peritoneal Catheter System, intended for symptomatic, non-malignant ascites drainage [11]. Conclusion - The chest drainage catheters market is poised for substantial growth from 2025 to 2032, with North America being a significant contributor to this expansion [11].

Core Viewpoint - ICU Medical, Inc. is set to release its second quarter 2025 earnings results on August 7, 2025, followed by a conference call to discuss these results [1][2]. Company Information - ICU Medical is a global leader in infusion systems, infusion consumables, and high-value critical care products used in various healthcare settings [3]. - The company is headquartered in San Clemente, California, and focuses on providing quality, innovation, and value to clinical customers worldwide [3].

Core Viewpoint - ICU Medical, Inc. is under investigation for potential securities fraud and unlawful business practices following a warning from the FDA regarding its infusion pump products [1][3]. Group 1: FDA Warning and Impact - On April 22, 2025, ICU received a warning letter from the FDA, citing unauthorized changes to two of its infusion pump products, labeling them as "adulterated" and "misbranded" [3]. - The FDA indicated that the 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 FDA's announcement, 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].

Company Performance - ICU Medical reported quarterly earnings of $1.72 per share, exceeding the Zacks Consensus Estimate of $1.23 per share, and up from $0.96 per share a year ago, representing an earnings surprise of 39.84% [1] - The company posted revenues of $599.49 million for the quarter ended March 2025, surpassing the Zacks Consensus Estimate by 5.54%, compared to $566.66 million in the same quarter last year [2] - Over the last four quarters, ICU Medical has consistently surpassed consensus EPS and revenue estimates [2] Stock Performance - ICU Medical shares have declined approximately 13.3% since the beginning of the year, while the S&P 500 has decreased by 4.3% [3] - The current Zacks Rank for ICU Medical is 3 (Hold), indicating that the shares are expected to perform in line with the market in the near future [6] Future Outlook - The consensus EPS estimate for the upcoming quarter is $1.66 on revenues of $569.35 million, and for the current fiscal year, it is $6.90 on revenues of $2.28 billion [7] - The outlook for the medical products industry is currently in the bottom 32% of over 250 Zacks industries, which may impact the stock's performance [8]

Financial Data and Key Metrics Changes - Revenue for Q1 was $599 million, representing a total company growth of 10% on a constant currency basis or 8% reported, aided by the end of the national shortage in IV Solutions [6][7] - Adjusted EBITDA increased by 26% to $99 million compared to $79 million last year [14] - Adjusted diluted earnings per share for the quarter was $1.72 compared to $0.96 last year [14] - Adjusted gross margin for the quarter was 37%, in line with expectations [13] Business Segment Data and Key Metrics Changes - Consumables business grew 10% constant currency and 9% reported, driven by new global customer implementations and price improvements [9] - IV Systems business grew 8% constant currency and 6% reported, supported by good dedicated set utilization and earlier-than-expected hardware installations [10] - Vital Care segment grew 11% constant currency and 10% reported, with IV Solutions being the largest component of segment growth [11] Market Data and Key Metrics Changes - The broader demand and utilization environment in Q1 remained attractive across almost every geography, although not at the levels seen last year [8] - The capital environment is status quo, with necessary investments being completed [8] Company Strategy and Development Direction - The company is focused on consistent execution combined with meaningful innovation to refresh its portfolio, particularly in its pump businesses [22] - The formation of a joint venture with Otsuka Pharmaceutical Factory is expected to enhance product offerings and access to technology [12] - The company aims to ensure all activities continue to move forward in concert with increasing revenues, focusing on optimizing its manufacturing network and driving profitability [32] Management's Comments on Operating Environment and Future Outlook - Management anticipates direct tariff expenses in FY 2025 to be in the range of $25 million to $30 million, with most recognized in the latter half of the year [18] - The weakening of the U.S. dollar is expected to offset almost half of the direct tariff expense [19] - Management remains optimistic about maintaining the low end of the guidance range for adjusted EBITDA and gross margin despite tariff impacts [50][51] Other Important Information - The company has been actively working on quality remediation and compliance, particularly regarding its MedFusion and CAD product families [24][26] - The company is committed to ensuring safety and compliance, which has involved significant investments in quality system and product-related remediation activities [15][26] Q&A Session Summary Question: Can you elaborate on the growth drivers in consumables? - Management noted that oncology growth has returned strongly, and products supporting renal and home infusion markets have also seen acceleration [36] Question: Is the growth in consumables primarily driven by price? - Management clarified that the growth is largely due to a lower Q1 last year and continued strength from the previous year [38] Question: Are you seeing more contribution from Duo in Infusion Systems? - Management indicated that there have been very few Duo installations to date, with expectations for more in the second half of the year [39] Question: Can you clarify the tariff impact? - Management emphasized that the $25 million to $30 million figure should not be annualized and highlighted the significant impact from tariffs on Costa Rica [41][42] Question: What is the outlook for guidance amidst tariff and currency impacts? - Management confirmed the goal to hold at least the low end of the guidance range, acknowledging the challenges posed by tariffs and currency fluctuations [50][51]

Financial Data and Key Metrics Changes - Revenue for Q1 was $599 million, representing a total company growth of 10% on a constant currency basis or 8% reported, aided by the end of the national shortage in IV Solutions [5][6] - Adjusted EBITDA increased by 26% to $99 million compared to $79 million last year, with adjusted EPS at $1.72 compared to $0.96 last year [12][13] - Adjusted gross margin for the quarter was 37%, in line with expectations, while total adjusted operating expenses represented 23.1% of revenue, slightly below the original full-year guidance of 24% [12][13] Business Segment Data and Key Metrics Changes - Consumables business grew 10% constant currency and 9% reported, driven by new global customer implementations and price improvements [7][10] - IV Systems business grew 8% constant currency and 6% reported, supported by good dedicated set utilization and earlier-than-expected hardware installations [8][9] - Vital Care segment grew 11% constant currency and 10% reported, with IV Solutions being the largest component of segment growth [10] Market Data and Key Metrics Changes - The broader demand and utilization environment in Q1 remained attractive across almost every geography, although not at the levels seen last year [6] - The capital environment is stable, with necessary investments being completed [6] Company Strategy and Development Direction - The company is focused on consistent execution and meaningful innovation to refresh its portfolio, particularly in its pump businesses [22][24] - The formation of a joint venture with Otsuka Pharmaceutical Factory is expected to enhance product offerings and access to technology [10][11] - The company aims to optimize its manufacturing network and drive profitability through strategic initiatives [33][34] Management's Comments on Operating Environment and Future Outlook - Management acknowledged the impact of recently implemented tariffs and the evolving global trade landscape, estimating direct tariff expenses for FY 2025 to be in the range of $25 million to $30 million [18][19] - The company remains committed to mitigating tariff impacts through various strategies, including cost controls and adjustments in incentive compensation [19][20] - Management expressed confidence in maintaining the low end of the guidance range for adjusted EBITDA and gross margin despite challenges [52][53] Other Important Information - The company has been actively working on quality remediation and compliance efforts, particularly related to its MedFusion and CAD product families [24][27] - The company is focused on ensuring safety and compliance while enhancing product quality, which has involved significant investments [27][28] Q&A Session Summary Question: What are the drivers behind the growth in consumables? - Management highlighted oncology growth and products supporting renal and home infusion markets as key drivers, with GPO activity and pricing changes contributing as well [37][38] Question: Is the growth in infusion systems attributed to Duo? - Management indicated that there have been very few Duo installations to date, with expectations for more in the second half of the year [41][42] Question: Can you clarify the tariff impact? - Management emphasized that the $25 million to $30 million tariff impact should not be annualized and detailed the geographic risks associated with it [43][44] Question: What is the outlook for gross margin and adjusted EBITDA? - Management confirmed the goal to hold at least the low end of the guidance range for gross margin and adjusted EBITDA, acknowledging the challenges posed by tariffs and currency fluctuations [52][53] Question: How is the reception of Plum Duo and Plum Solo from customers? - Management noted that while there is a strong incumbency advantage, there is potential for meaningful upgrade discussions as the installed base reaches the right time for upgrades [56][58]