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Associated Press
18-05-2025
- Business
- Associated Press
INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of ICU Medical, Inc.
NEW YORK, May 18, 2025 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of ICU Medical, Inc. ('ICU' or the 'Company') (NASDAQ: ICUI). Such investors are advised to contact Danielle Peyton at [email protected] or 646-581-9980, ext. 7980. The investigation concerns whether ICU and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices. [Click here for information about joining the class action] On April 22, 2025, ICU disclosed receipt of a warning letter from the U.S. Food and Drug Administration ('FDA'), citing unauthorized changes to two of the Company's infusion pump products. The FDA's warning letter stated that the pumps were 'adulterated' and 'misbranded,' noting that the Company's modifications 'can significantly impact the functionality of the device with respect to the infusion pumps delivery profile, [and] alarm functionality.' The FDA further stated that these changes may have significantly impacted the safety and efficacy of the devices, raising concerns about the adequacy of ICU's regulatory disclosures. On this news, ICU's stock price fell $6.04 per share, or 4.42%, to close at $130.68 per share on April 22, 2025. Pomerantz LLP, with offices in New York, Chicago, Los Angeles, London, Paris, and Tel Aviv, is acknowledged as one of the premier firms in the areas of corporate, securities, and antitrust class litigation. Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, Pomerantz pioneered the field of securities class actions. Today, more than 85 years later, Pomerantz continues in the tradition he established, fighting for the rights of the victims of securities fraud, breaches of fiduciary duty, and corporate misconduct. The Firm has recovered numerous multimillion-dollar damages awards on behalf of class members. See Attorney advertising. Prior results do not guarantee similar outcomes. CONTACT: Danielle Peyton Pomerantz LLP
Yahoo
10-05-2025
- Business
- Yahoo
ICUI Q1 Earnings Call: Product Upgrades and Tariff Headwinds Shape Outlook
Medical device company ICU Medical (NASDAQ:ICUI) reported Q1 CY2025 results topping the market's revenue expectations , with sales up 5.8% year on year to $599.5 million. Its non-GAAP profit of $1.72 per share was 34.4% above analysts' consensus estimates. Is now the time to buy ICUI? Find out in our full research report (it's free). Revenue: $599.5 million vs analyst estimates of $567.2 million (5.8% year-on-year growth, 5.7% beat) Adjusted EPS: $1.72 vs analyst estimates of $1.28 (34.4% beat) Adjusted EBITDA: $99.43 million vs analyst estimates of $88.48 million (16.6% margin, 12.4% beat) Operating Margin: 4.9%, up from 1% in the same quarter last year Free Cash Flow Margin: 6.1%, similar to the same quarter last year Market Capitalization: $3.52 billion ICU Medical's first quarter performance was driven by growth across all core business segments, with management highlighting momentum in consumables, infusion systems, and vital care. CEO Vivek Jain attributed the broad-based expansion to new global customer implementations and positive trends in key markets such as oncology and home infusion. Jain noted, 'Our consumables business saw rapid growth in niche markets and benefited from earlier-than-anticipated hardware installs in IV Systems.' Looking ahead, management's guidance is shaped by several moving pieces, including the impact of newly implemented tariffs and ongoing product upgrades. CFO Brian Bonnell stated that while the company aims to offset most tariff costs through mitigation measures and currency tailwinds, 'there is probably $5 to $10 million of unmitigated residual impact from tariffs' in 2025. Jain emphasized continued investment in pump innovation and compliance initiatives, positioning the company for a multi-year upgrade cycle and supporting reliable revenue growth. Management pointed to consistent execution and ongoing product investment as key drivers in the quarter, while also flagging regulatory and trade-related costs as areas of focus for the remainder of the year. Consumables business acceleration: Growth in the consumables segment was supported by new global customer implementations, improved product pricing, and demand in specialized markets like oncology and home infusion. Management identified group purchasing organization (GPO) activity and earlier contract resets as contributing factors. IV Systems product cycle: The infusion systems segment benefited from increased utilization of dedicated sets and some early hardware installs, though management clarified that widespread adoption of new products like PlumDuo is expected later in the year. Quality and regulatory remediation: Management described significant efforts to address quality issues in legacy products, including extensive remediation of MedFusion and CAD pumps and ongoing work to secure new regulatory clearances. CEO Vivek Jain stated, 'Modern devices and high compliance are table stakes in our industry.' Tariff and supply chain impact: The introduction of tariffs on products from Costa Rica, China, and Mexico will increase costs in 2025. While some mitigations are in place, management explained that tariffs on Costa Rica-sourced pumps represent the largest exposure, and the company has begun adjusting supply chains where possible. Joint venture formation: ICU Medical completed the formation of a joint venture with Otsuka Pharmaceutical Factory for IV Solutions, which is expected to provide long-term product and technology access. Management noted this is neutral to current earnings but strategically significant for the U.S. market. Management's outlook for the year centers on executing product upgrades, navigating tariff costs, and maintaining operational discipline as the company enters a period of portfolio refresh and supply chain adjustment. Product upgrade cycle: The company expects a multi-year upgrade cycle for its installed base of infusion pumps, with the launch of PlumSolo and PlumDuo positioned to drive adoption as customer contracts come up for renewal. Tariff mitigation efforts: Management is pursuing a range of mitigation strategies to offset new tariff costs, including supply chain adjustments, price renegotiations, and cost controls. However, residual headwinds of $5–10 million may persist if additional offsets are not identified. Regulatory compliance focus: Continued investment in quality remediation and securing new regulatory clearances for legacy product lines is expected to support both compliance and future product competitiveness, reducing operational risk. Jayson Bedford (Raymond James): Asked about sources of consumables growth and whether pricing or niche market demand was driving results. Management pointed to oncology and renal markets, GPO activity, and clarified that pricing was not the primary factor. Brett Fishbin (KeyBanc): Inquired about the geographic structure of tariff exposure and opportunities for further mitigation. CFO Brian Bonnell explained that Costa Rica-sourced products are the largest exposure, with ongoing actions to reduce impact from China and Mexico. Larry Solow (CJS Securities): Questioned the expected pace and customer receptivity to the new PlumSolo and PlumDuo pumps. CEO Vivek Jain described a gradual upgrade cycle, emphasizing the installed base's readiness for refresh due to device age. Michael Toomey (Jefferies): Asked if recent growth in infusion systems reflected market share gains or underlying market strength. Management cited improved utilization and earlier hardware installs as key contributors. Joseph Conway (Jefferies): Sought detail on marketing strategies for new pump products and expectations for customer adoption patterns. Jain noted the importance of safety features and flexibility for both single and mixed device environments. In the coming quarters, the StockStory team will be monitoring (1) the pace of customer adoption and upgrade activity for the PlumSolo and PlumDuo infusion pumps, (2) the effectiveness of tariff mitigation strategies and any adjustments to supply chain or pricing, and (3) regulatory progress on clearing legacy product lines. Progress on these fronts will be critical for sustaining revenue growth and managing cost pressures. ICU Medical currently trades at a forward P/E ratio of 19.8×. Should you load up, cash out, or stay put? See for yourself in our free research report. Market indices reached historic highs following Donald Trump's presidential victory in November 2024, but the outlook for 2025 is clouded by new trade policies that could impact business confidence and growth. While this has caused many investors to adopt a "fearful" wait-and-see approach, we're leaning into our best ideas that can grow regardless of the political or macroeconomic climate. Take advantage of Mr. Market by checking out our Top 5 Strong Momentum Stocks for this week. This is a curated list of our High Quality stocks that have generated a market-beating return of 176% over the last five years. Stocks that made our list in 2020 include now familiar names such as Nvidia (+1,545% between March 2020 and March 2025) as well as under-the-radar businesses like the once-micro-cap company Kadant (+351% five-year return). Find your next big winner with StockStory today. 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Yahoo
08-05-2025
- Business
- Yahoo
ICU Medical (NASDAQ:ICUI) Delivers Impressive Q1
Medical device company ICU Medical (NASDAQ:ICUI) reported Q1 CY2025 results beating Wall Street's revenue expectations , with sales up 6.7% year on year to $604.7 million. Its non-GAAP profit of $1.72 per share was 34.4% above analysts' consensus estimates. Is now the time to buy ICU Medical? Find out in our full research report. Revenue: $604.7 million vs analyst estimates of $567.2 million (6.7% year-on-year growth, 6.6% beat) Adjusted EPS: $1.72 vs analyst estimates of $1.28 (34.4% beat) Adjusted EBITDA: $99.43 million vs analyst estimates of $88.48 million (16.4% margin, 12.4% beat) Operating Margin: 2.1%, up from 1% in the same quarter last year Free Cash Flow Margin: 6.1%, similar to the same quarter last year Market Capitalization: $3.31 billion Vivek Jain, ICU Medical's Chief Executive Officer, said, 'First quarter results were generally in line with our expectations." Founded in 1984 and named for its initial focus on intensive care units, ICU Medical (NASDAQ:ICUI) develops and manufactures medical products for infusion therapy, vascular access, and vital care applications used in hospitals and other healthcare settings. A company's long-term performance is an indicator of its overall quality. Any business can put up a good quarter or two, but the best consistently grow over the long haul. Luckily, ICU Medical's sales grew at a solid 14.7% compounded annual growth rate over the last five years. Its growth beat the average healthcare company and shows its offerings resonate with customers. Long-term growth is the most important, but within healthcare, a half-decade historical view may miss new innovations or demand cycles. ICU Medical's recent performance shows its demand has slowed as its annualized revenue growth of 2.3% over the last two years was below its five-year trend. We can better understand the company's revenue dynamics by analyzing its most important segment, . Over the last two years, ICU Medical's revenue averaged 4.7% year-on-year growth. This segment has outperformed its total sales during the same period, lifting the company's performance. This quarter, ICU Medical reported year-on-year revenue growth of 6.7%, and its $604.7 million of revenue exceeded Wall Street's estimates by 6.6%. Looking ahead, sell-side analysts expect revenue to decline by 3.8% over the next 12 months, a deceleration versus the last two years. This projection doesn't excite us and indicates its products and services will face some demand challenges. Software is eating the world and there is virtually no industry left that has been untouched by it. That drives increasing demand for tools helping software developers do their jobs, whether it be monitoring critical cloud infrastructure, integrating audio and video functionality, or ensuring smooth content streaming. Click here to access a free report on our 3 favorite stocks to play this generational megatrend. Operating margin is an important measure of profitability as it shows the portion of revenue left after accounting for all core expenses – everything from the cost of goods sold to advertising and wages. It's also useful for comparing profitability across companies with different levels of debt and tax rates because it excludes interest and taxes. ICU Medical was profitable over the last five years but held back by its large cost base. Its average operating margin of 3% was weak for a healthcare business. Looking at the trend in its profitability, ICU Medical's operating margin decreased by 3.7 percentage points over the last five years, but it rose by 4 percentage points on a two-year basis. Still, shareholders will want to see ICU Medical become more profitable in the future. This quarter, ICU Medical generated an operating profit margin of 2.1%, up 1.1 percentage points year on year. This increase was a welcome development and shows it was more efficient. We track the long-term change in earnings per share (EPS) for the same reason as long-term revenue growth. Compared to revenue, however, EPS highlights whether a company's growth is profitable. ICU Medical's flat EPS over the last five years was below its 14.7% annualized revenue growth. This tells us the company became less profitable on a per-share basis as it expanded. We can take a deeper look into ICU Medical's earnings to better understand the drivers of its performance. As we mentioned earlier, ICU Medical's operating margin improved this quarter but declined by 3.7 percentage points over the last five years. Its share count also grew by 14.1%, meaning the company not only became less efficient with its operating expenses but also diluted its shareholders. In Q1, ICU Medical reported EPS at $1.72, up from $0.96 in the same quarter last year. This print easily cleared analysts' estimates, and shareholders should be content with the results. Over the next 12 months, Wall Street expects ICU Medical's full-year EPS of $6.98 to grow 3.2%. We were impressed by how significantly ICU Medical blew past analysts' EPS expectations this quarter. We were also excited its revenue outperformed Wall Street's estimates by a wide margin. Zooming out, we think this was a solid print. The stock remained flat at $144.25 immediately after reporting. ICU Medical may have had a good quarter, but does that mean you should invest right now? The latest quarter does matter, but not nearly as much as longer-term fundamentals and valuation, when deciding if the stock is a buy. We cover that in our actionable full research report which you can read here, it's free. Sign in to access your portfolio
Washington Post
08-05-2025
- Business
- Washington Post
ICU Medical: Q1 Earnings Snapshot
SAN CLEMENTE, Calif. — SAN CLEMENTE, Calif. — ICU Medical Inc. (ICUI) on Thursday reported a loss of $15.5 million in its first quarter. The San Clemente, California-based company said it had a loss of 63 cents per share. Earnings, adjusted for amortization costs and restructuring costs, were $1.72 per share.
Yahoo
08-05-2025
- Business
- Yahoo
Closed Systems Transfer Devices Market worth US$2.09 billion by 2030 with 7.0% CAGR
DELRAY BEACH, Fla., May 8, 2025 /PRNewswire/ -- The global Closed System Transfer Devices Market, valued at US$1.35 billion in 2024, is forecasted to grow at a robust CAGR of 7.0%, reaching US$1.49 billion in 2025 and an impressive US$2.09 billion by 2030. The closed system transfer devices market has been consistently increasing because of heightened awareness of the risks involved in working with hazardous drugs and the requirement for robust safety protocols within healthcare facilities. The reasons include stringent regulations, heightened concerns about worker safety, and a rise in cancer cases that fuel the use of chemotherapy drugs. In this report, the market is divided into closing mechanism, type, component, technology, end user, and region. Download PDF Brochure: Browse in-depth TOC on "Closed Systems Transfer Devices Market" 273 - Tables65 - Figures289 - Pages By Based on type, the closed system transfer devices market is categorized into membrane-to-membrane systems and needleless systems. In 2023, the membrane-to-membrane systems segment held the largest share, by type. The high share and fast growth of this segment are due to their ease of use and lower rate of contamination with double-membrane containment systems. Membrane-to-membrane systems offer higher safety by forming a fully isolated environment during drug transfer. By technology, the closed system transfer devices market is bifurcated into diaphragm-based devices, compartmentalized devices, and air cleaning/filtration devices. In 2023, the share of the diaphragm-based devices segment was the highest at 43.0%. Diaphragm-based devices tend to be compatible with a wide variety of drug delivery systems and container closures, making them versatile for different clinical uses. They offer flexibility for handling hazardous drugs. By geography, North America held the largest market share of the closed system transfer devices market in 2024 due to the ongoing research & development of innovative CSTD technologies and better safety, efficiency, and user experience. Additionally, tight regulations over handling hazardous drugs within healthcare environments necessitate the employment of CSTDs to ensure that there is reduced risk exposure to hazardous drugs. Enforcement of these regulations spurs the use of CSTDs within the region. Request Sample Pages : The key players in the global closed system transfer devices market include BD (US), ICU Medical, Inc. (US), EQUASHIELD (US), Corning Incorporated (US), Simplivia Healthcare Ltd. (Israel), JMS (Japan), Baxter (US), Terumo Corporation (Japan), Cardinal Health (US), B Braun Melsungen AG (Germany), West Pharmaceuticals Services, Inc. (US), CODAN Medizinische Geräte GmbH (Germany), Yukon Medical (US), and INSUNG MEDICAL Co., Ltd. (South Korea). ICU Medical, Inc. (US): ICU Medical, Inc. has a comprehensive portfolio for the safe handling of dangerous IV medications. Its range of products includes automated and needleless drug compounding systems. The company is engaged in a long-term supply deal with Terumo Corporation (Japan) to distribute its products throughout Japan and Asia, including IV therapy and CSTD products. Over the last three years, the company's infusion consumables segment has grown steadily, taking up the highest share of 37% of the total revenue mix. BD (US): BD has a broad product portfolio, including hazardous drug-safe devices such as the PhaSeal and Texium system. It has a global presence spanning more than 50 countries. The BD PhaSeal system works with a wide range of chemotherapeutic medications. It is more widely used in the US and other markets than other CSTDs. For more information, Inquire Now! Related Reports: Radiotherapy Market Infusion Pump Market Respiratory Care Devices Market Dermatology Devices Market Home Healthcare Market Get access to the latest updates on Closed System Transfer Devices Companies and Closed Systems Transfer Devices Market Size About MarketsandMarkets™: MarketsandMarkets™ has been recognized as one of America's Best Management Consulting Firms by Forbes, as per their recent report. MarketsandMarkets™ is a blue ocean alternative in growth consulting and program management, leveraging a man-machine offering to drive supernormal growth for progressive organizations in the B2B space. With the widest lens on emerging technologies, we are proficient in co-creating supernormal growth for clients across the globe. Today, 80% of Fortune 2000 companies rely on MarketsandMarkets, and 90 of the top 100 companies in each sector trust us to accelerate their revenue growth. With a global clientele of over 13,000 organizations, we help businesses thrive in a disruptive ecosystem. The B2B economy is witnessing the emergence of $25 trillion in new revenue streams that are replacing existing ones within this decade. We work with clients on growth programs, helping them monetize this $25 trillion opportunity through our service lines – TAM Expansion, Go-to-Market (GTM) Strategy to Execution, Market Share Gain, Account Enablement, and Thought Leadership Marketing. Built on the 'GIVE Growth' principle, we collaborate with several Forbes Global 2000 B2B companies to keep them future-ready. Our insights and strategies are powered by industry experts, cutting-edge AI, and our Market Intelligence Cloud, KnowledgeStore™, which integrates research and provides ecosystem-wide visibility into revenue shifts. 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