SOUTH JORDAN, Utah, March 18, 2025 (GLOBE NEWSWIRE) -- Merit Medical Systems, Inc. (NASDAQ: MMSI), a global leader of healthcare technology, announced that Chairman and Chief Executive Officer, Fred Lampropoulos, will visit the Nasdaq MarketSite in Times Square to ring the opening bell on Wednesday, March 19, 2025. The ceremony begins at 9:15 A.M. (EDT) and the bell ringing takes place at 9:30 A.M. "Merit’s listing on Nasdaq for 35 years marks a significant milestone in our company’s history,” said Lampropo ...

Group 1 - Medical technology companies have experienced a "flight to safety" in 2025, benefiting from increased investor interest [1] - Merit Medical (NASDAQ: MMSI) has outperformed the market, with shares rising nearly 20% since the last analysis [1]

Company Overview - Merit Medical Systems, Inc. (MMSI) has initiated the enrollment of the first patient in its multicenter, prospective PREEMIE study for the Bloom Micro Occluder System aimed at treating patent ductus arteriosus (PDA) in premature infants [1][2] - The Bloom Micro Occluder System is currently not approved for PDA treatment [1] Study Details - The PREEMIE study plans to enroll at least 55 premature infants with significant PDA across up to 10 U.S. study sites, targeting infants weighing between 600 g and 2,500 g [2] - The study will evaluate the safety and efficacy of the device over a six-month period as part of the premarket approval (PMA) application [2][4] Significance of the Study - PDA is a common congenital heart condition in premature infants, and the Bloom Micro Occluder System is designed as a minimally invasive treatment option [4] - An expert noted that there is currently no approved device for treating PDA in infants weighing 600 grams, making this study crucial for this high-risk population [5] Management Expectations - Merit Medical's management anticipates that the PREEMIE study will significantly enhance care for vulnerable premature infants who could benefit from PDA closure using a transcatheter device [6] Industry Prospects - The global PDA treatment market was valued at $2.4 billion in 2022 and is projected to reach $7.34 billion by 2030, growing at a CAGR of 15% [7] - The increasing demand for diagnostic tests and the rising incidence of PDA in infants are expected to drive market growth, positioning Merit Medical favorably within this niche [7] Recent Developments - Merit Medical reported robust revenue growth in its Cardiovascular unit in its fourth-quarter 2024 results [8] - The company received FDA PMA approval for the WRAPSODY Cell-Impermeable Endoprosthesis, allowing for commercialization in 2025 [8] - Positive six-month findings from the WAVE pivotal trial for the WRAPSODY device were also announced [9] Competitive Landscape - Boston Scientific Corporation (BSX) has entered into an agreement to acquire SoniVie Ltd. to expand its offerings in interventional cardiology [10] - AngioDynamics, Inc. (ANGO) has initiated a randomized study for the Auryon Atherectomy System [12] - Medtronic plc (MDT) released positive two-year results from the SMART Trial, showcasing its competitive position in the cardiovascular space [13]

SOUTH JORDAN, Utah, March 10, 2025 (GLOBE NEWSWIRE) -- Merit Medical Systems, Inc. (NASDAQ:MMSI), a global leader of healthcare technology, today announced enrollment of the first patient in its multicenter, prospective study of the Bloom Micro Occluder System for the treatment of patent ductus arteriosus (PDA) in premature infants (PREEMIE study). PDA is a congenital heart condition that occurs when the ductus arteriosus, a blood vessel connecting the aorta and pulmonary artery, does not close following bi ...

Core Insights - Merit Medical Systems, Inc. has initiated a multicenter, prospective study named PREEMIE to evaluate the safety and efficacy of the Bloom Micro Occluder System for treating patent ductus arteriosus (PDA) in premature infants [1][4] - The Bloom Micro Occluder System is designed as a minimally invasive treatment option for hemodynamically significant PDAs, utilizing a flexible delivery system to insert a self-expanding nitinol device [3][4] - The study aims to enroll at least 55 premature infants weighing between 600 g and 2,500 g across up to ten U.S. study sites, with a focus on assessing safety and efficacy over a six-month period [3][4] Company Overview - Merit Medical Systems, Inc. was founded in 1987 and specializes in the development, manufacture, and distribution of proprietary medical devices for interventional, diagnostic, and therapeutic procedures, particularly in cardiology, radiology, oncology, critical care, and endoscopy [5] - The company has a global presence with a sales force and clinical support team of over 800 individuals and employs approximately 7,400 people worldwide [5] Industry Context - Patent ductus arteriosus (PDA) is a common congenital heart condition in premature, low-birth-weight infants, which can negatively impact health and often requires treatment [2] - Current treatment options for PDA in small premature infants are limited, making the Bloom Micro Occluder System a potentially significant advancement in pediatric interventional cardiology [4]

Financial Data and Key Metrics Changes - Total revenue for Q4 2024 was reported at $355.2 million, representing a 9% year-over-year increase on a GAAP basis and a 10% increase on a constant currency basis [11][12] - Non-GAAP operating profit grew by 30%, with a non-GAAP operating margin of 19.6%, up approximately 305 basis points year-over-year [13][29] - Non-GAAP earnings per share increased by 26%, exceeding expectations [13][30] - Free cash flow generation for the fiscal year 2024 was over $185 million, up 67% year-over-year [14][30] Business Line Data and Key Metrics Changes - Cardiovascular segment sales grew by 8%, while the Endoscopy segment saw an impressive 88% growth [18] - Peripheral Intervention (PI) products increased by 5.5%, driven by strong sales in axis and embolotherapy products [20] - Cardiac Intervention product sales rose by 7%, with organic growth of approximately 1% [22] - OEM product sales surged by 22%, indicating strong demand in the U.S. despite challenges in international markets [23] Market Data and Key Metrics Changes - U.S. sales increased nearly 14% on a constant currency basis, exceeding expectations [24] - International sales grew by 5% year-over-year, with a 2% increase on an organic constant currency basis [24] - Sales in the APAC region showed modest growth of 4%, while EMEA sales were softer due to challenges in Russia and distributor markets [25] Company Strategy and Development Direction - The company aims for continued strong execution, solid constant currency growth, and improving profitability in 2025, alongside progress in its CGI program [15] - Financial guidance for 2025 includes net revenue growth of 8% to 10% year-over-year, with specific growth targets for cardiovascular and endoscopy segments [34] - The company is focused on maintaining a minimum of 5% organic constant currency growth and achieving operating margins of at least 20% [57] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the business's momentum and the ability to meet financial guidance for 2025 [15] - The impact of tariffs and potential retaliatory measures remains uncertain, with management monitoring the situation closely [38][39] - The company is optimistic about the WRAPSODY program and its market response, with upcoming presentations expected to provide further insights [45][72] Other Important Information - The company generated $65 million of free cash flow in Q4 2024, contributing to a total of over $185 million for the fiscal year [30][31] - As of December 31, 2024, the company had cash and cash equivalents of $376.7 million and total debt obligations of $747.5 million [32] Q&A Session Summary Question: EPS guidance concerns - Management acknowledged the conservative EPS guidance due to increased interest expenses and accounting treatment of convertible debt, impacting growth expectations [48][52] Question: OEM growth expectations - Management indicated strong demand in the U.S. for OEM products, with confidence in maintaining growth levels [64][67] Question: WRAPSODY revenue guidance - WRAPSODY's revenue guidance of $7 million to $9 million was confirmed to be included in overall financial guidance [87] Question: Endoscopy segment guidance - Management provided insights on the integration of sales forces and expressed confidence in achieving the guidance set for the Endoscopy segment [90][91] Question: Currency impact on revenue - Management discussed the hedging strategies in place to minimize currency impact, with a projected headwind of approximately 20 basis points [93][94] Question: Supply chain challenges - Management reported improved confidence in resolving previous supply chain issues, with ongoing monitoring [116] Question: R&D expenses - The increase in R&D expenses was attributed to short-term investments related to WRAPSODY, with expectations to return to historical levels [124][125]

Merit Medical (MMSI) reported $355.16 million in revenue for the quarter ended December 2024, representing a year-over-year increase of 9.4%. EPS of $0.93 for the same period compares to $0.81 a year ago.The reported revenue represents a surprise of +0.93% over the Zacks Consensus Estimate of $351.87 million. With the consensus EPS estimate being $0.83, the EPS surprise was +12.05%.While investors closely watch year-over-year changes in headline numbers -- revenue and earnings -- and how they compare to Wal ...

Merit Medical (MMSI) came out with quarterly earnings of $0.93 per share, beating the Zacks Consensus Estimate of $0.83 per share. This compares to earnings of $0.81 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 12.05%. A quarter ago, it was expected that this maker of disposable medical devices would post earnings of $0.80 per share when it actually produced earnings of $0.86, delivering a surprise of 7.50%.Over the last fo ...

Revenue Projections - Preliminary unaudited revenue for the year ended December 31, 2024, is projected to be approximately $1.355 to $1.357 billion, representing an increase of approximately 7.7% to 7.9% compared to 2023[2] - Preliminary constant currency revenue for the same period increased by approximately 8.4% to 8.6% year-over-year[5] - The impact of foreign exchange on preliminary unaudited revenue for 2024 is estimated at $7.9 million[9] - The preliminary unaudited revenue information is subject to completion of financial closing procedures and may materially differ from actual results[16] - The company does not typically disclose preliminary unaudited revenue due to the unpredictability of underlying assumptions[15] Financial Reporting - The financial results for Q4 and the full year 2024, along with fiscal year 2025 guidance, will be announced on February 25, 2025[3] - Merit Medical's management uses non-GAAP financial measures, such as constant currency revenue, to evaluate financial performance and compare results to prior periods[7] Company Operations - Merit Medical employs approximately 7,400 people worldwide and serves customers globally with a sales force and clinical support team of over 800 individuals[12] - The company is engaged in the development and distribution of proprietary medical devices used in various medical procedures, including cardiology and oncology[12] - Risks associated with the company's operations include supply chain disruptions, regulatory challenges, and potential product recalls[13]

Business Segments - The company operates through two segments: cardiovascular and endoscopy, focusing on enhancing global growth and profitability through R&D and operational optimization[26] - The cardiovascular segment includes product categories such as peripheral intervention, cardiac intervention, and custom procedural solutions, with a broad line of medical devices for vascular access[27] - The endoscopy segment includes innovative gastrointestinal solutions and pulmonary products, with recent acquisitions like the EsophyX® Z+ system for treating gastroesophageal reflux disease[46] - The oncology product line is dedicated to the diagnosis and treatment of breast and soft tissue tumors, with offerings like the SCOUT® Radar Localization System and CorVocet® Biopsy System[34] Product Development and Innovation - Recent expansions in the renal therapies portfolio include key products like the HeRO® Graft and BioFlo DuraMax® Catheter, aimed at improving long-term vascular access for chronic hemodialysis patients[30] - The company introduced several new products in 2024, including the Wrapsody Device and MIGHTYwire® Guide Wire, enhancing its product lineup[64] - The product development strategy emphasizes rapid conception and introduction of new products that meet customer needs, leveraging insights from healthcare professionals[51] - The company operates research and development facilities in California, Texas, Utah, Ireland, and France, focusing on innovation and product improvements[65][62] Market Performance and Sales - In 2024, U.S. sales accounted for 59% of net sales, while international sales grew by 4.8% and represented 41% of net sales[53][54] - China's market contributed 11% to net sales in 2024, with reported sales of $149.8 million, compared to $147.3 million in 2023 and $149.3 million in 2022[54] - The volume-based procurement (VBP) policy in China has negatively impacted sales prices and revenue since 2022, with expectations of continued effects into 2025[56] - The company targets high-growth markets such as interventional oncology and critical care, with a focus on addressing unmet healthcare needs[48] Regulatory and Compliance Challenges - The company is preparing to comply with new MDR regulations, which include stringent requirements for pre-market clinical evidence and post-market surveillance[86] - The regulatory approval process for medical devices is expensive and uncertain, with potential delays adversely affecting the company's financial condition and operations[87] - The company is subject to extensive regulatory scrutiny, including compliance with FDA requirements, which could impact product commercialization and financial results[175] - Compliance with quality system regulations is critical, as failure could lead to manufacturing shutdowns or product recalls, significantly impacting business operations[90] Competition and Market Environment - The company faces competition from larger firms and local suppliers in various markets, including China and Japan[70][72] - The healthcare industry's consolidation trend has led to increased demands for price concessions, negatively affecting revenues and pricing strategies[151] - The company faces significant competition from both established medical device companies and new entrants, including technology firms, which may limit market share and profitability[155] Financial and Operational Risks - The company has experienced supply chain challenges that could impact financial results, although raw materials are generally available[76] - Economic and geopolitical conditions, including inflation and trade policies, have created a challenging macroeconomic environment that could adversely impact the company's financial condition[145] - The company may incur substantial costs related to evaluating and integrating acquisitions, which could adversely impact financial results if not managed effectively[158] - Supply disruptions and increased costs may hinder the company's ability to recover expenses through price increases due to competitive pressures in the healthcare industry[144] Corporate Governance and Ethics - The company has a Corporate Integrity Agreement with the Office of Inspector General, requiring compliance and oversight measures[81] - The company is subject to various anti-corruption laws, including the FCPA, which require maintaining accurate records and compliance to avoid significant penalties[99] - Transparency laws require annual reporting of interactions with healthcare providers, and failure to comply could result in substantial penalties[101] Sustainability and Social Responsibility - The company has established a Corporate Sustainability Council to drive long-term environmental, social, and governance goals[115] - The company has reduced water consumption at its South Jordan, Utah location by investing in xeriscaping and water recirculation systems[118] - The company has implemented recycling programs for various materials, including food waste and plastics, to promote sustainability[123] - The company has engaged in humanitarian missions, donating products to various countries, including Belize and Ethiopia, in 2024[130] Human Resources and Workforce - The company has approximately 7,400 employees across 40 countries, emphasizing the importance of attracting and retaining talent for long-term growth[120] - The company achieved its tenth consecutive year of zero healthcare plan cost increases for U.S. employees participating in group healthcare plans[128] - The company has been recognized as a "China Top Employer" for four consecutive years, reflecting its commitment to excellence in human resources practices[126] Intellectual Property and Cybersecurity - The company’s ability to protect its intellectual property is crucial for competitiveness, but existing measures may not provide adequate protection against infringement[215] - Cybersecurity risks are increasing, with potential impacts on business operations, reputation, and financial condition due to data breaches or cyber-attacks[219] - The SEC has implemented new rules requiring greater disclosure regarding cybersecurity risk management, which may incur additional compliance costs[222] Future Outlook and Strategic Planning - Future growth is dependent on the development of new products and enhancements, requiring significant investment in research and development, clinical trials, and regulatory approvals[167] - Effective leadership succession planning is crucial, with the anticipated retirement of the CEO around December 31, 2025, which may disrupt operations if not managed properly[173] - Accurate forecasting of customer demand is critical; failure to do so may lead to inventory write-downs or inability to meet order requirements[169]