Core Insights - Merit Medical Systems, Inc. will participate in the 44th Annual J.P. Morgan Healthcare Conference from January 12-15, 2026, in San Francisco, California [1] - The company will provide an overview and update on January 13th at 4:30 pm Pacific Time / 7:30 pm Eastern Time [2] - Presentation materials will be available on the investor relations website, along with a live audio webcast and a replay for approximately 90 days [3] Company Overview - Merit Medical, founded in 1987, develops, manufactures, and distributes proprietary medical devices for interventional, diagnostic, and therapeutic procedures, focusing on cardiology, radiology, oncology, critical care, and endoscopy [4] - 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 [4]

Summary of Merit Medical Systems FY Conference Call Company Overview - **Company**: Merit Medical Systems (NasdaqGS: MMSI) - **Industry**: Medical Device Industry - **Key Executives**: CEO Martha Aronson, CFO Raul Parra Core Points and Arguments 1. **Leadership Transition**: Martha Aronson has recently joined Merit Medical, bringing nearly 30 years of experience in the medical device industry, including roles at Medtronic, Hillrom, and Ecolab [2][5][6] 2. **Growth Strategy**: Merit Medical aims to continue its growth through both organic investments and acquisitions, with ongoing initiatives planned through the end of 2026 [5][10] 3. **Executive Leadership Team**: A new executive leadership team has been formed to focus on strategic planning for growth beyond 2026 [6][10] 4. **Financial Guidance**: Merit Medical is confident in achieving its Continuous Growth Initiatives (CGI) goals, which include a revenue CAGR of 5%-7% and operating margins of 20%-22% [15][18] 5. **Wrapsody Product Launch**: The recent launch of Wrapsody is progressing well, with adjustments made to pricing strategies to enhance market penetration [25][27][29] 6. **Market Dynamics**: The company is navigating challenges in the China market, with volume growth remaining strong despite a decrease in sales percentage due to volume-based purchasing [56][57] 7. **OEM Business Performance**: The OEM segment is expected to grow in the mid to high single digits, with current performance aligning with expectations [63] 8. **M&A Strategy**: The M&A strategy will evolve to be more intentional, focusing on strategic fits that enhance the offerings for existing physician groups [64][66] Additional Important Insights 1. **Founder Involvement**: Fred Lampropoulos, the founder, will transition to a non-executive chairman role but will remain available for consultation and to leverage his network [12][13] 2. **Wrapsody's Impact on Renal Portfolio**: The Wrapsody product is expected to positively influence the renal therapy portfolio, enhancing sales force engagement with physicians [50][51] 3. **Clinical Data and Pipeline**: Future developments related to Wrapsody will depend on new clinical data and trials, with the company committed to maintaining confidentiality until solid information is available [36][38] 4. **Market Sentiment**: There is a perception that the market may not fully appreciate Merit Medical's consistent performance and growth potential, particularly in light of recent tariff impacts [15][16] 5. **Competitive Landscape**: The company is aware of competitive pressures and is adjusting its strategies accordingly, particularly in pricing and product offerings [29][30] This summary encapsulates the key points discussed during the conference call, highlighting Merit Medical's strategic direction, market challenges, and growth initiatives.

Core Viewpoint - Merit Medical (MMSI) has received an upgrade to a Zacks Rank 2 (Buy) due to an upward trend in earnings estimates, which is a significant factor influencing stock prices [1][3]. Earnings Estimates and Stock Price Impact - The Zacks rating system focuses on changes in earnings estimates, which are strongly correlated with near-term stock price movements [4][6]. - Rising earnings estimates for Merit Medical indicate an improvement in the company's underlying business, likely leading to an increase in stock price [5][10]. Zacks Rating System - The Zacks Rank stock-rating system classifies stocks into five groups based on earnings estimates, with a strong historical performance, particularly for Zacks Rank 1 stocks, which have generated an average annual return of +25% since 1988 [7][9]. - Only the top 20% of Zacks-covered stocks receive a "Strong Buy" or "Buy" rating, indicating superior earnings estimate revisions [10]. Earnings Estimate Revisions for Merit Medical - Merit Medical is expected to earn $3.69 per share for the fiscal year ending December 2025, with no year-over-year change, while the Zacks Consensus Estimate has increased by 0.1% over the past three months [8].

Core Insights - Merit Medical Systems, Inc. (MMSI) is identified as a quality business with strong organic growth and positive clinical trial results, indicating potential investment opportunities [1]. Group 1: Company Performance - MMSI has demonstrated robust organic growth, which is a positive indicator for its future performance [1]. - The company has achieved favorable outcomes in clinical trials, further enhancing its investment appeal [1]. Group 2: Investment Opportunities - The service "Value in Corporate Events" focuses on major corporate events such as earnings reports, M&A, and IPOs, providing actionable investment ideas [1]. - The investment group covers approximately 10 major events monthly, aiming to identify the best opportunities for investors [1].

Core Viewpoint - Merit Medical Systems, Inc. announced that the U.S. Centers for Medicare & Medicaid Services has deferred its application for Transitional Pass-Through incremental payment for the WRAPSODY Cell-Impermeable Endoprosthesis, with the earliest effective date now set for January 1, 2027 [1][2] Group 1: Company Strategy and Market Position - The company plans to withdraw its application for TPT incremental payment and will immediately begin full commercialization of the WRAPSODY CIE in the U.S. [2] - A new commercial strategy is being enacted to increase patient access and optimize the adoption and utilization of the WRAPSODY CIE, which is expected to improve patient outcomes and generate strong revenue growth [2] - The WRAPSODY CIE aims to restore vascular access for hemodialysis patients, with strong clinical evidence supporting its efficacy [2] Group 2: Financial Forecast - For the full year 2025, Merit forecasts U.S. revenue from WRAPSODY CIE sales to be in the range of $2 million to $4 million [2] Group 3: Regulatory Approvals - The WRAPSODY CIE received premarket approval from the U.S. FDA on December 19, 2024, and was approved by Health Canada on April 30, 2025 [3] - The device has also received the CE Mark for commercial use in the European Union and is available in Brazil [3] Group 4: Clinical Evaluation - Real-world clinical outcomes of the WRAPSODY CIE are being evaluated in the WRAP North America Registry, which aims to enroll up to 250 patients [5]

Core Insights - Merit Medical Systems, Inc. announced positive results from the randomized AVF arm of the WAVE trial, showcasing the effectiveness of the WRAPSODY CIE device in restoring vascular access for hemodialysis patients [1][4]. Company Overview - Merit Medical Systems, Inc. is a leader in healthcare technology, focusing on the development, manufacture, and distribution of proprietary medical devices for interventional, diagnostic, and therapeutic procedures [13]. - The company employs approximately 7,400 people globally and serves hospitals worldwide with a dedicated sales force and clinical support team [13]. Product and Trial Details - The WRAPSODY CIE is designed to restore vascular access in patients undergoing hemodialysis who face obstructions in their veins [2][6]. - The WAVE trial involved 245 hemodialysis patients treated with either the WRAPSODY CIE or percutaneous transluminal angioplasty (PTA) across 43 centers in the U.S., South America, and the U.K. [3][4]. - Results showed that 24 months post-treatment, the target lesion primary patency (TLPP) was significantly higher for the WRAPSODY CIE group at 48.6% compared to 29.8% for PTA (p<0.0001), and access circuit primary patency (ACPP) was also higher at 31.3% versus 20.6% (p=0.003) [4][9]. Regulatory Approvals - The WRAPSODY CIE received premarket approval from the U.S. FDA on December 19, 2024, and was subsequently approved by Health Canada on April 30, 2025 [6]. - The device has also received the Conformité Européenne (CE) Mark for commercial use in the European Union and is available in Brazil [6]. Ongoing Research and Registries - Real-world clinical outcomes of the WRAPSODY CIE are being evaluated in the WRAP North America Registry, which aims to enroll up to 250 patients [8]. - The WRAP Global registry is also assessing real-world outcomes outside of North America [8]. - Data from the WAVE trial and these registries will provide evidence on the largest cohort of patients for a single indication in dialysis access to date [10].

Core Insights - Merit Medical Systems, Inc. announced 24-month efficacy findings from the non-randomized AVG cohort of the WAVE trial, showcasing the performance of the WRAPSODY® Cell-Impermeable Endoprosthesis (CIE) for patients with advanced kidney disease undergoing hemodialysis [1][5][6] Group 1: Trial Overview - The WAVE trial aimed to evaluate the performance of the WRAPSODY CIE in restoring functional vascular access in patients with complications such as stenosis or occlusion [3] - The trial involved 43 centers across the United States, South America, and the United Kingdom [3] Group 2: Efficacy Results - In the non-randomized arm of the WAVE trial, 112 patients were treated with the WRAPSODY CIE, achieving a target lesion primary patency (TLPP) of 81.4% at 6 months, exceeding the established performance goal of 60% [4] - The TLPP at 12 months was 60.2%, and at 24 months, it was 41.7% [4][10] - The access circuit primary patency (ACPP) at 12 months was 36.2%, and at 24 months, it was 25.7% [4][10] Group 3: Regulatory Approvals - The WRAPSODY CIE received premarket approval from the US FDA on December 19, 2024, and was approved by Health Canada on April 30, 2025 [6] - The device has also received the Conformité Européenne (CE) Mark for commercial use in the European Union and is available in Brazil [6] Group 4: Future Research - Real-world clinical outcomes of the WRAPSODY CIE are being evaluated in the WRAP North America Registry, which aims to enroll up to 250 patients [8]

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Core Insights - Merit Medical reported revenue of $384.16 million for the quarter ended September 2025, reflecting a 13% increase year-over-year and surpassing the Zacks Consensus Estimate of $371.21 million by 3.49% [1] - The company's EPS for the quarter was $0.92, up from $0.86 in the same quarter last year, exceeding the consensus EPS estimate of $0.82 by 12.2% [1] Financial Performance - The stock has returned -0.8% over the past month, while the Zacks S&P 500 composite increased by 3.6%, with a Zacks Rank 2 (Buy) indicating potential outperformance in the near term [3] - Geographic sales showed strong performance, with International sales at $153.56 million (+15.2% YoY), APAC at $64.86 million (+7.4% YoY), and the United States at $230.6 million (+11.7% YoY) [4] - EMEA sales reached $71.53 million, representing a 22.3% increase year-over-year, while the Rest of World sales were $17.17 million (+18.5% YoY) [4] Segment Performance - Revenue from Cardiovascular-Peripheral Intervention was $144.78 million (+5% YoY), while Cardiovascular-Cardiac Intervention saw a significant increase to $116.68 million (+28.6% YoY) [4] - Endoscopy revenue was reported at $17.73 million (+4.4% YoY), and Cardiovascular-OEM revenue was $50.83 million (+17.2% YoY) [4] - Overall Cardiovascular revenue totaled $366.43 million, reflecting a 13.5% increase year-over-year, with Custom Procedural Solutions revenue at $54.14 million (+6.6% YoY) [4]

Financial Data and Key Metrics Changes - The company reported total revenue of $384.2 million, up 13% year-over-year on a GAAP basis and up 12.5% year-over-year on a constant currency basis, exceeding growth expectations [14][15] - Non-GAAP operating margin increased by 51 basis points year-over-year to 19.7%, with nearly 7% growth in non-GAAP EPS, exceeding expectations [15][32] - Free cash flow generated was $53 million, an increase of 38% year-over-year, contributing to a total of over $140 million in free cash flow for the first nine months of 2025 [15][32] Business Line Data and Key Metrics Changes - Cardiovascular segment sales grew by 13%, with cardiac intervention product sales increasing by 29% [26][28] - Endoscopy segment sales increased by 4%, with total revenue growth driven primarily by the cardiovascular segment [26][27] - Peripheral intervention product sales increased by 8%, while custom procedural solutions products increased by 6% [27][29] Market Data and Key Metrics Changes - U.S. sales increased by 12% on a constant currency basis, exceeding organic growth expectations [30] - International sales increased by 13% year-over-year, with specific regions like EMEA and the rest of the world exceeding expectations [30] - Sales in China decreased by 1%, attributed to broader macroeconomic conditions, although excluding VBP impacts, sales increased by 2% [30] Company Strategy and Development Direction - The company is focused on innovation and R&D, with recent product launches including the Prelude Wave hydrophilic sheath introducer and Embosphere microspheres for knee osteoarthritis treatment [16][17] - An acquisition of the C2 Cryo Balloon technology for $22 million is expected to strengthen the company's position in the gastroenterology market [25][26] - The company aims to leverage its strong free cash flow for investments in R&D and acquisitions, maintaining a focus on both organic and inorganic growth strategies [54] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the company's strong performance despite a dynamic global macro environment [15] - The updated financial guidance for 2025 reflects strong Q3 results, with expectations for continued growth and profitability [16][34] - The company is committed to achieving its CGI goals through the end of 2026, focusing on closing out a strong 2025 [54] Other Important Information - The company has made notable progress in securing clinical evidence for its Rhapsody CIE product, with ongoing studies and registries to support its market position [22][23] - The management team is actively engaging with stakeholders and focusing on building awareness for new products [10][13] Q&A Session Summary Question: Can you provide more color on the Rhapsody CIE response in the inpatient setting? - Management noted strong initial market response and highlighted the training of over 500 physicians, which has contributed to access and utilization in hospitals [46] Question: What is the source of the gross margin upside and its durability? - Management attributed the gross margin increase to a focus on product mix, pricing improvements, and operational efficiencies, while acknowledging tariff impacts [49][50] Question: What are the thoughts on 2026 and future M&A strategies? - Management indicated a focus on closing out a strong 2025 and emphasized the importance of both organic and inorganic growth, with no major shifts in capital allocation strategy expected [54]