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]

Financial Data and Key Metrics Changes - The company reported total revenue of $382.5 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 [8][9] - Non-GAAP operating margin increased nearly 109 basis points year over year to 21.2%, representing the highest performance in the company's history as a public company [9] - Non-GAAP EPS grew by 10%, exceeding expectations, and free cash flow increased by 20% year over year to $70 million [9][32] Business Line Data and Key Metrics Changes - Cardiovascular segment sales grew by 10% and endoscopy segment sales increased by 81% [24] - Cardiac intervention product sales rose by 23%, with organic growth of approximately 10% [25] - Peripheral intervention products and custom procedure solutions saw sales increases of 6% and above expectations, respectively [25] Market Data and Key Metrics Changes - U.S. sales increased by 17% on a constant currency basis and 10% on an organic constant currency basis [28] - International sales grew by 7% year over year, with a 2% increase on an organic constant currency basis [28] - Sales in China decreased by 6%, attributed to the broader macro environment [29][80] Company Strategy and Development Direction - The company announced the acquisition of BioLife Delaware LLC for $120 million, aimed at enhancing its product offerings in hemostatic solutions [10][11] - A comprehensive marketing plan for the Rhapsody CIE was launched, focusing on expanding physician relationships and securing reimbursement coverage [15][16] - The company is targeting a premium pricing strategy for the Rhapsody CIE, emphasizing its unique treatment options and clinical benefits [16] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to deliver strong execution and revenue growth despite a challenging global macro environment [10] - The company acknowledged a two-quarter delay in securing add-on reimbursement for the Rhapsody CIE in the outpatient setting but maintained long-term growth expectations [22][37] - Management emphasized the importance of their reimbursement strategy and ongoing engagement with CMS to secure necessary approvals [21][56] Other Important Information - The company updated its 2025 financial guidance, expecting GAAP net revenue growth of 10% to 11% and non-GAAP diluted EPS in the range of $3.52 to $3.72 [34][39] - The anticipated impact of tariffs on cost of goods was revised down to approximately $7 million, reflecting better-than-expected performance [38] Q&A Session Summary Question: Clarification on Rhapsody reimbursement process - Management clarified that they applied for a new technology APC assignment but did not receive it, and they plan to submit for TPT by September 1 [46][48] Question: Confidence in securing TPT - Management expressed high confidence in meeting TPT guidelines and emphasized the strength of their product data [55][60] Question: Sales performance in cardiac intervention - Management attributed the sales uplift to internal product development and the strategic acquisition of Cook Medical [100][106]

Financial Data and Key Metrics Changes - The company reported total revenue of $382.5 million, up 13% year over year on a GAAP basis and up 12.5% year over year on a constant currency basis [7][9] - Non-GAAP operating margin increased nearly 109 basis points year over year to 21.2%, representing the highest performance in the company's history as a public company [9] - Non-GAAP EPS grew by 10%, exceeding expectations, and free cash flow increased by 20% year over year to $70 million [9][34] Business Line Data and Key Metrics Changes - Cardiovascular segment sales grew by 10% and endoscopy segment sales increased by 81% [26] - Cardiac intervention product sales rose by 23%, with organic growth of approximately 10% [27] - Peripheral intervention products and custom procedure solutions saw sales increases of 6% and 4%, respectively [28] Market Data and Key Metrics Changes - U.S. sales increased by 17% on a constant currency basis, while international sales grew by 7% year over year [30] - Sales in China decreased by 6%, attributed to the broader macro environment [31][75] - The company expects low double-digit growth in EMEA and mid-teens growth in the Rest of the World region, with approximately 2% growth in the APAC region [37] Company Strategy and Development Direction - The company announced the acquisition of BioLife Delaware LLC for $120 million, aimed at enhancing its product offerings in hemostatic solutions [10][11] - A comprehensive marketing plan for the Rhapsody CIE was launched, focusing on raising awareness and expanding physician relationships [14] - The pricing strategy for Rhapsody CIE is based on a premium price relative to competitors, supported by clinical evidence demonstrating its efficacy [16][17] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to deliver strong execution and revenue growth despite a dynamic global macro environment [10] - The company acknowledged a two-quarter delay in securing add-on reimbursement for the outpatient setting but maintained long-term growth expectations for Rhapsody CIE [24][39] - Management emphasized the importance of their reimbursement strategy and ongoing engagement with CMS to secure necessary approvals [23][49] Other Important Information - The company updated its 2025 financial guidance, expecting GAAP net revenue growth of 10% to 11% and non-GAAP diluted EPS in the range of $3.52 to $3.72 [36][40] - The anticipated impact of tariffs on the cost of goods is expected to be significantly lower than previously forecasted [41][42] Q&A Session Summary Question: Clarification on Rhapsody reimbursement process - Management clarified that they applied for a new technology APC assignment but did not receive it, and they plan to submit for TPT by September 1 [49][50] Question: Confidence in securing TPT - Management expressed high confidence in meeting TPT guidelines and emphasized the strength of their product and data [62] Question: Sales performance in cardiac intervention - Management attributed the growth to internal product development and the strategic acquisition of Cook Medical, expecting continued strong performance [94][96]

Summary of Merit Medical Systems (MMSI) Conference Call Company Overview - **Company**: Merit Medical Systems (MMSI) - **Event**: Rhapsody Investor Conference Call - **Date**: January 28, 2025 - **Key Participants**: Fred Lampropoulos (CEO), Brian Lloyd (CLO), John Hall (EVP R&D), Daniel Patel (Medical Director), Caleb Konstanski (VP Sales & Marketing), Raul Parra (CFO) Core Industry and Product Insights - **Industry**: Medical Device Industry, specifically focusing on dialysis access solutions - **Product**: Rhapsody Cell and Permeable Endoprosthesis (CIE) - **FDA Approval**: Received pre-market approval from the FDA in December 2024, with commercial launch initiated in January 2025 [9][10] Key Points Discussed 1. **Strategic Initiative**: The Rhapsody CIE is part of a long-term strategic initiative that began in 2010, aimed at transitioning Merit towards higher-value therapeutic medical devices [11][12][13] 2. **Market Opportunity**: - Over 660,000 people in the U.S. live with end-stage renal disease, with approximately 560,000 undergoing in-center hemodialysis [38] - The addressable market for Rhapsody CIE includes over 420,000 U.S. patients using AV fistulas or AV grafts [39][40] - In 2023, there were 665,000 dialysis access maintenance procedures, with 95,000 stent units implanted [41][42] 3. **Clinical Validation**: - Rhapsody CIE demonstrated 84.6% target lesion primary patency at 12 months and 65.9% access circuit primary patency at 12 months in clinical trials [22][25] - A total of 423 patients were studied in the U.S. and international markets, with plans to enroll up to 500 patients in a post-market study [25][26] 4. **Innovative Features**: - The Rhapsody CIE includes a cell impermeable membrane to prevent tissue growth, a modified biocompatible PTFE to reduce thrombosis, optimized compression resistance, and a user-friendly catheter delivery system [20][21][22] 5. **Commercial Strategy**: - The U.S. commercialization strategy includes intensive training for sales teams, marketing plans, and engagement with physician advocates [44][46][48] - Targeted average selling price (ASP) for Rhapsody CIE is set at $5,800, positioned as a premium product [84][86] Financial Expectations - **Revenue Forecast**: Projected U.S. revenue from Rhapsody CIE in 2025 is estimated to be between $7 million and $9 million [63] - **Reimbursement Strategy**: Applications for new technology add-on payments (NTAP) and transitional pass-through payments (TPT) are underway, with decisions expected in June 2025 [55][57] Additional Considerations - **Challenges**: Pricing sensitivity in outpatient settings and the need for larger diameter sheets for Rhapsody CIE may impact adoption [35][36] - **Future Outlook**: The Rhapsody CIE is expected to be featured in multiple medical meetings and publications throughout 2025, enhancing awareness and credibility [58][61] Conclusion - Merit Medical Systems is positioned to leverage the Rhapsody CIE as a significant advancement in dialysis access technology, with a comprehensive strategy for market entry and growth, supported by clinical validation and a focus on improving patient outcomes.