Core Viewpoint - Investors are increasingly seeking growth stocks that demonstrate above-average growth potential, with Merit Medical (MMSI) identified as a strong candidate due to its favorable growth metrics and Zacks Rank [2][10]. Group 1: Earnings Growth - Merit Medical has a historical EPS growth rate of 21.5%, with projected EPS growth of 11.2% for the current year, surpassing the industry average of 10% [4]. - The company’s strong earnings growth is a key factor attracting investor interest, particularly for growth investors who favor double-digit growth rates [3]. Group 2: Cash Flow Growth - Merit Medical's year-over-year cash flow growth stands at 12.2%, significantly higher than the industry average of -2% [5]. - The historical annualized cash flow growth rate for the company is 11.5% over the past 3-5 years, compared to the industry average of 2% [6]. Group 3: Earnings Estimate Revisions - The current-year earnings estimates for Merit Medical have been revised upward, with the Zacks Consensus Estimate increasing by 0.5% over the past month [8]. - Positive trends in earnings estimate revisions are correlated with near-term stock price movements, indicating strong potential for the company [7]. Group 4: Overall Assessment - Merit Medical has achieved a Growth Score of B and a Zacks Rank of 2, reflecting its strong growth potential and positive earnings estimate revisions, making it a solid choice for growth investors [10].

Core Insights - Merit Medical (MMSI) has a strong track record of exceeding earnings estimates, particularly in the last two quarters, with an average surprise of 6.02% [1][3] - The company reported earnings of $0.86 per share for the last quarter, surpassing the Zacks Consensus Estimate of $0.80 per share by 7.50% [2] - The positive Earnings ESP of +3.03% indicates that analysts are optimistic about Merit Medical's near-term earnings potential, combined with a Zacks Rank of 2 (Buy) [6] Earnings Performance - In the previous quarter, Merit Medical's earnings were $0.92 per share against an expected $0.88, resulting in a surprise of 4.55% [2] - The favorable change in earnings estimates reflects analysts' growing confidence in the company's performance [3] Earnings ESP and Predictions - The Zacks Earnings ESP is a valuable metric that compares the Most Accurate Estimate to the Zacks Consensus Estimate, suggesting that recent analyst revisions may provide more accurate predictions [5] - Stocks with a positive Earnings ESP and a Zacks Rank of 3 or better have a nearly 70% chance of producing a positive surprise [4] Upcoming Earnings Report - Merit Medical's next earnings report is anticipated to be released on February 25, 2025, and the current indicators suggest a potential earnings beat [6]

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.

Merit Medical's Strategic Acquisitions and Market Position - The acquisition of Cook Medical's lead management portfolio is expected to enhance Merit Medical's position in the cardiac intervention market, particularly in Europe, with an estimated annual addressable opportunity of over $900 million across multiple regions [1] - The addition of the lead management business is anticipated to contribute more than $100 million in combined annualized CRM/EP revenues starting in 2025, strengthening the company's global cardiac intervention market presence [1] - The acquisition is also expected to boost Merit Medical's fast-growing, high-margin cardiac rhythm management/electrophysiology (CRM/EP) business [7] Merit Medical's Financial Performance and Guidance - Preliminary full-year 2024 revenues are estimated to be between $1.355 billion and $1.357 billion, representing a 7.7-7.9% increase from 2023 [4] - At constant currency, full-year 2024 revenues are projected to grow by 8.4-8.6% compared to 2023 [5] - The company plans to issue its full-year 2025 guidance alongside its fourth-quarter 2024 results announcement [6] Merit Medical's U.S. Market Strategy and WRAPSODY Program - The company is focused on entering the U.S. market following premarket approval, with a comprehensive U.S. commercial strategy in development [12] - Positive six-month findings from the WRAPSODY WAVE pivotal trial and progress in U.S. regulatory and reimbursement strategies highlight the potential of the WRAPSODY program [8] Merit Medical's Stock Performance and Industry Comparison - Shares of Merit Medical lost 0.9% between Oct. 1 and Dec. 31, 2024, underperforming the industry's 0.8% rise and the S&P 500's 3.7% gain [2] - Despite the short-term underperformance, the company's Zacks Rank of 2 (Buy) reflects positive sentiment [9] Industry Peers and Their Performance - Cencora (COR) has an estimated long-term growth rate of 10.4% and gained 0.2% between Oct. 1 and Dec. 31, 2024, outperforming the industry's 12.7% decline [3] - Labcorp (LH) has an estimated long-term growth rate of 8.4% and saw its shares rally 4.6% compared to the industry's 0.8% growth during the same period [3][10] - Cardinal Health (CAH) has an estimated long-term growth rate of 10.5% and gained 7.2% compared to the industry's 0.8% growth between Oct. 1 and Dec. 31, 2024 [13]

Core Viewpoint - Merit Medical Systems, Inc. reported preliminary unaudited revenue for the year ended December 31, 2024, in the range of approximately $1.355 to $1.357 billion, indicating a projected increase of about 7.7% to 7.9% compared to the previous year [2][8]. Financial Performance - The preliminary constant currency revenue for the year ended December 31, 2024, increased by approximately 8.4% to 8.6% compared to the prior year [2][8]. - The preliminary unaudited revenue for 2024 is estimated to be between $1.355 billion and $1.357 billion, with a year-over-year increase of 7.7% to 7.9% [8][10]. Upcoming Announcements - Merit plans to announce its financial results for the quarter and year ended December 31, 2024, and provide fiscal year 2025 guidance on February 25, 2025 [3][8]. - An investor conference call is scheduled for the same day at 5:00 p.m. Eastern [3][4]. Non-GAAP Financial Measure - The company uses a non-GAAP financial measure of constant currency revenue to provide insights into underlying business trends and performance, which may be useful for period-over-period comparisons [5][6]. - The constant currency revenue is adjusted for foreign exchange rates and hedging transactions, reflecting a more accurate performance measure [6][10].

Core Viewpoint - Merit Medical Systems, Inc. (MMSI) has received FDA premarket approval for its WRAPSODY Cell-Impermeable Endoprosthesis, which is expected to enhance its market position in the vascular intervention space and drive future revenue growth [20][19]. Company Summary - MMSI currently has a market capitalization of $5.72 billion, with fiscal 2024 revenue estimates at $1.35 billion, reflecting a 7.2% growth from fiscal 2023 [2]. - The WRAPSODY device is designed to improve long-term vessel patency in dialysis patients, addressing complications such as stenosis and thrombosis [12][4]. - The WRAPSODY WAVE pivotal trial showed promising results, with primary patency rates of 89.8% for AV fistula and 82.0% for AV graft patients at six months [13]. - Following the FDA approval announcement, MMSI's shares increased by 2.03% to $98.22, with a 29.9% gain over the past year compared to the industry’s 2.2% growth [10]. Industry Summary - The global hemodialysis market was valued at $76.9 billion in 2022 and is projected to reach $111.8 billion by 2032, growing at a CAGR of 3.8% [21]. - The need for improved dialysis access solutions is underscored by the prevalence of chronic cardiac diseases and end-stage renal disease, driving demand for advanced medical devices like the WRAPSODY [21][22]. - The FDA approval of the WRAPSODY device positions Merit Medical to capitalize on the growing market for vascular interventions, enhancing its competitive edge and opening new revenue streams [19].

Core Insights - Merit Medical Systems, Inc. has received premarket approval from the US FDA for the WRAPSODY Cell-Impermeable Endoprosthesis, allowing for commercialization in the USA starting in 2025 [6] - The WRAPSODY device is designed to improve long-term vessel patency in hemodialysis patients, addressing common issues such as stenosis and thrombosis [12][19] - Clinical trial results indicate high efficacy of the WRAPSODY device, with primary patency rates of 89.8% for AV fistula and 82.0% for AV graft patients at six months [18] Company Overview - Merit Medical, founded in 1987, specializes in the development, manufacture, and distribution of proprietary disposable medical devices for interventional, diagnostic, and therapeutic procedures [10] - The company employs approximately 7,200 individuals globally and serves hospitals worldwide with a dedicated sales force and clinical support team [10] Product Details - The WRAPSODY device features a unique design with a nitinol stent frame and a multi-layer structure aimed at reducing tissue accumulation and improving blood flow [7][12] - The device is indicated for use in treating stenosis or occlusion in the dialysis access outflow circuit, specifically in peripheral veins of individuals with AV fistulas and at the venous anastomosis of synthetic AV grafts [11] Market Context - In the United States, approximately 687,000 procedures are performed annually to maintain dialysis access, with nearly 100,000 involving stent placement [17] - The WRAPSODY device is expected to set a new standard of care in the treatment of vascular access complications for dialysis patients, as indicated by the positive outcomes from the WAVE trial [19]

SOUTH JORDAN, Utah, Dec. 16, 2024 (GLOBE NEWSWIRE) -- Merit Medical Systems, Inc. (NASDAQ:MMSI) ("Merit" or the "Company"), a global leader of healthcare technology, today announced the resignation of its President, Joseph C. Wright, effective January 3, 2025. The Company noted that prior to Mr. Wright's resignation, Merit had received notice of allegations regarding his conduct, which Merit's independent directors investigated with the assistance of independent counsel. The allegations were unrelated to Me ...

Core Insights - Investors in the Medical - Dental Supplies sector should consider Merit Medical (MMSI) and West Pharmaceutical Services (WST) for potential value opportunities [1] Zacks Rank and Value Scores - Merit Medical has a Zacks Rank of 2 (Buy), indicating a positive earnings outlook, while West Pharmaceutical Services has a Zacks Rank of 3 (Hold) [3] - The Zacks Rank system emphasizes companies with positive earnings estimate revisions, suggesting that MMSI is likely experiencing a more favorable earnings outlook [3] Valuation Metrics - MMSI has a forward P/E ratio of 30.86, compared to WST's forward P/E of 48.47, indicating that MMSI may be undervalued relative to WST [5] - The PEG ratio for MMSI is 2.57, while WST's PEG ratio is significantly higher at 24.42, suggesting that MMSI has better growth potential relative to its price [5] - MMSI's P/B ratio is 4.56, while WST's P/B ratio is 8.51, further indicating that MMSI is more attractively valued [6] Value Grades - Based on the analysis, MMSI earns a Value grade of B, while WST receives a Value grade of D, highlighting MMSI as the more favorable option for value investors [6]

Company Overview - Merit Medical Systems, Inc. (MMSI) announced positive six-month findings from the single-arm Arteriovenous Graft (AVG) cohort of its WRAPSODY Arteriovenous Access Efficacy (WAVE) pivotal trial, which assesses the efficacy and safety of the WRAPSODY device [1][3] - The WRAPSODY Cell-Impermeable Endoprosthesis is currently not approved for commercial distribution in the United States but is available in Brazil and the European Union [2] - The device is being used in the U.S. under an Investigational Device Exemption from the FDA, with findings from the WAVE trial supporting the premarket approval application for commercial use [3] Market Position and Financials - Merit Medical has a market capitalization of $6.12 billion and a projected earnings per share growth of 11.6%, higher than the industry's 7.5% [6] - The company delivered an earnings surprise of 7.5% in the last reported quarter [6] - Following the announcement of the trial findings, shares of the company lost nearly 0.4% at closing, despite historical synergies from product launches and positive trial outcomes [5] Product Significance - The WRAPSODY device is designed to restore and extend vessel access (patency) in hemodialysis patients, which is critical for patient survival [7] - Favorable results from the AVG arm of the WAVE trial are encouraging for physicians managing AVG patients, given the historically low patency rates [8] Industry Prospects - The global hemodialysis market was valued at $76.9 billion in 2022 and is anticipated to reach $111.8 billion by 2032, growing at a CAGR of 3.8% [9] - Factors driving the market include increasing awareness of hemodialysis and the rising prevalence of chronic cardiac diseases and end-stage renal disease [9] - The positive trial outcome is expected to solidify Merit Medical's foothold in the hemodialysis market [10] Recent Developments - In September, MMSI announced positive six-month findings from the randomized arteriovenous fistula arm of its WRAPSODY WAVE pivotal trial [11] - Over the past year, shares of the company have gained 46.2%, outperforming the industry's 9.1% rise and the S&P 500's 31.6% growth [12]