Merit Med Sys Inc - MMSI STOCK NEWS

Merit Medical Systems (NASDAQ: MMSI) announced positive six-month results from the single-arm AVG cohort of its WRAPSODY WAVE pivotal trial. The trial, involving 112 patients across 43 international sites, demonstrated 82% target lesion primary patency and 68.8% access circuit primary patency at six months. The WRAPSODY device achieved an efficacy rate of 81.4%, significantly exceeding the performance goal of 60% (p<0.0001). Safety outcomes were also favorable, with 95.4% of patients free from adverse events, surpassing the 89% performance goal (p=0.0162). The WRAPSODY Cell-Impermeable Endoprosthesis is designed to restore vessel access in hemodialysis patients and is currently available in Brazil and the European Union, pending FDA approval in the US.

Merit Medical Systems has completed the acquisition of Cook Medical's lead management portfolio for approximately $210 million, funded through cash on hand and credit facility borrowings. The acquired portfolio includes medical devices and accessories for lead management procedures in patients requiring pacemaker or defibrillator lead removal. This strategic move aims to strengthen Merit's electrophysiology and CRM business while enhancing its position in the global cardiac intervention market. The acquisition complements Merit's existing portfolio of steerable and specialty technologies used in cardiac rhythm disorder treatments.

Merit Medical Systems (NASDAQ: MMSI) reported strong Q3 2024 results with revenue of $339.8 million, up 7.8% year-over-year. The company achieved a GAAP operating margin of 11.0% and non-GAAP operating margin of 19.2%. GAAP EPS increased 8.0% to $0.48, while non-GAAP EPS grew 21.1% to $0.86. Free cash flow generation reached $120 million in the first nine months of 2024, up 116%. Based on strong performance, Merit raised its full-year 2024 guidance, projecting revenue between $1.344-$1.352 billion and non-GAAP EPS of $3.33-$3.38.

Merit Medical Systems (NASDAQ: MMSI) has announced it will release its financial results for the third quarter of 2024 on Wednesday, October 30, 2024, after the stock market closes. The company will hold an investor conference call on the same day at 5:00 p.m. Eastern time.

Interested parties can pre-register for the conference call to receive dial-in details. A live webcast and slide deck will also be available. Links for both the call registration and webcast will be provided on Merit's website.

Merit Medical Systems, founded in 1987, is a leading global manufacturer and marketer of healthcare technology. The company specializes in proprietary medical devices used in various medical procedures, particularly in cardiology, radiology, oncology, critical care, and endoscopy. Merit employs approximately 7,200 people worldwide and has a sales force and clinical support team of over 700 individuals serving customers globally.

Merit Medical Systems (NASDAQ: MMSI) has signed an agreement to purchase Cook Medical's lead management portfolio for $210 million. The acquisition is expected to add approximately $40 million in annual revenue starting in fiscal year 2025, strengthening Merit's electrophysiology and CRM business. The deal is projected to close in Q4 2024, subject to regulatory approvals.

Key points:

• Acquisition aligns with Merit's Continued Growth Initiatives (CGI)
• Expands Merit's presence in the cardiac intervention market
• Expected to be accretive to non-GAAP gross margin immediately
• Projected to be accretive to non-GAAP operating margin in the first full year post-close
• Anticipated to be accretive to non-GAAP earnings per share in the second full year post-close

Merit has updated its 2024 financial guidance to reflect the acquisition's impact, projecting net sales of $1.339 - $1.351 billion and non-GAAP earnings per share of $3.25 - $3.34.

Merit Medical Systems (NASDAQ: MMSI) announced positive 6-month results from the randomized arteriovenous (AV) fistula arm of its WRAPSODY Arteriovenous Access Efficacy (WAVE) pivotal trial. The study, involving 245 patients at 43 sites, compared WRAPSODY, a cell-impermeable endoprosthesis, to percutaneous transluminal angioplasty (PTA) for maintaining blood flow in dialysis patients' AV fistulas.

Key findings include:

• WRAPSODY achieved 89.8% target lesion primary patency at 6 months, compared to 62.8% for PTA (p<0.0001)
• Similar adverse event rates between WRAPSODY and PTA groups
• Results support WRAPSODY as a potential new standard of care for AV fistula patients

The data, presented at CIRSE 2024, will support Merit Medical's Premarket Approval application to the FDA for commercial use in the United States.

Merit Medical Systems (NASDAQ: MMSI) announced its participation in the 2024 Cardiovascular and Interventional Radiological Society of Europe (CIRSE) Annual Congress in Lisbon, Portugal. The company will present updates on two pivotal studies:

1. 6-month clinical outcomes from the WAVE study during the FIRST@CIRSE Clinical Trial session.

2. An overview of the MOTION study design and methodology during the News on Stage session.

Merit will also sponsor two symposia focusing on:

• Clinical management of synovial arterial hypervascularity in the knee (September 15)
• Maintaining long-term patency for hemodialysis patients (September 16)

These sessions can be viewed with a free myCIRSE account, with on-demand access available within 24 hours after the live sessions.

Merit Medical Systems (NASDAQ: MMSI) reported strong Q2 2024 results, with revenue of $338.0 million, up 5.6% year-over-year. Constant currency revenue increased 6.6%, while organic constant currency revenue grew 5.0%. The company's GAAP EPS rose 75.7% to $0.61, and non-GAAP EPS increased 16.8% to $0.92. Merit's GAAP operating margin improved to 13.6% from 9.0% in the prior year period, while non-GAAP operating margin expanded to 20.1% from 19.1%.

Based on these results, Merit has raised its full-year 2024 guidance. The company now expects net sales of $1,335 - $1,345 million, representing 6-7% growth, and non-GAAP EPS of $3.27 - $3.35, a 15-17% increase year-over-year. This updated guidance includes the impact of the EndoGastric Solutions acquisition completed on July 1, 2024.

Merit Medical Systems (NASDAQ: MMSI) announced plans to release findings from its WAVE study, examining the safety and efficacy of the WRAPSODY Cell-Impermeable Endoprosthesis for treating stenosis in the venous outflow circuit. The study enrolled 245 patients with arteriovenous fistula (AVF) stenosis and 113 with arteriovenous graft (AVG) stenosis.

Six-month safety and efficacy findings for the AVF cohort will be presented at the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) on September 14, 2024, in Lisbon. Additional presentations are scheduled at CIRSE and the Controversies in Dialysis Access (CiDA) Symposium in October.

The WRAPSODY device is not yet approved in the US but has received CE Mark for use in the European Union and is available in Brazil. Results from the WAVE study are expected to support Merit's Premarket Approval application to the FDA for commercial use in the United States.