Merit Med Sys Inc Stock Price, News & Analysis

Merit Medical Systems (NASDAQ: MMSI) has announced the enrollment of the first patient in its PREEMIE study, evaluating the Bloom Micro Occluder System for treating patent ductus arteriosus (PDA) in premature infants.

The multicenter, prospective study aims to enroll at least 55 premature infants weighing between 600g and 2,500g at up to ten U.S. sites. The study will evaluate the safety and efficacy of the device through six months as part of the premarket approval application.

The Bloom system is designed as a minimally invasive treatment option, using a flexible delivery system to insert a self-expanding nitinol device that blocks blood flow through the PDA. Currently, there is no approved device for PDA treatment in premature infants as small as 600 grams.

Merit Medical Systems (NASDAQ: MMSI) reported strong Q4 2024 results with revenue of $355.2 million, up 9.4% year-over-year. The company achieved constant currency revenue growth of 10.1% and organic growth of 6.1%.

Key Q4 metrics include GAAP operating margin of 10.3%, non-GAAP operating margin of 19.6%, and GAAP EPS of $0.46. Free cash flow increased 18.4% to $65.3 million.

For full-year 2024, Merit reported revenue of $1.357 billion, up 7.9%, with GAAP EPS of $2.03 (up 25.3%) and free cash flow of $185.7 million (up 67.5%).

Notable developments include the acquisition of Cook Medical's lead management portfolio, FDA approval of the Wrapsody device for dialysis patients, and integration of the EsophyX Z+ device.

The company issued FY2025 guidance projecting revenue of $1.470-1.490 billion (8-10% growth) and non-GAAP EPS of $3.58-3.70 (4-7% growth).

Merit Medical Systems (NASDAQ: MMSI) has announced preliminary unaudited revenue for 2024 ranging between $1.355 billion and $1.357 billion, representing a year-over-year growth of approximately 7.7% to 7.9%. On a constant currency basis, revenue growth is estimated between 8.4% and 8.6% compared to 2023.

The company plans to release its complete financial results for Q4 and full-year 2024, along with fiscal year 2025 guidance, after market close on February 25, 2025. An investor conference call will be held the same day at 5:00 p.m. Eastern time to discuss the results.

Merit Medical Systems (NASDAQ: MMSI) has received FDA premarket approval for its WRAPSODY Cell-Impermeable Endoprosthesis, enabling US commercialization in 2025. The device is designed to extend long-term vessel patency in dialysis patients who rely on arteriovenous (AV) fistulas or grafts.

The WRAPSODY device features a unique three-layer design with a nitinol stent frame, addressing common complications like stenosis and thrombosis. Clinical results from the WRAPSODY WAVE trial showed impressive target lesion primary patency rates of 89.8% for AV fistula and 82.0% for AV graft patients at six months.

Merit will host an informational conference call on January 28, 2025, to discuss the commercial opportunity.

Merit Medical Systems (NASDAQ: MMSI) announced the resignation of President Joseph C. Wright, effective January 3, 2025, following allegations regarding his conduct that were investigated by independent directors and counsel. The allegations were unrelated to Merit's operations or financial performance. Fred P. Lampropoulos has been re-appointed as Merit's President. Merit Medical, founded in 1987, is a global healthcare technology company specializing in proprietary disposable medical devices for interventional, diagnostic, and therapeutic procedures. The company employs approximately 7,200 people worldwide and maintains a sales force and clinical support team of over 700 individuals serving hospitals globally.

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.