Core Insights - Merit Medical Systems reported strong Q2 2025 results with GAAP revenue of $382.5 million, a 13.2% increase year-over-year, surpassing analyst expectations of $374.2 million [1][2] - Non-GAAP EPS reached $1.01, exceeding the estimate of $0.85, while GAAP EPS declined 11.6% to $0.54 [1][2] - The company experienced broad-based growth, particularly in the Cardiac Intervention and Endoscopy device lines, and raised its full-year revenue and non-GAAP earnings outlook [1][10] Financial Performance - Q2 2025 Non-GAAP EPS was $1.01, up 9.8% from $0.92 in Q2 2024 [2] - GAAP revenue was $382.5 million, compared to $338.0 million in Q2 2024, reflecting a 13.2% year-over-year increase [2] - Non-GAAP gross margin improved to 53.2%, and operating margin rose to 21.2% [2][7] Product Segment Performance - Cardiovascular devices generated $364.0 million, an 11.0% increase, with Cardiac Intervention products up 23.5% year-over-year [5] - The Endoscopy segment saw an 81.0% rise to $18.4 million, driven by acquisitions [6] Strategic Focus and Investments - The company emphasizes continuous product development, international market expansion, and regulatory compliance [3][4] - R&D investment for the quarter was $24.4 million, indicating a commitment to innovation [7] Acquisition and Compliance Costs - The quarter included significant acquisition and compliance expenses, with $21.5 million in amortization of acquired intangible assets and $1.6 million in MDR compliance costs [8] - Integration costs from recent acquisitions were recognized in non-GAAP adjustments, reflecting the company's growth strategy [8] Cash Flow and Capital Expenditures - Merit generated $89.1 million in free cash flow (non-GAAP) in the first half of 2025, an 8.1% increase year-over-year [9] - Capital expenditures rose to $34.8 million as the company invested in new products and expanded capacity [9] Future Outlook - Management raised FY2025 revenue guidance to $1.495–$1.507 billion and non-GAAP EPS to $3.52–$3.72 [10] - Cardiovascular segment revenue is projected to be $1.423–$1.434 billion, while the Endoscopy segment is expected to reach $72–$73 million [10]

Core Insights - ReShape Lifesciences has achieved certification for its Quality Management System (QMS) and medical devices under the EU Medical Device Regulation (MDR) and UK Conformity Assessment (UKCA), ahead of the December 31, 2027 deadline [1][3] - The EU MDR, effective since May 2021, imposes stricter requirements for clinical evaluation, post-market surveillance, and device traceability to enhance patient safety and product quality across the European Economic Area [2] - The certification positions ReShape Lifesciences among a select group of manufacturers compliant with the EU's rigorous standards, enabling the company to expand its product pipeline and maintain market access in Europe [3] Company Overview - ReShape Lifesciences specializes in weight loss and metabolic health solutions, offering a range of products including the FDA-approved Lap-Band System and investigational Diabetes Bloc-Stim Neuromodulation™ (DBSN™) system [4] - The company’s offerings include non-surgical options like the Obalon balloon technology, designed for long-lasting weight loss [4]