APYX — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-05-07

• The GLP market continues to rapidly evolve from a niche, high priced injectable drug segment to a broad competitive and increasingly accessible metabolic health platform. Recent approvals are expanding indications (beyond diabetes into obesity and cardiovascular risk) are significantly increasing th…

• We believe the increased use of GLP-1s had an initial negative impact on revenue for plastic and cosmetic surgeons and created uncertainty in the aesthetic space. However, we believe, that the use of these drugs will have a ripple effect which will drive people towards plastic surgery and may provid…

• October 13, 2025, we announced that we had submitted the 510(k) premarket notification to the FDA for the label expansion of AYON to include power liposuction. We anticipate receiving clearance in the second quarter of 2026.

• The consequences of global supply chain instability, inflationary cost increases, potential and actual tariffs, and their adverse impact to the global economy, continue to evolve. Accordingly, the significance of the future impact to our business and financial statements remains subject to significa…

• International sales represented approximately 35.1% of total revenues for the three months ended March 31, 2026 as compared with 28.5% of total revenues for the same period in the prior year. Management estimates our products have been sold in more than 60 countries through local dealers, coordinate…

Text removed vs the prior filing · source: 10-Q · 2025-11-06

• We believe the increased use of GLP-1s had an initial negative impact on the revenue for plastic and cosmetic surgeons and created uncertainty in the aesthetic space. However, we believe, that the use of these drugs will have a ripple effect which will drive people towards plastic surgery and may pr…

• On May 13, 2025, we announced that we had received 510(k) clearance from the U.S. Food and Drug Administration (the “FDA”) for the AYON Body Contouring System™ (“AYON”). We completed our soft launch of AYON, leveraging our relationships with key surgeons in critical geographies. Additionally, we com…

• The initial 510(k) clearance for AYON covers a wide variety of aesthetic treatments, including Renuvion to address loose and lax skin, ultrasound-assisted liposuction, electrosurgery to support procedures requiring removal of excess tissue and closed loop contouring, among others. October 13, 2025, …

• In November 2024, we undertook a cost saving restructuring which included an organizational reduction in force to better focus, optimize and streamline operations. As a result of the organizational changes, we reduced our workforce by nearly 25%. We estimate the annualized future cost savings from t…

• We are actively monitoring trade policy and tariff announcements including the recent executive orders issued by the U.S. federal administration regarding tariffs on imports from various countries, including the European Union, Canada, Mexico and China. In addition, we are monitoring the potential i…