Apyx Medical reports Q4 EPS (17c), consensus (14c)

Reports Q4 revenue $12.6M, consensus $12.94M. "Our revenue performance in the fourth quarter reflected the continued business disruption related to the Medical Device Safety Communication," said Charlie Goodwin, President and Chief Executive Officer. "While Advanced Energy revenue in the fourth quarter increased 49% sequentially, our results were ultimately below our expectations as global sales of our Advanced Energy generators remained lower than anticipated. In spite of these challenges, our team remained focused on educating the market about the strong safety and efficacy profile of our products and the additional 510(k) clearances we secured in 2022. In tandem, we continued to pursue regulatory clearance for a specific clinical indication which we believe will directly address the remaining limitations of the Safety Communication. To this end, we engaged with the FDA to obtain and incorporate their feedback on our proposed regulatory submission for this indication during the fourth quarter, and submitted our request for 510(k) clearance at the end of January." Goodwin continued: "While 2022 ultimately proved to be a challenging year, our team made important progress under difficult circumstances. We believe we are incrementally better positioned in 2023, with an expanding portfolio of 510(k) clearances for our targeted clinical indications, recently implemented activities to reduce operating expenses while preserving our capabilities as an organization, and additional financing secured to strengthen our balance sheet and enhance our financial flexibility. In 2023, we expect to grow global sales of our Advanced Energy products in excess of 35%, fueled by strong execution on our commercial and regulatory objectives, improving generator demand and handpiece utilization trends as we move through fiscal 2023. With large and rapidly growing addressable markets, unique technology supported by a strong portfolio of clinical evidence, and a dedicated team of employees, we are excited about our future prospects in 2023 and the years to come."