Apyx Medical(APYX) - 2019 Q3 - Earnings Call Transcript

Financial Data and Key Metrics Changes - Total revenue for Q3 2019 was $7.6 million, representing a growth of $3.9 million or 106% year-over-year [6][22] - Gross profit increased by approximately $2.5 million or 99% year-over-year to $5 million, with gross margins at 66.2% compared to 68.7% in the previous year [24] - Net loss from continuing operations for Q3 2019 was $4.3 million or $0.13 per diluted share, compared to a net loss of $438,000 or $0.01 per diluted share in Q3 2018 [25] Business Line Data and Key Metrics Changes - Advanced Energy segment sales increased by $3.1 million or 104% year-over-year to $6.1 million [22] - OEM segment sales increased by $800,000 or 116% year-over-year to $1.5 million, driven by sales related to a manufacturing agreement with Symmetry Surgical [22][23] Market Data and Key Metrics Changes - U.S. sales increased by $2.8 million or 101% year-over-year to $5.6 million, with advanced energy sales up by 96% and OEM sales up by 116% [8][23] - International sales increased by $1.1 million or 123% year-over-year to $2 million, with significant growth in Europe and Latin America [8][23] Company Strategy and Development Direction - The company is focused on four strategic initiatives: formalizing regulatory strategy, securing new clinical evidence, enhancing physician support, and improving manufacturing capabilities [10] - The company aims to position itself for long-term growth in the cosmetic surgery market through these initiatives [10] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strong financial performance and operational progress, raising guidance for revenue, net loss, and adjusted EBITDA loss for 2019 [32] - The company is optimistic about the global demand for its Advanced Energy technologies and aims to establish itself as a leader in the cosmetic surgery market [32] Other Important Information - The company updated its fiscal year 2019 revenue guidance to a range of $27.4 million to $27.9 million, representing growth of 64% to 67% year-over-year [28][29] - The company has made significant progress in regulatory affairs, including the initiation of clinical studies for new indications [12][15] Q&A Session Summary Question: Can you provide updates on international clearances? - Management indicated that they are pursuing registrations in international markets and have entered four new countries in 2019, but no new material countries are expected in Q4 2019 [36] Question: What are the next steps if the skin laxity trial is successful? - If the pilot study is successful, the company will submit the data to the FDA and, if approved, will proceed to Phase II of the study [37] Question: Will the skin laxity trial involve standalone Renuvion therapy? - Yes, the trial will involve Renuvion-only therapy without liposuction [40] Question: What is the timeline for the dermal resurfacing study? - Enrollment for the dermal resurfacing study is expected to begin by the end of the year [45] Question: How is the company managing supply and demand for handpieces? - The company is focused on operational excellence and is successfully keeping up with demand while seeing lower costs due to efficiency improvements [46]