Group 1 - Renuvion is recognized as the "Best Minimally Invasive Skin Tightener" by NewBeauty Awards, highlighting its effectiveness in addressing consumer beauty concerns [1][2] - The technology is the only FDA-cleared device for use after liposuction, with over 90 evidence-based clinical publications supporting its long-lasting results from a single treatment [2][5] - There has been a significant increase in consumer interest regarding loose skin, with searches for "sagging skin" rising by 168.7% in 2024 compared to the previous year [2] Group 2 - Apyx Medical Corporation specializes in advanced energy technology, particularly through its Helium Plasma Platform Technology marketed as Renuvion in cosmetic surgery and J-Plasma in hospital surgical markets [5] - The company emphasizes its ability to provide controlled heat to tissue, which is crucial for achieving desired surgical outcomes [5] - Apyx Medical has established OEM agreements with other medical device manufacturers, leveraging its expertise in unique waveforms [5]

Financial Data and Key Metrics Changes - Total revenue for Q4 2024 was $14.2 million, a decrease of 3% compared to $14.7 million in Q4 2023 [7][23] - Gross profit for Q4 2024 increased to $9 million, with a gross profit margin of 63.0%, up from 60.9% in the prior year [25] - Net loss attributable to stockholders was $4.6 million or $0.12 per share for Q4 2024, compared to a net loss of $9.6 million or $0.28 per share in Q4 2023 [28] Business Segment Data and Key Metrics Changes - Advanced Energy segment revenue was flat at approximately $12.1 million, with a 30% increase compared to Q3 2024 [8][24] - OEM segment sales decreased by 16% to approximately $1.6 million in Q4 2024 compared to Q4 2023 [24] - Domestic revenue increased by 1% year-over-year to $10.6 million, while international revenue decreased by 8% to $3.7 million [25] Market Data and Key Metrics Changes - The aesthetic market has faced challenges due to the macroeconomic environment and the adoption of GLP-1 drugs, which have diverted discretionary spending [9][10] - The company believes that patients who have lost weight due to GLP-1 drugs will seek surgical solutions, positioning the Renuvion system favorably [11][12] Company Strategy and Development Direction - The company is focusing on the launch of the AYON Body Contouring System, expected in the second half of 2025, which integrates multiple surgical technologies [16][18] - Apyx Medical aims to capitalize on the growing demand for surgical aesthetics, particularly for patients experiencing skin laxity after significant weight loss [12][60] - A restructuring program was implemented to reduce U.S. workforce by nearly 25%, aiming for annualized cost savings of approximately $4.3 million [20][21] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the momentum in the Advanced Energy segment and the potential for growth in 2025 [8][9] - The company anticipates total revenue for 2025 to be in the range of $47.6 million to $49.0 million, reflecting a slight increase from 2024 [30] - Management noted that the aesthetic space is experiencing disruption due to the impact of GLP-1 drugs, which could benefit companies with the right technologies [62] Other Important Information - The company completed a registered direct offering with net proceeds of approximately $6.8 million to strengthen its balance sheet [21] - Cash and cash equivalents as of December 31, 2024, were $31.7 million, down from $43.7 million a year earlier [29] Q&A Session Summary Question: Confirmation of gross margin for 2025 - Management confirmed that they expect gross margins to be around 60% for 2025 [34][35] Question: Timing and revenue expectations for AYON - Management indicated that the guidance for AYON has not been updated despite the earlier submission for FDA approval, and revenue expectations remain conservative [40][41] Question: Changes in direct-to-consumer campaign and future outlook - Management highlighted the success of the DTC campaign and the importance of addressing the needs of patients experiencing skin laxity due to weight loss [50][52] Question: Domestic vs. international market performance - Management noted that the U.S. market is performing better due to early adoption of GLP-1 drugs, with expectations for similar trends internationally [56][58] Question: Adoption of GLP-1s and utilization of Renuvion - Management reported growth in handpiece sales in the U.S. and noted that surgical practices are adapting to treat patients with skin laxity effectively [66][70] Question: Upgrades for the Apyx One Console - Management stated that there is still a significant number of customers who need to upgrade to the Apyx One Console before AYON's launch [72][75]

Financial Performance - For the year ended December 31, 2024, Apyx Medical incurred a loss from operations of $18.8 million and used $18.0 million of cash in operations[22]. - As of December 31, 2024, Apyx Medical had cash and cash equivalents of $31.7 million[22]. - The company plans to reduce annual operating expenses below $40 million in 2025 through identified cost savings[23]. - The company closed a $7.0 million registered direct offering, issuing 3,000,000 shares of common stock[29]. - The company anticipates needing to raise additional capital to fund operations due to recurring net losses and demand for technology adoption[97]. - The company incurred pre-tax charges of approximately $0.6 million in Q4 2024 for severance and employee termination benefits[22]. Cost-Saving Measures - The company reduced its U.S. workforce by nearly 25% as part of a cost-saving restructuring, estimating annualized future cost savings of approximately $4.3 million[22]. - The voluntary employee turnover rate was approximately 11.8% during 2024, reflecting the company's workforce stability[48]. Product Development and Regulatory Approvals - Apyx Medical submitted a 510(k) premarket notification to the FDA for the AYON Body Contouring System on January 6, 2025[20]. - The company plans to submit an additional 510(k) application for AYON in 2025 to expand its indications to include power-assisted liposuction[67]. - The Renuvion technology has received FDA clearance and CE mark, allowing for its sale in multiple countries, and is designed for controlled heat application in cosmetic procedures[59]. - The Renuvion APR handpiece received FDA clearance for coagulation of subcutaneous soft tissues following liposuction on May 10, 2023[83]. - The Renuvion Micro handpiece was cleared by the FDA on June 14, 2023, for delivering RF energy and/or helium plasma for soft tissue coagulation[84]. Market Trends and Opportunities - The global aesthetic surgery market is projected to grow steadily, driven by social media influence, beauty standards, and rising disposable income, despite a 2.9% year-over-year decline in liposuction procedures[39]. - The company anticipates that the increased use of GLP-1 medications may eventually drive demand for plastic surgery and Renuvion products due to associated skin laxity[38]. - Renuvion is the only FDA-approved device for treating skin laxity post-liposuction, potentially expanding the total available market for the company's products[38]. Intellectual Property - The company has been issued 38 patents in the U.S. and 57 foreign patents, with 14 pending U.S. patent applications and 19 pending foreign applications, indicating a strong focus on intellectual property[41]. - The company relies on trade secrets and non-disclosure agreements to protect its proprietary information, but breaches could lead to loss of competitive advantage[112]. Competitive Position - The company is the only one with helium-based plasma products and four specific FDA indications, maintaining a competitive position despite facing competition from RF-based and CO2 laser products[76]. - The company aims to become the sole provider of surgical equipment in the cosmetic surgery market through its direct sales force and international distributors[61]. Supply Chain and Regulatory Challenges - The company continues to face potential supply chain disruptions but has not yet experienced a meaningful backlog of sales orders[43]. - The company relies on global supply chains, which are subject to regulatory requirements and unexpected changes affecting sourcing and pricing[88]. - Increased regulatory scrutiny and enforcement may materially affect the company's financial condition and business operations[77]. - The global regulatory environment for medical devices is becoming increasingly stringent, impacting the time and cost of obtaining product approvals[125]. Manufacturing and Environmental Considerations - The company’s manufacturing facilities are located in Clearwater, Florida, and Sofia, Bulgaria, and are vulnerable to weather risks, particularly hurricanes[118]. - The company is subject to stringent environmental regulations that may impact manufacturing and sterilization processes, including compliance with laws like REACH and Proposition 65[133]. Future Outlook - The company is committed to investing in the development and marketing of Renuvion technology for long-term growth, although future revenue and profitability are uncertain[70]. - The company expects to launch the AYON product in 2025, but successful commercialization depends on obtaining necessary regulatory approvals and demonstrating safety and efficacy[102].

Financial Data and Key Metrics Changes - Total revenue for Q4 2024 was $14.2 million, a slight decrease of 3% compared to $14.7 million in Q4 2023 [7][23] - Gross profit for Q4 2024 increased to $9 million, with a gross profit margin of 63.0%, up from 60.9% in the prior year [25] - Net loss attributable to stockholders was $4.6 million or $0.12 per share for Q4 2024, compared to $9.6 million or $0.28 per share in Q4 2023 [28] Business Segment Data and Key Metrics Changes - Advanced Energy segment revenue was flat at approximately $12.1 million, with a 30% growth compared to Q3 2024 [8][24] - OEM segment sales decreased by 16% to approximately $1.6 million in Q4 2024 compared to Q4 2023 [24] - Domestic revenue increased by 1% year-over-year to $10.6 million, while international revenue decreased by 8% to $3.7 million [25] Market Data and Key Metrics Changes - The aesthetic market has faced softness due to macroeconomic factors and the adoption of GLP-1 drugs, which have diverted discretionary spending [9][10] - The company anticipates a surge in demand for surgical solutions as patients who have lost weight from GLP-1 drugs seek treatments for loose skin [11][12] Company Strategy and Development Direction - The company is focusing on the launch of the AYON Body Contouring System, expected in the second half of 2025, which integrates multiple surgical technologies [16][18] - Apyx Medical aims to position itself as a leader in surgical aesthetics, leveraging its proprietary technology and direct-to-consumer marketing strategies [12][15] Management's Comments on Operating Environment and Future Outlook - Management noted that the aesthetic space is undergoing significant changes due to the impact of GLP-1 drugs, which have disrupted traditional non-invasive procedures [61][62] - The company believes that its Renuvion system is uniquely positioned to meet the needs of patients post-weight loss, and it expects to see growth in surgical procedures as a result [11][12] Other Important Information - A restructuring program was implemented, reducing the U.S. workforce by nearly 25%, expected to yield annualized cost savings of approximately $4.3 million [20][21] - The company completed a registered direct offering with net proceeds of approximately $6.8 million to strengthen its balance sheet [21] Q&A Session Summary Question: Confirmation of gross margin for 2025 - Management confirmed that they expect gross margins to be around 60% for 2025, similar to 2024 [35][37] Question: Timing and revenue expectations for AYON - Management indicated that the guidance for AYON has not been updated despite the earlier submission for FDA approval, and revenue expectations remain conservative [40][42] Question: Success of direct-to-consumer campaign - Management highlighted that the direct-to-consumer campaign has significantly exceeded expectations, driven by the unique needs of patients experiencing skin laxity post-weight loss [52][53] Question: Domestic vs. international market performance - Management noted that the U.S. market is performing better due to early adoption of GLP-1 drugs, and they expect similar trends to emerge internationally [56][58] Question: Adoption of GLP-1s and utilization of Renuvion - Management reported growth in handpiece sales in the U.S. and noted that surgical practices are adapting to meet the needs of patients with skin laxity [67][70] Question: Upgrades for the Apyx One Console - Management stated that there is still a significant number of customers who need to upgrade to the Apyx One Console, and they plan to offer special pricing for existing customers [75]

Financial Results - Apyx Medical Corporation reported preliminary revenue results for Q4 and the year ended December 31, 2024[5] - The press release detailing these results was issued on January 13, 2025[5] Company Information - The company is listed on the Nasdaq Global Select Market under the trading symbol APYX[3] - Apyx Medical Corporation has not elected to use the extended transition period for new financial accounting standards[4] Reporting Format - The report includes a cover page interactive data file embedded within the Inline XBRL document[8]

Core Insights - Apyx Medical Corporation reported financial results for Q4 and the full year 2024, highlighting a decrease in total revenue but improved operational metrics and strategic initiatives [1][5][14]. Financial Performance - Total revenue for Q4 2024 was $14.2 million, a decrease of 3% from $14.7 million in Q4 2023 [8]. - Advanced Energy segment revenue was approximately $12.1 million, remaining flat year-over-year, while OEM segment revenue decreased by 16% to $2.1 million [5][8]. - For the full year 2024, total revenue decreased by 8% to $48.1 million compared to $52.3 million in 2023 [14]. Profitability Metrics - Gross profit for Q4 2024 increased slightly to $9.0 million, with a gross profit margin of 63.0%, up from 60.9% in the prior year [9]. - The net loss attributable to stockholders for Q4 2024 was $4.6 million, a significant reduction of 52% from $9.6 million in Q4 2023 [12]. - Adjusted EBITDA loss for Q4 2024 was $2.2 million, down from $4.7 million in the same period last year [13]. Operational Highlights - The company experienced a 5% increase in single-use handpiece units shipped in Q4 2024, with a notable 20% increase in the U.S. market compared to the previous year [4]. - Apyx Medical submitted a 510(k) premarket notification for the AYON Body Contouring System to the FDA ahead of schedule, with plans for a launch in the latter half of 2025 [4][20]. Cost Management - Operating expenses decreased to $12.0 million in Q4 2024, down from $14.7 million in the prior year, driven by reductions in various expense categories [10][16]. - The company implemented a cost-saving restructuring program, reducing its U.S. workforce by nearly 25%, which is expected to yield annualized savings of approximately $4.3 million [5][10]. Future Outlook - For 2025, the company projects total revenue in the range of $47.6 million to $49.0 million, with Advanced Energy revenue expected between $39.6 million and $41.0 million [20]. - Operating expenses are anticipated to remain below $40.0 million for the year [20].

Group 1 - Apyx Medical Corporation will release its financial results for the fourth quarter and fiscal year 2024 on March 13, 2025, before the market opens [1] - A conference call will be held on the same day at 8:30 a.m. Eastern Time to discuss the financial results and include a question-and-answer session [2] - The company specializes in advanced energy technology, particularly its proprietary helium plasma and radiofrequency technology marketed as Renuvion and J-Plasma [3] Group 2 - Renuvion and J-Plasma provide surgeons with the ability to deliver controlled heat to tissue, supported by over 90 clinical documents [3] - Apyx Medical has established OEM agreements with other medical device manufacturers, leveraging its expertise in unique waveforms [3]

Core Insights - Apyx Medical Corporation reported preliminary revenue results for Q4 and full year 2024, indicating a strong performance in the Advanced Energy segment with over 25% sales growth quarter-over-quarter [2][4] - The company anticipates launching the AYON™ Body Contouring System in the second half of 2025, pending FDA clearance, which is expected to enhance its position in the surgical aesthetics market [4] Preliminary Fourth Quarter 2024 Revenue Summary - Total revenue is expected to be in the range of approximately $14.1 to $14.3 million, representing a decrease of 4% to 3% year-over-year [6] - Advanced Energy revenue is expected to be in the range of approximately $12.0 to $12.2 million, which is relatively flat year-over-year [6] - OEM revenue is expected to be approximately $2.1 million, representing a decrease of 17% year-over-year [6] Preliminary Full Year 2024 Revenue Summary - Total revenue is expected to be in the range of approximately $48.0 to $48.2 million, representing a decrease of 8% year-over-year [6] - Advanced Energy revenue is expected to be in the range of approximately $38.5 to $38.7 million, representing a decrease of 11% year-over-year [6] - OEM revenue is expected to be approximately $9.5 million, representing growth of 6% year-over-year [6] Management Comments - The company expressed satisfaction with its financial performance in Q4 2024, highlighting improved U.S. capital sales and a doubling of generator unit sales compared to the first half of 2024 [4] - There is an increasing demand for treatments addressing loose and lax skin, partly due to significant patient weight loss from GLP-1 drugs, which the company aims to capitalize on [4]

Core Viewpoint - Apyx Medical Corporation has submitted a 510(k) premarket notification to the FDA for its AYON Body Contouring System, which aims to revolutionize body contouring procedures by providing an all-in-one solution for surgeons [1][2][4]. Product Development - The AYON Body Contouring System is designed to be versatile and innovative, integrating multiple advanced modalities to perform functions such as fat removal, tissue contraction, and aesthetic enhancement [2]. - The company plans to expand the indications for AYON with an additional 510(k) submission later in the year to include power-assisted liposuction [3]. Company Positioning - The AYON Body Contouring System is expected to differentiate Apyx Medical in the aesthetic surgical market, positioning the company as a premier provider in this field [4]. - The announcement of the submission was made approximately 90 days earlier than anticipated, highlighting the efficiency of the company's research, development, quality, and regulatory teams [4]. Company Background - Apyx Medical Corporation specializes in advanced energy technology, particularly its Helium Plasma Platform Technology products marketed as Renuvion and J-Plasma, which provide controlled heat to tissue for surgical procedures [5]. - The effectiveness of Renuvion and J-Plasma is supported by over 90 clinical documents, showcasing the company's commitment to innovation and clinical validation [5].

Core Viewpoint - Apyx Medical Corporation is actively engaging with investors by attending the 15th Annual Craig-Hallum Alpha Select Conference on November 19, 2024, in New York City, highlighting its commitment to investor relations and market presence [1]. Company Overview - Apyx Medical Corporation specializes in advanced energy technology, focusing on innovative products such as the Helium Plasma Platform Technology, marketed as Renuvion in the cosmetic surgery market and J-Plasma in the hospital surgical market [2]. - The Renuvion and J-Plasma technologies provide surgeons with the capability to deliver controlled heat to tissue, enhancing surgical outcomes, supported by over 90 clinical documents [2]. - The company also engages in OEM agreements with other medical device manufacturers, leveraging its expertise in unique waveforms [2].