CLEARWATER, Fla., April 24, 2025 (GLOBE NEWSWIRE) -- Apyx Medical Corporation (NASDAQ: APYX) (“Apyx Medical;” the “Company”), the manufacturer of a proprietary helium plasma and radiofrequency technology marketed and sold as Renuvion®, today announced that financial results for the first quarter of fiscal year 2025 will be released before markets open on Thursday, May 8th. Management will host a conference call at 8:00 a.m. Eastern Time on Thursday, May 8th to discuss the results of the quarter, and to host ...

Renuvion is the first and only body contouring technology that empowers consumers to feel and look their best, from the inside out by treating loose skin CLEARWATER, Fla., March 25, 2025 /PRNewswire/ -- Apyx Medical Corporation (NASDAQ: APYX) ("Apyx Medical" or the "Company"), the manufacturer of a proprietary helium plasma and radiofrequency platform technology marketed and sold as Renuvion®, announced today that Renuvion has been named this year's NewBeauty Award winner in the "Best Minimally Invasive Sk ...

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 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]

Focusing on advancing body contouring by providing the first all-in-one platform for the surgical suiteCLEARWATER, Fla., Jan. 06, 2025 (GLOBE NEWSWIRE) -- Apyx® Medical Corporation (NASDAQ:APYX) (“Apyx Medical”; the “Company”), the manufacturer of a proprietary helium plasma and radiofrequency technology marketed and sold as Renuvion®, is pleased to announce it has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (the “FDA”) for the AYON Body Contouring System. The AYON Bod ...

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].