The AYON Body Contouring System is the first FDA cleared all-in-one platform for the aesthetic surgical suite Plan to initiate the commercial launch of the AYON Body Contouring System to key opinion leader surgeons in critical geographies during the second half of 2025 CLEARWATER, Fla., May 13, 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 ...

Revenue Performance - Total revenue decreased by 7.9%, or approximately $0.8 million, for the three months ended March 31, 2025, compared to the same period in 2024[78]. - Advanced Energy segment sales increased by 5.8%, or approximately $0.4 million, driven by increased volume of single-use handpieces domestically[78]. - OEM segment sales decreased by 44.7%, or approximately $1.2 million, due to decreases in sales volume to existing customers[78]. - International sales represented approximately 28.5% of total revenues for the three months ended March 31, 2025[79]. Profitability and Expenses - Gross profit for the three months ended March 31, 2025, decreased 4.8% to $5.7 million, with a gross margin of 60.1%[80]. - Research and development expenses decreased by 42.4% to $0.8 million, primarily due to lower compensation and benefits costs[82]. - Salaries and related expenses decreased by 34.4% to $3.1 million, attributed to a reduction in workforce and discretionary bonuses[84]. - Selling, general and administrative (SG&A) expenses decreased by 30.9% to $3,382,000 for the three months ended March 31, 2025, compared to $4,897,000 in the same period of 2024, representing 35.9% of sales[85]. Future Outlook and Cost Management - The company anticipates clearance for the AYON device by the FDA in the first half of 2025, with a launch planned later in the year[70]. - The company expects annualized future cost savings of approximately $4.3 million from a workforce reduction of nearly 25%[72]. - The company plans to reduce annual operating expenses below $40 million in 2025 through identified cost savings initiatives[72]. Financial Position - Cash and cash equivalents decreased to approximately $31.0 million as of March 31, 2025, from approximately $31.7 million at December 31, 2024[91]. - Net cash used in operating activities improved to approximately $0.7 million for the three months ended March 31, 2025, compared to $6.3 million in the same period of 2024[92]. - The company has incurred recurring net losses and anticipates that losses will continue in the near term, planning to fund operations through existing cash and potential additional financing[94]. - As of March 31, 2025, the company had purchase commitments totaling approximately $2.9 million, expected to be purchased within the next twelve months[99]. Compliance and Agreements - The company entered into an amendment to the Perceptive Credit Agreement, reducing financial covenant revenue targets for the Advanced Energy segment to $37.0 million for 2025[96]. - The company was in compliance with the financial covenants of the Perceptive Credit Agreement as of March 31, 2025[96]. - Apyx Medical Corporation's financial report was signed by CEO Charles D. Goodwin II and CFO Matthew Hill on May 8, 2025[123][124]. Interest and Taxation - Interest income decreased by approximately $0.2 million to $304,000 for the three months ended March 31, 2025, compared to $495,000 in the same period of 2024, with a percentage of sales decline from 4.8% to 3.2%[86]. - Interest expense remained flat at approximately $1.4 million for both the three months ended March 31, 2025, and 2024[87]. - Income tax expense was approximately $49,000 for the three months ended March 31, 2025, compared to $53,000 in the same period of 2024, with effective tax rates of (1.2)% and (0.7)%, respectively[89].

Financial Data and Key Metrics Changes - Total revenue for Q1 2025 was $9.4 million, a decrease of 8% compared to $10.2 million in the same period last year [4] - Advanced Energy products revenue increased by 6% to $7.9 million, reflecting stronger sales trends in the U.S. [5] - OEM segment sales decreased by 44.7% to approximately $1.2 million [16] - Gross profit for Q1 2025 decreased to $5.7 million from $5.9 million in the prior year, but gross profit margin increased to 60.1% from 58.1% [16][17] - Net loss attributable to shareholders was $4.2 million or $0.10 per share, compared to $7.6 million or $0.22 per share in the prior year [18] Business Line Data and Key Metrics Changes - Advanced Energy segment revenue increased by 5.8% to $7.9 million due to increased volume of single-use handpieces and domestic sales of new generators [15] - OEM segment sales saw a significant decline of 44.7% due to decreased sales volume to existing customers [16] - Domestic revenue decreased by 3.4% year over year to $6.7 million, while international revenue decreased by 17.7% to $2.7 million [16] Market Data and Key Metrics Changes - The company noted a stabilization in demand for capital equipment in the U.S., with year-over-year increases for two consecutive quarters [5] - The growth of GLP-1 drugs is expected to drive demand for aesthetic treatments, particularly for patients experiencing loose skin due to rapid weight loss [8] Company Strategy and Development Direction - The company is focusing on the launch of the AON body contouring platform, which integrates multiple technologies into a single device [13] - Apyx Medical aims to position the AON system in the operating rooms of surgeons, enhancing its market share in aesthetic surgery [14] - The company is committed to maintaining expense control while supporting the AON launch, viewing it as a significant differentiator in the market [33] Management's Comments on Operating Environment and Future Outlook - Management acknowledged persistent macroeconomic headwinds affecting the global aesthetic space but remains optimistic about the growth potential driven by GLP-1s [7][8] - The company expects to return to more normalized cash burn for the remainder of 2025, projecting cash management will yield positive results into 2027 [19] - Revenue guidance for 2025 is set between $47.6 million and $49 million, with expectations for Advanced Energy revenue to increase [20] Other Important Information - Renuvion was awarded the 2025 New Beauty Award for Best Minimally Invasive Skin Tightener, highlighting its market position [11] - The company has implemented significant cost-cutting measures and a restructuring program to reduce cash burn and improve operational efficiency [6] Q&A Session Summary Question: Progress on AON platform and customer enrollment - Management indicated they are not ready to comment on the AON pipeline yet but noted excitement in the marketplace regarding upgrades to the APYX-ONE console [22][23] Question: Demand for APYX-ONE upgrades - Management confirmed they are seeing positive demand for upgrades to the APYX-ONE console as customers prepare for AON [24][25] Question: Tariff impacts on margins - Management stated they expect gross margins to remain around 60% for the year, indicating minimal impact from tariffs at this point [32] Question: Investments to support AON launch - Management emphasized that while controlling expenses is crucial, investments to support the AON launch will not be compromised [33]

Financial Data and Key Metrics Changes - Total revenue for Q1 2025 was $9.4 million, a decrease of 8% compared to $10.2 million in Q1 2024 [5][16] - Gross profit for Q1 2025 decreased to $5.7 million from $5.9 million in the prior year, with a gross profit margin of 60.1%, up from 58.1% [17][18] - Net loss attributable to shareholders was $4.2 million or $0.10 per share, compared to $7.6 million or $0.22 per share in the prior year [19] Business Line Data and Key Metrics Changes - Advanced Energy segment revenue increased by 6% to $7.9 million, driven by stronger sales of single-use handpieces in the U.S. [6][16] - OEM segment sales decreased by 44.7% to approximately $1.2 million, attributed to lower sales volume to existing customers [17] Market Data and Key Metrics Changes - Domestic revenue decreased by 3.4% year-over-year to $6.7 million, while international revenue decreased by 17.7% to $2.7 million [17] - The company noted a stabilization in demand for capital equipment in the U.S., with year-over-year increases for two consecutive quarters [6] Company Strategy and Development Direction - The company is focusing on the Renuvion offering as a key product for addressing loose and lax skin, particularly for patients experiencing rapid weight loss due to GLP-1 drugs [10][11] - AON body contouring platform is expected to differentiate the company in the market, with a planned launch in the second half of 2025 pending FDA clearance [14][15] Management's Comments on Operating Environment and Future Outlook - Management acknowledged persistent macroeconomic headwinds but expressed optimism about the growth potential from the GLP-1 market [7][9] - The company expects to return to more normalized cash burn for the remainder of 2025, projecting cash flow into 2027 [20] Other Important Information - The company implemented significant cost-cutting measures, resulting in a decrease in operating expenses to $8.7 million from $12.6 million in the prior year [19] - Renuvion won the 2025 New Beauty Award for Best Minimally Invasive Skin Tightener, highlighting its market recognition [12] Q&A Session Summary Question: Progress on AON platform and customer enrollment - Management indicated they are not commenting on the AON pipeline yet but noted excitement in the marketplace regarding upgrades to the APYX-one console [24][25] Question: Demand for APYX One console upgrades - Management confirmed they are seeing increased demand for the APYX One console as customers prepare for AON [26][27] Question: Tariff impacts and supply chain - Management stated they have manufacturing flexibility between the U.S. and Bulgaria to mitigate potential tariff impacts [30][31] Question: Margin impact from tariffs - Management expects gross margins to remain around 60% for the year, indicating minimal impact from current tariff considerations [34] Question: Investments to support AON launch - Management emphasized that while controlling expenses is important, investments to support the AON launch will not be compromised [35]

Core Insights - Apyx Medical Corporation reported a total revenue of $9.4 million for Q1 2025, a decrease from $10.2 million in the same period last year, primarily due to a significant drop in OEM revenue [5][7] - The Advanced Energy segment saw a 6% increase in revenue to $7.9 million, driven by strong sales of generator units and single-use handpieces [4][5] - The company is preparing to launch the AYON Body Contouring System in the second half of 2025, pending FDA clearance, which is expected to enhance its market position in surgical aesthetics [3][5] Financial Performance - Total revenue decreased by 8% year-over-year, with Advanced Energy revenue increasing by 6% while OEM revenue fell by 45% [5][7] - Gross profit for Q1 2025 was $5.7 million, with a gross profit margin of 60%, up from 58% in the prior year [8] - Operating expenses decreased significantly by $3.8 million to $8.7 million, reflecting cost-cutting measures implemented in the previous quarter [9] Loss and Adjusted EBITDA - The net loss attributable to stockholders decreased by 45% to $4.2 million, or $0.10 per share, compared to a loss of $7.6 million, or $0.22 per share, in Q1 2024 [11][20] - Adjusted EBITDA loss improved to $2.4 million from $5.3 million in the prior year, indicating better operational efficiency [11][26] Market Position and Strategy - Renuvion, the company's flagship product, was awarded the 2025 NewBeauty Award for "Best Minimally Invasive Skin Tightener," highlighting its growing recognition in the market [5][11] - The company aims to capitalize on the increasing demand for aesthetic procedures, particularly among patients using GLP-1 drugs for weight loss [3][5] - Apyx Medical's management expressed confidence in the company's path to profitability following recent restructuring and cost management efforts [6][9]

Revenue Performance - Total revenue for Q1 2025 was $9.4 million, a decrease of 8% compared to $10.2 million in Q1 2024[6] - Advanced Energy segment revenue increased by 6% to $7.9 million, driven by strong generator unit sales and U.S. single-use handpiece sales[4] - OEM revenue decreased by 45% to approximately $1.5 million, down from $2.8 million in the prior year[6] - Financial guidance for full year 2025 projects total revenue between $47.6 million and $49.0 million, with Advanced Energy revenue expected to be $39.6 million to $41.0 million[11] Profitability and Loss - Net loss attributable to stockholders decreased by 45% to $4.2 million, or $0.10 per share, compared to a net loss of $7.6 million, or $0.22 per share, in Q1 2024[9] - Adjusted EBITDA loss improved by 54% to $2.4 million, compared to $5.3 million in the same period last year[10] - The net loss attributable to stockholders for Q1 2025 was $4,150,000, an improvement from a net loss of $7,576,000 in Q1 2024, indicating a reduction of about 45.5%[23] - Adjusted EBITDA for Q1 2025 was reported at $(2,440,000), compared to $(5,337,000) in Q1 2024, reflecting a year-over-year improvement of approximately 54.4%[23] Cost Management - Operating expenses decreased by $3.8 million to $8.7 million, reflecting cost-cutting measures implemented in Q4 2024[8] - Stock-based compensation expense for Q1 2025 was $451,000, down from $1,128,000 in Q1 2024, a decrease of about 60%[23] Asset and Liability Management - As of March 31, 2025, total assets decreased to $60,160,000 from $64,842,000 as of December 31, 2024, representing a decline of approximately 7.5%[20] - Total current assets decreased to $51,851,000 in Q1 2025 from $56,440,000 in Q4 2024, a decrease of about 8.5%[20] - Total liabilities decreased slightly to $49,516,000 in Q1 2025 from $50,507,000 in Q4 2024, a reduction of approximately 2%[20] - Cash and cash equivalents as of March 31, 2025, were $31,011,000, down from $31,741,000 at the end of 2024, a decrease of about 2.3%[20] - The company reported a decrease in trade accounts receivable to $11,645,000 in Q1 2025 from $15,480,000 in Q4 2024, a decline of approximately 24.9%[20] - The accumulated deficit increased to $(82,061,000) as of March 31, 2025, compared to $(77,911,000) at the end of 2024, reflecting an increase of approximately 5.5%[20] - The company’s long-term debt increased to $34,127,000 in Q1 2025 from $33,893,000 in Q4 2024, an increase of about 0.7%[20] Product Development - The company plans to launch the AYON Body Contouring System in the second half of 2025, pending FDA clearance[4] - Renuvion won the 2025 NewBeauty Award for "Best Minimally Invasive Skin Tightener"[4] Gross Profit Margin - Gross profit margin increased to 60% in Q1 2025, up from 58% in Q1 2024, due to changes in product and geographic mix[7]

Company Overview - Apyx Medical Corporation specializes in advanced energy technology, particularly in the cosmetic surgery market with its Helium Plasma Platform Technology products marketed as Renuvion and J-Plasma [5] - Renuvion is the only FDA-cleared device for use after liposuction, addressing issues related to loose skin with more than 90 evidence-based clinical publications supporting its effectiveness [3][5] - The company aims to elevate people's lives through innovative products that provide controlled heat to tissue for desired surgical results [5] Marketing Strategy - Dolores Catania has been appointed as the Chief of Confidence for Apyx Medical's Renew You consumer marketing campaign, focusing on body contouring and the challenges of loose skin [1][2] - Catania will be featured in various marketing initiatives across multiple platforms, including social media, public relations, live engagements, and physician events [4] - The campaign emphasizes the emotional and physical benefits of Renuvion treatments, aiming to empower consumers in their personal transformations [3][4] Industry Position - Renuvion is recognized as the 1 body contouring technology trusted by doctors to effectively address loose skin challenges [3][6] - An independent survey indicated that 4 out of 5 board-certified or eligible cosmetic and plastic surgeons in the US agree on the effectiveness of Renuvion [6]

Company Overview - Apyx Medical Corporation is an advanced energy technology company focused on innovative products, including its Helium Plasma Platform Technology marketed as Renuvion in the cosmetic surgery market and J-Plasma in the hospital surgical market [3] - The effectiveness of Renuvion and J-Plasma is supported by over 90 clinical publications, demonstrating the company's commitment to clinical validation [3] Financial Results Announcement - Apyx Medical will release its financial results for the first quarter of fiscal year 2025 before markets open on Thursday, May 8th [1] - A conference call will be held at 8:00 a.m. Eastern Time on the same day to discuss the quarterly results and include a question-and-answer session [2] Investor Relations - The investor relations contact for Apyx Medical is Jeremy Feffer, Managing Director at LifeSci Advisors, who can be reached at 212-915-2568 or via email [3]

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]