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Apyx Medical Corporation Announces Approval and Commercial Launch of Apyx One Console and Single-Use Handpieces for Cosmetic Surgical Procedures in South Korea
Globenewswire· 2025-12-03 13:00
Core Insights - Apyx Medical Corporation has received regulatory approval for the Apyx One console and plans to launch commercial sales in South Korea, with initial orders expected in Q4 2025 [1][3] - The Apyx One console features a 3-in-1 energy system that allows for advanced surgical procedures, including Renuvion technology, and is designed for ease of use with adaptive touch screens and energy quantification [2] - The cosmetic surgery market in South Korea is projected to grow from $1.7 billion in 2024 to over $3.9 billion by 2033, indicating a significant opportunity for Apyx Medical's body contouring technology [3] Company Overview - Apyx Medical Corporation specializes in surgical aesthetics, offering innovative products such as Renuvion and the AYON Body Contouring System, which provide controlled heat to tissue for surgical procedures [4] - The AYON Body Contouring System is FDA-cleared and designed to integrate multiple surgical capabilities, enhancing the versatility and precision of body contouring treatments [4]
Apyx Medical Corporation Announces Pricing of $10 Million Public Offering of Common Stock
Globenewswire· 2025-11-18 12:30
Core Viewpoint - Apyx Medical Corporation has announced a public offering of 2,762,431 shares of its common stock at a price of $3.62 per share, with the offering expected to close on or about November 19, 2025 [1][2]. Group 1: Offering Details - The offering is underwritten by Lucid Capital Markets, which is acting as the sole book-running manager [2]. - The company has granted the underwriter a 45-day option to purchase an additional 414,365 shares at the public offering price [2]. - The net proceeds from the offering will be used for working capital and general corporate purposes [3]. Group 2: Regulatory and Documentation - The offering is made pursuant to a shelf registration statement filed with the SEC, which was declared effective on December 2, 2022 [3]. - A preliminary prospectus supplement and accompanying prospectus have been filed with the SEC and are available on their website [4]. Group 3: Company Overview - Apyx Medical Corporation specializes in surgical aesthetics, offering products like Renuvion and the AYON Body Contouring System, which provide innovative solutions in cosmetic surgery [6]. - The company’s technologies, including Helium Plasma Platform Technology, are supported by over 90 clinical documents, demonstrating their effectiveness [6]. - The AYON Body Contouring System is FDA-cleared and designed to integrate multiple surgical capabilities, enhancing the treatment options available to surgeons [6].
Apyx Medical Corporation Announces Proposed Public Offering of Common Stock
Globenewswire· 2025-11-17 21:05
Core Viewpoint - Apyx Medical Corporation is initiating an underwritten public offering of its common stock, subject to market conditions, with no assurance on the completion or terms of the offering [1]. Group 1: Offering Details - Lucid Capital Markets is the sole book-running manager for the offering [2]. - The offering is made under a shelf registration statement filed with the SEC on November 22, 2022, and declared effective on December 2, 2022 [2]. Group 2: Company Overview - Apyx Medical Corporation specializes in surgical aesthetics, offering products like Renuvion and the AYON Body Contouring System, which are designed to enhance surgical outcomes [5]. - The Renuvion and J-Plasma technologies provide controlled heat to tissue, supported by over 90 clinical documents [5]. - The AYON Body Contouring System is FDA-cleared and integrates multiple capabilities for comprehensive body contouring treatments [5].
Apyx Medical(APYX) - 2025 Q3 - Earnings Call Transcript
2025-11-06 14:02
Financial Data and Key Metrics Changes - Total revenue for Q3 2025 increased by 12% to $12.9 million compared to $11.5 million in the same period last year [5][16] - Gross profit for Q3 2025 increased to $8.3 million, with a gross profit margin of 64.4%, up from 60.5% in the prior year [17][19] - Net loss attributable to stockholders decreased to $2 million, or $0.05 per share, compared to $4.7 million, or $0.14 per share in the prior year [19] - Cash used in operating activities decreased to $3.5 million for Q3 2025, down from $4.4 million in the prior year [20] Business Line Data and Key Metrics Changes - Revenue from the surgical aesthetics segment increased by 19% to $11.1 million compared to $9.3 million last year, driven by the commercial launch of the Aon body contouring system [5][16] - OEM revenue decreased by 18% to $1.8 million for Q3 2025, down from $2.2 million in the same period last year, due to reduced sales volumes to existing customers [7][17] Market Data and Key Metrics Changes - Domestic revenue increased by 20% year-over-year to $9.3 million, while international revenue decreased by 4% year-over-year to $3.5 million [17] - The company noted that the medical device industry typically experiences seasonality, with revenue trends generally lowest in the first and third quarters [17] Company Strategy and Development Direction - The company announced a rebranding of its advanced energy segment to "surgical aesthetics" to better align with its mission and the results delivered by its products [5] - The Aon body contouring system is positioned as a groundbreaking solution in the market, integrating multiple functions to enhance surgical outcomes [9][10] - The company is focusing resources on the surgical aesthetics segment, particularly the Aon launch, which is seen as the future of the company [7][23] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the market's response to the Aon system, highlighting strong pre-sales and initial deliveries [6][14] - The company anticipates continued growth driven by the increasing adoption of GLP-1 medications, which create a demand for body contouring solutions [12][34] - Management updated revenue guidance for 2025 to a range of $50.5 million to $52.5 million, reflecting the strength of the Aon launch [21][22] Other Important Information - The company has successfully reduced operating expenses to $9.1 million for Q3 2025, down from $10.6 million in the prior year, due to cost-cutting measures [18] - Cash and cash equivalents as of September 30, 2025, were $25.1 million, down from $31.7 million as of December 31, 2024 [21] Q&A Session Summary Question: Clarification on generator sales decline - Management explained that the decline in generator sales is due to the integration of existing generators with the new Aon system, which is classified as Aon sales [25][26] Question: Gross margin impact and future expectations - Management refrained from providing specific guidance on gross margins but indicated that the surgical aesthetics business typically has the highest gross margins [27][29] Question: Expected uptake in consumables alongside capital sales - Management noted that new customers adopting Renuvion technology would drive consumable sales, while existing customers may not see significant increases [32] Question: Market demand trends and GLP-1 dynamics - Management confirmed that the market is being disrupted by GLP-1 drugs, with a significant percentage of patients being new to aesthetics, indicating a growing opportunity [34][35] Question: Pipeline growth and implementation - Management acknowledged an increase in guidance due to strong interest in Aon and confirmed that a third party is assisting with installations to meet demand [45][46] Question: International rollout plans for Aon - Management indicated that while the focus is currently on the U.S. market, there are plans to register Aon in various international markets, including Europe and Latin America [48][49]
Apyx Medical(APYX) - 2025 Q3 - Earnings Call Transcript
2025-11-06 14:02
Financial Data and Key Metrics Changes - Total revenue for Q3 2025 increased by 12% to $12.9 million compared to $11.5 million in the same period last year [5][16] - Gross profit for Q3 2025 increased to $8.3 million, with a gross profit margin of 64.4%, up from 60.5% in the prior year [17][19] - Net loss attributable to stockholders decreased to $2 million, or $0.05 per share, compared to $4.7 million, or $0.14 per share in the prior year [19] Business Line Data and Key Metrics Changes - Revenue from the Surgical Aesthetics segment increased by 19% to $11.1 million, driven by the AYON Body Contouring System launch and increased sales of single-use handpieces [5][16] - OEM revenue decreased by 18% to $1.8 million, attributed to reduced sales volumes to existing customers [7][17] Market Data and Key Metrics Changes - Domestic revenue increased by 20% year-over-year to $9.3 million, while international revenue decreased by 4% to $3.5 million [17] - The company noted that the medical device industry typically experiences seasonality, with revenue trends generally lowest in the first and third quarters [17] Company Strategy and Development Direction - The company announced the rebranding of its Advanced Energy segment to Surgical Aesthetics to better align with its mission and product offerings [5] - The focus has shifted towards the Surgical Aesthetics segment, particularly the AYON launch, which is seen as the future of the company [7][12] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the market's response to AYON, highlighting strong pre-sales and initial deliveries [6][15] - The company anticipates continued growth driven by the increasing adoption of GLP-1 medications, which create a demand for body contouring solutions [12][34] Other Important Information - The company has successfully reduced operating expenses to $9.1 million for Q3 2025, down from $10.6 million in the prior year [18] - Cash used in operating activities decreased to $3.5 million for Q3 2025, compared to $4.4 million in the prior year [19][20] Summary of Q&A Session Question: Clarification on generator sales decline - Management clarified that the decline in generator sales is due to customers integrating existing generators with AYON, rather than purchasing new generators [25][26] Question: Gross margin impact and future guidance - Management refrained from providing specific guidance on gross margins but indicated that the Surgical Aesthetics business typically has the highest gross margins [27][29] Question: Expectations for consumables uptake - Management noted that the greatest driver of consumable sales will come from new customers adopting Renuvion technology [32] Question: Market demand trends and GLP-1 dynamics - Management stated that the market is being disrupted by GLP-1 drugs, with a significant percentage of patients being new to aesthetics [34][35] Question: Growth in single-use handpieces - Management indicated that growth in handpieces is driven by new doctors adopting the technology and higher attach rates for Renuvion [39] Question: Pipeline growth and installation processes - Management confirmed an increase in guidance for Surgical Aesthetics and highlighted the effective management of supply chain and installations [45][46] Question: International rollout of AYON - Management discussed plans for international registration of AYON, with a focus on Europe and other regions in the future [48][49]
Apyx Medical(APYX) - 2025 Q3 - Earnings Call Transcript
2025-11-06 14:00
Financial Data and Key Metrics Changes - Total revenue for Q3 2025 increased by 12% to $12.9 million compared to $11.5 million in the same period last year [5][14] - Gross profit for Q3 2025 increased to $8.3 million, with a gross profit margin of 64.4%, up from 60.5% in the prior year [15][17] - Net loss attributable to stockholders decreased to $2 million, or $0.05 per share, compared to $4.7 million, or $0.14 per share in the prior year [17] - Cash used in operating activities decreased to $3.5 million from $4.4 million in the prior year [17][18] Business Line Data and Key Metrics Changes - Revenue from the surgical aesthetics segment increased by 19% to $11.1 million, driven by the commercial launch of the Aon body contouring system [5][14] - OEM revenue decreased by 18% to $1.8 million, attributed to reduced sales volumes to existing customers [6][15] Market Data and Key Metrics Changes - Domestic revenue increased by 20% year-over-year to $9.3 million, while international revenue decreased by 4% year-over-year to $3.5 million [15] - The market for aesthetic procedures is expected to grow significantly due to the increasing adoption of GLP-1 medications, with over 15 million people currently on these drugs in the U.S. [11][32] Company Strategy and Development Direction - The company announced a rebranding of its advanced energy segment to "surgical aesthetics" to better align with its mission and product offerings [5] - The Aon system is positioned as a comprehensive solution for body contouring, integrating multiple functions that address market needs [8][10] - The company plans to expand the Aon system internationally, targeting markets such as Europe and Latin America [43][44] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing commercial launch of Aon, which has exceeded expectations in terms of market interest and pre-orders [12][19] - The company anticipates a strong future in the aesthetic market, particularly due to the impact of GLP-1 drugs on patient demand for body contouring solutions [11][32] Other Important Information - The company updated its 2025 revenue guidance to a range of $50.5 million to $52.5 million, reflecting strong performance in the surgical aesthetics segment [18][20] - Gross margins are expected to be approximately 61% for the year, with total operating expenses not exceeding $40 million [21] Q&A Session Summary Question: Clarification on generator sales decline - Management explained that the decline in generator sales is due to the integration of the Aon system, where existing customers can upgrade their generators instead of purchasing new ones [24] Question: Gross margin impact from Aon rollout - Management refrained from providing specific guidance on gross margins but indicated that the surgical aesthetics business typically has the highest gross margins [26] Question: Expected uptake in consumables alongside capital sales - Management noted that new customer acquisitions would drive consumable sales, while existing customers may not see significant increases [30] Question: Market environment and GLP-1 dynamics - Management highlighted that the market is being disrupted by GLP-1 drugs, with a significant percentage of patients being new to aesthetic treatments [32] Question: Growth in handpiece sales - Management indicated that growth in handpiece sales was driven by new doctor adoption, higher attach rates, and standalone uses of Renuvion technology [36] Question: Pipeline growth and implementation - Management confirmed an increase in guidance due to strong interest in Aon and mentioned that a third party is assisting with installations to meet demand [40][41] Question: International rollout of Aon - Management stated that while the focus is currently on the U.S. market, plans for international registration and rollout are in consideration for 2026 [43][44]
Apyx Medical Corporation Reports Third Quarter 2025 Financial Results
Globenewswire· 2025-11-06 12:00
Core Insights - Apyx Medical Corporation reported a 19% increase in Surgical Aesthetics revenue for Q3 2025, driven by the successful commercialization of the AYON Body Contouring System [3][9] - The company anticipates further growth in sales following the pending FDA clearance for the AYON's label expansion to include power liposuction [4][7] - Total revenue for Q3 2025 reached $12.9 million, a 12.1% increase compared to $11.5 million in the same period last year [7][9] Financial Performance - Surgical Aesthetics revenue for Q3 2025 was $11.1 million, up from $9.3 million in Q3 2024, reflecting a 19% increase [9][10] - OEM revenue decreased by 18% to approximately $1.8 million in Q3 2025 compared to $2.2 million in Q3 2024 [7][9] - Gross profit for Q3 2025 increased to $8.3 million, with a gross margin of 64.4%, up from 60.5% in the prior year [10][12] Operating Expenses and Losses - Operating expenses decreased by $1.5 million to $9.1 million in Q3 2025 compared to $10.6 million in Q3 2024 [11] - Net loss attributable to stockholders was $2.0 million in Q3 2025, an improvement from a net loss of $4.7 million in Q3 2024 [12][24] - Adjusted EBITDA loss decreased significantly to $0.1 million for Q3 2025, compared to $2.4 million for the same period in 2024 [13][31] Future Outlook - The company raised its total revenue guidance for FY2025 to a range of $50.5 million to $52.5 million, up from the previous guidance of $50.0 million to $52.0 million [6][20] - Surgical Aesthetics revenue is expected to be between $43.0 million and $45.0 million for FY2025, compared to approximately $38.6 million reported for FY2024 [20] - The company plans to continue expanding the user base for AYON, which is expected to drive growth in single-use handpiece sales [4][6]
Apyx Medical Corporation to Participate in Upcoming November Investor Conferences
Globenewswire· 2025-10-27 12:00
Core Insights - Apyx Medical Corporation is set to participate in two upcoming investor conferences, showcasing its proprietary technologies [1][2] Company Overview - Apyx Medical Corporation specializes in advanced energy technology, focusing on innovative products such as Renuvion and the AYON Body Contouring System™ [3] - Renuvion and J-Plasma technologies provide surgeons with the ability to deliver controlled heat to tissue, supported by over 90 clinical documents [3] - The AYON Body Contouring System™ is an FDA-cleared platform that integrates multiple capabilities for comprehensive body contouring treatments [3] - The company also engages in OEM agreements with other medical device manufacturers, leveraging its expertise in unique waveforms [3]
Apyx Medical Corporation to Release Third Quarter of Fiscal Year 2025 Financial Results on November 6, 2025
Globenewswire· 2025-10-23 12:00
Core Viewpoint - Apyx Medical Corporation will release its financial results for the third quarter of fiscal year 2025 on November 6, 2025, before market opening [1] Financial Results Announcement - The financial results will be discussed in a conference call scheduled for 8:00 a.m. Eastern Time on the same day [2] - Interested parties can join the call by dialing 800-717-1738 or 646-307-1865 for international callers, using access code 73607 [2] - A live webcast of the call will be available and archived on the company's Investor Relations website [2] Company Overview - Apyx Medical Corporation specializes in advanced energy technology, focusing on innovative products like Renuvion and the AYON Body Contouring System™ [3] - The company’s Helium Plasma Platform Technology products are utilized in both cosmetic surgery and hospital surgical markets [3] - Renuvion and J-Plasma provide surgeons with the ability to deliver controlled heat to tissue, supported by over 90 clinical publications [3] - Apyx Medical also engages in OEM agreements with other medical device manufacturers, leveraging its expertise in unique waveforms [3]
Apyx Medical (NasdaqGS:APYX) Update / Briefing Transcript
2025-10-14 17:02
Apyx Medical (NasdaqGS:APYX) Conference Call Summary Company Overview - **Company**: Apyx Medical Corporation - **Event Date**: October 14, 2025 - **Key Product**: Apyx One Console, a body contouring system Industry Insights - **Market Context**: The surgical aesthetics market is evolving, particularly due to the rise of GLP-1 therapies for weight loss, leading to increased demand for body contouring solutions among post-weight loss patients [4][6] - **Market Size**: GLP-1 therapies are projected to exceed $100 billion by 2030, with 44% of users spending between $2,000 and $5,000 on aesthetic procedures, a 25% increase in spending [6] - **Patient Demographics**: 63% of GLP-1 users are new to aesthetics post-weight loss, indicating a growing patient population for plastic surgeons [6] Product Launch and Performance - **Product Launch**: Apyx One Console received approval in May 2025 and has undergone a successful soft launch with key surgeons across the U.S. [5][4] - **Sales Update**: Commercial sales began in September 2025, with ongoing sales in Q4 2025. A 510(k) submission for the power-assisted handpiece is expected to receive clearance in Q1 2026 [5][6] - **Technological Advancements**: The Apyx One Console integrates multiple technologies, including ultrasound-assisted liposuction and Renuvion for skin tightening, designed based on feedback from leading plastic surgeons [10][12] Clinical Insights - **Surgical Trends**: There has been a decline in liposuction procedures by 10.7%, while surgical lifts have increased by over 20%, reflecting the need for more complex surgical interventions for patients with lax skin [7][8] - **Patient Concerns**: 72% of GLP-1 users report loose skin as their primary concern, with 57% seeking treatment within six months post-weight loss [9] Feedback and Reception - **Surgeon Feedback**: Surgeons have expressed high satisfaction with the Apyx One Console, describing it as revolutionary and comparing it to luxury vehicles like Ferraris and Lamborghinis [13][14] - **Clinical Efficiency**: The integration of technologies in the Apyx One Console has led to improved surgical efficiency, with reduced procedure times and enhanced patient outcomes [32][51] Future Outlook - **Market Positioning**: Apyx Medical is well-positioned to capture growth in the surgical aesthetics market, particularly among post-weight loss patients seeking body contouring solutions [6][4] - **Anticipated Developments**: The upcoming launch of the power-assisted handpiece is expected to further enhance the capabilities of the Apyx One Console, attracting more surgeons and patients [65][66] Additional Insights - **Patient Experience**: The Apyx One Console aims to simplify the surgical process, reducing the need for multiple devices and improving the overall patient experience [21][22] - **Technological Trust**: Surgeons have shown a willingness to adopt the Apyx One Console based on the company's commitment to evidence-based medicine and the collaborative development process involving top surgeons [66][68] This summary encapsulates the key points discussed during the Apyx Medical conference call, highlighting the company's strategic positioning, product innovations, and the evolving landscape of the surgical aesthetics market.