Executive Summary / Key Takeaways

• Apyx Medical, an advanced energy technology company, is strategically positioning its proprietary Helium Plasma Technology (Renuvion) and the newly FDA-cleared AYON system to capitalize on the emerging market opportunity presented by patients seeking treatment for loose skin following rapid weight loss from GLP-1 drugs.
• Despite a challenging aesthetic market impacting capital equipment sales, the company demonstrated operational discipline in Q1 2025, significantly reducing operating expenses and cash burn through a recent restructuring and cost-saving initiatives, extending its cash runway into 2027.
• Recent financial performance shows growth in the core Advanced Energy segment's handpiece sales (up 14% domestically in Q1 2025) offsetting declines in OEM and international sales, contributing to a Q1 2025 net loss of $4.15 million, an improvement from $7.58 million in Q1 2024.
• The company's 2025 guidance projects total revenue of $47.6 million to $49.0 million, driven by Advanced Energy growth (specifically handpieces and initial AYON uptake) offsetting an expected decline in OEM, with a target of keeping total operating expenses below $40 million.
• The successful FDA clearance of the all-in-one AYON Body Contouring System in May 2025 is a significant catalyst, expected to differentiate APYX, kickstart equipment sales in the second half of the year, and expand its addressable market in surgical aesthetics, although risks related to market adoption, competition, and ongoing litigation remain pertinent.

Apyx Medical Corporation, incorporated in 1982, has evolved into a specialized advanced energy technology company operating primarily through two segments: Advanced Energy and OEM. At its core lies the proprietary Helium Plasma Platform Technology, marketed as Renuvion in the cosmetic surgery market and J-Plasma in the hospital surgical market. This technology offers surgeons a unique capability to deliver controlled heat to tissue, enabling precise coagulation and contraction. The company's strategic focus is firmly rooted in surgical aesthetics, aiming to provide innovative solutions that address critical patient needs, particularly in body contouring.

The competitive landscape in medical devices, especially energy-based systems, is dominated by large, diversified players like Boston Scientific (BSX), Stryker (SYK), Medtronic (MDT), and Johnson & Johnson (JNJ). These giants benefit from vast scale, extensive distribution networks, and significant R&D budgets. Apyx, in contrast, operates as a more focused, niche player. Its primary competitive moat lies in its differentiated Helium Plasma Technology. While precise, directly comparable quantifiable performance metrics across all competitor technologies are not always publicly detailed, Apyx highlights Renuvion's ability to rapidly heat and cool tissue in fractions of a second, suggesting advantages in safety, speed, and effectiveness compared to alternative methods like traditional RF. Clinical studies, such as those published in April 2025 evaluating Renuvion in abdominal body contouring post-weight loss, have reported favorable outcomes, including improvements in skin laxity and patient satisfaction, reinforcing its utility in combination with procedures like lipoabdominoplasty. Furthermore, Renuvion holds the distinction of being the only FDA-cleared device for use after liposuction in body contouring procedures to treat loose and lax skin, a significant regulatory differentiator that supports its market positioning.

Despite its technological edge and niche focus, Apyx faces inherent disadvantages relative to its larger competitors, primarily related to scale. This can translate to higher per-unit manufacturing costs compared to the economies of scale enjoyed by companies like Stryker or Johnson & Johnson. Apyx's financial performance metrics, such as its gross margins (around 60%) and negative operating and net margins, lag significantly behind the robust profitability seen in its larger, more diversified rivals (who typically achieve gross margins of 60-75%, operating margins of 15-30%, and net margins of 10-25%). This underscores the operational efficiency challenge inherent in competing against industry behemoths.

The aesthetic market has faced significant headwinds since mid-2023, driven by macroeconomic uncertainty, high interest rates impacting capital equipment purchases, and the disruptive emergence of GLP-1 drugs for weight loss. Management noted that the increased use of GLP-1s initially caused patients to delay aesthetic treatments, creating uncertainty and impacting revenue for plastic and cosmetic surgeons, which in turn affected capital equipment sales for companies like Apyx. However, the company views the rapid weight loss associated with GLP-1s as a potential long-term tailwind, as it often results in significant loose and lax skin requiring surgical intervention – an area where Renuvion, as the only FDA-cleared device for post-lipo skin laxity, is uniquely positioned.

In response to these market dynamics and the need to improve financial performance, Apyx implemented a significant cost-saving restructuring in November 2024. This included a reduction of nearly 25% of the U.S. workforce, reductions in board size and compensation, and the identification of additional cost savings across professional fees, R&D, credit card fees, and stock-based compensation. These actions are aimed at reducing annual operating expenses below $40 million in fiscal 2025, decreasing net loss, and extending the company's cash runway.

Recent financial results reflect the impact of these market conditions and strategic adjustments. For the first quarter ended March 31, 2025, total revenue decreased 7.9% year-over-year to $9.43 million, primarily due to a significant 44.7% decline in the OEM segment sales to $1.54 million, excluding sales under a specific manufacturing agreement. The core Advanced Energy segment, however, saw revenue increase by 5.8% to $7.89 million, driven by increased domestic volume of single-use handpieces (up 14% in the U.S.), domestic and international upgrades to the Apyx One Console, and domestic sales of new generators. These gains were partially offset by a lower average selling price for domestic generators and a general decrease in international sales. Handpiece revenue now constitutes over 60% of total Advanced Energy revenue, highlighting the importance of recurring procedure volume.

Gross profit for Q1 2025 decreased 4.8% to $5.67 million, but the gross margin improved to 60.1% from 58.1% in the prior year, primarily due to a more favorable segment and geographic mix. Operating expenses saw a substantial decrease, falling from $12.56 million in Q1 2024 to $8.72 million in Q1 2025, reflecting the impact of the cost-cutting measures. This led to a significant reduction in the loss from operations, which improved to $3.05 million in Q1 2025 from $6.62 million in the prior year period. The net loss attributable to stockholders also narrowed to $4.15 million ($0.10 per share) in Q1 2025, compared to $7.58 million ($0.22 per share) in Q1 2024.

From a liquidity standpoint, the company ended Q1 2025 with $31.01 million in cash and cash equivalents, down slightly from $31.74 million at the end of 2024.

Net cash used in operating activities improved dramatically, decreasing to $0.7 million in Q1 2025 from $6.3 million in Q1 2024, primarily due to better accounts receivable management and the reduced operating loss.

The November 2024 amendment to the Perceptive Credit Agreement adjusted financial covenants, including lower Advanced Energy revenue targets for 2025 ($37 million), 2026 ($52.4 million), and 2027 ($60.3 million), and introduced a maximum operating expense covenant ($40 million for 2025, $45 million for 2026). The company was in compliance with these covenants as of March 31, 2025, and believes its cost controls, working capital management, and anticipated AYON uptake will extend its cash runway into 2027.

Looking ahead, Apyx's reaffirmed 2025 guidance projects total revenue between $47.6 million and $49.0 million, relatively flat compared to $48.1 million in 2024. This assumes Advanced Energy revenue growth to a range of $39.6 million to $41.0 million, driven by continued handpiece strength and the anticipated launch of the AYON system, while OEM revenue is expected to decline to approximately $8.0 million. A key assumption in this guidance is that the challenging capital equipment market will persist at current levels. The company remains committed to its operating expense target of no more than $40 million for the year and expects gross margins to remain around 60%.

A significant catalyst for the company's future growth is the AYON Body Contouring System. Submitted for FDA 510(k) clearance in January 2025 and cleared in May 2025, AYON is designed as an all-in-one platform integrating Renuvion with other essential body contouring modalities like ultrasound-assisted liposuction, power-assisted liposuction (planned for a later submission), infiltration, aspiration, electrocoagulation, and fat transfer. This system is intended to be the only device a surgeon needs for comprehensive body contouring, offering versatility and efficiency. Early feedback from surgeons has been positive, confirming its potential as a welcome addition to practices. Apyx plans a soft launch in the second half of 2025, anticipating that AYON will kickstart equipment sales growth, capture new market share, and expand the total addressable market in aesthetic surgery, further positioning Apyx as a preferred surgical partner.

Despite the positive developments with AYON and cost control, risks remain. Product liability litigation, including cases alleging off-label use prior to FDA clearance, presents potential financial exposure that could exceed insurance coverage. The company is also monitoring the potential impact of tariffs and inflation on costs and margins. Continued compliance with debt covenants is essential and dependent on meeting revenue and operating expense targets.

Conclusion

Apyx Medical is navigating a dynamic aesthetic market by leveraging its differentiated Helium Plasma Technology and executing a strategy focused on operational efficiency and innovation. While facing headwinds from macroeconomic factors and the initial disruption caused by GLP-1 drugs, the company has demonstrated a commitment to cost discipline, significantly reducing its operating expenses and cash burn. The recent FDA clearance of the AYON Body Contouring System represents a pivotal moment, offering a potential game-changer that integrates multiple surgical modalities and positions Apyx to capitalize on the emerging tailwind of patients seeking solutions for loose skin post-GLP-1 weight loss. The company's outlook hinges on the successful launch and adoption of AYON in the latter half of 2025, coupled with continued growth in Renuvion handpiece sales and tight expense management, aiming to drive future revenue growth and extend its financial runway despite ongoing competitive pressures and litigation risks. Investors will be closely watching the AYON launch trajectory and the company's progress towards its financial targets.