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    Apyx Medical (APYX)

    Apyx Medical Corporation is a company specializing in energy-based medical devices, primarily targeting the cosmetic surgery and hospital surgical markets. It develops and sells innovative products based on its proprietary Helium Plasma Technology, marketed under the names Renuvion and J-Plasma. The company also engages in the contract manufacturing of surgical devices and accessories.

    1. Advanced Energy - Develops and markets Helium Plasma Technology products, including electrosurgical generators, single-use handpieces, and accessories, primarily for cosmetic surgery applications. These products enable precise tissue cutting, coagulation, and ablation using controlled heat.

      • Renuvion - Designed for use in the cosmetic surgery market by plastic surgeons and cosmetic physicians.
      • J-Plasma - Utilized in hospital surgical settings for procedures such as surgical oncology.
      • Apyx One Console - A multi-functional generator incorporating an advanced 3-in-1 energy system.
    2. OEM - Focuses on the development and contract manufacturing of surgical devices, accessories, and handpieces for third-party customers. All related expenses are recorded as cost of sales.

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    1. Given the significant 44.7% decline in OEM sales year over year, what specific strategies are you implementing to reverse this trend and ensure a more balanced revenue mix with advanced energy products?
    2. With the AYON system pending FDA clearance and a dedicated cadre of 20 ambassadors, how will you mitigate delays in regulatory approval and ensure that the launch timeline doesn’t adversely impact growth projections?
    3. Considering the persistent macroeconomic headwinds and recent tariff uncertainties, can you provide more detailed insights on how these external challenges might affect your short-term gross margins and what contingency plans are in place?
    4. As you face a rapidly evolving market influenced by the explosive growth of GLP-1 drugs, how do you plan to maintain your competitive edge and capture additional market share in an increasingly crowded aesthetic landscape?
    5. In light of your current emphasis on cost-cutting and cash management while investing in the AYON launch, what measures will you take to balance these objectives without compromising on innovation and long-term strategic growth?

    Recent press releases and 8-K filings for APYX.

    Apyx Medical Announces AON Body Contouring System Approval and Upward Revenue Guidance
    ·$APYX
    Guidance Update
    Product Launch
    New Projects/Investments
    • Apyx Medical received FDA approval for its AON body contouring system on May 11, with commercial sales planned to commence in September. This new system aims to consolidate and enhance existing surgical body contouring technologies.
    • The company increased its full-year revenue guidance by $2.7 million, now expecting total revenue between $50 million and $52 million for the year. This includes advanced energy revenue of $42 million to $44 million, reflecting approximately 10% growth.
    • Apyx Medical is capitalizing on the increased demand for skin tightening due to GLP-1 weight loss drugs, noting 63% of GLP-1 users seek such treatments. Their Renuvion product, the only FDA-approved device for loose and lax skin, saw US handpiece sales grow 14% in 2024, with 93,000 units sold.
    • The company is focused on achieving EBITDA positivity by 2026 through cost reductions, with operating costs projected to be less than $40 million in 2025, down from $53 million in 2023. Apyx Medical has approximately $30 million in cash, providing runway through 2027.
    Aug 12, 2025, 8:51 PM
    Apyx Medical Corporation Launches Renuvion® in China
    ·$APYX
    Product Launch
    New Projects/Investments
    • Apyx Medical Corporation launched its Renuvion® product in China as part of its international commercialization strategy.
    • The launch followed initial market clearance from the National Medical Products Administration of China.
    • Apyx Medical has entered into a distribution agreement with GlamMoon Medical Technology, the equipment distribution division of BeauCare Clinics Investment Co., Ltd. (BCC).
    • BCC is a leading platform company in China's medical aesthetics industry, operating over 60 medical aesthetics hospitals and clinics and having a group purchasing alliance with more than 400 alliance members as of Q1 2025.
    Jul 28, 2025, 12:08 PM
    Apyx Medical Corporation Reports First Quarter 2025 Financial Results
    ·$APYX
    Earnings
    Guidance Update
    Product Launch
    • Apyx Medical Corporation reported total revenue of $9.4 million in the first quarter of 2025, an 8% decrease compared to $10.2 million in the same period last year. This included a 6% increase in Advanced Energy revenue to $7.9 million and a 45% decrease in OEM revenue to $1.5 million.
    • The company significantly reduced its net loss, which decreased by 45% to $4.2 million in Q1 2025 from $7.6 million in Q1 2024. Adjusted EBITDA loss also decreased by 54% to $2.4 million from $5.3 million in the prior year period.
    • Apyx Medical reaffirmed its financial guidance for the full year 2025, expecting total revenue in the range of $47.6 million to $49.0 million and operating expenses of less than $40.0 million.
    • The company is preparing for the planned launch of the AYON™ Body Contouring System in the second half of 2025, pending U.S. FDA clearance, and its Renuvion product won the 2025 NewBeauty Award for "Best Minimally Invasive Skin Tightener".
    May 8, 2025, 11:12 AM