APYX

Apyx Medical Corp

NASDAQ · HEALTH CARE · SURGICAL & MEDICAL INSTRUMENTS & APPARATUS

2.41

−0.10 −3.98%

USD · close Oct 22

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MKT CAP $101.5MP/E —DIV YIELD —FCF YIELD -10.88%REV TTM $58.4M +25.6%NET INCOME −$8.6MNET DEBT $9.9M52W 2.36 – 4.86SEC XBRL · TTM TO Invalid Date

How APYX rewrote its risk factors

10-K ITEM 1A · FY2024 → FY2025

Text kept

81%

of sentences unchanged

Added

new sentences

Dropped

sentences removed

Length

+74

words, now 7,921

New in FY2025

In recent years, the Federal Reserve (the “Fed”) executed an aggressive tightening cycle increasing rates above 5% in 2023.
For most of 2024, the Fed paused rated increases and at the end of 2024 and throughout 2025 implemented several rate cuts.
The health of the economy may affect consumer purchases of discretionary services, such as cosmetic and aesthetic services, which could have a material adverse effect on our business, financial condition, results of operations and cash flows.
Uncertainty in the economy could adversely impact customer purchases of discretionary services, including cosmetic and aesthetic services.
Historically, some doctors have financed their purchase of capital equipment through third-party credit providers some of whom with which we have existing relationships.
Higher interest rates could increase our costs, decrease our selling price, or increase the monthly payments for consumer products financed through other sources of consumer financing.
Our cash needs will depend on numerous factors, including our revenues, successful completion of our FDA product clearance activities, our continued ability to commercialize our surgical aesthetics products, and our ability to reduce and control costs.
Our indebtedness levels and achievement of covenants could impact our business.
Our ability to successfully commercialize our products, including AYON, which launched in September 2025, will depend on a number of factors, any of which could delay or prevent commercialization, including: • our inability to obtain the necessary regulatory clearances or approvals for expanded indications, new products, or product modifications; • our inability to demonstrate, if required, the safety and efficacy of new products with data from preclinical studies and clinical trials; • if our product is determined to be ineffective or unsafe following approval, and is removed from the market or we are required to perform additional research and development to further prove the safety and effectiveness of the product before re-entry into the market; • if the regulatory approvals/clearances of our new products are delayed or denied, or we are required to conduct further research and development of our products prior to receiving regulatory approval; APYX MEDICAL CORPORATION • our inability to build and maintain a sales and marketing group to successfully launch and sell our new products; • if we experience sudden or extreme volatility in commodity prices and availability, including supply chain disruptions; • if we are required to allocate available funds to litigation matters; • if the needs of our physicians or their patients are not sufficiently met; • if we are unable to manufacture the quantity of products needed, in accordance with quality manufacturing standards, to meet market demand; • competition from other products or technologies prevents or reduces market acceptance of our products; • if we do not have, and cannot obtain, the intellectual property rights needed to manufacture or market our products without infringing on another company’s patents; or • if we are unsuccessful in defending against patent infringement, or other intellectual property rights claims, that could be brought against us, our products or technologies.
The energy-based medical device industry for the aesthetics market is highly competitive and we may be unable to compete effectively.
We have invested and continue to invest, substantial resources to develop and monetize our Renuvion and AYON technology into the aesthetic surgery market.
We have been issued 41 patents in the United States and 61 foreign patents.
We have 11 pending patent applications in the United States and 21 pending foreign applications.
Our intellectual property portfolio for our Renuvion, AYON and J-Plasma products continues to grow on an annual basis.
However, in the event that damages exceed the aggregate coverage limits of our policy, or if our insurance carriers disclaim coverage, or if we are unable to continue to obtain coverage on commercially reasonable terms, we believe it is possible that costs associated with these claims could have a material adverse impact on our consolidated financial position, results of operations and cash flows (see ITEM 3: Legal Proceedings).
The majority of our raw materials are purchased from single-source suppliers.
The decision to utilize our products may therefore be influenced by a number of factors, including: • consumer disposable income and access to consumer credit, which as a result of an unstable economy, may be significantly impacted; • the cost, safety and effectiveness of alternative treatments; • the success of our direct to consumer sales and marketing efforts; • the impact of GLP-1 drugs on the consumer demand as a result of a reallocation of discretionary spend to the drugs, the delay in aesthetic procedures as a result of patients waiting to hit their ideal weight, or the redistribution of aesthetic procedures away from traditional liposuction; and • the education of our customers and their patients on the benefits and uses of our products, compared to competitors’ products and technologies.
In addition, the FDA prohibits device manufacturers from promoting their products other than for the uses and indications set forth in the cleared product labeling.
We are subject to governmental export controls and regulations that could impair our ability to compete in international markets due to licensing requirements and subject us to potential liability if we are not in compliance with applicable laws.
These announcements may include: • our listing status on the Nasdaq Global Select Market; • our operating results falling below the expectations of public market analysts and investors; • developments in our relationships with or developments affecting our major customers; • negative regulatory action or regulatory non-approval with respect to our new products; • government regulation, governmental investigations, or audits related to us or to our products; • developments related to our patents or other proprietary rights or those of our competitors; • results of product liability claims or future claims; and • changes in the position of securities analysts with respect to our stock.
As of December 31, 2025, our outstanding stock options to our employees, officers, directors and consultants amounted to 7,579,377 shares of our common stock, representing approximately 18.1% of our outstanding common stock.
In connection with the execution of certain credit agreements, we issued warrants to purchase 1,500,000 shares of our commons stock, representing approximately 3.6% of our outstanding common stock.
Additionally, in the registered direct offering that we completed in November 2024, we issued 2,934,690 pre-funded warrants, of which 1,923,623 remain outstanding and unexercised, which will have a dilutive effect on our common stock outstanding when exercised.
As of the date of this annual report on Form 10-K, the dilution is 4.6%.
While we have concluded that, as of December 31, 2025, our disclosure and reporting controls were effective as included in Part II, Item 9A of this Form 10-K, there can be no assurance that future control deficiencies or material weaknesses will not be identified.
Changes in U.S. or foreign trade policies could significantly increase the cost of imported goods into the United States, which may materially reduce our sales or profitability.
Changes in U.S. or foreign trade policy could trigger retaliatory actions by affected countries, resulting in "trade wars," in increased costs for goods imported into the United States, which may reduce customer demand for these products if the parties having to pay those tariffs increase their prices, or in trading partners limiting their trade with the United States.

Gone since FY2024

We are in an inflationary period in the United States and is expected to continue at an elevated level in the near-term.
The Federal Reserve has raised interest rates to combat inflation and restore price stability.
The health of the economy may affect consumer purchases of discretionary services, such as cosmetic services, which could have a material adverse effect on our business, financial condition, results of operations and cash flows.
Uncertainty in the economy could adversely impact customer purchases of discretionary services, including cosmetic services.
Historically, some doctors have financed their purchase of generators through third-party credit providers some of whom with which we have existing relationships.
Higher interest rates could increase our costs or the monthly payments for consumer products financed through other sources of consumer financing.
Our cash needs will depend on numerous factors, including our revenues, successful completion of our FDA product clearance activities, our continued ability to commercialize our advanced energy products, and our ability to reduce and control costs.
Our indebtedness levels could impact our business.
Our ability to successfully commercialize our products, including AYON, which we expect to launch during 2025, will depend on a number of factors, any of which could delay or prevent commercialization, including: • our inability to obtain the necessary regulatory clearances or approvals for expanded indications, new products, or product modifications; • our inability to demonstrate, if required, the safety and efficacy of new products with data from preclinical studies and clinical trials; • if our product is determined to be ineffective or unsafe following approval, and is removed from the market or we are required to perform additional research and development to further prove the safety and effectiveness of the product before re-entry into the market; • if the regulatory approvals/clearances of our new products are delayed or denied, or we are required to conduct further research and development of our products prior to receiving regulatory approval; APYX MEDICAL CORPORATION • our inability to build and maintain a sales and marketing group to successfully launch and sell our new products; • if we experience sudden or extreme volatility in commodity prices and availability, including supply chain disruptions; • if we are required to allocate available funds to litigation matters; • if the needs of our physicians or their patients are not sufficiently met; • if we are unable to manufacture the quantity of products needed, in accordance with quality manufacturing standards, to meet market demand; • competition from other products or technologies prevents or reduces market acceptance of our products; • if we do not have, and cannot obtain, the intellectual property rights needed to manufacture or market our products without infringing on another company’s patents; or • if we are unsuccessful in defending against patent infringement, or other intellectual property rights claims, that could be brought against us, our products or technologies.
The energy-based medical device industry in the aesthetics market is highly competitive and we may be unable to compete effectively.
We have invested and continue to invest, substantial resources to develop and monetize our Renuvion technology into the cosmetic surgery market.
We have been issued 38 patents in the United States and 57 foreign patents.
We have 14 pending patent applications in the United States and 19 pending foreign applications.
Our intellectual property portfolio for our Renuvion and J-Plasma products continues to grow on an annual basis.
However, in the event that damages exceed the aggregate coverage limits of our policy, or if our insurance carriers disclaim coverage, or if we are unable to continue to obtain coverage on commercially reasonable terms, we believe it is possible that costs associated with these claims could have a material adverse impact on our consolidated financial position, results of operations and cash flows (see below ITEM 3: Legal Proceedings).
The majority of our raw materials are purchased from sole-source suppliers.
The decision to utilize our products may therefore be influenced by a number of factors, including: • consumer disposable income and access to consumer credit, which as a result of an unstable economy, may be significantly impacted; • the cost, safety and effectiveness of alternative treatments; • the success of our direct to consumer sales and marketing efforts; and • the education of our customers and their patients on the benefits and uses of our products, compared to competitors’ products and technologies.
In addition, the FDA has taken the position that device manufacturers are prohibited from promoting their products other than for the uses and indications set forth in the cleared product labeling.
We are subject to governmental export controls and economic sanctions that could impair our ability to compete in international markets due to licensing requirements and subject us to potential liability if we are not in compliance with applicable laws.
These announcements may include: • our listing status on the Nasdaq Global Select Market; • our operating results falling below the expectations of public market analysts and investors; • developments in our relationships with or developments affecting our major customers; • negative regulatory action or regulatory non-approval with respect to our new products; • government regulation, governmental investigations, or audits related to us or to our products; • developments related to our patents or other proprietary rights or those of our competitors and • changes in the position of securities analysts with respect to our stock.
As of December 31, 2024, our outstanding stock options to our employees, officers, directors and consultants amounted to 7,638,458 shares of our common stock, representing approximately 20.2% of our outstanding common stock.
In connection with the execution of the MidCap Credit Agreement and the Perceptive Credit Agreement, we issued warrants to purchase 1,500,000 shares of our commons stock, representing approximately 4.0% of our outstanding common stock.
Additionally, in the registered direct offering that we completed in November 2024, we issued 2,934,690 pre-funded warrants which will have a dilutive effect on our common stock outstanding when exercised.
As of the date of this annual report on Form 10-K, the dilution is 7.8%.
While we have concluded that, as of December 31, 2024, our disclosure and reporting controls were effective as included in Part II, Item 9A of this Form 10-K, there can be no assurance that future control deficiencies or material weaknesses will not be identified.
Changes in U.S. trade policies could significantly increase the cost of imported goods into the United States, which may materially reduce our sales or profitability.
Changes in U.S. trade policy could trigger retaliatory actions by affected countries, resulting in "trade wars," in increased costs for goods imported into the United States, which may reduce customer demand for these products if the parties having to pay those tariffs increase their prices, or in trading partners limiting their trade with the United States.

Sentence-level comparison of Item 1A in the two most recent 10-Ks (FY2024 ↗, FY2025 ↗). A reworded sentence counts as one dropped and one added, so heavy edits read as low “kept”. Headings and page furniture are stripped; nothing is summarised by a model.

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