CLEARWATER, Fla.--(BUSINESS WIRE)--Apyx Medical Corporation (Nasdaq: APYX) (“Apyx Medical;” the “Company”), the manufacturer of a proprietary helium plasma and radiofrequency technology marketed and sold as Renuvion®, today announced that its Renuvion technology will be featured in three educational sessions at the upcoming American Academy of Cosmetic Surgery’s 40th Annual Scientific Meeting, to be held in New Orleans, LA from February 22 – 24. “ Apyx Medical is pleased to see Renuvion featured in a varie ...

Core Viewpoint - Apyx Medical Corporation announced the publication of a peer-reviewed article demonstrating the safety of its Renuvion technology for contracting subcutaneous soft tissue following liposuction, which supports its FDA 510(k) clearance for this application [1][2][3] Group 1: Publication and Analysis - The peer-reviewed article published in the Aesthetic Surgery Journal Open Forum evaluated the use of Renuvion in 483 patients treated post-liposuction across 1,184 body areas [1][2] - The analysis included data from six published retrospective studies, focusing on the safety and efficacy of Renuvion compared to liposuction alone [2][3] - The authors concluded that Renuvion did not present new or increased risks when used after liposuction, and the risks were consistent across different body areas [3] Group 2: Company Background and Technology - Apyx Medical Corporation specializes in advanced energy technology, particularly its Helium Plasma Technology products marketed as Renuvion in cosmetic surgery and J-Plasma in hospital surgical markets [4] - The company emphasizes its ability to provide controlled heat to tissue, enhancing surgical outcomes [4]

[Part I. Financial Information](index=4&type=section&id=Part%20I.%20Financial%20Information) [Condensed Consolidated Financial Statements (Unaudited)](index=4&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements%20(Unaudited)) The financial statements show increased sales and gross profit, a narrowed net loss, and significant balance sheet changes from new financing and a property sale [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets and liabilities increased due to a rise in cash and a new term loan, while total equity slightly decreased reflecting the period's net loss Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | Sep 30, 2023 (Unaudited) | Dec 31, 2022 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $22,134 | $10,192 | | Total current assets | $50,150 | $42,972 | | Total assets | $59,446 | $51,775 | | **Liabilities & Equity** | | | | Total current liabilities | $10,294 | $11,850 | | Term loan, net | $9,009 | $0 | | Total liabilities | $25,860 | $13,982 | | Total equity | $33,586 | $37,793 | | Total liabilities and equity | $59,446 | $51,775 | [Condensed Consolidated Statements of Operations](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) Third-quarter and nine-month results show significant year-over-year sales growth and a reduction in both operating and net losses Q3 2023 vs Q3 2022 Performance (in thousands, except per share data) | Metric | Q3 2023 | Q3 2022 | | :--- | :--- | :--- | | Sales | $11,976 | $9,114 | | Gross Profit | $7,978 | $5,757 | | Loss from operations | $(4,637) | $(5,782) | | Net loss attributable to stockholders | $(4,629) | $(5,764) | | Loss per share (Basic and diluted) | $(0.13) | $(0.17) | Nine Months 2023 vs 2022 Performance (in thousands, except per share data) | Metric | Nine Months 2023 | Nine Months 2022 | | :--- | :--- | :--- | | Sales | $37,687 | $31,899 | | Gross Profit | $24,830 | $20,890 | | Loss from operations | $(11,483) | $(17,629) | | Net loss attributable to stockholders | $(9,106) | $(17,135) | | Loss per share (Basic and diluted) | $(0.26) | $(0.50) | [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Cash flow improved significantly due to a large tax refund, proceeds from a property sale, and a new term loan, resulting in a net cash increase Cash Flow Summary for Nine Months Ended Sep 30 (in thousands) | Activity | 2023 | 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | $(3,037) | $(15,750) | | Net cash provided by (used in) investing activities | $6,827 | $(868) | | Net cash provided by financing activities | $8,322 | $227 | | **Net change in cash and cash equivalents** | **$11,942** | **$(16,037)** | [Notes to Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) The notes detail FDA clearances and management's actions to mitigate substantial doubt about the company's ability to continue as a going concern - The company's recurring net losses and cash outflows raised **substantial doubt about its ability to continue as a going concern**[29](index=29&type=chunk) - Management believes actions taken, including the **new Perceptive Credit Agreement**, alleviate the substantial doubt about its ability to continue as a going concern[36](index=36&type=chunk) - The company received **multiple 510(k) clearances from the FDA** for its Renuvion® handpieces, which should help mitigate prior financial effects[24](index=24&type=chunk)[25](index=25&type=chunk)[27](index=27&type=chunk) - On May 8, 2023, the company completed a **sale-leaseback of its facility for $7.65 million**, receiving net cash proceeds of approximately $6.6 million[47](index=47&type=chunk) - On November 8, 2023, the company entered into a **new $45 million credit agreement with Perceptive**, using the initial loan to repay its existing MidCap loan[81](index=81&type=chunk)[83](index=83&type=chunk) - As of September 30, 2023, the company was **not in compliance with a net revenue covenant** of its MidCap Credit Agreement, an issue resolved by the subsequent loan repayment[73](index=73&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=30&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses Q3 revenue growth, improved gross margin, a narrowed operating loss, and actions taken to improve liquidity and alleviate going concern doubts [Results of Operations](index=34&type=section&id=Results%20of%20Operations) Q3 revenue grew 31.4% driven by the Advanced Energy segment, gross margin expanded, and operating expenses saw mixed changes Sales by Segment - Q3 2023 vs Q3 2022 (in thousands) | Segment | Q3 2023 | Q3 2022 | % Change | | :--- | :--- | :--- | :--- | | Advanced Energy | $9,836 | $7,080 | 38.9% | | OEM | $2,140 | $2,034 | 5.2% | | **Total** | **$11,976** | **$9,114** | **31.4%** | - The increase in Advanced Energy sales was driven by domestic customers upgrading to the **new Apyx One Console** and a higher average selling price[154](index=154&type=chunk)[155](index=155&type=chunk) - **Gross margin for Q3 2023 increased to 66.6%** from 63.2% in Q3 2022, primarily due to a more favorable sales mix[159](index=159&type=chunk) - Professional services expense **decreased 21.9%** for the nine-month period, mainly due to lower legal expenses[164](index=164&type=chunk) [Liquidity and Capital Resources](index=37&type=section&id=Liquidity%20and%20Capital%20Resources) Liquidity was bolstered by a new credit agreement, a property sale, and a tax refund, which management believes alleviates previous going concern doubts - **Cash and cash equivalents increased to $22.1 million** at September 30, 2023, from $10.2 million at year-end 2022[175](index=175&type=chunk) - Key actions to improve liquidity included a **new credit agreement for up to $45 million**, a sale-leaseback generating $6.6 million, and an $8.1 million tax refund[179](index=179&type=chunk)[180](index=180&type=chunk)[181](index=181&type=chunk) - Management believes that actions taken, particularly the new Perceptive Credit Agreement, **alleviate the conditions that previously raised substantial doubt** about going concern[182](index=182&type=chunk) [Quantitative and Qualitative Disclosures about Market Risk](index=43&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) This item is not applicable for the reporting period - The company states that Quantitative and Qualitative Disclosures about Market Risk are **not applicable**[203](index=203&type=chunk) [Controls and Procedures](index=44&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective, noting a change in internal control related to a new credit agreement - The CEO and CFO concluded that as of September 30, 2023, the company's **disclosure controls and procedures were effective**[205](index=205&type=chunk) - **New control activities were developed** related to the accounting for the new Credit Agreement, including review and compliance with debt covenants[206](index=206&type=chunk) [Part II. Other Information](index=45&type=section&id=Part%20II.%20Other%20Information) [Legal Proceedings](index=45&type=section&id=Item%201.%20Legal%20Proceedings) The company refers to financial statement notes for details on legal matters, including the dismissal of two significant lawsuits - For information on legal proceedings, the report refers to **Note 12** of the Condensed Consolidated Financial Statements[208](index=208&type=chunk) [Risk Factors](index=46&type=section&id=Item%201A.%20Risk%20Factors) No material changes to risk factors from the previous annual report were disclosed - **No material changes** to the risk factors from the Annual Report on Form 10-K for the year ended December 31, 2022, were reported[210](index=210&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=47&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales of equity securities during the period - **None reported**[212](index=212&type=chunk) [Other Information](index=47&type=section&id=Item%205.%20Other%20Information) The company reported no other information required to be disclosed under this item - **None reported**[212](index=212&type=chunk) [Exhibits](index=48&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the report, including certifications and XBRL data files - The report includes a list of filed exhibits, such as corporate governance documents, certifications, and **XBRL data**[214](index=214&type=chunk)

Apyx Medical Corporation (NASDAQ:APYX) Q3 2023 Earnings Conference Call November 9, 2023 8:00 AM ET Company Participants Charles Goodwin - President & CEO Tara Semb - CFO Conference Call Participants Frank Takkinen - Lake Street Capital Markets Matthew O'Brien - Piper Sandler Matt Hewitt - Craig-Hallum George Sellers - Stephens Dave Turkaly - JMP Securities Operator Please stand by. Hello, and welcome, ladies and gentlemen, to the Third Quarter of Fiscal Year 2023 Earnings Conference Call for Apyx Medical C ...

Financial Data and Key Metrics Changes - Total revenue for Q2 2023 increased by 32% year-over-year to $13.6 million, driven by Advanced Energy product sales which grew 40% year-over-year to $11.7 million [6][19] - Gross profit for Q2 2023 increased by $2.4 million or 34% year-over-year to $9.3 million, with a gross profit margin of 68.4% compared to 67.2% in the prior year [19] - Net loss attributable to stockholders decreased by $4.4 million or 82% year-over-year to $1 million, or $0.03 per share [21] Business Line Data and Key Metrics Changes - Advanced Energy sales increased 40% year-over-year and 21% quarter-over-quarter, with U.S. sales growing 38% year-over-year [7][8] - OEM sales decreased 4% year-over-year to $1.8 million, but exceeded expectations by approximately $400,000 [6] - The company achieved a $2 million reduction in operating loss year-over-year in Q2, excluding a $2.7 million gain from a sale leaseback transaction [17] Market Data and Key Metrics Changes - International Advanced Energy sales were impacted by safety communications, but there was strong growth in generator sales in Latin America and the Asia-Pacific region [9][10] - U.S. Advanced Energy sales were the primary driver of growth, with strong demand from existing users following the launch of the Apyx One console [8][10] Company Strategy and Development Direction - The company is focused on expanding clinical indications for Renuvion technology and enhancing its product portfolio, including the recent 510(k) clearance for the Renuvion micro handpiece [11][15] - Apyx Medical aims to position itself for sustainable profitability and strong free cash flow generation while expanding its share in the cosmetic surgery market [29] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving continued growth in Advanced Energy sales, driven by recent regulatory clearances and improved market conditions [28] - The company reaffirmed its 2023 revenue guidance of $59 million to $62 million, representing growth of approximately 33% to 39% year-over-year [23] Other Important Information - The company received an $8.1 million payment from the IRS for cash tax refunds, enhancing its balance sheet condition [18][22] - The limited market release of the Renuvion micro handpiece commenced at the end of July, with a full commercial launch targeted for Q4 2023 [16] Q&A Session Summary Question: What was the magnitude of the international softness in the quarter? - Management noted that international handpiece sales were lower than expected due to timing of distribution orders, but they anticipate these orders in the back half of 2023 [32][34] Question: What lift can be expected from the micro handpiece this year? - The micro handpiece is expected to provide a nice addition to the portfolio, particularly for smaller areas of treatment, with benefits anticipated more significantly in 2024 [35][37] Question: What has been the feedback from customers regarding the Apyx One console? - Initial feedback has been positive, highlighting advanced features such as touchscreen functionality and cloud connectivity, which have resonated well with surgeons [40][42] Question: How did utilization trend with liposuction versus standalone? - Management indicated a notable uptick in U.S. adoption following the FDA safety communication update in May, but specific trend data was not available [46][47] Question: Are there plans for seeking other incremental OUS approvals? - The company is still pursuing approvals in South Korea and China, but no new registrations were obtained in Q2 [58][59]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Title of each class Trading symbol(s) Name of each exchange on which registered Common Stock APYX Nasdaq Stock Market, LLC FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _____ to _____ Commission File Number: 0-12183 ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Title of each class Trading symbol(s) Name of each exchange on which registered Common Stock APYX Nasdaq Global Select Market FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _____ to _____ Commission File Number: 0-12 ...

Financial Data and Key Metrics Changes - Total revenue for Q1 2023 decreased 3% year-over-year to $12.1 million, exceeding expectations by approximately $900,000 [6] - Advanced Energy sales decreased 10% year-over-year to $9.7 million, also exceeding expectations by approximately $700,000 [6] - OEM sales increased 46% year-over-year to $2.5 million, approximately $200,000 higher than anticipated [7] - Gross profit decreased 8% year-over-year to $7.6 million, with a gross profit margin of 62.4% compared to 65.8% in the prior year [26] - Net loss attributable to stockholders was $3.5 million or $0.10 per share, compared to $5.9 million or $0.17 per share for Q1 2022 [27] Business Line Data and Key Metrics Changes - Advanced Energy sales in the U.S. increased by nearly 10% year-over-year, with U.S. generator sales increasing by approximately 40% [8] - International generator sales decreased by more than 60% year-over-year, impacted by safety communication issues [9] - The Apyx One Console was launched in late January, contributing to stronger than anticipated sales performance [20] Market Data and Key Metrics Changes - The market opportunity for Renuvion technology in the U.S. cosmetic surgery market is estimated at nearly $3 billion, with an annual opportunity exceeding $700 million [36] Company Strategy and Development Direction - The company is focused on enhancing the Renuvion product portfolio and expanding clinical evidence supporting its products [37] - The recent FDA updates and 510(k) clearances are expected to drive growth and address previous safety communication issues [41][42] - The company aims to maximize growth opportunities through direct-to-consumer marketing and empowering international distribution partners [36] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving revenue growth of at least 39% for the year, driven by recent regulatory clearances and the successful launch of the Apyx One Console [41] - The company anticipates stronger utilization trends as the year progresses, particularly in the U.S. market [49] Other Important Information - The company completed a sale and leaseback transaction for its Clearwater property, providing approximately $6.6 million in proceeds [24] - Cash and cash equivalents at the end of Q1 2023 were $16.3 million, compared to $10.2 million at the end of 2022 [28] Q&A Session Summary Question: Confidence in achieving full-year guidance - Management expressed confidence in achieving growth due to recent 510(k) clearances and the positive reception of the Apyx One Console [41] Question: Early conversations with clinicians regarding Renuvion usage - Management noted that existing customers were retained well, and the recent clearance for use after liposuction presents an opportunity to re-engage with clinicians [45] Question: Feedback from international distributors post-safety communication update - Management indicated that it was too early to assess feedback from international distributors following the recent update [49] Question: Visibility on generator sales pipeline - Management stated that they have forecasts and insights into the sales pipeline, with a focus on upgrading existing customers [51] Question: Impact of discounts on gross margins - Management clarified that the lower gross margins were primarily due to a higher proportion of OEM sales rather than the upgrade discounts [53]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Title of each Class Trading Symbol Name of each Exchange on which registered Common Stock, $.001 Par Value APYX Nasdaq Global Select Market FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _____ to _____ Commission File Num ...

Financial Data and Key Metrics Changes - Total revenue in Q4 2022 decreased 25% year-over-year to $12.6 million, approximately $300,000 below the low end of guidance [6][24] - Gross profit for Q4 2022 decreased $3.9 million or 32% year-over-year to $8.2 million, with a gross profit margin of 65.3% compared to 72.2% in the prior year [24][25] - Net loss attributable to stockholders was $6 million or $0.17 per share, compared to $2 million or $0.06 per share for Q4 2021 [27] Business Line Data and Key Metrics Changes - Advanced Energy sales decreased 30% year-over-year to $10.5 million, while OEM sales increased 15% year-over-year to $2.1 million [7][24] - Global generator sales decreased nearly 50% year-over-year, with U.S. generator sales down more than 40% year-over-year [8][9] - International handpiece sales saw year-over-year growth in Q4, particularly in Latin America, Europe, and APAC [10] Market Data and Key Metrics Changes - U.S. Advanced Energy product sales decreased by more than 30% year-over-year, while international generator sales decreased by more than 60% year-over-year [9][10] - The installed base and active installed base in the U.S. grew by 20% year-over-year despite the challenges [9] Company Strategy and Development Direction - The company is focused on advancing its regulatory strategy to secure additional 510(k) clearances and improve marketing capabilities [14][37] - Apyx Medical launched its first direct-to-consumer brand campaign titled "This is Me" to raise awareness of Renuvion technology [18] - The company aims to enhance its product portfolio with the new Apyx One Console, designed for improved functionality and user experience [19][20] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving revenue growth of 30% to 37% year-over-year for 2023, driven by Advanced Energy growth [29][35] - The company anticipates improving trends in generator and handpiece sales as it raises awareness of Renuvion technology [36][38] - Management emphasized the importance of driving cash flow from operations as a priority for 2023 [38] Other Important Information - The company expects to end 2023 with at least $18 million in cash and cash equivalents [33] - Apyx Medical has secured a new five-year credit facility of up to $35 million to enhance its financial position [20][22] Q&A Session Summary Question: Can you discuss the guidance for the year, especially in light of Q1 commentary? - Management expressed confidence in achieving at least 36% growth due to multiple tailwinds, including new marketing efforts and product launches [41][42] Question: What is the expected replacement cycle for the Apyx One generator? - The upgrade will be a new revenue source, and the company plans to fully sell the Apyx One by year-end [44][46] Question: What feedback has been received from the new marketing campaigns? - Initial feedback from the "This is Me" campaign has been very positive, resonating well with both consumers and surgeons [48][49] Question: What are the catalysts for recovery in OUS markets? - Management noted that understanding the safety communication has improved distributor confidence, leading to stronger sales in Latin America [51][52] Question: Does the recent 510(k) clearance cover use after liposuction? - The new clearance allows for the contraction of soft tissue, and the company is working with the FDA to clarify its implications [55][56] Question: Is the cash balance sufficient to alleviate going concern issues? - Management believes that the expected cash balance, along with discrete items, will alleviate the risk of going concern [57][59]