Apyx Medical Corporation (NASDAQ:APYX) Q4 2022 Earnings Call Transcript

Apyx Medical Corporation (NASDAQ:APYX) Q4 2022 Earnings Call Transcript March 16, 2023

Operator: Please stand by. Hello and welcome, ladies and gentlemen to Fourth Quarter and Fiscal Year 2022 Earnings Conference Call for Apyx Medical Corporation. At this time, all participants have been placed in a listen-only mode. At the end of the company’s prepared remarks, we will conduct a question-and-answer session. Please note that this conference call is being recorded and that the recording will be available on the company’s website for replay shortly. Before we begin, I would like to remind everyone that our remarks and responses to your questions today may contain forward-looking statements that are based on the current expectations of management and involve inherent risks and uncertainties that could cause actual results to differ materially from those indicated, including without limitation to those identified in the risk factors section of our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, our most recent 10-Q filing and the company’s other filings with the Securities and Exchange Commission.

Such factors maybe updated from time-to-time in our filings with the SEC, which are available on our website. We undertake no obligation to publicly update or revise our forward-looking statements as a result of new information, future events or otherwise. This call will also include references to certain financial measures that are not calculated in accordance with Generally Accepted Accounting Principles, or GAAP. We generally refer to these as non-GAAP financial measures. Reconciliations of those non-GAAP financial measures to the most comparable measures calculated and presented in accordance with GAAP are available in the earnings press release on the Investor Relations portion of our website. I would now like to turn the call over to Mr. Charlie Goodwin, Apyx Medical’s President and Chief Executive Officer.

Please go ahead, sir.

Charles Goodwin: Thanks, operator. Welcome everyone to our fourth quarter and fiscal year 2022 earnings call. I am joined on today’s call by our Chief Financial Officer, Tara Semb. Turning to a quick agenda of what we intend to cover today, I will start by reviewing our fourth quarter revenue results and the factors that contributed to our performance. Then I will provide you with an update of our operational progress during the fourth quarter and in recent months. Tara will then discuss our fourth quarter financial results in detail, as well as our financial guidance for 2023, which we introduced in our earnings release today. I will conclude with some thoughts on our outlook and key areas of focus in 2023 before we open the call for Q&A.

Let’s get started with a review of our fourth quarter revenue results. Our total revenue in the fourth quarter decreased 25% year-over-year to $12.6 million. These results were approximately $300,000 below the low end of our guidance range we provided on our November earnings call. Our total revenue performance was driven by softer than anticipated Advanced Energy sales, which decreased 30% year-over-year to $10.5 million and offset partially by better than expected OEM sales, which increased 15% year-over-year to $2.1 million. Looking at the performance in our Advanced Energy business in more detail, global sales of our Advanced Energy products continued to be impacted by business interruption related to the medical safety device communication, which was posted by the FDA in March of 2022.

While we anticipated continued disruption throughout the fourth quarter, the level of impact was higher than we anticipated, most notably, as it relates to global sales of our Advanced Energy Generators. In the fourth quarter, global generator sales decreased nearly 50% year-over-year driven by declines both domestically and internationally. These declines were moderated by a 10% decrease in global handpiece sales. As we have discussed in prior quarters, generator sales are primarily a reflection of sales to new users of our technology. This aspect of our Advanced Energy business has seen the most notable impact from the safety communication. While the pace of recovery in global generator sales was slower than our guidance had assumed, it is important to recognize that overall demand trends improved versus Q3 with generator sales increasing nearly 40% on a sequential basis.

Looking at our Advanced Energy performance by geographic region in more detail, sales of our Advanced Energy Generators in all markets continued to be more difficult than we had anticipated. In the U.S. specifically, sales of our Advanced Energy products decreased by more than 30% year-over-year with sales of our U.S. generators decreasing by more than 40% year-over-year. Given the confusion in the market related to the safety communication, our reps have continued to find that more time and effort has been required to help potential new customers understand the communication and the safety and efficacy profile of our technology, which has elongated our historical sales cycle. While generator sales to new customers remained impacted in 2022, we were pleased to grow both our total install base and our active install base in the U.S. by 20% year-over-year, which speaks to the success of our U.S. sales team has had in engaging with and educating customers since the safety communication was initially posted.

Outside the U.S. sales of our Advanced Energy Generators decreased by more than 60% year-over-year as we continued to experience weaker than anticipated demand for generators from distributors in key countries, most notably in Europe and Latin America. While distributor demand for handpieces in the fourth quarter varied across international markets we serve, we were pleased to see stronger than anticipated handpiece demand from our distributors in several countries in Latin America, Europe and APAC, which resulted in year-over-year growth in international handpiece sales in Q4. Shifting to discussion of our operational performance in the fourth quarter and recent months, during the fourth quarter our team remained focused on the two primary objectives that we outlined on our most recent earnings calls.

First we remained focused on our engaging with potential U.S. customers and our existing OUS distributors to clarify potential confusion related to the safety communication. As a reminder, in 2022, we obtained two new specific clinical indications, an indication for use in dermatological procedures for the treatment of moderate to severe wrinkles and rhytides and an indication to approve the appearance of lax or loose skin in the neck and submental region. Following our receipt of these two 510(k) clearances, the FDA issued updates to the safety communication with revisions to reflect each new indication. With this as a backdrop, during the fourth quarter, our team continued their work to communicate these important developments leveraging our updated marketing and educational materials, ensure prospective customers understand the overall safety and efficacy profile of our products, as supported by our IDE clinical studies, real world evidence and over 50 clinical publications and address any questions related to the safety communication.

The process has been more prolonged outside of the U.S. given our indirect commercial model. With this mind, we were pleased to host our first Latin America users meeting in early November which I was able to attend personally. This in-person meeting provided us with the opportunity to directly address the topic of the safety communication, clarify any potential misconceptions, and explain clinical and real world data supporting our advanced energy products. The event was also €“ the event also included a series of presentations and discussion panels with our KOLs, which proved to be very interactive, providing our customers in the Latin America region with the opportunity to learn from their peers. Overall, the meeting was very productive and well attended contributing our strong handpiece sales in Latin America during the fourth quarter.

With respect to our second primary objective, we obtained €“ we continued to advance our regulatory strategy to secure additional 510(k) clearances related to the use of our Renuvion technology in cosmetic surgery procedures. During the fourth quarter, our team engaged with the FDA to obtain their feedback on a proposed 510(k) submission for a specific clinical indication for the use of the Renuvion APR handpiece for the coagulation of subcutaneous soft tissues where needed following liposuction. We believe receiving clearance for this indication will address the remaining limitations of the safety communication. We submitted our related pre-submission request to the FDA in September and received the agency’s formal response and feedback in December.

This feedback was incorporated into our request for 510(k) clearance which we submitted at the end of January and announced via press release on February 1. Our request for 510(k) clearance is supported by substantial evidence demonstrating the safety of our Renuvion APR handpiece when used following liposuction procedures including data from our IDE clinical study in skin laxity, as well as real world evidence, we were able to conduct an analysis of the use of Renuvion following liposuction leveraging data from a large set of retrospective chart reviews. Our data set included treatment data from more than 480 patients and 1180 areas of the body. Importantly, when this data was compared to real world evidence for liposuction treatment gathered in literature review, our analysis demonstrated that there were no new or increased risks for Renuvion procedures, following liposuction procedures, compared to liposuction alone.

During the fourth quarter, we also completed and submitted our request for an additional 510(k) clearance to obtain an indication related to the use of the Renuvion APR handpiece for the contraction of soft tissue, including subcutaneous tissue where needed on the body. On February 27th, we were pleased to receive clearance for this indication further demonstrating the safety and effectiveness of our Renuvion technology when used to contract soft tissue. We were pleased with the strong progress our regulatory team has made in this past year, and in recent months, as we continue to secure clearances supporting the safe and effective use of our Advanced Energy products. In addition to these efforts, I’d like to share an update on the important operational progress we have made on several other fronts to position, Apyx Medical for improved financial performance in 2023.

Photo by National Cancer Institute on Unsplash

During the fourth quarter, our sales and marketing teams continued their efforts to prepare for the commercial launch related to the use of our Renuvion technology for the two new clinical indications that we secured in 2022. As a reminder, these two new clinical indications enable us to market our technology to both surgeons and potential patients for years in approximately 200,000 neck contouring procedures, and 200,000 wrinkle reduction procedures we estimate are performed in the U.S. each year. I am very pleased to announce that we began our launch for both indications on January 3rd. In tandem with this launch, we introduced our first direct-to-consumer brand campaign, titled. This is Me. Our launch and Direct-to-Consumer brand campaign are supported by a nationwide campaign featuring digital advertising on multiple platforms, social media initiatives and a dedicated patient-focused website, all designed to raise awareness of Renuvion and highlight the benefits of our technology.

While we remain in the early months of this launch, the feedback we have received from surgeons and patients has been very positive. In advance of launch, we were also pleased to see our technology featured in two popular television series focused on cosmetic procedures during the fourth quarter the e-channel series Botched and TLC series, Awake Surgery. On the new product front we completed preparations for the commercialization of our next-generation. Renuvion Generator, the Apyx One Console. In designing the Apyx One Console, our product development team work closely with members of the surgeon community. Our overarching goal was to enhance the functionality, ease of use and overall experience for our surgeon customers. With this in mind, the Apyx, One Console features key enhancements, including adaptive and intuitive, touchscreens, procedural presets for specific parts of the body, cloud connectivity, data, logging and sharing, remote upgrade capabilities and system diagnostics in an advanced gas system that measures and monitors gas, volume and usage.

In addition to these features, Apyx One is also designed to be compatible with future generations of our Renuvion handpieces. Following our launch in late January, the Apyx One is now available in the U.S. and we have introduced an upgrade program for all of our existing U.S. users. Lastly, in addition to our progress on the commercial, regulatory and new product development fronts, we have made important progress in recent months to enhance our balance sheet. In January, we were notified that the IRS had completed their examination of our federal income tax returns for 2018, €˜19 and €˜20 and approved that our cash tax refunds of at least $7.5 million be processed. We continue to await the receipt of these funds. On February 21st, we announced a new five-year agreement with MidCap Financial for a credit facility of up to $35 million.

The facility includes a senior secured term Loan of up to $25 million and a revolving line of credit up to $10 million. At closing, tranche one of the term loan provided us with approximately $8 million of net proceeds. On March 15th, we filed an 8-K disclosing our entry into a sale and leaseback agreement, which further strengthens our balance sheet, and financial condition. Under the terms of the agreement, the company sold our property located in Clearwater, Florida, including the building that houses our offices and manufacturing facility to VK Acquisitions LLC for gross proceeds of $7.65 million. The agreement is subject to customary due diligence and inspection period over the next 35 days. Upon closing we would expect to receive cash of approximately $6.7 million in proceeds from the sale of the – from the sale transaction, net of commissions, expenses and first-year deposit of our rent expense.

We believe the $8 million of net proceeds from tranche one of our term loan, the $6.7 million of cash from our sale and leaseback transaction, and the expected $7.5 million in tax refunds, together with potential future borrowings from our term loan, and available borrowings on our revolver facility provide ample liquidity to fund our strategic growth initiatives over the near term as we work to achieve our longer-term goals of generating sustainable profitability, and strong free cash flow generation in the future. Stepping back, while 2022 ultimately provided to be more challenging than we had anticipated, we remain pleased with the continued passion we have seen for our technology from our customers. Despite difficult circumstances, our team has achieved notable progress across many key aspects of our strategy as I just discussed.

We believe these achievements position Apyx Medical for a return to driving strong sales growth and important improvements in our profitability profile, with the ample liquidity to fund our strategic growth initiatives in the near term as we progress towards our longer term financial goals. I will discuss our 2023 outlook and related priorities further in a minute, but first, let me turn it over to Tara to review our quarterly financial results and 2023 guidance. Tara?

Tara Semb: Thanks, Charlie. I will begin my review of our financial performance at the gross profit line since Charlie covered our revenue results. Gross profit for the fourth quarter of 2022 decreased, $3.9 million or 32% year-over-year to $8.2 million. Gross profit margin was 65.3%, compared to 72.2% in the prior year period. The decrease in our gross margin was driven primarily by changes in the sales mix between our two segments, product mix within our Advanced Energy segment and higher cost to manufacture inventory as we continued to experience increased material and shipping costs. These headwinds to our gross margin performance were partially offset by geographic mix within our Advanced Energy segment with domestic sales comprising a higher percentage of total sales and by the increased mix of newer product models.

Operating expenses increased $0.3 million or 2% year-over-year to $14.2 million. The increase in operating expenses year-over-year was driven by professional services expenses and research and development expenses, which each increased by $0.3 million. These increases were partially offset by a $0.2 million decrease in SG&A and a $0.1 million decrease in salaries and related costs. Our operating expenses came in approximately $0.7 million above what our low end of guidance had assumed, driven by higher than anticipated SG&A and Professional Service expenses related to higher insurance and legal expenses and higher consulting fees respectively. Loss from our operations for the fourth quarter of 2022 increased $4.2 million or 251% year-over-year to $5.9 million.

Total other income that was $19,000 dollars, compared to total other expense of $0.2 million in the fourth quarter of 2021. Income tax expense was $0.2 million, compared to $0.1 million in the fourth quarter of 2021. Net loss attributable to stockholders was $6 million or $0.17 per share, compared to $2 million or $0.06 per share for the fourth quarter of 2021. Adjusted EBITDA loss for the fourth quarter of 2022 was $4.1 million compared $0.3 million in the prior year period. As a reminder, we provided a detailed reconciliation from net loss attributable to stockholders to non-GAAP adjusted EBITDA loss in our earnings press release this morning. As of December 31st 2022, the company had cash and cash equivalents of $10.2 million compared to $30.9 million as of December 31st 2021.

Cash used in operations in 2022 was $20.3 million, compared to $10.4 million last year. The increase in use of cash from operations is primarily attributable to the year-over-year increase in net loss and a roughly $3.5 million increase in cash used for working capital driven, primarily by strategic investments in our inventory to ensure our ability to meet demand amidst the challenging global supply chain environment, offset partially by better accounts receivable collections compared to the prior year period. Turning to a review of our 2023 financial guidance, which we introduced in our earnings press release today, for the 12 months ending December 31st 2023, we expect total revenue in the range of $58 million to $61 million, representing growth of 30% to 37% year-over-year.

Our total revenue guidance range assumes Advanced Energy revenue of $50 million to $53 million representing growth of approximately 36% to 44% year-over-year and OEM revenue of approximately $8 million representing growth of approximately 4% year-over-year. In terms of our profitability guidance for fiscal year 2023, we expect, net loss attributable to stockholders of approximately $14 million, compared to $23.2 million last year. Our formal financial guidance for 2023 incorporates the following considerations for modeling purposes: First, gross margins of approximately 65% to 67% percent this, year compared to 65% last year. We expect tailwinds to our gross margin as our revenue mix favors the Advanced Energy segment and our U.S. growth exceeds growth in sales to customers outside the U.S. We also expect continued margin tailwinds related to product mix within our Advanced Energy segment.

These tailwinds are expected to be partially or fully offset by year-over-year headwinds related to raw materials inflation, changes in foreign currency exchange rates against the US dollar, and to a lesser extent incremental rent expense related to our sale-leaseback transaction. Second, the year-over-year change in operating expenses to range between a decrease of 1% to growth of 5%.Third, total interest and other loss of approximately $1.4 million in 2023, compared to total interest and other income of approximately $0.7 million last year. Total interest and other loss in 2023 includes net interest expense of approximately $1.7 million and a $350,000 dollar gain in our other income loss line related to the lapse of the statutory limitations on our joint and several payroll liability.

Fourth, income tax benefit of approximately $2.2 million, compared to an expense of $0.4 million last year. We also expect non-cash depreciation and amortization of approximately $0.7 million, non-cash stock-based compensation of approximately $6 million, non-controlling interest of approximately $125,000 and weighted average diluted shares outstanding of approximately 34.8 million shares and for the first quarter of 2023, we anticipate total revenue in the range of $10.8 million to $11.2 million, driven by a decrease in Advanced Energy sales in the range of approximately 21% to 17% year-over-year, offset partially by growth in OEM sales of approximately 34% year-over-year. Finally, our formal financial guidance for 2023 assumes we end the year with at least $18 million in cash and cash equivalents and restricted cash on our balance sheet as of December 31st 2023.

This cash projection for the year ended 2023 includes a number of key assumptions and discrete items to bear in mind when evaluating our financial condition. First we expect normalized cash used in operating and investing activities of approximately $14.5 million in 2023. This reflects our expectation for GAAP net loss of $14 million, $0.5 million of CapEx and that our non-cash items including depreciation amortization and stock comp expense, as well as non-cash amortization related to our debt facilities are offset by cash used in working capital this year. Second, our cast projection for the year ended 2023 includes a one-time benefit to working capital of $7.5 million related to the tax refund discussed earlier and a one-time benefit to cash flow from investing activities of $6.7 million related to the sale-leaseback transaction.

Third, our cash projection for the year ended 2023 includes the $8 million of net proceeds, we received from tranche one of our term loan, but assumes no additional borrowings on either the term loan or the revolver in 2023. With that, I’ll turn the call back to Charlie for closing remarks.

Charles Goodwin: Thanks Tara. As mentioned our 2023 revenue guidance assumes total revenue growth of at least 30% year-over-year to $58 million, driven primarily by Advanced Energy growth of at least 36% year-over-year to $50 million. In 2023, the low end of our revenue guidance assumes improving year-over-year sales results as we progress through the year with the stronger Advanced Energy year-over-year growth trends in the second half versus growth trends in the first half. We expect strong contributions to growth from improving generator sales, most notably in the U.S. as we move through the year. We also expect improving handpiece sales trends in both the U.S. and OUS as we move through the year. We expect this improving performance to be driven by the recent and continued efforts of our team to raise awareness and educate the market on the safety and efficacy of our Renuvion technology with important tailwinds related to; the recent commercial launch of our Renuvion clinical indications obtained in 2022 and our related consumer-focused marketing activities.

Our recently obtained 510(k) clearance received for the use of Renuvion APR handpiece for the contraction of soft tissue and the recent commercial launch of our new Renuvion Apyx One generator. Importantly, the low end of our Advanced Energy revenue guidance assumes no change in the FDA safety communication as it stands currently. In addition to driving both adoption and utilization of our Advanced Energy products by leveraging these important tailwinds in 2023, we remain focused on continuing our strong pace of operational progress by executing on the following strategic initiatives: First, we remain focused on advancing our regulatory strategy to address the remaining limitations of the safety communication and improve our ability to market our technology.

Second, we will continue to enhance our Renuvion product portfolio by working to bring new technologies, like our Apyx One Console to market; and third, we will further expand our portfolio of clinical evidence supporting the use of our new products; and fourth, we will continue to closely manage our expenses and drive progress towards improving profitability, while evaluating additional non-dilutive opportunities to further enhance our balance sheet condition. As our guidance implies, in 2023, we expect to reduce our net loss attributed to stockholders by more than 40% year-over-year and I want to emphasize that driving improving cash flow from operations is a 2023 priority for our organization as part of our multi-year initiative to generate strong free cash flow on a sustainable basis in the future.

Through our recent achievements and continued progress on the initiatives I’ve outlined, we look forward to returning to our historical cadence of strong growth and our trajectory of progress towards profitability in 2023. Moreover with unique technology supported by a strong portfolio of clinical evidence, large and rapidly growing addressable markets that we are just beginning to penetrate and a dedicated team of employees, we remain excited about the future prospects in the years to come, as we drive innovation in the cosmetic surgery market. I’d like to conclude my remarks today by thanking our employees and distributors for their efforts and thanking them for the progress they’ve achieved amidst a challenging year. I’d like to thank our customers, investors and everyone on today’s call for their continued support of Apyx Medical.

With that operator, let’s now open the call for questions.

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Q&A Session

Operator: And our first question will come from Matthew O’Brien with Piper Sandler. Please proceed.

Matthew O’Brien : Morning. Thanks for taking my questions. Either Charlie or Tara, can you just talk about the guidance for the year, especially in light of the Q1 commentary? Because as I look back, historically the company in Q4 of €˜21 did about $16 million in total sales. You’d have to do about that for the rest of the year for Q3 through €“ sorry Q3 to Q4 to hit the low end of your guidance range. It just seems like, after a year of difficult visibility, there’s a lot of ramp that’s built in, especially in the back half of the year to get, even to the low end of the guidance. So the why do that coming off such a tough year and what gives you all that confidence?

Charles Goodwin : Yeah, thanks, Matt. I appreciate the question. So, the first thing is, is that we are confident in our ability to grow at least 36%. And the reason that we’re confident for that is for a few reasons. We actually have multiple tailwinds for growth. And the first is, is remember, we just started in January our commercialization related to the 510(k)s that we obtained earlier in €˜22 and this is the first time that we have been able to market directly to patients, to be able to talk to them about the benefits of Renuvion for these specific procedures and that we believe will develop and have tailwinds at in 2023. Second, our latest 510(k) clearance that we just obtained in February, this allows us to market the use of our Renuvion hand piece for the contraction of soft tissue anywhere on the body as needed.

And so that is another piece of marketing that we will be able to talk about and do as we move forward in 2023. And third, we actually just launched our new Apyx One Generator, which obviously features multiple enhancements and gives now the team another reason to engage with potential customers and not only will it do that is for the first time, we will have a source of revenue for upgrades associated with that from existing customers. So we’ve made important progresses in educating our users, potential new customers and we believe that these effects will help us in 2023. And importantly, that our low end of our guidance still assumes no change in the FDA safety communication and we also expect improving trends and contributions for our Advanced Energy growth to our existing OUS distributors to0.

So we believe that we’ve got a lot of new tailwinds behind us. We also were faced with easy comparisons in the second, through fourth quarter, as far as percentages go. And we believe that we can get back to growing this business and in 2023.

Matthew O’Brien : Got it. Thanks for that, Charlie. And then that kind of one part of the response there dovetails into the second question, just on Apyx One and the new generator. Can you give us a sense for what that replacement cycle might look like? I don’t know, I’m sure you don’t want to give us the number of customers you have but what level of upgrade or revenue opportunities be there in ’23 and even in ’24, as well. Thank you.