Hello, and welcome, ladies and gentlemen, to the Second Quarter of 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, 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 may be 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..

Thanks, operator. Welcome everyone to our second quarter earnings call. I’m 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’ll begin by discussing our second quarter revenue results and the drivers of our performance.

Then I will provide you with an update on operational progress and related highlights during the second quarter. Tara will discuss our second quarter financial results in detail and review our financial guidance for 2022, which we updated in our earnings press release today.

I’ll then discuss our updated outlook and focus areas for the second half of 2022 before we open the call for Q&A. With that, let’s begin with a review of our quarterly revenue results.

In the second quarter, total revenue decreased 8% year-over-year to $10.3 million and came in near the low end of our $10 million to $12 million range of expectations that we shared on our Q2 earnings call. The decrease in our total revenue was driven by Advanced Energy sales, which decreased 16% year-over-year to $8.4 million.

The performance in our Advanced Energy business was offset partially by OEM sales, which increased 55% year-over-year to $1.9 million.

Within our Advanced Energy business, as we had anticipated, our performance during the second quarter continued to be challenged by the medical safety device communication, which was posted on the FDA website on March 14.

The business disruption that resulted from this communication impacted sales of our Advanced Energy products globally over the course of Q2. Let me take a minute to unpack these dynamics in greater detail.

From a geographic perspective, the year-over-year decrease in Advanced Energy sales was almost exclusively driven by our performance outside of the United States. International sales of our Advanced Energy products were more impacted than we had anticipated.

And we experienced a significant slowdown in ordering an overall demand from OUS distributors due to the safety communication. Specifically, we saw weaker demand for both Advanced Energy generators and handpieces from our distributors in select countries most notably in Latin America.

As a result, international sales of generators and handpieces decreased more than 45% and 30% year-over-year respectively. From a timing perspective, our international sales performance was most affected in the last two months of the quarter.

This aligns with the feedback we received from our distributors indicating that the impact of the safety communication was more delayed internationally as compared to the U.S. In the U.S., we were pleased by the performance of our Advanced Energy business during the quarter, which exceeded our expectations.

As anticipated, we continue to experience slower sales of our Advanced Energy products in the U.S., most notably generator sales to new customers. However, I’m pleased to report that we saw material improvement in our U.S. business trends during each month of the quarter. As a result second quarter sales for our Advanced Energy products in the U.S.

decreased in the low single digits on a year-over-year basis. During the second quarter, our direct sales team and clinical support specialists continued to do an excellent job of engaging with our existing surgeon customers to address the safety communication, answer their questions, and provide information about the safety profile of our products.

Since the communication was posted, our focus as an organization has been to spend as much time with our existing customers as needed to ensure they are comfortable with the appropriate use of our products and understand their risk profile.

As I mentioned on our earnings call in May, we estimate to have connected directly with all of our existing U.S.

customers to discuss the safety, communication, and share related resources, including a letter from our Medical Advisory Board, an overview of the postmarket safety profile of our technology and a summary comparing the adverse event rates of our Advanced Energy products with other medical devices that our customers may be familiar with.

I am extremely proud of the way Apyx Medical has responded to this development. The feedback we have received from the U.S. customers has underlined for us their appreciation of our direct proactive approach to communication and willingness to provide any needed support.

We also continue to appreciate our customer’s passion for our helium plasma technology and their strong support for it during this challenging period. Internationally, given that we do not sell directly to surgeons, our focus has been on proactively engaging with and supporting our distributive partners in the same manner.

All of the resources used to inform our U.S. customers have been made available to our distributors. And in many cases translated to support their interactions with their surgeon customers.

In addition, we have also hosted multiple webinars for our distributors to educate them on the safety communication and its implications and keep them updated on our related interactions with the FDA and progress in securing additional 510(k) clearances for the use of our Advanced Energy products.

Shifting to a discussion of our operational highlights during the quarter. In addition to our customer engagement efforts, we continue to make strong progress during the second quarter in engaging with the FDA, following the safety communication and addressing their areas of focus.

As a reminder, in late March, we requested and held a meeting with the FDA’s postmarket team to present a detailed analysis of our medical device report data clarified the reported adverse events and provide important related context.

Following this meeting, we received feedback from the FDA on April 1 with requested revisions, including changes to certain messaging on our website, labeling and training. Our team worked quickly to incorporate the FDA’s requested revisions and submit our response to the agency.

In addition to these efforts, our regulatory team also made strong progress in securing specific clinical indications related to the use of our Advanced Energy products in target procedures.

During the second quarter, they continued to engage with the FDA during our 510(k) pre-market notification to obtain a specific clinical in indication for the use in dermal resurfacing procedures.

After several interactions with the agency in April and early May, we were pleased to announce 510(k) clearance for the specific clinical indication on May 26.

Our new Renuvion Dermal Handpiece is now indicated for dermatological procedures for the treatment of moderate to severe wrinkles and rhytides, limited to patients with Fitzpatrick skin types I, II or III. We are preparing for full commercial launch of Renuvion Facial Renewal, which we continue to target to begin by the end of 2022.

We are now able to market and sell our Renuvion Facial Renewal to surgeons and potential patients for use in the 200,000 wrinkle reduction procedures in the broader dermal resurfacing market, which we estimate are performed in the U.S. each year.

We were also pleased to see this, the FDA update their safety communication on June 2, to recognize this new 510(k) clearance. Together with the data from our related IDE clinical study, 510(k) clearance and the updated safety communication represent important validation for the safety and effectiveness of our Renuvion technology.

In addition to these efforts, we continue to advance the second objective of our multi-year regulatory strategy, securing an indication for the use of Renuvion in procedures to improve the appearance of lax skin. Our regulatory team submitted our 510(k) pre-market notification for this indication at the beginning of April.

As a reminder, this request was supported by the results of a related IDE clinical study, which included 65 patients treated at multiple centers. We were pleased to announce the results of the final phase of this study on July 8, which demonstrated Renuvion strong safety profile and effectiveness in these procedures.

Most notably, both the primary effectiveness and safety endpoints of the study were met. 82.5% of subjects demonstrated improvement in the appearance of lax skin in the neck and submental region at six months, post procedure and 96.9% of subjects experienced no pain to moderate pain in the seven days post-op procedure.

The efforts of our regulatory team during the second quarter culminated in our receipt of 510(k) clearance, which we announced on July 18. Our Renuvion APR handpiece is now indicated for use in subcutaneous dermatological and aesthetics procedures to improve the appearance of lax or loose skin in the neck and submental region.

This 510(k) clearance was followed shortly by another update by the FDA to their safety communication. Obtaining this clearance further expands our addressable market to include another 200,000 neck contouring procedures performed in the U.S. annually. We continue to expect to begin full commercial launch of our lax skin indication by the end of 2022.

Stepping back, as we progress through the remaining months of 2022, we believe that our two new 510(k) clearances along with the resulting updates to the FDA’s safety communication will help to mitigate the recent business disruption that we have seen.

Given these recent developments and our proactive engagement with both customers and the FDA, we continue to believe that this disruption related to the FDA safety communication will be transitory.

Longer term, these clearances provide us with the expanded addressable market and the enhanced ability to market our products that we have been seeking since we first began to focus on the cosmetic surgery market.

Securing these two 510(k) clearances for Renuvion represents the culmination of many years of focus and dedication from our team towards one of the key strategic initiatives for Apyx Medical that we have discussed on each of our earnings calls.

A special thanks to our regulatory and clinical teams, along with everyone who supported these initiatives for helping Apyx Medical to achieve the primary aims of our regulatory strategy through many years of hard work. Let me now turn it over to Tara to review our quarterly financial results and 2022 guidance.

Tara?.

Thanks, Charlie. I will start my review of our second quarter financial results at the gross profit line since Charlie already discussed our revenue results. Gross profit for the second quarter of 2022 decreased $0.6 million or 8% year-over-year to $6.9 million. Gross profit margin was 67.2% compared to 67.1% in the prior year period.

The slight increase in our gross margin was driven primarily 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 like our APR Handpiece, as we obtain registration and introduce them into the various countries we serve.

These benefits to our gross margin performance were partially offset by changes in the sales mix between our two segments with our OEM segment comprising a higher percentage of total sales and by higher cost to manufacture inventory, as we continue to experience increased shipping costs.

Operating expenses increased $1.3 million or 11% year-over-year to $12.9 million. The increase in operating expenses year-over-year was driven by an increase in salaries and related costs of $0.5 million, which was primarily due to higher compensation and benefits and stock-compensation expense.

An increase in professional services of $0.5 million, which was primarily due to higher legal fees and an increase in selling, general and administrative expenses of $0.3 million, which is primarily due to the return of in-person internal training events and trade shows in 2022.

Loss from operations for the second quarter of 2022 increased $1.9 million or 48% year-over-year to $6 million. Total other income net was $0.6 million compared to 0.1 million last year.

The year-over-year increase was driven by a $650,000 benefit from the relief of a portion of our joint and several payroll liability due to the lapse of the statute of limitations on that liability. Income tax expense was $0.1 million consistent with the prior year period.

Net loss attributable to stockholders was $5.4 million or $0.16 per share compared to $4 million or $0.12 per share for the second quarter of 2021. Adjusted EBITDA loss for the second quarter of 2022 was $3.4 million compared to adjusted EBITDA loss of $2.4 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. As of June 30, 2022, the company had cash and cash equivalent of $20.1 million compared to $30.9 million as of December 31, 2021.

Cash flow from operations for the first six months of 2022 was $10.4 million compared to $7.1 million last year. The increase in use of cash from operations is attributable to our strategic initiative to increase our inventory, to ensure we are able to meet customer demand in light of the challenging global supply chain environment.

We anticipate working capital use of cash to improve in the second half of 2022, compared to the first half of 2022.

Turning to a review of our 2022 financial guidance, which we updated in our earnings press release today for the 12 months ending December 31, 2022, we expect total revenue in the range of $51 million to $56.4 million representing growth of 5% to 16% year-over-year.

This compares to our prior range of $52.5 million to $59 million or growth of 8% to 22% year-over-year. Our total revenue guidance range assumes Advanced Energy revenue growth of 4% to 15% year-over-year to $44.5 million to $49.4 million compared to our prior range of $46 million to million $52 million or growth of 7% to 21% year-over-year.

And OEM revenue growth of approximately 18% to 27% year-over-year to approximately $6.5 million and $7 million unchanged compared to our prior guidance range. With respect to our Advanced Energy revenue guidance.

First, our guidance range reflects potential negative impacts on global new customer adoption and procedure related demand for handpieces as a result of the FDA medical device safety communication on March 14, 2022.

Second, our guidance range continues to assume contributions from the initial commercial launches for new specific clinical indications in dermal resurfacing procedures and procedures to improve the appearance of lax skin. We continue to expect to enter full commercial launch for both of these indications by year end 2022.

And third, our guidance range continues to assume that growth outside the U.S. is driven by demand in existing international markets. In terms of our profitability guidance for fiscal year 2022, we expect net loss attributable to stockholders in the range of $20.1 million to $16.6 million compared to our prior range of $19 million to $14.7 million.

An adjusted EBITDA loss in the range of $11.8 million to $8.2 million compared to our prior range of $10.1 million to $6.4 million. Our formal financial guidance for 2022 incorporates the following considerations for modeling purposes.

First, gross margins of approximately 67% to 69% this year, compared to our prior expectation of approximately 66% to 68% and 69% in fiscal year 2021. The year-over-year change in gross margin is driven primarily by revenue mix shifts between our Advanced Energy and OEM segments and product and geographic mix within our Advanced Energy segment.

Inflationary headwinds and our cost of goods sold compared to prior year and incremental costs related to manufacturing capacity that was previously attributable to our core segment and transition services agreements with Symmetry Surgical.

Second, operating expenses to increase in the range of 14% to 16% year-over-year consistent with our prior guidance assumptions. Third, net interest and other income of approximately $650,000 in 2022. Fourth, income tax expense of approximately $300,000 to $500,000.

And lastly, we expect non-cash depreciation and amortization of approximately $1 million. Non-cash stock-based compensation expense of approximately $7 million.

Non-controlling interests of approximately $114,000 compared to our prior expectation of approximately $150,000 and weighted average diluted shares outstanding approximately 34.6 million shares. Lastly, for the third quarter of 2022, we anticipate total revenue in the range of $10.6 million to $13.4 million.

In our OEM business, we expect growth of approximately 7% year-over-year at the midpoint and in our Advanced Energy business, we expect approximately 1% growth at the midpoint, although our guidance assumes a wide range from a year-over-year decline of approximately 12% to growth of 13% year-over-year.

With that, I’ll turn the call back to Charlie for closing remarks..

Thanks, Tara. We are updating our guidance today to reflect our Advanced Energy sales performance during the second quarter and revised expectations for the second half of 2022. Specifically, our updated revenue guidance now reflects business disruption related to the safety communication outside of the U.S.

Given, these are indirect markets, we expect the recovery in distributor ordering trends to be more prolonged than our prior guidance range had contemplated. Importantly, our updated guidance for Advanced Energy revenue in 2022 reflects higher growth expectations in the U.S. compared to our prior guidance range.

This is a direct result of the stronger than expected U.S. demand we experienced in the second quarter and our updated assumption for the demand in the U.S. during the second half of 2022.

Over the remaining months of 2022, Apyx Medical is focused on driving growth by engaging with and supporting our existing customers, raising awareness of the safety and effectiveness of Renuvion to facilitate its adoption in the global cosmetic surgery market and preparing to enter full commercialization for our two new clinical indications by year end.

Importantly, we believe our multi-look outlook has never been so compelling. By continuing our focus on diligent strategic execution, we will position Apyx to capitalize on our expanded addressable market opportunity and ultimately drive strong, sustained growth and progress towards profitability in the years to come.

Thank you to our employees, customers, distributors, shareholders, and everyone on today’s call for their continued support of Apyx Medical. With that, operator, let’s now open the call for questions..

Thank you. [Operator Instructions] And the first question will come from Dave Turkaly with JMP Securities. Please go ahead..

Great. Thank you. Charlie, maybe just one upfront. The – I guess, given the relative size, I'm glad that the impact from the MDSC was, I guess, higher internationally.

But why would it impact those OUS distributors, maybe even specifically in Latin America and their orders, the way they did, do you think or did you expect that?.

You’re talking outside the United States?.

Yes..

Yes. So our international results were below expectations as we experience a significant slowdown in ordering and overall demand from OUS distributors due to the safety communication. We did not see a slowdown across all OUS distributors only in select countries.

And as I mentioned in the remarks, it was most notably in Latin America and both generator and hand piece demand were impacted. And the pronounced slowdown occurred in mostly May and June. And so, yes, we did not initially forecast to have a decrease for this outside the U.S..

Yes, I guess I'm just trying to like ask specifically, given it was the FDA that came up with the MDSC, I was thinking – again, it's good that it happened this way. But I was thinking that the impact might be seen more domestically, clearly, it wasn't.

Do you have any, like, reason why that would be?.

Well, the only – as expected it did have a performance on our sales performance in the U.S. too in Q2. It was less than what we expected. Outside the United States though, it’s a global market and people communicate, doctors communicate, competitors communicate.

And so all of these things take a little bit more time outside of the United States to work their way out there. But yes, there were challenges outside the U.S. that we saw for sure..

Got it. I'm just going to sneak in, I mean, I guess, technically I got two, but they're sort of the same there, if I could. I think you said U.S. handpieces were up low single digits. And I think you also called out that the U.S. Advanced Energy saw material improvements in each month of the quarter.

I guess, when you commented on generators and that material improvement you saw in each month, was that handpieces and generators domestically?.

Yes. As we mentioned before, through the safety note, as generators sales to new customers were more impacted, which was what we saw in the quarter. But as we despite these challenges, we saw material improvements in the trends during each month of that quarter. and it was in both.

It was in both generators and handpieces that we actually saw that, to answer your question..

Thank you very much.

Thank you. Our next question comes from Matt Hewitt with Craig-Hallum Capital Group. Please go ahead..

Good afternoon. Thank you for taking the questions. Maybe the first one regarding the new approvals. Maybe if you could walk through or provide a little bit color about your strategy from a sales and marketing perspective with those approvals.

And has that – or has your plan or your strategy changed a little bit because of – or in light of the MDSC?.

So our team is focused on preparing to enter the full commercial launch for these two new indications that we have.

And part of these efforts like we talked about for facial renewal will be a soft launch with the new dermal hand piece, but we’re also developing the marketing materials, the direct-to-consumer materials and everything else, and our strategy for doing this for both facial renewal and skin laxity have not changed.

The only thing that has that we are still doing is just clearing up some of the confusion from the safety notice itself. And so the strategy for doing this is still the same. We are very much focused on executing this and through the next two quarters, that is going to be our major.

It's just getting people through this and having them understand what the two new indications both mean. It is helpful that we got the updates from the FDA when they updated their safety notifications. And so we are heads down focused on executing and bringing these things to marketplace, as we mentioned by the end of this year..

Okay. And then maybe if you could talk, I realize it's very early days, but what has been the reception post these approvals? What are you hearing from doctors? Are they getting into queue to be able to use the devices post on the approval? Any color along those lines would be helpful. Thank you..

Yes. Look, for us, this is – and for our customers, this is a major milestone. We have been working on this validation for ever since I came on Board here, and we actually finally got it.

And we have already had doctors from the podium talking about, finally, companies that are giving – there's a company that's giving us clinical-based evidence and scientific-based evidence to come up with their technology for the safety and efficacy of this product.

And so yes, this is a major, major milestone for this organization, and we couldn't be happier where we are right now, having these two approvals and being able to prepare and go after these 400,000 procedures that we have in these two new indications..

Great. Thank you..

Thank you. Your next question is from the line of Kyle Bauser with Lake Street Capital. Please go ahead..

Great. Thanks for all the updates here. Maybe I’ll just start on the full commercial launch by year end. Maybe just to follow up on that. So if we look out maybe 12 months, how should we kind of anticipate any sort of sales force ramp in terms of head count.

And then I guess similarly given the reduced reliance, I guess on physician kind of peer-to-peer education from a ramped up efforts of direct to consumer.

I mean, could we, at some point kind of see that professional services bucket on the income statement moderate a little bit? Or is it just kind of be kind of foot on the gas and continue on with both strategies both from professional services and direct-to-consumer internally?.

Yes. So first, thanks, Kyle, for the question. First, on the rep side. We actually added four reps in the second quarter, and we have a team now of 35 reps at quarter end. And as a reminder, the team also includes five managers and two independent sales agencies.

And we’re incredibly glad to have these new reps on Board in advance of our plant’s commercial launches. And we do not anticipate adding any more reps in the second half of 2022. And we had communicated about adding a handful around the launch of this product.

And so we're incredibly happy with the size of our sales force, and we're incredibly happy with the performance of our sales force. And now we just need to go and focus and execute to take advantage of these two opportunities.

In regard to your second question, we will still continue the peer-to-peer promotion, as we do right now with our PMPs that we have. And then we will layer on, which is new, obviously, which these clearances allow us to take advantage of is the direct to the consumer portion of that.

And so the PMPs will still continue and we will layer on the direct to the consumer..

Got it. No, that makes sense. Appreciate that. And then my follow up is, I guess, just kind of curious internationally, how have the registrations of the new hand piece kind of come along? I know you have to do it for every country.

So just kind of curious to the extent you can share how many international markets kind of still use the older hand piece or conversely, how many have converted to the new hand piece, just curious. Thank you..

Yes. So great question. We don’t give out that level of detail about where the – which countries are and which aren’t, but we’re making very good progress on that.

And you can actually see we have some headwinds on gross margin, but one of the tailwinds that we have on gross margin is the adoption of the APR handpiece and having that be adopted outside the United States. And as we’ve talked about before that tailwind will continue for the next year or two also.

So we’re happy with the progress that we’re making there..

Got it. Appreciate that. I’ll jump back in queue..

Thank you. [Operator Instructions] Our next question comes from the line of Matthew O’Brien with Piper Sandler. Please go ahead..

Hey, everyone. This is Joe on from Matt tonight. Just a quick one for us. So with the recent approval of skin laxity in neck, we're curious how impactful that indication could be to your business over the next 23 months, especially if there's anything quantitative there? Appreciate it. Thanks..

Yes. So we’re not going to talk about quantitative to what it’s going to do beyond the second half of this year and the expectations that we have for this year are already baked into our guidance. And – but it’s going to be a huge thing for the company.

It’s been one of our biggest strategic initiatives that we’ve been after and to actually have it and to be able to use it and market it, it has definitely increased the value of this company for sure.

So we’ll get – we’re focused right now on executing the third and fourth quarter, and then we'll get back to you guys at a later date to tell you what it means for 2023 and beyond..

Understood. Thanks, Charles..

Thank you..

Thank you. Our next question comes from the line of Dave Turkaly with JMP Securities. Please go ahead. Please go ahead..

Hey Charlie. Just one quick one. You mentioned the MDSC, the update. I'm just curious the specifics of what they now say. I know when we initially read those, they were kind of open-ended and somewhat scary and with the clearances in hand, I mean they're not recommending any of the, hey, don't use these – don't use Renuvion in these procedures.

I mean did they take away all that language? I haven't seen the updates, but I'm curious if you might comment on how they look now versus the original?.

Yes. So what they've updated is the fact that we have indications for the two specific clearances that we have, one for dermal resurfacing for wrinkles and rhytides, for on top of the skin, and one for under the skin in the neck and submental area.

The area that it still exists from the safety notification is that it says that we are still not cleared for use after liposuction, quite frankly, nobody is cleared for use after liposuction.

So that is really the only remaining thing from the safety notice that exists, but that's just – that's the same for everybody that competes in this space as far as not having a specific indication for use after liposuction..

Got it. Thank you.

You bet..

Thank you. We are currently showing no remaining questions at this time. That does conclude our conference for today. Thank you for your participation..