Good morning, ladies and gentlemen, and welcome to the First Quarter Fiscal-Year 2020 Earnings Call for Apyx Medical Corporation [Operator instructions]. 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 current expectations of management and involve inherent risks and uncertainties that could cause actual results to differ materially from those indicated, including those identified in the Risk Factors section of our most recent annual report on Form 10-K filed with the Securities and Exchange Commission as well as our most recent 10-Q filing.

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..

first, strong execution against our stated objectives to reduce operating expenses in light of the COVID related challenges; and second, a GAAP income tax benefit related to changes in corporate tax provisions as part of the CARES Act.

The first item will improve our near-term cash flow profile as our OpEx initiatives will benefit our reported P&L results in the coming quarters. And the adoption of the provisions under the CARES Act will result in a material tax refund later in 2020. Turning to review of our revenue results in the first quarter.

From a geographic standpoint, we experienced year-over-year declines in both our U.S. and OUS business this quarter. Our total U.S. sales declined 7% year over year to $3.6 million, while total international sales declined 20% year over year to $1.4 million.

In terms of revenue performance in each of our business segments, in our Advanced Energy business, sales declined 9% year over year to $4 million in our OEM business, sales declined 20% year over year to $1 million. The OEM sales results were entirely in line with our expectations and were not impacted by the COVID crisis.

Rather, they were a result of lower revenue generated in our legacy OEM business compared to first-quarter 2019, largely attributable to the timing of orders compared to the prior year period.

As discussed in our Q4 call, the revenue performance in our Advanced Energy business in Q1 was impacted by the crisis caused by the spread of the COVID pandemic.

We were very pleased with our Advanced Energy growth over the first two months of the quarter, where total revenue increased 33% year over year, driven by 58% growth in the sales of our hand pieces and 13% growth in sales of generators.

The growth trends over the first two months of 2020 reflects strong utilization based demand for our Renuvion technology hand pieces while the growth in generators reflects the initial impact of COVID-related disruption in our business, in our international markets beginning in February.

As discussed on our Q4 mid-March call, we had already begun to see the business trends show signs of disruption as a result of COVID. Specifically, we had seen a slowdown in the adoption and utilization, first in our international markets and then the U.S. as we move through the first few weeks of March.

Given the high level of uncertainty at that time, providing full year 2020 guidance was not possible. Instead, we elected to provide only our expectations for our financial results in Q1.

We shared that these Q1 expectations were based on the best information we had at that time and factored in a significant impact to our business from COVID-19 over the balance of the first quarter.

Our business deteriorated sharply in the weeks following our earnings call, and candidly, the decline we experienced over the second half of March was modestly sharper than we had contemplated in our Q1 guidance range.

This performance was a direct result of the preventative or protective actions taken by governments in response to the COVID-19 pandemic. As a reminder, the overwhelming majority of procedures performed using our Helium Plasma Technology are elective.

And as a result, many of these customers have been affected by government actions requiring elective procedures to be postponed and nonessential businesses to close temporarily. In the U.S., substantially all Renuvion procedures are performed in outpatient facilities, including doctors' offices and surgery centers.

During March, these businesses begin to temporarily close as states and cities across the U.S. implemented restrictions. While the timing of these closures across the U.S. varied by region, we experienced a rapid deterioration in procedural trends over the last two weeks of March as a result.

In March, total Advanced Energy sales declined nearly 50% year over year driven by sales of our international distributors declining 75% year over year and sales of our U.S. cosmetic surgery customers declining nearly 30% year over year. Regarding the deterioration in the U.S.

market over the last two weeks of March specifically, sales declined more than 40% year over year. Turning to a discussion of our response to COVID-19. Apyx Medical has been monitoring the COVID-19 pandemic closely.

We reacted quickly during the first quarter to protect the health and safety of our employees, patients, customers and distributor partners around the world. As a medical device company, we have been able to continue manufacturing operations.

To ensure the safe manufacturing environment, we divided our manufacturing personnel into multiple smaller shifts to allow for adequate social distancing.

We have also made other important improvements to our safety protocols, including requiring all employees to wear protective equipment while on-site and increasing the frequency of facility cleanings.

We have also placed restrictions on employees business travel, restricted access to the facilities and required that all nonessential employees work remotely until further notice.

In addition to the initiatives we have put in place to protect the health and safety, we have focused our direct sales team on remaining in close contact with their existing surgeon customers to do everything they can to provide them with support during this difficult time.

With this goal in mind, we have implemented additional training for our sales reps in order to sharpen their ability to engage with our customers virtually.

In addition to engaging with existing customers via virtual methods, our reps also continue to target and reach out to prospective accounts so that they will be well positioned when the recovery occurs and surgeons return to conducting elective cosmetic procedures.

Outside the U.S., we are closely monitoring the activities of our distributor partners and helping them navigate the challenges they face as a result of the slower demand they are seeing in their respective countries. Lastly, we have taken important steps to reduce our spending in light of the COVID-19 crisis.

While our spending during the first two months of 2020 reflected our normal business activities, in March, we began curtailing our cost in response to the impact of COVID-19 on the financial condition, beginning with reducing business travel expenses and implementing hiring restrictions.

We have identified other areas of our expense plan that can be delayed in order to maximize capital until the business environment outlook becomes more certain. These include further reductions to our discretionary spending, such as spending on trade shows, marketing and events and professional fees.

Additionally, we have temporarily delayed investment in certain R&D projects and clinical research studies until the environment normalizes, and we are able to pursue these activities efficiently.

Lastly, we have eliminated the bonus accrual related to the achievement of our 2020 performance objectives to further reduce the operating expense profile during this period of unprecedented uncertainty in the broader elective procedure environment.

Importantly, we continue to invest in key areas of our business that support our future growth, so we are well positioned as the market recovers from this pandemic. Most notably, we have no intention of changing the size of our sales team or furloughing any of our employees at this time.

We have spent considerable effort building and training a world-class sales team, and we are focused on ensuring that they are well prepared to drive our return to strong growth as the crisis subsides. We have also built a strong leadership team in recent years.

And I am proud to say that the team remains committed to our mission despite these challenging times. In addition, while we have temporarily delayed investment in certain clinical research studies, we continue to support the areas that are most important for our longer-term growth, including our U.S.

IDE clinical studies in dermal resurfacing and skin laxity. I'd like to now take a minute to update you on our operational progress with respect to the four strategic initiatives we are pursuing to position Apyx Medical for long-term growth in the cosmetic surgery market.

The first one to pursue specific clinical indications that will enable us to market and sell Renuvion for new targeted procedures. In the first two months of 2020, we continued to make progress in enrolling new patients in our two U.S. IDE clinical studies.

As a reminder, we designed and implemented these studies as part of our long-term strategy to pursue new clinical indications for the use of Renuvion, specifically for dermal resurfacing and skin laxity procedures. Clinical trial activity across the U.S.

has been significantly impacted by the disruption created due to COVID-19 and enrollment in these two studies have been paused as a result. Our clinical team is working closely with the investigators from both studies to help mitigate the impacts of this disruption and position us to resume enrollment once it is considered safe to do so.

While we plan to continue with both studies, we are currently unable to estimate when we will be in position to resume enrollment at this time. In addition to our regulatory progress, we also continued our efforts to expand our portfolio of clinical evidence supporting the use of our Renuvion technology, which is our second strategic initiative.

During the first quarter, we completed and submitted a clinical manuscript for the publication discussing the results of our first U.S. IDE study on dermal resurfacing. I am pleased to announce that this manuscript was published in April in a peer-reviewed journal, Lasers in Surgery and Medicine.

In 2020, we remain focused on completing and submitting at least three additional clinical manuscripts for publication. With respect to our third strategic initiative, enhancing physician and practice support for our cosmetic surgery customers.

During the first two months of 2020, our plans to host new physician mentor programs or PMPs and expand our presence and educational programming at industry conferences and trade shows proceeded as expected. Our events planned for March, however, were canceled due to COVID-19 pandemic.

In lieu of this in person programming, our sales and marketing and field clinical teams have been very active in engaging with our customers and prospects around the world.

We have hosted educational events virtually where we featured some of our leading clinician customers speaking on a wide range of topics, including side-by-side results comparing Renuvion to a leading competitor technology.

Our virtual education events have also included case studies to illustrate how our leading clinician customers have adopted Renuvion, their strategies for marketing and selling to new patients and their thoughts on pricing and ROI.

Last week, we hosted the first installment of a planned series of webinars designed to assist our customers and prospects with opening their practice post-COVID.

We are also engaging with clinical customers outside the U.S., including hosting multiple continuing education training sessions on J-Plasma and Renuvion with our current international distributors and multiple calls with groups of international prospects interested in learning about Renuvion technology.

And lastly, with respect to our fourth strategic initiative, improve our manufacturing capabilities and efficiencies. During the first quarter, we continued to work to implement new lean initiatives. This work remains an ongoing area of focus in order to drive progress in 2020 and the years to come.

Despite the many challenges we have faced, and we will continue to face as a result of the COVID-19 pandemic, I have been incredibly pleased with the response of our organization and the commitment that our employees have shown to supporting our customers and maintaining our operation during such a difficult period in our company's history Ultimately, Apyx Medical is well positioned to weather this crisis and return to our record of delivering strong growth as it subsides.

First, with over $51 million of cash on our balance sheet, we are very well capitalized. We believe we have adequate resources to fund our operations for multiple years.

Second, the strength of our balance sheet and our targeted strategies to control our near-term expenses allow us to support and invest in elements of our business that ensures we are poised to recover quickly and continue to drive progress with respect to our long-term growth strategy.

And third, we are not experiencing any significant disruption to our supply chain as a result of the COVID-19 pandemic, and our in-house manufacturing is progressing under our enhanced health and safety protocols.

Given the significant uncertainties associated with the COVID-19 pandemic, we recognize the investment community's desire for increased clarity and have elected to provide color on our current quarter trends.

Simply stated, the impact that COVID-19 has had on the activity of our customers and their patients has continued to represent an ongoing challenge for our Advanced Energy business. Our U.S. and international sales trends during the month of April continued to deteriorate. Relative to the year-over-year sales trends we saw during the month of March.

A significant amount of uncertainty remains in terms of when the restrictions on our customers will be lifted ultimately, when the patients will choose to undergo elective cosmetic procedures once our customers' practices are allowed to reopen.

We are encouraged by the announcements and initial activities related to lifting of the shelter in place restrictions over the past two weeks. And we expect our cosmetic surgeon customers to begin the process of reopening their offices as soon as their respective state mandates allow.

At this point, the pace and timing of when we see an uptick in elective procedure volume and the related increase in demand for our procedure-related hand pieces remains highly uncertain.

Naturally, we would expect the trends in adoption of Renuvion technology and the related improvement in generator sales trends to lag behind the improvement in elective procedure environments. Again, the timing of which remains difficult to predict at this time.

Importantly, the COVID-19 pandemic has not altered our competitive advantages in the market and the attractive long-term opportunities that we are pursuing.

With its ability to deliver heat to tissue in incredibly efficient and controlled manner, our Helium Plasma Technology continues to represent a unique energy modality with the ability to transform how procedures are performed in the cosmetic surgery market.

We continue to receive strong positive feedback from plastic and cosmetic surgeons highlighting the outcomes they have been able to achieve with our Renuvion products. We are focused on leveraging this unique technology to pursue an addressable market opportunity for the cosmetic surgery market that is estimated to be over $1.5 billion in the U.S.

alone. With significant opportunities outside the U.S. as we continue to pursue new registrations in key international cosmetic surgery markets going forward. And we are pursuing these opportunities with a commercial strategy that has demonstrated strong results over the last two years.

At the same time, the four strategic initiatives I have discussed earlier will position us to drive long-term growth in the cosmetic surgery market by facilitating the broad-based adoption of our technology.

For these reasons and many others, as the COVID-19 crisis subsides, we are poised to continue our work of bringing transformative solutions to our customers we serve and elevating the global cosmetic surgery market for the benefit of our surgeon customers, their patients and our shareholders.

I'll now turn the call over to Tara to review the first-quarter financial results in detail and discuss the comments made in our earnings press release this morning.

Tara?.

Thanks, Charlie. The discussion of our financial results today includes restatements as well as revisions to our historical financials as reported in our 10-K filed on March 31, 2020 and 10-Q as filed on May 8, 2020. We have updated the related reconciliation table with these items, which is available on the Investor Relations page of our website.

Given the detailed discussion by Charlie on our revenue performance, I will begin my review of our first-quarter financial results across the rest of the P&L. Gross profit for the first quarter of 2020 decreased $0.6 million or 16% year over year to $3 million. Gross profit margin for the first quarter of 2020 was 59.7% compared to 63.3% last year.

The primary drivers of the change in gross profit margin were product mix within both our Advanced Energy and OEM segments, revenue mix between our segments and geographical revenue mix, offset by improved product margins in our Advanced Energy segment as a result of our continued manufacturing efficiency initiatives.

Operating expenses for first-quarter 2020 increased $1.2 million or 13% year over year to $10.5 million compared to $9.3 million for the first quarter of 2019.

The year-over-year change in operating expenses was driven by a $0.8 million increase in selling, general and administrative expenses, a $0.3 million increase in professional services and a $0.3 million increase in R&D expenses. These increases were offset slightly by a $200,000 increase in related salaries and related costs.

As Charlie mentioned earlier, our proactive efforts to reduce our operating expenses reflect strong execution, specifically in response to the COVID pandemic, we identified more than $1.5 million and operating expense reductions compared to what was implied by our Q1 guidance.

Loss from operations for the first quarter of 2020 was $7.5 million compared to operating loss of $5.7 million last year. Net loss for the first-quarter 2020 was $2 million or $0.06 per diluted share compared to a net loss of $5.6 million or $0.17 per diluted share for the first quarter of 2019.

Our net loss for the first quarter of 2020 was significantly lower than the guidance range provided on our fourth quarter earnings call. In addition to the notable progress we made in reducing our operating expenses in the first quarter, we also benefited from a GAAP tax benefit in the period.

As detailed in our press release this morning, on March 27, 2020, the U.S. government enacted the CARES Act to provide relief from the coronavirus pandemic.

The CARES Act includes a net operating loss carryback provision by which the company recognized an income tax benefit of approximately $4.9 million in the first quarter of 2020 and expects to receive a cash tax refund of approximately $3.7 million by the end of 2020.

Together, the significant reduction in our operating expense profile and this provision in the CARES Act will help mitigate the financial impact of the COVID-19 pandemic. First-quarter 2020 adjusted EBITDA loss was $5.8 million compared to an adjusted EBITDA loss of $4.6 million last year.

As a reminder, we provided a detailed reconciliation from GAAP net loss to adjusted EBITDA in our press release this morning. As of March 31, 2020, the company had cash and cash equivalents of $51.4 million compared to cash and cash equivalents of $58.8 million as of December 31, 2019.

The company had working capital of $63.6 million as of March 31, 2020, compared to $64.4 million as of December 31, 2019.

Lastly, as mentioned in our earnings press release this morning, given the challenges and uncertainties posed by the ongoing global COVID-19 pandemic, the Company will not be providing full year 2020 financial guidance on today's call.

Assuming a more normalized business environment prevails at the time of our second quarter results conference call in August, we plan to provide updated expectations at that time. With that, I'll turn the call back to Charlie for closing remarks.

Charlie?.

Thanks, Tara. I'd like to close by once again thanking our employees for their resilience and dedication they've shown under very difficult circumstances during these past months. Based on our response to COVID-19, I'm convinced we have a strong team here at Apyx Medical that can weather any crisis.

I'd also like to thank our distributors, customers and shareholders for their continued support and those on the call for their interest in Apyx Medical. With that, operator, let's now open the call for questions..

Thank you. [Operator instructions] And our first question will come from Kyle Bauser with Dougherty & Company..

Charlie, Tara, thanks for taking the questions here. So from what I'm seeing, the cosmetic practices that are opening back up have been incredibly busy. So adding shifts on Saturday, coming in early during the week, etc. And according to the CDC, it looks like almost half the states have reopened for elective procedures.

So, I know it's early, and there's a lag associated with cosmetic practices, as you talked about.

But just curious if you've seen the same sort of heightened demand from any of your Renuvion users that have opened back up?.

Yes. Look, it's obviously not our standard practice to give color on current quarter trends, but we recognize the need for clarity and transparency as much as we can. We have started to see hand piece demand pick up in the second half of April.

So if you look at the first two weeks of April, we did absolutely no business, and we've seen very small demand pick up in the second half of April. And overall, in April, sales were down 90% year over year. As we move into May, you are correct.

We are starting to see a lot of these restrictions lift, and we are hearing from our customers that they, during the closures, were doing virtual consultations, were doing a lot to get their businesses ready to when they could open the doors that they did have a lot of demand.

And so we are starting to -- we are hearing the same trends from them, but we'll see how this plays out as it's unfolding, obviously, right now..

Got it. That's helpful. And I know things have slowed down temporarily.

But on the supply side of things, can you provide some more color around the lean initiatives that Lauren and Craig have been working on and how things have been going to modify manufacturing to support the higher handpiece volumes once things ramp up again?.

Yes.

The good news for us is that we have been deemed, obviously, an essential business this entire time, and we focused a lot on protecting the health and safety of our employees, number one, by making sure that they had the implementation of smaller shifts, they've protective clothing that we're making them where and then we basically shut down the manufacturing facilities to where only manufacturing can be there and all other nonessential people have been asked to work from home.

And one of the things that we talked about in the gross margin that we had just mentioned is that we did see already improved product margins in our Advanced Energy segment as a result of these manufacturing efficiencies. So we have not stopped doing that.

And we have not stopped any investment in that area as that is obviously key for us as we go forward, and we get back to the strong growth that we had over the last two years that, that will help us in years to come from a gross profit side of things..

Your next question will come from Matt Hewitt with Craig-Hallum Capital..

Good morning and thank you for taking the questions. Maybe the first one, attendance at the virtual events that you started to host when the Stage 1 and 2 lockdown mode, what did that look like relative to maybe some of the prior events that you had hosted? Obviously, those were more in person.

But maybe talk a little bit about the makeup of those virtual events.

Was that attracting a larger volume than you maybe would have seen given that these physicians were now essentially waiting for their businesses to reopen?.

Yes. I think that's a very good point. Whether we were doing events either at trade shows or our PMP programs. Obviously, those are limited by the number of people that travel to there or tend to go to that lecture at the show or at our PMP, we're limited by the number of doctors that somebody's facility can host at a given time.

Obviously, virtually, you don't have any of those restraints and people were at home. And in some cases, looking for things to do themselves. And so our virtual events were very well attended. And the last one that we just did just this last week, I think we had 123 participants, clinicians that were on the call.

So obviously, that is much larger from a magnitude of at least 10x that we would get at a PMP event. So yes, they were very well attended..

Well, that's great. And then as a follow-up question, looking internationally, one of the growth opportunities you've previously talked about is expanding Renuvion internationally.

How has coronavirus, COVID-19, how has that impacted your ability to get the device approved in other countries? And how quickly do you think that those processes can open back up? Thank you..

Yes. Obviously, I hate to start out, it depends. It depends on what's going on with each one of the countries. But as far as a registration point of view, we haven't seen anything that has been too much of a problem in any of the countries that we're working in and trying to get registration on as we move forward.

So we still remain confident that we will be able to get the registrations in the timelines that we had proposed, give or take a month or two at the most. But other than that, not much has been really impacted that we have seen so far on that..

[Operator instructions] Our next question is from Matt O'Brien with Piper Sandler..

Hi, guys. Good morning. This is Jerome for Matt.

Just from a customer perspective, I just was wondering if you have any sense for what percentage of your customers' offices that are open today? And then maybe could you speak to the economics of Renuvion that product to the practices relative to some of the other products and services that they provide?.

Yes. Well, the first thing is that substantially, the Renuvion procedures are all performed in outpatient facilities, so the offices and the surgery centers. So from doctor having control of their own environment and the patients, hopefully feeling safe coming into a smaller thing. We think that, that is a positive for us going forward.

We're encouraged so far from the initial activities in May of lifting the shelter in place. But it's really hard to have what percentage are open because everything is different from a state and local and then just the clinician being ready to go on. So we are seeing these restrictions lifted over the last two weeks, and we are encouraged by that.

And we expect these surgeons to get going as quickly as they can because they are small business owners, and they've got staff and they've got a business to run. And so we're confident that once each state, respective state lifts the restrictions that they will get back to work as soon as they possibly can..

Okay. That's very helpful. And then on the clinical trial front, the skin laxity and dermal resurfacing. I understand you said it's difficult to estimate when you're going to resume there. I think other Meditech companies have been kind of citing somewhere around the 6-month delay for a lot of the clinical trials.

Is there any reason to think yours maybe a little bit faster, slower? And then, I guess, is there anything that we need to be thinking about as far as — aside from just enrollment, but as far as patient follow-up or anything that could have the potential to have it pushed out a little bit more than that?.

I have no comment on what other companies are doing, and I don't know about that. Ours is really a function of our clinicians opening up their practices again. And being able to enroll patients. We were doing some virtual follow-up on some of our clinical studies, but I don't know how effective that is at this point in time.

And so once we get these guys back and going again and they can see the patients in person, we'll be able to have a much better idea of what that time frame is. It's just really hard to — I just can't give a time frame at this point in time..

Thank you. As we are currently showing no participants in the queue, that does conclude our conference for today. Thank you for your participation..