Apyx Medical - Earnings Call - Q4 2019

Transcript

Speaker 0

Good morning, ladies and gentlemen, and welcome to the Fourth Quarter and Fiscal Year twenty twenty Earnings Conference Call for Apex 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'd 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 those identified in the Risk Factors section of our most recent annual form on Form 10 ks 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 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, Apex Medical's President and Chief Executive Officer. Please go ahead, sir.

Speaker 1

Thanks, Kevin. Welcome, everyone, to our fourth quarter and full year twenty twenty earnings call. I'm joined on the call this morning by our Chief Financial Officer, Tara Sam. Let me provide you with a quick agenda for today's call. I'll begin with a review of our strong fourth quarter revenue results.

Following this discussion, I will provide you with an update on the operational progress we made during the quarter on our four initiatives we are pursuing as part of our longer term growth strategy. Tara will then provide a detailed review of our fourth quarter financial results and an overview of our 2021 financial guidance, which we introduced in our press release this morning. I will conclude with some additional thoughts on our near term areas of focus and long term outlook as we enter 2021. We will then open the call for questions. With that, let's get started with a review of our q four revenue results.

We were extremely pleased to report total revenue of $11,500,000 for the 2020, an increase of 37% year over year. Our total revenue results came in slightly above the high end of the preliminary range we provided in January and greatly exceeded our expectations for the fourth quarter. Recall that at the time of our Q3 earnings call, we expected total revenue to decrease year over year in the fourth quarter. We were very pleased with the revenue results we delivered this quarter, especially given the continued challenges related to COVID in our primary markets around the world. By geographic region, our total US sales for the 2020 increased 18% year over year to 6,600,000.0, while total international sales increased 74% year over year to 4,900,000.0.

And by business segment, our advanced energy sales increased 44% year over year to $9,900,000 and our OEM sales increased 4% year over year to $1,600,000 Our impressive Advanced Energy segment performance was largely driven by strong sales of our handpieces, which grew 78% year over year coupled with a 25% year over year increase in sales of our generators. It's important to note that the 78% year over year growth we saw in global sales of our handpieces was primarily driven by strong demand both domestically and internationally. Looking at our Advanced Energy sales performance more closely, in The U. S, we saw handpiece sales increase 80% year over year. Our U.

S. Handpiece sales were primarily driven by strong utilization based demand from our existing surgeon customers. Nearly all of our existing U. S. Customers were open and active throughout the quarter.

After working through their case backlogs during Q3, many reported they continued to see increased patient volumes throughout the fourth quarter, reflecting strong underlying procedure demand. While our access to prospective new customers improved during the fourth quarter, the capital equipment environment in The U. S. Remained challenging. As a result, U.

S. Generator sales declined high single digits on a year over year basis in the fourth quarter. Outside The U. S, international sales were the largest driver of the upside that we saw in our Advanced Energy business during the fourth quarter. I'm pleased to report that we saw year over year growth in international sales of both handpieces and generators, which increased 7588% respectively in Q4.

Our handpiece growth was surprisingly strong given the environment, fueled in part by orders from our distributor in Brazil. However, even excluding that demand, our international handpiece sales increased 45% year over year. Importantly, our growth in international sales of generators was predominantly fueled by orders from countries that we entered over the first nine months of twenty twenty, most notably orders from our distributor in Brazil. Overall trends in our international advanced energy business remain difficult to generalize given that the pace of recovery continues to vary by both region and country. Our performance in Latin America during the fourth quarter was bolstered by strong sales in Brazil and we saw pockets of strength in The Middle East, while performance in Europe, Canada and APAC regions continued to lag.

Turning to a discussion of our operational progress. We complemented our strong fourth quarter sales performance with notable progress on our four strategic initiatives to position APEX Medical for long term growth in the cosmetic surgery market. Starting with our first initiative to pursue specific clinical indications that will enable us to market and sell Renuvion for new targeted procedures, we were pleased to achieve multiple milestones during the fourth quarter with respect to our two IDE clinical studies. As a reminder, we are conducting these studies to support the pursuit of new indications for the use in dermal resurfacing and skin laxity procedures. In early November, we completed patient enrollment in our clinical study evaluating the use of Renuvion technology for dermal resurfacing procedures.

Following the completion of enrollment, our team has been focused on completing the ninety day follow-up visits for the enrolled patients. And collecting, aggregating, and analyzing the data from this study with the goal of submitting our request for five ten ks clearance by the May 2021. We also submitted one month safety data to the FDA from phase one of our IDE study evaluating the use of Renuvion in skin laxity procedures in the neck and submental regions. After reviewing the safety data, the FDA concluded that we met the requirements completing the phase one portion of the study. On November 23, we announced that the FDA approved our supplement, enabling us to move forward with phase two of this study.

Our approved supplement included changes to the treatment protocol based on feedback from our investigators during phase one, as well as an updated statistical analysis plan, and an increase in the number of investigational sites. I am pleased to report that we initiated enrollment in phase two in December as anticipated, and we will continue to expect to complete enrollment in the 2021. In terms of our OUS regulatory strategy, we continue to pursue regulatory clearance of our helium plasma technology in new countries with the goal of expanding our global commercial footprint. During the fourth quarter, I'm pleased to report that our regulatory team was able to obtain new product registrations in four new countries in Latin America and Eastern Europe. We do not expect these four countries to contribute materially to our performance in 2021, but remain pleased by our rapid pace of progress in obtaining new product registrations despite the global disruptions due to COVID.

Turning to our second strategic initiative, we continue to expand our portfolio of clinical evidence for Renuvion with several new publications during the fourth quarter. On October 20, we announced the publication of two peer reviewed articles which were both featured in the journal Dermatological Reviews. Each publication included data on our Renuvion technology from multiple retrospective chart review studies. One evaluated the independent use of Renuvion for subdermal coagulation in the neck, while the other evaluated its use in combination with liposuction for subdermal coagulation in various parts of the body. On October 26, another peer reviewed article was published in the Aesthetic Surgery Journal Open Forum, which focused on the use of Renuvion for subdermal coagulation following the contouring the upper and middle back regions with ultrasound assisted liposuction.

We were also pleased to see two additional publications during the quarter in the Biomedical Journal of Scientific and Technical Research, which focused on the use of our technologies in areas outside of cosmetic surgery procedures. Collectively, these publications continue to bolster our portfolio of evidence supporting the risk benefit profile of our technology when used across multiple areas of the body. With respect to our third strategic initiative, enhancing physician and practice support for our cosmetic surgery customers, in lieu of in person events, our team continued to organize and conduct educational programs virtually. In The US, we hosted four virtual physician education events, which were similar in format to our in person physician mentoring programs. These virtual events drew attendance from approximately 60 physicians.

Outside The US, we hosted two virtual training sessions to educate some of our distributors on the features and benefits of our helium plasma technology. Our team continued to develop new marketing materials, which are now available for our existing Renuvion customers to use via our online marketing portal. On our fourth and final strategic initiative, improving our manufacturing capabilities and efficiencies, our efforts to reduce the per unit manufacturing cost of our advanced energy products continues to demonstrate progress as a result of the expanding commercial adoption of our APR handpiece. Following the launch of our APR handpiece in early twenty twenty, we have focused on introducing this next generation product to our existing customer base. I'm pleased to report that by the 2020, nearly all of our North American customers had begun using our new handpiece for a portion of their procedures.

Importantly, the adoption of our APR handpiece was the primary driver of the improvement that we saw in our total gross margins during the fourth quarter, which increased approximately 80 basis points year over year. In summary, as a result of our strong sales performance in Q4, in spite of the continued headwinds created by the COVID pandemic, we were ultimately pleased to see sales decline by only 2% for the full year after experiencing a 24% decline in year over year sales during the 2020. As Tara will discuss further, we complemented our exceptional sales performance during the fourth quarter with strong year over year improvements in our total gross margins, net loss and adjusted EBITDA. And lastly, we continue to drive important progress on all of our long term strategic initiatives. The impressive financial and operating performance that we achieved is a direct result of our team's execution and their dedication to supporting our customers and their patients.

I'd like to congratulate them on a great quarter and a strong conclusion to a very challenging year. With that, let me turn the call over to Tara to discuss our fourth quarter financial results and 2021 guidance. Tara?

Speaker 2

Thanks, Charlie. I will begin my review of our Q4 financial results by continuing down the P and L. Gross profit for the 2020 increased $2,100,000 or 38.4% year over year to $7,700,000 Gross profit margin for the 2020 was 67.2% compared to 66.4% last year. The year over year increase in profit margins was driven in part by product mix within our Advanced Energy segment as well as improved product margins in our Advanced Energy segment due to our continued manufacturing efficiency initiatives and the introduction of new products, including the APR handpiece. The increase in profit margins was offset partially by product mix within our OEM segment and geographical revenue mix due to international sales growth outpacing domestic sales growth.

Operating expenses for the 2020 decreased $1,800,000 or 15.4% year over year to $9,800,000 compared to $11,500,000 for the 2019. The decrease in operating expenses year over year was driven by a $1,200,000 decrease in professional services, a $900,000 decrease in SG and A expenses and a $200,000 decrease in R and D expenses, partially offset by a $500,000 increase in salaries and related costs. The year over year decrease in operating expenses reflects the continued benefits from our initiatives to control costs and reduce our discretionary spending early in 2020 in response to the impact of COVID-nineteen on our financial condition. Loss from operations for the 2020 was $2,100,000 compared to operating loss of $6,000,000 last year. Income tax benefit for the 2020 was $400,000 compared to approximately $400,000 in the 2019.

Net loss attributable to stockholders for the 2020 was $1,500,000 or $04 per share compared to $5,400,000 or $0.16 per share for the 2019. Fourth quarter twenty twenty adjusted EBITDA loss was $700,000 compared to $4,800,000 last year. As a reminder, we provided a detailed reconciliation from GAAP net loss to adjusted EBITDA loss in our press release this morning. As of 12/31/2020, the company had cash and cash equivalents of $41,900,000 compared to $58,800,000 as of December 3139. As of 12/31/2020, the company had working capital of $56,900,000 including our expected tax refunds of approximately $7,500,000 that the company anticipates receiving during 2021 related to the net operating loss carrybacks resulting from the 2020 CARES Act.

Turning to a review of our 2021 financial guidance, which we introduced in our earnings press release this morning, we expect total revenue in the range of $36,700,000 to $38,700,000 representing growth of 32% to 40% year over year compared to total revenue of $27,700,000 in fiscal year twenty twenty. Total revenue guidance assumes Advanced Energy revenue in the range of approximately $32.3 to $34,300,000 representing growth of 45% to 55% year over year compared to Advanced Energy revenue of $22,200,000 in fiscal year twenty twenty. The Advanced Energy revenue range assumes that U. S. Growth is only driven by contributions from Renuvion sales related to its use as a subdermal coagulator following liposuction procedures and that international growth is driven primarily by demand existing international markets OEM revenue of approximately $4,400,000 representing a decline of 20% year over year compared to $5,500,000 in fiscal year twenty twenty.

In terms of profitability guidance for fiscal year twenty twenty one, we expect net loss attributable to stockholders in the range of 18,400,000.0 to $20,700,000 compared to $11,900,000 in fiscal year twenty twenty. And we expect adjusted EBITDA loss in the range of $12,000,000 to $14,600,000 compared to adjusted EBITDA loss of $14,500,000 in fiscal year twenty twenty. As a reminder, we have included a full reconciliation from GAAP net loss to non GAAP adjusted EBITDA loss in our earnings press release this morning. In addition to our formal financial guidance for 2021, we are providing some considerations for modeling purposes. First, our total company revenue growth will be driven exclusively by our Advanced Energy business, which at the midpoint of guidance range assumes growth of 50% year over year, more than offsetting the 20% decline we expect in OEM sales in 2021, driven primarily by COVID related recovery trends and the impact on demand from our OEM customers.

Second, the 50% growth at the midpoint in our Advanced Energy business this year will be driven by strong growth in both U. S. And in international markets. However, we expect roughly 60% growth in sales to U. S.

Advanced Energy customers and roughly 35% growth in sales to international Advanced Energy customers. Third, we expect gross margins in the range of 69% to 71% this year compared to 63.2% last year, driven primarily by continued mix benefits by segment, by geography and by product, specifically our continued manufacturing efficiency initiatives for our handpieces, including the APR handpiece. Fourth, we expect GAAP operating expense to increase approximately 22% year over year, driven by mid single digit growth in our normalized operating expenses, which excludes roughly 4,300,000.0 of COVID related expense reductions, including discretionary, travel and entertainment and other compensation related expenses that benefited our 2020 GAAP operating expense plus incremental stock based compensation expense in 2021 of approximately $1,300,000 and approximately $500,000 of initial expenses related to our joint venture partnership in China, which we established last year. Fifth, net interest and other expense of approximately $150,000 in 2021 compared to a benefit of approximately $700,000 last year. Sixth, income tax expense of approximately $180,000 in 2021 compared to an income tax benefit of $7,500,000 in 2020, which included the aforementioned net operating loss carryback tax benefit from the 2020 CARES Act.

Finally, we expect noncash depreciation and amortization of approximately 700,000 noncash stock based compensation expense in a range of 5,200,000.0 to $5,500,000 and weighted average diluted shares outstanding of approximately 35,000,000 shares. In addition to our formal financial guidance for 2021, while it is not our practice to provide quarterly guidance, given that we are reporting in the last week of the 2021, we thought it would be helpful to share our range of expectations for total revenue in the interest of transparency. We anticipate total revenue for the 2021 in the range of 7,800,000.0 to $8,000,000 representing growth of 55% to 60% year over year. This total revenue range assumes Advanced Energy revenue in the range of approximately 6,800,000.0 to $7,000,000 representing growth of 71% to 76% and OEM revenue of approximately $950,000 representing a decrease of 6% year over year. With that, I'll turn the call back to Charlie for closing remarks.

Charlie?

Speaker 1

Thanks, Tara. As we enter 2021, we remain optimistic about the prospects of our Advanced Energy business, and we are confident in our ability to drive Advanced Energy growth in the range of 45% to 55% year over year in 2021. With respect to our Q1 expectations specifically, we have continued to see evidence of strong utilization of our handpieces in The US along with demand from distributors internationally despite the surge in COVID cases in recent months. Meanwhile, the capital equipment environment continues to be impacted and the pace and timing of recovery remains uncertain, both domestically and internationally. As a reminder, we also see trends we also tend to experience seasonality purchasing trends with the first quarter generator sales typically representing the smallest portion of our full year generator sales.

Looking ahead, we continued strong global demand for our advanced energy handpieces and expanded OUS distribution network and continued clinical and regulatory progress. Apyx Medical is better positioned as a result of our focused execution in 2020. As we move beyond the first quarter, we look forward to recovering from the effects of COVID while continuing to execute against our four strategic initiatives to further enhance our opportunities in the years to come. Over the next few years, we believe APICS Medical is poised to deliver strong sustained growth and improving profitability with a global multibillion dollar addressable market opportunity, a strong balance sheet to support our growth initiatives, and a truly differentiated technology supported by expanding portfolio of clinical evidence. I'd like to close my remarks by emphasizing that we greatly appreciate the support of our employees, customers, distributors, and investors as we continue our mission to elevate the cosmetic surgery market to the next level by enabling surgeons and their patients to achieve the results that they are looking for.

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

Speaker 0

Thank you. If you'd like to ask a question, please signal by pressing star one on your telephone keypad. If you're using a speakerphone, please make sure you mute your function is turned off to allow your signal to reach our equipment. We do ask that you limit yourself to one question and one follow-up. If you'd like to ask additional questions, we invite you to add yourself to the queue again by pressing star one.

Our first question today is coming from Matthew O'Brien from Piper Sandler. Your line is now live.

Speaker 3

Great. I guess, Charlie or Tarek, based on what you just said about Q1 here and then and what we saw in Q4, I mean, did really well at Advanced Advanced Energy, about 10,000,000. Can you talk about some of the benefit that you saw in q four? And then when I net out what you said about, q one Advanced Energy from the guidance for the year, it assumes about 8,500,000.0 for each of the last three quarters, which is below what you did in q four. So it just feels like that's somewhat conservative, again, given all the momentum globally.

What are we missing as far as, you know, that kind of run rate for the last three quarters of the year in advanced energy that would be, you know, at at that kind of lower level versus what you just printed in q four?

Speaker 1

Well, hi, Matt. Thanks for, the comment. The first thing to remember is there's always the seasonality in q one. Q one is always our lowest, quarter, especially for capital sales and generator sales. And that seasonality did not change at all, as as we're sitting here today.

So, there's usually about a 20 to 30% decline in that seasonality from q four down to q one. And so we would expect q one, obviously, to be our our our lowest, our lowest number in in in the year.

Speaker 3

Okay. Sorry. Just to follow-up, and I I didn't ask the question real well. You did 10,000,000 in advanced energy in q four, which is great. Correct.

You know, you're guiding to '32 to '34 for the year. And, you know, it's you know, so it's well below that annualized rate, and I get it as keywords. It's better than normal. It just seems like it's it's a conservative outlook for the advanced energy business given all the momentum. Is there something new customers, CapEx, you know, that you really are trying to call out here?

Or are you just trying to be conservative with that number based on what happened The in q

Speaker 1

37% decline, we did 9.9 in in q four, and then we guided to advanced energy in q one of 06/2008 to '7. So it's right in line with that 30% decline that we typically see from the normal seasonality of our business.

Speaker 3

Got it. Okay. We'll follow-up offline. And then secondly, the international strength was, you know, really good to see. You know?

And and I know this has been a domestic story for a while here, but can you just talk about, what you're seeing? And and I think it was five new countries, and one of them was Brazil, obviously. But the strength that you're seeing there, and then, you know, how much should international contribute to the the story going forward? Because I know it's a big component to a lot of other aesthetic companies. Thanks.

Speaker 1

Yeah. So total US OUS sales were at 4,900,000.0, up 2.1, which represented that 74% year over year growth that you had talked about. And it was obviously much better than our expectations. And we were incredibly impressed by the growth with the strong demand from those customers, especially given the challenges of COVID in some of those markets. And the upside was really driven by a record December.

And the largest contributor to that upside was Brazil. They were about half of that, with the other half coming from demand in The Middle East, which actually came back pretty good in the fourth quarter. And then some of the other newer countries that, Thailand and Taiwan that put in some orders that we had gotten. And so we are very positive on our long term prospects, especially in Brazil being the second largest cosmetic market in the world. But if you look at surgical procedures, they actually do more surgical procedures than The United States.

I think the only thing that gives us any form of pause in Brazil, and one of the things that surprised us in the fourth quarter a little bit, is obviously they are being ravaged by COVID down there. And, you know, how they get past this COVID and what happens once they get past COVID, that's what we're really looking for. And obviously, I don't have a timeline of what happens with COVID down in Brazil. But that's the only reason that we have a little bit of pause. But the international sales, once we get through all of this, will continue to be a driver.

But we are only forecasting the growth for this year because of those factors. We're, only forecasting international to grow 35% this year.

Speaker 3

Got it. Thank you so much.

Speaker 0

Yeah. Thank you. Our next question is coming from Matt Hewitt from Craig Hallum Capital Group. Your line is now live. Good morning, and thank you

Speaker 4

for taking the questions. Maybe the first up, what do you think it's going to take to to kind of reinvigorate the the generator sales? Is that a you know, obviously, we're seeing some progress on the vaccine front. So is it just further rollout of that is gonna allow the the customers to get comfortable and and ultimately start buying generator skin? Or is there some other factor at play?

Speaker 1

Yeah. No. So I wanna be clear that generators keep getting better. Okay? Q four was better than q three.

Q three was better than q two. So generators are improving, they're just not at the level they were pre COVID. And it really comes down to, especially in The United States, is the protocols that offices are putting in place to try to keep everybody safe by not allowing new people in. And so as we get everybody vaccinated and as we get more normalization to trade shows and things like that, we would expect over time for those to get better. I just don't know exactly what that time is going to be.

We are starting to see a couple trade shows that are starting to have people at them, live people, instead of everything being done virtually. But even with those live shows, the attendance isn't that great yet. So, you know, we expect it to keep getting better as the year goes on, but it's really tough to predict when and and, you know, when that flip switch flips, if you will.

Speaker 4

Got it. And then maybe on on the people side, you know, last year, obviously, with with everything that happened, expenses were cut across the board, but it was, you know, travel. It was headcount, all sorts of areas. As you look at this year, how should we be thinking about the cadence of ramping those expenses back up, particularly as it comes to the travel and some of the incremental expenses? And then, I guess, tied to that, you know, what are your plans from a hiring perspective, particularly on the sales and marketing side?

Thank you.

Speaker 1

Yeah. So let me handle the sales and marketing side first. We're happy with the size of the of the team that we have today. And so, we will continue with that team throughout all of 2021. And, Tara will be able to walk you through, a very good exercise to show you where the savings were and where we see the growth in expenses.

But just figure there's about $4,300,000 of COVID related savings in 2020 that on a normalized basis will go back into the expenses. And then obviously, we're, you know, got the IDE studies that we're investing in and getting ready for dermal launches and things like that. So, she can walk you through all of that as we when when we talk after, but she's got the whole thing laid out for you.

Speaker 4

Great. Thank you. Yep.

Speaker 0

Thank you. Our next question is coming from David Kirkley from JMP Securities. Your line is now live.

Speaker 5

Yes. Hi. It's actually Danny on for Dave. Just had a few quick ones. First of all, handpiece demand domestically was again very strong this quarter, but we just wanted to ask more about the broader cosmetic surgery market.

You know, beyond your own company's execution, are you seeing any market dynamics that might be driving this growth? You know, do you think there's a higher willingness from patients to undergo these surgeries given the remote work, more convenient recovery, or maybe even additional stimulus? Any color on the more broader market would be fantastic. Thanks.

Speaker 1

Yeah. No. It's a very good question, Danny, and thank you. Yeah. You hit on some of the factors that are driving this.

I think what we continue to see and what we continue to hear from our customers is that demand for these procedures continues to be continues to be high. I think the thing that is interesting is because of all these different factors, I think our procedure in particular is, very good because it is a permanent solution, if you will, unlike some of these other less invasive modalities. And so I think you've got the function that you've got people at home. They've got the, time to recover. And they would prefer a more permanent solution as opposed to something that really doesn't quite get the job done.

And that's what our technology does. And I think you can see that by the demand for these procedures given this time. And so we're encouraged by that. And obviously, and from the customer point of view, they're very happy from that too and see that continuing.

Speaker 5

Great. And then just one follow-up. Yeah. You know, you mentioned, obviously, in March, you had a bit of a backlog that your customers have worked through by August. I may have missed it, but I just wanted to make sure.

Was there any, backlog that you saw being built up in 4Q with the resurgence in COVID? Or just any color around that or anything you saw would be great. Thanks.

Speaker 1

Yes. No. No. In The US, all our customers were open and working in Q4 and we just continued to see strong demand for those customers. Outside The United States, it's been a little trickier that some of the countries have been under lockdown in Q4.

And so some countries outside The United States are obviously not as strong as we would like it to be. But obviously, overall strength outside The US was obviously great in the fourth quarter. But there we're still being affected by some of those countries for sure that are that are having shutdowns and and aren't working at a 100%.

Speaker 3

Great. Thank you.

Speaker 1

Thank you.

Speaker 0

Our next question today is coming from Kyle Bauser from Collier Securities. Great

Speaker 6

updates. Maybe just following up on seasonality and kind of the strength you've seen internationally. I mean, back to the envelope math, in Q4, OUS sales for Advanced Energy were pretty much the same as U. S. Advanced Energy sales, is phenomenal considering, you know, a couple quarters before, you know, it's maybe a million versus almost 5,000,000 in in q four.

So just kind of wondering about the cadence heading into q one. I understand there's seasonality, it's in Brazil, particularly, it's a relatively new market. Can you just talk about was there a bolus of demand, pent up demand heading into getting clearance in that country, and we've seen a lot of nice strength. And and we should anticipate that, you know, kinda smoothing out a little bit, or do you you still see a a pretty massive opportunity for some low hanging fruit in that geography later this year.

Speaker 1

Yeah. So our preliminary our preliminary revenue expectations that we provided in our remarks assumed our growth advance energy of 71 to 76% in q one. And with that, we're expecting O U S growth of about 90% year over year in q one. And that is driven by the strong handpiece demand from existing countries. And obviously, a lower comparison, as q one last year, especially outside The United States, you know, COVID had an impact in the February time frame, so it's an easier comparison.

And our full year 2021 guidance on international assumes 35% year over year. When you're talking about Brazil specifically, you need to remember that obviously, every time that we have doctors from all over the world doing procedures, they're posting it on Instagram and talking about them. And doctors from all over the world that do these body contouring procedures get to see this. And so when we enter a market like Brazil, there is obviously a lot of people that have seen the work of a lot of these doctors and are looking forward to acquiring the technology. In a non COVID environment, I would expect us to be even doing more than we are in Brazil right now, and to be even growing more.

We think that Brazil is a very, will be a very key market for us in the future. As I mentioned before, they're the second largest cosmetic surgery market in the world, but they actually do more surgical procedures, in Brazil than The United States. So if you look at it just from a surgical perspective, it's actually a bigger market in The United States. And we would expect this market to be a big driver for years to come. The reason that we're cautious and the reason that we're you know, not pounding the table on Brazil right now is, as you know, they have COVID going on like crazy down there.

And I just don't have we just don't have good visibility on how long that's gonna last, what's gonna happen, and all those types of things that go along with that. So that's the only thing that gives us a pause about Brazil. In the long run, it it will be a very large market for us as we move forward.

Speaker 6

Got it. No. That makes sense. Agreed. I appreciate that.

And then, in terms of operating expenses, you gave a lot of nice guidance here. Maybe just more specifically in the professional services bucket, stepped down decent amount sequentially in q four. I know that's related to kind of peer to peer trainings. And and you you said that we're gonna see decent amount of incremental expenses, coming back into 2021. But how how should we think about that bucket?

Should should that step up, commensurate with the the nearly 5,000,000 in extra expenses this year? Any color there would be great.

Speaker 1

Yeah. I'll let Tara take the bridge.

Speaker 2

Yeah. I'm you know, I I think we have to first, you know, look at what the OpEx was in 2020, and and we we talked about in the prepared remarks that, you know, to normalize that, you'd add back about $4,300,000 in COVID savings, and that it would include that bucket to get to a normalized OpEx of just under $42,000,000 We're really just looking at an overall year over year change to that normalized OpEx amount of 6%, so mid single digits. And really, the other two big incremental spend items to consider is $1,300,000 in additional stock comp expense. And then, you know, we're ramping up activities in our China joint venture, so that's about $500,000 on top of that. But overall, you know, look at, you know, to the normalized 6% year over year.

Okay. And then with the incremental, it's total of 22.

Speaker 6

Okay. Got it. Thanks so much for taking my questions.

Speaker 2

Mhmm.

Speaker 0

Thank you. Our next question is coming from Russell Cleveland from Ren Capital. Your line is now live.

Speaker 7

Thanks for the good report, and congratulations on coming through a really rough period. My question is around the FDA initiatives. We talked about, one of the initiatives, the enrollment will be completed, in the third quarter. Explain that, what what that means. Are the tests ongoing?

We're just enrolling new people in in the study? Or give give us some color on these, when we're talking about the third quarter and and these initiatives.

Speaker 1

Okay. So remember, there's two studies that we're doing, the dermal resurfacing and the IDE for skin laxity. And the IDE for skin laxity is the one that we are currently enrolling patients. And just to remind everybody that there's 65 pay subjects that will be treated in up to eight centers. And we actually started enrollment of those patients, of those 65 subjects in December.

And we still expect to have all of those subjects enrollment completed sometime at the end of the third quarter. And then at the end of the third quarter, there is a six month follow-up on those patients. And then after the six month follow-up, we will analyze the data, prepare the submissions, and then submit to the FDA at that point in time there. So that's for the laxity study. On the dermal resurfacing study, that has been, we announced that enrollment is completed on that on November 5.

And we are now in the process of following up the patients for their 90 follow ups, analyzing the data and everything else. And we have always said that our goal was to submit for a five ten by the May. And we are on track to, submit that data to the FDA at the May. And then that typically is a ninety day plus process, to hear back from the FDA on that.

Speaker 7

Right. Well, thanks for that clarification. So we're making progress there on all fronts. So I appreciate that. That's all I have.

Speaker 1

Yeah. Thank you, Russell. And if I can just make one comment on top of that to the clinical team and our our sites. They did a magnificent job in working through COVID and keeping these studies on track and going. And to be able to sit here and tell you that we're on track to do all the things that we talked about having to navigate through COVID is just a testament to all the people that we have involved in this.

And so, if they're listening, thank you all very much for for, all your hard work and keeping that going. So thank you.

Speaker 0

Thank you. That does conclude our question and answer session. I'd to turn the floor back over to management for any further or closing comments.

Speaker 3

No. Thank you.

Speaker 0

That does conclude our conference today. We thank you for your participation