Q1 2021 Apyx Medical Corp Earnings Call
Please standby.
Good morning, ladies and gentlemen, and welcome to the first quarter of fiscal year 2021 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 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.
And those identified and the risk factors section of our most recent annual report on form 10-K filed with the Securities and Exchange Commission and as long as our most recent 10-Q filing.
Such factors may be updated from time to time and 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.
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 and 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 as President and Chief Executive Officer. Please go ahead Sir.
Thanks, Operator, welcome everyone to our first quarter earnings call I'm joined on this 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 first quarter revenue results.
Following this discussion I will share an update on the operational progress we made during the quarter towards the four strategic initiatives, we are pursuing to enhance our long term growth in the cosmetic surgery market.
Tara will then provide a detailed review of our financial results and an overview of our 2021 financial guidance, which we updated and in our press release this morning.
I will then conclude with some additional closing thoughts before we open the call for questions with that let's get started with the review of our revenue results.
In the first quarter of 2021 we delivered total revenue of $8 6 million representing growth of 73% year over year, which was well ahead of our expectations.
Our total revenue performance was especially noteworthy given the disruption created by the COVID-19, pandemic, which continued to challenge the overall operating environment, both in the U S and internationally.
By geographic region. The U S sales increased 54% year over year to $5 6 million, while total international sales increased 123% year over year to $3 1 million.
The year over year increase and total revenue was driven exclusively by our sales of our advanced energy products, which increased 92% year over year to $7 7 million more than offsetting a modest decline and our OEM business, which decreased 3%.
Year over year to $1 million.
Shifting to a more detailed discussion of our advanced energy business.
I am pleased to report that the 92% year over year growth, we saw and total advanced energy sales was driven by strong global sales of both our generators and hand pieces, reflecting and encouraging adoption and utilization of our technology and our key markets around the <unk>.
World.
As we mentioned on our earnings call in March during the first quarter, we continued to see strong utilization of our hand pieces and the U S.
Coupled with demand from our distributors internationally. Despite the elevated volumes of COVID-19 cases in many countries.
Our total advanced energy Handpiece sales ultimately grew by over 100% year over year.
In addition to our strong hand piece growth. The total advanced energy generator sales increased by more than 80% year over year.
And we were especially pleased to see strong sales of our generators, both domestically and internationally during the quarter given that the global capital equipment purchasing environment continues to remain challenged by the effects and uncertainty created by the COVID-19 pandemic.
With respect to our U S advanced energy business.
Utilization based demand from our existing cosmetic surgeon customers remain strong with hand piece growth of 92% year over year, Despite the uptick and COVID-19 cases in the month of December which persisted into January and February.
Our existing U S accounts remained open and active throughout Q1, and we saw improving year over year trends in each month of the quarter with growth and the month of March being the strongest.
The process of engaging with potential new U S customers continued to be challenged by COVID-19. However, these headwinds did ultimately improve and the first quarter and our direct sales team performed exceptionally well and enabling us to deliver 67% growth.
And U S generator sales year over year.
Q1 marked our return to year over year growth and U S generates a generator sales for the first quarter since the onset of the COVID-19 pandemic.
Importantly, while our U S generator growth and the first quarter was aided in part by an easier comparison and prior year periods, given the COVID-19 impacts in March of 2020.
Our U S generator sales results reflect strong growth compared to the first quarter of 2019, as well with sales up 37% and Q1 'twenty one versus Q1 19.
With respect to the underlying utilization based demand trends in Q1, our U S. Handpiece sales increased 92% year over year and were up more than 150% in Q1, 'twenty, one as compared to the first quarter of 2019.
With respect to our advanced energy business outside the U S.
Our international Advanced energy growth was very strong and was driven by.
Contributions from sales of hand pieces and generators, both of which increased more than 120% year over year and the first quarter.
The overall pace of recovery and many countries continue to lag behind the U S and remains difficult to characterize overall, but we were pleased to see important pockets of strength in certain regions, which fueled our strong performance.
International Handpiece sales growth was largely driven by strong sales to our distributors and Brazil and Taiwan.
Two countries, which we entered during the second quarter of 2020, while international generator sales growth was more evenly distributed across multiple countries.
Our international generator sales growth benefited from easier comparisons given the impact of COVID-19 and February and March of last year, but we were pleased to see sales increased 6% compared to the first quarter of 2019.
Turning to a review of our operational progress during the first quarter towards our four strategic initiatives to position apex medical for continued success and sustainable long term growth and the cosmetic surgery market.
First we continue to pursue our regulatory strategy to obtain specific clinical indications for targeted cosmetic surgery procedures and the U S, while securing product registrations and new countries internationally.
In the U S. Our two I day.
Clinical studies evaluating the use of renewable beyond and dermal resurfacing and skin laxity procedures continue to progress as we had anticipated.
During the first quarter, we completed the 90 day follow up visits for patients enrolled and our dermal resurfacing study.
Our team is preparing a request for five 10-K clearance.
Which we are still on track to submit by the end of this month.
We also made important progress and enrollment of patients and phase two of our IDE study evaluating the use of renewable beyond and skin laxity procedures in the neck, and Submental region, which we initiated in December of 2020.
And we remain on track to complete phase III enrollment and the third quarter of 2021.
Turning to our O U S regulatory strategy, our regulatory team continued to expand our global commercial footprint by obtaining regulatory clearance for our helium plasma technology in two new countries and eastern Europe as well as South Africa during the first quarter.
While we saw initial orders from our distributors and two of these countries during the quarter, which modestly benefited our advanced energy growth in Q1, we do not expect them to contribute materially to our performance. This year with that said we are pleased to achieve continued progress.
And on this aspect of our regulatory strategy and believe our success and driving new customer adoption and international markets is notable given the continued COVID-19 related disruption and these regions.
With respect to our second strategic initiative, we continue to expand the portfolio of clinical evidence for our renewed on technology and the cosmetic surgery market.
In March we were pleased to see a peer reviewed article published in the journal of cosmetic dermatology, which was authored by Dr. Jay David Ho Hum.
The article focused on the analysis of 22 subjects treated by Doctor Holcombe as part of our initial <unk> study.
Study focused on the use of renewable Leon and dermal resurfacing procedures.
Dr. Holekamp performed a quantitative comparison of the number of brown spots and and large pores as well as wrinkle area effect and thickness, both prior to and three months following dermal resurfacing with renew Leon.
Based on this analysis he found that a single pass treatment with renew beyond at low energy setting.
Yielded qualitative and quantitative improvements and facial skin appearance, specifically the number of brown spots decreased by 45% the number of enlarge pours decreased by 28%.
Wrinkle area decreased by 13%.
And wrinkle thickness decreased by 5% on average.
In short this new peer reviewed publication provides additional clinical validation, which we expect will support our clinical adoption. Following the receipt of U S regulatory clearance for this target procedure.
Turning to our third strategic initiative during the quarter, our commercial team continued to make progress and supporting new and existing cosmetic surgery customers and their practices.
Working together with some of our top surgeons and Kols, we organized and hosted three educational events for our new and potential surgeon customers.
These three events, we're open to both in person and virtual participation and saw more than 200, clinicians, reflecting the strong interest and our technology.
Our team also hosted five virtual training sessions to further educate some of our O U S distributors on our helium plasma technology.
We also continued to expand and enhance our portfolio of marketing materials for our existing surgeon customers.
During the quarter, we introduced an in office marketing kit, which we are providing to all new customers moving forward.
And this kit includes a variety of renew van branded materials, including brochures wall claims and scrubbed caps that can be used to help surgeons raise awareness and educate their customers on the benefits of renewing and technology.
And likewise, we launched and and event planning kit that customers can access on our online marketing portal, which provides them with everything they need to organize customer focused events and programs.
In early April we hosted our first users meeting a two day event with participation from roughly half of our existing comp.
Customers, representing more than 50 countries the.
And the event featured presentations and discussions hosted by 'twenty, two key opinion leaders and top surgeon users from around the world, which is now available for our entire customer base to access on demand via our online portal.
Lastly, regarding our fourth and final strategic initiative to improve our manufacturing capabilities and efficiencies. Our manufacturing team is continuing to drive further improvements and our overall manufacturing capabilities and efficiencies through the introduction of new manufacturing technologies and.
And our Clearwater facility and by approving the Handpiece production capabilities of our facility and Sofia Bulgaria.
Importantly, the early benefits of our team's strong execution of this strategic initiative, we're seeing and strong gross margin performance and the first quarter of 2021.
Specifically our focus in recent years on reducing the per unit manufacturing costs of our advanced energy hand pieces is.
As expected to drive material improvements and our Handpiece gross margin and the adoption of our APR hand pieces increases going forward.
As a reminder, our efforts in 2020 focused on introducing this product to our customers and North America and.
In 2021, we are expanding our focus to O U S markets, including where necessary securing the requisite registrations before commercial introduction and our key international markets and years to come.
All in all the first quarter marked a great start to 2021, we saw encouraging utilization and adoption trends and strong sales growth and our advanced energy business driven by balanced contributions to total year over year growth coming from sales of hand piece.
<unk> and generators as well as from customer demand in the U S and internationally.
Our sales performance translated into strong year over year improvements and our total gross margins and improvements and our adjusted EBITDA loss compared to the prior year period.
And our activities related to our four strategic initiatives continued to progress smoothly, leaving us better positioned to deliver strong sustained growth over the long term.
Our team did an exceptional job this quarter and I would like to take a moment to thank them for their effort and their commitment they've demonstrated to overcoming any obstacles as we revolutionize the cosmetic surgery market with our helium plasma technology.
With that let me turn the call over to Tara to discuss our first quarter financial results and our updated 2021 guidance Tara. Thanks.
Thanks, Charlie.
Kevin Charlie's detailed review of our first quarter revenue results I will begin my discussion of our Q1 financial results by continuing down the P&L.
Gross profit for the first quarter of 2021 increased $2 9 million or <unk>, 96% year over year to $5 9 million.
Gross profit margin for the first quarter of 2021 was 67, 8% compared to 59, 7% last year.
The year over year increase and gross profit margin was driven by revenue mix between our two segments.
And as well as improved product margins and our advanced energy segment due to the continued manufacturing efficiency initiatives that share.
Ali mentioned earlier.
The year over year increase and gross profit margin was offset partially by revenue mix by geography and by product.
Operating expenses for the first quarter of 2021 increased <unk> $1 million or 1% year over year to $10 6 million compared to $10 5 million for the first quarter of 2020.
The increase in operating expenses year over year was driven by a $9 million increase in salaries and related costs.
And $8 1 million increase and research and development expenses.
Partially offset by $8 $9 million decrease and in professional services and $8 1 million, a decrease and selling general and administrative expenses.
They're very modest year over year increase and operating expenses reflects the continued benefits from our initiatives to control costs and reduce our discretionary spending which began in the second quarter of 2020 and response to the impact of COVID-19 on our financial condition.
Loss from operations for the first quarter of 2021 was $4 7 million compared to operating loss of $7 $5 million last year.
Total other loss net was <unk> 1 million compared to total other income of <unk> 6 million last year.
The year over year change was primarily due to a benefit from the receipt of refunds and the first quarter of 2020 and tariffs paid in 2019, which did not benefit our financial results and the first quarter of 2021.
Income tax expense for the first quarter of 2021 was <unk> 1 million compared to a benefit of $4 9 million and the first quarter of 2020.
The year over year change and income tax expense was primarily due to the net operating loss carry back claim refund.
Ignite and the first quarter of 2020, which did not benefit our financial results and the first quarter of 2021.
Net loss attributable to stockholders for the first quarter of 2021 was $4 9 million or <unk> 14 per share compared to $2 million or <unk> <unk> per share for the first quarter of 2020.
First quarter 2021, adjusted EBIT loss was $3 4 million compared to a loss of $5 $8 million last year and improvement of $2 4 million or 41% year over year.
As a reminder, we provided a detailed reconciliation from GAAP net loss to adjusted EBITDA loss and our press release this morning.
As of March 31, 2021, the company had cash and cash equivalents of $39 5 million compared to $41 9 million as of December 31, 2020.
As of March 31, 2021, the company had working capital of $53 3 million <unk>.
Including expected tax refunds of approximately $7 5 million that the company anticipates to received during 2021 related to the net operating loss carry backs, resulting from the 2020 cares Act.
Turning to a review of our 2021 financial guidance, which we updated and our earnings press release. This morning.
For the 12 months ending December 31, 2021, we now expect.
Total revenue and the range of 37, six to $39 7 million representing growth of 36% to 43% year over year.
This compares to our prior guidance range of $36 seven to $38 7 million.
The updated total revenue guidance range assumes advanced energy revenue and the range of approximately $33, one to $35 2 million representing growth of 49% to 59% year over year.
This compares to our prior guidance range of 32, 3% to $34 3 million.
The updated advanced energy revenue guidance range continues to assume U S growth is only driven by contributions from me moving on sales related to its use.
And as a sub dermal coagulator following liposuction procedures.
And international growth, driven primarily by demand and existing international markets.
OEM revenue of approximately $4 4 million, representing a decline of 20% year over year. This is unchanged from our prior guidance range.
In terms of profitability guidance for fiscal year 2021, we expect net loss attributable to stockholders and the range of $23 million to $18 million.
This compares to our prior guidance range of 27% to $18 4 million.
And we expect adjusted EBITDA loss and the range of $14 one to $11 5 million. This compares to our prior guidance range up 14, 5% to $12 million.
As a reminder, we have included a full reconciliation from our GAAP net loss to non-GAAP adjusted EBIT loss and our earnings press release this morning.
Our formal guidance Frank our formal financial guidance for 2021 continues to incorporate the following considerations for modeling purposes.
First we assume our total company revenue growth for the full year 2021 period will be driven exclusively by our advanced energy business.
We expect strong advanced energy growth both in the U S and internationally.
And the midpoint of our advanced energy guidance now assumes roughly 63% growth and sales to U S advanced energy customers and 2021.
And roughly 40% growth and sales to international advanced energy customers compared to our prior guidance range, which assumes year over year growth of 60% and 35% respectively.
Second we continue to expect gross margins and 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 hand.
Pieces <unk>.
Including the APR Handpiece.
Third our GAAP operating expense assumptions increase as a result of the increase and our rubber revenue guidance expectation.
Accordingly, we now expect GAAP operating expenses to increase approximately 23% year over year, driven by mid single digit growth and our normalized operating expenses, which excludes roughly $4 $3 million of COVID-19 related expense reductions, including discretionary travel and entertainment.
And other compensation related expenses that benefited our 2020 GAAP operating expense.
Incremental stock based compensation expense and 2021 of approximately $1 3 million and approximately 500000 of initial expenses related to our joint venture partnership in China, which we established last year.
Fourth we continue to expect net interest and other expense of approximately 150000 and 2021 compared to a benefit of approximately 700000 last year.
Fifth we now expect income tax expense of approximately 250000 compared to an income tax benefit of $7 5 million last year, which included the aforementioned net operating loss carry back tax benefit from the 2020 Cares Act.
And six we expect non cash depreciation and amortization of approximately 700000 non.
And noncash stock based compensation expense and the range of five two to $5 5 million.
And weighted average diluted shares outstanding of approximately 35 million shares.
Lastly, while it is not our standard practice to provide quarterly expectations, given the significant impact of the COVID-19 pandemic and the second quarter of 2020.
And the related benefit to our Q2 21 year over year growth rate for the avoidance of doubt and the interest and in the interest of transparency, we expect our total revenue and the second quarter of 2021 to increase approximately 101 at 112% year over year. This.
And this total revenue range assumes advanced energy growth of approximately 165% to 180% and.
A decline and Oes OEM revenue of approximately 27% to 23% year over year.
With that I'll turn the call back to Charlie for closing remarks, Charley. Thanks, Tara we are raising our guidance for 2021 to reflect both our strong start to the year, including the encouraging adoption and utilization trends that we have seen as well as the continued confidence we have and our outlook.
For the remaining nine months.
With a solid balance sheet.
Global multibillion dollar addressable market opportunity and differentiated technology supported by an expanding portfolio of clinical evidence.
We remain well positioned to drive strong sustained revenue growth and improving financial performance as the global environment continues to recover.
We look forward to building on our recent momentum this year by continuing to deliver exceptional financial performance and strategic execution as we establish apex medical as a leading player in the global cosmetic surgery market.
I'd like to again, thank our employees for their hard work as well as our customers distributors and investors for their continued support for apex medical and our mission with that operator, let's now open the call for questions.
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 speaker phone. Please make sure. Your mute 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 if I each add yourself to the queue again by pressing star one and.
And our first question will come from Dave <unk> with JMP Securities.
Great Good morning, and congrats.
Congrats on the broad strength, you saw growth geographies and the.
And different product lines.
Charlie and we've asked this before and I'm just curious given how balanced debt growth was.
I know capital has always been a larger component, but I would assume it's got to be getting closer to 50 50, I just love to get your thoughts on sort of.
And where that mix stands today between the hand piece and the generators and if we are approximating that level.
Yeah. Thanks, David we appreciate the.
Question.
Yes, we were very happy with our generators being up 80% year over year, and Q1 and U S generator sales in particular were up 67% year over year.
And it was our first quarter of growth as we had talked about with the pandemic and the U S on the generator side and.
And it was incredibly impressive growth in light of still the COVID-19 related challenges that still.
<unk> on the U S side, we were up by 120% year over year, but that remember benefited from easy comps, but we still grew 6% over 19 and generator demand from multiple countries reflects our measured improvement and our operating environment quarter over quarter operating.
In an environment and certain O U S markets as far as the exact mix of generators to hand pieces. We're.
Obviously, not going to be talking about that in detail, but we are incredibly happy with the continued growth and utilization that we've seen globally and the adoption of renew beyond it is it very exciting for us and we're it makes us very confident about the future.
And I appreciate that and I had to drive a day. Thank you for that.
And then I guess as a follow up on the international front, you called out, Brazil, and Taiwan, and the Handpiece side, you mentioned strength and I guess across.
Across other countries and the generator, but obviously thats been very strong the last two quarters sequentially. So.
And any additional color you might give us there.
Maybe you and particularly on the generator side would be helpful.
Well I think that the.
And you are talking about those two countries in particular and when Youre talking about our long term regulatory strategy that we've had to get new countries, obviously theres going to be more generators that go into place right. When we get those because there is demand and a lot of those countries and so this strategy has been a.
Strategy that we've been talking about now since we've been here for three years and as we continue to keep adding new countries. Obviously generator adoption starts, but then the handpiece utilization and then follows and so all of this really starts to and to build a nice business outside the United States with.
Adoption of that and you could see that with the hand piece growth up more than 120%, but as we talked about.
Outside the United States from a COVID-19 perspective, it is really really a mixed bag outside the United States and some areas are are really being affected more than others and it is still hard to predict outside the United States how.
COVID-19 is recovering.
They're way behind on the vaccine and certain countries and things like that so.
Thank you.
You bet.
Okay.
Our next question comes from Matt Hewitt with Craig Hallum.
Good morning, congratulations on the strong quarter a couple of questions from me I was hoping to focus a little bit on the sales and marketing efforts.
Yes.
Here domestically and pockets of O U S as vaccines and rolled out.
<unk> co.
COVID-19 starts to decline or are you able to get out and about more from a sales perspective.
And to see your customers.
Should we be thinking about some of those costs ramping up over the course.
Over the year.
Year.
Yes, so we were very much.
Pleased with the progress that we made in the first quarter, specifically and the United States selling generators and.
And finally have and growth and that again and.
And we were very active on this front in Q1.
Despite the COVID-19, we have actually just started in April I think it was the very first in person trade show that actually.
And so we would expect as we go forward and the United States to have more in person trade shows, but as you can see that we hosted a hybrid event for our Pnp and that was in person and then virtual and it was wonderful because it was attended by about 200 docs.
And so and that's the same thing with the trade shows that were seeing is there a hybrid thing of in person and.
And virtual and so I think that this year you will start to see a lot more of that and I think that as obviously, we started attending more of those things and traveling and more of those things terror.
Youll start to see more of an increase and our expenses as we go forward through the through the rest of the year.
Got it and then maybe just a follow up on that it sounds like you've launched a couple of new marketing campaigns.
Would it be safe to assume that Q.
Q3 early Q4, you received the dermal resurfacing approval would it be safe to assume that you would add some sales resources and some head count and the sales team to really drive growth and that market. After the approval. Thank you.
Yes, no and good question so for the dermal resurfacing study week as I mentioned earlier, we continue to target. Our 500 10-K by the end of this month, we anticipate at least 90 days from the decision from the FDA our guidance and 2021 does not include contributions.
And from sales force dermal resurfacing, we do plan on getting the sales force together.
And August to plan and prepare for a potential limited launch during Q4, but.
But we really wouldn't expect any material contributions from a revenue perspective until our full commercial launch and 'twenty two and.
We're comfortable with the size of the sales organization that we have right now.
Understood great. Thank you. Thank you.
Our next question is from the line of Matt O'brien with Piper Sandler.
Hi, This is <unk> on for Matt. Thanks for taking the question congrats on the quarter and.
So first just looking at your guidance with the no change to OEM guide. Despite the segment doing a little bit better and Q1, and then we had anticipated.
And you just speak to some of the trends youre seeing with that business and why you left that unchanged.
Yeah. Thank you for the question for the OEM we had.
It's right in with what our guidance was for the first quarter. So the first quarter results that we had of $1 million or right. What we basically had expected and where we thought the business would be after Q1.
And.
Our guidance for 'twenty, one assumes a 20% decrease and revenue, which is approximately $4 $4 million and we did the $1 million and Q1 and so for US. It was right on what we expected and Thats why there was no change in the OEM and the OEM revenue.
And when you ask why is.
It is down this year remember, we've always talked about the.
And the OEM business being about a $5 million business. It did $5 five last year. We're forecasting this to do $4 for this year, but it is really driven by demand trends from COVID-19. Because remember these are sold to our partner customers that primarily sell these and hospitals.
And the hospital environment as Ben has been impacted globally by COVID-19 more than obviously our market here in the.
And the aesthetic space.
Great. Thank you that's helpful. And then just on the gross margin front, how should we think about the ramp throughout the year to get up from where we are now to that 69% to 71% range would it be like a pretty good.
And then sell improvement or will it be a little bit.
Lumpy any color on that would be helpful.
Yeah. So.
If you if you remember.
For the gross margins.
It was primarily driven by <unk>.
Our segment and by our product mix and the product mix, specifically on the APR Handpiece and we rolled out.
We rolled out the APR last year, and the United States and we're seeing obviously adoption of that and the U S. And we just started to do that outside the United States and so outside the United States, We would expect that.
As obviously, we will have more APR sold in the last quarter of the year outside the United States, then we will and the first quarter of the year and so that.
And that ramp will help drive the gross margin sequentially.
On a quarter by quarter basis.
Thank you.
Yes.
Thank you.
As a reminder to signals ask a question you May press star one on your telephone keypad and we do ask you to limit yourself to one question and one follow up.
Our next question is coming from the line of Russell Cleveland with Renn Capital. Please proceed with your question Sir.
Hi gang. Thanks, so much for the great numbers.
Quick questions first on the international scale.
A lot of places that we're not for example, like Argentina, and so forth can you comment on your international growth and how we're looking at the World and these places that we're not now.
Yeah.
So Russell as you know.
Our OS are O U S regulatory strategy has been something that we've been focused on and obviously, we're working on as fast as we can especially given the COVID-19 environment and a lot of these countries and a lot of some countries are more hampered by COVID-19 than others as far as their ministries of health of allowing these things.
But we never do comment on the timing of it because we're not in control of the timing of it but we are very encouraged that we were able to get three new registrations. This quarter, which is a testament to the team and the work that they're doing and then the strong growth that we had internationally of 120%.
And as obviously real exciting and this is a multi year.
And strategy for US also to really keep.
And to really keep adding to new countries and.
And our guidance really only assumed.
Growth or.
And from existing countries and we're not baking.
A lot of growth into when we get these new registrations, because we just arent and control of that.
Okay.
And my second question.
Our non FTA on the dermal resurfacing and return, which we call facelift.
Now that's being done currently we just don't have the regulatory approval, but that's being performed.
And as we speak with our technology is that correct.
It is an off label procedure, we cannot promote it and we do not promoted so it is being done you're correct because the clinician can decide to use the technology any way that they want to but there are a lot of clinicians that will not use a technology off label. They wait for the company to actually get.
And indications for that before they actually use it. So yes. It is being done but it is being done off label and it is something that we as an organization do not promoter or actually.
And commercialized in the marketplace today.
And you spoke about this earlier and indicated that really.
It would be.
Fourth quarter or going into next year.
Before we would really get the completion of the study.
And hopefully approvals and launch of our marketing campaign and that is that is that where we are.
So we are on track to submit.
Our 500 10-K by the end of this month. It is at least a 90 day process after that.
For the dermal resurfacing and then we plan to get the sales force together towards the end of August to start planning for a soft launch we always do a soft launch when we launch a certain product that will be in the fourth quarter. And then you would expect then to have material revenue from that and.
And 2022.
Great. Thanks again for the numbers.
And as my questions Alright, Thanks Ross.
Thank you.
We currently are showing no remaining questions at this time and that does conclude our conference for today. Thank you for your participation.
Thank you.