Earnings Call Transcript - INMD Q4 2022

Operator, Operator

Good morning, and welcome to InMode Fourth Quarter and Full Year Financial Results Conference Call. All participants will be in a listen-only mode. Please note this event is being recorded. I'd now like to turn the conference over to Miri Segal, MS IR. Please go ahead.

Miri Segal, MS IR

Thank you, operator, and everyone, for joining us today. Welcome to our conference call. Before we begin, I would like to remind our listeners that certain information provided on this call may contain forward-looking statements, and that the safe harbor statement outlined in today's earnings release also pertains to this call. If you have not received a copy of the release, please go to the Investor Relations section of the Company's website. Changes in business, competitive, technological, regulatory and other factors could cause actual results to differ materially from those expressed by the forward-looking statements made today. Our historical results are not necessarily indicative of future performance. As such, we can give no assurance as to the accuracy of our forward-looking statements and assume no obligation to update them, except as required by law. With that, I'd like to pass the call over to Moshe Mizrahy, Chairman and CEO. Moshe, please go ahead.

Moshe Mizrahy, Chairman and CEO

Thank you, Miri, and to everybody who is joining us. With me today are Dr. Michael Kreindel, our Co-Founder and Chief Technology Officer; Yair Malca, our Chief Financial Officer; Shakil Lakhani, our President in North America; Dr. Spero Theodorou, our Chief Medical Officer; and Rafael Likaman, our VP of Finance. Following our prepared remarks, we will all be available to answer your questions. We are pleased to report another record quarter with Q4 revenue of $133.6 million and $454.3 million for the full year, an increase of 21% compared to Q4 of 2021, and an increase of 27% compared to the full year 2021. This is a record level of revenue for an aesthetic medical company, and it is especially remarkable and exciting since we are achieving this milestone during a challenging global time. We believe our unique technology, strong dedication to the highest industry standards, our employee commitment, focused growth strategy in the U.S. and globally, and our diversified portfolio all contribute to our leadership position in the market. We value the trust of physicians and patients as we experience growing demand across the board. The success of the EmpowerRF platforms in 2022 exceeded our expectations, with revenue from this platform surpassing $45 million in 2022, well above our original guidance of $20 million. As we mentioned last quarter, the Morpheus8 device is becoming the gold standard in the aesthetic category, and we believe that it will continue to be one of our biggest growth drivers going forward, playing a major role in the platforms that we launch. In 2022, we announced an exciting new addition to our portfolio, the Envision platforms for dry eye treatment, which received certification in Canada last November. InMode Envision is an innovative technology that delivers targeted bipolar radio frequency energy to a small dedicated ocular area. We plan to launch the Envision platforms in the United States in the first half of this year, focusing on the ophthalmology market, and we are encouraged by the positive feedback that we have received from the Canadian market. Additionally, the next generation of Evoke, our hands-free platforms for face treatment, is planned to be launched in the second half of 2023. As part of our growth strategy, we continue to innovate as we launch new platforms or modalities every year, and we continue to explore potential acquisitions that could complement our presence in the aesthetic and wellness market. Now, I would like to turn the call over to Shakil, our President in North America. Shakil, go ahead.

Shakil Lakhani, President, North America

Thanks, Moshe, and everyone, for joining us. Once again, we are pleased to report another record quarter with continued positive momentum due to our diversified portfolio, growing market demand, and more frequent use of our platforms. InMode's growing installed base and the increase in the number of treatments performed led to consumable sales reaching 230,000 units in the fourth quarter, more than 749,000 in 2022. To support increased market demand, we continue to grow our sales team in North America and globally. In 2022, we enhanced our initiative to strengthen InMode's brand recognition. We sponsored several well-attended marketing events throughout the year and made a concentrated effort in expanding consumer awareness. We can say with confidence that our strong brand recognition, especially in North America, leads to a new situation where our platforms are being sought after and bought rather than sold. We expect this paradigm shift to continue and support our future growth. As mentioned by Moshe, the EmpowerRF platform has once again outperformed our projections. In addition, as we continue our strategy and expand into new areas of wellness, we plan on launching the Envision platform for the ophthalmology and optometry market during the first half of 2023, followed by the second generation of our hands-free platform for facial treatments during the latter half of the year. We believe that InMode's success in 2022 demonstrated our ability to expand into new categories and solidified our leadership position in the aesthetic and wellness market. Lastly, I'd like to thank our entire North American team for their continued hard work. I will now hand over the call to Yair for a review of the financial results in more detail. Yair?

Yair Malca, CFO

Thanks, Shakil, and hello, everyone. Thank you for joining us. Starting with total revenue, InMode generated a record $133.6 million in the fourth quarter of 2022, representing a 21% year-over-year increase, with a gross margin of 84% on a GAAP basis. For the full year of 2022, revenue totaled $454.3 million, an increase of 27% compared to 2021. Fourth quarter sales outside the U.S. accounted for $42.3 million, or 32% of sales, compared to 33% in Q4 last year. For the full year of 2022, sales outside the U.S. accounted for $155.7 million, or 34% of sales, the same as 2021. We are seeing growth coming from many different countries, and we are planning to establish at least one additional subsidiary later this year. To support our operations and growth, InMode now operates in a total of 80 countries with a sales team of more than 220 direct reps and over 69 distributors worldwide. Moving on, capital equipment in the fourth quarter represented 87% of total revenue, while consumables and service revenues accounted for the remaining 13%, identical to the ratio for the full year. GAAP operating expenses in the fourth quarter were $52.7 million and $183 million for the full year, which is a 33% and 34% increase year-over-year, respectively. Sales and marketing expenses increased slightly to $47 million in the fourth quarter compared to $35.3 million in the same period last year. Sales and marketing expenses for the full year of 2022 were $160.6 million compared to $119.4 million for 2021. This increase is attributed to hiring more sales representatives and increasing our presence in the U.S. and globally. Next, we look at share-based compensation, which increased to $7.1 million in the fourth quarter of 2022 and $24.5 million in the full year of 2022. On a non-GAAP basis, operating expenses were $46.1 million in this quarter compared to a total of $37.5 million in the same quarter of 2021, representing a 23% increase. For 2022, non-GAAP operating expenses were $160.4 million compared to $126.4 million for 2021. GAAP operating margin for Q4 was 45% and 44% for the full year of 2022. Non-GAAP operating margin for the fourth quarter of 2022 was 50% and 49% for the full year 2022. GAAP diluted earnings per share for the fourth quarter were $0.44 compared to $0.61 per diluted share in Q4 of 2021, and $1.89 in 2022 compared to $1.92 in 2021. Non-GAAP diluted earnings per share for this quarter were a record $0.78 compared to $0.64 per diluted share in the fourth quarter of 2021, and $2.42 for 2022 compared to $2.05 for 2021. Once again, we ended the quarter with a strong balance sheet. As of December 31, 2022, the Company had cash and cash equivalents, marketable securities, and deposits of $547.4 million. This quarter, InMode generated $57.2 million from operating activities. I would like to mention that in this quarter, it is more important than ever to focus on our non-GAAP results since, in our GAAP P&L, we have recorded a couple of one-time tax entries that were adjusted for non-GAAP purposes. With regard to taxes, InMode multiplied the provisions of the amendment to the investment law to its exempt profits accrued prior to 2020 and made a one-time payment of $12 million to the Israeli Tax Authority. In addition, the Company reached an agreement with the Israel Tax Authority under which the Company paid approximately $14.3 million on its undistributed exempt income for the year ended December 31, 2021 in January. As a result, we expect to save up to $28.5 million in potential future tax payments, and our entire cash balance is now free and clear of any additional corporate tax requirements. Before I turn the call back to Moshe, I'd like to reiterate our guidance for 2023. We expect revenues between $525 million and $530 million, non-GAAP gross margin between 83% and 85%, and non-GAAP income from operations between $236 million and $238 million. Non-GAAP earnings per diluted share are expected to be between $2.58 and $2.60. I will now turn over the call back to Moshe.

Moshe Mizrahy, Chairman and CEO

Thank you, Yair. Thank you, Shakil. Operator, we are ready for Q&A session. Hello, operator?

Operator, Operator

First question will be from Matt Miksic of Barclays. Please go ahead.

Matt Miksic, Analyst

Can you hear me okay?

Moshe Mizrahy, Chairman and CEO

Yes, we hear you okay.

Matt Miksic, Analyst

Great. So I have one question on the upcoming launches and then sort of a follow-up on the tone and flow of your current business in the U.S. On Envision, I'm curious about what sort of uptake we should think about the pace of that launch? And what sort of investments are you making behind it in terms of your field force or training, might be notable here as you laid out your 2023 guidance? And then I have one follow-up.

Moshe Mizrahy, Chairman and CEO

Regarding Envision, we're starting to launch it in the U.S. So I will ask Shakil to answer your question.

Shakil Lakhani, President, North America

Sure. We're going to put some pretty substantial resources behind it. Obviously, as we've discussed in the past, bifurcating the sales force is something that we like to do a little differently than what you'd expect. So, we will be building out specialty reps that are going to be specifically focused on Envision. And obviously, with the size of the market, the total addressable market for it is huge in terms of the ophthalmology and optometry world. So, we do see a large potential in what we can maximize out of this, but like anything else that we do, we're going to roll it out slowly. So, we're doing a soft launch start. And then as we start seeing proof of concept in terms of efficacy, marketing success for the practitioners, and so on and so forth, we will slowly start to invest further funds and resources into it.

Matt Miksic, Analyst

Great. It seems there has been a slight increase in some operating expenses compared to expectations for the upcoming year, and I assume that contributes to that situation. Is that accurate?

Shakil Lakhani, President, North America

I would say that's accurate.

Matt Miksic, Analyst

Okay. Great. Regarding the business environment in the U.S., many are interested in the health and sustainability of what has been a robust U.S. business, especially considering the spending patterns from a couple of years ago and potential softening ahead. This aligns with trends in any capital equipment market we observe, but there is some concern about the possibility of reduced spending or the need for demand catch-up. Can you discuss this flow and the dynamics related to the percentage of capital equipment sales that are financed and how that has changed over the last couple of years?

Shakil Lakhani, President, North America

Sure. So, we actually haven't seen that. It's actually gotten better. Funds have become a little easier. I mean, if you look at some of the stats, even for the Super Bowl and the average spending per family for people making a certain amount of income per year, it all went up by like 20% or 30%. So hopefully, with that, they'll keep spending, and we'll be able to help them with some of their weight loss goals and things of that nature. But we have seen the U.S. market just as strong as it has ever been from our perspective, and the way we finished it was extremely good. We've had a good start to Q1 so far. So, we don't anticipate anything changing there. In terms of the funding environment or the financing environment, we haven't seen much of a slowdown. We've got some really great partners, and we have some really good programs that are put together to help some of the physicians kind of get through. But in terms of spending, we haven't seen anything cut down. If everyone is talking about a potential recession, if we haven't already been in one per se, as of now, we haven't seen anything. If things change, we'll obviously keep you guys posted on that. Does that answer your question?

Matt Miksic, Analyst

Yes, it does. Thank you.

Operator, Operator

Thank you. Next question will be from Matt Taylor of Jefferies. Please go ahead.

Jon Lee, Analyst

This is Jon Lee in for Matt. Maybe I wanted to hear a little bit more on the guidance. Just the level of conservatism that's built in, any color on the quarterly cadence we should expect. And can you talk about Empower growth or the dollars embedded within the guidance?

Moshe Mizrahy, Chairman and CEO

Every year, we aim to be quite conservative in our guidance. For instance, last year we started with a projection of $220 million and ended at $455 million. The guidance for 2023 is cautious and constructed from the ground up, looking at each territory. I expect the final outcome to be better than what we’ve projected, but it depends on various factors including demand for 2023, international market dynamics like the situation between Russia and Ukraine, the evolution of the market in China amid ongoing COVID challenges, and supply chain issues. I believe we are well-prepared, but this year’s guidance is conservative, similar to previous years. Ultimately, we think we will perform better. Specifically for Empower, the embedded figure is 20% higher than in 2022.

Jon Lee, Analyst

Okay. Great. Anything on quarterly cadence we should be aware of?

Moshe Mizrahy, Chairman and CEO

Usually, we don't give quarterly guidance. But basically, you can take the same seasonality as in 2022 and apply it to the guidance. By the way, every quarter we will update the total guidance as we did in 2022 and in 2021. But typically, we are not giving guidance per quarter.

Jon Lee, Analyst

Okay. Great. I guess maybe just one follow-up, just on the M&A environment. You guys are definitely more focused on aesthetics and wellness. Was wondering if you can give us an update there now that you've been a little bit more public on what you're looking for. How is valuation? How is the conversations with targets been?

Moshe Mizrahy, Chairman and CEO

Well, currently, we are exploring several opportunities. We're not yet in the stage of doing official due diligence, and we have not yet involved any legal team. But we're looking into two or three companies in the wellness and aesthetic business that could complement our portfolio. We cannot give any timeline or any timetable to the process, but we're actually searching right now and we're doing it very seriously.

Operator, Operator

Thank you. Next question will be from Kyle Rose with Canaccord Genuity. Please go ahead.

Kyle Rose, Analyst

So, I just wanted to push back a little bit or just dig a little bit deeper into guidance for 2023, particularly regarding the prior comment about Empower being a 20% grower year-over-year. I mean, you came into the year '22 looking for that to be $20 million. You finished over $45 million. I guess I know you understand you're being conservative, but it seems to imply a slowdown in year two. And I would think that it would accelerate in year two, just given the focus you've had on rebuilding that market. So, can you maybe just help us understand how you're thinking about specifically Empower in the women's health market as we move into 2023?

Moshe Mizrahy, Chairman and CEO

Yes, we actually launched the Empower in Europe a few months ago. And we're now working country-by-country to get the final regulations from the regulatory bodies in each country in order to be able to sell it there. Don't forget, it's a women's health product which needs to get separate regulations. We did the same in Latin America in the fourth quarter, and we applied for regulations in Brazil, Mexico, Argentina, and also in Colombia. Hopefully, it will not take longer to get it. So, I assume that some time towards the second half of this year, we will start seeing some results in these two markets. I want to remind everybody that this is something that's relatively new to us, and we need to be very careful in the way we progress with this product to ensure that the doctors will be well-trained. We're entitled to build training centers in every country, have one or two or three luminary doctors in each country. It's a process. We try to be conservative in the guidance that we're giving, also in the United States. Yes, you're right, we initially provided guidance of $20 million and we achieved $45 million. This is great for us. Hopefully, the numbers we achieve in 2023 will be higher than 20% growth. But again, we try to be conservative and see what will happen during the year.

Shakil Lakhani, President, North America

I'll just add further to that. With any product launch, you're going to have some low-hanging fruit to start, and so we try to factor that in while still being conservative. I think we'll have a better idea midway through the year of how we're looking. But we feel good about the market. We've seen some good progress. We're going to penetrate the core specialties of that market a little further and continue to actually add on, very similar to what I mentioned with Envision, adding on some specialty reps to that. So, we do think that there's a bright future there. But again, factoring in some low-hanging fruit from new buyers, we are excited about the new technology, and then obviously, like we talked about with BodyTite for years, where we want to build longevity with the product. And as we've seen with, even Morpheus, it's become a brand, and it's grown in ways we did not expect, and we're hoping to get the same here. But we're still always cautious with how we forecast things.

Kyle Rose, Analyst

No, I can absolutely appreciate that. And then let's kind of translate that to the Envision product. I mean, it sounds like you've got some early positivity or positive signals coming out of Canada. This is going to be the first year of that product sometime in the first half. Is it fair to think about that as half of the initial guidance of what you thought Empower was, so like a $10 million to $20 million product? I mean, how should we think about that launch this year?

Moshe Mizrahy, Chairman and CEO

Regarding the Envision, we decided not to give guidance but rather to launch it in the United States slowly and gradually. Again, this is a new market for us, and we are learning how ophthalmology is and how optometrists are making decisions, and what kind of financing they can get. I mean, as we grow in this new category, we will be able to give better guidance and a better view of the market. We're just at the starting point. We sold some systems in Canada as a soft launch. And again, as I said, we have decided not to give guidance on Envision at this point.

Kyle Rose, Analyst

Okay. And then last question, and I'll hop back in queue is how should we be thinking about the China business moving forward? I think historically, you framed that somewhere around $2 million to $3 million, which can go to $4 million a quarter. But obviously, COVID has had a major impact there. How do we think about those trends as we move into, hopefully, more of a reopening or less of a COVID headwind from China?

Moshe Mizrahy, Chairman and CEO

Well, although China opened its doors and everybody can travel to China, there are still restrictions for the local people, and we have difficulties finding doctors and trainers to go there because of the current COVID situation. I'm sure that everybody understands the situation when there are around 30 million infections each day. So, I believe that in 2023, we'll see what will happen. We're still selling in the range of $2 million to $3 million per quarter. Hopefully, 2023 will be higher. However, until we understand what the situation is, we're not planning any marketing activities in China, bringing people and trainers from overseas to conduct workshops and conferences because we know that the private clinics are closed due to COVID, although China is open. I don’t understand the philosophy and strategy of the government regarding this. I hope this will be cleared up within the first or second quarter, and we will be smarter to answer this question.

Operator, Operator

Thank you. Next question will be from Mike Matson Needham & Company. Please go ahead.

Mike Stephen, Analyst

I just want to go back to the guidance for your operating expenses or operating income, I guess it's a better way to put it. So, it sort of implies about a 400 basis point decline from around 49% operating margin in 2022 to 45% in 2023. So, can you maybe just talk about why that's declining as much as it is and kind of where you're investing in '23 to cause that?

Moshe Mizrahy, Chairman and CEO

Yes. I mean, the gross margin will basically stay the same. The guidance for the gross margin will be between 83% to 85%. So on average, it will be 84%. I believe it's a great achievement taking into consideration the cost of electronic components and the supply chain, which is still broken. It's not yet back to normal. But we have decided to spend more on marketing, from 31% of revenue to 35% or 34.5% of revenue. We have decided to increase R&D and clinical work, especially in women's health and other areas. And essentially, we have decided to hire more people. Therefore, EBIT will go down by 4.5%, almost from 49% to 44.5%. But we see that as an investment. We will invest heavily in 2023 in Empower and also in Envision, which are new territories for us. It's not like aesthetics, and therefore, we have decided we have the resources, and we need to develop it, although it's an expense, but we consider it an investment.

Mike Stephen, Analyst

Okay. Got it. And I mean, this will be, at least based on your guidance, the second year where your EPS growth has lagged your revenue growth. So just stepping back and looking a little longer term, I mean, can you get back to driving operating leverage or at least growing your earnings in line with revenue? Or is this going to be a continual theme, where we see earnings growth slower than revenue growth because of these investments? I'm talking in like '24 and beyond.

Moshe Mizrahy, Chairman and CEO

Well, I believe in '24 and beyond, once the Empower and the Envision products position themselves as leaders in the market, similar to all of our aesthetic portfolio, we will continue to introduce products in the wellness sector including ENT, urology, erection dysfunction, and others. Consequently, I believe 2024 might be similar because new products, new categories, and new territories will require additional investment in marketing and R&D, among other things. I don't think the numbers that we're investing in R&D and marketing are higher than any of our competitors or any other companies in the medical devices space. I believe we are below the average. As far as G&A, we remain between 1% and 2%. We're still keeping that, trying to be lean and efficient. I believe gross margin will continue to be in the same range of 83% to 85%. But if you ask me about 2024, it will likely be similar to 2023.

Mike Stephen, Analyst

Okay. And then just on Envision. So I think when I spoke to you guys at our growth conference earlier this year, you mentioned that the timing on the dry eye clearance was expected to be in the third quarter. So it sounds like you're going to be launching the product before you have dry eye cleared. Is that correct? And then how big of a deal is that for the initial quarter or two, selling it without that? It seems like it's sort of a key feature on the product, but maybe the ophthalmologists understand that, hey, if I buy this thing, I'll get this feature in a couple of months or whatever.

Moshe Mizrahy, Chairman and CEO

Well, you are correct. We're in the process of obtaining an indication from the FDA for dry eye. However, I must say that the two handpieces involved with Envision, the Forma Eye and the Lumecca, the IPL, are cleared for other indications and for around the eyes. Therefore, we have the right to launch the product. In addition, we already have a study published, showing good results to the doctors and optometrists. Hopefully, in the third quarter, once we obtain the indication from the FDA, it will boost the momentum.

Operator, Operator

Next question will be from Jeff Johnson of Baird. Please go ahead.

Jeff Johnson, Analyst

Just a couple of questions here for me. One, Moshe, I just want to go back and clarify, as you were talking about 2024 operating margin or EBIT margin, you said kind of the same, but then you also talked about incremental investments. So, do you feel like this 45% level that we're going to be at in 2023, around 44.5% to 45%, that should stay consistent from here? When you say the same, is that kind of moving into 2024? Can we hold that mid-40% range? Just want to make sure that's what you were meaning there.

Moshe Mizrahy, Chairman and CEO

I believe, for your financial model, if you use a 45% EBIT for 2023 and 2024, that will be correct. I don't want to give any guidance for 2025 because this is too far away, two years from now. We'll see how these two years will develop, and we'll provide guidance sometime in 2024.

Jeff Johnson, Analyst

Yes, understood. That's helpful. And then Yair, just now that the profit and all the cash on the balance sheet is unencumbered from a tax perspective, just how should we think about the use of free cash flow? Obviously, I think you guys have talked a bit about some early-stage looking at some M&A opportunities. Any other uses of cash there around buybacks or anything else we should be thinking about?

Yair Malca, CFO

So, now all options are absolutely on the table. We've removed any restrictions or additional tax requirements. We are looking in all directions. The main thing we are looking at right now, as Moshe mentioned, is some M&A opportunities. However, buybacks or dividends or a combination of buybacks with M&A are always an option.

Moshe Mizrahy, Chairman and CEO

But we don't have any approved plan by the Board right now to do buybacks or dividends. This is just ideas that, in case we do not find any complementary acquisitions, we will consider it. But it's not on the table right now for 2023.

Jeff Johnson, Analyst

Understood. Last question. I think I asked you guys this every year on the fourth quarter call. Historically, we've tried to track your penetration rates in the U.S. plastics and dermatology markets, things like that. With the success you've had on Empower, that's getting harder to do. I think as the Company has matured here, I'm not yet sure if you're in the stage of replacing some systems. But when I look at that almost 8,000 placements cumulatively that you have in the U.S. now, any way to help us out on where you are in terms of penetration in your core plastic and dermatology offices? How much penetration room do you think is left in those markets over the next several years? Just help us think about that core business on the AccuTite, BodyTite, FaceTite, Morpheus8, and all that. How much more can that penetrate into certain offices here in the U.S.?

Moshe Mizrahy, Chairman and CEO

I would defer this question to Shakil, and maybe I will comment after.

Shakil Lakhani, President, North America

Yes, certainly. We've talked about this before, but we still have a very large runway in terms of what we're looking at because we have so many different platforms. Not every platform has been put into each office. But as we continue to help our practitioners implement some of these devices into their practices and help them succeed with them, we have a lot of great traction in terms of returning customers buying their second, third, and fourth units, so on and so forth. So I still think in terms of penetration, we have a long way to go. There are a lot of physicians out there. With Empower, I think we are going to start seeing more traction in the core markets as we put more focus on it. With the soft launch of Envision, transitioning from the soft launch to a full launch, we will start to see good upside there.

Jeff Johnson, Analyst

Shakil, can I push you on that? Just to clarify here on the call, would you share your penetration in core plastic and dermatology offices? Is it at 10%, 15%, 20%, 25%, or are we approaching 30%? Please help us estimate where you are in relation to the offices you could target.

Shakil Lakhani, President, North America

It's tough to say, and it's not that I'm trying to avoid your question. Each year, obviously, there are newer doctors out there. We're in training programs with our technology. They're very familiar with what we're offering. It's hard. I just don't want to give you a number and be totally way off and mess with your model. But I do think we still have a really large runway for this.

Moshe Mizrahy, Chairman and CEO

I would like to add to what Shakil said. For comparison, right now, there are more than 30,000 active laser equipment in the United States, or even more than that. We are now in the range of 8,000. Just consider that every doctor who uses laser for aesthetic procedures will eventually use RF for the same purposes. So we have a long way to go.

Operator, Operator

Thank you. This concludes our question-and-answer session. Now, I'd like to turn the conference back over to Mr. Moshe Mizrahy, chairman and CEO. Please go ahead.

Moshe Mizrahy, Chairman and CEO

Thank you, everybody, for joining us. I want to extend thanks to all employees of InMode around the globe. I want to thank the management of InMode for the great year. We have finalized all the plans for 2023 and start working on another exciting year. I hope that 2023 will be another record year for us. Thank you all, and see you soon at the end of the first quarter. Thanks.

Operator, Operator

Conference has now concluded. Thank you for attending today's presentation. You may now disconnect.