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23rd Annual Needham Virtual Healthcare Conference

Apr 9, 2024

Mike Matson
Head of MedTech Equity Research, Needham & Company

Good morning. Thanks for joining us at the 23rd Annual Needham Healthcare Conference. I'm Mike Matson, and I lead the MedTech Equity Research Team at Needham & Company. I'm pleased to introduce InMode this morning. Presenting from InMode, we have Moshe Mizrahy, the CEO of the company. Instead of a standard presentation, we are going to do a Q&A session. If you have any questions that you would like to ask, you can submit them electronically through the Needham Conference website, or feel free to email them to me at mmatson@needhamco.com, and I'll do my best to fit them in. So we're just going to go straight into the Q&A here. Moshe, you put out a press release this morning with some kind of initial guidance around your first quarter results.

I think one of the things that stood out to me there was you had revenue in the quarter, but you also gave sort of a pro forma number because of your launching some new systems and getting some pre-orders for those. So can you maybe just talk about this transition from your current platforms to your new platforms and how that's impacting the results?

Moshe Mizrahy
CEO, InMode

Yeah. Actually, we have launched three platforms sometime beginning of the year. One of them is the new minimally invasive device, which is, you know, I would say second generation for the old RFAL BodyTite , which is about 12 years old. We have developed something much faster and much easier to use, again, with the same technology, radio frequency, bipolar radio frequency. We have launched a new, I would say, more sophisticated Morpheus, which is one of our main products, as everybody knows, and also very comprehensive platforms that include different types of non-invasive medical aesthetic procedures. Unfortunately, we did not be able to deliver all the orders because of several reasons. One of them is the war in Israel and transportation of components, and, you know, many people on reserve duty, so the production line was not full.

Therefore, we have about close to 15 or a little bit more than $15 million that we need to deliver in the next few quarters. Hopefully, everything will settle in the next few months.

Mike Matson
Head of MedTech Equity Research, Needham & Company

Okay. Got it. So then, starting with, you know, the second quarter, you know, I'm not going to ask for guidance for the quarter specifically, but, you know, will you have caught up to the point where you can start to ship these orders? Are we going to see a couple more quarters where you're going to have pre-orders that you're not able to fulfill?

Moshe Mizrahy
CEO, InMode

I hope that we will fix all the issues in the second quarter and be able to ship at least part of the back order. If not, it will drag into the third quarter. But I'm sure that we will get more orders on the second quarter for those three new platforms and new technologies that we develop. And hopefully, within a quarter or two, everything will be online and will be straight, and we will be able to deliver everything that is an order.

Mike Matson
Head of MedTech Equity Research, Needham & Company

Okay. Got it. And then the other thing I noticed in the pre-announcement was that your gross margin was a little weaker than we've seen typically. And, you know, I assume it's related to this timing issue around the new products. But, you know, are you having to discount the older models, or was it just more of a volume issue or manufacturing, you know, ramp-up or something on the new units that led to that, or could it be?

Moshe Mizrahy
CEO, InMode

I mean, it's altogether. It's a combination of everything you said. It's a manufacturing ramp-up. It will be a little bit more expensive for us to bring all the components on time because of logistic issues in the Middle East, as you know. In addition to that, you know, just because we are recognizing only $80 million and not 95 or 96, and therefore the fixed cost was averaged on less revenue, and therefore it went down. I believe that with the additional pro forma and the stuff that we have to deliver, it will go back to 83% at least.

Mike Matson
Head of MedTech Equity Research, Needham & Company

Okay. Got it. And then just on the new platforms that you mentioned, so, you know, how will those be priced relative to the old platforms? And I mean the old platforms before any sort of, you know, discounting occurred because of the new ones. So is there any chance you're going to get a price premium for these new platforms?

Moshe Mizrahy
CEO, InMode

As you know, as you know, Mike, it's very difficult today since the economy is still in a slowdown mode to get a premium price for deliveries, especially when you have a new product and the market is not well educated enough to know how good is the system and whether they have benefit from that. We believe it is, but it will take some time. And therefore, we did not raise prices. We did not raise prices on the first quarter compared to 2023. In addition to that, we're trying to help with financing because interest rate is still very high, and lease packages are very high as well as far as cost per month. And it will take much more, I would say, longer time to get it approved.

Therefore, just because we have a strong balance sheet, we help a little bit with financing, as that cuts a little bit from our profitability. Hopefully, in the second half of the year, interest rate will start getting down, and that will help us a lot.

Mike Matson
Head of MedTech Equity Research, Needham & Company

Okay. Just on that point about the financing, I mean, you know, I've noticed, you know, looking at new cars and stuff, the manufacturers will kind of subsidize the loans to buy down the interest rates. So, I mean, is that kind of what you're doing, where you're helping maybe a little bit on the cost of the financing, or is it more you're actually using your balance sheet to actually lend out or do the financing yourselves?

Moshe Mizrahy
CEO, InMode

We do some in-house financing for those doctors who we trust and cannot get a five-year lease package because maybe they are relatively young doctors, and they have relatively young clinics. In addition to that, we work with the finance company to help a little bit with the interest rate. So we take a little bit of the finance cost on ours in some kind of a pool mechanism, and that helps the doctors to get the leasing and for us to sell it. But of course, it creates some issues to the profitability and the amount we can recognize on every deal.

Mike Matson
Head of MedTech Equity Research, Needham & Company

Okay. One new question on the new platforms that you're launching. So, you know, obviously, you've got this kind of supply chain or manufacturing bottleneck right now. But once you get past that, I mean, is there potential here for this to drive kind of an upgrade cycle among your customers that have some older systems? Do you think that the improvements are significant enough that, you know, in addition to new systems getting sold to new customers, you could have some upgrades?

Moshe Mizrahy
CEO, InMode

Yes, we do. We do. That's exactly what we're doing. We have an upgrade program to some customers. If the system is five years old, then they pay full money or the full price. If the system is less than five years old, meaning that they are still in the lease package and they have to pay the old lease package and the new one, we give them some discount when they buy the new system. And when the lease will be fully paid, we can take the old system and try to use part of it. We're not selling used equipment, of course. We don't have any used equipment program. But we would like to collect the old system. And therefore, I would say that at least in the next 9-12 months, we will do a lot of upgrades to those who are using our technology.

If they are happy, they want to go to the next generation. And I believe they deserve to work with us if they want to. If it's five years old and the lease is fully paid, then it's easier for them to get the new system. But if the lease is not fully paid and they have to pay, I would say, two payments per month, then we help them a lot with discount on the new system.

Mike Matson
Head of MedTech Equity Research, Needham & Company

Okay. Got it. All right. And then, you know, I want to move on to just kind of the macro headwinds that you've been seeing. And just based on the commentary and the press release, it doesn't sound like, you know, that those have gotten really any better. But just, you know, do you think it's at least stable in the sense that, you know, it's not getting worse? Or, you know, what's your view there? Is it getting better, getting worse, or just kind of consistent with what you've seen in the last couple of quarters?

Moshe Mizrahy
CEO, InMode

I believe that the first and the second quarter, the market will be stable. I don't think it will go down more than what it did. I believe that in the third quarter, we will start seeing some new momentum in the capital equipment market. We're in the capital equipment market. I mean, 80% or a little bit more than 80% of our business is capital equipment. Therefore, it all depends on the financing the doctor can get in order to buy the system. Although, I mean, we show the doctor that the payback or the justification for buying a new equipment is less than a year, even today, because, you know, the public still wants to get new, still wants to get treatment. I mean, in the last quarter, we sold more than 270,000 disposables, which is a record.

From a treatment point of view, we don't see any reduction or we don't see any slowdown. From a new equipment point of view, yes, it started on the third quarter of 2023, and it's continuing on the first quarter of 2024. I believe the second quarter will be stable compared to the first quarter, maybe a little bit better. But I don't anticipate that that will be, you know, a big jump unless something will happen on the stock, unless something will happen in the financing market.

Mike Matson
Head of MedTech Equity Research, Needham & Company

Yeah. So on that topic, in terms of, you know, financing and interest rates, I mean, if the Fed were to start cutting rates, you know, do you think how quickly do you think that would help? Or do you think there's sort of a lag effect there where it takes months or something after that, you know, to really make a difference?

Moshe Mizrahy
CEO, InMode

I believe once we start to see the trend, we don't have to see the interest rate go down to, you know, where it used to be, I don't know, 4%, 5%. When the interest rate will start going down, even with, I don't know, 1%, the market will create a new momentum and will be open again. I don't think we need to wait until it will be like in 2022 or 2021.

Mike Matson
Head of MedTech Equity Research, Needham & Company

Okay. All right. And then is the macro stuff, I mean, is this a global issue, or is it more concentrated in the U.S., or are you seeing this kind of equally in all the regions that you're in?

Moshe Mizrahy
CEO, InMode

It's more concentrated in the U.S., yes. Because the new product that we bring to the market, we start in the U.S. We always start in the U.S. Once we get the approval, we start in the U.S.

Mike Matson
Head of MedTech Equity Research, Needham & Company

Okay. Got it. All right. And so, you know, you mentioned the third quarter, and I mean, that's when the slowdown sort of started last year. So you will certainly have easier comps. So, I mean, it seems like there's potential for you, and you've got the new systems launching. So, you know, it seems like you should be able to get back to growth. I'm not asking for guidance, but is that kind of consistent with what you're saying, like third quarter, fourth quarter, second half of the year, things should definitely be better, certainly, than they have been in the first half?

Moshe Mizrahy
CEO, InMode

Yes. Yes. I believe the third and the fourth quarter will be better than the first and the second quarter. As you know, we try to be conservative in the guidance. Therefore, our guidance is around the same revenue that we did in 2023. We did not raise it. Actually, we lowered it a little bit even in the first quarter. I'm sure that 2025, if everything will be okay following the election in the United States, if everything will be according to what Wall Street is expecting, I believe that we will see a new momentum starting.

Mike Matson
Head of MedTech Equity Research, Needham & Company

Okay. And then I just had a question sent to me about, you know, since it's on the first quarter, I'll ask it now. Can you just comment? I know you probably can't give me specific growth rates, but U.S. versus OUS, was there, you know, a difference? Did you grow outside the U.S., I guess, in the first quarter on a reported basis, you know, excluding well, I guess, you know, you gave two numbers. So I guess I'll say on a reported, you know, actual recognized revenue and then on a, you know, including pre-orders, either of those, did you grow outside the U.S.?

Moshe Mizrahy
CEO, InMode

Dollar-wise, I believe the ratio between the US and non-US is, I would say, a little bit better than 60/40, maybe 58/42. System-wise, I believe it's more like 55% ROW and 45% US. Just because we're not recognizing the full value on the system on every sales since we're selling to distributors and we recognize only the transfer price to the distributors in most cases.

Mike Matson
Head of MedTech Equity Research, Needham & Company

Okay. All right. I want to move on to talk about some product-related questions. Your U.S. installed base was just over around 10,000 systems at the end of.

Moshe Mizrahy
CEO, InMode

Yes. Yes. And worldwide installed base is 23,000.

Mike Matson
Head of MedTech Equity Research, Needham & Company

Okay. If you look at the U.S., I mean, the numbers I've seen is there's kind of around 7,000 plastic surgeons, 11,000 dermatologists. That's 18,000. Now, I know you've launched products for gynecologists and ophthalmologists, but, you know, I guess how do we get comfortable that this slowdown isn't partially driven by, at least on the kind of derm and plastic side, that, you know, market saturation or that there are just so many systems out there now that, you know, that's a factor in the slowdown, I guess?

Moshe Mizrahy
CEO, InMode

I believe that actually all the surgical equipment that we manufacture and market, everything that penetrates the skin, either BodyTite, FaceTite, even Morpheus8 up to 7 millimeters, can be used by any aesthetic doctor in his clinic. They don't have to be a plastic surgeon to do minimally invasive surgical procedures. And therefore, you're right. There are about, I would say, 10,000 plastic surgeons in the U.S. who are performing, I would say, aesthetic procedures. We probably sold to, I would say, 30% of them. All the rest is not purely plastic surgeon. It's all kind of surgeon. Of course, all gynecologists and ophthalmologists, which we started in the last two years and ophthalmologists in the last year, all of them are doing surgical procedures, which penetrate the skin or penetrate the body.

Today, even with the new minimally invasive system, it's even become easier for doctors to do it in his clinic under local anesthesia while the patient is awake and it doesn't need to go to the hospital. Therefore, I mean, we do not distinguish today between plastic surgeon and aesthetic surgeon, which can be dermatologists and also all kinds of surgeons that want to get into aesthetic. There are many of them.

Mike Matson
Head of MedTech Equity Research, Needham & Company

Yeah. Okay. Got it. All right. And then so 2023 was, I think, the second full year of sales of the Empower gynecology system. So I think you had sales around $45 million in the first year of 2022. I think last year, early in the year, you said you should grow around 20%. You know, so how did that? I mean, I'm not asking for a specific number, but did you, you know, relative to that 20% target, how did you end up doing? And, you know, do you think that can continue to see growth in 2024 versus 2023?

Moshe Mizrahy
CEO, InMode

The first two quarters of 2022, we did a 20% growth. In the second two quarters of 2022, I'm talking about 2023, sorry. The second two quarters of the second half of 2023, we did not grow. So basically, altogether, we did around $45 million of Empower, which is the women's health. System-wise, just because we introduced the system also outside the US and outside the country when we recognized the full value, system-wise, we grew about 7% on the Empower for women's health. Money-wise, dollar-wise, it was the same $44-$45 million.

Mike Matson
Head of MedTech Equity Research, Needham & Company

Okay. Got it. All right. And then you also launched your Envision system for ophthalmologists last year. So can you give us a quick overview of the system and its capabilities?

Moshe Mizrahy
CEO, InMode

Yeah. But, you know, we introduced that sometime at the end of the second quarter of 2023. And altogether, we did more than $20 million in basically six months or six and a half months of 2023. And hopefully, we will do better in 2024.

Mike Matson
Head of MedTech Equity Research, Needham & Company

Okay. All right. So, I mean, if you take that, I think the number that you mentioned and you kind of annualize that, it seems like it's following a similar path to what we saw with Empower. So kind of more like $40 million or $50 million on an annualized basis in the first year. So is that the right way to think about this, that, you know, it follows like a similar adoption curve to what happened with Envision?

Moshe Mizrahy
CEO, InMode

You know, in the U.S., there are about 40 Empower. I mean, for Empower market, it's 45 or even more than that gynecologists in the U.S. Ophthalmologists are about 18,000. So I don't expect we will do the exact number. If our target is to do $30 million a year, and if we will do that, we will be very happy.

Mike Matson
Head of MedTech Equity Research, Needham & Company

Okay. And then can you just give us an update on the dry eye feature within the Empower, sorry, Envision system? I think you were going to run a trial to try to get that cleared through the FDA. I think the product's capable of doing it, but it's kind of you can't really market it, I guess, because it's sort of off-label right now or something, but.

Moshe Mizrahy
CEO, InMode

We do not. I mean, the handpieces to do the dry eye, the Forma -I and the Lumecca-I are already approved by the FDA for every part of the body. So we cannot make the claim based on FDA approval for treatment of dry eye because we're in the middle of the study, not yet concluded. The FDA has a lot of questions and a lot of requests. But treatments are done, and we are based all our marketing based on some study that we published and we showed the doctors.

Mike Matson
Head of MedTech Equity Research, Needham & Company

Okay. Got it. All right. And then I think another new product that you launched last year was the new hands-free system called Define. So can you just talk about how that compared to the prior version? And, you know, the hands-free, I mean, that category, it's seen some really strong growth during the pandemic, but since then, it's sort of been declining. I mean, this was even before the rest of the kind of the minimally invasive business saw some headwinds. So, you know, can you get this hands-free business back to growth with the new product, or?

Moshe Mizrahy
CEO, InMode

We believe, yes. We believe that eventually, once the Define will be adopted by the market and I'll talk about the Define in a second. We will go back to the numbers that we showed before the COVID. The COVID was a different time because during the COVID, everybody wanted a distance type of treatment. And body and face, hands-free, they Evoke and they Evolve were very successful and very popular. The Define replaced the Evoke. The Evoke is only hands-free. The Define, what we did, we added Morpheus face for the platforms and also Forma. So the doctor can do a combination treatment, hands-free plus the Morpheus or the Forma, and they are complementing each other. We brought it to the market, you know, in the last quarter of last year. This is the second quarter that we're selling it in the first quarter.

So far, it's not that easy to convince the doctors to flip from the Evoke that they bought. I have to say that they were not very happy with that because only hands-free is not a solution for medical aesthetics. I mean, you cannot take completely the doctor from the loop or from the treatment. We're actually doing a lot of workshops and training, basically, to convince the doctors that the combination of hands-free plus Morpheus plus Forma, which is a bipolar RF non-invasive, this is the solution for full face treatment.

Mike Matson
Head of MedTech Equity Research, Needham & Company

Okay. So just a quick question on this. So because it includes the kind of minimally invasive, some of the minimally invasive features as well or procedures, would this when you go break out your revenue to investors, would this fall into the minimally invasive category or the hands-free category?

Moshe Mizrahy
CEO, InMode

Everything that has the Morpheus that goes to the subdermal fat, meaning up to 7 mm, yes, for us, it's surgical. It's considered surgical by the FDA as well.

Mike Matson
Head of MedTech Equity Research, Needham & Company

Okay. No, that's fine. Just so, if this to the degree that this has stronger growth, it won't necessarily show up in the hands-free category. Okay.

Moshe Mizrahy
CEO, InMode

Yeah. But yeah, no, no, no. But outside, the Define is not categorized as surgical. The Define and later on, the Evolve, the new Evolve for the body that will bring to the market with Morpheus for the body will be considered as hands-free and not as surgical.

Mike Matson
Head of MedTech Equity Research, Needham & Company

All right. Got it. And so I want to move on to your pipeline. So I think, well, we talked about some of these new platforms, I guess. So can you maybe just talk a little bit more about the three new platforms and kind of, you know, what the key improvements are versus the old platforms? And I guess, is this the first time? I mean, this seems like the first time where you've, instead of kind of, you know, launching more of an iterative cycle, I guess, where you're taking an old platform and improving on it and launching just a new version of a prior platform versus something completely new. Is that fair?

Moshe Mizrahy
CEO, InMode

Well, let's put it this way. I mean, the new platforms that we bring to the market are not replacing the old stuff, which we continue to manufacture and sell. But I'll give you the differences. Let's start with the platforms that do the minimally invasive, which means the BodyTite, FaceTite, NeckTite, which is more surgical. I mean, the original technology had one cannula going into the body, to the subdermal fat, and the second cannula on the skin. It's a bipolar. It's like a two-cannula, bipolar, the two-cannula device. What we did now, we put the two polars inside the internal cannula, and we don't have the outside cannula. So doctor can go any depth they want. Doctor can walk either pulses or continuous. Doctor can walk much faster because it's more energy, 60 watts compared to 40 watts.

So it's, and doctor can go on any part of the body without limitation. They had some limitation with the old technology of the BodyTite just because you had the two cannulas and you have to be flexible on the body. Right now, the new technology is much more flexible, and we call it Quantum. It's Quantum handpieces. That's on the minimally invasive, and this is the new platforms we call Ignite. The second platforms on the Morpheus, what we did on the Morpheus, although it's the same technology, but we added some more important features. For example, okay, you can do what we call Burst. You can do in one pulse, you can go to 7 millimeter, and then the pins will go to 5 millimeter deep, pulse again, and then to 3 millimeter, and then go out.

So basically, you do 3 pulses while you punch the skin once. And you can determine the depth. You can do 642, 753, 762, any depth you want according to the doctor, you know, setup or protocol that you want to do. In addition to that, the new Morpheus, the doctor can determine how much energy he wants to deliver in every depth. For example, he wants to deliver 50% of the energy in the maximum depth, 7 millimeter, and then only 30% when he's on 5 millimeter depth, and then 12% or 20% when he's 2 millimeter deep in order not to create any possible burn on the skin. We call it scale. So basically, we're scaling the level of energy of every pulse or on every depth.

Some kind of these type of features were added to the new Morpheus, and the new Morpheus is not you can say it's replacing. Yes. But the doctor who has Morpheus today, they can either buy it just to have the new features. They are not replacing the old one. And new doctors will buy the new one. The third platform, it's called OptimasMAX, is basically a comprehensive platform. We can do all kinds of laser, IPL, and non-invasive treatment. And in the future, we intend to develop some new laser equipment or laser handpieces like Q-Switch, Erbium-YAG, which will go on the OptimasMAX. So it's a more powerful system, basically new design, much nicer, which I don't want to say replaced an old system, but it's a new system that we bring to the market.

Mike Matson
Head of MedTech Equity Research, Needham & Company

Okay. No, that's really helpful detail on those. But I guess I'm still a little confused when you say it's not replacing, but does that imply then you're going to solve the prior versions of this stuff, or you're going to phase those out?

Moshe Mizrahy
CEO, InMode

No. No. No. No. The new handpieces will go only on the new platforms. You cannot use them on the old platforms.

Mike Matson
Head of MedTech Equity Research, Needham & Company

But the platforms themselves, like the new platforms, once you completely transition over, like you're not going to sell the old versions anymore of the platform?

Moshe Mizrahy
CEO, InMode

The new handpieces, for example, the new handpiece of the Morpheus can go on the new platforms of the Morpheus. They cannot go on the old type of the platforms. So it's not just new technology and new handpieces. It's a complete new system.

Mike Matson
Head of MedTech Equity Research, Needham & Company

Yeah. No, no. I understand that. But what I'm getting at is like, are you going to have some kind of tiered offering where, you know, you sell like if the doctor wants to, you know, the top of the line, they get the new version, but then you still sell like the older, less capable version as well on the platforms? Or is it really just this is replacing the old platform that you had?

Moshe Mizrahy
CEO, InMode

Eventually, it will replace, but it will take time. In the meantime, we have to support the old system as well. Second, in certain countries, when we do not have yet the regulatory clearances for the very new system, we continue to sell the old system until the new platforms will be regulated and get clearances.

Mike Matson
Head of MedTech Equity Research, Needham & Company

Okay. Yeah. That makes sense. So you can't necessarily transition at all immediately because of the clearances and the requirement stuff. Okay. Got it. All right. And then longer term, you know, you talked about some of the other areas that are specialties you're targeting with some of your newer products. So I think you've talked about urology and ENT specifically. So can you maybe just give us an update there and, you know, when we could maybe see something or, you know, what types of procedures you'd be targeting there?

Moshe Mizrahy
CEO, InMode

On the ENT market, as I said before, we have two studies running right now in Israel for basically opening the breathing tunnels with bipolar RF, some type of Morpheus. The study is done in two hospitals in Israel. We did not finish it. You know, when you do a study like that, it's basically to help the fine-tuning of the device by the engineering because we learn and we upgrade and we continue with the study. I believe that that study will end sometime toward the fourth quarter. We don't have a full system yet, and we don't have the regulation yet. So I assume that sometime in the second half or maybe the late first half of 2025, we will launch this product on the erectile dysfunction platforms. We do a study now in the U.S. The initial results look interesting.

Again, we don't have the final design or the final engineering. But we have no intention to bring it to the market soon because 2024, we have the new minimally invasive OptimasMAX, the new Define, and basically the new Morpheus8. I believe that's enough for the market to digest. We don't want to cannibalize the old system faster than needed.

Mike Matson
Head of MedTech Equity Research, Needham & Company

Okay. Got it. All right. And then, you know, just the mix of your business, kind of the capital versus recurring, I mean, the recurring revenue has been creeping up kind of gradually. I think it was around 16% in 2024. So, you know, do you expect that, you know, what's the outlook there? Is that, you know, just going to continue to go up a point or two per year as a percentage of your, you know, overall sales? Or, I mean, is there anything you could do to get that, you know, to be a bigger component of your business?

Moshe Mizrahy
CEO, InMode

I believe that in the first quarter was a little bit above the 16%. I don't have the final, final numbers yet because we just completed the quarter. But it's probably something like 17 or a little bit more than that. If the disposable would grow 1% every year, we will be very happy.

Mike Matson
Head of MedTech Equity Research, Needham & Company

Yeah. Okay. That makes sense. All right. And then just a couple on the international business. So can you just talk about, you know, where you're at in terms of I mean, I know you're in a lot of countries now. So are there still, you know, attractive opportunities out there, other countries that you're not in that you plan to enter? Or are you mostly, you know, just more about penetrating the markets that you're in at this point?

Moshe Mizrahy
CEO, InMode

Well, in the second half of 2023, we opened two subsidiaries, one in Germany, which cover Belgium which cover Austria as well, and one in Japan. Basically, I'm here, and from here, I'm flying to Japan. We're doing the opening on the 14th of April. We hired the people, and hopefully, Japan will start to contribute to the top line and also to the bottom line. Germany, on the last quarter and the first quarter, which was the first full quarter for them, did well, better than what we expected and better than the distributor that we had before. So it will take at least, you know, half a year to get these two countries up and running in a way we wanted to do. We also add Belgium into the French subsidiary, and we go in Belgium direct, starting the second quarter instead of distributor.

You know, we did a complete turnaround in Spain, which was not a good market for us, but we hired different people. Listen, the international market is much more complicated than the U.S. because it's, you know, 27 different languages, 27 different regulatory bodies, which sometimes become very difficult. I'm here in China. And as you know, the CFDA is the worst because they never give you a time limit, and you can wait a year, two years before they come back to you. The same AN VISA in Brazil. The international market is not so easy. But my goal, eventually, to go direct enough on the international market, so it will be 50/50 with the U.S. on dollars and 60/40 on systems.

Mike Matson
Head of MedTech Equity Research, Needham & Company

Okay. Got it. And then, you know, so you're, I think you said, you're in Beijing right now. So, you know, I wanted to ask one on China specifically. I mean, you know, what we're hearing from a lot of medtech companies is that, you know, there's a number of challenges over there between this anti-corruption effort, the kind of volume-based purchasing, etc. And then the country, you know, does seem to be having some sort of, you know, economic challenges and stuff. So, you know, just can you give us an update on your business there and what's the outlook?

Moshe Mizrahy
CEO, InMode

The biggest obstacle in China is not corruption because we are a very honest company, and the distributors that we work with here, it's a good company. I mean, I just spent 3 days with them going to doctors. The market is developing. The big challenge in China is the regulation. Currently, we have only 3 systems regulated in China. I mean, minimally invasive and the Forma and Body FX, and we're trying to get. I hope this quarter we'll get the approval for the EMS for the Tone system that we manufacture. The other system, for example, the Morpheus, is not yet approved, although it's on the process for, I would say, 20 months already. So the biggest challenge in China is the regulation. It started when the COVID started. They stopped everything. They decided not to do any evaluation, any audit on new systems because of the COVID.

They reopened what they call the CFDA only last year, and the queue is huge. Hopefully, we'll get online on time to bring more product to the market. Once we have more product, we can double, double the market in China.

Mike Matson
Head of MedTech Equity Research, Needham & Company

Okay. All right. Well, we're almost out of time, but there is one question that I've, you know, someone sent, and, you know, it's a question I have as well. And, you know, so just on the balance sheet, I mean, you have a lot of cash. The stock's been pretty weak. I know you've gotten this question before, but just want to ask about your willingness to buy back stock. And then additionally, you know, I guess, M&A, I mean, you've talked about M&A as well. So, you know, you talked about M&A a lot, but you haven't really done anything yet. So, you know, where do things stand there? Is that still the priority, or would you consider a buyback?

Moshe Mizrahy
CEO, InMode

Well, I can tell you, Mike, that we're very active on the M&A. We did not sign with one bank, but we're very active. Actually, we gave three proposals in the last nine months, and we got three rejections. I have to tell you that I understand that we will not find a company with 80+ gross margin. I understand that, especially not something which is a capital equipment or something synergetic to us. I understand that very well. But the criteria by which we judge alternatives is to be at least accretive on the EPS within 12 months. And based on this formula, we gave proposals to three companies. And we got rejection because the expectation, it's all about expectation, was very high. But we will not buy a company just because the market pushes us to buy a company.

We buy a company whether it's synergistic and it will contribute at least to the EPS. I'm not saying to the gross margin. I'm not saying to operating margin, at least to the EPS with some kind of, you know, to be creative on the EPS. So far, we're not successful. Well, I don't know what will happen in the next few months, whether we'll be successful because we're exploring more opportunities now. At the end of the day, if we will not find anything, we will have to distribute the money as dividend or something.

Mike Matson
Head of MedTech Equity Research, Needham & Company

Okay. Dividend versus a buyback? Or, I mean, do you have a preference?

Moshe Mizrahy
CEO, InMode

I believe it's better because dividend is better. You get money.

Mike Matson
Head of MedTech Equity Research, Needham & Company

I mean, like a one-time dividend or like just establishing like an ongoing dividend?

Moshe Mizrahy
CEO, InMode

We don't have a strategy yet. I believe we don't. We don't have something that we decided. The board has to decide on that. It's not my, you know you know, it's not my decision. I'm a board member, but not making those decisions. It's $800 million. I wish I can take it, but I cannot or do something with it. But eventually, Mike, it belongs to the shareholders.

Mike Matson
Head of MedTech Equity Research, Needham & Company

Yeah. Okay. All right.

Moshe Mizrahy
CEO, InMode

It belongs to the shareholders.

Mike Matson
Head of MedTech Equity Research, Needham & Company

Okay. I think we're going to have to wrap up there, but thank you, Moshe. Good. Enjoy your time over there in China.

Moshe Mizrahy
CEO, InMode

Thank you very much. Thank you. Thank you for coming. Bye-bye.

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