Let me kick off this session with InMode. I'm Matt Taylor, the U.S. Medical Supplies and Devices Analyst here at Jefferies. From InMode, we have Moshe Mizrahy, the CEO, joining us here virtually on the screen, and also Yair Malca, the CFO, here next to me. We have about a half hour for some moderated Q&A, and maybe we'll go back and forth a little bit. Moshe, let me start high level with you and talk a little bit about just the company. I want to talk about how it's evolving. I'm sure there's some folks here who may be newer to the story. Maybe just take us through kind of the arc of your innovation evolution through minimally invasive and some of the newer platforms that you have, and talk about the opportunity from here.
OK, company InMode is about 16 years old. We basically started, we're based in Israel. Currently, we started with one technology and one market, which is called radiofrequency-assisted liposuction or lipolysis, which basically replaced some type of plastic surgery without a full surgical procedure, which means entering the body invasively with one incision point on the face, on the body, on the arm, and other area. We got the first FDA in 2016, and we grew from $22 million a year up to close to $500,000,000 a year in 2023. We have right now two years of tough time because of the slow economy all around the world. In the last three years, we decided to take the technology, which is basically a bipolar RF energy, to another indication. We started with women's health, vaginal contraction, urinary incontinence.
Now we are doing a study on overactive bladder and different types of vaginal treatment, like sex dysfunction, dryness, et cetera. Later, we decided to go into the ophthalmology market as well, and we developed another platform for dry eye and some aesthetic around the eyes, periorbital wrinkles, and full face rejuvenation. We are currently developing two new platforms, one for urologists, for erection dysfunction, and also for the ENT market, sleep apnea, snoring, and turbinate contraction. Everywhere we can take procedures from the hospital and the operating room using an energy-based device instead of scalpel with the full anesthesia, we're developing the platforms and the tool to do the treatment. The company is now around 640 people worldwide. We do the development and the manufacturing in Israel. We have currently 11 subsidiaries, five in Europe, Asia. We are developing now a company in China, Canada, U.S.
Now we're establishing a company in Argentina and also in other countries in Asia. In other countries, like 90 countries, we sell through exclusive distributors. As I said, we manufacture in Israel. We have two facilities. 2024 was a little bit tough year for us because of the slowdown economy in the United States and also in Europe. 2025 is the same. We do not see the momentum started again. We took the company public in 2019. Now we are about six years public company. In August, it will be six years. With the $7 a share, it went up up to close to $70 and $80, and then it went down. Now the stock price is around $14. We hope that the momentum will start again and we will go back to a normal condition and high profitability as we used to be.
The stock will react positively to our stock in the stock market. That's in a nutshell, but I don't want to spend all the time lecturing about InMode. I'm sure some people have questions, and I'm here to answer.
Great. Let me start with a couple more. Since Yair is here, maybe we could talk a little bit about the guidance this year and some of the prospects for growth. What are the key assumptions in the guidance, and just remind us overall how you're expecting to grow this year?
Overall guidance for the year is that we expect to stay flat compared to last year, at least on the top line. This is how we started the year. Q1 was a little bit softer than what we expected. We were a few million dollars below where we wanted to be. Since it is the first quarter of the year and also the slowest quarter of the year, we decided not to touch or not to change the revenue guidance for the year. What we did change based on Q1 was the estimated profitability for the year. The EPS and the operating margin and the gross margin a bit, we did make some adjustment to those. The assumption at the beginning of the year was that the revenue mix between U.S. and all U.S.
would be pretty much similar to what we've seen in previous years, which is U.S. accounts for between 62% to 65% of the business, and the rest is all U.S. What we've seen in Q1 is that the revenue mix is actually 50/50. We see that the U.S. is facing headwinds that are stronger than expected, and Europe and Asia are actually doing a little bit better than what we expected. In fact, Europe had the record quarter in Q1. We made some changes to the guidance assumption at the profitability level and assumed that the mix will remain 50/50 for the remainder of the year. Since the fact that the U.S. is actually the most profitable region for us, that has a direct impact on profitability.
Add to that the tariffs that were imposed at the beginning of April, because most of, as Moshe mentioned, most of our products are manufactured in Israel, they are subject to those new tariffs. We expect to see a hit on the profitability. We decided to absorb the impact of the tariff. We are not going to roll them over to our customers, mainly because of the fact that our prices are fairly high to begin with. In this economy, I think it will not be the right move to increase prices even more. We are going to take the hit for that. That is the decision we made. So far, the only change we made to the guidance was on the profitability side. We are looking to see how Q2 is going to shape and look like.
Q2, from a seasonal standpoint, is supposed to be a fairly strong quarter. It's too early to say how things are going to play out. We don't see major improvements in the market yet. Unfortunately, in our business, most of the revenue is generated, especially on the capital side, in the last few weeks of the quarter, with the last few days usually being the busiest of them all. We would not know how the quarter looks like until the end of the quarter. Once we see how the quarter looks like, and then we have six months in our bag, I think we'll be in a better position to talk about guidance in a more accurate fashion.
Great. Maybe as a follow-up, could I ask, given that mix was different than what you thought, why do you think you're seeing U.S. have more headwinds and Europe seemingly picking up a little bit? What's different?
Europe and Asia. First of all, some of the measures that we implemented in Europe, we made some changes. We started going direct in Germany, made some changes to some of the country managers in some of the countries in Europe. We start seeing some of the results now. Same in Asia-Pacific. We changed the head of sales for Asia-Pacific earlier this year, as well as some other changes, like going direct in Japan. It takes some time from the moment you open a direct subsidiary until you start seeing some meaningful contribution from this subsidiary. I think now we are starting to see the results of all those changes that we've made. In addition to the fact that in the U.S., in North America, overall, we are the biggest player, I would say.
It is very hard to avoid the headwinds where you are the biggest player in the market. You are basically the market. In Europe and Asia, we are fairly a smaller player, and it is easier to maneuver and grow despite the headwinds when you are smaller in territories when you are smaller. Overall, I think this is something that also other companies are reporting, that the headwinds in Europe and Asia are not as severe as the headwinds that we see in the U.S. This is not only something that InMode is experiencing.
Makes sense. I wanted to double-click on the pipeline and some of the things that Moshe was talking about, and maybe we could roll that back into how to think about growth in future years. InMode has done a pretty good job historically of having a steady cadence of new products. Moshe, before you were talking about moving into women's health and ophthalmology. First, I wanted to get sort of a pulse check on how those businesses are doing. Maybe you could give us an update on those. Then talk a little bit more about the pipeline that you mentioned in ENT and sleep, ED, those sorts of things, and how contributory they could be and when we might see them.
OK. We basically launched two platforms, one in the women's health business and one for the ophthalmology. One thing I wanted to say, although we call it women's health, but any platform that we develop will have one specialty or special treatment for OB-GYNs and gynecologists, but other indications for aesthetic. Because we believe that those doctors are looking for private money treatment, and we're giving them the chance, since they have the client base, to use women's health indication and also some aesthetic indication. The same with the ophthalmologists and also with the optometrists with the dry eye. With the same platforms, they can do full facial rejuvenation, Morpheus treatment for wrinkles and smooth face, and IPL for pigmented lesions and others. At the end of the day, we are an aesthetic company.
The reason why we opened the market into other medical communities is because we wanted to enlarge the customer base. When we approach any new medical community, we come with at least one or two indications which are specific to this medical community. In addition to that, we're giving them platforms that they can use for some type of aesthetic. Of course, minimally invasive, it's a little bit difficult for optometrists to do, but they can use the non-invasive handpieces in order to do some treatment that they can make more money, especially private money, with no relation to any code or reimbursement. The first system that we developed, which we call M-Power, is cleared by the FDA for pelvic floor restoration and also for vaginal treatment. We're now developing two studies with different handpieces for urinary incontinence and overactive bladder.
Overactive bladder, it's a big business in the United States, especially women after two or three births. We're doing a study which was approved by the FDA in order to get the indication. It might take time. Probably it will be ready sometime at the end of 2026, but it will be on the same platforms. Therefore, doctors will enjoy some indication that they can do now and upgrade the system later on. In the first year, we sold $40 million of M-Power. That was a surprise to us. That was in 2023. In 2024, it went down a little bit, like everything else, about 20%. The same with Envision, which we brought to the market early last year. We did very well in the first year.
Now, since the market for all types of medical equipment, especially capital equipment, also went down 20% like the other portfolio, the other platforms that we sell. Regarding future indication, we're developing some new indication for existing platforms, as I said, for the M-Power. Also, we are working on some indication for the ophthalmologists. ENT, we just finished a big study which will be published soon in one of their peer-reviewed magazines on contraction of turbinates to open the breathing tunnels. That is something that probably will come to the market after FDA approval sometime at the end of 2026. The platforms that we're developing using bipolar RF, non-invasive for erection dysfunction, also will probably come to the market sometime at the end of this year. It's now being tested by several doctors in the United States. The first results are looking very promising.
These two platforms hopefully will come to the market soon. We have, as I said, 15 different R&D projects in the R&D pipeline, and we intend to release two every year. Medical platforms need regulation, need training, regulation all over the world. We are dealing with 27 different regulatory bodies, and therefore, it takes time. Not all of our products are regulated worldwide yet. The main countries which we face long-term process are China, Brazil, some countries in Asia like Korea. The new MDR code for medical equipment in Europe makes it more difficult for regulation. We know how to do it. We have a regulatory team in Israel, and we are using in every country some consultant. It takes time, but we need patience. We are relatively resourceful. Currently, we have close to $500,000,000 in the bank.
We have to wait and see what will happen in the market and how fast we can get additional regulation.
OK, great. Maybe just one area I'm very curious about. You mentioned the OAB, and you're running a study there. Could you give us an update on that? Where are you on the study? When could that read out? What are kind of the early results telling you about the results in OAB?
Preliminary results on two studies which were done in the U.S. by Dr. Mickey Karam and in Colombia indicated very, very promising results. It was already published. There are some publications which were accepted by peer-reviewed and published on 32 patients, U.S. and Colombia. One treatment, one treatment, 15 minutes every treatment with basically Morpheus V up to 7 mm depth. We see good results. Based on these preliminary results, we filed what is called pre-submission or IDE with the FDA. The study was approved. We're now basically opening eight sites in the United States to do the study. It's a study with six to nine months follow-up. If we start to do the study this year, it will probably end up sometime in 2026. I don't know how long it will take with the FDA to get it approved.
We are very encouraged by the results and the process.
OK, great. Maybe I'll switch gears a little bit. I did want to ask you about some recent letters that you've received because the company did put out a press release in an 8-K, I believe, in response to some feedback from shareholders who were talking about capital allocation and wanting you to buy back more stock and just asking questions about management and the field management, field force management in North America. I guess the two questions I'll ask you is, number one, could you talk about the current state of the North American Salesforce? How do you feel about them? Are there any gaps? Maybe you could just review how you plan to allocate capital from here, given you have already repurchased a lot of shares. Are you going to continue doing that? Maybe look to do more with internal investment or M&A?
Let me start with the U.S., OK? That was your first question. I will continue with the capital allocation. Basically, in the United States, we used to have a President for North America. The President for North America, you know him, Shakil. You met him more than once. He was responsible for the entire U.S. and Canada, which at the time was around 70% of our business. I decided that to have one guy responsible for 70% of the business, I'm talking about sales, not development or manufacturing, et cetera, is too big. Therefore, we need to divide the territory. We divided the territory into three sub-territories. Canada is a country by itself with self-regulation, different than the FDA. For me, it's like Italy, Spain, Korea, and other countries with the same level of sales.
Therefore, Canada has a Managing Director report directly to me. The United States is divided into East and West. There are two Vice Presidents of Sales. One is responsible for the East and one responsible for the West. Both of them currently report to me. OK? I feel this is better because I spend every month at least one week in the U.S. working with them. We are doing some changes in the organization. For example, right now, we try to get a group of salespeople specializing in one or two platforms, and not everybody sells everything. I hope that when the slowdown in the U.S. will end and we will see some new momentum, I hope that this will work better. It seems like.
Regarding capital allocation, I'm sure you know that in the last two years, we actually bought back stock for $508 million, which I believe it's a lot of money, even for a small company like us. Basically, we bought back 30% of the shares. Now, there is one tax rule in Israel which allows us to buy 10% of the outstanding shares every year without paying dividend tax. That's what we did in the last two years, actually covering three years of 10%. Now, if we decide to buy more shares in 2025, we will need to pay 20% tax. I'm not sure the shareholders will like it. Maybe. There is at least one shareholder from a fund called Duma who believes that we need to do a tender offer and buy an additional 30% of the shares.
If we will do that, we will lose the opportunity to do M&A when the opportunity will present itself. Therefore, currently, all the options are on the table. Continue buying shares and pay 20% dividend, wait until January 2026 and buy another 10% without paying dividend tax, or use the money to do acquisition. I believe we discussed it in the past. Regarding M&A, we gave two proposals, official proposals to two companies to acquire. Both of them are in the injectable business. One is toxin, the other is filler. Apparently, it was not accepted. Maybe the price was too low. We cannot buy a company just because we need to do an M&A. We cannot find companies with 80% gross margin. Therefore, we need to be very selective here. I'm not saying we will not do more buyback. We probably will.
The question is whether to do it in 2025 or to do it in 2026. Now, regarding the letters that we're getting from Duma, there are some letters that he sent privately and two letters publicly. We basically sent him a public response twice. He wanted us to move the production from Israel to other countries in order to save a few cents on the manufacturing cost and improve the gross margin. We explained to him more than once that that cannot happen because we're not a mass production company. We have to manufacture the product according to regulatory rules. Every country is different. Therefore, we're manufacturing in small batches. We need the manufacturing close to the engineering and close to the development team. He kept saying it over and over again.
I do not know how many companies he managed in his life, but probably not industrial companies. Regarding the buyback, we told them, listen, look at the numbers. $508 million in two years. That is a lot of money. Apparently, it did not help the stock move up, unfortunately, unfortunately for the shareholders and unfortunately for me and for the management. We are doing everything we can in order to improve the business, which we believe is the most important factor in order to start seeing the new momentum.
I think that this is what's most important here. To keep in mind that we have a very strong management, which has proven its execution abilities over time. Aesthetics sometimes is a cyclical space. We've seen it during COVID. I think everybody needs to understand that InMode is the strongest and the most profitable company in this business. No one knows how this slowdown is going to play out. However it's going to look like, I think we are going to come out of it stronger on the other end of it. We have the resources. We have the technology. And we have the execution team in place to take us through this period.
Maybe I'll ask a couple of final ones. We only have about a minute left. One question that was kind of sparked by your comment is we have seen other aesthetic companies really struggling. I would imagine that this could be an opportunity for you to pick up some talent and maybe some new accounts. Is that helping you today? Is that a tailwind as we look into next year?
Again, I don't want to call it a tailwind, but definitely, once the economy starts improving, the fact that we might have less competition, not all of them will survive, I can tell you that. That definitely would help us then. Yes, we are picking up some talent from some of the companies that are struggling at the moment. As I said, once the economy starts improving, then we should expect to see a tailwind then.
All right, very good. Maybe last one. Just conceptually, help me understand, because we've seen a couple of tough years. Your business has rebased a bit. Let's say the environment does not improve at all. Would you actually grow in 2026, or do you think it would still be sort of flattish?
That's a very good question. It depends how the rest of the year would look like. If the economy is going to remain pretty much the same, maybe we would be able to grow. If things would get tougher, probably not. No one knows. Really, no one knows.
OK, great. I think we're out of time. Moshe, thanks for joining us virtually. And thanks, everybody, for your interest in InMode.
Thank you very much.
Thank you very much for having us.