Integrum AB (publ) (INTEGB) Earnings Call Transcript & Summary

Hello, and welcome to today's webcast with Integrum, where CEO, Martin Hillsten; and CFO, Jorgen Svanstrom, will be presenting. [Operator Instructions] And with that said, please go ahead with your presentation.

Thank you, Martin. Yes, my name is Martin Hillsten. I joined Integrum early May this year as the new CEO, and next to me is Jorgen Svanstrom, our CEO. We will hold this presentation for you this morning. Welcome, everyone. So just a quick recap what Integrum is all about. We are a Swedish company located in Gothenburg. We are commercially active in U.S. and Europe and Australia. 35 people working here in Gothenburg and about 12 people in the U.S. office in Boston area. We are listed on First North, as you probably know, and we founded in 1998. Next. Our vision is freedom of mobility for every person and our mission, to transform the lives of people with mobility challenges with cutting-edge solutions, today and tomorrow. So this technology is actually driven from the first invention of the dental implants and the osseointegration founded in the 60s, actually here in Gothenburg. This company, Integrum, was founded in 1998 and was CE marked in the OPRA system in 1999. And what we're working with today is the OPRA system, and we have the [ CE ] marking and the MDR certificate, and we also have the PMA for U.S., which was launched in 2020. So U.S., our main market, but we are also in Europe and Australia. As you can see, the Scandinavian countries, U.K., Benelux, Germany or the DACH area, Israel, Slovenia and Ukraine, as you probably have heard of. So we are working with amputees and changing the lives for those people. And about 3.9 million people living with amputees, limb loss, in the U.S. and in Europe. And in U.S. and Europe alone, about 350,000 amputation are performed every year. And in the U.S., about 120,000 are transfemoral amputees, which is our main patient group in the U.S. So the OPRA Implant System, the OPRA is abbreviation of Osteoanchored Prostheses for Rehabilitation of Amputees. And the OPRA system for Europe for the CE mark under the MDR regulation is transhumeral, above elbow. We have thumb and fingers; and we have the transfemoral, above-knee amputees. And for the FDA PMA approval is the transfemoral, the above-knee indication. So the OPRA system is basically a fixture. It's an implant, which is placed, in this case, in femur. And on top of the fixture, we're placing an abutment. And on the abutment, we are placing the OPRA Axor device, which is the connector between the OPRA system and the prosthesis, which can be supplied by different suppliers. So our patient-centric team approach, we have been talking to the market about our go-to-market strategy, with centers of excellence, with the patient in the center, and we're working together with the hospitals, with the surgeons. We are working together with the CPOs, which is the prosthetist. We have a daily contact with the amputees, and obviously, our R&D team here in Gothenburg at Integrum, and all the community that holding these amputees informed and what kind of products we can offer them. So what we -- I'm trying to do is improve the quality of life for these patient -- for this patient group and improvement in patient quality of life; elimination of socket-related problems, which is the main issue for transfemoral amputees; enhancing the osseoperception and embodiment, which means actually the connection between the prosthesis and the body, which is linked to improve our mobility and range of motion; ease in attaching and detaching the prosthesis, which is a major issue, and the extra device makes it very easy for these patients; improvement in ability to perform activities of daily living. So this quarter, Jorgen will go through the numbers for this quarter, but in general, we have a positive sales performance, especially in the U.S., and this is something that we focused strongly after the strategic shift earlier this year; increased use of the OPRA Implant System, so we are increasing the numbers of surgeries, the S1 number that we have communicated before; and we also have increased visibility in a growth industry, so we are improving our footprint in the osseointegration prosthesis environment. Next one. So I'm handing over to Jorgen to go through the numbers for our last quarter.

Thanks, Martin, and hey, everyone. Good to be back and presenting again. If you look at net sales, we end up at SEK 23.8 million for the quarter, which is a growth of 28.9% over the last quarter -- the corresponding quarter last year. I think it's important to mention, if you look to the -- at the graph to the left, you can see that there is a slight or not so slight maybe, but there's a seasonal effect in Q1 for each year because of summer, really. And so reflecting on that and looking at this number, we have done much better this Q1 than any other Q1 in the preceding years. And also, looking at the U.S., we have a growth of 41.2% in SEK, ending up at SEK 19.3 million for the quarter. Looking at the dollar value only, the growth is 56%. So a real growth there. The gross margin is 67% for the quarter as we write about. If you look at only direct material and commission -- sales commission, the gross margin is 81%. So basically, like last year's quarter -- corresponding quarter, and I think that -- well, the difference is mostly -- very much mostly because of tariffs really and our exports to the U.S. EBIT, SEK 11.1 million negative. That number also includes SEK 2.0 million provision that is related to the public offer that is currently under an acceptance period. So in operating terms, I'd say that it's an improvement over last year's quarter there as well. Cash flow, minus SEK 12.4 million in comparison to [ SEK 29.3 million plus ] last year in the corresponding quarter. But we have to remember that, that quarter also included a share issue of a nominal SEK 50 million. Well -- and that gives us a cash balance of SEK 27.2 million in comparison to last year's SEK 46.2 million. Looking at the S1 surgeries, we started 6 months ago showing our S1 surgeries as we think they are the strategic sales that we need to show you also how we are doing operationally. And looking at the U.S., we have 27 S1 surgeries in quarter 1 in comparison to 20, last year's same quarter. And in EMEA/APAC, we have 14 over 17 last year. That gives us a total of 41 S1 surgeries over 37 surgeries last year, and that means a 10% year-on-year growth of S1 surgeries. And of course, a little bit more in the U.S. than -- since we did a few less S1 surgeries in EMEA/APAC in this quarter. Yes. So with that, I conclude the numbers presentation, and I hand over to you, Martin.

Yes, thank you. It's very nice to see that the S1 are growing and the top line is also growing. So Martin, leaving over to you for questions coming in from the audience.

Thank you very much for that presentation. And yes, let's open up the Q&A section here. We'll start with the first one. Sales in the U.S. grew 41% organically and now represents the majority of the revenues. How sustainable is this growth trajectory, and what steps are you taking to maintain this momentum in this market?

So yes, thank you for the question. As we all know, as we presented before, the U.S. market is our main market and also the fastest growing. We are not guiding on top line, but in the strategic shift we had earlier this year and the plan and the tactics that we're now executing seeing that we have traction in the market. And we believe that the growth will continue. We'll not guide on any percentage or size or numbers, but what we're doing, we believe, is the right thing right now.

Yes -- excuse me for cutting in. But I mean, we hired a sales rep late last year and are looking for another one as well.

We are. Yes. It's an open position right now.

So I mean that will also have an impact, we hope.

The gross margin declined from 81% to 67%, largely due to tariffs. What is your outlook on margins going forward? And are you exploring ways to mitigate the tariff mix?

Yes. Of course. I'd say that one of the main problems is that it's a little bit uncertain if the tariffs will -- how long the tariffs will remain. So you have to factor that in when taking any measures. But of course, for everyone exporting goods to the U.S., if there are no provisions from the U.S. government that will exclude our products from tariffs, the only way to get around it is to investigate production in the U.S.

Yes, to conclude that. We're looking into different -- to take different measures to mitigate the tariffs and the impact for the overall business. As mentioned, the U.S. is the biggest and most important market right now. So it will affect us definitely. So we're looking into that.

You mentioned streamlining reimbursement processes in the U.S. What progress have we made so far and how much of a barrier is the reimbursement for adaptation of the OPRA Implant System?

Yes. It's -- so reimbursement is about financing the actual procedure and the products going into the patient. So when it comes to reimbursement and codes, Jorgen, you know the details about OPRA and the Axor, et cetera?

Yes, yes. For the Axor, we do have a reimbursement code for the Medicare way of getting reimbursed. And we are also exploring through other channels to just get the correct sort of codes so that CPOs, I mean, can get reimbursed as well in a good way. But then I'm not sure if the question is about that or if it's about the insurance companies and how they reimburse -- the other insurance companies and the other products. So if we can get clarification, maybe, yes?

It doesn't specifically say. It's more of how much of a barrier is reimbursement for adaptation of OPRA Implant System, that is pretty much the question.

Yes. I mean, I think long term, it's not much of a barrier, but it can sometimes create short-term problems that will sort of move surgeries and procedures because people have to solve that issue, but we are getting better and better at it. So I don't think that's a huge barrier right now.

Move on to the next question here. A total of 41 S1 procedures were conducted this quarter, 27 of them in the U.S. What is your target for procedure growth over the next 12 months, both in the U.S. and also internationally?

Yes. As mentioned before, we're not guiding on S1s nor top line, but our strategy is to grow, and we're setting up the organization to grow the business. So yes, we're looking -- our ambition is to grow S1s and top line, but we'll not guide how many S1s that we're looking in the coming 12 months. But the growth plan -- we are following the growth plan. And as you can see, with the numbers presented here today, things that we are doing are pointing in the right direction, and we will also improve the sales structure, especially in the U.S.

Beyond the U.S., which markets hold the greatest near-term potential for OPRA Implant System adoption and what steps are you taking to penetrate those markets?

Good question. The commercial approach is very important to us. And we're not going to detail which market that we are looking into right now, but we are expanding our commercial footprint and obviously, having each market evaluated in terms of cost, opportunity and margins. But we will not go into details for the operations doing there -- what we're doing right now.

You've signed new distribution agreements in Slovenia and the Ukraine. How important are such niche partnerships in your global growth strategy, would you say?

Well, that kind of agreements, we have communicated all the surgeries that we are performing in Ukraine. And that's a very important partnership, especially when it comes to volume. And also the digits of thumbs and fingers in Slovenia is also growing. And that kind of agreements and alliances is part of the strategy that we have, and very important to us.

Well, let's take one last question here. Becoming a legacy sponsor of the GCCO strengthens your visibility. How do you measure the impact of such initiatives on adoption, brand positioning and ultimately, revenue growth?

Yes. This GCCO agreement, the legacy sponsorship, is a 3-year contract, and we'll start with the first GCCO meeting in November in Charlotte, North Carolina, and this is a way for us to increase our footprint in this segment and increase visibility for OPRA system as a really, really good alternative for the conventional prosthetics. And it actually increase both impact for surgeons, for patients, for patient groups, for CPOs. So this is a good arena for us to be at and also control that kind of venue. So that's what -- why we are doing it.

Okay. Thank you very much, Martin and Jorgen, that concludes the Q&A session here. Thank you also both for presenting and answering all of our questions. And thanks, everyone, who joined today's presentation with Integrum. Have a great rest of the day. Thank you.

Thank you. Thank you for joining.