Integrum AB (publ)

Hello and welcome to today's webcast with the Intergrum, where CEO Mark Milsten and CFO Jørgen Svansten will be presenting. After the presentation, there'll be a Q&A. So if you have any questions, please submit using the form on the right. And with that said, please go ahead with your presentation.

Thank you, Martin. Yes, my name is Martin Hilsten. I joined Integrum early May this year as the new CEO. And next to me is Jørgen Svanström, our CEO. We will hold this presentation for you this morning. Welcome, everyone. So just a quick recap of what Integrum is all about. We are a Swedish company located in Gothenburg. We are commercially active in US and Europe and Australia. 35 people working here in Gothenburg and about 12 people in the US 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 in the 60s here actually here in Gothenburg this company integrum was founded in 1998 and was CE marking the opera system in 1999 and what we're working with today is the opera system and we have the DE marking and the MDR certificates and we also have the PMA for US which was launched in 2020. So US our main market but we are also in Europe and Australia. As you can see the Scandinavian countries, UK, Benelux, Germany or the Dutch 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 US and Europe and in the US and Europe alone. about 350,000 amputations are performed every year. And in the US, about 120,000 are transfemoral amputees, which is our main patient group in the US. So the OPERA implant system, the OPERA is the abbreviation of Osseoanchored Prosthesis for Rehabilitation of Amputees. And the opera 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, FDA PMA approval is the transfemoral, the above knee indication. So the opera system is basically a fixture. It's an implant which is placed in, in this case, in femur. And on top of the fixture, we're placing an abutment. And on the abutment, we are placing the opera axor device, which is the connector between the opera system and the prosthesis, which can be supplied by different suppliers. So our patient centric team approach, we have talking to the market about our go to market strategy with centers of excellence with the patient in the center and we working together with the hospitals, with the surgeons. We are working together with the CPOs, which is the prosthetist who have a daily contact with the amputees. And obviously our R&D team here in Gothenburg at the tech room and all the community that holding these entities informed and what kind of products we can offer them. So what we. trying to do is improve the quality of life for this patient group and improved inpatient quality of life, elimination of socket-related problems, which is the main issue for transfemoral amputees, enhancing the osteoporosis and embodiment, which means actually the connection between the prosthesis and the body, which is linked to Improved mobility and range of motion. Ease in attaching and detaching the prosthesis, which is a major issue and the Axra device makes it very easy for the patient. Improvement and ability to perform activities of daily living. So this quarter, Jørgen will go through the numbers for this quarter. But in general, we have a positive sales performance, especially in the US. And this is something that we focus strongly after the strategic shift earlier this year. Increased use of the OPERA 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 Jörgen 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 23.8 million SEC 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 at the graph to the left, you can see that there's 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 US, we have a growth of 41.2% in SEC, ending up at 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 uh the gross margin is 81 so uh basically like uh like last year's quarter corresponding quarter and uh i think that well the difference is uh mostly very much mostly because of tariffs really and our exports to the us EBIT 11.1 million negative. That number also includes 2.0 million SEK 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 12.4 million SEK in comparison to 29.3 plus last year in the corresponding quarter. But we have to remember that that quarter also included a share issue of a nominal 50 million SEK. Well, and that gives us a cash balance of 27.2 million in comparison to last year's 46.2. Looking at the S1 surgeries, we started six 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 US, we have 27 S1 surgeries in quarter one 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 10% year-on-year growth of S1 surgeries. And of course, a little bit more in the US than since we did a few less S1 surgeries in EMEA APAC in this quarter. Yeah, so with that, I conclude the numbers presentation and hand over to you, Morten.

Yeah, 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 US grew 41% organically and now represents the majority of revenues. How sustainable is this growth trajectory and what steps are taken to maintain this momentum in this market?

So, yeah, thank you for the question. As we all know, as we presented before, the US market is our main market and also the fastest growing. We're not guiding on top line, but 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 markets and we believe that the growth will continue. I will not guide on any percentage or size or numbers, but what we're doing, we believe, is the right thing right now.

Yeah, 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. Yeah, it's an open position right now. So, I mean, that will also have an impact, we hope.

Thank you for that answer. 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 effects?

Yeah, of course. Of course, I'd say that one of the main problems is that it's a little bit uncertain 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 US government that will exclude our products from tariffs, the only way to get around it is to investigate production in the US.

Yeah, to conclude that we're looking into different to take different measures to mitigate the tariffs and the impact for their own 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 thank you for that answer you mentioned streamlining reimbursement processes in the u.s what progress have you made so far and how much of a barrier is the reimbursement for adaptation for the oprah implant system um yeah it

So reimbursement is about financing the actual procedure and the products going into the patient. So when it comes to reimbursement and codes, Jörgen, you know the details about OPERA, the AXOR, etc.

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 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.

It doesn't specifically say, it's more of a how much of a barrier is reimbursement for adaptation of the opera implant system? That is pretty much the question.

Yeah, 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.

you thank you for that answer move on to the next question here a total of 41 s1 procedures were conducted this quarter 27 of them in the us what is your target for procedure growth over the next 12 months both in the us and also internationally yeah as mentioned before we're not guiding on s1s nor top line but our strategy is

to grow and we setting up the organization to grow the business. So, yeah, we're looking at our ambition is to grow as once and top line, but will not guide how many as once that we looking in the coming 12 months. But the growth plan, we are following the growth 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 US.

Thank you. And beyond the US, which markets hold the greatest near term potential for Oprah implant system adoption? And what's the strategy to penetrate those markets?

good question um 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 footprints and obviously having each market evaluated in terms of cost

opportunity and margins but we will not go into details for the operations doing that what we're doing right now you've signed the new distribution agreements in that 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.

Thank you. We'll 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?

Yeah, this gecko agreement, the legacy sponsorship is a three year contract and we'll start with the first gecko meeting in November in Charlotte, North Carolina. And this is a way for us to increase our footprint in this segment and Yeah, increased visibility for opera system, FNL, really, really good alternative for the conventional prosthetist and to 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 why we're doing it.

Okay. Thank you very much, Martin and Jørgen. That concludes the Q&A section here. Thank you also both for presenting and answering all of our questions. And thanks everyone who tuned in to this presentation with Integrum. Have a great rest of the day. Thank you.

Thank you. Thank you for joining.