Harbor Health Care ETF Price & Performance (MEDI)

Now it's close to 30%. Also, EMEA is keeping the pace for the year. With almost 11% growth for this quarter. While Asia Pacific continues to be down. This quarter at 24%. Looking at the EBIT ending at $25,800,000 that is a 16% growth over the same quarter last year. Still, the margin is on the lower side at 17.1%. And this is very much driven by an extremely high activity level in the fourth quarter. We did launch the new Intuis software with several launch events and projects connected to that launch. We also arranged the European cardiac meeting with the distributor meetings and other events in Lisbon this quarter. We sponsored the International Coronary Congress meeting in London and had also a big presence there. We arranged a Capital Markets Day in London and we also had some expenses now coming in from the PATEN study. When we then move on to looking at 2024 as a whole, we are reporting SEK 562,600,000.0 in revenues, so that is a 6.9% increase. Currency effect is again quite modest. Meaning that the currency neutral sales development is at 5.4%. And the third party product portfolio have really performed extremely well all through the year, ending at 13% growth.

And we're still seeing then a softer development in our own product sales ending at 3.9%. However, I'm very happy to see double digit growth from The Americas, which is really [indiscernible] where we want to see it. Also, I think EMEA is delivering very impressive 8% growth for the year. And Asia Pacific, as we have seen, continues to be down. For the year, it's actually a bigger contribution or effect of softness in Japan and not so much related to the transition that we had gone through in China, where we had gone from distributor supported sales model to a direct presence in China. Looking at the EBIT, we are ending at SEK 131,000,000, so that is the same level as last year. And that, of course, takes the margin down to 23.3%. And to summarize this, while The Americas and the EMEA show really solid sales development, it is the APAC sales challenges that or the decline in the sales in APAC that is challenging our margin. And that creates this effect since we are continuing to invest in our business. We do have higher operating expenses now from this direct market, China, Canada and Sweden. We have over the time strengthened our R and D and product innovation teams.

We have been launching the Intuit software, in particular with high expenses in the fourth quarter. And we're also investing in key clinical marketing studies. In summary, medicine continues. [indiscernible] deliver profitable growth showing solid cash flow and also have an optimistic outlook for 2025. So the Board of Directors are suggesting a dividend of NOK6 per share. And with that introduction, I will leave the word to Thomas. Thank you, Gary.

Good morning, everyone. I will go straight to the P and L and our numbers. As usual, Kari will take us through sales figures in regions and product splits. So will not go into that detail when I go through the P and L. But to explain the change in gross margin, that means cost of material and cost of goods. We have a margin improvement of 3%. And the reason for that is that we increase more on our own product sales versus third party, even though third party is also on the double digit end. Third party is only 15% of the total revenue and therefore we get a an improved margin when 85% of sales is with a better gross margin. And therefore, the percentage increase in gross profit. Salary and social expenses increases Kari mentioned Americas up 30%. And of course, with this growth in sales, commissions to sales reps increases. We also have more employees in this quarter compared to last quarter, so that adds to expenses. And last but not least, general adjustments in salaries explains the increase in the fourth quarter versus third fourth quarter last year. Karim mentioned the high activity level when it comes to other operating expenses.

And don't need to repeat that other than I'd just like to add and Karl will talk more about this later on with the change in the commercial operations. And And with this change, we also had some one off recruitment [indiscernible] EBITDA ends up with €3,000,000 for the quarter Depreciation is down €500,000 And obviously, some assets are fully depreciated. Operating profit, up 16% or 3,500,000.0 net finance positive with SEK $2,500,000 That leaves us with a pretax profit of $28,300,000 and profit after tax, up 11%. Ends at 21,300,000.0 which is the same top line growth 11%. For the year, when it comes to the margin, kind of the same explanation, although our third party products increases with 13% for the year in our own products in NOKs, increases 5.8%. Since third party is a smaller portion of the total, we are able to improve margins percentage point. Salary and social expenses, the direct initiatives in Sweden, Canada, China increases expenses, but also we have an effect actually of the the introduction of double shift in pro production. We initiated that in 2023, so we had expenses related to it, but it wasn't fully operational with with all the new employees on from to the second shift before the beginning of the third quarter.

So therefore, we have a full year effect of that. All these things also explains why other expenses increases in addition to what's already been mentioned for the fourth quarter. EBITDA ends up of €400,000 for the year, so it's more or less on the same level as last year. Have a slightly higher depreciation expenses compared to 2023. And operating profit ends €400,000 below last year or more or less the same, 131,000,000 or €100,000 and an EBIT margin, which is which is slightly down from 25% to 23.3 Financial net finance is posted by €3,200,000 Financial income is basically interest rate, but also gains realized and unrealized gains on foreign exchange Net or sorry, financial expenses is only related to realized gain realized or unrealized losses on foreign exchange. Pretax profit ends at SEK124.2 million and profit after tax same as last year, dollars 103,800,000.0 If you look at the balance sheet, intangible assets increases, there are two reasons for that. We had two major development projects. One is the Intuis software project, which we will talk more about later. But also the project related to increased efficiency within pro production. Fixed assets increases, this is related to an extended lease at the main office with five years.

Inventory levels are increasing and higher than what it was by the end of last year. However, we're down from the peak we had in by the end of the second quarter. So in the second quarter, we ended at €164,000,000 Now we're down at 160,500,000.0 Although revenue increases, risk customer receivables reduced That means we have a good and effective cash collection. And as you can see, solid cash position ends at €179,200,000 by the end of the year, which is improvement from last year's 152%. Strong equity increases from 100 and SEK one hundred and thirty six point six million euros The increased long term liability is related to what I just mentioned when it comes to fixed assets and that's the lease added lease obligation related to offices head offices here in Oslo. Some key figures. Earnings per share increases this quarter since we have a better profit for this quarter compared to last year. However, for the year, we end at the same level, $5.67 per share. The change in equity and the reduction We do have an increased total balance sheet, and there's three major reasons for that. One is the development projects that we went through when we looked at the balance sheet and also the increased lease obligations and also increased inventory levels.

Cash flow, solid cash flow, cash flow operation, increases from €115,000,000 to €141,500,000 Cash from investments is related to our product development, EUR18.6 million is related to that and another EUR4 million is related to to outplacement of systems in The U. S. A, the so called lease or PPP solution. Cash flow from financial activities, 82,000,000 is related to dividend and the rest is cash from lease activities. All in all, very solid cash position. We end at hundred and €79,200,000 which is very comfortable for us Thank you very much. And with that, I leave the word to Kari.

Okay. So we will dig into the various aspects of the business, starting with looking after development of our flow and imaging systems in units. So we can see here that we have a a softer quarter going down from the fourth quarter last year. Five less units sold, but Americas is up by two units, which is encouraging. EMEA is also up by four units and we see that is Asia Pacific that is taking this down this quarter, much related to weaker imaging sales to Japan. And for the year, is also Asia Pacific that is driving the number of imaging systems down. Then it's interesting to see that we see a somewhat upward trend in imaging probe sales over the past four quarters. And Americas up by five units this this quarter. EMEA is also up by four units. Again, Asia Pacific is [indiscernible] So the increase here is also speaking to utilization of the imaging technology out there. Looking at our flow only systems in units, so this is at the same level as fourth quarter last year. [indiscernible] It's indicating some recovery from past quarters. Americas up four units, while both EMEA and Asia Pacific is a bit down for this quarter.

For the year is again Asia Pacific that is driving the number of imaging systems down. Flowproves in units for the quarter, it's a modest 1.6% growth, but looking at the year in full, it's actually 55.6% growth. And this is coming despite we see a lower unit sales of systems. So that really speaks to robust utilization amongst the current users and customers. And again, very happy to see a significant up 23%, while the other regions for the quarter is a little bit down. Going further into the territories here, so Americas, €61,700,000 in sales in the fourth quarter €237,200,000 for the year. Currency neutral, up almost 30% for the quarter and about 10%. For the year. So this is a performance that we like to see from our biggest growth contributor It is also encouraging to know that both Canada and Latin America, which are smaller parts of Americas, but they are still both contributing very positively to the overall result. Looking a little bit closer into the performance in The U. S. A. In isolation. So we see for the quarter significant improvements in capital sales, of systems both for the quarter and for the year.

And this is something that we have seen been quite weak through 2023 and also in the beginning of this year. And we have attributed this tendency as a consequence of the what we call the macroeconomic headwinds with high inflation and so on. And a more conservative approach to purchasing new technologies. If we look at the number of procedures, we do see that the total number of procedures sold is flat for the quarter and for the year. But the flow procedures from capital accounts are growing for the quarter at 6.6% and for the year at 5.6%. This is very promising and we saw of course, related to the increase in capital sales as well. And then we can see that the number of procedures coming from our PPP or lease accounts is going down. It doesn't necessarily mean that we're losing cost customers. New customers, they tend to be capital accounts. That's one factor. And we also see that some of our current PPP and lease customers tend to convert to capital when their agreements expire. For the quarter, we also see good growth in number of new customers, 10 and also 26 new customers for the full year.

So a very positive development from The USA. Asia Pacific as mentioned several times now, it is weaker than we saw in the same period last year, both for the quarter and for the year. And as we have mentioned several times now, the growth for the year has been challenged quarter by quarter. From exceptionally high system sales to our distributor for China prior to Medisin going direct in the second quarter in twenty twenty three. So this has been a significant effect. We have seen that this effect is becoming smaller and smaller, and that is very promising. And we have much better visibility, of course, into the the inventory states at our local distributors. And are looking now forward into 2025 with optimism. When it comes to Japan, we have seen very weak sales to the distributor in Japan for the year. And while we cannot identify any less interest from Japanese customers or any particular trends that can explain this. We are actively collaborating with our distributors here to really understand market dynamics. And of course, we're evaluating strategies to optimize the business there. So we will continue to report back what is happening in Japan.

EMEA has had a very strong year. Revenues up 10.9% for the quarter, 8% for the year. And also very encouraging to see that this growth is coming from our direct markets, especially Spain and Germany and also Sweden. Has had a great year. And in total, they have shown a growth of almost 20% for the year. Our third party products sold in Norway, Sweden and Denmark were also have had a very strong year ending at 13% growth. This is a highly diversified product portfolio with some larger agencies that is contributing a lot, but very good performance from from most parts of this portfolio. So this summarizes the regional performance revenue. Here, I just want to point to the quarterly development in China because this is our own organization, our direct operation in China for the quarter delivered €14,200,000 in sales, So that's close to €16,700,000 that was delivered last year. And then I can mention that there was some minimum commitment from the local distributors in China, which was also contributing last year. So just showing that the performance from our local team is is absolutely decent and promising going forward. When it comes to Japan, as I said, it's been weak and 49.7% down for the year says all about that.

At the same time, we're seeing some type of recovery in the fourth quarter. We mentioned this in the third quarter as well that we had reports on a stronger pipeline of project for the fourth quarter. And Japan is then delivering closer to a normal performance. So it will be very interesting to see how this develops going forward. Looking at the split between cardiac product and vascular products, We see that the vascular growth is very low for quarter, but ends at 15% for the year. And now the vascular portfolio makes up 19% of the total sales of own products. So steadily growing the portion of ASEK sales year by year. When it comes to the split between flow and imaging products, As we will recall, imaging has really been growing very highly over several years, but had a setback in 2023 and also for the most part during 2024. This quarter, we are seeing a little bit improvement with 10% growth in our imaging portfolio. Still, we are a little bit down for the year. But there is no again no signals from customers that the interest is decreasing. And we do believe that the sales of this product will pick up as we are moving forward.

And we are keeping track on the contribution from sales of probes and PPP cards and lease agreements, what we call recurring revenues. And for 2024, that ends at 73.7% on the total. To our strategy and our recent activities to implement this strategy. As you will recall, we have a strategy that is adapted to the various geographies and market completions. So typically in markets where we have very strong penetration with [indiscernible] Our strategy is to focus a lot on converting that installed base to imaging. Then in markets where we have lower penetration, it's very much about marketing and also product innovation for ease of use to really get new potential customers and users intrigued by the technology. And really wanting to get on board In emerging high growth economies with the more price sensitivity, we also want to be flexible when it comes to pricing and that also Yeah. Developed a specific solution of our technology to fit better. So this is also part of our strategy. And vascular. So we for all around the world, we want to build our position in the vascular surgery field. And last but not least, as we are strengthening our position in many markets, we will continue to go direct in more countries going forward.

So starting now with some comments around our activities for product innovation for ease of use. To explain a little bit also how we're thinking about product innovation, Some years ago, we established what we call an external innovation team, which is a small team of engineers innovators, which are working very closely with our customers. And being responsible for proof of concept testing and piloting. And this was arranged in order to have a much more rapid testing and avoid that we are putting well, let's say bad ideas into the formal product development process, which is much more both costly and more stringent. So this is part of the reason why we have increased the OpEx also from R and D and from innovation. Looking forward, innovation, well, we started as an innovator in the mid-90s. With launching the first flow meter, the CardioMed, and we have come out with several generations of the equipment since then. Then in 2010, we also launched the high frequency ultrasound imaging, which was really a new paradigm with the VIRQC. And then the MiRQ took over in 2014, and we are developing the next generation But going forward, we should all expect concentration on digital innovation.

And in December, we then launched the Intuis software platform, and this is the first initial projects that we're working on. That will reach the market in the time to come. So the Intuie, a new software platform, what is it? So it is both a response to users' request but it's also for MediStim internally to really revamp our software architecture for the product software and making sure that it's developed now on cutting edge approved solutions. This is going to help us shorten the development time for next upgrades. But going back to the users' request, of course, we have had very intimate interaction interactions and thought feedback from all our users from various initiatives over the years. And they told us that although it is rather easy to learn the TTFM technique. Still, it is a need for a more intuitive user interface. [indiscernible] And as technology develops, of course, it's also relevant to us for interpretation guidance. And we would like to do that sophisticated in the future, but at least in this version of the software, we are providing reference values so that the measurements that are shown on the screen is compared to what the surgeons in question believes are good values, and we also provide some guidance there.

The new software also provides context data, and that will help increase the quality of the utilization of the technology. It will help data analysis and also help the reporting and increase the the value of the report coming out of the procedure. So there are many benefits. And so far, the feedback from surgeons that has taken a look at the new software are very, very positive. So just want to stress in Chile that is definitely a solution that will offer advanced support for clinical decision making. But it's just the beginning. And amongst other things, we are working on expanding this technology to vascular applications in the near future. The vascular surgery area the strategy is to build a position there. And we believe that one of the best ways to do that is actually to do a clinical project together with leaders in this field. So in December, we were also actually in November, we were launching the PATENT study, which is a clinical study on flow and imaging in peripheral peripheral bypass surgery. And peripheral bypass surgery, that is a treatment [indiscernible] [indiscernible] patients that has occlusions in the arteries at the in the lower limbs.

And we call this critical limit threatening ischemia, which is an advanced stage of peripheral artery disease. This is a very serious disease disease. It has a very negative prognosis. We can see that within a year after the initial diagnosis, one year amputation rates approximately twelve percent mortality at fifty percent at five years, seventy percent at ten years. So that really speaks to the serious condition And while bypass surgery is is a great treatment strategy, about twenty percent of these bypasses fail today. So very clearly, there is a need for improved inter operative guidance and control. And here is where Medisin comes in and we can help. And the timing for this project is really good because as in Cabot surgery, also in vascular, endovascular treatments is the first choice.

But a recent study from 2022 has shown that open surgery may provide better results. So there's a lot of interest and attention going into this procedure. Not only peripheral bypass, but also other variants of after surgery at the moment. The goal with the study is to detect technical issues with the graft and giving the surgeon the opportunity to correct this intraoperatively. So while the patient is on the operating table, also to identify grafts with a high risk of failure and separate from grafts with lower failure risk. So this is the prognostic value. [indiscernible] this is going to be a or is a prospective non randomized It's an international multi center study. And it will enroll around four fifty patients. And the endpoints here, first of all, primary endpoint is graft patency rate at one year, but we're also going to follow the number of revisions or surgical changes based on the information from the flow and imaging technology, so very much like what we did in the request study for cabbage. As you can see here, also early graft failure rate, major adverse limb events, reinterventions and amputation free survival are secondary endpoints. And very important we have absolutely the top thought leaders in this field participating in the investigator team.

So Professor Michael Comte is the lead investigator on the trial. Was the first author of the global guidelines. For this procedure. We have the Secretary General from the European Society, Professor Margit Venemont, We also have the President of the Japanese Society of Vascular Surgery, Professor Asuma. And we have the first quarter of this trial that I just mentioned, which is so important, challenging the use of endovascular procedures only. Professor Aleck Farber. We also have two past presidents from the Society of Vascular Surgery in The United States, including Professor Mees, which was the President in 2024. And many other really influential surgeons as well as part of the investigator team. So we do believe that the patent study has the potential to be a game changer for us in vascular surgery and in the vascular segment, very much like how the request study was transformative for the adoption of imaging in CABG. Finally, I would like to add some comments about some organizational developments that will support accelerated growth going forward. This is information that was disclosed in January. And the stated in our press release that with the launch of the Intuis soft patent study, which will support all of our activities in vascular surgery, this is really the perfect time to strengthen our commercial efforts.

So what we have done is to reorganize a little bit how we are approaching the commercial part of our business. And we have appointed Mr. Mike Karim as Chief Commercial Officer. Which is a very, very experienced person with many years of experience from the medical device segments, a lot from the cardiac and vascular side. And which is really bringing a lot of expertise into commercialization of products like ours. So extremely happy to have my Karim on board. We have also changed the the leadership of our Americas sales region, and we are introducing Mr. Tony Winter as a new Vice President of this region. So our ambition is to enhance our commercial initiatives We believe that with this organization, we are also enabling better collaboration, sharing of best practices across all regions. And we believe this is going to be very important to deliver the growth that we are foreseeing. So Medistin is ready for 2025.

And by that, I think we will open up for questions.

Yes, we have some questions coming in here. The It's great to see growth in Americas at more than 30% for the quarter. Do you expect USA to continue to drive growth in the future?

Yes. I think yes, appointed to it's very reassuring to see that The Americas and The U. S. In particular is coming back at higher growth. So remembering that we had actually a deceleration decline in sales in The Americas every quarter in 2023, even in the first quarter this year. And then we've seen a gradual uptake of sales there starting from a modest 6%, then delivering a strong 17% in the third quarter and now close to 30% in the fourth quarter. And we do believe that this is this is following sort of the the REVE in the economy at large. With at least more stability when it comes to inflation and interest rates and so on and so forth. So that's what we're also hearing from the market. That that climate is improving. And I would also say that with the general changes that we're making to the commercial organization, I mean, to the benefit of all our regions, but also for The USA. And their ambitions there, I think that will be greatly supported by this new organization that we have established. So yes, the answer to that question is yes, I do believe Americas will contribute to good growth going forward.

Thank you. And then some questions on Intuie.

IntuI was presented in December. When do you expect to start seeing an effect in sales? And does the software require FDA or European approval?

Yes. So we have the approvals that we need for the Intuis software. So the regulatory issues will not be sort of a barrier for getting this software to the market. Now going forward, when we are selling systems for the most part, those systems will be with Intuit inside. And those systems will be sold at the premium because we believe this is a valuable addition to the total technology. So it really defends a price increase there. Of course, we will have some some projects and some quotes that we have been working on for a long time under, let's say, the legacy software. Which will also continue to be sold. So for a some time period, we will have both versions of the software out there in the market. In the second half of the year, we will also have developed and we call an upgrade kit for upgrading the installed base on the MiraCue Medistim so that we can go after those systems and customers and offer this upgrade kit to get them up to the best or to the latest software. So that's another avenue for revenue generations from the Intuit launch. And then, of course, I think longer term, which is maybe even more important than the impact now in 2025 is really that the ease of use and the new features will make the whole solution more attractive.

We're lowering the barrier of learning the system to creating value from the system to understand how they can really benefit from the system and these are the most important features with the whole software.

Yes, Kevin, an extra question on the IntuE. How is the revenue model for IntuE software?

Yes. So as I mentioned, it will be a premium price for this software or for SIT the for the upgrade kits that will be sold separately as a separate And then it's a question on tariffs. Many businesses have been stepped [indiscernible] How will this affect Medisin with a big share of its sales coming from The U. S? Yes, that's mine, Karim.

While we hear about tariffs from The U. S, obviously, 25%. As of now, we are not really sure whether that is for medical devices. That remains to be seen. When it comes to the pricing, as such, we will then if it's a 25% tariff, we will clearly try to recover that by increasing our price particularly.

And but the fourth in in The U. S. That is actually fit for system production. So if this last week, we could consider actually setting up a system production in our facilities in Minneapolis. Than avoiding a lot of these additional tariffs. Thank you.

And a question on dividend. Dividend in Medistem has historically been at a lower level than what is adjusted by the Board this year. Why this increase compared earlier? Would it not be wiser to reinvest some of these funds into product development, market expansion and such?

Good question. Last year, ending 2023, we saw some uncertainties. And therefore, we did not increase the dividend. We have tried historically to increase the dividend every year. Because of those uncertainties in 2023, we were more prudent and just set the dividend at the same level. We will now, as we've seen earlier today, we have a very, very strong cash position ending when we go out on 2024. And we have also for 2025 before we we evaluate before we look into the level of dividend already, made sure that we financed our activities going into 2025. And we also have a good result this year. And we also think that our outlook is good. So therefore, we are comfortable increasing the dividend from 4.5% to 6 NOK per share. This will be €110,000,000 in in payment. We have €180,000,000 ending. 2024, and we think the outlook is positive. So that's why we are able to pay this dividend.

Thank you. [indiscernible] How does Medisim avoid the classic pitfall of prioritizing sales growth over long term product development? What measures ensure the right balance between short term metrics and maintaining technological leadership?

Kari?

Well, I think that the the changes we made to our approach to innovation shows that we have a very long term perspective on this. And we, of course, have also many years of experience in developing products for this industry. And we know very well about all the struggles and all the hardships that it takes to really both keep medical devices on the market and also to develop, launch and and get new products out there. So So I think it's a balance of [indiscernible] That you need to have an engineering team that is working closely with the operations. And solving problems. There will always be some issues out there in the market. It comes from technical issues or there can be components going out of availability and there is changes engineering changes that comes up as a solution to those and that requires R and D resources. At the same time, you need to make sure that you are dedicating a portion of your R and D resources to only work with product development. And that is exactly what we've done with the this external innovation team. So the small group, three headcounts that are in this team, they're not really allowed to work on anything operational.

They They are only allowed to be engaged with customers, do this product prototyping and testing and bring that back to the organization and the development engineers. So I think that is one way of approaching that balance.

Thank you. That's it. Good questions.

Okay. Then we will thank everybody for the participation this morning. And wish everybody a good day.