Embla Medical Hf S/Adr

And good morning and welcome to the EMPLA Medical Conference call where we will review the third quarter results for 2024. I'm Sett Solvasson, President and CEO of EMPLA Medical and joining me today here from Copenhagen is our Chief Financial Officer, Artna Svensdottir and EMPLA Medical's Head of Investor Relations, Klaus Sinders. Today we'll discuss the financial performance and progress we've made during the third quarter The presentation should take roughly 15 minutes, after which there will be an opportunity to ask questions during a Q&A session. If you go to the next slide, please. We continue to deliver solid growth. Organic sales growth was 7%, and local currency growth was 11%, including an impact from M&A and currency. We continue to see a strong momentum in EMEA, driven by prosthetics and neurophotics, as well as patient care. Our bracing and support business, however, delivered a more modest growth for the quarter. Our EBITDA margin came in strong at 22%, supported by the cost reduction initiatives implemented in our manufacturing operations during the first quarter, as well as positive product mix and cost control. Artna will go through our financials in more detail later. We are executing well on our growth 27 strategy and reiterate our four-year guidance of 6% to 8% organic sales growth and around 20% EBITDA margin before special items. We continue to execute on our strategic initiatives, and in the second quarter, we launched two new bionic knee solutions, Navi by Usher and Icon by College Path. Both solutions continue to be rolled out in selected markets during the year, and a full launch of both knee solutions is expected early 2025. I'm also encouraged to see the third generation of our naked prosthetics technology being launched during the third quarter. This generation features some significant enhancement to the finger and hand portfolio with improved durability and personalization. These upgrades were driven by customer feedback and demonstrate how quickly we're able to adapt to feedback from our markets and individuals that use our products. Nine months ago, we acquired Turing Gantt, a leading maker of lower limb neuro-orthotic components. The acquisition was an important step in our growth journey and an expansion into the field of neuro-orthotics, a field we are optimistic about as we are broadening our ability to support individuals with chronic mobility challenges. We are very pleased to see the integration of Eurigens going well. In the third quarter, the neuro-orthotics portfolio was rolled out in new markets such as the UK and Australia, and it's our plan to continue to leverage our commercial infrastructure in other markets to bring neuro-orthotic products to even more patients. As announced in July, it's our intent to unite our network of patient care facilities under a new brand identity called Formotion. The Formotion brand will be introduced gradually to the markets we operate in within patient care, and here during the third quarter, we rebranded our clinics in the Netherlands to Formotion, and additional markets will follow in quarter four. And ultimately, it's a goal that the Formotion brand will encompass the entire network of our global OMP patient care facilities as we move forward. In the US, Medicare has expanded access to advanced bionics for less mobile patients, so-called K2 patients, and the coverage expansion took effect 1st of September. I will go through some of the important key takeaways from the US Medicare expansion in the coming slides as we've received a lot of questions about this change. And then last but not least, the global team of our elite para-athletes who wear Usher prosthetics won 22 medals and set five new Paralympic records during the 2024 Paralympic Games in Paris. And it was great to see the fantastic performance from our team of athletes who dominated several categories while wearing our carbon fiber cheetah sport blades. And if you turn to the next slide, please, on the U.S. Medicare expansion, as earlier mentioned, as of September 1st, U.S. Medicare has expanded its coverage of microprocessor needs, in other words, bionic needs, to include K2 amputees. This is the most significant coverage expansion in lower extremity prosthetics we've seen over the last 25 years. For the first time, U.S. Medicare will now allow for less mobile patients with amputations above the knee to receive bionic knees. Substantial research has, over the years, supported that more advanced prosthetic devices such as bionics lead to significant clinical benefits for less mobile patients, including reduced risk of falling, improved mobility, and increased patient confidence while walking. In turn, healthcare costs or the cost burden should also decrease over time while quality of life should substantially increase. In addition, the extended coverage may also grant these functional level 2 MQTs access to a compatible high active food solution as a complement to the bionic knee when certain coverage criteria are met. And if you turn to the next slide, please. With Medicare's expansion of NPKs to less mobile K2 patients, we see a potential to grow over time as the number of patients that use advanced bionic solutions will increase. These functional level K2 amputees are typically patients characterized by being a limited community walker who can handle curbs, stairs, and uneven surfaces. Opposite, you have the K3 and K4 patients who today qualify for advanced prosthetic devices. These patients are often characterized by being more active beyond basic needs and can navigate most barriers unhindered. It's still too early for us to quantify the potential uptake and impact on, let's say, the market size as the new policy will not automatically create access for every person currently classified as a K2 amputee. Today, Medicare accounts for roughly 30% of the revenue of an average O&P patient care facility in the US with an annual coverage of bionic needs of roughly $100 million. While Medicare's coverage expansion does not, as previously As we've briefly talked about, does not automatically require other payers to follow suit. Historically, this has been the case with many of the commercial payers that have adopted Medicare's guidelines on coding and fees as a baseline for how they decide on coverage. From a claims perspective, we also know that the number of claims between the K-3 and K-2 patient populations is roughly the same today. However, in dollar value, the split is more like 90-10 since the more advanced prosthetic solutions have been restricted to the more active K-3 or K-4 functional level equities. If you then turn back to the quarter and go through the geographical overview of our performance, and if you go to the next slide, please, we continue to see strong momentum in EMEA, with 13 percent growth in the quarter. Growth in EMEA was driven by our prosthetics and neuro-orthotics, as well as our patient care segment. This is the fourth consecutive quarter we have posted double-digit growth in the region. Sales in APAC were solid for the quarter with 6% organic growth, mainly driven by our business in Australia, where we are starting to see an improvement in the reimbursement approvals, which have impacted sales in the first half of the year. Sales in Americas were soft in the quarter, although selected patient care markets in key product categories in prosthetics and neuro-orthotics demonstrated good growth, while we had soft sales in other categories and locations. As expected, we are yet to see any impact from the U.S. Medicare expanded coverage for K2 patients. If you turn to the next slide, please, on our prosthetics and neurothoracic segments, we delivered 9% organic growth for the coasters driven by Strong volume growth and increased fitting of high-end solutions. In EMEA, we saw continued strong momentum driven by, again, volume growth across all our major markets, and especially in bionics. In the Americas, sales remained somewhat soft, while sales in APAC were particularly strong in Australia, where we are seeing the reimbursement backlog impacting sales in the first half of the year, starting to gradually move back to normal. In the neuro-orthotics, we continue to see solid performance from Führer & Gantz, which we acquired earlier this year. And if you turn to the next slide, please, on bracing and support, this segment grew by 1% organically. Growth in this part of our business has, during the year, been impacted by somewhat challenging market dynamics in selected products, categories which has led to soft performance in both EMEA and Americas. In APAC, we continue to deliver a strong quarter mainly driven by our business in China as well as Australia and New Zealand delivered excellent growth in the region. And if you turn to the next slide, please, on patient care, our patient care business delivered strong organic growth in the quarter of 9% driven by strong patient volume growth and positive mix impact also especially in Europe and Australia. This now concludes our sales performance overview for the quarter, and I would like to hand it over to you, Arne, to go through the financials, please.

Thank you, Svet. If you please turn to the next slide for an overview of our financials. Gross profit margin was 63% in the third quarter compared to 62% in the same period last year. The increase is attributed to the cost reduction initiatives in manufacturing executed during the first quarter of the year, as well as positive product mix and increased manufacturing efficiency. We are pleased to see that OPEX growth continues to be well managed. In the third quarter, OPEX grew 4% organic relative to delivering organic sales growth of 7%. With an increase in gross profit margin and effective cost control in our OPEX, I'm pleased to report a strong EBITDA margin for the quarter of 22%, with a three percentage point expansion from the same period last year. Net profit grew 58% in the quarter and was 22 million or 10% of sales compared to 14 million or 10% of sales in the third quarter last year. Effective tax rate for the quarter was around 22%. If you can please turn to the next slide for the status on our cash flow and leverage. During the third quarter, CAPEX was $9 million, or 4% of sales. CAPEX has come down in quarter three relative to quarters in the first half of the year, as facility expansion programs to support our growth have largely been concluded. All things equal, CAPEX is expected to return to a more normalized level of 3% to 4% of sales in the coming period. In third quarter, we delivered strong free cash flow driven by solid cash generation from our operations. Additionally, positive effect from working capital and lower CapEx contributed to stronger cash flow. Inventories, however, remain somewhat elevated due to buildup of bionic solutions inventory as we are preparing for a full launch early next year. On the leverage, we see our net interest bearing debt to EBITDA ratio coming down, putting us back within our targeted range of two to three times EBITDA. Our share back program remains paused, and we will continue to re-evaluate the situation as leverage ratio continue to come down. With this overview, I will hand back to Sveit for his final remarks and comments around guidance.

Thank you, Arnav. Please turn to the next slide. In line with the strong performance we've seen to date, we reiterate our guidance for the full year at 6% to 8% organic sales growth and around 20% EBITDA margin before special items. The guidance does not assume any meaningful impact from the recently launched innovation, including the new bionic knee solutions, as these continue to be rolled out gradually in selected markets as part of our limited launch program. A full launch of NAVI and ICON is expected early 2025, as previously announced. Neither do we assume any meaningful impact for 2024 from the U.S. Medicare reform for extended coverage for K2 patients. With this overview, our presentation is now concluded, and we would like to open the call for questions. Operator, if you can please move to the next slide, and the Q&A can begin. Please, thank you.

Thank you. As a reminder, to ask a question, please press star one one on your telephone and wait for your name to be announced. To withdraw your question, please press star one and one again. We will now take the first question. First question is coming from the line of Natalia Davis from Intron Health. Please go ahead.

Hi, thank you so much for taking my questions. Just a couple from me. The first is, could we get a sense of the growth rate that you've seen for the Fiora and Gents business and if it's in line with pre-acquisition double-digit growth? And the second question, could you just provide some insights into how your R&D and SG&A costs are projected to evolve through 2025 and 2026, particularly in light of any planned product launches or the rollout of Navi and Icon MPKs? Thank you.

Yeah, hi and good morning. Thanks for your questions. On the Führer & Gens piece, we don't really report specifically on Führer & Gens, but what we did communicate when we acquired this business is that our expectation is to deliver strong double-digit growth, and that's what we continue to see, also as we start to introduce these products in other markets where we are leveraging our commercial infrastructure globally and relationships with O&P providers. With regards to sales and marketing and R&D cost, let's say as you model that going forward, if we take a step back on the sales and marketing cost, we do have scalability and are well invested in the biggest healthcare markets. And that scalability has largely been reinvested, you could say, in building our footprint in private pay markets. So you should expect some operating leverage, but not much on either sales and marketing nor the R&D line. There's no expected step up in R&D as such. as a percentage of sales, but I will just maybe mention that we do expect R&D costs to be a little bit higher here in quarter four on a run rate basis than in quarter three. I hope that's helpful.

Thank you so much.

Thank you.

Thank you. Once again, if you wish to ask a question, please press star one and one on your telephone. That's star 1 and 1 to ask a question. There are no further questions on the telephone at this time. I would like to hand over for any webcast questions.

Yeah, so we received a few questions from Nordea, who has some challenges in dialing in. So the first question is, what is the initial feedback on your product launches, especially the Navi and the ICOM Bionic Knees, which are in limited launch?

Yeah, we'll start with that one. We've received good feedback on both products. The Navi is... you could say a next generation of a rheologic platform that has some enhanced features waterproof being one and and some improved stance controls and further improvements enabling enabling patients to to walk up and down stairs. So we are just very encouraged by the feedback we see or we hear on the Navi and are excited to go into a more full launch mode here in 2025.

Good. There's also questions from Carnegie, but they also have chances in dialing in. I don't know.

We will now take the question from Carnegie. One moment, please. Niles Granot lives. Your line is open now.

Thank you. Good morning. Firstly, can you talk about if you have incurred any extraordinary costs in this quarter related to the rebranding of your Formotion clinic network? And secondly, could you just extrapolate a little bit on why you don't expect any effect from the broader coverage of bionic products in the U.S. in quarter four. Thank you.

Yeah, hi, Neil. Thanks for your questions. Well, yes, there is cost, obviously, in and around an effort to rebrand our patient care products. Network there is we will reinvest the part of these that you could call it through the year-over-year marketing cost that we do have In in our patient care business into into this effort so we don't we will not book any extraordinary cost in this disregard and don't expect this to have any let's say meaningful impact on our overall financial picture. It's a gradual, we will do this gradually over the next couple of years, this moving into the Formotion brand. With regards to the LCD changes in the US, we are seeing a lot of activity in the market in the sense that our customers are are building up knowledge and building their processes in terms of how to fit K2 patients with bionic needs, meaning there is some documentation and some tests required to make sure that reimbursement is there. So we don't, we do, let's say, we do obviously expect some K2 patients to be fitted with bionics here in Coaster 4, but we don't expect this to have any meaningful impact on our growth here in 2024.

Great, thank you. Perhaps you could just tell us then when it comes to the rebranding of your Formotion network, how long have you come? Are you kind of 20 or 40 percent into the rebranding process? And then also, Could you also talk about how many countries that you have introduced the Fjord and Gens products into and when you expect to launch those products into the U.S. market?

We are very, let's say the Formotion rebrand journey is very early days. We have just started in the Netherlands, which is a small part of our patient care business. We'll introduce the Formotion brand in, also in the U.S. later this year and in other smaller locations in Europe. So it's very, very early days. This is a change program that will stretch into next year and probably also into 26. And we'll, as I said earlier, take it step by step. On your second questions with regards to Führer & Gantz, again going back to our earlier communication here, we did communicate when we acquired the business that 70% of sales was in Germany and with the remaining sales being in a handful of European markets. As we write in our announcement today, we are preparing to introduce also Führer & Gantz into Australia and in the UK so it is that we're still talking about a handful of markets but we and going back to the logic for why we are good owners of this business is because individuals that have neuro or mobility challenges as a result of neurological complications are in most cases or in many cases referred to orthopedic and prosthetic clinics and and this is where we intend to leverage our obviously our own clinical platform and our relationships with with OMP clinics in a global global context but it is it is still it is still early days but we are moving in line with our with our price right thank you thank you we will now take the next question

one moment please the next question comes from the line of eway to from scb please go ahead hi good morning uh thank you for taking my question i have a a few questions i do one at a time uh firstly just looking at your u.s business and especially the bracing support uh segment I remember the first half you were impacted by the cyber attack on your customer. And I understand that this has somehow eased here. But what can explain the weakness here in Q3? And what is your expectation for the remaining of the year?

Thanks for your question. Our bracing business, we have a strong position in bracing in a few of the biggest healthcare markets, US, the big healthcare markets in Europe. And in bracing, we provide fundamental, let's say, solutions that are prevalent in each and every healthcare system and provide a fairly comprehensive portfolio of bracing, where we've seen the most positive growth dynamics that is in and around our osteoarthritis bracing, where we provide bracing as an alternative to knee replacement surgery. And that segment continues to do well, where we, however, have had more headwind that is in and around product categories which are you could say simpler and where cost is a bigger topic and where there's also been some pressure in and around reimbursement or limited price increases so it's a little bit of a mixed bag we continue to see as I said earlier positive progress on the osteoarthritis front while we have had more headwind in and around some of these more, you could say, commoditized categories that are exposed to more price pressure where we have seen some erosion. However, we continue to be optimistic on the bracing business and our intention to grow in line with the market, which is low single-digit growth rates.

Thanks, and I just want to follow up here. Is there any market you are looking into a possibility to divest the bracing support business, or any market that's been sort of a long-term loss-making, and you could see that it could lift your group margin as you did in France?

No, we don't have any plans of that. And as you mentioned, we did go through, our brazing business has changed substantially since pre-COVID, where we divested a part of our business in France and a part of our business in the U.S. And now we have a much stronger portfolio, and we have no intention of divesting any part of that business.

Okay. Okay. And when you mentioned the price pressure, could you elaborate or confirm if that is sort of increasing competition due to the increasing competition?

No, I wouldn't. I mean, this has always been a competitive field as such. And it's also important to remember that we are only in the reimbursed part of the bracing market. We don't compete in, let's say, the very low-end sort of markets. private pay market we compete in the reimbursed market and it's where all let's say those that compete in that market are subject to regulatory requirements quality requirements and our customers are and it's a lot about being a complete provider and of a complete portfolio where we it's not as much where we if you compare to the prosthetics and neural segment where we compete on differentiation here we're competing on ease of doing business, having a full portfolio of high-quality bracing solutions. But it is also a very regional business in the sense that reimbursement is very different country by country, and there are pockets especially as I mentioned earlier, in and around the more commoditized categories, which are more exposed to price pressure. While on the other hand, where we continue to see solid growth on the osteoarthritis side, where we have rather positive growth dynamics in all of our major markets.

Great, thank you. And next question is on the Australia. I understand you have benefits a bit from the penalty amount from this delay to reimbursement approval. Could you please indicate that on the Q3 growth and maybe also comment on the Q4, if you can give any indication?

Yes. I mean, Australia is a relatively large share of our APAC business. We talked about this in the first half of the year that there were some procedural complications in processing claims. in the NDIS system in Australia that seems to be gradually normalizing, you could say. There's a little bit of pent up or demand that is being released here in quarter three and quarter four, but it's not gonna impact the bigger picture as such. But it's an important market for us and it's nice to see that it's gradually or it's back to normal in Australia.

Okay, thanks. So it is a very small positive boost on your growth here in the quarter.

Yeah, you could say a small. It was a very small drag here in the first half of the year, and it's a slight boost here in the second half of the year, yeah.

Okay, great. Thanks. And my next question on the gross margin here in Q3, it improved year over year, but actually lower than Q2. And is there like seasonality here? And if you could also confirm that you have not been impacted by a higher shipping cost?

We haven't been, shipping cost hasn't been an any major theme in our cost way. And yes, there can be a little bit seasonal fluctuations between costs around the cross-profit margin, but I think the big picture is that we are about one percentage point up if you look at the nine months. And that is, again, a result of the actions we took earlier in the year in around cost reduction in our manufacturing operations, as well as mix and general productivity enhancement on also our patient care front. Perfect, thanks.

Last question on your CapEx to sales guidance. And could you remind us what is driving the higher investment here?

So in CapEx, we have been investing in facilities just to support our growth, mainly in Iceland and in the US. And the facility investments are now coming to an end. So we are back to more normal level of CapEx.

Is it a capacity or automation? Because we also understand on the other hand that you have been cutting costs also in the production.

Some of it is. We have also been investing just to expand the facility for R&D activities. But yes, also some capacity expansion in the U.S. as well.

Okay, great. Thanks. I'll jump back to the queue. Thanks, Maria.

Thank you. If there are no further questions on the phone at this time, I would like to hand back over for webcast questions.

Yeah, I got a few additional questions from Maria. So what are the next steps to leverage the U.S. coverage expansion? and what are the biggest speed bumps that you need to get past to start selling to the K2 patients.

Again, going back to the big picture, so what the, let's say, Medicare has concluded is that getting more patients using better solutions is always as equal going to drive down cost and increase the quality of life for these individuals. And if we see the data that we also went through here earlier Medicare covers about we estimate about 30% of the of the amputee population in the US and and about half of their of the claims processed are related to K2 patients. So no matter how you look at it, it's gonna grow the addressable market for prosthetic devices. However, it's also important to remember that our business and the business of our customers is about servicing this existing population that is out there, that every year, need to come back for maintenance or upgrade or renewal of their prosthetic device. So the easiest way to think about this is that over time, the patient population that now has access to only lower level devices, if you will, will gradually get access to better devices. And there's a certain amount of fixed capacity in the system as well to see a fixed number of patients. So we will, we estimate from next year that we'll start to see an impact from this, both on our, let's say, bionics business, but also remember that the system has now also decided to allow for access for more for higher end feet as well. So we expect our customers to gradually build up confidence and their processes around documentation such that they will start to get K2 patients onto better prosthetic devices. So we expect this to deliver, let's say, gradual growth. And what is also important to remember that Medicare is only 30%, only covers about 30% of the amputee population, but we do expect, it's our assumption that private payers will adopt the line that Medicare has taken here, but we don't know the timing around that. So, yeah, I hope that answers your question. It's about our customers, and that's also what we are working on now. We are working heavily on sort of material and education material to support our customers on the reimbursement side going forward.

There's another one for Sven here from the ESO regarding APAC. So what is driving the soft sales in some of the APEC markets if you exclude Australia?

That is mainly another big market for us in the APEC region is China. And we have seen slow performance in China. China's always been a growth market for us, but with the economic softness in China, remember this is a private pay market, that has impacted demand here in 2024. And yeah, we've seen an overall very slow year in China compared to prior years. With that said, we still remain optimistic on our potential in this market, given low utilization of good mobility devices, and we'll continue to invest and grow our presence in China. But this has been an unusually slow year.

Then there's two questions here for Anna. First one is on CapEx. So these investments we have made recently, will it lift gross margin? And if so, how fast?

I don't expect this investment to lift the gross profit margin as such. It is more to support generally our our both R&D activities as well as increased capacity we needed in operation.

Good. And then a final question here from Nordea on the net financials. So how should we think about net finances going forward?

Net financial is basically two components. This is the financial expenses, the interest rate, and then the exchange differences. On the financial expenses, we can say that our interest rate cost is now currently around 4%, just to keep that clear. And we expect that you see basically that interest rates are coming down. made yesterday about reduction in rates. And you can say that if you want to see the combination of US dollars and US, we have now US dollars approximately 25% of our loan or our borrowing portfolio and Euro 75%. You can use that to estimate the cost.

I'll hand back to the moderator to take any final questions from the audience.

Once again, if you wish to ask a question, please press star 1 and 1 on your telephone. That's star 1 and 1 if you wish to ask a question. There are no further questions at this time. I would like to hand back to management for any closing remarks.

Well, yeah, thanks everyone for dialing in this morning. Please refer to our announcement with regards to our investor relations activities here over the next weeks and months. Otherwise, yeah, I just wish you all a good day. Thank you very much.