Okay, let's start. Good morning, and thank you for joining this call. I'm Jesper Söderqvist. I'm the CEO of Boule. I'm currently in Dubai, where Boule is participating in Medlab Middle East, which is a significant exhibition in the field of laboratory medicine, attracting some 30,000 participants. Today, I will be presenting our year-end results and also give you a business and organization update. Back at our headquarters in Stockholm, we have our departing CFO, Jan Benjaminson, ready to support and help out with any questions that you may have after the presentation. Please be aware that this presentation is being recorded, and if you don't want to be on video with your comments or questions, please let us know after the call, and we will delete those parts.
You have the opportunity to place questions in the team chat during the pre-presentation, and then after my presentation, we will open up for questions. Thank you again for being here, and let's get started. In Q4, Boule achieved several significant highlights, and I'm particularly pleased that we can report a good organic sales growth of 4.3%. This growth has been driven mainly by our vet sales across Europe and also instrument sales in Asia, and this is related to a larger order of 1,200 instruments to India, where about 1/3 was delivered in the fourth quarter.
We report a strong operating cash flow, and this is thanks to our increased focus on operational efficiency, and I'm really pleased to see that those activities are really paying off. Also, in December, we delivered our first product from our partner's new reagent factory in India, and, you know, this really marks the start of our new business model, where instead of product sales, we will have, license revenues, from India. This will, you know, decrease our top-line growth, but it will increase our, gross margins going forward. And also, local production in India will enable our partners to participate in public tenders, which is a requirement from the Indian government to financing these public tenders, that you have local production and Make in India products.
At Medlab, you know, this week, we are particularly excited, since we showcase several new products, and we show our new veterinary instrument, H50, that we released last summer. But we also show our new five-part solutions, you know, the Medonic M55, and the Swelab Lumi, which is based on new cutting-edge technology platform. So really happy to be here, and myself and a few of my colleagues will report a little bit where we are on our platform projects and our new products that are coming out. But let's start with the financials. So we report a growth negative 1%. However, that is actually equivalent to an organic growth of 4.3%. Gross margin decreased slightly with 0.2 percentage points.
Despite that, we have this larger order to India, which is strategically priced, which reduced our gross profit in the period. This strategically priced order will, however, increase our installed base in India and will secure future consumables revenues with higher margin. Our EBIT increased by 0.4 percentage points. However, adjusted for one-offs, which is related to write-offs of fixed assets, the EBIT that we report would have been SEK 15 million, instead of the SEK 7 million that we show in our EBIT margin. We continue to work on our working capital, and we can report a strong operating cash flow of SEK 21 of SEK 29 million in the period.
Our investments in our new technology platform is, was SEK 21 million during the fourth quarter, and this is really showing the commitment we have to bring out these new products, but also move Boule to the forefront of innovation in the coming years. So if you look at the sales bridge, you know, where we reported sales of SEK 148 million, we actually had the best quarter in 2023 in the last quarter. However, we had exceptionally strong quarter in 2022. So it is a reasonable, you know, sales also in U.S., despite that it shows some negative growth here.
The growth in Asia was mainly driven by this larger instrument order to India, and then we continued to see a decline in Eastern Europe due to the war in Ukraine. Then, you know, as I said initially, in Europe, we had a strong sales of our new veterinary solutions. If you look at, you know, our profitability, you know, despite some of the challenges we have in the market and also the strategic price orders, you know, we had a fairly good gross profit. You know, gross margins remain at the same level as last year. And that is really thanks to the improvements we have done in production, particularly instrument production.
If you look at OpEx, it increased in the period, but this is mainly due to the one-time cost where we did write off all fixed assets, both in marketing but also in R&D, related to older assets that we will not use going forward as we renew our product portfolio. And as I said, you know, reported for this one-time cost, our EBIT margin would have been 10% instead of the 7% that we report in the period. So, you know, to get a better view of the business, I really like this rolling 12-month graph. And as you can see here, that we had a good instrument sales in the quarter, and you see that the instruments rolling 12 months is increasing.
We sold slightly more than 1,100 instruments. You know, a large portion of that is thanks to this larger order in India, but also the number of veterinary instruments increased in Europe. The increase of veterinary sales is both related to this new product, the H50 V, which is the five-part instruments, but also when we bundle that offer with our legacy instrument, the four-part, Exigo H400, you know, it has turned out to be a very strong offering, and we have seen growth both for the five-part and the four-part instruments during the later part of 2023.
You can see that our reagent revenue is, you know, leveling out, and I think that is related to both that we see, you know, some lower testing in on our installed base on three parts, but also that we now in December started our new business model, where we start to instead of getting revenue from product sales, get a smaller revenue from the license business model, but which comes then instead with a higher margin. If you look at Asia overall, we actually had increase of consumable sales in Southeast Asia, out-- if you look outside India.
If we look at our OEM business, which has, you know, shown a significant, significant growth in the last few years, we had our best quarter actually in the fourth quarter during for last year. But if you compare it to the fourth quarter of 2022, we had exceptional sales. So in this quarter, the reported sales is actually down 19%. But I would say that, you know, the business continues to develop very well. And I'm also very excited to see that, you know, we have put more and more emphasis on our OEM consumable business and putting, you know, both marketing, sales, and development efforts.
That has really resulted in that we have a number of new projects in our pipeline, and, you know, it's been filling up the last year, which will create significant growth opportunities, going forward. So I look very positively on our, you know, advancements in consumers and what we can achieve in for that business, going forward. So if we zoom out a little bit and look at the market, you know, what is it looking like? So in the U.S., our focus is really on the OEM business until we have FDA approval and released our new instruments in the U.S. market.
So the OEM business has developed well, and I'm expecting that it will continue to develop well over the coming years and also have some, you know, significant opportunities, you know, longer term that can contribute to our growth in the U.S. In Asia, we see really intense competition, mainly from Chinese manufacturers and several markets, you know, and the biggest market being India, really favor local manufacturing. And we have now taken steps to both produce reagents locally, but also started a project to transfer production of our older three-part instruments to India so that we can have a stronger position in India when it comes to making India products.
In Western Europe, I think, you know, you've seen that from, from many companies, but it's really a difficult investment climate, and, you know, the market has been volatile. What we see is that, you know, the opportunities in, in vet seems to be, you know, quite solid and, you know, we look favorable at how our, the veterinary business will develop going forward. Eastern Europe, it's, it's very tragic, but there's no, really no end to Russia's war in, in Ukraine, and I expect to see further declines of our business in, in Eastern Europe. In LATAM, we haven't seen, you know, strong growth lately, and it's really related to that large, large part of this market is doing, you know, volume testing is really done on the five-part instruments.
So it did, this will create, you know, good opportunities, when we come with our updated portfolio, but our, our three-part sales is, is fairly, you know, moderate in LATAM currently. However, we have identified, you know, growth opportunities in, in the veterinary market, and, and we are considering to, release our new product also for sales in LATAM, the coming year. Middle East and Africa, you know, and being here in, in Dubai, I can really see it's a very dynamic region, and we have created, an increased footprint. We have several new, distributors coming on board. However, there are, you know, difficulties with, with payment restrictions from several, markets and, and weak currencies, which really limit sales, short-term at least.
So overall, I mean, we are operating in a very volatile market, you know, with you know, uncertain you know, economic and geopolitical development. And of course, you know, the latest development will you know, increase costs for supply chain and logistics if there's no kind of short-term solution to the war in the Middle East. But I would say, you know, despite this market volatility, you know, we continue to invest in healthcare portfolio, and also in the market, there are continued investment in healthcare overall. And you know, this will continue in the emerging markets as expected, and which will create also increased sales of diagnostics, where we will benefit from.
So, as I said, you know, we are in Dubai this week, and we are showcasing our new products for the first time to customers. So we have recorded a little video yesterday, which was the first day of the show. So I thought I would share this video with you, and you can listen to a few of my colleagues here what they experience in Dubai.
Hi, I'm Jeanette Nikus, and I'm Product Manager at Boule Diagnostics. I'm here at MedLab Middle East in Dubai, the annual conference. This year, I'm happy to announce that I've brought with me a couple of new members of the Boule Hematology family. We're introducing the 950 series, and this is Medonic M55. And on the other side, on the other side, [guess]HemoCue Pro, so different product lines of the same platform, so opening today.
Hello, my name is Admir Gusic . I am Sales Director for Europe, Middle East, and Africa. Together with your team from Boule, we are in Dubai to present our new five part, of course, the rest of the products what we have. I'm very happy to tell to you that we have a lot of meeting that we booked, which means your sales from Africa, Middle East, because we have a very big interest about Boule products. Of course, the new five, five part, and our three part. I thank you more from Wassim that we meet here in Dubai, and take part with Middle East.
Hello, Hani. We are here in the MedLab in Dubai, the most important exhibition for the medical equipment and laboratory equipment in the region. We are proud to meet our family partners from Boule, that they are excited to grow our business in the region. I wish everybody successful show. Thank you.
Hello, everyone. My name is George Wanyoike the Area Manager for Africa for Boule. We are so excited to see you here today and to also invite you for the Arab Health, MedLab. We are excited to present our five-part analyzer that we have been waiting to launch to the world. Very exciting product. We are really having a lot of people who are interested in that from us, and also to be part of our distribution network. So please welcome and enjoy the show.
So with these new systems, as with all Boule hematology analyzers, we are targeting the decentralized testing market. So it's been very expected from our partners and customers with the robustness that hematology, Boule hematology analyzers bring. So as with our three-part analyzers, these new systems contain the Boule SWEDAC system, making the analyzers really robust, that allows installations in remote areas. But at the same time, we bring measurement quality at par with the central laboratory, which is so important for doctors and patients to have accurate results, especially for decision-making.
Please unmute, Jesper.
Sorry, I was on mute. Thank you for pointing that out. So it feels really good to be here in Dubai and that we started to know the launch of these new products. And as Jeanette alluded to, I mean, we show that we have a robust and accurate instrument performance, and we compare that to central laboratory equipment, and we can, you know, show the same accurate results. So this is really, you know, really exciting and I'm very happy too that we got to this point now. We're in the final preparations of our performance evaluation, where we will do clinical trials at several sites in the US.
We're in discussions with FDA regarding the, you know, the details of the clinical studies. We have some, you know, things we need to iron out before we can complete the protocols. We'll see how that ends. What we know is that the requirements for the CE mark, according to IVDR, we have a good grip on, and we are continuing to be committed to submit the regulatory submissions for both CE and FDA for year-end. However, it could be that we will submit for CE a couple of months earlier because we may need to extend the studies in the U.S. to have a FDA approval for our solution for the micro pipette adapter, which is a unique feature that we have with our instruments.
However, our plans to start sales during the first half of 2025 remains, and yeah, so everything is, you know, moving ahead. Very, very happy that we have reached this point now. Also, I would like to make another announcement, and that is that we have strengthened our executive team, as we already announced, Jan Benjaminson is handing over the responsibility as CFO for Boule to Holger tomorrow. Holger comes with a, you know, solid career in various finance positions working at ASSA ABLOY. He has during a fairly long period, so he has a lot of, you know, experience working in a manufacturing company similar to the Boule operation. So I'm very happy to have Holger on board. We have also hired Simonetta Tumbiolo.
Born and raised in Italy, she has a Ph.D. in biomedical chemistry and has worked in various marketing roles, and it's really a great addition to the team as we will increase our marketing efforts going forward when we launch our new products. So great additions to our team, and really happy to welcome them. So in summary, you know, we are operating in a very volatile market, and I think, you know, as an organization, we're becoming better and better to manage, you know, the various challenges that we have seen the last few years and also probably will see going forward.
I would like to point out that we are continuing to increase our installed base, and thanks to the business model we have in Boule, where we place instruments and then have recurring revenue during the lifetime of the instruments. You know, I think this makes a very robust business model that we will continue to leverage going forward. Of course, building a larger installed base will be significantly faster once we release our new five-part instruments, because this is really where the market is growing. And I think with this instrument, we will have a very strong position in the decentralized market for human diagnostics. And then with the updates we have done on the veterinary portfolio last year, I expect to see growth coming this coming year.
Then, of course, you know, the OEM has grown very well the past few years, and we will continue to invest to grow this business going forward. So and then, you know, short term, in 2024, we have a lot of activities focusing and optimizing our working capital and really drive efficiency in the production, and that is how we will improve our profitability short term, going forward. So with that, I would, you know, thank you for your attention and open up for questions. So I can see that Sten here has raised his hand. So Sten, please.
Sorry. Can you hear me now?
We can hear you. Welcome, Sten.
Excellent. Thank you. Thank you very much. Thanks for taking my questions. First of all, regarding the CapEx, when do you expect to see that coming down? I think you previously said it kind of peaked in Q3. Now, it looks like it has been relatively stable into Q4. Is it fair to assume that it will come down in Q1 and Q2 of 2024, or?
No, I think it will remain roughly at this level. You know, the significant decline will come, you know, after we release the instrument and start production. So, you know, the major step down in investments will really come in during 2025 or starting in 2025.
Okay. Thank you. Then regarding India, you said in the report that the order to India had a negative impact on the gross margin of 4.4%, and now you said that you shipped roughly one third of that order. So is it fair to assume that the gross margin, all else being equal, will be held back in the first half, then, for 2024?... for the same reason?
I would say it's of course the major impact will come in on the gross margin will be held back on during the first quarter and then improve going into the second quarter.
Okay. Thank you. And then when it comes to the U.S. filing for the new system, if you can give me, just remind me about the timeline from the time you file until approval, how long is that process for these kind of instruments?
Well, the nominal time from FDA is 120 days, but we all know that this is not happening. So-
Yeah
... very often, at least. And it, you know, the review timelines has really varied, you know, particularly the last few years related to the pandemic. So but I would say I cannot really judge.
Sure.
But, I mean, it seems that, you know, if you talk to people, you know, a reasonable estimate, at least, is around six months for the 510(k). Sometimes it goes faster, and sometimes it goes slower.
Yeah, sure.
It's really out of our control. I think the good thing is that we have, you know, we have had, you know, pre-sub meetings. We have a good dialogue with FDA, where we're really discussing, you know, the study protocols in detail. You know, so I don't think we will expect any, you know, surprises once we file, you know, the 510(k).
And when do you expect to know for sure if you need to do that extra study before filing?
Well, let's say, we will know by the end of the first quarter, you know, what if we need to extend the study period. But it basically means that we probably need to prolong the study time for FDA. And if that is the case, we will, you know, we'll file for CE mark before 510(k).
Sure.
And then-
Excellent.
Just to say, you know, just to be clear on that, for most of the markets, I mean, you know, clearly in Europe, you need a CE mark. In U.S., you need a 510(k). But the markets around the world, you know, they can live with, you know, either or. So-
Sure
... for us, it's good because we have two options, right? And it seems like now that the review times for the CE mark with the notified body are coming down, as well.
Yes. Thank you. My final question is regarding 2024, and I know you don't like to give us a guidance. So, without giving a guidance, would you still expect the sales growth to improve year-over-year compared to 2023, despite all the turbulence in the world and what have you?
I prefer not to answer that question. I mean, I think you answered it yourself when you said that, you know, the world is turbulent. We operate in a very volatile market. There are so many things that it's really outside our control. If we don't have too many surprises, I think we have a, you know, solid plan going forward, but you know, where it will end, I don't know.
Okay. Thank you. Appreciate it.
Next question? You know, I cannot see, so, so please let me know if there, there are some questions. Was there any questions in the-
Yes. This is Christian from Pareto, if I may.
Please, Christian.
Okay, great. Thank you.
Go ahead.
This, the first question is a follow-up on your CapEx in the product platform. You wrote in the report that you expect the investments to be at the level of 2023. So is that around SEK 70-75 million for the full year 2024?
I don't give such, you know, detailed estimates going forward, but I mean, is that it's roughly at the same level.
Yep.
And then we look at the overall-
So-
Also, you have to be clear, we look at the overall investment, which is, you know, not only in R&D, but it's also related to production, equipment, et cetera-
Yes
... going forward.
Okay. Thank you. Are expenses for clinical trials included in this number?
Yes.
Okay, great. And, in your organic sales growth of 4.3% in Q4, would it be possible to break down how much of it, it was due to price adjustments versus volume growth?
I prefer not to answer that question. I mean, I think we report what we report, and those are the details that you that we will give out.
All right.
Mm-hmm.
And if we're looking on the underlying EBIT margin, adjusted for write-downs coming in at 10%, how should we think about the EBIT margin in 2024? Do you expect to maintain at this level or...?
So I mean, we don't give any, you know, detailed forecast going forward. So... But as you can see, if you look at over the last year, we have, you know, done improvements, you know, on, in our earnings, you know, quarter by quarter. You know, there are some ups and downs related to, you know, some of the significant events, which are sometimes, you know, very often outside of our control. What I can say is that we, you know, have—I think the organization is performing better and better, and that we are seeing, you know, significant improvements in our, in our operations, and particularly in instrument manufacturing, which I think will help us driving profitability in 2024.
Okay, excellent. Thank you very much.
Any more questions? Okay, then thank you very much for your attention and, and for participating in this call. I wish you all a nice day, and, see you soon again. Take care. Bye-bye.