Devyser Diagnostics AB (publ) (DVYSR) Earnings Call Transcript & Summary

Welcome to the Devyser 2024 Capital Market Day. It's a real pleasure to see you all here. It's actually the first time we have a Capital Market like this. I'm really glad to see so many participants, actually more than we expected. So I apologize for being a bit crowded. I'm also glad that we can be here in our new facility. After the meeting, you will have a chance, if you haven't seen it yet, to take a tour around the facility. The day today is also taped. I know that quite many will watch afterwards. We have seen an exceptional increased interest for Devyser over the last year. And I think this Capital Market Day is a good opportunity for you to learn more about the company, but also to ask questions and get them answered. Today's speakers, in addition to myself, you will today listen to our Chief Scientific Officer, Dr. Michael Uhlin; and our Chief Commercial Officer, Theis Kipling. Our U.S.-based Vice President, Market Access and Reimbursement, will also speak today, and his name is Jeff Salzman. You will also listen to Jakob Nilsson, who will speak a bit later after the break. They will all introduce themselves in connection with their presentations. In the audience, we have also our CFO, Sabina Berlin, to my right here and Camilla Wiberg, also to my right. And at the end of the room, we have Anders Hedrum, one of the Founders; and our Head of Italy, Virginio Marra. We have also the tall guy over there, it's [ Ole Mueberg ], Vice President, Quality and Regulatory Affairs. Don't hesitate to reach out to them during the break or afterwards if you have a question that you would like to have answered. We have also 3 Board members here, our Chairman, Mia Arnhult; and Thomas Eklund; and Lars Hockenstrom. Today's agenda, I will start with a recap of Devyser. Michael Uhlin will then give an overview of our product portfolio. Our Chief Commercial Officer, Theis Kipling, will walk us through our commercialization plan. Our Vice President, Market Access and Public Affairs, Jeff Salzman, he will speak about our work in the U.S. when it comes to market access and reimbursement. His presentation has been taped to avoid interruptions, but he will be online during the Q&A session. Twenty to 3:00 we have a break, 20 minutes break, and we will serve coffee in the lounge where we met just before the meeting. After the break, we'll listen to Dr. Jakob Nilsson from the University of Zurich. He will discuss opportunities what he sees with cell-free DNA. After that, I will give some closing remarks. We will have a Q&A session at the end of the day, but it's also okay to ask questions directly after each presentation, but let's keep it to 2 or 3 questions. If you have more, we may save them at the end to the general Q&A session. For those who are interested, we will have a guided tour in the facility just after the meeting. 10 minutes past 4:00 you should then be in the reception area where you came in. At Devyser, we are driven by passion among the employees to help patients get the correct diagnosis in the shortest possible time because we know that help people to live longer and we save lives with this. Just over the last 12 months, more than 400,000 people have been tested with our products. And that's something we are very proud of, both myself and my colleagues. So even if high revenue growth and high margins are important for us, that's not the reason why we go to work every day. You know that our work can help people live longer. Our mission is to be the pioneering leader of diagnostic solutions and provide fast, accurate and easy-to-use solutions to labs worldwide. Our vision is a world where personalized medicine is universally available, thanks to simplified and reliable genetic tests. Devyser is a pioneer in utilizing next-generation sequencing technology, NGS technology. NGS enables highly accurate and sensitive testing and has thereby transformed precision medicine. The advancements in technology have made early detection and early intervention, more accessible to more patients. It has significantly improved patient care and reduced health care costs. However, we strongly believe that we are just at the beginning of a fantastic future journey. So what's the reason to our success. Our customers select Devyser because we provide simple, accurate and efficient genetic testing solutions. Our kits and software are easy to implement, maintain and use. This simplified workflow has been the foundation for our successful growth because we design our products with a deep understanding of the clinical laboratory workflow and put the genetic laboratory team in focus. We sell solutions that are simplified to the labs workflow, thereby saving time and by saving time, saving money. Thus, there are financial initiatives for our customers for the labs to use our products. It may differ slightly between different competitive products. But in general, for our products compared with competitive products, lower amount of DNA is needed and less preprocessing is required. We reduce the hands-on time. We also reduce the total time for the laboratory. The training time for labs staff is also significant lower and shorter with our products than with the competitive products. The company is celebrating 20 years this year. Many things have happened since the company was founded in 2004. The list can be very, very long. If I were to pick a couple of them, the most important milestones, I would pick the regulatory approvals in Europe, including the IVDR approvals as early as 2022. I would also pick the switch from distributor sales to direct sales in certain countries. Other important milestones are the signed agreements with the industry giants, Thermo Fisher and Illumina during 2023 and 2024. A final pick would also be our decision to set up our own CLIA-certified laboratory in the U.S. last year. When we write a 30-year history book, I'm sure we can look back on these milestones and see them as fundamental cornerstones in our success. We sell genetic testing solutions to guide targeted cancer therapies, diagnose heredity diseases and products for post-transplantation monitoring. All development and all manufacturing are taking place in-house here in this facility in Arsta, Stockholm. But we have also almost 10 subsidiaries abroad, sales offices. In total, we are today around 120 employees. We offer products within 3 areas. The biggest is hereditary diseases. It represents about 70% of our total revenue. The second biggest is oncology tests. They represent about 20% of our total revenue. And the smallest but highest -- but the area with highest growth is our transplantation products, and they represent plus 10% at the moment. The growth in the company is high. It has been that and it is. And I would say it's actually very high. Since 2015, we have had a CAGR of 35%, and we reached SEK 200 million in revenue for the last 12 months. With our innovative products, high market growth and a well-suited commercial organization, we do not see anything at the moment that can protect us from having the same nice development also going forward. It should be pointed out that we have only invested in building up a commercial organization in the last few years. Before 2022, we hardly invested in marketing and sales at all. Implementing a commercial organization and the entry into commercial agreements with industry giants will help us to drive sales in the future. With this short introduction, I would like to leave over to our Chief Scientific Officer, Michael Uhlin, and he will give an overview of our product portfolio.

Thank you, Fredrik. So I will now quickly walk you through our product portfolio, and then I will spend some time on our future focus areas and then I will even glimpse and show you a little bit about the hints of the future for Devyser. So I joined Devyser last year, responsibility of Research and Development, Innovation and Clinical Affairs and also the Laboratory Activities over in U.S. I still have my professorship at Karolinska in clinical immunology, which is very nice to have both parts. I used to be the former Head of Clinical Immunology Department at Karolinska University Hospitals, and I had several leadership positions in the Academy, University hospital environment and also the industry. I started my career in infection biology when I did my PhD and then I did a shift into a more translational environment. So an environment very close between the clinic and the bench, so where you did lab work. So I shifted into immunology, and I also worked a lot in transplantation. So even if I only joined Devyser last year, I have actually dealt with Devyser for more than 5 years. I dealt with Devyser as a clinical customer using some of Devyser's products since more than 5 years. And this was a very good experience. I mean, very good, very solid products. So when I had the possibility to join Devyser last year, I also was fortunate because during the years, several people have moved from the hospital environment to Devyser. So I had a lot of former colleagues that I can call and then I can ask them so should I join Devyser? And I got a very informal or uniformal answer from all of them saying that yes, please, because this is an environment of very high dedication. There's a lot of knowledge in the house. And also, we are commonly in Devyser striving for providing as good and accurate precision medicine in the form of diagnostics for our patients. And I would say that, honestly, that was a big factor in making the transition to Devyser last year, which I definitely do not regret. So if you look at Devyser, it stands on a very solid foundation. It has over 25 well-established diagnostic kits on the market. And we are definitely a respected name, both in hereditary diseases, oncology and transplantation, as Fredrik mentioned, since a couple of years. And what is also nice is that it's definitely can be seen our focus of quality over the years, while we have an exceptionally low customer complaint levels on our products. So 2 decades of work, I mean, 20 years anniversary for Devyser this year, hard work, craftmanship and perfectionism have definitely solidified our reputation for continued growth into the future. Another very good thing with Devyser is that, historically, Devyser have been constantly at the forefront of technological advancements adopting early different breakthroughs in molecular biology. And that also is seen in our quite diverse portfolio where we span over 3 technologies. So we are in PCR, we have our legacy products in fragment analysis, and we also have very successful kits also in next-generation sequencing. But of course, to be this wide, there is also some, what you say, both opportunities, but we have to prioritize. We have to prioritize so we can maintain excellence in the fields that we are operating. So while fragment analysis continues to have a steady growth, we have actively chosen to shift more resources to more developing products in the area of next-generation sequencing. That's not to say that we forget the fragment analysis, we will still do regulatory upgrades if necessary, but more focus put on the newer technologies. And this decision will definitely bring us more competitive and align with the future developments of the technological platforms. I have a very nice task now, and that is that I will give you some highlights for 2025. I must say that it's not an easy task because there is so much activities ongoing, but I have picked what I think it's most interesting. And I will share 3 different categories with you. I will share 3 new products launched 2025, some improving software highlights and also some enhanced regulatory compliance. So we can start by the regulatory upgrades. So during 2025, we will aim to secure IVDR status on 2 of our blockbuster products. CFTR, so cystic fibrosis, and also thalassemia. Thalassemia, we'll also add some additional features that we have gotten feedbacks from clinical customers. So it will make the product even more competitive against different other companies. With regards to software, in the beginning of Devyser history, maybe it was easy to say that Devyser was more of a chemistry company. Nowadays, it's important that we deliver not only chemistry but entire solutions involving the software. Because the software is as important as the chemistry in order to provide accurate results to the clinicians and later the patient care. So during next year, we will provide an AI-based tool to complement our Accept products with regards to organ transplantation. We'll have a new software suite for transfusion medicine products, and we will further IVDR status on our transplantation software. The 3 new products, the working names, genomic blood group typing, foetal typing and HLA loss, I will walk you through on the next coming slides. So genomic blood group typing. So this is typing trying to make the matching as accurate as possible between donors or blood products and recipient patients. So very quickly, I would define transfusion medicine for you. So transfusion medicine is a branch in medicine, which is concerned with everything from collecting blood from donors, testing, processing, storing and then in the end line, transfusing these blood products into the patients that is in need. And often, this is patients that is severely ill after major trauma or big surgeries or some other very foetal complications. So the foetal transfusion medicine is a very conservative area. They have more or less -- I'm not exaggerating using the same techniques for decades with regards to matching the donor recipients. But now they are on the brink of making a big introduction of molecular technology, and that is next-generation sequencing. And this, to a very large degree, resembles the situation of transplant diagnostics 15 to 20 years ago when they made a shift into more advanced molecular technology. And at that time, Devyser was present, Devyser could introduce Chimerism and it could later introduce Accept kits. And we are now there and seeing this happen, and Devyser wants to make -- or, wants to help make this transition also in the transfusion medicine category. So how will we do that? We have already potential products that will complement the RHD product that we have. We are running several ongoing clinical studies already. And that is very beneficial as we come back to the next slide also that we will already have clinical data when the product is out in the market to show that this has clinical validation and utility. And we are building our own software in order to interpret the results from the kits. The second product, working name foetal typing. The clinical situation here is that if you have certain proteins between the mother and the fetus, and if they are different, there is a risk that the maternal immune system will create a response against the protein in the fetus. And this response, fortunately, it's not such a big problem during the first pregnancy and the baby is born. But unfortunately, the response in the immune system will reside as a memory to the second pregnancy. And then you might have, in certain cases, a lethal immune reaction against the fetus, which will have lethal consequences for the baby. So we have now developed a comprehensive NGS-based kits and corresponding software that can predict this, can used early during pregnancy, noninvasive and a very good complementary to RHD kits, either as a reflex or as a complementary. And we have also -- the same thing with this one as the slide before, we have a clinical study that has already been finalized, showing that the clinical utility for this is very nice. And the third of the 3, HLA loss. I'm not saying it worth more or less than the other 2, maybe a little bit closer to my heart, while it's transplant related from my background. The situation here is that tumor cells and tumors, unfortunately, are quite smart. I mean they want to grow. They want to grow as much as possible in whatever situation they are in the body. And unfortunately, they are going to create problems and disaster. And in order to do that, one of the things that the tumor cells has to do, they have to escape the immune system because one of the main actions of the immune system is to strike down and kill tumor cells. And it has several mechanisms to do this avoid. After stem cell transplantation, there is a particular mode of action for the tumor cells, and that is to literally split out parts of a chromosome. And the chromosome, it splits out has the information that we create the proteins that are important for the immune system to recognize the tumors. So what the tumor does in the situation is that it becomes invisible to the immune system. And of course, that's not really good, and then it will come back in the form of a relapsing malignancy. And this information is this happens is very important for the clinicians because if they know that this has happened, it will directly influence which kind of treatment modality they will use in order to save the patient. If they don't have the information, they might even end up using a treatment modality that will be directly lethal. And this, of course, will be a very good complement to the Chimerism assay as of the stem cell transplantation. So this is a very neat innovative step used from our very dedicated crew in Devyser. It's important also not only, I would say only, I will not bring down the value of these things. But it's also important not only to work in short-term advancement with new products, you also have to work a little bit more in the long term. And that could be long-term innovation by developing the technical platforms that we are using in order to produce the products. And I'm very happy to say that at the moment, I think that we have within Devyser, we have made a leap in the sense of creating an upgrade of the technical platform by adding absolute quantification of cell-free DNA. I will not say more than what that means. I know that Jakob Nilsson, on the last lecture, he is going to mention a little bit more about cell-free DNA. But you have to take my word that I see it as a leap. If it's a big leap or a small leap, I mean, that we will see in the next coming years. But it's important to have both the long-term and the short-term focus. So this particular innovation with regards to the technique, I see as a potential upgrade of the Devyser engine with regards to the technical platform. And that is something what will give us a very interesting and potential choice where should we put this engine. Should we put this in the transplantation area? I would guess, yes, somehow because there is where the invention comes from. But it also opens up other situations. Maybe we can also explore inflammatory diseases, companion diagnostics. It can also potentially be used as a liquid biopsy marker looking at oncology, minimal to residual disease; sports medicine, there's a lot of opportunities there, and we will see where we go. But it's definitely very promising. Before ending and leaving the word to Theis, I also want to mention our extensive clinical study program, something that is very important. We are very actively initiating and also sponsoring clinical studies. By doing that, we gain entry to different hospitals, and we also create future customers because when they have used our very nice products, then they are stuck and then they're going to use them. We are actively involved in more than 30 clinical studies, 5 continents. It's ranging from everything from scientific studies where we work together with the clinics in order to test our new concepts, regulatory studies where we need information for IVDR or potentially FDA, multicenter studies and also small studies, so validation studies, where more or less one clinic wants to implement something, we give them a couple of kits, we interact with them, we give them some tips how they are supposed to do the studies. And then when they like it, then they start using them. And here you see some logos of the many centers that we collaborate with. And now, of course, being a little bit picky, we pick the best ones. But several of these ones like Mayo, UCL, University Hospital Zurich, this is top 10 university hospitals in the world. And together with all of these names, now you have Devyser's brand, which I think is very, very nice. Hand-in-hand with this, we are also getting more scientific traction. This is also important because you have to remember that many of these clinicians that are stakeholders deciding if they are going to go for our products, they are also scientists. So they are going to read scientific papers and then those papers are going to be part of the decision if they are going to use Devyser products in the end. So making a simple search, there is more than 30 scientific papers just the last couple of years, and that's a massive increase compared to earlier years, and that's mainly NGS products actually. 9 different products in scientific papers and also scientific congresses. And at the same time, in order to get more feedback from the outside, we are strengthening the knowledge by forming a Scientific Advisory Board. Happy to say that Jakob Nilsson here is going to present, he is one of the members of our Scientific Board. And here you have some examples of publication where we either work very closely together with centers or we use pick up the scientific papers afterwards because people have used our product and they want to for the rest of the scientific community to present the data that they have achieved. So I end with saying that I think that the future looks not bright but super bright. And then I hand it over to Theis.

Before doing that, maybe we have some questions to Michael. And please raise your hand and we will get a microphone.

Erik Hultgard from Carnegie. I have a few questions on my end. And Fredrik, I promise you I will keep it to a maximum of 2. Perhaps starting with sort of the larger sort of fundamental question. The most important thing about Devyser is its platform, the development engine, one tube solution. And I think one crucial aspect here is how tricky is it to copy this concept. You've obviously been doing this for quite some time, a few decades and nobody else copied it, but it is part trade secret part patented. So if you can give us some type of clarification on how well protected your moat is?

So the patents are still valid, for sure. I would say, I would speculate a little bit that it's not so easy to just copy it straight out because many competitors, they have gone in a long way in another direction, not maybe aiming for one tube solution and then suddenly introduce that into an already workflow, that's not easy. So I would say that, that also strengthened, what you say, not by patents, but the trade secret of Devyser. It will take many years for other competitors to go in that direction from where they are at the moment.

I would have a follow-up question, but I only have 2. Maybe we take the other one today. But another aspect, the software part. You talked about quite a lot of software upgrades. And if I'm correct, software has been kind of a soft spot within Devyser in comparison to competitors. So where do your new software stack up against sort of your main competitors out there, your genetics, your CareDx, et cetera, et cetera?

And now you're talking about the ones I mentioned for the transfusion medicine or in general?

In general, sort of where we're coming from and where we're at today in terms of the new software development.

Okay. So I will not admit that we have a soft spot. I think it has been developed quite a lot during recent years to increase the standard of it, but it can definitely be improved further. But I think that we have 2 very good teams, so I think we are definitely competitive with regards to software.

I think we have time for 1 or 2 more questions.

Yes, perhaps just 2. So first of all, you talked about this new test now for 2025. So the plan is to launch them in 2025, okay? And then the follow-up is regarding this HLA test, so that has a tight connection to the Chimerism test, which you now have a deal with Thermo Fisher. So are you planning to include that into that agreement as well? Or are you going to try to sell it by yourself?

That question I leave to Theis.

I think that we have not yet guided on. But I think there's a lot into it what you're saying, but we're yet to confirm.

Ludvig, did you have a question?

No.

Okay. Thank you, Michael. There will be more time for further questions at the end. So please, Theis.

Thank you. And thank you, Michael, also. I mean making leaps is why we are here and especially representing the commercial organization, as you will sure appreciate. For this next session, I'm particularly excited to be able to give you a deeper look into the commercial engine of Devyser, including sharing some new depths and some new details, which we yet have not shared with you guys in the past. You'll see also that we will be sharing these deep dives at this Capital Markets Day as well as future Capital Markets Day. So you will get a deeper dive at these events more than you will see at the earnings calls. For the sake of introduction and for those I have not personally met yet, my name is Theis Kipling. I'm the Chief Commercial Officer since 2022, where I joined Devyser from a similar position at also a Stockholm-based company called Atlas antibodies, a subsidiary of Patricia Industries. I'm Danish, as you may hear from my accent, and I'm living Northrop Copenhagen with my family, 2 kids and my wife, but I worked here on site in Stockholm for the past 4 years. Before starting to work in Stockholm, I was heading up the Pathology Diagnostics Business with the American company, Agilent, both in Germany and before that, also in Italy. And I've been throughout my career working in international positions within the health care industry. My dark past is that I'm initially from the numbers side of things, as I have a master's degree from Copenhagen Business School within finance and a background, an initial part of my career within controlling. Let's dive into the Devyser part. So at Devyser, as you have heard, we are serving 3 verticals across oncology, hereditary disease and transplantation, which represents a very, very large addressable market of several billions of euros. Oncology is by far the most competitive and transplantation, the area where we have the most growth. Due to the size of the available market, we will have a very large market to collect revenues from in the many years ahead of us. When looking on a Q3 year-to-date level on revenues, the split is 21% of the revenue sitting within oncology, another 67% sitting in hereditary and 13% sitting in transplantation. From a new launch perspective, we have, as you heard from Michael, one new product in '25 within oncology, we have 2 to 3 within hereditary, and we have 4 to 5 within transplantation to be launched. Hence, we expect to be able to maintain or potentially even exceed the growth across these 3 verticals, however, still with transplantation to continue as the fastest-growing portfolio. It's worth noting down here to the bottom right, the increased number of indications within solid organ transplantation, proposed transplantation monitoring, which we, in particular, are very excited about. And you'll hear a lot more about that in the remaining slides here. You've heard me say before that we are commercializing through 4 distinct channels. The first being direct sales, which we use for established markets and being our preferred channel when markets are large enough to host our own sales force. The second channel is partners, which is where we today have Thermo Fisher. Partnerships can be either exclusive or nonexclusive. And usually, partners take a large responsibility for regulatory issues, for customer support and the liaison towards key opinion leaders. Third channel is lab services. A recent investment of ours, which is our clear laboratory in Atlanta, Georgia and the U.S., where we today are selling services using both our own products, but also running services on behalf of third-party companies, such as the U.K.-based oncology company named [indiscernible] as well as there will be pharma companies. The fourth and last channel is distributors, which also can be exclusive as well as nonexclusive and where we today have around 50 distributors globally. And usually, once we see a distributor market grow into becoming a sizable market that can host our own sales organization, then we convert that market into channel #1 as a direct sales business. Now we will move into the transplantation part of the portfolio, which is the fastest growing, as I've mentioned. I will be focusing my presentation on the transplantation business here and especially focusing it on the U.S. opportunities that we are seeing with particular focus on the FDA program that we have announced for our solid organ transplantation test. There are several reasons for why we decided to do this investment into seeking FDA clearance. But the main reason is that we believe in testing democratization into local hospitals instead of the big corporate testing service companies that today is dominating this field. Devyser have since day 1 developed our tests with the mindset of these being simple enough to work in any local laboratory. Simple and local will lower the costs for the laboratories while increasing the patient benefit through a faster turnaround time. Currently, the reimbursement for solid organ testing as a service is around USD 2,800 or equivalent to approximately SEK 30,000. Today, there's no FDA-cleared tests for monitoring of solid organs. And consequently, there is no reimbursement aside some general codes, which may or may not be recognized for reimbursement. And you will hear Jeff later on talk about this. Our main competitors tests, they have all been developed as a send-out test, which makes it difficult usually and tedious to implement into a local laboratory. Whereas when it comes to our tests, it's exactly the opposite. In addition to this, we have also conducted a large market intelligence in the U.S., informing us that customers actually do want to take this testing back home, localizing it in their own laboratories. Hence, we see several reasons making us believe that we can actually carve out a fairly attractive market share within this field within the U.S. In our view, an FDA-approved test for solid organs can change the revenue flow in the market, which will then -- in the market that with in turn improve the turnaround time, which is going to be critical for patients, both as well as will lower the general cost for society on a per-test basis. The picture to the left shows the current flow in the market with the hospitals sending their samples to the services laboratory who are then running the tests, sending back the results and collecting the reimbursement from the payers. In the picture to the right, we try to show how we believe that the revenue flow within this market will change following FDA approval. In this situation, a hospital can run the test themselves and in much shorter time, provide an answer to the patient and then collects the reimbursement from the payers. This, we believe, based on the market intelligence and research will make patients and hospitals want to take back the testing as it both benefits their patients as mentioned, and not least, benefit hospitals through this new revenue stream. So we maintain our belief that the services business also will remain being large and attractive. So there will be 2 markets to serve. And hence, we do anticipate also that our lab increasingly will be capturing market share within that specific channel. Moving into how the future could look like. So to provide some models on how success might look like, we have shown revenue potential in a scenario with a 2% market share versus another scenario with 25% market share. The way of monitoring is different with newly transplanted patients and their first 1 or 2 years following transplantation versus the maintenance patient group who are already living with a transplanted organ. The main difference is in how frequent you're being monitored. In addition to the number of times that you monitor a patient that can vary across organs, usually with heart being the indication where the most frequent monitoring happens. And there, we have one of the experts in the room who can put more efforts to this specific element, including how far has monitoring become as a concept within the market. The potential revenues might range from about SEK 0.5 billion in the 2% scenario to up to SEK 6 billion in the 25% scenario on the total population perspective within the U.S. alone. What is difficult to assess at this point is the proportion of the market staying within services, so on the left side and how much market share we can take with the shift towards the right side on the previous picture. The scenario of the FDA-approved assay here, it's important to note that we estimate that the manufacturer of the test would keep 1/3. That's going to be important. Usually, in the U.S., the manufacturer keep 1/3 of a localized test and reimbursement. As we are planning to commercialize together with Thermo Fisher, there will also be a revenue sharing with those guys. But despite all revenue sharing across hospital and channel, there is still a potential revenue stream to Devyser of approximately up to SEK 1 billion, which is a lot more than what we are dealing with today. Part of our belief in reaching or even potentially exceeding 25% comes from the partnership exactly with Thermo Fisher, leveraging their dominant market position within the transplantation space. During the next 2 slides, I will be providing you with another level of detail and insights on the other parts of the business and beyond what we usually share as already mentioned. When we look at verticals and technology, both are performing really well and both taking market share. When sharing CAGR here, I have used a 3-year horizon and extrapolated on our 2024 Q3 year-to-date numbers by dividing them in 3 and multiplying by 4 to get a full year number for 2024. That said, we see a strong 28% CAGR in both Oncology and Hereditary, whilst the Transplantation vertical grows 73%, but that's just taking up until Q4. And as you've heard, Fredrik shared at the earnings call, we received a large order from Thermo Fisher in October, meaning in Q4, which is not baked into this number. Moving to the technology side and from a technology perspective, our oldest portfolio being the fragment analysis portfolio continues to take market share by growing impressively 14% in a market that grows modest single digits. Our NGS portfolio grows 34%. But again, here, you need to note that is without this order that I just mentioned that we got from Thermo Fisher on NGS products in October. Lastly is the PCR portfolio representing our RHD test, which grows 43%. And here, for those who follow the press releases, you will know that we have declared that we won a big tender in Wales. We have great traction in Canada and soon to see traction in the U.S., which yet not is reflected in the number. When taking a look at our individual high-performance products transplantation and RHD, we see our tests for cystic fibrosis growing 27% and thalassemia growing 53%. Both of these products have a lot of potential and will continue to grow fast, not least in the U.S. On a final note, it's also worth mentioning that we have been able to increase prices by 9% in 2023, another 8% in 2024. And we have just flagged an average 7% increase for 2025, something that we have carefully decided on following doing price analysis, market and competitor analysis and obviously combining that with our own price-to-value assessment. So with that, I am closing the commercial deep dive, handing it over to Jeff Salzman in a prerecorded video. But Jeff, as communicated, will be with us live for the Q&A session.

Thank you, Theis. Before starting the video, maybe we have a couple of questions here. Erik?

Two questions. And first of all, potentially on the FDA situation because there is a lot going on with the CLIA labs and the lab developed test in the U.S. And obviously, you've now taken the position to clear a few tests to be FDA approved. How much or how important is it that you struck this Illumina agreement in regards to these tests? Because MiSeq at least as far as I'm aware is the only FDA-approved NGS machine.

And to that point, it's very binary. Without that agreement with Illumina, we couldn't pursue. At least it would be a very challenging route. And the reason for that being is that Illumina have a research use only test which you cannot use for a cleared FDA test. And then they have the DX, the diagnostic box that is locked, so you can't tweak it on a user level, which is going to be very important because that's where we will substantiate all the data that we are generating so that the customer more or less is left with just pressing a button. And then the customer knows that whatever is now happening within the machine has been validated in accordance to the standards and cannot be tweaked by the user. So -- and that is very binary. Without that -- those agreements with Illumina, we wouldn't be able to stand here and declare an ambition to go after FDA clearance.

And just a follow-up question on that. And I think we talked about this, you and me on the last earnings call. Like cystic fibrosis is one of your tests that you're pursuing the FDA route with. The competing product on the market today is from Illumina. And you state that it's a binary way forward that you need to be aligned with Illumina. So can you just outline how this works?

So they are FDA cleared to my recollection already, right? Illumina is also one of the few products, current living and fulfilling the guidance that was recently issued about a year ago where you need to monitor and match 100 markers, right? But as I've also said on that earnings call, there are not that many companies actually having products with or without FDA approval, actually fulfills that threshold has -- recently were defined by the association behind the guidelines. So going -- so this is obviously a play to win in this market, right? And overcoming that regulatory barrier will enable us to get a broader traction within the U.S., obviously, head-to-head with Illumina, but they play to a short, they need to allow companies like ours onto their platforms. And I think from our meetings, we have several. We know our friends at Illumina very well, also from my own past career days at Agilent. They do want to have these type of partnerships.

And last question on my end. It might sound a little bit biased here. But how important is that you're a European diagnostic company developing generic test kits when coming to addressing this large hospital market. Because you're going up against lab-developed tests. These are designed to work in single labs or a chain of labs. These are not designed to be fit into the workflow of a hospital. So how much -- or how well does that play into you grabbing a majority market share in this niche?

I think within these niches, and there are several, so that's the beauty and the challenge with Devyser that we need to look at various segments specific before we can confirm anything, right? But I think when doing that across cystic fibrosis, across transplantation, I think that's -- the market should be perfectly suited to take on a test like ours. Going into oncology, I think it's a little bit different, right? Because that dynamic is different. We work and serve an Amplicon-based technology, which is much more targeted, and also all our products are very diagnostically focused, right? It's very binary, yes and no. In the oncology space, there is a ton of additional data information, as you sequence a whole genome, which is not where we are playing. So I think our assays and there are multiple different ways of getting it docked into a workflow that is already preexisting in a successful way with technical terms that spike in and so forth. So I don't see that as in any way a barrier.

Do you have time?

Yes, we have and Ludvig also after you.

Okay. I'll be quick. So you spoke a bit about the test for the other solid organs. So heart, lung and liver. But Michael Uhlin did not speak about them when talking about the 2025 launches. So what's the plan here?

I think we -- they are actually already in the hands of most of the companies out there in the research use fashion, because it's essentially the same product you can use for these different organs. So Michael and the team are working with leading experts and fellow people also in Canada, and so forth, as he talked about, right, to validate, so that -- from a regulatory perspective can be launched as well. And I think we have declared that we are...

Yes. So they are in the...

That's IVDR. So...

Okay. And Michael more showed highlights, and we are behind highlights with these products.

All right. And just a last one then. So just thinking about the difference when you are offering the tests in your CLIA lab versus selling them then to the hospitals. So from the hospitals' perspective, is there a benefit that they received some revenue stem from the test versus now when they are only sending their samples to [ CareDx ] for instance?

That's a great question. Yes, I mean, that's why I'm so excited about what we're about to do here because today, there is -- how it works is in [indiscernible], the patient goes to hospital, post-transplantation follow-up, gets the blood draw. And then that sample is sent out to CareDx, natera any of those, there's very successful companies out there. And then they get a result back. And there are very limited reimbursement flow to the hospital. So they get zero benefit, you can say. I think and I personally subjectively believe that not only can we lower turnaround time, which matters for health care providers like the gentleman over there. But also in the U.S., as we all know, is a very capitalistic market, money really matters. And here, we will open up a channel of revenues going into the hospital system. So I don't think I need to carve out much more argument to have a very meaningful conversation with the decision-makers in U.S. hospitals. So they do want -- that's why they're in the profession, make it better for the patients. If they can lower turnaround time instead of being 2 weeks to 1 week, or even lower, of course, that would be a heavy weighing argument. But when they can also go with that argument to their administration and say, we're going to have to invest some money over here. But if we do that, and Jeff does what he has promised to deliver on, then there will be a very significant revenue flow that those hospitals can then benefit from, which they're also going to need because, obviously, they will have to invest into capital equipment, the DX Illumina sequencer and other aspects. But that funding flow will be secured by the FDA clearance.

More short question, one from Ludvig and [indiscernible].

Okay. Yes, so continuing a bit on that last one. So would you say that the transplant clinics typically have the instruments and competence already to run your tests? Or...

I think that is a question, we're still running around together with Thermo Fisher mapping out who has their [indiscernible] only who has the DX instrument. So there, we are already screening and scouting that market. We are pretty well ahead because there are other instruments that those laboratories also in some instances would need technical thing, but a taped station from Agilent is validated in our workflow, some of them didn't. So we had a successful agreement with Agilent so that Thermo Fisher can place those boxes out there and the same we're now doing with Illumina.

Okay. And then also on the RHD test, I believe you still have quite limited sales in the U.S. for this, although you have approved in the LDT setting at your CLIA lab. Like what is required for you to sell this test typically? Is it going out to different hospitals and sell in your service? Or is it -- how is the sales process typically going here?

I mean that can go in many ways. I personally believe in partnerships in this one because this is going to be so broadly spread across the country. So if I were to sustain a sales force that would be successfully knocking on those doors, it will be a rather significant investment that we would have to make. There is one -- as to my knowledge, one real big player out there, who successfully have an RHD test, which was quite timely also with the shortage of the program, which is the prophylactic injection that has been market dominating in the U.S. There is one player. They did have earnings call release just a few weeks ago with quite attractive growth from especially the RHD. And then you have 4, 5, 6 other equally large companies in the U.S. who doesn't have one. And I feel rather confident that they are looking at Devyser because Devyser have a test that is already validated on U.S. soil in our CLIA lab, right? So we can rather quickly get into network, which is [indiscernible] and get benefit from those infrastructures. Still to be proven. So -- but I feel confident that at least we are well positioned to have that conversation at least.

Right. And then it would be sold as a send-out test from the reference lab you are right...

Then you could be either send out as a reference test from our lab or it can be then buying our kit essentially and validating into their own laboratory. It can be both ways.

[indiscernible] Well, thanks for hosting this, first of all, very informative. One risk that we're running here with all the excitement and all the new products and whatnot and you're showing these very interesting scenarios is there's a bit of absence of timelines. And we have a bunch of finance literate Excel jockeys in the room, and it's very easy to get carried away in Excel to figure out what something is worth. But it's quite different to run a company from running an Excel spreadsheet. So could you provide us with some guidance on when we should expect these milestones and these scenarios? Is there a timeline attached to them? Or how should we think about them?

Yes, I agree with you. We have a lot of opportunities. But we are a bit careful saying too much about timelines. One question we get quite often is the timeline for the FDA approval for the Accept product. We would like to wait a bit until we have some more information about that because my experience is that you can -- you get -- they're always delayed, and they're not provided earlier than expected. So we are a bit careful. As soon as we have more information, we will share that for the Accept. Same goes with the other products. We are a bit careful for the time being.

I think one -- it usually only goes one way, right? I mean it's -- things take more time than we want, customers want and so forth. So...

And what we have is our financial targets, and we will come back to them at the end of the day. So that's what we stay with. Okay. With that, I think we should move over then. We are 2 or 3 minutes late, but let's move over to Jeff Salzman.

Thank you for your time today. I'm Jeff Salzman, Vice President of Market Access and Public Affairs at Devyser based in the Washington, D.C. area of the United States. My career in market access and the diagnostics industry spans more than 30 years, having held leadership roles at various innovative companies, including at CareDx, where I led the effort to secure Medicare and private payer coverage for AlloSure Kidney, which became the foundation for their entire AlloSure franchise. Today, I'd like to share how Devyser is strategically building our U.S. market assets presence through a sophisticated dual model approach leveraging work we do for testing services offered at our laboratory in Georgia to support our long-term kit objectives for years to come. My comments today pertain to our U.S.-based business. So what is market access? The term market access generally refers to 3 core elements: coverage, coding and reimbursement. Coverage, meaning that the payer community has deemed our testing to be medically necessary, and as such, they provide positive insurance coverage for our services. Coding, meaning that how we bill payers, public and private, using CPT codes that are issued by the American Medical Association, or AMA. And reimbursement, ensuring that our services are paid at a rate that is acceptable and appropriate. As this relates to our efforts in the United States market, we are creating coverage pathways for laboratory services that could be leveraged for our future kit business, beginning with obtaining coverage with Medicare, which I'll discuss in just a moment. Second, the process involves implementing a comprehensive coding strategy that aligns with both public and private payer requirements serving both business models. Third, we will work to secure competitive reimbursement from Medicare as well as the private payer community. I'd like to give you an example of Devyser's dual business model approach from a market access perspective. Of course, Devyser Genomic Laboratories or, DGL, is our laboratory in the state of Georgia. We're pursuing Medicare coverage for our transplant trace cell-free DNA assay to be performed as a service in Georgia. In the future, we'll also be seeking Medicare coverage for the Devyser One Lambda Accept cell-free DNA test kit, which is the same test to transplant trace. Transplant trace is the service and Accept cell-free DNA is the kit. The work we are doing now to establish coverage, coding and reimbursement for transplant trace will be leveraged to support the Accept cell-free DNA test kit, meaning that our clients who purchase these kits should have a clear pathway to getting paid for the testing that they perform. The advantages of this approach are numerous, including that it provides Devyser with a revenue opportunity in the nearer term for the services that we perform in Georgia. It also provides Devyser with the opportunity to gain and grow our market presence in the United States. And of course, it gives Devyser the opportunity to build relationships with transplant centers nationwide. For this particular test, Devyser will soon be able to offer both the service and the kit to transplant centers, giving them the flexibility to choose the approach that works best for their needs. This also provides transplant centers with a potential revenue opportunity when they perform testing using our kit as opposed to sending the test to a third party. I see this as a win-win opportunity for transplant centers and Devyser. So let's talk about Medicare. Medicare administered by the Centers for Medicare and Medicaid Services, or CMS, is the federal health insurance program covering more than 67 million Americans. While Medicare primarily serves senior 65 and older, it also covers certain Americans with disabilities regardless of age, including those diagnosed with end-stage renal disease, or ESRD. This automatic Medicare eligibility continues after kidney transplantation, resulting in Medicare coverage for approximately 80% of kidney transplant recipients. This creates a clear market opportunity for Devyser and transplant trace where Medicare will be our primary payer once coverage is established. As the nation's largest health care payer and primary coverage decision-maker, securing Medicare coverage is key to our success. While Medicare coverage policies can be established nationally by CMS through a national coverage determination, or an NCD, most molecular diagnostic coverage decisions are handled regionally by Medicare Administrative Contractors, or MACs, as they're known. Devyser's Georgia Laboratory is under the jurisdiction of Palmetto GBA, one of the aforementioned MACs. Palmetto launched the MolDX Molecular Diagnostics program in 2011 to perform technology assessments, determine pricing and published coverage decisions for molecular diagnostic testing for Medicare beneficiaries located in their jurisdictions, which again includes the state of Georgia. MolDX is considered the gold standard for molecular diagnostics coverage decisions. Our strategic location in Georgia provides Devyser with significant advantages, including providing a clear pathway to Medicare coverage via the MolDX program, standardized technical assessments and coverage decisions that often influence both Medicare Advantage insurance plans and commercial insurers nationwide. Our market access goals are strengthened by strategic partnerships with key industry coalitions that align with our core business objectives. Devyser has memberships in AdvaMed and C21, the coalition for a 21st century Medicine, reflecting our commitment to both business models. Through AdvaMed, the largest medical technology association in the United States, we gained broad medical device expertise and direct support for reimbursement planning. This will be especially valuable to us as we prepare for kits submissions to both the FDA and CMS. Our membership in C21 gets Devyser deep insight into public and private molecular diagnostic testing policies that could impact coverage, coding and reimbursement for our testing. Together, these memberships ensure that we stay ahead of any industry changes while building value for both our laboratory services and kit businesses. They provide practical resources and expertise we're using right now at Devyser Genomic Laboratories, which will directly benefit our future kit customers. These relationships are particularly valuable as we navigate an evolving regulatory landscape. And speaking of the evolving landscape, I'd like to address how we're approaching regulatory developments in the United States. As some of you may know, in May of this year, the U.S. Food and Drug Administration issued their final rule for oversight of laboratory developed tests, often referred to as LDTs, with initial compliance beginning in May of 2025. While there are pending legal challenges and potential legislative alternatives and an upcoming administration change, our approach remains proactive, yet flexible. Through our industry associations, we maintain real-time awareness while preparing for various scenarios. This ensures we're well positioned to adapt and succeed regardless of how the regulatory landscape evolves. And our membership in both AdvaMed and C21 gives Devyser a seat at the table, so to speak, with policy discussions and decision makers. Further, we've recently hired a U.S.-based Director of Quality and Regulatory Affairs to ensure we are prepared for whatever awaits us in 2025 and beyond. As I mentioned, we're now preparing for our first submission to MolDX for coverage of transplant trace. To strengthen our submission and help ensure a successful outcome, we've engaged with 2 former MolDX associates who previously were reviewers and have direct first-hand experience with the MolDX technology assessment process. I'm happy to report that we're making great progress. And in fact, we have our first pre-submission with MolDX in December. We've applied to be a participating Medicare provider, which is a requirement to actually build Medicare for the services that we perform. We are registered with MolDX not only for transplant trace but also as a first step in obtaining coverage for our first 4 assays that we'll be offering from our lab in Georgia. We've developed a coding and pricing strategy for our testing, which I'll expand upon in just a moment. And finally, we have a revenue cycle management company under contract to handle our billing. Therefore, once we achieve Medicare coverage of transplant trace, we'll be well prepared for a successful launch. I'd like to talk for a moment about Devyser's value proposition with the payer community here in the United States. Payers are motivated when companies like Devyser can offer high-quality, cost-effective care that provides clear clinical utility and improves patient outcomes. In the case of transplant trace, our value proposition centers on delivering high-quality transplant monitoring while reducing overall costs. Tests that are similar to transplant trace has been historically priced close to $2,800. By positioning transplant trace at a lower price point than current alternatives, we're demonstrating our commitment to sustainable health care economics, not only for payers such as Medicare, but to transplant centers and transplant patients alike. And we can do this while still maintaining excellent margins. Further, our plan includes applying for a Category 1 CPT code with the American Medical Association post launch, which will solidify our coding and pricing on the Medicare clinical laboratory fee schedule. It's another win-win for Devyser and transplant centers alike. So in summary, I'll close by emphasizing our path forward for market access in the United States. We anticipate our first Medicare coverage determination for Devyser Genomic Laboratories by next summer, establishing a revenue channel for the company through our laboratory in Georgia. Our experience there will inform our kit commercialization and coverage pathway, creating a repeatable process for future market expansion with additional lab services and test kits. With both laboratory and kit offerings, we are building a practical approach to serve the U.S. market effectively and successfully. Thank you for your time and interest today.

I have a couple of questions from the audience here. We take them immediately. Ulrik Trattner to start with.

Can you hear me? Great. If we start off, a lot of focus, of course, on getting reimbursement here of Medicare and Medicaid. And over the last few weeks, a lot has changed in the U.S. in terms of President-elect Donald Trump appointing Dr. Oz, planning to shake the tree in terms of reimbursement for the Medicare and Medicaid. Where do you see the risk lies in that? And it seems like a lot of companies are more and more positioning themselves to address private pay. So just how much or how are you working on getting access to this?

Well, if I understand the question correctly, are you saying because of the new administration coming in that what's our path forward with the administration or specifically, what you're asking is...

What risks do you see in the path forward in terms of reimbursement levels and as well as how you're addressing and how you're working with private pay in addition to the Medicare and Medicaid segment?

So clearly, it's anybody's guess with what's going to happen over the next couple of months and years. What I would say, and this is my own personal opinion, that with the Trump administration coming in, I would venture to say that there's slightly less of a risk for a major impact to pricing with the clinical laboratory fee schedule with the FDA final rule of oversight of LDTs, that's really, that's where I thought your question was going actually because the first stage of the final rule comes into play in May of next year, as I was saying in my presentation. All of the conference calls with the industry groups that I mentioned in my presentation are all suggesting that labs like ours need to continue to move forward and be prepared for FDA oversight. But, there's a slightly less change that the Trump administration is going to make this a priority or rather that they would make that -- we think that there's lot of big chance, I worded that wrong, sorry, that there's, that the Trump administration will likely not make this a priority, so which means that the final rule would stay in effect. But at the same time, there are Republican members of Congress that have expressed that there should be an alternative LDT regulation as opposed to the final rule. So that's why I say, where would this all shake out? I don't know, but we just need to make sure that we're prepared for May of next year, which we are. As far as pricing, that's a great question. And as I sit here and think about it, I believe that for our immediate plan, say, for 2025, in terms of what I laid out and with the launch of transplant [Trace], the initial prices is going to come from MolDX anyway and not from CMS, it's the clinical laboratory fee schedule. So I don't think that there's a big risk there that will be impacted negatively. And as I also mentioned in my presentation that we plan to work with CMS and the payer community. We believe we can offer transplant [trace] at a lower price than the competitors and still do really well with it. So I think if we were going in expecting a higher price than the competition, I would be a little nervous right now. But knowing what I know in terms of what our plans are for pricing and quoting, I think we'll be okay. I really do.

One more question before we take a short break.

Yes. Ludvig Lundgren from Nordea. So just a question on the pricing and reimbursement value that you mentioned there in the end. So you're planning to be a bit lower than competitors, if I understood correctly. Could this be that hospitals then choose to still go with the other ones that are more reimbursed, so to say? Or will this be more beneficial from the hospital side as well?

Well, it's still beneficial to the hospital side. That's a great question, but let me explain that with the send-out model to CareDx, Natera or Transplant Genomics in your lab, when it's sent out like that, the hospital really doesn't make a penny. The money for the testing goes to the lab that's performing the testing. So whether that's reimbursed at the approximate $2,800 that they're currently getting or something lower that we're looking for, it's still money that they're not getting today. So I think that I would expect that most transplant centers will still find it very attractive to run the test and collect that money. Reimbursement usually just comes down, right? And so here's an opportunity for a transplant center to make more money for testing that's already being performed, but they get to keep at this time. So it's nice to saying, I really think that transplant centers are going to find that very attractive.

Okay. And do you think that this then will be a very profitable like product for the hospitals then, I guess?

I mean I would differ that Theis to talk about pricing of it, but just in terms of what we'll sell the test kit for or what Thermo Fisher sells to test kit for versus where I expect reimbursement to land. Again, as I mentioned, although I was talking about transplant trace as a service, but the margins are still very, very strong that I think most other laboratories and other types of testing would be quite envious of the types of margins that we have, even at a lower price. The cost of NGS technology has come down a lot since CareDx launched AlloSure in 2017. And Medicare knows that, by the way. I've actually had a conversation with the medical Director at [MolDX] about this very topic, more than a year ago before I was with the company. So that's why I think that Medicare in knowing what I know about how MolDX views pricing for this types of -- for these types of tests and where we plan to come in, I think Medicare will be very happy. The transplant centers will be happy that eventually, this will be an opportunity for them to make additional revenue. And the private payer community is always looking to save money. So I think that we will be very well positioned with this.

Great. Thank you very much, Jeff. You will have an opportunity to ask questions to Jeff during the general Q&A session. Now it's time for a short break. We said earlier, 3:00, let's meet here 5 past. Coffee is served in the lounge where you met earlier. Take an opportunity to grab one of our 20 years anniversary books on the table outside. And you can also see our products outside here. So meet here 5 minutes past 3. [Break]

And then I have the pleasure to introduce Jakob Nilsson, the next speaker, and he will introduce himself. Welcome. The stage is yours.

Thank you, Fredrik. So this is me, right? So I'm the Head of Transplant Immunology at the University Hospital of Zurich. And I'm also a medical adviser here at Devyser. And I've been in Zurich for the past 8 years, heading transplant immunology there. And before working in Zurich, I was working at the Karolinska for many years in the fields of infectious diseases, immunology, and transplant medicine. So I'm here today to talk a little bit to you about what's called donor-derived cell-free DNA in post-transplant monitoring. So this, what I will talk about is all about solid organ transplantation. So it's not about stem cell transplantation. So we're talking about kidney transplantation, lung transplantation, liver transplantation, heart transplantation, pancreas transplantation is the main thing what we do in Zurich and what's done worldwide. And I hope that I'm not going to be too technical for you. But I'm going to try to give you some background and then get into the assay a bit and then get into how we are using it at the moment and what I see a bit in the future. So just to start a bit of background on donor derived cell-free DNA and on cell-free DNA in general. So in the blood stream, of course, you have lot of cells floating around and most of them have DNA inside of them, but you also have a DNA that's not cell associated. So you have DNA that's floating around by itself without being associated with cells. And this is what we refer to as cell free DNA. And if you look at cell free DNA in a person and not in the transplant setting, but just in a normal human being, this is a very interesting diagnostic possibility because you can think about it. For instance, in the pregnant female we know that fetus will secrete cell free DNA into the circulation. We use this for a lot of prenatal diagnostics where we can look at trisomy 21 for instance or you can do a lot of other fetal diagnostics. You can have it in the setting of tumors, which Mike talk a bit about with the concept of a liquid biopsy, where you can see the DNA that's being secreted from the tumor cells and you can sequence it and you can look at mutations and you can quantify it in a setting of tumor biology. And you can also, of course, look at the cell free DNA just from the own person because cell free DNA is derived from cells that are either dying through necrosis or apoptosis, so it will be a reflection of what's happening in your body at a certain time point. So the cell free DNA will be typically in the form of quite short oligonucleotides. So the length of these oligonucleotide is typically around 150 to 200 base pairs centered around 170 typically, and this has to do just with how the DNA has occurred on the nucleosomes and how it's degraded by nucleases, but this will be your peak size where we find the cell free DNA. And of course, in the setting, if you have, in this instance, a transplanted kidney. You -- within your blood stream as a transplant recipient have a mixture of your own cell free DNA and cell free DNA coming from the transplanted organ, right? So you will have both of these cell free DNA molecules existing at the same time. And it's, of course, a given then that if your transplanted kidney is experiencing a lot of cell death and cell loss within the graft, it's going to release a lot more cell-free DNA into the circulation as a marker of what we call graft damage. And we can with a lot of different techniques because there are genetic differences in the transplant graft compared to recipient, we can with several different techniques decide if the DNA that we are finding the cell-free DNA, if it's coming from the organ that's been transplanted or if it's coming from the recipient itself. So you can do this with sex mismatches and you can use different types of polymorphis between individuals to nail down from which part of the body this DNA is coming. Is it coming from the transplanted organ, from the recipient itself? And you can also do this with different types of technology platforms. So you can use different types of next-generation sequencing or you can also use qPCR or digital droplet PCR. And it all boils down to a basic calculation in the end, where we want to know how large of a fraction of the total cell-free DNA is coming from the transplanted organ. And this is what we quantify in the end with these assays. So that's just very short as a background to cell-free DNA and to donor-derived cell-free DNA. So I just wanted to switch a bit into post-transplant monitoring just to give you a sense on of what we are doing with our transplanted patients after transplantation. And post-transplant monitoring, it's all about this. So it's all about trying to extend the survival of the transplanted graft, which indeed extends the survival of the transplanted patients, right? So this is what it's all about. So this is a graft looking at kidney transplantation from Europe with what we call death censored graft survival. That means that somebody is losing their graft without dying, right? So it's a patient that's losing their grafts and will be in the need of a new transplant graft. And you can see that there are 3 different eras represented here. And with these eras, you see that we are improving. So transplant outcomes are improving, which is important. But you still see that if you go out 10 years, you will see that maybe also in the latest era, about 20% of the patients that have been transplanted have already lost their kidney. And this is, of course, something that we want to prevent because if they lose their kidney, then they will have to be put on the waiting list again, and we will have to put in a new kidney, right? And if you imagine transplanting somebody who is 20 or 15, then you can imagine that they will need 3 to 4 maybe kidneys during the lifetime, right? And since we have a scarcity of organs, it's better -- much better if you just need one, right? So this is the whole idea of the topic. Now when you see these improved outcomes, it's also very important to note that this is in the background of the field being much more challenging now today than it was 20 years ago. And why is it much more challenging? It's because of this lower hand side here, where you can see, what's happened with recipient age, what's happened with donor age and what's happened with so-called expanded criteria donors. So this is all in the setting of kidney transplantation. So what we're doing now compared to 10, 15, 20 years ago, we're transplanting all the patients with older donors and with organs that are much worse than what we were using before, right? So it becomes even more difficult. And it's because of these improvements that we can do this, right? So because the improvements are there, so we have less risk in what we're doing. The indications for transplantations are expanding, right? And the age gap or the age limit of when we consider transplanting lung is expanding. So 10 years ago, we would never have transplanted anybody with a lung over 60. And now we're sort of, yes, just 1 lung, maybe it's a very fresh 72-year-old, why not, right? Why not 1 lung, right? Because the life expectation is so good and the outcome is getting so good. So you can imagine that when we start doing this more, and we're really pushing the envelope on what we're using for organs, then we need to improve our monitoring even more, right? So it really puts an incentive of that. So coming back to transplant loss again, why are these patients, so I'm talking about kidneys all the time now, but you can extrapolate this to lung transplants and to heart transplant and to some extent, also to liver transplants. Why are these patients that are losing their grafts? Why are they losing their grafts, right? So this is a central question. So this is just one study on kidney transplantation, trying to look at patients who are losing their grafts, why are they losing their grafts. And it's a lot of details here, and you don't have to look at it at all, but just notice these 64% here, which are all rejection. So rejection is the big cause of loss of transplant graft, right? So 2/3 of the patients are losing their grafts due to rejection. And of course, if you don't want to lose your graft rejection, it's very important to take your immunosuppressive drugs. And you can see here that about half of them that are losing their grafts, they're not really taking their immunosuppressive drugs like they should, right? So we know this is a problem. But you see that half of them are really adherent, right? So they really take their drugs as prescribed, but still they lose their graft. So this is the process of the immune system rejecting the graft, which is the main barrier, of course, to organ transplantation between humans. And with current diagnostic tools, I shouldn't really say current because we have cell-free DNA that we're just -- that we're using. But with maybe previous diagnostics or the type of diagnosis that are used in the largest part of transplant centers worldwide, we are detecting problems with the graft quite late in the process of rejection. And this is why -- this is due to the fact that we are focused mostly on organ function to detect rejection. So we are screening and seeing how the graft organs is functioning. And when we -- start to see a drop off in function, then we think that something is wrong with it, and then we do additional diagnostics. But really, usually when the drop off comes in organ function, you have a process that started long ago and that's slowly led to this problem with organ function. And often, you need to lose maybe 50% to 70% of your organ function for us to notice it because you have additional capacity. And this is also probably why it's quite difficult to treat when we are noticing it. So not only is it important to notice this, but it's probably very important to notice it earlier because if we can notice these changes very early, then we can sort of stop the process at an early stage where it would be theoretically and also probably really practically much more easy to stop this process. So if we're thinking about the text like donor derived cell-free DNA and the clinical utility of it, you will have this typical clinical management algorithm where we will use these genetic differences that exist between the donor organ and recipient to detect cell-free DNA within the blood with our NGS method, and we can then follow these relative values of donor derived cell-free DNA and look for changes in sort of a monitoring procedure. And if we have elevated values, we can get back to additional diagnostic steps or interventions. And I will get more into the details on that in a short while. Just before I do that, I just want to say a few words on the assay that Devyser has developed and are now selling together with Thermo and One Lambda. So this is as you know, an NGS-based assay. So what we need for this assay is, of course, blood is what we're using, then we extract cell-free DNA, then we have the PCR parts of the assays to create our sequencing library. Then the sequencing library is put on the NGS device. And then we have the final step of data analysis. So it's a very generic type of laboratory work, which we do for a lot of other tests that we have. So we have already the platforms in the laboratory. So we just need to put, of course, the kits on to already existing hardware. For the data analysis, it's a very straightforward setup. So what we're getting out in the end is the percent of donor derived cell-free DNA within the software, and we get some quality markers so that we know that the test has been running accurately. And this is the important part that, that Mike touched upon is that software because the diagnostics, especially in the setting of NGS is more complex, and we have many more markers, software is getting more and more important, for us to be able to really get the maximum out of these tests. And the test uses 50 indel markers. So what's indels? so Indels are genetic changes between individuals in the form of insertions added extra base pairs or deletions subtracted base pairs. So it's really indels that we're looking for. In the test, we use 50 indels spread out across all the autosomal chromosomes, and these have been then specifically designed to not be ethnicity associated so that you can also find informative markers between siblings and such things, which is important in transplant constellation since it's not uncommon for living donor kidney donations to happen between family members, for instance, and you still need to be able to separate the DNA in this sense. Good. So that's the assay. So back a bit to how we're using the assays at the moment. And I think this is really one of the big usages that's really making a lot of sense. And this is to use this assay instead of doing graft biopsies. So the gold standard for diagnosing rejection at the moment is really to do with graft biopsy. If this is in the setting of a kidney transplant, typically, a kidney transplant is placed subcutaneously in the lower part of the abdomen. So it's very accessible with an ultrasound and you can do biopsies, like you see in the ultrasound, you see the kidney outline here. And you see exactly what angle you want to use with your needle to do your biopsy. The problem, however, is that it's associated with bleeding, of course, discomfort and it's also, of course, intensive that you have to have a physician doing it, and the patient has to come in and stay in the hospital for a couple of hours and so on and so forth. So it's something that is a bit complicated. For a heart transplant, we do endovascular biopsies, either arterial or venous endovascular, so we're basically going in through the veins or the arteries depending if we want to go into the right-hand side or the left-hand side of the heart. And we are basically, then nipping off a part of the muscle from the inside, pulling it out. So this is also something that's invasive. You have the risk of bleeding and everything. And of course, it's labor-intensive to do this. And what you then do with the biopsies currently is that you do what we are calling histology. That means the pathologists are looking at it. So this is glomeruli from a transplanted kidney, for instance, if they're looking for signs of inflammation and rejection. What we're also doing with the biopsies is that we are doing genomics or omic studies on them. So in this case, we use something called the molecular microscope where we have 58,000 probes, looking at RNA expression within the biopsy. And then we use a complex principal components analysis, to place our biopsies in a matrix of other biopsies to predict outcome. But as you can imagine, doing histology for a long time for pathologist or doing large arrays is expensive and very labor intensive, right? So they are good techniques. But together with the invasive procedure, plus what we're doing with the biopsies afterwards, it's very labor-intensive. So what we want to get out of test in the sense of omitting biopsies is what we call a very, very high negative predictive value, right? So you want to be on the safe side. If you test is really low, you want to be able to say with a very high certainty that you don't have any problems in your organ, right? And for cell-free DNA, this is very nice. So if you set your cutoff very low. So here's just a publication from 2022 for heart transplantation, where you can say that if you set a cutoff of 0.13%, then you have a negative predictive value of 97% for rejection, which means that in 97% of the case, you don't need to do a biopsy in the setting. So you can omit the biopsy, right? Then, of course, everybody who has the value above the cut will not have rejection, but at least you can narrow down your biopsies to really those ones where you have questions, right? So this is the use that we're putting it to. And this has been implemented in a couple of centers. I'm just showing you data now from one center from a publication from last year. So here on the right side, you see in black the number of heart biopsies that the center is doing every year. And you can see that they implement cell-free DNA testing in 2019. And then you see how the biopsies are going down dramatically in the years afterwards, right? So here in the gray area are coronary angiographies that they also do. So you can see that they remain unchanged by these policy. It's not that they're transplanting less or they have less patients that they're doing because they're doing the same amount of coronary angiographies, but just the biopsies are going down. And this is then the predicted savings depending on your model of calculating that per patients when you don't have to do these heart biopsies. And just to give you sort of a perspective, if we transplant, the heart transplant patient, we do typically biopsies every other week, in the beginning. So it's a lot of biopsies, right? And so this extrapolates into very interesting possibilities. Cool. So this is in the terms of trying to skip the biopsy, right? So this is one of the focuses that we have. The other one is in what we call early detection. So is it possible with this technique to detect problems with a transplanted graft earlier than with current techniques. And here, the answer is also yes. So you don't have to get into weeds of this study, but it's a study called the ProActive study, which follows around 4,600 kidney transplanted patients, where you have taken material for cell-free DNA analysis prospectively gathered within the study. And then we are just looking now at the subgroup of 400 patients that had a biopsy. And around 336 of them did not show any rejection in the biopsy and the other one stayed right? And now we are sort of stepping back before the biopsy. So you see the biopsies here at [indiscernible], then you have minus 1 month, 2 months, 3 months, 4 months, 5 months and 6 months, and we are looking at the cell-free DNA values. And the cell-free DNA values that are interesting here for us are in blue. And you can see already at 5 months and 4 months before the biopsy was made because they suspected rejection, you could see signs of rejection in the cell-free DNA. So it's an early marker as well for rejection, which enables us to push this time window when we detect rejection to the left and intervene earlier. So it's a very encouraging interesting finding in a large observational cohort. So this is in terms of omitting biopsies and screening for rejection. And I think another application, which is really coming on, especially during the last year is to use this assay to evaluate therapy response. So this is interesting due to the fact that we have a very rapid turnover of cell-free DNA within the blood. So it's generated by cell death, of course, both from a graft or from your own cells, of course. And when the DNA is coming out into the blood, it's very rapidly cleared, typically through enzymes and, of course, through different process of phagocytosis. So that the half-life is between minutes to a couple of hours, and then it's going to be clear. So you have a very rapid turnaround, which means that our analysis is really a snapshot at a moment in time. And the next days could be different, right? So what we're testing when we're testing the fraction is really a snapshot in time. And if you're thinking about this patient that we are following now with sequential values after transplantation, and we suddenly see an uptick, and we say, "Oh, maybe it's a rejection. We say we do a biopsy, we confirm that it's rejection." And now we start to treat this rejection, right? So the next idea is then quite obvious. So we want to see if the rejection treatment is working. And typically, this has been a bit difficult to evaluate because you need to -- with your rejection treatment, you need to impact the problems you have in organ function. And since I told you already that you get organ function very late in a rejection response. You can also imagine that it takes quite a while to improve the organ function once you start treating. But with cell-free DNA being a very rapid and very early marker, you can do this much quicker. So just to show you that this is something that's really coming into the field, I'm just going to show you a publication from this summer. So the publication is on treatment of rejection in kidney transplantation and they're looking at a new antibody targeting CD38, doesn't matter, can be whatever, and they're evaluating how this works. So it's a randomized prospective lead controlled trial. So they just have 11 patients in each group. So they have a placebo group and they have a felzartamab group. So the placebo group is just getting standard of therapy without felzartamab, placebo instead. And then you have zartamab group, and you're treating from baseline until week 24. And this is just to show you how the biopsies are moving. So the plot staying like this with placebo means that 8 of 11 biopsies with standard therapy are still showing rejection at 24 weeks, whereas for felzartamab, you can see very nicely for this company, you had 9 patients that clear rejection with this therapy. So it seems like to be a good therapy for antibody immediate rejection in the setting of kidney transplantation. Then they stop therapy at week 24. And you can see in felzartamab group that quite a few of them then relapsed into their rejection. But this is not the interesting part for us. The interesting part for us is that they, of course, did cell-free DNA as a valuation during the study. So it's coming in to be really an endpoint in all studies looking at interventions. And here, you can see very nicely in the group that got felzartamab, how the cell-free values are just going down very quickly at 12 weeks, showing a very nice treatment response and aligning with the biopsy results that they had. And you can see also once you stop treatment, you sort of lose a bit of the difference between the groups. So I think this is really moving into treatment monitoring aspect as well. And I think all studies going forward that looking to try intervention in solid organ transplantation will have to have a cell-free DNA part coupled to them for the evaluation. So with that, I would just like to add or just like to summarize. I might add something as well in the end. But I would just like to summarize that donor derived cell-free DNA has been really established, I think, as a reliable, robust, I say, for looking at graft damage in the setting of solid organ transplantation. And it's important that, yes, they have very high negative predictive value, especially if you set your cut off very low, right? So it has a very nice negative predictive value, which allows you to not do surveillance biopsies. Then you also have this interesting possibility of detecting rejection earlier, which allows for earlier interventions and sequential measurements in the setting of rejections can allow you to assess your treatment response to therapy. And I think this is a really key thing for transplant medicine, which is accelerating outcome. So as you saw in my graph on transplant survival for a kidney graft, in Switzerland, for instance, the mean time -- the mean half-life of a kidney transplant is 13.6 years. So the problem is if you want to try new immunosuppressive for instance, you have to wait quite a long time in your placebo-controlled trial before you can see a difference in graft loss. But if you have really good biomarkers, you can push that time line maybe to 6 months, and you can accelerate the whole development of new interventions by having just the right biomarkers for evaluation. I think in this setting, really donor derived cell-free DNA is very interesting. With that, I'd like to finish, and I'll be happy to take any questions that you might have.

Great. Thank you very much and very interesting presentation. A few questions on my end and potentially going back to sort of the last few slides, on your show and the utilization of assays. And you showed a nice graph over the ones that are losing the graft despite of being adherence to their immunosuppressant therapy. To what degree do you believe that these can actually be treated and saved in time for them to keep their grafts?

I mean this is very much a psychological question. So because adherence is sort of, is a difficult problem, right? So I think there, you, of course, have the possibility if you can have an early marker of that things are going bad, and you can highlight adherence in the setting, of course, this helps, right? So I think it's a psychological thing that you can use with the patient. So I used to work a lot with HIV patients. And there, you have this excellent marker, which is called viral load, right? So you can measure how much virus they are replicating. And they have to take combination therapy, just like immunosuppressants. They have to take combination antiretroviral therapy, right? So usually, they're on 3 drugs. And if they are not taking their drugs and they're starting to replicate, they don't really feel it, usually, right? So they don't feel bad, but it's taking a toll out of their immune system. But by having this fantastic endpoint in forms of viral load, you can plot it for them in the setting of a curve, and they can see what happens when they're not taking their drug because you have a direct feedback on that, which is immensely helpful to treat such patients because they're also taking treatment to not die in 10 years, which is a very abstract thing for a person to do. And I think cell-free DNA in this setting is not as good as viral load in the setting of HIV treatment, but it's sort of going in that direction, at least. Yes.

Great. And a practical question. Cell-free DNA tests for post-transplant monitoring is a fairly new product. And you mentioned during the presentation that you have a fairly generic workflow and potentially a lot of interest on my end, if you can precise how exactly sort of you established that workflow and protocol for setting up this sort of entire sequencing with the DNA extraction. And if you feel that the support out there from white papers from the Thermo Fisher and the Devyser helps you to guide how to work with these products.

Yes, absolutely. So I think as Mike was talking about transplant medicine as a general moved into sequencing maybe around 10 years ago in earnest, right? So we are very interested in these HLA genes that Mike also talked about in the setting of the HLA loss kit. So we've been sequencing HLA genes for the last 10 years using NGS. So a lot of transplant labs already have the Illumina devices in their labs. They're already extracting DNA, right? So you have automated machines for that robots for that as well. So typically, what you need to do is that you need to just use a bit of another kit for the cell-free extraction. And then you can use your same NGS products that you already have in the lab to run these tests. So it's, of course, dependent on the size of the lab and the size of the transplant center. So if you have a very small lab and a small transplant center, you might not have moved into NGS yet, right? So this will be more of a barrier view. But for all the larger centers especially university centers, they have basically all equipment in place to do this with very minor tweaks.

And just one last question. In your view and being an holistic view or -- how many sort of times per year would you like to monitor a patient and potentially take a kidney patient as for example?

I mean it's difficult to predict. So I would think that we are testing at the moment post-transplant or something called anti-HLA antibodies. So we're testing for the immune response against the foreign HLA proteins so that we typically test at 1 month, 3 months, 6 months and 12 months during the first year for standard kidney transplantation. I think that would be sort of something that a lot of laboratories would probably adopt to just do that one to one. But I think you have then this added part of testing it in the setting of rejections and for treatment responses. And this is just for kidney transplantation. So I think that's where the field is really evolving because for sure, nobody knows exactly what makes sense. And it's, of course, also going to be very dependent on reimbursement as it is, how much money is available really to do these tests, and what are your options and alternatives. If you look to cardiac transplantation, of course, to heart transplantation, when you're still doing biopsies every other week, it makes absolute sense to then do every other week, right, because you're just exchanging one method for another, which is lot less invasive and also cheaper. So I think depending on the different organs, it will also be very individual.

And I guess if one were to perform health economic studies on this, you would essentially imply this, as you mentioned, quite frequent.

Yes. Yes. I mean it all depends on reimbursement and pricing and what you can do. But transplant medicine, especially in the early follow-up period is very intense in the follow-up. And there's a lot of controls being done, right? And a lot of laboratory values being taken. So in the whole sum of the first year post transplant, this is actually very cheap, right? It's a very small part, of the whole total cost.

So just one -- I got two questions. And the first one is perhaps a bit technical, but you mentioned this 97% negative predictive value. So just thinking about the opposite of that. So you don't want to give excessive immunosuppressants to patient either. So what's the like true positive rate that you have with these tests?

Yes. So you should not see it as a test for rejection. It's a test for graft damage. And in this setting, you don't have any false positives because if you can detect DNA coming out of the organ, it's releasing DNA. So you don't have any false positives. But for instance, if you have a kidney transplant and it gets a bacterial infection, it will release a lot of DNA, right, into your bloodstream. So it's not a rejection, but it's an infection. So you still have to treat it. So it's really a marker of graft damage. And that means that the specificity for rejection will heavily depend upon the group that you study, right? So you can always -- sensitivity, specificity, you can play around with it how much you want because you can just select your patient groups that you are using it on, right? So it will depend on the setting. But that's why really the negative predictive value is, I think, the important part because it allows you to stratify where you need to do invasive diagnostics. I think that's how you should apply it. So if you're above the cut off, you do the diagnostics, invasive and you see what the problem is basically.

Okay. Great. And the other ones, just from a broader sense, now you mentioned that we've done sequencing within transplant diagnostics now for 10 years. So within academia, within your areas as a researcher, like how accepted would you say that the cfDNA is as a marker? And do you get any pushback and what kind of pushback is that?

I think there are basically 2 kinds of pushbacks, I think it's very accepted, very established as a marker. So I think the question within the field is a bit how to use it, right? And what settings that is does it really provide additional value. And then I think one should not underestimate, but this especially pertains to the U.S. market, that the pricing previously in the centralized lab testing, which is, frankly, ridiculous, right, for what they provide, has really been offputting for a lot of people. So I think this is something that one has to overcome with really kits that are priced reasonably according to invention and what they really contain and are put into the hands of the people in the local laboratories. I think really this is a key step to build back this trust, but I think skepticism. Otherwise, that it won't be something that gets broadly implemented, I don't see that at the moment. But as with all new diagnostics that are coming into a complex field, where a lot is at stake, it's going to take time. So this is always what happens, right? So you want it to go fast and you want the implementation to go fast, but it always, for me, it's a slow process where it has to be adoption. Of course, from the clinicians, it has to be adopted from reimbursement agencies. You have to see adoptions also from the patient community. So it will, for sure, take some time to implement it. But from -- purely from a principal mechanistic viewpoint, it's very hard to see why this is not a very good diagnostic tool.

Thank you very much, Jakob. We will have some closing remarks now, and then we have an opportunity to ask more questions if you have any to Jakob, myself, or Theis or Mike. So with our innovative products, a high market growth and a well-suited commercial organization, that we have heavily invested in over the last 2 years and some of the best commercial partners in the world. We are confident that the nice development we have seen can continue going forward. While we may face individual challenges in some quarters, we are more than confident that the nice development we have seen over the years can continue and even enhance. In the fall of 2021 in connection with our IPO, we communicated 3 financial goals, which we are still very confident in. The first financial goal is a revenue growth. The Devyser growth target is to achieve an annual organic growth in excess of 30%. In 2021, we reached 42%. In 2022, we reached 35%. And in 2023, we reached 34%. We continue to be confident that we can reach our financial goal and to deliver organic growth in excess of 30%. The second financial goal is to achieve a gross margin in excess of 80% by 2024, 2026. We put this target in place for 2021 when we had a gross margin of about 75%. Actually, already in Q1 2022, we reached this target, and we have been over that since then. In 2022, reached 82%. And then in 2023, 85%. So if you exclude Q2 and Q3 this year when we have heavily invested in the move to this facility, we have been above that target since 2022. The third financial goal is to have an operating margin in excess of 20%. Since the fall of -- since the fall of 2021, a lot of very exciting opportunities have opened up for us, and we have pursued some of them to build our future during 2024. And that will build hopefully higher revenue growth in the future. For example, we have during 2024 take extra cost to build up our CLIA-certified laboratory in the U.S. We have, during 2024, also invested quite much in regulatory work to get our products regulatory approved all around the world. And as mentioned before, the move to this building has been quite costly during 2024. However, we are very confident that the investments we have done in 2024 are very well invested money. These activities and investments will all contribute to substantially increase future revenue already in 2025 and 2026. We constantly update our financial -- our long-term financial plan, and we will work with an updated long-term strategy at the moment. And based on this, we have -- we continue to be very confident that we will reach also the last financial target. That is an EBIT margin in excess of 20% latest during 2026. However, with growth in excess of 30% and a gross margin above 80%, this is probably only a start of a very profitable journey beyond 2026. So let's stop here and move over to the last section, the Q&A section. And please feel free to ask questions to myself and to the other gentlemen on my right. Ulrik?

I have a ton of questions, and I promise I will return the mic before asking all of them. Starting off direct sales in Europe. We're now 2, 2.5 years deep into converting distributor sales into direct sales. And we talked about this historically that it is a 12- to 18-month running phase before these markets generate meaningful profits on your end. Are you able to provide us with some type of update on where we are at in terms of that process? Are you happy about the progress? Which markets are we expected to potentially turn into direct sales in the coming years? And what to expect?

Yes. Maybe I'll leave over the question to Theis.

Happy to provide some color to that question, Ulrik. I mean, in general, we're happy, right? We reconfirm that at the past several earnings calls, happy about the traction, also happy about the outlook. In terms of what is happening in addition to what we have already shared, I mean, Virginio, who's standing down there, as I lovingly say, he's part of the furniture of Devyser and the guy behind the success in Italy recently took over Spain, this is very important market, not least for transplantation. Also overseeing Latin America, injecting 2 additional headcount into Spain. We are adding headcount into U.K. As I mentioned to you during the break, we're adding headcounts to Germany. And we do so because we follow this investment logic whenever there is a certain threshold of additional new revenue, that's a trigger for injecting headcount. So if I didn't have that as the proof point to the CFO, I wouldn't get that blessing to inject those headcounts. So it's a good -- and the fact that I do get the blessing is a positive sign of the traction that we are having in the direct markets of Europe.

Great. And second question would relate to one of your financial targets, the profit margin of about 20%, somewhere between '24 and '26. And we're about to conclude '24, and it's quite obvious that we're not at 20%. So can you give us some type of road map here on how to achieve the 20% margin target? Like we're sitting in this new office. Obviously, that has carried a lot of investment. You invested in a couple of other things that has perhaps should be seen as one-offs, but where should we see sort of the margins coming from? Is it purely volume on sales? Or how should we sort of gap the bridge to your market target?

Good question. And as I said, we are very confident that we will reach the 20% EBIT margin, latest end of 2026. We have a very fully invested organization at the moment. So you will not see that growth in the expenses as you have seen 2023 and 2024. So question, the answer is probably yes on the question if it will be volume. With a growth of 30% plus and a gross margin of 80% plus, not even Theis or Michael can spend that amount of money. So I'm rather confident that we can reach that.

And just a quick follow-up on that. Is there any -- do you say you're fully invested in the organization? Is there not any white spots out there where you need that you feel that you would require to do some investments to be of the organization.

Now we have this rule that if we add another EUR 1 million in sales, then we can add another person or salesperson in that area. And that will happen also during 2025, 2026.

[indiscernible] Handelsbaken. So first one, it would be interesting to hear a bit more on the road map in the U.S. Are there any historical case studies of where a send-out test or an outsourced LDT test has been replaced by a direct hospital test so we can look at sort of a case study of how long it took and any historical precedences in such a scenario that you're looking at in the U.S.

Good question. I cannot answer that. I don't know if any one.

Maybe Jeff online would be the one I would call on. You will probably have the most insights, Jeff, but I'm not sure even if you can answer.

Yes. I can't think of one off the top of my head, I apologize for that. Let me think about it. If something comes to my mind, I will chime back in, okay?

No worries. I guess the core of my question is a little bit of how we could think of the pathway towards achieving reimbursement after a successful FDA approval, sort of the time line following an approval. I understand that time lines are always challenging, but if there's any way we could get a sense of that sort of post approval time line for reimbursement.

Did you hear the question, Jeff?

Yes.

We do not disclose the time line for the FDA, but how long after an FDA probably can we expect reimbursement?

Well, keep in mind, as I was mentioning during the presentation that transplant trace, which we're working on now will set the stage, so to speak, for reimbursement for the accept kit, cell-free DNA kit. So I would expect -- I mean I know you're asking about a time line, but I would expect it to be very quick because the work will have already been done, and I'll just need to demonstrate, we will need to demonstrate that what they already provide coverage for with transplant trace is the same as except cell-free DNA. So it's hard to me to be specific with a time line anyway, but I would say of all the tests I've worked on, this should be one of the easiest moving from transplant trace to accept because again, the work has already been done at that point.

Okay. So quick conversation, very clear. And the final question, little bit on the, it seems like the FA test portfolio and maybe oncology as well as being a little bit less prioritized going forward, should we assume that part of the business will be sort of a slower growing business going forward as you put more focus on post transplantation business? Or what should we think about that more molecular diagnostic part of the business in the future.

Yes. I'll let Theis answer that as well.

I can answer that one. No, I would not expect that fragment analysis portfolio be slower in growth in any way. It's not something we usually brag a lot about, but I think we have a fantastic opportunity with the fragment analysis portfolio because it's a legacy portfolio. The industry doesn't -- our competitors doesn't have the wealth or the magnitude of products like we do. And I doubt that they will bring those through IVDR. We are -- thanks to Olle and his great efforts very well suited to get all of those products towards IVDR. And if we do so, I think we can corner a very attractive market that at least would maintain what we're seeing today.

But you are right, we do not develop that many new FA products.

So Ludvig here at Nordea. So regarding your partnership with One Lambda and Thermo Fisher, you seem to be very satisfied with what they have been like offering to you and having helped you. So, can you elaborate a bit on your thoughts using them also to distribute other tests, maybe in the U.S., for example, the cystic fibrosis test and so on.

It would be speculation at this point in time. But there is obviously a pretty tight correlation between cystic fibrosis, which is the lung disease and a transplantation need, right? And then that Jakob probably can talk to. And that means that we do have interest from also Thermo Fisher to take this on as part of the portfolio, but there's nothing that is formalized in any way and maybe never will. But because it's so closely connected, it would make a lot of, potentially a lot of sense.

Right. And would that be through the One Lambda subsidiary? Or is that another part of Thermo Fisher then that would...

I think that's a Thermo Fisher question.

Okay. Okay. And second one, you recently announced that you got an approval for the Devyser Compact in China. Is this like what you have waited for it to like start selling this product more in China? Or do you also await some reimbursement decision or someone there?

No, we were waiting to get this regulatory clearance. And I believe we have been waiting 7 years, something like that. And in the peak days, we probably had a few million that then went away when they were tightening up the regulatory aspects down there. Now we're back and would obviously assume that it will resume to where it was and hopefully then some. But what it also does is it put us on the map with the Chinese regulatory authorities, right? And also shows us and our partner in China that we can actually do this successfully. So -- but we will, time will tell. It's a complex market.

And I suspect there is a lot of local competitors in China, how -- like -- do you expect this market to be quite similar to like the other markets you're in? Or...

Yes and no. Yes and no. I mean we -- full transparency, we're not going to be investing significantly into China. Not that we're not doing anything because we are, as you can see from getting complex products approved. But we have a very firm view on winning in Europe, especially the large markets that we are operating in. And especially across North America. Once we see that we are where we need to be, then we can divert investments to opening up markets like China. So it will be a sequential logic that we will be applying.

Okay. And the final one to Jakob. So yes, I didn't, we didn't have time for the questions then, but maybe I can ask it now. So Devyser use indels for their tests. And I believe most, if not all competitors use like SNP-based testing to distinguish between patient and donor. Would you say this is a strength for the Devyser? Or is this not really the main problem, so to say, in the testing?

No, I think it's definitely a strength because it allows you, so the problem with using SNP is that you have PCR and sequencing artifacts also on the Illumina platform, which will, that type, which we call noise, and this will interfere with your ability to be quantifiable. So I think it's absolutely a strength that you use indels instead because typically, what you have to do in the other setting is that you will have to use more markers. And if you use more markers, you had to take more places on the flow cells, and you can't put so many samples on the flow cells, and so it all turns down to how economically feasible it is for lab to run the test. So fewer markers with good accuracy is of course, is better for everyone in the end, cost wise.

So then does the Devyser test scale better than, for example, the CareDx test which I believe...

Yes. Because you, so it depends on the sequencing device you have, how many reads you can put on to the flow cells, right? So of course, in this setting, if you have fewer markers per patient that you're putting, you can put much more tests on the same flow cell, and they have a fixed cost, so of course, it gets better here.

Right. And is it possible to quantify the difference between the 2 tests?

I mean you can do this, but then you have to take into account sensitivity. So of course, the more reads you have, the more sensitive you are. So it depends also on what you want to achieve for sensitivity, but you can theoretically calculate exactly how many reads you have on a given flow cells and what that's going to give you for sensitivity. So this is what we do when we plan our runs. So we plan around how many samples we can put on a certain type of hardware. Yes.

Thanks. A couple for you, Theis. So you mentioned that you have another pharma deal now coming in the immediate near future for the CLIA lab, so just around the time line a bit? And what kind of value could that be? Is it similar to the cited one? Or could you give any sort of color on that?

If I insinuate it that we have a deal, then that was an overstatement because we don't, right? Then you have heard about it already. But we do have interest from several well known pharma companies, which we have had in all fairness, since we opened the door to the lab, right? We have not yet won successfully one of those big ones, but they keep on coming. We are a small company. We are a new laboratory. And that, I think everybody should and would appreciate that, that warrants some questions. And I think we are now with a year under our belts, created enough substance to position us to successfully take some of those opportunities. So I remain hopeful and bullish on getting some of these deals done, if it's in the very immediate or near future, I can't promise, but we are hopeful.

Okay. It sounded like you said that during your presentation, but -- it sounded like you said that during your presentation that it was one that's coming in the immediate near future.

I think let's see. Let's see.

Okay. All right. And maybe a last one, I don't know who was supposed to answer this, but for 2025 now, like which of these different areas do you see as the biggest growth opportunities? Is it the CLIA lab reimbursement? Or is it the Thermo deal and that distribution? Or is it direct presence in the U.S. or expanding in Europe? Like what...

I think in terms of at least once we hit and get a fully in the U.S., it will absolutely be North America, right, staying within the silo of transplantation, the lab will generate a lot of revenue until we have the FDA clearance with us, right? Until then, it will be standing on 2 legs. It will be the research use products. that will be generating revenues as that's the channel Thermo is kicking with, right? And then the lab that we are now scaling up. And as soon as Jeff, as he mentioned, have succeeded with his efforts, getting reimbursement, then we will see that certainly to start scale, right? And that would be a rather, I think, aggressive scaling at that point in time, whenever that comes. So that would mean that they were in transportation, both [IUO] with Thermo and our lab, which is not covered by the Thermo contract at this point of time with both scale. And then it will be, as I believe, more of a switch, I think you turn on that engine together with Thermo Fisher following the FDA approval. But in between today and then, it's a fantastic product. We just won, we cover the whole Sweden. So if you just had newborns, then they were properly tested with the Devyser test, right? We have Germany. We have Wales, we just announced. We have Canada, so we will soon most likely cover most of Canada. Coming back on that one with confirmation. And then once we get into U.S., if we get it into U.S., I believe we will, then that will be a significant revenue driver as well. So U.S., for sure, it has to be just from the sheer size of things, the reimbursement is radically different, but Europe is right there, right? So Virginio was chasing another Italy in the markets he has taken over Torbjörn, who is the other VP and Head of the other markets in Europe, doing the same, and those are doing a fantastic job. So -- and that's the beauty. Again, we have a wide portfolio. We have strong presence in a wide number of countries. And we haven't even started to look at APAC, Asia Pacific, where there is a ton of opportunity. So I hope that answers.

Great. Some -- a few follow-up questions on my end and potentially, you mentioned here in past in Canada. And you're mentioning sort of imminent decision to potentially cover the entire Canada. And I'm guessing you're referring to the Blood Canada tender that has been talked about. Could you quantify what that would imply? You already have a tender awarded in Canada? Just put it into context of -- in terms of is it bigger, larger, sort of smaller?

It will be with a lot of caveats. So there is one region, the largest region in Canada, the Ontario region that has not yet been declared, who will take that? And will it be a provider utilizing Devyser products or not. That will interfere with that number, I essentially would be thinking about. So I would refrain from giving you any number until I have more confidence in that number, right? But again, also there, regardless of Ontario or not, we do have a very good position there.

Sure. And you have 3 product areas. A lot of tests in sort of subdivisions of these. Do all of these get enough love from Devyser, or would potentially some of these tests fit better in a different organization where you would essentially sell these on license?

It's not something we have gone into. Transplantation is a good example. Of course, there are multiple takers for license deal and taking it all under their own brand. We are not in that type of business. We do believe that we can follow and run a fairly segmented process. And then as I also mentioned to a couple of you, we believe a lot in partners, right? So you will see probably that we will be scaling the partnerships. And some of those will have a better outlet, better infrastructure to carry some of those products. But no, I'm not here to give any of the products away or to take licenses. I don't believe that's -- we are in no way in a position that we even should consider doing so.

Great. And last question on my end. On the oncology franchise, the oncology portfolio that you have, a lot of companies are working with HBOC, BRCA, hotspot testing, do you feel that your position in the market is as competitive as for the rest of the product portfolio? And then is that the area where you should put in the effort, potentially going back to Richard's question here on potentially prioritizing certain segments.

Yes. I mean oncology is a super attractive field, right? And it's probably the field where most acceleration has happened technology-wise, moving into the large panels, as I told you about. We're not there. We're out -- we remain being on the amplicon basis. Even though we are pushing the envelope and the limits with what you can do on Amplicon-based sequencing, we won't ever be with that technology, a whole sequence, the genome sequencing company, right? But again, Virginio and friends are looking at potential opportunities out there. So we are constantly exploring what we can do not only to protect the current market share we have in the stronghold of Italy, but also continue to build, right? So -- and Michael and your team are doing a lot of assessments and investments into pushing the boundaries of what we have, but also potentially taking on new technology aspects.

Any other questions? If not, thank you for coming today. As said earlier, we will have a tour now if you are interested and have not seen our new facility. And let's meet more or less now in the reception. And Andrea will take you on a tour. Thank you for today.