Good day and welcome to this Capital Markets Day for SenzaGen, both those of you who are online and those of you who are audience in the room. My name is Rodd Nahlveen, and I will be the moderator for today. This event will provide an in-depth overview of the strategic priorities of SenzaGen, as well as the value-creating initiatives that will drive the company towards profitable growth. The agenda for today is there will be an introductory remark from the Chairman of SenzaGen, Carl Borrebaeck. He is also a professor at the University of Lund in Immunology, as well as a founder of the company and a significant shareholder. That will then be followed by a presentation of the CEO and President, Mr. Peter Nählstedt, who will guide you through the strategic initiatives and also talk about the financials and the financial outlook.
There will be Ian Kimber, Professor in Toxicology at the University of Manchester. He is also a member of the board and a key opinion leader who will talk to you about the allergy. That will then be followed by a break. After the break, there will be a presentation from Henrik Johansson, the Chief Scientist, and Anders Fodderid, the Vice President in Sales. There will also be a testimony of an honorable customer via a video. That will then be followed by a Q&A session where both of you online will have the opportunity to ask questions. You can actually start already now in the designated field that you have. You here in the room will also obviously be able to do that. There will be a concluding remark by Mr. Peter Nählstedt.
I would also like to remind you to turn off your cell phone. Thank you. Without further ado, Mr. Borrebaeck, please. Karl.
Thank you very much, Rodney. And thank you and welcome to this Capital Markets Day. It is actually the first in SenzaGen's history. We had a small one in Lund, but this is the real one, obviously in the main city of Sweden. I will be rather brief. Why do we have a Capital Markets Day? I think so much is happening now in the company, so many good things, both scientifically and commercially. The timing is perfect. Before I leave the floor to Peter, our CEO, I will make two points, which I think are of interest both commercially and scientifically. We have a solid foundation in science. Why is that important? We are mimicking an animal. Everybody is leaving animal testing. It is a complicated system that we are now building in vitro.
We were actually the first one some years ago who started with genomics and machine learning. We are still the absolute leader in this field. There is no one close as a competitor with the accuracy and the sensitivity and specificity that we have in our tests. That also, of course, reflects in the commercial growth. The second one is that, which is maybe more of an anecdote, but it has a real important message, is that some years ago, or let me say it like this: of all the companies we started, SenzaGen is the company that we invoiced our first customer the first day. If you're investing in pharma or med tech, you know that that's unheard of. That was SEK 50,000 to Bayer in Hamburg. They are making the Nivea.
They would like to test our test and also had some substances. SEK 50,000 today will not get you far in the test system we offer because we have grown tremendously. We are actually now turning around SEK 60-70 million. That is kind of a nice trajectory. I invite you all to be part of that journey, SEK 50,000- SEK 60 million. Two points. Without further ado, I will leave the floor to Peter, our CEO. That is him. Go, Peter.
Thank you very much, Karl. Welcome also from my side, audience here in the room. Nice to see you all. And you that I can't see, but are also listening in through the Capital Markets Day online. I'm the CEO and President of SenzaGen. I took on the role as CEO in 2021, end of 2021, following a board membership that I had. I've worked now 25 years or so in commercial roles, almost exclusively within the life science and more specifically in the life science tools area, working with both commercial development and organic growth projects, M&A growth projects.
I'm now in my most exciting role that I had in my career, I should say, because this company, it's so motivating to work with a company that is making a big difference in terms of technology and is having its impact through innovations that are developed through our own universities and now in commercial phase. It's very rewarding. Also rewarding is the vision of SenzaGen. It's to replace animal testing and also advancing and protecting human health. I think we have a later presentation which will show just that. We've had a fantastic development since 2021, I should say, also earlier, of course. Since 2021, the business has grown 600%. The organic growth of the GARD platform has been 385%. The business is also very scalable because we have a gross margin which has been stable around 60-70%.
In 2024, it was 67. We have invested in the platform and in the company and are approaching now a break-even on the cost base we have with a small loss last year. As you that follow us, and I will come back to that later, have a break-even in the third quarter. Our financial position is solid. We have a good cash situation that gives us a solid platform to grow further and expand the company, both with the commercial activities and our R&D activities. SenzaGen is operating on a market that is undergoing a paradigm shift. The market of in vitro toxicology testing, in vitro means done not on animals or humans. The market for efficacy testing, which is testing the effect of drugs or chemicals or other substances, the market globally is $13 billion.
We have narrowed that down into our service of an addressable market and came up with a figure of $500 million. This is the area where we have services which we can sell today. You can see the market or geographical split. It is mostly advanced in Europe. It's 39% of the market, but the U.S. or the Americas is very close with 38%. The Asian market is growing up and is currently at 23%. There is a growth figure on the graph, 6-9.5%. It's a quite fast organic growth of this market, and it has strong drivers. First, we have scientific progress. We are definitely one of the scientific drivers and proofs of that. There are developments in mimicking human biology and interpreting and calculating and coming closer to real human biology. That's one driver.
The second driver is the regulatory landscape and compliance. To simplify, what was sort of nice to do, not using animals, is in many cases becoming must-do, not use. That is the trend we see, and that will drive the market. Thirdly, it is cost-effectiveness. Non-animal testing is quicker and less costly than running through expensive animal trials. The final driver of the market is around ESG and sustainability engagement from large corporations that have active programs in bringing down the number of animal trials. Our group is consisting of three separate companies. We have SenzaGen, our mother company based in Lund. It is 65% of our revenues. We are 21 employees based in Lund. We are experts in non-animal toxicology. We have a test lab in Lund, GLP certified, one of a few that there are actually in the Nordic region. We are developers of a GARD technology.
We acquired a company called VitraScreen in 2021. It is 30% of our revenues, 10 staff, and they complement SenzaGen by having something called non-animal efficacy models. Whilst SenzaGen, the original model, is around testing for safety, VitraScreen can also test for efficacy. In 2022, we made the second acquisition, which is of an advisory firm called ToxHub. They provide advice to customers. It makes up around 5% of our revenue. They have three staff, but have a big network of other consultants to be able to serve customers and scale their business. Looking at how our sales footprint looks, it is a very diversified sales footprint. Europe is 75% of our business in 2024, but Americas is 23% and a little bit of business in Asia.
The channel split, and we will talk more about our sales channels later today, is that we have 90% plus of our business is direct sales, so relationships with big international clients. We also have the ability to reach and leverage through distributors and license partners, which make up together 9%. SenzaGen is interesting in terms of the industry split that we serve. We not only serve one industry. It is a pretty even spread of our sales between the chemical sector, cosmetic sector, and the medical device sector. We also have a little bit, and is actually growing this year, of sales into the pharmaceutical sector. Going slightly deeper into our three companies, I already said we have SenzaGen. It is an operating company of SenzaGen, was starting in 2014. It is a little bit more than 10 years old.
Developers of the GARD platform, which is a machine learning and genomics-based technology platform that replaced animal testing for skin sensitization. As I already alluded to, it is one of a few Nordic GLP certified labs that can conduct tests for customers. We have now developed a very deep expertise within skin toxicology, but also in genomics and machine learning. This is a rather unique combination, which is continuing to drive our business. Our customer portfolio is really consisting of world-leading companies across the globe and across industries. You see here that we have a business with L'Oréal, the largest cosmetic company in the world. We will later today hear from Sonova, who is a world-leading hearing aid manufacturer based in Switzerland. We have in the chemical sector companies like ExxonMobil, Pharma, Lundbeck. The largest groups in the world are testing on GARD.
The other parts of our business are VitraScreen and ToxHub. I already said VitraScreen is part of the group since 2021. They offer efficacy testing with a specific expertise in something called 3D human tissue models. They have also developed a test platform called AURA. I will try to explain what that is in some simplistic form. AURA is mini organs. It is about 200 cells organized in space. The cells can represent various organs. Let's say it is a skin organoid when it is cells from the dermis that organize themselves like a skin, and you can use it to test for efficacy without using an animal or using a human for that matter. That is the test platform that VitraScreen has developed and that we serve the preclinical efficacy testing segment with.
The strategic value of having that access in our group is, of course, that not only can we do then the safety and toxicology testing that we do with SenzaGen, we also can address the other parts of the development phase of our clients. ToxHub is based in Rome. It is a specialized toxicology risk assessment and regulatory strategy advisor. Founded by senior certified toxicologists, they have a network within devices, pharma, cosmetics, and also offering something called in silico services. Now I know I have introduced the word in vitro, meaning not using animals or humans, but in silico means using computer modeling and simulation. That is a service that they can offer. That really strengthens our group. ToxHub helps us sell more tests to the clients by their advisory knowledge, but they can also offer supplementary value to the clients.
That is really how our group hangs together, the toxicology and efficacy testing of SenzaGen and VitraScreen combined with the documentation, test strategy, regulatory support of ToxHub. We work together on cross-sales, so selling each other's services, which actually grew 28% in 2024. We have at times joint R&D projects. The other big thing is that by having two labs, we can allocate tests depending on where we have the best potential loading and not compromise on delivery times to the clients. We have a great management team. It is an experienced team. What I am in particular happy with is that we have a blend of commercial, company expertise, people that worked within other businesses helping to grow and form them. I have some experience around that for sure.
Also, Tina, who is our VP for Marketing and Communications, actually present in the room in the back, has this expertise from other growth companies combined with a scientific and specific customer knowledge from Anki and Henrik, who are present here in the room and who you will hear later from today. Marianne, who is our Finance VP and has been with the company since we started. We have Helen working with HR and development of our organization, and she has experience also from growth companies like BioGaia. Our Board of Directors, I am happy also that we have two members of the board here today, Professor Karl, who gave the introductory speak. I will be followed on stage by Professor Kimber.
Anki, who worked with developing many startup companies, Paul, who has extensive experience from the European chemical industry in both M&A roles and in management roles, and Paula, who has worked with commercial development in life science companies in the Nordic area. That is the company in a nutshell. I will now switch over and tell you a bit more about our financial performance and our progress to date. Actually, we have developed our strategy quite a bit since we started in 2017. I think that is quite common that companies develop something, bring it to market, and good companies listen to the market, take it back and refine our strategy and develop further.
SenzaGen launched a fantastic platform of GARD tests between 2017 and 2020 with the GARD skin for skin sensitization, GARD air for respiratory sensitization, medical device for testing for skin sensitization, but in particular in the area of devices, and then the dose response for finding out the potency of chemicals. That's a fantastic platform, and technically it was completed in 2020. In 2021, we looked through our strategy and decided to broaden it. Basically, when we sell a skin sensitization test and work on one very large client like L'Oréal, for sure they test for skin sensitization, but there are 20 other endpoints that they need to investigate. There is a good opportunity for us to broaden our market share by offering more services. That's what we did.
You can see the sort of blue bar here below the years is that we have actually insourced and implemented complementary tests within skin, so irritation and corrosion, which are other endpoints, cytotoxicity for devices, which is an important toxicology test. This year, we actually implemented a complementary test to GARD called EpiSensA. That is what we did for in-licensing. We also looked at, of course, pure acquisitions where we have two acquisitions performed in 2021 and 2022. This development has really served us well. I think we have, through the acquisitions, taken several steps in understanding the market and understanding the portfolio of customers and actually increasing the portfolio quite a lot. This development of the strategy certainly had an impact on sales, and this is only since 2020.
You can see the, I think I talked about the 600% plus growth since 2020. That's up to the SEK 57.7 million that we reached last year. Through these last years, we also had this stable gross margin between 65-70%. EBITDA, I think when I took on the role as CEO, I sort of said, "Look, it's okay. I think the market will understand that it will take a while to develop this company and to get it profitable. We need to stop having a growth of sales like that and a loss like that because that means that we have a continuous need of making share issues to cover that gap.
We need to start to turn it and close so that you can see that the sales are growing, but the profit or reduction of loss is actually growing faster. That is exactly what you can see has happened also. We have had a focus on getting the company to break even. Last year, we came close. In Q3, which I am coming to now, we hit the zero on the EBITDA point. Zooming in a little bit on the very recent history of our group, we had net sales of SEK 15.2 million in quarter three, which is a growth of 15%. If we could have used fixed currencies, we would have had 18% growth. We sell, of course, almost everything in euros and dollars and very, very little in Swedish krona to a few customers we have here locally.
We break out GARD because it is sort of the biggest part of our business, and it's interesting for our investors to follow how GARD is doing. That grew 12% or 15% in constant currencies. Our operating result came in at break even, measured as EBITDA. That's an improvement over the quarter three 2024 with 1.2. How we ended up there is that we actually kept costs at exactly the same level as Q3 2024, but we increased sales 15% and kept the gross margin stable. It's not more difficult than that. Gross margin was 66%. Okay, so it's one point. I think when you talk about companies our size, not much to debate, but it has a slight product mix effect. Sometimes we sell services which are a little more towards the 65%, and sometimes we sell with an approach 70.
The cash situation, we had cash and cash equivalents of SEK 29 million at the end of September. That is down from SEK 42 million in 2024. That is sort of also following the share issue that we performed in the summer. We have had temporary effects on the cash flow, very high invoicing just at the end of September. That has brought up our accounts receivable, and that is also why you see the cash outflow. We believe that this is a temporary effect, and we should see a strong cash flow now in Q4, early Q4. Recent developments around our business is that GARD has had a positive performance with 12% quarter-on-quarter growth. I should say that we still have had a little bit of headwind with the market.
The very large orders that we usually get every quarter, we did get two large orders in Q3. It is, of course, orders that we got a little earlier in the year that builds up the main part of the Q3 sales. I think the 12% is good given that we did not have any larger orders earlier in the year that were particularly large. We have analyzed what is going on this year with the sales in GARD because we grew a little bit slower than what we did earlier year. When analyzing it, we have more customers than before. That is not the problem. We have as many new customers. That is not the problem either. We have a high loyalty, 85%, not a problem either. We had slightly lower value per order. That is because we missed these sort of larger one-off projects.
We think it's a temporary effect. People are a bit more careful with our development budgets. We are looking forward to getting these larger sales back. There are certainly many of them in our quotation pipeline. One thing we achieved in Q3, early Q3, was a regulatory breakthrough called OECD Test Guideline 497. In 2022, we got the first breakthrough when we got GARD skin approved as an OECD standard test method. At the same time, OECD approved a combination method guideline called 497. I know this is a little bit complex, but bear with me for a second. In this guideline of combination, there were three particular test methods mentioned. If you use those three, then regulators across OECD countries said, "You're free." Even if we achieved a standard certification, we were not mentioned in this particular guideline.
That created a little bit of a problem. We got that sorted now. Now GARD is included in the 497. VitraScreen grew 15%. ToxHub has a very, very strong performance this year. It used to be 5% of our sales. This year, it is 9%. They tripled their revenue quarter on quarter in Q3. It is a very good development driven by our work with finding new clients, focus on sales and marketing, but also on them getting a slightly better market for medical device certifications, driven by the MDR deadline in Europe coming up in 2027. That is the company to date. You that are here and have been following us, this is not new to you. I will now switch over to looking ahead, which might be more interesting in a capital market day.
We have four strategic initiatives that we will bring home before 2030. We will establish GARD as an industry standard in devices, medical devices. We will continue to develop the GARD platform through approvals and upgrades to the platform we have. We will then scale the company with new innovations, and we will expand our market reach. These are the four key pillars. As we saw, we have performed two good acquisitions. We can also perform more strategic acquisitions to complement and enhance our growth. First one, establish GARD as an industry standard in medical device. We will go a little deeper into that later today. What we want is that there is no in vitro test standard in device testing.
The ISO framework, which dictates how companies should test a device for making sure it's safe for humans, has only an animal test written in the guideline. No in vitro alternative. We have been mentioned in the annex of the guideline, but it is not a pre-approved method yet. We want to be the first method approved as a standard, and it has a great potential. We think that we can reach the full inclusion in 2027. Whilst we are working on the development program that Henrik will describe a little more in detail, we are also doing commercial preparation. We are already doing pilot sales to big medical device companies. We are signing master service agreements, going through all that so that we are getting ready. We have also trained our license partners to be able to perform GARD skin medical device.
The second big initiative is getting GARD upgraded through complementing regulatory approvals and technology upgrades. I already spoke about the 497 upgrade. That is complete in Q3 2025. We have not yet seen the sales effect of that, but not to worry. It was the same when we got GARD skin approved in 2022. It took months, a few quarters before we really started to see the effect coming. The dose response is the other platform. It is a major breakthrough to be able to determine the potency of a chemical or a mixture. Getting this into the OECD guideline as a standalone tool for risk assessment will be another major commercial driver for the company. We are working on getting that done. We are also working on upgrading the GARD platform. Now it is 10 years ago that the development started, and the world has moved on.
We are working on upgrading the technology parts of it, which will make it easier for us to out-license the method and also reduce our cost of goods. Third initiative, expand the market reach, competitiveness, and enhance the model. We really think we figured out how we should do it in Europe. We focus on large multinationals that have in-house product development and recurring needs. In the U.S., short term, we are growing a CRO network. We do also have direct relationships, but we will try to narrow down and really focus on sort of top 10 in each industry and have a larger part through distributors and license partners. We continue to position ourselves as a thought leader in non-animal testing, try to go beyond the skin sensitization also into new areas by methods that we are now mastering can do.
Fourth one is to scale with new innovations. When we have completed the medical device, dose response, and these very exciting projects, we can go into new innovations. With the competence and knowledge we have around GARD, we can develop genomics and machine learning-based methods into other areas that are adjacent to the testing needs for the clients. We have also built up a significant amount of data, genomics data, for instance, around skin sensitization and how immune cells react. This can be utilized for further developments now with AI tools. This VitraScreen AURA mini organs type of testing systems are really, really hot and interesting ones to sell out to pharma. These are innovations that we will continue to scale. Looking at this more from a timing perspective, how are we going to do this?
Short term, we believe the company is in break-even phase. During this phase, we will grow, and we will grow under increasing profitability. You have already seen what can make us grow in this phase. The 497 approval makes it easier for us to broaden the client base into standard testing. VitraScreen, who we acquired four years ago, have gone through a management change, and we are working on getting them back onto profitability and growth. We had a good Q3, so we are working on repeating that now going forward. Midterm, and now when I talk about short, mid, and long term, I realize it is a bit unclear, but all these phases, we will be in the scaling phase before 2030. The midterm phase, I think Henrik also has a view on when we will complete the growth initiatives.
We will go into midterm acceleration phase. During this phase, our sales will grow much faster than they are currently doing because we get GARD into medical device as a standard method, and we get dose response, OECD approved. This will set us on a path where we can then launch new services and products. We are small. We cannot do everything at once. That is why we go through the short-term break-even phase, making sure that we complete the really important acceleration phase projects. When we hit that, we will go into preparing the scaling technology. Through these phases, of course, if we find an interesting target that can complement and enhance our growth and make it easier to access customers, leverage our technology, that is an option for us to grow through this period.
The sales impact of this organic growth plan, we sketched it out like this. It is really indicative, I should say, and it is sort of based on exactly where we are now in November 2025. The break-even phase, we will have growth, and it is not insignificant. I think the scaling of this map is fooling you a little bit, but the acceleration phase really is expected to drive the company up to new levels and where we will have a continuous growth into 2030. I want to stress that this is our organic growth plan. To sum up, a successful growth story today, about to accelerate. That is how we view the company. Our vision is to replace animal testing.
We have a great market with good drivers, three group companies well positioned to drive growth in this market, proven commercial track record of working with the world's largest organizations and delivered significant sales and profitability development, test innovation, and also acquisitions, stable company platform that will enable us to continue to grow from the short-term break-even phase into the acceleration phase and thereafter scale the company into new areas. That is the strategy, how we see the timing and a little bit of an indicative sales impact short term. With that, I would like to hand over the word to Professor Kimber, member of our board, Professor of Toxicology, key opinion leader. Welcome, Ian.
Thanks very much. Thank you. Good afternoon, everybody. Pleasure to be here. My name's Ian Kimber. I'm Emeritus Professor of Toxicology at the University of Manchester. As Peter said, I've had the honor of being a member of the board for some years now. What I'd like to do is give you a perspective on skin sensitization testing because that's at the heart of the origins of SenzaGen. The theme I've been asked to address is how skin sensitization testing has evolved in the last two or three decades. The theme of my presentation is therefore from guinea pigs to mice to non-animal methods or NAMs, as they become called these days. I think it's important to understand what the health hazards are of skin sensitization. People think this is just a little rash and maybe a major investment in this is unnecessary.
In fact, it's quite a serious problem. Nickel allergy is the most common form of skin sensitization resulting in allergic contact dermatitis. This on the right is a patient who's undergoing patch testing to try and identify the cause of her dermatitis, what the inducing chemical is. You can see that here we're getting positive responses on the back. This is through patch testing. This is somebody who has a nickel allergy. That might not look too awful, but in fact, allergic contact dermatitis can be severe and debilitating. This is a series of patients from the Manchester region selected to show different forms, different manifestations of allergic contact dermatitis. The lady with the eye is a nickel dermatitis. You can see the suppurative lesions on the feet of a patient there. This is from rubber additives in shoe wear.
The man with the very sore face has come about through plant allergens, bedding plants and then wiping his hand over his face like this. The one on the right is again a nickel allergy. These can be very unpleasant, very debilitating, having a big physical and psychological consequence for the individual. They're fairly discreet in terms of anatomical location, but they can be widespread. This is somebody who's got what's called a SOFA dermatitis. When SOFAs are being transported from Asia to the U.S. or Europe, they're put in container ships, and there's a lot of damp. People wanted to put something in, an antifungal agent that prevents mildew in the SOFAs. They chose to use a substance, an antifungal agent called dimethyl fumarate. They used that without first checking whether it could cause sensitization or not. It does cause sensitization.
This is somebody who's been sitting with not too many clothes on on a sofa and has widespread allergic contact dermatitis. The point is, this is a really unpleasant, important, and very common disease. It's estimated that in the Western world alone, something like 50 million people have skin sensitization. Many of those will at one point or other in their lives suffer from allergic contact dermatitis. Let's look very briefly at the development of sensitization. How does this work? This is a very simplified diagrammatic representation of the key events that happen during skin sensitization. Sensitization develops when an individual comes into contact with the sensitizing chemical on the skin. That chemical is recognized as foreign by the immune system.
Dendritic cells that are found in various compartments of the skin play a pivotal role in processing that chemical allergen and delivering it to lymph nodes. Lymph nodes are where lymphocytes exist. These dendritic cells present that allergen to responsive lymphocytes that divide. That division is probably the pivotal point in the acquisition of sensitization because then you have a large number of lymphocytes that can recognize the inducing chemical as foreign and react very quickly and very aggressively when that same chemical is seen at the same or a different skin site. That is the clinical problem. That is a very superficial summation of the mechanism. The challenge is being able to identify and characterize chemicals that cause skin sensitization. Really, actually, tests were done on humans back in the 1940s. We will not go into that. In the 1950s, guinea pig testing was developed.
A number of guinea pig tests that were used. The most common and most widespread used was the guinea pig maximization test. I won't go into details of this, but essentially what you're doing is putting a chemical on a guinea pig, trying to sensitize it, and then challenging it at a different skin site to see whether or not we see lesions. This is a positive response in that guinea pig. That's with one chemical. To perform that test, you need 30 guinea pigs. It's been estimated that in the period guinea pig testing was the mainstay of sensitization identification, many hundreds of thousands of guinea pigs have been used. It's a pretty crude test. The next stage really was to think about the mechanistic basis. You've seen this slide before, mechanistic basis of skin sensitization.
One of the key elements was immune activation, stimulation of lymphocyte proliferation in lymph nodes draining the site of exposure. That proliferation of T lymphocytes is something that can be measured in mice. That led to the development of what we called the local lymph node assay. I won't go into this in detail, but essentially, animals are exposed, mice are exposed on areas to the test chemical. What we do is measure whether that induces proliferation in the lymph nodes draining the site of exposure. That can be measured by injecting the animals with tritiated thymidine. That labels dividing cells, and you can measure the amount of division as a function of the incorporation of this radioisotope. Pretty simple stuff. For this test, one only needed 12 animals, and you could do a dose response with that method.
It gained favor. This is an example of the sort of results you get from this. On the left, the test results with 2,4-dinitrochlorobenzene, a very potent contact allergen, where you can see a dose-dependent increase in lymphocyte proliferation indicative of the acquisition of sensitization. On the right is a non-sensitizing chemical that causes irritation but not sensitization called para-aminobenzoic acid. That method gained traction, and it was approved as a regulatory test method in the early 2000s and has been used extensively since then. It still requires animals. It is less damaging to the animal. One requires fewer animals, but animals are still required. The new imperative, what I have called it, is the development of test methods that better reflect human biology and do not require the use of animals.
It is those two objectives that have really driven the investment in new sensitization test methods. Not using animals is an obvious benefit. Nobody wants to use animals. The better reflecting human biology is something that is not always so obvious. If you think back to the pictures I showed you of allergic contact dermatitis in humans, you remember nickel allergy, the most common human contact allergen. Mice do not react to nickel. There are important human differences between humans and mice and humans and guinea pigs. Humans respond to nickel, mice do not. The local lymph node assay cannot detect nickel and see it as a potential human problem. Twofold benefits: one is to reduce or eliminate the need for animals. The second is to have more human-relevant test methods. I am not going to go through this slide in any detail.
The important point is that in the last 10 or 15 years, there's been a significant investment in innovative research into the molecular and cellular mechanisms that result in skin sensitization. Out of that has come an adverse outcome pathway where we contract at the molecular and cellular level all the events, all the things that are happening from initial exposure to the development of active sensitization. There's a huge literature describing that. The key events I want to draw your attention to today are these. These are events that happen very early on following exposure to a chemical. The first is the chemical has to bind directly or indirectly to a protein to be seen by the immune system. Secondly, it has to stimulate what are called danger signals to alert the immune system to the fact that there's a threat from this exposure.
The third is to activate dendritic cells, which are responsible for moving the chemical from the skin via draining lymphatics to lymph nodes and there presenting it in an immunogenic form to T lymphocytes. This is where GARD comes in. You'll be hearing a lot more of that. This is from Henrik. Excuse me. GARD is the Genomic Allergen Rapid Detection Method. This provides an accurate way of identifying skin sensitizing chemicals without recourse to animals. That is a great way without animals to identify skin sensitizers. There is another challenge. That is that not all chemicals are created equal. In fact, we know that skin sensitizing chemicals differ by up to five orders of magnitude in terms of their skin sensitizing potency. Chemical allergens differ enormously in how effective they are at sensitization. What is potency?
It is the ease with which a chemical is able to induce skin sensitization. Or put another way, it is a reflection of the local concentration of a chemical that is required to initiate the skin sensitization process. The importance of that is the more potent a contact allergen, the lower will be the concentration required for the acquisition of sensitization. That is an important challenge because identifying a skin sensitizer is one thing, but determining what the safe level of exposure might be to humans is entirely different. That has been a real challenge. GARD, I believe, has cracked that challenge because the GARD skin dose response assay, again, more of which you will be hearing later, has the ability to measure skin sensitizing potency.
Because it can do that using GARD skin dose response, we can now identify what a safe level is of a skin sensitizer that can be put in things like fragrance formulations that will not cause skin sensitization. Put another way, GARD skin dose response provides a way of establishing robust quantitative risk assessments so that we can always be sure that humans are not exposed to dangerous levels of contact allergens that will cause skin sensitization. GARD skin dose response is the only single test method that is currently able to do that. I think that is a real achievement and a very important and exciting scientific development. Thank you for your attention. I think my job is to tell you that there is now a break. Thanks for your attention.
Thank you, Ian. Yes, as you rightly point out, there will be a pause now.
We're a few minutes ahead of the schedule. Let's meet here again, let's say five minutes to half past one, 1:25, that is. Thank you. There will be some leg stretching, and we have some lavatories for you. Thank you. Okay, welcome back, everyone, from the break. Now it's time to dig more into the details of SenzaGen. The first speaker here after the break will be Henrik Johansson, Chief Scientist at SenzaGen. If I believe you are number one or number two employee? Number one, yes. This is a special person. Henrik, please, the stage is yours.
Thank you, Rodney. I'm happy to be here today to talk to you guys. I think most of you don't know so much about me since before, so I'll just briefly give a short introduction to myself.
I have an academic background, an engineer in biotechnology, and I have a PhD in immunotechnology, both from Lund University. I have gathered about 15 or more years of experience as a researcher and a research leader in the fields of cell biology, molecular biology, and immunology. My specialization is in in vitro assay development, which is, of course, apparent since this is what SenzaGen do. I am the first employee, was employed in 2014, and I have been Chief Scientist since 2020. I am also an expert in various groups internationally. I am part of the Medical Device ISO group that handles skin sensitization and irritation. I am also part of the OECD expert group on defined approaches of skin sensitization. My personal career, of course, goes very much hand in hand with the path of, or the progress of SenzaGen and the development of SenzaGen.
As you may know, the company was founded in 2010, and at that time, I was a PhD student at Lund University, supervised, in fact, by a certain Professor Carl Borrebaeck, with us here today. I also had the opportunity to meet with, discuss, and learn from other experts, including Ian Kimber, during this stage. When the cosmetics ban was enacted in EU, of course, we had more reason to accelerate our efforts within the company. I was employed by the company in 2014, and I was with the company struggling through the startup years up until also 2017, when we became more commercially active, having finalized our technology development and the validation of the technology.
Usually, when I do these types of presentations, I spend a lot of time to talk about biology, and I know this will not be the main focus or interest here today. I am also very happy to follow Ian Kimber because this makes my work so much easier. I do not really have to go into all of the details, as you are now all experts on the immunological mechanisms of skin sensitization. What we do is we focus primarily on this cell called the dendritic cell, which you can view as a sentinel in the periphery of the body where exposure to chemicals occurs. These cells react in a multitude of ways upon chemical exposure, and these effects can be measured by studying the protein of the cells or the gene expression profiles of the cells.
That is exactly the basis of what we do with the GARD method. Again, I will not go into much detail, but GARD is based on in vitro cultivation of a cell model of these dendritic cells. We measure the gene expression patterns following chemical exposure. There are 196 genomic biomarkers that are of specific interest. We feed that data into machine learning-assisted classification algorithms and are able to classify the chemicals based on a decision value from a so-called support vector machine. While we developed this method and had it validated, also the regulatory landscape has evolved. Ian already alluded to this, but Guinea Pig methods have been used for skin sensitization testing since the 1960s, basically. They were largely replaced in most sectors by the LLNA when it was introduced in the 1990s.
The LLNA was, in fact, developed by Ian Kimber and colleagues, and it became a test guideline in the early 2000s. Timing well with the cosmetic ban, however, the paradigm shifted around 2015 when the first in vitro test methods were introduced. Of importance, GARD skin is now in these test guidelines. We were introduced in 2022. The regulatory landscape has further evolved into what is known as the defined approaches or integrated testing strategies. The first such test guideline was published in 2021. As Peter also mentioned before, GARD is now included also in this test guideline. GARD is now competing in a regulatory landscape, which is a level playing field with quite a few advantages and unique opportunities. We are not happy there. We are not content. We are going to keep evolving and developing the method and technology.
To do so, we have a few strategic R&D initiatives ongoing, which I would now like to introduce more in detail. These are the GARD skin medical device method, the dose response method, and a project that we refer to as XP, which includes a technological platform upgrade, also briefly introduced by Peter. Moving forward into the future, we want to also discuss a little bit on how we see our new endpoint research. Starting with the GARD skin medical device method, as you know already now, this is a method that has been developed a few years ago. It is on the market. We are providing it as a service for R&D purposes to a lot of companies, including, for example, Sonova, which will be with us later here today.
It is not yet fully regulatory compliant because the medical device industry has their own rules and their own set of regulatory frameworks. Regulatory testing in the medical device industry is governed by the ISO 10993 series of standards. What this figure wants to demonstrate is, I can realize that maybe not all of you can see all of the details, but what we want to highlight is that there are a vast number of different types of medical devices, ranging from implants to wound care dressings and so on. There are also a lot of different endpoints that are of interest to study. Irritation and skin sensitization and cytotoxicity are the three endpoints that all medical devices need to test. There is a potentially huge market here.
This is an opportunity for SenzaGen since this skin sensitization testing, as of today, is primarily conducted in animals. If you look at the statistics to the right, we see that 90% of all skin sensitization testing in animals are being performed in the medical device sector. While for other sectors, the ratio of animal testing has vastly gone down already because they have already progressed more into an in vitro standard. There is a notably slower uptake of so-called NAMs in the medical device sector. This is an opportunity that we would like to address with the medical device method, the GARD skin medical device method. If we have a look at the timeline, we see that we are already doing R&D sales and pilot regulatory sales in Europe.
What this initiative is all about is to validate the method formally and push it into the ISO standard. We see this happening in a few phases where we have already completed the first one. We have finalized the protocols for the method, and we have published those results. We have proven the concept in a so-called feasibility study. What we've done this year is to move on into a so-called pre-validation study. This is just a snapshot of results that were presented at the ISO group meeting in June this year. The data was very well received, and we more or less got the go-ahead and the green light to move forward into what is referred to as the validation study.
To do that, we recruit naive laboratories that we train in the method, and we perform a study aiming to not only requalify the performance of the method, but also demonstrate the reproducibility across laboratories and so on. Moving on to the GARD skin dose response method, we foresee a very similar progression through phases in the upcoming years. As Ian has already mentioned, GARD skin dose response is quite unique in that it is capable of not only providing a hazard classification of a test chemical, but also a quantitative potency response. This can be used in what is called a point of departure in a downstream risk assessment strategy. Risk assessment is, of course, different from hazard since you can accept the hazard if the cost-benefit is good enough, but you need to understand the risk. To do that, you need a starting point.
That starting point is the sensitizing potency of the test chemical. That is something that we can do with the dose response method illustrated in the figures here. These are very similar to the figures that Ian showed in how the LLNA works. That is exactly what the dose response method is. You can view it as an in vitro analogue to the LLNA method. It is unique in the fact that it can only otherwise be achieved with animal experimentation or a combination of several methods in what is referred to as a defined approach. The method is on the market already. We are doing R&D sales for risk assessment. It's quite a big seller, actually, which I believe that Andy will talk more about. We now want to push this also into the OECD test guidelines.
In the years leading up to this one, we have published a substantial amount of several peer-reviewed articles. We have quite a good understanding of the method's performance. This performance has also been superficially reviewed by the SCHWAB. What is missing is, again, the between-lab reproducibility estimation. We need to make sure that this is a method that can be reproduced also in other laboratories. We are recruiting partner laboratories and generating validation data. I did not actually mention it for the medical device case, but for both of these cases, we expect to have the data generated during next year, moving into the peer review processes following on.
This is how we foresee that this times with what Peter Nählstedt refers to as the acceleration phase around 2027-2028, of which the last part, of course, would be the regulatory peer review leading up to the adaptation in the OECD test guideline. The next case I would like to talk a little bit about is the XP project. It's different in that it is not a method development project, but rather a technological platform upgrade of existing methods. Basically, what we do is we have a certain set of instrumentation to perform our gene expression analysis when we quantify the genomic biomarkers of our biomarker signatures. By upgrading this instrumentation, we expect that this project will come with certain advantages, including facilitating a larger outreach to global CROs. We expect that this may improve gross margin.
Perhaps most importantly, it would also enable new endpoint method development in a more resource-effective and streamlined way. We are already underway also with this project. GARD signature transfer has been completed. We are about to publish our proof of concept results on this. We will take these results into the OECD expert groups again for regulatory review and expect to have an update to the already now existing test guideline for GARD skin to include the opportunity for end users to freely choose among available instrumentation technological platforms on which they can collect their raw data for gene expression. Lastly, Peter also touched upon this subject a little bit with new endpoint research.
This is where we believe that we can apply SenzaGen know-how and SenzaGen infrastructure and technology to develop new methods, not only for skin sensitization, but also for other hazardous endpoints, which is of a major concern to human health and therefore also of a major concern for the industries producing products in these segments. To give a few examples of what that might entail, we have listed here genotoxicity, which is the ability of a chemical to damage or otherwise harmfully interact with DNA or other genetic material in the human body. Immunotoxicity or immunosuppression, which is the ability of a substance to suppress or otherwise interact with a normal immune response. One very a lot discussed example of that may include, for example, the PFAS that you may have heard about in Ronneby.
This is a perfect example of an immunosuppression where you can actually see adverse effects following chemical exposure, which leads, for example, that these exposed individuals do not respond to vaccination as intended, for example. Developmental neurotoxicity is the ability of a substance to adversely affect the development of the fetus. Postnatal exposure can also have this type of effect. It, of course, damages the normal development of the neurotoxicity pathways in the brain and then the neurosystem. Lastly, we believe that AI can be a major driver for innovation in SenzaGen, as we foresee that it can, at least to some extent, replace conventional testing, which is carried out today. These are all fields where we have active initiatives ongoing. I expect that we will talk more about that in coming years.
As Peter mentioned, this is what we foresee to be heavily investigating in the later phase, starting about 2030. To summarize, we have a very active R&D portfolio in SenzaGen, and most of them have finalized their technological phases and are now in so-called regulatory phases or starting to become regulatory in 2026, where we expect to have, in particular, a lot of data coming in on GARD skin medical device and dose response. Again, you see how these arrows more or less line up with 2027-2028, where we expect to have an impact from these strategic initiatives on the acceleration phase of the company. To summarize, GARD is a product of, as Karl also mentioned, scientific expertise and quite a few years of academic research.
Of importance, we are now fully regulatory compliant, with GARD skin being part of both OECD test guidelines of relevance for skin sensitization, that is 442E and 497, which makes us compete in a level playing field with outstanding technology. We continue to develop the method, both to have a broad applicability and deep and sharp utility of the methods. We do this by strategic R&D initiatives, which I have been talking about here today. We expect that these initiatives will greatly impact and align with the growth phases of SenzaGen, mainly then the acceleration phase, taking start 2027-2028 and moving into the late stage where we can also benefit from new endpoint research development. With that, I would like to conclude my presentation, and I will introduce Karla from Sonova, who will give a testimony on how they actually use these methods today.
Hello, my name is Karla Linow. I'm a chemist by education and now a research engineer and biological safety specialist at Sonova. Sonova is a global leader in innovative hearing care solutions, from personal audio devices and wireless communication systems to audiological care services, hearing aids, and cochlear implants. The group was founded in 1947 and is headquartered in Stäfa, Switzerland. Meanwhile, Sonova is present in more than 100 countries with over 18,000 employees and makes CHF 3.9 billion in sales. As Biological Safety Specialist at Sonova, it is within my responsibility to perform biological risk assessments for our hearing aids according to the ISO 10993 standard on the biological evaluation of medical devices. Biological tests in vivo and in vitro are an important pillar for those risk assessments.
The latest changes in the regulatory landscape, including updates to applicable ISO 10993 standards, show a slow but steady paradigm shift away from animal testing towards increasingly more in vitro methods. However, this shift is not yet universal across all regulatory frameworks, but we clearly believe that in vitro tests, such as SenzaGen's GARD skin assay, will eventually completely replace animal assays for sensitization. We at Sonova rely on a comprehensive risk assessment, not only on biological testing, but also taking into account material information, previous testing, and safe history of use. We have been using in vitro methods that utilize human cells for the assessments of irritation and sensitization risks for many years now, as they are much more preferred from an ethical point of view, but very often are also more sensitive compared to the state-of-the-art animal assay.
While global regulatory acceptance is still evolving, we employ these methods during early material screening in the development and optimization of material manufacturing processes or to close gaps when we otherwise have sufficient data. My colleagues started the collaboration with SenzaGen before I started at Sonova almost six years ago. Therefore, we have been able to follow some major developments, including the GARD skin medical device assay, the dose response assay, the OECD adoption, and the still ongoing discussions in the ISO working group to adopt these methods in the ISO 10993 framework. I already mentioned why we prefer in vitro methods over in vivo methods in general.
Regarding the GARD skin approach, this has, besides its security, sensitivity, and specificity, the very important advantage of using oil as a non-polar solvent, while other in vitro methods require extraction in aggressive solvents, which often degrade the material and therefore lead to unrealistic results. Therefore, depending on the maturity of the project, already available information, and material properties, GARD skin medical device or dose response assay are often the method of choice for us. With this, I want to thank the SenzaGen team for their constant efforts and important work for the acceptability of in vitro methods. I personally also want to thank SenzaGen for our very valuable collaboration over the last six years.
Thank you, Karla. This was a customer testimony. That is also an introduction to our final speaker of today.
Just to highlight the benefits of GARD for Sonova, it's actually transitioning from animal testing to in vitro methods, reflecting also a broader industry shift. The GARD skin medical device and dose response assays are now key tools in their biological safety testing. This method enables early detection of sensitizers, reduces development risks, and strengthens the product safety. That is from Sonova. With this, I would like to welcome the last but not least speaker, Anders Fodderid, the Vice President and also Head of Sales at SenzaGen. Anders, please, the stage is yours.
Thank you very much, Rodd. Hello, everyone. As Rodd mentioned, I had the pleasure of bein g the last speaker of today's session. Some think it's a disadvantage, but I see it as an advantage because now all of the concept has already been introduced.
I'm going to take you through the sales process at SenzaGen today. I'm going to start with a very brief introduction to myself, and I'm moving a bit ahead. I've been working for SenzaGen now for seven years. I combine my commercial role with a strong scientific background. I have a Master of Science in Biotechnology and a PhD in Immunology. I've been working with assay development now for about 15 years. I'm together with Henrik, also one of the co-developers of the GARD technology. I also have the pleasure of representing SenzaGen at several industry expert groups that together work to promote the regulatory adoption of new approach methods, including the ISO working group for medical devices and also the OECD expert group for respiratory sensitization.
When we talk about the GARD assay and some of the unique features of the assays, there are essentially three features that are most critical to our clients. First of all, the GARD assay has a very high predictive performance. It uses a combination of very modern tools, genomic and machine learning. By using these tools, we can also generate more human-relevant data, as we already heard in Henrik and Ian's presentations. The other really critical feature is that the assay works very well for testing very challenging test materials. Many of these materials cannot be tested using the conventional in vitro assays. It also avoids the potential challenges of having to use animal models, which is not allowed in the cosmetic industry, for example. The other thing that is really, really critical is the potential of also generating quantitative data.
This data can be used to establish safe concentrations, which we already heard in previous presentations. We can deliver all of this using a very efficient protocol, a very time-efficient protocol, which helps our client to bring their products into the market at a much higher pace. SenzaGen drives sales via two complementary sales channels. The majority of our sales come from direct sales, which is led by our sales team in Sweden and in Italy, where we have a very strong focus on interacting with global major companies that have a recurrent testing need. In addition to that, we also work together with distributors and license labs, which help us to also penetrate new markets, establish collaboration with local clients, and also scale the business in a very cost-efficient way. Our sales process is generally very technical.
We interact directly with product safety specialists at some of the major companies. You will see this later on in the presentation as well. In order to meet this demand, our sales team has a very strong technical background and also a long experience within the industry. This really helps us to build relationships with some of the key clients and also build confidence that our method works and that we are able to sell this type of strategies. Our sales team is also contributing in the publication of scientific publications. We are invited to give lectures at international congresses, and we are also represented in some of the industry expert groups. Together, members of our sales team are very well involved in the scientific process, and we are also considered as a key opinion leader within the field.
Our services are generally needed when customers aim to place new products onto the market. We have a very loyal customer base. We are continuing to expand our number of clients, and the clients are often very satisfied with our services. Once they have ordered the services, they often become recurrent clients. I would like to give you an example on this. This is the sales number from 2024, last year. Here you can see that the majority of our revenue comes from recurrent customers. 72% of our revenue from last year, and I think it is even more than that the first half of this year. You can also see we have a very high net promoter score, 86. That means that our customers are very happy with the results from the testing, and they also recommend our services.
In addition, we continue to bring new customers in. You can see the number of clients that are gradually increasing from year to year. They are also slowly then transitioning into recurrent customers, which continue to then drive the increase in net sales. This is just one case study on how our sales process normally looks like. It normally starts with a customer that orders a pilot study to evaluate our services, to evaluate the GARD assay, see how it works for their test substances. Based on the results from this pilot study, they often implement the assay into their standard testing program and start to use it continuously. They often commission smaller projects, but at a much higher frequency, leading to a much higher accumulated order value during the following years. You can see one example here from one client.
We approach this client and work with the client for it normally takes about 6-18 months before they actually commission any testing. Then they start with a smaller pilot study. After that, you see from the following year, they start to implement the service and, in this case, order studies for more than double the size of the pilot project. This is one specific case study, but this is a very common example on how our sales process actually looks like. As I briefly mentioned before as well, SenzaGen is working very intensely to establish solid collaboration with some of the major companies on the market. This slide shows an example of some of the customers that we've been working with and also published data together with during the last few years that represent different industry segments.
You have already heard a presentation from Karla at Sonova on how the GARD assay can be used to improve the safety of medical devices. Another example here is the collaboration with Lundbeck from the pharmaceutical industry, where the quantitative data that the assay can actually generate contributes to increasing the safety for workers during occupational or during production of the pharmaceutical active ingredients. We are also collaborating with ExxonMobil in the chemical industry, where the GARD assay can be used to test really, really challenging test materials. For those of you that know ExxonMobil, they produce petroleum-based products. This does not normally work very well in the conventional in vitro assay. I have a case study I would like to show you later on as well. I think most of you know the company L’Oréal. It is one of the biggest cosmetic companies in the world.
L’Oréal used the GARD skin dose response assay to establish safe concentrations of sensitizers that they can include in their cosmetic products. We are also collaborating then with Unilever in the personal care and cosmetic industry, where they also use the combination of the GARD skin dose response assay and the potential to test really challenging material in order to establish safe concentration in their personal care products. I would like to show you a few case studies as well that we generated together with our clients. The first one I would like to show you as well is the case study I was mentioning by ExxonMobil. One of the major challenges that they face, and also other players in the chemical industry, is that their test materials are so challenging. They are so hydrophobic, so they do not really work in the conventional OECD-validated assays.
In order to evaluate if the GARD assay could be used for testing of these materials, we performed a rather large pilot study together with ExxonMobil. In this case, we tested 16 different materials, and none of these materials could actually be tested in any of the other in vitro OECD assays. All of these materials could be tested using the GARD assay, and the results also correlated very, very well with available reference data, both from human studies and from the animal studies. Based on this, we could demonstrate that the assay works very well for this type of really challenging test materials and also thereby fulfill an unmet need within the chemical industry. The second case study I would like to highlight today is a collaboration with Clarins. I think most of you also know Clarins.
It's a big producer of raw materials that are used in cosmetic products. They generally use naturally derived ingredients. You extract basically your chemicals, your crude mixture from plants or whatever naturally derived materials that are available. Here we have also a similar problem. These materials are so hydrophobic, meaning that you cannot really dissolve them in water. They're not really applicable for testing, neither in the conventional assays. In case they could actually be tested, the results are often not conclusive, meaning that you cannot actually draw any conclusion based on the testing data. In this specific case, we tested two materials, plant-derived ingredients, and both of them could be tested without any technical challenges. Again, the results correlated very well with the expectations from Clarins. This actually means that they incorporated the GARD skin assay into their safety testing program.
They basically screen all their raw materials before they place them on the market using the GARD skin assay. This also kind of highlights where the GARD assay can be used to fulfill an unmet testing need within the cosmetic industry. The final case study I would like to mention today is a collaboration between SenzaGen and Essity, where we also investigated the potential of not only testing chemicals, but also seeing whether we could use the GARD skin medical device approach to test solid materials. Essity produces a lot of personal care materials. In this case, they were interested to see whether they can actually test their baby diapers or feminine personal care materials. What we did was to perform a pilot study where we tested baby diapers. We generated the data, and the data looks very nice.
Based on the results from this study, we also had a poster together with Essity at a scientific conference, and they have now also implemented the GARD skin medical device assay into their internal procedure. They can basically use it in order to ensure the safety of their products before they actually place the product on the market. On the final slide, I would like to just highlight some of the growth opportunities that we see at SenzaGen. I think we've already been discussing it a bit. In short term, we really now start to see attraction based on the successful implementation of the GARD skin assay into the OECD test guideline 497. As I also briefly mentioned before, it takes about 6-18 months before we can actually have the customer commit to the sales.
We are already now seeing a lot of traction for this type of regulatory testing among our clients. In a more midterm or long term, we also see a huge potential of the GARD skin medical device assay. As Henrik briefly mentioned, all medical devices need to be tested for the endpoint of skin sensitization. The really good thing here is that we do not really see any competition. The GARD skin medical device assay is by far the assay that is closest to being regulatory accepted on the market. We have already seen that regulators in Europe accept data from the GARD skin medical device assay for regulatory purposes in Europe.
We expect to, when we have the final ISO acceptance of this result, that there will also be an increase in regulatory acceptance of the GARD assay in the U.S., and that will increase the demand quite significantly. This is also outside the predictions that Peter mentioned before regarding the addressable market, because this is not even included into those estimates. With that, I would like to very briefly conclude. We are strengthening our market position through our growing number of customers, and many of these customers also become recurrent clients. We are very good at testing those types of substances that cannot be tested in the conventional OECD-validated assay. This is one of the unique selling points of the GARD assay. We also still see one of the biggest opportunities ahead, which is then the regulatory implementation of the medical device approach.
By that, I would like to invite Rodd Nahlveen back to the stage and open up for the Q&A session. Thank you very much.
Thank you, Anki. I would like to welcome back Henrik and Peter on stage. We will now start to have Q&As. For those of you who are online, you have the opportunity then to ask questions in the designated field. We already have a few good questions here, but more the merrier. If you want to express it in Swedish, please feel free to do that, and I will translate to the best of my knowledge. We also have a microphone here, so if you have a question here in the audience, please raise your hand and state your name and number or organization before asking the question. We start here in the room. Do we have anyone here? Yes, please.
Can you please describe the competitive landscape?
Yes. I can make a first attempt, and then maybe Andy can help me out with this question. In general, the GARD is a unique method in combining genomics and machine learning and has, in that capacity, no real direct competitor. Of course, people must test for skin sensitization using other methods before we develop the method and so on. We compete with these standard methods that were approved before. The companies that perform these methods, you could say, differ from very large contract research organizations. An example is Eurofins or Charles River, and down to smaller specialized contract research organizations. They can also be very local. The market is a bit fragmented from these local players on contract research, but there are a few big dragons that offer the standard test. Do you want to add something, Andy?
Yeah, I think I agree. In terms of difficult-to-test materials or challenging materials, there is very little competition. I think we are definitely a market leader in that specific segment. We start to see some clients that used to test in the standard OECD tests that they normally have quite simple chemicals, but they also start to use the GARD assay because we have the additional pull of being able to offer the add-on with the quantitative potency assessment. But it's a conservative field. It takes some time to get these people on board. In terms of medical devices, as I briefly mentioned as well, there is very little competition in terms of in vitro methods, and GARD assay is closest to having the full regulatory acceptance in that specific segment.
But has succeeded to OECD guidelines? Complete with us.
Yes, there have been other methods adopted, standard methods. There is one method which we implemented. I showed it in my earlier slide. It was called EpiSensA. So that's a method that was OECD-validated 2024. We saw an opportunity to complement GARD. The method is not as advanced as GARD, but it represents, and I think Ian showed these key events, key event one, two, and three, so different parts of a reaction that leads to sensitization. EpiSensA addressed an earlier part of this, and they managed it. That's one example. There is also one method that L’Oréal developed themselves that got accepted. There are some activities in the field.
Maybe part of your other question about the competitive landscape might be, and I get that question a lot, so I answer it even though you did not ask it, has to do around pricing and what about how that looks in terms of these testing services. We have deliberately priced GARD at a small premium compared to the standard tests. The standard tests are around EUR 3,000-EUR 4,000 per test item, and then the GARD is EUR 7,000-EUR 8,000. That is higher, but there is also this EpiSensA, which is priced similarly to GARD skin. Comparing then to animal trials, the LLNA test, the mouse test is, I think, Andy, EUR 8,000-ish?
Yeah, somewhere between eight and 10, I think.
The guinea pig test, the cruel guinea pig test we saw is around EUR 10,000.
I have just one more question regarding, it seems to be a little bit unclear regarding the regulatory issues because it seems like some, like Sonova, they are doing the old tests with animals and are working with you as well. It seems like do they need to use you? It's a bit unclear if the companies must order you or not.
Yeah. You're right. It is a bit unclear because there is a transition going on, and we're sort of in the middle of a transition. There is a transition for Sonova in terms of for certain aspects of their product, they must use animals to get their products registered in the market they need to sell at. In Europe, they can rely on, to some instance, on non-animal data using our method, but it is not mandated to use it. You're right, it is a little bit unclear, but as per her statement, they think that they will transition into complete animal-free in the future, but we are not there yet. That answers.
Do I have more questions here from the room? I think here, or? No. You want?
Can you elaborate a little bit about your current dialogue with new customers, where you are and its locations?
Yes, Mikel. I think I'll let Andy talk about how the sales pipeline and the type of customers and where they are based looks like.
Yes. I have been traveling almost all over the world the last six months. We are starting to build some momentum in Asia as well. I've been to China discussing with clients. I've been to South America talking with new clients. We also have a few other clients in Brazil, for example, and also a lot of focus now in the U.S. There was a statement from FDA earlier this year, the medical agency in the U.S., that they also start to promote in vitro testing. The last month, we have been focusing a lot to build a customer base as well within the pharmaceutical industry. Pharma is big. Medical device is really big to prepare for the regulatory acceptance. We continue as well to focus on the cosmetic companies globally and more specifically as well in France and Germany, for example.
Can you give us a ballpark figure for Europe and for the U.S.?
What we saw, Mikel, in Q3, actually sales were half US, half Europe. Looking at how the pipeline, we have not, I do not think we have a split of the pipeline exactly like that, so I cannot give you an exact answer. My overall feel is that the US business is growing a little faster than the European one. You saw 2024, we had 25% sales in the U.S. I think that is a trend that we have a bit more U.S. Andy has been traveling to South America. We do have a Brazilian customer, but I do not think it will have a particularly big impact on the sales in the foreseeable future. I expect the sales to continue to have a lot in Europe, but the growing part in the U.S. Yeah.
Thank you.
We have some here from the web. Why is reaching break-even such a key milestone before you expect growth to accelerate?
Yeah, it's a good question. I think reaching break-even is a fundamental part of a business. It needs to be profitable, but it is also a natural effect of the work we're doing. We're growing and we're keeping our costs at the same level, and then we will be at break-even and profitable. It's not really a milestone we have set to become profitable. It's a natural evolution, but it will give us financial stability so that we can bring the growth initiatives to completion and get into this medical device standard testing and really accelerate from there. That's the answer. It's not a milestone that we've said we must be break-even before this date, but it's a result of our work in keeping costs in check and growing the top line.
Another one here. You've made two acquisitions over the past years, which now seems to be gaining good momentum. Are you already evaluating additional acquisition opportunities, or will that come later?
Yeah, I think the acquisitions we made really accelerated our understanding of the total market, and it more or less doubled our customer portfolio in one go. It was a really big step in getting the whole context of the market together under our own wings. We have not paused our effort or given up on that. We have an active agenda, and we are looking at a number of companies. If we find, if one of these companies that we have identified, if the conditions are right, and with right, I mean both from a commercial and financing point of view, we will for sure execute on that to grow the company further.
Of the four strategic initiatives, which do you see as most critical for you to success? Will you pursue all four in parallel, or will you focus on them more sequentially?
Yeah, I think this question has partly been presented today, but maybe Henrik, you can help me out with this question about how we will work on our initiatives and which one we see as most important.
Absolutely. They are definitely being conducted in parallel. As you may recall from the timelines, we estimate to have generated data for all of the big projects in 2026. Obviously, we are working on them already now, and we will continue to do so in the first half of 2026. We work with them in parallel, but I should also emphasize that should the situation arise where we have to prioritize between projects due to limited resources, we will prioritize the medical device method, as we believe that will have the largest impact on the market in the end.
We have a question here about your industries. Across your target industries, where do you see the strongest potential for future growth?
Yes, so one of the strengths of SenzaGen, I think, is that we're not dependent on one particular industry, and there are testing required in both cosmetics, medical device, pharma, and chemicals, and also actually food and nutrition, which is maybe less known. But maybe Andy, you want to take a stab at this question.
Yeah, I think most in the midterm and short term, we see the medical device as the most important segment, I think. There are so many devices available, and all of them need to be tested for the endpoint of skin sensitization. That is taken into combination with that there is very little competition. There are very few other methods being developed for this purpose. This is something that we see can drastically have an impact on the amount of sales we can do. We are already seeing an increasing demand as well from the medical device industry already now. They are reaching out to us. They would like to have more information on how the assay works because they want to be prepared when the update to the regulations are really there.
In a more long-term goal, we are looking into how we can also penetrate the pharmaceutical market. Pharma is a really big market. They have a lot of money. We have not traditionally been very good at this market because they have not been testing a lot for skin sensitization, and they have also been using a lot of animals. With the products and materials we have in our R&D portfolio, we think and believe that we can also gradually start to address the pharmaceutical industry.
We have one question here from the room.
Yes, it was interesting, and I wonder about your research. How do you conduct your research? Is it together with a university, or do you do it in-house, and can you get external funds for it? It would be interesting to hear your comment.
Please, Henrik.
It's a healthy mix of all of the above. Of course, following the spin-off of the company from Lund University, more and more research has been centralized to the company. We use our own technicians and our own scientists, Andy and myself included, to bring these projects forward. Now when it comes to collaborations, these are more one-on-one projects on a case-by-case basis. We have existing collaborations with both Lund University and Uppsala University to give a few examples. The strategic initiatives that are funded by largely the capital influx from last year, they are being conducted by the company at the company with our facilities, instrumentation, and our technicians.
We have one question here about ToxHub in Q3. It seems activity in ToxHub was very strong in Q3, so I suppose you have to use external consultants to achieve missions. Do you plan to add more internal resources to ToxHub?
Yeah, so that's sort of a little bit of the benefit of ToxHub that we can have a rather small fixed payroll, not payroll, I mean payroll with three employees. And then they have a network of many more consultants that they can draw upon to meet certain questions. If demand continues on this level, for sure we need to convert some of those external consultants into in-house people. Yes, the short answer is yes, but not unnecessarily so.
One final question so far from the web. How do you view the potential to broaden the R&D portfolio over the next years?
Yeah, I think this is a good question for Henrik.
The potential is vast, I would say, and I think we also give a few examples of that here today. Not only then in the short to midterm, but also moving into the long term, we do have active initiatives, for example, in genotoxicity and AI and other areas where we believe that our competences and already established position as a leader of innovation in this market will become very useful.
Thank you. Do we have any more questions here from the room? Okay, if not, before Peter gives his concluding remarks, there will be an on-demand version of this presentation on the SenzaGen website from tomorrow. You can use the same URL that you used today. After your concluding remarks, there will be some refreshments for people here in the room. Obviously, if you're online as well, but you need to fix it yourself. There will also be more opportunities to have the really tricky questions to the management team and also parts of the board. With that, I leave the word over to you, Peter.
Thank you very much, Rodd. I guess it's up to me to conclude this last two hours of SenzaGen-only information that you have been absorbing. I think I'll do it by focusing really forward. Growth plan and key priorities until 2030. We are currently in a break-even phase. We keep costs in check, and we leverage our existing growth momentum by going into standard testing with the 497 approval that we gained and working with the commercial development that I think Anders spoke about. We will have growth in this phase and continue to increase our profitability. The bigger opportunity is in the future about getting into the acceleration phase with the company. The biggest initiative we have ongoing should be rather clear by now that we view that as the medical device certification, an area where they perform 1,000 tests per year.
To give you a reference, at SenzaGen, we currently do about 300 tests this year. The 1,000 tests are done in the EU alone, and the U.S. market is estimated to be about twice as big. This is a really, really big opportunity, and we are extremely well positioned to be first on market to get this certification. That is the acceleration that we see ahead of us. You know it's difficult. There are so many opportunities, and we are a small group, but we try to be really smart about these other opportunities in new fields like genotoxicity, using AI, developmental toxicity, and other endpoints. We have small, sometimes external projects which we wait until they mature.
As we are delivering the acceleration phase projects, these can then become our focus and really be used in an upscaling phase of a company, which we think can happen around 2029. For sure, we will be in it by 2030. In these three phases, we can perform strategic acquisitions of companies and technology sales channels that can enhance our growth. For the organic growth plan, this is sort of a sketchy image of how our sales can develop. We are currently in the break-even phase, and we are at the 2025 mark. We can expect to grow. We can expect to grow with profitability in this phase. We can enter the acceleration phase. When we, and thanks to you who participated in this share issue one year ago, we have funding to develop the acceleration phase projects.
Those projects will contribute with up to or about or more, we are not sure, but for sure SEK 100 million per year of incremental growth two years after completion. That is sort of what we have modeled out here. There comes a phase where we can launch new services. We know that the U.S. has been a little bit behind Europe in the acceptance of non-animal methods, but the signals from the FDA and NIH have been very clear this year. They want to see a transition into non-animal testing, and we think that is where we will be well positioned to take part of that. A strategic plan should also not just be for the next 12 months. This is how we sort of look at the organics for the next few years.
I would like to finish off with what I see as top reasons to invest in SenzaGen for those of you who are listening or not here or have not invested yet. For those of you who are already owners, perhaps of increasing your holdings in this company. One, we have a large growing market, and the trends are in our favor of transition into non-animal testing. Two, the global trends in the regulatory landscape are about going from nice to do into must do in terms of regulations, ethics, and human-relevant solutions. We are at the forefront. Three, we have leading technology. We have a clear technology leader in this niche field around skin sensitization testing with a GARD platform. We have other services in our group that we have developed that will complement it.
Number four, this is really a proven and scalable business model. We had a break-even result in Q3, and we have been growing for the last few years. We have kept our gross margin at a healthy level of 65-70%. We have also been able not only to develop large accounts and sales and new solutions and bring them through regulatory approvals, we have also been able to acquire companies. That brings us to the fifth point where you should invest in SenzaGen, and that is that we have a fantastic team. I think you agree with me, having seen the people we have had on stage today, that we are able to do great things from our small footprint, and we have the best and fastest growing years ahead of us. That concludes this day.
As CEO of this company, I'm living my dream of leading this technology company, bringing Swedish innovation out to international companies, something I wanted to do when I did my master's degree a few years ago. I would like to thank you who came here to listen to this in person. I would like to thank the audience online for sure. Those of you who are listening to this afterwards, thanks for taking part of this message. You're welcome to join us as a shareholder. For those of you who are in the room, welcome to treat yourself to coffee. Myself, Andy, Henrik, Tina, Ian, and Karl will remain in the room for answering, as you said, Rodd, the more difficult questions. Also thank you to Halvason and Halvason for the wonderful arrangement today. Thanks very much for having us. We appreciate it a lot.