Welcome back to DNB Carnegie Small & Micro-Cap seminar. We are now moving on into the animal health business, and we will be listening to Intervacc. Here with me, I have CEO Carl-Johan Dalsgaard. Very welcome. Thank you. Please, the floor is yours, Carl-Johan. Thank you. I am a human veterinary medicine person, and this is a veterinary company, and my background is an MD PhD from Karolinska, I am venture partner with HealthCap since many years, so being operational in companies where HealthCap are invested. That is why I have taken on this assignment. I have been the CEO for Intervacc for six months plus now. Intervacc is well advanced in breakthrough vaccines in animal health, but it is also an animal health company. I think there is an opportunity to widen the scope maybe. But the vaccines are truly breakthrough, and they are based on a proprietary. It does not mean that we own it, but it means that we are the only one doing it on a platform technology that is superior for vaccines in this area. Now, we focus, of course, commercially on the lead product, which is a horse vaccine, Strangvac for strangles, and I'll show you a little bit about that. It's really an unprecedented efficacy. There's two, three vaccines here and there on the market, but it doesn't compare. In the pipeline, there is a vaccine that's called piggyBac that's for a Streptococcus suis that affects piglets. Here there's nothing on the market, and this is really a huge commercial opportunity because the pig farms are, of course, counting the dollars, and if you can reduce their cost because of this infection, you can, of course, sell a vaccine. In Scandinavia, then we have a profitable and a strategic veterinary portfolio that we entertain, and it becomes a very nice little shop with veterinary products that is meant to complement the in-house vaccines as well. So we're building that in parallel, and we're listed on First North as we said, and we have a market cap of approximately 400 million. I think it's a bit less right now with SEK 127 million in cash. Coming back to the platform then. The bacteria, they do have adhesion proteins, so they need to adhere to tissue to infect the host. In this case, this is Strangvac. We have selected eight different adhesion proteins, and that is enough to prevent the adhesion of the bacteria to the tissue. We have fused them into three different proteins and then inject them, and these are the antigens. So it is the recombinant version of the adhesion proteins or adhesion molecules from the bacteria. They're, of course, carefully selected, so it means that if we take them out, there won't be any infection. Then the horse then generates antibodies with strong affinity to multiple targets, and that's the secret behind the efficacy of these vaccines. It's not a secret, but that's the reason why they're so efficacious. We basically cover it. So they're highly e ffective, and it's also a vaccine that's very easy to administer and safe and well-tolerated. I'll give some more highlights. But it gives really a superior immune response. On the product side, then we're selling Strangvac, the strangles vaccine in Europe, and the two next milestones, I think we have sent in a request for label change, meaning that we would like to see the label saying that we can revaccinate every 12 months, which fits more into the ordinary vaccine schemes for horse owners. Then we're relaunching in France and Germany from July. It's been in the U.K. h as been basically the best market in Europe for us so far. We're doing this together with a partner, Dechra s o that's Strangvac U.K. In the U.S., of course, we have the biggest market, and there we are in late clinical trials. We're completing the clinical program by first quarter next year, and we are, of course, in discussions with CVB, the regulatory body in the U.S. So that's complete the regulatory safety trial will be this year, and then complete the efficacy trial will be quarter one next year. There we don't have a limit in terms of labeling. Strangvac in Sweden is also doing very well w e have our own sales force, and we're increasing around 100% right now. Then we have piggyBac with EU, of course, also a possibility for U.S. and other markets. There we are completing the efficacy studies, but we know that it works. The good news with vaccine studies on animals is that you do challenge studies. You challenge the animals that are vaccinated or placebo animals with the right bacteria and in high doses. That means that if we have a good result there, then we know it will work in field studies. We know that piggyBac works, and we are now complementing the file with looking at different serotypes. We are looking at different doses we are looking at different adjuvants to have a final product to be then developed GMP and then into the late clinical trials. Then we have the veterinary portfolio that is a portfolio of marketed products. Now, coming back to strangles i t is an upper airway streptococci. We can get streptococcus also as humans in the upper airways, and this is the most frequently diagnosed infection in horses. The reason why it is called strangles is that they develop abscesses that in the end may even strangle the animal to death. So there is mortality in this. In some cases, they are up to 10% mortality, sometimes up to 100% morbidity s o it can become severe. Of course, it is not only the horses that are affected, but you of course have restrictions on what you can do. If you have a business with horses, you may have to require quarantine and transport restrictions and everything. So it can also have a financial impact for people doing business with horses. So it is more common than flu, for instance, that horses are vaccinated mandatory for today. It is definitely worse than flu s o it is a severe disease. If we look at the number of horses that we could access, we say that there is a global population that we are looking for of 60 million horses. But of course, we are looking at North America, we are looking at Europe, and we are looking at Australia, New Zealand, and those are the primary markets. Here we have with different percentages of horses vaccinated for something like flu or a few other things. In the U.S., they are very keen on vaccinating their horses. So there it is about 70% that are vaccinated. There is also a strangles vaccine there that really does not work. But it is still used, and I think it is about between 12% and 20% are vaccinated against strangles as well. So, if we take one or two doses per year, the addressable primary market is up to 11 million doses annually. Of course, not every horse will be vaccinated like that, but it gives you a feel for the maximum market. The important thing for us with this vaccine, again, also is that we have a prolonged or a long period where we have protection, which means that we can put this into the vaccination schemes that horses normally have, and then we will have a once yearly booster, which is what people are doing for flu vaccine, for instance. That is mandatory in Sweden for competing horses and traveling horses. So we have submitted a label change variation to get this into the label, which of course will be important for us. So if we look at then the real-world experiences, there is one case where horses were exposed to an outbreak, and of the vaccinated horses, I would say 90% were disease-free. One actually got colic, but it is counted as strangles anyhow. Two horses were not okay after this, and the other one has a mild case. Here, of the 65 horses that were not vaccinated, 74% got strangles. It is ineffective, and this is now an outbreak situation. If we summarize, we have 94% protection when we do the challenge studies, which is really we are giving 100 million bacteria into the nose of one horse i t is really tough t hat is far beyond what you get exposed to in real life. In field studies, we have 100% protection in many cases i t is safe and well-tolerated. We have the correlates of protection, means that we have sustained antibody levels. We have a T-cell response. We also have cross-reactivity for another streptococcus suis that causes respiratory problems. Not as bad as strangles, but you also have the isolation and so forth with this one. It can be given during outbreaks with other vaccines given to mares and foals. It has a lot of very good features. Comparing to human vaccines, I think this is a little bit extraordinary. If you look at the market introduction where we have been h ere we look at the number of vials, meaning the number of vials reaching the market, not what we sell, because we sell them in bigger packs, and that could be very up and down between quarters. If we look at the aggregated build on, there is a dip right now, but we are on our way to build up the sales, and we are relaunching in France and Germany. We have been focusing primarily on key opinion leaders, and you have to work your way through the key opinion leaders and then to vets. Of course, we cannot make ads to horse owners directly, which is unfortunate. You can have that for humans, it is okay, but for this vaccine, it is not for some weird reason. We have key opinion leaders both in Sweden and the U.K. now that are really ambassadors doing trials, publishing, writing guidelines, working for us in the sense that they are making the recommendations. These people are, of course, very important for us. If we look at the rollout we have had, and as I said, first to have the approval, we are not there yet in the U.S., but the buy-in for key opinion leaders we had in Sweden and U.K., definitely. We are working with France and Germany. We had a meeting in the U.K. with key opinion leaders from all over Europe and also in the U.S. I think we can start to turn that green, the label, we are still waiting. It is still amber. Hopefully during this year, we will be able to change that. Then getting into guidelines. In Sweden and U.K., we are definitely into guidelines. The meeting that we had in spring will generate publications with new guidelines, and that will be the basis for guidelines even in countries like Germany, who have been not so much on the map for us until recently. Of course, the best thing would be if we get it mandatory. We are not there. That is, of course, something that you then could build on together with the flu vaccine, for instance. Now, if we focus on this and think about 50% of the number of horses that are vaccinated in these markets, these are the number of horses that we are then addressing. As you can see, U.S. is really the big market for us. Talking about U.S. then, the pivotal trial is ongoing w e have had to breed our own horses for the pivotal study. They are now growing t hey will be vaccinated by year-end, depending on when they have been born. Then they will be challenged, and then we will have the data during first quarter. Safety is ongoing e verything looks fine I think we have passed more than 400 horses now in the U.S. This challenge study was just to test doses of the bacteria for the challenge, and this is also completed. Now, if we think about the market opportunity, these are just examples, again, giving you a feel for if we think about the peak vaccination, 40%-70% having flu as a comparator. The million doses per year would be 1.5 then one or two per year with the market value. Giving a price that we have around in Sweden, you find the numbers, and if you get a 35% market share. You can play around with the figures t his is examples that will give you the magnitude of horses and market need. Of course, the U.S. market entry will be the catalyst for us t hat is clear n ow coming to PiggyBac. That is a huge medical need. We then vaccinate the sows, which means that before they give birth to their piglets and the piglets get then the protection from the milk over the first two months when they are sensitive to this infection, and then they slowly build up their own defense. This is an infection that in total in Europe costs EUR 250 million per year to take care of mortality, antibiotics. They are preparing some autogenous vaccines locally. 70% of all farms in Europe are affected by streptococcus suis, and it is not only one serotype. They have several at the same time. The total accessible market in Europe, we estimate to 30 million doses per year. Of course, in the U.S., there are about 8 million sows. So U.S. is a little bit smaller than Europe here. In China, there are half a billion of pigs but 1/10 of sows. But we do not calculate with China in our estimates. Now, if we look at what we can do, these are vaccinated animals and proportion with no disease, and this is a heavy infection. This is really overkill if you are thinking about what will happen with these piglets in real life. But we have a pretty good protection against serotype 2, which is the most prevalent in Europe and U.S. We have also shown that we have a good protection against serotype 9. If we look at the vaccine and what it can cover, it is a pan-serotype vaccine, but we have to show that. The first two that we worked with is this one, serotype 2 where we have good protection. Serotype 9 also shown good protection. But as you can see, these are the different proteins, adhesion molecules that we have picked out. It is 23 here to cover different serotypes and this will become a pan-serotype vaccine. That is important because in one farm, it is not only one serotype. One serotype may be dominating, but if you vaccinate against one, which some of the competitors are aiming for, there will be another one that will take over. You need a pan-serotype and then you do not have to check for which kind of bacteria you have. Doing the same mathematical exercise to giving you just a feel for what the market could be. Million pigs now, million sows is 1/10. If we have a peak vaccination in this of 70% because here you calculate what you lose from being infected and what you can gain in terms of money will have a much higher grade of vaccination. Of course, if you think about three doses per year and if you give it a price of, I just picked a price that could be a reasonable price for an example, again, we have not tested that. You will see that EU is a bigger market here. U.S. is, of course, a market and then South America and China could be added later on. There are many pigs per farm. In Sweden, we have 40 veterinaries that takes care of pigs, which is a very low number compared to horses. There are huge farms. It is easy to get access to the people that are marketing, that are treating, taking care of pigs t he veterinary medicine portfolio, this is just to give you a flare. We have pig products, we have horse products, but we also have other products for cats and dogs and sheep and so forth. Again, this is a growing business. We are developing some synergies and we will continue to do that, and it is profitable, and it could be a nice little business in parallel. The team we have is now, I would say, a more complete management team where we have most recently recruited a clinical or a production specialist and we are also focusing on a project management, especially for Strangvac U.S. Then also a very recent recruit is Anna-Carin Lagerlöf, a commercial officer. Then the board of directors, you probably recognize some of these faces. Now, financially then, as I said, we have had a little dip in Europe. We are relaunching a bit or relaunching with new efforts. Total sales have increased in 25, about 70%. Strangvac sales in Europe, pretty high. We are going down a bit in Europe. In Sweden, still 100% plus. We have a cash position. This is Q1, so I said SEK 127 for Q2. Then we can look at the accumulated or the rolling sales month by month, last 12 months. In summary, the platform enable us to have fantastic products, I would say. The catalyst for Strangvac is the U.S. launch i t will increase if we can give it together with flu in Europe. The second catalyst will definitely be launching PiggyBac w e have not yet communicated any sales target because it is a little bit turnaround situation. Thank you. Thank you so much, Carl-Johan. If you have any question to Carl-Johan, please raise your hand and I hand you the mic. I just start with one question y ou have been on the European market for quite some time, at least for some years. Sales have been picking up and so on, but what is the right expectation from an investor side to have on Strangvac broadly in the next couple of years when it comes to sales? I think it depends on a few things. It depends, of course, on the performance of our partner Dechra and the possibility, first of all, to say that you have revaccination every 12 months, which then makes life so much easier. We had before or still have the duration of immunity two months in the label, and of course, no one brings out a vet every second month to inject their horses, which would be crazy. So that will be one important thing. The other important thing is, of course, awareness of the disease, and it is a lot of information needed. Of course, if you do not have any outbreaks around you do not see what catastrophe it can be. But we have a trotting stable that been closed for a year with three dead horses, and they really have had problems. It is very much a matter of how you can communicate and also get through to the horse owners, not only to the vets but also to the horse owners through the vets then. Finally, if it can become mandatory, it would of course change. Mandatory, I mean for traveling horses, for competing horses, which is not all of the horses, but it is certainly an important part. That is for Europe. In the U.S., I think it will be much easier for us because you have an awareness of infectious diseases in a much better way in the U.S. Also bigger stables there. They vaccinate up to seven different infectious diseases, and 70% of the horses are already vaccinated. So it will be different marketing play there. Do you believe Dechra has their investments in Strangvac been slowed by the limited label on the product? I think that is true. They are also reorganizing t hey were bought by EQT. As you probably know t hat means that they, of course, start to turn things around and look at everything, and they say they have horses as a prioritized area right now, so we will see how that will pan out. But of course, everyone knows that a new leadership may change things, of course. Mm-hmm. And we have a- Just one question. Do you have a question? Yes. Please go ahead. Impressing market. If you are worried about the competitors and competition, please. For piggyBac, zero right now t here are vaccines in development, and I think the first one will come next year, but it is only a serotype 2 vaccine, which means that they will have first to test to show that they have serotype 2 in their farm, and then they will not go after the serotype 9 strains nor the other ones. There will be a shift or a drift with serotype 9 taking over when they use them. That is piggyBac w hen it comes to Strangvac, there is a live attenuated vaccine sold in the U.S. called Pinnacle. That means that you give bacteria into the nose, attenuated, but they also cause infection because that is the way it should cause a mild infection. But there has actually been death caused by this vaccine. There is another one that is also very poorly documented. They are documented in their first registrational studies. That is it. I do not think they are pretty protective at all. But of course, it is big companies behind them, and that can be an issue to compete with. Any other questions? Yes. Just let me try to reach you. Okay. I was just wondering, you had presence in Australia, whereas the market in South America seems like it is 10 times the number of horses. How do you think about sort of market? I think the horse industry or the horse is much better organized in Australia and New Zealand. It is more spread out. In all honesty, I do not think we have investigated the South American market. In New Zealand, we had that on the back burner. We said, we need to show that we can increase sales in Sweden, that we have a good product, that people really buy it. Number two, we should work on Europe because we are not by far where we should be. Then we had New Zealand and Australia on the back burner and said, "That is the next interesting market." We were actually requested from New Zealand, from the race horsing industry. They had 20 outbreaks in Northern New Zealand. They were requesting us to send vaccines there with an exemption, whether we get an approval as an exemption. We just submitted the U.K. file and the data we have and shipped vaccines to New Zealand, and they are actually asking for a bit more. It is not huge math. It shows the appreciation of the vaccine there, which means that we now have decided, yes, maybe we should go for full registration in New Zealand, which will then make it easier to do it in Australia, where there are 10 times as many horses as in New Zealand. So it will come, but it is not around the corner. South America will be slower. There is a lot of pigs in South America as well. It is markets that are more difficult. We have to take them step by step then. Okay. You have also a question. What is the price of one dosage, and how often do you have to repeat it? Every year, or? The price varies in Sweden. I think it is around SEK 300, which means that you then have to add, you have to have a vet that comes out and do the injection, which we eventually could change if you have bigger stables that, I do not know what they are called, but you can have a special education to do injections. But you still have to have a vet to prescribe. Today, if you look at the recommendations, the guidelines from key opinion leaders and authorities, they say every year, half year, every year. If you look at our label, it says second month, every second month. Every second month? Yes. It is a restriction. It is not that you should do it. It is a restriction. We cannot, again, talk about it in 12 months. But we have filed for an extension. Scientifically, it is obvious that it works that way. Let us see if regulators accept that. You can keep the mic. Just turning to the U.S. How well does the interaction with the authorities move from your side? Has it been smooth and I think so. They are requesting a lot in a sense I mean we h ave now safety data from, say, 100,000 vaccinations with basically no serious adverse events. I think we have three breakthrough infections despite this, three out of 100,000. I think that is pretty good. They are requesting 600 safety ponies for safety trials, which I do not know why. We have done them, and we are doing what they are requesting. Then clearly, they would like to see the vaccine because they know that their vaccines on the market are not as good as this one. Key opinion leaders in the U.S. are really excited about this. We had no issues, no problems whatsoever to recruit horses to the safety trial because they got the vaccine for free then. That was swift. Finally, your view on the risks of the efficacy study. There is always risk with these kinds of efficacy studies because you instill so many bacteria. It may be that the delta is not that great. It means that you may need more animals than we have planned for, and we will have to see that that could happen. What one should then, and the way we are thinking about it is that we have evidence from European trials, from real life. We have the correlates of protection with very good data, and we can put it all together with the efficacy trial. I think that is important. It also depends on what kind of endpoint you look for in the efficacy trial that we should do. I feel optimistic about us passing through the needle for registration in the U.S. as well. Sounds very good. Look forward for following you and the studies.