AcuCort AB

Hello and a warm welcome to Kvartalsrapporter with Investor Studio. Today with Akko Kort's CEO Jonas Jönmark who will present the results and significant events during the quarter. Jonas will of course also answer questions. So as always, when we send live, you can ask questions to the one who presents, and you do that in the chat field. We handle the questions at the end of the presentation. So with that, it's time for me to turn to Jonas. Jonas, it was fun to see you, if one on the link, but I understand that you have been busy with reality.

Yes, I was hoping to be able to share the studio with you there. But the reality is that it puts some priorities, which is positive.

Yes, of course. Jonas, go through the presentation, the result and the quarter.

Yes, as you have probably seen, you who follow AppCourt, we have had a very strong start this year. I'm going to give you some details here. Som väntat hade vi ingen omsättning under första kvartalet. Resultatet efter skatt uppgick till minus 6,8 miljoner vilket också var enligt plan. Resultatet per aktie före och efter utspärring uppgick till minus 3 öre. Kassabehållningen vid periodens utgång uppgick till strax över 21 miljoner kronor. Let's move on. Let's summarize the orders for the Nordic market so far. In the first quarter of 2024, we had an order that was the launch order for the Nordic market. And then we have had three following completion orders. The last order was made by our partner in the fourth quarter of 2025. And that order was released this Friday, so it is ready for approval in France. And there we will see the result of it in the next quarter. And then we can certainly expect more orders here in the future. Important events during the first quarter. Yes, we have not avoided anyone that we have written the largest commercial agreement of the company. And we did that with Glenmark Pharmaceuticals for the countries of Germany, Holland, Czech Republic, Slovakia, Ukraine and Austria. We have also finally, after a long time of discussions with the American Medical Administration, FDA, come to an agreement on what is called the Pediatric Study Plan. And that is something that you must have in all types of applications in the USA. And what the agreement means for us is that Aquacort will not have to do any child studies in order to be able to submit our application for market acceptance in the USA. We have participated in important partnering conferences where the interest for Accocort has been very, very large. So I thought I would share with you a little more detail a little later in the presentation about that. But in summary, we have had a very strong start this year. The Glenmark Agreement means that we go from a market of 20 million inhabitants in the north to a market of almost 200 million people. It is a fairly large expansion for us, which is very, very positive. A few words about Glenmark. Yes, Glenmark is one of the top 100 companies in the world. It's a very resource-rich and knowledgeable partner for us. They have presence in over 80 countries. And as I said, a financially and resource-rich company. They have a long experience in taking this type of product to the market. The agreement covers the six European markets I mentioned earlier. The key market is Germany. Germany is Europe's individual largest pharmaceutical market. And it is also a very important reference market. If you are on the German market, it is easier to enter other markets. Greenland, the agreement with them, there they take responsibility for the entire commercial part. about marketing and distribution. They also become what we call MAH. MAH means Market Authorization Holder. So they will be responsible for the whole regulatory part. And that means that AkkoKort releases the resources required to be MAH. We also release the cost to be MAH. So it's a very good solution for us. The agreement in itself is that during a five-year period, Glenmark connects in a step-by-step model to buy a certain volume per year from us, which is a very good agreement for our part. The agreement with Glenmark is also a springboard for several partnerships, which became very clear when we were at BioEurope Spring here in Lisbon. Agreement with the FDA. We have an IPS-band in place. What we need to do is renew our application for what we call a small business waiver. and that is that we will not have to pay the application fee to the FDA, which corresponds to 16 million kronor. We have been granted such a fee earlier, or at least two times, and the lifespan of such a Small Business Waiver is one year. That is why we now just need to renew our Small Business Waiver. So we will be able to submit our NDA. That is, the application to register the product on the American market. Participants at partner conferences. I said that the interest was great. We were two people at BioEurope Spring in Lisbon. Together we had 44 pre-booked meetings. It's very big. Then it's the back-to-back meeting in three days. Very good reception. We had about half of the companies from Europe, a fourth was from the USA and a fourth was companies from Asia. And this has now led to the fact that when we came home, we have written a long series of security agreements with these companies. And now we are starting a negotiation and a due diligence process with many of these companies. Vi har också varit med på Vetenskaplig kongress i DIN. Några i teamet är precis hemkomna från en av Europas viktigaste konferenser när det gäller allergi, och det var i Frankrike. And we also take care of meeting potential partners for the French market and opinion leaders, build relationships with them for the French market, which is also very important. What's around the corner here now, and which is also very well timed, it is Bio International in San Diego, USA. And here we come in with approved IPSP and ready to submit our application, which will make us a very strong player in the partner discussions for the American market at that meeting. We will also be at IACI, the European Allergy Congress in Istanbul. We will also be at the European Respiratory Society in Barcelona. It is a meeting where we meet lung doctors, opinion leaders in Europe regarding lung medicine and potential commercial partners within our area. Later this fall, BioEurope will be in Cologne There we will also be with the partnering meetings. So it is really loaded here now. Something we see in our launch and something we see in our partner discussions is that our potential partners see the advantage of our product being approved for a wide range of indicators. Vi har lanserat inom allergiska reaktioner, inklusive akuta allergiska reaktioner, men vi ser även användningsområden som är godkända som akutsvår astma, förebyggande behandling vid cancerläkemedel, krupp hos små barn, hjärnsvullnader, hjärntumörer och operationer, svåra akuta hudsjukdomar, other autoimmune diseases, such as the treatment of pulmonary rheumatism and the treatment of COVID-19. These are the indications that we have approved in the north. Then there are actually a long number of other indications that our molecule is approved for in other parts of the world. And this is something that has been very positive in our discussions with potential commercial partners. Vi är nu mitt i vår expansion till nya marknader. Fokus är självklart de europeiska länderna och även språngbrädan mot USA. Men vi ska inte glömma att det finns andra länder som också är intressanta utanför här, inte bara USA. Vi har stort intresse från länder som Australien, Sydkorea, Japan, Malaysia, Brasilien, Kanada med flera. Our business model is, of course, to run a capital-easy business model. We are not going to build any large market and sales organizations, but we are going to go to the market via a global network of distributors and license holders. A successful launch in the Nordic countries has proved to be a very good springboard for new markets, including the deal with Glenmark. We mainly look at two types of deals. It is pure distribution deals, that is, commercial partners buy the product from us and then put it on its market. A good example is the Unimedic Pharma and Glenmark agreement. Then something that I see very positively is a license agreement where you have an upfront payment and milestone payments. And it is typical when you look at larger markets like the USA and so on, where you have that type of agreement. Det är en noggrann urvalsprocess. Det är lätt att hoppa för snabbt in med en partner. Därför är det jätteviktigt att vi gör våra due diligence-processer och ser att man verkligen har de finansiella resurserna och har det åtagande man vill ha i avtalen. En sån sak jag kan nämna där, det är ju våra långt dragna diskussioner med Lunatis i Mellanöstern. In my opinion, it has taken too long and therefore we now have other candidates that we discuss in parallel with the market in the Middle East. Just to increase the pressure and get those discussions in hand. The upcoming milestones, what do we see around the corner? It is a commercial agreement with Lunatus or another partner that we are discussing with. A approved extension of our Small Business Waiver. More orders in our leading European countries, both for the Nordic countries, but also under the agreement that we have with Glenmark. Ytterligare orders från Unimedic. Fortsatt expansion i USA. Bio International i USA kommer bli väldigt intressant för oss. Så där hoppas jag på att kunna komma hem med lite goda nyheter. Publikationer i vetenskapliga tidskrifter. Vi har två manus på gång. Ett är inlämnat till en tung vetenskaplig tidskrift. Där är hälften av dem som är peer reviewer har tittat på article and I think it's good. We are still waiting for the other half of peer reviewers. The time has passed. As soon as we get the first article approved, we can submit the next article for review. Expansion in foreign countries, outside of Europe, outside of the USA. I mentioned a few countries here that are very interesting for us, such as South Korea, Japan, Australia, Malaysia, South Africa, Brazil, Canada, with several. And the success of our product, Secmelit, lays the foundation for further innovation drugs. Let's talk a bit about our product, Sekmelit, and refresh the memory of everyone who is here. Sekmelit is a very fast and smooth treatment for acute allergic reactions. What it is, it is a mouth film, large as a trademark, very large market potential, somewhere between 25 and 30 million people are diagnosed with this annually. Only in the EU and USA. This is a big market. The market size is just over 3 billion US dollars and grows by 11%. We are becoming more and more allergic. And there is a clear need for an easily accessible and effective treatment for these patients. De tillgängliga behandlingarna som finns idag med tabletter som ska tas ut, blisterförpackningar, någonstans mellan 15 och 20 stycken, krossas, lösas i vatten, otympliga att ha med sig och så vidare, svåra att administrera, det gör att det finns ett tydligt medicinskt behov, både hos läkarna och hos patienterna för den här typen av behandling. In the studies we did, we did a study on just over 400 patients, where 70% of the patients preferred a mouth film for their tablets. And then I wondered, of course, the last 30%, what was it with those who wanted to have tablets left? It was the patients who never or very rarely got an allergic reaction. But the more often and the more difficult allergic reactions you got, the more you preferred a mouth film. If we look at our research and studies with the doctors, nine out of ten doctors want to prescribe our product. If we look at the Nordic market, we are in the classic situation for a launch in the Nordic countries, where the doctors are on our side, but we have to drive the patients, help the patients to the doctors. You can hear that my nose is a bit tight because I'm allergic to pollen and it's a high dose of birch pollen here today. And I think we'll see an effect here of that the pollen season starts during the coming months on the Nordic market. Let's look at the entire allergy market. Remember that I said that there are many other big indications of this. We have chosen to start with allergy because there is a very clear market demand there. If we look at the entire pyramid as the allergy market, then it is the base of the pyramid. That's where you find me. I go to the pharmacy, take my antihistamine, but then we have the next step in the pyramid. It's the patients who have had a difficult allergy. They need to complete their antihistamine treatment with a product such as the care. as a rescue medication because the antihistamine is not enough. Then we have the top of the pyramid, it is actually 1% of the entire pyramid, it is those who have their adrenaline pen because they risk getting anaphylaxis. Then they should take their adrenaline pills first, then they should take a strong steroid such as our product, and then they should take their anti-stamina in this. But our focus market is in the middle of this pyramid, and this is where we find a market size solely on allergy, at 3 billion euros annually in this. If we look at the company as an investment case, an innovative product, clear clinical benefit, high patient need in the product, low development risk. The product is approved by four independent pharmaceutical authorities. The product is well developed. The money we use now in the company goes directly to commercialization. Sales started in the four largest Nordic countries. Big market over 30, I wish 30 billion dollars, but 3 billion dollars. If you just look at the allergy sector, about a third of the world's population suffers from allergic symptoms. Many of them are our upcoming patients. There is a strong, competent team, experienced management behind the company and behind the product. Thank you so much so far. It's your turn, Carl.

Thanks for that. It's exciting. We've already got some questions in. I'm going to try to have some structure on this and start with what you mentioned about being tipped in the nose. It is so that the flower and pollen time is coming and you can see that a little bit in advertising to the right and to the left. But when do you start to see that in sales? Does it take a quarter before this materializes?

I think we will see that in the next order from Unimedic. Now Unimedic has just received a big order from us. And the reason it's big is that they should be ready for the pollen season.

That's interesting because the graph you had from Unimedic, it looks incredibly appetizing quarter by quarter. Do we dare to extrapolate that with regard to the season and pollen?

I am very optimistic. I see that the use is increasing all the time in the Nordic countries.

So I keep my fingers crossed. As a friend of order, we have orders coming in from Unimedic, but in your first slide, according to the plan, you had no sales. So the question is, when will sales from Unimedic materialize?

Unimedic has ongoing sales from themselves to the pharmacy. It is not the sales we produce, it is produced by Unimedic itself. It is a sale that we, to be fair, produce by the orders we receive. And the one who follows the curve there sees that every order is getting bigger and bigger.

But things go according to plan and then it will be prepared. You also mentioned a milestone. There have consistently been questions about the FDA. And now you have an agreement. This pediatric study is important. When will you get an answer to the application for Small Business Waiver?

I will say a very important thing. When it comes to the IPSP, what we have agreed on is that we will not need to do any study before you can submit our NDA. Answers to the Small Business Waiver, we expect to have some kind of answer here just before the summer. But in parallel, we are updating our NDA to FTA's requirements. So we should be ready to send it in.

And for a playboy, does this mean that the application for market approval can come now, or are we waiting for something?

We will send it in as soon as we have received our Small Business Waiver, or soon thereafter.

Getting a Small Business Waiver sounds very good to me. Why do you get approval for that?

It's because you are allergic to it. It's time for a Sekmelit. It's because you are a small company with a very important product for the American market. So if you are a small company, you get this waiver because the American Medical Agency considers this product important for the American market.

It's a quality sign, you could say.

Yes.

Then it is in the interests of the authorities to approve this. Great Britain, Poland and France, there is still no agreement. And you talk about growing both in Europe and abroad. But how does it look there?

Great Britain, France and Poland are big, very interesting markets for us. And they were some of the countries we concentrate on especially now when we were at BioEurope in Lisbon. So there are now dialogues on all markets. We have had dialogues there before, but what is nice now is that we have several that we can play against each other.

That's a good segue, because we've got some questions in before, and it was about the status of Lunatus. You say that you're talking to other candidates, and at the same time you mention Lunatus in the future. Do you see a deal ahead of you, or what should we see ahead of us?

First of all, I would like to have a deal with Lunatus, because we have a deal process and things like that. Then that they pull the legs after themselves can be increased by competition. If they could not meet our requirements, because it is a lot about risk management in that part of the world, and actually to get paid. Then we have other companies that are strong that we have a dialogue with in parallel. We will let Lunatus know that we have a parallel discussion.

With these parallel discussions, we have a question about the meetings in Lisbon. You get more interest in the Asian market. Is it from Lisbon, Vienna and Paris, or are there other parts?

The interest from Asia comes from that we have extended trade to some companies that we think are interesting in the area. And they have found it interesting to meet with us. And after the meetings we have had at BioEurope, we have gone in and written a security agreement and now the dialogues continue.

Last time we met here, you had just returned from Lisbon. It was very productive. You mentioned that you had 44 meetings in three days. Then there has been ECEM in Vienna and Allergy Conference in Paris. Do you have enough staff? In my opinion, 44 meetings are 44 different prospective partners or companies. How do you handle this?

It's about prioritization and planning. As I said, we're going to run a Capital One model. It's work peaks and work peaks. Right now, we're in a very positive work peak. And people will like to drive here now until large parts of Europe go on vacation.

When you take these kind of trade fairs, who finds who there? Is it the company in the main that is looking for you or are you looking for the company?

It's both. In Lisbon, it was probably 60-40. 60 that fell on us, 40 that we chased. We have a very good map of the companies we want to work with. We have gone against them in the first place.

Exciting. What should we expect from Accocort in the coming quarter? What do you dare to say?

Yes, I think we should have a look at what is happening both on the partnering side and on the US side. I think you will see a lot there.

So partner USA, and then everyone can feel how the pollen hits here in the cold north. Exciting, Jonas, and as they say, you have to watch this space because there is more to come.

Absolutely. I think those who don't follow us on LinkedIn or YouTube should do that.

Thank you for that, Jonas. A lot of information and exciting. And thanks to you who have watched and asked questions both before and after. And I'll see you in a little while.