AcuCort AB

Hello and welcome to Investor Update. Today we have the Q1 report from AccuCort, which will be presented by AccuCort's CEO Jonas Jönmark via link. But as always, when we broadcast live, you can ask questions to the management, and you do that in the chat field. We will handle the questions after the presentation. With that said, it's high time to welcome Jonas Jönmark, CEO of AccuCort. Hello, Jonas. How are you? Hey.

It's great here. It's full speed on all the cylinders.

Yes, I understand. As I said, it was a quarter as hectic as the year ended. So with that said, here you go. Let's go through your presentation.

Thank you very much. And welcome, everyone, who takes the time to watch this presentation. We are in a very intensive period of expansion after the very successful new emissions we did here at the beginning of the year. We are quickly entering the first quarter. As you have seen, no change has happened during the period. However, we have received an order for the Danish market from our commercial partners. And our team is preparing an order that is coming for the rest of the Nordic countries. The result after the tax went up to minus 6.5 million kronor, or yes, 6.5 million kronor, which was planned. And the result per share before and after the expansion went up to minus 0.04. In the cash box at the beginning of the period, there was about 38 million kronor. And important events during and after the quarter. Yes, you have seen that our pre-emission was recorded at 160%. And we went against the current, against many other biotech companies who tried to do the same thing during the same period. And that added about 48 million kronor to our emissions costs. So we have a stable economic foundation to take us forward in the company. We can also prove that we have good results in our phase four study in Sweden. The study where patients have received our product and been able to compare it to their previous allergy treatment. And there we have a very good and strong outcome. And what is happening now is that we are preparing a script together with our experts and opinion leaders for publication in international, heavy, scientific magazines. And that is all to build muscles for our sales and marketing in the world. We have also received a renewal of market benefits in Sweden, Denmark and Norway. And as I mentioned earlier, we have received an order from Denmark. And our partner, our current partner, will expand into Denmark now during the month of June. So right now there is a lot of preparation activities on the Danish market. A few words about our pre-emission and what the money will be used for. We did a unit emission of about 48 million kronor, which is a target of 160%. And this money will be used for the approval process at the FDA. And the further approval processes within EU-Europe. But also our partner and license-taking discussions in the US and EU and some interesting markets outside the US and Europe. As you certainly know, legal invitations in the US cost a lot. An approval process with the US Department of Health costs a lot too. But we have received a non-tax from the 16 million that would otherwise cost the company to register the product in the US. To this end, the money will be used for the personal administration of the company and also for marketing of the company. So we are making sure that we keep a high visibility on the stock market for existing shareholders and future investors in the company. Our strategy for global commercialization. Our goal, our vision is that our product should be available to all world markets in all corners of the world. We start with the Nordic market, which is our home market. Our sales are started in Sweden, Norway and Finland. And here are the sales curves for the expected drug launch. A very strong investment by our commercial partner Unimedic. They have gone beyond all you can imagine in terms of activities and so on. Above and beyond in the markets. So it looks very good. We start the sales in Denmark in June, as I mentioned earlier. We will see additional approval in the most important European countries and in the US. We have very long discussions now on a detailed level with companies for the most important European countries, such as Germany, France, the UK and several other countries. I expect that we will see some news in the near future. What we are looking for is distributors and license holders. It is important to be very careful with who you choose as a partner. I think that our collaboration with Unimedic shows what you can gain when you find the right partner. And furthermore, we have secured volume production within the EU border. So it is very easy for us to transport goods within Europe. I will say something about the US as well. We have had a dialogue with the US Department of Medicine and we have asked for their response to our IPSP. They have communicated back to us that they have some organizational challenges on the other side of the Atlantic. They are working on our IPSP, but it has been delayed on their side. We are in close contact, so we can get it in place so that we can submit our full application during this year. Will it be a milestone? Yes, additional commercial agreements in leading European countries. I mentioned some very important countries where we have come a long way. We are now at a level of detail, including Germany, France, the UK, Poland and a few other European countries. The coming milestone is also the market license in the US. Additional orders from our partner Unimedic Pharma for the Nordic market. The team is now preparing to receive such an order. Expansion in the US and expansion in selected countries outside of Europe and the US. Something that is also around the corner is publications in scientific journals of our Phase 4 studies that we are working on. A lot is happening behind the scenes in the company. We have a team that is working hard to get things in place in time. There will be exciting news during spring and summer. I will mention the market potential. There is a very high market potential for a product like SecMellit. If we look at the allergy market as a whole, as a pyramid, we can easily find a moderate allergy. We, the Polish allergists, can go to the pharmacy and buy our anti-stamina recipe-free. But we have a large number of patients who have a moderate to severe allergy where the anti-stamina is not enough. Here we see about 25 to 30 million diagnoses in Europe and the US annually. The market value is around 3 billion US dollars on a yearly basis. We have a very high potential with this product. The top of the pyramid is 1% life prevalence. That is what we call anaphylaxis. It is the patients where primary treatment is adrenaline. It is not really our patient group. Our patient group, our target group, is the center of this pyramid. It has a very high potential. It is not possible to avoid when you look at the media right now. There is a lot of pressure on news and comments about allergies. We are in the season of allergies. That is exactly what we need in the Nordic market. Unimedic has worked very well, very well with the doctors in the Nordics. What we need now is for the patients to come to the doctors and renew their recipes. The doctors are on our side. The patients now need to come to the doctor. The articles that you see here in Svenska Dagbladet and other forums help us to drive the patients to the doctor. I can't help but to summarize the advantages here as a summary at the end of the presentation. Our product, SecMallet, is a fast and smooth treatment. It is difficult to have acute allergic reactions. The large amount in the middle of this pyramid. Somewhere between 25 and 30 million people are diagnosed annually with this, only in Europe and the US. The market size is huge. We have market potential only in that segment on a little over 3 billion US dollars on a yearly basis. When you talk to patients, patient associations and look at the studies we have done, there is a great need for an easily accessible, effective treatment for these patients. Both the patients and the doctors see it. It is a contrast to the treatment that exists today. There are tablets that you should bring with you, blister cards that should be dissolved in water and that should be drunk. It is difficult to manage. You need access to water and glass and so on. In the studies we have done, we see that 70% of the patients prefer a mouth film for the tablets. That is incredibly strong. The remaining 30% are the patients who rarely get any kind of severe allergic reaction. Even stronger in our studies, we see that 9 out of 10 doctors are willing to prescribe our product. So, these are incredibly strong numbers. What we need now is that the patient must go to the doctor and renew their prescription. Then the doctors switch over to our product. Very exciting things are happening. Things are happening during the spring and summer. I think you should follow us on LinkedIn and YouTube or have an eye on our website, akukort.com. Here we will be able to present what is happening along the way. I thought we could ask some questions now, Karl. What do you say?

Yes, let's do it. It was a quick and snappy presentation. It is always good to repeat the unique abilities of SWEK-milit. You mentioned the first order from Denmark. Then you talked a bit about the Nordic countries. How is the sales in the Nordic countries? What are the factors that you need to consider?

The sales in the Nordic countries are on the curve of what you can expect. It is good that our partner Unimedic has built up a team so that it is possible to quickly reach all pharmacies after hand, as the patients order. We have received a very strong and good reception from the doctor. What we see now is that the patients must go to the doctor after hand. The patients to the doctor are the most important thing now so that we can get our hockey stick.

So it is a bit out of your hands. Now you have done what you need to do and the product is there.

It is in our hands. We work hard to help the patient to the doctor.

You mentioned Unimedic here and that they have done a test job here. What is the ideal partner? What are you looking for?

What we are looking for when it comes to commercial partners is of course to have the resources to handle a market launch. You also need to have the competences behind it. You need to have the channels to work on important opinion leaders within the allergy segment. The partner should not have to start from scratch because it takes a long time. A good example is Unimedic as a partner for us where you have the channels to work on, the muscle to sell and very good sellers on the field. Good, knowledgeable sellers.

You mentioned the team and that is you. You have had at least a lot to do during the last year, so to speak. Do you need to expand or is it good as it is?

We are a small but very effective team. Everyone who works in the team has done this before from different perspectives, which is great. We compete with each other. It is very likely that we will see recruits in the future after we grow. Now it is expansion that matters. I mentioned Germany and some other European countries that are around the

corner. When you mention Germany, do you dare to give us a timeline when it comes to SEKMELIT in Europe, regardless of whether it is Germany, France, the UK or Poland? I

would say that keep an eye on the new year's clothes during the spring and summer.

You have also mentioned that the goal, and it is a product, is that you will be in all countries. Are there any countries outside of Europe and the US that are more interesting than others in this situation?

In this situation, we have actually dialogues with countries in Asia, including China and India. There are two gigantic markets that are interesting for this product. We also have dialogues in several countries, dialogues in Australia.

What must be in place first for new countries?

It always starts with a agreement on a contract. It is a license agreement with upfront payment. Smaller markets and so on can be looked at as distributor agreements. But if we look at large markets, especially in the US, we are looking for a license agreement with upfront payment and mil-stops payment.

The US is a bit of the holy grail here. You mentioned that you are waiting for an answer from the FDA, so as I interpret it here, it is more organisational on their side. But I will expose my ignorance here and refer to something else you said. You got an exception from something in the US, and the FDA is involved in that as well. What does the exception mean?

It is called a small business waiver. It means that we as a development company, and now a small pharmaceutical company, can negotiate with a exception from having to pay the application fee. And we have done that. It means that we do not have to pay the 16 million kronor for a approved process. I

interpret it, and you do not have to comment on it, but I interpret it as if you, on the side of the FDA, and the ones responsible here, are still very positive about both the Ackerkort and SecMilit.

The FDA in our dialogues has confirmed that there is a need on the market for this type of product. We will go through their barrier.

If you look at the times, and the plans, can you imagine that you announce the agreement on several different parts, or do you have to take it step by step? Can you imagine an agreement in France and Poland, and at the same time something happens in the US? Can you handle that?

What I see in front of me is that, given the US process, and how long it is, we will have an agreement in place for it in Europe. We will get volume in Europe, which strengthens our financial position very well. And after we get closer to an approved US, we will get an agreement in place in the US. The closer we are to an approved US, the stronger the position of trade we as a company have.

It is always difficult with times. There are some things that are natural when you are in control. You have hinted that you will look at the press releases. But without going into the exact dates, what do you want to be the next milestone for us in the market? Should we wait until the next quarter, or will things come in between?

How much can you

answer? I

think we should look at three things. One is commercial agreements in Europe, orders for the Nordic market, and publications in our scientific journals where we publish our product to this target group in a scientific way.

I will again expose my ignorance. When it comes to the scientific journals, there is nothing I subscribe to. Maybe you will come up with a press release when it is published. Or should we look for publications?

We will publish press releases when all this comes. We will also have publications available on our website for those who want to get in depth.

Jonas, thank you for that. It was very exciting. You have your hands full. Not just you, but your and your future partners. So I say thank you so much, Jonas. Thank you. It was fun to be here. We say thank you to you who have watched. See you again. Bye.