Enrollment complete for the 2nd North American Phase 3 study According to this Swedish financial news outlet:
https://www.redeye.se/research/946026/moberg-pharma-completed-enrollment-for-the-phase-3-study-in-the-us
According to this interview it will be at least 15 months before they have topline data:
https://www.redeye.se/research/934969/moberg-pharma-videointervju-med-vd-anna-moberg
I tried an online service to translate from Swedish to English:
Host: [00:00:06] Welcome to Redeye. Today, we're going to talk to Anna Ljung, CEO of Moberg Pharma, who is here to talk a bit about her ongoing share issue. Welcome Anna!
CEO: [00:00:17] Thank you very much!
Host: [00:00:19] A lot of positive things have happened in the company during a period here. Including approval in Sweden. Can you tell us a bit more about the Swedish approval?
CEO: [00:00:28] Yes, absolutely. It was our second approval that we received. We have received several, and most importantly, it was our first and final approval. It is important for us because it is seen as we say, that we get the volumes up and sell the product prescription free so that you can go directly to the pharmacy and buy without seeing a doctor first. Sweden is our home market, so we need to get this national approval. We have a total of 13 countries where we are in this process of getting national approvals and we have managed to get some, but not all. But we expect it to be ongoing here in the coming months. Sweden is our home market. That's where we want to start launching and that launch is planned together with our partner Derma, which is actually the same team that we once launched our first generation product with. So it's great to be able to collaborate with them once again so that what has happened in practical terms is that with the national approval, yes, but then all the artwork is locked so that we have been able to send our artwork to production so that the tube that we will eventually take our medicines, it is sent for production and then the production of the actual product will also take place here in the autumn. The goal is to get the launch underway as soon as possible. So that's where we are.
Host: [00:01:52] It is a good basis for a so-called two-stage launch program starting in Sweden.
CEO: [00:02:00] Yes, I think so. This is our home market. It is a market where we have a strong presence, a market that we know extremely well. So it is important for us to get a quick approval in Sweden and this two-stage rocket that you mention. This is because we completed our decentralized process. We then received recommendations for national approval in 13 countries. But it's not just us that has to be approved, it's our manufacturer and it's actually also our manufacturer's manufacturer of the active substance. Thereby, we had 2-3 manufacturers in the file. Only one of them was approved and it was not our manufacturer. So if you look at the short term, we have a very limited amount of available terminology. That's why we need. We do two things. We are working on trying to find new manufacturers and we are also working on getting the term from the manufacturer that was not approved here last summer. Making a supplementary application, you could say. To get them into the file But this means that we cannot launch a full-scale launch right now, but we have to focus on, in this case Sweden where we know that now we have received approval so we can actually put the product on the shelf in Sweden in a reasonably short time. So that gives us a presence in our home market.
CEO: [00:03:22] We can test the marketing messages properly. It creates more security data for those countries that do not go directly to autism. So there is a lot we gain by doing that. And you should also remember that you. In parallel with this, we are conducting another research study in the United States, which we are in the middle or towards the end of, one might even say, patient recruitment. So we have communicated that we expect all patients to be recruited by the end of the year and then it will take another 15 months until we have topline data for that study and then we believe, based on that, that we will then be able to submit an application for approval in the US based on the data and that we will be able to strengthen the product's claim, including a shorter treatment time globally. So those are important pieces of the puzzle. And if you look at the timeline, because it takes a while to add a new machine manufacturer just given the process times here, it may be that it is timed so that we have time to get this data and can make an even stronger launch but with new data. When we do the big roll-out across Europe with Bayer, our major partner, we had everything for Scandinavia.
Host: [00:04:36] As I said, you have a strong partner, we are in a good position and they are behind this strategy with which you have the new strategy.
CEO: [00:04:44] Absolutely. But of course this means that we, we have had tremendous help from them through this regulatory process and now we are working together for the upcoming launch.
Host: [00:04:57] The ongoing issue that you have. What will that money be used for?
CEO: [00:05:02] Yes, in a nutshell. When we got the message in the summer that we do not have sufficiently fine our full approval for our full launch, we saw that we need to divide the launch into two steps and this means that we unfortunately do not really get the revenue in the near future that we had expected. Therefore, a need for capital arises and we have chosen to launch this new issue, which is in the middle of the period for right now, so that we take in 100 million now and then still gain from it.
Host: [00:05:33] If you take a look at. As I said, you've already done this process before with a previous product, and that speaks volumes for your success this time around. What do you see as your biggest obstacles as a company right now to reach in one to one-half year? As a comment. What are the major obstacles you see ahead? There are some.
CEO: [00:05:57] Yes, in terms of the regulatory risk, I would say that now we know that we have got approval. It feels wonderfully safe. We also got our first CE approval so we know that this product can be approved, at least in some European countries. Certainly not all of them initially, but a number of them, so that has been extremely important for us. Yes, as far as the clinic is concerned, because we have the approval, we know that the clinic will last and then the third part. It's all about marketing capacity, and it's obviously nice to have a partner like Bayer with their capacity. Can the horse which is the world leading sponge brand and to put our product under that brand. In fact, I can't think of a better way to reduce launch risk than to use that kind of established partner and established brand.
Host: [00:06:56] One last question, as you said you came to power yourself is largely in the US. What is the strategy behind it?
CEO: [00:07:05] It is about our historical knowledge. We have previously had our own marketing company in the US. It has worked very well in the US. You have really three prescribing groups and the largest of these prescribing groups are specialists in it. They don't exist in Europe but in the US it's a big prescribing group and then there are dermatologists and general practitioners, dermatologists and general practitioners. Yes, there are many companies that have their strengths in this group. But these specialists are a bit neglected by the big companies because there are no really big products in this category and these are doctors that we have built relationships with for many years because we have had Kerasal on the market for a long time and built an umbrella brand. So really we want to use the knowledge that we already have. We are convinced that a niche player with a limited investment and the right conditions is the kind of product that can take a market-leading position here for a limited investment. In fact, this should be kept in mind in clinical trials. We have shown that 76% of patients become fungus-free and this is better than any other tropical alternative. So what we have done. We take Terbinafine, which is the most commonly used substance for nail fungus, but usually in tablet form. A great product, but it has a side effect profile that is not so fun, where you actually risk liver damage and some patients have unfortunately died. So taking the product that you know works. But instead of taking the detour through the body, apply it directly to the nail. It has 40 times higher concentrations under the nail where the fungus sits, but you have a thousand times lower concentrations in your blood. It is basically our invention and of course with a long patent protection and so on.
Host: [00:09:05] If you look at the short term, what should you look out for? But it has come when we have had a lot of positive approvals and so on. Except for the issue, if you think in other terms. What to look out for in the rest of this year and into 2024?
CEO: [00:09:22] Yes, but it is of course that we continue and generate national approvals and we will communicate this in our quarterly reports we have communicated and then before this launch that the launch will take place as planned. Then there is the manufacturing issue where you have mentioned that we are working on two fronts. Firstly, to identify alternative manufacturers and there we have a dialog with five companies and secondly, to try to get the authorities to re-evaluate generating more data so that the manufacturer we have worked with can be approved. So these are important deliveries. And then, of course, that we continue as planned with the North American study where we expect that. Get the last patient in before the end of the year. Then we know. Then the clock starts. When the last patient has come in, well then it's 15 months until we connect the data. So many exciting things are happening.
Host: [00:10:14] That sounds good. Thank you very much Anna!
CEO: [00:10:16] Thank you!