Moberg Pharma AB (publ)

Good afternoon and welcome to the Moberg Pharma telephone conference. My name is Charlie and I'll be coordinating the call today. If you'd like to ask a question at the end of the presentation you can do so by pressing star 5 by 1 on the telephone keypad. I will now hand over to our host Anna Young, CFO, to begin. Anna, please go ahead.

Thank you and welcome to this telephone conference following the press release this morning. And this call will be recorded and uploaded on our webpage following completion. So with me today, I have our Chief Medical Officer Anders Bredesen and our Chief Scientific Officer Amir Tavakol. And before opening up for questions, I would like to provide a short summary on the information that we received this morning. So in essence, we received information about clinical cure in a subset of patients for our North American phase 3 study for MOB15 against onychomycosis. And the number of patients who have achieved clinical cure in this blinded subset of patients is lower than our expectations. And clinical cure, that's the sufficient assessment of the amount of affected nail area for a patient. For clinical cure, this has to be zero. you are perfectly healthy looking male without any abnormalities. In total, there are three parameters, clinical cure, negative frontal culture, and negative microscopy, together that make up the complete cure, which is the study's primary endpoint, the direction that Tessier will look at. All three need to be met. So a low clinical cure means that complete cure also has to be low. The information that we have received is blinded. We don't know if a patient has received the drug or not, and also do not know the percentage of patients receiving drugs in this sample. However, the total number that we have achieved of complete cure in this subset is lower than our expectations, and thus the risk of the study not meeting its primary endpoint, complete cure, has increased. Therefore, we assess the risk of not being able to commercialize MOB15 in the US based on this study, has significantly increased, which requires us to fund this press release. Our priority is to protect the integrity of the study data, both when it comes to using the study results in discussions with regulatory authorities, but also since there are patients with ongoing treatment in this study. When it comes to implications for our products on the market in the EU, we have an approved product that has a different dosing. This approved product works as documented in previous clinical trials, so we don't expect any consequences from this trial. We will not speculate on possible outcomes or what this means for the future potential of MOD15, and we need to rate top-line results to avoid drawing premature conclusions. Once we get these top-line data, those, of course, will be analyzed. We expect to be able to get top-line data in December and final data to follow thereafter, and only then we will be able to analyze the situation of our company for the different markets, and we will get back to you as soon as we can. With that summary, I open up for questions.

Of course, thank you. If you'd like to ask a question via the telephone lines, please dial star followed by one on your telephone keypad. If you choose to withdraw your answer, please press star followed by two. When preparing to ask a question, please ensure you're unmuted locally. As a reminder, that's star followed by one on your telephone keypads now. Our third question comes from Jacob Rowe of Rowe Fund LLC. Jacob, your line is open. Please go ahead.

Hi, sorry about that. Was there any impact to mycological QRAs, and is this going to have any impact impact, you believe, on future patent extensions?

So we have only just gotten a first test of all the data, and we have not achieved any data on mycological cure, so only on clinical cure. So it's premature to draw any conclusions when it comes to future patentability, since we're lacking key components. We only have one of these three components that make up the complete QR in the trial.

Okay, thank you.

Thank you. Our next question comes from Dakota Quince, who is a private investor. Dakota, your line is open. Please go ahead.

I just have one question. Seeing as the odds to positively affect the change to the label have been reduced, is there any consideration for pulling forward the European launch? Thank you.

I think there are two parameters that set the timeline for the European launch. We obviously wanted to have stronger claims coming from this ongoing study, and we've We still want to see the results in the ongoing study, but I think more importantly, we also need that approval of a turbine supplier before launching in Europe. And given the timelines, we expect to get approval by end of this year, and then there is a delay from when we get the approval until when we can actually get the product on shelf, since the the pharmacy chains have their decision meeting, I would say, roughly six months before they actually put the product on the shelf. So whether it's possible to put the product on the shelf during next year, that will depend on when we get this approval. But we can already now see that given that the high season starts in Q1, if you want to launch the product during the high season, it's really a high season, 2026 and not 2025.

Thank you. As a reminder, if you'd like to ask a question, please dial star followed by one on your telephone keypads now. That's star followed by one to ask a question. Our next question comes from Gang Lu, who is also a private investor. Gang, your line is open. Please go ahead. Gang, your line is open. Please proceed with your question. We have no response from Yang's line, so we'll move on to the next questioner. Our next question comes from Theo Kirikou, who is also a private investor. Theo, please go ahead.

Hi, Anna. I just wanted to check, is the EU approval, is the EU launch affected? I'm going to leave this touched on it, but I just want to clarify. Is the EU launch affected by the US Phase 3 data and are any of the milestones with Bayer attached to the Phase 3 data? Thanks.

So if I start with the regulatory piece, we don't see that the regulatory piece in Europe will be affected, since we have an approved product that has a different dosing than the dosing that we tried in this ongoing study. So this approved product in the EU, it works as documented in previous clinical studies. When it comes to actually launch plans for Europe, it's both the collaboration between us and Bayer, and I think it is premature to draw any conclusions based on this press release that is effective, because we need to see the top-line data. And once we have received the top-line data, we will, of course, engage in this dialogue with all our existing partners.

Thank you. As another reminder, if you'd like to ask a question, please dial star followed by one. Our next question is from Chris Bale of Pier 1 Capital. Fish and wine is open. Please proceed.

Morning, Anna. Can you tell me, does this affect the launch in Canada at all?

I would say it's the same reply as for the launch in Canada. In Europe, once we have the top-line data, we will, of course, have a dialogue with all our partners. But I would say that my expectation is for Canada, for Europe, we're relying heavily on the already approved drug in Europe and that file.

Thank you. Our next question comes from Hugo Mogar of Bavaro. Hugo, please go ahead.

Hi, Anna. I have a question on my end. The first one is, can you confirm about the requirement for applying to the FDA? Was there an expectation of, like, a statistical difference on completion rates with that second trial? And the second one is that in the communication, you mentioned below expectation. Can you give a bit more color on what were the expectations from mobile side? Thank you.

Yes. So, what we have communicated previously is that FDA requires two studies, that's where we show superiority, and we have one of these studies already in place, and our goal is that this current study will provide that second study that is needed. And our communication today, earlier today, this morning, tells that we see that the likelihood that we're being able to commercialize the product in the U.S. based on this study has significantly decreased. So we're not saying whether we can or cannot register and launch the product based on this study. We're just saying that the risks that we will not be able to do it based on this study have increased.

As a final reminder if you would like to ask a question via the telephone lines on todays call please dial star followed by 1 on the telephone keypads now. Our next question comes from Alex Ack he is also a private investor. Alex your line is open please go ahead.

Thanks very much hi Anna just two questions for me first of all I was wondering if you I guess in some way quantify what you mean by significantly decrease. Do you think the chances of approval in the United States, given the data you received this morning, do you think they're still above 50% or are they below 50%? And my second question is, would you launch another task to see whether perhaps a more frequent application of the ointment of the topical would meet the clinical cure objective and how long would that take and how much would it cost? Thank you.

Yes, so if I start with the first question, so I think going back to, you know, in addition to what I've already said, that, you know, we see that the risk of not being able to commercialize has increased. But we cannot really speculate on possible outcomes and, you know, percentages. It's premature, and we have to wait for the actual readout of the data. I'm sorry, but I didn't fully hear your second question. So could you please repeat that?

Yes, I'm sorry about that. So the second question was, you know, you tried a different way of administering the topical, where there would be a frequent application followed by an infrequent application, and that has not achieved the clinical cure. So I guess the nail is still somewhat dry after that, at least what you received from the data you received this morning. Would you be willing to try another set of clinical trials where there would be something in between, such as, you know, frequent and then less frequent application and then even less frequent application? Or would that take too long and cost too much?

I think, for starters, we're not at the position where we would say that that we have a clear conclusion on the results in the study. We're still saying that the risk has increased, and that's really what we need to inform the market about. But we only have a limited set of data, so it's a subset of the total data. It's one of the three parameters that makes up the complete cure, and it's blinded data, and we as a company have not fully controlled this data. So that makes it very hard, or I would say impossible, to draw conclusions based on this. So we cannot really tell whether our hypothesis with the whitening of the nails are correct or incorrect in this instance. So therefore, it's not possible for us to speculate on next steps. We just have to wait for the final data and analyze that. We would, of course, also want to look at male photos and mycology data, and none of that is available.

Okay. Thank you.

Thank you. Our next question comes from Fabulous Holm of Samuelson. Fabulous, your line is open. Please go ahead.

Hi. If this study does not show good top-line results in years, what's the path forward in Canada? Does Canada require two studies for approval, or would you submit your previously completed European phase three trials for approval in Canada?

Thank you. Thank you. We believe that the European dossier is sufficient to file in Canada, so we don't think that the outcome of this study will be necessary in order to file in Canada.

Thank you. Our next question comes from Sean Coppergy, who's also a private investor. Sean, your line is open. Please go ahead.

Hi, thank you. Could you please let us know what the N of the subset of data is? So the study is something like, I forget, 378 or 386 participants in total. Is the subset meaning it's like only some of those? And if so, how many of those people is the subset drawn from?

Yeah, so I'm going back to that it's an absolute priority for us to protect the integrity of the study data. And for that reason, we have decided after looking into the regulatory issue not to disclose details about number of subjects. It's a sufficiently big data set so that we feel comfort that this data is accurate and we need to send out this press release, but we're not disclosing the numbers.

Okay, thank you.

Our next question comes from David Shafari of AXA Capital Management. David, your line is open. Please go ahead.

Thank you. My question was just answered by the previous person, so I have your question.

Of course. Thank you. Our next question comes from Hede Miller, who is also a private investor. Hede, your line is open. Please go ahead.

Hi, thank you. I was wondering if it's safe to file bills. Is there any other way that we can get an FDA approval based on the previous regimen?

I think it's too early to answer that. I don't know the answer to that.

Our next question comes from Diego of Nostra Castle. Diego, your line is open. Please go ahead.

So I have two questions. Question number one would be, if we exclude the US, what other geographies around the world can you use the European study for approval? And I'll ask the second one afterwards.

Yes, so that's a difficult question to answer. I think there are many geographies where European data can be used, either standalone or with a local study. But it's hard to give a general answer. I think for the markets where we have partners in place, for Israel and for Canada, the standalone European data seems to be sufficient without any local registration. For other territories, such as China or Japan, we would expect local studies to be required. So it really varies between territories.

In the case of, for example, China and Japan, how long would the process take in order for you to find a local partner and then require local studies?

So the demands on local studies can also vary a lot. So I think it's hard to give a general answer. But of course there is, regardless of which country you're looking at, there is a local registration procedure and the the timing of that varies greatly. So I think there is a great advantage in us having approval in 13 countries in the EU already in place and also having partners in several territories in place.

I appreciate that and I'm moving to the second question which is obviously the vast majority of the answers that you guys have given so far have been quite generalistic and in some sort of way almost very conservative of mildly pessimistic. So, you know, if we take a step back and if you look at your company right now and if you look at the next, you know, several years and the opportunity that you guys have with your product, what are you really optimistic about? And us as, you know, investors, like, what should we be really optimistic about?

I think it's the fact that we do have approval in Europe and we do have a very successful market first launch in Sweden where we managed to become the market leader within almost immediately and we have now taken more than 40% of the market share in Sweden during this launch.

Thank you very much.

Thank you. Our next question is a follow-up from Jacob Rowe of Roadfund LLC. Jacob, your line is open. Please go ahead.

Hey again. So are you guys expecting a sales impact in Sweden? I understand that the launch was based off of past studies, but I'm assuming that this study going poorly will impact sales. Just curious what your thoughts on that. And then I have a second follow-up question that I'd love to answer to after this.

Well, I don't see a direct link, I must say. If we look at Sweden being an OTC market, then I think we have a really strong proposition in the Swedish market. So I would not see an immediate link. And we still don't know what the outcome in the study will be. So I don't foresee any change in the way we look at the Swedish market.

Okay, I'm actually just going to skip my second question. Thank you.

Our next question is another follow-up and it's from Hugo Mogar. Hugo, your line is open. Please go ahead.

Yes, thank you. Like, given what has been implemented so far and, as you mentioned, the lack of real answers that we have from this subset of data, What was motivating the PR that you released this morning? Was it legal driven? Did you have like a shame that led to that? Because it feels that the impact on the company's valuation has been tremendous as opposed to what you're saying, meaning we have very limited knowledge about what the impact will really be from the study. Thank you.

Yes. So you're absolutely correct. This is legally driven. And as part of the process to prepare the database closing, we received the blinded data on a portion of the patients. And that was unexpected to us. And unfortunately, we had to ask them that information.

Thank you. At this time, we have no further questions. Apologies. We have had a late question registered from Guillermo Infante, who is also a private investor. Guillermo, your line is open. Please go ahead.

Hi, thank you for taking my call. So my question is regarding the number of patients in the sub-sect of the data. I know you, I don't think I fully understood how relevant this is. Are we talking about the majority of the data, minority, a small section, any cuts in any way? Anything that you could give us?

Yeah, so we really want to protect the integrity of the study. And for that reason, we have decided not to disclose the numbers or values of this subset. Also, since it's blinded, so it's hard to judge. But the subset of data is substantial enough to lower our expectations.

Okay, thank you.

Thank you. Our next question comes from Felix Lindbergh. He's a private investor. Felix, the line is open. Please go ahead.

Thank you. I was just wondering if I don't quite get the rationale for not pulling the EU launch forward, given that the rationale for pushing forward was to improve the label. Could you provide some more reasoning for that?

Yes. We have two reasons for pushing the EU launch. The study was one, but I think the most important one was that, as you might recall, we did not get our turbanethane supplier approved when we got the approval. So we only have very limited amounts of turbanethane, the active substance, in MOB15. And for that reason, we could not launch in several countries. We had only sufficient drug to launch in Sweden. And in parallel, we have been working, trying to get a new urban essence supplier approved, and we actually have two tracks there. We have one company, which we have filed an application and expect approval by the end of this year, and we also have another company that we're collaborating with where the substances have been produced and stability studies are ongoing so that we will be able to

Yeah, I was wondering then if I interpreted correctly that now the main bottleneck for launching the rest of the EU is the supply question. And as I understand it then, you're basing online to finish that by end of this year, maybe early next year. And if that's the case, why wait for the launch in the EU until 2026?

So once we have the approval, the new turban essence supplier approved, then there is a selling period towards the pharmacy chain. So the pharmacy chain will not accept a new product that cannot guarantee that we can deliver the product in time, basically. So if I look at those timelines, they're typically up to six months. So in practice, if we get the approval by year end, this is a highly seasonal product where you have the majority of sales in Q2. So you really want to hit the market in Q1, and you also have limited windows when you can enter the market. It's typically two to three times a year when you can put a new product on the shelf. So that puts logistic limitations there. Since we don't want to launch during off-season, we think that does not promote long-term growth. You want a successful launch. That's rather important. So for that reason, if we want to hit the peak season, then it's peak season 2026 and not peak season 2035.

Thank you.

Thank you. Our next question comes from Will Pruitt, who is a private investor. Will, your line is open. Please go ahead.

Great. Thank you. Good morning. Good afternoon, everyone. Thanks for the call, Anna. I have two questions. The first one is, you know, it sounds like you guys are going to wait until you have all the data before making a call on how to proceed with potential further studies. But could you just confirm, what did the P3 in the U.S. actually cost?

I don't think we have disclosed that information.

Okay. And then the second question is, you know, a previous caller asked about other markets which could potentially still be open with the European dossier. And it's going to vary by country, but just to ask about three in particular, South Korea, Germany, and the U.K., Could you give us some idea of whether or not those would still be potentially open markets with the dossier as it stands right now?

Yeah, so if we start off with South Korea, there we have a partner in place. So with that partner, we're currently awaiting data, and then we'll have discussions about what is required. When it comes to the UK, after Brexit, it's a totally separate process, but a rather similar process to the European approval process. But it's a separate process. And I think this is really driven. UK is an interesting market. We had to prioritize. So us and Bayer prioritized the European countries that belong to Europeans union and where we could just keep the same process. But we expect, you know, in the future to also include UK. For Germany, it's part of the European Union, so it's part of the countries that we can add to the process. So our European approval is starting countries right now. We have plans to add additional countries. We're not disclosing, you know, exactly when and in what order. It you know, sticking with the decision that is taken together with Bayer, the timeline for adding additional countries to the existing file in Europe, that's also dependent on other items that affect the file, because you cannot change several things. Certain changes cannot happen at the same time as you're doing other changes. So, for example... this turbo-nation supplier that we need to get approved in Europe, you cannot have a process where you do that type of change and at the same time add additional countries. So this sets the timeline for adding more countries within the European Union.

Great. Thank you very much. We now have a follow-up from Diego Chonitzar. Diego, your line is open. Please go ahead.

Hi, Diana. Thank you for taking my follow-up question. So first follow-up question is, I understand you guys don't want to disclose the subset of patient data, but how does that compare, the clinical cure compare with peers currently?

I didn't quite hear your question. Sorry about that.

So how does the result of the subset of patients compare in terms of the clinical cure versus peers?

Yes. So as I was saying, we were disappointed with the data, and that's the reason for the pressure. And we will not comment on the level as such. But I think it's sufficient to say that it's disappointing. Yes.

Okay, question number two. So if we just focus on Canada and then Europe, my understanding is that in this campaign we're focusing on starting around peak season 2026, so that would be the beginning of the year 2026. Assuming that that's basically the launch date, how long do you think you need in order for you to get comfortable?

I think if we looked at the Swedish ones, the excellent rollout, our expectation is that this product is strong enough for us to have, you know, great rollout throughout. Our goal is basically that every market where we decide to launch, this product will be the market leader. I'm not sure we will succeed in every market, but that's definitely our goal.

I understand. So if we look at something like the Swedish launch, that would be, I wouldn't say the base expectation, but that would be kind of like the modus operandi that you would like to have in all the different countries within Europe.

Yes, I think the Swedish loan is an excellent example of a successful loan.

Fantastic. And the last question that I want to ask management is, if basically management is willing to commit a good portion of their compensation as share compensation in order to show commitment with the future launch of the product both in Europe and Canada and hopefully in different countries around the world.

It's not the typical way you ask in Sweden. I will consider your question.

Thank you very much for that and thank you for taking my questions.

Our next question is another follow-up, and that's from Guillermo Insante. Guillermo, your line is open. Please go ahead.

Hi, Anna. Final question for me. It's regarding the buyback potential given the cash balances that you guys have and the recent share performance. Anything that you could comment on that? Thank you.

Good thoughts. First of all, we need to analyze the data before making any kind of decisions of financial nature. So we will wait for the top line data in December and final data, and only then we will be able to analyze the situation for the different markets and whether we have investment opportunities or whether there are possibilities to distribute funds. So we'll get back to you.

Our next question comes from Simon Vallen, who is also a shareholder. Simon, your line is open. Please go ahead.

Hello, Anna. It's 5 to 13 today, as we can see. So we're down 65%.

Yes, unfortunately, I noticed.

Yeah. So we're down 65%. Do you have any words or anything you want to say to us shareholders about this situation?

I think the situation is extremely regrettable. It's an awful position to be in when you're having a listed company. You get this information, but you don't get the full information. I'm legally obliged to give this information to the market without being able to really tell what this means for the long term for the company. So I'm I'm sad that this has happened, but we're working towards doing the best of the situation. My first and foremost priority is the data integrity of the studies and gifting us to top-line data as quickly as possible.

Okay, I understand. So it's kind of like your hands are... slide behind you back in a moment. You only had the responsibility to report this findings, but you can't really argue with it because you don't have additional data. And patients is the key, if I understand you correctly.

Well, the patients, all patients are reclusive, but there are fewer patients that are reclusive. So, both... Oh, sorry.

I think...

I think that's the key component here, to await the final data. Of course, we as a management team, we will look at different scenarios and we will do our utmost for preparing the company for this data that is to come. But, yeah, it's right now. Very little we can do as management except then continue running the study and making sure that we keep data integrity and that we keep timelines.

Thank you.

We have another follow-up from Diego Tremensara. Diego, your line is open. Please go ahead.

I hope you don't take this personally, it's just because we are shareholders of the company and I'm a client of your product as well, so that's why I'm asking this amount of questions. But by the end of the year, basically, so we'll get the results by the end of the year, is there anything the management can do in order for the company to signal some positive news around the product itself, the rollout of the product, in order for us to be on this until the end of the year? without any news and given the lack of data disclosed so far today, you know, we are supposed to basically assume not very good things.

I'm not really sure I understood the question.

So the question is, is there anything that you as a company and that management can do over the next couple of months before we get the full results of the study to signal positive news around the product and the company and the development and the roll-up of the product in the different markets in which it operates.

I mean, we will, of course, continue towards our goal to make MOB15 the leading product within Omnicomacosis in as many markets as possible. Right now, we're in a limbless of a limbless situation, I would say, given that we have this data that we have shared with you, but we don't have the full picture. And I think the full picture will impact how we target the different markets. So, we will continue to work on, I think, as I mentioned before, the key here is to to make sure that we keep the integrity of the study and to make sure that we execute as best as possible and get the data out to all of you as quickly as possible.

Thank you. Thank you. We have no further questions registered via the telephone line, so I'll hand back over to Anna for any final or further closing remarks.

Thank you, Operator. And thank you all for calling in. I wish the circumstances were better, but I appreciate you taking the time. And I would also remind everyone that the recordings of this call will be published on our webpage shortly. Thank you all for listening in.

Ladies and gentlemen, this concludes today's call. Thank you for joining us at Disconnect Your Life.