Hello, and welcome to the Moberg Pharma Q1 report. Throughout the call, all participants will be in listen-only mode, and afterwards, there will be a question- and- answer session. Just to remind you, this conference call is being recorded. Today, I'm pleased to present CEO Anna Ljung. Please go ahead with your meeting. Thank you. Hi, my name is Anna Ljung, I'm the CEO of Moberg Pharma. I also have our VP of Finance, Mark Beveridge, on the call today. We're happy to present the Q1 report. You will find the report on our website. There you'll also have a PowerPoint presentation. That's the presentation that I will be basing this telephone meeting on. I'll start on page three in that presentation with an overall. We're a Swedish pharmaceutical company that base our products on drug delivery of known substances, which reduces time to market and development risk compared to traditional drug development. Our lead program is MOB-015 in onychomycosis, nail fungus. There we see a global sales potential of $250 million-$500 million annually. We recently finalized two large phase III trials on more than 800 patients. We met primary endpoint in these trials and have sufficient data to file for registration in EU, and we're targeting such a filing during this autumn. Based on average processing times of one and a half years, we expect approval early 2023, following with the launch by the end of 2023. We're not doing it all by ourselves. We do have partnerships in place for, I would say, all the major markets except U.S. Perhaps the two most important ones are EU, where we have Bayer as a partner, the world leader in OTC antifungal treatment with the brand Canesten, and also I want to highlight Taisho for Japan. In total, our partnerships include milestones of $120 million in addition to payments for product sales. This is not the first time we're taking an onychomycosis product to market. We have a tried and tested model, where we work with strong local partners that take responsibility for and invest in the marketing and sales, where we're responsible for the development, production, and supply. This is a model that does not tie capital with the exception of U.S., where we want to build our own presence targeting podiatrists. In parallel to preparing this EU submission, we're planning a meeting with FDA, as we believe one additional study is needed for the U.S. It will be very similar to the one that we have already conducted as the North American study, but with a shorter dosing regimen. That would enable even stronger claims and higher complete cure. On page four, the significant events during this period, we've really focused on registration preparations, and they're progressing according to plan. The most important step forward during this quarter was that we received final comments on our pediatric plan from EMA. Our goal remains unchanged to submit this registration application during the second half of this year and to be able to launch by the end of 2023. We also secured additional funding during this quarter in January. We did a fully subscribed rights issue without using any guarantees. That also meant that we could terminate the old financing agreement with Nice & Green, and that was terminated without cost for the company. We did strengthen the intellectual properties during this quarter as we were granted a patent for MOB-015 in India. In addition to all the other patents, we basically have a patent protection until 2032 in all major markets. We are also working very actively with our global trademark portfolio, where we own those domains and trademarks for several brand names to enable this global registration that we're preparing. We're filing in each territory with Moberg's brand names. Of course, in territories where we have partners with strong brand names, those brand names will be used on the market. The registration brand names, those we own. We also finalized the spin-off that was completed by the listing of OncoZenge that took place in February via this Lex Asea divestment, where the share owners of Moberg also received shares in OncoZenge. Looking at our financials, this spin-off also resulted in a positive earnings effect of SEK 35 million, and they're included in the total profit. That explains the high total profit for this particular quarter. Turning to page 5, despite that one out of 10 people suffers from onychomycosis, there is really no good treatment alternatives available today. I would say the most effective treatment is oral terbinafine, the same molecule that we're using, but we're applying it topically. Using oral terbinafine is associated with risk of liver damage and interaction with other drugs. In our phase III, MOB-015 showed 70%-84% mycological cure, killing the fungi, and this is substantially higher than reported for other topical treatments that have levels of 30%-54%, and it's on par with oral terbinafine, but with 1,000 times less drug concentration in plasma. These are ideal characteristics of an efficacious topical drug with non-systemic exposure. Turning to slide six, in comparing our data to our competitors, this graph shows the relationship between mycological cure rates and complete cure rates for current onychomycosis drugs. The pattern seems a little bit different between the U.S. competitive market and the EU competitive landscape, but essentially it's the same, where you have a clear correlation between mycological cure and complete cure. We do have a world-leading mycological cure, better than any topicals and on par with oral terbinafine. The complete cure, we will adjust that rate via new dosing regimen. A shorter treatment time has the potential to increase complete cure rates. This is based on our very high mycological cure rates, and that we get 40 times higher levels of terbinafine in the nail bed compared to oral terbinafine. We know that three month treatment with oral terbinafine is effective, and we also know that the onset of the antifungal effect is more rapid for MOB-015 than for oral terbinafine. By reducing the treatment, we're reducing this hydrating effect that creates this whitish discoloration that is temporary, but is the reason behind our low complete cure rate. Reducing this hydration effect, reducing the impact of the clinical cure assessment at week 52. Of course, this data will not only be used for our U.S. trial, but also to strengthen claims worldwide. Turning to page seven, we have recently received final comments on our pediatric plan from EMA, and we see a good chance of coming to agreement with authorities on a realistic pediatric plan with a clinical study including less than 30 children, and this study will not start now, it will start later. We're expecting a final decision from EMA this autumn. Given the discussions that we have had, we believe that it's possible for us to do a full registration, a so-called 8.3 route, and obtain data exclusivity. This would give us up to 10- years of data exclusivity from first market approval to complement our existing patent protection in all major markets up to 2032. It's really this approval by the pediatric committee that sets the timetable for our plan to submit the registration application during this autumn. We expect it to be approved within 18- months. We're planning for a launch by the end of 2023. For the U.S., we're planning for this meeting with the FDA after we have a little bit less to do in the European setting. We have that assumption that one additional study may be needed for registration in the U.S. Turning to the next page, looking at that study is really about shortening the dosing regimen, but keeping everything else from the phase III study that we recently completed in the U.S. Of course, from a patient perspective, it's a huge benefit, not having to have a daily dosing for a full year, but instead having daily dosing for two to three months, and then just follow up once weekly. We also see this rapid improvement that further strengthens our case. In the phase III, actually 75% of the patients saw improvement already at the first follow-up visit. I think overall, the profile of MOB-015 is really that this is the only topical alternative that will compare to oral treatment when it comes to efficacy, but without the safety issues. We believe that this could take a market-leading position with being the treatment of choice. Turning to the financial part of this report, on slide nine, PR financials. There are no surprises in the figures, I would say. Cost of operations are in line with previous periods. We capitalized investments in MOB-015, but as the studies are finalized, these investments are very limited. The cash position at the end of this quarter is about SEK 150 million, much thanks to the rights issue that was finalized in January. In February, BUPI was spun off via this distribution of shares in OncoZenge, and the successful IPO of OncoZenge on the First North. This spin-off also resulted in a positive earnings effect of SEK 25 million to Moberg Pharma, so that is included in the total profit in Q1. The total profit for us in Q1 ended up on SEK 19 million. On page 10, in summary, we have an exciting journey ahead delivering on EU submission this year, receiving feedback from FDA and initiating the additional U.S. study. I think these milestones are very important and expected to create significant value as they enable launch in EU by the end of 2023 and commercialization in the U.S., the largest and most important market, as well as strengthening claims globally. These are key steps in our journey to make MOB-015 the future market leader in onychomycosis. I'll stop there and happy to open up for questions. Thank you. If you do wish to ask a question, please press zero one on your telephone keypad. If you wish to withdraw your question, you may do so by pressing zero two to cancel. There will be a brief pause while questions are being registered. We have a question coming from the line of Mats Hyttinge from Redeye. Please go ahead. Your line is open. Hi, Anna. Just a very short question on that you really seem that you still have the year on track on the timeline. That is what I want to confirm, that there's no changes to the timeline. It's pretty much the same as before, right? Yeah. It's exactly the same timeline. We're aiming for this registration during this autumn. If you look at the average approval times, they're about one and a half years. That's what we're expecting. It could be shorter. It could, of course, also be longer, but we're calculating with us having an average application, so approval early 2023 and then launch straight thereafter, basically. Okay. Thank you very much. Thank you. Thank you. I remind you that if you want to ask a question, you will have to press zero one on your telephone keypad now. We have no further questions at this time. Speakers, please go ahead. Okay. Thank you. I just want to thank everyone for listening in. Of course, if you have additional questions, don't hesitate to reach out to me, send me an email or give me a call. Thank you, everyone, and have a good day. This now concludes our conference call. Thank you all for attending. You may now disconnect your lines.