Hello, and welcome to the Moberg Pharma Q2 report. Throughout the call, all participants will be in a 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 Anna Ljung, CEO. Please go ahead with your meeting. Thank you, hello. My name is Anna Ljung, and I'm the CEO of Moberg Pharma. I also have our VP of Finance, Mark Beveridge, with me here today. We're happy to present the Q2 report that was published earlier this morning. You can find the report on our website. There we also have a PowerPoint presentation, and that's the presentation that I will be using today in this telephone meeting. Let me start on page three on that presentation. We're a Swedish pharmaceutical company that base our product from drug delivery of known substances, which reduces time to market and development risk compared to traditional drug development. Our lead program is MOB-015 against nail fungus, with global sales potential of $250 million-$500 million annually. We're now preparing to file for registration in EU based on the outcome of the two phase III trials on more than 800 patients, where we met primary endpoint and 76% of patients were fungal free, mycological cured. That is higher than ever reported for topical treatment. We're targeting filing during this autumn. Based on average processing times of one and a half year, we expect approval early 2023, which would enable us to launch the product by end of 2023. We do have commercial partnerships in place with strong partners in all major territories, including Bayer for Europe and Taisho for Japan. In total, our partnerships include milestones of $120 million in addition to payments for product sales. We do have a tried and tested model where we work with strong local partners that take responsibility for and invest in marketing and sales, where we take responsibility for development and production and deliver finished products. This model do not tie any capital, with the exception of U.S., where we want to build our own presence targeting podiatrists. We learned a lot when we commercialized our first generation nail fungus product, Kerasal Nail. We built an OTC business with annual revenue of SEK 440 million, and our products were sold in more than 30,000 stores. That business we divested for SEK 1.4 billion back in 2019. We now want to repeat that this year with MOB-015, a product with much greater potential, targeting becoming the future market leader in nail fungus. Turning to page four. Our main activities during this quarter have been centered around registration preparations. Most importantly, we have recently received final comments on the pediatric plan, where EMA requested some supplemental data that we're now providing. We expect the final decision in September. This sets the timeline for the registration approval that will be filed later this year. During the summer, results from a North American phase III study were published in JAAD, where the principal investigator in our phase III study, Professor Gupta from University of Toronto, concluded in the paper that MOB-015 was effective in treating nail fungus and has a favorable benefit to risk ratio, as the lack of systemic absorption of MOB-015 reduces the potential for systemic adverse events seen in oral terbinafine. We have further strengthened the management team with Agneta Larhed, who has broad experience with regulatory issues in drug development, including working for the Swedish MPA as well as companies as Orexo and Q-Med. We have further strengthened our board with addition of Nikolaj Sörensen. Turning to page five and the need for better nail fungus treatment. It's a very common disease, increasing with age. Despite that one out of 10 people suffers from nail fungus, there's currently no good treatment alternatives available. In the U.S. alone, there's more than 30 million patients, but despite that only 5 million scripts are sold annually, so there's a lot of untreated patients. The most effective treatment is oral terbinafine, which is associated with the risk of liver damage and interaction with other drugs. A survey showed that 72% of U.S. doctors avoid prescribing oral terbinafine due to the side effect profile. MOB-015 uses exactly the same molecule, terbinafine, but applies it topically. We have shown that we have 1,000 times h igher levels of the terbinafine in the nail and 40 times higher levels in the nail bed compared to oral treatment. 1,000 times less drug concentration in plasma, thus removing the risk for systemic side effects. Moving on to slide six on the competitive landscape. This graph shows our positioning compared to other treatment alternatives. Normally, there's a clear relationship between mycological cure rates, that's curing the fungi, and complete cure rates. Once you have cured the fungi, healthy nail will regrow. In our data, we have well-reading mycological cure. We will address the complete cure rate via new dosing regimen, as shorter treatment time has the potential to increase complete cure rates for MOB-015. Data from the two Phase III studies in North America and Europe, totaling 800 patients, are the basis for this. We achieved primary treatment target without serious adverse events in both studies. 76% of patients were fungal free, which is higher than ever reported for an external treatment, among par or even higher than oral terbinafine, current gold standard. While our technology enables high delivery of terbinafine through the nail, its hydrating properties also cause transient whitening in the nails, making the assessment of clinical cure challenging, and that contributed to the low complete cure rate. Learnings from the Phase III studies enable a shorter dosing regimen expected to increase complete cure. Once daily treatment for not more than three months, followed by maintenance treatment once weekly should provide sufficiently high concentrations of terbinafine in the nail, as we currently have 40 times higher terbinafine levels compared to three months of oral treatment, and enable normalization of the water content in the nail during the maintenance treatment period. Also from a patient perspective, a shorter treatment period is highly attractive instead of having daily treatment for a full year as required by most topical treatments. On page seven, we have received final comments on our pediatric plan from the EMA and see a good chance of coming to agreement with authorities on a realistic pediatric plan with a clinical study including a limited number of children in the age group 6- 17 years. We expect a final decision from the Paediatric Committee during September. After discussions with authorities, we believe that we can utilize a full registration route and obtain 10 years of data exclusivity from first market approval in complement to our existing patent protection in all major markets up to 2032. This really sets the timetable for our plan to submit the registration application in Europe during the second half of this year. We expect approval within 18 months, and that indicates that MOB-015 could be launched in Europe by the end of 2023. For the U.S., we're planning for one additional study. It will be very similar to the North American study that we already completed, but with a shorter dosing regimen, enabling even stronger claims and higher complete cure. In addition to enabling U.S. approval, the additional study is expected to strengthen claims globally, substantially increasing market potential. Turning to page eight. By focusing on the approval process in Europe, we expect to be able to launch the product very soon in Europe, and that corresponds to one fourth of the global market potential for MOB-015. As we have secured strong commercial partners both for EU, Japan, and Canada, we're in a good position to make the most of the upcoming launch while we keep the rights to the U.S., as it is by far the largest market corresponding to half the global potential. We'll move on to the financial part of the report. On slide nine, you will see our financials. Generally speaking, our expenses are in line with previous periods. We continue to invest in MOB-015 development, which is capitalized. Given that we're in the registration phase, those investments are currently limited. Due to BUPI spin-off in the separate company, OncoZenge, on the successful IPO of that company in February, we have positive earnings effect of SEK 24 million in total profits this year. At the beginning of the year, we completed a SEK 150 million rights issue, and that means that we're currently well-funded with financing in place for both registration activities and further clinical development and can fully focus on our operations. Our current cash position is SEK 124 million. Turning to page 10. In summary, we have an exciting journey ahead. The next milestone is the expected approval from EMA's Paediatric Committee in September, which will be followed by the EU submission later this autumn, as well as preparations for one 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., which is the largest and most important market, as well as strengthening claims globally. I think these are key steps in our journey to make MOB-015 the future market-leading nail fungal. Thank you for listening in. I'm 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. Our first question comes from the line of Mats Hyttinge from Redeye. Please go ahead. Hello. Hi, Anna and Mark. Can you hear me? Yes. Hello. Hi. It's some very short questions. I know that you seem to be on the progress on most fronts and everything, but I just want to enhance what you think are the most important things there going forward. I know it's a long process, and the market is a little impatient about this. You think you're still on track for what you've said before, right? You reiterate your plan, per se. Yeah, we're still on track, and I think in near future, it's really the registration process in Europe, working together with our partner, Bayer, making sure that we get the strongest possible registration file and to get a really good launch for the product in 2023. That, for me, is the main focus right now. In parallel, we would love to start that additional study in the U.S. because that would open up the U.S. market for us. Since the U.S. market is the biggest market within onychomycosis, that too is important. I think making sure that we have sufficient quality, the best possible quality in our registration file, and also continue to prepare for launch together with our partners. That is key. Okay. Just thinking about this PDCO committee in September decision. Do you feel a bit more comfortable with that one, or is it pretty much the same as before? I would say that we have had some dialogues over the summer. Comparing with last report, I thought I was rather confident then, and I continue to be rather confident. Okay. If anything, my confidence level has increased. Of course, as always with these things, we don't know until we receive the decision. Now we have reason to believe that decision will come in September, and of course, we will press release it as soon as we have it. Okay. Just one short question on financials. Could we expect that when the Axlora registration comes closer, that you will have some increased costs in relation to this? I think the registration costs are fairly limited. I would say looking forward, of course, if we're starting one additional clinical study, that will increase cost spending. The regulatory phase is, I would say, rather limited, although we, of course, use a lot of consultants. We do a lot of work in-house, and we have our partners that also are doing some work. Limited costs, I would say, during the registration phase. Okay. Thank you. That was it. Thank you very much. Thank you for the questions. Just as a final reminder, if you do wish to ask a question, please press zero one on your telephone keypad now. As there seems to be no further questions, I'll hand it back to the speakers. Thank you. I just want to thank everyone for listening in. Of course, if you have additional questions, you can always reach out to me. I just want to say thank you, everyone, and have a good day. This concludes the conference call. Thank you all for attending. You may now disconnect your lines.