Moberg Pharma AB (publ)

Hello and welcome to the Moverd Pharma Q1 report. Throughout the call, all participants will be in lithium-aminoid, and afterwards, there will be a question or answer session. Just to remind you, this content will be in record. Today, I am pleased to present CEO Anna Jung. Please go ahead with your meeting.

Thank you. Hi, my name is Anna Jung, and I'm the CEO of Moverd Pharma. I also have our great CEO of Finance, Mark Everidge, on the call today. we're happy to present the Q1 report, and you'll find the report on our website, and there you'll also have a PowerPoint presentation, and that's the presentation that I will be placing this teleconferencing on. I'll start on page 3 in that presentation, with an overall. We're a Swedish pharmaceutical company that makes products from a variety of known substances. which reduces time to market and development risk compared to traditional drug development. And our lead program is month 15 in Ultima Corpus, and there we see a global sales potential of $250 to $500 million annually. We recently finalized two large phase 3 trials on more than 800 patients. and we left Canada on point in these trials and have sufficiently satisfied for registration in the EU and we're targeting such a planning during this autumn. Based on average processing times of one and a half years, we expect approval early 2023 and following the launch by the end of 2023. And we're not doing it all by ourselves, we do have partnerships in place for I would say all the major markets except Europe. So perhaps the two most important ones are here, where we have Bayer as a partner, the world leader in MCC anti-fungal treatment, which is a brand channel. And also I want to highlight Taishu, Japan. And in total, our partnership is a milestone of $20 million in addition to payments to product sales. This is not the first time we're taking an analytical product to market. We have a tried and tested model where we work with strong local partners that get responsibility for, I mean, that's the market we're in today, where we're responsible for the development, production, and supply. And this is a model that does not tie capital to the exceptional of the U.S., so we want to build our own presence. The entire length of preparing this EU submission, we are planning on using the FTA, as we believe one additional study is needed for the US. It will be very similar to one that we have already conducted as a North American study, but with a shorter bouncing resonance. That would enable even stronger pain and higher complete cure. On page 4, the significant events during this period were really focused on registration preparations, and that projected according to them. The most important step forward during this quarter was that we received final comments on our KGS-10 from IMA, and our rule remained unchanged. to submit this registration application during the second half of this year and to be able to launch by the end of 2021. We also secured additional funding during this quarter in January. We did a fully subscribed VR tissue without losing any guarantees. That also meant that we could terminate the old financing agreement with my student and that would terminate the development for the company. We did strengthen the intellectual property during this quarter as we were granted a patent for multi-sealing in India. In addition to all the other platforms, we basically have a platform protection until 2032 in all major markets. And we're also working very actively with our global trademark portfolio, where we own those documents and trademarks for several band names to enable this global registration that we're preparing. So, we're refining in each territory a Moogard's brand name. And, of course, in each territory where they have cost us their own brand name, those brand names will be used on the market. But the registration brand name, both we own. Here is the finalized costumers. that was completed by the listing of Uncle Bench in February via this next FAFIA by that month, where the shareholders of Moberg also received shares in Uncle French. And looking at our financials, this stream of also results in a positive earnings effect of 35 million. very included in the total profits for this particular author. Turning to page 5, in fact, that's one of the ten people who talked to me about this. There is no good treatment of policies available today. Also, the most effective treatment is oral codenafin. It's the same molecule that we're using that we're applying the property. Using oral codenafin is associated with risk of liver damage and interaction with other drugs. And in our case 3, what we've seen shows 74% ecological cure, healing the fungi, and this is substantially higher than reported for other tropical treatments that have levels of 30 to 54 percent, and they compare with oral sardinafil. That's 1,000 times less drug concentration than plasma. And these are ideal characteristics of an efficacious toxin drug with no systemic exposure. Turning to slide six, we're comparing our data for compositors. This graph shows the relationship between mycological TOR rate and complete TOR rate. for current endometriosis drugs. The pattern is a limited sequence between the US competitive market and the EU competitive market, but essentially it's the same, where you have a clear correlance between mycological cure and complete cure. We do have a well-being in mycological cure. This is an anecdotal among caries or also venison. And the complete cure, we will adjust that rate, be a new dose in regimen, a shorter treatment time has the potential to increase complete cure rate. And this is safe from our very high mycological cure rate, and that we get 40 times higher levels of furbinacin in the main web compared to oral furbinacin. We know that female treatment for oral fibrinophen is effective, and we also know that the onset of the antifungal effect is more rapid for non-pregnant female for oral fibrinophen. So, by reducing the treatment, we're reducing the effect that creates this white discoloration that is temporary. That is the reason behind our low-complete cure rate. Reducing the hydration effect, reducing the impact of the clinical tour assessment as much as possible. This data will not only be used for our junior side, but also to a certain degree worldwide. Coming to page 7, we have recently received final comments on our progressive plan from EMA. And we see a good chance of coming to agreement with authorities on a realistic cardiac exam, with a clinical study including less than 30 children. And this study will not start now, it will start later. So we're asking a panel decision from Irma this autumn. And given the discussions that we have had, we believe that it's possible for us to do a full registration and a so-called based on the growth and obtain data exclusivity. So this would give us up to 10 years of data exclusivity for first market approval, which would complement our 50 patent protection in all major markets up to 2032. And it's really this approval by this progressive committee that sets the timetable for our plan to protect the registration application during this autumn. We expect it to be approved within 18 months. So we're planning for a launch by the end of 2023. And for the U.S., we're planning to receive the FDA after this, after we have left it to do in the opioid sector. And we have that assumption that one additional study may be needed for registration in the U.S. On turning to the next page, the thing about study is really about shortening and diluting the resonance, but keeping everything else from the phase three study that we recently completed in the U.S. And 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 a week. And we also see this rapid improvement that other centers have seen. So in the case here, actually 75% of the patients for improvement already have started So I think overall, the profile of this industry, of this is the only possible alternative that will compare to oral treatment when it comes to obstetrics, just without the safety issues. We believe that this could take a market-leading position with seeing the treatment approach. Returning to the financial part of this report, on slide 9, which is to our financials. There are no surprises in the figures, I would say. Cost of operations are in line with previous periods. There are capitalized investments in month 15, but as the study has analyzed, these investments are very uniform. And the cash position at the end of this quarter is about $1.5 million or less, much thanks to the right position that was finalized in January. And then in February, due to the collapse, there is distribution of shares in 0%. And this successful IPO, 1% on the first month. This in-off also results in a positive earnings effect of 25 million kronos given by Pharma. All that is included in the token faucet issue 1. The token faucet for us, issue 1, ended up on 19 million. On page 10, in summary, we have an exciting journey ahead, commingling on EU submission for this year. including feedback from SBA, and initiating the additional new study. These large stocks are very important and expected to create significant value. They enable emerging yields by the end of 2023 to commercialization in the U.S., the largest amount supported market, as well as strengthening sales in New Zealand. These are key tasks, not only to make focus on the future market leader in non-semitology,

I'll stop there. I don't have enough for questions.

Thank you. If you do wish to ask a question, please press 01 on the telephone keypad. And if you wish to withdraw your question, you may do so by pressing the return button.

And I'll do a brief pause while questions are being registered. And we have a question coming from the line of Matt's English from Red Eye.

Please go ahead. Your line is open.

Hi Anna, it's a very short question. You really seem that you are on track on the timeline. That's what I want to confirm. There's no changes to the timeline. You're still pretty much the same as before, right?

Yeah, it's pretty much the same timeline. We're aiming for this registration. during this autumn, and then if you look at the average approval time, they're about one and a half years, so that's what we're expecting, and then 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 01 on the up there from C-side now. And we have no further questions at this time. Okay.

Thank you. Then I just want to thank everyone for listening in. And, of course, if you have additional questions, don't hesitate to reach out to me on my email or via my phone.

Thank you, everyone, and have a good day.