Moberg Pharma AB (publ) (MOB) Earnings Call Transcript & Summary

Hello, and welcome to Moberg Pharma Q3 report for 2021. [Operator Instructions] Today, I am pleased to present CEO, Anna Ljung. Please begin your meeting.

Thank you, and hello, everyone. My name is Anna Ljung. I'm the CEO of Moberg Pharma. And with me today, I also have our VP of Finance, Mark Beveridge. And we're happy to present the Q3 report that was published this morning. You can find the report on our website, and there, you will also find a PowerPoint presentation that I will use throughout this call. Now start on Page 3 on that presentation is giving that overview of Moberg Pharma. 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. And our lead program is MOB-015 against nail fungus. And here, we see that we have the possibility to be -- to become the global market leader within onychomycosis, targeting a global sales potential of $250 million to $500 million on an annual basis. And we're currently preparing to file for registration in EU based on the outcome of the 2 large Phase III studies that we completed with more than 800 patients. In these studies, we met the primary endpoint and 76% of patients were fungus free and mycological cured, and that is higher than ever reported for an external treatment and on par with oral treatment. So we're targeting filing this autumn. And based on average processing times of 1.5 years, we expect approval early 2023, which would enable launch by the end of 2023. We do have commercial partnerships in place with strong partners in major territories, including Bayer for Europe, Taisho for Japan, Dongkoo for Korea, Cipher for Canada, and we actually yesterday announced one additional partnership with Allderma for Scandinavia. And we -- it's not the first time we're launching onychomycosis product. We do have a proven commercial track record with our first-generation product, Kerasal Nail, where we sold more than 15 million units and build a SEK 440 million franchise. We learned a lot during the commercialization process of this first-generation nail fungus product. And the goal here is to use the lessons learned and build a business that is even -- that has even greater potential and targeting becoming the future market leader in nail fungus. On Page 4, our main activities during this quarter has been focused on the approval process. And one major milestone that we achieved was that we received approval for the pediatric plan for EMA. We will -- and I'll talk more about that, but we also secured a partnership with Allderma for the Scandinavian country. And further on, we have started to work with preparation for the next Phase III study that will take place in the U.S. We also thank that the management team, Agneta Larhed, who has broad experience within regulatory issues and drug development and including working with the Swedish MPA in companies like Orexo and Q-Med. And finally, the Swedish Tax authorities published a notification of allocation of acquisition costs after the spin-off of BUPI through the distribution of shares in OncoZenge to our shareholders and the successful listing of OncoZenge on Nasdaq First North Growth Market earlier this year. And of that original acquisition cost of shares in Moberg Pharma, 88% is allocated to remaining shares in Moberg and 12% to the distributed shares in OncoZenge. Let's talk a little bit more about our EU approval process, and this received approval that -- for the pediatric plan from EMA, and I'm now on Page 5, where we -- in September, received this positive decision that enables us to pursue a full M&A with data exclusivity in Europe for up to 10 years after first market approval, complementing our existing patent protection in all major markets up to 2032. We will initiate such a pediatric study during the second half of 2022 on 30 children between age -- between 6 to 17 years, and we have until 2026 to finalize this study. And we intend to submit the EMA application through a decentralized product, and we're now in discussions with several regulatory authorities on the possibility of serving as a reference country and also when they can process our application based on their current workloads. And our goal remains to submit the registration for adults before the end of this year. And that would enable expected approval early 2023 and launch by the end of 2023. Turning to Page 6. Yesterday, we announced a new collaboration covering Sweden, Denmark and Norway with Allderma, which is a Swedish pharmaceutical company that sells and markets OTC drugs and personal care products in Scandinavia. And Allderma actually managed by the same persons which were responsible for the original Nordic launch of Nalox, our first-generation nail fungus product. And in this collaboration, Allderma is responsible for marketing and sales, while we are responsible for manufacturing and delivery of the product. And this agreement also includes co-financial marketing activities and market-based financial terms. And when Nalox was launched in Sweden, it quickly became the market leader and grow the market by 400% during the first 5 quarters. So we're really excited about and look forward to repeating this successful cooperation. I see a great benefit in being directly involved in the launch of MOB-015 in our home market. This aspect gets closer to consumers, pharmacies and doctors and get a genuine understanding of how the product works for the patients. We can thus develop best practices prior to the continued launches with our partners globally. If I turn to Page 7. For the U.S., we're planning for one additional study for the registration. And 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. And in addition to enabling U.S. approval, this additional study is expected to strengthen claims globally, substantially increasing market potential. And the risk in this new study is significantly reduced using the experience gained in the previous study, and we will actually work the same CRO and we will have the same principal investigator, Professor Gupta, from University of Toronto as in that previous North American study. And of course, we'll reuse those sites that were successful and so on. So it's a derisked new study that we're planning to start early next year. So our goal is to submit documentation on this new study to the FDA and the ethical committee during the first quarter of next year. Moving on to the financial part of the report on Slide 9 -- sorry, Slide 8, you see our financials. And I would say, as usual, our expenses are in line with the previous periods. We continue to invest in the MOB-015 development, which is capitalized. But given that we are in registration phase, those investments are limited. And due to the BUPI spin-off in OncoZenge and that IPO that follows, we have a positive earnings effect of SEK 24 million in total profit this year. And in the beginning of this year, we also completed the SEK 150 million rights issue. That means that we currently well-funded with financing in place for both registration activities and for the clinical development and thus, we can fully focus on our operations. And our current cash position is SEK 111 million. And turning to Page 9. To summarize, we do have an exciting journey ahead. The next milestone is the EU submission before year-end as well as preparations for the new U.S. study, where we plan to submit documentation during this first quarter next year. And I think these milestones are very important, and we expect to create significant value as we enable both to launch in EU by the end of 2023; and commercialization in the U.S., the largest and most important markets; as well as strengthening claims globally. I think these are key steps in our journey to make MOB-015, the future market leader in nail fungus. So basically, taking that overall picture, I think we're making progress gradually towards our goal, and we continue to deliver according to plan. So this was a rather short summary of what has happened in this quarter. But thank you for listening in, and I'm happy to open up for questions, if there are any.

We do not have any questions from our telephone conference. I hand back over to our speakers.

Thank you. Then I just want to thank everyone for listening in. And of course, if you have additional questions available over the phone or e-mail, you can reach out to me and Mark as well. And then I just wish you, everyone, have a good day.