Moberg Pharma AB (publ)

Hello, everyone, and thank you for joining the Moberg Pharma Q4 Report call. My name is Marie, and I will be coordinating your call today. During the presentation, you can register your question by pressing star followed by one on your telephone keypad. If you change your mind, please press star followed by two. I will now hand over to your host, Anna Leong, CEO, to begin. Please go ahead.

Thank you, and good afternoon, everyone. Thank you for joining our Q4 earnings call today. I'm Anna Jöns, CEO of Moberg Pharma, and I also have our VP of Finance, Mark Beveridge, with me here today. We're happy to present our Q4 report that you can find on our webpage. There you can also find a PowerPoint presentation that I both based this call upon. This call will be recorded and uploaded to our webpage. In today's call, I will provide an overview of our performance this quarter, key business developments, and highlights to take into initiatives shaping our path forward. I am proud to report that Perklara continues to lead the Swedish market, achieving 31% market share in value and 25% in units for the full year in pharmacy sales and consumers, despite consumer marketing launching only in the beginning of April. Importantly, momentum continued in Q4, with figures reaching 33% in value and 26% in units, demonstrating demands for products continuing even in those seasons. These figures confirm the strengths of our product, marketing strategy, and our overall market leadership validates our execution and further underscores the potential for sustained expansion across Europe. Building upon this momentum, we are now expanding into Norway, a key milestone in our broadening European growth strategy. Initial deliveries have already been made, and we're launching pharmacy and healthcare staff education alongside targeted consumer marketing in the lead-up to the high season. Norway represents a promising market for Teclara, and we are confident that with our strategy, we will be able to capture a significant market share. Teclara has only become the market leader in Sweden, but also expanded the social market, reinforcing our strategic approach, and was awarded best launch of the 2024 as both Kronos Pharmacy and DOS Pharmacy supply meetings. We have observed that our targeted market campaigns and strategic pricing structure have played an integral role in capturing consumer interest and fostering brand loyalty. With 13 EU market approvals in place, coupled with the success of the Swedish launch, we are well positioned for additional rollouts in 2026. In December, we reported top-line results from the North American Phase III study for MOB15. While the primary endpoint was not met with the reduced dosing regimen, the study yielded valuable insights into dosage trade-offs. We confirmed lower drug levels resulted in reduced nail discoloration, but also a lower mycological cure rate. Eight weeks of daily dosing did not deliver sufficient turbinatin in the nail to kill off the nail fungus, before switching to weekly maintenance treatment. Our hypothesis remains there is a trade-off between delivering enough terminaffin and avoiding overhydration and white discoloration of the nose. While this overhydration is temporary, it makes it difficult to assess the clinical cure in a clinical study setting. An additional study with a longer follow-up and or different combination of daily treatment and maintenance treatments could have the potential to generate stronger care efficacy data. The conclusions from previous studies remain valid. Our earlier North American Phase III study demonstrated superiority, and the EU study supports our finding, although it is not defined as a superiority study. Given that the FDA generally requires two independent studies providing superiority, additional data is needed. Following extensive discussions with the regulatory experts and statisticians, we have determined that the meeting with FDA is not feasible based on our current data package, as the study did not meet its primary aim, thus lacking the necessary data to file an application in the U.S. Given this, additional clinical data is required before we can proceed with an FDA submission, resulting in an extended U.S. launch timeline. The company's board of directors have decided to recognize an intangible aspect in Permanent, reflecting the student's approach to this matter. Our long-term ambitions remain unchanged. We're committed to conducting an additional US clinical study to secure a CA approval, enhance the overall marketing case, and support our ongoing patent application. In the near term, our primary focus remains on scaling the EU and markets where we have existing approvals. By executing successful EU launches and gaining commercial traction where we have existing approvals, we are building a strong foundation for growth before considering new US studies or investing in marketing outside of Europe. Our European rollout plan is designed for long-term value creation, which includes strategic partnerships, targeted educational campaigns, and aggressive market penetration efforts to ensure marketing reaches its full commercial potential. The pharmaceutical landscape is evolving, requiring agile hybrid approaches to commercialization. Over the past couple of months, we have made strategic decisions regarding our partnerships, adapting to market dynamics and aligning long-term value creation. By mutually ending our partnership with Baylor, we retained full rights to Mod 15 in Europe, while maintaining previous milestone payments. This decision aligns with our broader vision to have greater control over commercialization strategy and brand positioning. Similarly, we have concluded our partnership in South Korea due to the highly competitive and structurally unique market conditions. South Korea presents a challenging environment where generic competition and pricing pressure makes it difficult to achieve sustainable profitability. By stepping away from this market at this time, we can allocate our resources more effectively towards regions that offer the highest potential for return on investment. These changes provide us with better flexibility and manage our activities and investments in group and nature according to our strategic priorities. As a first step, we have decided to take a more active role in commercialization, including ownership of the trademark to enhance margins. Discussions with potential European partners are ongoing. We believe that this approach will not only improve our financial position, but also strengthen our brand identity across few European markets. We secured a new termination supply during the quarter, eliminating a key bottleneck for future market launches and enabling us to plan further expansions with confidence. Ensuring a stable supply chain is critical for our long-term success, and we're pleased to have secured a partner to support our growth and business. Going forward, our intention is to adopt a commercialization model similar to a successful US strategy, positioning Terklar as a premium brand while expanding our portfolio through acquisitions. Historically, this approach has created economies of scale and valuable brand expertise. By levering on our experience and expertise, we aim to replicate our past successes and further strengthen our market position. As mentioned earlier, we are now launching Terclara in Norway, making a significant step in our European expansion strategy. Given the strong performance in Sweden, we see great potential for Terclara to establish itself as the market leader in Norway as well. We are actively working with pharmacists, healthcare professionals and consumer groups to ensure a smooth and successful rollout. With EU approvals already in place, we remain on track for additional rollouts in 2026. The Swedish launch demonstrated that Teclara not only captured the leading market position, but also contributed to the expansion of the total market. This success is a testament to the strength of our strategic approach, and we're eager to build on this momentum. In our two large phase 3 studies, 76% of patients became fungus-free, a world-leading outcome that significantly outperforms any other topical treatment. This success validates our strategy and provides a strong foundation for further European expansion and long-term growth. We remain energized and optimistic about the future. Our refined strategic focus on Europe, strengthened commercialization models, and growing market momentum position us well for continued success. Looking ahead, we will focus on maximizing our European opportunities while maintaining a long-term commitment to the U.S. markets. With our expanded market presence and ongoing strategic initiatives, we are confident in our ability to drive sustainable growth and create long-term value for our shareholders. Thank you for your time today. I will now open up the floor for questions.

To ask a question, please press star followed by one on your telephone keypad now. If you change your mind, please press star followed by two. When preparing to ask your question, please ensure that your device is unmuted locally. Our first question is from Guillermo Infant from Home Personal. Please go ahead.

Hi, Anna. Thank you for taking my call. I wanted to know if you can discuss a little bit the partners that we still have standing, like Cypher and the Israeli Patajis. Have you been in touch with them? How have been the conversations around our current strategies? That's the first question. I have two others if I have time.

Thank you. Yes, of course, we are in dialogue with our existing partners, and I would say that we have a good dialogue with all our partners. So, well, it's up for each partner to comment on their specific markets, but we're pleased with our collaborations in all territories.

Great. And then how many more countries in the EU could we get approved based on the EMA data that we've submitted? Because we're fully approved for 13 countries. What would be the max that we could get based on the file that we have submitted?

Well, there is no limitation. We could include all of the EU countries if we want. We will have to think about the timeline for doing this. We still have an open... variation for including an additional Turbinefin supplier and we can't have any open items in our file when we want to include more countries. So it's definitely within our plans to include more countries, but we have to do things in the right order. So it's not fully up to the timeline.

Perfect, but there's no limit. We can go to all of them after we have this intermediate step. Great. And in terms of timing of a potential, you know, new phase three in the U.S., can you discuss potential ticket size of this and how long would it take? Obviously, we cannot discuss timing, but just to have an idea in terms of, you know, the cash requirements of the business.

Yeah, so we want to – show that we're successful not only in Sweden, but in some of the major European territories first. And that will also generate additional data that I think will be supportive when we conduct this study. So it's both from a financial perspective. We want to make sure that we invest in our goals for marketing in Europe first. I think we don't want that dilution that it would require to do an additional U.S. study now. We want to prove to the world that this product is really working in real-life consumers, just as it is in Sweden, in major European territories, before conducting that additional U.S.

study. Perfect. That's it. Thank you very much, and good luck with the new EU partners.

Thank you. As a reminder, to ask a question, please press star followed by one on your telephone keypad. We have a question from Samir Devani from RX Securities. Please go ahead.

Thanks for taking my question. I just wanted to ask, there wasn't much guidance given in today's press release, so maybe you could help us with understanding what sort of revenue expectation you have this year, and also how much cash you intend to burn. You've got quite a significant cash balance, so you didn't seem to burn too much in Q4. So I was just wondering if you could help us with that. Thanks very much.

Yes, we're not giving forward-looking statements when it comes to our test positioning, but I can conclude that the markets where we will be launching Q4 This year, that is Sweden and Norway. And as you know, we have just received the approval for the urban essence supplier. And the timeline means that we cannot access more markets this year. It will be 2026. That will be significant revenues coming from new sales. So, I mean, adding one market, I would say that Norway is roughly... off the size of the Swedish market so that gives some guidance but it's really 2026 when I expect sales to take off and as you mentioned we do have a good cash position and we will invest of course in these launches but we don't expect to use a lot of that cash in the near future.

Is it fair to say that you are financed to sustain profitability then on that basis?

Yes, I would say that.

Okay, thanks very much.

As a reminder, to ask a question, please press star followed by one on your telephone keypad. As we currently have no further questions, I will hand back to Anna for closing remarks.

Okay. Thank you all for calling in. The recordings of this call will be published on our webpage shortly. Thank you, everyone, and have a nice day.

This concludes today's call. Thank you for joining. You may now disconnect your lines.