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

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. [Operator Instructions] I will now hand over to your host, Anna Ljung, CEO, to begin. Please go ahead.

Thank you, and good afternoon, everyone. Thank you for joining our Q4 earnings call today. I'm Anna Ljung, 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 web page. There you can also find a PowerPoint presentation that I base this call upon. This call will be recorded and uploaded to our web page. In today's call, I will provide an overview of our performance this quarter, key business developments and highlight strategic initiatives shaping our path forward. I'm proud to report that Terclara continues to lead the Swedish market, achieving 31% market share in value and 25% in units for the full year in pharmacy sales to end consumers, despite consumer marketing launching only in the beginning of April. Importantly, the momentum continued in Q4 with figures reaching 33% in value and 26% in units, demonstrating demand for products continuing even in the low season. These figures confirm the strength 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 health care staff education alongside targeted consumer marketing in the lead up to the high season. Norway represents a promising market for Terclara, and we are confident that with our strategy, we will be able to capture a significant market share. Terclara not only become the market leader in Sweden, but also expanded the total market, reinforcing our strategic approach and was awarded Best launch of the 2024 at both Kronan pharmacy and Doz pharmacy supplier 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 markets 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 MOB-015. 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. 8 weeks of daily dosing did not deliver sufficient terbinafine 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 terbinafine and avoiding overhydration and white discoloration of the nail. 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 treatment could have the potential to generate stronger efficacy data. The conclusions from previous studies remain valid. Our earlier North American Phase III study demonstrated superiority and the EU study supports our findings, although it's not designed as a superiority study. Given that the FDA generally requires 2 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 endpoint, 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 time line. The company's Board of Directors has decided to recognize an intangible asset impairment, reflecting the prudent approach to this matter. Our long-term ambitions remain unchanged. We're committed to conducting an additional U.S. clinical study to secure FDA approval, enhance global marketing claims 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 U.S. 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 MOB-015 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 partnership, adapting to market dynamics and aligning long-term value creation. By mutually ending our partnership with Bayer, we retained full rights to MOB-015 in Europe while maintaining previous milestone payments. This decision aligns with our broader vision to have greater control over the 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 Europe and Asia 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 key European markets. We secured a new terbinafine 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 ambitions. Going forward, our intention is to adapt the commercialization model similar to our successful U.S. strategy, positioning Terclara as a premium brand while expanding our portfolio through acquisitions. Historically, this approach has created economies of scale and valuable brand equity. By leveraging on our experience and expertise, we aim to replicate our past successes and further strengthen our market position. As mentioned earlier, we have now launched 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, health care 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 Terclara 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 large -- 2 large Phase III 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 model 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. market. 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 shareowners. Thank you for your time today. I will now open up the floor for questions.

[Operator Instructions] Our first question is from [ Guillermo Infante from Home Personal ].

I wanted to know if you can discuss a little bit the partners that we still have standing like Cipher and the Israeli Padagis. Have you been in touch with them? How has been the conversations around our current strategy? That's the first question. And 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, though, have to think about the time line for doing this. We still have an open variation for including an additional terbinafine 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 us, the time line.

Perfect. But there is no limit. We, in theory, can go to all of them after we have these intermediate steps.

Yes.

Great. And in terms of timing of a potential new Phase III 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 the cash requirements of the business.