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 a 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 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 webpage. There you can also find a PowerPoint presentation that I both base 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 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 product 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 healthcare 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 became the market leader in Sweden but also expanded the total market, reinforcing our strategic approach and was awarded Best Launch of 2024 at both Kronans 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 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 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.
Eight 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 nails. 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 defined as a superiority study. Given that 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 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 timeline. The company's board of directors has decided to recognize an intangible asset impairment reflecting a 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 retain full rights to MOB-015 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 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 supplier 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 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 our experience and expertise, we aim to replicate our past successes and further strengthen our market position. As mentioned earlier, we're 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 Terclara not only captured a 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 III studies, 76% of patients became fungus-free, a world-leading outcome that significantly outperformed 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 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 Infante from Cowen & Company . 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 Cipher and the Israeli Padagis. Have you been in touch with them? How have 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. It is up for each partner to comment on their specific market, but we're pleased with our collaborations in all territories.
Great. 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?
There is no limitation. We could include all of the EU countries if we want. We've all had to think about the timeline 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. It is definitely within our plans to include more countries, but we have to do things in the right order. It is not fully up to us the timeline.
Perfect. There is no limit. We, in theory, can go to all of them after we have this intermediate step. Great. 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.
Yes. We want to show that we're successful not only in Sweden but in some of the major European territory sparks, and that will also generate additional data that I think will be supportive when we conduct this study. It is both from a financial perspective. We want to make sure that we invest in our go-to-marketing in Europe first. I simply 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 was not much guidance given in today's press release. 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 have got quite a significant cash balance, so you did not seem to burn too much in Q4. 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 cash positioning, but I can conclude that the markets where we will be launching this year are Sweden and Norway. As you know, we have just received the approval for this terbinafine 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. I mean, adding one market, I would say that Norway is roughly half the size of the Swedish market, so that gives some guidance. It's really 2026 when I expect sales to take off. 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 web page shortly. Thank you, everyone, and have a nice day.
This concludes today's call. Thank you for joining. You may now disconnect your lines.