Moberg Pharma AB (publ)

STO:MOB

Hello, everyone, and thank you for joining the Moberg Pharma Q3 Earnings Call. My name is Becky, and I will be your operator today. [Operator Instructions] I will now hand over to your host, CEO of Moberg Pharma, Anna Ljung, to begin. Please go ahead.

Thank you, and good afternoon, everyone. Thank you for joining our Q3 earnings call today. I'm Anna Ljung, CEO of Moberg Pharma, and I also have our VP of Finance, Mark Beveridge, with me today.

We're happy to present our Q3 report that you can find on our web page. There you can also find a PowerPoint presentation that I'll base this call upon. And this call will be recorded and uploaded to our web page. In today's call, I'll be providing an overview of our performance this quarter, discussing key developments in our business and highlighting important strategic milestones.

Starting with the positive developments, I'm proud to report that Terclara continues to lead the market in Sweden. The launch has exceeded our expectations, making a strong and successful market entry that has established our presence effectively. Year-to-date, we captured 30% of the market share by value and 25% by units in pharmacy sales to end consumers.

Terclara became first available in stores in February this year with the bulk of initial resets occurring on the shelves from March. Looking at the period from the first full month of sales in April to the end of this quarter, Terclara reached a market share of 37% in value and 31% in units in pharmacy sales to consumers. For Q3 specifically, those figures amounted to 34% by value and 78% (sic) [ 28% ] by units.

Our distribution network has expanded with Terclara now available in more than 90% of Swedish pharmacies and represented in every major pharmacy chain. This broad accessibility has been pivotal in driving category growth, which rose by an impressive 41% during the third quarter. The reception from the market has been remarkable.

We were honored to have Terclara recognized as the best launch of the year by Kronans Apotek and DOZ Apotek. Additionally, our partner, Allderma received an honorable mention from Apoteket Hjärtat for their contributions as a health care provider. We could not have wished for a better launch.

We have also managed to overcome initial distribution challenges. Initially, one major pharmacy chain chose not to stock Terclara. However, due to the strong patient demand, 45 of the chain's pharmacies ordered the product through independent wholesalers. This resulted in the chain formally including Terclara into its lineup, highlighting the significant interest and trust from consumers.

This high demand has also led us to speed up our production schedule. We successfully brought forward our next planned production delivered in August, which helped maintain stock levels for distribution.

However, due to lead times in manufacturing and booking of advertising campaigns, our Q3 market share did see some temporary adjustments compared to Q2. To mitigate the risk of out-of-stock situations, we reduced marketing efforts, but we're pleased to see sales recover healthily by the end of the quarter.

Ensuring supply of our active ingredient, terbinafine, to enable further launches remain a priority. We have secured enough terbinafine to meet current needs for the Swedish market until we transition to a new supplier.

We continue to work according to plan on our two parallel tracks to ensure a stable supply of terbinafine with the goal of getting at least one terbinafine supplier approved in the near term. We have answered questions from the Swedish MPA regarding this application and are now awaiting the agency's decision regarding supplier approvals.

Turning now to the U.S. market and our ongoing Phase III clinical study that nears completion. We received blinded data from a subset of patients, indicating that the clinical cure rates might be below our initial expectations. This insight has led us to adjust our outlook for the study's primary endpoint and consider the increased risk of not achieving U.S. commercialization based on this trial alone.

For approval in the U.S., the FDA normally requires two studies showing superiority. We already have one such study in place, and the current trial was designed to provide a second study and potentially enhance our dossier with a modified dosing regimen. It will be a major competitive advantage for our patients to only need weekly treatments after the initial phase.

Our priority is to protect the data integrity of the study, not to preserve the ability to use the study results in discussions with the regulatory authorities and because there are patients currently ongoing treatment in the study. We anticipate announcing the top line results in December with further analysis expected to continue thereafter. And only then we will be able to fully assess the situation. We work with leading experts in the field to analyze and understand data as it becomes available.

Regarding our European commercial outlook, it's crucial to emphasize that in EU, we have an approved product that has a different dosing. This approved product works as documented in previous clinical trials.

Even for the markets where we have partners outside of Europe and are preparing the registration file, the local registration file refers to the European dossier. We have approvals in 13 EU countries and remain on track for our launch with approval countries in 2026, leveraging on the strong foundation laid by our Swedish success.

We have five strong partners in place, including Bayer for Europe and Cipher in Canada. Allderma has once again proven to be an excellent partner in Sweden. Their leadership marked by previous successes with Nalox in the Nordics has been a key factor in our positive results. Our collaboration model with Allderma serves as a blueprint for future launches.

The fact that the Swedish launch has been so successful and that we not only immediately became the market leader, but also grew the total market is a clear indication that our message truly resonates where we have shown in two large Phase III studies that 76% of patients become fungus-free, which is world-leading and better than any topical treatment.

Turning to the figures. Our revenue for the quarter was SEK 3.9 million, with product sales of SEK 2.2 million and a milestone payment of SEK 1.7 million. As the launch started this year, there are no revenue in the comparison period. Cost-wise, we are following our projections, and we also have a strengthened cash positioning following the TO 2 warrants this summer. Cash at the end of this quarter was SEK 309 million.

In summary, the strong performance of Terclara in Sweden demonstrates that our strategy is effective, both in terms of product positioning and market expansion. The recognition from the industry and positive feedback from consumers validate our approach and underscore our potential for growth in new markets. While we remain cautious with our expectations for the U.S. Phase III results, we are confident that our proactive planning and strategic collaborations position us well for the future.

Thank you for your attention. I'll stop here and are happy to open up for questions.

[Operator Instructions] Our first question is from [indiscernible].

My question is regarding the milestone payment from Bayer. Can you elaborate on how much more should we expect in the coming quarters? What are the milestones for? And basically, if this was at the end of the quarter or in the beginning of the quarter?

Yes. So this milestone is earned -- is a part of a larger process, basically bound by specific targets and criteria set out by our contractual terms with Bayer. And as before, we don't comment on the milestones to come.

We have only given the total amount of milestones for each partner, and we will report them when they happen, but I will perhaps repeat again that the majority of our milestones, and that's true for, I would say, every partner agreement, is sales related and then we have some development milestones.

And the other question that I had, basically, if you could comment on -- I don't know if this is already being discussed or not, but a potential OTC route in the U.S.

Sorry, I didn't quite hear the question. Could you repeat it?

Yes. I was wondering if assuming that the Phase III results don't change much from what unfortunately was already sent or basically the results are not so great, but they are good enough to get an approval. Basically, it's better than placebo. Is there anything that could be done to push for an OTC route in the U.S. with the FDA, given there are no side effects on this product?

Yes. So I think based on this initial data that we received, we're, of course, investigating all possible routes to market given different scenarios. And among those, one is OTC.

[Operator Instructions] We currently have no further questions. So I'll hand back to Anna for closing remarks.

Thank you, operator, and 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 good day.

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