Moberg Pharma

NINE-MONTH PERIOD (JAN-SEP 2024)

• Net income SEK 8.8 million (0)
• EBITDA SEK -15.7 million (-17.4)
• Operating profit (EBIT) SEK -16.7 million (-19.2)
• Total profit SEK -11.8 million (-14.6)
• Diluted earnings per share SEK -0.34 (-1.24)
• Cash and cash equivalents amounted to SEK 309.0 million (101.5)

THIRD QUARTER (JUL-SEP 2024)

• Net income SEK 3.9 million (0)
• EBITDA SEK -3.0 million (-6.6)
• Operating profit (EBIT) SEK -3.3 million (-7.3)
• Total profit SEK -1.3 million (-5.8)
• Diluted earnings per share SEK -0.03 (-0.36)
• Cash and cash equivalents amounted to SEK 309.0 million (101.5)

SIGNIFICANT EVENTS DURING THE THIRD QUARTER

• Terclara continues to be the market leader in Sweden. The company's partner Allderma has won the award for best Swedish launch at both Kronan pharmacy's and Doz pharmacy's supplier meetings.
• Moberg Pharma lowers expectations for primary treatment target in ongoing Phase 3 study based on a subset of data. Topline results are expected before the end of the year.

SIGNIFICANT EVENTS AFTER THE QUARTER

• No significant events

CEO COMMENTS

Terclara® continues to be the market leader in Sweden and we could not have wished for a better start to the launch. For the U.S., we are lowering our expectations for the primary endpoint in the ongoing phase 3 study as we await the study results and subsequent analysis to understand the implications. Until then, we continue to build upon the positive momentum in our business from our current launch.

Best launch of the year
Year to date, we achieved a market share of 30% of the value and 25% of the units of pharmacy sales to end consumers, despite marketing to consumers only starting in April.[1] Corresponding figures for the third quarter were 34% of the value and 28% of the units. The product is now also available at more than 90% of Swedish pharmacies and through all pharmacy chains in Sweden. The launch of Terclara® has also led to growth in the category as a whole of 41% in Q3.

The launch has received recognition from the industry, with Terclara being named best launch of the year by the chains Kronans Apotek and Doz Apotek. In addition, our partner Allderma has received an honorable mention as the best health care provider from Apoteket Hjärtat.

At the launch, all but one of the major pharmacy chains included Terclara® in their range. The pharmacy chain that chose not to bring in the product initially has now added Terclara®, after 45% of pharmacies affiliated with the chain ordered the product through an independent wholesaler thanks to demand from patients – another acknowledgement of patients’ great interest in the product.

The sales success led us to bring forward the next planned production, which was delivered in August and ensures that the wholesale warehouse for the Swedish market remains well-stocked. Although we manufactured back in July, there are lead times from manufacturing to the product being on the shelf, as well as lead times for advertising campaigns that affected our market share in Q3 compared to Q2. We reduced marketing as to not risk an out-of-stock situation and have seen a healthy recovery in sales at the end of the quarter.

Continued focus on manufacturing and supply
As mentioned earlier, we have secured enough terbinafine (the active ingredient in Terclara®) to meet the needs of the Swedish market until a new terbinafine supplier is in place. With a focus on manufacturing, we participated at CPHI[2] in October, an opportunity for us to meet and thank many of the companies that help us with the challenges that a drug launch entails. We continue according to plan to work on two parallel tracks to ensure a stable long-term supply of terbinafine ahead of the pan-European rollout, with the goal of getting at least one terbinafine manufacturer approved in the near term. We have answered questions from the Swedish Medicincal Products Agency regarding the application and are now awaiting the agency's decision.

Phase 3 results in the U.S. by year-end
As part of the analysis work in preparation for closing our ongoing North American Phase 3 study, we were given blinded data on a subset of patients. The total number of patients who have achieved clinical cure in this subset of patients is lower than our expectations and we therefore assess that the risk of not being able to commercialize the product in the U.S. based on this study has increased. For approval in the U.S., the FDA normally requires 2 studies with superiority. We already have one such study in place. The ongoing study was designed based on a new dosing that could enable registration documentation in the U.S. and both meet demanded regulatory requirements and strengthen the product's marketing claims globally. In the event of a positive outcome, only having to treat weekly after the initial phase is a major competitive advantage for our patients.

The company's priority is to protect the data integrity of the study, both as not to undermine the possibilities of using study results in discussions with regulatory authorities, and as there are patients with ongoing treatment in the study. We will not speculate on possible outcomes or what this means for MOB-015's future potential, but await the study results and subsequent analysis.

The value of collaborations with key opinion leaders
We engage world-leading experts to be able to analyze and understand data as it becomes available. We already have a well-developed collaboration with the foremost experts in nail fungus. As an example, we participated at the EADV Congress 2024[3] in Amsterdam in September – an opportunity to further deepen our relationships with key opinion leaders. The topline results will be announced in a press release as soon as they are available in December, while subsequent analysis of the outcome will likely require more time and discussions with, among others, key opinion leaders and partners.

Our commercial product is based on previous studies with higher dosing
The ongoing North American study has a reduced dosage compared to the company's commercial product – 8 weeks of daily treatment followed by weekly maintenance treatment; the commercial product has daily dosage throughout the treatment period. Approval in the EU is based on previous studies and in that respect nothing changes. Even for those markets where we have partners outside Europe where we prepare the registration file, the local registration file refers to the European dossier. We have approvals in 13 EU markets and plans are unchanged for a pan-European launch in 2026 based on the successful launch in Sweden this year.

Allderma's approach and good results show why they are an excellent partner in our home market. Allderma is run by the leaders responsible for the launch of our first-generation nail fungus product, Nalox®, in the Nordics. Our close collaboration with Allderma has paid dividends and we now have a recipe for success for future launches.

A message that works
The success of the Swedish launch with Terclara® not only emerging as the market leader, but also expanding the total market, is a clear indication that our marketing message really works. In two large phase 3 studies, 76% of patients become fungus-free, which is world-leading and better than any other topical treatment. This success confirms our strategy and provides a solid foundation to build on as we prepare to expand into new markets.

Anna Ljung, CEO Moberg Pharma