Efinaconazole

THE YEAR (JAN-DEC 2024) Net revenue SEK 9.8 million (0) EBITDA SEK -23.5 million (-25.4) Operating profit (EBIT) SEK -324.8 million (-27.5) Total profit SEK -255.1 million (-21.1) Diluted earnings per share SEK -6.74 (-1.33) Cash and cash equivalents amounted to SEK 293.3 million (60.6) FOURTH QUARTER (OCT-DEC 2024) Net revenue SEK 1.0 million (0) EBITDA SEK -7.8 million (-8.0) Operating profit (EBIT) SEK -308.1 million (-8.2) Total profit SEK -243.3 million (-6.4) Diluted earnings per share SEK -5.21 (-23) Cash and cash equivalents amounted to SEK 293.3 million (60.6) SIGNIFICANT EVENTS DURING THE FOURTH QUARTER Terclara® continues to be the market leader in Sweden. A new terbinafine supplier has been secured for Terclara®/MOB-015. As a result, terbinafine availability is no longer a limiting factor for the company’s launch plans. Topline data from the Phase 3 study has been reported. MOB-015 did not meet the primary endpoint using 8 weeks of daily dosing followed by weekly maintenance dosing. The company’s focus going forward will be on the effective daily dosing regimen approved in 13 EU countries. Moberg Pharma and Bayer have mutually terminated the license agreement, where Moberg Pharma has regained full rights to MOB-015 in the EU and maintains previous milestone payments. SIGNIFICANT EVENTS AFTER THE QUARTER The launch of Terclara® (MOB-015) is beginning in Norway. The experience from Sweden inspires confidence in the Norwegian market, and the launch of Terclara® in Norway follows the same approach as in Sweden. In February, the first deliveries were made to Norwegian pharmacies, followed by targeted information campaigns for pharmacy staff and healthcare professionals. In parallel, consumer marketing will intensify ahead of the peak season, when the demand for nail fungus treatment traditionally increases. VD COMMENTS Terclara® continues to lead the Swedish market, solidifying its position as the market leader. Building on this momentum, we are now taking the next step by expanding to Norway. A new terbinafine supplier has been secured, eliminating a key bottleneck for future market launches. After publishing the North American phase 3 topline data, we reevaluated our U.S. plans and made a strategic decision to focus on the European markets, where strong momentum and the approval of our effective daily dosing regimen in 13 EU countries present the best opportunities for growth. For the full-year 2024, Terclara® achieved a market share in Sweden of 31% in value and 25% in units in pharmacy sales to end consumers, despite consumer marketing only beginning in April.[1] Notably, Q4 figures reached 33% in value and 26% in units – remarkable growth within a limited time period. Refined Strategy Following Phase 3 Study Results In December, the topline data from the North American Phase 3 study for MOB-015 were published. In line with previous announcements, it was confirmed that the primary endpoint was not met with 8 weeks of daily dosing followed by weekly maintenance dosing. Mycological cure (fungus-free) was lower than observed in previous studies. The North American study reduced the dosage compared to the company’s commercial product with daily dosage throughout the treatment period. EU approval is based on previous studies and is not impacted by the new study results. As predicted, the lower dosage reduced discoloration of the nails[2], but it also resulted in a lower mycological cure rate. Our analysis is that 8 weeks of daily dosing did not deliver sufficient terbinafine into the nail to kill the fungus before switching to weekly maintenance treatment. Our hypothesis has not changed, that there is a trade-off between delivering enough terbinafine and avoiding overhydration/white discoloring of the nails. While overhydration is temporary, it makes it difficult to assess the clinical cure in a clinical study. One possible solution to the problem is an additional study with a longer follow-up and/or a different combination of daily treatment and maintenance treatment, with the potential to generate stronger efficacy data. Our view is that additional clinical data needs to be generated before we can apply for approval in the U.S. This means a delay of the expected U.S. launch, and the company’s board of directors has decided therefore to recognize an intangible asset impairment. Moberg Pharma has a long-term ambition to implement an additional clinical study in the U.S. to secure FDA approval, strengthen global marketing claims, and support our ongoing patent application. In the near term, the company’s priority is firmly on the European markets, where MOB-015 is already approved. By showcasing the product’s market-leading potential through successful EU launches, we are building a strong foundation for growth before considering a new study in the U.S. or investing in marketing outside of Europe. Strategic Realignment and Partnership Changes We mutually agreed with Bayer to terminate our partnership, due to strategic considerations and the study results. This means that we regained full rights to MOB-015 in Europe while maintaining previous milestone payments from Bayer. Our partnership in the Republic of Korea has concluded as well. Due to the highly competitive and structurally unique nature of the Korean market—where Jublia (efinaconazole) has gone generic, OTC and Rx channels are blurred, and pricing and reimbursement dynamics are unfavorable—we have decided not to pursue further collaboration in Korea at this time as it does not set us up for success. These changes gives us an opportunity to manage our activities and investments in Europe and Asia according to our priorities and the company’s long-term strategy for value creation. As a first step, we have decided to take a more active role in commercialization, establishing a stronger direct presence in the EU, including ownership of the trademark, to enhance margins. Discussions with potential partners in Europe are underway to support this strategy, and I look forward to sharing updates as plans take shape. We intend to use a commercialization model similar to the one we previously successfully implemented in the U.S. by positioning Terclara as a premium brand complemented by additional products through acquisitions. Historically, we have been successful in identifying, acquiring, and developing smaller brands from larger companies, which has created economies of scale and valuable brand equity. Expanding Momentum Across Europe A new terbinafine supplier was secured during the quarter, which means that terbinafine availability is no longer a limiting factor for our launch plans, enabling us to plan further expansion with confidence. In February 2025, we proudly announced the launch of Terclara® in Norway – a significant step in our European expansion strategy. Initial deliveries have been made to Norwegian pharmacies with pharmacy and healthcare staff education and targeted consumer marketing planned in the lead-up to high season. We see great potential for Terclara® to become established as the market leader in Norway as well, building on our remarkable success in Sweden. With approval in 13 EU markets, we are on track for additional rollouts in 2026, fueled by the success of the Swedish launch. Terclara® not only emerged as the market leader in Sweden but also expanded the total market, demonstrating the strength of our marketing message. In two large phase 3 studies, 76% of patients became fungus-free - world-leading outcomes that far surpass any other topical treatment. The success validates our strategy and provides a strong foundation as we expand into new markets and continue driving growth in Europe. We remain energized and optimistic about the future, as Moberg Pharma continues to set new benchmarks for innovation, performance and market leadership. Anna Ljung, CEO Moberg Pharma [1] Source: IQVIA MIDAS, Pharmacy Sell-Out data, January - December 2024 [2] In previous phase 3 studies, whitish nails were noted after 12 weeks daily treatment in ~70% of patients, with the new dosing less than 50% of patients seemed affected by whitish nails at 12 weeks CONFERENCE CALL CEO Anna Ljung will present the report at a telephone conference today, February 11th, 2025, at 3:00 p.m. CET. Telephone: SE 010 884 80 16, US +1 646 664 1960 Access code: 223155 ABOUT THIS INFORMATION This information is information that Moberg Pharma is Obliged to make public persuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out below, at 8.00 a.m. CET on February 11th, 2025. FOR ADDITIONAL INFORMATION Anna Ljung, CEO, Phone: +46 70 766 60 30, e-mail: anna.ljung@mobergpharma.se Mark Beveridge, VP Finance, Phone: +46 76 805 82 88, e-mail: mark.beveridge@mobergpharma.se