Sweden · Delayed Price · Currency is SEK Moberg Pharma AB Earnings Call Transcripts
Fiscal Year 2026
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A topical terbinafine treatment for nail fungus achieved rapid market leadership in Sweden and Norway, with strong clinical results and a premium price. Expansion is underway across Europe via partnerships, with regulatory approval for Lamisil branding as a near-term milestone.
Fiscal Year 2024
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Terclara solidified market leadership in Sweden and began expansion into Norway, with further EU rollouts planned for 2026. U.S. launch is delayed pending new clinical data, but the company remains well-financed and focused on European growth.
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The North American phase III study for MOB-015 did not meet its primary endpoint, with only 1.5% achieving complete cure and lower mycological cure rates than prior studies. Strategic focus will shift to Europe, leveraging strong results and market leadership in Sweden, while U.S. regulatory plans are put on hold.
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Terclara led the Swedish market in Q3, achieving 34% value and 78% unit share, and drove 41% category growth. U.S. phase III results may fall short of expectations, but European expansion remains on track with approvals in 13 countries.
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Blinded interim data from a North American phase III study showed lower-than-expected clinical cure rates for MOB-015, raising the risk of not meeting the primary endpoint and impacting U.S. commercialization prospects. EU and Canadian launches remain on track, with the EU launch dependent on supply chain approvals.