Santhera Announces Half Year 2025 Financial Results and Provides Corporate Update

Core Insights - Santhera Pharmaceuticals reported a significant increase in total revenue by 70% to CHF 24 million for the first half of 2025, driven by strong sales of AGAMREE and growing royalty revenues [5][23][24] - The company is advancing the global rollout of AGAMREE, particularly in the US, Germany, Austria, and the UK, with expectations for continued growth in sales and market share [3][6][14] - Santhera has secured additional financing of approximately CHF 20 million to support increased product demand and global launches, maintaining a cash-flow break-even guidance for mid-2026 [21][31] Financial Performance - Total revenue increased to CHF 24 million from CHF 14.1 million in H1 2024, with product sales rising 76% to CHF 11.6 million [5][23][24] - Royalties from licensing partners surged to CHF 5.4 million, a 500% increase compared to CHF 0.9 million in H1 2024, indicating strong growth in the US and China [5][24] - Operating loss widened to CHF 35.4 million from CHF 17.7 million in H1 2024, primarily due to a one-time milestone payment of USD 25 million [31][28] Market Expansion - AGAMREE has achieved over 40% market penetration among steroid-using DMD patients in Germany, with Austria exceeding 50% market share [6][7] - The UK market has positively contributed following the nationwide launch in April 2025, supported by favorable NICE guidance [8] - Santhera is actively pursuing pricing and reimbursement discussions in Spain, Italy, and the Nordic regions, with launches expected from Q4 2025 to Q1 2026 [10][11][12] Strategic Initiatives - The company is focusing on expanding its distribution agreements across multiple regions, including five Gulf Cooperation Council countries, India, and Türkiye [15][17] - Santhera plans to present long-term clinical outcomes from the GUARDIAN study in early Q4 2025, which may further support AGAMREE's market position [18] - The company is not planning near-term investments in additional indication expansions for AGAMREE but is looking to leverage partnerships for future studies [19] Leadership and Governance - Santhera appointed Catherine Isted as CFO in February 2025 and Dr. Melanie Rolli to the Board in May 2025, enhancing its leadership team with experienced professionals [20]