Santhera Pharmaceuticals (SANN) H2 2024 earnings summary

Executive summary

• AGAMREE, a differentiated steroid for Duchenne muscular dystrophy (DMD), achieved rapid commercial rollout and approvals in the U.S., Europe, U.K., China, and Hong Kong, with launches in Germany, Austria, and the U.K.

• Achieved 30% market share among steroid-treated DMD patients in Germany and Austria within one year of launch, with further launches and reimbursement negotiations ongoing in other European markets.

• U.S. partner Catalyst Pharmaceuticals exceeded revenue guidance, generating $46 million in 2024 and guiding $100–110 million for 2025.

• Financing secured in August 2024 extends cash runway to mid-2026, supporting expansion and operations.

• Manufacturing expansion underway in Switzerland and the U.S. to ensure supply security and cost efficiency.

Financial highlights

• Total 2024 revenues were CHF 39.1 million, down from CHF 103.4 million in 2023 due to prior year milestone income from outlicensing.

• Product sales reached CHF 14.8 million in 2024, up from CHF 0.8 million in 2023, driven by AGAMREE launches.

• Royalties and milestone revenue totaled CHF 19.3 million in 2024, down from CHF 99.9 million in 2023.

• Operating expenses were CHF 57 million, up 15% year-over-year excluding a one-time gain in 2023.

• Operating loss for 2024 was CHF 33.2 million, compared to a CHF 68.8 million profit in 2023.

Outlook and guidance

• 2025 revenue guidance is CHF 65–70 million; 2028 revenue target is EUR 150 million, including royalties and direct sales.

• 2030 guidance projects over EUR 150 million in direct sales, not including distributor/license markets or milestones.

• Operating expenses (SG&A and R&D) expected at CHF 50–55 million for 2025 and beyond, excluding non-cash share compensation.

• Break-even projected by mid-2026, with no further fundraising anticipated under current plans.