Santhera Pharmaceuticals (SANN) H1 2025 earnings summary

Executive summary

• AGAMREE, a differentiated corticosteroid for Duchenne muscular dystrophy (DMD), achieved rapid global rollout with approvals and launches in the US, Europe, UK, China, and Hong Kong, and strong adoption in Germany, Austria, and the US.

• Market share exceeded 50% in Austria and reached 40% in Germany among steroid-using DMD patients, with rapid uptake in the UK and over 250 patients treated in China since launch.

• Global AGAMREE sales (including partners) exceeded USD 100 million over four quarters, triggering a USD 25 million milestone payment.

• New CHF 20 million financing was secured in September 2025, extending cash runway to mid-2026 and supporting inventory build-up for surging demand.

• Executive and board changes included the appointment of a new CFO and board member in 2025.

Financial highlights

• Total revenues for H1 2025 were CHF 24 million, a 70% year-over-year increase, driven by strong product sales and royalties.

• Product revenues reached CHF 11.6 million, up 76% from the prior year, mainly from Germany, Austria, and the UK.

• Revenues from US and Chinese partners totaled CHF 12.4 million, up 63% year-over-year.

• Operating expenses for H1 2025 were CHF 27.3 million (CHF 25 million excluding share-based payments), in line with guidance.

• Operating loss was CHF 35.4 million; excluding the USD 25 million milestone payment, the loss was reduced by CHF 2.6 million from last year.

Outlook and guidance

• Full-year 2025 revenue guidance raised to exceed CHF 65–70 million, reflecting strong growth in direct and partner markets.

• 2028 revenue guidance maintained at EUR 150 million from direct and partner markets, excluding milestones.

• 2030 direct market sales expected to exceed EUR 150 million, with additional upside from royalties and partners.

• Operating expenses for 2025 and beyond expected in the CHF 50–55 million range, excluding non-cash share compensation.

• Cash-flow break-even targeted for mid-2026.