Santhera Pharmaceuticals (SANN) H1 2024 earnings summary

Executive summary

• Agamree launched in Germany (Jan 2024), Austria (Feb 2024), and by partner Catalyst in the U.S. (Mar 2024), with rapid uptake exceeding expectations in all markets.

• Over 25% of DMD patients on steroids in Germany and Austria switched to Agamree within eight months, despite no prior clinical trial exposure in those countries.

• Regulatory progress includes U.K. MHRA approval, launches in Germany, Austria, and the U.S., and ongoing priority review in China, with launch expected in Q1 2025.

• Strategy realigned to focus on direct commercialization in Western Europe, expanding to Nordics, Portugal, Ireland, and a new distribution partnership for Central/Eastern Europe.

• Financing of up to CHF 69 million closed in August 2024, extending cash runway into 2026 and supporting growth initiatives.

Financial highlights

• Revenue for H1 2024 was CHF 14.4 million, up from CHF 3.9 million year-over-year, entirely from Agamree.

• CHF 6.5 million of revenue from Germany and Austria since launch; CHF 6.4 million from milestones/royalties (China, U.S.); CHF 1.3 million from product sales to partners.

• Operating expenses rose to CHF 26.7 million, mainly due to development and CMC costs, including CHF 2.2 million in one-off product development costs.

• Operating loss was CHF 17.7 million, CHF 2.6 million lower year-over-year; net loss CHF 15.3 million (CHF 1.35/share) vs. CHF 23.3 million (CHF 2.09/share) prior year.

• Cash at June 30 was CHF 16.5 million, up from CHF 1.7 million year-over-year; post-period financing increased cash to CHF 52 million by end of August.

Outlook and guidance

• Cash runway extended into 2026, with break-even targeted for that year; main risk is European sales and final pricing.

• Guidance for CHF 150 million in European revenue by 2028 reaffirmed, with patient numbers and pricing assumptions providing a buffer.

• Operating spend for 2024 expected around CHF 50 million, with incremental costs for new markets managed within this range.

• Expansion of Agamree commercialization in Europe, with launches planned in the Nordics, Portugal, and Ireland, and ongoing pricing negotiations in major markets.

• Decision on new Agamree indications delayed until at least end of 2025, with focus on DMD and further clinical studies to support safety profile.