Santhera Pharmaceuticals Holding AG

Santhera reported total revenues of CHF 24 million for the first half of 2025, up 70% year over year. Product revenues were CHF 11.6 million, up 76%, and revenues from U.S. and Chinese partners totaled CHF 12.4 million versus CHF 7.6 million a year earlier. Operating expenses were CHF 27.3 million, operating loss was CHF 35.4 million, and cash and cash equivalents at June 30, 2025 were CHF 18.4 million. The company said global sales across its own and partner markets were in excess of $100 million at the end of Q2, triggering a $20 million milestone payment to ReveraGen in cost of sales. For 2025, management raised revenue guidance to above the prior CHF 65 million to CHF 70 million range and maintained operating expense guidance of CHF 50 million to CHF 55 million excluding non-cash share compensation; it also maintained 2028 guidance of EUR 150 million and 2030 guidance of above EUR 150 million in direct markets. Management said the new CHF 20 million financing extends runway through cash flow breakeven by mid-2026.

The CEO was absent due to shoulder surgery, so strategic commentary came mainly from Catherine Isted. Management's tone was confident and growth-focused, emphasizing AGAMREE’s differentiation in Duchenne muscular dystrophy and the company’s ability to expand into more geographies. They framed the business as being in execution mode, with more launches, more partnerships, and the possibility of adding a second product in the rare disease space to leverage existing infrastructure.

Catherine Isted highlighted strong first-half financial execution and said costs remained under control despite revenue growth. She cited CHF 24 million in revenue, CHF 27.3 million in operating expenses, CHF 35.4 million in operating loss, and CHF 18.4 million in cash at June 30, 2025. She also explained that the company secured CHF 20 million of additional financing through a CHF 10 million convertible bond and USD 13 million from extending the R-Bridge royalty monetization, saying the capital was needed mainly for higher inventory and working-capital needs tied to partner demand. She reiterated operating expense guidance of CHF 50 million to CHF 55 million for 2025 on a constant portfolio basis, excluding share-based compensation.

Analysts focused on European rollout, pricing and reimbursement, China launch timing and demand, manufacturing capacity, the new royalty deal, and whether AGAMREE could help patients who had stopped standard steroids restart treatment. Management said Germany pricing and the U.K. NICE recommendation can support reimbursement discussions elsewhere, that China demand has been stronger than expected with more than 250 patients treated, and that the second manufacturing site should deliver first supplies in Q4 2025. On the new R-Bridge agreement, management said terms were better than before, with a lower cap and lower coupon rate, and on long-term data they pointed to the GUARDIAN study, with results expected in Q4, as a key catalyst for demonstrating durability and safety differentiation.