The Swiss rare disease specialist expects to reach breakeven in the third quarter of 2026 without raising additional funds.
Santhera Pharmaceuticals (SIX:SANN, OTC:SPHDF, FRA:S3F0), the Swiss specialty pharma group listed on the SIX Swiss Exchange, has reconfirmed it expects to reach cash flow breakeven during the third quarter of 2026, requiring no additional fundraising, as its Duchenne muscular dystrophy (DMD) drug AGAMREE delivered revenues well ahead of guidance.
Total revenue for the year ended 31 December rose 97% to CHF 77.2 million, comfortably exceeding the company's original guidance range of CHF 65 to 70 million.
AGAMREE, a dissociative steroid designed to offer the muscle-preserving benefits of corticosteroids with a better safety profile, generated product sales of CHF 25.8 million in Santhera's direct European markets, up 72% year-on-year, with Germany and Austria reaching market shares of more than 40% and 50%, respectively, among corticosteroid-treated DMD patients.
In the United States, licensing partner Catalyst Pharmaceuticals reported $117 million in AGAMREE sales during 2025, triggering a $12.5 million milestone payment to Santhera and lifting the company's combined royalties and milestone income by 37% to CHF 23.1 million.
Spain and Italy are the next European markets set to launch, with pricing agreements reached in both countries and commercialisation in Italy expected to follow publication in the Official Gazette this quarter.
Santhera also booked CHF 28.3 million in revenue from product and service supply to partners, up sharply from CHF 7.2 million in 2024, partly reflecting a major new licensing agreement signed in January 2026 with Nxera Pharma covering Japan and key Asia-Pacific markets, valued at up to $215 million plus royalties, with a $40 million upfront payment.
Operating expenses fell 7% to CHF 53.0 million, though the operating loss widened slightly to CHF 37.6 million from CHF 33.1 million in 2024, reflecting the scale of the commercial build-out.
Cash and cash equivalents stood at CHF 22.4 million at year-end, against CHF 40.9 million a year earlier, following CHF 20.5 million of growth capital secured in September 2025 from investors, including Partners Group.
Chief executive Dario Eklund, who is stepping down in July with Orlando Oliveira appointed as his successor, said long-term clinical data of up to eight years continued to reinforce AGAMREE's differentiated profile.