Santhera Pharmaceuticals Holding Ltd.

Latest Results (27.12.2025):

Santhera Pharmaceuticals Holding Ltd. — results for the six months ended June 30, 2025 (H1 2025; includes Q2 2025): Santhera reported strong top-line growth driven by AGAMREE commercialization, with total revenue rising to CHF 24.0 million (up 70% versus H1 2024) but an operating loss of CHF 35.4 million (net loss CHF 38.8 million) in H1 2025. Cost of sales rose sharply to CHF 32.1 million primarily due to a USD 25 million sales milestone (CHF 20.3 million) payable to partners; cash stood at CHF 18.4 million at June 30, 2025, and additional financing of ~CHF 20 million was secured in September 2025 to support growth and inventory.

Revenue and growth

Total revenue for H1 2025 was CHF 24.0 million (H1 2024: CHF 14.1 million). Product sales reached CHF 11.6 million (+76%), and Santhera recognized CHF 12.4 million from partners (royalties, milestones and product supply), reflecting strong partner-led growth.

Sales, partners and market traction

Global AGAMREE sales (including partners) exceeded USD 100 million on a four-quarter basis, triggering a USD 25 million sales milestone. Catalyst (U.S.) reported USD 49.4 million of AGAMREE sales in H1 2025 and is guiding USD 100–110 million for FY2025 (which could yield an additional USD 12.5 million milestone to Santhera). China partner Sperogenix has commenced commercial rollout (non‑reimbursed) and reported early uptake.

Cost of sales and milestone impact

Cost of sales rose to CHF 32.1 million (H1 2024: CHF 5.2 million). The increase reflects higher direct/indirect costs from commercialization and the CHF ~20.3 million (USD 25m) milestone payment to ReveraGen and R‑Bridge, which materially inflated COS for the period.

Operating expenses and results

Operating expenses (excluding non-cash compensation) were CHF 25–27.3 million range for the period (total operating expenses CHF 27.3m vs CHF 26.7m in H1 2024). The operating loss was CHF 35.4 million (H1 2024: loss CHF 17.7m); excluding the USD 25m milestone, the operating loss reduced YoY by CHF ~2.6 million per the company.

Cash, liquidity and financing

Cash and cash equivalents were CHF 18.4 million at June 30, 2025 (Dec 31, 2024: CHF 40.9m). Post-period the company secured ~CHF 20 million of growth capital (USD 13m royalty monetization with R‑Bridge plus CHF 10m convertible bond upsizing/extension with Highbridge) to meet inventory and launch needs. Cash‑flow break‑even guidance is maintained for mid‑2026.

Balance sheet and equity

Total assets were CHF 130.8 million and total liabilities CHF 133.3 million, producing shareholders’ equity of CHF -2.6 million at June 30, 2025. The negative equity reflects recognition of the milestone payable; management cites anticipated partner milestones and the new financing in support of going concern and operations to mid‑2026.

Commercial rollout and country updates

Direct European uptake continues: Germany now treats ~40% of steroid‑using DMD patients with AGAMREE and Austria exceeds 50% market share for steroid‑using DMD patients. UK launched nationwide in Q2 2025 after positive NICE guidance. Reimbursement/pricing discussions are progressing in Spain, Italy, Nordics, Benelux, France and Switzerland with launches planned through H2 2025–2026. Distribution deals signed for GCC countries, India and Türkiye post-period.

Guidance and outlook

Santhera now expects FY 2025 revenue to exceed its prior guidance range of CHF 65–70 million. Operating expense guidance (ex non‑cash share‑based comp) remains CHF 50–55 million for full year 2025. Company reiterates longer‑term revenue ambitions (2028 and 2030 targets) and continues to focus resources on maximizing the DMD opportunity for AGAMREE.