Santhera Pharmaceuticals (SANN) H2 2025 earnings summary

Executive summary

• Achieved rapid global expansion and commercial momentum in 2025, with AGAMREE reaching over 40% market share in Germany and 50% in Austria among corticosteroid-treated DMD patients, and strong launches in the UK, Spain, and Italy.

• Secured major partnerships and licensing agreements in APAC (Nxera, up to USD 215 million plus royalties), and expanded distribution in GCC, India, Türkiye, Russia, and Latin America.

• U.S. sales via Catalyst reached USD 117 million in 2025, with 90% of DMD Centers of Excellence prescribing AGAMREE and 2026 guidance of USD 140–150 million.

• Over 800 patients treated in China since September 2025, with NRDL reimbursement expected by early 2027 and local manufacturing under discussion.

• Long-term clinical data and GUARDIAN study results presented, reinforcing AGAMREE's safety, efficacy, and differentiation, supporting further market uptake.

Financial highlights

• Total revenue grew 97% to CHF 77.2 million in 2025, exceeding guidance of CHF 65–70 million; product sales up 72% to CHF 25.8 million.

• Royalties and milestones increased 37% to CHF 23.1 million, including a USD 12.5 million milestone from Catalyst.

• Operating expenses decreased 7% to CHF 53.0 million, with lower development and admin costs offset by higher marketing spend.

• Operating loss widened to CHF 37.6 million, mainly due to higher cost of goods and milestone expenses.

• Year-end cash and equivalents at CHF 22.4 million, with major receipts from Nxera and Catalyst in Q1 2026.

Outlook and guidance

• 2026 revenue guidance set at CHF 80–90 million, with product sales expected to grow over 50% despite a 17% German price reduction.

• Royalty and milestone income projected to rise, driven by Nxera upfront payment and continued US growth.

• Cash flow breakeven targeted for Q3 2026, with no additional funding required.

• 2028 revenue guidance at EUR 150 million (excluding milestones); 2030 direct market sales expected to exceed EUR 150 million.

• Supply and services revenue to decrease post-Q1 2026 as Catalyst moves to own manufacturing.