Santhera Pharmaceuticals Half Year Results for the six months ending 30 June 2026

Orlando Oliveira, CEO of Santhera said: “We made strong progress in the first half of 2026, with growing commercial momentum for AGAMREE® and significant advances in patient access globally. In Europe, pricing and reimbursement agreements in Spain and Italy mean that AGAMREE® is now commercially available in four of the five major EU markets, while our agreement with Nxera significantly expands our reach across key APAC territories. Importantly, the long-term data presented in March further reinforced AGAMREE®’s differentiated profile in DMD and has supported increased physician adoption. With our partners also continuing to rapidly expand access across their territories, AGAMREE® is reaching a growing number of patients worldwide, positioning us well to build on this momentum through the remainder of 2026 and beyond.”

Operational Highlights (Including post period events)

Four of five major EU markets now commercially launched: Pricing and reimbursement agreements were secured in Spain and Italy during the first half of 2026, adding to continued strong commercial momentum in Germany and the UK.

Strategic APAC licensing agreement signed with Nxera: Exclusive licensing agreement for Japan, South Korea, Australia and New Zealand valued at up to USD 215 million plus royalties, including USD 30 million in cash and a USD 10 million equity investment in Santhera.

Continued progress across mid-sized direct European markets: Swissmedic approved AGAMREE® in Switzerland in January 2026, while pricing and reimbursement was agreed in Luxembourg in August, marking the first Benelux market to secure reimbursement.

Distributor markets continue to expand: Santhera expanded its agreement with Biomedica to include Georgia, Kazakhstan, Belarus, Azerbaijan and Uzbekistan, while Genesis secured marketing authorization for AGAMREE® in Serbia in September, further expanding patient access across its territories.

Long-term data further reinforce AGAMREE®’s differentiated profile: Data from up to eight years of AGAMREE® treatment, including baseline results from the ongoing Phase 4 GUARDIAN study, were presented at MDA in March 2026, demonstrating comparable long-term effectiveness to standard-of-care corticosteroids alongside clinically meaningful safety advantages.

Additional data and label expansion support continued growth and positioning: CHMP adopted a positive opinion recommending extension of AGAMREE®’s EU authorization to patients from two years of age, while emerging real-world experience from a case series in adult, non-ambulatory DMD patients presented at ICNMD showed stabilization or improvement in upper-limb function in this patient population.

Executive and Board Changes: Orlando Oliveira was appointed CEO in July, Marc Clausse joined as Chief Commercial Officer in June, and Dr. Srishti Gupta was elected to Santhera’s Board in May.

Financial Highlights

Total revenue increased 101% to CHF 48.3 million (H1 2025: CHF 24.0 million), driven by strong growth in product sales and income recognized from the Nxera licensing agreement.

Product sales increased 48% to CHF 17.2 million (H1 2025: CHF 11.6 million), reflecting continued strong growth across Santhera’s launched markets.

Royalties and milestones increased to CHF 29.1 million (H1 2025: CHF 6.5 million), primarily driven by the USD 30 million (CHF 24.2 million) cash upfront payment received under the Nxera licensing agreement.

Revenue from the supply of products and services to partners decreased, as expected, to CHF 2.1 million (H1 2025: CHF 5.9 million), primarily reflecting Catalyst’s transition to direct sourcing.

Global AGAMREE® sales, including partner sales, exceeded USD 175 million on a fourconsecutive-quarter basis in Q2 2026, triggering a USD 20 million (CHF 16.3 million) sales milestone payment obligation, recognized in cost of sales.

Operating expenses decreased 8.4% to CHF 25.0 million (H1 2025: CHF 27.3 million), primarily due to lower development costs.

Operating loss narrowed significantly to CHF 6.6 million (H1 2025: CHF 35.4 million).

Cash and cash equivalents increased to CHF 41.8 million at June 30, 2026, compared with CHF 22.4 million at December 31, 2025.

Full-year 2026 guidance maintained, with total revenue expected to be in the range of CHF 80– 90 million.

Cash and cash equivalents: While cash is expected to remain broadly stable at 30 September levels through the end of the year, the movement of inventory purchases into Q1 2027, combined with a mandatory German price reduction effective from Q1 2027, is expected to result in a decline in cash during H1 2027, before the Company returns to cash generation in the second half of the year. This change in the cash profile, however, will not require the Company to seek any additional funding.

Half Year Report

The Santhera Half Year Report 2026 (English only) is available for download on the Company’s website at www.santhera.com/financial-reports.

Analyst Briefing

Santhera’s management team will be hosting a briefing for analysts and investors via a webcast at 14:00 CEST (08:00 EDT) on 30 September 2026.

Register here: https://www.investormeetcompany.com/santhera-pharmaceuticals-holding-ag/registerinvestor A recording of the webcast and the results presentation will be made available on the website following the event.

For further information, please contact:

Santhera
Catherine Isted, Chief Financial Officer
IR@santhera.com
ICR Healthcare
Santhera@icrhealthcare.com

Stifel +44 (0)20 7710 7600
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Octavian +41 (0)44 520 1588
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