Press Release: Santhera Pharmaceuticals Full Year Results for the Year Ended 31 December 2025

Ad hoc announcement pursuant to Art. 53 LR

A conference call will be held on April 28, 2026, at 14:00 CEST / 13:00 BST / 08:00 EDT.

Details are at the end of this news release

AGAMREE(R) delivers strong growth as global expansion accelerates

Pratteln, Switzerland, April 28, 2026 -- Santhera Pharmaceuticals (SIX: SANN) today announces its full year results for the year ended 31 December 2025.

Dario Eklund, CEO of Santhera, said: "Our strong performance in 2025 reflects the continued momentum of AGAMREE(R), with rapid adoption across our core European markets and growing contributions from our global partners, driving a near-doubling of revenues. We have also significantly expanded our global reach, with strategic partnerships such as Nxera in Asia-Pacific, alongside Catalyst in the U.S. and Sperogenix in China, enabling broader patient access worldwide. At the same time, long-term clinical data of up to eight years continue to reinforce AGAMREE's differentiated profile, demonstrating improved safety while maintaining efficacy comparable to standard-of-care corticosteroids. With a strengthened financial position and a clear path to cash flow breakeven in 2026, we are well positioned to build on this momentum as we continue to expand access and deliver long-term value for patients and shareholders."

Operational Highlights (including post period events)

-- Strong commercial momentum in core EU markets: AGAMREE continued to

deliver strong uptake across Santhera's direct markets in 2025, with

Germany and Austria building on the foundation established in 2024 and

reaching market shares of over 40% and 50%, respectively, among

corticosteroid-treated DMD patients. Following its Q2 2025 launch, the UK

is demonstrating encouraging early adoption, with uptake trends broadly

in line with Germany's initial trajectory.

-- Advancing pricing and reimbursement across Europe: Santhera made further

progress in expanding access to AGAMREE across key European markets. In

February 2026, pricing in Spain was agreed, with launch planned

imminently. In April 2026, strong progress was made with the Italian

authorities, with agreement reached on price. Following publication in

the Official Gazette, expected this quarter, commercialization will

begin.

-- Global partnerships driving growth and reach: Collaborations with

Catalyst Pharmaceuticals ("Catalyst") in North America and with

Sperogenix in China continued to support both revenue growth and patient

access. In the U.S., Catalyst reported USD 117 million in AGAMREE sales

in 2025, triggering a USD 12.5 million milestone payment to Santhera. In

China, Sperogenix initiated commercial rollout in September 2025, with

more than 800 patients treated to date.

-- Strategic APAC partnership with Nxera: In January 2026, Santhera entered

into an exclusive licensing agreement with Nxera Pharma covering Japan

and key Asia-Pacific markets. The agreement, valued at up to USD 215

million plus royalties, includes a USD 40 million upfront payment

(comprising USD 30 million cash and USD 10 million equity investment) and

significantly expands Santhera's global footprint.

-- Long-term data reinforce differentiated profile: New clinical data,

including follow-up of up to eight years, demonstrated sustained efficacy

comparable to standard-of-care corticosteroids alongside a markedly

improved safety profile, supporting AGAMREE's positioning as a long-term

treatment option in DMD.

-- Continued expansion into new territories: Santhera further broadened

global access to AGAMREE through new regional distribution partnerships

across markets including the Gulf Cooperation Council countries, India,

Türkiye, and Russia, supporting ongoing international rollout.

-- Executive and Board changes: Santhera continued to evolve its leadership

team and governance structure during the year, with the appointment of

Catherine Isted as Chief Financial Officer and Dr. Melanie Rolli to the

Board. Post year-end, Marc Clausse was appointed Chief Commercial

Officer. In April 2026, Santhera announced a planned leadership

transition, with Dario Eklund stepping down as Chief Executive Officer

and Orlando Oliveira appointed as CEO, effective July 15, 2026. Dario

Eklund will support an orderly handover.

Financial Highlights:

-- Total revenue grew by 97% to CHF 77.2 million (2024: CHF 39.1 million),

driven by strong growth in AGAMREE adoption across Europe and the U.S.

This was significantly ahead of the original guidance of CHF 65--70

million.

-- Product sales increased by 72% to CHF 25.8 million (2024: CHF 15.0

million), reflecting accelerating AGAMREE adoption in Germany and Austria,

as well as early sales from the UK following launch in Q2 2025.

-- Royalties and milestones were up 37% to CHF 23.1 million (2024: CHF 16.9

million), driven by higher royalties from licensing partner Catalyst in

the U.S., and the receipt of a USD 12.5 million sales milestone payment

after achieving more than USD 100 million of U.S. sales in calendar year

2025, underlining AGAMREE's increasing global momentum.

-- Revenue from the supply of products and services to partners was CHF 28.3

million (2024: CHF 7.2 million).

-- Operating expenses were CHF 53.0 million (2024: CHF 56.9 million).

Operating expenses decreased by 7% year-on-year, due to lower development,

general and administrative expenses, partially offset by higher marketing

and sales expenses.

-- Operating loss was CHF 37.6 million (2024: CHF 33.1 million).

-- Financing: In September 2025, the Company secured an additional CHF 20.5

million of growth capital from existing investors Highbridge and R-Bridge,

and new investor Partners Group.

-- Cash and cash equivalents were CHF 22.4 million (2024: CHF 40.9 million).

-- Cash flow breakeven: The Company reconfirms its prior guidance that it

expects to reach cash flow breakeven during Q3 2026, with no additional

funding required.

Full Year 2025 Report

The Santhera Full Year Report 2025 (English only) is available for download on the Company's website at https://www.globenewswire.com/Tracker?data=T5Kc_TaUUKg0OJ1-DcgsOSP0EcmUpml5NxHeb3bxPTuOOdEXLMMFoGJGS2ljpv4zdSlu50sS1Pmg_axbSDEwoUhdiAqXs7ikyYxVe9jCM0-SpqJd7_F-9JrQuz2wiG_-vm-RRNRtIcX1qry4j6kUHg== 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 ET) on 28 April 2026.

Register here: https://www.investormeetcompany.com/santhera-pharmaceuticals-holding-ag/register

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 https://www.globenewswire.com/Tracker?data=QBIo5TyFxgq2KliJ813MySFrIP84DPxWnnvIML5ES3rr5FaaJtRrKJ-i4xC40Cxhk7FFGvS9ie6NXGOLxKrD3xF_bCV5fH0gccHs_QgaUrw=

ICR Healthcare:

Santhera@icrhealthcare.com https://www.globenewswire.com/Tracker?data=VSadovvWDZaHa1lEqNCRcb4IcLoot8S_7sYoWpfj5_aiUP2RqiM8-85qJzHQipmDyIbSN_hT9gb5XIfhUcmXtBiBgpAN0OwWuBUz9OAcMSesmpY1CROe2u_2z-o1HdFX

Stifel

+44 (0)20 7710 7600

Brough Ransom, Charles Hoare, Fred Walsh

Octavian

+41 (0)44 520 1588

Serge Monnerat, Marius Zuberbuehler

About Santhera

Santhera Pharmaceuticals (SIX: SANN) is a Swiss specialty pharmaceutical company focused on the development and commercialization of innovative medicines for rare neuromuscular diseases with high unmet medical need. The Company has an exclusive license from ReveraGen for all indications worldwide to AGAMREE(R) (vamorolone), a dissociative steroid with novel mode of action, which was investigated in a pivotal study in patients with Duchenne muscular dystrophy (DMD) as an alternative to standard corticosteroids. AGAMREE for the treatment of DMD is approved in the U.S. by the Food and Drug Administration (FDA), in the EU by the European Commission (EC), in the UK by the Medicines and Healthcare products Regulatory Agency (MHRA), in Switzerland by Swissmedic, in China by the National Medical Products Administration (NMPA), in Hong Kong by the Department of Health (DoH) and in Canada by Health Canada. Santhera has out-licensed the rights to AGAMREE as follows: to Catalyst Pharmaceuticals for North America; to Sperogenix Therapeutics for China and certain countries in Southeast Asia; and to Nxera Pharma for Japan, South Korea, Australia, and New Zealand. For further information, please visit https://www.globenewswire.com/Tracker?data=T5Kc_TaUUKg0OJ1-DcgsOeasVDcqSCFHUflnK2rliLMthYty1kx3HYParL1E33Hyl0NAYhibtexRRYSyFoHL1vLvXN2zuUnuR-9DsNcEkRtU4EousWmoiFj6fovrJYjjrsG1rCH4eRuuXKwhAEYIhjd0A6PUWpmVz3OXvn7iJmDkCdf_uHivc_cNn7HsX8Xc www.santhera.com.

AGAMREE(R) is a trademark of Santhera Pharmaceuticals.

Disclaimer / Forward-looking

This communication does not constitute an offer or invitation to subscribe for or purchase any securities of Santhera Pharmaceuticals Holding AG. This publication may contain certain forward-looking statements concerning the Company and its business. Such statements involve certain risks, uncertainties and other factors which could cause the actual results, financial condition, performance or achievements of the Company to be materially different from those expressed or implied by such statements. Readers should therefore not place undue reliance on these statements, particularly not in connection with any contract or investment decision. The Company disclaims any obligation to update these forward-looking statements.

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