Santhera Pharmaceuticals Holding Ag · SIX:SANN
Santhera Pharmaceuticals — H1 2025 Earnings Presentation
29 slides from Santhera Pharmaceuticals's earnings presentation, Sep 23, 2025
Slide 1: 6 months Ending 30 June 2025
6 months Ending 30 June 2025 23 September 2025
Slide 2: Santhera speakers today
Santhera speakers today fsanthera Catherine Isted Dr. Shabir Hasham CFO CMO
Slide 3: Disclaimer
This presentation is not and under no circumstances to be construed as a solicitation, offer, or recommendation, to buy or sell securities issued by Santhera Pharmaceuticals Holding AG. Santhera Pharmaceuticals Holding AG makes no representation (either express or implied) that the information and o
Slide 4: Santhera Pharmaceuticals
SIX Swiss Exchange listed company (SANN) Santhera • Global headquarters near Basel (Switzerland) • About 110 employees; will remain <150 employees Pharmaceuticals AGAMREE® is a differentiated product in Duchenne muscular A fully integrated dystrophy (DMD) • A unique dissociative corticosteroid which
Slide 5: No cure and high medical need
1. No cure and high medical need 2. Onset at age 3-5 years and life expectancy in the late 20s to mid-30s 3. Progressive muscle weakness needing chronic treatment 4. Loss of ambulation in early teenage years followed by respiratory failure and cardiac complications 5
Slide 6: Corticosteroids are the standard of care in combination
Corticosteroids are the standard of care in combination with other treatments Corticosteroids can delay disease progression by 2-3 years Corticosteroids have limitations due to serious side-effects Start too late Dose too little Stop too soon 6
Slide 7: Dose, risk, side effects
Cataracts/ glaucoma (12-25%) Long bone fractures Vertebral (20-60%) DOSE RISK Growth fractures stunting (76%) Weight (37-72%) Behavioral gain challenges (6-65%) (34-38%) SIDE EFFECTS COMMONLY LEAD TO DOSE ALTERATIONS AGE 1. Cowen L, et al. BMC Neurol. 2019;19:84; 2. Wong B, et al. J Pediatr. 2017;18
Slide 8: Retained anti-inflammatory action and efficacy
Retained anti-inflammatory action and efficacy Reduction of steroid-associated side effects related to: ‒ growth ‒ bone health ‒ behavior May have additional benefits – Heart health On time On dose On treatment 8
Slide 9: Around 300,000 individuals affected globally
Around 300’000 individuals affected globally 90% of patients are diagnosed in NA/Europe 50-75% of patients on steroid treatment Patients are treated in specialized centers HCPs familiar with steroid usage 9
Slide 10: Market by region
€ North America China/SE Asia ROE € ROW * Santhera estimates 10
Slide 11: Commercial rollout and H1 2025 highlights
1 4 • Approximately 40% of steroid using DMD patients in Germany now • Early access program continued in 2025 with commencement of treated with AGAMREE non-reimbursed commercial rollout in September • Austria becomes first country to have >50% market share* • Increased expectations for demand in 202
Slide 12: AGAMREE patient uptake and pricing
of steroid using DMD patients now treated with AGAMREE ‒ newly diagnosed aged 4-5 ‒ switchers aged 6-12 ‒ increasing number of older DMD patients of steroid using DMD patients now treated with AGAMREE No clinical trial sites/experience prior to launch Federal price in Germany EUR 3’612.50 (per 100ml
Slide 13: Development and launch timeline
2024 2025 2026 Status Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 H1 H2 Germany / Austria Launched Launch Pricing negotiations PHASE 1 UK Launched Pricing negotiations Launch Spain Submitted NPP* Pricing negotiations Submission Italy NPP* Pricing negotiations Q1 2025 PHASE 2 Nordic Submitted Pricing negotiations Benelu
Slide 14: Catalyst 2025 guidance for AGAMREE
H1 sales already ahead of FY 2024 sales of USD 46 Mio Catalyst 2025 guidance for AGAMREE: Net sales of USD 100-110 Mio Sales of >USD 100 Mio within the year leads to a milestone payable to Santhera of USD 12.5 Mio 14
Slide 15: Early access and commercial launch
Early access program (EAP) in Hainan province was launched in June 2024 Commercial launch in the non-reimbursed market commenced in September 2025 More than 250 DMD patients treated to date Demand expectations increased for 2025/2026, leading Santhera to bring forward inventory plans 15 *National Re
Slide 16: Revenue and operating loss
1 5 (H1 2024: CHF 14.1 (H1 2024: CHF Mio), 70% growth driven by revenue from strong product 26.7 Mio) with increased Sales and Marketing offset by sales in launched markets in addition to royalty and decrease in R&D products supply revenue 2 6 (H1 2024: CHF 6.6 Mio), an (H1 2024: CHF 17.7 Mio increa
Slide 17: Convertible loan extension and royalty monetization
Convertible loan extension: (Highbridge Capital Management) Highbridge will provide an additional CHF 10 million via a new convertible note with the existing CHF 7 million convertible bond exchanging, at parity The new convertible bond will have a three-year maturity, with a conversion price set at
Slide 18: New 2025 revenue guidance
New 2025 revenue guidance: FY revenues in excess of CHF 65-70 Mio 2028 revenue outlook: EUR 150 Mio – including direct and partnered markets, and royalty income from North America and China, but excluding potential milestones payments received from partners 2030 revenue outlook (direct markets): Exp
Slide 19: Self commercialization in core European countries
Self commercialization Acquire rights to additional in core European synergistic late-stage countries rare/orphan assets Grow AGAMREE Leverage in synergy with other international products & explore partnership for worldwide potential in additional commercialization indications with partners 19
Slide 20: We have everything in place to successfully serve the DMD market
We have everything in place to successfully serve fsanthera the DMD market a Ve = A differentiated A clear A strong & A nimble Funded to product with growth growing partner organization projected cash- worldwide rights strategy network with expertise breakeven 20
Slide 21: Thank you / Appendix
Thank you For your time APPENDIX santhera
Slide 22: Supporting references
1. https://countrymeters.info/en/Germany ; 2. https://www.dgm.org/muskelerkrankungen/muskeldystrophie-duchenne-becker; 3. Treat-NMD query (07/2023)
Slide 23: Supporting references
1. https://countrymeters.info/en/Germany ; 2. https://www.dgm.org/muskelerkrankungen/muskeldystrophie-duchenne-becker; 3. Treat-NMD query (07/2023)
Slide 24: First supply ready from second CMO
First supply ready from second CMO for geographical expansion and security of supply supply chain & reduces lead time manufacturing cost and working capital Catalyst Pharmaceuticals evaluates second manufacturer in US Sperogenix Therapeutics plans for local manufacturing until 2029 (latest) 24
Slide 25: Geographic expansion targets
⚫ Turkey ⚫ S. Korea ⚫ GCC ⚫ Australia/NZ ⚫ Brazil/LatAm ⚫ India ⚫ Japan ⚫ Russia tbd 25
Slide 26: Headquarters functions and license partners
Headquarters functions support own country teams, licensing and commercialization partners License Partners Catalyst (North America) Sperogenix (Greater China/SEA) Quality Medical & PV Affairs Santhera Germany, Austria, Switzerland Strategic United Kingdom, Ireland Regulatory Marketing France Centra
Slide 27: Our data builds on over patient-years exposure
Our data builds on over 200 patient-years exposure from santhera more than 200 boys treated for up to 7 years Ph 2a Long-term Extension Expanded Access Program (N=153) Pivotal VISION-DMD (N=121) conser | FOR-DMD External Comparator Study (N=196)?° External comparison Pivotal study 2.5-year compariso
Slide 28: Direct markets, distributors and licensed markets
Direct markets Distributors Licensed (Western Europe) (Eastern Europe & other) Catalyst / Sperogenix Revenues booked Low-high teens Booked revenue guidance 100% >60% 2028: EUR 150 Mio to SANN % gross royalty* Royalty payment (less mid-high (less mid-high (less mid-high to originator single digit % r
Slide 29: Executive leadership
Dario Eklund Catherine Isted Dr. Oliver P. Chief Executive Officer Chief Financial Officer Kronenberg Chief Legal Officer and Secretary to the Board Dr. Shabir Hasham Marc Schrader Dr. Geert-Jan van Chief Medical Officer Chief Technology Officer Daal Chief Commercial Officer 29
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