Santhera Pharmaceuticals Holding Ag · SIX:SANN
Santhera Pharmaceuticals — FY2024 Earnings Presentation
26 slides from Santhera Pharmaceuticals's earnings presentation, April 2025
Slide 1: Year Ending 31 December 2024
Year Ending 31st December 2024 April 2025
Slide 2: Santhera speakers today
Santhera speakers today fsanthera Dario Eklund Catherine Isted Dr. Shabir Hasham CEO CFO CMO (Q&A)
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) • Global headquarters near Basel (Switzerland) Santhera • 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: Duchenne muscular dystrophy: 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 but have limitations
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: Side effects commonly lead to dose alterations
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: AGAMREE: retained efficacy with reduced steroid side effects
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 progress and highlights
1 4 • In Germany and Austria almost 30% of patients on steroid treatment • Early access program commenced during 2024, approval Dec 2024 switched to AGAMREE within the first 12 months • Commercial rollout expected mid 2025 on a non-reimbursed basis 2 5 • Additional distribution agreements signed to
Slide 12: AGAMREE in Germany and Austria after one year
AGAMREE in Germany and Austria after one year ‒ newly diagnosed aged 4-5 ‒ switchers aged 6-12 clinical trial sites/experience prior to launch Federal in Germany (per 100ml bottle) as per German formula Germany reference market for several other countries 12
Slide 13: Rapid adoption of AGAMREE by patients in Germany
Rapid adoption of AGAMREE® by patients in Germany serthes THEIR FUTURE ~ OUR FOCUS All 10 leading expert centers in High adoption at pediatric centers with Germany prescribing AGAMREE future potential stepmap.de @ 13
Slide 14: European launch timeline by country
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 In preparation Pricing negotiations Ben
Slide 15: Net sales outperform initial guidance
Net sales of outperform initial guidance of 15
Slide 16: China and Hong Kong approvals
AGAMREE incorporated into both the Priority Review Program and the Breakthrough Therapy Program Hong Kong approval followed 9 days later in the same month 16
Slide 17: Second manufacturer supply ready
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) 17
Slide 18: Financial results 2024
1 5 (2023: CHF 32 Mio) (2023: CHF 103.4 Mio) Driven by revenue from strong product sales in Germany 2023 was positively impacted by net gain of CHF 17.0 Mio and Austria, offset out by significant licensing milestones on sale of the idebenone business. Excluding this gain, recognised in 2023 from out
Slide 19: Guidance and outlook
2025 revenue guidance: CHF 65-70 Mio 2028 revenue outlook: EUR 150 Mio – this covers direct and partnered markets, as well as royalty income from North America and China, excludes potential milestones payments received from partners 2030 revenue outlook (direct markets): Expect > EUR 150 Mio of sale
Slide 20: Growth strategy
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 20
Slide 21: Everything in place to 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 21
Slide 22: Time for questions
Time for questions We are pleased to take your guestions \santhera
Slide 23: Thank you / Appendix
\santhera Thank you For your time APPENDIX and participation
Slide 24: Additional territories
⚫ Turkey ⚫ S. Korea ⚫ GCC ⚫ Australia/NZ ⚫ Brazil/LatAm ⚫ India ⚫ Japan ⚫ Russia tbd 24
Slide 25: Headquarters functions support country teams and 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 26: Data from patient-years of 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
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