Santhera Pharmaceuticals Holding Ag · SIX:SANN
Santhera Pharmaceuticals — Investor Presentation (May 2025)
30 slides from Santhera Pharmaceuticals's investor presentation, May 2025
Slide 1: Santhera Pharmaceuticals Investor Presentation May 2025
Pa Cee Santhera Pharmaceuticals Investor Presentation May 2025 ‘egy “ANY
Slide 2: 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 3: 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 4: Duchenne muscular dystrophy: 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 4
Slide 5: 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 5
Slide 6: Steroid 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 7: 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 7
Slide 8: 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 8
Slide 9: Market split by region
€ North America China/SE Asia ROE € ROW * Santhera estimates 9
Slide 10: Global rollout underway
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 11: 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 11
Slide 12: 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 B
Slide 13: Germany patient population
1. https://countrymeters.info/en/Germany ; 2. https://www.dgm.org/muskelerkrankungen/muskeldystrophie-duchenne-becker; 3. Treat-NMD query (07/2023)
Slide 14: Patient population and market opportunity
1. https://countrymeters.info/en/Germany ; 2. https://www.dgm.org/muskelerkrankungen/muskeldystrophie-duchenne-becker; 3. Treat-NMD query (07/2023)
Slide 15: Net sales outperform initial guidance
Net sales of outperform initial guidance of 15
Slide 16: Priority Review and Breakthrough Therapy programs in China
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 CMO supply ready for geographical expansion
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: 2024 financial results
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: We have 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: Thank you / Appendix
Thank you For your time APPENDIX santhera
Slide 23: Additional territories
⚫ Turkey ⚫ S. Korea ⚫ GCC ⚫ Australia/NZ ⚫ Brazil/LatAm ⚫ India ⚫ Japan ⚫ Russia tbd 23
Slide 24: Operating model and commercialization 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 25: 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
Slide 26: Term loan and royalty monetization agreement
Term Loan: (Highbridge Capital Management) Received CHF 35 Mio from a 4-year term loan: Interest rate of 3-month SARON Plus 9.75% 1st two years interest only, remainder 15% pa amortization, bullet repayment Aug 28 Existing CHF 7 Mio private convertible bond with a strike of CHF 10 extended by 12 mo.
Slide 27: Revenue streams by market type
Direct Markets Distributors Licensed (Western Europe) (E 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 % royalty
Slide 28: Royalty payment flows
Total gross royalty (low-high teens %*) Royalty payments to originator (mid-high single digit %*) $’s Net royalty payments (mid single digits up to 11%) Royalty payments Royalty retained by SANN payments to CBC TIME 28 * For sales <$500 Mio, for sales >$500 Mio additional royalties are booked but al
Slide 29: Share structure and major shareholders
Number ‘000 Comments Listed shares outstanding 13,514 Less Treasury (642) Basic shares outstanding 12,872 Dilution Convertible bonds 697 CHF 6,971k Maturing Aug 2025 at a strike of CHF 10 237k at strike CHF 11.10 Warrants 237 458k at strike CHF 20.00 – not included Employee Schemes 576 Vested Total
Slide 30: Management team
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 30
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