Oncosil Medical (OSL) Investor presentation summary

Commercialisation and market opportunity

• OncoSil™ device delivers targeted brachytherapy for pancreatic cancer, now approved in over 34 countries with a global addressable market of US$4.2bn and no direct competition.

• Commercial ramp-up is expected in FY25, supported by new market entries, label expansions, and increased hospital access in the EU and UK.

• Attractive unit economics with an average price of ~US$24k per device and gross margin expected to rise from 50% to 65% in FY25, targeting >75% at scale.

• Expansion into new geographies and delivery methods, including percutaneous access for interventional radiologists, is anticipated to accelerate adoption.

• Second manufacturing facility in Sydney is operational, supporting commercial scale-up and margin improvement.

Clinical evidence and patient outcomes

• Comparative analysis shows OncoSil™ plus chemotherapy increases median overall survival to 20.0 months versus 13.0 months for chemotherapy alone.

• Surgical resection and downstaging rates more than doubled with OncoSil™ plus chemotherapy compared to chemotherapy alone.

• Landmark studies demonstrate significant tumour volume reduction, improved progression-free survival, and established safety profile.

• PanCO study showed 1 in 3 patients became eligible for curative surgery, with 6 of 10 resected patients alive at 32 months follow-up.

• Increased tumour vascularity observed post-OncoSil™ implantation, potentially enhancing chemotherapy delivery.

Regulatory and commercial milestones

• Achieved UKCA certification, removing post-market restrictions in the UK; MDR approval in the EU anticipated in Q4 2024.

• G-BA approval and conditional reimbursement secured for 84 hospitals in Germany.

• Distribution agreements signed in the Middle East, Turkey, and expansion planned in LATAM, France, South Korea, and Switzerland.

• Ongoing pivotal studies (PANCOSIL, TRIPP-FFX) targeting label expansions for new delivery methods and chemotherapy combinations.

• Constructive engagement with US FDA for bile duct cancer indication and Human Device Exemption pathway.