Immunocore Holdings Plc Q4 FY2023 earnings call

• KIMMTRAK: Achieved $239 million in net sales in 2023. 2024 growth opportunities include continued US commercial growth, Q4 data from TEBE-AM trial, and ATOM trial recruitment in 2024. Approved in 38 countries, launched/reimbursed in 12.
• Clinical Portfolio: Advanced clinical portfolio with announcement of first PRAME Phase 3 trial in first line advanced cutaneous melanoma, to randomize first patient in Q1. PRAME clinical data updates for melanoma, ovarian, and lung in 2024. Two new candidates in clinic: PIWIL1 for colorectal/GI cancers (CTA submitted Dec 2023) and HIV Phase 1 data expected in 2024.
• Innovation: Added two novel tissue-targeted autoimmune programs for type 1 diabetes and dermatology indications.

The main segment is KIMMTRAK. In 2023, KIMMTRAK generated $238.7 million in net revenues, representing a 70% year-on-year growth. In the fourth quarter, net revenues were $67.6 million, an 8% increase from the prior quarter. Growth was primarily driven by continued commercial progress in the United States. KIMMTRAK is approved in 38 countries and launched/reimbursed in 12, with over 2,000 patients treated globally since the start of its first clinical trial.

• KIMMTRAK: Continue growth momentum in the US, expect top-line results from TEBE-AM Phase 2 portion in Q4 2024, and ATOM trial to start randomizing in H2 2024.
• PRAME: Phase 3 PRISM-MEL301 melanoma trial to share monotherapy/anti-PD1 combo data in Q2; ovarian monotherapy/chemo combo data in Q3; lung data in Q4. Phase 3 trial in first line melanoma to start randomizing patients soon.
• PIWIL1: CTA submitted in Dec 2023, trial to start in H2 2024.
• HIV: Phase 1 data expected in 2024.

• Uncertainty in clinical trial outcomes, including timing and success of PRAME, PIWIL1, and HIV trials.
• Regulatory approval processes for new candidates and indications could be delayed or face challenges.
• Market adoption and pricing in new therapeutic areas may not meet expectations.

Q: On KIMMTRAK advanced melanoma study readout, primary endpoint and scenarios A: The Phase 2 part of the study has dual primary endpoints of ctDNA and overall survival. At the end of the year, ctDNA will be mature and survival will be directional, informing whether to drop an arm or resize the study Q: PRAME updates, patient numbers, readouts A: Cutaneous melanoma data to be shared in Q2, ovarian in Q3, and lung in Q4. Enrollment methods vary by tumor type; for lung, a methodical approach focusing on select subsets initially Q: KIMMTRAK ex-US sales flat, growth plan A: Ex-US sales flat due to established market; primary growth driver is the US, driven by community penetration, with mid-term growth from TEBE-AM data and long-term from ATOM trial Q: PRAME Phase 3 strategy, combination with nivo A: Focus on first line, design is tebentafusp + nivo vs nivo; primary endpoint is progression free survival, secondary is overall survival; ctDNA is an exploratory endpoint Q: PIWIL1 in CRC, immune desert issue A: PIWIL1 is not expressed in normal vital tissues, has broad expression in about a quarter of CRC patients, and mechanism doesn't rely on preexisting immunity/infiltration in the tumor Q: HIV med study success A: Success would be reduction in CD4 T cells with HIV, delay in viral rebound; need to share data with KOLs to interpret what constitutes success