Replimune Group (REPL) 12th Annual Cantor Fitzgerald Global Healthcare Conference summary

Commercial launch and operational readiness

• Achieved FDA approval for TUDRIQEV (RP1) in combination with nivolumab for advanced melanoma; product expected to reach patients within 60 days of approval.

• Commercial infrastructure is being built, with 70% of the team hired and full staffing expected by launch; many team members have prior experience with the product.

• Launch strategy targets 200 early adopter academic hospital accounts with established infrastructure for rapid uptake, focusing on operational workflow and training.

• Key launch metrics include account readiness, workflow implementation, new patient starts, and reinitiation rates; initial earnings may be lower due to dosing mix.

• Permanent J-code for reimbursement expected in April, with temporary codes used in the interim; targeted accounts are equipped to handle these codes.

Market adoption and financial outlook

• Uptake expected to be gradual in the first six months, accelerating in the second half of the launch year as operational workflows mature.

• Expansion to broader community accounts planned for six to nine months post-launch, with full market coverage over a year plus.

• Gross to net assumptions are in line with other newly launched buy-and-bill oncology products; initial hospital-based focus leads to higher 340B patient mix.

• Cost of goods is about 10%, with potential for gross to net improvement as market expands.

• Real-world usage may vary, but pricing is based on median volume from clinical trials; label allows for physician discretion in retreatment.

Clinical development and future pipeline

• Ongoing phase III IGNYTE-3 confirmatory study for TUDRIQEV is on track, with a primary overall survival endpoint and readout expected around 2030.

• Durable responses observed in prior trials, with 50% three-year survival in advanced melanoma; deep lesion injections are emphasized for optimal outcomes.

• Manufacturing capacity is stable, with a year of inventory and no disruptions reported.

• Plans to expand RP1 into non-melanoma skin cancers and organ transplant patients, with data supporting durable responses and potential new indications.

• Next-generation product RP2 is in phase II/III trials for uveal melanoma, with a go/no-go decision expected early next year and first PFS data readout around 2028.