Replimune Group, Inc. Q2 FY2027 earnings call

Sushil Patel (CEO) and Michelle DiNapoli (CCO) outlined the following key operational updates:

• Commercial Launch Status: Tudor Kev is the first commercial product from the RPX platform, with strong early traction among melanoma institutions. In the first three weeks post-launch, leading centers have ordered the drug, and many have identified patients for treatment.
• Supply Chain Readiness: The company maintains over a year’s worth of inventory produced at its in-house manufacturing facility, ensuring next-day delivery capability to meet immediate patient demand.
• Physician Adoption & Label Utility: Physicians appreciate the broad label, which allows treatment of patients progressing on PD-1 therapy without requiring prior BRAF targeted therapy. Both oncologists and interventional radiologists are actively adopting the therapy for superficial and image-guided injections.
• Customer Engagement Funnel:
  • Engagement: Proactive engagement has been achieved with more than 70% of the initial 200 target accounts.
  • Access: Approximately 20 accounts have swiftly placed Tudor Kev on formulary, with some expediting or bypassing standard reviews due to urgency.
  • Orders: Over 15 institutions have written prescriptions as of the call date, treating patients within less than 20 business days.
• Coverage and Reimbursement: Tudor Kev was rapidly listed as an NCCN Category 2A recommendation. Major commercial payers and Medicare have established favorable coverage policies, including provisions for retreatment. A permanent J-code is anticipated by April 2027.
• Team Build-out: The commercial team is nearly fully staffed and right-sized, including account managers and an operational excellence team comprising nurses, pharmacists, and IR experts to support site workflows.
• Pipeline Updates: The REVEAL study in uveal melanoma (IGNITE3) and the confirmatory melanoma study I3 are enrolling well across additional sites in Europe.

The company did not record any product revenue in the fiscal second quarter ended September 30, 2026, as the first commercial shipments of Tudor Kev occurred in early October. Consequently, there are no absolute financial figures or revenue contribution percentages for product segments for this period. The company expects to report its first product revenue in the subsequent fiscal third quarter.

Management provided limited forward-looking quantitative guidance, focusing instead on qualitative trajectory and operational metrics:

• Revenue Expectations: No specific revenue guidance was provided for future quarters. Management noted that revenue recognition may span multiple quarters because dosing is based on lesion size, patients may receive eight or more cycles, and product is shipped per treatment visit.
• Launch Trajectory: Management expects momentum to continue building weekly. They anticipate doubling the number of accounts initiating patients by the end of the calendar year, with several additional facilities expected to come online through formulary approvals in November.
• Expansion Strategy: The priority remains the top 200 accounts (covering ~30% of national melanoma patients) for the first six months. However, management indicated readiness to accelerate into the next wave of 250 regional accounts if operational readiness and penetration of the initial group are sufficient.
• J-Code Timeline: A permanent J-code is expected to be in place by April 2027, which is anticipated to foster broader adoption, particularly in community settings.

The transcript highlights the following operational and strategic risks:

• Variable Patient Volume and Cost: Actual cost per patient varies significantly based on tumor burden and the number of cycles received. Dosing is volume-dependent (approx. 1 mL/cm), making it difficult to predict exact patient numbers from order volumes in the early launch phase.
• Operational Bottlenecks: While no major holdups were reported, institutional processes vary. Some accounts face slower Pharmacy and Therapeutics (P&T) committee reviews, though physicians remain eager to treat.
• Execution Risk in Expansion: Accelerating into the next wave of accounts requires maintaining high operational standards. Management emphasized doing things "right" to ensure repeat treatments and positive patient/physician experiences before scaling broadly.
• Market Competition: The transcript notes limited treatment options for patients progressing on PD-1-based therapy, but the evolving landscape remains a competitive factor.

Q: Analyst asked about gating factors for modeling launch cadence and requested metrics for patient or account tracking since no revenue guidance was given. / A: CEO and CFO explained that tracking exact patient numbers is difficult due to variable dosing volumes based on lesion size. Instead, they advised tracking funnel metrics: accounts on formulary and those writing first scripts. They expect to provide further insights on average volume used once cohorts complete their eight+ cycles.

Q: Analyst inquired about the mix of superficial vs. deep injections, formulary restrictions on usage volume, and whether the IGNITE trial population represents real-world diversity. / A: CEO confirmed adoption of both injection types, noting deep visceral lesions require interventional radiology. CFO stated IGNITE was representative. Regarding formulary, she confirmed no volume restrictions exist; payer policies support the label, allowing up to 8 cycles plus retreatreatment, with some policies permitting up to 24 doses.

Q: Analyst questioned the proportion of superficial versus deep injections and how lesion location affects treatment volume. / A: CEO stated it is too early to generalize volume differences by lesion type. He noted that while deep injections (lung/liver) tend to use higher volumes, superficial treatment volume depends on the number of lesions. Each patient's needs differ, preventing early generalization of volume profiles.

Q: Analyst asked about the characterization of early adopter centers (academic vs. community) and how physicians are positioning Tudor Kev relative to other PD-1 refractory treatments. / A: CCO clarified that early adopters are primarily academic/hospital-based centers with intratumoral experience and IR capabilities, as expected. However, surprising rapid adoption by regional centers was noted. CEO added that the broad label allows use in various lines of therapy, including adjuvant or frontline progression, depending on physician judgment.

Q: Analyst asked about the timeline for expanding beyond the initial 200 accounts and if the current pace could accelerate entry into the next wave of 250 accounts. / A: CCO reiterated the 6-month focus on the top 200 accounts covering 30% of patients. She expressed confidence in accelerating into the next wave if operational readiness permits, noting proactive interest from regional centers. CEO emphasized prioritizing successful execution and patient experience over speed, stating they will expand when fully ready.