Replimune Group, Inc. (REPL)·Q4 2025 Earnings Summary

Executive Summary

• Q4 FY2025 was focused on regulatory progress and commercial readiness for RP1; the FDA completed late-cycle review and manufacturing inspections with the PDUFA date set for July 22, 2025 and no advisory committee planned .
• Operating spend stepped up ahead of launch: R&D $54.0M and SG&A $25.4M; quarterly net loss was $74.1M and year-end cash was $483.8M, supporting runway into Q4 2026 .
• Versus consensus, Q4 EPS missed: actual ($0.82) vs Wall Street consensus ($0.69); revenue remained $0 given clinical-stage status (values retrieved from S&P Global).
• Near-term stock catalysts: ASCO data readouts on deep lesion injection rationale, the June 24 Investor Day, and the RP1 PDUFA decision and subsequent label/commercialization path .

What Went Well and What Went Wrong

What Went Well

• FDA interactions remained constructive; late-cycle meeting and manufacturing inspections complete with no impediments identified and no advisory committee planned ahead of PDUFA .
• Commercial launch infrastructure fully in place, including specialty distribution, state licenses, a ~60-person customer-facing team, and novel IROC roles to coordinate interventional radiology and oncology .
• IGNYTE data supports treatment rationale: durable responses in ~one-third of patients; strong systemic activity including non-injected visceral lesions; ASCO to showcase response by superficial vs deep/visceral injections and biosafety .

What Went Wrong

• Quarterly loss widened with higher pre-launch OpEx: R&D $54.0M (+$11.4M YoY) and SG&A $25.4M (+$9.2M YoY); net loss increased to $74.1M (vs $55.1M LY) .
• Q4 EPS missed Wall Street consensus (actual ($0.82) vs estimate ($0.69); values retrieved from S&P Global), reflecting accelerated spend and no product revenue yet.
• Continued cash burn ahead of commercialization, with cash stepping down from $536.5M at Q3 to $483.8M at year-end despite runway guidance maintained into Q4 2026 .

Financial Results

*Values retrieved from S&P Global.

Estimates vs Actuals (Wall Street consensus via S&P Global):

KPIs (Clinical/operational):

Guidance Changes

Earnings Call Themes & Trends

Management Commentary

• “We remain actively engaged with the FDA and recently completed the late cycle meeting and manufacturing inspections… We believe there are no impediments. We’re on track for our July 22 PDUFA.” – Emily Hill, CFO .
• “We estimate ~13,000 patients progress on or after PD‑1 annually in the U.S. with ~80% eligible for RP1… administered in the outpatient setting.” – Sushil Patel, CEO .
• “Our customer-facing team… ~60 people… and our IROC role will coordinate medical oncology and interventional radiology to support image-guided administration.” – Chris Sarchi, CCO .
• “ASCO will share responses by injection type… strong rationale for deep lesion injections to maximize outcomes… biosafety shows rapid neutralization.” – Sushil Patel, CEO .

Q&A Highlights

• Medical education and ASCO: New analyses on superficial vs deep/visceral injection response; biosafety neutralization supports outpatient workflow .
• Launch trajectory: Broad/rapid adoption expected; ~350 key accounts treat half of melanoma patients; IR access prevalent; >90% surveyed ready to use RP1 upon approval .
• Access/NCCN/EMR: Plan to submit to drug compendia and EMR vendors covering ~85% of databases on day 1 to minimize access barriers .
• IGNYTE‑3 enrollment: Focus on U.S. pre-PDUFA; expand to UK/Australia/Europe post-PDUFA to sustain enrollment trajectory .
• Manufacturing resilience/COGS: In-house facility designed for RPx; off‑the‑shelf supply for next‑day use; redundancy for RP1 and future RP2/RP3 .
• Revenue guidance: Company to provide launch tracking metrics (patients/payers); revenue guidance deferred until further into launch .

Estimates Context

• Q4 FY2025 EPS missed consensus: actual ($0.82) vs Street ($0.69), driven by heightened pre‑launch OpEx and no revenue contribution yet (values retrieved from S&P Global).
• Next-quarter cadence: Early commercialization milestones will shape Street revisions; management emphasized patient/payer metrics over near‑term revenue guidance .
• Target price consensus stood at ~$12.57 with 7 estimates (values retrieved from S&P Global).

Key Takeaways for Investors

• Regulatory trajectory remains favorable ahead of the RP1 PDUFA, with no AdCom and completed inspections; watch for label breadth reflecting real‑world anti‑PD‑1‑failed populations .
• Launch infrastructure and payer/EMR preparations aim to reduce friction; the IROC model could accelerate adoption in accounts with interventional radiology .
• Clinical narrative is shifting toward deep lesion injection strategies, potentially improving outcomes and reinforcing the interventional immuno‑oncology paradigm .
• Near-term spend will stay elevated; monitor cash burn vs runway (into Q4 2026) and confirmatory trial enrollment momentum across U.S. and RoW .
• Expectation management: With revenue guidance deferred, track qualitative adoption indicators (trained accounts, specialty distribution readiness, compendia/EMR updates) for early traction .
• Pipeline breadth with RP2 (uveal melanoma, HCC) supports medium‑term optionality beyond melanoma; upcoming data presentations/events can re-rate expectations .
• Trading lens: ASCO/Investor Day/PDUFA are key catalysts; EPS miss likely less material near term vs regulatory and launch updates; sentiment hinges on FDA decision and initial adoption metrics .

Citations:

• Q4 FY2025 8-K and press release:
• Q4 FY2025 earnings call transcript:
• Prior quarters for trend analysis: Q3 FY2025 8-K/press release ; Q2 FY2025 8-K/press release

Note: Any values marked with an asterisk and all consensus figures are retrieved from S&P Global.