Replimune Group (REPL) investor relations material

Executive summary

• FDA granted accelerated approval Aug. 6 for TUDRIQEV plus nivolumab in adults with unresectable advanced cutaneous melanoma progressing after anti-PD-1 therapy; U.S. availability began Oct. 1.

• More than 70% of 200 priority accounts had been engaged by Oct. 23; more than 15 institutions had prescribed and begun treating patients.

Financial highlights

• Fiscal Q2 2027 product revenue was $0; first commercial shipments began in early October, with first product revenue expected in fiscal Q3.

• Q2 R&D expense was $34.4M versus $57.9M YoY; SG&A was $21.9M versus $26.4M, and total operating expenses were $56.3M versus $84.3M.

• Q2 net loss was $57.1M versus $83.1M YoY; six-month net loss was $126.9M versus $169.8M.

• Six-month operating cash use was $123.4M versus $158.2M; financing provided $161.3M, including August offering proceeds and a September debt draw.

• Inventory was $9.9M at Sept. 30 after inventory capitalization began following FDA approval.

Outlook and guidance

• Cash and cash equivalents are expected to fund operations for more than 12 months from issuance of the financial statements, including TUDRIQEV commercialization.

• No revenue guidance; first product revenue is expected in fiscal Q3, and revenue from a patient may be recognized over multiple quarters as treatment visits occur.

• Expenses are expected to rise with commercialization, confirmatory studies and RP2/RP3 development; future spending depends on clinical, regulatory and commercial outcomes.

• IGNYTE-3, the ~400-patient confirmatory trial with overall survival as primary endpoint, is actively enrolling; REVEAL is enrolling in uveal melanoma.

• RP2 REVEAL Phase 2/3 transition and preliminary RP2 findings in HCC and biliary tract cancer are expected in Q1 2027; a permanent J-code is anticipated in H1 2027.