EPS of $-0.82 increased by 8.9% from previous year
Net income of -74.13M
""data from the Ignite Study shows that roughly one-third of patients are able to achieve durable response in a high unmet need setting with few options."" - Sushil Patel
Replimune Group Inc (REPL) QQ4 2025 Financial Results and RP1 Commercial Readiness for Anti-PD-1 Failed Melanoma
Executive Summary
Replimune reported a materially negative quarterly and annual bottom line in Q4 2025 as the company advances RP1 toward potential FDA approval for anti-PD-1 failed melanoma. The BLA was acknowledged by the FDA in early 2025 with priority designation and a PDUFA target date of July 22, 2025, underscoring a pivotal inflection point for commercialization. Ignite 3, the confirmatory trial with overall survival as the primary endpoint, is underway and enrollment in the U.S. is on track with more than 100 sites planned globally, signaling a robust pathway to a potential launch upon approval. The company presented a clear strategic plan to commercialize RP1, including a U.S. manufacturing facility capable of supporting initial demand and long-term supply, a dedicated 60-person commercial organization, and a novel interventional radiology coordination framework to enable image-guided intra-tumoral injections.
Key Performance Indicators
Operating Income
-79.33M
QoQ: -20.15% | YoY:-35.01%
Net Income
-74.13M
QoQ: -11.74% | YoY:-34.60%
EPS
-0.82
QoQ: -3.80% | YoY:8.89%
Revenue Trend
Margin Analysis
Key Insights
Profitability: Q4 2025 net income of -$74.1M; FY2025 net loss of -$247.3M; EPS (diluted) -$0.82 for Q4 2025. YoY metrics show gross profit decline and higher operating costs as R&D and SG&A scale for commercialization.
Revenue and gross profit: Revenue not reported for Q4 2025; Q4 2025 gross profit of $0.736M on cost of revenue of -$0.736M, with gross profit YoY down ~-78.3% based on quarterly comparison.
Expenses: R&D expense surged to $55.0M in Q4 2025 and $189.4M for FY2025; SG&A was $24.3M in Q4 2025 and $72.2M for FY2025. Stock-based compensation contributed $4.5M in Q4 2025 and $18.4M in FY2025 R&D; SG&A included $3.8M and $16.6M in SBC, respectively.
Cash and liquidity: Ended FY2025 with $483.8M in cash and equivalents; management contends existing liquidity can fund operations into Q4 2026, supporting RP1 commercialization readiness.
Milestones and guidance: PDUFA date set for July 22, 2025; Ignite 3 confirmatory trial ongoing with broad site expansion plans; management anticipates providing patient-based and payer metrics rather than revenue guidance during the early commercialization window.
Financial Highlights
- Profitability: Q4 2025 net income of -$74.1M; FY2025 net loss of -$247.3M; EPS (diluted) -$0.82 for Q4 2025. YoY metrics show gross profit decline and higher operating costs as R&D and SG&A scale for commercialization.
- Revenue and gross profit: Revenue not reported for Q4 2025; Q4 2025 gross profit of $0.736M on cost of revenue of -$0.736M, with gross profit YoY down ~-78.3% based on quarterly comparison.
- Expenses: R&D expense surged to $55.0M in Q4 2025 and $189.4M for FY2025; SG&A was $24.3M in Q4 2025 and $72.2M for FY2025. Stock-based compensation contributed $4.5M in Q4 2025 and $18.4M in FY2025 R&D; SG&A included $3.8M and $16.6M in SBC, respectively.
- Cash and liquidity: Ended FY2025 with $483.8M in cash and equivalents; management contends existing liquidity can fund operations into Q4 2026, supporting RP1 commercialization readiness.
- Milestones and guidance: PDUFA date set for July 22, 2025; Ignite 3 confirmatory trial ongoing with broad site expansion plans; management anticipates providing patient-based and payer metrics rather than revenue guidance during the early commercialization window.
Income Statement
Metric
Value
YoY Change
QoQ Change
Gross Profit
736.00K
-78.27%
N/A
Operating Income
-79.33M
-35.01%
-20.15%
Net Income
-74.13M
-34.60%
-11.74%
EPS
-0.82
8.89%
-3.80%
Key Financial Ratios
returnOnAssets
-13.4%
returnOnEquity
-17.8%
priceToBookRatio
1.89
priceEarningsRatio
-2.65
Net Income vs. Revenue
Expense Breakdown
Management Commentary
- Strategy and regulatory momentum: Management emphasized RP1’s pathway to potential approval, with a PDUFA date of July 22, 2025 and a breakthrough therapy designation with priority review. Quote: “data from the Ignite Study shows that roughly one-third of patients are able to achieve durable response in a high unmet need setting with few options.” (Sushil Patel)
- Launch readiness and market access: Management outlined a comprehensive commercial plan, including a 60-person team, a dedicated interventional radiology coordination group (IROC), a patient support hub, and a distribution network designed for next-day delivery. Quote: “We estimate approximately 13,000 patients progress on or after PD-1 treatment annual in the U.S., and about 80% of these patients would be eligible for RP1.” (Chris Sarchi)
- Financial position and runway: CFO highlighted a robust cash runway into Q4 2026 to fund commercialization activities, with no near-term debt issuance implied. Quote: “We ended the fiscal year with cash and cash equivalents totaling $483.8 million ... runway into the fourth quarter of 2026.” (Emily Hill)
- Ignite 3 trial performance: While not yet fully disclosed, management indicated enrollment in the U.S. is progressing with >100 sites globally planned for Ignite 3, with OS as primary endpoint. (Sushil Patel)
"data from the Ignite Study shows that roughly one-third of patients are able to achieve durable response in a high unmet need setting with few options."
— Sushil Patel
"We ended the fiscal year with cash and cash equivalents totaling $483.8 million as compared to $420.7 million ... runway into the fourth quarter of 2026, which includes scale up for the potential commercialization of RP1 ..."
— Emily Hill
Forward Guidance
- Short-term: Maintain focus on completeness of CMC readiness and FDA interactions to avoid bottlenecks for the July 2025 PDUFA decision. Management has indicated ongoing engagement with the FDA with no impediments observed post late-cycle meeting and inspections.
- Revenue guidance: Management stated revenue guidance will be deferred until farther into the launch, with initial emphasis on patient numbers and payer coverage metrics.
- Longer-term: If RP1 achieves approval, RP1 launch would target anti-PD-1 failed melanoma patients in the U.S. and later expanded geography; continued clinical development for RP2, RP3, and RPx to broaden addressable indications.
- Key monitorables for investors: PDUFA outcome on 7/22/2025, Ignite 3 enrollment progress, labeling discussions reflecting broad anti-PD-1 failure melanoma population, manufacturing capacity scalability, and payer coverage adoption.
Competitive Position
Company
Gross Margin
Operating Margin
Return on Equity
P/E Ratio
REPL Focus
0.00%
0.00%
-17.80%
-2.65%
NUVL
0.00%
0.00%
-6.99%
-18.63%
VTYX
0.00%
0.00%
-11.60%
-1.32%
ASND
91.90%
0.22%
36.40%
-51.65%
UTHR
89.70%
48.60%
4.68%
13.23%
Gross Profit Margin
Operating Profit Margin
Return on Equity
P/E Ratio Comparison
Investment Outlook
Base-case investment thesis centers on RP1 receiving FDA approval for anti-PD-1 failed melanoma by July 2025 and achieving broad, rapid adoption driven by a unique intra-tumoral delivery model, demonstrated systemic activity, and a prepared commercial infrastructure. The current liquidity runway into late 2026 reduces near-term dilution risk, allowing management to invest in Ignite 3 data transparency, payer discussions, and EMR integration to accelerate uptake. However, meaningful upside hinges on successful regulatory outcomes, robust post-approval labeling that reflects IGNITE population, and the ability to scale manufacturing and distribution to meet demand. Investors should monitor PDUFA outcome, Ignite 3 enrollment progress, label discussions, and early commercialization metrics (patient numbers, payer coverage, and net revenue trajectory) as primary catalysts. Given the pre-revenue status and elevated burn, REPL remains a high-risk, high-reward name with substantial optionality if RP1 delivers on its clinical and commercial promises.
Key Investment Factors
Growth Potential
RP1 could become a first-line option for patients who progress on PD-1 therapy in advanced melanoma, with a sizable addressable US population (~13,000 patients/year) and potential expansion into RP2/RPx programs to address other cancers. The IROC framework and image-guided intra-tumoral injections create a defensible, specialty-driven adoption path that could enable rapid uptake post-approval.
Profitability Risk
Regulatory risk surrounding the BLA finalization and potential post-approval label scope; clinical risk given Ignite data are from a single-arm trial; market risk from competitive regimens and reimbursement dynamics; manufacturing scale-up risk and dependence on RP1's successful commercialization trajectory.
Financial Position
Strong liquidity with $483.8M in cash at 3/31/2025 and a cash runway into 2026; No long-term debt reported; high annual burn driven by R&D and SG&A to support commercialization; pre-revenue status implies reliance on regulatory success for value realization.
SWOT Analysis
Strengths
Significant cash runway with $483.8M at 3/31/2025 supporting commercialization readiness into 2026
FDA breakthrough designation and priority review for RP1 with PDUFA date set for July 22, 2025
Ignite 3 confirmatory trial underway with OS endpoint and broad global site expansion
Robust manufacturing capacity in the U.S. with inventory build to support launch
Replimune Group Inc (REPL) QQ1 2025 Earnings Analysis: Heavy R&D burn with no revenue, strong liquidity position, and an upcoming RP1-driven value pro...