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Replimune Group Inc (REPL)
NASDAQ:REPL
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Replimune Group
(NASDAQ:REPL)
Rating:42Neutral
Price Target:―
Positive Factors
Product Potential
TUDRIQEV is likely to be a successful first therapeutic in Replimune's skin cancer franchise, given IGNYTE data in melanoma, which significantly de-risked.
Negative Factors
Clinical Trials
Replimune will likely need to re-run its clinical studies to get to approval and may not have enough cash on its books to get there, in our view.
Financial Outlook
Analysts adjust the rating of shares to Underperform and cut the target price to $2/share, reflecting uncertainty at the new FDA and the cash required to re-run studies.
Market Entry Delays
RP1's potential U.S. market entry has been pushed back to 2029, while its probability of approval has been lowered to 50% from the prior 95%.
Regulatory Challenges
The FDA has issued a Complete Response Letter regarding the Biologics License Application for RP1 in anti-PD-1-failed melanoma, which is likely a negative surprise for many investors.
Replimune Group (REPL) vs. SPDR S&P 500 ETF (SPY)
Market Cap
$546.98M
Dividend YieldN/A
Average Volume (3M)14.27M
Price to Earnings (P/E)―
Beta (1Y)1.47
Revenue GrowthN/A
EPS Growth4.28%
CountryUS
Employees479
SectorHealthcare
Sector Strength37
IndustryBiotechnology
Share Statistics
EPS (TTM)N/A
Shares Outstanding77,807,175
10 Day Avg. Volume39,351,086
30 Day Avg. Volume14,273,415
Financial Highlights & Ratios
PEG Ratio-0.48
Price to Book (P/B)0.72
Price to Sales (P/S)0.00
P/FCF Ratio-1.98
Enterprise Value/Market Cap-0.36
Enterprise Value/RevenueN/A
Enterprise Value/Gross ProfitN/A
Enterprise Value/Ebitda6.07
Forecast
1Y Price Target
$4.29Price Target Upside-38.98% Downside
Rating ConsensusHold
Number of Analyst Covering9
Replimune Group Business Overview & Revenue Model
Company DescriptionReplimune Group, Inc. (REPL) is a biotechnology company focused on developing oncolytic immunotherapies for the treatment of cancer. The company operates in the healthcare sector, specifically within the biopharmaceutical industry. Replimune's core products are based on its proprietary Immulytic platform, which is designed to enhance the systemic anti-tumor immune response by using genetically engineered viruses to selectively infect and kill cancer cells while sparing normal tissue.
How the Company Makes MoneyReplimune Group generates revenue primarily through partnerships, collaborations, and licensing agreements with other pharmaceutical and biotechnology companies. These partnerships often involve upfront payments, milestone payments, and potential royalties based on the successful development and commercialization of their oncolytic immunotherapies. While Replimune is still in the clinical trial phase for many of its product candidates, such collaborations are crucial for funding ongoing research and development activities. Additionally, the company may also receive government grants or funding from cancer research organizations to support its innovative work in oncolytic virotherapy.
Replimune Group Earnings Call Summary
Earnings Call Date:Jul 31, 2025
(Q4-2025)
| % Change Since: -6.89%|
Next Earnings Date:Oct 30, 2025
Earnings Call Sentiment Positive
The earnings call reflected a generally positive sentiment, emphasizing significant progress towards the approval and launch of RP1 with strong clinical data and a well-prepared commercial strategy. However, increased expenses and losses, along with a lengthy enrollment period for a confirmatory trial, present challenges that need to be addressed.Q4-2025 Updates
Positive Updates
Breakthrough Therapy Designation
RP1 received Breakthrough Therapy Designation with priority review from the FDA, with a PDUFA date set for July 22, 2025.
Strong Clinical Data for RP1
Data from the Ignite Study shows that roughly one-third of patients achieve durable response in a high unmet need setting, with a median duration of response over 20 months and more than 55% of patients alive at 3 years.
Launch Readiness for RP1
The company is fully prepared for the commercial launch of RP1, with a trained customer-facing team, established distribution model, and patient support hub ready to ensure broad and rapid adoption.
Financial Stability and Cash Runway
Replimune ended the fiscal year with $483.8 million in cash and equivalents, projecting a cash runway into the fourth quarter of 2026.
Commercial Infrastructure Developed
Built a commercial organization comprising approximately 60 people focused on demand generation and support for RP1 launch.
Negative Updates
Increased Net Loss
The company reported a net loss of $74.1 million for the fiscal fourth quarter and $247.3 million for the fiscal year ended March 31, 2025, compared to previous periods.
High Research and Development Expenses
Research and development expenses for the fiscal year were $189.4 million, up from $175 million the previous year, primarily due to increased personnel and facility-related costs.
Extended Enrollment Period for IGNITE3
IGNITE3 trial is expected to take a couple of years to complete enrollment, which may delay further data on RP1's broader application.
Company Guidance
During the Replimune Fiscal Year Fourth Quarter 2025 Financial Results and Corporate Update Conference Call, the company provided guidance on several key metrics. The call highlighted the progress towards the potential approval and launch of RP1, with a PDUFA date set for July 22, 2025. The Ignite 3 confirmatory trial is underway, with a primary endpoint of overall survival, and enrollment in the U.S. is on track with over 100 sites planned globally. Replimune's U.S. manufacturing facility has produced commercial inventory to support the RP1 launch, and the company is well-capitalized with cash and cash equivalents totaling $483.8 million as of March 31, 2025, which is expected to fund operations into the fourth quarter of 2026. Research and development expenses for the fiscal year totaled $189.4 million, while selling, general, and administrative expenses were $72.2 million. The company's net loss for the fiscal year was $247.3 million. The call also addressed Replimune’s strategies for market penetration and commercial readiness for RP1, targeting approximately 13,000 patients who progress on or after PD-1 treatment annually in the U.S., with about 80% eligible for RP1.Replimune Group Financial Statement Overview
Summary
Replimune Group is in an early growth stage, heavily investing in R&D, which impacts profitability and cash flow. While the company maintains a strong equity position, it experiences significant operational losses typical for its industry phase. Future financial performance will depend on successful product development and commercialization.Income Statement
Replimune Group has shown minimal revenue with a TTM revenue of $4.04 million, indicating an initial phase of commercial operations. The company is experiencing significant negative EBIT and EBITDA margins due to high operating expenses, typical for biotechnology firms in research phases. Net profit margins are also deeply negative, reflecting ongoing losses as the company invests heavily in R&D.30
Negative
Balance Sheet
The balance sheet shows a strong equity position relative to liabilities, with a debt-to-equity ratio of 0.06 in TTM. The equity ratio stands at 79.9%, indicating a low leverage. However, substantial net losses contribute to a low return on equity, typical for companies heavily investing in development before achieving commercial success.45
Neutral
Cash Flow
Operating cash flow remains negative, reflecting cash outflows associated with R&D activities. Despite this, the company has managed robust financing activities, maintaining liquidity with significant cash reserves. Free cash flow has shown a marginal decline, emphasizing the need for efficient cash management to support ongoing operations.35
Negative
| Breakdown | Dec 2025 | Dec 2024 | Dec 2023 | Dec 2022 | Dec 2021 |
|---|---|---|---|---|---|
Income Statement | |||||
| Total Revenue | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 |
| Gross Profit | 0.00 | -2.65M | -2.45M | -4.58M | -4.14M |
| EBITDA | -261.63M | -230.20M | -170.30M | -114.41M | -76.48M |
| Net Income | -247.30M | -215.79M | -174.28M | -118.04M | -80.87M |
Balance Sheet | |||||
| Total Assets | 551.33M | 487.72M | 646.59M | 461.19M | 543.10M |
| Cash, Cash Equivalents and Short-Term Investments | 483.80M | 420.67M | 583.39M | 395.65M | 476.30M |
| Total Debt | 76.17M | 75.87M | 60.76M | 32.84M | 33.28M |
| Total Liabilities | 135.49M | 113.21M | 91.30M | 49.96M | 44.37M |
| Stockholders Equity | 415.84M | 374.51M | 555.29M | 411.23M | 498.73M |
Cash Flow | |||||
| Free Cash Flow | -198.94M | -191.13M | -130.32M | -84.52M | -63.78M |
| Operating Cash Flow | -192.25M | -185.47M | -128.05M | -82.18M | -61.39M |
| Investing Cash Flow | -23.80M | 97.20M | -142.50M | -1.81M | -188.78M |
| Financing Cash Flow | 252.40M | 16.28M | 311.30M | 6.60M | 372.46M |
Replimune Group Technical Analysis
Neutral
7.03
Price Trends
8.99
Negative
9.05
Negative
10.77
Negative
Market Momentum
-1.25
Positive
46.68
Neutral
32.48
Neutral
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For REPL, the sentiment is Neutral. The current price of 7.03 is below the 20-day moving average (MA) of 8.38, below the 50-day MA of 8.99, and below the 200-day MA of 10.77, indicating a bearish trend. The MACD of -1.25 indicates Positive momentum. The RSI at 46.68 is Neutral, neither overbought nor oversold. The STOCH value of 32.48 is Neutral, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Neutral sentiment for REPL.
Replimune Group Risk Analysis
Replimune Group disclosed 60 risk factors in its most recent earnings report. Replimune Group reported the most risks in the "Finance & Corporate" category.
Finance & Corporate - Financial and accounting risks. Risks related to the execution of corporate activity and strategy
Latest Risks Added 0 New Risks
Replimune Group Peers Comparison
Overall Rating
UnderperformOutperform
Sector (51)
Financial Indicators
Name | Overall Rating | Market Cap | P/E Ratio | ROE | Dividend Yield | Revenue Growth | EPS Growth |
|---|---|---|---|---|---|---|---|
56 Neutral | $1.21B | ― | -57.92% | ― | -13.37% | 2.57% | |
55 Neutral | $1.10B | ― | -63.56% | ― | 270.02% | 32.69% | |
51 Neutral | $7.30B | 0.27 | -62.71% | 2.44% | 15.02% | 0.60% | |
49 Neutral | $592.14M | ― | -33.48% | ― | -25.88% | -29.16% | |
42 Neutral | $546.98M | ― | -62.58% | ― | ― | 4.28% | |
40 Underperform | $324.29M | ― | -60.45% | ― | ― | 6.99% |
* Healthcare Sector Average
Performance Comparison
REPL
Replimune Group
7.03
-3.07
-30.40%
XNCR
Xencor
8.32
-10.86
-56.62%
RCKT
Rocket Pharmaceuticals
3.05
-17.83
-85.39%
NTLA
Intellia Therapeutics
11.64
-12.21
-51.19%
PRAX
Praxis Precision Medicines
54.22
-2.56
-4.51%
Replimune Group Corporate Events
Product-Related AnnouncementsRegulatory Filings and Compliance
Replimune Group Advances Cancer Treatment with FDA Submission
Positive
Nov 21, 2024
Replimune Group, Inc. has made significant strides in cancer treatment with its submission of a biologics license application to the FDA for its lead product, RP1, in combination with nivolumab, targeting advanced melanoma. The FDA has granted Breakthrough Therapy designation to this innovative therapy, which could expedite its availability for patients with limited options. This development marks a promising advancement for Replimune, as their novel oncolytic immunotherapy shows potential for substantial improvement over existing treatments.
Glossary
BuyA stock rated as a "Buy" is expected to perform better than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock is likely to deliver higher returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
HoldA stock rated as a "Hold" is expected to perform in line with the overall market or a specific benchmark. This rating indicates that the stock is neither particularly compelling nor unfavorable for investment. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
SellA stock rated as a "Sell" is expected to perform worse than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock may deliver lower returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
Disclaimer
This AI Analyst Stock Report is automatically generated by our AI systems using advanced algorithms and publicly available financial, technical, and market data. While the information provided aims to be accurate and insightful, it is intended for informational purposes only and should not be considered financial advice. Any content created by an AI (Artificial Intelligence) system may contain inaccuracies and/or contain errors. Investing in stocks carries inherent risks, and past performance is not indicative of future results. This report does not account for your personal financial circumstances, objectives, or risk tolerance. Always conduct your own research or consult with a qualified financial advisor before making investment decisions. The analysis and recommendations provided are based on historical and current data and may not fully reflect future market conditions or unexpected developments. Neither the creators of this report nor its affiliated entities guarantee the accuracy, completeness, or reliability of the information presented. Use this report at your own discretion and risk.