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Replimune Group Inc (REPL)
NASDAQ:REPL
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Replimune Group
(NASDAQ:REPL)
Rating:42Neutral
Price Target:―
Positive Factors
Financial Stability
REPL ended F1Q with $403.3M in cash and cash equivalents, guiding to having sufficient cash runway to fund operations into 4Q26.
Pipeline Progress
Other pipeline programs remain on track with multiple clinical trials continuing to enroll patients.
Therapeutic Potential
TUDRIQEV is likely to be a successful first therapeutic in Replimune's skin cancer franchise, given IGNYTE data in melanoma.
Negative Factors
Clinical Trial Issues
The CRL indicated several notable issues with the RP1 program, including the IGNYTE trial not being an adequate well-controlled trial sufficient to demonstrate effectiveness.
Financial Concerns
Replimune will likely need to re-run its clinical studies to get to approval and may not have enough cash on its books with limited financing options.
Regulatory Challenges
The FDA issued a Complete Response Letter regarding the Biologics License Application for RP1, which was viewed as a negative surprise.
Replimune Group (REPL) vs. SPDR S&P 500 ETF (SPY)
Market Cap
$412.13M
Dividend YieldN/A
Average Volume (3M)17.25M
Price to Earnings (P/E)―
Beta (1Y)0.53
Revenue GrowthN/A
EPS Growth-1.07%
CountryUS
Employees479
SectorHealthcare
Sector Strength53
IndustryBiotechnology
Share Statistics
EPS (TTM)-0.95
Shares Outstanding78,055,850
10 Day Avg. Volume4,598,070
30 Day Avg. Volume17,247,511
Financial Highlights & Ratios
PEG RatioN/A
Price to Book (P/B)N/A
Price to Sales (P/S)N/A
P/FCF RatioN/A
Enterprise Value/Market Cap1.27
Enterprise Value/Revenue355.42
Enterprise Value/Gross Profit-184.93
Enterprise Value/Ebitda-1.94
Forecast
1Y Price Target
$4.14Price Target Upside-26.07% Downside
Rating ConsensusHold
Number of Analyst Covering9
Replimune Group Business Overview & Revenue Model
Company DescriptionReplimune Group, Inc., a biotechnology company, develops oncolytic immuno-gene therapies to treat cancer. It uses its proprietary Immunotherapy platform to design and develop product candidates that are intended to activate the immune system against cancer. The company's lead product candidate is RP1, a selectively replicating version of herpes simplex virus 1, which is in Phase I/II clinical trials for a range of solid tumors; and that is in Phase II clinical trials for patients with cutaneous squamous cell carcinoma. It is also developing RP2, which is in Phase I clinical trials for an anti-CTLA-4 antibody-like protein in order to block the inhibition of the immune response otherwise caused by CTLA-4; and RP3 that is in Phase I clinical trials to express immune-activating proteins that stimulate T cells. Replimune Group, Inc. was founded in 2015 and is headquartered in Woburn, Massachusetts.
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:Aug 07, 2025
(Q4-2025)
| % Change Since: 1.82%|
Next Earnings Date:Oct 30, 2025
Earnings Call Sentiment Positive
The earnings call provided a positive outlook, highlighting significant regulatory achievements, strong commercial readiness, and financial stability. However, the increase in net loss and operational expenses presents challenges. The overall sentiment is optimistic about RP1's potential launch and market adoption.Q4-2025 Updates
Positive Updates
Breakthrough Therapy Designation and Priority Review for RP1
RP1 has been recognized as a breakthrough therapy with priority review, with a PDUFA date set for July 22, 2025. The company has completed late-cycle meetings and manufacturing inspections with the FDA, indicating substantial regulatory progress.
Strong Commercial Readiness for RP1 Launch
Replimune has completed the build-out of its commercial infrastructure, including a customer-facing team of approximately 60 people, a patient support hub, and a distribution model ready for next-day delivery.
Financial Stability and Cash Position
The company ended the fiscal year with $483.8 million in cash and cash equivalents, providing a cash runway into the fourth quarter of 2026, supporting commercial launch plans and ongoing operations.
Potential for Broad and Rapid Adoption of RP1
Significant interest from medical oncologists and interventional radiologists, with over 90% willing to utilize RP1 routinely upon approval, suggests strong market potential for RP1 in advanced melanoma.
Negative Updates
Increased Net Loss
The company's net loss increased to $74.1 million for the fiscal fourth quarter and $247.3 million for the fiscal year ended March 31, 2025, compared to $55.1 million and $215.8 million, respectively, for the prior year.
Significant Increase in Operational Expenses
Research and development expenses increased to $54 million for the fiscal fourth quarter, and selling, general, and administrative expenses rose to $25.4 million, reflecting higher costs related to scaling operations and commercial preparations.
Company Guidance
During the Replimune Fiscal Year Fourth Quarter 2025 Financial Results and Corporate Update Conference Call, significant progress was highlighted across regulatory, clinical, and commercial fronts as the company approaches the potential approval and launch of RP1. The product has been recognized as a breakthrough therapy with a priority review and a PDUFA date set for July 22, 2025. The Ignite 3 confirmatory study is underway, with over 100 planned global sites, focusing on overall survival as the primary endpoint. Replimune estimates that approximately 13,000 patients progress on or after PD-1 treatment annually in the U.S., with 80% of these patients potentially eligible for RP1. The company ended the fiscal year with $483.8 million in cash and cash equivalents and anticipates a cash runway into the fourth quarter of 2026. Research and development expenses totaled $189.4 million for the fiscal year, with a net loss of $247.3 million. The company has completed its commercial infrastructure build-out, comprising approximately 60 people, and plans to provide critical services through the Replimune Connect Plus patient support hub.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 | TTM | Dec 2025 | Dec 2024 | Dec 2023 | Dec 2022 | Dec 2021 |
|---|---|---|---|---|---|---|
Income Statement | ||||||
| Total Revenue | 1.47M | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 |
| Gross Profit | -2.83M | -3.50M | -2.65M | -2.45M | -4.58M | -4.14M |
| EBITDA | -269.54M | -261.63M | -230.20M | -170.30M | -114.41M | -76.48M |
| Net Income | -280.22M | -247.30M | -215.79M | -174.28M | -118.04M | -80.87M |
Balance Sheet | ||||||
| Total Assets | 469.51M | 551.33M | 487.72M | 646.59M | 461.19M | 543.10M |
| Cash, Cash Equivalents and Short-Term Investments | 403.34M | 483.80M | 420.67M | 583.39M | 395.65M | 476.30M |
| Total Debt | 76.33M | 76.17M | 75.87M | 60.76M | 32.84M | 33.28M |
| Total Liabilities | 132.79M | 135.49M | 113.21M | 91.30M | 49.96M | 44.37M |
| Stockholders Equity | 336.71M | 415.84M | 374.51M | 555.29M | 411.23M | 498.73M |
Cash Flow | ||||||
| Free Cash Flow | -227.86M | -198.94M | -191.13M | -130.32M | -84.52M | -63.78M |
| Operating Cash Flow | -220.10M | -192.25M | -185.47M | -128.05M | -82.18M | -61.39M |
| Investing Cash Flow | 11.49M | -23.80M | 97.20M | -142.50M | -1.81M | -188.78M |
| Financing Cash Flow | 155.60M | 252.40M | 16.28M | 311.30M | 6.60M | 372.46M |
Replimune Group Technical Analysis
Negative
5.60
Price Trends
7.88
Negative
8.21
Negative
10.32
Negative
Market Momentum
-0.70
Negative
45.18
Neutral
65.68
Neutral
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For REPL, the sentiment is Negative. The current price of 5.6 is above the 20-day moving average (MA) of 5.41, below the 50-day MA of 7.88, and below the 200-day MA of 10.32, indicating a neutral trend. The MACD of -0.70 indicates Negative momentum. The RSI at 45.18 is Neutral, neither overbought nor oversold. The STOCH value of 65.68 is Neutral, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Negative 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 |
|---|---|---|---|---|---|---|---|
62 Neutral | $810.84M | ― | -43.63% | ― | ― | -13.05% | |
54 Neutral | $1.07B | ― | -50.34% | ― | 6.07% | -2.28% | |
51 Neutral | $7.77B | -0.12 | -39.78% | 2.21% | 22.68% | -1.42% | |
43 Neutral | $752.26M | ― | -50.67% | ― | 41.86% | 10.48% | |
43 Neutral | $932.38M | ― | -43.82% | ― | ― | -7.33% | |
42 Neutral | $412.13M | ― | -73.44% | ― | ― | -1.07% | |
33 Underperform | $822.81M | ― | -109.12% | ― | ― | 7.58% |
* Healthcare Sector Average
Performance Comparison
REPL
Replimune Group
5.60
-4.54
-44.77%
AVXL
Anavex Life Sciences
9.55
3.23
51.11%
RCUS
Arcus Biosciences
10.48
-7.53
-41.81%
ORIC
Oric Pharmaceuticals
9.69
0.09
0.94%
NRIX
Nurix Therapeutics
9.65
-14.37
-59.83%
SANA
Sana Biotechnology
3.60
-2.24
-38.36%
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.