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Replimune Group Inc (REPL)
NASDAQ:REPL
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Replimune Group
(NASDAQ:REPL)
Rating:42Neutral
Price Target:―
Positive Factors
Clinical Efficacy
RP1 + Opdivo achieved an objective response rate of 33.6% in anti-PD1 failed melanoma patients, which is significantly higher than what would be expected with an anti-PD1 agent alone.
FDA Approval
The FDA granted the Biologics License Application (BLA) Priority Review for RP1 + Opdivo, with no potential review issues identified.
Financial Stability
Replimune's cash position firmly sets up the company for a strong launch and further development of its portfolio.
Negative Factors
Regulatory Uncertainty
The FDA has accepted REPL's BLA for RP1 and granted priority review, with a PDUFA date set for July 22, 2025.
Treatment Competition
Replimune's RP1 + Opdivo combination therapy shows potential differentiation against other treatments like Amtagvi™ due to its efficacy and safety profile.
Replimune Group (REPL) vs. SPDR S&P 500 ETF (SPY)
Market Cap
$643.67M
Dividend YieldN/A
Average Volume (3M)1.23M
Price to Earnings (P/E)―
Beta (1Y)1.58
Revenue GrowthN/A
EPS Growth4.28%
CountryUS
Employees331
SectorHealthcare
Sector Strength40
IndustryBiotechnology
Share Statistics
EPS (TTM)-0.82
Shares Outstanding77,086,750
10 Day Avg. Volume1,471,615
30 Day Avg. Volume1,226,079
Financial Highlights & Ratios
PEG Ratio4.78
Price to Book (P/B)1.68
Price to Sales (P/S)0.00
P/FCF Ratio-3.35
Enterprise Value/Market Cap0.25
Enterprise Value/Revenue9.85
Enterprise Value/Gross Profit60.08
Enterprise Value/Ebitda-0.19
Forecast
1Y Price Target
$19.00Price Target Upside125.65% Upside
Rating ConsensusStrong Buy
Number of Analyst Covering5
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:May 22, 2025
(Q4-2025)
| % Change Since: -0.47%|
Next Earnings Date:Jul 31, 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 | |||||
| TTM | Mar 2024 | Mar 2023 | Mar 2022 | Mar 2021 | Mar 2020 |
|---|---|---|---|---|---|
| Income Statement | Total Revenue | ||||
| 4.04M | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | Gross Profit |
| 2.65M | -2.65M | -2.45M | -4.58M | -4.14M | -1.81M | EBIT |
| -241.06M | -234.77M | -177.08M | -118.31M | -79.95M | -56.20M | EBITDA |
| -224.33M | -230.20M | -170.30M | -114.41M | -76.48M | -52.60M | Net Income Common Stockholders |
| -228.24M | -215.79M | -174.28M | -118.04M | -80.87M | -52.63M |
| Balance Sheet | Cash, Cash Equivalents and Short-Term Investments | ||||
| 61.55M | 420.67M | 583.39M | 395.65M | 476.30M | 168.56M | Total Assets |
| 65.15M | 487.72M | 646.59M | 461.19M | 543.10M | 234.10M | Total Debt |
| 0.00 | 75.87M | 60.76M | 32.84M | 33.28M | 41.79M | Net Debt |
| -17.58M | 1.41M | -85.83M | -73.11M | -149.24M | -17.71M | Total Liabilities |
| 93.22M | 113.21M | 91.30M | 49.96M | 44.37M | 50.38M | Stockholders Equity |
| -28.07M | 374.51M | 555.29M | 411.23M | 498.73M | 183.72M |
| Cash Flow | Free Cash Flow | ||||
| -191.98M | -191.13M | -130.32M | -84.52M | -63.78M | -67.09M | Operating Cash Flow |
| -184.69M | -185.47M | -128.05M | -82.18M | -61.39M | -60.55M | Investing Cash Flow |
| 7.11M | 97.20M | -142.50M | -1.81M | -188.78M | -5.23M | Financing Cash Flow |
| 252.40M | 16.28M | 311.30M | 6.60M | 372.46M | 100.17M |
Replimune Group Technical Analysis
Neutral
8.42
Price Trends
8.81
Negative
10.75
Negative
11.14
Negative
Market Momentum
-0.14
Negative
49.58
Neutral
55.48
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 8.42 is above the 20-day moving average (MA) of 8.39, below the 50-day MA of 8.81, and below the 200-day MA of 11.14, indicating a neutral trend. The MACD of -0.14 indicates Negative momentum. The RSI at 49.58 is Neutral, neither overbought nor oversold. The STOCH value of 55.48 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 57 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 1 New Risks
1.
Investing in our common stock involves a high degree of risk. You should carefully consider the risks and uncertainties described below, together with all of the other information in this Quarterly Report on Form 10-Q, including our consolidated financial statements and related notes and "Management's discussion and analysis of results of operations and financial condition." If any of the following risks are realized, our business, financial condition, operating results and prospects could be materially and adversely affected. In that event, the price of our common stock could decline, and you could lose part or all of your investment. The risks and uncertainties described below are not the only ones we face. Additional risks and uncertainties not presently known to us or that we currently believe to be immaterial may also adversely affect our business. Q4, 2024
Replimune Group Peers Comparison
Overall Rating
UnderperformOutperform
Sector (53)
Financial Indicators
Name | Overall Rating | Market Cap | P/E Ratio | ROE | Dividend Yield | Revenue Growth | EPS Growth |
|---|---|---|---|---|---|---|---|
55 Neutral | $801.08M | ― | -56.17% | ― | -34.57% | -6.31% | |
54 Neutral | $948.82M | ― | -57.92% | ― | -13.37% | 2.57% | |
53 Neutral | $5.14B | 3.23 | -45.01% | 2.85% | 17.55% | -0.69% | |
49 Neutral | $764.86M | ― | -63.56% | ― | 270.02% | 32.69% | |
47 Neutral | $551.57M | ― | -33.48% | ― | -25.88% | -29.16% | |
42 Neutral | $643.67M | ― | -62.58% | ― | ― | 4.28% | |
40 Underperform | $675.52M | ― | -60.45% | ― | ― | 6.99% |
* Healthcare Sector Average
Performance Comparison
REPL
Replimune Group
8.42
3.24
62.55%
CMRX
Chimerix
8.54
7.60
808.51%
XNCR
Xencor
7.75
-15.65
-66.88%
RCKT
Rocket Pharmaceuticals
2.33
-18.61
-88.87%
NTLA
Intellia Therapeutics
9.32
-13.40
-58.98%
PRAX
Praxis Precision Medicines
36.10
-9.11
-20.15%
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
OutperformA stock rated as "Outperform" is expected to perform better than the overall market or a specific benchmark over the near-to-medium term. This rating suggests that the stock is likely to deliver higher returns compared to the average returns of other stocks in the same sector or market index. Investors might consider this stock a good buying opportunity.
NeutralA stock rated as "Neutral" is expected to perform in line with the overall market or a specific benchmark. This rating indicates that the stock is neither particularly attractive nor unattractive for investment. Investors may consider holding onto the stock, as it is not expected to either significantly outperform or underperform the market.
UnderperformA stock rated as "Underperform" is expected to perform worse than the overall market or a specific benchmark over the near-to-medium term. This rating suggests that the stock may deliver lower returns compared to the average returns of other stocks in the same sector or market index. Investors might consider selling the stock or avoiding it as an investment.
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.