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RegenXBio (RGNX)
NASDAQ:RGNX
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RegenXBio
(NASDAQ:RGNX)
56Neutral
Positive Factors
Clinical Trial Success
RGX-202 elicits consistent and robust microdystrophin expression across all treated ages.
Financial Health
RGNX ended the period with $272.7 million in cash and equivalents, which is expected to fund operations into the second half of 2026.
Regulatory Progress
The FDA has accepted the Biologics License Application for RGX-121 with a Priority Review, indicating the importance and potential impact of the treatment.
Negative Factors
Competitive Concerns
Safety will be closely scrutinized following a patient death from acute liver failure linked to a competitor's treatment, highlighting the need for ongoing monitoring.
Regulatory Uncertainty
An accelerated approval pathway for RGX-202 for DMD may be viewed by some as having somewhat lower probability of success currently.
RegenXBio (RGNX) vs. S&P 500 (SPY)
Market Cap
$445.93M
Dividend YieldN/A
Average Volume (3M)1.20M
Price to Earnings (P/E)―
Beta (1Y)2.27
Revenue Growth80.70%
EPS Growth46.66%
CountryUS
Employees353
SectorHealthcare
Sector Strength41
IndustryBiotechnology
Share Statistics
EPS (TTM)0.12
Shares Outstanding50,160,350
10 Day Avg. Volume1,492,954
30 Day Avg. Volume1,202,514
Financial Highlights & Ratios
PEG Ratio-0.21
Price to Book (P/B)1.53
Price to Sales (P/S)0.00
P/FCF Ratio-2.23
Enterprise Value/Market CapN/A
Enterprise Value/RevenueN/A
Enterprise Value/Gross ProfitN/A
Enterprise Value/EbitdaN/A
Forecast
1Y Price Target
$31.73Price Target Upside256.92% Upside
Rating ConsensusStrong Buy
Number of Analyst Covering11
RegenXBio Business Overview & Revenue Model
Company DescriptionRegenXBio Inc. (RGNX) is a biotechnology company focused on the development, commercialization, and licensing of gene therapy products. The company leverages its proprietary NAV Technology Platform to develop treatments for a range of retinal, metabolic, and neurodegenerative diseases. RegenXBio's core offerings include gene therapy product candidates designed to address unmet medical needs by delivering therapeutic genes to patients using viral vectors.
How the Company Makes MoneyRegenXBio generates revenue primarily through licensing agreements and collaborations related to its NAV Technology Platform. The company licenses its technology to other pharmaceutical and biotechnology companies, which in turn develop and commercialize gene therapy products. RegenXBio receives upfront payments, milestone payments, and royalties on sales of products developed using its platform. Additionally, the company engages in strategic partnerships and collaborations to co-develop therapies, sharing both the costs and profits. These partnerships often provide funding for research and development, contributing significantly to RegenXBio's earnings.
RegenXBio Financial Statement Overview
Summary
RegenXBio faces significant financial challenges with declining revenues and ongoing losses. Although the balance sheet shows moderate leverage, diminishing equity and assets, along with negative cash flow trends, highlight liquidity concerns.Income Statement
RegenXBio has experienced declining revenue over recent years, notably a significant drop from 2021 to 2022, contributing to negative growth rates. The company has been operating at a loss, with negative EBIT and net income margins, indicating challenges in achieving profitability. Gross profit margins remain positive but declining revenue impacts overall performance.40
Negative
Balance Sheet
The company maintains a manageable debt-to-equity ratio, indicating moderate leverage. However, stockholders' equity has been decreasing, reflecting potential financial strain. The equity ratio suggests a reasonable level of equity financing, yet decreasing total assets and equity pose concerns about long-term stability.55
Neutral
Cash Flow
RegenXBio's operating cash flow has been consistently negative, and free cash flow has also been negative, indicating cash flow challenges. The free cash flow to net income ratio reflects insufficient cash flow generation to cover losses, suggesting potential liquidity issues.45
Neutral
| Breakdown | ||||
| Dec 2024 | Dec 2023 | Dec 2022 | Dec 2021 | Dec 2020 |
|---|---|---|---|---|
| Income Statement | Total Revenue | |||
| 83.33M | 90.24M | 112.72M | 470.35M | 154.57M | Gross Profit |
| 49.76M | 53.03M | 58.18M | 418.51M | 118.85M | EBIT |
| -233.35M | -268.13M | -262.88M | 159.98M | -119.23M | EBITDA |
| -198.23M | -239.46M | -244.24M | 169.54M | -96.83M | Net Income Common Stockholders |
| -227.10M | -263.49M | -280.32M | 127.84M | -111.25M |
| Balance Sheet | Cash, Cash Equivalents and Short-Term Investments | |||
| 234.69M | 275.26M | 364.64M | 457.44M | 475.74M | Total Assets |
| 465.99M | 573.97M | 833.27M | 1.11B | 708.16M | Total Debt |
| 82.03M | 89.29M | 94.80M | 86.68M | 72.65M | Net Debt |
| 24.51M | 54.77M | -2.15M | -258.53M | -265.77M | Total Liabilities |
| 206.34M | 262.23M | 317.07M | 349.61M | 330.41M | Stockholders Equity |
| 259.65M | 311.74M | 516.20M | 764.30M | 377.75M |
| Cash Flow | Free Cash Flow | |||
| -175.56M | -228.37M | -238.21M | 134.70M | -80.93M | Operating Cash Flow |
| -173.13M | -218.41M | -207.49M | 218.88M | -54.06M | Investing Cash Flow |
| 103.45M | 190.94M | -11.93M | -406.64M | 122.76M | Financing Cash Flow |
| 92.68M | -34.97M | -28.84M | 195.25M | 200.21M |
RegenXBio Technical Analysis
Positive
8.89
Price Trends
7.56
Positive
7.51
Positive
9.08
Negative
Market Momentum
0.26
Positive
57.38
Neutral
52.88
Neutral
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For RGNX, the sentiment is Positive. The current price of 8.89 is above the 20-day moving average (MA) of 8.58, above the 50-day MA of 7.56, and below the 200-day MA of 9.08, indicating a neutral trend. The MACD of 0.26 indicates Positive momentum. The RSI at 57.38 is Neutral, neither overbought nor oversold. The STOCH value of 52.88 is Neutral, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Positive sentiment for RGNX.
RegenXBio Risk Analysis
RegenXBio disclosed 48 risk factors in its most recent earnings report. RegenXBio reported the most risks in the “Tech & Innovation” category.
Finance & Corporate - Financial and accounting risks. Risks related to the execution of corporate activity and strategy
Latest Risks Added 0 New Risks
RegenXBio Peers Comparison
Overall Rating
UnderperformOutperform
Sector (52)
Financial Indicators
Name | Overall Rating | Market Cap | P/E Ratio | ROE | Dividend Yield | Revenue Growth | EPS Growth |
|---|---|---|---|---|---|---|---|
56 Neutral | $445.93M | ― | -47.44% | ― | 80.70% | 46.66% | |
53 Neutral | $431.44M | ― | -83.24% | ― | -100.32% | -197.69% | |
52 Neutral | $5.15B | 3.02 | -44.64% | 2.83% | 16.44% | -0.47% | |
50 Neutral | $444.26M | ― | 344.74% | ― | -47.32% | -26.67% | |
50 Neutral | $579.59M | ― | -159.34% | ― | -48.97% | 69.32% | |
48 Neutral | $412.73M | ― | -34.26% | ― | 271.44% | 26.65% | |
34 Underperform | $364.02M | ― | -45.82% | ― | ― | 10.38% |
* Healthcare Sector Average
Performance Comparison
RGNX
RegenXBio
8.89
-6.98
-43.98%
IVA
Inventiva
3.11
-0.59
-15.95%
TSHA
Taysha Gene Therapies
2.70
-0.39
-12.62%
VERV
Verve Therapeutics
4.63
-1.32
-22.18%
ERAS
Erasca
1.28
-0.96
-42.86%
AMLX
Amylyx Pharmaceuticals Inc
4.84
3.00
163.04%
RegenXBio Earnings Call Summary
Earnings Call Date:May 12, 2025
(Q1-2025)
| % Change Since: 11.54%|
Next Earnings Date:Jul 30, 2025
Earnings Call Sentiment Positive
The earnings call revealed a strong start to the fiscal year for REGENXBIO, with significant clinical and financial progress. The company's strategic partnerships and manufacturing capabilities position them well for future commercial success, though regulatory uncertainties and competitive pressures remain challenges.Q1-2025 Updates
Positive Updates
Strong Clinical Progress
REGENXBIO reported significant advancements in their late-stage clinical programs, including RGX-121 for MPS II and RGX-202 for Duchenne muscular dystrophy, with over 50% enrollment reached in pivotal studies.
Strategic Partnerships
The company established a key strategic partnership with Nippon Shinyaku to commercialize neurodegenerative franchises, including RGX-121 and RGX-111, enhancing their commercial prospects.
Solid Financial Position
The company ended the quarter with $272 million in cash, cash equivalents, and marketable securities, up from $245 million at the end of 2024, thanks to a $110 million upfront payment from Nippon Shinyaku.
Upcoming Data and Approvals
REGENXBIO anticipates FDA approval for RGX-121 in the second half of 2025 and plans to submit a BLA for RGX-202 in mid-2026.
Manufacturing Capabilities
Their Manufacturing Innovation Center in Maryland is set to produce RGX-202 commercial supply beginning in the third quarter of 2025, with the capacity to produce up to 2,500 doses annually.
Positive Phase I/II Data
The Phase I/II data for RGX-202 showed consistent microdystrophin expression and functional improvements in patients, with a favorable safety profile.
Negative Updates
Regulatory Uncertainty
There is some uncertainty around the FDA's acceptance of the BLA for RGX-121, which is expected imminently, and potential changes in regulatory requirements for gene therapies.
Competitive Challenges
The company faces competitive challenges in the Duchenne muscular dystrophy space, particularly from Sarepta Therapeutics, which has experienced regulatory and commercial hurdles.
Company Guidance
In the first quarter of 2025 earnings call, REGENXBIO provided guidance on several key metrics, highlighting robust progress across their gene therapy pipeline. The company anticipates FDA acceptance of the BLA for RGX-121, a potential first gene therapy for MPS II, with an expected approval in the second half of 2025. RGX-202, their candidate for Duchenne muscular dystrophy, has surpassed 50% enrollment in its pivotal study, with a BLA submission planned for mid-2026. The company is preparing for commercial supply production in Q3 2025, capable of producing 2,500 doses annually. Financially, REGENXBIO ended Q1 2025 with $272 million in cash, projecting this to fund operations into the second half of 2026, excluding potential non-dilutive financing. Additionally, the company is progressing on its retinal programs in collaboration with AbbVie, with pivotal trials for ABBV-RGX-314 targeting wet AMD and diabetic retinopathy.RegenXBio Corporate Events
Product-Related AnnouncementsBusiness Operations and Strategy
RegenXBio Partners with Nippon Shinyaku for Gene Therapies
Positive
Mar 4, 2025
On March 4, 2025, REGENXBIO Inc. announced the closing of a strategic partnership with Nippon Shinyaku to develop and commercialize gene therapies RGX-121 and RGX-111 for Mucopolysaccharidosis II and I, respectively, in the United States and Asia. This collaboration is expected to enhance REGENXBIO’s ability to progress its programs, potentially leading to transformative treatments for patients with these rare diseases. RGX-121, anticipated to be the first gene therapy for MPS II, may receive FDA approval by late 2025, highlighting the partnership’s potential impact on the company’s operations and industry positioning.
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.