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RegenXBio (RGNX)
NASDAQ:RGNX
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RegenXBio
(NASDAQ:RGNX)
56Neutral
Positive Factors
Efficacy
RGX-202 elicits consistent and robust microdystrophin expression across all treated ages.
Safety Profile
RGX-202 demonstrates a favorable safety profile with no serious adverse events and no adverse events of special interest.
Negative Factors
Competitor Risks
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.
Market Sentiment
A recent DMD patient death after being treated with Elevidys could temper physician enthusiasm for the class in the near-term.
RegenXBio (RGNX) vs. S&P 500 (SPY)
Market Cap
$317.24M
Dividend YieldN/A
Average Volume (3M)1.08M
Price to Earnings (P/E)―
Beta (1Y)1.66
Revenue Growth-7.66%
EPS Growth23.04%
CountryUS
Employees353
SectorHealthcare
Sector Strength71
IndustryBiotechnology
Share Statistics
EPS (TTM)-4.64
Shares Outstanding50,116,910
10 Day Avg. Volume1,178,194
30 Day Avg. Volume1,081,541
Financial Highlights & Ratios
PEG RatioN/A
Price to Book (P/B)N/A
Price to Sales (P/S)4.95
Price to Cash Flow (P/CF)-3.30
P/FCF Ratio0.00
Enterprise Value/Market CapN/A
Enterprise Value/RevenueN/A
Enterprise Value/Gross ProfitN/A
Enterprise Value/EbitdaN/A
Forecast
1Y Price Target
$32.70Price Target Upside416.59% Upside
Rating ConsensusStrong Buy
Number of Analyst Covering11
RegenXBio Business Overview & Revenue Model
Company DescriptionREGENXBIO Inc., a clinical-stage biotechnology company, provides gene therapy product candidates to deliver genes to cells to address genetic defects or to enable cells in the body to produce therapeutic proteins or antibodies that are intended to impact disease. Its gene therapy product candidates are based on NAV Technology Platform, a proprietary adeno-associated virus gene delivery platform. The company's lead product candidate is RGX-314, which is in Phase III clinical trial for the treatment of wet age-related macular degeneration. It is also developing RGX-121 that is in Phase I/II clinical trial to treat mucopolysaccharidosis type II;RGX-111, which is in Phase I/II clinical trial for treating mucopolysaccharidosis type I;RGX-181 which is in pre clinic stage for the treatment of late-infantile neuronal ceroid lipofuscinosis type II disease;RGX-202, to treat Duchenne muscular dystrophy which is in phase I/II clinical trial; and RGX-381, to treat the ocular manifestations of CLN2 disease which is in preclinical stage. REGENXBIO Inc. also licenses its NAV Technology Platform to other biotechnology and pharmaceutical companies; and has a collaboration and license agreement with Neurimmune AG to develop novel gene therapies. REGENXBIO Inc. was founded in 2008 and is headquartered in Rockville, Maryland.
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
Negative
6.33
Price Trends
7.08
Negative
7.73
Negative
9.56
Negative
Market Momentum
-0.39
Positive
45.77
Neutral
37.51
Neutral
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For RGNX, the sentiment is Negative. The current price of 6.33 is below the 20-day moving average (MA) of 7.12, below the 50-day MA of 7.08, and below the 200-day MA of 9.56, indicating a bearish trend. The MACD of -0.39 indicates Positive momentum. The RSI at 45.77 is Neutral, neither overbought nor oversold. The STOCH value of 37.51 is Neutral, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Negative 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 (48)
Financial Indicators
Name | Overall Rating | Market Cap | P/E Ratio | ROE | Dividend Yield | Revenue Growth | EPS Growth |
|---|---|---|---|---|---|---|---|
56 Neutral | $317.24M | ― | -79.49% | ― | -7.66% | 23.04% | |
48 Neutral | $6.46B | 1.17 | -48.25% | 2.67% | 19.50% | 0.61% | |
45 Neutral | $323.40M | ― | -100.88% | ― | -77.06% | -705.82% | |
43 Neutral | $306.57M | ― | 344.74% | ― | 17.91% | -10.55% | |
43 Neutral | $365.84M | ― | -36.36% | ― | 174.98% | 25.06% | |
39 Underperform | $255.29M | ― | -121.94% | ― | -46.07% | 71.52% | |
31 Underperform | $351.25M | ― | -43.68% | ― | ― | 10.38% |
* Healthcare Sector Average
Performance Comparison
RGNX
RegenXBio
6.33
-11.17
-63.83%
IVA
Inventiva
3.29
-0.02
-0.60%
TSHA
Taysha Gene Therapies
1.28
-1.30
-50.39%
VERV
Verve Therapeutics
4.12
-3.02
-42.30%
ERAS
Erasca
1.24
-0.69
-35.75%
AMLX
Amylyx Pharmaceuticals Inc
3.90
1.89
94.03%
RegenXBio Earnings Call Summary
Earnings Call Date: Mar 13, 2025 | % Change Since: -3.36% | Next Earnings Date: Apr 30, 2025
Earnings Call Sentiment Positive
The earnings call presents a largely positive outlook with significant advancements in multiple programs, strong partnerships, and a solid financial position. The highlights of new BLA submissions, expected FDA approvals, and strategic partnerships significantly outweigh the lowlights, which include a decrease in cash and R&D expenses.Highlights
BLA Submission and Expected FDA Approval for RGX-121
REGENXBIO has submitted their first Biologics License Application (BLA) for RGX-121, a treatment for Hunter syndrome, with an expected FDA approval in Q4 2025.
Advancement in Diabetic Retinopathy Program
The diabetic retinopathy program is advancing to the pivotal stage with plans for BLA filings in 2026.
Strong Partnership with Nippon Shinyaku
Partnership with Nippon Shinyaku for MPS programs, providing strategic significance and potential milestones and revenue.
RGX-202 Duchenne Muscular Dystrophy Program Progress
Pivotal study for RGX-202 is rapidly advancing, with enrollment nearly halfway complete. Plans for a BLA submission by mid-2026.
ABBV-RGX-314 Retinal Franchise Progress
Partnership with AbbVie is advancing with late-stage studies and potential milestone payments as part of a $1.8 billion collaboration.
Strong Financial Position
Ended 2024 with $245 million in cash and securities, funding operations into the second half of 2026, with options for non-dilutive financing to extend runway.
Lowlights
Decrease in Cash and R&D Expenses
Cash, cash equivalents, and marketable securities decreased from $314 million to $245 million. R&D expenses decreased from $232 million to $209 million.
Company Guidance
During the REGENXBIO earnings call for the fiscal year ending December 31, 2024, the company provided several key metrics and guidance for future developments. The company ended the fiscal year with $245 million in cash, cash equivalents, and marketable securities, a decrease from $314 million the previous year, but with expectations to fund operations into the latter half of 2026. Notably, REGENXBIO submitted a Biologics License Application (BLA) for RGX-121 under the accelerated approval pathway, with a potential FDA approval anticipated in the fourth quarter of 2025. The company is also progressing with their pivotal study for RGX-202, aiming for a mid-2026 BLA filing, and expects to complete enrollment by the end of the year. Furthermore, their partnership with AbbVie includes a $1.8 billion collaboration, with anticipated milestone payments to bolster non-dilutive financing options. The company highlighted their robust commercial readiness with the capacity to produce 2,500 doses of RGX-202 annually, and they are actively preparing for the commercial launch of multiple gene therapies.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.