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Abeona Therapeutics (ABEO)
NASDAQ:ABEO
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Abeona Therapeutics
(NASDAQ:ABEO)
47Neutral
Positive Factors
Commercialization Preparation
Abeona is preparing for the commercialization of pz-cel by onboarding treatment centers, engaging payers, and educating stakeholders.
Patent Protection
The company has obtained additional patent protection for pz-cel, extending its use for the treatment of RDEB until June 2037 and its packaging and transport system until July 2040.
Regulatory Approval
The FDA has accepted Abeona's Biologics License Application for prademagene zamikeracel, with an approval decision date set.
Negative Factors
Market Competition
The efficacy and long-term durability of prademagene zamikeracel, along with the high list price of a competing product, should enable Abeona to outcompete Filsuvez in the RDEB population.
Regulatory Challenges
The CRL for pz-cel only raised CMC-related issues, with no safety or efficacy concerns, boosting confidence in its resolution.
Abeona Therapeutics (ABEO) vs. S&P 500 (SPY)
Market Cap
$215.98M
Dividend YieldN/A
Average Volume (3M)461.25K
Price to Earnings (P/E)―
Beta (1Y)0.45
Revenue Growth-100.00%
EPS Growth30.33%
CountryUS
Employees136
SectorHealthcare
Sector Strength78
IndustryBiotechnology
Share Statistics
EPS (TTM)-2.25
Shares Outstanding48,533,800
10 Day Avg. Volume722,674
30 Day Avg. Volume461,253
Financial Highlights & Ratios
PEG RatioN/A
Price to Book (P/B)N/A
Price to Sales (P/S)63.96
Price to Cash Flow (P/CF)-4.60
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
$18.67Price Target Upside277.17% Upside
Rating ConsensusStrong Buy
Number of Analyst Covering3
Abeona Therapeutics Business Overview & Revenue Model
Company DescriptionAbeona Therapeutics Inc. (ABEO) is a clinical-stage biopharmaceutical company focused on developing cell and gene therapies for serious genetic diseases. Based in the United States, the company's primary areas of focus include rare and life-threatening conditions such as recessive dystrophic epidermolysis bullosa (RDEB) and other genetic disorders. Abeona's core product candidates leverage advanced gene editing and cell therapy technologies aimed at providing transformative treatments for patients with unmet medical needs.
How the Company Makes MoneyAbeona Therapeutics generates revenue primarily through strategic partnerships, grants, and licensing agreements related to its proprietary technologies and product candidates. The company may receive upfront payments, milestone payments, and royalties from these collaborations as their therapeutic products progress through clinical development and towards commercialization. Abeona's focus on rare genetic disorders often attracts funding from non-profit organizations and governmental bodies interested in supporting the advancement of novel treatments for these conditions. Additionally, successful commercialization of their therapies, if achieved, would provide direct revenue from product sales.
Abeona Therapeutics Financial Statement Overview
Summary
Abeona Therapeutics faces significant financial challenges with no revenue, consistent losses, and negative cash flows. Despite manageable debt, the shrinking equity base and declining return on equity indicate struggles in value creation and financial returns.Income Statement
Abeona Therapeutics shows a concerning trend with no revenue in the latest year, indicating potential challenges in product commercialization. The persistent negative net profit margin and declining EBIT and EBITDA margins reflect ongoing operational struggles and financial losses over recent years.15
Very Negative
Balance Sheet
The balance sheet indicates a moderate financial position with a relatively low debt-to-equity ratio, suggesting manageable leverage. However, the shrinking equity base and decreasing return on equity highlight challenges in value creation and financial returns for investors.40
Negative
Cash Flow
Cash flow analysis reveals negative free cash flow growth and a declining operating cash flow to net income ratio, underscoring liquidity challenges. The reliance on financing activities suggests potential sustainability concerns without generating positive cash flow from operations.25
Negative
| Breakdown | ||||
| Dec 2024 | Dec 2023 | Dec 2022 | Dec 2021 | Dec 2020 |
|---|---|---|---|---|
| Income Statement | Total Revenue | |||
| 0.00 | 3.50M | 1.41M | 3.00M | 10.00M | Gross Profit |
| 0.00 | 1.90M | 964.00K | -1.46M | -20.14M | EBIT |
| -64.21M | -47.13M | -45.26M | -89.84M | -81.42M | EBITDA |
| -64.21M | -50.57M | -34.38M | -76.80M | -74.52M | Net Income Common Stockholders |
| -63.73M | -54.19M | -31.81M | -88.61M | -88.35M |
| Balance Sheet | Cash, Cash Equivalents and Short-Term Investments | |||
| 97.72M | 52.23M | 52.15M | 45.02M | 95.03M | Total Assets |
| 108.93M | 64.00M | 64.21M | 79.59M | 151.20M | Total Debt |
| 23.05M | 5.40M | 7.63M | 9.38M | 8.73M | Net Debt |
| -309.00K | -9.07M | -6.59M | -23.56M | -3.87M | Total Liabilities |
| 64.90M | 49.18M | 37.45M | 28.21M | 48.65M | Stockholders Equity |
| 44.03M | 14.83M | 26.76M | 51.38M | 102.55M |
| Cash Flow | Free Cash Flow | |||
| -58.46M | -37.34M | -43.61M | -69.82M | -36.35M | Operating Cash Flow |
| -56.02M | -37.01M | -43.48M | -65.67M | -35.02M | Investing Cash Flow |
| -39.24M | 208.00K | -23.96M | 66.06M | -83.71M | Financing Cash Flow |
| 104.14M | 37.06M | 43.17M | 24.86M | 1.94M |
Abeona Therapeutics Technical Analysis
Negative
4.95
Price Trends
5.36
Negative
5.60
Negative
5.54
Negative
Market Momentum
-0.18
Positive
26.67
Positive
11.81
Positive
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For ABEO, the sentiment is Negative. The current price of 4.95 is below the 20-day moving average (MA) of 5.09, below the 50-day MA of 5.36, and below the 200-day MA of 5.54, indicating a bearish trend. The MACD of -0.18 indicates Positive momentum. The RSI at 26.67 is Positive, neither overbought nor oversold. The STOCH value of 11.81 is Positive, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Negative sentiment for ABEO.
Abeona Therapeutics Risk Analysis
Abeona Therapeutics disclosed 48 risk factors in its most recent earnings report. Abeona Therapeutics 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
Abeona Therapeutics Peers Comparison
Overall Rating
UnderperformOutperform
Sector (48)
Financial Indicators
Name | Overall Rating | Market Cap | P/E Ratio | ROE | Dividend Yield | Revenue Growth | EPS Growth |
|---|---|---|---|---|---|---|---|
48 Neutral | $6.86B | 1.11 | -50.22% | 2.47% | 16.71% | 1.53% | |
48 Neutral | $11.39M | ― | -184.09% | ― | ― | 68.50% | |
47 Neutral | $215.98M | ― | -216.57% | ― | -100.00% | 30.33% | |
46 Neutral | $63.99M | ― | -273.36% | ― | 194.23% | 45.50% | |
35 Underperform | $527.25M | ― | -238.46% | ― | 71.17% | 23.89% | |
30 Underperform | $7.76M | ― | 234.90% | ― | ― | 62.35% |
* Healthcare Sector Average
Performance Comparison
ABEO
Abeona Therapeutics
4.95
-2.75
-35.71%
BLRX
Bioline RX Ltd Sponsored ADR
2.94
-30.00
-91.07%
QURE
uniQure
9.75
4.55
87.50%
BCLI
Brainstorm Cell Therapeutics
1.23
-8.89
-87.85%
ADAP
Adaptimmune Therapeutics
0.32
-1.03
-76.30%
Abeona Therapeutics Earnings Call Summary
Earnings Call Date: Mar 20, 2025 | % Change Since: -4.81% | Next Earnings Date: May 8, 2025
Earnings Call Sentiment Positive
The call reflects a generally positive outlook for Abeona Therapeutics, driven by anticipated FDA approvals and substantial revenue potential from pz-cel. The company is well-positioned with strong financial backing and manufacturing capabilities. However, the initial launch will be supply constrained, and general and administrative expenses have increased significantly due to launch preparations.Highlights
Potential FDA Approvals
Abeona Therapeutics is anticipating FDA approval for prademagene zamikeracel (pz-cel) for recessive dystrophic epidermolysis bullosa (RDEB) with a PDUFA date on April 29, 2025. Additionally, the company is expecting a second approval for UX111 for Sanfilippo syndrome type A with a PDUFA date of August 18, 2025.
Commercial Launch Preparations
Launch preparations for pz-cel are underway. Five renowned EB treatment centers in the U.S. are in the process of becoming pz-cel qualified treatment centers. The company anticipates launching pz-cel in Q3 2025, pending FDA approval.
Significant Revenue Potential
Abeona estimates 1,500 treatment opportunities for pz-cel in the U.S., with a cumulative revenue potential of more than $2 billion, assuming a conservative floor of $1.5 million per treatment.
Strong Manufacturing Capabilities
Abeona's Cleveland facility is non-CDMO dependent and has a maximum capacity to support up to 10 pz-cel treatments per month. The company plans to gradually ramp up manufacturing capacity to 10 monthly treatments by the first half of 2026.
Financial Position
Abeona has cash, cash equivalents, short-term investments, and restricted cash of $98.1 million as of December 31, 2024, providing sufficient financial resources to fund operations into 2026.
Lowlights
Supply Gated Launch
The launch of pz-cel will be supply gated, with an initial manufacturing capacity of only four treatments per month, gradually increasing to 10 treatments per month by 2026.
Increased General and Administrative Expenses
General and administrative expenses increased to $29.9 million for the full year ended December 31, 2024, compared to $19 million in 2023, primarily due to commercial launch preparation costs.
Ongoing Challenges with Manufacturing Capacity
A planned annual manufacturing shutdown for maintenance during the December-January holiday timeframe could temporarily impact production capacity.
Company Guidance
During the call, Abeona Therapeutics discussed significant metrics related to the upcoming potential approval and launch of their therapy, prademagene zamikeracel (pz-cel), for recessive dystrophic epidermolysis bullosa (RDEB). The company highlighted that they are six weeks away from the PDUFA date of April 29, 2025, with a plan to launch in the third quarter of this year, pending FDA approval. Abeona estimates around 750 RDEB patients in the U.S. with moderate to severe wounds, representing approximately 1,500 treatment opportunities, as each patient may require an average of two treatments. The company projects a cumulative revenue potential of more than $2 billion in the U.S. alone, based on a conservative floor of $1.5 million per treatment. Initial manufacturing capacity is expected to support four treatments per month, gradually increasing to a maximum of 10 treatments by the first half of 2026. Abeona also mentioned a cash runway into 2026, with cash reserves of $98.1 million as of December 31, 2024.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.