Education
About Us
Working with TipRanks
Follow Us
Abeona Therapeutics (ABEO)
NASDAQ:ABEO
Top Page
Abeona Therapeutics
(NASDAQ:ABEO)
50Neutral
Positive Factors
Financial Performance
The analyst raised the 12-month price target for Abeona's stock, reflecting increased confidence in the company's market potential and product pricing strategy.
Market Strategy
Abeona Therapeutics has a solid commercial plan for ZEVASKYN, including onboarding multiple qualified treatment centers and engaging payers to ensure patient access.
Regulatory Approval
The FDA approved the Biologics License Application for Abeona's lead candidate, prademagene zamikeracel, signaling confidence in its treatment potential.
Negative Factors
Commercial Risks
The ability to reach break-even at a modest throughput of approximately 3 patients per month indicates a strong potential for profitability, but also underscores the challenge of achieving sufficient patient volume.
Pricing Concerns
ZEVASKYN's list price is significantly higher than initially forecasted, which could potentially limit patient access and raise affordability concerns.
Regulatory Challenges
The CRL for pz-cel only raised CMC-related issues, with no safety or efficacy concerns, boosting confidence in its resolution, though it highlights potential regulatory hurdles.
Abeona Therapeutics (ABEO) vs. S&P 500 (SPY)
Market Cap
$280.84M
Dividend YieldN/A
Average Volume (3M)2.18M
Price to Earnings (P/E)―
Beta (1Y)0.73
Revenue Growth-100.00%
EPS Growth30.33%
CountryUS
Employees136
SectorHealthcare
Sector Strength53
IndustryBiotechnology
Share Statistics
EPS (TTM)0.50
Shares Outstanding48,799,866
10 Day Avg. Volume4,826,353
30 Day Avg. Volume2,177,758
Financial Highlights & Ratios
PEG RatioN/A
Price to Book (P/B)N/A
Price to Sales (P/S)0.00
Price to Cash Flow (P/CF)0.00
P/FCF Ratio0.00
Enterprise Value/Market Cap0.64
Enterprise Value/RevenueN/A
Enterprise Value/Gross ProfitN/A
Enterprise Value/EbitdaN/A
Forecast
1Y Price Target
$20.20Price Target Upside284.03% Upside
Rating ConsensusStrong Buy
Number of Analyst Covering5
Abeona Therapeutics Business Overview & Revenue Model
Company DescriptionAbeona Therapeutics Inc., a clinical-stage biopharmaceutical company, develops gene and cell therapies for life-threatening rare genetic diseases. Its lead program is EB-101, an autologous, gene-corrected cell therapy that is in Phase III clinical trial for recessive dystrophic epidermolysis bullosa. The company also develops ABO-102, an adeno-associated virus (AAV)-based gene therapy for Sanfilippo syndrome type A; ABO-201 to treat CLN3 disease; ABO-401 for the treatment of cystic fibrosis; and ABO-50X for the treatment of genetic eye disorders. In addition, it is developing AAV-based gene therapy through its AIM vector platform programs. The company was formerly known as PlasmaTech Biopharmaceuticals, Inc. and changed its name to Abeona Therapeutics Inc. in June 2015. Abeona Therapeutics Inc. was incorporated in 1974 and is headquartered in New York, New York.
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
5.26
Price Trends
5.17
Positive
5.41
Negative
5.60
Negative
Market Momentum
0.28
Negative
47.43
Neutral
38.18
Neutral
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 5.26 is below the 20-day moving average (MA) of 5.35, above the 50-day MA of 5.17, and below the 200-day MA of 5.60, indicating a neutral trend. The MACD of 0.28 indicates Negative momentum. The RSI at 47.43 is Neutral, neither overbought nor oversold. The STOCH value of 38.18 is Neutral, 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 (52)
Financial Indicators
Name | Overall Rating | Market Cap | P/E Ratio | ROE | Dividend Yield | Revenue Growth | EPS Growth |
|---|---|---|---|---|---|---|---|
60 Neutral | $233.70M | ― | -36.07% | ― | ― | -7.93% | |
52 Neutral | $5.23B | 3.70 | -41.86% | 2.84% | 16.58% | -0.16% | |
50 Neutral | $280.84M | ― | -216.57% | ― | -100.00% | 30.33% | |
47 Neutral | $239.47M | ― | -33.88% | ― | ― | -22.66% | |
46 Neutral | $253.37M | ― | -23.68% | ― | ― | 14.60% | |
44 Neutral | $246.62M | ― | -33.52% | ― | ― | 27.92% | |
33 Underperform | $216.81M | ― | -139.56% | ― | ― | -33.79% |
* Healthcare Sector Average
Performance Comparison
ABEO
Abeona Therapeutics
5.26
0.86
19.55%
ATXS
Astria Therapeutics
4.42
-5.15
-53.81%
ITOS
iTeos Therapeutics
6.44
-5.76
-47.21%
AVIR
Atea Pharmaceuticals
2.80
-1.13
-28.75%
CMPX
Compass Therapeutics
1.76
0.18
11.39%
CADL
Candel Therapeutics
4.54
-6.29
-58.08%
Abeona Therapeutics Earnings Call Summary
Earnings Call Date:Mar 20, 2025
(Q4-2024)
| % Change Since: 1.15%|
Next Earnings Date:May 08, 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.Q4-2024 Updates
Positive Updates
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.
Negative Updates
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.Abeona Therapeutics Corporate Events
Regulatory Filings and Compliance
Abeona Therapeutics Hosts Conference Call and Webcast
Neutral
Apr 29, 2025
On April 29, 2025, Abeona Therapeutics Inc. hosted a conference call and webcast, providing a presentation that was furnished as Exhibit 99.1 to a Current Report on Form 8-K. The company clarified that the information shared is not considered ‘filed’ under the Securities Exchange Act of 1934 unless explicitly stated in future filings.
Spark’s Take on ABEO Stock
According to Spark, TipRanks’ AI Analyst, ABEO is a Neutral.
Abeona Therapeutics faces substantial financial hurdles with negative cash flows and no revenue growth. The potential for FDA approval and high revenue from pz-cel offer a positive outlook, yet initial supply constraints and increased expenses present risks. Technical analysis indicates limited momentum, and the negative valuation metrics reflect challenges typical for a biotech at this stage.
To see Spark’s full report on ABEO stock, click here.
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.