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Abeona Therapeutics Inc (ABEO)
:ABEO
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Abeona Therapeutics
(NASDAQ:ABEO)
Rating:50Neutral
Price Target:―
Positive Factors
Financial Performance
The sale of the Rare Pediatric Disease Priority Review Voucher for $155M provides Abeona with sufficient cash for more than two years of operating expenses without needing additional capital.
Market Potential
ZEVASKYN showed robust performance in the pivotal Phase 3 VIITAL study, meeting its efficacy endpoints and demonstrating significant healing in large chronic wounds.
Regulatory Approval
FDA’s broad approval of Zevaskyn for the treatment of wounds in adult/pediatric RDEB patients represents an important milestone which appropriately now transitions focus to the commercial execution of a high-margin business.
Negative Factors
Pricing Concerns
ZEVASKYN's list price is significantly higher than initially forecasted, suggesting a strong revenue potential for Abeona.
Profitability Timeline
Abeona anticipates becoming profitable in early 2026, with projections indicating potential profitability before the end of this year depending upon the trajectory of the ZEVASKYN launch.
Abeona Therapeutics (ABEO) vs. SPDR S&P 500 ETF (SPY)
Market Cap
$329.45M
Dividend YieldN/A
Average Volume (3M)2.59M
Price to Earnings (P/E)―
Beta (1Y)0.81
Revenue Growth-100.00%
EPS Growth30.33%
CountryUS
Employees136
SectorHealthcare
Sector Strength41
IndustryBiotechnology
Share Statistics
EPS (TTM)-0.24
Shares Outstanding51,156,734
10 Day Avg. Volume987,633
30 Day Avg. Volume2,594,012
Financial Highlights & Ratios
PEG Ratio-0.14
Price to Book (P/B)7.34
Price to Sales (P/S)0.00
P/FCF Ratio-4.72
Enterprise Value/Market Cap0.93
Enterprise Value/Revenue54.13
Enterprise Value/Gross Profit-183.40
Enterprise Value/Ebitda-1.45
Forecast
1Y Price Target
$21.10Price Target Upside225.62% Upside
Rating ConsensusStrong Buy
Number of Analyst Covering5
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 Earnings Call Summary
Earnings Call Date:May 15, 2025
(Q1-2025)
| % Change Since: 20.22%|
Next Earnings Date:Aug 18, 2025
Earnings Call Sentiment Positive
The earnings call highlighted the successful FDA approval and positive market reception of ZEVASKYN, as well as strategic financial moves to ensure the company's stability. However, delays in patient treatment and increased operating expenses were noted as challenges.Q1-2025 Updates
Positive Updates
FDA Approval of ZEVASKYN
Abeona Therapeutics received FDA approval for ZEVASKYN, the first and only autologous cell-based gene therapy for Recessive Dystrophic Epidermolysis Bullosa (RDEB).
First Qualified Treatment Center Activated
Lurie Children's Hospital of Chicago has been activated as the first Qualified Treatment Center for ZEVASKYN, enabling patient identification and scheduling.
Strong Initial Market Response
Abeona Assist has received inquiries from approximately 30 patients and families across the U.S. just two weeks after ZEVASKYN's approval.
Positive Financial Outlook
The sale of a Priority Review Voucher (PRV) for $155 million is expected to fully fund operations for over two years, extending the runway through projected profitability in early 2026.
Outcomes-Based Agreements Executed
Abeona has executed outcomes-based agreements with two payer contracting organizations, enhancing potential patient access to ZEVASKYN.
Positive Clinical Data Presentation
At the Society for Investigative Dermatology annual meeting, two late-breaking abstracts were presented highlighting ZEVASKYN's efficacy and safety.
Negative Updates
Delayed Initial Patient Treatment
The first patient treatment with ZEVASKYN at Lurie Children's is not expected until the third quarter of 2025, indicating a slower than anticipated rollout.
Increased Operating Expenses
Research and development expenses increased to $9.9 million in Q1 2025, up from $7.2 million in Q1 2024, due to scale-up activities.
Net Loss for the Quarter
Abeona reported a net loss of $12 million for the first quarter of 2025, though this is an improvement from a $31.6 million loss in the same period in 2024.
Company Guidance
During the Abeona Therapeutics First Quarter 2025 Conference Call, the company provided a comprehensive update on the commercial launch of ZEVASKYN, which was approved by the U.S. FDA as the first autologous cell-based gene therapy for Recessive Dystrophic Epidermolysis Bullosa (RDEB). Key metrics highlighted include the activation of the first Qualified Treatment Center (QTC) at Lurie Children's Hospital of Chicago, and the anticipation of treating the first patient in the third quarter of 2025. Abeona Assist, their patient hub, received inquiries from about 30 patients and families, indicating strong demand. Financially, Abeona reported cash and equivalents of $84.5 million as of March 31, 2025, and expects net proceeds of $152 million from the sale of a priority review voucher (PRV), which will fund operations for over two years. The company reiterated its goal of treating 10 to 14 patients in 2025 and achieving profitability by early 2026, supported by outcomes-based agreements with major payer organizations.Abeona Therapeutics Financial Statement Overview
Summary
Abeona Therapeutics exhibits significant financial challenges, characterized by consistent losses, lack of revenue growth, and negative cash flows. Despite manageable debt levels, the company's financial health is at risk without a turnaround in operational performance and revenue generation.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 | |||||
| TTM | Dec 2024 | Dec 2023 | Dec 2022 | Dec 2021 | Dec 2020 |
|---|---|---|---|---|---|
| Income Statement | Total Revenue | ||||
| 0.00 | 0.00 | 3.50M | 1.41M | 3.00M | 10.00M | Gross Profit |
| -1.67M | 0.00 | 1.90M | 964.00K | -1.46M | -20.14M | EBIT |
| -69.61M | -64.21M | -47.13M | -45.26M | -89.84M | -81.42M | EBITDA |
| -45.46M | -64.21M | -50.57M | -34.38M | -76.80M | -74.52M | Net Income Common Stockholders |
| -44.19M | -63.73M | -54.19M | -31.81M | -88.61M | -88.35M |
| Balance Sheet | Cash, Cash Equivalents and Short-Term Investments | ||||
| 84.16M | 97.72M | 52.23M | 52.15M | 45.02M | 95.03M | Total Assets |
| 99.36M | 108.93M | 64.00M | 64.21M | 79.59M | 151.20M | Total Debt |
| 23.98M | 23.05M | 5.40M | 7.63M | 9.38M | 8.73M | Net Debt |
| 8.04M | -309.00K | -9.07M | -6.59M | -23.56M | -3.87M | Total Liabilities |
| 57.97M | 64.90M | 49.18M | 37.45M | 28.21M | 48.65M | Stockholders Equity |
| 41.40M | 44.03M | 14.83M | 26.76M | 51.38M | 102.55M |
| Cash Flow | Free Cash Flow | ||||
| -63.00M | -58.46M | -37.34M | -43.61M | -69.82M | -36.35M | Operating Cash Flow |
| -59.88M | -56.02M | -37.01M | -43.48M | -65.67M | -35.02M | Investing Cash Flow |
| -27.21M | -39.24M | 208.00K | -23.96M | 66.06M | -83.71M | Financing Cash Flow |
| 85.47M | 104.14M | 37.06M | 43.17M | 24.86M | 1.94M |
Abeona Therapeutics Technical Analysis
Positive
6.48
Price Trends
5.51
Positive
5.47
Positive
5.72
Positive
Market Momentum
0.23
Positive
60.53
Neutral
52.60
Neutral
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For ABEO, the sentiment is Positive. The current price of 6.48 is above the 20-day moving average (MA) of 6.07, above the 50-day MA of 5.51, and above the 200-day MA of 5.72, indicating a bullish trend. The MACD of 0.23 indicates Positive momentum. The RSI at 60.53 is Neutral, neither overbought nor oversold. The STOCH value of 52.60 is Neutral, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Positive 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 1 New Risks
1.
The Complete Response Letter related to our Biologics License Application for pz-cel for the treatment of patients with recessive dystrophic epidermolysis bullosa may impair our ability to successfully commercialize pz-cel. Q3, 2024
Abeona Therapeutics Peers Comparison
Overall Rating
UnderperformOutperform
Sector (54)
Financial Indicators
Name | Overall Rating | Market Cap | P/E Ratio | ROE | Dividend Yield | Revenue Growth | EPS Growth |
|---|---|---|---|---|---|---|---|
60 Neutral | $300.07M | ― | -41.31% | ― | ― | -7.93% | |
54 Neutral | $5.28B | 3.29 | -45.38% | 2.80% | 16.77% | -0.08% | |
50 Neutral | $329.45M | ― | -271.78% | ― | -100.00% | 30.33% | |
47 Neutral | $276.42M | ― | -30.47% | ― | ― | -22.66% | |
44 Neutral | $279.91M | ― | -32.89% | ― | ― | 27.92% | |
41 Neutral | $386.57M | ― | -23.68% | ― | ― | 14.60% | |
33 Underperform | $280.58M | ― | -98.14% | ― | ― | -33.79% |
* Healthcare Sector Average
Performance Comparison
ABEO
Abeona Therapeutics
6.48
2.21
51.76%
ATXS
Astria Therapeutics
5.22
-3.63
-41.02%
ITOS
iTeos Therapeutics
10.18
-6.52
-39.04%
AVIR
Atea Pharmaceuticals
3.19
-0.51
-13.78%
CMPX
Compass Therapeutics
2.36
1.05
80.15%
CADL
Candel Therapeutics
5.55
-1.60
-22.38%
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.