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Abeona Therapeutics (ABEO)
NASDAQ:ABEO
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Abeona Therapeutics
(NASDAQ:ABEO)
41Neutral
Positive 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 approval
The FDA has accepted for review the Biologics License Application (BLA) seeking accelerated approval for ABO-102 gene therapy as a treatment for patients with Sanfilippo syndrome type A.
Negative Factors
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
$237.35M
Dividend YieldN/A
Average Volume (3M)303.73K
Price to Earnings (P/E)―
Beta (1Y)0.34
Revenue Growth-100.00%
EPS Growth-12.27%
CountryUS
Employees84
SectorHealthcare
Sector Strength78
IndustryBiotechnology
Share Statistics
EPS (TTM)-2.70
Shares Outstanding43,471,030
10 Day Avg. Volume384,221
30 Day Avg. Volume303,732
Financial Highlights & Ratios
PEG RatioN/A
Price to Book (P/B)N/A
Price to Sales (P/S)67.81
Price to Cash Flow (P/CF)-4.90
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
$15.50Price Target Upside193.56% Upside
Rating ConsensusModerate Buy
Number of Analyst Covering2
Abeona Therapeutics Business Overview & Revenue Model
Company DescriptionAbeona Therapeutics, Inc. is a clinical stage biopharmaceutical company, which engages in the development of gene therapy for severe and life threatening rare diseases. It programs include EB-101 (gene-corrected skin grafts) for recessive dystrophic epidermolysis bullosa (RDEB); ABO-102 (AAV-SGSH), an adeno-associated virus (AAV) based gene therapy for Sanfilippo syndrome type A (MPS IIIA) and ABO-101 (AAV NAGLU), an AAV based gene therapy for Sanfilippo syndrome type B (MPS IIIB). The company was founded in 1974 and is headquartered in New York, NY.
How the Company Makes MoneyAbeona Therapeutics primarily makes money through the development and potential commercialization of its advanced therapy medicinal products. Revenue streams include milestone payments, licensing fees, and potential future sales of successfully developed therapies. Additionally, the company may receive funding through research grants, collaborations with other biotech and pharmaceutical companies, and strategic partnerships aimed at advancing its pipeline. As of now, Abeona is in the clinical trial phase, so much of its revenue is dependent on securing partnerships and achieving significant clinical milestones that unlock further investment and non-dilutive funding opportunities.
Abeona Therapeutics Financial Statement Overview
Summary
Abeona Therapeutics is facing significant financial challenges, with declining revenues, negative profit margins, and persistent net losses. The company is also experiencing a cash burn and relies heavily on external financing. Improvements in operational efficiencies are needed to enhance profitability and cash flows.Income Statement
Abeona Therapeutics has experienced declining revenues from 2020 to TTM 2024, with a significant drop in revenue growth. Gross profit margin is negative, indicating high cost relative to revenue. Net profit margin is also negative due to persistent net losses. EBIT and EBITDA margins are substantially negative, reflecting ongoing operational challenges.25
Negative
Balance Sheet
The debt-to-equity ratio is moderate, showing manageable leverage levels, but total liabilities are significant compared to assets. Return on equity is negative, reflecting consistent net losses. The equity ratio is relatively low, indicating a smaller cushion of equity against liabilities.40
Negative
Cash Flow
Free cash flow is consistently negative, and the growth rate of free cash flow is also negative, indicating cash burn. The operating cash flow to net income ratio is unfavorable, reflecting inefficiencies in converting sales into cash. Financing activities are primarily supporting cash flows, highlighting dependence on external funding.30
Negative
| Breakdown | |||||
| TTM | Dec 2023 | Dec 2022 | Dec 2021 | Dec 2020 | Dec 2019 |
|---|---|---|---|---|---|
| Income Statement | Total Revenue | ||||
| 2.82M | 3.50M | 1.41M | 3.00M | 10.00M | 0.00 |
| Gross Profit | |||||
| -288.00K | 1.90M | 964.00K | -1.46M | -20.14M | -8.68M |
| EBIT | |||||
| -60.75M | -47.13M | -45.26M | -89.84M | -81.42M | -77.09M |
| EBITDA | |||||
| -63.96M | -50.57M | -34.38M | -76.80M | -74.52M | -67.61M |
| Net Income Common Stockholders | |||||
| -71.03M | -54.19M | -31.81M | -88.61M | -88.35M | -76.68M |
| Balance Sheet | Cash, Cash Equivalents and Short-Term Investments | ||||
| 84.97M | 52.23M | 52.15M | 45.02M | 95.03M | 129.26M |
| Total Assets | |||||
| 174.40M | 64.00M | 64.21M | 79.59M | 151.20M | 223.38M |
| Total Debt | |||||
| 30.00M | 5.40M | 7.63M | 9.38M | 8.73M | 7.95M |
| Net Debt | |||||
| 11.25M | -9.07M | -6.59M | -23.56M | -3.87M | -121.31M |
| Total Liabilities | |||||
| 40.35M | 49.18M | 37.45M | 28.21M | 48.65M | 44.95M |
| Stockholders Equity | |||||
| 134.04M | 14.83M | 26.76M | 51.38M | 102.55M | 178.43M |
| Cash Flow | Free Cash Flow | ||||
| -50.57M | -37.34M | -43.61M | -69.82M | -36.35M | -69.33M |
| Operating Cash Flow | |||||
| -48.69M | -37.01M | -43.48M | -65.67M | -35.02M | -62.82M |
| Investing Cash Flow | |||||
| -46.59M | 208.00K | -23.96M | 66.06M | -83.71M | 59.98M |
| Financing Cash Flow | |||||
| 106.29M | 37.06M | 43.17M | 24.86M | 1.94M | 113.90M |
Abeona Therapeutics Technical Analysis
Negative
5.28
Price Trends
5.53
Negative
5.81
Negative
5.49
Negative
Market Momentum
-0.09
Negative
45.97
Neutral
78.09
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 5.28 is below the 20-day moving average (MA) of 5.45, below the 50-day MA of 5.53, and below the 200-day MA of 5.49, indicating a bearish trend. The MACD of -0.09 indicates Negative momentum. The RSI at 45.97 is Neutral, neither overbought nor oversold. The STOCH value of 78.09 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 (49)
Financial Indicators
Name | Overall Rating | Market Cap | P/E Ratio | ROE | Dividend Yield | Revenue Growth | EPS Growth |
|---|---|---|---|---|---|---|---|
49 Neutral | $6.84B | 0.05 | -53.14% | 2.48% | 24.49% | -3.26% | |
48 Neutral | $11.58M | ― | -184.09% | ― | ― | 68.50% | |
45 Neutral | $675.96M | ― | -238.46% | ― | 71.17% | 23.89% | |
44 Neutral | $114.38M | ― | -53.54% | ― | 145.37% | 57.01% | |
41 Neutral | $237.35M | ― | -209.50% | ― | -100.00% | -12.27% | |
32 Underperform | $9.35M | ― | 234.90% | ― | ― | 46.67% |
* Healthcare Sector Average
Performance Comparison
ABEO
Abeona Therapeutics
5.28
-2.86
-35.14%
BLRX
Bioline RX Ltd Sponsored ADR
3.05
-44.15
-93.54%
SRNE
Sorrento Therapeutics
0.01
0.00
0.00%
QURE
uniQure
13.78
8.96
185.89%
BCLI
Brainstorm Cell Therapeutics
1.56
-3.37
-68.36%
ADAP
Adaptimmune Therapeutics
0.45
-1.01
-69.18%
Abeona Therapeutics Earnings Call Summary
Earnings Call Date: Nov 14, 2024 | % Change Since: -13.44% | Next Earnings Date: Mar 24, 2025
Earnings Call Sentiment Neutral
The earnings call demonstrated significant progress towards the approval and commercialization of pz-cel, with strategic steps in place for launch and financial stability. However, there remain challenges related to manufacturing capacity and ongoing financial losses.Highlights
Resubmission of BLA for pz-cel Accepted
The FDA accepted the resubmission for review and set a PDUFA date of April 29, 2025, indicating progress towards potential approval.
New U.S. Patents Issued
A new U.S. patent for pz-cel was issued with an expiration date of 2037, and another patent will issue relating to its packaging and transport system, expiring in 2040.
Commercial Launch Preparations
A strong commercialization team has been assembled, and 5 EB centers are targeted for launch. Approximately 750 pz-cel-eligible U.S. RDEB patients have been identified.
Favorable Medicare Reimbursement
CMS granted a product-specific procedure code and favorable MS-DRG 018 assignment, supporting reimbursement for Medicare RDEB patients.
Financial Position
Cash resources of $110 million as of September 30, 2024, expected to fund operations into 2026.
Lowlights
Continued Losses
Net loss was $30.3 million for the third quarter of 2024, including a $15.2 million loss from remeasurement of the fair value of warrant and derivative liabilities.
Manufacturing Capacity Limitations
Current manufacturing capacity is limited to 10 patient runs per month, which may not meet anticipated demand at launch.
Regulatory Challenges
The focus remains on addressing CMC-related issues from the CRL, particularly identity testing and Stargardt, as these are key areas for FDA review.
Company Guidance
In the third quarter 2024 earnings call for Abeona Therapeutics, several key metrics and updates were shared regarding their lead product candidate, prademagene zamikeracel (pz-cel). The company successfully resubmitted its biologics license application (BLA) to the FDA, which was accepted with a PDUFA date set for April 29, 2025. They have a manufacturing capacity of up to 10 patient runs per month, with plans for expansion. Commercialization efforts include building a team of about 20 members and targeting five initial EB centers across the U.S. to facilitate patient access. Financially, Abeona reported cash and equivalents of $110 million as of September 30, 2024, with a net loss of $30.3 million for the quarter, including a $15.2 million loss from warrant liabilities. The company anticipates having sufficient financial resources to fund operations into 2026, without accounting for potential revenue from pz-cel sales or a priority review voucher, which could be valued at over $150 million.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.