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Abeona Therapeutics (ABEO)
NASDAQ:ABEO
Earnings Data
Report Date
May 08, 2025TBA Not Confirmed
Period Ending
2025 (Q1)Consensus EPS Forecast
-0.38Last Year’s EPS
-1.16Same Quarter Last Year
Strong Buy
Based on 3 Analysts Ratings
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Earnings Call Summary
Earnings Call Date:Mar 20, 2025
|% Change Since: -4.42%
|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.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.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.
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ABEO Earnings History
The table shows recent earnings report dates and whether the forecast was beat or missed. See the change in forecast and EPS from the previous year.
Beat
Missed
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ABEO Earnings-Related Price Changes
Report Date | Price 1 Day Before | Price 1 Day After | Percentage Change |
|---|---|---|---|
| Mar 20, 2025 | $5.20 | $5.14 | -1.15% |
| Nov 14, 2024 | $6.10 | $5.95 | -2.46% |
| Aug 12, 2024 | $4.42 | $4.95 | +11.99% |
| May 15, 2024 | $4.20 | $4.71 | +12.14% |
Earnings announcements can affect a stock’s price. This table shows the stock's price the day before and the day after recent earnings reports, including the percentage change.
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FAQ
When does Abeona Therapeutics (ABEO) report earnings?
Abeona Therapeutics (ABEO) is schdueled to report earning on May 08, 2025, TBA Not Confirmed.
What is Abeona Therapeutics (ABEO) earnings time?
Abeona Therapeutics (ABEO) earnings time is at May 08, 2025, TBA Not Confirmed.
Where can I see when companies are reporting earnings?
You can see which companies are reporting today on our designated earnings calendar.
What companies are reporting earnings today?
You can see a list of the companies which are reporting today on TipRanks earnings calendar.
What is ABEO EPS forecast?
ABEO EPS forecast for the fiscal quarter 2025 (Q1) is -0.38.
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