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- **ZEVASKYN Launch Momentum**: Despite Q4 2025 patient treatment delay, Abeona reports 30 identified candidates (double Q2 levels) and 12 ZPOFs finalized, signaling strong demand.
- **Assay Issue Resolved**: Manufacturing delay caused by a false positive sterility assay was resolved in November, enabling resumed biopsy collections.
- **Broad Payer Coverage**: All major commercial payers and all 51 state Medicaid programs now cover ZEVASKYN, with CMS J-code simplifying claims.
- **Financial Strength**: $207.5 million cash position supports operations for over 2 years, with narrowed net loss to $5.2 million in Q3 2025.

**【CEO Summary Section】**
- Abeona reported significant operational progress in Q3 2025, despite a temporary delay in the first patient treatment for ZEVASKYN due to assay optimization. The first patient treatment is now expected in Q4 2025.
- Patient demand doubled, with 30 identified candidates across 3 Qualified Treatment Centers (QTCs), up from 12 in Q2. Twelve patients have already received ZEVASKYN Product Order Forms (ZPOFs).
- The company remains confident in achieving its 2026 launch goals, citing growing QTC network expansion and broad market access.

**【CTO/CFO Financial Commentary】**
- A manufacturing delay occurred due to a false positive in a rapid sterility assay, requiring retesting and regulatory submissions. The issue was resolved in November 2025, allowing resumption of biopsy collections.
- The company maintains a strong cash position of $207.5 million, sufficient to fund operations for over 2 years without ZEVASKYN revenue.
- R&D expenses decreased by 53% YoY to $4.2 million, while SG&A increased 202% YoY to $19.3 million, reflecting commercial launch costs.

**【CCO Commercial Update】**
- ZEVASKYN achieved broad payer coverage, with all major commercial plans (e.g., UnitedHealthcare, Cigna) and all 51 state Medicaid programs covering the therapy.
- A permanent J-code for ZEVASKYN was established by CMS, effective January 1, 2026, simplifying claims processing.
- The QTC network expanded to 3 sites, including Children's Hospital Colorado, with additional centers in active discussions.

**【CFO Financial Results】**
- Net loss narrowed to $5.2 million (Q3 2025) from $30.3 million (Q3 2024), driven by reduced R&D costs and reclassified expenses.
- Cash, cash equivalents, and investments totaled $207.5 million, providing financial flexibility for the commercial launch.

**【Q&A Highlights】**
- 12 ZPOF patients are progressing through insurance approvals, with some scheduled for biopsy in Q4 2025. The company expects a high conversion rate to treatment.
- Profitability guidance remains unchanged, with plans to achieve positive cash flow in 2026.
- The prior authorization process is streamlined, with no step edits observed, and most payers covering ZEVASKYN to the label.

Abeona Therapeutics Inc. (ABEO) Q3 2025 Earnings Call Transcript

- **FDA Approval Milestone**: ZEVASKYN approved for RDEB, with first commercial revenue expected Q3 2025.
- **Strong Launch Momentum**: 50+ identified patients across 2 QTCs; 10-14 treatments projected for 2025.
- **Payer Success**: 100% prior authorization approvals; UHC coverage aligns with FDA label.
- **Financial Strength**: $225.9M cash; net income $108.8M driven by PRV sale.
- **Manufacturing Ramp-Up**: Capacity to treat 10/month by mid-2026, no FDA inspection risks.

**【CEO Opening Remarks】**
- Announced FDA approval of ZEVASKYN for recessive dystrophic epidermolysis bullosa (RDEB) in April 2025.
- Launched commercial operations with 2 qualified treatment centers (QTCs): Lurie Children's Hospital of Chicago and Lucile Packard Children's Hospital at Stanford.
- Anticipate first commercial revenue in Q3 2025 following patient treatment.
- Encouraged by strong community response and 50+ identified patients across QTCs.

**【Chief Commercial Officer (CCO) Update】**
- 2 QTCs have identified ~12 patients for treatment; ~36 additional referrals from non-QTC centers.
- Manufacturing capacity to treat 10 patients/month by mid-2026, up from current 3/month.
- Payer coverage secured with UnitedHealthcare (UHC) and CMS, with 100% prior authorization approvals to date.
- Patient journey from biopsy to treatment takes ~3-4 months, expected to shorten as QTCs gain experience.

**【CFO Financial Update】**
- Cash reserves: $225.9M (June 2025) vs. $98.1M (Dec 2024), providing >2 years of operating runway.
- Net income: $108.8M (Q2 2025) driven by PRV sale; EPS: $2.07 basic, $1.71 diluted.
- R&D expenses: $5.9M (Q2 2025) down from $9.2M (Q2 2024) due to reclassification to SG&A.
- SG&A: $17.1M (Q2 2025) up 100% YoY due to commercial launch costs.

**【Q&A Highlights】**
- **Patient Identification**: 50+ identified patients across QTCs; ~36 additional referrals from non-QTC centers.
- **Manufacturing Capacity**: 10/month by mid-2026; no FDA inspection risks for expansion.
- **Payer Trends**: 100% prior auth approvals; UHC coverage aligns with FDA label.
- **International Expansion**: Exploring EU and Japan markets, but Cleveland facility may supply global demand initially.
- **Revenue Recognition**: Revenue booked upon surgical application; no staged payments.

Abeona Therapeutics (ABEO)-14 Aug 25-2025 Q2 Earnings call transcript

- **ZEVASKYN Launch Momentum**: FDA-approved gene therapy activated at Lurie Children's Hospital, with first patient treatment in Q3 2025 and 10-14 patients targeted in 2025.
- **Financial Strength**: $155M PRV sale extends cash runway to 2026, with Q1 2025 net loss narrowing to $12M.
- **Commercial Traction**: 30+ patient inquiries post-approval, outcomes-based agreements with major payers, and 10+ patients/month capacity by Q2 2026.
- **Pipeline Progress**: Ophthalmology asset RS1 set for H2 2026 clinical trial, leveraging external manufacturing to reduce capital intensity.
- **Key Risk**: Dependency on payer approvals and treatment center activation timelines to achieve revenue targets.


**【CEO Summary Section】**
- ZEVASKYN, the first autologous cell-based gene therapy for RDEB, received FDA approval in early 2025. The first Qualified Treatment Center (Lurie Children's Hospital) is activated, with the first patient expected to be treated in Q3 2025.
- Late-breaking clinical data at SID 2025 demonstrated durable wound closure and absence of oncogenic risks, reinforcing ZEVASKYN's safety and efficacy.
- Sold the Priority Review Voucher (PRV) for $155M, strengthening the balance sheet to fund operations through 2026 and beyond.

**【CFO Financial Commentary】**
- Cash, cash equivalents, and short-term investments totaled $84.5M as of Q1 2025, excluding PRV proceeds.
- R&D expenses increased 37% YoY to $9.9M, driven by manufacturing scale-up and preclinical development.
- G&A expenses rose 38% YoY to $9.8M, reflecting commercial launch preparations.
- Net loss narrowed to $12M (Q1 2025) from $31.6M (Q1 2024), with PRV proceeds expected to extend the cash runway to early 2026.

**【Commercial Progress (CFO & CCO)】**
- Abeona Assist received 30+ patient inquiries in the first two weeks post-approval, highlighting high unmet need.
- Activated Lurie Children's Hospital as the first QTC, with additional geographically dispersed centers expected by end-2025.
- Secured outcomes-based agreements with two major payers, covering ~100M commercially insured lives.
- Guided to treat 10-14 patients in 2025, with a ramp-up to 10+ patients/month by early 2026.

**【Q&A Highlights】**
- Manufacturing capacity: 4 patients/month at launch, scaling to 10+ patients/month by Q2 2026 without facility expansion.
- Reimbursement: Revenue recognized post-treatment, with pre-approval payer agreements to minimize financial risk.
- Pipeline: Ophthalmology asset (RS1) on track for H2 2026 clinical trial, leveraging CDMO partnerships for efficient development.
- PRV sale: Net proceeds ~$152M, with no impact on existing liabilities.

**【Risks & Challenges】**
- Dependent on payer approvals and treatment center activation timelines.
- Initial patient volumes may be lower than expectations due to complex manufacturing and reimbursement processes.
- Competitive dynamics with existing RDEB therapies (e.g., VYJUVEK, FILSUVEZ) could limit market share.


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