Abeona Therapeutics (ABEO) investor relations material

Commercial launch and demand trends

• Achieved commercial stage with ZEVASKYN approval for recessive dystrophic epidermolysis bullosa; strong patient demand and favorable payer coverage reported.

• 12 ZEVASKYN Product Order Forms (ZPOFs) secured, with demand growing to nearly 30 identified patients; majority are organic to activated centers.

• Three QTCs activated, with plans to expand to 5–7 centers in the next 3–6 months and potentially up to 10 long-term, focusing on strategic geographic coverage.

• Over 100 eligible patients identified at current QTCs, with referrals from non-QTCs increasing; total pool of identified patients is growing beyond 50.

• Conversion from identified patients to ZPOFs is strong, with administrative and payer processes expected to shorten lead times to 2–3 months.

Manufacturing and operational updates

• Temporary pause in patient biopsy collection due to a false positive in a new rapid sterility assay; issue resolved and process improved to reduce false positives to under 1%.

• Biopsy-to-product process is tightly scheduled: 25 days for manufacturing, 84-hour shelf life post-harvest, and immediate processing upon biopsy arrival.

• Manufacturing capacity at 4–6 slots per month, expanding to 10 by mid-2026; further expansion to 20 slots possible by late 2027, contingent on demand and global supply considerations.

• Patient retreatment is expected, with evidence from clinical trials showing multiple treatments per patient; total addressable market estimated at 1,500 treatment opportunities.

Reimbursement and payer landscape

• Permanent J Code effective January 1, 2025, expected to streamline reimbursement and reduce administrative burden for hospitals.

• Baseline Medicaid coverage achieved in all 50 states; 60% of patients are commercially insured, with strong policy adoption and value-based agreements in place.

• Value-based agreements provide discounts for retreatment; payer policies generally align with product label, with some restrictive cases overturned via medical necessity.