ABEONA THERAPEUTICS Q2 FY26 earnings call ABEO

Abeona Therapeutics continued its ZEVASKYN commercial rollout, expanding its Qualified Treatment Center (QTC) network to 7 activated sites nationwide, including Cincinnati Children's, CHOP, and UTMB. CHOP completed its first treatment in July, shortly after activation in May, and UTMB completed its first patient biopsy. The company achieved its stated goal of activating 7 QTCs by the end of the year, enhancing patient access and commercial footprint.

The launch of ZEVASKYN has revealed several real-world complexities. These include the need for seamless real-time coordination across multiple stakeholders due to the product's 84-hour shelf life, leading to scheduling disruptions. Patient health deterioration also caused 2 last-minute biopsy cancellations in Q2. Additionally, manufacturing yields can be influenced by variability in incoming biopsy material, resulting in 1 low-yield batch in Q2 and 1 out-of-spec batch in Q3, for which no revenue was recognized.

CMS granted New Technology Add-on Payment (NTAP) status for ZEVASKYN, effective October 1, 2026, for fiscal year 2027. This status provides supplemental reimbursement for hospitals for eligible new, high-cost, and innovative therapies during inpatient stays, helping to cover costs beyond standard DRG payments. This is a significant external validation of ZEVASKYN's newness, cost criterion, and substantial clinical improvement, particularly for Medicare beneficiaries who represent about 10% of the RDEB payer mix.

Management addressed manufacturing challenges, noting that the low-yield batch in Q2 was a rare event, the first encountered, and attributed to variations in incoming biopsy material. The out-of-spec batch in Q3 was due to an identity test (Pan-CK marker expression) specification set during BLA review without sufficient GMP manufacturing experience. The company is working with the FDA to revisit these specifications, confident that real-world data supports a revision.

The company emphasized continued engagement with the Epidermolysis Bullosa (EB) community, participating in the Debra Care Conference and Society of Pediatric Dermatology Annual Meeting. Patient ambassadors from the Strong Together Network shared their experiences, fostering dialogue and connecting patients with resources. With the expanded QTC network, approximately 40% of the addressable market now has in-state access to a QTC, with additional patients traveling from out of state.

Abeona announced a change in its financial reporting strategy to provide maximum transparency and align with standard commercial-stage practices. Future quarterly disclosures will focus solely on completed operational achievements, specifically patients treated during the quarter and net revenue recognized, moving away from leading indicators like scheduled biopsies that were subject to external variables.