Abeona Therapeutics (ABEO) investor relations material

Company transition and product launch

• Transitioned from R&D to commercial stage after first product approval in late 2025, expanding from 80–90 to 250 employees and establishing GMP manufacturing and supply.

• ZEVASKYN, an autologous cell sheet-based gene therapy for recessive dystrophic EB, launched in December 2025, offering multi-year wound healing from a single application.

• Unique launch challenges include ultra-rare disease focus, 84-hour product shelf life, and need for multidisciplinary treatment centers.

• Launch strategy emphasizes foundation building, site activation, and patient ambassador networks to support adoption.

• Commercially treated patients often previously used VYJUVEK, highlighting ZEVASKYN’s differentiated value for large, chronic wounds.

Market landscape and differentiation

• ZEVASKYN addresses a severe genetic disorder with high morbidity and mortality, offering a durable, one-time treatment compared to weekly alternatives.

• Both ZEVASKYN and VYJUVEK are needed for different wound types; ZEVASKYN is suited for large, contiguous wounds.

• Clinical data show up to 12 years of wound healing from a single application, supporting its unique value proposition.

Commercialization and operational learnings

• Launch requires coordination among surgeons, anesthesiologists, and EB physicians at qualified centers, with each site needing to replicate clinical success.

• Patient-to-patient communication and ambassador programs are key to building trust and awareness.

• Initial bottlenecks vary by institution, often related to payer mix and institutional learning curves; cross-pollination of best practices is ongoing.

• Leading indicators for launch momentum include number of centers, treated patients, and patient interest; 40% of the addressable market is now within reach of a qualified center.