Abeona Therapeutics Inc. Q4 FY2025 earnings call

Vish Seshadri mentioned growing patient demand for ZivaSkin, launch delayed to quarter four 2025 but 2026 launch execution ramps up. Treated one patient this quarter, biopsied three additional patients with treatment schedule over coming weeks. Madhav Vasanthavada said demand for ZivaSkin continues to grow, identified eligible patients now more than 100, two patients treated, three biopsied, expect more biopsies this month. Four QTCs activated, two treating patients, other two moving through administrative process. Actively onboarding five additional centers, goal to have at least seven QTCs active by end of 2026. All major commercial payers have published coverage policies for ZivaSkin, representing roughly 80% of commercially covered lives, and has baseline coverage across all Medicaid programs for all 50 states, CMS established permanent HCPCS J-code for ZivaSkin effective January 1, 2026.

Total revenue for the year ending December 31st, 2025 was $5.8 million. Total revenue includes $3.4 million in license and other revenues and $2.4 million in net product revenue. License and other revenues were primarily driven by a clinical milestone of $3 million achieved in the fourth quarter of 2025 under our sublicense agreement for Rett syndrome with Tayshia gene therapies. Net product revenue reflects the patient treatment in December. Cost of sales for 2025 was $1.5 million. Total research and development, or R&D, spending for 2025 decreased $7.6 million to $26.8 million compared to $34.4 million in 2024. Selling general and administrative, or SG&A, expenses for 2025 were $65 million, an increase of $35.1 million over 2024. Net income was $71.2 million for the year ended December 31st, 2025, or $1.34 per basic, and $1.01 per diluted common share.

2026 is about solidifying commercial blueprint, expect launch execution to ramp up in 2026. Goal to have at least seven QTCs active by end of 2026. Anticipate average net revenues to normalize as payer mix expands. Believe there's a pretty good chance of achieving profitability with certain patient per month targets.

Q: Comment on the cadence with which qualified treatment centers are likely to be stood up in the coming months and specific factors influencing speed, drivers of R&D spending over 2026 and beyond.

A: Madhav Vasanthavada said working with five centers, one imminent, goal to have seven active by end of year. Factors like centers waiting for approval, payer mix, institutional bureaucracies. R&D spend drivers include registry study costs and pipeline development costs, shift from R&D to SG&A with commercial transition.

Q: Comment on relative coalescing or concentration of patients around QTCs, timeline from receipt of start form to treatment initiation, confidence in achieving profitability.

A: Expect other centers to have decent pool of patients, three-pronged approach. Current timeline from receipt of start form to treatment initiation is variable, average four to five months, expect to improve. Believe there's a pretty good chance of achieving profitability with certain patient per month targets.

Q: Comment on target number of QTCs, reimbursement side, dialogue between QTCs, dispersal throughout geography.

A: Target QTC number is five to seven, realistic goal for seven this year. Reimbursement has mix of inclusion-exclusion criteria but physicians can overturn with letters of medical necessities. QTCs talk to each other about best practices and administrative steps. Goal is geographically dispersed QTCs for patient access.

Q: Comment on manufacturing sterility testing, patient and physician feedback.

A: Confident sterility testing resolution is behind them, currently running at six patients per month, ramping up to 10 per month by second half of year. Too premature to comment on patient and physician feedback as only two patients treated and not enough time passed.

Q: Questions about treated patients, re-treatment, exclusions.

A: Treated patients were not simultaneously on Vijuvex. Physicians say patients would require second round of ZivaSkin treatment, no exclusion criteria seen for re-treatment based on published policies.