Abeona Therapeutics(ABEO) - 2025 Q3 - Earnings Call Transcript

Financial Data and Key Metrics Changes - As of September 30, 2025, the company had cash, cash equivalents, restricted cash, and short-term investments totaling $207.5 million, providing significant financial flexibility for the ZEVASKYN commercial launch [15] - Research and development (R&D) spending for Q3 2025 was $4.2 million, a decrease from $8.9 million in Q3 2024, primarily due to costs capitalized into inventory and reclassification of certain costs to selling, general, and administrative expenses (SG&A) [16] - SG&A expenses increased to $19.3 million in Q3 2025 from $6.4 million in Q3 2024, reflecting the reclassification of R&D expenses and increased costs associated with the commercial launch [16] - The net loss for Q3 2025 was $5.2 million, or negative $0.10 per share, compared to a net loss of $30.3 million, or negative $0.63 per share, in Q3 2024 [16] Business Line Data and Key Metrics Changes - The ZEVASKYN commercial launch is progressing, with the first patient treatment delayed to Q4 2025 due to optimization of a product release assay, but demand is growing [5][6] - The number of identified eligible patients at qualified treatment centers (QTCs) has more than doubled to approximately 30, up from over 12 previously reported [11] - The activation of Children's Hospital Colorado as a QTC brings the total to three, alongside Lurie Children's Hospital of Chicago and Lucille Packard Children's Hospital Stanford [12] Market Data and Key Metrics Changes - ZEVASKYN has received positive coverage decisions from major commercial payers, covering over 80% of commercially insured lives, and has baseline coverage across all 51 state Medicaid programs effective October 1, 2025 [13] - A permanent product J-code for ZEVASKYN will be established by CMS effective January 1, 2026, simplifying claims and reimbursement processing [14] Company Strategy and Development Direction - The company is focused on scaling the ZEVASKYN commercial launch to meet patient demand and expanding its QTC network [5][6] - The management team has been strengthened with the appointment of Dr. James A. Gao as Senior Vice President, Head of Clinical Development and Medical Affairs, to advance the pipeline [18] Management's Comments on Operating Environment and Future Outlook - Management remains confident in achieving 2026 launch goals despite the delay in the first patient treatment, citing trends in patient demand and market access [5][6] - The company expects to maintain a profitable business in the first half of 2026, with no significant impact from the treatment delay [29] Other Important Information - The company paused collecting additional patient biopsies to investigate a performance issue with a release assay, resuming in November 2023 [9] - The company plans to participate in the Stifel 2025 Healthcare Conference following the earnings call [16] Q&A Session Summary Question: Expected timeline for patients to receive treatment - Management indicated that several patients have already received prior authorizations and are scheduled for biopsies in November and early 2026 [24] Question: Impact on profitability timeline due to treatment delay - Management does not foresee a significant impact on the timeline to profitability, maintaining guidance for the first half of 2026 [29] Question: Routine maintenance shutdown of the plant - A shutdown for routine maintenance is scheduled for mid-December to early January, as mandated by the FDA [32] Question: Current lead time for ZEVASKYN Product Order Forms - The current lead time is about three months, but management expects this to decrease as more patients progress through the process [36] Question: Attrition rate among patients with ZEVASKYN Product Order Forms - Management expects a high conversion rate among patients who have received ZPOFs, as these are motivated patients [44] Question: Prior authorization process for RDEB patients - The prior authorization process involves clinical and financial discussions, with most payers following inclusion/exclusion criteria from clinical trials [50] Question: Biopsies and sterility release criteria - Management confirmed that they have resumed biopsies and are not guiding on the number of biopsies completed yet [54] Question: Patients on background Vyjuvek or Filsuvez - Management does not have visibility into the exact number of patients currently on these treatments but expects many to be [58] Question: UMass not listed as a QTC - Different sites have various reasons for not being onboarded, including financial constraints and trade policy differences [62]