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 -$0.10 per share, compared to a net loss of $30.3 million, or -$0.63 per share, in Q3 2024 [16] Business Line Data and Key Metrics Changes - The ZEVASKYN commercial launch is progressing, with growing patient demand and the activation of a third qualified treatment center (QTC), Children's Hospital Colorado [5][12] - The number of identified eligible patients at QTCs has more than doubled to approximately 30, up from over 12 previously reported [11] - The company has received ZEVASKYN Product Order Forms (ZPOFs) for 12 patients, indicating strong interest and movement towards treatment [10] Market Data and Key Metrics Changes - ZEVASKYN has received coverage decisions from all major commercial payers, covering over 80% of commercially insured lives, and has baseline coverage across all 51 state Medicaid programs [13] - A permanent product J-code for ZEVASKYN will be established by CMS effective January 1, 2026, which is expected to simplify 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] - The management is actively discussing the onboarding of additional EB centers across the U.S. to further expand ZEVASKYN's geographic footprint [12] - The company aims to achieve profitability in the first half of 2026, despite the delay in the first patient treatment [30] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving 2026 launch goals based on trends in patient demand and market access, despite a temporary delay in the first patient treatment [5][6] - The management highlighted the importance of maintaining high-quality standards in manufacturing personalized drug products [8] - The company is encouraged by the doubling of identified patients and the favorable payer landscape for ZEVASKYN [19] Other Important Information - The company has paused collecting additional patient biopsies to investigate and optimize a release assay that encountered performance issues [9] - The gene therapy program for X-linked retinoschisis, ABO-503, has been selected for the FDA Rare Disease Endpoint Advancement Pilot Program, which may accelerate development [18] Q&A Session Summary Question: Expected timeline for patients to receive treatment - Management indicated that several patients have already been scheduled for biopsy in November and early 2026, with treatment expected to follow if all paperwork is completed [24][26] Question: Impact on profitability timeline due to treatment delays - Management does not foresee a significant impact on the timeline for achieving profitability, maintaining guidance for the first half of 2026 [30] Question: Status of routine maintenance shutdown - The company confirmed a planned shutdown for routine maintenance starting mid-December and lasting about a month [34][35] Question: Biopsy collection during optimization pause - No biopsies were collected during the pause; the company prioritized resolving the assay issue before proceeding [36] Question: Lead time for ZEVASKYN Product Order Forms - Management expects the lead time to decrease as more patients progress through the treatment process and payer policies become established [39][42] Question: Attrition rate among patients with ZPOFs - Management anticipates a high conversion rate for patients with ZPOFs, as these are motivated patients who have expressed interest in treatment [47][49] 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 [52] Question: Revenue recognition timeline - Revenue is recognized when the product is administered to the patient, with cash flow considerations varying by site [58]