Rick Miller

Rick Miller from Cantor Fitzgerald asked for an update on ADMA Biologics' efforts to expand third-party supply contracts for RSV plasma and secure additional sourcing.

Answer

President and CEO Adam Grossman confirmed that third-party supply agreements are performing well, with increased plasma collection and ongoing testing. He noted a new supply contract with the acquirer of three divested plasma centers, adding 30 centers initially and projected to grow to 50, bringing total access to over 280 collection centers. He also acknowledged strong partnerships with Grifols and Kedrion, emphasizing the normalized collection of RSV plasma.

Rick Miller, on behalf of Kristen Kloska, asked for additional color on the factors driving management's confidence in raising revenue guidance for the back half of 2025 and into 2026.

Answer

President and CEO Adam Grossman attributed the confidence to record ASCENIV utilization, strong product pull-through, positive real-world physician and patient experiences, the impact of direct-to-patient medical education programs, and new institutional adoptions. CFO and Treasurer Brad Tade added that the raised 2026 guidance reflects 24% year-over-year revenue growth, 51% adjusted EBITDA growth, and 61% adjusted net income growth.

Rick Miller sought additional details on the factors driving ADMA Biologics' confidence in raising revenue guidance for the second half of the current year and into the next year. He also asked about any remaining gating factors after the FDA's lot release of yield-enhanced product before its expected impact in the fourth quarter.

Answer

President and CEO Adam Grossman attributed the confidence to record product pull-through, real-world physician and patient experiences, and increased product availability. He also cited the positive impact of direct-to-patient medical education programs and the field team's success in onboarding new institutions. CFO Brad Tade highlighted the raised 2026 guidance, projecting 24% year-over-year revenue growth, 51% adjusted EBITDA growth, and 61% adjusted net income growth. Adam Grossman confirmed there are no further gating factors, stating that the majority of product sales in Q4, including ASCENIV and BIVIGAM, are expected to be from yield-enhanced product, expressing excitement for Q4 and 2026.

Rick Miller inquired whether the issues raised in the UX111 IRL were expected and asked for any insights. He also questioned how the strategic restructuring impacts the priorities of the gene therapy pipeline.

Answer

Emil Kakkis, Chief Executive Officer and President, clarified that the IRL issues were known, but the FDA is now requiring all supportive documentation (e.g., SOPs, follow-ups on effectiveness) to be included in the BLA resubmission, which is typically provided during an inspection. Regarding the gene therapy pipeline, he stated the restructuring focuses on getting late-stage programs approved, with plans to diversify the pipeline beyond gene therapy while continuing some work in the area.

Rick Miller asked if the issues raised in the UX111 IRL were expected and requested any insights into them. He also inquired about how the strategic restructuring impacts priorities within the gene therapy pipeline.

Answer

CEO Emil Kakkis clarified that the IRL issues were known to both parties, but the FDA is now requiring all supportive documentation (e.g., SOPs, follow-ups on effectiveness) to be included in the BLA resubmission, which is typically provided during an inspection. He confirmed they have the answers and will provide the substantial documentation promptly. Regarding the gene therapy pipeline, Kakkis stated that the restructuring focuses on getting late-stage programs approved (two gene therapies at BLA, OTC in Phase 3, Wilson in Phase 2). While they had hoped to advance another gene therapy, the current focus is on existing assets, and the company aims for diversification beyond gene therapy in its early-stage pipeline.

Rick Miller (Cantor Fitzgerald) asked about the planned December plant shutdown for routine maintenance, its reopening timeline, and if any biopsies collected before the temporary pause required re-biopsy.

Answer

Vishwas Seshadri (CEO, Abeona) confirmed the plant shutdown from mid-December to early January for about a month. Brian Kevany (SVP, Chief Technical Officer, and Chief Scientific Officer, Abeona) clarified this is an FDA-mandated requirement for general maintenance and recalibrations. Vishwas Seshadri (CEO, Abeona) stated that no biopsies were collected and not sent to manufacturing before the temporary pause, as the company proactively avoided collecting new biopsies until the assay issue was resolved.

Rick Miller of Cantor Fitzgerald asked about the specific factors that made Lurie Children's the first activated treatment center and sought details on the wound profiles of patients contacting the Abeona Assist hub.

Answer

Chief Commercial Officer Dr. Madhav Vasanthavada explained that patient selection for initial treatment slots depends on clinical manifestation and insurance type, with commercially insured patients likely having faster access. Regarding patient inquiries, he stated that callers represent a wide age spectrum and typically have large wounded body areas, though specific wound profiles are not collected by the hub. CEO Dr. Vish Seshadri added that they receive consolidated updates, not patient-specific health information.

Rick Miller from Cantor Fitzgerald asked about promising signals from preclinical models of ImmTOR-IL regarding long-term follow-up post-dosing and inquired about the key criteria for selecting future autoimmune indications beyond having a known auto-antigen.

Answer

Chief Scientific Officer Takashi Kishimoto highlighted ESGCT data showing ImmTOR plus an engineered IL-2 mitigated immune responses out to Day 131. President and CEO Carsten Brunn added that while the platform has broad applicability, the initial focus for new indications is on liver-directed autoimmune diseases like PBC, where ImmTOR naturally accumulates.