David Martin

David Martin from Bloomberg asked if Aurinia expects global markets for LUPKYNIS to achieve similar penetration rates as the U.S. market. Martin also inquired whether physicians are combining B-cell and T-cell therapies for lupus nephritis or primarily choosing one over the other.

Answer

President and CEO Peter Greenleaf stated that global markets are not expected to catch up to U.S. penetration due to differing pricing, reimbursement, and guidelines, noting that international contributions are not a major percentage of the overall LUPKYNIS business. Regarding combination therapies, Greenleaf mentioned a rationale for combining B-cell and T-cell mediated therapies and that Aurinia is seeing discussions and planning internally to explore this through R&D. Chief Medical Officer Dr. Greg Keenan added that combining targeted B-cell and T-cell approaches makes logical sense compared to non-specific immunosuppression, and academics in the field are also posing this as an efficient treatment strategy.

David Martin asked if global markets for LUPKYNIS are expected to achieve similar penetration rates to the U.S. in the lupus nephritis patient population. Martin also inquired whether physicians are combining B-cell and T-cell therapies or primarily choosing one over the other in clinical practice.

Answer

Peter Greenleaf, President and CEO, stated that global markets are not expected to catch up to U.S. penetration due to differing pricing, reimbursement, and guideline implementation, noting that international contributions are not a major percentage of the overall LUPKYNIS business. Regarding combination therapy, Greenleaf acknowledged the rationale for combining B-cell and T-cell mediated therapies for faster or more effective proteinuria reduction, and mentioned internal discussions and planning for potential R&D work in this area. Dr. Greg Keenan, Chief Medical Officer, added that combining targeted B-cell and T-cell approaches is a logical scientific direction for more efficient treatment, and the company intends to explore this further.

David Martin asked if the presence of ANDA filers implies they have solved the difficult LUPKYNIS manufacturing process. He also inquired about the timeline for major events in the patent litigation and what endpoints in the AUR200 Phase I data could differentiate it from other APRIL/BAFF inhibitors.

Answer

President and CEO Peter Greenleaf stated the company has no insight into the ANDA filers' manufacturing capabilities but hasn't changed its position on its own proprietary process. He declined to provide a timeline for the ongoing litigation. For AUR200, Greenleaf explained that the Phase I data will reveal key PK/PD properties like half-life and impact on biomarkers (IgG, IgA, IgM), which will allow the market to assess its profile against competitors.

David Martin of Bloom Burton & Co. asked how ABCL575 is positioned against IL receptor antibodies like Dupixent, whether it would compete for first- or second-line therapy, and if there is evidence that patients who fail IL-4 therapies might respond to an OX40 ligand approach.

Answer

President and CEO Dr. Carl Hansen opined that the OX40/OX40L mechanism would likely enter as a second-line therapy behind Dupixent but could eventually compete for first-line due to potential advantages in durability. He noted that while not clinically proven, the biology suggests it would be an orthogonal therapy, and anecdotal data from other drugs supports the idea that it could be effective in patients who fail Dupixent.