Financial Data and Key Metrics Changes - In Q2 2025, net product sales reached approximately $94.8 million, representing an 82% year-over-year growth [22][24] - FILSPARI net product sales in the U.S. were approximately $71.9 million, showing significant year-over-year growth [22][16] - The net loss for Q2 2025 was $12.8 million or $0.14 per basic share, compared to a net loss of $70.4 million or $0.91 per basic share for the same period in 2024 [25] Business Line Data and Key Metrics Changes - FILSPARI's performance in the IgA nephropathy market was highlighted, with strong demand from both new and repeat prescribers [5][16] - The commercial team reported 745 new patient start forms in Q2, a 43% increase compared to the same period last year [17] - THIOLA and THIOLA EC contributed $23 million in net product sales for the second quarter [22] Market Data and Key Metrics Changes - The company is preparing for a potential launch of FILSPARI for FSGS, with a PDUFA date set for January 13, 2026 [14] - The addressable patient population for FILSPARI in the U.S. is estimated at 70,000, with about 70% having elevated proteinuria levels below 1.5 grams per gram [81] Company Strategy and Development Direction - The company aims to establish FILSPARI as the foundational therapy for IgA nephropathy and is advancing its pipeline for rare diseases [5][10] - The strategy includes generating robust clinical evidence, broad access aligned with full approval indications, and real-world clinical experience [6][7] - The company is focused on expanding its commercial organization in preparation for the potential FSGS launch [19] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the continued growth of FILSPARI, driven by robust underlying demand and the anticipated removal of certain REMS [26][20] - The management team highlighted the importance of early intervention in treatment and the growing recognition of FILSPARI's nephroprotective profile [18][19] - The company remains optimistic about its strategy and the feedback from the medical community [20] Other Important Information - The company recognized $19.6 million in licensing collaboration revenue, including a one-time milestone payment of $17.5 million from CSL Vifor [23] - As of June 30, 2025, the company had cash, cash equivalents, and marketable securities totaling approximately $319.5 million [25] Q&A Session Summary Question: What do you anticipate the major topics could be for the FSGS AdCom? - Management indicated the need for educational components about the disease and the importance of proteinuria as a validated endpoint [31][34] Question: Can you comment on the cadence and level of engagement with the FDA regarding the REMS update for FILSPARI? - Management noted that interactions with the FDA have been progressing as expected, similar to previous experiences [38][40] Question: When will you gain insight into the timing of the advisory committee panel meeting? - Management stated that the advisory committee meeting is expected to take place sometime in Q4, given the PDUFA date of January 13 [45][47] Question: What would it take to remove the REMS entirely? - The strategy involves a two-step process, first seeking to lessen testing frequency and then pursuing full removal [51][52] Question: How are the new data from recent studies being received by the medical community? - The data have been received positively, with excitement about the nephroprotective effects of FILSPARI [54][56] Question: Can you comment on the dynamics and breakdown of growth contributions from stocking, new patients, and persistence rates? - Management confirmed that the revenue growth was performance-driven, with high persistence rates and strong demand [59][62] Question: What are the headwinds or bottlenecks in terms of uptake? - Management identified the urgency to treat patients as a key issue, but noted that the introduction of new treatment options is expected to help [105][106]