Financial Data and Key Metrics Changes - Total revenues increased to $57.3 million in Q1 2025 from $32.6 million in Q1 2024, primarily driven by net product revenues which rose to $55.8 million from $31 million [22][25] - Net income for Q1 2025 was $6.1 million compared to a net loss of $18 million in Q1 2024, reflecting strong revenue growth [25][26] - Cost of goods sold decreased to $7.6 million in Q1 2025 from $11.6 million in Q1 2024, attributed to the full amortization of a non-cash charge related to Auryxia [23][24] Business Line Data and Key Metrics Changes - Vafcio generated $12 million in net product revenues in Q1 2025, exceeding guidance of $10 million to $11 million [6][22] - Auryxia net product revenues increased to $43.8 million in Q1 2025 from $31 million in Q1 2024, despite losing IP exclusivity [22][23] Market Data and Key Metrics Changes - The top five dialysis organizations have ordered Vafcio, with revenues primarily coming from small to mid-sized dialysis organizations treating approximately 150,000 patients [8][14] - The VOICE study is progressing towards full enrollment, with about 75% of the target 2,200 subjects enrolled [10] Company Strategy and Development Direction - The company aims to expand the use of Vafcio in both dialysis and non-dialysis patient populations, with plans to initiate a Phase III VALOR trial in the second half of 2025 [10][11] - The focus remains on increasing the breadth and depth of prescribing among current customers while unlocking new customers [21][27] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the strong early performance of Vafcio, highlighting the importance of prescriber education and patient retention [6][21] - The company is confident in its financial position and ability to achieve profitability based on its current operating plan [26][27] Other Important Information - The company ended Q1 2025 with $113.4 million in cash and cash equivalents, bolstered by a public offering that raised over $46 million [26] - The company has at least 12 months of Vafcio inventory on hand in the U.S. and does not expect significant tariff-related impacts [24] Q&A Session Summary Question: Update on timelines for adding Vafcio to protocols at large dialysis organizations - Management indicated that a large pilot is planned to operationalize protocols, with training expected to take about a month, followed by a pilot duration of two to three months [29][31][34] Question: Shift from Auryxia prescriptions to authorized generic - Management noted that the impact of the authorized generic has been minimal in Q1 2025, with expectations that it will not significantly affect business in Q2 [46][48][49] Question: Net price dynamics as large dialysis providers come on board - Management acknowledged that net prices may decrease as volumes increase, but there will be variability in pricing due to the competitive environment [53][55] Question: Demand drivers for Vafcio and reimbursement trends - Management highlighted that demand is driven by clinical efficacy and economic incentives, with positive trends in Medicare Advantage coverage [70][72][78] Question: Inventory stocking trends with large dialysis organizations - Management expects initial stocking for pilots but does not anticipate significant issues with inventory levels due to efficient distribution networks [84][88] Question: Market landscape for label expansion opportunities - Management expressed excitement about the non-dialysis market, which is comparable in size to the dialysis market, and emphasized the potential for significant revenue growth [90][92][94]