Financial Data and Key Metrics Changes - Total revenue for Q2 2021 was $52.9 million, down from $90.1 million in Q2 2020, primarily due to lower collaboration revenue following the completion of the global Phase 3 clinical development program for vadadustat [26] - Net product revenue for Auryxia increased by 7.4% to $33 million in Q2 2021 compared to $30.7 million in Q2 2020, indicating strong commercial execution despite the ongoing COVID-19 environment [27] - The net loss for Q2 2021 was $83 million, an improvement from a net loss of $175.8 million in Q2 2020, attributed to the non-recurrence of a one-time impairment charge and lower operating expenses [30] Business Line Data and Key Metrics Changes - Auryxia's performance showed a positive trend with a 7.4% increase in net product revenue, reflecting the product's favorable profile and critical nature in treating patients [27] - Research and development expenses decreased to $37.2 million in Q2 2021 from $52.8 million in Q2 2020, driven by the completion of the INNO2VATE and PRO2TECT clinical programs [29] Market Data and Key Metrics Changes - The U.S. dialysis market represents a potential $2 billion opportunity, with approximately 560,000 dialysis patients expected to grow as the population ages [10][17] - The shift towards home dialysis is accelerating, with reports indicating it is the fastest-growing segment of the dialysis population, supported by CMS payment models [19] Company Strategy and Development Direction - The company aims to position vadadustat as a first-in-class treatment for anemia due to chronic kidney disease (CKD), leveraging its existing commercial footprint and nephrology-focused sales force [9][20] - The go-to-market strategy includes exclusive distribution relationships and a focus on both dialysis and non-dialysis markets, with plans to support rapid adoption post-approval [20][21] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in vadadustat's potential and the positive feedback from the kidney community regarding its Phase 3 data published in the New England Journal of Medicine [14][15] - The company is focused on pre-launch activities for vadadustat, anticipating a successful U.S. launch in 2022, subject to regulatory approval [17][24] Other Important Information - The company ended Q2 2021 with $247 million in cash and equivalents, sufficient to fund operations for at least the next 12 months [31] - The company expects to receive milestone payments from Otsuka upon vadadustat's approval, estimated at $15 million for dialysis and $50 million for non-dialysis indications [32] Q&A Session Summary Question: Could you talk about the likelihood of the FDA convening a panel for vadadustat? - Management indicated that the FDA previously stated not to expect a panel, but they are preparing for one just in case [37] Question: Can you confirm the MACE analysis population for vadadustat? - The analysis was an intent-to-treat analysis in the safety population, following patients until the study's completion [38] Question: What are the dynamics of home dialysis and the TDAPA process? - Home dialysis is a growing segment, and the company believes vadadustat is well-positioned for rapid adoption in this market [46][47] Question: How do the reimbursement dynamics differ between dialysis and non-dialysis? - Dialysis reimbursement is contract-driven at the organization level, while non-dialysis involves typical contracting with payers and PBMs [77] Question: Are there any updates on Auryxia's litigation? - The litigation is ongoing, and updates will be provided as they become available [63]
Akebia Therapeutics(AKBA) - 2021 Q2 - Earnings Call Transcript