Akebia Therapeutics(AKBA) - 2021 Q3 - Earnings Call Transcript

Financial Data and Key Metrics Changes - Total revenue for Q3 2021 was $40.8 million, down from $60 million in Q3 2020, primarily due to lower collaboration revenues related to vadadustat [17][19] - Auryxia net product revenue increased by 7% to $36.8 million in Q3 2021 compared to $34.4 million in Q3 2020, reflecting a higher net revenue per pill and some one-time true-ups [17][19] - Net loss for Q3 2021 was $59.5 million, slightly improved from a net loss of $60 million in Q3 2020 [19] Business Line Data and Key Metrics Changes - Auryxia continues to show revenue growth despite challenges in the market due to COVID-19, with the team adapting to a hybrid approach for customer engagement [16][44] - The company is preparing for the launch of vadadustat, which is expected to address the unmet needs of over half a million adult patients on dialysis, representing a potential $2 billion market opportunity in the US alone [12][14] Market Data and Key Metrics Changes - There are approximately 560,000 dialysis patients in the US, with about 90% currently treated with erythropoiesis-stimulating agents (ESAs) [10] - The market opportunity for vadadustat is larger than previously anticipated, with the potential to be the first-in-class HIF-PHI in the US [9][55] Company Strategy and Development Direction - The company aims to establish vadadustat as the new oral standard of care for anemia due to CKD, focusing on both dialysis and non-dialysis markets [14][32] - Akebia is investing in pre-commercialization activities to differentiate vadadustat from current standards of care and ensure broad access for patients [15][16] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming PDUFA date for vadadustat, highlighting the potential for approval as a pivotal catalyst for the company [7][12] - The management team is optimistic about the market's reception of vadadustat, especially following positive feedback from the nephrology community regarding recent data presentations [23][24] Other Important Information - The company ended Q3 2021 with $207.2 million in cash and equivalents, which is expected to fund operations for at least the next 12 months [19][20] - Akebia has established a strong presence in the kidney community with Auryxia, which is expected to support the successful launch of vadadustat if approved [16] Q&A Session Summary Question: Feedback from the nephrology community on vadadustat - Management noted that nearly 60% of physicians are likely to prescribe HIF-PHIs, indicating positive reception of vadadustat data [23][24] Question: Update on potential FDA panel - The company is currently the only HIF-PHI in front of the FDA and has not received indications for a panel, but remains prepared for one [28] Question: Readiness for vadadustat launch - Management confirmed that they have adequate supply and a strong commercial team in place for a successful launch [42][56] Question: Growth drivers for Auryxia - Recent growth in Auryxia revenue is attributed to a resilient team adapting to market challenges, despite overall market difficulties [44][45] Question: Medicare Part D reimbursement for Auryxia - The company is actively seeking legislative solutions for IDA coverage while continuing to grow the hyperphosphatemia market [50][51]