Akebia Therapeutics(AKBA) - 2020 Q3 - Earnings Call Transcript

Financial Data and Key Metrics Changes - Total revenue for Q3 2020 was $60 million, down from $92 million in Q3 2019, primarily due to lower collaborative revenue as the company advanced the vadadustat development program [17][18] - Net product revenue for Auryxia increased by 14.6% to $34.4 million compared to $30.0 million in Q3 2019, although the company remains cautious due to the impact of CMS' non-coverage decision and COVID-19 uncertainties [19] - The company reported a net loss of $60 million for Q3 2020, compared to a net loss of $54.6 million in Q3 2019 [20] Business Line Data and Key Metrics Changes - Collaborative revenue decreased as development costs for vadadustat declined, with 80% of these costs reimbursed by Otsuka [18] - Royalty revenue from the sale of vadadustat in Japan amounted to $373,000 since its launch in late August 2020, indicating early commercial performance [18] Market Data and Key Metrics Changes - The potential market opportunity for vadadustat in the US is estimated at $2 billion, targeting over 500,000 adult patients with anemia due to CKD on dialysis [10][16] - The company is also preparing for a Marketing Authorization Application in Europe in collaboration with Otsuka [10] Company Strategy and Development Direction - The company aims to position vadadustat as a new oral standard of care for treating anemia due to CKD in dialysis patients, with a focus on regulatory submission for potential US approval [9][10] - Akebia is leveraging its renal expertise and existing nephrology-focused commercial organization to support a strong launch of vadadustat upon approval [11][12] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the INNO2VATE results, which they believe provide a straightforward path to advance vadadustat towards potential approval [9] - The company is focused on executing pre-commercialization activities and ensuring readiness for a strong launch, while also maintaining a robust publication plan to support vadadustat's potential [14][15] Other Important Information - The company ended Q3 2020 with cash, cash equivalents, and available-for-sale securities of $269.3 million, which is expected to fund operations beyond the anticipated US launch of vadadustat [21] Q&A Session Summary Question: Concerns about FDA acceptance of non-pre-specified analysis - Management clarified that the continuous age variable was pre-specified and that they are confident in the analysis presented to the FDA [24][25] Question: Plans for regulatory approval using a Priority Review Voucher - The company still has the option to use the PRV, but discussions with partners are ongoing [28][29] Question: Filing for NDAs for dialysis and non-dialysis patients - Management confirmed that there will be one NDA that includes both populations, and they are planning to file as early as possible next year [32] Question: Additional studies required by the FDA - No indication was given that additional studies would be necessary, and management expressed confidence in the data presented [46][47] Question: Differences in cardiovascular events between US and non-US patients - Management noted that the difference in MACE was driven by patients treated to a higher hemoglobin target outside the US, and emphasized that treating to a target of 10 to 11 does not increase cardiovascular risk [54][55]