FibroGen(US:FGEN)2022-08-09 02:41Financial Data and Key Metrics Changes - Total revenue for Q2 2022 was $29.8 million, a 22% increase from $24.4 million in Q2 2021 [29] - Net product revenue from roxadustat sales in China was $23.3 million, compared to $13.4 million in the same period last year [29] - Net loss for Q2 2022 was $72.6 million, or $0.78 per share, compared to a net loss of $134 million, or $1.45 per share, in Q2 2021 [37] Business Line Data and Key Metrics Changes - Roxadustat net sales in China totaled $53.1 million, slightly up from $52.8 million in Q2 2021, driven by an over 80% increase in volume [23][31] - Development revenue associated with co-development efforts for roxadustat was $5.5 million, down from $19.66 million in Q2 2021 [30] - Drug product revenue for roxadustat bulk drugs was $1.1 million, compared to a negative $8.6 million in the same period last year [30] Market Data and Key Metrics Changes - Roxadustat continues to be the number one branded treatment for anemia of CKD, with significant growth in volume expected to continue [25] - The diagnosed prevalence of idiopathic pulmonary fibrosis (IPF) is approximately 330,000 patients across the US, EU, China, and Japan, representing a significant market opportunity [15] - The pancreatic cancer market has over 90,000 diagnosed patients, with a low five-year disease-free survival rate of around 10%, indicating a large unmet need [17] Company Strategy and Development Direction - The company is focused on three areas: accelerating the development of Pamrevlumab in three indications, ensuring commercial success of roxadustat outside the US, and increasing research productivity [7][8] - The company expects topline data in 2023 from multiple pivotal Phase 3 trials, including Zephyrus-1 for IPF and LELANTOS trials for DMD [14][41] - The company aims to leverage its strong financial position, with $517.6 million in cash, to support ongoing and future clinical trials [38][42] Management's Comments on Operating Environment and Future Outlook - Management highlighted the strong performance of roxadustat in China, despite COVID-related challenges, and expressed optimism for continued growth [27][66] - The company anticipates further releases of deferred revenue in future quarters, indicating a positive outlook for cash flow [34] - Management emphasized the significant unmet needs in the therapeutic areas being targeted, particularly for IPF and DMD, and the potential for Pamrevlumab to address these needs [16][20] Other Important Information - The company has filed a prospectus supplement for an at-the-market equity offering, although there are no near-term plans to utilize it [40] - The company is committed to advancing Pamrevlumab as a potential first-in-class medicine in Phase 3 development [41] Q&A Session Summary Question: Any updates on the interim analysis for IPF and DMD studies? - Management confirmed there are no planned interim analyses for the IPF or DMD studies, but all have independent safety monitors [46] Question: Can you provide more details on the IPF opportunity and trial design? - The IPF trial is placebo-controlled, allowing treatment-naive and treatment-experienced patients, but they cannot be on background therapy when entering the trial [51] Question: What is the status of the DMD studies and their endpoints? - Endpoints for the DMD studies have been discussed with the FDA, and if efficacy is demonstrated, there is a path forward for filing approval [48][62] Question: How has COVID impacted performance in China? - Management noted that while COVID has affected revenues, roxadustat has seen an increase in volume, suggesting a net positive impact [66] Question: Will the results from LELANTOS-1 and LELANTOS-2 be sufficient for separate filings? - Management believes either study could support a filing based on strong data, given the high unmet need in DMD [77]