FibroGen(US:FGEN)2020-11-08 12:12Financial Data and Key Metrics Changes - Total revenue for Q3 2020 was $44 million, compared to $33.2 million for Q3 2019, indicating a year-over-year increase [29] - Net income for Q3 2020 was $33 million, or $0.36 per basic share, compared to a net loss of $49.4 million, or $0.57 per basic share, in Q3 2019 [30][34] - Operating costs and expenses were $11.7 million for Q3 2020, down from $86 million in the same period last year [30] Business Line Data and Key Metrics Changes - Roxadustat sales in China reached $22.7 million in Q3 2020, up from $15.7 million in Q2 2020, reflecting strong market uptake [16] - Development revenue contributed $20.7 million, and sales of bulk drug product to AstraZeneca accounted for $2.3 million [29] Market Data and Key Metrics Changes - Roxadustat was listed in hospitals representing approximately 55% of the CKD anemia market opportunity in China by the end of Q3 2020, up from 45% at the end of Q2 2020 [17] - The number of patients treated with Roxadustat in China more than doubled from 40,000 to 90,000 from Q2 to Q3 2020, although sales did not match this rise [47][50] Company Strategy and Development Direction - The company aims to make Roxadustat the standard of care for treating CKD anemia in China and is preparing for its launch in the U.S. and other countries [18][19] - A new collaboration agreement with AstraZeneca is expected to improve profitability and predictability for the Roxadustat franchise [31] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in navigating challenges posed by the COVID-19 pandemic and highlighted a strong cash position of approximately $720 million at the end of Q3 2020 [36] - The company anticipates $245 million in potential milestones over the next nine months for expected U.S. and EU approvals [34] Other Important Information - The company is conducting ongoing Phase IIIb clinical trials for Roxadustat in the U.S. dialysis setting, with results expected in the first half of 2021 [71] - The company has a strong pipeline, with top-line data for various trials expected in 2021 and 2022 [24][27] Q&A Session Summary Question: Implications of a black box warning for Roxadustat - Management indicated that a black box warning could slow initial uptake but may not significantly impact long-term market potential, especially in the dialysis setting where similar warnings exist for current treatments [40][42] Question: Market dynamics in China regarding patient numbers and sales - Management clarified that the reported patient numbers are cumulative and do not directly correlate with sales, emphasizing strong underlying business fundamentals [49][51] Question: Launch trajectory for Roxadustat in dialysis and non-dialysis populations - Management expects a rapid ramp-up in the dialysis population and is focused on educating the market about the importance of treating anemia in the non-dialysis population [55][58] Question: Update on pamrevlumab pancreatic cancer study - Top-line resection data for the pamrevlumab study is expected in the second half of 2022 [66] Question: Engagement with large dialysis providers in the U.S. - Management confirmed ongoing discussions with large dialysis providers and expressed confidence in securing contracts post-approval [79] Question: Competitive landscape and LDL reduction data - Management believes that while LDL reduction data is beneficial, the overall cardiovascular safety profile is more critical for the product's acceptance [66][90]