• Total Revenue: $46.3 million in Q3 2024, a 15% increase from $40.1 million in Q3 2023.
• Roxadustat Net Product Revenue in China: $46.2 million in Q3 2024, a 57% increase from $29.4 million in Q3 2023.
• Total Roxadustat Net Sales in China: $96.6 million in Q3 2024, a 25% increase from $77.1 million in Q3 2023.
• Operating Costs and Expenses: $63.1 million in Q3 2024, a 39% decrease from $103.6 million in Q3 2023.
• R&D Expenses: $21.7 million in Q3 2024, a 65% decrease from $61.2 million in Q3 2023.
• G&A Expenses: $17.6 million in Q3 2024, a 31% decrease from $25.6 million in Q3 2023.
• Net Loss: $17.1 million in Q3 2024, compared to a net loss of $63.6 million in Q3 2023.
• Cash, Cash Equivalents, and Accounts Receivable: $160 million as of September 30, 2024.
• Guidance for Full Year 2024 China Net Product Revenue: Between $135 million and $150 million.
• Guidance for Roxadustat Net Sales in China: Revised to $330 million to $360 million for full year 2024.

• Warning! GuruFocus has detected 7 Warning Signs with FGEN.

Release Date: November 12, 2024

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Positive Points

• FibroGen Inc (NASDAQ:FGEN) reported a 57% year-over-year increase in net product revenue for Roxadustat sales in China.
• The company has a solid cash position with $160 million in cash, cash equivalents, and accounts receivable, expected to fund operations into 2026.
• Roxadustat continues to perform well in China, maintaining a 45% market share and showing a 25% increase in total net sales year-over-year.
• FibroGen Inc (NASDAQ:FGEN) is advancing its oncology pipeline with FG-3246 and FG-3180, showing promising efficacy signals in prostate cancer treatment.
• The company has implemented significant cost reduction measures, reducing operating expenses by 39% year-over-year, and transitioning to a virtual work environment.

Negative Points

• FibroGen Inc (NASDAQ:FGEN) faces uncertainties with potential generic competition for Roxadustat in China, which could impact future revenue.
• The company recorded a net loss of $17.1 million for the third quarter of 2024, despite revenue growth.
• There is a potential delay in the approval of the chemotherapy-induced anemia indication, which could affect revenue projections.
• The company has experienced a decrease in development revenue, with expectations of it remaining below half a million dollars for the remainder of 2024.
• FibroGen Inc (NASDAQ:FGEN) has reduced its headcount by approximately 75% in the US, which may impact operational capabilities.

Q & A Highlights

Q: In the Phase 2 portion of the investigator-sponsored study, will the top-line results expected in the first half of next year include both the escalation and expansion cohorts? A: Yes, the top-line results will include data from both the escalation cohorts and the expansion cohort, which is dosed at 2.1 mg per kg along with 160 mg per day of Enzalutamide. The results will mature over time as more patients reach the six-month RPFS data point. (Thane Wettig, CEO)

Q: Regarding the PET imaging agent, how long do patients typically have to wait to get a PET image after administration? A: The expectation is that it will be days post-exposure to the PET imaging agent, not minutes. The exact number of days will be determined in the ongoing work at UCSF, but it is likely to be around six days. (Thane Wettig, CEO)

Q: For the Phase 2 trial planned for Q1 2025, will all 75 patients be imaged with FG-3180? A: The majority of the 75 patients will be treated with the imaging agent at the outset of therapy, followed by treatment with the ADC. The PET imaging agent will be ready shortly after the first patient is dosed in the monotherapy trial. (Thane Wettig, CEO)

Q: Can you explain the sequential decrease in guidance for Roxadustat net sales in the fourth quarter? A: The guidance considers a potential approval of the CIA indication, which would require accruing further into deferred revenue due to future expected performance. If the CIA approval flows into 2025, we may be on the higher end of the guidance spectrum. (Juan Graham, CFO)

Q: Was there a $12.5 million change in deferred revenue this quarter? A: Yes, there was a $12.5 million release from deferred revenue this quarter, which increased the revenue. However, if future expected revenue increases, we would need to defer more revenue, reducing the revenue for that specific quarter. (Juan Graham, CFO)

For the complete transcript of the earnings call, please refer to the full earnings call transcript.