Release Date: August 06, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- FibroGen Inc (FGEN, Financial) reported a significant increase in roxadustat net product revenue in China, with a 108% year-over-year growth for the second quarter of 2024.
- The company raised its full-year 2024 guidance for roxadustat net sales in China due to strong performance, expecting between $320 million to $350 million.
- FG-3246, a first-in-class ADC targeting CD46, showed promising results in Phase 1 trials for metastatic castration-resistant prostate cancer, with a median radiographic progression-free survival of 8.7 months.
- FibroGen Inc (FGEN) maintains a strong cash position with approximately $147.1 million in cash, cash equivalents, and accounts receivable, expected to fund operations into 2026.
- The company is exploring potential partnering opportunities for its regained rights to roxadustat in the US and other territories, which could open new revenue streams.
Negative Points
- The pamrevlumab clinical trials in pancreatic cancer did not meet the primary endpoint of overall survival, leading to a significant cost reduction plan and a 75% reduction in US headcount.
- FibroGen Inc (FGEN) recorded a net loss of $15.5 million for the second quarter of 2024, although this was an improvement from the previous year.
- The company is winding down its internal development of two immuno-oncology programs due to organizational changes and resource constraints.
- There is potential for future competition from generic versions of roxadustat in China, which could impact market share and pricing.
- The performance of roxadustat in Astellas territories has been weaker than expected, affecting future forecasted cash inflows related to these regions.
Q & A Highlights
Q: Given the singular focus on FG-3246 now, do you have any plans on accelerating its development to maximize the asset's value for shareholders? Also, how do you as a US entity access the cash derived from roxadustat revenue in China?
A: Thane Wettig, CEO: FG-3246 has always been a priority asset, and we are prosecuting it with speed. We have an important interaction with the FDA this quarter to inform the Phase 2 trial design. Juan Graham, CFO: We have been repatriating cash from China through a registered debt facility and are exploring other avenues to continue this process.
Q: How soon could you look to partner your two preclinical candidates, and would you wait for Phase 1 data or proceed with preclinical data?
A: Thane Wettig, CEO: We plan to showcase a preclinical data set to potential partners. Our anti-galectin-9 antibody has an extensive data set, and we feel confident about the optimization work on our CCR8 antibody. We will start partnership activities immediately.
Q: What's the nature of the update we can expect from the top-line data of FG-3246's combo trial with enzalutamide? What would be considered a clinically meaningful PFS benefit?
A: Deyaa Adib, CMO: The combination study has shown encouraging results with a 10.2-month radiographic PFS in heavily pretreated patients. The current bar for this setting is around six months. We expect to publish top-line results from the combination study in the first half of 2025, with a total of 36 patients.
Q: Can you comment on how much of the updated guidance is driven by potential approval of a CIA indication versus continued volume growth from the CKD indication? Also, what are your thoughts on the pricing impact from the generic launch of roxadustat?
A: Thane Wettig, CEO: The guidance raise is due to strong performance in the CKD indication alone. Christine Chung, SVP China Operations: We have not seen the launch of generics in the market yet, and there are no plans to change pricing until we are subject to volume-based purchasing.
Q: Regarding FG-3246, beyond PET positive patients, is there any other population that might benefit from the combination?
A: Thane Wettig, CEO: The Phase 2 trial will explore the correlation between CD46 expression and response to the drug. Deyaa Adib, CMO: While PET46 pre-selection is the primary focus, there could be opportunities in all-comers if data continues to show strong signals.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
