• Total Revenue: $50.6 million for Q2 2024, a 14% increase year-over-year.
• Roxadustat Net Product Revenue in China: $49.6 million for Q2 2024, a 108% increase year-over-year.
• Total Roxadustat Net Sales in China: $92.3 million for Q2 2024, a 21% increase year-over-year.
• Operating Expenses: $61.6 million for Q2 2024, a 53% decrease year-over-year.
• R&D Expenses: $34.1 million for Q2 2024, a 64% decrease year-over-year.
• SG&A Expenses: $22.3 million for Q2 2024, a 29% decrease year-over-year.
• Net Loss: $15.5 million for Q2 2024, compared to $87.7 million in Q2 2023.
• Cash, Cash Equivalents, and Accounts Receivable: $147.1 million as of June 30, 2024.
• Roxadustat Net Sales Guidance for China 2024: $320 million to $350 million.
• FibroGen China Net Product Revenue Guidance for 2024: $135 million to $150 million.

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

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 (NASDAQ:FGEN) 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 (NASDAQ: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 (NASDAQ: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.