FibroGen(FGEN) - 2024 Q2 - Earnings Call Transcript

Financial Data and Key Metrics Changes - Total revenue for Q2 2024 was $50.6 million, an increase of 14% year-over-year from$ 44.3 million in Q2 2023 [30] - Roxadustat net product revenue in China was $49.6 million, up 108% from$ 23.9 million in Q2 2023, driven by a 33% increase in volume and a deferred revenue release of $18 million [30][31] - Operating costs and expenses decreased by 53% year-over-year to$ 61.6 million from $132.4 million in Q2 2023 [34] - Net loss for Q2 2024 was$ 15.5 million, compared to a net loss of $87.7 million in Q2 2023 [36] Business Line Data and Key Metrics Changes - Roxadustat continues to perform well in China, with total net sales of$ 92.3 million in Q2 2024, a 21% increase from $76.4 million in Q2 2023 [26][32] - The company is raising its full-year 2024 guidance for net product revenue to between$ 135 million and $150 million, reflecting strong performance in the anemia of chronic kidney disease indication [11][34] Market Data and Key Metrics Changes - Roxadustat maintains a 46% market share in China as of May 2024, with expectations for continued growth despite the approval of generics [27][29] - The company anticipates an approval decision for chemotherapy-induced anemia in the second half of 2024, which could significantly enhance revenue [11] Company Strategy and Development Direction - The company is focusing on the development of FG-3246, a first-in-class antibody drug conjugate for metastatic castration-resistant prostate cancer, with plans to initiate a Phase 2 trial in early 2025 [10][25] - A significant cost reduction plan is being implemented, including a 75% reduction in U.S. workforce, to streamline operations following the disappointing results of pamrevlumab trials [9][36] - The company is exploring partnership opportunities for its remaining pipeline assets, including roxadustat in the U.S. for indications with high unmet needs [12][18] Management's Comments on Operating Environment and Future Outlook - Management expressed disappointment over the pamrevlumab trial results but emphasized the potential of FG-3246 and the strong performance of roxadustat in China [8][39] - The company expects its cash position of approximately$ 147.1 million to fund operations into 2026, despite recent challenges [15][38] Other Important Information - The company has regained rights to roxadustat in the U.S. and is actively seeking partnerships for its development [18][39] - The company has made significant advancements in derisking its immuno-oncology programs, with plans to initiate partnership discussions soon [14] Q&A Session Summary Question: Plans to accelerate FG-3246 development - Management confirmed that FG-3246 has always been a priority asset and will be prosecuted with speed, with an important FDA interaction planned [44] Question: Liquidity of cash generated in China - The company has been repatriating cash from China through registered debt facilities and is exploring additional avenues for cash repatriation [45] Question: Timeline for partnering preclinical candidates - Management indicated that discussions for partnering would begin immediately, with a focus on preclinical data for the anti-galectin-9 antibody and IND filing for CCR8 expected in 2025 [46][47] Question: Update on FG-3246's combination trial with enzalutamide - The combination study has shown promising results, with a bar for clinically meaningful radiographic progression-free survival set at around six months [51][52] Question: Impact of generic roxadustat on pricing - Management noted that while generics have been approved, they have not yet launched, and there are currently no plans to change pricing until subjected to volume-based purchasing [56][58]