FibroGen Q2 2024 Financial Results and Business Update

FibroGen, Inc. recently announced its financial outcomes for the second quarter of 2024 and shared updates on its operational strategies and research developments.

One of the key announcements was the company's decision to implement a major cost-reduction plan in the U.S. This initiative includes a 75% reduction in its U.S. workforce. This decision was influenced by the disappointing outcomes of late-stage trials for pamrevlumab in pancreatic cancer. Consequently, FibroGen is redirecting its focus and research investments towards FG-3246 and PET46, which hold promise for treating metastatic castration-resistant prostate cancer (mCRPC).

FG-3246, an anti-CD46 antibody-drug conjugate, showed encouraging results in a Phase 1b/2 study. Combined with enzalutamide, FG-3246 demonstrated a median radiographic progression-free survival (rPFS) of 10.2 months in mCRPC patients. A substantial portion of these patients, 71%, showed a decline in prostate-specific antigen levels. The company expects to release topline results from the Phase 2 portion of the study in the first half of 2025. Additionally, FibroGen anticipates the initiation of a Phase 2 monotherapy dose optimization study for FG-3246 in early 2025.

Financially, the company saw a net revenue growth of 14% in the second quarter compared to the same period last year. This growth was largely driven by the performance of roxadustat in China, with a 33% increase in volume year-over-year. Roxadustat's net sales in China amounted to $92.3 million for the quarter. As a result, FibroGen has raised its full-year net product revenue guidance to a range of $135 million to $150 million, expecting total roxadustat sales in China to fall between $320 million and $350 million.

At the end of June 2024, FibroGen reported $147.1 million in cash, cash equivalents, and accounts receivable, projecting its cash runway to extend into 2026. Despite a net loss of $15.5 million for the second quarter, a significant reduction from the $87.7 million loss reported in the same quarter of the previous year, the company remains optimistic about its financial health and future prospects.

Thane Wettig, CEO of FibroGen, expressed a mix of disappointment and optimism. While the results from the pamrevlumab pancreatic cancer trials were not as hoped, Wettig highlighted the promising future of FG-3246 and PET46. He also acknowledged the robust sales performance of roxadustat in China.

Recent results from the pamrevlumab trials were less favorable. The drug did not meet primary endpoints in both the PanCAN Precision Promise Phase 2/3 trial for metastatic pancreatic ductal adenocarcinoma (mPDAC) and the LAPIS Phase 3 study for locally advanced, unresectable pancreatic cancer (LAPC).

Looking ahead, the company is focused on its oncology pipeline, particularly FG-3246. Topline results from ongoing studies are expected in the first half of 2025, and new trials are set to begin in early 2025.

FibroGen also anticipates an approval decision for roxadustat for chemotherapy-induced anemia in China in the latter half of 2024. If approved, this could bring a $10 million milestone payment from AstraZeneca.

In summary, FibroGen is undergoing significant strategic shifts in response to recent clinical trial results and market performance. The focus is now on advancing promising candidates in their oncology pipeline and capitalizing on the strong market performance of roxadustat in China. Despite recent setbacks, the company is positioning itself for potential future successes with a streamlined focus and strategic investments in promising therapies.

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