FibroGen Q1 2024 Financial Results

FibroGen, Inc., a biopharmaceutical company based in San Francisco, has released its financial results for the first quarter of 2024 and provided updates on significant developments. The company is marking a robust start to the year, propelled by notable advancements in its oncology pipeline and strong sales performance in China.

One of the key highlights is the release of promising Phase 1 data for FG-3246, a CD46-targeted antibody-drug conjugate, in the treatment of metastatic castration-resistant prostate cancer. This data suggests potential efficacy and safety, setting the stage for further clinical development. Additionally, FibroGen's roxadustat business in China continues to grow significantly, contributing to a 55% year-over-year increase in net revenue for the first quarter, totaling $55.9 million.

FibroGen's Chief Executive Officer, Thane Wettig, expressed optimism about the recent progress and future prospects. He highlighted the upcoming topline data from two critical late-stage clinical trials involving pamrevlumab for pancreatic cancer. Specifically, the Pancreatic Cancer Action Network (PanCAN) Precision PromiseSM Phase 2/3 study is expected to provide topline data on metastatic pancreatic cancer by mid-2024, while the LAPIS Phase 3 study will deliver insights into locally advanced unresectable pancreatic cancer by the third quarter of 2024.

The company's financial health remains solid, with cash, cash equivalents, investments, and accounts receivable totaling $214.7 million as of March 31, 2024. This financial cushion is projected to sustain operations into 2026, reinforcing FibroGen's confidence in its long-term strategic plans.

In China, the performance of roxadustat has been particularly noteworthy. The first quarter saw net product revenue of $30.5 million from roxadustat sales, reflecting a 26% increase compared to the same period in 2023. Total roxadustat sales in China, including contributions from the joint distribution entity with AstraZeneca, reached $79.4 million, marking a 24% increase year-over-year. The drug continues to dominate the anemia of chronic kidney disease (CKD) market in China, driven by a 39% increase in volume.

Looking ahead, FibroGen anticipates several important milestones. The company expects a decision on the approval of roxadustat for chemotherapy-induced anemia (CIA) in China in the second half of 2024. If approved, this could trigger a $10 million milestone payment from AstraZeneca. Additionally, the oncology pipeline is set to expand with initial data from a Phase 1 study of FG-3246 in combination with enzalutamide for metastatic castration-resistant prostate cancer, expected to be presented at ASCO 2024. Furthermore, a Phase 2 monotherapy dose optimization study for FG-3246 is planned for the second half of 2024, with an IND filing for FG-3175, an anti-CCR8 monoclonal antibody, slated for 2025.

The recent appointment of Deyaa Adib, MD as Chief Medical Officer underscores FibroGen's commitment to advancing its clinical programs. Dr. Adib brings extensive experience to the role, which will be instrumental in guiding the company's ongoing and future clinical trials.

In summary, FibroGen's first quarter of 2024 has been characterized by significant clinical advancements, strong financial performance, and strategic initiatives aimed at extending its cash runway and expanding its therapeutic portfolio. With several key milestones on the horizon, the company is well-positioned to continue its momentum in the biopharmaceutical landscape.