US-based biotechnology company FibroGen Inc., (NASDAQ: FGEN) has reported its financial results for the third quarter of 2023, showcasing a significant year-on-year (YOY) increase in global sales. The company’s revenues rose by 155% to USD 40.1 million, reflecting the success of its anti-anemia drug for chronic kidney disease (CKD), Evrenzo (roxadustat), in the Chinese market through a joint venture (JV) with AstraZeneca (AZ, NASDAQ: AZN).
Revenues and JV Performance in China
FibroGen’s JV with AstraZeneca reported sales of USD 77.1 million during the quarter, marking a 31% increase YOY. FibroGen’s share of these revenues amounted to USD 29.4 million. This substantial growth in China contributes significantly to the company’s overall financial performance.
Net Loss Reduction and Cash Holdings
The company’s net losses were reduced to USD 63.6 million, down from USD 91.7 million a year prior. FibroGen’s cash holdings stand at USD 283.0 million, providing a solid financial foundation for ongoing operations and future investments.
International Marketing and Revenue from API Supply
Roxadustat, a first-in-class hypoxia-inducible factor–prolyl hydroxylase (HIF-PH) inhibitor, is approved in Europe, Japan, and other markets, with Astellas responsible for marketing the drug. In Q3, FibroGen received USD 1.3 million in drug product revenue from supplying the active pharmaceutical ingredients for roxadustat to Astellas.
Pipeline Developments and Filings
FibroGen has filed a supplementary filing in China to expand roxadustat’s approval to treat chemotherapy-induced anemia (CIA), with an approval decision expected in mid-2024. The company is also continuing the development of pamrevlumab, a first-in-class connective tissue growth factor (CTGF) inhibitor, despite reporting negative Phase III results earlier this year for the treatment of ambulatory patients with Duchenne muscular dystrophy (DMD). FibroGen awaits data from one Phase III and another Phase II/III trial for pamrevlumab in locally advanced unresectable pancreatic cancer (LAPC) and metastatic pancreatic cancer, respectively, in the upcoming quarters.
Future Pipeline Plans
In addition to its ongoing trials, FibroGen plans to initiate a Phase I monotherapy trial for FG-3246, a first-in-class antibody-drug conjugate (ADC) targeting a novel epitope on CD46 for metastatic castration-resistant prostate cancer (mCRPC), with results expected by Q1’24.-Fineline Info & Tech
