FibroGen(US:FGEN)2025-11-10 21:11Financial Performance - For the three months ended September 30, 2025, revenue was $1.1 million, a decrease from $5.2 million in the same period in 2024[149]. - Loss from continuing operations for the three months ended September 30, 2025, was $13.1 million, or $3.25 per share, compared to a loss of $48.3 million, or $12.01 per share, in the same period in 2024[153]. - For the three months ended September 30, 2025, total revenue increased by $1.0 million, or 775%, compared to the same period in 2024, while for the nine months, it decreased by $21.3 million, or 81%[204]. - Net drug product revenue for the three months ended September 30, 2025, was $957,000, a 465% increase, while for the nine months, it was $4.8 million, an 81% decrease compared to the same periods in 2024[206]. - The company recorded net product revenue of $167.2 million for the three months ended September 30, 2025, compared to $46.2 million in 2024, and $226.7 million for the nine months ended September 30, 2025, compared to $126.4 million in 2024[199]. Operating Costs and Expenses - Operating costs and expenses for the three months ended September 30, 2025, were $6.5 million, down from $47.8 million in the same period in 2024, primarily due to a $18.6 million restructuring charge in Q3 2024[150]. - Total operating costs and expenses decreased by $41.3 million, or 86%, for the three months ended September 30, 2025, and decreased by $132.2 million, or 78%, for the nine months ended September 30, 2025, compared to the same periods a year ago[216]. - Research and development expenses decreased by $18.8 million, or 94%, for the three months ended September 30, 2025, and decreased by $72.6 million, or 82%, for the nine months ended September 30, 2025, compared to the same periods a year ago[220]. - Selling, general and administrative expenses decreased by $4.1 million, or 43%, for the three months ended September 30, 2025, and decreased by $20.5 million, or 50%, for the nine months ended September 30, 2025, compared to the same periods a year ago[221]. Cash and Investments - Cash and cash equivalents increased to $118.0 million as of September 30, 2025, from $50.5 million at December 31, 2024, following the sale of China operations[154]. - Cash and cash equivalents, investments, and accounts receivable totaled $121.1 million at September 30, 2025[238]. - Net cash provided by operating activities was $13.6 million for the nine months ended September 30, 2025, primarily due to a net income of $197.7 million adjusted for non-operating cash items[240]. - Net cash used in financing activities was $86.0 million for the nine months ended September 30, 2025, including $75.0 million to pay off senior secured term loan facilities[248]. - Net cash provided by investing activities was $87.1 million for the nine months ended September 30, 2025, mainly from $90.2 million net proceeds from the divestiture of FibroGen International[245]. Business Developments - The company initiated a Phase 2 monotherapy dose optimization study of FG-3246 for metastatic castration-resistant prostate cancer (mCRPC) in Q3 2025, with interim results expected in the second half of 2026[163]. - The Phase 2 trial will enroll 75 patients and evaluate the optimal dose of FG-3246 based on efficacy, safety, and pharmacokinetics[164]. - The company plans to submit the Phase 3 trial protocol for roxadustat in anemia associated with lower-risk myelodysplastic syndromes to the FDA in Q4 2025[148]. - The planned Phase 3 trial for roxadustat will involve approximately 200 patients with lower-risk MDS, focusing on safety and efficacy[169]. - FibroGen is developing FG-3180, a companion PET imaging agent, to assess the diagnostic performance in identifying mCRPC lesions[163]. Collaborations and Agreements - The collaboration agreements with Astellas and AstraZeneca have generated a total of $790.1 million through September 30, 2025[188]. - FibroGen terminated the AstraZeneca U.S./RoW Agreement on February 25, 2024, returning all non-China roxadustat rights, with total consideration received of $439.0 million[192]. - The company retains rights to roxadustat in the U.S., Canada, and Mexico, while Astellas is commercializing it in Europe and Japan[147]. - FibroGen recognized a cumulative catch-up net adjustment of $25.7 million to drug product revenue in Q1 2024 due to the termination of the AstraZeneca U.S./RoW Agreement[215]. Discontinued Operations - The operating results related to FibroGen International are classified as discontinued operations in the condensed consolidated statements of operations[232]. - The company entered into a Share Purchase Agreement with AstraZeneca to sell all equity interests of FibroGen International, which closed on August 29, 2025[231]. - FibroGen received $210.4 million in cash at the closing of the sale of FibroGen International to AstraZeneca on August 29, 2025, with an additional $10.0 million subject to holdbacks[234]. Future Outlook - FibroGen expects future revenues to fluctuate due to the uncertain timing and amount of collaboration agreement payments and drug product sales[203]. - The company anticipates needing substantial additional funding for ongoing operations and development efforts[251]. - As of September 30, 2025, the company had $65.0 million of liability related to the sale of future revenues under the RIFA with NovaQuest[253].