FibroGen(FGEN)2023-11-05 16:00Financial Performance - Revenue for Q3 2023 was $40.1 million, a 155.5% increase from $15.7 million in Q3 2022[163] - Net loss for Q3 2023 was $63.6 million, compared to a net loss of $91.7 million in Q3 2022, reflecting improved revenue and reduced operating costs[165] - Total revenue increased by $24.4 million, or 155%, for the three months ended September 30, 2023, and increased by $14.2 million, or 13%, for the nine months ended September 30, 2023 compared to the same periods a year ago[217] - Loss before income taxes for the three months ended September 30, 2023, was $64.2 million, compared to a loss of $91.9 million in the same period of 2022[265] - The company anticipates continued net losses for the foreseeable future despite expected increases in revenues from commercial sales of roxadustat[285] Cash and Investments - Cash and cash equivalents totaled $120.9 million as of September 30, 2023, down from $155.7 million at the end of 2022[167] - Cash and investments decreased by $159.6 million from December 31, 2022, primarily due to cash used in operations[167] - As of September 30, 2023, the company had short-term investments of $130.4 million, down from $266.3 million as of December 31, 2022[273] - Net cash used in operating activities for the nine months ended September 30, 2023, was $296.7 million, significantly higher than the $93.4 million used in the same period of 2022[275] - Net cash provided by investing activities for the nine months ended September 30, 2023, was $143.4 million, primarily from $300.5 million of proceeds from maturities of investments[280] - Net cash provided by financing activities for the nine months ended September 30, 2023, was $123.0 million, including $71.3 million from senior secured term loan facilities[283] Operating Costs - Total operating costs for Q3 2023 were $103.6 million, a decrease from $109.4 million in Q3 2022[163] - Total operating costs and expenses decreased by $5.8 million, or 5%, for the three months ended September 30, 2023, but increased by $7.0 million, or 2%, for the nine months ended September 30, 2023, compared to the same periods a year ago[245] - Research and development expenses decreased by $14.0 million, or 19%, for the three months ended September 30, 2023, and decreased by $4.0 million, or 2%, for the nine months ended September 30, 2023, compared to the same periods a year ago[254] - Selling, general and administrative expenses decreased by $4.3 million, or 14%, for the three months ended September 30, 2023, compared to the same period a year ago[255] - A restructuring charge of $12.6 million was recorded during the three months ended September 30, 2023, primarily consisting of severance payments and employee benefits contributions[257] Product Revenue - Roxadustat generated $29.4 million in net product revenue in Q3 2022, with ongoing commercialization efforts in China and other approved markets[164] - The company recognized $29.4 million in net product revenue from roxadustat for the three months ended September 30, 2023, compared to $17.4 million for the same period in 2022[209] - Total product revenue, net increased by $12.0 million, or 69% for the three months ended September 30, 2023, and increased by $17.9 million, or 30% for the nine months ended September 30, 2023, compared to the same periods a year ago[228] - Drug product revenue, net for the three months ended September 30, 2023 was $1,320,000, representing a 132% increase compared to a loss of $4,077,000 in the same period of 2022[211] - Sales to Falikang revenue, net increased by $11.5 million, or 77% for the three months ended September 30, 2023, and increased by $17.5 million, or 34% for the nine months ended September 30, 2023, compared to the same periods a year ago[232] Clinical Development - Pamrevlumab is in Phase 3 clinical development for locally advanced unresectable pancreatic cancer, with topline data expected in Q1 2024[171] - Pamrevlumab did not meet primary endpoints in the Phase 3 trial for Duchenne Muscular Dystrophy, but preliminary safety data indicated it was generally well tolerated[173][174] - In a Phase 3 clinical study for chemotherapy-induced anemia, roxadustat demonstrated non-inferiority to recombinant erythropoietin alfa on the primary endpoint of hemoglobin change[178] - FG-3246 showed a PSA50 interim response rate of 45% and an objective partial response rate of 19% in a Phase 1 clinical study for metastatic castration-resistant prostate cancer[184] - The company plans to initiate a PET biomarker driven Phase 2 trial of FG-3246 in the second half of 2024[185] Collaborations and Agreements - The company entered into an exclusive option agreement to acquire Fortis Therapeutics for $80 million, with potential contingent payments of up to $200 million[194] - The collaboration agreements with Astellas and AstraZeneca have generated a total consideration of $790.1 million and $516.2 million, respectively, through September 30, 2023[200][204] - AstraZeneca collaboration agreements contributed a total of $1,625,700,000 in cash consideration, with $516,200,000 received and $1,109,500,000 in potential cash payments[210] - License revenue for the three months ended September 30, 2023 was $2,649,000, a decrease of 57% compared to $22,590,000 for the same period in 2022[218] - The company does not expect to receive most or all of the additional potential milestones under the Astellas Japan Agreement, Astellas Europe Agreement, and AstraZeneca U.S./RoW Agreement based on current development plans[210] Future Outlook and Risks - The company anticipates needing additional capital beyond the next 12 months, with potential dilution of existing stockholders if equity is issued[287] - The company may incur additional expenses related to the workforce reduction, impacting future financial resources[287] - The company has established a full valuation allowance against its net deferred tax assets due to uncertainty in realization[266] - Future milestone payments under license agreements could total up to approximately $697.9 million, contingent on achieving specific developmental milestones[292] - The company expects costs of goods sold to increase in relation to drug product revenue as inventories are depleted[248]