Financial Data and Key Metrics Changes - Total revenue for Q2 2024 was $50.6 million, an increase of 14% year-over-year from $44.3 million in Q2 2023 [30] - Roxadustat net product revenue in China was $49.6 million, up 108% from $23.9 million in Q2 2023, driven by a 33% increase in volume and a deferred revenue release of $18 million [30][31] - Operating costs and expenses decreased by 53% year-over-year to $61.6 million from $132.4 million in Q2 2023 [34] - Net loss for Q2 2024 was $15.5 million, compared to a net loss of $87.7 million in Q2 2023 [36] Business Line Data and Key Metrics Changes - Roxadustat continues to perform well in China, with total net sales of $92.3 million in Q2 2024, a 21% increase from $76.4 million in Q2 2023 [26][32] - The company is raising its full-year 2024 guidance for net product revenue to between $135 million and $150 million, reflecting strong performance in the anemia of chronic kidney disease indication [11][34] Market Data and Key Metrics Changes - Roxadustat maintains a 46% market share in China as of May 2024, with expectations for continued growth despite the approval of generics [27][29] - The company anticipates an approval decision for chemotherapy-induced anemia in the second half of 2024, which could significantly enhance revenue [11] Company Strategy and Development Direction - The company is focusing on the development of FG-3246, a first-in-class antibody drug conjugate for metastatic castration-resistant prostate cancer, with plans to initiate a Phase 2 trial in early 2025 [10][25] - A significant cost reduction plan is being implemented, including a 75% reduction in U.S. workforce, to streamline operations following the disappointing results of pamrevlumab trials [9][36] - The company is exploring partnership opportunities for its remaining pipeline assets, including roxadustat in the U.S. for indications with high unmet needs [12][18] Management's Comments on Operating Environment and Future Outlook - Management expressed disappointment over the pamrevlumab trial results but emphasized the potential of FG-3246 and the strong performance of roxadustat in China [8][39] - The company expects its cash position of approximately $147.1 million to fund operations into 2026, despite recent challenges [15][38] Other Important Information - The company has regained rights to roxadustat in the U.S. and is actively seeking partnerships for its development [18][39] - The company has made significant advancements in derisking its immuno-oncology programs, with plans to initiate partnership discussions soon [14] Q&A Session Summary Question: Plans to accelerate FG-3246 development - Management confirmed that FG-3246 has always been a priority asset and will be prosecuted with speed, with an important FDA interaction planned [44] Question: Liquidity of cash generated in China - The company has been repatriating cash from China through registered debt facilities and is exploring additional avenues for cash repatriation [45] Question: Timeline for partnering preclinical candidates - Management indicated that discussions for partnering would begin immediately, with a focus on preclinical data for the anti-galectin-9 antibody and IND filing for CCR8 expected in 2025 [46][47] Question: Update on FG-3246's combination trial with enzalutamide - The combination study has shown promising results, with a bar for clinically meaningful radiographic progression-free survival set at around six months [51][52] Question: Impact of generic roxadustat on pricing - Management noted that while generics have been approved, they have not yet launched, and there are currently no plans to change pricing until subjected to volume-based purchasing [56][58]

FibroGen (FGEN) came out with a quarterly loss of $0.16 per share versus the Zacks Consensus Estimate of a loss of $0.26. This compares to loss of $0.65 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of 38.46%. A quarter ago, it was expected that this biotech drug developer would post a loss of $0.31 per share when it actually produced a loss of $0.33, delivering a surprise of -6.45%. Over the last four quarters, the company ha ...

Revenue Performance - Revenue for the three months ended June 30, 2024, was $50.6 million, a 14.5% increase from $44.3 million in the same period of 2023[123]. - Roxadustat commercial sales in China contributed $49.6 million for the three months ended June 30, 2024, compared to $23.9 million in the same period of 2023, representing a 74.1% increase[124]. - Net product revenue for Q2 2024 was $49.6 million, a 108% increase from $23.9 million in Q2 2023[160]. - Total revenue for the six months ended June 30, 2024, was $106.5 million, up 32% from $80.5 million in the same period last year[163]. - Sales to Falikang generated net revenue of $46.0 million for Q2 2024, a 124% increase from $20.5 million in Q2 2023[169]. - Total product revenue, net increased by $25.8 million, or 108%, for Q2 2024 compared to Q2 2023[170]. - Revenue from sales to Falikang increased by $25.5 million, or 124%, for the three months ended June 30, 2024, and by $31.2 million, or 75%, for the six months ended June 30, 2024, compared to the same periods a year ago[173]. Financial Losses and Expenses - Net loss for the six months ended June 30, 2024, was $48.5 million, a significant reduction from a net loss of $164.4 million for the same period in 2023[128]. - Operating costs and expenses for the three months ended June 30, 2024, were $61.6 million, down from $132.4 million in the same period of 2023, reflecting a decrease of 53.5%[123]. - Operating expenses decreased due to a $24.6 million one-time charge in the prior year and lower clinical trial expenses by $17.7 million for the three months ended June 30, 2024[126]. - Total operating costs and expenses decreased by $70.8 million, or 53%, for the three months ended June 30, 2024, and by $96.1 million, or 39%, for the six months ended June 30, 2024, compared to the same periods a year ago[183]. - Selling, general and administrative (SG&A) expenses decreased by $8.9 million, or 29%, for the three months ended June 30, 2024, and decreased by $20.4 million, or 31%, for the six months ended June 30, 2024, compared to the same periods a year ago[190]. Research and Development - FG-3246 demonstrated a median radiographic progression-free survival of 8.7 months in a Phase 1 clinical study for metastatic castration-resistant prostate cancer[137]. - The company plans to initiate a Phase 2 monotherapy dose optimization study of FG-3246 in the first quarter of 2025[137]. - FG-3246 in combination with enzalutamide showed a median radiographic progression-free survival of 10.2 months in a Phase 1b/2 study with 17 patients[138]. - The maximally tolerated dose of FG-3246 was established at 2.1 mg/kg adjusted body weight, combined with enzalutamide 160 mg/day[138]. - Research and development expenses decreased by $61.4 million, or 64%, for the three months ended June 30, 2024, and by $97.5 million, or 57%, for the six months ended June 30, 2024, compared to the same periods a year ago[183]. - The company has implemented efforts to streamline operations, which may continue to decrease research and development expenses over time[186]. Cash and Financing - Cash and cash equivalents totaled $140.7 million as of June 30, 2024, a decrease of $101.0 million from December 31, 2023[128]. - Net cash used in operating activities was $99.2 million for the six months ended June 30, 2024, compared to $212.2 million for the same period in 2023[203]. - Total net cash provided by investing activities was $123.5 million for the six months ended June 30, 2024, compared to $89.2 million for the same period in 2023[204]. - The company anticipates continued losses despite expected revenue increases from commercial sales of roxadustat in China, Japan, and Europe[208]. - The company expects to need substantial additional funding to support ongoing operations and research and development efforts[209]. Collaborations and Agreements - The collaboration agreements with Astellas and AstraZeneca have generated a total of $790.1 million in consideration through June 30, 2024[152]. - The AstraZeneca U.S./RoW Agreement generated $439 million in milestone and upfront payments before its termination in February 2024[155]. - Future milestone payments under license agreements could total approximately $697.9 million, contingent upon achieving specific developmental and regulatory milestones[213]. Clinical Trials and Pipeline - Pamrevlumab did not meet the primary endpoint of overall survival in the PanCAN's Precision Promise trial, with a median overall survival of 17.3 months compared to 17.9 months in the control arm[143]. - The Phase 3 LAPIS trial for pamrevlumab included 284 patients, randomized 1:1 to receive either pamrevlumab or placebo[144]. - The preclinical pipeline includes FG-3165 and FG-3175, both targeted antibodies for immuno-oncology, with FG-3165 receiving FDA clearance for investigational new drug application[144][145]. - FibroGen made four quarterly payments totaling $5.4 million to Fortis for development obligations related to FG-3246[147]. - If the option to acquire Fortis is exercised, FibroGen will pay $80 million, with potential contingent payments of up to $200 million for regulatory approvals[147].

Core Insights - FibroGen's stock is experiencing a significant decline due to the failure of clinical trials for pamrevlumab, a treatment for pancreatic cancer [1][2] - The trials did not meet their primary endpoint of overall survival, which is a critical measure in clinical research [1][2] - The company plans to terminate the pamrevlumab program and reduce its workforce by 75% as part of a cost-saving strategy [3] Clinical Trial Results - The first clinical trial aimed at treating metastatic pancreatic cancer with pamrevlumab failed to meet its primary endpoint [1] - The second trial involved pamrevlumab in combination with gemcitabine and nab-paclitaxel for unresectable pancreatic cancer, which also did not achieve the primary endpoint [2] - Both trials were advanced studies, with the metastatic pancreatic cancer trial in Phase 2/3 and the unresectable pancreatic cancer trial in Phase 3 [2] Company Response - CEO Thane Wettig expressed disappointment over the trial results, highlighting the hope for pamrevlumab to provide innovative treatment options for pancreatic cancer patients [3] - The company is shifting to a cost-saving mode following the trial failures, indicating a significant restructuring effort [3] Stock Market Impact - Following the announcement of the trial failures, FibroGen's stock price dropped by 44.4% [4]

Conference Call and Webcast Toll-free: 1-877-300-8521 International investors: 1-412-317-6026 Webcast: Click here About FibroGen For Investor Inquiries: David DeLucia, CFA Vice President of Corporate FP&A / Investor Relations InvestorRelations@fibrogen.com SAN FRANCISCO, July 30, 2024 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) will announce second quarter 2024 financial results on Tuesday, August 6 after the market close. FibroGen will also conduct a conference call on that day at 5:00 PM Eastern Tim ...

SAN FRANCISCO, June 18, 2024 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ:FGEN) today announced it will host the second part of its virtual KOL investor event series on Wednesday, June 26, 2024 at 10:00 AM ET. To register, click here. A live question and answer session will follow the formal presentation. Rahul Aggarwal, MD is a Professor of Medicine and Thomas Perkins Distinguished Professor of Cancer Research at the University of California San Francisco. He is the Associate Director for Clinical Research i ...

Core Insights - FibroGen is collaborating with Regeneron Pharmaceuticals to evaluate two monoclonal antibodies, FG-3165 and FG-3175, in combination with Regeneron's anti-PD-1 therapy, LIBTAYO®, for treating select solid tumors [1][2] - FG-3165 targets Galectin-9 (Gal9), which suppresses T and NK cell activation, while FG-3175 targets CCR8, a receptor over-expressed on T regulatory cells in solid tumors [2][5][6] - The FDA has cleared the Investigational New Drug (IND) application for FG-3165, with an IND submission for FG-3175 anticipated in 2025 [4][6] Company Overview - FibroGen, Inc. is focused on developing novel therapies in cancer biology, with other products in development including Pamrevlumab for pancreatic cancer and Roxadustat for anemia in chronic kidney disease [7] - The company is expanding its research portfolio to include immuno-oncology product candidates for solid tumors [7]

Core Insights - FibroGen is collaborating with Regeneron Pharmaceuticals to evaluate two monoclonal antibodies, FG-3165 and FG-3175, in combination with Regeneron's anti-PD-1 therapy, LIBTAYO®, for treating select solid tumors [1][2][3] Group 1: Clinical Trials and Collaborations - FG-3165 targets Galectin-9 (Gal9), which suppresses T and NK cell activation, while FG-3175 targets CCR8, a receptor over-expressed on T regulatory cells in solid tumors [2][5][6] - Both FG-3165 and FG-3175 have shown complementary mechanisms of action with PD-1 inhibitors in preclinical studies, suggesting potential for improved clinical outcomes when combined with LIBTAYO® [1][2][5] - FibroGen will sponsor Phase 1 trials for both monotherapy and combination treatments, with Regeneron providing the drug supply [3] Group 2: Regulatory Developments - The FDA has cleared the Investigational New Drug (IND) application for FG-3165, with plans to initiate a Phase 1 trial in select solid tumors in the second half of 2024 [4][5] - An IND submission for FG-3175 is anticipated in 2025 [4][6] Group 3: Company Overview - FibroGen is focused on developing novel therapies in cancer biology, with other products in development including Pamrevlumab for pancreatic cancer and Roxadustat for anemia in chronic kidney disease [7] - The company is expanding its research portfolio to include immuno-oncology candidates targeting solid tumors [7]

The safety and efficacy of FG-3165 will be evaluated in a Phase 1 trial in select solid tumors Plan to begin enrollment in 2H 2024 SAN FRANCISCO, June 03, 2024 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company's Investigational New Drug (IND) of FG-3165, a galectin-9 (Gal9) targeted monoclonal antibody under development for treatment of solid tumors characterized by high Gal9 levels of expression. "The FDA's IND clearan ...

The safety and efficacy of FG-3165 will be evaluated in a Phase 1 trial in select solid tumors Plan to begin enrollment in 2H 2024 SAN FRANCISCO, June 03, 2024 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company's Investigational New Drug (IND) of FG-3165, a galectin-9 (Gal9) targeted monoclonal antibody under development for treatment of solid tumors characterized by high Gal9 levels of expression. "The FDA's IND clearan ...