Financial Results Announcement - FibroGen, Inc. will announce its first quarter 2025 financial results on May 12, 2025, after market close [1] - A conference call will be held on the same day at 5:00 PM Eastern Time to discuss the company's corporate and financial performance [1] Conference Call Details - The management team will host a conference call and webcast presentation to discuss financial results and provide a business update [2] - A live Q&A session will follow the presentation, and interested parties can access the live audio webcast [2] Company Overview - FibroGen, Inc. is a biopharmaceutical company focused on developing novel therapies in cancer biology and anemia [3] - Roxadustat is approved in multiple regions, including China, Europe, and Japan, for treating anemia in chronic kidney disease patients [3] - The company is evaluating a development plan for roxadustat in anemia associated with lower-risk myelodysplastic syndrome in the U.S. [3] - FG-3246, a first-in-class antibody-drug conjugate targeting CD46, is in development for metastatic castration-resistant prostate cancer [3] - The development program also includes FG-3180, a CD46-targeted PET biomarker [3]

Core Insights - FibroGen, Inc. announced the publication of a Phase 1 study of FOR46 (FG-3246), an immune-modulating antibody-drug conjugate targeting CD46, in patients with metastatic castration-resistant prostate cancer (mCRPC) [1][2] Group 1: Study Overview - The Phase 1 study was a multi-center, first-in-human, open-label dose escalation and expansion study evaluating safety, tolerability, and anti-tumor activity in 56 heavily pre-treated patients [3][6] - The study showed FG-3246 had an acceptable safety profile with the most frequent adverse events being infusion-related reactions (48.2%), neutropenia (41.1%), and peripheral neuropathy (32.1%) [6][9] - The confirmed objective response rate was 20% with a median duration of response of 7.5 months, and the disease control rate was 80% [6][9] Group 2: Future Development Plans - The company plans to initiate a Phase 2 monotherapy dose optimization study of FG-3246 in mCRPC by mid-2025 [4][5] - Topline results from a combination trial of FG-3246 and enzalutamide are expected in the second half of 2025 [4][11] Group 3: Background on mCRPC - Prostate cancer is the second most common malignancy in men, with approximately 13% of men diagnosed during their lifetime [10] - There are about 65,000 drug-treatable mCRPC cases in the U.S. annually, with a 5-year survival rate of approximately 30% [10] Group 4: About FG-3246 - FG-3246 is a potential first-in-class fully human antibody-drug conjugate targeting CD46, which is present at high levels in prostate cancer and other tumor types [11] - The drug is currently in an ongoing Phase 1/2 study at UCSF, evaluating it in combination with enzalutamide, with topline data expected in the second half of 2025 [11] Group 5: Company Overview - FibroGen, Inc. focuses on developing novel therapies in cancer biology and anemia, with Roxadustat approved in multiple countries for treating anemia in chronic kidney disease [12]

FibroGen, Inc. (NASDAQ:FGEN) Q4 2024 Earnings Conference Call March 17, 2025 5:00 PM ET Company Participants Joanne Greller - LifeSci Advisors Thane Wettig - CEO David DeLucia - CFO Conference Call Participants Andy Sieh - William Blair Matthew Keller - H.C. Wainwright Operator Hello everyone, and welcome to the FibroGen Fourth Quarter and Full Year 2024 Earnings Conference Call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question-and-answer s ...

Financial Data and Key Metrics Changes - For Q4 2024, total revenue was $3.1 million, down from $3.6 million in Q4 2023, representing a decrease of approximately 14% [38] - For the full year 2024, total revenue was $29.6 million, compared to $46.8 million in 2023, a decline of about 37% [38] - The company recorded a net loss from continuing operations of $8.7 million in Q4 2024, compared to a net loss of $62.5 million in Q4 2023, indicating a significant improvement [42] - For the full year 2024, the net loss from continuing operations was $153.1 million, down from $323 million in 2023, reflecting a reduction of approximately 52% [42] Business Line Data and Key Metrics Changes - Development revenue for Q4 2024 was $0.4 million, down from $2.6 million in Q4 2023 [39] - Drug product revenue for Q4 2024 was $2.7 million, up from $1.1 million in Q4 2023, showing an increase of approximately 145% [40] - For the full year 2024, drug product revenue was $27.7 million, compared to $18.8 million in 2023, an increase of about 47% [40] Market Data and Key Metrics Changes - The total addressable market for FG-3246 in metastatic castration-resistant prostate cancer (mCRPC) is estimated to exceed $5 billion annually [13] - The unmet need in late-stage prostate cancer is highlighted by the grim five-year survival rate of approximately 30% for patients diagnosed with mCRPC [13] Company Strategy and Development Direction - The company announced the sale of FibroGen China to AstraZeneca for approximately $160 million, which is expected to close by mid-2025 [9] - The focus is on advancing FG-3246 and FG-3180 in mCRPC, with plans for a Phase 2 monotherapy study and a meeting with the FDA regarding roxadustat for anemia associated with lower-risk MDS [11][47] - The company aims to create value for shareholders by refining its focus on high-value oncology indications and extending its cash runway into 2027 [46] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's strategic transformation and the potential for significant value creation through its focused pipeline [46] - The upcoming FDA meeting regarding roxadustat is anticipated to provide clarity on the development path for anemia associated with lower-risk MDS [33][47] Other Important Information - The company has implemented a significant cost reduction plan, resulting in a decrease in total operating costs and expenses by 51% year-over-year for 2024 [41] - The company expects total operating costs for 2025 to be between $70 million and $80 million, representing a 58% reduction from 2024 [44] Q&A Session Summary Question: Can you characterize the level of stringency for the futility analysis coming up in mid-2026? - Management indicated that the futility analysis will assess both safety and efficacy parameters, but specific details were not disclosed at this time [56] Question: What are the qualifications for patients who have experienced radioligand treatment in the trial? - Patients treated with Pluvicto previously are eligible for the trial, provided they have not been treated within the prior 28 days [55] Question: Will the cost-saving measures open up possibilities for new assets or indications? - Management stated that there are no plans to branch out into new assets at this time, maintaining a focus on advancing existing programs [70] Question: What are the expectations going into the upcoming FDA meeting regarding roxadustat? - The wish list includes the ability to proceed with a previously established dose without additional dose-finding work and to conduct a placebo-controlled trial [72][76]

Product Development and Commercialization - FibroGen's lead products, roxadustat and FG-3246, are critical for the company's success, with ongoing reliance on their development and commercialization[22] - The regulatory approval process for product candidates remains highly uncertain, impacting future market potential[25] - FibroGen Beijing, a wholly-owned subsidiary, holds regulatory licenses for roxadustat in China, with a focus on maintaining compliance with local regulations[25] - The company has decommissioned its API manufacturing facility in Cangzhou, China, and plans to source roxadustat API from WuXi STA[25] - FibroGen's joint venture, Falikang, is responsible for distributing roxadustat in China, with AstraZeneca providing sales and marketing support[25] - Future financial performance and operational success are contingent on the outcomes of ongoing clinical trials and regulatory approvals[22] Financial Transactions and Profit Sharing - The sale of FibroGen International to AstraZeneca Treasury Limited is pending, with various closing conditions that must be satisfied[31] - FibroGen Beijing and AstraZeneca shared interim profit/loss from April 1, 2020, to December 31, 2020[523] - Net transaction price from product sales to Falikang commenced on January 1, 2021, based on a percentage of Falikang's net sales[523] - Gross transaction price is influenced by Falikang's operating expenses and payments to AstraZeneca for roxadustat sales and marketing efforts[523] - The gross transaction price is capped at a percentage of Falikang's net roxadustat sales[523] - Profit share adjustments aim to achieve a 50/50 profit share from current period roxadustat net sales in China[523] - Adjustments to date have resulted in a reduction to the transaction price and related accounts receivable from Falikang[523] Risks and Challenges - The company faces significant risks associated with international operations, particularly in China, which could adversely affect business performance[25] - FibroGen's ability to raise capital and market stock may be impacted by unfavorable government policies on cross-border relations and international trade[28] - The company emphasizes the importance of maintaining its intellectual property rights amid competitive pressures and regulatory challenges[22]

Core Viewpoint - FibroGen, Inc. reported its financial results for Q4 and full year 2024, highlighting a strategic focus on advancing its clinical programs and improving its financial position through cost reduction and the sale of FibroGen China to AstraZeneca for approximately $160 million [1][2][8]. Financial Performance - Total revenue from continuing operations for Q4 2024 was $3.1 million, a decrease from $3.6 million in Q4 2023 [6]. - For the full year 2024, total revenue was $29.6 million, down from $46.8 million in 2023 [14]. - The net loss from continuing operations for Q4 2024 was $8.7 million, or $0.08 per share, compared to a net loss of $62.5 million, or $0.63 per share, in Q4 2023 [14][20]. - The net loss for the full year 2024 was $153.1 million, or $1.53 per share, compared to a net loss of $323.0 million, or $3.32 per share, in 2023 [14][20]. Recent Developments - The company plans to initiate a Phase 2 monotherapy trial of FG-3246, an ADC targeting CD46 for mCRPC, by mid-2025 [2][7]. - The sale of FibroGen China is expected to close by mid-2025, which will extend the company's cash runway into 2027 [8][14]. - FibroGen has completed a cost reduction program, aiming to create a leaner organization with a stronger financial position [2][8]. Upcoming Milestones - The initiation of the Phase 2 monotherapy dose optimization study of FG-3246 is anticipated by mid-2025 [8][11]. - Topline results from the Phase 2 portion of the investigator-sponsored study of FG-3246 in combination with enzalutamide are expected in the second half of 2025 [7][8]. Product Pipeline - FG-3246 is a first-in-class ADC targeting CD46, currently in a Phase 1b/2 study at UCSF [10][11]. - Roxadustat, an oral medication for anemia, is in development for lower-risk myelodysplastic syndrome (LR-MDS) and has a Supplemental New Drug Application accepted in China [5][12].

Financial Results Announcement - FibroGen, Inc. will announce its fourth quarter and full year 2024 financial results on March 17, 2025, after market close [1] - A conference call will be held on the same day at 5:00 PM Eastern Time to discuss the company's corporate and financial performance [1] Conference Call Details - The management team will host a conference call and webcast presentation to discuss financial results and provide a business update, followed by a live Q&A session [2] - Interested parties can access the live audio webcast and register for phone access to receive dial-in details [2] - A replay of the webcast will be available for a limited time on FibroGen's website [2] Company Overview - FibroGen, Inc. is a biopharmaceutical company focused on developing novel therapies in cancer biology and anemia [3] - Roxadustat is approved in multiple regions, including China, Europe, and Japan, for treating anemia in chronic kidney disease patients [3] - The company is evaluating a development plan for roxadustat in anemia associated with lower-risk myelodysplastic syndrome in the U.S. [3] - FG-3246, a first-in-class antibody-drug conjugate targeting CD46, is in development for metastatic castration-resistant prostate cancer, along with FG-3180, a CD46-targeted PET biomarker [3]

Transaction Details - FibroGen entered into a share purchase agreement with AstraZeneca to sell FibroGen International for approximately $160 million, including $85 million in cash and an estimated $75 million in net cash held in China[7]. - The transaction is expected to close by mid-2025, pending regulatory approval from the China State Administration for Market Regulation[7]. - Upon closing, AstraZeneca will acquire all rights to roxadustat in China, Hong Kong, and Macao, while FibroGen retains rights in the United States, Canada, and Mexico[8][9]. - The cash payable by AstraZeneca at closing includes holdbacks of $6 million for final net cash adjustments and $4 million for indemnity claims[10]. - FibroGen will assign its rights to certain patents and trademarks related to roxadustat in the regions acquired by AstraZeneca[12]. - AstraZeneca is a long-time commercialization partner for roxadustat in Greater China and South Korea[8]. Financial Information - As of December 31, 2024, FibroGen estimated it had approximately $121.1 million in cash, cash equivalents, and accounts receivable[15]. - The estimated cash held in China is subject to change before closing, and the total amount payable to Morgan Stanley Tactical Value may also change materially[14]. - The preliminary financial information provided is unaudited and may be subject to adjustments before the year-end audited financial statements are completed[16][17]. Employment Impact - The sale will result in the cessation of employment for Christine L. Chung, Senior Vice President of China Operations, who is entitled to severance benefits[19].

Core Viewpoint - FibroGen, Inc. has announced the sale of its China subsidiary to AstraZeneca for approximately $160 million, which is expected to strengthen its financial position and extend its cash runway into 2027 [1][2]. Financial Impact - The sale includes an enterprise value of $85 million plus an estimated $75 million in net cash held in China at closing, totaling approximately $160 million [2][7]. - Following the transaction, FibroGen will repay its term loan facility to Morgan Stanley Tactical Value, simplifying its capital structure [2][7]. Strategic Developments - The transaction allows FibroGen to continue advancing its clinical development programs, particularly for FG-3246, a first-in-class CD46 targeting antibody drug conjugate, and FG-3180, a companion PET imaging agent, with a Phase 2 trial for FG-3246 expected to begin in Q2 2025 [2][5]. - FibroGen retains rights to roxadustat in the U.S. and other markets not licensed to Astellas, and is evaluating a development plan for roxadustat in anemia associated with lower-risk myelodysplastic syndrome (LR-MDS) [4][8]. Market Position - Roxadustat is a leading treatment for anemia in chronic kidney disease in China, with a pending regulatory decision for chemotherapy-induced anemia [3].

Core Viewpoint - FibroGen, Inc. has announced the sale of its China subsidiary to AstraZeneca for approximately $160 million, which is expected to strengthen its financial position and extend its cash runway into 2027 [1][2]. Financial Impact - The sale includes an enterprise value of $85 million plus an estimated $75 million in net cash held in China at closing, totaling around $160 million [2][7]. - Following the transaction, FibroGen plans to repay its term loan facility to Morgan Stanley Tactical Value, simplifying its capital structure [2][7]. Strategic Developments - The transaction allows FibroGen to continue advancing its clinical development programs, particularly for FG-3246, a first-in-class antibody-drug conjugate, and FG-3180, a companion PET imaging agent, with a Phase 2 trial expected to start in Q2 2025 [2][5]. - FibroGen retains rights to roxadustat in the U.S. and other markets not licensed to Astellas, and is evaluating a development plan for roxadustat in anemia associated with lower-risk myelodysplastic syndrome (LR-MDS) [4][8]. Market Position - Roxadustat is a leading treatment for anemia in chronic kidney disease in China, with a pending regulatory decision for chemotherapy-induced anemia [3][8].