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]

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. 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]

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].

Core Viewpoint - FibroGen, Inc. has appointed David DeLucia as Chief Financial Officer (CFO), effective December 16, 2024, following the resignation of Juan Graham on December 15, 2024 [1][2]. Group 1: Leadership Changes - David DeLucia will report to CEO Thane Wettig and will lead FibroGen's global finance organization [2]. - DeLucia has nearly 15 years of financial leadership experience in the life sciences industry, previously serving as Vice President at FibroGen [3][4]. Group 2: Company Strategy and Vision - CEO Thane Wettig expressed confidence in DeLucia's capabilities to lead the finance organization and contribute to the company's strategic goals, particularly in advancing FG-3246 and its companion diagnostic FG-3180 [3]. - DeLucia emphasized the company's transformation into a lean organization and its focus on developing novel therapies for cancer and related conditions [3]. Group 3: Company Overview - FibroGen is a biopharmaceutical company focused on developing novel therapies in cancer biology, with products like Roxadustat approved in multiple countries for treating anemia in chronic kidney disease [5]. - The company is also developing FG-3246, a first-in-class antibody-drug conjugate targeting CD46 for metastatic castration-resistant prostate cancer, along with a related PET imaging agent [5].

Financial Data and Key Metrics Changes - Total revenue for Q3 2024 was $46.3 million, a 15% increase from $40.1 million in Q3 2023 [37] - Roxadustat net product revenue in China was $46.2 million for Q3 2024, up 57% from $29.4 million in Q3 2023 [37][39] - The company recorded a net loss of $17.1 million or $0.17 per share, compared to a net loss of $63.6 million or $0.65 per share in Q3 2023 [45] Business Line Data and Key Metrics Changes - Roxadustat sales in China totaled $96.6 million in Q3 2024, a 25% increase from $77.1 million in Q3 2023, driven by a 34% increase in volume [28][39] - The company reiterated its full-year net product revenue guidance of $135 million to $150 million, raising the lower end of the guidance for roxadustat net sales in China to $330 million to $350 million [9][41] Market Data and Key Metrics Changes - Roxadustat maintained a 45% brand value share in China as of August 2024 [29] - The company expects an approval decision for chemotherapy-induced anemia in early 2025, which would provide a significant growth opportunity [10][29] Company Strategy and Development Direction - The company is focusing on advancing FG-3246 and FG-3180 in metastatic castration-resistant prostate cancer (mCRPC) as a key priority [8] - The company regained rights to roxadustat in the U.S. and is exploring development opportunities for anemia in patients with lower-risk myelodysplastic syndromes [33][34] - The company aims to enhance roxadustat's value and is actively seeking partnerships for its oncology pipeline [51][52] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's refined focus and strong foundation to create shareholder value [12] - The anticipated initiation of the Phase 2 dose optimization study for FG-3246 in Q1 2025 and top-line results from the Phase 2 portion of the combination study are expected in the first half of 2025 [26][53] Other Important Information - The company has reduced its operating costs significantly, with total operating costs and expenses for Q3 2024 at $63.1 million, down 39% year-over-year [42] - Cash, cash equivalents, and accounts receivable stood at $160 million as of September 30, 2024, reflecting an increase of $12.9 million quarter-over-quarter [47] Q&A Session Summary Question: Clarification on Phase II study and data release - Management confirmed that top-line results for the investigator-sponsored trial will include data from both the escalation and expansion cohorts, with expectations for results in the first half of next year [56] Question: Logistics of PET imaging agent - Management indicated that the PET imaging agent will require a longer wait time for imaging compared to current standards, likely around six days post-exposure [59] Question: Guidance on roxadustat sales and deferred revenue - Management explained that the guidance for roxadustat sales considers potential approval of the chemotherapy-induced anemia indication, which may affect revenue recognition [66]

FibroGen (FGEN) came out with a quarterly loss of $0.17 per share versus the Zacks Consensus Estimate of a loss of $0.38. This compares to loss of $0.52 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 55.26%. A quarter ago, it was expected that this biotech drug developer would post a loss of $0.26 per share when it actually produced a loss of $0.16, delivering a surprise of 38.46%.Over the last four quarters, the company has ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FIBROGEN, INC. (Exact name of registrant as specified in its charter) Form 10-Q (Mark One) ☑ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-36740 | --- | --- | --- | |-------------------------- ...