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].

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 ...

Topline results from Phase 2 portion of the investigator-sponsored study of FG-3246, a first-in-class antibody-drug conjugate (ADC) targeting CD46, in combination with enzalutamide in patients with metastatic castration-resistant prostate cancer (mCRPC) are expected in 1H 2025Initiation of Phase 2 monotherapy dose optimization study of FG-3246 in mCRPC anticipated in 1Q 2025Third quarter net revenue growth of 15% year over year, driven by strong performance of roxadustat in China, with year over year volume ...

SAN FRANCISCO, Nov. 04, 2024 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) will announce third quarter 2024 financial results on Tuesday, November 12 after the market close. FibroGen will also conduct a conference call on that day at 5:00 PM Eastern Time with the investment community to further detail the company's corporate and financial performance. Conference Call and Webcast Toll-free: 1-877-300-8521International investors: 1-412-317-6026Webcast: Click here To access the call, participants should di ...

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 ...