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FibroGen Reports Second Quarter 2025 Financial Results and Provides Business Update
GlobeNewswire News Room· 2025-08-11 20:02
Core Insights - FibroGen reported financial results for Q2 2025, showing total revenue of $1.3 million, an increase from $1.0 million in Q2 2024, and a net loss of $13.7 million compared to a net loss of $47.1 million in the same period last year [16][21]. Recent Developments - The company is advancing its clinical pipeline, with the Phase 2 monotherapy trial of FG-3246 expected to start in Q3 2025 [2][6]. - FibroGen reached an agreement with the FDA to advance roxadustat towards a pivotal Phase 3 trial for lower-risk myelodysplastic syndromes (LR-MDS) [2][7]. - The sale of FibroGen China to AstraZeneca is expected to close in Q3 2025 for approximately $210 million, which includes $125 million in net cash [6][7]. Financial Overview - As of June 30, 2025, FibroGen reported $23.5 million in cash and cash equivalents in the U.S. and $142.1 million in total consolidated cash [16]. - The company expects its cash runway to extend into 2028 following the sale of FibroGen China [6][16]. Upcoming Milestones - The initiation of the Phase 2 trial for FG-3246 is anticipated in Q3 2025, with topline results from an investigator-sponsored study expected in Q4 2025 [6][8]. - FibroGen plans to file the pivotal Phase 3 clinical trial protocol for roxadustat in Q4 2025 [8]. Product Development - FG-3246 is a potential first-in-class antibody-drug conjugate targeting CD46, currently in a Phase 1b/2 study in combination with enzalutamide for metastatic castration-resistant prostate cancer [11][12]. - Roxadustat is in clinical development for chemotherapy-induced anemia and is already approved in several countries for treating anemia in chronic kidney disease [13][14].
FibroGen to Report Second Quarter 2025 Financial Results
GlobeNewswire News Room· 2025-08-04 20:02
Group 1 - FibroGen, Inc. will announce its second quarter 2025 financial results on August 11 after market close [1] - A conference call and webcast presentation will be held on the same day at 5:00 PM Eastern Time to discuss financial results and provide a business update [2] - The company is focused on developing novel therapies for cancer biology and anemia, with its drug Roxadustat approved in multiple countries for treating anemia in chronic kidney disease patients [3] Group 2 - FibroGen is also evaluating a development plan for Roxadustat in anemia associated with lower-risk myelodysplastic syndrome in the U.S. [3] - The company is developing FG-3246, a first-in-class antibody-drug conjugate targeting CD46 for metastatic castration-resistant prostate cancer [3] - FG-3180, an associated CD46-targeted PET biomarker, is also in development [4]
FibroGen Announces 1-for-25 Reverse Stock Split
GlobeNewswire News Room· 2025-06-12 20:02
Core Viewpoint - FibroGen, Inc. will implement a 1-for-25 reverse stock split to increase the per-share market price and regain compliance with Nasdaq listing requirements [2][3]. Group 1: Reverse Stock Split Details - The reverse stock split will be effective at 5:00 p.m. Eastern Time on June 16, 2025, with trading on a split-adjusted basis starting June 17, 2025 [1]. - The number of issued and outstanding shares will decrease from approximately 101.1 million to about 4.0 million shares [3]. - Stockholders will receive cash payments for any fractional shares instead of receiving fractional shares [3]. Group 2: Approval and Purpose - The reverse stock split was approved by stockholders at the 2025 Annual Meeting held on June 4, 2025 [2]. - The primary goal of the reverse stock split is to increase the market price of FibroGen's common stock to meet Nasdaq's minimum bid price requirement [2]. Group 3: Company Overview - FibroGen is a biopharmaceutical company focused on developing novel therapies for cancer and anemia [5]. - Roxadustat is approved in multiple regions for treating anemia in chronic kidney disease patients [5]. - The company is also developing FG-3246, an antibody-drug conjugate for metastatic castration-resistant prostate cancer [5].
FibroGen Appoints Michael Kauffman, M.D., Ph.D. to its Board of Directors
Globenewswire· 2025-06-09 20:02
Company Overview - FibroGen, Inc. is a biopharmaceutical company focused on developing novel therapies in cancer biology and anemia [4] - The company has an approved product, Roxadustat (爱瑞卓®, EVRENZO™), for treating anemia in chronic kidney disease (CKD) patients in multiple regions including China, Europe, and Japan [4] - FibroGen is evaluating a development plan for Roxadustat in anemia associated with lower-risk myelodysplastic syndrome (LR-MDS) in the U.S. [4] - The company is also developing FG-3246 (FOR46), a first-in-class antibody-drug conjugate targeting CD46 for metastatic castration-resistant prostate cancer [4] Leadership Appointment - Dr. Michael Kauffman has been appointed to the Board of Directors of FibroGen effective June 4, 2025 [1] - Dr. Kauffman is recognized as a biotech industry veteran with extensive experience in drug development, particularly in oncology [2] - His expertise is expected to be invaluable as FibroGen progresses its pipeline and approaches near-term clinical milestones [2] Dr. Michael Kauffman's Background - Dr. Kauffman has approximately 30 years of experience in the life sciences industry, focusing on oncology therapeutic products [3] - He currently serves as CEO and president of Nereid Therapeutics Inc. and is a board member of several other biotech companies [3] - His previous roles include co-founder and CEO of Karyopharm, CMO of Onyx Pharma, and leadership positions at Millennium Pharmaceuticals and Biogen [3] - Dr. Kauffman holds an MD and PhD from Johns Hopkins Medical School and is board certified in Internal Medicine [3]
FibroGen(FGEN) - 2025 Q1 - Earnings Call Presentation
2025-05-16 09:07
FibroGen Transformation and Financial Outlook - FibroGen China 的出售给阿斯利康的总对价预计约为 1.85 亿美元,比最初的指导增加了 2500 万美元[3] - 出售 FibroGen China 是获得在中国持有的所有净现金(约 1 亿美元)的最有效方式,并将现金流延长至 2027 年下半年[3] - 该公司将偿还摩根士丹利 Tactical Value 定期贷款融资[3] FG-3246 and FG-3180 Program in mCRPC - FG-3246 是一种潜在的同类首创的 CD46 靶向 ADC,在预处理的 mCRPC 中具有临床意义的反应和良好的安全性[3] - FG-3246 单药治疗在 5L+ mCRPC 患者中显示出有意义的单药治疗临床活性,中位 rPFS 为 8.7 个月[13, 14] - 在评估 FG-3246 与恩杂鲁胺联合用药的 mCRPC 研究的 1b 期中期结果中,中位 rPFS 的初步估计值为 10.2 个月[18, 19] - 预计 2025 年第三季度启动 FG-3246 的 2 期单药治疗试验,包括 FG-3180,用于 ARSI 后/化疗前 mCRPC[3] - 预计 2025 年第四季度获得 FG-3246 与恩杂鲁胺联合用药的 mCRPC 研究的 2 期部分的主要结果[3, 20] Roxadustat Development Opportunity - 在较低风险 MDS 引起的贫血症中,Roxadustat 具有完全自主的后期美国开发机会[3] - 在 MATTERHORN III 期试验的亚组结果中,接受 roxadustat 治疗的输血负担较高的患者与安慰剂相比,达到 TI 的患者更多,在 28 周内 TI ≥ 56 天的患者比例为 36.1%,而安慰剂组为 11.5%[43, 44] - 预计 FDA 将在 2025 年第三季度就 roxadustat 治疗 LR-MDS 相关贫血症的潜在途径提供反馈[3]
FibroGen (FGEN) Reports Q1 Loss, Tops Revenue Estimates
ZACKS· 2025-05-12 22:20
Company Performance - FibroGen reported a quarterly loss of $0.16 per share, significantly worse than the Zacks Consensus Estimate of $0.03, representing an earnings surprise of -633.33% [1] - The company posted revenues of $2.74 million for the quarter ended March 2025, exceeding the Zacks Consensus Estimate by 71.19%, but down from $55.9 million in the same quarter last year [2] - Over the last four quarters, FibroGen has surpassed consensus EPS estimates two times and topped consensus revenue estimates three times [2] Stock Movement and Outlook - FibroGen shares have declined approximately 41.8% since the beginning of the year, compared to a -3.8% decline in the S&P 500 [3] - The company's earnings outlook will be crucial for future stock performance, with current consensus EPS estimates at -$0.09 for the coming quarter and -$0.60 for the current fiscal year [4][7] - The current estimate revisions trend for FibroGen is mixed, resulting in a Zacks Rank 3 (Hold), indicating expected performance in line with the market [6] Industry Context - The Medical - Drugs industry, to which FibroGen belongs, is currently ranked in the top 27% of over 250 Zacks industries, suggesting a favorable outlook compared to lower-ranked industries [8] - Empirical research indicates a strong correlation between near-term stock movements and trends in earnings estimate revisions, which could impact FibroGen's stock performance [5]
FibroGen(FGEN) - 2025 Q1 - Earnings Call Transcript
2025-05-12 22:02
Financial Data and Key Metrics Changes - For Q1 2025, total revenue was $2.7 million, a significant decrease from $25.4 million in the same period in 2024 [28] - Total operating costs and expenses for Q1 2025 were $17.7 million, down from $74.5 million in Q1 2024, representing a 76% year-over-year decrease [29] - The net loss from continuing operations for Q1 2025 was $16.8 million, or $0.16 per share, compared to a net loss of $49 million, or $0.49 per share, in Q1 2024 [29] Business Line Data and Key Metrics Changes - R&D expenses for Q1 2025 were $9.2 million, down from $36.5 million in Q1 2024, a decrease of 75% year-over-year [29] - SG&A expenses for Q1 2025 were $8.1 million, compared to $16.7 million in Q1 2024, a decrease of 51% year-over-year [29] Market Data and Key Metrics Changes - The total addressable market for FG3246 in metastatic castration-resistant prostate cancer (mCRPC) is estimated to be over $5 billion in annual sales [10] - Approximately 290,000 men are diagnosed with prostate cancer each year in the U.S., with 65,000 being drug-treatable patients in the metastatic castration-resistant stage [9] Company Strategy and Development Direction - The company is focused on advancing its U.S. pipeline opportunities, particularly FG3246 and FG3180, while divesting FibroGen China to simplify operations and extend cash runway [5][6] - The sale of FibroGen China to AstraZeneca is expected to close in Q3 2025, with total consideration now estimated at approximately $185 million, an increase from the initial guidance [5][6][27] Management Comments on Operating Environment and Future Outlook - Management expressed confidence in the refined focus and multiple near-term catalysts across clinical programs, positioning the company well for shareholder value creation [9] - The company anticipates FDA feedback on roxadustat's development for anemia associated with lower-risk myelodysplastic syndromes (MDS) in Q3 2025 [8] Other Important Information - The company reported cash flow positive results in Q1 2025, generating $7.3 million in cash flow on a consolidated basis [30] - Upon closing the China transaction, the company plans to pay off its senior secured term loan, resulting in a cash outflow of approximately $80 million [30] Q&A Session Summary Question: Regarding clinical development on FG3246 and market dynamics after Pluvicto approval - Management confirmed that Pluvicto experienced patients will be allowed in the Phase II monotherapy trial to mitigate enrollment challenges [39][40] Question: Comments on recent FDA correspondence regarding roxadustat - Management reported favorable interactions with the FDA, including timely responses for IND filings and Type C meeting requests [41][42][43] Question: Feasibility studies in colorectal cancer given cash infusion from AstraZeneca - Management indicated that they will hold off on colorectal cancer studies for now, focusing on initiating the Phase II monotherapy trial [44][45] Question: Rate limiting steps ahead of the upcoming Phase II monotherapy study - The close of the China transaction is the primary rate limiter for starting the Phase II monotherapy trial [50] Question: Evolving commercial opportunity for FG3180 - Management highlighted the importance of the Phase II trial in assessing the commercial potential of FG3180 as a diagnostic tool [52][54]
FibroGen(FGEN) - 2025 Q1 - Earnings Call Transcript
2025-05-12 22:00
Financial Data and Key Metrics Changes - For Q1 2025, total revenue was $2.7 million, a significant decrease from $25.4 million in Q1 2024 [27] - Total operating costs and expenses for Q1 2025 were $17.7 million, down 76% year-over-year from $74.5 million in Q1 2024 [28] - The net loss from continuing operations for Q1 2025 was $16.8 million, or $0.16 per share, compared to a net loss of $49 million, or $0.49 per share, in Q1 2024 [28] Business Line Data and Key Metrics Changes - The company is focused on advancing FG3246 and FG3180 in metastatic castration-resistant prostate cancer (mCRPC) [6] - Roxadustat is being developed for anemia associated with lower-risk myelodysplastic syndromes (MDS), with a Type C meeting request filed with the FDA [8][23] Market Data and Key Metrics Changes - There are approximately 290,000 men diagnosed with prostate cancer annually in the U.S., with 65,000 being drug-treatable patients in the mCRPC stage [9] - The total addressable market for FG3246 in mCRPC is estimated to exceed $5 billion in annual sales [10] Company Strategy and Development Direction - The company is divesting FibroGen China to AstraZeneca, with total consideration expected to increase to approximately $185 million, extending the cash runway into the second half of 2027 [5][26] - The strategic focus is on U.S. pipeline opportunities, particularly FG3246 and FG3180, and advancing clinical trials [4][6] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the refined focus and multiple near-term catalysts across clinical programs to create shareholder value [9] - The company anticipates important feedback from the FDA regarding roxadustat and plans to initiate the Phase II monotherapy study for FG3246 and FG3180 in mCRPC [31] Other Important Information - The company recorded cash flow positive results in Q1 2025, generating $7.3 million in cash flow on a consolidated basis [29] - The IND for FG3180 was cleared, allowing it to be used alongside FG3246 in upcoming trials [7][12] Q&A Session Summary Question: Regarding clinical development on FG3246 and market dynamics after Pluvicto approval - Management confirmed that Pluvicto experienced patients will be allowed in the Phase II monotherapy trial to mitigate enrollment challenges [38][39] Question: Comments on recent FDA communications regarding roxadustat - Management reported favorable interactions with the FDA, including timely responses to IND filings and Type C meeting requests [40][42] Question: Feasibility studies in colorectal cancer due to cash infusion from AstraZeneca - Management indicated that while colorectal cancer is a potential opportunity, the immediate focus is on starting the Phase II monotherapy trial [44][45]
FibroGen(FGEN) - 2025 Q1 - Quarterly Report
2025-05-12 20:10
Financial Performance - For the three months ended March 31, 2025, revenue was $2.739 million, a significant decrease from $25.364 million in the same period of 2024[132]. - Operating costs and expenses for the same period were $17.659 million, down from $74.546 million year-over-year, primarily due to cost control measures and the termination of certain agreements[132][133]. - The loss from continuing operations for Q1 2025 was $16.766 million, or $0.16 per share, compared to a loss of $49.046 million, or $0.49 per share, in Q1 2024[134]. - For the three months ended March 31, 2025, total revenue decreased by $22.6 million, or 89%, to $2.7 million compared to $25.4 million in the same period in 2024[190]. - Drug product revenue, net, fell by $21.9 million, or 89%, to $2.6 million for the three months ended March 31, 2025, primarily due to the termination of the AstraZeneca U.S./RoW Agreement[191]. - Research and development expenses decreased by $27.3 million, or 75%, to $9.2 million for the three months ended March 31, 2025, reflecting cost reduction efforts[202]. - Operating costs and expenses decreased by $56.9 million, or 76%, to $17.7 million for the three months ended March 31, 2025, compared to $74.5 million in the same period in 2024[198]. - Interest income and other income (expenses), net decreased by $1.8 million, or 82%, compared to the same period a year ago, primarily due to lower interest income[208]. - Loss from continuing operations before income taxes was $16.8 million for the three months ended March 31, 2025, compared to a loss of $49.0 million for the same period in 2024[211]. - Cash and cash equivalents totaled $33.609 million as of March 31, 2025, down from $50.482 million at the end of 2024[132]. - Cash and cash equivalents decreased to $33.6 million as of March 31, 2025, from $50.5 million as of December 31, 2024[219]. - Net cash provided by operating activities was $2.7 million for the three months ended March 31, 2025, compared to a net cash used of $59.3 million for the same period in 2024[222][224]. - The company anticipates continued losses despite expected revenue increases from commercial sales of roxadustat in China, Japan, and Europe[230]. - There is substantial doubt about the company's ability to continue as a going concern within 12 months if additional funding is not secured[231]. Development and Clinical Trials - FibroGen is developing FG-3246, a potential first-in-class ADC targeting CD46, with a Phase 2 study expected to begin in Q3 2025 for metastatic castration-resistant prostate cancer (mCRPC)[129][143]. - The company anticipates feedback from the FDA regarding the development plan for roxadustat in lower-risk MDS in Q3 2025[131]. - A share purchase agreement with AstraZeneca is set to close in Q3 2025, involving the sale of FibroGen International and its roxadustat assets in China[129]. - The confirmed objective response rate for FG-3246 in a Phase 1 study was 20%, with a median duration of response of 7.5 months[146]. - The disease control rate for FG-3246 was 80%, with 48% of patients exceeding 24 weeks of treatment[146]. - The combination treatment of FG-3246 with enzalutamide demonstrated a median radiographic progression-free survival (rPFS) of 10.2 months in a Phase 1b/2 study[147]. - The maximally tolerated dose of FG-3246 was established at 2.1 mg/kg adjusted body weight, combined with enzalutamide 160 mg/day[147]. - In the Phase 2/3 MATTERHORN trial, 47.5% of patients in the roxadustat arm achieved transfusion independence for 56 consecutive days, compared to 33.3% in the placebo arm[157]. - A post-hoc analysis showed that 36.1% of roxadustat patients with a higher transfusion burden achieved transfusion independence, versus 11.5% in the placebo group (p=0.047)[157]. - FibroGen plans to file a Type-C meeting request with the FDA regarding roxadustat for anemia associated with lower-risk MDS in Q2 2025, expecting feedback in Q3 2025[158]. Collaborations and Agreements - The company entered into a Share Purchase Agreement with AstraZeneca for approximately $185 million, including $85 million in cash and an additional cash amount of approximately $100 million[160]. - The collaboration with Astellas and AstraZeneca is crucial for the development and commercialization of roxadustat, with total consideration received through March 31, 2025, amounting to $790.1 million[175]. - FibroGen terminated the AstraZeneca U.S./RoW Agreement, effective February 25, 2024, returning all non-China roxadustat rights except for South Korea, with total consideration received of $439.0 million[179]. - The AstraZeneca China Agreement remains unaffected, with total consideration received through March 31, 2025, amounting to $81.2 million[180]. - The company entered into a Share Purchase Agreement with AstraZeneca to sell all equity interests of FibroGen International, expected to close in Q3 2025[213]. Financial Position and Liabilities - As of March 31, 2025, the company had $73.4 million in senior secured term loan facilities, with $10.5 million in interest expected to be paid within the next 12 months[233]. - The company has $61.0 million in liabilities related to the sale of future revenues, with a potential payment cap of $125.0 million anticipated by 2031[234]. - Total non-cancelable purchase obligations amounted to $2.3 million for general purchases, $0.7 million for roxadustat manufacturing, and $0.3 million for FG-3246 manufacturing[232]. - The company has established a full valuation allowance against its net deferred tax assets due to cumulative net losses since inception[212]. - The company may issue and sell shares of common stock having an aggregate offering price of up to $30.0 million under an Equity Distribution Agreement with BofA Securities[218]. Operational Changes and Cost Management - Employee-related costs decreased by $7.8 million due to a reduction in force action and cost control efforts[203]. - Clinical trials costs decreased by $6.9 million primarily due to the termination of pamrevlumab programs in response to clinical data results[203]. - SG&A expenses decreased by $8.6 million, or 52%, for the three months ended March 31, 2025, compared to the same period a year ago[204]. - Cost of goods sold dropped by $21.1 million, or 99%, to $252,000 for the three months ended March 31, 2025, due to the cumulative catch-up adjustment related to the AstraZeneca agreement[199]. - Inventory decreased by $2.9 million due to lower production in China after decommissioning the API manufacturing facility[229]. - Accounts receivable increased by $24.7 million, primarily driven by a $26.0 million receivable from AstraZeneca related to past transactions[229]. - Deferred revenue decreased by $10.2 million, with $5.7 million reclassified to accrued liabilities due to changes in estimated variable consideration[229]. - Accrued interest expense related to the sale of future revenues decreased by $3.6 million, with $5.7 million interest paid during the quarter[229]. - The company has made four quarterly payments totaling $5.4 million to Fortis for the development of FG-3246, with the last payment of $1.7 million made in Q1 2024[169]. - If the option to acquire Fortis is exercised, the company will pay $80 million and could owe up to $200 million in contingent payments for regulatory approvals[170]. - The preclinical portfolio includes FG-3165 and FG-3175, both targeting immune checkpoints for the treatment of solid tumors[164][166].
FibroGen(FGEN) - 2025 Q1 - Quarterly Results
2025-05-12 20:05
Financial Performance - Total revenue from continuing operations for Q1 2025 was $2.7 million, a decrease of 89.3% compared to $25.4 million in Q1 2024[16] - Net loss from continuing operations for Q1 2025 was $16.8 million, or $0.16 per share, compared to a net loss of $49.0 million, or $0.49 per share, in the same period last year[16] - Total operating costs and expenses for Q1 2025 were $17.7 million, down from $74.5 million in Q1 2024[20] - The company reported a net income of $4.6 million from discontinued operations in Q1 2025, compared to a net loss of $32.9 million in the same period last year[20] Strategic Transactions - The sale of FibroGen China to AstraZeneca is expected to total approximately $185 million, with net cash held in China at closing estimated to be around $100 million[6] - Upon closing of the sale of FibroGen China, the company's cash runway is extended into the second half of 2027[6] Clinical Development - The initiation of the Phase 2 monotherapy trial of FG-3246 in mCRPC is anticipated in Q3 2025[6] - Topline results from the Phase 2 portion of the investigator-sponsored study of FG-3246 in combination with enzalutamide are expected in Q4 2025[6] - A Type-C meeting request has been filed with the FDA for roxadustat in the treatment of anemia associated with LR-MDS, with feedback expected in Q3 2025[8] Cash Position - Cash, cash equivalents, and accounts receivable totaled $128.4 million as of March 31, 2025[16]