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 ...

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].

FibroGen (NASDAQ:FGEN) stock is falling hard on Wednesday after the biopharmaceutical company reported results from failed clinical trials. The first failed clinical trial covers the treatment of metastatic pancreatic cancer with pamrevlumab. FibroGen said that this didn't meet its primary endpoint of overall survival. This was determined based on the protocol pre-specified Bayesian statistical analysis. The second failed study covered the use of pamrevlumab combined with gemcitabine + nab-paclitaxel to tre ...

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 ...