Financial Performance - Total revenue for the three months ended September 30, 2022, was $15.735 million, a significant decrease of 90.1% compared to $155.973 million for the same period in 2021[11]. - The net loss for the three months ended September 30, 2022, was $91.650 million, compared to a net income of $49.798 million for the same period in 2021, indicating a shift of approximately $141.448 million[14]. - The company reported a comprehensive loss of $92.066 million for the three months ended September 30, 2022, compared to a comprehensive income of $50.207 million for the same period in 2021[14]. - The net loss for the nine months ended September 30, 2022, was $227,479, compared to a net loss of $155,945 for the same period in 2021, representing a 45.8% increase in losses[24]. - The company reported a basic net loss per share of $(0.98) for the three months ended September 30, 2022, compared to a net income per share of $0.54 for the same period in 2021[11]. - The company reported a basic net loss per share of $2.43 for the nine months ended September 30, 2022, compared to a basic net loss per share of $1.69 for the same period in 2021[41]. Assets and Liabilities - As of September 30, 2022, total assets decreased to $608.837 million from $773.821 million as of December 31, 2021, representing a decline of approximately 21.3%[7]. - Cash and cash equivalents as of September 30, 2022, were $155.960 million, down from $171.223 million as of December 31, 2021, a decrease of approximately 8.9%[7]. - Total current liabilities increased to $251.994 million as of September 30, 2022, from $225.497 million as of December 31, 2021, an increase of about 11.8%[7]. - Total stockholders' equity decreased to $26.306 million as of September 30, 2022, from $209.146 million as of December 31, 2021, a decline of approximately 87.4%[7]. - The accumulated deficit as of September 30, 2022, was $1,491,513,000, reflecting a net loss of $227,479,000 during the nine-month period[19]. Revenue and Collaboration Agreements - The total consideration received under the Astellas Japan Agreement through September 30, 2022, amounted to $105.1 million, excluding drug product revenue[48]. - Under the Astellas Europe Agreement, the total consideration received through September 30, 2022, reached $685.0 million, excluding drug product revenue[54]. - The cumulative revenue recognized under the Astellas Europe Agreement through September 30, 2022, was $618.975 million[55]. - The total license and development revenue recognized under the Astellas Europe Agreement for the nine months ended September 30, 2022, was $897.880 million[55]. - The aggregate amount of consideration received under the AstraZeneca U.S./RoW Agreement through September 30, 2022, totaled $439.0 million, excluding drug product revenue[58]. - The total consideration received for milestone and upfront payments under the AstraZeneca China Agreement through September 30, 2022, was $77.2 million[62]. Clinical Development and Pipeline - The company is developing pamrevlumab, which is in Phase 3 clinical development for multiple conditions, retaining exclusive worldwide rights[27]. - Roxadustat, an oral small molecule, is approved in several regions for treating anemia in chronic kidney disease, with ongoing collaborations for its commercialization[28][29]. - The company has a diversified pipeline that includes late-stage clinical programs and preclinical drug candidates targeting unmet medical needs in oncology, immunology, and fibrosis[31]. - The company completed enrollment of the Phase 2/3 clinical trial MATTERHORN for roxadustat in myelodysplastic syndromes, expecting topline data in the first half of 2023[149]. - The company expects topline data from the Phase 3 trial ZEPHYRUS-1 for pamrevlumab in idiopathic pulmonary fibrosis in mid-2023, having completed enrollment of 356 patients[154]. - The company expects topline data from the Phase 3 trial LELANTOS-1 for pamrevlumab in Duchenne muscular dystrophy in the first half of 2023, having enrolled 99 non-ambulatory patients[158]. Cash Flow and Investments - Net cash used in operating activities for the nine months ended September 30, 2022, was $93,420, significantly higher than $27,272 for the same period in 2021[24]. - The company’s investing activities generated net cash of $88,023 for the nine months ended September 30, 2022, compared to a net cash used of $376,405 in the same period of the previous year[24]. - Cash and cash equivalents totaled $155,960 thousand as of September 30, 2022, down from $171,223 thousand at December 31, 2021[99]. - Short-term and long-term investments decreased to $270.340 million as of September 30, 2022, from $401.763 million as of December 31, 2021[136]. - The company held $84.4 million of cash and cash equivalents outside the U.S. for its China operations as of September 30, 2022[99]. Legal and Regulatory Matters - The company is facing ongoing legal proceedings, including securities class action complaints and shareholder derivative actions, which could materially impact its business and financial condition[123]. - The Company does not expect to receive most or all of the remaining AstraZeneca U.S./RoW Agreement milestones due to lack of agreement on further development funding[58]. - The company has evaluated options for transitioning away from LIBOR and does not expect a material impact on its financial statements upon adoption of the new guidance[46].

Financial Data and Key Metrics Changes - Total revenue for Q2 2022 was $29.8 million, a 22% increase from $24.4 million in Q2 2021 [29] - Net product revenue from roxadustat sales in China was $23.3 million, compared to $13.4 million in the same period last year [29] - Net loss for Q2 2022 was $72.6 million, or $0.78 per share, compared to a net loss of $134 million, or $1.45 per share, in Q2 2021 [37] Business Line Data and Key Metrics Changes - Roxadustat net sales in China totaled $53.1 million, slightly up from $52.8 million in Q2 2021, driven by an over 80% increase in volume [23][31] - Development revenue associated with co-development efforts for roxadustat was $5.5 million, down from $19.66 million in Q2 2021 [30] - Drug product revenue for roxadustat bulk drugs was $1.1 million, compared to a negative $8.6 million in the same period last year [30] Market Data and Key Metrics Changes - Roxadustat continues to be the number one branded treatment for anemia of CKD, with significant growth in volume expected to continue [25] - The diagnosed prevalence of idiopathic pulmonary fibrosis (IPF) is approximately 330,000 patients across the US, EU, China, and Japan, representing a significant market opportunity [15] - The pancreatic cancer market has over 90,000 diagnosed patients, with a low five-year disease-free survival rate of around 10%, indicating a large unmet need [17] Company Strategy and Development Direction - The company is focused on three areas: accelerating the development of Pamrevlumab in three indications, ensuring commercial success of roxadustat outside the US, and increasing research productivity [7][8] - The company expects topline data in 2023 from multiple pivotal Phase 3 trials, including Zephyrus-1 for IPF and LELANTOS trials for DMD [14][41] - The company aims to leverage its strong financial position, with $517.6 million in cash, to support ongoing and future clinical trials [38][42] Management's Comments on Operating Environment and Future Outlook - Management highlighted the strong performance of roxadustat in China, despite COVID-related challenges, and expressed optimism for continued growth [27][66] - The company anticipates further releases of deferred revenue in future quarters, indicating a positive outlook for cash flow [34] - Management emphasized the significant unmet needs in the therapeutic areas being targeted, particularly for IPF and DMD, and the potential for Pamrevlumab to address these needs [16][20] Other Important Information - The company has filed a prospectus supplement for an at-the-market equity offering, although there are no near-term plans to utilize it [40] - The company is committed to advancing Pamrevlumab as a potential first-in-class medicine in Phase 3 development [41] Q&A Session Summary Question: Any updates on the interim analysis for IPF and DMD studies? - Management confirmed there are no planned interim analyses for the IPF or DMD studies, but all have independent safety monitors [46] Question: Can you provide more details on the IPF opportunity and trial design? - The IPF trial is placebo-controlled, allowing treatment-naive and treatment-experienced patients, but they cannot be on background therapy when entering the trial [51] Question: What is the status of the DMD studies and their endpoints? - Endpoints for the DMD studies have been discussed with the FDA, and if efficacy is demonstrated, there is a path forward for filing approval [48][62] Question: How has COVID impacted performance in China? - Management noted that while COVID has affected revenues, roxadustat has seen an increase in volume, suggesting a net positive impact [66] Question: Will the results from LELANTOS-1 and LELANTOS-2 be sufficient for separate filings? - Management believes either study could support a filing based on strong data, given the high unmet need in DMD [77]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 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 June 30, 2022 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 FIBROGEN, INC. (Exact name of registrant as specified in its charter) Delaware 77-0357827 (State or Other Jurisdiction of ...

FibroGen, Inc. (NASDAQ:FGEN) Q1 2022 Earnings Conference Call May 9, 2022 5:00 PM ET Company Participants Michael Tung – Corporate Strategy/Investor Relations Enrique Conterno – Chief Executive Officer Mark Eisner – Chief Medical Officer Juan Graham – Chief Financial Officer Thane Wettig – Chief Commercial Officer Chris Chung – Senior Vice President of China Operations Conference Call Participants Michael Yee – Jefferies Andy Hsieh – William Blair Yaron Werber – Cowen Annabel Samimy – Stifel Operator Ladies ...

Revenue Performance - Revenue for the three months ended March 31, 2022, was $60.8 million, a 58% increase from $38.4 million in the same period in 2021[125]. - In Q1 2022, total revenue increased by $22.4 million, or 58%, to $60.8 million compared to $38.4 million in Q1 2021[171]. - License revenue for Q1 2022 was $22.6 million, a 100% increase from $0 in Q1 2021, primarily due to a $25.0 million regulatory milestone from Astellas for EVRENZO® approval in Russia[177]. - Product revenue, net, rose by $3.5 million, or 23%, to $18.9 million in Q1 2022 from $15.4 million in Q1 2021[171]. - Development and other revenue decreased by $2.8 million, or 19%, to $11.8 million in Q1 2022 compared to $14.6 million in Q1 2021[179]. - Drug product revenue for Q1 2022 was $7.6 million, down 10% from $8.5 million in Q1 2021[171]. - FibroGen recognized net product revenue of $18.9 million from its collaboration with AstraZeneca in China for Q1 2022, compared to $15.4 million in Q1 2021[166]. - Total product revenue, net increased by $3.5 million, or 23%, for the three months ended March 31, 2022, compared to the same period a year ago, reaching $18.9 million[182]. - Direct sales revenue, net decreased by $2.3 million, or 46%, for the three months ended March 31, 2022, compared to the same period a year ago, totaling $2.7 million[183]. - Sales to Falikang revenue, net increased by $5.8 million, or 56%, for the three months ended March 31, 2022, compared to the same period a year ago, amounting to $16.2 million[185]. Expenses and Losses - Net loss for the three months ended March 31, 2022, was $63.2 million, or $0.68 per share, compared to a net loss of $71.8 million, or $0.78 per share, in the prior year[129]. - Operating costs and expenses for the three months ended March 31, 2022, increased by $14.9 million compared to the same period in 2021, primarily due to higher drug development and clinical trial expenses[128]. - Research and development expenses increased by $14.3 million, or 19%, for the three months ended March 31, 2022, totaling $89.0 million[198]. - Total operating costs and expenses increased by $15.0 million, or 14%, for the three months ended March 31, 2022, totaling $123.8 million[191]. - Cost of goods sold increased by $0.8 million, or 25%, for the three months ended March 31, 2022, compared to the same period a year ago, reaching $4.2 million[192]. - SG&A expenses remained relatively flat for the three months ended March 31, 2022, compared to the same period a year ago, totaling $30.6 million[200]. Cash Flow and Financial Position - Cash and cash equivalents, investments, and accounts receivable totaled $565.4 million as of March 31, 2022, a decrease of $25.0 million from December 31, 2021[130]. - Cash and cash equivalents as of March 31, 2022, were $185.9 million, with short-term investments of $242.2 million and long-term investments of $93.5 million[211]. - Net cash used in operating activities was $8.5 million for the three months ended March 31, 2022, compared to $45.0 million for the same period in 2021[216]. - Net cash provided by investing activities was $25.9 million for the three months ended March 31, 2022, primarily from $76.1 million of proceeds from maturities of investments[222]. - Net increase in cash and cash equivalents was $14.7 million for the three months ended March 31, 2022, compared to a decrease of $244.9 million for the same period in 2021[218]. - As of March 31, 2022, $96.9 million of operating lease liabilities were reported, with $15.3 million expected to be paid within the next 12 months[229]. - The company anticipates needing substantial additional funding for ongoing operations and research and development efforts[226]. - Cash flows from the joint venture with AstraZeneca are intended to remain onshore in China for future expansion or debt obligations[212]. Clinical Trials and Development - The company is conducting two Phase 3 studies of pamrevlumab for idiopathic pulmonary fibrosis, with topline data expected in mid-2023[146]. - Enrollment for the Phase 2/3 trial of roxadustat in myelodysplastic syndromes is ongoing, with topline data expected in the first half of 2023[138]. - The company expects topline overall survival data from the Phase 3 trial of pamrevlumab for locally advanced unresectable pancreatic cancer in the first half of 2024[148]. - The company has completed enrollment of the Phase 3 trial for pamrevlumab in Duchenne muscular dystrophy, with topline data expected in the first half of 2023[150]. - The company expects to complete enrollment of its Phase 3 clinical trial, LELANTOS-2, with approximately 70 ambulatory DMD patients by Q2 2022[151]. Future Revenue and Collaborations - Total cash consideration received through March 31, 2022, from collaboration agreements with Astellas and AstraZeneca amounted to $1.3 billion, with potential future payments of $1.3 billion[169]. - The company anticipates fluctuations in revenue due to the uncertain timing and amount of collaboration payments and product sales[175]. - Future revenues will continue to be generated from collaboration agreements, including license fees, milestone payments, and royalties on drug product sales[175]. - Future milestone payments for research and pre-clinical stage development programs could total approximately $704.1 million under license agreements with HiFiBiO and others, contingent on achieving specific milestones[231]. Market Risks and Accounting Policies - The effective tax rate for the three months ended March 31, 2022, remained at (0.2)%[207]. - The company reported no material changes to its exposure to market risks during the three months ended March 31, 2022[237]. - There were no material changes in critical accounting policies, estimates, and judgments during the three months ended March 31, 2022, compared to the previous year[236]. - The company had no relationships with unconsolidated organizations or financial partnerships for off-balance sheet arrangements during the three months ended March 31, 2022[232].

FibroGen, Inc. Corporate Presentation March 2022 Forward-Looking Statements 2 This presentation contains "forward-looking" statements that involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this presentation, including statements regarding our future financial condition, business strategy, and plans, and objectives of management for future operations, are forward looking statements. These forward-looking statements can generally be identified b ...

FibroGen Reports Fourth Quarter and Full Year 2021 Financial Results February 28, 2022 Forward-Looking Statements This presentation contains "forward-looking" statements that involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this presentation, including statements regarding our future financial condition, business strategy, and plans, and objectives of management for future operations, are forward looking statements. These forward-looking stat ...

FibroGen, Inc. (NASDAQ:FGEN) Q4 2021 Earnings Conference Call February 28, 2022 5:00 PM ET Company Participants Michael Tung - VP, Corporate Strategy and IR Enrique Conterno - CEO Juan Graham - CFO Mark Eisner - CMO John Hunter - CSO Thane Wettig - CCO Chris Chung - SVP, China Operations Conference Call Participants Annabel Samimy - Stifel Michael Yee - Jefferies Alex Ramsey - William Blair Operator Good day, and thank you for standing by and welcome to the FibroGen Fourth Quarter 2021 Financial Results Con ...

Product Dependence and Competition - The company is heavily reliant on the success of its lead product, roxadustat, and its second compound, pamrevlumab, for future growth[16] - The FDA issued a complete response letter for roxadustat, decreasing the likelihood of approval and successful commercialization in the U.S., which may delay expected revenue[16] - The company faces significant competition in the pharmaceutical industry, which may impact the market acceptance of its product candidates[16] - The company has limited commercialization experience, which poses risks to achieving sustained commercial success for its products[16] - The regulatory approval process for product candidates is highly uncertain, and the company may not obtain necessary approvals[20] International Operations and Risks - The company is subject to various risks associated with international operations, particularly in China, which could adversely affect its business[21] - The company has established a joint venture, Falikang, with AstraZeneca to distribute roxadustat in China, where it holds a 51.1% ownership stake[25] - Cash flows from FibroGen Beijing are intended to remain onshore in China, with no debt repayments or distributions to entities outside of China to date[29] - The company’s liquidity position and capital contributions to FibroGen Beijing depend on various factors, including potential government policies affecting operations in China[29] - The company’s operations may be affected by unfavorable government policies on cross-border relations and international trade, impacting competitive position and market price of common stock[28] Financial Reporting and Market Risks - The company identified material weaknesses in its internal control over financial reporting as of December 31, 2020, which have since been remediated[20] - The ongoing COVID-19 pandemic could continue to adversely affect the company's business operations[22] - The company is exposed to market risks primarily due to fluctuations in foreign currency exchange rates, with most revenue from collaboration agreements denominated in U.S. dollars[735] - As of December 31, 2021, the company did not have material financial assets and liabilities in foreign currencies, indicating a hypothetical 10% change in exchange rates would not have resulted in a material net gain or loss[736] - The primary objective of the company's investment activities is to preserve capital while maximizing income from cash and cash equivalents, primarily investing in money market funds as of December 31, 2021[737] - The company has not entered into any hedging arrangements regarding foreign currency risk or other derivative financial instruments to date[738]

FibroGen, Inc. Corporate Presentation November 2021 Forward-Looking Statements 2 This presentation contains "forward-looking" statements that involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this presentation, including statements regarding our future financial condition, business strategy, and plans, and objectives of management for future operations, are forward looking statements. These forward-looking statements can generally be identifie ...