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 ...

FibroGen Reports Third Quarter 2021 Financial Results November 9, 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 gen ...