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 ...

FibroGen, Inc. (NASDAQ:FGEN) Q3 2021 Earnings Conference Call November 9, 2021 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 Conference Call Participants Annabel Samimy - Stifel Edwin Zhang - H.C. Wainwright Michael Yee - Jefferies Geoffrey Porges - SVB Leerink Paul Choi - Goldman Sachs Andy Hsieh - William Blair Operator Hello. Thank you for standing by. Welcome to the FibroGen Third Quarter 2021 Fin ...

Financial Performance - Revenue for the three months ended September 30, 2021, was $155.973 million, a significant increase from $44.032 million in the same period of 2020, representing a growth of 253%[169] - Net income for the three months ended September 30, 2021, was $49.798 million, compared to a net income of $33.004 million for the same period in 2020, reflecting a year-over-year increase of 51%[169] - License revenue for Q3 2021 was $116.4 million, a 100% increase compared to the previous year[211] - Total revenue for Q3 2021 increased by $111.9 million, or 254%, compared to the same period last year[216] - Development and other revenue for Q3 2021 was $26.1 million, a 26% increase from $20.7 million in Q3 2020[211] - Product revenue for Q3 2021 was $13.4 million, a decrease of 41% compared to the previous year[211] - Total product revenue, net for the nine months ended September 30, 2021, was $42.2 million, a 3% decrease from $43.3 million in the same period in 2020[225] Operating Costs and Expenses - Operating costs and expenses for the three months ended September 30, 2021, were $104.999 million, up from $11.702 million in the same period of 2020, indicating a substantial increase due to higher sales and marketing expenses[173] - Total operating costs and expenses increased by $93.3 million, or 797%, for the three months ended September 30, 2021, and by $126.9 million, or 52%, for the nine months ended September 30, 2021, compared to the same periods a year ago[233] - Research and development expenses increased by $17.4 million, or 30%, for the three months ended September 30, 2021, and by $98.3 million, or 56%, for the nine months ended September 30, 2021, compared to the same periods a year ago[240][242] - SG&A expenses increased by $74.8 million, or 153%, for the three months ended September 30, 2021, and by $25.0 million, or 39%, for the nine months ended September 30, 2021, compared to the same periods a year ago[244][245] Cash and Investments - Cash and cash equivalents totaled $274.527 million as of September 30, 2021, down from $678.393 million at the end of 2020, a decrease of $403.866 million[169] - As of September 30, 2021, the company had cash and cash equivalents of $274.5 million, with short-term and long-term investments totaling $211.9 million and $142.6 million, respectively[259] - The company reported a net cash used in operating activities of $27.3 million for the nine months ended September 30, 2021, primarily due to a net loss of $155.9 million adjusted for non-operating cash items[263] - For the nine months ended September 30, 2021, net cash used in investing activities was $376.4 million, mainly from purchases of available-for-sale securities totaling $397.9 million[269] Product Development and Regulatory Updates - The FDA issued a complete response letter regarding Roxadustat's NDA for CKD anemia, indicating that it could not be approved in its current form[181] - The company is conducting a Phase 2/3 trial for Roxadustat in anemia associated with myelodysplastic syndromes, with topline data expected between the second half of 2022 and the first half of 2023[182] - Pamrevlumab has received multiple designations from the FDA, including Rare Pediatric Disease designation and Fast Track designation for the treatment of Duchenne muscular dystrophy[187] - The company expects topline overall survival data from the Phase 3 clinical program for pamrevlumab in pancreatic cancer in the first half of 2024[189] - The company expects topline data from the LELANTOS-1 Phase 3 trial in the first half of 2023[191] - The LELANTOS-2 trial is enrolling approximately 70 ambulatory DMD patients, with a treatment period of 52 weeks[192] Collaboration and Licensing Agreements - The company recognized $120.0 million in milestone payments from Astellas due to the approval of EVRENZO® in Europe[199] - Total cash consideration received from collaboration agreements with Astellas and AstraZeneca through September 30, 2021, was $1.28 billion[209] - Total potential cash payments from collaboration agreements amount to $2.54 billion, including upfront and milestone payments[209] - Future milestone payments under license agreements could total approximately $359.1 million, contingent upon achieving specific developmental and regulatory milestones[278] - The company has an exclusive license agreement with Eluminex, which includes an $8.0 million upfront payment and potential future payments of up to $100.0 million[195] Market Position and Sales - Roxadustat had a 33% value share in the erythropoiesis stimulating agents and HIF-PH inhibitors market in China as of October 2021[179] - Falikang became fully operational in January 2021, and it is the primary customer for roxadustat sales in China[282] - Revenue from roxadustat sales is recognized when control is transferred to Falikang, based on estimated transaction price per unit and actual quantity delivered[284] - Direct sales to pharmaceutical distributors in provinces not covered by Falikang also contribute to revenue, with revenue recognized upon transfer of control[289] Financial Risks and Future Outlook - The company anticipates continued losses despite revenue growth from roxadustat product sales in China, and is implementing cost reduction efforts following a Complete Response Letter (CRL) for roxadustat in the U.S.[260] - The company expects substantial additional funding will be needed to support ongoing operations and research and development efforts[260] - The company is subject to risks related to the development and commercialization of novel therapeutics, which may lead to unforeseen expenses and complications[260] - The company has not identified any material changes to its exposure to market risks as of September 30, 2021[295]