Drug Development and Clinical Trials - Roxadustat is approved in China, Europe, Japan, and other countries for treating anemia in chronic kidney disease (CKD) patients, both on and off dialysis[35]. - The company expects to report topline results from seven pivotal clinical studies with two different drug candidates within the next 18 months[35]. - Pamrevlumab is in Phase 3 clinical development for idiopathic pulmonary fibrosis, locally advanced unresectable pancreatic cancer, and Duchenne muscular dystrophy, with exclusive worldwide rights retained by the company[34]. - The company plans to file up to two Investigational New Drug (IND) applications in the second half of 2023 for antibodies targeting CCR8 and Galectin-9[36]. - The company expects to report topline results from five ongoing Phase 3 studies of pamrevlumab within the next 18 months[43]. - Roxadustat is being studied in a Phase 3 trial for anemia in MDS, with topline data expected in Q2 2023[120]. - The Phase 3 trial for roxadustat in chemotherapy-induced anemia has enrolled 159 subjects, with topline data expected in Q2 2023[126]. - The LELANTOS-1 trial for non-ambulatory DMD patients completed enrollment of 99 patients, with topline data expected in the second quarter of 2023[89]. - The Phase 3 clinical trial for pamrevlumab in locally advanced unresectable pancreatic cancer enrolled 284 patients, with topline data expected in the first half of 2024[76]. Market and Sales Performance - Roxadustat sales volume in China grew over 80% in 2022, capturing a 34% value share in the CKD anemia segment[103]. - Roxadustat is expected to continue robust growth in 2023 due to increased adoption by patients and doctors, supported by treatment guidelines recommending HIF-PH inhibitors[104]. - In Europe, sales of roxadustat are anticipated to accelerate in 2023 due to reimbursement and launches in additional countries[106]. - The U.S. has approximately 39 million CKD patients, with an estimated 6 million suffering from anemia[108]. - Current anti-fibrotic therapies for IPF generated over $4 billion in worldwide sales in 2021, with Roche and Boehringer Ingelheim reporting sales of approximately $1.12 billion and $2.9 billion respectively for their products[52]. - Major market sales of pancreatic cancer drugs are projected to grow from $1.3 billion in 2016 to approximately $3.7 billion by 2026[71]. Regulatory and Compliance Challenges - The company faces significant risks related to the regulatory approval process for its product candidates, which may not be obtained[28]. - The pharmaceutical industry in China is highly regulated, and changes in regulations could materially affect the company's operations[28]. - Regulatory compliance is critical, with extensive requirements for clinical testing, manufacturing, and marketing, which the company is actively managing[175]. - The FDA's approval process involves significant scrutiny, and the company must ensure compliance with cGMP standards throughout the product lifecycle[182]. - The company is subject to numerous federal and state healthcare regulations, including HIPAA and the Physician Payments Sunshine Act, which impose strict compliance obligations[189][190]. - The approval process for new drugs in China requires completion of multiple clinical trial phases and oversight by the NMPA, which can be time-consuming and complex[206][208]. Competition and Market Position - The company faces competition from multiple pharmaceutical companies in the anemia treatment market, particularly in CKD, IPF, pancreatic cancer, and DMD[150]. - Roxadustat competes with currently marketed ESAs, which have been used for over 30 years in treating anemia in CKD[154]. - If approved, pamrevlumab will compete with Roche's Esbriet® and Boehringer Ingelheim's Ofev® for IPF treatment, which are already established oral therapies[164]. - The company is facing competition from other agents in clinical development for both IPF and DMD, which may impact patient recruitment and market entry[170]. Financial and Revenue Generation - For the fiscal year ended December 31, 2022, 40% of the company's revenue was generated from collaboration agreements, while 59% was from roxadustat commercial sales in China[136]. - The company received $49.8 million from NovaQuest as part of a revenue interest financing agreement related to future revenues from Astellas' sales of roxadustat[149]. - The company has entered into long-term commercial supply agreements to meet clinical and commercial needs as product candidates progress through development[171]. Intellectual Property and Patent Management - The U.S. Patent Term Restoration Act allows for a patent restoration term of up to five years for product candidates[213]. - The company plans to apply for patent term restoration for each product candidate to extend patent life beyond current expiration dates[213]. - Only one patent applicable to an approved product is eligible for extension, and the application must be submitted before the patent expiration[213].

Financial Data and Key Metrics Changes - Total revenue for Q3 2022 was $15.7 million, a significant decrease from $156 million in Q3 2021, primarily due to a $120 million milestone payment received in the previous year and a decrease in co-development revenue [25][26][28] - Net loss for Q3 2022 was $91.7 million, or $0.98 per share, compared to a net income of $49.8 million, or $0.54 per share, in Q3 2021 [33] - Cash, cash equivalents, and investments were reported at $441.6 million as of September 30, 2022, with an expected year-end balance of $380 million to $410 million [33][35] Business Line Data and Key Metrics Changes - Roxadustat net sales in China for Q3 2022 were $59 million, a 2% increase from $57.8 million in Q3 2021, driven by an over 80% increase in volume [21][28] - FibroGen's portion of roxadustat net product revenue in China was $17.4 million for Q3 2022, compared to $13.4 million in Q3 2021, representing a 29% increase [26][28] - Development revenue associated with co-development efforts for roxadustat was $2 million in Q3 2022, down from $26.1 million in Q3 2021 [26] Market Data and Key Metrics Changes - Roxadustat continues to be the 1 branded treatment for anemia in chronic kidney disease (CKD) by value share, with significant unit growth since its NRDL listing in 2020 [22][23] - The diagnosed prevalence of idiopathic pulmonary fibrosis (IPF) is approximately 330,000 patients across the U.S., EU, China, and Japan, indicating a substantial market opportunity [14] Company Strategy and Development Direction - The company is focused on three strategic areas: delivering pivotal Phase III data for pamrevlumab in three indications, ensuring the commercial success of roxadustat outside the U.S., and increasing research productivity [8][9] - The company anticipates top-line data from seven pivotal Phase III studies starting in the first half of 2023 through mid-2024, which is expected to be transformational for FibroGen [10][12] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the enrollment of a broad range of patients for the ZEPHYRUS program, including those with more severe conditions [40] - The company remains optimistic about the commercial potential of pamrevlumab and roxadustat, with plans to explore various options to strengthen its balance sheet [35][36] Other Important Information - A royalty monetization transaction with NovaQuest Capital Management secured $50 million of additional non-dilutive capital, strengthening the company's balance sheet [7][24] - The company is fully enrolled in five of its seven Phase III trials, with pivotal readouts expected to begin in 2023 [24] Q&A Session Summary Question: Can you speak to your confidence in enrolling subjects of similar severity to the Phase IIb PRAISE trial? - Management expressed high confidence in enrolling a broad range of patients, including more severe cases, in the ZEPHYRUS program [40] Question: If successful in the ZEPHYRUS programs, will you consider running an adjunct trial? - Management indicated that they are exploring life cycle options, including adjunct trials, depending on the outcomes of the ZEPHYRUS trials [41][42] Question: How do you expect the treatment paradigm to shift if successful in IPF? - Management noted that they are enrolling both naive patients and those who have previously been on standard care, expecting a broad label for pamrevlumab [52] Question: What kind of efficacy was seen in the Phase II WHITNEY study in CIA? - The WHITNEY study demonstrated the ability to increase hemoglobin and improve anemia, with the selected dose taken forward into the China Phase III study [86] Question: What is the status of the European launch of roxadustat? - The launch has been slower than expected, primarily due to reimbursement negotiations in Germany and other European countries [88][90]

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 ...