FibroGen, Inc. (NASDAQ:FGEN) Q1 2023 Earnings Conference Call May 8, 2023 5:00 PM ET Company Participants Michael Tung - Vice President, Corporate Strategy & Investor Relations Enrique Conterno - Chief Executive Officer Juan Graham - Chief Financial Officer Mark Eisner - Chief Medical Officer John Hunter - Chief Scientific Officer Conference Call Participants Jason Gerberry - Bank of America Andy Hsieh - William Blair Danielle Brill - Raymond James Paul Choi - Goldman Sachs Michael Yee - Jefferies Annabel S ...

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 March 31, 2023 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 ...

Forward-Looking Statements Forward-looking statements involve known and unknown risks, uncertainties, assumptions, and other factors that may cause our actual results, performance, or achievements to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements, including the other risks and uncertainties that are described in the Risk Factors section of our most recent annual report on Form 10-K or quarterly report on Form 10-Q filed wi ...

FibroGen, Inc. (NASDAQ:FGEN) Q4 2022 Earnings Conference Call February 27, 2023 5:00 PM ET Company Participants Michael Tung - VP of Corporate Strategy and IR Enrique Conterno - CEO Mark Eisner - Chief Medical Officer Juan Graham - CFO Thane Wettig - Chief Commercial Officer Conference Call Participants Andrew Tsai - Jefferies Jason Gerberry - Bank of America Andy Hsieh - William Blair Danielle Brill - Raymond James Yaron Werber - Cowen Annabel Samimy - Stifel Operator Thank you for standing by, and welcome ...

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].

FibroGen, Inc. (NASDAQ:FGEN) Q3 2022 Earnings Conference Call November 7, 2022 5:00 PM ET Company Participants Michael Tung - IR Executive Enrique Conterno - CEO & Director Juan Graham - CFO Mark Eisner - EVP & Chief Medical Officer Thane Wettig - EVP & Chief Commercial Officer Christine Chung - SVP, China Operations Conference Call Participants Jason Gerberry - Bank of America Merrill Lynch Jack Padovano - Stifel, Nicolaus & Company Michael Yee - Jefferies Alexander Nackenoff - Raymond James & Associates A ...

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].

FibroGen, Inc. (NASDAQ:FGEN) Q2 2022 Earnings Conference Call August 8, 2022 5:00 PM ET Company Participants Michael Tung - Corporate Strategy and IR Enrique Conterno - CEO Mark Eisner - Chief Medical Officer Juan Graham - CFO Thane Wettig - Chief Commercial Officer Chris Chung - Senior Vice President of China Operations Conference Call Participants Michael Yee - Jefferies Annabel Samimy - Stifel Andy Hsieh - William Blair Brendan Smith - Cowen Paul Choi - Goldman Sachs Jason Gerberry - Bank of America Oper ...

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 ...