FibroGen Reports Second Quarter 2023 Financial Results August 7, 2023 Forward-Looking Statements 2 This presentation contains forward-looking statements regarding FibroGen's strategy, future plans and prospects, including statements regarding the development and commercialization of the company's product candidates, the potential safety and efficacy profile of its product candidates, and its clinical programs. These forward-looking statements include, but are not limited to, statements under the caption "Up ...

Financial Performance - Revenue for Q2 2023 was $44.3 million, a 48.8% increase from $29.8 million in Q2 2022[152]. - Net loss for Q2 2023 was $87.7 million, compared to a net loss of $72.6 million in Q2 2022, resulting in a net loss per share of $0.90[156]. - Total revenue for the three months ended June 30, 2023, increased by $14.5 million, or 49%, compared to the same period in 2022, while total revenue for the six months decreased by $10.2 million, or 11%[210]. - License revenue for the three months ended June 30, 2023, was $1.0 million, a decrease of 69% compared to $3.2 million in the same period of 2022[211]. - Development and other revenue decreased by $0.3 million, or 5%, for the three months ended June 30, 2023, and decreased by $8.2 million, or 47%, for the six months ended June 30, 2023[214]. - Product revenue, net for the three months ended June 30, 2023, was $23.9 million, an increase of 3% compared to $23.3 million in the same period of 2022[204]. - Drug product revenue, net for the three months ended June 30, 2023, was $14.3 million, a 6% increase compared to $1.1 million in the same period of 2022[208]. - Other revenue for the three months ended June 30, 2023, was $1.0 million, a 274% increase compared to $0.3 million in the same period of 2022[214]. - Total product revenue, net increased by $0.6 million, or 3% for the three months ended June 30, 2023, and increased by $5.9 million, or 14% for the six months ended June 30, 2023, compared to the same periods a year ago[219]. Operating Costs - Operating costs for Q2 2023 were $132.4 million, up from $108.0 million in Q2 2022, primarily due to increased product revenue and clinical trial expenses[154]. - Total operating costs and expenses increased by $24.3 million, or 23% for the three months ended June 30, 2023, and increased by $12.8 million, or 6% for the six months ended June 30, 2023, respectively[236]. - Research and development expenses increased by $24.5 million, or 35% for the three months ended June 30, 2023, compared to the same period a year ago[236]. - Selling, general and administrative expenses increased by $923,000, or 3% for the three months ended June 30, 2023, compared to the same period a year ago[236]. - Cost of goods sold decreased by $1.1 million, or 16% for the three months ended June 30, 2023, and decreased by $1.8 million, or 17% for the six months ended June 30, 2023, respectively[237]. - Cost of goods sold associated with roxadustat commercial sales in China was $3.6 million for Q2 2023, a decrease of $1.3 million, or 26% year-over-year[238]. Cash and Investments - Cash and cash equivalents totaled $152.6 million as of June 30, 2023, a decrease of $3.1 million from $155.7 million at the end of 2022[158]. - Total cash, cash equivalents, and investments decreased by $81.3 million from December 31, 2022, primarily due to cash used in operations[158]. - As of June 30, 2023, the company had short-term investments of $183.1 million, down from $266.3 million as of December 31, 2022[262]. - Net cash used in operating activities was $212.2 million for the six months ended June 30, 2023, compared to $41.5 million for the same period in 2022[265][267]. - Net cash provided by investing activities was $89.2 million for the six months ended June 30, 2023, primarily from $192.9 million of proceeds from maturities of investments[268]. - Net cash provided by financing activities was $123.0 million for the six months ended June 30, 2023, mainly from $71.3 million net proceeds from senior secured term loan facilities[271]. Clinical Development - Roxadustat generated $23.9 million in net product revenue from commercial sales in China during Q2 2023[154]. - Pamrevlumab is in Phase 3 clinical development for locally advanced unresectable pancreatic cancer, with topline data expected in Q1 2024[162]. - The Phase 3 trial for pamrevlumab in ambulatory Duchenne muscular dystrophy (DMD) completed enrollment of 73 patients, with topline data expected in August 2023[164]. - The Phase 3 trial for pamrevlumab in idiopathic pulmonary fibrosis did not meet its primary endpoint, with a mean decline in FVC of 260 ml compared to 330 ml in the placebo group[167]. - In a Phase 3 study for chemotherapy-induced anemia, Roxadustat demonstrated non-inferiority to recombinant erythropoietin alfa on the primary endpoint of hemoglobin change[171]. - FG-3246 showed a PSA50 response rate of 45% and an objective partial response rate of 19% in a Phase 1 clinical study for metastatic castration-resistant prostate cancer[177]. - The company is developing a PET biomarker for FG-3246 in collaboration with UCSF, with a Phase 2 trial anticipated to start in the second half of 2024[178]. Financing and Agreements - A financing agreement was established for a $75 million senior secured term loan to support ongoing operations[183]. - An exclusive option agreement was signed to acquire Fortis Therapeutics, with a potential payment of $80 million upon acquisition and up to $200 million in contingent payments[187]. - The company recognized $1 million in upfront payments under the Eluminex Agreement during Q2 2023, with additional milestone payments recognized[190]. - Total cash consideration received through June 30, 2023, from collaboration agreements amounted to $1,306.3 million, with potential cash consideration of $1,237.0 million, totaling $2,543.3 million[203]. - Future milestone payments under license agreements could total approximately $697.9 million, contingent on achieving specific developmental milestones[280]. Future Outlook - The company anticipates needing substantial additional funding for ongoing operations and research and development efforts[274][275]. - The company expects future development services to continue through 2024, with co-development services in China expected to continue through 2028[206]. - The company anticipates fluctuations in revenue generated from collaboration agreements due to the uncertain timing and amount of payments and sales[209]. - The liquidity position of FibroGen Beijing is influenced by various factors, including potential future cash distributions and debt obligations[263]. - The company has not made any debt repayments or distributions from FibroGen Beijing to entities outside of China to date[263].

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 ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Title of each class Trading Symbol Name of each exchange on which registered Common Stock, $0.01 par value FGEN The Nasdaq Global Select Market 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 September 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 Commiss ...

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 ...