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].

Financial Data and Key Metrics Changes - For Q1 2023, total revenue was $36.2 million, a decrease from $60.8 million in the same period of 2022, primarily due to a one-time $25 million payment received in the prior year for regulatory approval of roxadustat in Russia [51] - The company reported a net loss of $76.7 million or $0.81 per share, compared to a net loss of $63.2 million or $0.68 per share in Q1 2022 [69] - Operating costs decreased to $112.3 million from $123.8 million year-over-year, with R&D expenses down to $74.5 million from $89 million [67] Business Line Data and Key Metrics Changes - Roxadustat sales in China generated $24.2 million in net product revenue for Q1 2023, up from $18.9 million in Q1 2022, representing a 28% increase [31] - Total roxadustat net sales in China reached $64.1 million, a 47% increase from $43.5 million in Q1 2022, driven by over 50% increase in volume [28][65] Market Data and Key Metrics Changes - The company highlighted a significant unmet medical need in the idiopathic pulmonary fibrosis (IPF) market, with approximately 120,000 patients in the US and only about one-third receiving treatment [21][22] - The diagnosed prevalence of IPF across the US, EU, China, and Japan is approximately 330,000 patients, with current therapies generating over $4 billion in global net revenue in 2022 [41] Company Strategy and Development Direction - The company aims to deliver pivotal Phase 3 pamrevlumab data in three high-value indications: IPF, Duchenne muscular dystrophy (DMD), and locally advanced unresectable pancreatic cancer [34] - FibroGen is focused on advancing its early-stage pipeline and expects to file up to two INDs by the end of 2023 [48][55] - The company has entered into an exclusive license with Fortis Therapeutics for FOR46, targeting a novel epitope on CD46 present in certain cancers [27] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the upcoming top-line data from four Phase 3 trials through Q3 2023 and two more by mid-2024 [13][30] - The CEO emphasized the importance of maintaining a strong financial position and discipline while progressing through 2023 [29][54] Other Important Information - The company reported $373.6 million in cash, cash equivalents, investments, and accounts receivable as of March 31, 2023, sufficient to fund operations through 2024 [52] - FibroGen completed a structured loan agreement with Morgan Stanley for up to $150 million, with the first tranche of $75 million already funded [70] Q&A Session Summary Question: Can you characterize the 25 patients who dropped out of the PRAISE study? - Management confirmed that the study was analyzed by intention to treat, meaning all available data from patients who dropped out were included in the analysis [57][79] Question: What proportion of patients do you think will be eligible for treatment with FOR46? - The company estimates that over 50% of patients will be eligible based on biomarker imaging, although this is based on a small data set [82] Question: Can you provide insights on the combination of pamrevlumab with standard of care? - Management indicated that while pamrevlumab can be used in combination with standard care, the trial design does not formally test this combination [96][100] Question: What are the projected discontinuation rates for ZEPHYRUS-1? - The company has not disclosed specific rates but is making efforts to keep patients on study, anticipating a robust data set [100] Question: Can you remind us about regulatory discussions regarding filing based on ZEPHYRUS-1 and PRAISE results? - Management stated that they believe they will be in a good position to file if ZEPHYRUS-1 results replicate PRAISE [117]

Financial Performance - Revenue for Q1 2023 was $36.2 million, a decrease of 40.5% compared to $60.8 million in Q1 2022[142]. - Net loss for Q1 2023 was $76.7 million, or $0.81 per share, compared to a net loss of $63.2 million, or $0.68 per share in Q1 2022[143]. - Total revenue for the three months ended March 31, 2023, was $36.2 million, a decrease of $24.7 million or 41% compared to the same period in 2022[179][184]. - License revenue decreased by $16.6 million or 73% to $6 million for the three months ended March 31, 2023, primarily due to the absence of revenue from Astellas[185]. - Total development and other revenue decreased by $7.9 million, or 67%, for Q1 2023 compared to Q1 2022, with total development revenue at $3.7 million[189]. - Product revenue increased by $5.3 million or 28% to $24.2 million for the three months ended March 31, 2023[179]. - Net product revenue from the AstraZeneca China Agreement was $24.2 million for the three months ended March 31, 2023, compared to $18.9 million in the same period in 2022[177]. Cash and Investments - Cash and cash equivalents totaled $188.6 million as of March 31, 2023, an increase from $155.7 million at the end of 2022[142]. - Total cash, cash equivalents, and investments decreased by $69.1 million from December 31, 2022, primarily due to cash used in operations[144]. - Net cash used in operating activities was $(101.6) million for the three months ended March 31, 2023, compared to $(8.5) million for the same period in 2022[231][233]. - Net cash provided by investing activities was $103.5 million for the three months ended March 31, 2023, primarily from $104.8 million of proceeds from maturities of investments[235]. - Net cash provided by financing activities was $31.5 million for the three months ended March 31, 2023, primarily from $30.8 million net proceeds received under the ATM Program[239]. - The company believes its existing cash and investments will meet anticipated cash requirements for at least the next 12 months, but may need additional capital thereafter[241]. Research and Development - Upcoming topline data expected for pamrevlumab in IPF from ZEPHYRUS-1 in mid-2023 and ZEPHYRUS-2 in mid-2024[150]. - Phase 3 trial for pamrevlumab in LAPC completed enrollment of 284 patients, with topline data expected in the first half of 2024[151]. - Roxadustat achieved over 50% increase in sales volume in Q1 2023 compared to Q1 2022, holding approximately 35% market share in China[157]. - Roxadustat did not meet its primary efficacy endpoint in the Phase 3 MATTERHORN trial, with 47.5% of patients achieving red blood cell transfusion independence compared to 33.3% in the placebo group (p=0.217)[158]. - The Phase 3 trial for roxadustat in chemotherapy-induced anemia has enrolled 159 subjects, with topline data expected in Q2 2023[159]. Expenses - Total operating costs and expenses decreased by $11.6 million, or 9%, for Q1 2023, totaling $112.3 million compared to $123.8 million in Q1 2022[207]. - Research and development expenses decreased by $14.5 million, or 16%, for Q1 2023, totaling $74.5 million compared to $89.0 million in Q1 2022[207]. - Selling, general and administrative (SG&A) expenses increased by $3.7 million, or 12%, for the three months ended March 31, 2023, compared to the same period a year ago[215]. - Interest expense increased significantly to $(2,372) thousand for the three months ended March 31, 2023, compared to $(97) thousand in the same period a year ago, representing a 2,345% increase[215]. - Interest income and other income improved by $1.4 million, or 422%, for the three months ended March 31, 2023, compared to the same period a year ago[220]. Agreements and Obligations - A financing agreement was entered into on April 29, 2023, providing for a $75 million initial term loan and up to $75 million in delayed draw term loans contingent on clinical milestones[160]. - An exclusive option agreement to acquire Fortis Therapeutics was established, with an upfront payment of $5 million and a potential acquisition cost of $80 million, plus up to $200 million in contingent payments[162][165]. - Total cash consideration received through March 31, 2023, from collaboration agreements amounted to $1.3 billion, with potential additional payments of $1.2 billion[178]. - The company had a total of $98.9 million of cash and cash equivalents held outside of the U.S. in foreign subsidiaries, including $77.6 million in China[227]. - The company has outstanding non-cancelable purchase obligations totaling $51.9 million, with $28.9 million expected to be paid within the next 12 months[243]. - Future milestone payments for research and preclinical stage development programs could total approximately $697.9 million, contingent on achieving specific milestones[245]. Market and Operational Risks - Roxadustat product sales in China began generating revenue in Q3 2019, but the company anticipates continued losses for the foreseeable future[240]. - The company is subject to risks related to the development and commercialization of novel therapeutics, which may lead to unforeseen expenses and complications[240]. - There were no material changes to the company's exposure to market risks during the three months ended March 31, 2023[249]. - There have been no material changes in critical accounting policies or estimates during the three months ended March 31, 2023[248]. - The company did not have any off-balance sheet arrangements during the three months ended March 31, 2023[246].

Pamrevlumab Development - Pamrevlumab is a unique Phase 3 investigational drug with potential disease-modifying mechanism across fibrotic diseases[14,18] - Phase 3 data is being delivered in three high-value indications: Idiopathic pulmonary fibrosis (IPF), Duchenne muscular dystrophy (DMD), and locally advanced pancreatic cancer (LAPC)[7] - PRAISE Phase 2 study in IPF showed a 4.33% FVC%-Predicted Difference and a 60% relative difference between pamrevlumab and placebo[25] - In Locally Advanced Pancreatic Cancer, patients with Pamrevlumab Day 15 C min ≥median (150 μg/mL) had a median OS of 9.0 months and a 1-Year OS Rate of 34.2%, compared to 4.4 months and 10.8% for those <median (150 μg/mL)[46] Roxadustat Update - Roxadustat is a novel, first-in-class treatment for CKD anemia, leveraging the body's natural response to hypoxia[10,87] - Roxadustat net sales to distributors in China were $53.1 million in Q4 2022, compared to $32.0 million a year ago, driven by a volume increase of over 90%[102,97] - Roxadustat China unit volume was up 78% in 2022 compared to the same period last year[103,105] Pipeline and Financial Status - The company advanced its pipeline and delivered on its clinical trial goals by completing enrollment of six pamrevlumab and roxadustat pivotal trials[3] - The company has a strong financial position with $442.7 million in cash as of December 31, 2022, and continues to remain focused on financial discipline[4,123]

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].

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 ...