Financial Data and Key Metrics Changes - For Q2 2023, total revenue was $44.3 million, a 49% increase from $29.8 million in Q2 2022 [53] - Roxadustat net sales in China reached $76.4 million, up 44% from $53.1 million in Q2 2022 [85] - The company recorded a net loss of $87.7 million, compared to a net loss of $72.6 million in Q2 2022 [59] - Operating costs for Q2 2023 were $132.4 million, up from $108 million in Q2 2022, primarily due to a one-time charge of $24.6 million related to an asset acquisition [57][58] Business Line Data and Key Metrics Changes - Roxadustat generated $14.3 million in drug product revenue for the bulk drug product sold to Astellas, compared to $1.1 million in Q2 2022 [54] - Development revenue associated with roxadustat co-development efforts was $4.1 million, down from $5.2 million in Q2 2022 [54] - The net transfer price from roxadustat sales in China was $23.8 million, an increase of 31% year-over-year [56] Market Data and Key Metrics Changes - Roxadustat's market share in China rose to 39% in Q2 2023, marking the highest since its launch [45] - The company anticipates that the approval of roxadustat for chemotherapy-induced anemia could lead to over $500 million in annual net sales in China [44] Company Strategy and Development Direction - The company focuses on four strategic pillars: pamrevlumab, roxadustat, early-stage oncology pipeline, and maintaining a strong cash position [15][28] - Pamrevlumab is being developed for multiple indications, including Duchenne muscular dystrophy and pancreatic cancer, with upcoming late-stage readouts expected [34][92] - The company has implemented a cost reduction plan to extend its cash runway into 2026, allowing for continued investment in its pipeline [27][91] Management's Comments on Operating Environment and Future Outlook - Management remains optimistic about the company's opportunities despite recent setbacks, highlighting the potential of pamrevlumab and the strong performance of roxadustat in China [4][28] - The company expects to achieve significant savings from its restructuring efforts and maintain sufficient cash to fund operations into 2026 [89][91] Other Important Information - The company has filed a supplemental new drug application for roxadustat in patients with chemotherapy-induced anemia, expecting approval in mid-2024 [44] - The company is pursuing IND filings for two innovative oncology molecules in 2024 [26][64] Q&A Session Summary Question: What is your base case for the timing of a potential generic entry for roxadustat? - The composition matter patent expires in mid-2024, and generics are not expected until after that date [69] Question: Why are you excited about the FOR46 ADC program? - The program has shown a partial response rate of about 20% in a difficult-to-treat patient population, which is promising [71] Question: Can you provide insights on the LAPIS trial and its potential use of event-free survival as a surrogate for accelerated approval? - The primary endpoint is overall survival, and interim analysis for event-free survival did not meet the necessary criteria [118] Question: What are the avenues for filing secondary benefits from the North Star assessment in the ambulatory DMD trial? - Any positive data from the ambulatory trial will be explored for regulatory pathways with the FDA [127] Question: Can you clarify the status of the term loan with Morgan Stanley Tactical Value? - The loan has a maturation date of May 2026, and there are no current plans for early repayment [129]

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].

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].