KYNTRA BIO, INC. 10-Q

ITEM 1. FINANCIAL STATEMENTS CONDENSED CONSOLIDA TED BALANCE SHEETS (In thousands, except per share amounts) (Unaudited) March 31, 2024 December 31, 2023 Assets Current assets: Cash and cash equivalents $ 105,734 $ 113,688 Short-term investments 71,865 121,898 Accounts receivable, net ($ 7,122 and $ 6,079 from related parties) 37,083 12,553 Inventories 27,335 41,565 Prepaid expenses and other current assets 36,150 41,855 Total current assets 278,167 331,559 Restricted time deposits 1,658 1,658 Property and equipment, net 12,166 13,126 Equity method investment in unconsolidated variable interest entity 5,776 5,290 Operating lease right-of-use assets 64,751 68,093 Other assets 3,350 3,803 Total assets $ 365,868 $ 423,529 Liabilities, redeemable non-controlling interests and deficit Current liabilities: Accounts payable $ 4,353 $ 17,960 Accrued and other current liabilities ($ 45,870 and $ 39,814 to a related party) 164,286 172,891 Deferred revenue ($ 7,901 and $ 7,220 to related parties) 12,863 12,740 Operating lease liabilities, current 15,231 14,077 Total current liabilities 196,733 217,668 Product development obligations 17,446 17,763 Deferred revenue, net of current ($ 2,343 and $ 9,705 to a related party) 147,118 157,555 Operating lease liabilities, non-current 62,511 66,537 Senior secured term loan facilities, non-current 72,213 71,934 Liability related to sale of future revenues, non-current 52,216 51,413 Other long-term liabilities ($ 2,458 and $ 656 to a related party) 3,786 2,858 Total liabilities 552,023 585,728 Commitments and Contingencies Redeemable non-controlling interests 21,480 21,480 Stockholders’ deficit: Preferred stock, $ 0.01 par value; 125,000 shares authorized; no shares issued and outstanding at March 31, 2024 and December 31, 2023 — — Common stock, $ 0.01 par value; 225,000 shares authorized at March 31, 2024 and December 31, 2023; 99,474 and 98,770 shares issued and outstanding at March 31, 2024 and December 31, 2023 995 988 Additional paid-in capital 1,652,243 1,643,641 Accumulated other comprehensive loss ( 6,507 ) ( 6,875 ) Accumulated deficit ( 1,874,853 ) ( 1,841,920 ) Total stockholders’ deficit attributable to FibroGen ( 228,122 ) ( 204,166 ) Nonredeemable non-controlling interests 20,487 20,487 Total deficit ( 207,635 ) ( 183,679 ) Total liabilities, redeemable non-controlling interests and deficit $ 365,868 $ 423,529 The accompanying notes are an integral part of these unaudited condensed consolidated financial statements 2 Table of Contents FIBROGEN, INC. CONDENSED CONSOLIDATED S TATEMENTS OF OPERATIONS (In thousands, except per share amounts) (Unaudited) Three Months Ended March 31, 2024 2023 Revenue: License revenue $ — $ 6,000 Development and other revenue (includes $ 294 and $ 1,624 from a related party) 878 3,891 Product revenue, net (includes $ 27,113 and $ 21,372 from a related party) 30,538 24,161 Drug product revenue, net (includes $ 1,184 and $ 2,109 from a related party) 24,486 2,109 Total revenue 55,902 36,161 Operating costs and expenses: Cost of goods sold 25,753 3,491 Research and development 38,392 74,486 Selling, general and administrative 22,820 34,275 Total operating costs and expenses 86,965 112,252 Loss from operations ( 31,063 ) ( 76,091 ) Interest and other, net Interest expense ( 4,996 ) ( 2,372 ) Interest income and other income (expenses), net 2,570 1,036 Total interest and other, net ( 2,426 ) ( 1,336 ) Loss before income taxes ( 33,489 ) ( 77,427 ) Provision for income taxes 33 74 Investment income in unconsolidated variable interest entity 589 796 Net loss $ ( 32,933 ) $ ( 76,705 ) Net loss per share - basic and diluted $ ( 0.33 ) $ ( 0.81 ) Weighted average number of common shares used to calculate net loss per share - basic and diluted 98,982 94,691 The accompanying notes are an integral part of these unaudited condensed consolidated financial statements 3 Table of Contents FIBROGEN, INC. CONDENSED CONSOLIDATED STATE MENTS OF COMPREHENSIVE LOSS (In thousands) (Unaudited) Three Months Ended March 31, 2024 2023 Net loss $ ( 32,933 ) $ ( 76,705 ) Other comprehensive income (loss): Foreign currency translation adjustments 392 ( 248 ) Available-for-sale investments: Unrealized gain (loss) on investments, net of tax effect ( 24 ) 1,398 Other comprehensive gain (loss), net of taxes 368 1,150 Comprehensive loss ( 32,565 ) ( 75,555 ) The accompanying notes are an integral part of these unaudited condensed consolidated financial statements 4 Table of Contents FIBROGEN, INC. CONDENSED CONSOLIDATED STATEMENT S OF CHANGES IN STOCKHOLDERS’ DEFICIT (In thousands, except share data) (Unaudited) For The Three Month Period Common Stock Additional Paid-in Accumulated Other Comprehensive Accumulated Nonredeemable Non-Controlling Total Redeemable Non-Controlling Shares Amount Capital Income (Loss) Deficit Interests Deficit Interests (Note 3) Balance at December 31, 2023 98,770,247 $ 988 $ 1,643,641 $ ( 6,875 ) $ ( 1,841,920 ) $ 20,487 $ ( 183,679 ) $ 21,480 Net loss — — — — ( 32,933 ) — ( 32,933 ) Change in unrealized gain or loss on investments — — — ( 24 ) — — ( 24 ) — Foreign currency translation adjustments — — — 392 — — 392 — Shares issued from stock plans, net of payroll taxes paid 704,151 7 ( 160 ) — — — ( 153 ) — Stock-based compensation — — 8,762 — — — 8,762 — Balance at March 31, 2024 99,474,398 $ 995 $ 1,652,243 $ ( 6,507 ) $ ( 1,874,853 ) $ 20,487 $ ( 207,635 ) $ 21,480 Balance at December 31, 2022 94,166,086 $ 942 $ 1,541,019 $ ( 5,720 ) $ ( 1,557,688 ) $ 19,967 $ ( 1,480 ) $ — Net loss — — — — ( 76,705 ) — ( 76,705 ) — Change in unrealized gain or loss on investments — — — 1,398 — — 1,398 — Foreign currency translation adjustments — — — ( 248 ) — — ( 248 ) — Issuance of common stock under ATM Program 1,541,579 15 31,116 — — — 31,131 — Shares issued from stock plans, net of payroll taxes paid 915,644 9 898 — — — 907 — Stock-based compensation — — 16,112 — — — 16,112 — Balance at March 31, 2023 96,623,309 $ 966 $ 1,589,145 $ ( 4,570 ) $ ( 1,634,393 ) $ 19,967 $ ( 28,885 ) $ — The accompanying notes are an integral part of these unaudited condensed consolidated financial statements 5 Table of Contents FIBROGEN, INC. CONDENSED CONSOLIDATED S TATEMENTS OF CASH FLOWS (In thousands) (Unaudited) Three Months Ended March 31, 2024 2023 Operating activities Net loss $ ( 32,933 ) $ ( 76,705 ) Adjustments to reconcile net loss to net cash used in operating activities: Depreciation 810 2,542 Amortization of finance lease right-of-use assets 10 423 Net accretion of premium and discount on investments ( 1,294 ) ( 689 ) Investment income in unconsolidated variable interest entity ( 589 ) ( 796 ) Loss on disposal of property and equipment — 1 Stock-based compensation 8,762 16,112 Non-cash interest expense related to sale of future revenues — 2,249 Impairment of investment — 1,000 Realized loss on sales of available-for-sale securities — 271 Changes in operating assets and liabilities: Accounts receivable, net ( 24,685 ) ( 1,299 ) Inventories 13,786 ( 1,940 ) Prepaid expenses and other current assets 5,271 38 Operating lease right-of-use assets 3,286 3,237 Other assets 219 1,072 Accounts payable ( 13,587 ) 40,473 Accrued and other liabilities ( 2,989 ) ( 66,266 ) Operating lease liabilities, current 1,180 ( 371 ) Deferred revenue ( 10,202 ) ( 18,877 ) Accrued interest expense related to sale of future revenues ( 3,638 ) — Accrued interest for finance lease liabilities 14 ( 56 ) Operating lease liabilities, non-current ( 4,001 ) ( 2,720 ) Other long-term liabilities 1,292 710 Net cash used in operating activities ( 59,288 ) ( 101,591 ) Investing activities Purchases of property and equipment ( 29 ) ( 591 ) Purchases of available-for-sale securities ( 8,628 ) ( 2,472 ) Proceeds from sales of available-for-sale securities — 1,730 Proceeds from maturities of investments 59,933 104,815 Net cash provided by investing activities 51,276 103,482 Financing activities Repayments of finance lease liabilities ( 12 ) ( 71 ) Repayments of lease obligations — ( 101 ) Cash paid for payroll taxes on restricted stock unit releases ( 153 ) — Proceeds from issuance of common stock under ATM Program, net of commissions — 30,750 Proceeds from issuance of common stock under employee stock plans — 907 Net cash provided by (used in) financing activities ( 165 ) 31,485 Effect of exchange rate change on cash and cash equivalents 223 ( 526 ) Net increase (decrease) in cash and cash equivalents ( 7,954 ) 32,850 Total cash and cash equivalents at beginning of period 113,688 155,700 Total cash and cash equivalents at end of period $ 105,734 $ 188,550 The accompanying notes are an integral part of these unaudited condensed consolidated financial statements 6 Table of Contents FIBROGEN, INC. NOTES TO THE CONDENSED CONSOL IDATED FINANCIAL STATEMENTS (Unaudited) 1. Significant Accounting Policies Description of Operations FibroGen, Inc. (“FibroGen” or the “Company”) is headquartered in San Francisco, California, with subsidiary offices in Beijing and Shanghai, People’s Republic of China (“China”). FibroGen is developing and commercializing a diversified pipeline of novel therapeutics that work at the frontier of cancer biology and anemia. Pamrevlumab, a human monoclonal antibody targeting connective tissue growth factor, is in Phase 3 clinical development for the treatment of locally advanced unresectable pancreatic cancer. Pamrevlumab is also in Phase 2/3 development for the treatment of metastatic pancreatic cancer. To date, the Company has retained exclusive worldwide rights for pamrevlumab. Roxadustat is an oral small molecule inhibitor of HIF prolyl hydroxylase activity. Roxadustat (爱瑞卓 ® , EVRENZO TM ) is approved in China, Europe, Japan, and numerous other countries for the treatment of anemia in chronic kidney disease (“CKD”) for patients who are on dialysis and not on dialysis. Roxadustat is in clinical development for chemotherapy-induced anemia in China. FibroGen is also developing earlier stage clinical and preclinical product candidates, FG-3246, FG-3165 and FG-3175, to address unmet patient needs in oncology. Basis of Presentation and Principles of Consolidation The condensed consolidated financial statements include the accounts of FibroGen, its wholly-owned subsidiaries and its majority-owned subsidiaries, as well as any variable interest entity (“VIE”) for which FibroGen is the primary beneficiary. All inter-company transactions and balances have been eliminated in consolidation. For any VIE for which FibroGen is not the primary beneficiary, the Company uses the equity method of accounting. The Company operates as one reportable segment — the discovery, development and commercialization of novel therapeutics to treat serious unmet medical needs. The unaudited condensed consolidated financial statements and related disclosures have been prepared in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”) applicable to interim financial reporting and with the instructions to Form 10-Q and Rule 10-01 of Regulation S-X of the U.S. Securities and Exchange Commission (“SEC”) and, therefore, do not include all information and footnote disclosures normally included in the annual consolidated financial statements. The financial information included herein should be read in conjunction with the consolidated financial statements and related notes in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, filed on February 26, 2024. Based on its current operating plan, which contemplates the maintenance of a minimum balance of $ 30 million of unrestricted cash and cash equivalents held in accounts in the U.S., as required under the debt covenants associated with the senior secured term loan facilities, the Company believes that its existing cash and cash equivalents, short-term investments and accounts receivable will be sufficient to meet its anticipated cash requirements for at least the next 12 months from the date of issuance of the financial statements. However, the Company may need additional capital to fund its operations and its liquidity assumptions may materially differ. For example, the Company may utilize its available financial resources sooner than it currently expects and may incur additional expenses. In addition, the Company may elect to raise additional funds at any time through equity, equity-linked, debt financing arrangements or from other sources. 7 Table of Contents Use of Estimates The preparation of the condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and reported amounts of revenues and expenses during the reporting period. The more significant areas requiring the use of management estimates and assumptions include valuation and recognition of revenue and deferred revenue, specifically, estimates in variable consideration for drug product sales, and estimates in transaction price per unit for the China performance obligation. On an ongoing basis, management reviews these estimates and assumptions. Changes in facts and circumstances may alter such estimates and actual results could differ from those estimates. In the Company’s opinion, the accompanying unaudited condensed consolidated financial statements include all normal recurring adjustments necessary for a fair statement of its financial position, results of operations and cash flows for the interim periods presented. Significant Accounting Policies The accounting policies used by the Company in its presentation of interim financial results are consistent with those presented in Note 2 to the consolidated financial statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, filed on February 26, 2024. Net Loss per Share Potential common shares that would have the effect of increasing diluted earnings per share are considered to be anti-dilutive and as such, these shares are not included in the calculation of diluted earnings per share. The Company reported a net loss for each of the three months ended March 31, 2024 and 2023. Therefore, dilutive common shares are not assumed to have been issued since their effect is anti-dilutive for these periods. Diluted weighted average shares excluded the following potential common shares related to s tock options, service-based restricted stock units (“RSUs”), performance-based RSUs (“PRSUs”), total shareholder return (“TSR”) awards and shares to be purchased under the 2014 Employee Stock Purchase Plan (“ESPP”) for the periods presented as they were anti-dilutive (in thousands): Three Months Ended March 31, 2024 2023 Employee stock options 12,484 7,578 RSUs, PRSUs and TSR awards 3,605 2,762 ESPP 533 362 16,622 10,702 Risks and Uncertainties The Company’s future results of operations involve a number of risks and uncertainties. Factors that could affect the Company’s future operating results and cause actual results to vary materially from expectations include, but are not limited to, the results of clinical trials and the achievement of milestones, research developments, actions by regulatory authorities, market acceptance of the Company’s product candidates, competition from other products and larger companies, the liquidity and capital resources of the Company, intellectual property protection for the Company’s proprietary technology, strategic relationships, and dependence on key individuals, suppliers, clinical organization, and other third parties. Recently Issued Accounting Guidance Not Yet Adopted In November 2023, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures, which requires all public entities, including public entities with a single reportable segment, to provide in interim and annual periods one or more measures of segment profit or loss used by the chief operating decision maker to allocate resources and assess performance. In addition, this guidance requires disclosures of significant segment expenses and other segment items as well as incremental qualitative disclosures. This guidance is effective for fiscal years beginning after December 15, 2023, and interim periods after December 15, 2024, with retrospective application required, and early adoption permitted. The Company is currently in the process of evaluating the effects of this guidance on its related disclosures. 8 Table of Contents In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures , which requires enhanced income tax disclosures, including specific categories and disaggregation of information in the effective tax rate reconciliation, disaggregated information related to income taxes paid, income or loss from continuing operations before income tax expense or benefit, and income tax expense or benefit from continuing operations. This guidance is effective for annual periods beginning after December 15, 2024, with early adoption permitted. The Company is currently in the process of evaluating the impact of this pronouncement on its related disclosures. 2. Collaboration Agreements, License Agreement and Revenues Astellas Agreements Astellas Japan Agreement In June 2005, the Company entered into a collaboration agreement with Astellas Pharma Inc. (“Astellas”) for the development and commercialization (but not manufacture) of roxadustat for the treatment of anemia in Japan (“Astellas Japan Agreement”). Under this agreement, Astellas agreed to pay license fees, other upfront consideration and various milestone payments, totaling $ 172.6 million . The Astellas Japan Agreement also provides for tiered payments based on net sales of product (as defined) in the low 20% range of the list price published by Japan’s Ministry of Health, Labour and Welfare, adjusted for certain elements, after commercial launch. The aggregate amount of consideration received through March 31, 2024 totaled $ 105.1 million , excluding drug product revenue that is discussed under the Drug Product Revenue, Net section below. Based on its current development plans for roxadustat in Japan, the Company does not expect to receive most or all of the additional potential milestones under the Astellas Japan Agreement. Amounts recognized as license revenue and development revenue under the Astellas Japan Agreement were not material for the three months ended March 31, 2024 and 2023. The transaction price related to consideration received through March 31, 2024 and accounts receivable has been allocated to each of the following performance obligations under the Astellas Japan Agreement (in thousands): Astellas Japan Agreement Total Consideration Through March 31, 2024 License $ 100,347 Development revenue 17,099 Total license and development revenue $ 117,446 There was no license revenue or development revenue resulting from changes to estimated variable consideration in the current period relating to performance obligations satisfied or partially satisfied in previous periods for the three months ended March 31, 2024 under the Astellas Japan Agreement. The Company does no t expect material variable consideration from estimated future co-development billing beyond the development period in the transaction price related to the Astellas Japan Agreement. In 2018, FibroGen and Astellas entered into an amendment to the Astellas Japan Agreement that allows Astellas to manufacture roxadustat drug product for commercialization in Japan (the “Astellas Japan Amendment”). The related drug product revenue is described under the Drug Product Revenue, Net section below. Astellas Europe Agreement In April 2006, the Company entered into a separate collaboration agreement with Astellas for the development and commercialization of roxadustat for the treatment of anemia in Europe, the Middle East, the Commonwealth of Independent States and South Africa (“Astellas Europe Agreement”). Under the terms of the Astellas Europe Agreement, Astellas agreed to pay license fees, other upfront consideration and various milestone payments, totaling $ 745.0 million . U nder the Astellas Europe Agreement, Astellas committed to fund 50 % of joint development costs for Europe and North America, and all territory-specific costs. The Astellas Europe Agreement also provides for tiered payments based on net sales of product (as defined) in the low 20% range . The aggregate amount of consideration received under the Astellas Europe Agreement through March 31, 2024 totaled $ 685.0 million , excluding drug product revenue that is discussed under the Drug Product Revenue, Net section below. Based on its current development plans for roxadustat in Europe, the Company does not expect to receive most or all of the additional potential milestones under the Astellas Europe Agreement. 9 Table of Contents Amounts recognized as license revenue and development revenue under the Astellas Europe Agreement were as follows for the three months ended March 31, 2024 and 2023 (in thousands): Three Months Ended March 31, Agreement Performance Obligation 2024 2023 Astellas Europe Agreement Development revenue $ 287 $ 1,529 The transaction price related to consideration received through March 31, 2024 and accounts receivable has been allocated to each of the following performance obligations under the Astellas Europe Agreement as follows (in thousands): Astellas Europe Agreement Total Consideration Through March 31, 2024 License $ 618,975 Development revenue 287,004 Total license and development revenue $ 905,979 There was no license revenue or development revenue resulting from changes to estimated variable consideration in the current period relating to performance obligations satisfied or partially satisfied in previous periods for three months ended March 31, 2024 under the Astellas Europe Agreement. The Company does not expect material variable consideration from estimated future co-development billing beyond the development period in the transaction price related to the Astellas Japan Agreement. In 2021, the Company entered into an EU Supply Agreement with Astellas under the Astellas Europe Agreement (“Astellas EU Supply Agreement”) to define general forecast, order, supply and payment terms for Astellas to purchase roxadustat bulk drug product from FibroGen in support of commercial supplies. The related drug product revenue is described under the Drug Product Revenue, Net section below. AstraZeneca Agreements AstraZeneca U.S./Rest of World (“RoW”) Agreement Effective July 30, 2013, the Company entered into a collaboration agreement with AstraZeneca AB (“AstraZeneca”) for the development and commercialization of roxadustat for the treatment of anemia in the U.S. and all other countries in the world, other than China, not previously licensed under the Astellas Europe and Astellas Japan Agreements (“AstraZeneca U.S./RoW Agreement”). On February 23, 2024, the Company and AstraZeneca entered into an agreement to terminate the AstraZeneca U.S./RoW Agreement, effective as of February 25, 2024. Pursuant to the termination and transition agreement, AstraZeneca returns all of their non-China roxadustat rights to the Company, with the exception of South Korea, and provides certain assistance during a transition period. In addition, as a part of this termination and transition agreement, AstraZeneca will receive tiered mid-single digit royalties on FibroGen’s sales of roxadustat in the terminated territories, or thirty-five percent of all revenue FibroGen receives if it licenses or sells such rights to a third-party. Neither party incurred any early termination penalties. The aggregate amount of consideration for milestone and upfront payments received under the AstraZeneca U.S./RoW Agreement through the termination totaled $ 439.0 million , excluding drug product revenue under the Master Supply Agreement with AstraZeneca under the AstraZeneca U.S./RoW Agreement (“AstraZeneca Master Supply Agreement”), entered in 2020, which is described under the Drug Product Revenue, Net section below. In addition, resulting from the above-mentioned termination and transition agreement, the Company and AstraZeneca settled the outstanding balances relating to past transactions under the AstraZeneca Master Supply Agreement. Accordingly, during the three months ended March 31, 2024, the Company accounted for the termination of the AstraZeneca U.S./RoW agreement as a contract modification under the Accounting Standards Codification (“ASC”) 606, Revenue from Contracts with Customers (“ASC 606”) and recorded a cumulative catch-up adjustment as described under the Drug Product Revenue, Net section below. The Company’s collaboration agreement with AstraZeneca for roxadustat in China, as described below, remains in place. 10 Table of Contents AstraZeneca China Agreement Effective July 30, 2013, the Company (through its subsidiaries affiliated with China) entered into a collaboration agreement with AstraZeneca for roxadustat for the treatment of anemia in China (“AstraZeneca China Agreement”). Under the terms of the AstraZeneca China Agreement, AstraZeneca agreed to pay upfront consideration and potential milestone payments, totaling $ 376.7 million . The AstraZeneca China Agreement is structured as a 50/50 profit or loss share (as defined), which was amended under the AstraZeneca China Amendment in 2020 as discussed below, and provides for joint development costs (including capital and equipment costs for construction of the manufacturing plant in China), to be shared equally during the development period. The aggregate amount of such consideration received for milestone and upfront payments through March 31, 2024 totaled $ 77.2 million . On September 18, 2023, the Company received the formal notice, from Beijing Medical Products Administration, of renewal of its right to continue to market Roxadustat in China through 2028. The Company evaluated the regulatory milestone payment associated with this renewal under the AstraZeneca China Agreement and concluded that this milestone was achieved in the third quarter of 2023. Accordingly, the consideration of $ 4.0 million associated with this milestone was included in the transaction price and allocated to performance obligations under the AstraZeneca U.S./RoW Agreement and the AstraZeneca China Agreement, $ 3.5 million of which was recognized as revenue during the third quarter of 2023 from performance obligations satisfied or partially satisfied. A s of March 31, 2024, t he $ 4.0 million milestone was recorded as a contract asset and was fully netted against the contract liabilities (deferred revenue) related to the AstraZeneca China Agreement. AstraZeneca China Amendment In July 2020, FibroGen China Anemia Holdings, Ltd., FibroGen (China) Medical Technology Development Co., Ltd. (“FibroGen Beijing”), and FibroGen International (Hong Kong) Limited and AstraZeneca entered into an amendment to the AstraZeneca China Agreement, relating to the development and commercialization of roxadustat in China (the “AstraZeneca China Amendment”). Under the AstraZeneca China Amendment, in 2020, FibroGen Beijing and AstraZeneca completed the establishment of a jointly owned entity, Beijing Falikang Pharmaceutical Co., Ltd. (“Falikang”), which performs roxadustat distribution, as well as conducts sales and marketing through AstraZeneca. Substantially all direct roxadustat product sales to distributors in China are made by Falikang, while FibroGen Beijing continues to sell roxadustat product directly in one province in China. FibroGen Beijing manufactures and supplies commercial product to Falikang based on a gross transfer price, which is adjusted for the estimated profit share. The net product revenue from the sales to Falikang and the net product revenue from direct sales distributors in China are described under Product Revenue, Net section below. Prior to the above-mentioned termination of the AstraZeneca U.S./RoW Agreement, the Company evaluated under the ASC 606 and accounted for the AstraZeneca U.S./RoW Agreement and the AstraZeneca China Agreement as a single arrangement with the presumption that two or more agreements executed with a single customer at or around the same time should be presumed to be a single arrangement. As a result of the termination of the AstraZeneca U.S./RoW Agreement, during the three months ended March 31, 2024, the Company recorded the final development revenue under the AstraZeneca U.S./RoW Agreement and AstraZeneca China Agreement. Amounts recognized as license revenue and development revenue under the AstraZeneca U.S./RoW Agreement and AstraZeneca China Agreement were as follows for the three months ended March 31, 2024 and 2023 (in thousands): Three Months Ended March 31, Agreement Performance Obligation 2024 2023 AstraZeneca U.S./RoW Agreement and AstraZeneca China Agreement Development revenue $ 468 $ 2,032 The transaction price relat ed to consideration received and accounts receivable through the termination of the AstraZeneca U.S./RoW Agreement has been allocated to each of the performance obligations under the AstraZeneca U.S./RoW Agreement and AstraZeneca China Agreement, including $ 344.5 million for license, $ 625.6 million for co-development, information sharing and committee services, and $ 399.5 million for China performance obligation (with cumulative revenue of $ 222.9 million through March 31, 2024) that is recognized as product revenue, as described under Product Revenue, Net section below. There was no license revenue or development revenue resulting from changes to estimated variable consideration in the current period relating to performance obligations satisfied or partially satisfied in previous periods for the three months ended March 31, 2024 under the AstraZeneca U.S./RoW Agreement through the agreement termination. 11 Table of Contents Product Revenue, Net Product revenue, net from the sales of roxadustat commercial product in China was as follows for the three months ended March 31, 2024 and 2023 (in thousands): Three Months Ended March 31, 2024 2023 Direct Sales: Gross revenue $ 3,786 $ 3,060 Discounts and rebates ( 360 ) ( 273 ) Sales returns ( 1 ) 2 Direct sales revenue, net 3,425 2,789 Sales to Falikang: Gross transaction price 43,560 34,249 Profit share ( 19,023 ) ( 14,988 ) Net transaction price 24,537 19,261 Decrease in deferred revenue 2,576 2,111 Sales to Falikang revenue, net 27,113 21,372 Total product revenue, net $ 30,538 $ 24,161 Direct Sales Product revenue from direct roxadustat product sales to distributors in China is recognized in an amount that reflects the consideration that the Company expects to be entitled to in exchange for those products, net of various sales rebates and discounts. The total discounts and rebates were immaterial for the periods presented. Due to the Company’s legal right to offset, at each balance sheet date, the rebates and discounts are presented as reductions to gross accounts receivable from the distributor, or as a current liability to the distributor to the extent that the total amount exceeds the gross accounts receivable or when the Company expects to settle the discount in cash. The Company’s legal right to offset is determined at the individual distributor level. The contract liabilities were included in accrued and other current liabilities in the condensed consolidated balance sheet and the rebates and discounts reflected as reductions to gross accounts receivable for direct sales were immaterial as of March 31, 2024 and December 31, 2023, respectively. Sales to Falikang – China Performance Obligation Substantially all direct roxadustat product sales to distributors in China are made by Falikang. FibroGen Beijing manufactures and supplies commercial product to Falikang. The net transfer price for FibroGen Beijing’s product sales to Falikang is based on a gross transfer price, which is adjusted to account for the 50/50 profit share for the period. The roxadustat sales to Falikang marked the beginning of the Company’s China performance obligation under the Company’s agreements with AstraZeneca . Product revenue is based on the transaction price of the China performance obligation. Revenue is recognized when control of the product is transferred to Falikang, in an amount that reflects the allocation of the transaction price to the performance obligation satisfied during the reporting period, and is expected to continue through 2033, which reflects our best estimates. Any net transaction price in excess of the revenue recognized is added to the deferred balance to date, and will be recognized in future periods as the performance obligation is satisfied. Periodically, the Company updates its assumptions such as total sales quantity, performance period, gross transaction price and profit share and other inputs including foreign currency translation impact, among others. Following updates to its estimates, the Company recognized $ 2.6 million from the previously deferred revenue of the China performance obligation during the three months ended March 31, 2024. The product revenue recognized for the three months ended March 31, 2024 included a decrease in revenue of $ 2.1 million resulting from changes to estimated variable consideration in the current period relating to performance obligation satisfied in previous periods. Comparatively, following updates to its estimates, the Company recognized $ 2.1 million from the previously deferred revenue of the China performance obligation during the three months ended March 31, 2023. 12 Table of Contents The following table includes a roll-forward of the related deferred revenue that is considered as a contract liability (in thousands): Balance at December 31, 2023 Additions Recognized as Revenue Currency Translation and Other Balance at March 31, 2024 Product revenue - AstraZeneca China performance obligation - deferred revenue $ ( 179,851 ) $ ( 24,950 ) $ 27,113 $ 1,057 $ ( 176,631 ) Deferred revenue includes amounts allocated to the China performance obligation under the AstraZeneca arrangement as revenue recognition associated with this unit of accounting is tied to the commercial launch of the products within China and to when the control of the manufactured commercial products is transferred to AstraZeneca. Contract assets and liabilities related to rights and obligations in the same contract are recorded net on the condensed consolidated balance sheets. As of March 31, 2024, deferred revenue included $ 149.7 million related to China performance obligation, which represents the net of $ 176.6 million of deferred revenue presented above and a $ 26.9 million unbilled milestone and co-development revenue under the AstraZeneca China Amendment. As of March 31, 2024 , approximately $ 5.0 million of the above deferred revenue related to the China unit of accounting was included in short-term deferred revenue, which represents the amount of deferred revenue associated with the China unit of accounting that is expected to be recognized within the next 12 months, associated with the commercial sales in China. Due to the Company’s legal right to offset, at each balance sheet date, the rebates and discounts, mainly related to profit sharing, are presented as reductions to gross accounts receivable from Falikang, which was $ 3.4 million and $ 3.0 million as of March 31, 2024 and December 31, 2023 , respectively. Drug Product Revenue, Net Drug product revenue from commercial-grade active pharmaceutical ingredient (“API”) or bulk drug product sales to Astellas and AstraZeneca was as follows for the three months ended March 31, 2024 and 2023 (in thousands): Three Months Ended March 31, 2024 2023 Astellas Japan Agreement $ ( 2,205 ) $ 1,732 Astellas Europe Agreement 1,021 377 AstraZeneca U.S./RoW Agreement 25,670 — Drug product revenue, net $ 24,486 $ 2,109 Astellas Japan Agreement The Company updates its estimate of variable consideration related to the API shipments fulfilled under the terms of Astellas Japan Amendment at each balance sheet date. As a result, the Company recorded a reduction to the drug product revenue of $ 2.2 million for the three months ended March 31, 2024. Specifically, the change in estimated variable consideration was based on the API held by Astellas at period end, adjusted to reflect the changes in the estimated bulk product strength mix intended to be manufactured by Astellas, and foreign exchange impacts, among others. During the three months ended March 31, 2023, the Company updated its estimate of variable consideration related to the API shipments fulfilled under the terms of Astellas Japan Amendment, and accordingly recorded an adjustment to the drug product revenue of $ 1.7 million. Specifically, the change in estimated variable consideration was based on the API held by Astellas at period end, adjusted to reflect the changes in the estimated bulk product strength mix intended to be manufactured by Astellas, and estimated yield from the manufacture of bulk product tablets, among others. As of March 31, 2024, t he balances related to the API price true-up under the Astellas Japan Agreement were $ 1.6 million in accrued liabilities and $ 2.5 million in other long-term liabilities, representing the Company’s best estimate of the timing for these amounts to be paid. As of December 31, 2023, the balances related to the API price true-up under the Astellas Japan Agreement were $ 1.2 million in accrued liabilities and $ 0.7 million in other long-term liabilities. 13 Table of Contents Astellas Europe Agreement The Company transferred bulk drug product for commercial purposes under the terms of the Astellas Europe Agreement and the Astellas EU Supply Agreement in the prior years. The Company recognized the related fully burdened manufacturing costs as drug product revenue in the respective periods and recorded the constrained transaction price in deferred revenue due to a high degree of uncertainty associated with the variable consideration for revenue recognition purposes. The Company updates its estimate of variable consideration related to the bulk drug product transferred in prior years at each balance sheet date. During the fourth quarter of 2023, the Company transferred bulk drug product for commercial purposes under the terms of the Astellas Europe Agreement and the Astellas EU Supply Agreement, and recognized the related fully-burdened manufacturing costs of $ 0.8 million as drug product revenue, and recorded $ 17.7 million as deferred revenue due to a high degree of uncertainty associated with the variable consideration for revenue recognition purposes. In addition, the Company updated its estimate of variable consideration related to the bulk drug product transferred in prior years. Specifically, the change in estimated variable consideration was based on the bulk drug product held by Astellas at the period end, adjusted to reflect the changes in the estimated transfer price, forecast information, shelf-life estimates and other items. As a result, for the year ended December 31, 2023, the Company reclassified $ 38.7 million from the related deferred revenue to accrued liabilities. As of December 31, 2023, the related balance in accrued liabilities was $ 38.6 million. Further for the three months ended March 31, 2024 , the Company reclassified $5 .7 million from the related deferred revenue to accrued liabilities. As of March 31, 2024, the balances related to the bulk drug product price true-up under the Astellas Europe Agreement and the Astellas EU Supply Agreement were $ 44.3 million in a ccrued liabilities, representing the Company’s best estimate that these amounts will be paid within the next 12 months. The Company recognized royalty revenue of $ 1.0 million and $ 0.4 million as drug product revenue from the deferred revenue under the Astellas Europe Agreement during the three months ended March 31, 2024 and 2023, respectively. It is the Company’s best estimate that the remainder of the deferred revenue will be recognized as revenue when uncertainty is resolved, based on the performance of roxadustat product sales in the Astellas territory. The following table includes a roll-forward of the above-mentioned deferred revenues that are considered as contract liabilities related to drug product (in thousands): Balance at December 31, 2023 Recognized as Revenue Reclassified to Accrued Liability / Accounts Payable Balance at March 31, 2024 Drug product revenue - deferred revenue: Astellas Europe Agreement $ ( 16,925 ) $ 1,021 $ 5,660 $ ( 10,244 ) AstraZeneca U.S./RoW Agreement As described under AstraZeneca Agreements section above, pursuant to the termination and transition agreement related to the AstraZeneca U.S./RoW Agreement, the Company and AstraZeneca settled the outstanding balances relating to past transactions under the AstraZeneca Master Supply Agreement. Accordingly, during the three months ended March 31, 2024, the Company accounted for the termination of the AstraZeneca U.S./RoW agreement as a contract modification under the ASC 606 and recorded a cumulative catch-up net adjustment of $ 25.7 million to the drug product revenue. A s of March 31, 2024, t he related accounts receivable was $ 26.0 million and the related accrued liabilities were $ 11.5 million . Comparatively, the related accrued liabilities were $ 11.2 million as of December 31, 2023. Both the accounts receivable and accrued liabilities have been settled in April 2024. Corresponding to the drug product revenue, during the three months ended March 31, 2024, the Company recorded the related cost of goods sold of $ 21.1 million. 14 Table of Contents Eluminex Agreement In July 2021, FibroGen exclusively licensed to Eluminex Biosciences (Suzhou) Limited (“Eluminex”) global rights to its investigational biosynthetic cornea derived from recombinant human collagen Type III. Under the terms of the agreement with Eluminex, as amended and restated in January 2022, Eluminex made an $ 8.0 million upfront payment to FibroGen during the first quarter of 2022. In addition, FibroGen may receive up to a total of $ 64.0 million in future manufacturing, clinical, regulatory, and commercial milestone payments for the biosynthetic cornea program, as well as $ 36.0 million in commercial milestones for the first recombinant collagen III product that is not the biosynthetic cornea. FibroGen will also be eligible to receive mid-single-digit to low double-digit royalties based upon worldwide net sales of cornea products, and low single-digit to mid-single-digit royalties based upon worldwide net sales of other recombinant human collagen type III products that are not cornea products. In April 2023, FibroGen and Eluminex entered into an Amended and Restated Exclusive License Agreement (“A&R Eluminex Agreement”) in order to add to the license rights to recombinant human collagen Type I (in addition to the rights to collagen Type III that were already licensed). The A&R Eluminex Agreement included additional total upfront payments of $ 1.5 million. During the three months ended March 31, 2023 , the Company recognized a $ 3.0 million milestone payment based on Eluminex implanting a biosynthetic cornea in the first patient of its clinical trial in China, and a $ 3.0 million manufacturing related milestone payment. During the first quarter of 2022, FibroGen and Eluminex entered into a separate contract manufacturing agreement, under which the Company is responsible for supplying the cornea product at cost plus 10 % of its product manufacturing costs until its manufacturing technology is fully transferred to Eluminex, which occurred by the end of 2023 . The related contract manufacturing revenue was recorded as other revenue and included in development and other revenue in the condensed consolidated statement of operations. Amounts recognized as revenue under the agreements with Eluminex were as follows for the three months ended March 31, 2024 and 2023 (in thousands): Three Months Ended March 31, Agreement Performance Obligation 2024 2023 Eluminex License revenue $ — $ 6,000 Other revenue - contract manufacturing 116 235 3. Variable Interest Entity Consolidated Variable Interest Entity - Fortis On May 5, 2023 (the “Option Acquisition Date”), the Company entered into an exclusive option agreement to acquire Fortis Therapeutics (“Fortis”) with its novel Phase 1 antibody-drug conjugate, FOR46 (now referred to as “FG-3246”), that targets a novel epitope on CD46 preferentially expressed on certain cancer cells. FG-3246 is in development for the treatment of metastatic castration-resistant prostate cancer with potential applicability in other solid tumors and hematologic malignancies. If FibroGen exercises the option to acquire Fortis, it will pay Fortis an option exercise payment of $ 80.0 million, and thereafter, legacy Fortis shareholders would be eligible to receive from FibroGen up to $ 200.0 million in contingent payments associated with the achievement of various regulatory approvals. If FibroGen acquires Fortis, it would also be responsible to pay the University of California, San Francisco (“UCSF”), an upstream licensor to Fortis, development milestone fees and a single digit royalty on net sales of therapeutic or diagnostic products arising from the licensing arrangement between Fortis and UCSF . If FibroGen chooses not to acquire Fortis, its exclusive license to FG-3246 would expire. Pursuant to an evaluation agreement entered into with Fortis concurrent with the option agreement (together the “Fortis Agreements”), FibroGen has exclusively licensed FG-3246 and will control and fund future research, development, including a Phase 2 clinical study sponsored by FibroGen, and manufacturing of FG-3246 during the up-to four-year option period. As part of the clinical development strategy, FibroGen will continue the work to develop a PET-based biomarker utilizing a radiolabeled version of the targeting antibody for patient selection. Additionally, the Company is obligated to make four quarterly payments totaling $ 5.4 million to Fortis in support of its continued development obligations, of which the last payment was $ 1.7 million and was made during the three months ended March 31, 2024. 15 Table of Contents Pursuant to the guidance under Accounting Standards Codification (“ASC”) 810, Consolidation (“ASC 810”), the Company determined that Fortis is a VIE and that the Company is the primary beneficiary of Fortis, as through the Fortis Agreements the Company has the power to direct activities that most significantly impact the economic performance of Fortis. Therefore, the Company consolidated Fortis starting from the Option Acquisition Date, and continues to consolidate as of March 31, 2024. Fortis has authorized and issued common shares and Series A preferred shares. As of the Option Acquisition Date and March 31, 2024 , the Company owned approximately 2 % of Fortis’ Series A preferred shares, which was acquired previously and carried at zero cost. The NCI attributable to the common shares is classified as nonredeemable NCI, as it is 100 % owned by third party shareholders. The NCI attributable to the approximately 98 % of Series A preferred shares owned by other investors are classified as redeemable NCI in temporary equity, as the preferred shares are redeemable by the non-controlling shares holders upon occurrence of certain events out of the Company’s control. Subsequent to the Option Acquisition Date, Fortis’ net income is allocated to its common shares and preferred shares based on their respective stated rights. Fortis’ net loss is allocated to its common shares only as the holders of preferred shares do not have a contractual obligation to absorb such losses. As of March 31, 2024, total assets and liabilities of Fortis were immaterial. For the three months ended March 31, 2024, Fortis’ net income (losses) was immaterial. Equity method investment - Unconsolidated VIE - Falikang Falikang is a distribution entity jointly owned by AstraZeneca and FibroGen Beijing. FibroGen Beijing owns 51.1 % of the outstanding shares of Falikang. Pursuant to the guidance under ASC 810, the Company concluded that Falikang qualifies as a VIE. As Falikang is a distribution entity and AstraZeneca is the final decision maker for all the roxadustat commercialization activities, the Company lacks the power criterion, while AstraZeneca meets both the power and economic criteria under the ASC 810 to direct the activities of Falikang that most significantly impact its performance. Therefore, the Company is not the primary beneficiary of this VIE for accounting purposes. As a result, the Company accounts for its investment in Falikang under the equity method, and Falikang is not consolidated into the Company’s condensed consolidated financial statements. The Company records its total investments in Falikang as an equity method investment in an unconsolidated VIE in the condensed consolidated balance sheet. In addition, the Company recognizes its proportionate share of the reported profits or losses of Falikang as investment gain or loss in unconsolidated VIE in the condensed consolidated statement of operations and as an adjustment to its investment in Falikang in the condensed consolidated balance sheet. Falikang has not incurred material profit or loss to date. The Company may provide shareholder loans to Falikang to meet necessary financial obligations as part of its operations. To date, there has been no such loans. The Company’s equity method investment in Falikang was as follows (in thousands): Entity Ownership Percentage Balance at December 31, 2023 Share of Net Income Currency Translation Balance at March 31, 2024 Falikang 51.1 % $ 5,290 $ 589 $ ( 103 ) $ 5,776 Falikang is considered a related party to the Company. See Note 9, Related Party Transactions , for related disclosures. 16 Table of Contents 4. Fair Value Measurements The fair values of the Company’s financial assets that are measured on a recurring basis are as follows (in thousands): March 31, 2024 Level 1 Level 2 Level 3 Total Money market funds $ 45,216 $ — $ — $ 45,216 Corporate bonds — 6,075 — 6,075 Commercial paper — 47,985 — 47,985 U.S. government bonds 4,948 31,264 — 36,212 Agency bonds — 4,944 — 4,944 Total $ 50,164 $ 90,268 $ — $ 140,432 December 31, 2023 Level 1 Level 2 Level 3 Total Money market funds $ 12,288 $ — $ — $ 12,288 Corporate bonds — 13,992 — 13,992 Commercial paper — 88,289 — 88,289 U.S. government bonds 42,797 4,994 — 47,791 Agency bonds — 9,830 — 9,830 Total $ 55,085 $ 117,105 $ — $ 172,190 The Company’s Level 2 investments are valued using third-party pricing sources. The pricing services utilize industry standard valuation models, including both income and market-based approaches, for which all significant inputs are observable, either directly or indirectly, to estimate fair value. These inputs include reported trades of and broker/dealer quotes on the same or similar investments, issuer credit spreads, benchmark investments, prepayment/default projections based on historical data and other observable inputs. During the three months ended March 31, 2024 and 2023 , a total of $ 26.3 million and $ 7.0 million, respectively, of U.S. treasury notes and bills were transferred from Level 1 to Level 2 as such instruments were changed to off-the-run when they were issued before the most recent issue and were still outstanding at measurement day. 5. Balance Sheet Components Cash and Cash Equivalents Cash and cash equivalents consisted of the following (in thousands): March 31, 2024 December 31, 2023 Cash $ 37,167 $ 63,396 Commercial paper 15,887 36,016 Money market funds 45,216 12,288 U.S. government bonds 7,464 1,988 Total cash and cash equivalents $ 105,734 $ 113,688 At March 31, 2024 and December 31, 2023, a total of $ 27.6 million and $ 32.2 million of the Company’s cash and cash equivalents were held outside of the U.S. in its foreign subsidiaries to be used primarily for its China operations, respectively. 17 Table of Contents Investments The Company’s investments consist primarily of available-for-sale debt investments. The amortized cost, gross unrealized holding gains or losses, and fair value of the Company’s investments by major investments type are summarized in the tables below (in thousands): March 31, 2024 Amortized Cost Gross Unrealized Holding Gains Gross Unrealized Holding Losses Estimated Fair Value Corporate bonds $ 6,073 $ 2 $ — $ 6,075 Commercial paper 32,098 — — 32,098 U.S. government bonds 28,747 1 — 28,748 Agency bonds 4,946 — ( 2 ) 4,944 Total investments $ 71,864 $ 3 $ ( 2 ) $ 71,865 December 31, 2023 Amortized Cost Gross Unrealized Holding Gains Gross Unrealized Holding Losses Estimated Fair Value Corporate bonds $ 13,988 $ 9 $ ( 5 ) $ 13,992 Commercial paper 52,273 — — 52,273 U.S. government bonds 45,783 20 — 45,803 Agency bonds 9,830 1 ( 1 ) 9,830 Total investments $ 121,874 $ 30 $ ( 6 ) $ 121,898 The following table summarizes, for all available for sale securities in an unrealized loss position, the fair value and gross unrealized loss by length of time the security has been in a continual unrealized loss position (in thousands): March 31, 2024 Less than 12 Months 12 Months or More Total Estimated Fair Value Gross Unrealized Holding Losses Estimated Fair Value Gross Unrealized Holding Losses Estimated Fair Value Gross Unrealized Holding Losses U.S. government bonds $ 12,956 $ — $ — $ — $ 12,956 $ — Agency bonds 4,944 ( 2 ) — — 4,944 ( 2 ) Total $ 17,900 $ ( 2 ) $ — $ — $ 17,900 $ ( 2 ) December 31, 2023 Less than 12 Months 12 Months or More Total Estimated Fair Value Gross Unrealized Holding Losses Estimated Fair Value Gross Unrealized Holding Losses Estimated Fair Value Gross Unrealized Holding Losses Corporate bonds $ — $ — $ 3,495 $ ( 5 ) $ 3,495 $ ( 5 ) U.S. government bonds 4,984 — — — 4,984 — Agency bonds 4,987 ( 1 ) — — 4,987 ( 1 ) Total $ 9,971 $ ( 1 ) $ 3,495 $ ( 5 ) $ 13,466 $ ( 6 ) The contractual maturities of all available-for-sale investments were within one year as of March 31, 2024. The Company periodically assesses whether the unrealized losses on its available-for-sale investments were temporary. The Company considers factors such as the severity and the reason for the decline in value, the potential recovery period and its intent to sell. For debt securities, the Company also considers whether (i) it is more likely than not that the Company will be required to sell the debt securities before recovery of their amortized cost basis, and (ii) the amortized cost basis cannot be recovered as a result of credit losses. Based on the results of its review, the Company did no t recognize any impairment for its available-for-sale investments during the three months ended March 31, 2024 and 2023. 18 Table of Contents Inventories Inventories consisted of the following (in thousands): March 31, 2024 December 31, 2023 Raw materials $ 1,079 $ 1,376 Work-in-progress 20,600 34,614 Finished goods 5,656 5,575 Total inventories $ 27,335 $ 41,565 As described under Note 2, Collaboration Agreements, License Agreement and Revenues above, resulting from the termination and transition agreement related to the AstraZeneca U.S./RoW Agreement, the Company was reimbursed $ 12.6 million for work-in-progress inventory, which was written off and recognized as cost of goods sold during the three months ended March 31, 2024. Prepaid Expenses and Other Current Assets Prepaid expenses and other current assets consisted of the following (in thousands): March 31, 2024 December 31, 2023 Contract assets $ 26,894 $ 26,481 Deferred revenues from associated contracts ( 26,894 ) ( 26,481 ) Net contract assets — — Insurance proceeds receivable for litigation settlement 28,500 28,500 Prepaid assets 5,780 6,644 Other current assets 1,870 6,711 Total prepaid expenses and other current assets $ 36,150 $ 41,855 The unbilled contract assets as of March 31, 2024 and December 31, 2023 included $ 22.9 million and $ 22.5 million, respectively, related to unbilled co-development revenue under the AstraZeneca China Amendment. In addition, the unbilled contract assets as of March 31, 2024 and December 31, 2023 each included the $ 4.0 million unbilled regulatory milestone payment under the AstraZeneca China Agreement. See the AstraZeneca China Agreement section in Note 3, Collaboration Agreements, License Agreement and Revenues , for details. As of each of March 31, 2024 and December 31, 2023 , the Company recorded a $ 28.5 million receivable in prepaid expenses and other current assets, corresponding to the accrued litigation settlement of the same amount related to the Company’s agreement in principle with plaintiffs to settle the class action lawsuit. As the Company maintains insurance that covers exposure related to the class action lawsuit, this amount is fully recoverable under the Company’s insurance policies. The determination that the recorded receivables are probable of collection is based on the terms of the applicable insurance policies and communications with the insurers. See the Accrued and Other Current Liabilities section below, and the Legal Proceedings and Other Matters section in Note 10, Commitments and Contingencies , for details. 19 Table of Contents Accrued and Other Current Liabilities Accrued and other current liabilities consisted of the following (in thousands): March 31, 2024 December 31, 2023 Preclinical and clinical trial accruals $ 26,397 $ 27,663 API and bulk drug product price true-up 57,370 50,978 Litigation settlement 28,500 28,500 Payroll and related accruals 7,398 20,267 Inventory cost related 8,521 — Accrued co-promotion expenses - current 11,425 10,309 Roxadustat profit share to AstraZeneca 6,952 7,084 Property taxes and other taxes 7,346 6,615 Professional services 4,711 7,103 Current portion of liability related to sale of future revenues 1,213 5,654 Accrued restructuring charge — 3,697 Other 4,453 5,021 Total accrued and other current liabilities $ 164,286 $ 172,891 The accrued liabilities of $ 57.4 million and $ 51.0 million for API and bulk drug product price true-up as of March 31, 2024 and December 31, 2023, respectively, resulted from changes in estimated variable consideration associated with the API shipments fulfilled under the terms of the Astellas Japan Amendment, the bulk drug product transferred under the terms of the Astellas Europe Agreement and the Astellas EU Supply Agreement, and the bulk drug product shipments to AstraZeneca under the terms of the AstraZeneca Master Supply Agreement. Included in the balance as of March 31, 2024 , the amount due to AstraZeneca was $ 11.5 million , as discussed under the Drug Product Revenue, Net section in Note 2, Collaboration Agreements, License Agreement and Revenues, resulting from the termination and transition agreement related to the AstraZeneca U.S./RoW Agreement, and has been settled in April 2024. In addition, the Company recorded an accrued inventory related cost of $ 8.5 million as of March 31, 2024, as part of the cost of goods sold resulting from this termination and transition agreement. See Note 2, Collaboration Agreements, License Agreement and Revenues, for details. As of March 31, 2024 and December 31, 2023 , the accrued litigation settlement of $ 28.5 million was related to the Company’s agreement in principle with plaintiffs to settle the class action lawsuit. The Company maintains insurance that covers exposure related to the class action lawsuit. As the amount is fully recoverable under the Company’s insurance policies, the Company recorded a corresponding receivable in prepaid expenses and other current assets in the condensed consolidated balance sheet. The determination that the recorded receivables are probable of collection is based on the terms of the applicable insurance policies and communications with the insurers. See the Legal Proceedings and Other Matters section in Note 10, Commitments and Contingencies , for details. 6. Senior Secured Term Loan Facilities On April 29, 2023, the Company entered into a financing agreement (“Financing Agreement”) with investment funds managed by Morgan Stanley Tactical Value, as lenders (the “Lenders”), and Wilmington Trust, National Association, as the administrative agent, providing for senior secured term loan facilities consisting of (i) a $ 75.0 million initial term loan (the “Initial Term Loan”), (ii) a $ 37.5 million delayed draw term loan that will be funded upon the achievement of certain clinical development milestones (“Delayed Draw Term Loan 1”) and, (iii) an uncommitted delayed draw term loan of up to $ 37.5 million to be funded at the Lenders sole discretion, (“Delayed Draw Term Loan 2” and, together with the Initial Term Loan and Delayed Draw Term Loan 1, the “Term Loans”). Pursuant to the Financing Agreement, the Lenders have funded the Initial Term Loan. The clinical development milestones which could have triggered Delayed Draw Term Loan 1 were not achieved, and the Lenders have not funded Delayed Draw Term Loan 2. As such, these features expired during 2023. The Company has determined that certain other features embedded within the Loan should be bifurcated and accounted for separately as a derivative. At inception and as of March 31, 2024, the fair values of such derivatives were negligible due to the low probability of the underlying events. The Term Loans shall accrue interest at a fixed rate of 14.0 % per annum, payable monthly in arrears. The Term Loans shall mature on May 8, 2026 . The Term Loans will not be subject to amortization payments. The Company is permitted to prepay the Term Loans from time to time, in whole or in part, subject to payment of a make-whole amount equal to the unpaid principal amount of the portion of the Term Loans being repaid or prepaid, plus accrued and unpaid interest of the portion of the Term Loans being repaid or prepaid, plus an amount equal to the remaining scheduled interest payments due on such portion of the Term Loans being repaid or prepaid as if such Term Loans were to remain outstanding until the scheduled maturity date. 20 Table of Contents The initial issuance costs and the related transaction costs, totaling $ 3.7 million is amortized as interest expense using the effective interest method over the term of the Initial Term Loan and are reported on the balance sheet as a direct deduction from the amount of the Initial Term Loan. The effective annual interest rate of the Initial Term Loan was 16.13 % for three months ended March 31, 2024 . The Company recorded interest expense of $ 2.9 million for the three months ended March 31, 2024. As of March 31, 2024 , the related accrued interest was $ 0.4 million. The Company was in compliance with all debt covenants associated with the senior secured term loan facilities as of March 31, 2024 , including maintaining a minimum balance of $ 30 million of unrestricted cash and cash equivalents held in accounts in the U.S. The Company’s senior secured term loan facilities as of March 31, 2024 were as follows (in thousands): March 31, 2024 Principal of senior secured term loan facilities $ 75,000 Less: Unamortized issuance costs and transaction costs ( 2,787 ) Senior secured term loan facilities, ending balance 72,213 Less: Current Portion classified to accrued and other current liabilities — Senior secured term loan facilities, non-current $ 72,213 7. Liability Related to Sale of Future Revenues On November 4, 2022, the Company entered into a Revenue Interest Financing Agreement (the “RIFA”) with an affiliate of NovaQuest Capital Management (“NovaQuest”), pursuant to which the Company granted NovaQuest 22.5 % of its drug product revenue and 10.0 % ( 20.0 % for fiscal year 2028 and thereafter) of its revenue from milestone payments that it is entitled to under the Astellas Agreements , for a consideration of $ 50.0 million (“Investment Amount”) before advisory fees. In November 2022, the Company received the Investment Amount, net of initial issuance costs, and accounted for it as long-term debt based on the terms of the RIFA because the risks and rewards to NovaQuest are limited by the terms of the transaction. The related debt discount and transaction costs are amortized as interest expense based on the projected balance of the liability as of the beginning of each period. As payments are made to NovaQuest, the balance of the liability related to sale of future revenues is being effectively repaid over the life of the RIFA. The payments to NovaQuest are accounted for as a reduction of debt. The Company may prepay its obligations to NovaQuest in full at any time during the term of RIFA. The prepayment amount varies from $ 80.0 million to $ 125.0 million less any revenue interest payments made up to such prepayment date. Under the RIFA the Company shall pay to NovaQuest up to a specified maximum amount (“Payment Cap”) of (a) $ 100.0 million, if the payment is made on or before December 31, 2028; (b) $ 112.5 million, if the payment is made on or after January 1, 2029, but on or before December 31, 2029; or (c) $ 125.0 million, if the payment is made after January 1, 2030. After January 1, 2028, if the product (as defined) is not commercialized for a consecutive twelve-month period, then, the payments owed under the RIFA by the Company to NovaQuest for each fiscal year shall be the greater of: (i) the amount which would otherwise be due pursuant to revenue interest payments terms; or (ii) $ 10.0 million. Before December 31, 2028, if the sum of all payments under the RIFA paid to NovaQuest, does not equal or exceed $ 62.5 million, then the Company shall pay NovaQuest the difference of these two amounts by no later than March 1, 2029. If, by no later than December 31, 2030, the sum of all payments under the RIFA paid to NovaQuest does not equal or exceed $ 125.0 million, then the Company shall pay NovaQuest the difference of these two amounts by no later than March 1, 2031. NovaQuest will retain this entitlement until it has reached the Payment Cap, at which point 100 % of such revenue interest on future global net sales of Astellas will revert to the Company. Over the course of the RIFA, the effective interest rate is affected by the amount and timing of drug product revenue and revenue from milestone payments recognized, the changes in the timing of forecasted drug product revenue and revenue from milestone payments, and the timing of the Company’s payments to NovaQuest. On a quarterly basis, the Company reassesses the expected total revenue and the timing of such revenue, recalculates the amortization of debt discount and transactions costs and effective interest rate, and adjusts the accounting prospectively as needed. The Company’s estimated effective annual interest rate was 15.96 % as of March 31, 2024. 21 Table of Contents The following table summarizes the activities of the liability related to sale of future revenues for the three months ended March 31, 2024: Three Months Ended March 31, 2024 Liability related to sale of future revenues - beginning balance $ 57,067 Interest paid ( 5,653 ) Interest expense recognized 2,015 Liability related to sale of future revenues - ending balance 53,429 Less: Current portion classified to accrued and other current liabilities ( 1,213 ) Liability related to sale of future revenues, non-current $ 52,216 During the three months ended March 31, 2024, the Company recognized, under Astellas Agreements, development revenue of $ 0.3 million , and a net reduction to drug product revenue of $ 1.2 million . See Note 2, Collaboration Agreements, License Agreement and Revenue , for details. During the three months ended March 31, 2024 , the Company recognized the related non-cash interest expense of $ 2.0 million. Based on the current estimates of drug product revenue and revenue from milestone payments under the Astellas Agreements, and taking into the consideration of the terms discussed above, the Company anticipates to reach a Payment Cap up to $ 125.0 million by 2031. 8. Income Taxes Provisions for income tax for the three months ended March 31, 2024 and 2023 were primarily due to foreign taxes. Based upon the weight of available evidence, which includes its historical operating performance, reported cumulative net losses since inception, the Company has established and continues to maintain a full valuation allowance against its net deferred tax assets as it does not currently believe that realization of those assets is more likely than not. 9. Related Party Transactions Astellas is an equity investor in the Company and is considered a related party. The Company recorded license and development revenue related to collaboration agreements with Astellas of $ 0.3 million and $ 1.6 million for the three months ended March 31, 2024 and 2023, respectively. The Company recorded a reduction to drug product revenue from Astellas of $ 1.2 million for the three months ended March 31, 2024 and recorded drug product revenue from Astellas of $ 2.1 million for the three months ended March 31, 2023. See Note 2, Collaboration Agreements, License Agreement and Revenues , for details. The Company’s expense related to collaboration agreements with Astellas was immaterial for each of the three months ended March 31, 2024 and 2023. As of March 31, 2024 and December 31, 2023 , accounts receivable from Astellas were $ 0.3 million and $ 0.8 million, respectively. As of March 31, 2024 and December 31, 2023 , total deferred revenue from Astellas was $ 10.2 million and $ 16.9 million, respectively. As of March 31, 2024, the amounts due to Astellas, included in accrued and other current liabilities, and other long-term liabilities, totaled $ 48.3 million. As of December 31, 2023, the amount due to Astellas, included in accrued and other current liabilities , and other long-term liabilities, totaled $ 40.5 million. Falikang, an entity jointly owned by FibroGen Beijing and AstraZeneca is an unconsolidated VIE accounted for as an equity method investment, and considered as a related party to the Company. FibroGen Beijing owns 51.1 % of Falikang’s equity. See Note 3, Equity method investment - Variable Interest Entity , for details. The net product revenue from Falikang was $ 27.1 million and $ 21.4 million for the three months ended March 31, 2024 and 2023, respectively. See the Product Revenue, Net section in Note 2, Collaboration Agreements, License Agreement and Revenues , for details. 22 Table of Contents The investment income in Falikang was $ 0.6 million and $ 0.8 million for the three months ended March 31, 2024 and 2023, respectively. As of March 31, 2024 and December 31, 2023, the Company’s equity method investment in Falikang was $ 5.8 million and $ 5.3 million , respectively. See Note 3, Equity method investment - Variable Interest Entity , for details. The other income from Falikang was immaterial for each of the three months ended March 31, 2024 and 2023. As of March 31, 2024 and December 31, 2023 , accounts receivable, net, from Falikang, were $ 6.8 million and $ 5.2 million, respectively. 10. Commitments and Contingencies Contract Obligations As of March 31, 2024 , the Company had outstanding total non-cancelable purchase obligations of $ 35.6 million, including $ 22.8 million for manufacture and supply of pamrevlumab, $ 1.7 million for manufacture and supply of roxadustat, and $ 11.0 million for other purchases and programs. The Company expects to fulfill its commitments under these agreements in the normal course of business, and as such, no liability has been recorded. Some of the Company’s license agreements provide for periodic maintenance fees over specified time periods, as well as payments by the Company upon the achievement of development, regulatory and commercial milestones. As of March 31, 2024 , future milestone payments for research and preclinical stage development programs consisted of up to approximately $ 697.9 million in total potential future milestone payments under the Company’s license agreements with HiFiBiO (for Gal-9 and CCR8), Medarex, Inc. and others. These milestone payments generally become due and payable only upon the achievement of certain developmental, clinical, regulatory and/or commercial milestones. The event triggering such payment or obligation has not yet occurred. As of March 31, 2024, the Company had $ 77.7 million of operating lease liabilities. In addition, see Note 6, Senior Secured Term Loan Facilities and Note 7, Liability Related to Sale of Future Revenues for details of the related obligations. Legal Proceedings and Other Matters From time to time, the Company is a party to various legal actions, both inside and outside the U.S., arising in the ordinary course of its business or otherwise. The Company accrues amounts, to the extent they can be reasonably estimated, that the Company believes will result in a probable loss (including, among other things, probable settlement value) to adequately address any liabilities related to legal proceedings and other loss contingencies. A loss or a range of loss is disclosed when it is reasonably possible that a material loss will incur and can be estimated, or when it is reasonably possible that the amount of a loss, when material, will exceed the recorded provision. The Company did not have any material accruals for any active legal action, except for the class action settlement mentioned below, in its condensed consolidated balance sheet as of March 31, 2024, as the Company could not predict the ultimate outcome of these matters, or reasonably estimate the potential exposure. Between April 2021 and May 2021, five putative securities class action complaints were filed against FibroGen and certain of its current and former executive officers (collectively, the “Defendants”) in the U.S. District Court for the Northern District of California. The lawsuits allege that Defendants violated the Securities Exchange Act of 1934 by making materially false and misleading statements regarding FibroGen’s Phase 3 clinical studies data and prospects for U.S. Food and Drug Administration approval. On August 30, 2021, the Court consolidated the actions and appointed a group of lead plaintiffs. On October 17, 2023, the parties reached an agreement in principle to settle the class action at $ 28.5 million. Accordingly, as of December 31, 2023, the Company recorded the $ 28.5 million in accrued and other current liabilities in the condensed consolidated balance sheet. The Company maintains insurance that covers exposure related to the class action lawsuit. As the amount is fully recoverable under the Company’s insurance policies, the Company recorded a corresponding receivable in prepaid expenses and other current assets in the condensed consolidated balance sheet. The determination that the recorded receivables are probable of collection is based on the terms of the applicable insurance policies and communications with the insurers. The Court preliminarily approved the settlement on February 13, 2024 and a hearing on final approval is scheduled for May 16, 2024. Another case, filed on May 25, 2023, against the same defendants, asserting similar claims as the class action and additional common-law and California state fraud claims was voluntarily dismissed on December 20, 2023. 23 Table of Contents Between July 30, 2021 and April 3, 2024, seven shareholder derivative complaints were filed, naming as defendants certain of our current and former officers and certain current and former members of our board, as well as FibroGen as nominal defendants (the “Derivative Lawsuits”). Of these Derivative Lawsuits, four were filed in the Delaware Court of Chancery (the “Delaware Chancery Derivative Actions”), two were filed in the U.S. District Court for the District of Delaware (the “Delaware Federal Derivative Actions”), and one was filed in the U.S. District Court for the Northern District of California (the “California Federal Derivative Action”). The plaintiffs assert state and federal claims based on some of the same alleged misstatements as the securities class action complaint. The complaints seek unspecified damages, attorneys’ fees, and other costs. The status of the seven Derivative Lawsuits is currently as follows: • Two of the Delaware Chancery Derivative Actions, filed on April 14, 2022, and June 1, 2023, have been consolidated (the “Delaware Chancery Consolidated Derivative”). On February 1, 2024, Defendants moved to dismiss the Delaware Chancery Consolidated Derivative action. In the other two Delaware Chancery Derivative Actions, filed in the Delaware Court of Chancery on December 3, 2023 and April 3, 2024, Defendants have not been formally served, though the parties are in the process of negotiating a stay of the actions pending resolution of the motion to dismiss the Delaware Chancery Consolidated Derivative action; • Two of the Delaware Federal Derivative Actions remain stayed. One is stayed pending the resolution of the putative securities class action, and the other is stayed pending resolution of the motion to dismiss the Delaware Chancery Consolidated Derivative action; and • The California Federal Derivative Action was voluntarily dismissed on January 22, 2024. The Company believes that the claims asserted in the Derivative Lawsuits are without merit and it intends to vigorously defend against them. However, any litigation is inherently uncertain, and any judgment or injunctive relief entered against FibroGen or any adverse settlement could materially and adversely impact its business, results of operations, financial condition, and prospects. In the fourth quarter of 2021, the Company received a subpoena from the SEC requesting documents related to roxadustat’s pooled cardiovascular safety data. The SEC followed up with a subpoena for additional documents in the second quarter of 2024. The Company is fully cooperating with the SEC. The Company cannot predict with any degree of certainty the outcome of the SEC’s investigation or determine the extent of any potential liabilities. The Company also cannot predict whether there will be any loss as a result of the investigation nor can it provide an estimate of the possible loss or range of loss. Any adverse outcome in this matter or any related proceeding could expose the Company to substantial damages, penalties, or reputational harm that may have a material adverse impact on the Company’s business, results of operations, financial condition, growth prospects, and price of its common stock. Between 2022 and 2024, the Company’s Board of Directors received six litigation demands from purported shareholders of the Company, asking the Board of Directors to investigate and take action against certain current and former officers and directors of the Company for alleged wrongdoing based on the same allegations in the pending derivative and securities class action lawsuits. The Company may in the future receive such additional demands. Starting in October 2021, certain challenges have been filed with the China National Intellectual Property Administration against patents which claim a crystalline form of roxadustat. Final resolution of such proceedings will take time and the Company could not predict the ultimate outcome, or reasonably estimate the potential exposure. Indemnification Agreements The Company enters into standard indemnification arrangements in the ordinary course of business, including for example, service, manufacturing and collaboration agreements. Pursuant to these arrangements, the Company indemnifies, holds harmless, and agrees to reimburse the indemnified parties for losses suffered or incurred by the indemnified party, including in connection with intellectual property infringement claims by any third party with respect to its technology. The term of these indemnification agreements is generally perpetual any time after the execution of the agreement. The Company has entered into indemnification agreements with its directors and officers that may require the Company to indemnify its directors and officers against liabilities that may arise by reason of their status or service as directors or officers to the extent permissible under applicable law. The maximum potential amount of future payments the Company could be required to make under these arrangements is not determinable. The Company believes the estimated fair value of these arrangements is minimal. 24 Table of Contents