KYNTRA BIO, INC. 10-K

ITEM 9A. CONTROLS AND PROCEDURES Attached as exhibits 31.1 and 31.2 to this Annual Report on Form 10-K are certifications of our Chief Executive Officer and our Chief Financial Officer required by Rule 13a-14(a) and 15d-15(e) promulgated under the Securities Exchange Act of 1934, as amended (the “Rule 13a-14(a) and 15d-15(e) Certifications”). This Controls and Procedures section of the Annual Report on Form 10-K includes the information concerning the controls evaluation referred to in the Rule 13a-14(a) and 15d-15(e) Certifications. Evaluation of Disclosure Controls and Procedures Our management, with the participation of our Chief Executive Officer and our Chief Financial Officer, has evaluated the effectiveness of our disclosure controls and procedures as of December 31, 2020, the end of the period covered by this Annual Report on Form 10-K. Disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended (the “ Exchange Act”)) are designed to provide reasonable assurance that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the U.S. Securities and Exchange Commission’s rules and forms and that such information is accumulated and communicated to the company’s management, including its Chief Executive Officer and Chief Financial Officer, as appropriate to allow timely decisions regarding required disclosure. Based on our evaluation, the Chief Executive Officer and Chief Financial Officer have concluded that our disclosure controls and procedures were not effective as of December 31, 2020 because of the material weaknesses in our internal control over financial reporting described below. Management’s Annual Report on Internal Control over Financial Reporting Our management is responsible for establishing and maintaining adequate internal control over financial reporting as such term is defined in Rule 13a-15(f) of the Exchange Act. Our internal control over financial reporting is a process established under the supervision of and with the participation of our management, including our Chief Executive Officer and our Chief Financial Officer. Internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles. Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. In addition, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate. Management, with the participation and under the supervision of our Chief Executive Officer and our Chief Financial Officer , evaluated our internal control over financial reporting as of December 31, 2020, the end of our fiscal year, using the criteria established in Internal Control - Integrated Framework (2013) set forth by the Committee of Sponsoring Organizations of the Treadway Commission. Based on our evaluation, our management has concluded that our internal control over financial reporting was not effective as of December 31, 2020 because of the material weaknesses in our internal control over financial reporting described below. A material weakness is a deficiency, or combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of annual or interim financial statements will not be prevented or detected on a timely basis. As of September 30, 2020, we have identified a material weakness in the risk assessment component of internal control as we did not appropriately design and maintain an effective risk assessment process at a precise enough level to identify new and evolving risks of material misstatement to the financial statements as a result of changes in our business operation. This material weakness gave rise to the following additional control deficiencies, which we also determined to be material weaknesses. We did not design and maintain effective controls related to the timely identification of shipments associated with drug product revenue, and we did not design and maintain effective controls related to the timely identification of changes in estimated variable consideration related to drug product revenue. 169 Each of these material weaknesses could result in material misstatements in the drug product revenue, contract asset or contract liability account balances or disclosures in our annual or interim consolidated financial statements that would not be prevented or detected. The material weaknesses described above did not result in any material misstatements of our consolidated financial statements or disclosures, but did result in immaterial out-of-period adjustments to drug product revenue related to pre-commercial shipments of drug product, contract assets and contract liabilities, and related financial statement disclosures during the quarter ended September 30, 2020. The effectiveness of the Company’s internal control over financial reporting as of December 31, 2020 has been audited by PricewaterhouseCoopers LLP, an independent registered public accounting firm, as stated in their report that appears herein. Remediation Plan and Status Our Board of Directors and management are committed to maintaining a strong internal control environment. We have developed a detailed remediation plan and are making progress of what will be a multi-step remediation process to fully remediate the material weaknesses described above. Specifically, as of December 31, 2020, we have started, and will continue to the process of the steps including, but not limited to, the following: • We have performed a comprehensive risk assessment process, and will continue to refine the risk assessment, to identify and design our control activities related to the above mentioned material weaknesses; • We have identified and designed new controls and procedures associated with drug product revenue, and where applicable implemented new procedures and controls during the fourth quarter of 2020, and will continue to implement new procedures and controls in the future; and • We started the process to hire additional resources to strengthen our accounting and internal audit functions. In addition, we will continue to assess risks on a continuous basis to timely identify new exposures or risk categories as business practices change, and we plan to conduct a comprehensive review and, as applicable, update our existing internal control framework to ensure that it has identified, developed and deployed the appropriate business process controls to meet the objectives and address the risks identified. The material weaknesses will not be considered remediated until the applicable controls operate for a sufficient period of time and management has concluded, through testing, that these controls are operating effectively. We believe the measures described above will remediate these material weaknesses and strengthen our internal control over financial reporting. As we continue to evaluate and work to remediate these material weaknesses, we may determine to take additional measures to address these deficiencies or determine to modify certain of the remediation measures described above. Limitations on the Effectiveness of Controls In designing and evaluating the disclosure controls and procedures, management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives. In addition, the design of disclosure controls and procedures must reflect the fact that there are resource constraints and that management is required to apply its judgment in evaluating the benefits of possible controls and procedures relative to their costs. Because of the inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and not be detected. Changes in Internal Control over Financial Reporting There was no change in our internal control over financial reporting identified in connection with the evaluation required by Rule 13a-15(d) and 15d-15(d) of the Exchange Act that occurred during the most recent fiscal quarter ended December 31, 2020 that materially affected, or is reasonably likely to materially affect, our internal control over financial reporting. ITEM 9B. OTHER INFORMATION None. 170 PART III ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE The information required by this item is incorporated by reference to our Proxy Statement for our 2021 Annual Meeting of Stockholders to be filed with the SEC within 120 days after the end of the fiscal year ended December 31, 2020. Code of Conduct We have adopted a Code of Business Conduct that applies to all of our directors, officers and employees. A copy of our Code of Business Conduct can be found on our website ( www.FibroGen.com ) under “Corporate Governance.” The contents of our website are not a part of this report. In addition, we intend to promptly disclose the nature of any amendment to, or waiver from, our Code of Business Conduct that applies to our principal executive officer, principal financial officer, principal accounting officer or persons performing similar functions on our website in the future. ITEM 11. EXECUTIVE COMPENSATION The information required by this item is incorporated by reference to our Proxy Statement for our 2021 Annual Meeting of Stockholders to be filed with the SEC within 120 days after the end of the fiscal year ended December 31, 2020. ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS The information required by this item is incorporated by reference to our Proxy Statement for our 2021 Annual Meeting of Stockholders to be filed with the SEC within 120 days after the end of the fiscal year ended December 31, 2020. ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE The information required by this item is incorporated by reference to our Proxy Statement for our 2021 Annual Meeting of Stockholders to be filed with the SEC within 120 days after the end of the fiscal year ended December 31, 2020. ITEM 14. PRINCIPAL ACCOUNTING FEES AND SERVICES The information required by this item is incorporated by reference to our Proxy Statement for our 2021 Annual Meeting of Stockholders to be filed with the SEC within 120 days after the end of the fiscal year ended December 31, 2020. 171 PART IV ITEM 15. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES (a) We have filed the following documents as part of this Annual Report on Form 10-K: 1. Consolidated Financial Statements Information in response to this Item is included in Part II, Item 8 of this Annual Report on Form 10-K. 2. Financial Statement Schedules Schedule II is included on page 168 . All other schedules are omitted because they are not required or the required information is included in the consolidated financial statements or notes thereto. 3. Exhibits See Item 15(b) below. (b) Exhibits —We have filed, or incorporated into this Annual Report on Form 10-K by reference, the exhibits listed below. Where an exhibit is incorporated by reference, the number in parentheses indicates the document to which cross-reference is made. Refer to the end of this table for a listing of cross-reference documents. Exhibit Incorporation By Reference Number Exhibit Description Form SEC File No. Exhibit Filing Date 3.1 Amended and Restated Certificate of Incorporation of FibroGen, Inc. 8-K 001-36740 3.1 11/21/2014 3.2 Amended and Restated Bylaws of FibroGen, Inc. S-1/A 333-199069 3.4 10/23/2014 4.1 Form of Common Stock Certificate. 8-K 001-36740 4.1 11/21/2014 4.2 Shareholders’ Agreement by and among FibroGen International (Cayman) Limited and certain of its shareholders, dated as of September 8, 2017. 10-Q 001-36740 4.6 11/8/2017 4.3 Common Stock Purchase Agreement by and between FibroGen, Inc. and AstraZeneca AB, dated as of October 20, 2014. S-1/A 333-199069 4.17 10/24/2014 4.4 Description of Capital Stock of FibroGen, Inc. 10-K 001-36740 4.4 3/2/2020 10.1(i)+ FibroGen, Inc. Amended and Restated 2005 Stock Plan. S-1 333-199069 10.3(i) 10/1/2014 10.1(ii)+ Forms of stock option agreement, restricted stock purchase agreement and stock appreciation right agreement under the FibroGen, Inc. Amended and Restated 2005 Stock Plan. S-1 333-199069 10.3(ii) 10/1/2014 10.1(iii)+ Form of stock option agreement under the FibroGen, Inc. Amended and Restated 2005 Stock Plan applicable to options exchanged pursuant to FibroGen, Inc.’s 2010 amendment and exchange offer. S-1 333-199069 10.3(iii) 10/1/2014 10.1(iv)+ Form of 2010 amendment to the form of stock option agreement under the FibroGen, Inc. Amended and Restated 2005 Stock Plan applicable to options amended pursuant to FibroGen, Inc.’s 2010 amendment and exchange offer. S-1 333-199069 10.3(iv) 10/1/2014 172 10.1(v)+ Form of 2013 amendment to the form of stock option agreement under the FibroGen, Inc. Amended and Restated 2005 Stock Plan applicable to options amended or exchanged pursuant to FibroGen, Inc.’s 2010 amendment and exchange offer. S-1 333-199069 10.3(v) 10/1/2014 10.2+ FibroGen, Inc. 2014 Equity Incentive Plan and forms of agreement thereunder. S-1/A 333-199069 10.4 11/12/2014 10.3+ FibroGen, Inc. 2014 Employee Stock Purchase Plan. S-1/A 333-199069 10.5 11/12/2014 10.4+ FibroGen, Inc. Non-Employee Director Compensation Policy, as amended. 10-Q 001-36740 10.1 5/7/2020 10.5+ FibroGen, Inc. 2018 Bonus Plan. 8-K 001-36740 10.5 2/16/2018 10.6 Lease Agreement by and between FibroGen, Inc. and X-4 Dolphin LLC, dated as of September 22, 2006; as amended by First Amendment to Lease by and between FibroGen, Inc. and X-4 Dolphin LLC, dated as of October 10, 2007; as amended by Second Amendment to Lease by and between FibroGen, Inc. and X-4 Dolphin LLC, dated as of June 29, 2009; as amended by Third Amendment to Lease by and between FibroGen, Inc. and Are-San Francisco No. 43, LLC (as successor in interest to X-4 Dolphin LLC), dated as of May 19, 2011; as amended by Fourth Amendment to Lease by and between FibroGen, Inc. and Are-San Francisco No. 43, LLC, dated as of September 8, 2011. S-1 333-199069 10.8 10/1/2014 10.7 Lease for Premises in Beijing BDA Biomedical Park by and among Beijing FibroGen Medical Technology Development Co., Ltd., Beijing Economic and Technology Investment Development Parent Company and Beijing BDA International Biological Pharmaceutical Investment Management Co., Ltd., effective as of February 1, 2013, as supplemented by the Supplementary Agreement to Lease of Premises in Beijing BDA Biomedical Park by and among Beijing FibroGen Medical Technology Development Co., Ltd., Beijing Economic Technology Investment Development Parent Company and Beijing BDA International Biological Pharmaceutical Investment Management Co., Ltd., dated as of January 30, 2013. S-1 333-199069 10.9 10/1/2014 10.8+ Form of Employment Offer Letter. S-1 333-199069 10.10 10/1/2014 10.9† Collaboration Agreement, by and between FibroGen, Inc. and Astellas Pharma Inc., effective as of June 1, 2005. 10-Q 001-36740 10.1 11/5/2020 173 10.9(i)† Amendment No. 1 to Collaboration Agreement, by and between FibroGen, Inc. and Astellas Pharma Inc., effective as of January 1, 2013. 10-K 001-36740 10.9(i) 2/27/2019 10.10† Anemia License and Collaboration Agreement, by and between FibroGen, Inc. and Astellas Pharma Inc., effective as of April 28, 2006. S-1 333-199069 10.12 10/1/2014 10.11† Amendment to Anemia License and Collaboration Agreement, by and between FibroGen, Inc. and Astellas Pharma Inc., effective as of August 31, 2006. S-1 333-199069 10.13 10/1/2014 10.12 Amendment No. 2 to Anemia License and Collaboration Agreement, by and between FibroGen, Inc. and Astellas Pharma Inc., effective as of December 1, 2006. S-1 333-199069 10.14 10/1/2014 10.13† Supplement to Anemia License and Collaboration Agreement, by and between FibroGen, Inc. and Astellas Pharma Inc., effective as of April 28, 2006. S-1 333-199069 10.15 10/1/2014 10.14† Amendment No. 3 to Anemia License and Collaboration Agreement, by and between FibroGen, Inc. and Astellas Pharma Inc., dated as of May 10, 2012. S-1 333-199069 10.16 10/1/2014 10.15† Amended and Restated License, Development and Commercialization Agreement (China) by and among FibroGen China Anemia Holdings, Ltd., Beijing FibroGen Medical Technology Development Co., Ltd., FibroGen International (Hong Kong) Limited and AstraZeneca AB, effective as of July 30, 2013. 10-Q 001-36740 10.3 11/5/2020 10.16† Amended and Restated License, Development and Commercialization Agreement (for the U.S. and Certain Other Territories) by and between FibroGen, Inc. and AstraZeneca AB, effective as of July 30, 2013. 10-Q 001-36740 10.2 11/5/2020 10.17† License Agreement by and between FibroGen, Inc. and the University of Miami and its School of Medicine, dated as of May 23, 1997. 10-Q 001-36740 10.4 11/5/2020 10.18† First Amendment to May 23, 1997 License Agreement by and between FibroGen, Inc. and University of Miami, effective as of July 29, 1999. 10-Q 001-36740 10.5 11/5/2020 10.19 Research and Commercialization Agreement by and among FibroGen, Inc., GenPharm International Inc., Medarex, Inc. and FibroPharma, Inc., effective as of July 9, 1998. S-1 333-199069 10.21 10/1/2014 10.20 Amendment No. 1 to Research and Commercialization Agreement by and among FibroGen, Inc., GenPharm International Inc., Medarex, Inc. and FibroPharma, Inc., effective as of June 30, 2001. S-1 333-199069 10.22 10/1/2014 174 10.21† Amendment No. 2 to Research and Commercialization Agreement by and among FibroGen, Inc., GenPharm International Inc., Medarex, Inc. and FibroPharma, Inc., effective as of January 28, 2002. 10-Q 001-36740 10.6 11/5/2020 10.22† License Agreement by and between FibroGen, Inc. and the Dana-Farber Cancer Institute, Inc., effective as of March 29, 2006. 10-Q 001-36740 10.7 11/5/2020 10.23 Amendment No. 1 to License agreement by and between FibroGen, Inc. and Dana-Farber Cancer Institute, Inc., effective as of February 28, 2006. S-1 333-199069 10.25 10/1/2014 10.24 Amendment No. 2 to License Agreement by and between FibroGen, Inc. and Dana-Farber Cancer Institute, Inc., effective as of March 14, 2006. S-1 333-199069 10.26 10/1/2014 10.25+ Form of Indemnity Agreement by and between FibroGen, Inc. and its directors and officers. S-1/A 333-199069 10.27 10/23/2014 10.26(i)† Process Development and Clinical Supply Agreement by and between FibroGen, Inc. and Boehringer Ingelheim Pharma GmbH & Co. KG, effective as of November 29, 2007. S-1 333-199069 10.28(i) 10/1/2014 10.26(ii)† Letter Agreement by and between FibroGen, Inc. and Boehringer Ingelheim Pharma GmbH & Co. KG, effective as of June 26, 2008. S-1 333-199069 10.28(ii) 10/1/2014 10.26(iii)† Letter Agreement by and between FibroGen, Inc. and Boehringer Ingelheim Pharma GmbH & Co. KG, effective as of August 18, 2008. S-1 333-199069 10.28(iii) 10/1/2014 10.26(iv)† Amendment No. 1 to the Process Development and Clinical Supply Agreement by and between FibroGen, Inc. and Boehringer Ingelheim Pharma GmbH & Co. KG, effective as of May 28, 2009. S-1 333-199069 10.28(iv) 10/1/2014 10.26(v)† Amendment No. 3 to the Process Development and Clinical Supply Agreement by and between FibroGen, Inc. and Boehringer Ingelheim Pharma GmbH & Co. KG, effective as of November 5, 2010. S-1 333-199069 10.28(v) 10/1/2014 10.26(vi)† Amendment No. 4 to the Process Development and Clinical Supply Agreement by and between FibroGen, Inc. and Boehringer Ingelheim Pharma GmbH & Co. KG, effective as of January 24, 2011. S-1 333-199069 10.28(vi) 10/1/2014 10.26(vii)† Amendment No. 5 to the Process Development and Clinical Supply Agreement by and between FibroGen, Inc. and Boehringer Ingelheim Pharma GmbH & Co. KG, effective as of April 15, 2011. S-1 333-199069 10.28(vii) 10/1/2014 10.26(viii)† Amendment No. 6 to the Process Development and Clinical Supply Agreement by and between FibroGen, Inc. and Boehringer Ingelheim Pharma GmbH & Co. KG, effective as of May 26, 2011. S-1 333-199069 10.28(viii) 10/1/2014 175 10.26(ix)† Amendment No. 7 to the Process Development and Clinical Supply Agreement by and between FibroGen, Inc. and Boehringer Ingelheim Pharma GmbH & Co. KG, effective as of January 1, 2012. S-1 333-199069 10.28(ix) 10/1/2014 10.26(x)† Amendment No. 8 to the Process Development and Clinical Supply Agreement by and between FibroGen, Inc. and Boehringer Ingelheim Pharma GmbH & Co. KG, effective as of July 10, 2012. S-1 333-199069 10.28(x) 10/1/2014 10.26(xi)† Amendment No. 9 to the Process Development and Clinical Supply Agreement by and between FibroGen, Inc. and Boehringer Ingelheim Pharma GmbH & Co. KG, effective as of November 26, 2012. S-1 333-199069 10.28(xi) 10/1/2014 10.26(xii)† Amendment No. 10 to the Process Development and Clinical Supply Agreement by and between FibroGen, Inc. and Boehringer Ingelheim Pharma GmbH & Co. KG, effective as of June 21, 2013. S-1 333-199069 10.28(xii) 10/1/2014 10.26(xiii)† Amendment No. 11 to the Process Development and Clinical Supply Agreement by and between FibroGen, Inc. and Boehringer Ingelheim Pharma GmbH & Co. KG, effective as of July 9, 2013. S-1 333-199069 10.28(xiii) 10/1/2014 10.26(xiv)† Amendment No. 12 to the Process Development and Clinical Supply Agreement by and between FibroGen, Inc. and Boehringer Ingelheim Pharma GmbH & Co. KG, effective as of August 1, 2013. S-1 333-199069 10.28(xiv) 10/1/2014 10.26(xv)† Amendment No. 13 to the Process Development and Clinical Supply Agreement by and between FibroGen, Inc. and Boehringer Ingelheim Pharma GmbH & Co. KG, effective as of March 6, 2014. S-1 333-199069 10.28(xv) 10/1/2014 10.26(xvi)† Amendment No. 14 to the Process Development and Clinical Supply Agreement by and between FibroGen, Inc. and Boehringer Ingelheim Pharma GmbH & Co. KG, effective as of February 5, 2014. S-1 333-199069 10.28(xvi) 10/1/2014 10.26(xvii)† Amendment No. 15 to the Process Development and Clinical Supply Agreement by and between FibroGen, Inc. and Boehringer Ingelheim Pharma GmbH & Co. KG, effective as of October 20, 2014. 10-Q 001-36740 10.28(xvii) 11/12/2015 10.26(xviii)† Amendment No. 16 to the Process Development and Clinical Supply Agreement by and between FibroGen, Inc. and Boehringer Ingelheim Pharma GmbH & Co. KG, effective as of December 8, 2014. 10-Q 001-36740 10.28(xviii) 11/12/2015 10.26(xix)† Amendment No. 17 to the Process Development and Clinical Supply Agreement by and between FibroGen, Inc. and Boehringer Ingelheim Pharma GmbH & Co. KG, effective as of December 8, 2014. 10-Q 001-36740 10.28(xix) 11/12/2015 176 10.26(xx)† Amendment No. 18 to the Process Development and Clinical Supply Agreement by and between FibroGen, Inc. and Boehringer Ingelheim Pharma GmbH & Co. KG, effective as of February 15, 2015. 10-Q 001-36740 10.28(xx) 11/12/2015 10.26(xxi)† Amendment No. 19 to the Process Development and Clinical Supply Agreement by and between FibroGen, Inc. and Boehringer Ingelheim Pharma GmbH & Co. KG, effective as of March 1, 2015. 10-Q 001-36740 10.28(xxi) 11/12/2015 10.26(xxii)† Amendment No. 20 to the Process Development and Clinical Supply Agreement by and between FibroGen, Inc. and Boehringer Ingelheim Pharma GmbH & Co. KG, effective as of June 1, 2015. 10-Q 001-36740 10.28(xxii) 11/12/2015 10.26(xxiii)† Amendment No. 21 to the Process Development and Clinical Supply Agreement by and between FibroGen, Inc. and Boehringer Ingelheim Pharma GmbH & Co. KG, effective as of May 29, 2015. 10-Q 001-36740 10.28(xxiii) 11/12/2015 10.26(xxiv)† Amendment No. 23 to the Process Development and Clinical Supply Agreement by and between FibroGen, Inc. and Boehringer Ingelheim Pharma GmbH & Co. KG, effective as of September 1, 2015. 10-Q 001-36740 10.28(xxiv) 11/12/2015 10.26(xxv)† Amendment No. 22 to the Process Development and Clinical Supply Agreement, by and between FibroGen, Inc. and Boehringer Ingelheim Biopharmaceuticals GmbH, effective as of April 14, 2016. 10-Q 001-36740 10.26(xxv) 8/8/2016 10.26(xxvi)† Amendment No. 24 to the Process Development and Clinical Supply Agreement, by and between FibroGen, Inc. and Boehringer Ingelheim Biopharmaceuticals GmbH, retroactively effective as of September 15, 2015. 10-Q 001-36740 10.26(xxvi) 8/8/2016 10.26(xxvii)† Amendment No. 25 to the Process Development and Clinical Supply Agreement, by and between FibroGen, Inc. and Boehringer Ingelheim Biopharmaceuticals GmbH, retroactively effective as of October 15, 2015. 10-Q 001-36740 10.26(xxvii) 8/8/2016 10.26(xxviii)† Amendment No. 26 to the Process Development and Clinical Supply Agreement, by and between FibroGen, Inc. and Boehringer Ingelheim Biopharmaceuticals GmbH, effective as of June 30, 2016. 10-Q 001-36740 10.26(xxviii) 8/8/2016 10.26(xxix)† Amendment No. 27 to the Process Development and Clinical Supply Agreement, by and between FibroGen, Inc. and Boehringer Ingelheim Biopharmaceuticals GmbH, effective as of July 25, 2016. 10-Q 001-36740 10.26(xxix) 11/8/2016 10.26(xxx)† Amendment No. 28 to the Process Development and Clinical Supply Agreement, by and between FibroGen, Inc. and Boehringer Ingelheim Biopharmaceuticals GmbH, effective as of September 22, 2016. 10-Q 001-36740 10.26(xxx) 11/8/2016 177 10.26(xxxi)† Amendment No. 29 to the Process Development and Clinical Supply Agreement, by and between FibroGen, Inc. and Boehringer Ingelheim Biopharmaceuticals GmbH, effective as of December 20, 2016. 10-K 001-36740 10.26(xxxi) 3/1/2017 10.26(xxxii)† Amendment No. 30 to the Process Development and Clinical Supply Agreement, by and between FibroGen, Inc. and Boehringer Ingelheim Biopharmaceuticals GmbH, effective as of December 20, 2016. 10-K 001-36740 10.26(xxxii) 3/1/2017 10.26(xxxiii)† Amendment No. 31 to the Process Development and Clinical Supply Agreement, by and between FibroGen, Inc. and Boehringer Ingelheim Biopharmaceuticals GmbH, effective as of March 2, 2017 10-Q 001-36740 10.26(xxxiii) 5/9/2017 10.26(xxxiv)† Amendment No. 32 to the Process Development and Clinical Supply Agreement, by and between FibroGen, Inc. and Boehringer Ingelheim Biopharmaceuticals GmbH, effective as of September 1, 2017 10-K 001-36740 10.26(xxxiv) 2/27/2018 10.26(xxxv)† Work Order No. 1 to the Process Development and Clinical Supply Agreement, by and between FibroGen, Inc. and Boehringer Ingelheim Biopharmaceuticals GmbH, effective as of September 1, 2017 10-K 001-36740 10.26(xxxv) 2/27/2018 10.26(xxxvi)† Amendment No. 33 to the Process Development and Clinical Supply Agreement, by and between FibroGen, Inc. and Boehringer Ingelheim Biopharmaceuticals GmbH, effective as of January 4, 2019 10-Q 001-36740 10.26(xxxvi) 5/9/2019 10.27† State-Owned Construction Land Use Right Granting Contract by and between FibroGen (China) Medical Technology Development Co., Ltd. and The Bureau of Land and Resources of Cangzhou, dated as of February 24, 2017 10-Q 001-36740 10.32 5/9/2017 10.28† Commercial Supply Agreement by and between FibroGen, Inc. and Catalent Pharma Solutions, LLC, effective as of January 1, 2020 10-K 001-36740 10.28 3/2/2020 10.29† Master Supply Agreement by and among FibroGen, Inc., Shanghai SynTheAll Pharmaceutical Co., Ltd. and STA Pharmaceutical Hong Kong Limited, effective March 2, 2020 8-K 001-36740 99.1 3/24/2020 10.30† Amendment No.1 to Master Supply Agreement by and among FibroGen, Inc., Shanghai SynTheAll Pharmaceutical Co., Ltd. and STA Pharmaceutical Hong Kong Limited, effective May 11, 2020 10-Q 001-36740 10.2 8/6/2020 178 10.31† Second Amended and Restated License, Development and Commercialization Agreement by and among FibroGen China Anemia Holdings, Ltd., FibroGen China Medical Technology Development Co., Ltd., FibroGen International (Hong Kong) Limited, and AstraZeneca AB, effective July 1, 2020 10-Q 001-36740 10.3 8/6/2020 10.32† Amendment No. 1 to the Amended and Restated License, Development and Commercialization Agreement by and between FibroGen, Inc. and AstraZeneca AB, effective July 1, 2020 10-Q 001-36740 10.4 8/6/2020 10.33† Amendment No. 2 to Master Supply Agreement by and among FibroGen, Inc., Shanghai SynTheAll Pharmaceutical Co., Ltd. and STA Pharmaceutical Hong Kong Limited, effective July 24, 2020 10-Q 001-36740 10.8 11/5/2020 10.34† Master Supply Agreement by and between FibroGen, Inc. and AstraZeneca UK Limited, effective September 10, 2020 10-Q 001-36740 10.9 11/5/2020 10.35*† Master Services Agreement by and between FibroGen, Inc. and Samsung Biologics Co., Ltd., effective as of October 30, 2020 — — — — 10.36*† Product Specific Agreement by and between FibroGen, Inc. and Samsung Biologics Co., Ltd., effective as of October 30, 2020 — — — — 10.37+ Offer Letter, by and between FibroGen, Inc. and Pat Cotroneo, dated as of October 23, 2000. S-1 333-199069 10.31 10/1/2014 10.38+ Offer Letter, by and between FibroGen, Inc. and K. Peony Yu, dated as of November 21, 2008. S-1 333-199069 10.30 10/1/2014 10.39+ Offer Letter, by and between FibroGen, Inc. and James Schoeneck, dated as of September 18, 2019. 10-Q 001-36740 10.7 11/12/2019 10.40+ Offer Letter, by and between FibroGen, Inc. and Christine Chung, dated as of June 17, 2008. 10-K 001-36740 10.32 3/2/2020 10.41+ Offer Letter, by and between FibroGen, Inc. and Elias Kouchakji, dated as of January 24, 2014. 10-K 001-36740 10.33 3/2/2020 10.42+ Offer Letter, by and between FibroGen, Inc. and Enrique Conterno, dated as of December 17, 2019. 10-K 001-36740 10.34 3/2/2020 10.43+ Offer Letter, by and between FibroGen, Inc. and Thane Wettig, dated as of May 7, 2020. 10-Q 001-36740 10.1 8/6/2020 10.44*+ Offer Letter, by and between FibroGen, Inc. and Mark Eisner, dated as of October 22, 2020. — — — — 10.45+ Form of Executive Officer Change in Control and Severance Agreement 10-K 001-36740 10.35 3/2/2020 21.1* Subsidiaries of FibroGen, Inc. — — — — 23.1* Consent of PricewaterhouseCoopers LLP. — — — — 179 24.1* Power of Attorney (included in signature pages). — — — — 31.1* Certification of Chief Executive Officer, as required by Rule 13a-14(a) or Rule 15d-14(a). — — — — 31.2* Certification of Chief Financial Officer, as required by Rule 13a-14(a) or Rule 15d-14(a). — — — — 32.1* Certification of Principal Executive Officer and Principal Financial Officer, as required by Rule 13a-14(b) or Rule 15d-14(b) and Section 1350 of Chapter 63 of Title 18 of the United States Code (18 U.S.C. §1350)(1). — — — — 101.INS* Inline XBRL Instance Document — — — — 101.SCH* Inline XBRL Taxonomy Schema Linkbase Document — — — — 101.CAL* Inline XBRL Calculation Linkbase Document — — — — 101.DEF* Inline XBRL Definition Linkbase Document — — — — 101.LAB* Inline XBRL Labels Linkbase Document — — — — 101.PRE* Inline XBRL Taxonomy Presentation Linkbase Document — — — — 104 Cover Page Interactive Data File (embedded within the inline XBRL document) — — — — * Filed herewith. † Portions of this exhibit (indicated by asterisks) have been omitted as the Company has determined that (i) the omitted information is not material and (ii) the omitted information would likely cause competitive harm if publicly disclosed. + Indicates a management contract or compensatory plan. (1) This certification accompanies the Form 10-K to which it relates, is not deemed filed with the Securities and Exchange Commission and is not to be incorporated by reference into any filing of FibroGen, Inc. under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended (whether made before or after the date of the Form 10-K), irrespective of any general incorporation language contained in such filing. (c) Financial Statement Schedules —See (a) 2 above. All other financial statement schedules are omitted because they are not applicable because the requested information is included in the consolidated financial statements or notes thereto. ITEM 16. FORM 10-K SUMMARY None 180 SIGNATURES Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this Annual Report on Form 10-K to be signed on its behalf by the undersigned, thereunto duly authorized, in the City of San Francisco, State of California. FIBROGEN, INC. Date: March 1, 2021 By: /s/ Enrique Conterno Enrique Conterno Chief Executive Officer (Principal Executive Officer) Date: March 1, 2021 By: /s/ Pat Cotroneo Pat Cotroneo Senior Vice President, Finance and Chief Financial Officer (Principal Financial and Accounting Officer) 181 POWER OF ATTORNEY KNOW ALL PERSONS BY THESE PRESENTS, that each person whose signature appears below constitutes and appoints Enrique Conterno and Pat Cotroneo, jointly and severally, his or her attorneys-in-fact, each with the power of substitution, for him or her in any and all capacities, to sign any amendments to this Annual Report on Form 10-K, and to file the same, with exhibits thereto and other documents in connection therewith with the Securities and Exchange Commission, hereby ratifying and confirming all that each of said attorneys-in-fact, or his substitute or substitutes, may do or cause to be done by virtue hereof. Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant and in the capacities and on the dates indicated. Signature Title Date /s/ Enrique Conterno Chief Executive Officer (Principal Executive Officer) March 1, 2021 Enrique Conterno /s/ Pat Cotroneo Senior Vice President, Finance and Chief Financial Officer (Principal Financial and Accounting Officer) March 1, 2021 Pat Cotroneo /s/ James A. Schoeneck Chairman of the Board and Director March 1, 2021 James A. Schoeneck /s/ Suzanne Blaug Director March 1, 2021 Suzanne Blaug /s/ Aoife Brennan, M.B., B.Ch. Director March 1, 2021 Aoife Brennan, M.B., B.Ch. /s/ Benjamin F. Cravatt, Ph.D. Director March 1, 2021 Benjamin F. Cravatt, Ph.D. /s/ Jeffrey L. Edwards Director March 1, 2021 Jeffrey L. Edwards /s/ Jeffrey W. Henderson Director March 1, 2021 Jeffrey W. Henderson /s/ Maykin Ho, Ph.D. Director March 1, 2021 Maykin Ho, Ph.D. /s/ Thomas F. Kearns Jr. Director March 1, 2021 Thomas F. Kearns Jr. /s/ Kalevi Kurkijärvi, Ph.D. Director March 1, 2021 Kalevi Kurkijärvi, Ph.D. /s/ Gerald Lema Director March 1, 2021 Gerald Lema /s/ Rory B. Riggs Director March 1, 2021 Rory B. Riggs 182