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Ual Annual Report

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Ual Annual Report WHEN GREAT MINDS COME TOGETHER, BIG IDEAS COME TO LIFE. 2018 ANNUALUAL REPORTR April 2019 Dear Fellow Shareholders, 2018 was a truly transformative year for our company, highlighted by the achievement of significant milestones toward our goal of advancing care for patients with kidney disease. Leveraging our fully-integrated infrastructure to advance care for patients with kidney disease Through the successful completion of our merger with Keryx Biopharmaceuticals in December 2018, we are now a fully-integrated company with capabilities ranging from research through commercialization. We now have an expanded and highly complementary portfolio focused on addressing significant unmet needs for patients with kidney disease. Our unique assets include Auryxia® (ferric citrate), a U.S. Food and Drug Administration (FDA)-approved product in two indications, and vadadustat, an investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) in Phase 3 clinical development, which we believe has the potential to drive a paradigm shift in the treatment of anemia due to chronic kidney disease (CKD). We believe these innovative assets represent exciting growth opportunities for our company. Auryxia: Building on strong momentum Auryxia is the only oral iron tablet approved in the U.S. to treat non-dialysis dependent adult CKD patients for iron deficiency anemia (IDA) and dialysis-dependent adult CKD patients for hyperphosphatemia. During 2018, our commercial team made significant progress in driving uptake of the drug, with volume and share gains for 2018 exceeding those of all other phosphate binders, both branded and generic. Nephrologists have a favorable perception of Auryxia across three of the most important needs in the hyperphosphatemia market: a lower pill burden, a favorable tolerability profile, and a palatable formulation. We remain focused on continuing momentum and translating this favorable perception by prescribers into significant growth opportunities for Auryxia. Vadadustat: Executing on value-driving clinical milestones With regard to vadadustat, we are thrilled with the progress we made in 2018 with our global Phase 3 program, as well as with positive top-line results released earlier this year from two pivotal Phase 3 studies in Japanese patients, conducted by our partner Mitsubishi Tanabe Pharma Corporation (MTPC). Each of the pivotal studies conducted by MTPC, one in non-dialysis dependent subjects and one in hemodialysis-dependent subjects, met its primary endpoint. Collectively, these results add to the dataset indicating the potential for vadadustat to effectively treat renal anemia due to CKD in both dialysis-dependent and non-dialysis dependent adult patients, and we look forward to MTPC’s submission of a Japanese New Drug Application expected in 2019. We remain focused on executing the clinical development program for vadadustat, including INNO2VATE and PRO2TECT, our Phase 3 programs designed to support potential regulatory filings in multiple key markets in dialysis-dependent and non-dialysis dependent patients, respectively. This is an exciting time for Akebia I’m proud of our team’s accomplishments across 2018. Our transformation to a fully-integrated company is a significant achievement and a testament both to the strength of our team and to the support of our shareholders. Importantly, it reflects our continuing commitment to help patients with kidney disease. There is much work ahead, and we remain confident that we are well-positioned to drive both innovation and long-term growth for the benefit of all our stakeholders. We expect 2019 to be another exciting year for Akebia! On behalf of the Board of Directors and the employees of Akebia, thank you for your continued support. SincerelySincerely, John P. Butler President and Chief Executive Officer UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ⌧ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2018 OR " TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number 001-36352 AKEBIA THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware 20-8756903 (State or other jurisdiction of (I.R.S. Employer incorporation or organization) Identification No.) 245 First Street, Cambridge, MA 02142 (Address of principal executive offices) (Zip Code) Registrant’s telephone number, including area code: (617) 871-2098 Securities registered pursuant to Section 12(b) of the Act: Title of each class Name of each exchange on which registered Common Stock, par value $0.00001 per share The Nasdaq Global Market Securities registered pursuant to Section 12(g) of the Act: None Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. YES ! NO " Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Act. YES " NO ! Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. YES ! NO " Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). YES ! NO " Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K (§ 229.405) is not contained herein, and will not be contained, to the best of registrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K. ! Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act. Large accelerated filer " Accelerated filer ! Non-accelerated filer " Smaller reporting company " Emerging growth company ! If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ! Indicate by check mark whether registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). YES " NO ! The aggregate market value of the voting and non-voting common equity held by non-affiliates of the registrant, based on the closing price of the registrant’s Common Stock on The Nasdaq Global Market on June 30, 2018, was $534,415,547. The number of shares of registrant’s Common Stock outstanding as of March 15, 2019 was 117,122,262. DOCUMENTS INCORPORATED BY REFERENCE Portions of the Proxy Statement for the registrant’s 2019 Annual Meeting of Stockholders are incorporated by reference into Part III of this Annual Report on Form 10-K. TABLE OF CONTENTS Page No. PART I 4 Item 1. Business ................................................................................................................................................................. 4 Item 1A. Risk Factors ............................................................................................................................................................ 42 Item 1B. Unresolved Staff Comments................................................................................................................................... 90 Item 2. Properties ................................................................................................................................................................ 90 Item 3. Legal Proceedings................................................................................................................................................... 90 Item 4. Mine Safety Disclosures ......................................................................................................................................... 93 PART II 94 Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities............................................................................................................................................................ 94 Item 6. Selected Financial Data .......................................................................................................................................... 96 Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations................................. 97 Item 7A. Quantitative and Qualitative Disclosures About Market Risk................................................................................ 112 Item 8. Financial Statements and Supplementary Data ...................................................................................................... 113 Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure ...............................
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