UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2019 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from __________to__________ | --- | --- | |--------------------------------------------------------------------------------------------|----------------------- ...

Akebia Therapeutics, Inc. (NASDAQ:AKBA) Q3 2019 Earnings Conference Call November 12, 2019 9:00 AM ET Company Participants Kristen Sheppard - VP of IR John Butler - President and CEO Jason Amello - CFO Conference Call Participants Chris Raymond - Piper Jaffray Eric Joseph - JP Morgan David Lebowitz - Morgan Stanley Difei Yang - Mizuho Securities Ed Arce - H.C. Wainwright Justin Burns - RBC Capital Markets Operator Ladies and gentlemen, and welcome to the Akebia Therapeutics Third quarter Financial Results a ...

Akebia Therapeutics Inc. (NASDAQ:AKBA) Q2 2019 Results Conference Call August 8, 2019 9:00 AM ET Company Participants Kristen Sheppard - Vice President of Investor Relations John Butler - President and Chief Executive Officer Jason Amello - Chief Financial Officer Conference Call Participants Eric Joseph - JP Morgan Nicole Gabreski - Piper Jaffray David Lebowitz - Morgan Stanley Robert Hazlett - BTIG Alexandre Bouilloux - Mizuho Securties Chad Jason - Needham & Company Ed Arce - H.C. Wainwright Operator Goo ...

Part I. Financial Information [Item 1. Financial Statements](index=5&type=section&id=Item%201.%20Financial%20Statements) The unaudited condensed consolidated financial statements for Q2 2019 reflect the company's financial position, operations, and cash flows post-Keryx merger [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets decreased to $823.5 million by June 30, 2019, primarily due to reduced cash and securities Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | June 30, 2019 | December 31, 2018 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $87,212 | $104,644 | | Available for sale securities | $49,553 | $216,996 | | Total current assets | $316,396 | $468,275 | | Goodwill | $55,053 | $55,053 | | Other intangible assets, net | $309,413 | $328,153 | | **Total assets** | **$823,528** | **$996,540** | | **Liabilities & Equity** | | | | Total current liabilities | $185,618 | $265,693 | | Total liabilities | $304,172 | $360,612 | | Total stockholders' equity | $519,356 | $635,928 | | **Total liabilities and stockholders' equity** | **$823,528** | **$996,540** | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Q2 2019 total revenues reached $100.8 million, but net loss widened to $58.2 million due to increased operating expenses Statement of Operations Highlights (in thousands, except per share data) | Metric | Three Months Ended June 30, 2019 | Three Months Ended June 30, 2018 | | :--- | :--- | :--- | | Product revenue, net | $29,089 | $— | | License, collaboration and other revenue | $71,714 | $48,793 | | **Total revenues** | **$100,803** | **$48,793** | | Total cost of goods sold | $37,669 | $— | | Research and development | $85,694 | $71,917 | | Selling, general and administrative | $36,068 | $12,538 | | **Operating loss** | **($59,523)** | **($35,662)** | | **Net loss** | **($58,170)** | **($34,069)** | | **Net loss per share** | **($0.49)** | **($0.60)** | Statement of Operations Highlights (in thousands, except per share data) | Metric | Six Months Ended June 30, 2019 | Six Months Ended June 30, 2018 | | :--- | :--- | :--- | | Product revenue, net | $52,200 | $— | | License, collaboration and other revenue | $121,269 | $94,723 | | **Total revenues** | **$173,469** | **$94,723** | | Total cost of goods sold | $68,926 | $— | | Research and development | $168,045 | $133,321 | | Selling, general and administrative | $70,359 | $21,562 | | **Operating loss** | **($135,492)** | **($60,160)** | | **Net loss** | **($130,591)** | **($57,487)** | | **Net loss per share** | **($1.11)** | **($1.09)** | [Condensed Consolidated Statements of Cash Flows](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities significantly increased to $176.3 million for H1 2019, resulting in a $17.4 million net cash decrease Cash Flow Summary (in thousands) | Activity | Six Months Ended June 30, 2019 | Six Months Ended June 30, 2018 | | :--- | :--- | :--- | | Net cash used in operating activities | ($176,295) | ($11,334) | | Net cash provided by investing activities | $164,506 | $8,866 | | Net cash provided by (used in) financing activities | ($5,643) | $96,123 | | **Increase (decrease) in cash** | **($17,432)** | **$93,655** | [Notes to Condensed Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Notes detail operations, Keryx merger impact, going concern uncertainty, accounting policies, revenue, assets, debt, and commitments - The company is a biopharmaceutical firm focused on developing and commercializing therapeutics for kidney disease, with commercial product Auryxia and lead candidate vadadustat in Phase 3 development[20](index=20&type=chunk) - The company completed its merger with Keryx Biopharmaceuticals, Inc. on **December 12, 2018**, integrating the commercial product Auryxia[21](index=21&type=chunk) - Management's ASC 205-40 analysis concluded "substantial doubt" about the company's ability to continue as a going concern for the next twelve months, as certain potential funding is excluded from the formal assessment[23](index=23&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=43&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses post-merger focus, revenue, wider net loss, and liquidity, including going concern disclosure [Results of Operations](index=49&type=section&id=Results%20of%20Operations) Q2 2019 total revenues increased to $100.8 million, but operating loss widened to $59.5 million due to higher R&D and SG&A expenses Comparison of Three Months Ended June 30, 2019 and 2018 (in thousands) | Item | Q2 2019 | Q2 2018 | Change | | :--- | :--- | :--- | :--- | | **Total revenues** | **$100,803** | **$48,793** | **$52,010** | | Product revenue, net | $29,089 | $— | $29,089 | | License, collaboration revenue | $71,714 | $48,793 | $22,921 | | **Total cost of goods sold** | **$37,669** | **$—** | **$37,669** | | Research and development | $85,694 | $71,917 | $13,777 | | Selling, general and administrative | $36,068 | $12,538 | $23,530 | | **Operating loss** | **($59,523)** | **($35,662)** | **($23,861)** | | **Net loss** | **($58,170)** | **($34,069)** | **($24,101)** | - Collaboration revenue increased primarily due to an additional **$11.1 million** from the Otsuka U.S. Agreement and a **$9.8 million** increase from the MTPC Agreement, including a **$10.0 million** JNDA filing milestone[254](index=254&type=chunk) [Liquidity and Capital Resources](index=53&type=section&id=Liquidity%20and%20Capital%20Resources) The company's liquidity includes $136.8 million in cash and securities, with a cash runway into Q3 2020, despite formal "substantial doubt" about going concern - Cash, cash equivalents, and available for sale securities totaled approximately **$136.8 million** as of June 30, 2019[276](index=276&type=chunk) - Net cash used in operating activities for H1 2019 was **$176.3 million**, primarily due to the Phase 3 vadadustat program, inventory, and merger liabilities[277](index=277&type=chunk) - The company's cash runway is expected to fund operations into **Q3 2020**, but accounting standards lead to "substantial doubt" about its ability to satisfy obligations for the next twelve months[284](index=284&type=chunk) [Quantitative and Qualitative Disclosures about Market Risk](index=58&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) The company's primary market risk is interest rate sensitivity on its cash and securities portfolio, with no material impact expected from a 100 basis point change - The company's primary market risk is interest rate sensitivity on its **$136.8 million** portfolio of cash and securities[333](index=333&type=chunk) - Due to the short-term nature of the investment portfolio, an immediate **100 basis point** change in interest rates is not expected to have a material effect on its fair market value[333](index=333&type=chunk) [Controls and Procedures](index=58&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls and procedures were effective as of June 30, 2019, with no material changes to internal controls during the quarter - Management concluded that as of **June 30, 2019**, the company's disclosure controls and procedures were effective at the reasonable assurance level[335](index=335&type=chunk) - No material changes were made to the company's internal control over financial reporting during the quarter ended **June 30, 2019**[336](index=336&type=chunk) Part II. Other Information [Legal Proceedings](index=59&type=section&id=Item%201.%20Legal%20Proceedings) The company is involved in multiple legal proceedings, including shareholder litigation, Auryxia patent defense, and challenges to competitor patents - The company is defending against consolidated shareholder lawsuits in Delaware related to the Keryx merger, alleging false and misleading statements in the registration statement[340](index=340&type=chunk) - Keryx received Paragraph IV certification notices for Auryxia ANDAs from multiple generic manufacturers, leading to patent infringement lawsuits and **30-month** FDA approval stays[345](index=345&type=chunk)[346](index=346&type=chunk)[347](index=347&type=chunk) - The company is actively challenging the validity of competitor FibroGen, Inc.'s HIF-related patents in various jurisdictions to ensure freedom to operate for its vadadustat program[354](index=354&type=chunk)[361](index=361&type=chunk)[362](index=362&type=chunk) [Risk Factors](index=63&type=section&id=Item%201A.%20Risk%20Factors) The company faces risks including Keryx merger integration, going concern uncertainty, commercialization, development, third-party reliance, and intellectual property litigation - The company may fail to realize anticipated Keryx merger benefits due to integration difficulties, loss of key personnel, and unforeseen liabilities[365](index=365&type=chunk) - A key financial risk is the company's history of losses and the "substantial doubt" about its ability to fund obligations for the next twelve months, potentially impeding capital raising[379](index=379&type=chunk) - Commercial success is threatened by generic competition for Auryxia, with multiple ANDAs filed, and potential competition for vadadustat from other HIF-PHI inhibitors[397](index=397&type=chunk)[423](index=423&type=chunk) - The company is heavily reliant on third parties for manufacturing Auryxia and vadadustat and for conducting clinical trials, creating supply, quality, and regulatory risks[513](index=513&type=chunk)[518](index=518&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=112&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company repurchased 55,324 shares of common stock in April 2019 to cover tax liabilities for vested RSUs, with no unregistered sales during the quarter - In **April 2019**, the company repurchased **55,324** shares of common stock at an average price of **$7.70** per share to cover tax liabilities for certain officers related to vested RSUs[632](index=632&type=chunk)[637](index=637&type=chunk) [Other Information](index=112&type=section&id=Item%205.%20Other%20Information) Akebia provided an unconditional guaranty and security interest for Keryx's $40 million SVB line of credit, following a waiver of existing defaults - On **August 7, 2019**, Akebia provided an unconditional guaranty and granted a security interest to SVB for its subsidiary Keryx's **$40 million** line of credit[634](index=634&type=chunk) - On **July 31, 2019**, SVB waived existing events of default under the Keryx loan and security agreement[640](index=640&type=chunk) [Exhibits](index=114&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Form 10-Q, including merger agreements, corporate documents, various contracts, and officer certifications

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2019 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. (NASDAQ:AKBA) Q1 2019 Results Conference Call May 9, 2019 9:00 AM ET Company Participants Kristen Sheppard - Vice President of Investor Relations John Butler - Chief Executive Officer Jason Amello - Chief Financial Officer Conference Call Participants Chris Raymond - Piper Jaffray Alex Bouilloux - Mizuho Securities Eric Joseph - JP Morgan Chad Messer - Needham & Company Ed Arce - H.C. Wainwright Robert Hazlett - BTIG Ishmael Asante - Morgan Stanley Kennen MacKay - RBC Capital Marke ...

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 incorporation or organizatio ...

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