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 June 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from __________to__________ Commission File Number 001-36352 AKEBIA THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware 20-8756903 (S ...

Akebia Therapeutics, Inc. (NASDAQ:AKBA) Q2 2023 Earnings Conference Call August 25, 2023 9:00 AM ET Company Participants Mercedes Carrasco - Senior Director of Corporate Communications and Investor Relations John Butler - President and Chief Executive Officer Ellen Snow - Senior Vice President, Chief Financial Officer, Treasurer Steven Burke - Senior Vice President, Research & Development and Chief Medical Officer Conference Call Participants Allison Bratzel - Piper Sandler Ed Arce - H.C. Wainwright Julian ...

Akebia Therapeutics, Inc. (NASDAQ:AKBA) Q1 2023 Earnings Conference Call May 8, 2023 8:30 AM ET Company Participants Mercedes Carrasco - Senior Director of Investor and Corporate Communications John Butler - Chief Executive Officer Dave Spellman - Chief Financial Officer Conference Call Participants Allison Bratzel - Piper Sandler Thomas Yip - H.C. Wainwright Operator Good day, and thank you for standing by. Welcome to the Akebia's First Quarter 2023 Financial Results Conference Call. At this time, all part ...

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, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from __________to__________ Commission File Number 001-36352 AKEBIA THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware 20-8756903 ( ...

Akebia Therapeutics, Inc. (NASDAQ:AKBA) Q4 2022 Earnings Conference Call March 9, 2023 8:30 AM ET Company Participants Mercedes Carrasco - Investor Relations and Corporate Communications John Butler - President and Chief Executive Officer David Spellman - Senior Vice President, Chief Financial Officer Conference Call Participants Allison Bratzel - Piper Sandler Ed Arce - H.C. Wainwright & Co. Robert Hazlett - BTIG Operator Good day, ladies and gentlemen. Thank you for standing by and welcome to Akebia's Fou ...

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, 2022 (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) 245 First Street, Cambridge, MA 02142 (Address of principal executive offices) (Zip Code) Delaware 20-8756903 (I.R.S. Employer Identification No.) Registrant's telephone ...

Akebia Therapeutics, Inc. (NASDAQ:AKBA) Q3 2022 Results Conference Call November 3, 2022 4:30 PM ET Company Participants Mercedes Carrasco - Senior Director of Corporate Communications John Butler - CEO, President and Director David Spellman - Senior VP, CFO and Treasurer Conference Call Participants Allison Bratzel - Piper Sandler Thomas Yip - H.C. Wainwright Operator Good day and thank you for standing by. Welcome to the Akebia's Third Quarter 2022 Financial Results Conference Call. At this time, all part ...

Akebia Therapeutics Inc. (NASDAQ:AKBA) Q2 2022 Earnings Conference Call August 4, 2022 4:30 PM ET Company Participants Mercedes Carrasco - Senior Director of Corporate Communications John Butler - CEO, President and Director Steve Burke - Senior VP of Research and Development and Chief Medical Officer David Spellman - Senior VP, CFO and Treasurer Conference Call Participants Allison Bratzel - Piper Sandler Operator Hello, and welcome to the Akebia Second Quarter 2022 Financial Results. [Operator Instruction ...

Part I. Financial Information This section presents Akebia Therapeutics, Inc.'s unaudited condensed consolidated financial statements, management's discussion, market risk disclosures, and internal controls [Item 1. Financial Statements](index=7&type=section&id=Item%201.%20Financial%20Statements) This section presents Akebia Therapeutics, Inc.'s unaudited condensed consolidated financial statements, highlighting increased Q2 revenues, a shift to net income, and management's going concern doubt - Management concluded **substantial doubt exists about the Company's ability to continue as a going concern** for at least twelve months due to uncertainties in funding its operating plan[32](index=32&type=chunk) Condensed Consolidated Balance Sheet Data (in thousands) | Account | June 30, 2022 | December 31, 2021 | | :--- | :--- | :--- | | Cash and cash equivalents | $143,893 | $149,800 | | Total current assets | $304,163 | $272,010 | | Total assets | $521,804 | $525,550 | | Total current liabilities | $233,680 | $256,493 | | Total liabilities | $459,504 | $449,094 | | Total stockholders' equity | $62,300 | $76,456 | Condensed Consolidated Statements of Operations (in thousands, except per share data) | Metric | Three Months Ended June 30, 2022 | Three Months Ended June 30, 2021 | Six Months Ended June 30, 2022 | Six Months Ended June 30, 2021 | | :--- | :--- | :--- | :--- | :--- | | Total revenues | $126,759 | $52,913 | $188,458 | $105,217 | | Operating income (loss) | $33,902 | $(79,341) | $(24,591) | $(144,277) | | Net income (loss) | $29,276 | $(83,038) | $(33,145) | $(152,618) | | Net income (loss) per share - basic | $0.16 | $(0.51) | $(0.18) | $(0.97) | Condensed Consolidated Statements of Cash Flows (in thousands) | Cash Flow Activity | Six Months Ended June 30, 2022 | Six Months Ended June 30, 2021 | | :--- | :--- | :--- | | Net cash used in operating activities | $(52,280) | $(133,887) | | Net cash (used in) provided by investing activities | $(114) | $39,941 | | Net cash provided by financing activities | $47,536 | $111,846 | | (Decrease) increase in cash | $(4,858) | $17,900 | [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=35&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses financial performance, including a 32% Auryxia revenue increase, the Otsuka collaboration termination, and a 42% workforce reduction, while acknowledging ongoing going concern doubt - The FDA issued a **Complete Response Letter (CRL) for vadadustat's NDA** on March 29, 2022, preventing approval for anemia due to CKD, with next steps for U.S. dialysis patient approval under review[159](index=159&type=chunk) - Following the vadadustat CRL, Akebia implemented a **42% workforce reduction** in April 2022, incurring a **$14.5 million restructuring charge** in Q2 2022 to refocus on Auryxia and its development portfolio[164](index=164&type=chunk)[197](index=197&type=chunk) Comparison of Results of Operations (in thousands) | Line Item | Three Months Ended June 30, 2022 | Three Months Ended June 30, 2021 | Six Months Ended June 30, 2022 | Six Months Ended June 30, 2021 | | :--- | :--- | :--- | :--- | :--- | | Product revenue, net | $43,703 | $32,959 | $85,151 | $63,367 | | License, collaboration and other revenue | $83,056 | $19,954 | $103,307 | $41,850 | | Research and development | $26,027 | $37,214 | $69,860 | $77,825 | | Selling, general and administrative | $32,807 | $41,651 | $77,134 | $82,979 | | Restructuring | $14,531 | $0 | $14,531 | $0 | | Net income (loss) | $29,276 | $(83,038) | $(33,145) | $(152,618) | - The **termination of the Otsuka collaboration** on June 30, 2022, resulted in **$81.1 million in Q2 2022 collaboration revenue**, including a **$55.0 million termination payment**[191](index=191&type=chunk) - As of June 30, 2022, cash and cash equivalents totaled **$143.9 million**, with management's belief in sufficient funding contingent on external cost avoidance and contract amendments, contributing to **going concern uncertainty**[208](index=208&type=chunk)[213](index=213&type=chunk) [Item 3. Quantitative and Qualitative Disclosures about Market Risk](index=50&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) The company faces market risks from interest rate fluctuations on cash and foreign currency exchange rates, particularly for Japanese yen-denominated royalty payments - Primary market risks include **interest rate risk** on **$143.9 million in cash and cash equivalents** and **foreign exchange risk** from Japanese yen-denominated royalty payments[229](index=229&type=chunk)[230](index=230&type=chunk) - A **5.0% change in the JPY/USD exchange rate** would have impacted revenues by approximately **$0.1 million** for the six months ended June 30, 2022[230](index=230&type=chunk) [Item 4. Controls and Procedures](index=50&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were ineffective as of June 30, 2022, due to a material weakness in internal control over inventory - Management concluded that **disclosure controls and procedures were not effective** as of June 30, 2022, due to a **material weakness in internal control over financial reporting**[232](index=232&type=chunk) - The material weakness pertains to **ineffective inventory controls**, specifically regarding reconciliation review, costing validation, excess and obsolete reserve assessment, and physical count verification[234](index=234&type=chunk) - Remediation efforts for the material weakness are ongoing, but it was **not considered remediated** as of June 30, 2022[234](index=234&type=chunk)[235](index=235&type=chunk) Part II. Other Information This section details Akebia Therapeutics, Inc.'s legal proceedings, significant risk factors, and other required disclosures [Item 1. Legal Proceedings](index=53&type=section&id=Item%201.%20Legal%20Proceedings) Akebia is engaged in extensive intellectual property litigation against FibroGen for vadadustat and is defending against stockholder class-action lawsuits related to the 2018 Keryx merger - The company is engaged in **extensive patent litigation against FibroGen, Inc.** across Europe, Japan, and the UK, challenging HIF-related patent validity with mixed results and ongoing appeals[238](index=238&type=chunk)[244](index=244&type=chunk)[246](index=246&type=chunk) - Akebia is defending against **putative class-action lawsuits** from former Keryx stockholders alleging misleading disclosures in the 2018 merger registration statement regarding vadadustat's safety and commercial prospects[252](index=252&type=chunk)[254](index=254&type=chunk) - A federal securities class action filed in March 2022 alleges **materially false and misleading statements** regarding the Phase 3 PRO2TECT clinical trial and vadadustat's commercial viability[257](index=257&type=chunk) [Item 1A. Risk Factors](index=56&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant risks including historical losses, going concern doubt, Auryxia's commercial dependency, FDA CRL for vadadustat, and internal control weaknesses - The company has a history of **significant losses**, with a **$1.5 billion accumulated deficit** as of June 30, 2022, and uncertain profitability, exacerbated by the **FDA's CRL for vadadustat**[261](index=261&type=chunk)[262](index=262&type=chunk) - **Substantial doubt exists about the company's ability to continue as a going concern**, driven by reliance on external cost-saving measures and loan agreement covenants regarding going concern qualification[279](index=279&type=chunk)[280](index=280&type=chunk)[282](index=282&type=chunk) - The business is **substantially dependent on Auryxia's commercial success**, facing risks from competition, pricing pressure, and an adverse Medicare coverage decision for its IDA indication[316](index=316&type=chunk)[328](index=328&type=chunk) - The **FDA's CRL for vadadustat** cited safety concerns, including failure to meet a primary safety endpoint in non-dialysis patients, increased thromboembolic risk in dialysis patients, and potential drug-induced liver injury[368](index=368&type=chunk)[381](index=381&type=chunk) - A **material weakness in internal control over financial reporting** persists, specifically related to the inventory process, impacting its completeness, accuracy, and valuation[514](index=514&type=chunk)[515](index=515&type=chunk) - The **42% workforce reduction** implemented in April/May 2022 following the CRL may not yield anticipated savings and could disrupt operations, including Auryxia commercialization[509](index=509&type=chunk)[510](index=510&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=107&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales of equity securities during the quarter ended June 30, 2022 - **No unregistered sales of equity securities** occurred during the three months ended June 30, 2022[566](index=566&type=chunk) [Item 5. Other Information](index=107&type=section&id=Item%205.%20Other%20Information) The company reported no other information for this item during the period - The company reported **no information** for this item[566](index=566&type=chunk) [Item 6. Exhibits](index=108&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Form 10-Q, including corporate governance documents, various agreements, and officer certifications - Key exhibits include the **Termination and Settlement Agreement with Otsuka Pharmaceutical Co. Ltd.** and the **Second Amendment and Waiver to the loan agreement with BioPharma Credit PLC**[568](index=568&type=chunk)