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)

Akebia Therapeutics, Inc. (NASDAQ:AKBA) Q1 2022 Earnings Conference Call May 9, 2022 4:30 PM ET Company Participants Mercedes Carrasco - Director, Corporate Communications John Butler - CEO, President & Director David Spellman - SVP, CFO & Treasurer Conference Call Participants Allison Bratzel - Piper Sandler & Co. Mara Goldstein - Mizuho Securities Antonio Arce - H.C. Wainwright & Co. Rohit Bhasin - Needham Operator Ladies and gentlemen, thank you for standing by, and welcome to the Akebia First Quarter 20 ...

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, 2021 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) (State or other jurisdiction of incorporatio ...

Financial Data and Key Metrics Changes - Total revenue for Q3 2021 was $40.8 million, down from $60 million in Q3 2020, primarily due to lower collaboration revenues related to vadadustat [17][19] - Auryxia net product revenue increased by 7% to $36.8 million in Q3 2021 compared to $34.4 million in Q3 2020, reflecting a higher net revenue per pill and some one-time true-ups [17][19] - Net loss for Q3 2021 was $59.5 million, slightly improved from a net loss of $60 million in Q3 2020 [19] Business Line Data and Key Metrics Changes - Auryxia continues to show revenue growth despite challenges in the market due to COVID-19, with the team adapting to a hybrid approach for customer engagement [16][44] - The company is preparing for the launch of vadadustat, which is expected to address the unmet needs of over half a million adult patients on dialysis, representing a potential $2 billion market opportunity in the US alone [12][14] Market Data and Key Metrics Changes - There are approximately 560,000 dialysis patients in the US, with about 90% currently treated with erythropoiesis-stimulating agents (ESAs) [10] - The market opportunity for vadadustat is larger than previously anticipated, with the potential to be the first-in-class HIF-PHI in the US [9][55] Company Strategy and Development Direction - The company aims to establish vadadustat as the new oral standard of care for anemia due to CKD, focusing on both dialysis and non-dialysis markets [14][32] - Akebia is investing in pre-commercialization activities to differentiate vadadustat from current standards of care and ensure broad access for patients [15][16] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming PDUFA date for vadadustat, highlighting the potential for approval as a pivotal catalyst for the company [7][12] - The management team is optimistic about the market's reception of vadadustat, especially following positive feedback from the nephrology community regarding recent data presentations [23][24] Other Important Information - The company ended Q3 2021 with $207.2 million in cash and equivalents, which is expected to fund operations for at least the next 12 months [19][20] - Akebia has established a strong presence in the kidney community with Auryxia, which is expected to support the successful launch of vadadustat if approved [16] Q&A Session Summary Question: Feedback from the nephrology community on vadadustat - Management noted that nearly 60% of physicians are likely to prescribe HIF-PHIs, indicating positive reception of vadadustat data [23][24] Question: Update on potential FDA panel - The company is currently the only HIF-PHI in front of the FDA and has not received indications for a panel, but remains prepared for one [28] Question: Readiness for vadadustat launch - Management confirmed that they have adequate supply and a strong commercial team in place for a successful launch [42][56] Question: Growth drivers for Auryxia - Recent growth in Auryxia revenue is attributed to a resilient team adapting to market challenges, despite overall market difficulties [44][45] Question: Medicare Part D reimbursement for Auryxia - The company is actively seeking legislative solutions for IDA coverage while continuing to grow the hyperphosphatemia market [50][51]

Akebia Therapeutics, Inc. (NASDAQ:AKBA) Q2 2021 Results Conference Call August 5, 2021 9:00 AM ET Company Participants Kristen Sheppard - SVP, IR John Butler - CEO David Spellman - CFO Dr. Steven Burke - Chief Medical Officer Dell Faulkingham - Chief Commercial Officer Conference Call Participants Ally Bratzel - Piper Sandler Bert Hazlett - BTIG Eric Joseph - JP Morgan Ed Arce - H.C. Wainwright Operator Good day, ladies and gentlemen, and welcome to Akebia Therapeutics Second Quarter of 2021 Financial Resul ...

Akebia Therapeutics, Inc. (NASDAQ:AKBA) Q1 2021 Earnings Conference Call May 10, 2021 9:00 AM ET Company Participants Kristen Sheppard - Senior Vice President, Investor Relations John Butler - Chief Executive Officer David Spellman - Chief Financial Officer Conference Call Participants Ally Bratzel - Piper Sandler Alethia Young - Cantor Fitzgerald Difei Yang - Mizuho Securities Bert Hazlett - BTIG David Lebovitz - Morgan Stanley Ed Arce - H.C. Wainwright Operator Good day, ladies and gentlemen and welcome t ...