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]

Financial Data and Key Metrics Changes - Total revenue for Q2 2021 was $52.9 million, down from $90.1 million in Q2 2020, primarily due to lower collaboration revenue following the completion of the global Phase 3 clinical development program for vadadustat [26] - Net product revenue for Auryxia increased by 7.4% to $33 million in Q2 2021 compared to $30.7 million in Q2 2020, indicating strong commercial execution despite the ongoing COVID-19 environment [27] - The net loss for Q2 2021 was $83 million, an improvement from a net loss of $175.8 million in Q2 2020, attributed to the non-recurrence of a one-time impairment charge and lower operating expenses [30] Business Line Data and Key Metrics Changes - Auryxia's performance showed a positive trend with a 7.4% increase in net product revenue, reflecting the product's favorable profile and critical nature in treating patients [27] - Research and development expenses decreased to $37.2 million in Q2 2021 from $52.8 million in Q2 2020, driven by the completion of the INNO2VATE and PRO2TECT clinical programs [29] Market Data and Key Metrics Changes - The U.S. dialysis market represents a potential $2 billion opportunity, with approximately 560,000 dialysis patients expected to grow as the population ages [10][17] - The shift towards home dialysis is accelerating, with reports indicating it is the fastest-growing segment of the dialysis population, supported by CMS payment models [19] Company Strategy and Development Direction - The company aims to position vadadustat as a first-in-class treatment for anemia due to chronic kidney disease (CKD), leveraging its existing commercial footprint and nephrology-focused sales force [9][20] - The go-to-market strategy includes exclusive distribution relationships and a focus on both dialysis and non-dialysis markets, with plans to support rapid adoption post-approval [20][21] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in vadadustat's potential and the positive feedback from the kidney community regarding its Phase 3 data published in the New England Journal of Medicine [14][15] - The company is focused on pre-launch activities for vadadustat, anticipating a successful U.S. launch in 2022, subject to regulatory approval [17][24] Other Important Information - The company ended Q2 2021 with $247 million in cash and equivalents, sufficient to fund operations for at least the next 12 months [31] - The company expects to receive milestone payments from Otsuka upon vadadustat's approval, estimated at $15 million for dialysis and $50 million for non-dialysis indications [32] Q&A Session Summary Question: Could you talk about the likelihood of the FDA convening a panel for vadadustat? - Management indicated that the FDA previously stated not to expect a panel, but they are preparing for one just in case [37] Question: Can you confirm the MACE analysis population for vadadustat? - The analysis was an intent-to-treat analysis in the safety population, following patients until the study's completion [38] Question: What are the dynamics of home dialysis and the TDAPA process? - Home dialysis is a growing segment, and the company believes vadadustat is well-positioned for rapid adoption in this market [46][47] Question: How do the reimbursement dynamics differ between dialysis and non-dialysis? - Dialysis reimbursement is contract-driven at the organization level, while non-dialysis involves typical contracting with payers and PBMs [77] Question: Are there any updates on Auryxia's litigation? - The litigation is ongoing, and updates will be provided as they become available [63]

Financial Performance - Total revenues for the three months ended June 30, 2021, were $52.913 million, a decrease of 41.2% compared to $90.142 million for the same period in 2020[24] - Net loss for the six months ended June 30, 2021, was $(152.618) million, compared to $(236.498) million for the same period in 2020, reflecting a 35.4% reduction[24] - The company reported net losses of $83.0 million for the three months ended June 30, 2021, compared to $175.8 million for the same period in 2020, indicating a reduction in losses by approximately 52.8%[178] - The operating loss for the six months ended June 30, 2021, was $144.3 million, an improvement of $88.7 million (approximately 38.0%) compared to an operating loss of $232.9 million for the same period in 2020[210] Revenue Breakdown - Product revenue, net for the six months ended June 30, 2021, was $63.367 million, up 5.3% from $59.905 million for the same period in 2020[24] - Total net product revenue from U.S. sales of Auryxia was $33.0 million for the three months ended June 30, 2021, compared to $30.7 million for the same period in 2020, representing an increase of 7.5%[44] - For the six months ended June 30, 2021, total net product revenue was $63.4 million, up from $59.9 million in the same period of 2020, reflecting a growth of 5.9%[44] - License, collaboration, and other revenue decreased to $19.95 million in Q2 2021 from $59.45 million in Q2 2020, primarily due to lower payments under collaboration agreements[202] Expenses and Liabilities - Operating loss for the three months ended June 30, 2021, was $(79.341) million, an improvement from $(173.819) million for the same period in 2020[24] - Total liabilities increased to $437.232 million as of June 30, 2021, compared to $396.521 million as of December 31, 2020[22] - Selling, general and administrative expenses increased to $41.651 million for the three months ended June 30, 2021, compared to $35.482 million for the same period in 2020[24] - Research and development expenses for the three months ended June 30, 2021, were $37.214 million, down from $52.819 million for the same period in 2020[24] Cash and Investments - Cash and cash equivalents increased to $246.992 million as of June 30, 2021, from $228.698 million as of December 31, 2020[22] - Total cash, cash equivalents, and restricted cash at the end of the period was $249.0 million, compared to $247.8 million at the end of June 30, 2020[31] - The Company raised approximately $771.4 million in net proceeds from equity sales since inception, including $53.4 million from ATM offerings in the quarter ended June 30, 2021[182] Inventory and Accounts Receivable - Inventory totaled $97.06 million as of June 30, 2021, compared to $86.31 million at the end of 2020, with raw materials at $2.06 million and work in process at $78.29 million[126] - Accounts receivable related to product sales increased to approximately $35.0 million as of June 30, 2021, compared to $21.9 million as of December 31, 2020[46] - The Company recorded a write-down of inventory of $5.4 million for the six months ended June 30, 2021[31] Future Outlook and Development - The Company expects to finance future cash needs through product revenue, public or private equity or debt transactions, and payments from collaborators[35] - The Company will require additional capital to pursue development and commercial activities related to Auryxia and vadadustat[35] - The Company anticipates ongoing decreases in collaboration revenue due to the completion of the global Phase 3 clinical development program for vadadustat[202] - The Company plans to submit a Marketing Authorization Application for vadadustat to the EMA in 2021[176] Regulatory and Collaboration Agreements - The FDA assigned a Prescription Drug User Fee Act (PDUFA) target action date of March 29, 2022, for the New Drug Application of vadadustat[34] - The collaboration agreements with Otsuka and MTPC include an aggregate commitment of approximately $573.0 million in cost-share funding, with $272.0 million received at the onset of these agreements[182] - The Company began recognizing royalty revenues from Mitsubishi Tanabe Pharma Corporation from the sale of Vafseo in August 2020[34] COVID-19 Impact - The ongoing COVID-19 pandemic has negatively impacted revenue growth, particularly due to higher hospitalization and mortality rates among kidney patients[184] - The company’s revenue growth continues to be negatively impacted by higher hospitalization and mortality rates in the kidney patient populations served due to COVID-19[212]

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 ...

Akebia Therapeutics, Inc. (NASDAQ:AKBA) Q4 2020 Earnings Conference Call February 25, 2021 9:00 AM ET Company Participants Kristen Sheppard - VP, IR John Butler - CEO, President & Director David Spellman - SVP, CFO & Treasurer Conference Call Participants Christopher Raymond - Piper Sandler & Co. Difei Yang - Mizuho Securities Antonio Arce - H.C. Wainwright & Co. David Lebowitz - Morgan Stanley Eric Joseph - JPMorgan Chase & Co. Operator Ladies and gentlemen, thank you for standing by, and welcome to Akebia ...

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, 2020 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 ...

Financial Data and Key Metrics Changes - Total revenue for Q3 2020 was $60 million, down from $92 million in Q3 2019, primarily due to lower collaborative revenue as the company advanced the vadadustat development program [17][18] - Net product revenue for Auryxia increased by 14.6% to $34.4 million compared to $30.0 million in Q3 2019, although the company remains cautious due to the impact of CMS' non-coverage decision and COVID-19 uncertainties [19] - The company reported a net loss of $60 million for Q3 2020, compared to a net loss of $54.6 million in Q3 2019 [20] Business Line Data and Key Metrics Changes - Collaborative revenue decreased as development costs for vadadustat declined, with 80% of these costs reimbursed by Otsuka [18] - Royalty revenue from the sale of vadadustat in Japan amounted to $373,000 since its launch in late August 2020, indicating early commercial performance [18] Market Data and Key Metrics Changes - The potential market opportunity for vadadustat in the US is estimated at $2 billion, targeting over 500,000 adult patients with anemia due to CKD on dialysis [10][16] - The company is also preparing for a Marketing Authorization Application in Europe in collaboration with Otsuka [10] Company Strategy and Development Direction - The company aims to position vadadustat as a new oral standard of care for treating anemia due to CKD in dialysis patients, with a focus on regulatory submission for potential US approval [9][10] - Akebia is leveraging its renal expertise and existing nephrology-focused commercial organization to support a strong launch of vadadustat upon approval [11][12] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the INNO2VATE results, which they believe provide a straightforward path to advance vadadustat towards potential approval [9] - The company is focused on executing pre-commercialization activities and ensuring readiness for a strong launch, while also maintaining a robust publication plan to support vadadustat's potential [14][15] Other Important Information - The company ended Q3 2020 with cash, cash equivalents, and available-for-sale securities of $269.3 million, which is expected to fund operations beyond the anticipated US launch of vadadustat [21] Q&A Session Summary Question: Concerns about FDA acceptance of non-pre-specified analysis - Management clarified that the continuous age variable was pre-specified and that they are confident in the analysis presented to the FDA [24][25] Question: Plans for regulatory approval using a Priority Review Voucher - The company still has the option to use the PRV, but discussions with partners are ongoing [28][29] Question: Filing for NDAs for dialysis and non-dialysis patients - Management confirmed that there will be one NDA that includes both populations, and they are planning to file as early as possible next year [32] Question: Additional studies required by the FDA - No indication was given that additional studies would be necessary, and management expressed confidence in the data presented [46][47] Question: Differences in cardiovascular events between US and non-US patients - Management noted that the difference in MACE was driven by patients treated to a higher hemoglobin target outside the US, and emphasized that treating to a target of 10 to 11 does not increase cardiovascular risk [54][55]

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, 2020 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) | --- | --- | |-- ...