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) | --- | --- | |-- ...

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, 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) Delaware 20-8756903 (S ...

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, 2020 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) Q1 2020 Earnings Conference Call May 5, 2020 8:30 AM ET Company Participants Kristen Sheppard - SVP, IR John Butler - President and CEO Steven Burke - Chief Medical Officer Jason Amello - CFO Conference Call Participants Allison Bratzel - Piper Sandler Eric Joseph - JPMorgan Difei Yang - Mizuho Securities Bert Hazlett - BTIG Chad Messer - Needham & Company Ed Arce - H.C. Wainwright David Lebowitz - Morgan Stanley Kennen MacKay - RBC Capital Markets Operator Good morni ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Securities registered pursuant to Section 12(g) of the Act: None 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, 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. (Exact name of registrant as specified in its charter) Delaware 20-875 ...

Akebia Therapeutics, Inc. (NASDAQ:AKBA) Q4 2019 Earnings Conference Call March 10, 2020 9:00 AM ET Company Participants Kristen Sheppard - Vice President, Investor Relations John Butler - President and Chief Executive Officer Jason Amello - Chief Financial Officer Conference Call Participants Chris Raymond - Piper Sandler Eric Joseph - JPMorgan Difei Yang - Mizuho David Lebowitz - Morgan Stanley Ed Arce - H.C. Wainwright Bert Hazlett - BTIG Kennen MacKay - RBC Capital Markets Operator Ladies and gentlemen t ...