Akebia Therapeutics, Inc. · NASDAQ:AKBA
Akebia Therapeutics — Investor Presentation (September 2021)
22 slides from Akebia Therapeutics's investor presentation, Sep 9, 2021
Slide 1: Bettering the Lives of People Impacted by Kidney Disease
BETTERING THE LIVES OF PEOPLE IMPACTED BY KIDNEY DISEASE John P. Butler, President and CEO (Nasdaq: AKBA) September 2021 Exhibit 99.1
Slide 2: Cautionary Note on Forward-Looking Statements
CAUTIONARY NOTE ON FORWARD-LOOKING STATEMENTS Statements in this presentation regarding Akebia’s strategy, plans, prospects, expectations, beliefs, intentions and goals are forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, as amended, and inc
Slide 3: Driving Momentum: Our History
driving MOMENTUM 2020 2021 Positive Phase 3 Top-line Data Reported May 2020 October 2020 Global Phase 3 Data Presented at ASN Kidney Week Pre-NDA Meeting with FDA November 2020 Global Phase 3 Program Methods Manuscripts Published in Nephrology Dialysis Transplantation & American Heart Journal OUR HI
Slide 4: Vadadustat for Anemia Due to CKD Under FDA Review
HIF-PH or HIF-PHI is hypoxia-inducible factor prolyl hydroxylase inhibitor. NDA is New Drug Application. PDUFA is Prescription Drug User Fee Act. 1. In June 2020, Akebia announced an investigator-sponsored clinical study by UTHealth of vadadustat for ARDS. This study is being conducted under an Inve
Slide 5: Anemia Due to CKD: Unmet Needs
ESKD is End Stage Kidney Disease. ESA is erythropoiesis-stimulating agent. EPO is erythropoietin. Sources: 1 . Stauffer et al, PLOSONE, 2014. 2 2020 USRDS Annual Data Report: https://adr.usrds.org/2020/reference-tables. BURDEN OF DISEASE Quality of life: fatigue, weakness, dizziness, shortness of br
Slide 6: Vadadustat: Potential First-in-Class Oral HIF-PHI
In the U.S., vadadustat is an investigational HIF- PH inhibitor that is not approved by the FDA. An oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) designed to stimulate endogenous EPO production; Based on Nobel Prize winning science Positioned to be potential oral standard of c
Slide 7: Potential New Oral Standard of Care for Anemia Due to CKD
Vadadustat is not approved by the FDA. POTENTIAL NEW ORAL STANDARD OF CARE FOR ANEMIA DUE TO CKD An oral HIF-PH inhibitor designed to stimulate endogenous EPO production CLINICAL DATA HAS SHOWN THAT VADADUSTAT: Increased hemoglobin in predictable and controlled manner Minimized hemoglobin overshoots
Slide 8: Vadadustat Dialysis Phase 3 Results
Positive global Phase 3 data demonstrated the efficacy and cardiovascular safety of vadadustat compared to darbepoetin alfa in adult patients with anemia due to CKD on dialysis, including prevalent and incident patients. Met Primary Efficacy Endpoint: Mean Change from Baseline in HGB Levels: Dialysi
Slide 9: Vadadustat Non-Dialysis Phase 3 Results
VADADUSTAT Positive global Phase 3 data demonstrated the efficacy of vadadustat compared to darbepoetin alfa in adult patients with anemia due to CKD not on dialysis; however, vadadustat did not meet the primary safety (MACE) endpoint of the PRO2TECT studies. (Prevalent and Incident Populations) Sou
Slide 10: Peer Reviewed Publications of Global Phase 3 Data
23 VADADUSTAT PEER REVIEWED PUBLICATIONS OF GLOBAL PHASE 3 DATA AND RESULTS Safety and Efficacy of Vadadustat for Anemia in Patients Undergoing Dialysis April 2021 Vadadustat in Patients with Anemia and Non–Dialysis-Dependent CKD April 2021 ASN Webcast October 23, 2020 ASN Presentation October 23, 2
Slide 11: Vadadustat U.S. Dialysis Market
$2 Billion Estimated U.S. Dialysis Market Opportunity2 Sources: 1. 2020 USRDS Annual Data Report: https://adr.usrds.org/2020/reference-tables. 2 Based on internal estimates and industry reports estimating ESA pricing. Unique market dynamics; Dialysis center clinical protocols Approx. 556K U.S. patie
Slide 12: Secure U.S. approval *Pursuant to the Vifor Amended Agreement, Akebia granted Vifor (International) Ltd.
Secure U.S. approval *Pursuant to the Vifor Amended Agreement, Akebia granted Vifor (International) Ltd. (“Vifor Pharma”) an exclusive license to sell vadadustat to Fresenius Kidney Care and to certain other third party dialysis organizations in the U.S., upon approval of vadadustat by the FDA, the
Slide 13: *Pursuant to the Vifor Amended Agreement, Akebia granted Vifor (International) Ltd. (“Vifor Pharma”) an
*Pursuant to the Vifor Amended Agreement, Akebia granted Vifor (International) Ltd. (“Vifor Pharma”) an exclusive license to sell vadadustat to Fresenius Kidney Care and to certain other third party dialysis organizations in the U.S., upon approval of vadadustat by the FDA, the earlier of reimbursem
Slide 14: *Pursuant to the Vifor Amended Agreement, Akebia granted Vifor (International) Ltd. (“Vifor Pharma”) an
*Pursuant to the Vifor Amended Agreement, Akebia granted Vifor (International) Ltd. (“Vifor Pharma”) an exclusive license to sell vadadustat to Fresenius Kidney Care and to certain other third party dialysis organizations in the U.S., upon approval of vadadustat by the FDA, the earlier of reimbursem
Slide 15: Advancing Vadadustat for Potential Additional Indications: ARDS
ADVANCING VADADUSTAT FOR POTENTIAL ADDITIONAL INDICATIONS Ongoing investigator-sponsored clinical study by evaluating vadadustat as potential therapy to prevent and lessen the severity of acute respiratory distress syndrome (ARDS) Randomized double-blind, placebo-controlled study, up to 400 adult pa
Slide 16: Leverage Kidney Focused Portfolio to Pursue Expansion Opportunities
Establish vadadustat as standard of care for anemia due to CKD Advance vadadustat for ARDS1 and other indications; Leverage HIF technology Expand into other kidney disease areas with praliciguat2 and through internal research FUTURE OPPORTUNITIES LEVERAGE KIDNEY FOCUSED PORTFOLIO TO PURSUE EXPANSION
Slide 17: United States Profit Sharing with Otsuka
United States Akebia to share profit equally on all U.S. sales of vadadustat with Otsuka (50/50) Akebia and Otsuka to share (50/50) a majority of the profit from sales of vadadustat to Fresenius Kidney Care (FKC) and certain other third party dialysis organizations1 1. Pursuant to the Vifor Amended
Slide 18: Auryxia
Auryxia is the only iron-based, non-calcium, non-chewable phosphate binder indicated for the treatment of hyperphosphatemia in adult patients with CKD on dialysis. FDA approved in two indications: 18 Iron Deficiency Anemia (IDA) in patients with CKD not on dialysis Sources: 1. 2020 USRDS Annual Data
Slide 19: Strategic Focus and Anticipated 2021 Milestones
Ongoing investigator-sponsored clinical study by UTHealth evaluating vadadustat for ARDS U.S. NDA filed with FDA; PDUFA date: March 29, 2022 Phase 3 results published in New England Journal of Medicine Leverage Auryxia as commercial foundation for vadadustat in CKD In-licensed praliciguat, June 2021
Slide 20: Sources and Phase 3 Study Appendix
Sources: 1. K.-U. Eckardt, et al. Global Phase 3 Clinical Trials of Vadadustat for Treatment of Anemia in Patients With Dialysis-Dependent Chronic Kidney Disease. Presented at: American Society of Nephrology Kidney Week; October 22, 2020. 2. K.-U. Eckardt, et al. Safety and Efficacy of Vadadustat fo
Slide 21: Important Safety Information
Important Safety Information CONTRAINDICATION AURYXIA® (ferric citrate) is contraindicated in patients with iron overload syndromes, e.g., hemochromatosis WARNINGS AND PRECAUTIONS Iron Overload: Increases in serum ferritin and transferrin saturation (TSAT) were observed in clinical trials with AURYX
Slide 22: Thank You Questions?
THANK YOU QUESTIONS?
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