Akebia Therapeutics, Inc. · NASDAQ:AKBA
Akebia Therapeutics — 39th Annual J.P. Morgan Healthcare Conference (January 2021)
16 slides from Akebia Therapeutics's conference presentation, Jan 12, 2021
Slide 1: Bettering the Lives of People Touched by Kidney Disease
Exhibit 99.1 Akebia THERAPEUTICS BETTERING THE LIVES th OF PEOPLE TCHES 39* Annual J.P. Morgan BY KIDNEY DISEASE Healthcare Conference January 13, 2021 John P. Butler, President and CEO (Nasdaq: AKBA)
Slide 2: Forward-looking statements
Statements in this presentation regarding Akebia’s strategy, plans, prospects, populations; the timing of or likelihood of regulatory filings and approvals, including labeling or expectations, beliefs, intentions and goals are forward-looking statements within the meaning of other restrictions, such
Slide 3: Our History: Innovation and Potential
OUR HISTORY Innovation and Potential ® Auryxia AKEBIA TODAY 2021 F O RW ARD MOME N T U M Auryxia In the U.S., vadadustat is an investigational HIF PH inhibitor that is not approved by the FDA. 3 3OUR HISTORY Innovation and Potential ® Auryxia AKEBIA TODAY 2021 F O RW ARD MOME N T U M Auryxia In the
Slide 4: Akebia Today: 2021 Forward Momentum
AKEBIA TODAY 2021 F OR WA R D M OM E N TUM V AD AD U S T A T ADOPTION OF VADADUSTAT IN JAPAN FOR BOTH DIALYSIS AND NON-DIALYSIS AN ORAL HIF-PH INHIBITOR FOR THE ADULT PATIENTS TREATMENT OF ANEMIA DUE TO CHRONIC KIDNEY DISEASE (CKD) NEPHROLOGY FOCUSED COMMERCIAL TEAM IN THE U.S. WITH AURYXIA® ü PHASE
Slide 5: Burden of Disease, Unmet Needs, Clinical Impact
BURDEN OF DISEASE UNMET NEEDS CLINICAL IMPACT >500K Anemia due to CKD can contribute to PEOPLE IN THE U.S. risk of ESKD, cardiovascular (CV) ON DIALYSIS WITH disease, stroke, cognitive impairment, 2 ANEMIA DUE TO CKD CV-related complications and death ESKD is End Stage Kidney Disease. ESA is erythro
Slide 6: Lead Investigational Product Candidate: Vadadustat
L E AD I N VE S T I G AT I O N AL V AD ADU S TAT P R O D U C T CA N D ID AT E INNOVATIVE CONVENIENT ORAL ROBUST CLINICAL COMMERCIAL MoA DOSING RESULTS BREADTH An oral hypoxia-inducible Potential oral alternative to Positive Phase 3 clinical Strong commercial factor prolyl hydroxylase injectable ESAs
Slide 7: Robust Clinical Data: Vadadustat
R O B U S T CLIN ICA L D ATA V AD ADU S TAT An oral HIF-PH inhibitor designed to stimulate endogenous EPO production : Phase 3 Program ü Demonstrated efficacy and cardiovascular safety of vadadustat for the treatment of anemia due to CKD in POTENTIAL NEW ORAL adult patients on dialysis STANDARD OF C
Slide 8: Mean Change from Baseline in HGB Levels: Dialysis Dependent CKD Patients
Mean Change from Baseline in HGB Levels: Dialysis Dependent CKD Patients V AD AD U S TAT 1 INNO VATE Phase 3 Conversion (3,554 Prevalent DD-CKD Patients) 2 G L O B A L PHASE 3 Vadadustat efficacy demonstrated in two P R OG R A M Phase 3 studies: ü Achieved primary and key secondary efficacy endpoint
Slide 9: Vadadustat cardiovascular safety demonstrated across two Phase 3 studies
Vadadustat cardiovascular safety demonstrated across two V AD AD U S TAT Phase 3 studies: G L O B A L ü Achieved primary and key secondary safety endpoints PHASE 3 Primary and Key Secondary Safety Endpoints: Dialysis Dependent CKD Patients P R OG R A M 1 INNO VATE Phase 3 Studies (Prevalent and Inci
Slide 10: Summary of Treatment Emergent Adverse Events (TEAEs)
Summary of Treatment Emergent Adverse Events (TEAEs) V AD AD U S TAT and TEAEs Occurring in >10% of Patients in Either Treatment Group G L O B A L 1 INNO VATE Phase 3 Studies (Prevalent and Incident DD-CKD Patients) 2 PHASE 3 P R OG R A M Two Phase 3 Studies 3,923 Adult Patients on Dialysis Source:
Slide 11: Advancing Vadadustat for Patients on Dialysis: 2021 Milestones
ADVANCING VADADUSTAT FOR PATIENTS ON DIALYSIS 2021 INNO VATE Data 2 Positive Top-line Presented at ASN Completed Pre-NDA MI LE S T O N E S INNO VATE Data 2 Meeting with FDA Kidney Week Reported • Publication of Inno2vate Data in Peer Reviewed Journal; Expected in 2021 • U.S. NDA Submission to FDA Ex
Slide 12: High Growth Opportunity: Vadadustat in U.S. Dialysis Market
H I GH GR O W TH O PPO R TU N I TY V AD ADU S TAT I N U . S. DI ALY SI S MARK E T Unmet clinical needs of CKD patients on dialysis $2 Billion Approx. 556K U.S. patients on dialysis; 90% Estimated U.S. 1 treated for anemia due to CKD Dialysis Market 2 Opportunity Unique market dynamics with dialysis
Slide 13: Well Positioned Upon Vadadustat Approval and Launch
WEL L P OS I T I ON ED U P ON V AD ADU S TAT A P P R O VA L A N D LA UN C H Go-to-market ü Convenient oral dosing for all dialysis patients with unique opportunity to support and grow U.S. home dialysis strategy positions market vadadustat for 1 ü Favorable reimbursement model with TDAPA potential r
Slide 14: Future Revenue Structures: Vadadustat
FU T U RE RE VE N U E S T RU C T U RE S V AD ADU S TAT In addition to potential regulatory and commercial milestone payments, Akebia will receive the following on net sales of vadadustat, subject to approval: Akebia to share profit equally on all U.S. sales of vadadustat with Otsuka (50/50) • Akebia
Slide 15: Creating Future Value for Akebia: Strategic Objectives
1 3 • Ongoing investigator-sponsored • U.S. NDA submission to FDA clinical study by UTHealth expected as early as possible in 2021 2021 Creating evaluating vadadustat as • EU MAA submission expected in 2021 potential therapy to prevent and lessen the severity of acute Future Value for respiratory di
Slide 16: Thank You | Questions?
Akebia THERAPEUTICS THANK YOU | QUESTIONS?
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