Akebia Therapeutics, Inc. · NASDAQ:AKBA
Akebia Therapeutics — Investor Presentation (June 2019)
26 slides from Akebia Therapeutics's investor presentation, Jun 4, 2019
Slide 1: Akebia Therapeutics: Dedicated to Advancing Care for Patients with Kidney Disease
Akebia Therapeutics DEDICATED TO ADVANCING CARE FOR PATIENTS WITH KIDNEY DISEASE
Slide 2: Cautionary Note on Forward-Looking Statements
CAUTIONARY NOTE ON FORWARD - LOOKING STATEMENTS Statements in this presentation regarding Akebia’s strategy, plans, prospects, required to develop and commercialize Akebia’s product candidates and operate expectations, beliefs, intentions or goals are forward-looking statements within the company, a
Slide 3: Fully Integrated Biotech Company Focused On Kidney Disease
Akebia Therapeutics Fully Integrated Biotech Company Focused On Kidney Disease John P. Butler, President and CEO
Slide 4: FDA-Approved Products, Cash Runway and Clinical Catalysts
FDA – APPROVED Product revenue in two FDA- Expect cash resources1 to fund approved indications with operations into Q3 2020. $168 million substantial growth potential cash position2. Multiple clinical catalysts over next 12 to 18 Experienced nephrology focused months for Phase 3 product candidate wi
Slide 5: Significant Strategic Partnerships
Akebia Therapeutics Significant Strategic Partnerships
Slide 6: Our Vision
OUR VISION Improve the Health of Patients with Kidney Disease through Better Diseased Management and Novel Therapeutics
Slide 7: Development Program in CKD: Dialysis and Non-Dialysis
Akebia Therapeutics CKD On Dialysis HYPERPHOSPHATEMIA IRON DEFICIENCY ANEMIA IN DIALYSIS FDA approved in two indications IN NON-DIALYSIS ANEMIA DUE TO ANEMIA DUE TO CKD IN CKD IN DIALYSIS In global Phase 3 with read-outs NON-DIALYSIS beginning 2019 DEVELOPMENT PROGRAM
Slide 8: Auryxia
Auryxia Akebia Therapeutics
Slide 9: Auryxia Opportunity in the Hyperphosphatemia Market
Dialysis AURYXIA OPPORTUNITY IN THE HYPERPHHPSPHATEMIA MARKET: Patient Dissatisfaction With Standard OF Care And Nephrologist Positive Perception
Slide 10: Nephrologist Survey on Phosphate Binder Preference
Nephrologists When Asked: anticipate “If you yourself (nephrologist) prescribing had to take a phosphate binder, which would you choose?” 3 more Auryxia 6 2 Chose Auryxia months from now SOURCES: 1 Spherix Global Insights Bone and Mineral Metabolism, quantitative market research survey, Q4 2018, n=1
Slide 11: Dialysis Binder Prescription Share and KDIGO Guideline
Dialysis Binder Prescription Share (YE’17) “In adult patients with CKD G3a-G5D “As a result of KDIGO CKD-MBD guideline Other update, I anticipate decreasing my use of receiving phosphate-lowering treatment, we suggest restricting dose ca-based binders in my dialysis patients3” Calcium + of calcium-b
Slide 12: Auryxia: Solid Performance
AURYXIA: SOLID PERFORMANCE Total Pro-forma Unaudited Total Prescriptions Market Share Full-Year Auryxia Sales In 2018 Increased 72% To Increased Market Share In 2017 Source: IQVIA NPA, Dialysis SP TRx Data *2018 Annual Auryxia revenue is pro-forma unaudited combined full-year Auryxia sales including
Slide 13: Auryxia: Improving Q2 FY19 Outlook
AURYXIA: IMPROVING Q2FY19 OUTLOOK Highest prescription Highest prescription demand in first demand in first of any quarter since of any quarter since Auryxia launch Auryxia launch Well positioned to Drive Continued Growth in 2019
Slide 14: Auryxia Opportunity in the Iron Deficiency Anemia Market
Non-Dialysis AURYXIA OPPORTUNITY IN THE IRON DEFICIENCY ANEMIA (IDA) MARKET:
Slide 15: Nephrologist Survey on Auryxia in Iron Deficiency Anemia
Ferrous sulfate is Ferrous sulfate and Auryxia is significantly significantly better (1, 2) Auryxia are similar (3) better (4, 5) Very likely to use after traditional oral iron failure GI Tolerability* 4% 20% 76% Disclaimer: Not Very likely to use in place of traditional oral iron Based Improvement
Slide 16: Investigator-Sponsored Study of Ferric Citrate Presented at ERA-EDTA 2018
Non-Dialysis DR. GEOFF BLOCK ET AL PRESENTED RESULTS FROM AN INVESTIGATOR - SPONSORED STUDY OF FERRIC CITRATE AT ERA - EDTA 2018 Geoffrey A Block, Martha Persky, Gerard Smits, Laura Kooienga, Rupal Mehta, Tamara Isakova, Myles Wolf and Glenn Chertow • Single-center, open-label, randomized trial “The
Slide 17: Vadadustat
Vadadustat
Slide 18: Vadadustat in Phase 3 Cardiovascular Outcomes Trials
Vadadustat Vadadustat now in Phase 3 cardiovascular outcomes trials for anemia due to CKD in non-dialysis and dialysis subjects. Vadadustat is an investigational HIF PH inhibitor that is not approved by the FDA or any other regulatory authority.
Slide 19: Vadadustat: Oral HIF PH Inhibitor Stimulating Endogenous EPO
Vadadustat is an oral HIF PH inhibitor designed to stimulate endogenous EPO production, with the potential to increase hemoglobin while avoiding supra-physiological epo levels Kaplan-Meier Survival Curves1 EPO vs Time with Darbepoetin Alfa (SC) EPO vs Time with vadadustat (Oral) Death, Heart Failure
Slide 20: PROTECT Phase 3 Studies in Non-Dialysis Subjects
Non-Dialysis Cardiovascular Outcomes PROTECT Phase 3 Studies Anemia due to CKD in Non-Dialysis Dependent Subjects 3,700 â‰^ N Not ESA Treated ESA Treated Vadadustat vs Vadadustat vs Darbepoetin Alfa Darbepoetin Alfa Change in hemoglobin (Hb) from baseline Major Adverse Cardiovascular Events (MACE)
Slide 21: Global Phase 3 Program for Vadadustat in Non-Dialysis
Non-Dialysis GLOBAL PHASE 3 PROGRAM FOR VADADUSTAT FOR NON-DIALYSIS Additional Non-Primary Endpoints INDIVIDUAL MACE COMPONENTS CHRONIC HEART FAULURE THROMBOTIC EVENTS HOSPITALIZATIONS HB EXCURSIONS TIME IN RANGE (HB) IV IRON USE CKD PROGRESSION
Slide 22: Global Phase 3 Program for Vadadustat in Dialysis: INNOVATE
Dialysis GLOBAL PHASE 3 PROGRAM FOR VADADUSTAT FOR DIALYSIS NDA/MAA Core Package Cardiovascular Outcomes INNOVATE Phase 3 Studies Anemia due to CKD in Dialysis Subjects 3,900 N New-Onset Dialysis ESA Treated Vadadustat vs Vadadustat vs Darbepoetin Alfa Darbepoetin Alfa Change in hemoglobin (Hb) from
Slide 23: Additional Ongoing and Planned Dialysis Studies
Dialysis GLOBAL PHASE 3 PROGRAM FOR VADADUSTAT FOR DIALYSIS Additional ongoing/planned Studies to Support Value Proposition Phase 2, Open-label, efficacy, safety, PK/PD in DD1-CKD, control arm epoetin alfa, modified once daily (QD) and Three Times a Week (TIW) dosing, and ESA Hyporesponders, Open-la
Slide 24: Vifor Agreement and Fresenius Dialysis Center Uptake
Mircera Uptake into Fresenius Dialysis Centers1 100% 80% Unique market dynamics with treatment adoption driven by protocols 60% Agreement with Vifor (International) Ltd. positions vadadustat for rapid uptake in 40% Fresenius LDO subject to FDA approval* 20% Recent amendment expands agreement, facili
Slide 25: Upcoming Clinical Readouts
Japan Phase 3 MTPC Japan CKD Phase 3 DD And NDD Read-out; 2019 FO RWARD-2 Phase 2 DD Top-2 line Results; 2019 INNO VATE Phase 3 DD Top-line 2 Results; Q2 2020* PRO TECT Phase 3 NDD Top-line 2 Results; Mid-2020* *Subject to accrual of MACE events.
Slide 26: Thank You / Questions?
Akebia Therapeutics THANK YOU I QUESTIONS?
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