Akebia Therapeutics, Inc. · NASDAQ:AKBA
Akebia Therapeutics — 37th Annual J.P. Morgan Healthcare Conference 2019
28 slides from Akebia Therapeutics's conference presentation, Jan 7, 2019
Slide 1: 37th Annual J.P. Morgan Healthcare Conference, January 2019
Exhibit 99.1 37% Annual J.P. Morgan THERAPEUTICS Healthcare Conference January 2019 “eAkebiar
Slide 2: Forward-looking statements
Statements in this presentation regarding Akebia’s strategy, plans, prospects, expectations, beliefs, intentions or goals are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including but not limited to statements regarding the expec
Slide 3: Fully integrated biotech company focused on kidney disease
Akebia: Fully integrated biotech company focused on kidney disease with complementary portfolio and financial strength Product revenue in two FDA-approved indications with substantial growth potential Multiple clinical catalysts over next 18 months for Phase 3 product candidate with multi-billion-do
Slide 4: Akebia's mission is to advance care for patients with kidney disease
Akebia’s mission is to advance care for patients with kidney disease SOURCES: 1 United States Renal Data System. 2018 USRDS annual data report: Epidemiology of kidney disease in the United States. National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Bethes
Slide 5: Kidney disease is a major public health challenge in the US and globally
Kidney disease is a major public health challenge in the US and globally *Quality of Life. SOURCES: 1 Centers for Disease Control and Prevention. Chronic Kidney Disease Surveillance System—United States. http://www.cdc.gov/ckd.; 2 United States Renal Data System. 2018 USRDS annual data report: Epide
Slide 6: Fully integrated biotech company with complementary portfolio and financial strength
Akebia: Fully integrated biotech company focused on kidney disease with complementary portfolio and financial strength 1 Hypoxia Inducible Factor Prolyl Hydroxylase. 2 Includes prepaid quarterly committed cost share funding from Akebia’s collaborators. 3 Cash, cash equivalents and available for sale
Slide 7: Different market dynamics in dialysis vs. non-dialysis
Different market dynamics in dialysis vs. non-dialysis, with opportunity for adoption in large existing dialysis market and for high growth potential in non-dialysis market 1 Most injectable drugs and biologics and their oral or other form of administration are included, specifically erythropoiesis-
Slide 8: Complementary portfolio with strong commercial potential in dialysis and non-dialysis
Complementary portfolio with strong commercial potential in dialysis and non-dialysis *Subject to the regulatory authorities approval; SOURCES: 1 DRG CKD Dialysis Market Forecast.; 2 Evaluate Pharma ESA WW sales extraction (07/2018).; 3 Subject to the accrual of Major Adverse Cardiovascular Events (
Slide 9: CKD on Dialysis
CKD ON DIALYSIS -pAkebia
Slide 10: 2018 Auryxia commercial performance shows strong momentum
2018 Auryxia commercial performance shows strong momentum driven by hyperphosphatemia use SOURCE: Monthly prescription and market share data as of 11/30/18. 1 Iron deficiency anemia 2 Prior authorization. Total 2018 prescriptions up 91% YTD Nov’18 vs. Nov’17 Market share growth from 2.2% to 6.4% in
Slide 11: Strong momentum for Auryxia in phosphate binder market
Strong momentum for Auryxia in phosphate binder market Phosphate Binder Market Needs2 Non-calcium Less pill burden Favorable tolerability profile Palatable formulation Change in Phosphate Binder TRx (000s) 2017 to 20181 SOURCES: 1 IQVIA NPA Data; Fresenius Rx, DaVita Rx & USRC Dispense Data.; 2 Comb
Slide 12: Major growth opportunity for Auryxia in the hyperphosphatemia market
Major growth opportunity for Auryxia in the hyperphosphatemia market following treatment guideline update SOURCES: 1 Phosphate Binder Use, by type. DOPPS Practice Monitor. https://www.dopps.org/dpm/DPMSlideBrowser.aspx. Accessed 12.21.2018.; 2 KDIGO 2017 Clinical Practice Guideline Update for the Di
Slide 13: Patient dissatisfaction with SoC and positive perception of Auryxia
Patient dissatisfaction with standard of care (SoC) and nephrologist positive perception of Auryxia create two-pronged tailwinds in the hyperphosphatemia market ~20% patients discontinue use of Renvela1 65% cite pill burden 42% cite tolerability issues Nephrologists view Auryxia’s profile favorably
Slide 14: Vadadustat is an oral HIF PH inhibitor stimulating endogenous EPO production
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 High EPO level is associated with increased CV risk SoC with injectable ESAs result in supra-physiological EPO levels Vadadu
Slide 15: Global Phase 3 program for vadadustat in dialysis
Global Phase 3 program for vadadustat designed to assess efficacy, safety and cardiovascular outcomes, with additional data to support value proposition Efficacy and adjudicated safety EPs consistent with INNO2VATE (but not powered for MACE) Conversion from ESA, TIW dosing PRO Additional Non-Primary
Slide 16: Concentration into large US dialysis networks creates opportunity for vadadustat
Concentration into large US dialysis networks creates major opportunity for vadadustat *Subject also to inclusion in the ESRD bundle. SOURCES: 1 ESA Use, by type. DOPPS Practice Monitor. https://www.dopps.org/dpm/DPMSlideBrowser.aspx. Accessed 12/19/2018.; 2 TDAPA: Transitional drug add-on payment a
Slide 17: CKD Non-Dialysis
CKD NON-DIALYSIS THERAPEUTICS
Slide 18: Advanced non-dialysis CKD characterized by progressive laboratory abnormalities
Advanced non-dialysis CKD is characterized by progressive laboratory abnormalities, with opportunity for better disease management SOURCES: 1 Gutierrez O, Isakova T, Rhee E, Shah A, Holmes J, Collerone G, Juppner H, Wolf M: Fibroblast growth factor-23 mitigates hyperphosphatemia but accentuates calc
Slide 19: Investigator-sponsored study of ferric citrate at ERA-EDTA 2018
Dr. Geoff Block et al presented results from an investigator-sponsored study of ferric citrate at ERA-EDTA 2018 *Keryx Biopharmaceuticals, Inc. (now a wholly owned subsidiary of Akebia) provided funding and study medication for this investigator initiated study.; SOURCE 1 Geoffrey Block, Martha Bloc
Slide 20: Major commercial opportunity in IDA for non-dialysis patients
Major commercial opportunity in IDA for non-dialysis patients, driven by limited efficacy of traditional oral iron combined with preference to avoid IV iron Nephs believe oral iron achieves optimal response in only ~25% of patients1 Nephs currently prescribe oral iron first line, despite limited sat
Slide 21: Nephrologists believe Auryxia has strong potential in IDA
Nephrologists believe Auryxia has strong potential in IDA Nephrologist perspective on Auryxia to Potentially Address the Unmet Need1 48% Very likely to use after traditional oral iron failure * Gastrointestinal; ** Transferrin saturation SOURCES: 1 Auryxia ATU market research survey Q3 2018 (n= 102
Slide 22: ESA treatment has decreased dramatically, leaving many patients untreated
In anemia due to CKD market, ESA treatment has decreased dramatically driven primarily by CV risk, leaving many patients with low hemoglobin untreated SOURCE: 1 Spherix RealWorld Dynamix Renal Anemia market research survey and chart review, Feb 2018 (172 nephrologists, 1059 patient records). High pr
Slide 23: Global Phase 3 program for vadadustat in non-dialysis
Global Phase 3 program for vadadustat designed to assess efficacy, safety and cardiovascular outcomes, with additional data to support potential for new oral SoC in anemia due to CKD Not ESA Treated Vadadustat vs Darbepoetin Alfa ESA Treated Vadadustat vs Darbepoetin Alfa Primary Efficacy Endpoint:
Slide 24: Strong financial position
Strong financial position Approximately 117 million shares outstanding at December 31, 2018 $431 million cash position1 Expect existing cash resources2 and estimated product revenue to fund operations into Q3 2020 Growing revenue stream expected, driven by Auryxia sales and collaboration revenue3 1
Slide 25: Expected near-term clinical catalysts for vadadustat
Expected near-term clinical catalysts for vadadustat starting in 2019 through mid-2020 *Subject to accrual of MACE events. # Interim 36 week data. FO2RWARD-2 Phase 2 DD top-line results; 2019 INNO2VATE Phase 3 DD top-line results; Q1 2020* PRO2TECT Phase 3 NDD top-line results; Mid-2020* MTPC Japan
Slide 26: Pipeline
Pipeline My PRE-CuUNICAL | PHASE PHASE 3 Targeted Timing Regulatory Filing NDA [BB waa [@ | unoa PIPELINE ANEMIA IN CKD — VADADUSTAT Program NDD-CkD “@Akebiar PROSTEGT Correction \ Full enrollment: 2019 =H PROTECT Conversion {Top-tine results: Mid-2020" =H DD-CKD fi i Full enrollment: Mar 2019 nl LJ
Slide 27: What's next? Value creation through portfolio maximization and pipeline growth
What’s next? Strong value creation through portfolio maximization and pipeline growth, driven by our mission to advance care for patients with kidney disease 1 Cash, cash equivalents and available for sale securities, pro forma, unaudited, as of 9/30/2018. Full integration & Financial strength Stron
Slide 28: Fully integrated biotech company focused on kidney disease
Akebia: Fully integrated biotech company focused on kidney disease with complementary portfolio and financial strength Product revenue in two FDA-approved indications with substantial growth potential Multiple clinical catalysts over next 18 months for Phase 3 product candidate with multi-billion-do
Akebia Therapeutics — 37th Annual J.P. Morgan Healthcare Conference 2019 on 6ix