Akebia Therapeutics, Inc. · NASDAQ:AKBA
Akebia Therapeutics — Investor Presentation (July 2024)
27 slides from Akebia Therapeutics's investor presentation, July 2024
Slide 1: Unlocking the Power of the Hypoxia-Inducible Factor (HIF) Pathway
Unlocking the Power of the Hypoxia- Inducible Factor (HIF) Pathway Delivering Innovation for Patients with Chronic Kidney Disease (CKD) This presentation is intended for investor purposes only and is not intended for promotional purposes July 2024 Nasdaq: AKBA 1
Slide 2: Cautionary Note on Forward-Looking Statements
C A U T I O N A R Y N OT E O N F O R WA R D - LO O K I N G S TAT E M E N T S Statements in this presentation regarding Akebia Therapeutics, Inc.’s (“Akebia’s”) strategy, plans, improved operating margins and anticipated revenue from Auryxia are expected to provide a prospects, expectations, beliefs,
Slide 3: Built on foundation of scientific expertise, financial strength and operational effectiveness
Built on foundation of scientific expertise, financial strength and operational effectiveness Vafseo® Auryxia® HIF-based Pipeline (vadadustat) tablets (ferric citrate) FDA approved for the $170.3 million net Targeting areas of unmet treatment of anemia due product revenue in 2023 need in acute care
Slide 4: Vafseo (vadadustat) Tablets Overview
Vafseo® (vadadustat) Tablets Overview
Slide 5: Vafseo (vadadustat) Tablets indicated for anemia due to CKD
Vafseo® (vadadustat) Tablets indicated for the treatment of anemia due to chronic kidney disease (CKD) in adults who have been receiving dialysis for at least three months • Hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor based on Nobel-prize winning science • Once-daily oral tablet •
Slide 6: Anemia Management for Dialysis Patients
Anemia Management for Dialysis Patients $1 Billion1 U.S. Market ~90% ~541,000 Prevalent Dialysis treated for anemia2 CKD Patients3 Payment for anemia ~90%Most patients on dialysis management is included in (Medicare and Medicare bundled payment Advantage) are reimbursed through bundled payment 1USRD
Slide 7: Drive Toward a New Oral Standard of Care
Drive Toward a New Oral Standard of Care Key Launch Initiatives through Product Availability in January 2025 Enable broad Demonstrate the Drive demand from utilization through potential additional prescribers effective benefits of Vafseo for contracting patients 7
Slide 8: A New Choice in Anemia Management
Drive demand from A New Choice in Anemia Management prescribers EPO vs Time with injectable ESAs1 120 Highly differentiated new product positioned to deliver Median EPO Concentration 100 Darbepoetin alfa 0.45 mcg/kg (single dose, SC potential new oral standard of care. administration) 80 Clinical da
Slide 9: Growing Interest and Positive Sentiment for HIFs
Drive demand from Growing Interest and Positive Sentiment for HIFs prescribers ~85% Unaided awareness of Nephrologists Defined the Needs in Anemia Management1 HIF class among U.S. nephrologists1 Need a drug that: can be orally administered ~52% • Nephrologists plan to • allows the body to physiologi
Slide 10: Potential Near-Term Target Populations
Drive demand from Potential Near-Term Target Populations prescribers Conversation Shift from Awareness to Use Cases >80,000 on home dialysis1 Opportunity to Differentiate Near Term to Drive Adoption >150,000 patients on higher ESA doses2 1FMC Capital Markets Day 2023 presentation, DaVita 2022 Annual
Slide 11: Dialysis Coverage and Contracting
Enable broad utilization through Dialysis Coverage and Contracting effective contracting Value in Portfolio ~541,000 85%+ Covered by Medicare and Reimbursed Through Bundle2 Prevalent Dialysis CKD Patients1 36%+ TDAPA Eligible and Reimbursed on Top of Bundle2 Treated by Physicians, Contracted through
Slide 12: Illustrative Pricing Dynamics During and Post TDAPA
Enable broad utilization through Illustrative Pricing Dynamics During and Post TDAPA* effective contracting Contracted 1Q 2025 2Q 2025 3Q 2025 4Q 2025 1Q 2026 2Q 2026 3Q 2026 4Q 2026 2027 2028 2029 2030 2031 Off Invoice Discount Volume-Based Rebates Bring Price Down TDAPA Period Ends Price in line w
Slide 13: Robust Published Data Set
Demonstrate the potential additional Robust Published Data Set benefits of Vafseo for patients Critical to Continue to Build Body of Evidence Data supports that vadadustat increased endogenous erythropoietin production, INNO2VATE and PRO2TECT Phase 3 improved iron availability & global clinical prog
Slide 14: Vafseo U.S. Launch Timeline
Vafseo U.S. Launch Timeline April 2024 July 2024 October 2024 January 2025 Approved TDAPA Designation and (March 2024) File TDAPA Announce WAC HCPCS Codes Assigned (October) Product Availability ASN Kidney Week (October 24-27) Expect Feedback from FDA TDAPA Submission on Non-Dialysis Label Accepted
Slide 15: Vafseo Label Expansion Opportunities
Vafseo® (vadadustat) Tablets Label Expansion Opportunities
Slide 16: Label Expansion Opportunity: Patients Transitioning to Dialysis
Label Expansion Opportunity Non-Dialysis Dependent Anemia May Not Be Optimally Managed in Patients Patients Transitioning to Dialysis In patients with pre-hemodialysis Hb <9.0 g/dL (n=4855), 73.4% did not receive ESA pre-HD1 All-cause Mortality Risk in Patients With Association of 6-Month Pre-ESRD H
Slide 17: Label Expansion Opportunity: Incident Dialysis Patients
Label Expansion Opportunity Incident Dialysis Studies of Cardiovascular Safety of Vadadustat Compared with Patients Darbepoetin Alfa in Patients New to Dialysis with CKD-Related Anemia Patients New to Dialysis from INNO2VATE + PRO2TECT Trials (sub population analysis) The risk of MACE in patients
Slide 18: Label Expansion Opportunity: Alternative Dosing Regimen
Label Expansion Opportunity Alternative FOCUS Study: Safety and Efficacy of Vadadustat Thrice Weekly in Dosing Regimen Dialysis Patients with Anemia Due to Chronic Kidney Disease Vadadustat total (600mg and 900mg groups combined) was noninferior to Mircera for mean change in Hb from baseline to th
Slide 19: Pipeline
Pipeline
Slide 20: Novel HIF-Based Compounds
Novel HIF-Based Compounds Acute care asset to enter clinic as early as 2025 HIF Stabilization in Acute Care Indications Angiogenesis Gluconeogenesis Cell survival Anti-inflammation Glycolysis Pipeline targeting areas of high unmet need in acute care settings AKB-9090 Acute Care Molecule AKB-10108 NI
Slide 21: Financial Outlook
Financial Outlook
Slide 22: Strong Cash Position
Strong Cash Position Current Cash and Cash from Operations Anticipated to Fund Operations for at Least Two Years* Product Capital for Reduced Operating Expenses Revenue Growth Strategic Use • Auryxia 2023 net product • Drew down second revenue of $170.3 tranche of $55 million million; expect growth
Slide 23: Drive Toward a New Oral Standard of Care
Drive Toward a New Oral Standard of Care Key Launch Initiatives through Product Availability in January 2025 Enable broad Demonstrate the Drive demand from utilization through potential additional prescribers effective benefits of Vafseo for contracting patients 23
Slide 24: Important Safety Information
Important Safety Information Sources CO N F I DE N T I A L
Slide 25: Important Safety Information about Vafseo
I M P O RTA N T S A F E T Y I N F O R M AT I O N a b o u t VA FS E O (vadadustat) tablets WARNING: INCREASED RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, and THROMBOSIS OF VASCULAR ACCESS. See full prescribing information for complete boxed warning. VAFSEO increases the risk
Slide 26: Important Safety Information about Vafseo (continued)
I M P O RTA N T S A F E T Y I N F O R M AT I O N a b o u t VA FS E O (vadadustat) tablets(continued) CONTRAINDICATIONS • Known hypersensitivity to VAFSEO or any of its components • Uncontrolled hypertension WARNINGS AND PRECAUTIONS • Increased Risk of Death, Myocardial Infarction, Stroke, Venous Thr
Slide 27: Important Safety Information about Vafseo (continued)
I M P O RTA N T S A F E T Y I N F O R M AT I O N a b o u t VA FS E O (vadadustat) tablets(continued) • Gastrointestinal Erosion Gastric or esophageal erosions occurred in 6.4% (4.0 per 100 PY) of patients receiving VAFSEO and 5.3% (3.3 per 100 PY) of darbepoetin alfa-treated patients. Serious gastro
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