Akebia Therapeutics, Inc. · NASDAQ:AKBA
Akebia Therapeutics — Conference Presentation (January 2025)
28 slides from Akebia Therapeutics's conference presentation, Jan 13, 2025
Slide 1: Bettering the Lives of People Impacted by Kidney Disease
1 Bettering the Lives of People Impacted by Kidney Disease John Butler, CEO January 2025 NASDAQ: AKBA
Slide 2: Cautionary note on forward-looking statements
Cautionary note on forward-looking statements Statements in this presentation regarding Akebia Therapeutics, Inc.’s (“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
Slide 3: First Vafseo (vadadustat) Shipment on January 9
3 First Vafseo® (vadadustat) Shipment on January 9
Slide 4: Leading commercial-stage company focused on kidney disease
Leading commercial-stage company focused on kidney disease 4 Vafseo® (vadadustat) launched as treatment for anemia due to chronic kidney disease for adult patients on dialysis ~$1billion U.S. market opportunity in dialysis patient population1 Nobel prize-winning Hypoxia-Inducible Factor (HIF)-based
Slide 5: Vafseo launch underway
Vafseo launch underway 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 Click here for the Full Prescribing Information, including BOXED WARNING and Medication Guide. 5 FDA appr
Slide 6: Nearly 25% of patients with anemia due to CKD fall below target hemoglobin levels
Nearly 25% of patients with anemia due to CKD fall below target hemoglobin levels 2 Suboptimal approach for home dialysis patients since ESAs need to be injected subcutaneously or intravenously Patients who are ESA hyporesponders (~20% of patients on dialysis) have higher rates of hospitalization an
Slide 7: An oral HIF-PH inhibitor with the potential to become standard of care
An oral HIF-PH inhibitor with the potential to become standard of care for treatment of anemia due to CKD 7 Unique mechanism of action built on Nobel Prize-Winning science Stimulates body’s natural response to hypoxia Enhances body’s natural production of EPO Activates iron mobilization Simple titra
Slide 8: U.S. Dialysis Patients Treated for Anemia
U.S. Dialysis Patients Treated for Anemia ~500K Patients1 Home dialysis and higher ESA dose dialysis patients are particularly underserved segments of a billion-dollar U.S. market opportunity Higher ESA Dose = ~150K patients7 May be associated with all-cause mortality and cardiovascular complication
Slide 9: Strong operational execution sets stage for successful launch
Strong operational execution sets stage for successful launch 9 Secured commercial contracts Established pricing Secured TDAPA reimbursement Built prescriber demand Contracts in place with dialysis organizations covering nearly 100% of U.S. CKD patients on dialysis Wholesale Acquisition Cost = ~$15,
Slide 10: Nephrologist feedback indicates most would consider prescribing Vafseo
7% 20% 43% 75% 94% 99% 1% 0 months 1 month 2-4 months 6 months 12 months >12 months Would not consider prescribing Cumulative percentage of respondents who would consider prescribing Vafseo after the indicated timeframe post-launch (n=75)9 Nephrologist feedback indicates most would consider prescrib
Slide 11: Driving toward potential standard of care: VOICE trial
Driving toward potential standard of care VOICE The Vafseo Outcomes In-Center Experience trial ~2,200 = Target Patient Enrollment Timing = 18 Months from Last Patient Randomized Collaborative Clinical Trial More than 650 subjects enrolled as of January 10, 2025 Additional studies initiated and plann
Slide 12: We believe we are positioned to succeed in the dialysis market
We believe we are positioned to succeed in the dialysis market…. …and to chart a path to capitalize on significantly larger non-dialysis market opportunity.
Slide 13: Anemia may not be optimally managed in CKD non-dialysis population
In patients with pre-hemodialysis Hb <9.0 g/dL (n=4855), 73.4% did not receive ESA pre-HD10 All-cause Mortality Risk in Patients With Pre-HD Hb ≥9.0 g/dL (n=3662) vs <9.0 g/dL (n=4461)11 6-Month Pre-ESRD Hb, g/dL <9 9-<10 10-<11 11-<12 ≥12 0.8 — 1.0 — 1.2 — 1.5 — H R fo r A ll- C au se M or ta lit y
Slide 14: Frustration with ESA use driving declining treatment rates in CKD non-dialysis anemia
Frustration with ESA use driving declining treatment rates in CKD non- dialysis anemia13 14 20% 45% 24% 36% 18% 35% 15% 27% 17% 27% CKD Stage 4 CKD Stage 5 2020 2021 2022 2023 2020 2021 2022 2023 Percentage of patients treated with ESAs14 2024 2024
Slide 15: Opportunity for Vafseo as HIF-based approach in CKD non-dialysis anemia
Opportunity for Vafseo as HIF-based approach in CKD non-dialysis anemia is viewed favorably15 15 16% 9% 11% 27% 22% 15% Right away Within three months Within six months Within a year More than a year Never 7% 42% 51% Extremely familiar (8-10) Moderately familiar (4-7) Not at all familiar (1-3) Nephr
Slide 16: Payor dynamics drive significantly larger non-dialysis market opportunity
• Predominantly private and unbundled government payment • Therefore, expected to garner higher net pricing vs. dialysis Payor dynamics for anemia treatment in non-dialysis segment drive significantly larger market opportunity vs. dialysis segment 16 U.S. non-dialysis market payor dynamics: ~$1 Bill
Slide 17: Prespecified U.S. analysis in PRO2TECT showed no increased MACE risk versus ESA
Prespecified U.S. analysis in global PRO2TECT study demonstrated no increased MACE risk versus ESA in the subpopulation17 17 Global study missed primary MACE endpoint
Slide 18: FDA correspondence acknowledges unmet need; planned Phase 3 trial
FDA correspondence with Akebia acknowledges an unmet need for safer and orally available therapies to treat anemia due to CKD in certain non-dialysis patients. Planned Vafseo Phase 3 clinical trial in patients with late-stage CKD anemia not on dialysis Planned Phase 3 Trial Design: Cardiovascular Ou
Slide 19: Pipeline
Pipeline
Slide 20: Advancing HIF-based pipeline targeting high unmet needs
Advancing HIF-based pipeline targeting high unmet needs 20 ROP (rare disease) • ~$1.5B+ U.S. market opportunity • ~30K patients20 • No approved treatment ARDS • ~$2B U.S. market opportunity • ~200K patients19 • No approved treatment CS associated AKI • ~$1.5B+ U.S. market opportunity • ~900K CS pati
Slide 21: Our Transformation Begins
Our Transformation Begins
Slide 22: Key 2025 objectives and catalysts
22 Advance pipeline including initiating first in human trial for AKB-9090 Fully enroll VOICE Trial Execute Vafseo U.S. commercial launch Initiate Vafseo Phase 3 trial in non-dialysis patients in mid-2025 Key 2025 objectives and catalysts
Slide 23: Akebia Therapeutics
Akebia THERAPEUTICS
Slide 24: Important Safety Information about VAFSEO: Boxed Warning
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 of thrombotic vascular events, including major adverse cardiovascular events (MACE). Targ
Slide 25: Contraindications, Warnings and Precautions
CONTRAINDICATIONS • Known hypersensitivity to VAFSEO or any of its components • Uncontrolled hypertension WARNINGS AND PRECAUTIONS Increased Risk of Death, Myocardial Infarction, Stroke, Venous Thromboembolism, and Thrombosis of Vascular Access A rise in hemoglobin (Hb) levels greater than 1 g/dL ov
Slide 26: Important Safety Information about VAFSEO (continued)
IMPORTANT SAFETY INFORMATION about VAFSEO (vadadustat) tablets(continued) 26 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 gastrointestinal (GI) erosions,
Slide 27: Sources
SOURCES 27 1 USRDS(https://usrds-adr.niddk.nih.gov/2022/end-stage-renal-disease/1-incidence-prevalence-patient-characteristics-and-treatment-modalities);DOPPS (https://www.dopps.org/DPM/DPMSlideBrowser.aspx); Based on internal estimates and industry reports estimating ESA pricing 2 A) United States
Slide 28: Sources (continued)
SOURCES 28 15 Spherix Global Insights; Patient Chart Dynamix; Chronic Kidney Disease, ND (US) 2024 16 Stauffer ME, Fan T. Prevalence of anemia in chronic kidney disease in the United States. PLoS One. 2014 Jan 2;9(1):e84943. doi: 10.1371/journal.pone.0084943. PMID: 24392162; PMCID: PMC3879360 17 The
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