Akebia Therapeutics, Inc. · NASDAQ:AKBA
Akebia Therapeutics — Q2 2025 Earnings Presentation
25 slides from Akebia Therapeutics's earnings presentation, Aug 7, 2025
Slide 1: Bettering the Lives of People Impacted by Kidney Disease
Bettering the Lives of People Impacted by Kidney Disease July 2025 NASDAQ: AKBA 1
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: Leading commercial-stage company focused on kidney disease
Leading commercial-stage company focused on kidney disease 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 Pursuing label expansion of Vafseo for late-stage non-dialy
Slide 4: 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. Transition
Slide 5: Initial Vafseo U.S. launch metrics
Initial Vafseo U.S. launch metrics First quarter 2025 net product revenues of $12 million Through the end of March 2025, > 640 prescribers with an average of ~12 each Orders received from 5 of top 5 dialysis organizations Claims data indicates some Medicare Advantage plans covering Vafseo 5
Slide 6: An oral HIF-PH inhibitor with the potential to become standard of care
Unique mechanism of action built on Nobel An oral HIF-PH inhibitor with Prize-Winning science the potential to become Stimulates body’s natural response to hypoxia standard of care for treatment of anemia due to CKD Enhances body’s natural production of EPO Activates iron mobilization Controls hemog
Slide 7: Home dialysis and higher ESA dose patients are underserved segments of a billion-dollar market
Home dialysis and higher ESA dose dialysis patients are particularly underserved segments of a billion-dollar U.S. market opportunity U.S. Dialysis Patients Treated for Anemia ~500K Patients1* Home use = ~80K patients2 Injectable ESAs are particularly Home cumbersome in the home setting Use Home dia
Slide 8: Strong operational execution in 2024 set stage for Vafseo launch
Strong operational execution in 2024 set stage for Vafseo launch Contracts in place with dialysis organizations covering nearly Secured commercial contracts 100% of U.S. CKD patients on dialysis Established pricing Wholesale Acquisition Cost = ~$15,500 per patient annually Transitional Drug Add-On P
Slide 9: VOICE: Driving toward potential standard of care
Driving toward potential standard of care Additional studies initiated and planned to demonstrate potential additional Vafseo benefits and support label expansion VOICE The Vafseo Outcomes In-Center Experience trial Patients randomized to oral Vafseo 300 mg tablets administered three times per week
Slide 10: 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 11: Anemia may not be optimally managed in CKD non-dialysis population
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-HD4 All-cause Mortality Risk in Patients With Association of 6-Month Pre-ESRD Hb Levels With Pre-HD Hb ≥9.0 g/dL (n=3662) vs <9.0 g/dL (n=4461)5 1
Slide 12: Declining treatment rates in CKD non-dialysis anemia
Declining treatment rates in CKD non-dialysis anemia Percentage of patients treated with ESAs7 45% 36% 35% 27% 27% 24% 20% 18% 17% 15% 2020 2021 2022 2023 2024 2020 2021 2022 2023 2024 CKD Stage 4 CKD Stage 5 12
Slide 13: Opportunity for Vafseo as HIF-based approach in CKD non-dialysis anemia is viewed favorably
Opportunity for Vafseo as HIF-based approach in CKD non-dialysis anemia is viewed favorably8 Nephrologist familiarity with Nephrologist treatment of anemia in HIF-PH inhibitors CKD NDD will increase substantially if % of respondents (n=197) HIF-PH inhibitors are FDA approved % of respondents (n=197)
Slide 14: Prespecified U.S. analysis in PRO2TECT study demonstrated no increased MACE risk
Prespecified U.S. analysis in global PRO2TECT study demonstrated no increased MACE risk versus ESA in the subpopulation9 Global study missed primary MACE endpoint 14
Slide 15: Payor dynamics drive significantly larger non-dialysis market opportunity
Payor dynamics for anemia treatment in non-dialysis segment drive significantly larger market opportunity vs. dialysis segment ~$1 Billion ~500K patients U.S. non-dialysis market with anemia1 U.S. Dialysis payor dynamics: Market Opportunity • Predominantly private and unbundled government payment U.
Slide 16: VALOR: Planned Vafseo Phase 3 trial in late-stage CKD anemia
Planned Vafseo Phase 3 clinical trial in patients with VALOR late-stage CKD anemia not Planned Vafseo Phase 3 on dialysis. cardiovascular outcomes study Protocol to be finalized; TARGET PATIENT ENROLLMENT: Akebia to refine based on ~1,500 U.S. subjects with Stage 4 or 5 CKD not on dialysis FDA feedb
Slide 17: Pipeline
Akebia THERAPEUTICS PN Pipeline 7 all ely i é - AMEE 2 : se ‘ll , 4 ~ *% mf
Slide 18: Advancing HIF-based pipeline targeting high unmet needs
Advancing HIF-based pipeline targeting high unmet needs AKB-9090 CS associated AKI • ~$1.5B+ U.S. market opportunity (Novel HIF-PH inhibitor) • ~2M CS patients11 Planned Phase 1 • No approved treatment Vadadustat ARDS Phase 2A • ~$2B U.S. market opportunity ~$5B U.S. • ~200K patients12 AKBA-9090 Opp
Slide 19: Our Transformation Begins
Akebia THERAPEUTICS PN - _ “4 Daf Our Transformation Begins Mle, 4 hi te ‘i * - Ae = 2
Slide 20: Key 2025 objectives and catalysts
Key 2025 objectives and catalysts Execute Vafseo U.S. Initiate Vafseo Phase 3 trial commercial launch in non-dialysis patients in 2H 2025 Advance pipeline including Fully enroll VOICE Trial initiating first in human trial for AKB-9090 20
Slide 21: Appendix
Akebia THERAPEUTICS PN Appendix 7 all ely i é - AMEE 2 : se ‘ll , 4 ~ *% mf
Slide 22: Important Safety Information about Vafseo
IMPORTANT SAFETY INFORMATION about VAFSEO (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 of thrombotic vascular eve
Slide 23: Important Safety Information about Vafseo (continued)
IMPORTANT SAFETY INFORMATION about VAFSEO (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 Thromboembolism, and Thrombosis
Slide 24: Important Safety Information about Vafseo (continued)
IMPORTANT SAFETY INFORMATION about VAFSEO (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 gastrointestinal (GI) erosions, inc
Slide 25: Sources
SOURCES 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 FMC Capital Markets