Akebia Therapeutics, Inc. · NASDAQ:AKBA
Akebia Therapeutics — Investor Presentation (January 2024)
22 slides from Akebia Therapeutics's investor presentation, Jan 8, 2024
Slide 1: Unlocking the Power of the HIF Pathway: Delivering Innovation for Patients with CKD
Unlocking the Power of the Hypoxia- Inducible Factor (HIF) Pathway Delivering Innovation for Patients with Chronic Kidney Disease (CKD) January 2024 Nasdaq: AKBA 1
Slide 2: 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 Act of 1995, as amended, and include, but are
Slide 3: Built on foundation of scientific expertise, financial discipline and operational effectiveness
Auryxia®(ferric citrate) $170.0-$171.0 million in 2023 preliminary unaudited net product revenue with potential for growth in 2024 Built on foundation of scientific expertise, financial discipline and operational effectiveness HIF-based Pipeline Targeting areas of unmet need in acute care settings M
Slide 4: Auryxia (ferric citrate): Generating Consistent Revenue to Fund Innovation
Hyperphosphatemia in adult patients with chronic kidney disease (CKD) on dialysis (2014) Iron deficiency anemia in adult patients with CKD not on dialysis (2017) A medication FDA approved for: Generating Consistent Revenue to Fund Innovation Auryxia® (ferric citrate) 4
Slide 5: Auryxia Revenue Funds Innovation
Auryxia Revenue Funds Innovation 5 Auryxia will continue to contribute meaningful near- term cash to business • Expect revenue growth in 2024 • March 2025 loss of exclusivity • Potential revenue upside in 2025 and 2026 due to phosphate binders being added to the bundle and eligible for Transitional
Slide 6: Vadadustat: Unlocking the Power of the HIF Pathway
6 Oral HIF prolyl-hydroxylase inhibitor (PHI) to treat anemia due to CKD Vadadustat* Leveraging HIF stabilization for anemia management enables a potential new standard of care Vadadustat as a treatment for anemia for adult dialysis dependent chronic kidney patients Approved for use in 36 countries
Slide 7: Vadadustat Could Offer Providers and Patients a New Choice in Anemia Management
Vadadustat Could Offer Providers and Patients a New Choice in Anemia Management 7 Highly differentiated new product positioned to deliver potential new oral standard of care if approved. Maintained EPO within physiologic range3 0 20 40 60 80 100 120 0 5 10 15 Days Darbepoetin alfa 0.45 mcg/kg (singl
Slide 8: Significant U.S. Market Opportunity
Significant U.S. Market Opportunity* 8 $1 Billion1 Most patients on dialysis (Medicare and Medicare Advantage) are reimbursed through bundled payment ~558,000 CKD Patients on Dialysis5 ~90%6 treated for anemia ~36%+7 enhanced access via add-on payment Payment for anemia management is included in bun
Slide 9: Drive Toward a New Oral Standard of Care
Drive Toward a New Oral Standard of Care* Opportunity to Differentiate Near Term to Drive Adoption *If vadadustat is approved. >80,000 on home dialysis8 >100,000 patients start dialysis annually10 >150,000 patients on higher ESA doses9 9
Slide 10: Elements in Place for a Successful U.S. Launch
Elements in Place for a Successful U.S. Launch* 10 Embedded Commercial Team ~30 key account managers supported by full operations team Differentiated Renal Expertise Deep leadership, Board and organizational experience and existing relationships with dialysis organizations Commercial Partnership CSL
Slide 11: Post-Approval Label Expansion Opportunity: Alternative Dosing Regimen
CONFIDENTIALPost-Approval Label Expansion Opportunity11 Alternative Dosing Regimen FOCUS Study: Safety and Efficacy of Vadadustat Thrice Weekly in Dialysis Patients with Anemia Due to Chronic Kidney Disease • Vadadustat total (600mg and 900mg groups combined) was noninferior to Mircera for mean chan
Slide 12: International Market Collaborations Provide Additional Upside
MTPC has exclusive development and commercialization rights to vadadustat in Japan and certain other Asian countries Vadadustat is approved for non-dialysis and dialysis adult patients in Japan and is marketed by MTPC under the trade name VAFSEO® Germany-based pharmaceutical company with exten
Slide 13: Post-Approval Label Expansion Opportunity: Non-Dialysis Dependent Patients
CONFIDENTIALPost-Approval Label Expansion Opportunity13 Anemia May Not Be Optimally Managed in Patients Transitioning to Dialysis Non-Dialysis Dependent Patients In patients with pre-hemodialysis Hb <9.0 g/dL (n=4855), 73.4% did not receive ESA pre-HD12 0.83 0.86 0.88 0.0 0.2 0.4 0.6 0.8 1.0 1.2 3 M
Slide 14: Novel HIF-Based Compounds Pipeline
14 Acute care asset to enter clinic as early as 2025 Novel HIF-Based Compounds Pipeline targeting areas of high unmet need in acute care settings HIF Stabilization in Acute Care Indications Angiogenesis Cell survival Glycolysis Gluconeogenesis Anti-inflammation AKB-9090 Acute Care Molecule Acute Kid
Slide 15: Acute Kidney Injury (AKI)
AKI is a sudden decline in the ability of kidneys to work and perform their normal functions. The case for HIF-stabilization Stabilization of HIF by prolyl hydroxylase inhibition (PHI) leads to the release of erythropoietin, a shift in anaerobic metabolism and decreased inflammatory responses that c
Slide 16: Acute Respiratory Distress Syndrome (ARDS)
ARDS is a life-threatening lung injury that results in low blood oxygen levels and difficulty breathing most commonly due to pneumonia, aspiration, or sepsis. The case for HIF-stabilization Stabilization of HIF by prolyl hydroxylase inhibition leads to release of erythropoietin, increased extracellu
Slide 17: Retinopathy of Prematurity (ROP)
The leading cause of blindness in preterm infants in the world that occurs due to abnormal blood vessel growth in the retina. ROP is caused by the high oxygen therapy used to treat preterm babies. Hyperoxia can induce HIF1a degradation and prevent normal retinal development. HIF-PHIs can protect the
Slide 18: AKB-10108 Promoted Retinal Growth and Prevented Neovascularization
18 Vehicle Control AKB-10108Rat oxygen-induced retinopathy model AKB-10108 Promoted Retinal Growth and Prevented Neovascularization* Peripheral avascular retina Neo-vascularization In mouse and rat models of ROP, AKB- 10108 demonstrated a statistically significant, >50% reduction in retinal vaso-obl
Slide 19: HIF Pipeline
HIF Pipeline 19 Vafseo Anemia DD-CKD Anemia NDD-CKD Japani Vafseo Anemia DD-CKD EU,U.K., Switzerland Australiaii Taiwan, Koreaiii Vadadustat Anemia DD-CKD United States Vadadustat Anemia NDD-CKD Globaliv AKB-9090 AKI, ARDS Global AKB-10108 ROP Global Indication Region Discovery Phase 1 Phase 2 Phase
Slide 20: Financial Outlook: Path to Expected Profitability
Financial Outlook: Path to Expected Profitability 20 Continued financial discipline with improved operating margins and anticipated revenue from Auryxia are expected to provide a foundation to maximize value for vadadustat*. Reduced Operating Expenses Strengthening Balance Sheet Amendment in October
Slide 21: Summary: Auryxia, HIF-based Pipeline and Vadadustat
Auryxia®(ferric citrate) $170.0 - $171.0 million in 2023 preliminary unaudited net product revenue with potential for growth in 2024 Opportunity to potentially mitigate patent cliff due to 2025 phosphate binder TDAPA reimbursement Built on foundation of scientific expertise, financial discipline and
Slide 22: References
1USRDS(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 2Doshi S et al. Journal of Cli
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