Akebia Therapeutics, Inc. · NASDAQ:AKBA
Akebia Therapeutics — Conference Presentation (June 2023)
13 slides from Akebia Therapeutics's conference presentation, Jun 7, 2023
Slide 1: Commercial Depth. Operational Excellence. A Commitment to Advance Innovation
Commercial Depth. Operational Excellence. A Commitment to Advance Innovation to Address Unmet Needs. John P. Butler, CEO June 2023 Exhibit 99.1
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: Forward toward Our Purpose to Better the Lives of People Impacted By Kidney Disease
Forward toward Our Purpose to Better the Lives of People Impacted By Kidney Disease
Slide 4: Marked progress in past four months
Marked progress in past four months: Approval in the EU and United Kingdom European Commission and Medicines and Healthcare products Regulatory Agency approved Vafseo® (vadadustat) for the treatment of symptomatic anemia associated with chronic kidney disease in adults on chronic maintenance dialysi
Slide 5: Vadadustat U.S. Regulatory Process
May 2023 Vadadustat U.S. Regulatory Process March 2022 ▪ Akebia received CRL that outlined the following key concerns: ▪ Elevated MACE risk in non-dialysis patients ▪ Elevated risk of thromboembolic events driven by vascular access thrombosis (VAT) ▪ Elevated risk of drug induced liver injury (DILI)
Slide 6: Illustrative Timeline
Type A Meeting with FDA Resubmit NDA for vadadustat for patients on dialysis PDUFA Potential Approval TDAPA Designation* Commercial Launch* June 2024 Prepare Briefing Book, Request Receive minutes Notified of acceptance January 2024 May 2023 Anticipate 6-month review File for TDAPA* January 2025 Pro
Slide 7: Market Opportunity + Launch Readiness
Market Opportunity + Launch Readiness ▪ Anemia due to CKD is well recognized, but not always well controlled ▪ Despite available options, a percentage of patients still do not achieve Hb levels within the target range Approximately 88% of 550,000 patients on dialysis are treated with an ESA Akebia i
Slide 8: Global Support for VAFSEO
Global Support for VAFSEO ▪ Vafseo approved in 33 countries including EU and U.K. ▪ Review underway in Switzerland, Australia and Taiwan with responses expected in 2023 ▪ Planning to explore review processes in Canada, China and LATAM Regulatory Status Market Potential ▪ At least 325,000 dialysis pa
Slide 9: Revenue + Cash Management
Revenue + Cash Management ▪ $177M net product revenue in FY2022 ▪ Reported as of May 8, 2023 revenue guidance of $175-$180M Ongoing financial discipline and anticipated cash to fund operating plan for 12+ months provide foundation to maximize value for Vafseo and fund innovation Revenue to Fund Curr
Slide 10: HIF pathway and vadadustat lifecycle management
Angiogenesis Iron homeostasis Energy metabolism pH regulation EPO production Cell cycle and growth HIF pathway1-4 Utilizing Akebia’s investigations into the HIF mechanism of action in anemia due to CKD to other hypoxic conditions, such as acute respiratory distress syndrome. The discovery of HIF has
Slide 11: Current In-Market Therapies and Development Plans
Discovery Phase 1 Phase 2 Phase 3 In Regulatory Review Process Approved In Market Auryxia Hyperphosphatemia Iron Deficiency Anemia United States, Japan and Taiwan Vafseo1 Anemia DD-CKD Anemia NDD-CKD Japan Vafseo Anemia DD-CKD European Union, U.K. vadadustat Anemia DD-CKD United States Switzerland A
Slide 12: Milestones since January 2023 and anticipated catalysts
Milestones since January 2023 ✓ Vadadustat approved in 33 countries ✓ Agreement with Medice to commercialize Vafseo in Europe, U.K. ✓ Clear path forward for resubmission of vadadustat NDA in U.S. ✓ Continued Auryxia revenue stream ✓ Noted operational cost savings Anticipated Catalysts through Decemb
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