Akebia Therapeutics, Inc. · NASDAQ:AKBA
Akebia Therapeutics — Investor Presentation (January 2023)
20 slides from Akebia Therapeutics's investor presentation, Jan 9, 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 David A. Spellman, CFO Mercedes Carrasco, IR & Corp Comm January 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: A Commitment to Address Patients' Unmet Needs
A Commitment to Address Patients’ Unmet Needs
Slide 4: Maximize Value and Advance Innovation
Maximize Value and Advance Innovation 1 Auryxia® (ferric citrate) net product revenue up 27% in the first three quarters of 2022 vs first three quarters of 2021 R&D and SG&A expenses down 17% in the first three quarters of 2022 vs first three quarters of 2021* Revenue + Cash Management 2 VafseoTM in
Slide 5: Strategic Pillar: Revenue and Cash Management
Strategic Pillar: Revenue and Cash Management
Slide 6: Auryxia (ferric citrate) Serving the Renal Market
Auryxia® (ferric citrate) Hyperphosphatemia in patients with CKD on dialysis (2014) Iron deficiency anemia in patients with CKD not on dialysis (2017) FDA approved in two indications: Serving the Renal Market Compelling product profile with favorable MoA efficacy and tolerability Akebia Cares: Ensur
Slide 7: Cost Management Principles In Place
Cost Management Principles In Place YTD Expenses ↆ17% 2022 from 2021 ↆ30% 2022 from 2020 $100M $67M Senior Secured Debt Balance** Operating Expenses 9 Months YTD (Q1-Q3) 2020-2022 Q1-Q3 Q1-Q3 Q1-Q3 $208M* $80M Expense Management - Q3 2022 R&D: $27.4M; Down from $40.5M in Q3 2021 SG&A: 30.9M; Down fr
Slide 8: Strategic Pillar: Support Vadadustat Globally
Strategic Pillar: Support Vadadustat Globally
Slide 9: Anemia due to CKD is well recognized, but not always well controlled
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 range1 Anemia due to CKD not well recognized and many patients not under care of nephrologist Patients less often treated, influen
Slide 10: Vadadustat status and market potential
Vadadustat U.S. rights subject to license agreement with CSL Vifor that leverages their exclusive distribution into certain dialysis organizations, representing ~60%2 of the dialysis market. $2B estimated U.S. dialysis market potential3 Investigational oral HIF-prolyl hydroxylase inhibitor for anemi
Slide 11: Strategic Pillar: Pipeline and Strategic Growth
Strategic Pillar: Pipeline and Strategic Growth
Slide 12: Current In-Market Therapies and Development Plans
Discovery Phase 1 Phase 2 Phase 3 In Regulatory Review Process In Market Auryxia Hyperphosphatemia Iron Deficiency Anemia United States Japan Taiwan Vafseo1 Anemia DD-CKD Anemia NDD-CKD Japan vadadustat Anemia DD-CKD Anemia NDD-CKD United States2 European Union Access Countries3 Other MTPC Territori
Slide 13: Strategic Investment to Advance Pipeline: HIF Expertise
Angiogenesis Iron homeostasis Energy metabolism pH regulation EPO production Cell cycle and growth HIF pathway1-4 Strategic Investment to Advance Pipeline Utilizing Akebia’s investigations into the HIF mechanism of action in anemia due to CKD to other hypoxic conditions, such as acute respiratory di
Slide 14: Acute Respiratory Distress Syndrome (ARDS)
Acute Respiratory Distress Syndrome (ARDS) Life-threatening acute form of lung disease characterized by acute bilateral pulmonary edema, severe hypoxia Usually requires intubation and mechanical ventilation1 Prevents other organs from getting the oxygen they need to function When stabilized, HIF tri
Slide 15: Limitations of Standard of Care in ARDS
Current standard of care is non-specific and focused on minimizing mechanical ventilation Extended use of mechanical ventilation may lead to long term pulmonary damage due to ventilator induced lung injury and subsequent fibrosis Despite improvement in treatment strategies, a study indicated high ho
Slide 16: Pre-Clinical Evidence and UTHealth Clinical Study
Pre-Clinical Evidence3 Mouse model used to evaluate effect of vadadustat when administered 8 hours after lipopolysaccharide-induced lung inflammation and assessed at 24 hours Compared to control, vadadustat-treated mice had: Significantly lower bronchoalveolar lavage cell, neutrophil, and macrophage
Slide 17: Integrated Biotechnology Company
Integrated Biotechnology Company Existing cash resources and product revenue expected to be sufficient to fund current operating plan through at least 12 months** Auryxia® (ferric citrate) in market Experienced Account Managers targeting key accounts Medical Science Liaison Team with significant ren
Slide 18: Akebia's Leadership Team
Corporate Officers Akebia’s Leadership Team Chief Executive Officer John Butler Chief Financial Officer David Spellman Chief Medical Officer Steven K. Burke, M.D. Chief Operating Officer Michel Dahan Chief Legal Officer Nikki Hadas SVP, Manufacturing Thierry Bilbault SVP, Quality Kimberly Garko SVP,
Slide 19: 2023 A Defining Year Building on Our Strategic Pillars
Maximize Value and Advance Innovation in Area of Unmet Patient Needs 2023 A Defining Year Building on Our Strategic Pillars 1 Continue Year over Year Revenue Growth of Auryxia Decrease Year over Year Operating Expenses (R&D + SG&A) Revenue + Cash Management 2 Potential European approval of vadadusta
Slide 20: Akebia
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