Ardelyx, Inc. · NASDAQ:ARDX
Ardelyx — Corporate Update (December 2019)
22 slides from Ardelyx's corporate update, Dec 3, 2019
Slide 1: Passionately committed to bettering the lives of patients with cardiorenal diseases
Exhibit 99.1 Passionately committed to bettering the lives of patients with cardiorenal diseases
Slide 2: Forward-Looking Statements
Forward-Looking Statements To the extent that statements contained in this presentation are not descriptions of historical facts regarding Ardelyx, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor of the Private Securi
Slide 3: Implications of Positive Phase 3 PHREEDOM Results
Implications of Positive Phase 3 PHREEDOM Results: Tenapanor for the Treatment of Hyperphosphatemia PHREEDOM data support tenapanor as monotherapy Successfully achieved primary endpoint with statistically significant results (p<0.0001) 77% of tenapanor-treated patients in the intent-to-treat populat
Slide 4: Comprehensive Development Program Supports Tenapanor Opportunity
Comprehensive Development Program Supports Tenapanor Opportunity © Ardelyx, Inc Expect Potential: NDA submission in mid-2020 FDA approval in mid-2021 DUAL MECHANISM BENEFIT Phase 3 AMPLIFY Phase 3 PHREEDOM MONOTHERAPY long-term use Phase 4 NORMALIZE NORMALIZE real-world study MONOTHERAPY First Phase
Slide 5: PHREEDOM and NORMALIZE Results
PHREEDOM and NORMALIZE Results David Rosenbaum, Ph.D., Chief Development Officer Investigational, first in class phosphate absorption inhibitor that provides an innovative and differentiated non-binder approach to phosphorus control © Ardelyx, Inc
Slide 6: Tenapanor First-in-Class Approach
TENAPANOR FIRST-IN-CLASS APPROACH TARGETS primary pathway of phosphate absorption BLOCKS paracellular uptake of phosphorus WORKS without inherent limitations of binders Unlike phosphate binders, tenapanor is a phosphate absorption inhibitor that… © Ardelyx, Inc Novel Mechanism of Action with Tenapan
Slide 7: PHREEDOM Pivotal Phase 3: Evaluating long-term use of tenapanor monotherapy
PHREEDOM Pivotal Phase 3: Evaluating the long-term use of tenapanor monotherapy © Ardelyx, Inc OBJECTIVE 52-week trial to evaluate the long-term efficacy, safety and tolerability of monotherapy tenapanor in CKD patients on dialysis PRIMARY END POINT The difference in change in serum phosphorus betwe
Slide 8: PHREEDOM: Achieved Statistically Significant Primary Endpoint
PHREEDOM: Achieved Statistically Significant Primary Endpoint Primary endpoint: Statistically significant (p<0.0001) difference in least squared mean serum phosphorus change A delta of 1.4 mg/dL as compared to placebo Secondary analyses: In the 26-week open label treatment period, 77% of tenapanor p
Slide 9: Tenapanor was Generally Well Tolerated
Tenapanor was Generally Well Tolerated 52% (220/419) of patients self-reported loose stools/diarrhea during the open label 26-week treatment period Approximately 90% (196/220) events were judged by the investigator to be mild to moderate in nature 16% of tenapanor-treated patients in the 26-week ope
Slide 10: NORMALIZE: Ongoing Phase 4 Study Design
NORMALIZE: Ongoing Phase 4 11/17/2019 Analysis © Ardelyx, Inc WHY NORMALIZE? To obtain real-world evidence regarding the dual mechanism of tenapanor and sevelamer to reduce patients’ serum phosphorus levels to normal (<4.6 mg/dL) while minimizing medication burden To develop a roadmap to demonstrate
Slide 11: NORMALIZE: Patient Characteristics
NORMALIZE: Patient Characteristics Expected to enroll up to 180 patients Currently 96% (116/121) of eligible patients have enrolled to date 76 entered from the tenapanor arm 40 entered from the active safety control arm (sevelamer) 73 patients have been evaluated who have >1 month of treatment (1-3
Slide 12: NORMALIZE: Initial Results are Favorable to DOPPS
NORMALIZE: Initial Results are Favorable to DOPPS NORMALIZE 42% (31/73) patients treated for >1 month had serum phosphorus levels <4.6 mg/dL 71% (52/73) of patients treated for >1 month had serum phosphorus levels ≤5.5 mg/dL Dialysis Outcomes Practice Patterns Study (DOPPS) Practice Monitor – June 2
Slide 13: Closing remarks
Closing remarks Mike Raab, CEO Investigational, first in class phosphate absorption inhibitor that provides an innovative and differentiated non-binder approach to phosphorus control © Ardelyx, Inc
Slide 14: Phosphate Level is an Independent Predictor of Morbidity and Mortality in Dialysis
Phosphate Level is an Independent Predictor of Morbidity and Mortality in Patients on Dialysis1 © Ardelyx, Inc Serious Potential Consequences With Elevated Phosphorus Levels 1. Block, GA, et al. Mortality, and Morbidity in Maintenance Hemodialysis. J Am Soc Nephrol 15: 2208–2218, 2004 Relative Morta
Slide 15: High Unmet Need for Novel Hyperphosphatemia Treatments
© Ardelyx, Inc There is a High Unmet Need for Novel Hyperphosphatemia Treatments 1. Spherix RealWorld Dynamix, Dialysis 2018 Approximately 85% of dialysis patients require phosphate lowering treatment1 of patients treated with binders had at least one phosphorus level >5.5 mg/dL in the past six mont
Slide 16: Inherent Limitations with Phosphate Binder Mechanism of Action
Inherent Limitations with Phosphate Binder Mechanism of Action © Ardelyx, Inc BIND DIETARY PHOSPHATE IN THE GUT MOA requires mealtime dosing Dosing frequency LIMITED BINDING CAPACITY Number of pills Size of pills Formulation POOR TOLERABILITY Constipation Bloating Nausea Diarrhea Challenges with Eff
Slide 17: Tenapanor Controls Phosphorus with One Small Pill Taken Twice Daily
Tenapanor Controls Phosphorus with One Small Pill Taken Twice Daily © Ardelyx, Inc One week dose of most prescribed phosphate binder ~3+ pills TID with meals and snacks One week dose of Tenapanor 1 pill BID FEWER PILLS SMALLER PILLS LESS FREQUENT DOSING DIFFERENTIATED TOLERABILITY
Slide 18: Significant Opportunity for Tenapanor in Hyperphosphatemia Market
© Ardelyx, Inc 1. United States Renal Data System. 2018 USRDS annual data report: Epidemiology of kidney disease in the United States. National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, 2018. 2. IQVIA 2019 Significant Opportunity for Tenapa
Slide 19: Ardelyx is Well-Positioned to Commercialize Tenapanor in the US
Ardelyx is Well-Positioned to Commercialize Tenapanor in the US © Ardelyx, Inc Experienced Commercial Team with Cardiorenal Experience Building Specialized US Commercial Organization Targeting Nephrologists (~6,000) Clear unmet need Innovative product with differentiated and novel MOA to meet unmet
Slide 20: 2019 has been a Significant, Transformational Year
2019 has been a Significant, Transformational Year ✓Kyowa Kirin Corporation initiated Phase 2 tenapanor trial in hyperphosphatemia in Japan ✓Publication of successful Phase 3 monotherapy trial for tenapanor in JASN ✓Established commercial team with highly talented, experienced leadership ✓Strengthen
Slide 21: 24-Month View of Potential Milestones and Catalysts
24-Month View of Potential Milestones and Catalysts © Ardelyx, Inc • AMPLIFY Phase 3 results to be presented at scientific meetings throughout 2020+ • PHREEDOM Phase 3 results to be presented at scientific meetings throughout 2020+ • Ongoing market development and pre-commercial activities • Expect
Slide 22: Thank you
Thank you