Ardelyx, Inc. · NASDAQ:ARDX
Ardelyx — J.P. Morgan Healthcare Conference 2019
20 slides from Ardelyx's conference presentation, Jan 7, 2019
Slide 1: Breakthrough Science for Better Health
BREAKTHROUGH SCIENCE FOR BETTER HEALTH J.P. Morgan Healthcare Conference 2019 Exhibit 99.1
Slide 2: 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 Securities Reform Act of 1995, in
Slide 3: A Cardiorenal Biotech Company
A Cardiorenal Biotech Company Expanding treatment access world-wide via strategic collaborations Seasoned management team with proven track record Opportunity for U.S.-focused renal commercial organization Lead product candidate, tenapanor, with >$1B market potential Developing first-in-class, disru
Slide 4: Collaborations to Access Markets
COLLABORATIONS TO ACCESS MARKETS Kyowa Hakko Kirin for cardiorenal diseases in Japan: $30M upfront, up to $55M in total development milestones and 8.5B yen in commercialization milestones, high-teen royalties Fosun Pharma for HP and IBS-C in China: $12M upfront, $113M in milestones, mid-teen to 20%
Slide 5: ESRD Patients on Dialysis Require Our Attention
End-Stage Renal Disease (ESRD) Patients on Dialysis REQUIRE OUR ATTENTION 1. CDC HIV in the United States 2014 (~6,700) 2. CDC Hepatitis C 2016 (~18,000) 3. ACS Breast Cancer Facts & Figures 2017-2018 (~41,000) 4. National Kidney Foundation, ESRD in the U.S. 2016 5. Savica, V Nephrol Dial Transplant
Slide 6: No Changes to Treatment Approach Since Phosphate Binders in 1970s
NO CHANGES TO TREATMENT APPROACH SINCE INTRODUCTION OF PHOSPHATE BINDERS IN 1970s 1. Fissel 2016 2. DOPPS Practice Monitor, December 2015. www.dopps.org/DPM Control of serum phosphorus limited by poor compliance and adherence to phosphate binder treatment ~1 OUT OF 2 PATIENTS IS NOT COMPLIANT with t
Slide 7: Pill Burden and Dose: The #1 Challenge for Patients
1. 800mg of Renvela (sevelamer carbonate) up to three times per day with meals per package insert 2. Investigational small molecule currently in Phase 3 development. Target dose 10-30 mg BID. (10 mg shown here) PILL BURDEN AND DOSE: The #1 Challenge for Patients with Hyperphosphatemia POTENTIAL TO I
Slide 8: HP Patients and Physicians Ready for First Non-Binder Treatment Option
HP Patients and Physicians Ready for the FIRST NON-BINDER TREATMENT OPTION 1. 2017 KDIGO CKD-MBD Guideline Update; Kidney International (2017) 92, 26–36 2. IQVIA binder TRx Market Share 12 months through November 2018 BINDERS REMAIN THE ONLY TREATMENT option TODAY2 New evidence from three randomized
Slide 9: First-in-Class Treatment for ESRD Patients with Hyperphosphatemia
Tenapanor inhibits NHE3 which transports luminal sodium in exchange for cellular protons Cellular proton retention reduces tight junction permeability to phosphate Reduced tight junction phosphate permeability results in reduced paracellular absorption of luminal phosphate 1 2 3 Selective NHE3 Inhib
Slide 10: Tenapanor Efficacy Demonstrated in First Phase 3 HP Study
Robust treatment effect in responders2 2.56 mg/dL mean change in serum phosphorus levels in responder population (baseline to end of 8-week treatment period) Statistically significant results* 1.01 mg/dL mean delta between placebo and tenapanor (95% CI -1.44, -0.21) Primary endpoint: -0.82 mg/dL LS
Slide 11: Tenapanor Second Phase 3 Registration Study Enrolled
Tenapanor Second Phase 3 Registration Study Enrolled Topline Results in 4Q 2019 Up to 3 weeks washout (phosphate binders removed) Screening Randomization Consent Tenapanor n~420 Active Safety Control n∼140 Up to 3 Weeks 6-Months (26-Week) End of Treatment RE-RANDOMIZATION 3 Months (12 Weeks) 3 Month
Slide 12: Appeal and Use of Tenapanor
APPEAL AND USE OF TENAPANOR 34% 47% 19% Would use tenapanor first line before phosphate binders Would add tenapanor to the binder regiment to boost efficacy Would use second line as a monotherapy if first line binder failed How Would You Use Tenapanor? 12 The US Dialysis Market: Implications for ten
Slide 13: Combination Use with Binders
COMBINATION USE WITH BINDERS Tenapanor potential differentiation Efficacy / adherence & compliance a large issue 65% of patients >4.5mg/dL1 Only 11% of HD patients being treated with binders currently take more than one brand2 (no efficacy benefit) Manage side effects Manage costs Tenapanor’s effect
Slide 14: Tenapanor and Sevelamer Synergistic in Rats
COMBINATION USE WITH BINDERS Presented at ASN 2018 14 Mean ± SEM data shown; One-way ANOVA; N=6/group; **** = p < 0.0001 compared to vehicle; #### = p < 0.0001 compared to tenapanor alone; ^^ = p < 0.05 compared to sevelamer alone Tenapanor Alone Tenapanor + Sevelamer Tenapanor + Sevelamer Actual Pr
Slide 15: TEN-02-202: AMPLIFY Study Design
15 TEN-02-202: AMPLIFY Tenapanor as Adjuvant Therapy to Phosphate Binders Study Design Randomized, double-blind and placebo controlled 30 mg bid starting dose that can be titrated to 20 mg or 10 mg Key Inclusion Criteria 3 doses of phosphate binders/day, serum phosphorus ≥ 5.5 mg/dL and ≤ 10 mg/dL a
Slide 16: Clear Path to Commercialization
$500 – $700M COMMERCIAL OPPORTUNITY Data-driven, KOL-led market Specialized U.S. commercial organization targeting nephrologists Highly experienced renal team Access outside the U.S. via strategic collaborations BRINGING TENAPANOR TO HP PATIENTS Clear Path to Commercialization
Slide 17: Partnering to Bring Tenapanor to Patients with IBS-C Worldwide
to Bring Tenapanor to Patients with IBS-C Worldwide PARTNERING ~11M PEOPLE WITH IBS-C ESTIMATED IN THE U.S. ALONE1 Strategic collaborations extend reach to patients worldwide Fosun Pharma and Knight granted development and commercialization rights in China and Canada Additional partnerships being pu
Slide 18: Significant Hyperkalemia Market Waiting to Be Tapped
SIGNIFICANT HYPERKALEMIA MARKET WAITING TO BE TAPPED Independent Market Research, Spherix Global Insights Einhorn LM, et al. Arch Intern Med. 2009 Jun 22;169(12):1156-62 Mozaffarian D, et al. Circulation. 2015 Jan 27;131(4):e29-322 DRIVERS TO CREATING A HYPERKALEMIA MARKET 2M patients in US with hyp
Slide 19: RDX013 Program: Expanding Our Renal Footprint
RDX013 PROGRAM Expanding Our Renal Footprint RDX013 PROGRAM Novel, oral potassium secretagogue program Convenient, small pill dosing Increases fecal potassium excretion; reduces serum potassium Allows optimal dosing of anti-hypertensives ~1000x improved in vivo efficiency vs binders RDX013 produces
Slide 20: Breakthrough Science for Better Health
First-in-class cardiorenal medicine with a unique and differentiated MOA Seasoned management with proven track record Optimizing global patient access through strategic collaborations Breakthrough Science for BETTER HEALTH Significant market opportunity in cardiorenal alone: hyperphosphatemia Go-to-