Ardelyx, Inc. · NASDAQ:ARDX
Ardelyx — Corporate Update (October 2017)
26 slides from Ardelyx's corporate update, Oct 11, 2017
Slide 1: Ardelyx Reports Positive T3MPO-2 Phase 3 Trial Results in IBS-C
ARDELYX REPORTS POSITIVE T3MPO-2 PHASE 3 TRIAL RESULTS IN IBS-C OCTOBER 11, 2017 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: Positive T3MPO-2 Results Support NDA Submission in 2H18
POSITIVE T3MPO-2 RESULTS SUPPORT NDA SUBMISSION IN 2H18
Slide 4: Significant and Growing IBS-C Market
SIGNIFICANT AND GROWING IBS-C MARKET GROWTH DRIVERS FOR IBS-C MARKET Increasing awareness of Rx treatment options Significant prescription growth Millions of untreated patients Sustained relief needed Reduction in abdominal pain needed Return of health-related quality of life and work productivity T
Slide 5: T3MPO-2 Phase 3 Study Results
T3MPO-2 PHASE 3 STUDY RESULTS
Slide 6: T3MPO-2: Study Design
Same inclusion/exclusion criteria as T3MPO-1 and Phase 2b Same 12-week treatment period primary endpoint Patients meeting Rome III criteria for diagnosis of IBS-C Active disease as measured by 2 week screening period with mean weekly CSBM < 3, SBM ≤ 5, and Ab Pain ≥ 3 T3MPO-2: 6-Month Tenapanor IBS-
Slide 7: T3MPO-2: Demographics
Characteristic Tenapanor Placebo Overall n 293 300 593 Age 46.1 44.8 45.4 Gender [n (%)] Male Female 53 (18.1) 240 (81.9) 53 (17.7) 247 (82.3) 106 (17.9) 487 (82.1) Race [n (%)] White Black 185 (63.1) 92 (31.4) 192 (64.0) 92 (30.7) 377 (63.6) 184 (31.0) Baseline BMI (m2/kg) 30.50 30.88 30.69 Baselin
Slide 8: T3MPO-2: 6 of 12-Week Responder Results
T3MPO-2: 6 OF 12-WEEK RESPONDER RESULTS Tenapanor 50 mg BID (n=293) Placebo (n=300) p-value Combined responder (abdominal pain and CSBM responder) 36.5% 23.7% p <0.001 CSBM responder (increase ≥ 1 CSBM from baseline) 47.4% 33.3% p <0.001 Ab pain responder (≥ 30% pain reduction from baseline) 49.8% 3
Slide 9: Phase 3 Comparison: 6 of 12-Week Combined Responder Rates
PHASE 3 COMPARISON: 6 of 12-WEEK COMBINED RESPONDER RATES Linzess results are from Chey et al. Am J Gastro 2012 and Rao et al Am J Gastro 2012 Trulance results are from data presented at DDW 2017 for 3mg dose Non Head-to-Head Phase 3 Trials Placebo is in white 35 30 5 10 15 20 25 40 0 33.6 21.0 33.7
Slide 10: T3MPO-2: 9 of 12-Week Responder Results
T3MPO-2: 9 OF 12-WEEK RESPONDER RESULTS Tenapanor 50 mg BID (n=293) Placebo (n=300) p-value Combined responder (abdominal pain and CSBM responder) 18.4% 5.3% p <0.001 CSBM responder (≥ 1 CSBM increase from baseline and ≥ 3 CSBM ) 22.2% 6.0% p <0.001 Ab pain responder (≥ 30% pain reduction from basel
Slide 11: Phase 3 Comparison: 9 of 12-Week Combined Responder Rates
PHASE 3 COMPARISON: 9 of 12-WEEK COMBINED RESPONDER RATES Linzess results from Chey et al. Am J Gastro 2012 and Rao et al Am J Gastro 2012 Non Head-to-Head Phase 3 Trials Placebo is in white 17.5 15.0 2.5 5.0 7.5 10.0 12.5 20.0 0 12.1 5.1 12.7 3.0 13.7 3.3 18.4 5.3 Linzess Ph3 #1 Linzess Ph3 #2 Tena
Slide 12: T3MPO-2: Durable Responder Results
T3MPO-2: DURABLE RESPONDER RESULTS Tenapanor 50 mg BID (n=293) Placebo (n=300) p-value Combined responder (abdominal pain and CSBM responder) 18.1% 5.0% p <0.001 CSBM responder (≥ 1 CSBM increase from baseline and ≥ 3 CSBM ) 21.2% 5.7% p <0.001 Ab pain responder (≥ 30% pain reduction from baseline)
Slide 13: T3MPO-2: 6 of 26-Week Responder Results
T3MPO-2: 13 of 26-WEEK RESPONDER RESULTS Tenapanor 50 mg BID (n=293) Placebo (n=300) p-value Combined responder (abdominal pain and CSBM responder) 35.5% 24.3% p =0.003 CSBM responder (≥ 1 CSBM increase from baseline) 41.3% 31.0% p =0.010 Ab pain responder (≥ 30% pain reduction from baseline) 50.2%
Slide 14: T3MPO-2: Mean Weekly CSBMs
T3MPO-2: MEAN WEEKLY CSBMS (COMPLETE SPONTANEOUS BOWEL MOVEMENTS)
Slide 15: T3MPO-2: Treatment Emergent Adverse Events
T3MPO-2: TREATMENT EMERGENT ADVERSE EVENTS Adverse Reactions TEN 50mg n = 293 Placebo n = 300 Diarrhea 47 (16.0) 11 (3.7) Abdominal Distension 10 (3.4) 1 (0.3) Flatulence 9 (3.1) 3 (1.0) Nasopharyngitis 13 (4.4) 11 (3.7) TEAEs in > 2% of patients treated and higher than placebo
Slide 16: Linzess Package Insert vs Potential Tenapanor Package Insert
Adverse Reactions Linzess 290 mcg n = 807b % Placebo n = 798b % Tenapanor 50 mg bid n = 602b % Placebo n = 601b % Gastrointestinal Diarrhea Abdominal pain Flatulence Abdominal distension 20 7 4 2 3 5 2 1 15 -a 3 3 3 - 2 0 Infections and Infestations Viral gastroenteritis 3 1 - - Nervous System Disor
Slide 17: Market Research: IBS-C Patients
MARKET RESEARCH: IBS-C PATIENTS
Slide 18: Significant Opportunity to Address Underserved Patients
SIGNIFICANT OPPORTUNITY TO ADDRESS UNDERSERVED PATIENTS Only 21% of patients are (very) satisfied >3/4 of Rx-treated patients are not currently satisfied 2/3 of IBS-C Patients Willing to Try Another Rx Market research projects conducted in 252 IBS-C patients by Perleberg Pharma Partner Health Resear
Slide 19: Patients Cite Multiple Reasons for Discontinuing Treatment
PATIENTS CITE MULTIPLE REASONS FOR DISCONTINUING TREATMENT % of patients who discontinue due to diarrhea is similar for all currently available treatments Market research projects conducted in 252 IBS-C patients by Perleberg Pharma Partner Health Research International GmbH, 2017
Slide 20: Significant Opportunity to Address Underserved Patients
SIGNIFICANT OPPORTUNITY TO ADDRESS UNDERSERVED PATIENTS Patients with IBS-C are seeking effective treatments that relieve their symptoms In 170 patients surveyed: 72% of patients currently treated with a prescription would be interested in using tenapanor 69% of IBS-C patients treated with OTC thera
Slide 21: A Clear Need for New IBS-C Treatments with Novel MOA
A CLEAR NEED FOR NEW IBS-C TREATMENTS WITH NOVEL MOA 72% 28% An Rx product with a novel MOA A new generation of an existing Rx product 72% of HCPs prefer a new treatment with a novel MOA to manage IBS-C Normalization of bowel movements (3/week – 3/day) seen as most important attribute 39% sufficient
Slide 22: T3MPO-1 Profile: The View from IBS-C Treating Physicians
T3MPO-1 PROFILE: THE VIEW FROM IBS-C TREATING PHYSICIANS (5) Very Different (4) (3) (2) (1) Very Similar (5) Very Interested (4) (3) (2) (1) Not At All Interested ~60% of HCPs think tenapanor is “different/ very different” from currently available IBS-C treatments ~75% of HCPs are “very interested/
Slide 23: Physicians Support Non-Responders Switching to Another Rx
PHYSICIANS SUPPORT THAT THE MAJORITY OF NON-RESPONDING PATIENTS WILL SWITCH TO ANOTHER RX Base: Majority of non-responding patients will switch to another prescription treatment Most important features of an IBS-C RX medication underscore the potential role of tenapanor Market research projects cond
Slide 24: Tenapanor Commercial Opportunity in IBS-C and Next Steps
TENAPANOR COMMERCIAL OPPORTUNITY IN IBS-C AND NEXT STEPS
Slide 25: Tenapanor Market Drivers for IBS-C
Modest penetration with tenapanor represents >$500M commercial opportunity TENAPANOR MARKET DRIVERS FOR IBS-C ~$1 BILLION in annual revenues by prescriptions today1 IMPORTANT OPPORTUNITY TO EXPAND INTO CIC AND OIC 2016 product sales in SEC filings for branded Rxs Based on Phase 3 data 2015 AGA Repor
Slide 26: Positive T3MPO-2 Study Supports Tenapanor Registration
POSITIVE T3MPO-2 STUDY SUPPORTS TENAPANOR REGISTRATION T3MPO-2 RESULTS IN-LINE WITH PHASE 3 EXPECTATIONS Statistical significance achieved for primary endpoints, supporting approvability Statistical significance for all secondary endpoints evaluated in topline results Highest 6 of 12-week combined r