Ardelyx, Inc. · NASDAQ:ARDX
Ardelyx — Q2 2017 Earnings Presentation
22 slides from Ardelyx's earnings presentation, Aug 8, 2017
Slide 1: Breakthrough Science for Better Health
BREAKTHROUGH SCIENCE FOR BETTER HEALTH August 8, 2017 NASDAQ: ARDX
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: Resources Aligned to Deliver on Late-Stage Portfolio
RESOURCES ALIGNED TO DELIVER ON LATE-STAGE PORTFOLIO STRATEGIC REVIEW AND CORPORATE RESTRUCTING CONDUCTED; IMPROVED OPERATING PERFORMANCE AND EXTENDED RUNWAY • Near-term company objectives: • $148.7M in cash, cash equivalents and marketable securities at end of 2Q17 - Advancing tenapanor and RDX7675
Slide 4: Focused Execution on Important Late-Stage Milestones
FOCUSED EXECUTION ON IMPORTANT LATE-STAGE MILESTONES ü Successfully completed Phase 3 study of tenapanor for hyperphosphatemia ü Successfully completed T3MPO-1 Phase 3 study of tenapanor for IBS-C • Begin patient enrollment in 2nd Phase 3 study of tenapanor for hyperphosphatemia – Sept/Oct • Report
Slide 5: Tenapanor: A More Than $1 Billion Commercial Opportunity
TENAPANOR: A MORE THAN $1 BILLION COMMERCIAL OPPORTUNITY EVALUATING STRATEGIC PARTNERSHIP OPPORTUNITIES TO BRING TENAPANOR TO MARKET PRIMARY ENDPOINT ACHIEVED PRIMARY ENDPOINT ACHIEVED IN 1ST PHASE 3 FOR IBS-C IN 1ST PHASE 3 FOR HYPERPHOSPHATEMIA 2ND Phase 3 fully enrolled & data early Q4; Preparing
Slide 6: Growth Drivers for IBS-C Market; The Role for Tenapanor
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 pr
Slide 7: A Clear Need for New IBS-C Treatments with Novel MOA
A CLEAR NEED FOR NEW IBS-C TREATMENTS WITH NOVEL MOA Recently conducted market research (post T3MPO-1) among 50 healthcare providers (GIs and PCPs)1 Only 2 of 5 patients are sufficiently Normalization of bowel movements 72% of HCPs prefer a new treatment treated today (3/week – 3/day) seen as most w
Slide 8: T3MPO-1 Primary Endpoint Achieved
T3MPO-1 PRIMARY ENDPOINT ACHEIVED T3MPO-1: 12-Week Tenapanor IBS-C Phase 3 Trial • T3MPO-1 achieved primary endpoint of statistical significance for 6 of 12 combined responder rate • Seven out of eight key secondary endpoints met statistical significance • Data to be assessed with T3MPO-2 results in
Slide 9: Tenapanor: Role in IBS-C Based on T3MPO-1 Data
TENAPANOR: ROLE IN IBS-C BASED ON T3MPO-1 DATA ü ACHIEVED STATISTICALLY SIGNIFICANT PRIMARY ENDPOINT ü ABILITY TO NORMALIZE BOWEL HABITS ü WELL-TOLERATED ü FIRST-IN-CLASS MECHANISM OF ACTION BASIS FOR APPROVABILITY BASIS FOR COMMERCIAL VIABILITY 6 of 12 Weeks Combined Responder Rates 9 of 12 Weeks C
Slide 10: T3MPO-1 Profile: The View from IBS-C Treating Physicians
T3MPO-1 PROFILE: THE VIEW FROM IBS-C TREATING PHYSICIANS Recently conducted market research (post T3MPO-1) among 50 healthcare providers (GIs and PCPs)1 HCPs view T3MPO-1 efficacy 58% of HCPs 8% (normalization) and 9-week data think 72% of HCPs as most important 26% tenapanor is are “different/ “ver
Slide 11: T3MPO Program: Fully Enrolled & On Way to Completion
T3MPO PROGRAM: FULLY ENROLLED & ON WAY TO COMPLETION T3MPO-1: 3-MONTH TENAPANOR IBS-C PHASE 3 TRIAL COMPLETED; PRIMARY ENPOINT ACHIEVED T3MPO-2: 6-MONTH TENAPANOR IBS-C PHASE 3 TRIAL • Same design and patient population as T3MPO-1 and Phase 2b • Same 12-week treatment period primary endpoint • Data
Slide 12: IBS-C Market Drivers for Tenapanor's Commercial Potential
IBS-C MARKET DRIVERS FOR TENAPANOR’S COMMERCIAL POTENTIAL IMPORTANT OPPORTUNITY TO EXPAND INTO CIC AND OIC ~$1 BILLION Limited IBS-C Rx treatment options available IN ANNUAL REVENUES BY Two-thirds of patients do not PRESCRIPTIONS TODAY1 respond to currently available branded Rx treatments2 MODEST PE
Slide 13: Tenapanor: Game Changing for Hyperphosphatemia
TENAPANOR: GAME CHANGING FOR HYPERPHOSPHATEMIA GROWTH DRIVERS FOR HYPERPHOSPHATEMIA2 • Aging baby boomers • Increase in ESRD prevalence in U.S. by 5% per year • ESRD patients make up 1% of U.S. Medicare population, but account for 7% of Medicare budget • >100,000 U.S. patients on kidney transplant l
Slide 14: Tenapanor: Impact on Treatment of HP
TENAPANOR: IMPACT ON TREATMENT OF HP POOR COMPLIANCE AND ADHERENCE LIMITS DAILY DOSE CHRONIC USE RESULTING IN SUBOPTIMAL RESULTS 2/3 OF PATIENTS ARE NOT AT TARGET PILL BURDEN SERUM PHOSPHORUS LEVELS AT ANY POINT (19+ pills/day; ½ are IN TIME5 phosphate binders4) and side-effects associated with bind
Slide 15: Hyperphosphatemia 1st Phase 3 Successfully Completed
HYPERPHOSPHATEMIA 1st PHASE 3 SUCCESSFULLY COMPLETED Primary Endpoint Achieved; Statistically Significant Difference in Change in Serum Phosphorus ü Statistically significant for primary endpoint 8-week randomized treatment period followed by 4-week, - 80 of 164 classified as responders (serum doubl
Slide 16: Tenapanor Comparison to Renagel in Hyperphosphatemia
TENAPANOR COMPARISON TO RENAGEL IN HYPERPHOSPHATEMIA RENAGEL PACKAGE INSERT DATA TENAPANOR 1st PHASE 3 TRIAL (sevelamer n=81; Ca. Acetate n=83) Completers6n=164 (n=164) 1001 90 0.9 80 0.8 Cumulative Percent 70 0.7 60 0.6 50 0.5 0.4 40 0.3 30 0.2 20 0.1 10 0 ,8 ,6 ,4 ,2 0 2 4 Phosphorus Change from B
Slide 17: Tenapanor: On the Path for Approval for HP Treatment
TENAPANOR: ON THE PATH FOR APPROVAL FOR HP TREATMENT CONFIRMATORY PHASE 3 PROTOCOL UNDER REVIEW BY FDA TO OPTIMIZE POTENTIAL FOR CLINICAL AND REGULATORY SUCCESS • Planned design: 26-week randomized treatment period followed by up to 12-week, double-blind, placebo-controlled, randomized withdrawal (R
Slide 18: Tenapanor: Potential First Small Molecule, Non-Phosphate Binder Treatment
TENAPANOR: POTENTIAL FIRST SMALL MOLECULE, NON-PHOSPHATE BINDER TREATMENT FOR HYPERPHOSPHATEMIA “New evidence from 3 randomized controlled trials supports a more general recommendation to restrict calcium based phosphate binders in hyperphosphatemic patients across all severities of CKD.”1 2016 MARK
Slide 19: Large Hyperkalemia Market Waiting to Be Tapped
LARGE HYPERKALEMIA MARKET WAITING TO BE TAPPED 200k patients with 900k patients with DRIVERS TO CREATING A ESRD on dialysis1 Stage 3/4 CKD2 HYPERKALEMIA MARKET • New treatments to shape a chronic market • Expanding use of life-saving RAAS inhibitors that cause hyperkalemia • New anti-diabetics cause
Slide 20: RDX7675: Distinct Advantages Over Today's Standard-of-Care
RDX7675: DISTINCT ADVANTAGES OVER TODAY’S STANDARD-OF-CARE AVAILABLE TREATMENTS RDX7675 RDX7675 SHOWS IMPROVED PALATABILITY IN HEALTHY VOLUNTEER TASTE TEST1 1.3X 1.5X 8 1.75X 2X 7 6 5 • Gritty texture 4 • Sodium counter-ion; leads 3 to fluid overload and edema 2 ü Bead design enhances 1 mouth feel a
Slide 21: Advancing RDX7675 Program to Registration
ADVANCING RDX7675 PROGRAM TO REGISTRATION SIGNIFICANT COMMERCIAL POTENTIAL $300M+ MARKET OPPORTUNITY $3+ billion hyperkalemia market potential with new treatment1 Chronic market not yet built 505(b)(2) pathway enables a single Phase 3 clinical trial and supports accelerated development and path to m
Slide 22: Focused on Delivering Late-Stage Pipeline and Value
FOCUSED ON DELIVERING LATE-STAGE PIPELINE AND VALUE 2019 2018 2017 • Launch-ready for IBS-C • Additional NDA submissions • First NDA submission for tenapanor for IBS-C • Prepare for tenapanor IBS-C market launch • Drive other Phase 3 programs toward completion ü Advance Phase 3 programs: tenapanor f