Ardelyx, Inc. · NASDAQ:ARDX
Ardelyx — Investor Presentation (June 2017)
20 slides from Ardelyx's investor presentation, Jun 22, 2017
Slide 1: Breakthrough Science for Better Health
BREAKTHROUGH SCIENCE FOR BETTER HEALTH NASDAQ: ARDX Exhibit 99.1
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: Creating First-in-Class Medicines
CREATING FIRST-IN-CLASS MEDICINES Our goal is to dramatically enhance the treatment of patients with gastrointestinal and cardiorenal diseases.
Slide 4: Tenapanor: Driving Towards Commercialization
TENAPANOR: DRIVING TOWARDS COMMERCIALIZATION A $1B+ OPPORTUNITY PRIMARY ENDPOINT ACHIEVED IN 1ST PHASE 3 FOR IBS-C 2ND Phase 3 fully enrolled & data early Q4; Preparing for 2018 NDA submission APPROVABILITY supported by 1st Phase 3 readouts in IBS-C and hyperphosphatemia COMMERCIALLY DISTINCT and co
Slide 5: 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 Reduced abdominal pain Return of health-related quality of life and work productivity THE ROLE FOR
Slide 6: 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 7: Tenapanor: Role in IBS-C Based on T3MPO-1 Data
TENAPANOR: ROLE IN IBS-C BASED ON T3MPO-1 DATA 21.0 13.9 14.2 17.8 18.7 5.1 3.0 3.3 6 of 12 Weeks Combined Responder Rates (non head-to-head trials) 9 of 12 Weeks Combined Responder Rates (non head-to-head trials) Chey et al. Am J Gastro 2012 and Rao et al Am J Gastro 2012 Data Presented at DDW 2017
Slide 8: 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 58% of HCPs think tenapanor is “different/ very different” from currently available IBS-C treatments 72% of HCPs are “very interested/ in
Slide 9: T3MPO Program: Fully Enrolled & On Way to Completion
Same design and patient population as T3MPO-1 and Phase 2b Same 12-week treatment period primary endpoint Data readout in early Q4 2017 Preparing for 2018 NDA submission T3MPO-3 open-label safety study; results expected in late 2017 T3MPO-2: 6-Month Tenapanor IBS-C Phase 3 Trial T3MPO PROGRAM: FULLY
Slide 10: 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 2016 product sales in SEC filings for branded Rxs Based on Phase 3 data Modest penetration with tenapanor represents $400M - $500M commercial opportunity ~$1 BILLION in annual revenues by brand
Slide 11: Tenapanor: Game Changing for Hyperphosphatemia
TENAPANOR: GAME CHANGING FOR HYPERPHOSPHATEMIA 1. IMS Health website 2. https://pharm.ucsf.edu/kidney/need/statistics THE ROLE FOR TENAPANOR New treatment mechanism to replace phosphate binders Significant reduction in serum phosphorous and FGF-23 Substantially reduced pill burden and pill sizes Eas
Slide 12: Tenapanor: Impact on Treatment of HP
TENAPANOR: IMPACT ON TREATMENT OF HP 4. Chiu 2009 5. DOPPS Practice Monitor, December 2015. www.dopps.org/DPM 6. Lederer 2016 Nearly half of patients are not compliant with their current treatment6 Pill burden (19+ pills/day; ½ are phosphate binders4) and side-effects associated with binders prohibi
Slide 13: Confirmatory Phase to Begin Mid-2017
CONFIRMATORY PHASE 3 TO BEGIN MID-2017 Planned design: 26-week randomized treatment period followed by up to 12-week, double-blind, placebo-controlled, randomized withdrawal (RW) and open-label extension study Same primary endpoint as 1st Phase 3 study 320 ESRD patients Tenapanor 30 mg BID with the
Slide 14: Tenapanor for HP: A Cardiorenal Franchise Opportunity
TENAPANOR FOR HP: A CARDIORENAL FRANCHISE OPPORTUNITY Cardiorenal presents an opportunity to build a specialized commercial infrastructure of ~75-100 people (alternative options available) Plan to focus efforts on U.S. commercialization; leverage strategic partnerships for ex-U.S. Efficient investme
Slide 15: Massive Hyperkalemia Market Waiting to Be Tapped
MASSIVE HYPERKALEMIA MARKET WAITING TO BE TAPPED New treatments to shape a chronic market Expanding use of life-saving RAAS inhibitors cause hyperkalemia New anti-diabetics cause hyperkalemia Building of a chronic market 2M patients in US with hyperkalemia that require treatment 900k patients with S
Slide 16: RDX7675: Distinct Advantages Over Today's Standard-of-Care
RDX7675: DISTINCT ADVANTAGES OVER TODAY’S STANDARD-OF-CARE Available Treatments RDX7675 Bead design enhances mouth feel and palatability Lack of added sodium or sorbitol aligned with best clinical practice Issued composition of matter patent through 2034 Spherical beads Calcium-sorbitol counter-ion
Slide 17: Expanding Cardiorenal Franchise with RDX7675
EXPANDING CARDIORENAL FRANCHISE WITH RDX7675 1 Internal estimates $3+ billion hyperkalemia market potential with new treatment1 Chronic market not yet built Synergistic opportunity within U.S. cardiorenal franchise 505(b)(2) pathway supports accelerated development and path to market Simple distribu
Slide 18: Managing Balance Sheet While Advancing Pipeline
MANAGING BALANCE SHEET WHILE ADVANCING PIPELINE ~$173M in cash and securities at end of 1Q17 No debt Current runway into 3Q18 No plans to finance before T3MPO-2 data Multiple options to extend runway Significant partnering opportunities to efficiently bring tenapanor to market and strengthen balance
Slide 19: Executing Toward Tenapanor Commercialization
EXECUTING TOWARD TENAPANOR COMMERCIALIZATION FEBRUARY Successfully completed Phase 3 study of tenapanor for hyperphosphatemia MID-YEAR Initiate 2nd Phase 3 study of tenapanor for hyperphosphatemia MAY Successfully completed T3MPO-1 Phase 3 study of tenapanor for IBS-C EARLY 4Q17 Report results from
Slide 20: Innovation That Drives Value
INNOVATION THAT DRIVES VALUE BUILDING A VALUABLE GI PORTFOLIO Completion of IBS-C T3MPO program by end of 2017 Tenapanor on path for NDA submission for IBS-C in 2018 Fast-follower programs with RDX8940, RDX011 and RDX023 Significant opportunity to partner and access non-dilutive capital BUILDING A V