REVA Medical — Investor Presentation (November 2018)
34 slides from REVA Medical's investor presentation, Nov 14, 2018
Slide 1: REVA Medical Corporate Presentation November 2018
REVA Medical Corporate Presentation November 2018 ©2018 REVA Medical CC100021 Rev. I Exhibit 99.1
Slide 2: Important Notice
Important Notice Not an Offer for Securities This presentation does not constitute an offer, invitation, solicitation or recommendation with respect to the purchase or sale of any security in the Company nor does it constitute financial product advice nor take into account your investment objectives
Slide 3: REVA Medical is a leader in bioresorbable polymer technologies for vascular applications
REVA Medical is a leader in bioresorbable polymer technologies for vascular applications Commercializing proprietary products for Coronary Artery Disease and Peripheral Artery Disease and pursuing Embolization Therapies
Slide 4: ~$9 Billion Market Opportunity in Vascular Applications
~$9 Billion Market Opportunity in Vascular Applications Coronary Artery Disease ~$4 billion global stent market CAD is the most common type of heart disease Occurs when a build-up of plaque blocks blood flow to the heart Peripheral Artery Disease: Below-the-Knee $1.5 billion global market potential
Slide 5: REVA's Disruptive Technology: Tyrocore
REVA’s Disruptive Technology: Tyrocore™ Tyrocore Properties Proprietary bioresorbable polymer Strong for excellent mechanical properties X-ray visible, ideal for vascular procedures Naturally biocompatible: derived from the tyrosine amino acid Polymer properties are tailorable to meet a clinical app
Slide 6: REVA's Product Portfolio Built from Tyrocore
REVA’s Product Portfolio Built from Tyrocore Disease Product Regulatory Status Commercial Stage Coronary Artery Disease Fantom® and Fantom Encore™ Bioresorbable Scaffolds CE Mark Available in Europe and Middle East Peripheral Artery Disease: Below-the-Knee MOTIV™ Bioresorbable Scaffolds CE Mark Limi
Slide 7: Coronary Program
Coronary Program
Slide 8: BRS are Designed to Improve Long-Term Outcomes Compared to Metal DES
BRS are Designed to Improve Long-Term Outcomes Compared to Metal DES Support Vessel Healing Safely Resorb Device-Free Vessel 3.3% per year increase in MACE with DES2 BRS are designed to resorb and eliminate risk of device-related adverse events New-Generation DES Continue to Accrue Adverse Events th
Slide 9: REVA Has Demonstrated Excellent Clinical Performance with Fantom
REVA Has Demonstrated Excellent Clinical Performance with Fantom 1) Data on file at REVA Medical. MACE rates presented: Abizaid, A. New 24-month data from the FANTOM II clinical trial. EuroPCR 2018. 2) Ellis S, Kereiakes, D. A bioresorbable everolimus-eluting scaffold versus a metallic everolimus-el
Slide 10: Fantom Has Also Demonstrated Low Scaffold Thrombosis
Fantom Has Also Demonstrated Low Scaffold Thrombosis Fantom (n=240) Absorb (n=1,322) Xience DES (n=686) Study FANTOM II1 ABSORB III ABSORB III Scaffold Thrombosis Acute (0 to 1 day) 0% 0.15%2 0.58%2 Subacute (2 to 30 days) 0.4% 0.91%2 0.15%2 Late/Very Late (>31 days) 0.4% 0.76%2,3 0%2,3 1) Abizaid,
Slide 11: REVA Has Launched Its 3rd Generation: Fantom Encore
REVA Has Launched Its 3rd Generation: Fantom Encore Our Tyrocore Polymer Makes Fantom Encore the Most Advanced BRS Thinnest strut profile of any commercial, CE Mark BRS for deliverability and vessel healing X-ray visible for treatment accuracy Key ease-of-use features like single-step inflation and
Slide 12: Impact on BRS Market
Impact on BRS Market Competitors with PLLA scaffolds like Absorb gone from European market Chinese and Indian competitors with PLLA scaffolds focused on Chinese market with no plans to enter Europe Single remaining European competitor with magnesium-based scaffold is redesigning their product and po
Slide 13: Absorb is Beginning to Demonstrate the Value of Bioresorption
Fortunately, Absorb is Beginning to Demonstrate the Value of Bioresorption Absorb and Xience Show Equivalent Performance between 3 & 4 Years Kereiakes D, et al. Clinical Outcomes Following Complete Bioresorption of the Absorb Everolimus-Eluting Bioresorbable Scaffold: Four-Year Results from the ABSO
Slide 14: REVA's Coronary Program Status
REVA’s Coronary Program Status Q3 2017 Q4 2017 Q1 2018 Q2 2018 Q3 2018 Targeted Launch Direct Sales in Germany, Switzerland, and Austria Distributor: Turkey Direct: Belgium and Netherlands Distributor: Italy Customers 125% increase 78% increase 38% increase 18% increase Billings1 $105,000 $98,000 $1
Slide 15: Building Clinical Evidence to Change the ESC Guidelines and Drive Commercial Use
Building Clinical Evidence to Change the ESC Guidelines and Drive Commercial Use FANTOM I First-in-human safety study (n=7) Year 4 FANTOM II Cohorts A&B Multi-center safety and performance study (n=240) Year 3 FANTOM II Cohort C Long lesion and multiple vessel study (n=30-50) enrolling FANTOM STEMI
Slide 16: REVA's Shift in Business Strategy
REVA’s Shift in Business Strategy In coronary we will focus in Europe on commercial growth and driving change to the ESC Guidelines Our broader business strategy has shifted to: Right-sized operations for slower projected coronary growth Increased focus on peripheral and embolization therapy program
Slide 17: Peripheral Program
Peripheral Program
Slide 18: Peripheral Artery Disease of the Lower Limbs
Peripheral Artery Disease of the Lower Limbs Below-the-Knee (BTK) Common indications are claudication and critical limb ischemia Patients have reduced blood flow leading to wounds, infections, and amputation Critical limb ischemia (CLI) is a heart attack for the leg 25% of CLI patients have amputati
Slide 19: Current Treatment Options
Current Treatment Options Treatment Benefit Challenge Balloon angioplasty (POBA) Restores blood flow to the vessel High rates of restenosis Drug-coated balloons (DCB) Restores blood flow to the vessel Delivers drug to reduce tissue growth during initial vessel healing Lacks mechanical support and su
Slide 20: Bioresorbable Scaffolds May Improve Treatment for Patients with PAD
Bioresorbable Scaffolds May Improve Treatment for Patients with PAD Value of BRS: Provide mechanical support and sustained drug delivery during vessel healing Eliminate issues associated with metal fracture Preserve retreatment options
Slide 21: BRS Shown to Help Patients with PAD
BRS Shown to Help Patients with PAD Below-the-Knee Abbott’s Absorb scaffold in BTK1: 33 patients with critical limb ischemia treated with Absorb 100% of critical limb ischemia patients avoided amputation at 1 year Meril’s Credence scaffold in BTK2: 30 patients with critical limb ischemia treated wit
Slide 22: REVA's MOTIV BTK Bioresorbable Scaffold
REVA’s MOTIV BTK Bioresorbable Scaffold CE Mark secured in July 2018 Made with Tyrocore Thin strut profile for deliverability and vessel healing X-ray visible for treatment accuracy Strong for vessel support Sustained drug delivery to maintain vessel patency 1st & Only BRS Approved for Below-the-Kne
Slide 23: Peripheral Milestones
Limited launch of MOTIV in Europe, Q1 2019 Evaluating pathways for geographic expansion Polymer R&D for optimal characteristics of scaffolds for ATK applications Development of tailored bioresorbable scaffolds for peripheral artery disease applications Peripheral Milestones
Slide 24: Embolization Therapy Program
Embolization Therapy Program
Slide 25: Embolization Therapy is an Established Procedure with Large Market Opportunity
Embolization Therapy is an Established Procedure with Large Market Opportunity Embolization Overview Purpose to occlude blood vessels to restrict the supply of blood to a tumor in order to shrink the tumor Minimally invasive procedures Performed by Interventional Radiologists Particles are delivered
Slide 26: REVA's Technology Fills an Unmet Need
REVA’s Technology Fills an Unmet Need Not Visible Under X-Ray X-Ray Visible Permanent Absorbable Opportunity for REVA REVA Has the Only X-ray Visible and Bioresorbable Embolic Microbead
Slide 27: REVA's Bioresorbable Embolic Microbeads
REVA’s Bioresorbable Embolic Microbeads X-ray visible for treatment accuracy Compressible and buoyant for ease-of-use and injectability Biocompatible for safety Loadable for drug delivery Resorbable to avoid chronic inflammation and allow retreatment REVA’s Polymer Technology Meets All Requirements
Slide 28: Safety and Efficacy Demonstrated in Pre-Clinical Study
Safety and Efficacy Demonstrated in Pre-Clinical Study Renal embolization in swine model Size reduction of treated tissue observed in all animals No evidence of thrombosis, hemorrhage, or inflammation Pre-embolization Post-embolization Densely Packed Microbeads
Slide 29: Embolization Therapy Milestones
Finalize product design Complete bench and pre-clinical testing Evaluate 510k as path to US clearance Conduct early feasibility studies of small molecule and large molecule drug-loaded microbeads targeting oncology Embolization Therapy Milestones
Slide 30: Innovating to Build a $1+ Billion Company
Innovating to Build a $1+ Billion Company Sources: Coronary estimate: DRG MedTech 360 Market Report IC Devices Europe, June 2015; . PAD Markets: REVA estimates based on BTK: Nehler M, et al. Epidemiology of peripheral arterial disease and critical limb ischemia in an insured national population. J V
Slide 31: Experienced Management Team
Experienced Management Team Reggie Groves Chief Executive Officer Brandi Roberts Chief Financial Officer Jeffrey Anderson SVP, Clinical and Regulatory Affairs Carmelo Mastrandrea VP, Europe Joann Yao Sr. Dir., Global Marketing
Slide 32: Board of Directors
Board of Directors Ray Larkin, Chairman (2017– ) Eunoe Inc, Bentley Labs, Nellcor Puritan Bennett Reggie Groves, CEO (2017– ) Medtronic, McKinsey Bob Stockman, Co-Founder (1999– ) Ioptex, “A” Company, Critikon Brian Dovey (2001– ) Domain Associates, Rorer Group Robert Thomas (2010– ) Citigroup Austr
Slide 33: REVA Investment Highlights
REVA Investment Highlights LARGE, PROFITABLE MARKETS DISRUPTIVE TECHNOLOGY Commercializing FANTOM LAUNCHING IN PERIPHERAL MARKET $4 billion coronary stent market ripe for innovation $3.6 billion market opportunity for BRS to treat below- and above-the-knee peripheral artery disease $1.3 billion mark
Slide 34: o Fantom, Fantom Encore, and MOTIV have CE Mark only. Fantom, Fantom Encore, and
o Fantom, Fantom Encore, and MOTIV have CE Mark only. Fantom, Fantom Encore, and MOTIV are available in select countries in Europe and the Middle East. Fantom, Fantom Encore, and MOTIV not available in the U.S. or other countries that do not accept CE Mark. Fantom, Fantom Encore, MOTIV, and Tyrocore