REVA Medical — Investor Presentation (June 2018)
32 slides from REVA Medical's investor presentation, Jun 26, 2018
Slide 1: REVA Medical Corporate Presentation June 2018
REVA Medical Corporate Presentation June 2018 ©2018 REVA Medical CC100021 Rev. H 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 a proprietary product for Coronary Artery Disease and pursuing Peripheral Artery Disease and Embolic therapies
Slide 4: REVA's Disruptive Technology Tyrocore
REVA’s Disruptive Technology Tyrocore™ Proprietary bioresorbable polymer Uniquely designed for vascular scaffold applications Derived from naturally occurring tyrosine amino acid Covalently bound iodine for radiopacity Patent protection for 19 biomaterial polymer families Polymer properties are tail
Slide 5: The Problem: Coronary Artery Disease
The Problem: Coronary Artery Disease Cardiovascular Disease is the leading cause of death globally1 1. Source: World Health Organization Factsheet, May 2017. http://www.who.int/mediacentre/factsheets/fs317/en/ https://www.cdc.gov/heartdisease/facts.htm Coronary Artery Disease (CAD) is the most commo
Slide 6: Evolution of Treatments for CAD
Evolution of Treatments for CAD Open Heart Surgery CABG 1960s Balloon Angioplasty 1970s Bare Stents 1990s 2002 Drug-Eluting Stents (DES) History of rapid innovation
Slide 7: Global Coronary Stent Market
Global Coronary Stent Market WW Market Share Abbott (Xience Sierra) 32% Boston Scientific (Synergy) 33% Medtronic (Resolute Oynx) 28% Other 7% Market data source: Year 2017, JP Morgan Equity Research Interventional Cardiology Market Model Feb. 2018. ~$4 BILLION US: $1.4B Japan: $440M Europe & Asia:
Slide 8: Large and Rapid Market Share Disruptions with New Technology Introductions
Large and Rapid Market Share Disruptions with New Technology Introductions Source: JP Morgan Equity Research Interventional Cardiology Market Model Dec. 2016. BMS 1st Gen BMS 2nd Gen DES 1st Gen DES 2nd Gen Innovation Matters: Current players not focused on R&D creating opening for companies with a
Slide 9: Current Standard of Care (DES) Carries Long-Term Risk for Short-Term Benefit
Current Standard of Care (DES) Carries Long-Term Risk for Short-Term Benefit 1) Serruys P, et al. Incidence of restenosis after successful coronary angioplasty: a time-related phenomenon. A quantitative angiographic study in 342 consecutive patients at 1, 2, 2, and 4 months. Circ 1988;77:361-71. 2)
Slide 10: Next Evolution: Bioresorbable Scaffolds
Next Evolution: Bioresorbable Scaffolds Open Heart Surgery CABG 1960s Bioresorbable Drug-Eluting Scaffolds 2013 and beyond Balloon Angioplasty 1970s Bare Stents 1990s 2002 Drug-Eluting Stents (DES)
Slide 11: What is a Bioresorbable Scaffold?
What is a Bioresorbable Scaffold? Temporary implantable device restores blood flow to diseased arteries Provides radial support to artery during healing process Elutes drug to limit excess tissue formation Encapsulates within vessel wall Dissolves from the body over time and restores natural vessel
Slide 12: Given the Value of BRS over DES The Choice is Clear
Given the Value of BRS over DES The Choice is Clear Value to Physician and Patient Avoid an unnecessary permanent implant Allows artery to return to its natural state to restore freedom of movement May reduce the rate of future clinical events Preserves maximum flexibility for future treatment optio
Slide 13: 1st Generation BRS Did Not Meet Expectations
1st Generation BRS Did Not Meet Expectations 2017 Abbott stops Absorb sales8 1) Calculated as Absorb Sales / DES Sales from JP Morgan Equity Research Interventional Cardiology Market Model Feb. 2018. 2) Abbott press release, Jan. 2011. 3) Abbott press release, Sept. 2012. 4) Jaguszewski M, et al. Ac
Slide 14: History Repeats: Late Stent Thrombosis Nearly Stopped DES
History Repeats: Late Stent Thrombosis Nearly Stopped DES Without Continued Innovation, We Might Not Have 2nd Generation DES 1) BA & BMS TLR: Kiemeneji F, et al. Continued Benefit of Coronary Stenting Versus Balloon Angioplasty: Five-Year Clinical Follow-Up of Benestent-I Trial. JACC 2001;37:1598-60
Slide 15: REVA's 2nd Generation Fantom BRS Improves Over 1st Generation
REVA’s 2nd Generation Fantom BRS Improves Over 1st Generation Our Tyrocore Polymer Makes Fantom the Most Technically Advanced BRS DES Absorb Fantom X-Ray Visibility Thin strut profile for deliverability and vessel healing X-ray visible for treatment accuracy Key ease-of-use features like single-step
Slide 16: Fantom Clinical Performance: Excellent Clinical Performance through 2 Years
Fantom Clinical Performance Excellent Clinical Performance through 2 Years 1) FANTOM II: Data on file at REVA Medical. MACE rates presented: Abizaid, A. New 24-month data from the FANTOM II clinical trial. EuroPCR 2018. 2) ABSORB II: Chevalier B, et al. The 2-year Clinical Outcomes of the ABSORB II
Slide 17: Demonstrated Low Scaffold Thrombosis
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, A. New 24-month
Slide 18: Fantom Leading BRS Competition
Fantom Leading BRS Competition Product Novel Material Thin Struts X-Ray Visible Commercial Status Fantom REVA Medical Tyrocore 125 µm Yes CE Mark Magmaris Biotronik Magnesium >150 µm No CE Mark DESolve Elixir Medical PLLA >150 µm No CE Mark Absorb Abbott PLLA >150 µm No Off market Aptitude Amaranth
Slide 19: Fantom Launch Underway
Fantom Launch Underway Q3 2017 Q4 2017 Q1 2018 Q2-Q4 2018 Targeted Launch Direct Sales in Germany, Switzerland, and Austria Direct: Belgium and Netherlands Distributor: Europe, Middle East, South America Customers 125% increase 78% increase tba Billings1 $105,000 $98,000 $128,000 tba Revenue2 $17,00
Slide 20: Large Addressable Market in Europe
Large Addressable Market in Europe REACHABLE MARKET Stents available: 1.4M Includes countries with favorable distribution and reimbursement TARGET MARKET Stents available: 1.1M Direct: Austria, Belgium, Germany, Netherlands, Switzerland Distributor: Czech Republic, Denmark, Finland, Italy, Norway, P
Slide 21: Attractive Direct Sales Market Opportunity with Geographic Growth Potential
Attractive Direct Sales Market Opportunity with Geographic Growth Potential1 Revenue Potential European Target Markets Direct Sales in Target Accounts $36 million – 20% share Direct Sales in Target Markets $7 million – each 1% share $140 million – 20% share Distributors: $4 million – each 1% share M
Slide 22: Expanding Evidence through the Fantom Global Clinical Program
Expanding Evidence through the Fantom Global Clinical Program 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 Single center pilot
Slide 23: Extending Technological Lead: Fantom Encore
Extending Technological Lead Fantom Encore – 3rd Generation Bioresorbable Scaffold No changes to Tyrocore polymer composition or scaffold design Improved polymer processing and manufacturing techniques 1) Includes coating. Ormiston, J. New BRS Platforms. Presented EBC Rotterdam 2016.; Foin, N. Biome
Slide 24: Improving Peripheral Artery Disease Treatment with Bioresorbable Scaffolds
Improving Peripheral Artery Disease Treatment with Bioresorbable Scaffolds The Challenge Underdiagnosed: estimated > 200 million cases worldwide1 Strong mechanical forces in the legs High restenosis rates require retreatment Value of BRS Treat the diseased segment and leave nothing behind Preserve r
Slide 25: Making the World's First X-ray Visible, Absorbable Embolic Bead
Making the World’s First X-ray Visible, Absorbable Embolic Bead Embolization Overview Purpose to occlude blood vessels to restrict the supply of blood to a tumor Common Applications Oncology, especially hepatocellular carcinoma Uterine fibroids Benign prostatic hyperplasia Benefits of Tyrocore Embol
Slide 26: Long Term Growth Strategy
Long Term Growth Strategy WIN IN CORONARY INVEST IN PERIPHERAL AND EMBOLICS Geographic Growth European countries Countries that accept CE Mark New approvals, e.g. Brazil, Japan, US Product Improvements Fantom Encore: next generation with thinner struts New sizes including longer lengths and larger d
Slide 27: 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; Peripheral estimate: BTK: Nehler M, et al. Epidemiology of peripheral arterial disease and critical limb ischemia… JVS 2014.; ATK: Murabito J, et al. Temporal trends in t
Slide 28: Experienced Management Team
Experienced Management Team Reggie Groves Chief Executive Officer Brandi Roberts Chief Financial Officer Jeffrey Anderson SVP, Clinical and Regulatory Affairs Richard Kimes SVP, Operations Carmelo Mastrandrea VP, Europe Joann Yao Sr. Dir., Global Marketing
Slide 29: 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 30: Corporate Priorities & Milestones
Corporate Priorities & Milestones CORPORATE PRIORITIES Ensuring Fantom’s commercial success Expanding our business Managing our cash position UPCOMING MILESTONES Launch of Fantom Encore full matrix, 2018 Geographic expansion to additional countries in Europe, Middle East, and South America, 2018 CE
Slide 31: REVA Investment Highlights
REVA Investment Highlights LARGE, PROFITABLE MARKET DISRUPTIVE TECHNOLOGY Commercializing FANTOM® INNOVATIVE PIPELINE FIRST & ONLY proprietary polymer for coronary bioresorbable scaffolds: Fantom® and Fantom Encore made with Tyrocore™ ~$4 billion coronary stent market ripe for innovation Proprietary
Slide 32: o Fantom has CE Mark only. Fantom is available in select countries in Europe
o Fantom has CE Mark only. Fantom is available in select countries in Europe and the Middle East. Fantom is not available in the U.S. or other countries that do not accept CE Mark.