REVA Medical Corporate Presentation June 2018 ©2018 REVA Medical CC100021 Rev. H Exhibit 99.1
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, taxation situation, financial situation or needs. An investor must not act on the basis of any matter contained in this presentation but must make its own assessment of the Company and conduct its own investigations and analysis. Information is a Synopsis Only This presentation only contains a synopsis of information on the Company and, accordingly, no reliance may be placed for any purpose whatsoever on the sufficiency or completeness of such information. Information presented in this presentation is subject to change without notice and REVA does not have any responsibility or obligation to inform you of any matter arising or coming to their notice after the date of this presentation, which may affect any matter in the presentation. Forward-Looking Statements This presentation contains or may contain forward-looking statements that are based on management's beliefs, assumptions and expectations and on information currently available to management. All statements that are not statements of historical fact, including those statements that address future operating performance and events or developments that we expect or anticipate will occur in the future, are forward-looking statements, such as those statements regarding the projections and timing surrounding our plans to commence commercial operations and sell products, conduct clinical trials, develop pipeline products, incur losses from operations, list our securities for sale on a U.S. stock exchange, and assess and obtain future financings for operating and capital requirements. Readers should not place undue reliance on forward-looking statements. Although management believes forward-looking statements are reasonable as and when made, forward-looking statements are subject to a number of risks and uncertainties that may cause actual results to vary materially from those expressed in forward-looking statements, including the risks and uncertainties that are described in the "Risk Factors" section of our Annual Report on Form 10-K filed with the US Securities and Exchange Commission (the “SEC”) on March 7, 2018, and as may be updated in our periodic reports thereafter. Any forward-looking statements in this presentation speak only as of the date when made. REVA does not assume any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise. Disclaimer This presentation and any supplemental materials have been prepared by the Company based on available information. The information contained in this presentation is an overview and does not contain all information necessary to make an investment decision. Although reasonable care has been taken to ensure the facts stated in this presentation are accurate and that the opinions expressed are fair and reasonable, no representation or warranty, express or implied, is made as to the fairness, accuracy, completeness, or correctness of such information and opinions and no reliance should be placed on such information or opinions. To the maximum extent permitted by law, none of the Company, or any of its members, directors, officers, employees, or agents or advisers, nor any other person accepts any liability whatsoever for any loss, however arising, from the use of the presentation or its contents or otherwise arising in connection with it, including, without limitation, any liability arising from fault or negligence on the part of the Company or any of its directors, officers, employees, or agents. Fantom, Fantom Encore, and Tyrocore are trademarks of REVA Medical, Inc.
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
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 tailorable to meet a clinical application by modifying: Strength Flexibility Degradation time Drug delivery profile $4B Market $1.5B Market Potential $2.1B Market Potential Vascular Applications Coronary Artery Disease Peripheral Artery Disease, Above the Knee Peripheral Artery Disease, Below the Knee Sources: CAD Market: JP Morgan Equity Research Interventional Cardiology Market Model Dec. 2016; PAD Markets: BTK: Nehler M, et al. Epidemiology of peripheral arterial disease and critical limb ischemia in an insured national population. JVS 2014.; ATK: Murabito J, et al. Temporal trends in the incidence of intermittent claudication from 1950-99. AJE 2005.; Population data from United Nations online database.; Embolics: Market Research Engine, 2017. $1.3B Market Potential Embolic Particles
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 common type of heart disease CAD occurs when a build-up of plaque in a coronary artery blocks the flow of blood to the heart muscle Treatments for CAD aim to restore blood flow through the blocked artery
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
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: $2.1B Large and Profitable “The good news about those [CRM and stent] businesses is, they are extremely profitable and they generate high cash flows.” Miles White, CEO Abbott, Q2 2017 Earnings Call
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 disruptive innovation
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) Gada H, et. Al. 5-year results of a randomized comparison of Xience V everolimus-eluting and Taxus paclitaxel-eluting stents. J Am Coll Cardiol Intv 2013;6:1263-6; Data from year 5 to 10 extrapolated from 5-year data. TLF = cardiac death, target vessel MI, ischemic-driven TLR ~2% Increase in Target Lesion Failure Rates Every Year Following Treatment2 Mechanical vessel support is only needed for 3-6 months1 DES are a permanent metal implant for life DES are associated with long-term risk for adverse events
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)
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 motion Restores Blood Flow Supports Vessel Healing Dissolves and Restores Motion
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 options (bypass grafting, MRI, CT) “The ideal of a stent that does its job and disappears is a valuable long-term goal, especially in young patients with long life-expectancy.” EuroPCR 2017 course director Dr. William Wijns 1. Wood, S. New Absorb BVS meta-analysis begs the question: when to stop studying a first-gen device. tctmd.com July 2017.
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. Acute thrombosis of bioabsorbable scaffold in a patient with acute coronary syndrome. EHJ 2013 doi:10.1093/eurheartj/eht060. 5) Capodanno D, et al. Percutaneous coronary intervention with everolimus-eluting bioresorbable vascular scaffolds in routine clinical practice: early and midterm outcomes from the European multicenter GHOST-EU registry. EI 2015;10:1144-1153. 6) Ellis S, et al. Everolimus-eluting bioresorbable scaffolds for coronary artery disease. NEJM 2015;373:1905-15. 7) Serruys P, et al. ABSORB II: Three year clinical outcomes from a prospective, randomized trial of an everolimus-eluting bioresorbable vascular scaffold vs an everolimus-eluting metallic stent in patients with coronary artery disease. Presented TCT 2016. 8) Cox, C. No more Absorb BVS: Abbott puts a stop to sales. tctmd.com 2017. 2016 ABSORB II 3-year results reveal very late thrombosis events7 2015 ABSORB III 1-year results show trend towards higher scaffold thrombosis compared to DES6 2011 CE Mark2 2012 European commercial launch3 1st Gen BRS (Absorb) European Market Share1 2013 Emerging reports of acute scaffold thrombosis in ACS4 2014 Higher than expected early/mid-term scaffold thrombosis in GHOST-EU study5
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;37:1598-603. 2) BMS ST: Ellis S, et al. Long-term safety and efficacy with paclitaxel-eluting stents. JACC 2009;2:1248–59. 3) DES: Jensen LO, et al. Safety and efficacy of everolimus versus sirolimus eluting stents 5 year results from SORT-OUT IV. JACC 2016;67:751-62. 4) Wells Fargo Securities Yearly Drug-Eluting Stent Sales Estimates: 2010A to 2018E, Feb 2018. DES designed to reduce restenosis (TLR) rates But, stent thrombosis emerged as a large concern FDA Advisory Panel convened 12/2006 to evaluate DES and stent thrombosis risks DES lost nearly 30% market share to BMS as physicians returned to using BMS over these safety concerns4 2nd generation DES technical advancements resulted in improved outcomes and are now the standard of care 5-Year Event Rates1,2,3 TLR ST
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 inflation and higher expansion range Biocompatible for safety Stable for room temperature shipping and storage
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 Trial: First Randomized Comparison between the Absorb Everolimus Eluting Bioresorbable Vascular Scaffold and the XIENCE Everolimus Eluting Stent. TCT 2015. 3) ABSORB III: Ellis S, Kereiakes, D. A bioresorbable everolimus-eluting scaffold versus a metallic everolimus-eluting stent: ABSORB III. Presented ACC 2017. 4) BIOSOLVE II: Haude M, et al. Short and midterm safety, clinical performance and multimodality imaging results of the drug-eluting absorbable metal scaffold: Combined data of the BIOSOLVE-II and BIOSOLVE-III trials. EuroPCR 2017. 5) SPIRIT IV: Stone G, et al. Randomized Comparison of Everolimus- and Paclitaxel-Eluting Stents 2-Year Follow-Up From the SPIRIT IV Trial. JACC 2011;58(1):19-25. 6) RESOLUTE US: Mauri L. 2-year clinical outcomes from the pivotal RESOLUTE US study. Presented ACC 2012. *FANTOM II primary endpoint was Major Adverse Cardiac Events (MACE) which includes non-target vessel MI. The 24-month MACE rate was 5.0%.
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 data from the FANTOM II clinical trial. EuroPCR 2018. 2) Ellis S, et al. Everolimus-eluting bioresorbable scaffolds for coronary artery disease. NEJM 2015;373:1905-15. 3) Ellis S, Kereiakes, D. A bioresorbable everolimus-eluting scaffold versus a metallic everolimus-eluting stent: ABSORB III. Presented ACC 2017. Strong Performance through 24 Months
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 PLLA 115 µm No CE Submitted MeRes100 Meril PLLA 100 µm No Commercial in India Competitor material and strut thickness: Ormiston, J. New BRS Platforms. Presented EBC Rotterdam 2016.; Foin, N. Biomechanical Assessment of Bioresorbable Devices. Presented CRT 2017.
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 $17,000 $28,000 65% growth $53,000 89% growth tba Milestones 1st commercial shipments FANTOM II interim 2-year clinical data release Fantom Encore 2.5 mm CE Mark BTK CE Mark submission FANTOM II 2-year data release European Post Market Trial Fantom Encore Full Product Line Launch Making Commercial Progress Every Quarter Product billings are invoiced at the time of shipment. Revenue is recognized per our policy outlined in Form 10-Q filed with the US Securities and Exchange Commission (the “SEC”) on May 9, 2018.
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, Portugal, Spain, Sweden EUROPEAN MARKET Stents available: 2.2M 2.2 MILLION 1.4 MILLION 1.1 Million INITIAL DIRECT TARGET ACCOUNTS Stents available: 180k 150 large hospitals >1,000 procedures annually Prior experience with BRS European stent market data source: DRG MedTech 360 Market Report IC Devices Europe, June 2015; 180 THOUSAND
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 Middle East and South America Target Markets Distributors: $2.5 million – each 1% share 1) Calculations based on estimated annual procedures and an illustrative ASP of $1,000 direct or $800 distributor SHARE GROWTH DRIVERS Clinical experience New product launch Indication expansion: long lesion, multi-vessel, AMI
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 study in STEMI (n=10-20) enrolling FANTOM Post Market Trial European post-market trial (n=1,500) enrolling FANTOM III (US pivotal trial) Multi-center RCT vs. metallic DES (n=1,800-2,200) planning FANTOM Asia Multi-center RCT vs. metallic DES (n=350-400) planning Enrollment Complete – In Follow Up Enrolling Planning
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. Biomechanical Assessment of Bioresorbable Devices. Presented CRT 2017. 2) Bench testing on 3.0 mm scaffolds in water at 37°C. Radial strength measured at 15% compression. Tests performed by and data on file at REVA Medical. Achieving a Thinner Strut Profile without Compromising Strength Widens the Gap between REVA and the Competition Strut Profile Absorb1 Magmaris1 Fantom Fantom Encore 2.5 mm 157 µm n/a 125 µm 95 µm 3.0 mm 157 µm 166 µm 125 µm 105 µm 3.5 mm 157 µm 166 µm 125 µm 115 µm Radial Strength2 N/mm Higher is better
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 retreatment options Eliminate issues associated with metal fracture Proof of concept Abbott’s Esprit BRS: 11.8% TLR at 2-years (n=35)2, compares favorably to DES: 19.5% with paclitaxel-eluting Zilver stent DCB: 30% with paclitaxel-eluting Lutonix DCB 1) del Conde, I. Prevalence and importance of PAD diagnosis and treatment. ISET 2017. 2) Lammer J, et al. Bioresorbable Everolimus-Eluting Vascular Scaffold for Patients With Peripheral Artery Disease (ESPRIT I) 2-Year Clinical and Imaging Results. JACC CI 2016;9(11)1178-87. REVA Peripheral Development Plans Secure CE Mark in BTK and run initial post-market study Polymer R&D for optimal characteristics of scaffolds for ATK applications Development of tailored bioresorbable scaffold products $1.5B Market Potential $2.1B Market Potential Above the Knee Below the Knee Large Global Market Potential
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 Embolization Particles Visible under x-ray Easy to use / injectable Shapeable Controlled compressibility Absorbable to avoid chronic inflammation Loadable for drug delivery Preserves retreatment option Large Market Opportunity Competitive Landscape 1) Pleguezuelo M, et al. TACE versus TAE as therapy for hepatocellular carcinoma. ERAT 2008;8(10):1623-41. 2) Stewart EA, et al. Epidemiology of uterine fibroids: a systematic review. BJOG 2017;124:1501–12. 3) Lu SH, Chen CS. Natural history and epidemiology of benign prostatic hyperplasia. FJS 2014;47:207-10. 500,000 new cases of hepatocellular carcinoma are diagnosed every year1 75% of women will develop uterine fibroids in their lifetime2 50% of men will develop BPH by age 603
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 diameters Indication Expansion Long lesions Multi-vessel disease Acute myocardial infarction Clinical Evaluation Pursue below the knee CE Mark with current platform Assess product performance Polymer R&D Invest in development of novel polymers specifically designed for peripheral artery and embolic applications Develop New Products Introduce scaffolds for below and above the knee revascularization Tailor novel embolic products to various applications
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 the incidence of intermittent claudication from 1950-99. AJE 2005.; Population data from United Nations database. Embolics estimate: 2016 Market Research Engine Embolics Report. Coronary Revenue Potential Peripheral and Embolics Market Opportunities $3.6+ BILLION Europe: 37% Japan: 17% U.S.: 46% BELOW AND ABOVE THE KNEE $1.3+ BILLION Europe: 28% ROW: 39% U.S.: 33% EMBOLIC PARTICLES Europe Distributor ME & SA Distributor All CE Mark Japan US Revenue calculation assumes 20% market share and $1,000 ASP Cumulative revenue potential with new market entry: Europe Direct Target Markets
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
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 Australia, multiple boards Ross Breckenridge, MA FRCP PhD (2015– ) Silver Creek Pharmaceuticals, University College London Hospital Steve Oesterle (2018– ) Medtronic, NEA, Temasek, Harvard & Stanford
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 Mark for Fantom in below-the-knee application, 2018 US conditional IDE study protocol approval, anticipated 2018
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 bioresorbable polymer technologies for vascular applications Strong IP patent protection extending 2029-2034 Commercial: Germany, Switzerland, Austria, Turkey In progress: Countries in Europe, Middle East, and South America Multiple opportunities for growth: Geographic growth and expanded clinical evidence for coronary scaffolds New products for below and above the knee peripheral artery disease and embolics CORPORATE FACTS Listed on Australian securities exchange in 2010 (ASX: RVA.AX) Cash: $14.9 million1 Mkt Cap: $70 million2 Potential US stock market listing 2018; SEC registered Includes cash, cash equivalents, and investment securities as of March 31, 2018. US dollars as of close June 19, 2018.
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.
