Inspiremd Inc. · NASDAQ:NSPR
Inspiremd — Investor Presentation (January 2019)
30 slides from Inspiremd's investor presentation, Jan 9, 2019
Slide 1: InspireMD Investor Presentation
inspireND INVESTOR PRESENTATION NYSE AMER: NSPR | January 2019
Slide 2: Forward Looking Statements
Forward Looking Statements This presentation contains “forward-looking statements.” Such statements may be preceded by the words "intends, may,” “will,” "plans," “expects,” "anticipates," “projects,” "predicts," “estimates,” "aims," "believes," "hopes," “potential” or similar words. Forward-looking
Slide 3: About InspireMD
About InspireMD InspireMD is a commercial-stage medical device company developing and marketing innovative embolic prevention systems (EPS) that can prevent harmful consequences, with a primary focus on preventing stroke in patients with carotid artery disease (CAD) COMPANY TECHNOLOGY PRODUCTS NYSE
Slide 4: Company Highlights
Company Highlights Tectrcrtemeet tram 4 potential paradigm shit in the treatment of carotid artery disease and stroke prevention EPS Highly differentiated with strong KOL support REESE CURESceRayE Seven completed and four ongoing clinical trials multiple trials Demonstrates strong benefits versus co
Slide 5: Leadership
Leadership Significant track records of success Boston, (Pfizer President and CEO Scientific Craig Shore ‘ @ Michael Berman Boston, % S Director Scienufic Gl“ LUTONIX Campbell Rogers, M.D. O HeartFlow Cordis. Bee Director Sol Barer, Ph. Special Advisor to the Board inspireMD January 20191 5
Slide 6: Stroke is the Second Biggest Cause of Death
Stroke is the Second Biggest Cause of Death An estimated 15 million people suffer from stroke annually? + 5.7 million deaths" + 5 million people left permanently disabled? * $34 billion associated with stroke management in the US alone? 18 16 14 12 10 CNR O® mischaemic Heart Disease Stroke ml Other
Slide 7: Stroke Prevalence Increasing Among Young People
Stroke Prevalence Increasing Among Young People Between 1990 and 2013, there was a significant increase in the global prevalence of ischemic stroke among young people aged 20-64 Approximately 85% of all strokes are ischemic strokes, which result from a lack of blood flow to the brain Carotid artery
Slide 8: Unmet Need: A Safer Technology for Stroke Prevention in CAD
Unmet Need: A Safer Technology for Stroke Prevention in CAD Surgery vs. Carotid Artery Stenting Filter Protected Stenting (CAS) Carotid Endarterectomy (CEA) “Gold standard”', but... Patient friendly, long-term durability’, Invasive; risk of surgical complications Non-Invasive: risk of complications
Slide 9: Embolization Following Carotid Artery Stenting
Embolization Following Carotid Artery Stenting Plaque protrusion through stent struts occurs in up to 65% of conventional carotid stents, depending on plaque morphology/symptomatic status and stent type. The consequence is cerebral embolization, either directly or via additional thrombus formation.
Slide 10: Consequences Range from Neurological Deficit to Stroke
Consequences Range from Neurological Deficit to Stroke Pree Post-intervention showing successful opening of the occluded carotid artery with conventional stenting and an MRI showing multiple micro-infarcts (obstructions) post- procedure due to liberation of embolic particles. Pre-intervention showin
Slide 11: A Billion Dollar Market Opportunity
A Billion Dollar Market Opportunity Carotid procedures today are primarily surgical 80% of Market mCEA =CAS MicroNet™ covered stents could become the Gold Standard Carotid procedures tomorrow could be mostly minimally invasive with CGuard™ of Market 2.2M diagnosed with carotid artery disease 2017: ~
Slide 12: The InspireMD Solution: CGuard EPS
The InspireMD Solution: CGuard™ EPS CGuard™ EPS Plaque protrusion may lead to early and late distal embolization Debris Arterial ~y Dy Wall Stent_Y Struts The MicroNet™ permanently covers plaque and stops “debris” from passing through the mesh. + Ultrathin PET mesh made of a single 20 micron fibre f
Slide 13: The InspireMD Solution: CGuard EPS
The InspireMD Solution: CGuard™ EPS No plaque coverage - leading to plaque protrusions or The MicroNet™ permanently covers plaque and prolapse passing into the vessel lumen prevents “debris” from passing through the mesh. CGuard™ EPS »Net mesh preventing prolapse 9113 inspireMD
Slide 14: Positive CGuard EPS Clinical Experience
Positive CGuard™ EPS Clinical Experience CARENET Clinical Trial (2014) 30 Patient Safety and Efficacy clinical trial Zero major adverse cardiac or cerebral events (MACCE) at 30 days (Comparative data 5.72%") ‘50% fewer new ischemic lesions with lesion volume being 10x times ‘smaller compared to hist
Slide 15: Independent Clinical Validation
Independent Clinical Validation Independent study conducted in 30 patients with internal carotid artery disease Clinical results (2016) 100% success in implanting the CGuard™ EPS No peri- or post-procedural complications No deaths, major adverse events, minor or major strokes, or new neurologic symp
Slide 16: Independent Clinical Validation (continued)
Independent Clinical Validation (continued) The Iron-Guard Registry + Physician initiated + 12 large Italian medical centers + 200 patients Clinical Results + 100% success in implanting the CGuard EPS + No major adverse cerebrovascular cardiac events at 30 days + DW-MRI performed in 61 of 200 patien
Slide 17: CGuard EPS vs Conventional Stents and Surgery
CGuard™ EPS vs Conventional Stents and Surgery 30 day MACE results (Major and Minor Adverse Cardiac and Cerebral Events) * CGuard™ EPS has a superior profile versus historical data on both conventional 6.00% carotid stents and surgery _ Sed) See 4.50% (3) CGuard™ is a next-generation stent Aine supp
Slide 18: A Leading Vascular Surgeon's View
A Leading Vascular Surgeon’s View “The CGuard™, in comparison to other [carotid] stents, even in comparison to other mesh covered stents, is a very easy to use device. Very simple, you take it off the shelf and you use it and that’s it.” “Patient risks associated with stenting using CGuard™ are far
Slide 19: CGuard EPS - Accelerating Sales Growth
CGuard™ EPS - Accelerating Sales Growth Growth continues to accelerate for 2018/2017 Year End Sales in USD Sept. YTD Sales in USD 2,500,000 2,500,000 (2,268,345 1,500,000 1,500,000 7,315,000 1,147,000" 1,000,000 1,000,000 500,000 500,000 Year End 2016 Year End 2017 Sept. YTD 2017, Sept. YTD 2018 ins
Slide 20: Accelerating CGuard Sales Growth: Italy
Accelerating CGuard™ Sales Growth: Italy Italy CGuard sales in USD Italy Sept. YTD 2017 and 2018 CGuard sales in USD 600,000 Pano WU 600,000 500,000 — 5 400000 423,000 — } 365,000 aogiw00 ui iM 300,000 - - 300,000 i a 229,000. . 200,000 : 200,000 + 7 100,000 a 100,000 ul iM | 0 - - - ate oni Sept. Y
Slide 21: Accelerating CGuard Sales Growth: Germany
Accelerating CGuard™ Sales Growth: Germany New Distributor in Q2 2017 Growth Trend is accelerating 700,000 600,000 500,000 400,000 300,000 200,000 100,000 0 Sept. YTD in USD 602,000 236,000 ‘Sept. YTD 2017 Sept. YTD 2018 January 2019 1 21
Slide 22: Accelerating CGuard Sales Growth: Poland
Accelerating CGuard™ Sales Growth: Poland Sept. YTD in USD 200,000 179,000 180,000 New Distributor in 160,000 Q2 2017 140,000 120,000 Growth Trend is accelerating 100,000 80,000 63,000" 60,000 40,000 20,000 0 ‘Sept. YTD 2017 Sept. YTD 2018 inspireMD January 20191 22
Slide 23: Addressable Stroke Prevention Device Market
Addressable Stroke Prevention Device Market SQ \ SX = O° O 13mn people 2.2mn people ~600,000 received Untapped market: At Plus roughly globally with high with HGS surgical/stent least 1.6mn patients 10mn people who grade carotid diagnosed treatment could be helped by are undiagnosed stenosis (HGS) 2
Slide 24: Commercial Strategy
Commercial Strategy Transition current users of conventional carotid stents to CGuard™ EPS Communication of CGuard™ EPS clinical data Continue to support investigator initiated clinical registries Engage advisory board, further develop network of KOLs, establish centers of excellence Expand footprin
Slide 25: CGuard EPS Product Development
CGuard™ EPS Product Development + Pre-IDE FDA submission for CGuard™ EPS February 2017 + Formal FDA meeting held April 2017 + 9 months of pre-clinical work required to file IDE application to begin a US clinical trial Innovative Pipeline Developments Evaluating synergistic opportunities + Proactivel
Slide 26: Recent/Upcoming Anticipated Milestones
Recent/Upcoming Anticipated Milestones Continued clinical trial/registry results Establish Centers of Guard approval in Excellence Approval in Australia Saal 12018 22018 12019 MID2019 22019 CGuard approval and Guard U.S. IDE launch in Mexico. submission Continued market execution and revenue growth
Slide 27: Intellectual Property Portfolio
Intellectual Property Portfolio PATENT RIGHTS ISSUED OWED PENDING USA 12 A. 7 Rest of World 36 2 22 Proprietary platform technology supported by a robust intellectual property portfolio Continue to strengthen and broaden patent protection globally to enable future pipeline products inspireMD January
Slide 28: Summary Financials
Summary Financials NYSE AMER NSPR Stock Price (1/4/19): $0.17 Average three month daily trading volume: 1.9M Shares outstanding (12/31/18): 38.4M Shares Outstanding Including full conversion of preferred shares and prefunded warrants 44.7M (12/31/18): Market Capitalization including full conversion
Slide 29: Summary
Summary Q Focused on the deadly and catastrophic problem of stroke that is estimated to cost the healthcare system more than $34BB annually in the US alone Q@ The current addressable market for CGuard ™ EPS is estimated to be $1BB with the potential to further expand into the 1.6MM patient populatio
Slide 30: James Barry, President and CEO; Craig Shore, CFO
James Barry, Ph.D., President and CEO Craig Shore, CFO inspireMD 888.776.6804 888.776.6804 jimb@inspiremd.com craigs@inspiremd.com