Silk Road Medical — Investor Presentation (August 2019)
30 slides from Silk Road Medical's investor presentation, Aug 27, 2019
Slide 1: Silk Road Medical
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Slide 2: Forward Looking Statement
Forward Looking Statement Certain information contained in this presentation and statements made orally during this presentation relate to or are based on studies, publications, surveys and other data obtained from third-party sources and Silk Road’s own internal estimates and research. While Silk R
Slide 3: Commercial-stage company with TCAR for stroke prevention
Commercial-stage company that has established an TCAR entirely new, minimally invasive for procedure with potential to Stroke become the standard of care in a multi-billion $ market Prevention ~2,000 >10,000 $60-62M Q2 US Procedures WW Procedures 2019 Exp. Revenue (<5% market penetration1) (74-79% Y
Slide 4: Relentless Focus on Patient Outcomes
Relentless Focus on Patient Outcomes Every patient. Every day. 3
Slide 5: Carotid Artery Disease – 33% of Ischemic Strokes
Carotid Artery Disease – 33% of Ischemic Strokes Cause of stroke: Plaque fragments break off and move to brain Current Prevalence 4.3M people in US have carotid stenosis Source: Weerd M Stroke 2010; Modus Health Group 2018, Vascularweb.org 4
Slide 6: A Dated Standard of Care
A Dated Standard of Care Carotid Endarterectomy 65 years Major Adverse Events Collateral Damage Hospital Economics Accountable Care 5
Slide 7: CAS: An Unacceptable Tradeoff
“CAS: An Unacceptable Tradeoff” SURGICAL: ENDOVASCULAR: Carotid Endarterectomy Transfemoral Carotid Artery Stenting (CEA) (CAS) 65 years Since the ‘90s Crossing the lesion ~83% Crossing ~14% 1 of procedures the aortic of procedures arch SIGNIFICANT adverse events LOWER adverse events LOW 30-day stro
Slide 8: A ~$2.6B Annual US Treatment Opportunity in 2018
A ~$2.6B Annual US Treatment Opportunity in 2018 427K Greenfield opportunity Diagnoses Convert current procedures $1.0B 1 Established market with suboptimal treatments $665M High Surgical Risk, ~2/3 or 111K procedures 168K 259K 2 Treated1 Monitored $340M Standard Surgical Risk, ~1/3 or 57k procedure
Slide 9: The New Normal: Endovascular Procedures
The New Normal: Endovascular Procedures THE LAST FRONTIER: Open to Endo Conversion Cerebral 79% Aneurysms Carotid Artery Disease: Coronary U.S. 76% Artery Disease 17% Endo1 83% Thoracic/ Surgical Abdominal 70% 168K Aortic Procedures Aneurysms in 2018 Peripheral 85% Arterial Disease = Endo = Surgical
Slide 10: TCAR is the Solution
TCAR is the Solution TCAR Paradigm Shift: Transcarotid Minimally Invasive Avoids Aortic Arch Avoids Cranial Nerve Plexus High Rate Flow Reversal Neuroprotection TCAR combines advantages from both worlds: surgical principles of neuroprotection and game changing Accurate stenting endovascular technolo
Slide 11: TCAR Carotid-Specific Dedicated Portfolio
TCAR Carotid-Specific Design, ENHANCE® Dedicated Portfolio Transcarotid Peripheral Access Kit ENROUTE® Transcarotid Neuroprotection System (NPS) Helps Protect the Brain During the Procedure ENROUTE® Transcarotid Stent System Helps Protect the Brain After the Procedure ENROUTE® 0.014” Guidewire 10
Slide 12: The proof is in the filter
The proof is in the filter >10,000 TCAR procedures worldwide1 1 As of 04/30/2019 11
Slide 13: Proven Stent Durability
Proven Stent Durability Carotid Artery Stenting (CAS) % Stroke The weak link Risk is the procedure… NOT Carotid Endarterectomy (CEA) the stent 30 days 10 years+ Time Source: CREST 10-year follow-up, N Engl J Med 2016; 374:1021 1031. 12
Slide 14: Clinical Trials: Day Stroke Rate
Clinical Trials: 30 Day Stroke ROADSTER Trial Design and Purpose ROADSTER1 CREST2 4.1% • 1st time TCAR in the US “The overall stroke rate of 1.4% is the lowest reported to date for any prospective, multi- center trial of carotid stenting.” • 1st generation NPS – J Vasc Surg 2015;62:1227-35 2.3% • Su
Slide 15: Growing Clinical Evidence
Growing Clinical Evidence ROADSTER2 Real World Registry: 30 Day Stroke Validates low stroke rate 4.1% seen in ROADSTER1 Confirms Short Learning Curve 80% of enrolled physicians new to TCAR 2.3% Low Rates of 30-Day MAEs Stroke/Death/MI (1.7%), Stroke/Death (0.8%), acute CNI (1.3%) and permanent CNI (
Slide 16: Coding, Coverage, Payment: Unprecedented alignment
CODING COVERAGE PAYMENT September 2016 Unprecedented alignment TCAR High Surgical Risk: Symptomatic and Asymptomatic 15
Slide 17: Challenging the Standard of Care
Challenging the Standard of Care Matched Population: 5,160 TCAR Patients vs. 5,160 CEA Patients TCAR Surveillance Project 1.8 1.6 Significantly No Significant 1.4 Favors TCAR Difference p<0.38 (0.83-1.65) 1.2 Odds p<0.64 p<0.63 Ratio p<0.19 (0.64-1.32) 1.0 p<0.001 p<0.09 (0.46-1.61) p<0.001 (0.58-1.
Slide 18: TCAR: Established Codes and Payment
TCAR: Established Codes and Payment Physician: CPT Code Hospital: ICD-10 Codes TCAR 37215 $1,050 TCAR DRGs 034-36 $13,850 CEA 35301 $1,187 CEA DRGs 037-39 $9,360 171 3.0 1.9 74 ROADSTER CEA: CREST* ROADSTER CEA: CREST* Procedure Time (minutes) Length of Stay (days) Medicare national average payment
Slide 19: Procedure Margin Economic Value Proposition
Procedure Margin Economic value proposition easily understood by Value Analysis Committees CEA DRG1 038 PROCEDURE2 CEA HOSPITAL3 TCAR DRG1 035 PROCEDURE2 TCAR HOSPITAL3 REIMBURSEMENT COSTS1 PROCEDURE REIMBURSEMENT COSTS1 PROCEDURE MARGIN MARGIN Hospital stay margin: TCAR furthers the economic advant
Slide 20: Why Vascular Surgeons Have Adopted TCAR
Why Vascular Surgeons Have Adopted TCAR which is moving towards the standard of care Growing clinical P2P influence & inter/intra evidence base specialty competition Quality initiatives and Better patient and economic incentives physician experience 19
Slide 21: Easy-to-Learn Procedure with Many Physicians Trained
Easy-to-Learn Procedure with Many Physicians Trained Indicative Short Learning Curve Minimal procedure support First 10: 3-5 adoption Training inflection procedures 20
Slide 22: Commercial Strategy: Efficient Go-to-Market
Commercial Strategy: Efficient Go-to-Market Concentrated Market Growing Adoption ~2,750 physicians perform Clinically-Focused ~80% of procedures1 Direct Sales Force ~1,275 >8,000 ~500 ~75% ~775 Concentrated 4,573 hospital base and procedure volume drives efficient coverage model 2 2 2018 2019E 2018
Slide 23: Attractive Business Model
Attractive Business Model Procedural Sale ENROUTE® Transcarotid ENHANCE® Neuroprotection System Transcarotid Peripheral Access Kit 4 Products 1 Procedure Compelling ENROUTE® Transcarotid Gross Margins Full Procedure Stent System 1 ENROUTE® 75% ASP 0.014” Guidewire 1 Six months ended June 30, 2019 22
Slide 24: Building and Maintaining a Sustainable Competitive Advantage
Building and Maintaining a Sustainable Competitive Advantage Easy to Support of Teach and Learn TCAR Key Society Procedure Sole Player in Greenfield Opportunity Dedicated Carotid Compelling Sales Force Clinical Data Robust TCAR-Specific Intellectual Reimbursement Property Unique Transcarotid Regulat
Slide 25: Procedure-Driven Ramp
Procedure-Driven Ramp $14.9 16 $12.8 14 $11.5 ~2,000 12procedures $9.6 10 $7.8 8 $5.7 6 4 2 0 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 2017 2018 2019 Procedure YoY Growth 220% 195% 142% 118% 120% 98% US Procedures Net revenue ($mm) 24
Slide 26: Solid Financial Profile
Solid Financial Profile Quarterly Results1 Annual Results2 ($ millions) ($ millions) <5% procedure share3 $14.9 $60.0 - $62.0 >8,000 $7.8 $34.6 4,573 $14.3 1,806 Q2 2018 Q2 2019 2017 2018 2019E* 1 Represents three-months ended June 30, 2019 compared to three-months ended June 30, 2018 2 Represents t
Slide 27: Well-Positioned for Long Term Growth
NEW MARKETS Well-Positioned for INTERNATIONAL EXPANSION Long Term Growth MARKET EXPANSION LABEL EXPANSION PRODUCT EXPANSION Heart MARKET Aortic Arch Brain OUS CONVERSION Penetration of Markets medically Standard managed surgical risk TCAR Penetrate accessories existing high surgical risk procedures
Slide 28: Built For Size and Scale: Proven Management Team
Built For Size and Scale Proven Management Team Erica Rogers Lucas Buchanan President & CEO Chief Financial Officer Med360, Visiogen, Boston Sci, Target The Vertical Group, Medtronic, E&Y Andrew Davis EVP Global Sales & Marketing Medtronic, Acelity, Boston Scientific Richard Ruedy EVP Clinical, Reg,
Slide 29: A New Era, A New Vascular Category
A New Era, A New Vascular Category ~$2.6B US MARKET Carotid artery disease is a multi-billion dollar category with one TCAR player with the potential to become the standard of care for the last OPPORTUNITY endovascular frontier COMPELLING Safety, effectiveness and clinical advantages of TCAR have be
Slide 30: Appendix
APPENDIX
Silk Road Medical — Investor Presentation (August 2019) on 6ix