Ra Medical Systems Filed pursuant to Rule 433 under the Securities Act of 1933, as amended Dated May 15, 2020 Registration Statement No. 333-237701 Ra Medical Systems, Inc. NYSE: RMED Corporate Presentation May 15, 2020
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Ra Medical Snapshot DABRA—Excimer laser that utilizes disposable catheters for crossing total chronic occlusions (CTOs) and ablating a channel in occlusive peripheral vascular disease. DABRA is used as a tool to treat peripheral artery disease (PAD), a form of peripheral vascular disease. Photoablation to disintegrate plaque in the artery Designed to track the patient’s true lumen Established safety profile, effective, easy-to-use, and competitively priced No serious device-related adverse events reported in our 2017 pivotal study or in our post-market surveillance Regulatory clearances in US and Europe PHAROS—Dermatology, same laser platform as DABRA US FDA 510(k) clearance and Europe CE Mark for psoriasis, vitiligo, atopic dermatitis and leukoderma
Highlights Novel Therapeutic Solution with Positive Clinical Study Results Existing US Reimbursement Structure Time Efficient and Easy-to-Use Solution Cost Benefits to Outpatient-Based Catheterization Laboratories $1.1B Targeted Global Annual TAM; >17M PAD Sufferers in the US Single-Use Catheters Highly Experienced Leadership
Peripheral Artery Disease Disease Overview Atherosclerosis of the lower extremities—most commonly in the legs Smoking, genetic predisposition, diabetes, age and obesity may increase risk Characterized by reduced blood flow to surrounding tissue If untreated can cause critical limb ischemia (CLI) resulting in ulceration, infection or gangrene and may result in limb amputation or death if left untreated Disease BurdenUp to 200,000 amputations performed annually in the US as a result of PAD Patient Care Diagnosed by primary care physician, podiatrist or other specialist Treatment by interventional cardiologist, interventional radiologist or vascular surgeon Only 20 to 30% of peripheral artery disease patients are actively being treated
Current Treatments and Limitations Non-Invasive Management Interventional Procedures Surgical Procedures Lifestyle Changes Often hard to sustain Pharmacotherapy Generally prescribed for life and do not treat the obstruction, making them ineffective for many More aggressive treatments often required Angioplasty Trauma due to balloon inflation may cause vessel to reocclude Possible dissection May damage arterial walls Does not remove plaque Not well suited for highly calcified lesions and bifurcations Often requires stenting Stenting Subject to fractures Cannot be removed Atherectomy Can damage vessel walls due to potential mechanical and thermal trauma Bypass Surgery Invasive procedure Requires general anesthesia Multi-day hospital stay Amputation Life altering procedure
DABRA Technology and Mechanism of Action DABRA Technology 308 nanometer excimer laser system Unique liquid-filled, full aperture ratio catheter High quality lumen Minimizes mechanical or thermal trauma Mechanism of Action Photoablation Removes blockages by breaking the bonds of the obstructing plaque directly Plaque broken down into fundamental chemistry Plaque Removal Process Crosses through totally occluded lesions Improves blood flow before after Photoablation light energy breaks molecular bonds of atherosclerotic plaque
Our Solution: DABRA Portable Easy to store Intuitive interface Easy calibration Proprietary catheter Therapy Cost and Time Efficient Can cross and de-bulk wide variety of plaque Soft thrombus to hard calcified plaque Tool used by physicians to treat Chronic Total Occlusions (CTOs) prior to other alternative treatments Ability to use Above-the-Knee (ATK) and Below-the-Knee (BTK) Monotherapy or adjunct to angioplasty or other treatments Programs available without need for capital equipment purchase Designed to track the true lumen Average of approximately two and a half minutes of lasing time per procedure DABRA Features
9 Clinically Demonstrated Solutions Safety Record Pivotal Study 1 • Multi - site study at four sites in US and Mexico • Enrolled 64 patients with target blockage refractory to guidewire crossing Primary Efficacy Endpoint: • Successful crossing of target lesion based on angiographic analysis at time of procedure • 0% reported device - related serious adverse events 2 (SAE), observed in our 2017 pivotal study DABRA Effectiveness (pivotal study) 0 10 20 30 40 50 60 70 80 90 100 94% 1. The pivotal study formed the basis of our May 24, 2017 510(k) clearance. 2. For information on how we defined device - related SAEs for purposes of our pivotal study, see https://clinicaltrials.gov/ct2/show /study/NCT02653456
Large US Addressable Market Opportunity KEY DRIVER Current US Market Opportunity MARKET OPPORTUNITY Global Annual Total Addressable Market (TAM) Opportunity in 2017 $1.1B1 >17 Million PAD Sufferers in the US Coronary Artery Disease Other Vascular Occlusions In-Stent Restenosis Atherectomy (with a pre-specified improvement in luminal patency) Increased Awareness Evolving Physician Practice Patterns We target the high-growth outpatient based catheterization laboratories segment for PAD For global atherectomy devices, based on third-party research Only 20–30% of PAD Patients actively treated Potential Future Growth Applications TREATED PATIENTS (Not FDA approved) PREVALENCE
Payors and Reimbursement Approvals / Clearances DABRA: US FDA 510(k), CE Mark PHAROS: US FDA 510(k), CE Mark Payor Coverage Reimbursement claims for DABRA procedures typically submitted by providers to Medicare or other third-party payors using established Current Procedural Terminology (CPT) codes Pharos treatments are reimbursable by Medicare and nearly all major insurance companies under three CPT codes that differ based on the affected area to be treated
Physician Practice Needs Ease of Use Established Safety and Efficacy Versatility Able to cross and debulk Economics We believe our solution expands provider economics
Pharos Excimer Laser Used by Physicians to Treat Chronic Skin Diseases Psoriasis—chronic autoimmune disorder that causes cells to rapidly accumulate and affects the surface of the skin causing scales and red patches Vitiligo—autoimmune condition causing the skin to turn white due to the loss of pigment from the melanocytes, the cells that produce the pigment melanin, which give the skin its color Atopic dermatitis—results in itchy, red, swollen and cracked skin Market Opportunity for Chronic Skin Disease Psoriasis, vitiligo and atopic dermatitis are common skin disorders Psoriasis affects ~7.5 million in US, >2% of the population ~$135 billion annually in direct, indirect, quality of life and comorbidity health care costs Vitiligo affects 0.5%-1.0% of the population worldwide Skin conditions affect ~125 million individuals worldwide ~17.8 million Americans suffer from dermatitis
Pharos Science, Advantages and Reimbursement Pharos Science Same laser platform as DABRA 308-nanometer laser—the center of action spectrum for most immune-mediated inflammatory diseases Does not use heat or ablate lesions—treatments are generally painless Adjustable aiming beam accurately targets only diseased tissue, sparing healthy skin from exposure Delivers uniform dosing for optimal results Small footprint for space conservation, among the lightest of excimer lasers Advantages Topical treatments, such as steroids and vitamin D derivatives, may require frequent ongoing application Pharmaceutical treatment may be associated with systemic side effects Clearance and Reimbursement Granted FDA 510(k) clearance for psoriasis, vitiligo, atopic dermatitis and leukoderma Clearance from Europe CE Mark, and China Food and Drug Administration Reimbursed using established CPT codes for excimer laser treatment of inflammatory skin disease
Fully Operational Manufacturing Facility Carlsbad, CA Sizable capacity for laser and catheter production 41,000 sq. ft. Carlsbad, CA with three controlled environments manufacturing facility fully staffed and operational Existing facility expected to be capable of manufacturing > 400 lasers/year and 140,000 catheters/year Fully capitalized with all equipment owned ISO13485 certified, FDA and CA state inspected Laser Assembly Controlled Environments
Pipeline Indications (Not FDA Approved1) DABRA (Vascular) PHAROS (Dermatology) Atherectomy (IDE submitted) (with a pre-specified improvement in luminal patency) Cutaneous T-Cell Lymphoma (CTCL) Coronary Artery Disease (CAD) In-Stent Restenosis Other Vascular Occlusions No application has been made to the FDA as of the date hereof for these indications (except Atherectomy, pivotal trial underway).
Intellectual Property Portfolio Patents covering several aspects of the laser systems and delivery device The Company believes that its intellectual property comprises novel and useful inventions that can be protected by patents, and as such, has filed patent applications directed to innovative methods and apparatus patents Issued patents as of March 6, 2020 include: 6 US / 2 International Patent/File No. Title Filing Date Country Status 9,700,655 ZL201280061080.0 27659449, 962,527 10,245,417 10,322,266 10,384,038 10,555,772 Small flexible liquid core catheter for laser ablation in body lumens and methods for use Small flexible liquid core catheter for laser ablation in body lumens and methods for use Small flexible liquid core catheter for laser ablation in body lumens and methods for use Methods and devices for treatment of stenosis of arteriovenous fistula shunts Devices for extending shelf life of liquid core catheters Method and device for treatment of stenosis of arteriovenous fistula shunts Method and device for treatment of stenosis of arteriovenous fistula shunts Laser ablation catheters having expanded distal tip window for efficient tissue ablation 10/12/2012 10/12/2012 10/12/2012 10/15/2014 10/02/2017 10/2/2017 10/2/2019 11/22/2016 USA China Europe USA USA USA USA USA USA Issued Issued Issued Issued Issued Issued
18 Executive Team and Board of Directors Will McGuire Chief Executive Officer Andrew Jackson Chief Financial Officer Jeffrey Kraws President Dan Horwood General Counsel and Secretary Martin Colombatto Chairman. Former VP and General Manager of Broadcom Maurice Buchbinder, MD Interventional Cardiologist Master of Surgery from McGill University William Enquist Former President of Global Endoscopy of Stryker Will McGuire Chief Executive Officer, Ra Medical Former CEO Second Sight, former executive at Covidien, AtheroMed, Spectranetics. Richard Mejia Former Partner of Ernst & Young Mark Saad Partner and COO of Alethea Capital Management LLC, Former CFO of Cytori Therapeutics and former executive director of UBS Investment Bank Joan Stafslien Former General Counsel of NuVasive and CareFusion Executive Team Board of Directors
Financial Overview Ra medical system
[logo] Financial Overview
Business Model Laser Module Capital Placement and Sale DABRATM Catheter Consumable Recurring Revenue Practical, easy to use equipment, anticipated recurring revenue single-use catheter solution
Results of Operations ($ in thousands) Vascular Net Revenue Dermatology Net Revenue Total Net Revenue Gross Profit (Loss) Operating Expenses: Selling, General and Administrative (Incl. $0.9M and $20.4M stock comp exp.) Research and Development (Incl. $0.1M and $1.5M stock comp exp.) Total Operating Expenses Loss from Operations Net Loss Adjusted EBITDA * Quarter Ended Year Ended Mar. 31, 2020 Dec. 31, 2019 $113 $1,261 $(210) $6,285 $1,295 $7,580 $(7,790) $(7,701) $(6,165) $1,275 $5,924 $7,199 $(1,651) $51,549 $4,530 $56,079 $(57,730) $(56,957) $(32,437) * Adjusted EBITDA is a non-GAAP measure and is calculated as net profit (loss) excluding interest income (expense), income tax expense and certain recurring, non-cash charges such as depreciation and amortization of long-lived assets as well as stock-based compensation expenses. See appendix for reconciliation to the most directly comparable GAAP measure.
Financial Position ($ in thousands) Cash and Cash Equivalents and Short Term Investments Working Capital1 Total Assets Equipment Financing Accumulated Deficit Total Stockholders’ Equity As of Mar. 31, 2020 As of Dec. 31, 2019 $23,440 $30,577 $22,667 $29,186 $36,300 $44,081 $482 $558 $(124,858) $(117,157) $26,474 $33,150 We define working capital as current assets less current liabilities
Milestones 3Q18 – IPO 1Q19 – Started Registry to study the benefit and safety profile of DABRA over a two-year term 2Q19 – Hired VP Quality, Regulatory and Clinical Affairs 3Q19 – Launched Pharos, Optimized 3Q19 – Received FDA approval for IDE to initiate atherectomy clinical trial 1Q20 – Enrolled first patient in clinical trial with DABRA for atherectomy 1Q20 – Enhanced and next generation products design, including potential over-the-wire offering for DABRA 1Q20 – Hired Dr. Chris Folk as VP Engineering 1Q20 – Hired Will McGuire as CEO Engage partners to expand markets, both geographical and product offerings
Highlights Novel Therapeutic Solution with Positive Clinical Study Results Existing US Reimbursement Structure Time Efficient and Easy-to-Use Solution Cost Benefits to Outpatient-Based Catheterization Laboratories $1.1B Targeted Global Annual TAM; >17.M PAD Sufferers in the US Single-Use Catheters Highly Experienced Leadership
Appendix
Reconciliation of Net loss to Adjusted EBITDA ($ in thousands) Statement of Operations Data: Net loss Depreciation and amortization Interest income Interest expense Income tax expense EBITDA Stock-based compensation Adjusted EBITDA Quarter Ended Mar. 31, 2020 Year Ended Dec. 31, 2019 $(7,701) $(56,957) $578 $1,750 $(114) $(1,038) $25 $250 - $15 $(7,212) $(55,980) $1,047 $23,543 $(6,165) $(32,437)