Sensus Healthcare, Inc. · NASDAQ:SRTS
Sensus Healthcare — IPO Roadshow (May 2016)
42 slides from Sensus Healthcare's IPO roadshow presentation, May 19, 2016
Slide 1: Issuer Free Writing Prospectus
Issuer Free Writing Prospectus Filed Pursuant to Rule 433 Registration No. 333 - 209451
Slide 2: Safe Harbor Forward-Looking Statements
Safe Harbor Forward - Looking Statements This presentation includes statements that are, or may be deemed, ‘‘forward - looking statements.’’ In some cases, these forward - l ooking statements can be identified by the use of forward - looking terminology, including the terms “believes,” “estimates,”
Slide 3: Free Writing Prospectus
Free Writing Prospectus This presentation highlights basic information about the Company and the offering. Because it is a summary, it does not contain all of the information that you should consider before investing. This offering may only be made by means of a prospectus. We have filed a registrat
Slide 4: Offering Summary
Offering Summary Issuer Sensus Healthcare, Inc. Offering Size 1,750,000 Units Over - Allotment Option 262,500 Units (15%) Unit Composition One share common stock and one warrant to purchase one share of common stock Expected Price $6.25 per Unit ($6.00 per share, $0.25 per warrant) Listing / Symbols
Slide 5: Overview
Overview ▪ Design, manufacture and market FDA - approved Superficial Radiation Therapy (SRT) technology » Strong IP portfolio (3 FDA clearances, 2 provisional patent applications and several other applications being prepared for submission) » Over 220 installations worldwide » Key markets: Dermatolo
Slide 6: Management Team
Management Team Joseph C. Sardano, President and CEO ▪ Elscint Medical Imaging – Vice President driving Sales & Marketing, led to joint acquisition between General Electric and Picker Medical (Philips) Imaging totaling approximately $650M. ▪ GE Healthcare – GSM, Functional Imaging (Positron Emission
Slide 7: Our Technology: Superficial Radiation Therapy (SRT)
Our Technology Superficial Radiation Therapy (SRT) ▪ Proven technology » Orthovoltage was first developed in the mid - 1900s ▪ Low energy Photon Radiotherapy » 100% of the energy is focused directly onto the surface of the skin using custom applicators » Penetrates no deeper than 5mm below the surfa
Slide 8: Value Proposition
Value Proposition Practice Patient ▪ Cost effective ▪ Increased productivity ▪ Excellent ROI ▪ Existing CPT codes ▪ Improved cash flow ▪ Additional treatment choices ▪ No anesthesia, cutting, bleeding, stitching, or scarring ▪ Painless ▪ Comparable cure rates as Mohs Surgery (95%+) ▪ Recurrence rate
Slide 9: Skin Cancer: Large & Growing Market
0.00 0.50 1.00 1.50 2.00 2.50 3.00 3.50 4.00 4.50 Volume Cancer Type Estimated Cancer Incidence Rates for 2011 Skin Cancer: Large & Growing Market Source: American Cancer Society; Cancer Facts and Figures 2011 ▪ Fastest growing cancer indication with 6M+ new cases/year by 2020 ▪ 3X greater than all
Slide 10: Skin Cancer: Treatment Challenges
▪ Current gold standard treatment for non - melanoma skin cancer (NMSC) ▪ Invasive & complicated ▪ Requires highly - skilled surgeon ▪ Often results in poor cosmetic outcomes in facial areas, forcing patients to consider reconstructive surgery and wound care ▪ Pre existing conditions (diabetes, hear
Slide 11: SRT-100 vs. Mohs Surgery
Parameter SRT Mohs Procedure Time 40 sec avg./ 10 - 20 treatments 1 - 3 hours Treatment Type Non - Invasive Invasive Modality Therapy Mode SRT Surgery Who Rad Onc / Derm / Plastic Surgeon Mohs Surgeon Pain N Y Anesthesia N Y Practice Setup / Cost of Entry Low High Avg. Reimbursement Per Patient $1,3
Slide 12: Keloids: Large & Growing Market
Keloids: Large & Growing Market ▪ A keloid is an area of irregular fibrous tissue formed at the site of a scar or injury ▪ NIH estimates over 11 million individuals worldwide living with keloid scars » Genetic predisposition to having keloids: African Americans, Latinos, Asians » Incidence is estima
Slide 13: Keloids: Treatment Challenges
▪ Mono - therapeutic treatment methods may reduce the size of the keloid, but are not a permanent solution ▪ Recurrence rates of keloids are very high – up to 90% ▪ Expensive treatments that are often paid out of pocket; insurance does not cover treatment unless combined with SRT ▪ Significant compl
Slide 14: Key Sales Targets
Mohs Surgeons Dermatologists Plastic Surgeons Hospitals and Surgery Center Procedures Radiation Oncologists 14 Key Sales Targets
Slide 15: Go-to-Market Strategy
Go - to - Market Strategy ▪ Expand U.S. Operations » Sales & Marketing • Increase direct sales account reps to 20+ in 2016, 30+ in 2017 (+5 YTD) • Hire marketing director in Q2/Q3 of 2016 » Added clinical support professional in Q1 2016 » Added direct regional service engineer in Q1 2016 ▪ Expand In
Slide 16: Reimbursement
▪ SRT reimbursement coverage available for skin cancer and keloid treatment » Skin cancer: Medicare Part B and most insurance carriers accept SRT treatment » Keloids: Aetna, Humana and other insurance carriers cover excisional surgery with SRT treatment ▪ SRT reimbursement policy changes by CMS make
Slide 17: Historical Annual Results
Historical Annual Results 17 $000 2011 2012 2013 2014 1 2015 Revenue 4,045 7,020 10,479 5,810 10,273 Cost of Sales 1,583 2,295 3,600 2,055 3,699 Gross Profit 2,462 4,725 6,879 3,755 6,574 Operating Expenses: Sales and Marketing 2,249 2,876 3,966 4,208 3,743 General & Administrative 1,194 1,068 1,453
Slide 18: Quarterly Results
Quarterly Results 18 $000 Q1 2015 Q1 2016 Revenue 1,930 3,035 Cost of Sales 724 1,102 Gross Profit 1,206 1,933 Operating Expenses: Sales and Marketing 916 944 General & Administrative 330 686 Research & Development 440 293 Total Operating Expenses 1,686 1,923 Operating Income (Loss) (480) 10 Interes
Slide 19: Capitalization
Capitalization Common Shares 10,368,041 91.5% Warrants Outstanding 1 630,763 5.6% Options Issued 2 14,517 0.1% Restricted Shares 3 320,000 2.8% Fully Diluted Shares 11,333,321 100% 1 Weighted average exercise price $2.42 2 Weighted average exercise price $4.13 3 Estimated restricted s hares to be gr
Slide 20: Investment Considerations
Investment Considerations 20 x Disruptive Technology with Significant Advantages Compared to Existing Treatments x Large, Growing, Underserved Market x Strong IP portfolio (3 FDA clearances, 2 provisional patent applications and several other applications being prepared for submission) x Over 220 In
Slide 21: Appendix
Appendix 21
Slide 22: Non-GAAP Financial Measures
Non - GAAP Financial Measures 22 $000 2011 2012 2013 2014 2015 Net Income (Loss), as reported (1,685) (177) 108 (3,699) (237) - - - Add: - - - Depreciation and amortization 163 177 266 273 316 Taxes (1) 2 11 49 4 69 Interest, net 9 25 19 19 16 Stock compensation expense - - 1 6 6 Adjusted EBITDA, no
Slide 23: Non-GAAP Financial Measures
Non - GAAP Financial Measures 23 $000 Q1 2015 Q1 2016 Net Income (Loss), as reported (485) 2 Add: Settlement of litigation - 112 Depreciation and amortization 73 85 Taxes (1) 1 5 Interest, net 5 7 Stock compensation expense 2 2 Adjusted EBITDA, non - GAAP (404) 213 (1) Taxes include all taxes paid b
Slide 24: China Distribution Partner and International Expansion
▪ In December 2014, we signed Chindex Medical Limited (a JV of Shanghai Fosun Pharmaceutical (Group) Ltd. and Chindex International) as our exclusive distribution partner in China ▪ Chindex currently distributes aesthetic lasers for Syneron Candella , DaVinci surgical robotics for Intuitive Surgical
Slide 25: Skin Cancer: Competitive Landscape
Skin Cancer: Competitive Landscape Type of Procedure Description Challenges Cure Rate Mohs Surgery Tumor is removed with a thin layer of tissues around it. Procedure is repeated until the last layer examined under the microscope is tumor free. Expensive; invasive; painful; often poor cosmetic result
Slide 26: Keloids: Competitive Landscape
Keloids: Competitive Landscape Treatment Anticipated Effects Dosing / Frequency Efficacy in Reducing Keloid Size Hygienic Relief: Washing and Drying Relief of itching, pain, general discomfort As needed N/A Antihistamines Relief of itching, pain, burning sensation As needed N/A Corticosteroid Inject
Slide 27: Intellectual Property
Intellectual Property ▪ Sensus has received two critical patents and trademarks for its initial system design and is aggressively pursuing a portfolio of patents for key features in its SRT - 100 Vision™ system. Current Patents / Trademarks ▪ Patent No. 7372940: Radiation therapy system with risk mi
Slide 28: CPT Codes
CPT Codes CPT® Code Procedure Description 77280 Therapeutic radiology simulation-aided field setting; simple 77285 Therapeutic radiology simulation-aided field setting; intermediate 77290 Therapeutic radiology simulation-aided field setting; complex 77300 Basic radiation dosimetry calculation, centr
Slide 29: SRT Value Proposition
SRT - 100 Value Proposition Design Feature Practice Benefit Clinical Advantage Compact mobile design ▪ Mobility, reduced floor space requirements and lower setup installation costs ▪ Flexible treatment work areas & patient throughput X - ray tube arm range of motion ▪ Fast easy treatment setup for i
Slide 30: The SRT-Vision Image-Guided Therapy
The SRT - 100 Vision™ Image - Guided Therapy “SEE & TREAT” ▪ SRT - 100 Vision is designed to: » Track disease progression » Plan treatment » Guide therapy » Administer radiation » Evaluate treatment ▪ Target teaching / research hospitals & larger community hospitals ▪ Multiple energy levels 10kV – 1
Slide 31: Non-Equipment Products & Services
Non - Equipment Products & Services ▪ Applicators to treat various sized lesions in different areas of the body – 3 Pac ▪ Sentry TM Extended Warranty Service Program (years 2 to 5) ▪ EMR system connectivity module ▪ Opportunity for consumables program: » Disposable lead shielding replacements » Disp
Slide 32: Regulatory Approvals
Regulatory Approvals ▪ Sensus has received U.S. FDA 510(k) marketing clearance for its SRT devices in both NMSC and Keloid treatment. ▪ Other regulatory approvals include: ▪ CE Mark (Europe) ▪ CFDA (China) ▪ Health Canada ▪ Russia ▪ Actively seeking regulatory approvals in: ▪ Argentina ▪ Brazil ▪ In
Slide 33: Board of Directors & Medical Advisory Board
Board of Directors & Medical Advisory Board 33 Board of Directors Medical Advisory Board ▪ Joseph Sardano , CEO ▪ John Heinrich, Audit/Comp ▪ Sam O’Rear , Audit ▪ William McCall, Audit/Comp Dermatology – ▪ Clay Cockerell , M.D. - TX ▪ Mark Nestor, M.D. - FL ▪ Armand Cognetta Jr., M.D. - FL ▪ William
Slide 34: Skin Cancer: Clinical Studies
Skin Cancer: Clinical Studies ▪ SRT is proven to be safe with a comparable cure rate to Mohs surgery ▪ Cognetta et al (2012) conducted a retrospective analysis on 1,715 confirmed primary cutaneous basal cell carcinoma (“BCC”) and squamous cell carcinoma (“SCC”) treated with SRT between 2000 and 2010
Slide 35: Keloids: Clinical Studies
Keloids: Clinical Studies ▪ SRT is proven to be safe and the most effective treatment in reducing recurrence of Keloids when combined with excision surgery Study N Results Chaudhry et al (1994) 2.8% recurrence rate with a follow - up period mean of 5.6 years Jones et al (2015) 100% cure rate Doombos
Slide 36: Skin Cancer: SRT Treatment Before / During / After
Before / During / After Skin Cancer: SRT Treatment I. Initial treatment – 300 cGy dose II. Sixth treatment at end of week two – cumulative dose of 1,800 cGy III. Final treatment at end of week four 36 IV. Patient follow - up, 3.5 months post treatment
Slide 37: Skin Cancer: SRT Treatment Before / During / After
Skin Cancer: SRT Treatment 37 Before / During / After
Slide 38: Skin Cancer: SRT Treatment Before / During / After
38 Before / During / After Skin Cancer: SRT Treatment
Slide 39: Skin Cancer: SRT Treatment Before / During / After
39 Before / During / After Skin Cancer: SRT Treatment
Slide 40: Skin Cancer: SRT Treatment Before / During / After
300 cGy 2,450 cGy 40 Before / During / After Skin Cancer: SRT Treatment
Slide 41: Skin Cancer: SRT Treatment Before / During / After
300 cGy 2,250 cGy 41 Before / During / After Skin Cancer: SRT Treatment
Slide 42: Keloids: SRT Treatment Before / After
Before / After ▪ Recent study (Jones et al 2015) shows100% cure (H - N) ▪ Potential to utilize SRT to prevent Keloids Keloids: SRT Treatment Before After 42