Profound Medical Corp · TSX:PRN
Profound Medical — Investor Presentation (March 2020)
25 slides from Profound Medical's investor presentation, March 2020
Slide 1: Customizable, Incision-Free Ablation Therapies
Customizable, Incision-Free Ablation Therapies Corporate Presentation | March 2020 NASDAQ: PROF © 2020 Profound Medical Corp. TSX: PRN
Slide 2: Forward-Looking Statements
Forward-Looking Statements Certain statements in this presentation and oral statements made during this meeting may contain “forward-looking statements” within the meaning of applicable securities laws, including the “safe harbour provisions” of the Securities Act (Ontario), with respect to Profound
Slide 3: Market & Industry Data; Use of Projections
Market & Industry Data Use of Projections Market data and industry forecasts contained in this presentation have been obtained This presentation may contain financial forecasts with respect to our estimated future from industry publications, various publicly available sources and subscription-based
Slide 4: “My life should not have to change”
“My life should not have to change” U.S. FDA Cleared, August 2019 Ablation of Prostate Tissue 4
Slide 5: Prostate Anatomy
Prostate Anatomy Source: Kirby (1997) An Atlas of Prostatic Diseases, The Encyclopedia of Visual Medicine Series. 5
Slide 6: Current Landscape of Prostate Disease in the U.S.
Current Landscape of Prostate Disease in the U.S. 2.9 million patients 10 million patients Common treatment options currently living with living with Benign associated with significant prostate cancer on Prostatic Hyperplasia side effects such as active surveillance* (“BPH”)** incontinence and erect
Slide 7: TULSA-PRO
TULSA-PRO Customizable, Predictable, Incision-Free Real-time MR imaging 1 • Customized treatment plan Transurethral bladder applicator prostate Transurethral directional ultrasound for Heating 2 thermal ablation; water cooling of urethra Individually controlled pattern and rectum Transducer elements
Slide 8: TULSA-PRO System Components
TULSA-PRO System Components Robotic Arm, Energy Surgeon Console Disposable Computer Hardware System Control Room Applicators Capital Equipment One-Time Consumables • Compatible with MR from leading companies, Philips and Siemens • Recurring revenue business model 8
Slide 9: TACT: Clinical Trial
TACT: Clinical Trial Pivotal Study of Whole-Gland Ablation in a Clinically-Significant Patient Population Intermediate (67%) n = 115 13 clinical sites 5 countries 45 -80 years old Prostate Cancer Risk Low (33%) PSA primary efficacy endpoint resolutely met: Prostate volume significantly reduced, • PS
Slide 10: TACT Summary
TACT Summary Literature Review of Other Trials Provided for Context TACT Study Literature Review TULSA Prostatectomy Radiation HIFU Biopsy / 21% Clinically Significant 16 – 24% +Margin 1 28% Clinically Significant 4 59 – 61% Negative 5-6 Histology (Meta-Analysis) (Intent to treat) 14% Insignificant
Slide 11: Clinical & Commercial Development
Clinical & Commercial Development TULSA-PRO Timeline Developments in Europe ● Limited launch ● EU physicians ● Treatment run ● Added sites in Europe in EU expand use to rate expanded (1.5T Scanners) ● First patient include both to 10 patients ● First system sold in ● CE Marked prostate cancer per mo
Slide 12: Clinical Application
Clinical Application Learnings From Limited EU Launch Organ Confined Prostate Cancer Benign Salvage / Palliative Low Risk Intermediate Risk High Risk Large prostate BPH 1 Customized ablation 2-7 Recurrence after radiation 8 • Preservation of • Targeted ablation (focal, or regional) • Localized recur
Slide 13: TULSA-PRO Unique Flexibility
TULSA-PRO Whole Gland Unique Flexibility Ablation Benign large Analogous to Malignant lesion Whole gland post prostate with lower surgery and with lower urinary Hemi-gland radiation radiation failure urinary tract tract symptoms symptoms 13
Slide 14: Clinical Application & Adoption
Clinical Application & Adoption Learnings From Limited EU Launch Prostatectomy Radiation TULSA Throughput: • 2 typically • Multiple sessions: • 4 in a day Procedures/Day • 3 on a longer day 5-to-40 over 4-to-8 weeks • Consistent treatment times • Outpatient procedure for most patients Patient Recove
Slide 15: U.S. Market Entrance Strategy
U.S. Market Entrance Strategy TULSA-PRO Increase Early Adopter Potential Delivery Business 'Profound Genius Awareness Pipeline Channels Models Services' • TACT clinical data • Already visited • Opinion leading • Recurring • Start-up clinical presented at >10 about 75 potential hospitals / Centers re
Slide 16: Centers of Excellence
Centers of Excellence TACT Trial Sites • Includes many of the TACT study sites • Will likely be relatively low volume while TULSA is a patient self-pay procedure • Best positioned to help drive long-term adoption by: - Participate in additional trials designed to support reimbursement - Training nex
Slide 17: Commercial Imaging Centers
Commercial Imaging Centers • 8,000 -10,000 imaging centers in U.S.; 40% owned 1. by private equity or public companies Referring Physicians • Growing presence in urology due to MRI Urologists diagnostics, MRI-guided biopsy, MRI-guided follow- up • Centers provide: - Service Imaging Center - Technolo
Slide 18: Reimbursement Pathway
Reimbursement Pathway From “Cleared” to “Covered” CPT Code C-Code + Medicare Advantage C-Code + Patient Pay PPO’s 18
Slide 19: TULSA-PRO: Pre-Reimbursement “Patient Paid”
TULSA-PRO: Pre-Reimbursement “Patient Paid” Significant Market Opportunity, Even With Low Single-Digit Initial Penetration Levels New Prostate Cancer Diagnosis (U.S. + Canada) 180,0001 BPH, Prostates, surgical candidates, Unusual shapes (U.S. + Canada) 400,0002 Total Opportunity, # of patients 580,0
Slide 20: “C-Code”
“C-Code” • Applied for a new technology “C-Code” in November 2019 • Typically takes 6 months to obtain a decision from CMS • If approved, would provide for a 3-year period of coding and billing methodology for facility costs 20
Slide 21: “CPT Code”
“CPT Code” Publication Package Rationale Level N US % Start • TULSA U.S. momentum at key teaching sites 115 48% 1. TACT 2.0 5-year • Increase US patient % 2b Started (+35=150) (60%) • Re-treat TACT 1.0 patients 144 in 2:1 2. BPH RCT 6-month • Anchor study for Level 1 data 1b ~100% 2020 96 TULSA • St
Slide 22: Longer Term
Longer Term Building an Incision- & Radiation-Free Ablative Therapeutic Platform Oncology, Highly Symptomatic Chronic Diseases 22
Slide 23: SONALLEVE
SONALLEVE Current Approvals Europe: CE Marked China: CNMPA Approved Over 200 • Uterine Fibroid Treatment Publications • Bone Metastasis Pain from leading U.S. & • Pediatric Bone European clinicians • Hyperthermia and hospitals • Abdominal Cancer 23
Slide 24: SONALLEVE Market Development Strategy
SONALLEVE Market Development Strategy U.S. & Western Markets China Partnered with Cologne University Hospital to develop Philips as distribution partner critical clinical data for cancer and highly symptomatic • Small Profound direct sales team chronic diseases Enter U.S. market with Humanitarian De
Slide 25: In Summary
In Summary Introducing TULSA-PRO Business Model Designed Future Investments to U.S. Market to be Capital Efficient • Strategically expand U.S.-based • TULSA-PRO: focus on U.S. sales team, continue work with MRI partners • Sonalleve: focus on Asia with • Additional clinical trials for larger distribu
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