Photocure ASA · OSL:PHO
Photocure ASA — Q3 2019 Earnings Presentation
32 slides from Photocure ASA's earnings presentation, Nov 7, 2019
Slide 1: Results for Third Quarter and the First Nine Months 2019
PHOTOCURE ASA RESULTS FOR THIRD QUARTER AND THE FIRST NINE MONTHS 2019 7 November 2019 Daniel Schneider, President and CEO Erik Dahl, CFO
Slide 2: Disclaimer
DISCLAIMER By reading this company presentation (the “Presentation”), or attending any meeting or oral presentation held in relation thereto, you (the “Recipient”) agree to be bound by the following terms, conditions and limitations. The Presentation has been produced by Photocure (the “Company”) fo
Slide 3: Our mission is to deliver transformative solutions for bladder cancer patients
OUR MISSION IS TO DELIVER TRANSFORMATIVE SOLUTIONS WHICH IMPROVE THE LIVES OF BLADDER CANCER PATIENTS Photocure’s four step strategy will deliver our mission 1 2 3 4 Accelerate Expand Acquire Transform • Drive the breadth •A Generate sales in • Partner and in- • Build a global and depth of new geogr
Slide 4: Non-muscle invasive bladder cancer is one of the most common cancers
NON-MUSCLE INVASIVE BLADDER CANCER IS ONE OF THE MOST COMMON CANCERS WITH SIGNIFICANT RECURRENCE RATE AND HIGH DISEASE BURDEN ~700K More than 60% surgical procedures disease recurrence at 1 year1 annually in USA and EU Tumor as seen through a cystoscope 10% ‒ 30% disease progression1 ~2.2M 3.7 USD B
Slide 5: Cystoscopy is currently the only method for managing recurring bladder cancer
CYSTOSCOPY IS CURRENTLY THE ONLY METHOD FOR MANAGING RECURRING BLADDER CANCER 5-Year Relative Survival Rate (%) Bladder Cancer Progression and Recurrence NMIBC MIBC Key therapeutic aim is to avoid progression from non- 98 muscle invasive bladder cancer (“NMIBC”) to muscle 88 invasive bladder cancer
Slide 6: The patient journey – long term follow-up with repeat procedures
THE PATIENT JOURNEY – CHARACTERIZED BY LONG TERM FOLLOW-UP WITH REPEAT PROCEDURES Outpatient & Clinic Diagnostic Cystoscopy Targeting flexible scope ~700k procedures Operating room EU/USA TURBT Targeting Rigid scope Symptoms ~1.6 mill procedures EU/USA Outpatient & Clinic Surveillance Cystoscopy fle
Slide 7: Hexvix/Cysview for better detection and management of NMIBC
HEXVIX®/CYSVIEW® FOR BETTER DETECTION AND MANAGEMENT OF NMIBC A Drug Device combination for better visual contrast between benign and malignant cells is taken up selectively Hexvix / Cysview is used by cancer cells in with a blue light enabled the bladder cystoscope, from Karl making them Storz, Wol
Slide 8: Blue light cystoscopy with Hexvix/Cysview
BLUE LIGHT CYSTOSCOPY WITH HEXVIX®/CYSVIEW® A TRANSFORMATIVE SOLUTION TO IMPROVE THE LIVES OF PATIENTS WITH BLADDER CANCER Key benefits • Improved Patient outcomes (diagnostic accuracy + surgical results) • Significant reduction of disease recurrence • Reduction in disease progression • Improved cos
Slide 9: Hexvix/Cysview outlook: beyond diagnostics
HEXVIX®/CYSVIEW® OUTLOOK: BEYOND DIAGNOSTICS Recent studies – although very early-stage – show a different kind of potential for Hexvix/Cysview Photocure has the intention to further investigate Hexvix/Cysview for its therapeutic effect 9
Slide 10: Positioned for growth
Positioned for growth
Slide 11: Delivering on key 2019 objectives
DELIVERING ON KEY 2019 OBJECTIVES Significant growth of Cysview ® Accelerate Cysview ® in US flexible in US TURBT market cystoscopy surveillance market US Q3 revenue growth in USD 42%, in- 54% growth YOY in installed blue light market volume increase in Q3 of 34% enabled cystoscopes in market Total
Slide 12: Accelerated momentum: consecutive quarters of record revenues in US
ACCELERATED MOMENTUM 7 CONSECUTIVE QUARTERS OF RECORD REVENUES IN US 25 228 24 476 21 159 18 419 16 063 16 473 12 722 10 942 11 292 10 041 10 167 7 582 7 782 8 033 7 068 1Q16 2Q16 3Q16 4Q16 1Q17 2Q17 3Q17 4Q17 1Q18 2Q18 3Q18 4Q18 1Q19 2Q19 3Q19 US (1000 NOK) 12
Slide 13: Accelerated momentum: installed base of cystoscopes in the US
ACCELERATED MOMENTUM INSTALLED BASE OF CYSTOSCOPES IN THE US YTD: +54 BL 211 2017 - 2018: +53 BL 188 171 157 104 83 65 51 36 25 2012 2013 2014 2015 2016 2017 2018 1Q2019 2Q2019 3Q2019 13
Slide 14: Strategy – Target key hospitals
THE INVESTMENT MADE WILL DELIVER RETURNS Strategy – Target Key Hospitals in the 30 largest MSAs in the US 2018/19 – We have built the Commercial Foundation • Sales team focused on top 700+ centers that influence bladder cancer care in their regions • Team is composed of 27 Surgical Sales Executives
Slide 15: Hexvix/Cysview – key enablers in place and ready for growth
HEXVIX®/CYSVIEW® – KEY ENABLERS IN PLACE AND READY FOR GROWTH Penetration POSITION IN THE LIFE CYCLE KEY SUCCESS FACTORS 100% Approval Surgical & surveillance 75% Denmark Acceptance Major & local guidelines Permanent and 50% Access favorable reimbursement Nordic “Activated” Patient demand via advoca
Slide 16: Supportive environment and increasing awareness
SUPPORTIVE ENVIRONMENT & INCREASING AWARENESS FOR BECOMING THE STANDARD OF CARE FOR THE DETECTION AND MANAGEMENT OF BLADDER CANCER • Inclusion in Bladder Cancer treatment guidelines BLC™ with Hexvix® /Cysview® is strongly recommended by US, European and national guidelines as well as expert panels.
Slide 17: Increasing awareness through marketing, congresses, data and publications
INCREASING AWARENESS THROUGH MARKETING ACTIVITIES, CONGRESS ATTENDANCE, DATA GENERATION & PUBLICATIONS 17
Slide 18: Reimbursement: continued improvements
REIMBURSEMENT: CONTINUED IMPROVEMENTS BLC bundled, USD 3-4k CMS just announced favorable reimbursement evolution for Cysview in the US, in the Hospital Outpatient setting: – Complexity adjustment for one more procedure code (52214) – Additional reimbursement compared to 2019: • USD 92 increase compa
Slide 19: Cevira License Agreement
Cevira® License Agreement
Slide 20: Cevira: license agreement with Asieris
CEVIRA®: LICENSE AGREEMENT WITH ASIERIS ASIERIS MEDITECH CO., • Asieris is a subsidiary of the China-based • Its leading drug candidate, an oral drug for Ltd. Jiangsu Yahong Meditech Co., Ltd., a treating non-muscle invasive bladder specialty pharma company fully committed cancer, is in a registrati
Slide 21: Cevira: terms of license agreement with Asieris
CEVIRA®: TERMS OF LICENSE AGREEMENT WITH ASIERIS TERMS OF THE LICENSING AGREEMENT* • Under the License Agreement, Photocure will receive a total signing fee of USD 5 MIL within 6 months after signing. • Approval of the initial indication will result in USD 18 MIL in China (est 2024) and USD 36 MIL i
Slide 22: Cevira – payments under the license agreement for HSIL indication
CEVIRA® – PAYMENTS UNDER THE LICENSE AGREEMENT FOR HSIL INDICATION Expected timeframe (from Dosing of 1st patient US/Europe study signing 01 July • Initiating Phase 3 clinical study to US/Europe Acceptance NDA in China, approval NDA China Royalties 2019) • China NDA, submission and approval $ Accept
Slide 23: Financials
Financials — ae
Slide 24: Segment performance third quarter 2019
SEGMENT PERFORMANCE THIRD QUARTER 2019 Commercial Franchise Amounts in NOK million Q3 ’19 Q3 ‘18 Change YTD ‘19 YTD ‘18 Change • US: Continued strong revenue growth, Q3 42% and Commercial Franchise YTD 45% in USD Nordic revenue 9.9 10.6 -7% 33.7 33.5 1% – Installed base of rigid and flex BLC 211 at
Slide 25: Consolidated income statement third quarter 2019
CONSOLIDATED INCOME STATEMENT THIRD QUARTER 2019 • Operating expenses, increase driven by Amounts in NOK million Q3 ‘19 Q3 ‘18 Change YTD ‘19 YTD ‘18 Change – Planned investments in US commercial Hexvix/Cysview revenue 51.1 43.5 18% 154.4 126.6 22% operations (sales & marketing) Other revenue 9.7 0.
Slide 26: Cash flow third quarter 2019
CASH FLOW THIRD QUARTER 2019 • Cash flow from operations Q3 improved MOK Amounts in NOK million Q3 ‘19 Q3 ‘18 YTD ’19 YTD ‘18 15.2 MIL to NOK 9.9 MIL, driven by payment Operations cash flow 9.9 -5.3 -9.8 -35.3 from Asieris of USD 1.0 MIL and other Earnings before tax 5.3 -6.3 -7.4 -29.4 improvements
Slide 27: Balance sheet 30 September 2019
BALANCE SHEET 30 SEPTEMBER 2019 30.09 31.12 • Non current assets Amounts in NOK million 2019 2018 Non current assets 73.1 77.8 – Investments of NOK 16.1 MIL in tangible and intangible assets is driven by investments in Cysview phase 3 project Investments 16.1 24.6 – Deferred tax asset of NOK 49.1 MI
Slide 28: Summary and Outlook
Summary and Outlook — ——
Slide 29: Our mission is to deliver transformative solutions; maintain guidance
OUR MISSION IS TO DELIVER TRANSFORMATIVE SOLUTIONS WHICH IMPROVE THE LIVES OF BLADDER CANCER PATIENTS Photocure’s four step strategy will deliver our mission 1 2 3 4 Accelerate Expand Acquire Transform • Drive the breadth •A Generate sales in • Partner and in- • Build a global and depth of new geogr
Slide 30: Back-up slides
Back-up slides
Slide 31: Share information
SHARE INFORMATION Major shareholders Listed on Oslo 21,796,387 >USD 144 MIL High Seas AS KLP Stock Exchange shares issued Market cap Fondsfinans Radiumhospitalets Forskningsstiftelse Myrlid AS Other shareholders (<2.5% stake) 10,2% 7,4% 5,3% 3,0% 2,4% 71,7% 31
Slide 32: Hexvix/Cysview versus NBI versus WLC
HEXVIX®/CYSVIEW® VERSUS NBI VERSUS WLC WLC NBI BLC™ image with Olympus image with Olympus with Hexvix® / Cysview® You see vessels You see the tumors Narrow Band Imaging Cysview®/Hexvix® is highly selective enhances visualization of and absorbed specifically blood vessels and surface by cancerous cel