Photocure ASA · OSL:PHO
Photocure ASA — Q4 2019 Earnings Presentation
31 slides from Photocure ASA's earnings presentation, Feb 27, 2020
Slide 1: Photocure ASA End of Year 2019 & Q4 Presentation
PHOTOCURE ASA END OF YEAR 2019 & Q4 PRESENTATION 27 February 2020 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: 2019 Highlights and Subsequent Events
2019 HIGHLIGHTS AND SUBSEQUENT EVENTS Financial growth highlights: • Positive growth rates in Nordics, US and Partner countries • US: Strong revenue growth, in USD FY 43% – US accounts for nearly 50% of our total sales revenue • Installed base of rigid and flex BLC 223 (of which 26 flexible scopes)
Slide 4: Photocure at a Glance
PHOTOCURE AT A GLANCE Accelerating revenue growth: Oslo (HQ) +23% total sales USD 220M revenue growth in Market cap** Princeton (NJ) 2019 USD 37M global 175K Avg daily Norwegian commercial-stage pharmaceutical in-market sales* volume LTM company focused on bladder cancer with commercial operations i
Slide 5: Photocure Before and Now
PHOTOCURE BEFORE AND NOW: Continue success of Hexvix/Cysview Expand portfolio of New strategic focus: bladder cancer assets The Bladder Cancer Company 2020 + beyond Global Leader in Photodynamic Therapy (PDT) 2018 As of 1997 5
Slide 6: 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 7: Large Unmet Needs in Non-Muscle Invasive Bladder Cancer
LARGE UNMET NEEDS IN NON-MUSCLE INVASIVE BLADDER 9th 550,000 200,000 most common new cases1 deaths annually cancer worldwide1 of which 75% are men1 CANCER (NMIBC) COMMON #1 USD 5.7 Billion Highest per patient Cost of Bladder Cancer in the US, lifetime treatment costs projection for 20203 EXPENSIVE o
Slide 8: The Patient Journey – Characterized by 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 9: 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 10: "You Cannot Treat What You Cannot See!"
“YOU CANNOT TREAT WHAT YOU CANNOT SEE!” Risk that 20-35% of cancer patients will be missed, if Blue Light Cystoscopy is NOT used1,2 Risk of wrong risk-classification leading to mis-management of disease, if Blue Light Cystoscopy is NOT used White Light Cystoscopy (WLC) Blue Light Cystoscopy (BLC™) w
Slide 11: Complete 1st TURBT – Critical for Patient Outcomes
BLUE LIGHT CYSTOSCOPY CAN PROVIDE AN ACCURATE AND COMPLETE 1ST TURBT – CRITICAL FOR PATIENT OUTCOMES Bladder Cancer Progression and Recurrence NMIBC MIBC 98 Key therapeutic aim is to avoid progression from 88 non-muscle invasive bladder cancer (“NMIBC”) to muscle invasive bladder cancer (“MIBC”) 63
Slide 12: Positioned for growth
Positioned for growth
Slide 13: 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% Acceptance Major & local guidelines Denmark Permanent and 50% Access favorable reimbursement Nordic “Activated” Patient demand via advoca
Slide 14: Supportive Environment & 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 15: US: Accelerated Momentum – 8 Consecutive Quarters of Record Revenues
US: ACCELERATED MOMENTUM 27790 27 790 8 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 4Q19 US (1000 NOK) 15
Slide 16: US: Accelerated Momentum – Installed Base of Cystoscopes
US: ACCELERATED MOMENTUM INSTALLED BASE OF CYSTOSCOPES IN THE US 223 157 104 83 65 51 36 25 2012 2013 2014 2015 2016 2017 2018 2019 16
Slide 17: US: The Investment Made Will Deliver Accelerated Returns
US: THE INVESTMENT MADE WILL DELIVER ACCELERATED 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 28 Surgical S
Slide 18: Hexvix/Cysview Future Potential: Therapeutic Patent Secured
HEXVIX®/CYSVIEW® FUTURE POTENTIAL: THERAPEUTIC PATENT SECURED Recent early stage studies show a potential treatment effect of Blue Light Cystoscopy (BLC™) with Hexvix1 Study results: a treatment effect could be related to – direct anti-tumor effect – immune cell activation Photocure has the intentio
Slide 19: IP Strategy
IP Strategy _ =o
Slide 20: Drug-Device Combination – Hurdles to Market Entry
DRUG-DEVICE COMBINATION ‒ HURDLES TO MARKET ENTRY NO PDT PRODUCTS HAVE EXPERIENCED GENERIC COMPETITION (VISUDYNE, METVIX) TO DATE 1 IP*/Intellectual Property 3 Technical/Manufacturing 4 Regulatory hurdles Review multiple patents, regulatory data hurdles A drug-device combination product. ANDA1 for p
Slide 21: Key Strategic Initiatives to Strengthen Long-Term Competitiveness
IN ADDITION, PHOTOCURE IS CONTINUOUSLY FOCUSING ON KEY STRATEGIC INITIATIVES TO FURTHER STRENGTHEN ITS LONG-TERM COMPETITIVENESS Continuous monitoring of landscape Strengthen customer engagement Continued product development + IP Prepare launch of authorized generics 21
Slide 22: Cevira License Agreement
Cevira® License Agreement
Slide 23: Cevira: License Agreement with Asieris
CEVIRA®: License Agreement terms: LICENSE AGREEMENT WITH ASIERIS USD 250 mill potential in total: ASIERIS MEDITECH • Asieris is a subsidiary of the China-based Jiangsu CO., Ltd. Yahong Meditech Co., Ltd., a specialty pharma Under the License Agreement, company Photocure will receive a total signing
Slide 24: Q4 2019 Financials
Q4 2019 Financials —_ eS
Slide 25: Segment Performance Fourth Quarter 2019
SEGMENT PERFORMANCE FOURTH QUARTER 2019 Commercial Franchise Amounts in NOK million Q4 ’19 Q4 ‘18 Change FY ‘19 FY ‘18 Change • US: Strong revenue growth, in USD Q4 39% and FY Commercial Franchise 43% Nordic revenue 14.5 13.5 7% 48.2 47.0 3% – Installed base of rigid and flex BLC 223 at quarter end,
Slide 26: Consolidated Income Statement Fourth Quarter 2019
CONSOLIDATED INCOME STATEMENT FOURTH QUARTER 2019 • Operating expenses, increase driven by Amounts in NOK million Q4 ‘19 Q4 ‘18 Change FY ‘19 FY ‘18 Change – Planned investments in US commercial Hexvix/Cysview revenue 58.8 46.3 27% 213.2 172.9 23% operations (sales & marketing) Other revenue 56.8 3.
Slide 27: Cash Flow Fourth Quarter 2019
CASH FLOW FOURTH QUARTER 2019 • Cash flow from operations Q4 and FY Amounts in NOK million Q4 ’19 Q4 ‘18 FY ’19 FY ‘18 improved due to sign-on payments from Operations cash flow 30.4 11.2 20.7 -24.1 Asieris. Earnings before tax 53.3 -7.3 45.9 -36.7 – Other operations cash flow includes deferred reve
Slide 28: Balance Sheet December 2019
BALANCE SHEET 31 DECEMBER 2019 31.12 31.12 • Non current assets Amounts in NOK million 2019 2018 – Investments of NOK 13.6 million in tangible and intangible Non current assets 70.5 77.8 assets is driven by investments in Cysview phase 3 project Investments 13.6 24.6 – Deferred tax asset of NOK 38.3
Slide 29: Summary and outlook
Summary and outlook = ——
Slide 30: Creating the Leading Bladder Cancer Company
CREATING THE LEADING BLADDER CANCER COMPANY 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 geographies license synergistic Bladder Cancer Hexvix/Cysview assets to Company usage in key •B Enhance the value stren
Slide 31: Q&A
Q&A