Photocure ASA · OSL:PHO
Photocure ASA — Corporate Update (April 2020)
40 slides from Photocure ASA's corporate update, Apr 27, 2020
Slide 1: Photocure – Company Update
PHOTOCURE ‒ COMPANY UPDATE 27 April 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 ASA (the “Company”
Slide 3: Disclaimer (continued)
DISCLAIMER (CONTINUED) This Presentation contains certain forward-looking statements relating to inter alia the business, financial performance and results of the Company and the industry in which it operates. Forward-looking statements concern future circumstances and results and other statements t
Slide 4: Photocure at a glance
PHOTOCURE AT A GLANCE Accelerating revenue growth: Oslo (HQ) +23% total sales NOK 1.5 billion revenue growth in Market cap** Princeton (NJ) 2019 NOK 330M global 650K Avg daily in-market sales* volume YTD** Norwegian commercial-stage pharmaceutical company focused on bladder cancer with commercial op
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 U.S., lifetime treatment costs projection for 20203 EXPENSIVE
Slide 8: 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 mismanagement of disease, if Blue Light Cystoscopy is NOT used White Light Cystoscopy (WLC) Blue Light Cystoscopy (BLC™) wi
Slide 9: Expand and Acquire World Wide Rights to Hexvix
Expand and Acquire World Wide Rights to Hexvix
Slide 10: Key deal constructs
KEY DEAL CONSTRUCTS • Agreement with Ipsen for the return of Hexvix® sales, marketing and distribution rights in Europe and other markets currently controlled by Ipsen • Photocure will commence the commercial operations with Hexvix in Europe from 1 October 2020 – Countries not currently partnered or
Slide 11: Photocure unlocks tremendous potential in Europe
PHOTOCURE UNLOCKS TREMENDOUS POTENTIAL IN EUROPE Strategic opportunity Value-creation opportunity • Apply commercial success & strong growth in the • After transition year targeting 20-30% annual revenue Nordic and the U.S. markets to the European region growth in current Ipsen territories • Deep kn
Slide 12: Large untapped potential in the European market
LARGE UNTAPPED POTENTIAL IN THE EUR 150 MILL EUROPEAN MARKET (CURRENT EU PENETRATION (EXCEPT DACH) <5% WITH OPPORTUNITY TO REACH NORDIC LEVEL OF 40%) Europe U.S. Europe: 165,000 new US: 82,500 new cases, NORDICS cases, 550,000 280,000 prevalent 40% penetration prevalent cases, and cases, and more th
Slide 13: Synergistic opportunity leveraging our internal expertise
SYNERGISTIC OPPORTUNITY LEVERAGING OUR INTERNAL EXPERTISE: Get people in place with competencies and Drive use of Hexvix in existing clinics skills to address challenges and opportunities Expand the number of clinics EU General Manager recruited to lead Leverage Photocure’s relationship with equipme
Slide 14: Q1 update and guidance
Q1 update and guidance — _——
Slide 15: 1st quarter highlights contributing to strategy implementation
1ST QUARTER HIGHLIGHTS CONTRIBUTING TO PHOTOCURE STRATEGY IMPLEMENTATION Financial growth highlights: • Positive growth rate in Q1, Hexvix/Cysview revenue growth of 6% – Some impact of Covid-19 during the last weeks of the quarter • Q1 revenue growth YoY in U.S. was 21% in USD, driven by 17% growth
Slide 16: Covid-19 organization response
COVID-19 ORGANIZATION RESPONSE • Transparency: Informing the markets early on (for details, see Market Update #2, April 7, 2020) • Market & Demand situation: Bladder cancer treatments are prioritized procedures but there are short-term postponements of procedures • Priority on the health and welfare
Slide 17: Optimistic to rebound from Covid-19 impact in H2
OPTIMISTIC TO REBOUND FROM COVID-19 IMPACT IN H2 BLCTM with Hexvix®/Cysview® can play an integral part in this situation: postponed procedures* do not postpone aggressive cancer progression • Patient safety through better detection of bladder cancer tumors, in spite of the potential longer check-up
Slide 18: Segment performance first quarter 2020
SEGMENT PERFORMANCE FIRST QUARTER 2020 Commercial Franchise Amounts in NOK million Q1 ’20 Q1 ‘19 Change FY ‘19 Commercial Franchise • US: Strong revenue growth 33%. Growth in USD 21%, driven by unit sales and price US revenue 28.2 21.2 33% 98.7 – Impact of Covid-19 on unit sales from last two weeks
Slide 19: Consolidated income statement & cash position first quarter 2020
CONSOLIDATED INCOME STATEMENT & CASH POSITION FIRST QUARTER 2020 • Operating expenses, increase driven by Amounts in NOK million Q1 ‘20 Q1 ‘19 Change FY ‘19 – Planned investments in US commercial operations (sales & marketing) as well as program spending Hexvix/Cysview revenue 54.4 51.2 6% 213.2 – S
Slide 20: Guidance: approximately 1BN revenue in 2023
GUIDANCE: APPROXIMATELY 1BN REVENUE IN 2023 • Current-year guidance: – Q1 revenue growth YoY in U.S. at 21% in USD, driven by 17% growth in unit sales – Near term temporary pressure on revenue due to COVID-19 impact – Rebound in H2: steady return expected • 2023 guidance: – Group revenues ambitions
Slide 21: Positioned for growth
Positioned for growth
Slide 22: 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 DACH “Activated” Patient demand via a
Slide 23: 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 24: US: accelerated momentum – installed base of cystoscopes
US: ACCELERATED MOMENTUM INSTALLED BASE OF CYSTOSCOPES IN THE US 238 223 157 104 83 65 51 36 25 2012 2013 2014 2015 2016 2017 2018 2019 Q1 2020 24
Slide 25: US: accelerated momentum – consecutive quarters of record revenues
US: ACCELERATED MOMENTUM 28 214 28214 27790 27 790 9 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 1Q20 US (1000 NOK) 2
Slide 26: 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 27: 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 28: IP Strategy
IP Strategy _ =o
Slide 29: 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 30: 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 (in the U.S.) 30
Slide 31: Cevira License Agreement
Cevira® License Agreement
Slide 32: 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 Under the License Agreement, CO., Ltd. Yahong Meditech Co., Ltd., a specialty pharma Photocure has received a total signing company
Slide 33: Summary and outlook
Summary and outlook = ——
Slide 34: Our opportunity for increasing momentum
OUR OPPORTUNITY FOR 6- This is why we 1- Increased global focus on health post INCREASING MOMENTUM maintain the long-term guidance Covid-19. Opportunities to improve dialogue with healthcare authorities and enhance public awareness about bladder cancer 5- The need for Bladder 2- BLCTM with Hexvix®/C
Slide 35: 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 36: Q&A
Q&A
Slide 37: Appendix
Appendix
Slide 38: The patient journey – characterized by long term follow-up
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 39: 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 40: 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