Photocure ASA · OSL:PHO
Photocure ASA — Q1 2020 Earnings Presentation
37 slides from Photocure ASA's earnings presentation, May 7, 2020
Slide 1: Photocure ASA Results for 1st Quarter 2020
PHOTOCURE ASA RESULTS FOR 1ST QUARTER 2020 7 May 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: Photocure at a Glance
PHOTOCURE AT A GLANCE Accelerating revenue growth: Oslo (HQ) +23% total sales NOK 1.7 billion revenue growth in Market cap** Princeton (NJ) 2019 NOK 330M global 649K Avg daily in-market sales* volume YTD** Norwegian commercial-stage pharmaceutical company focused on bladder cancer with commercial op
Slide 4: 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 5: 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 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: Creating a New Standard of Care
BLUE LIGHT CYSTOSCOPY: CREATING A NEW STANDARD OF CARE “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
Slide 9: Blue Light Cystoscopy Can Provide an Accurate and Complete 1st TURBT
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 10: Q1 2020 Highlights and Financials
Q1 2020 Highlights and Financials
Slide 11: 1st Quarter Highlights Contributing to Photocure Strategy Implementation
1ST QUARTER HIGHLIGHTS CONTRIBUTING TO PHOTOCURE STRATEGY IMPLEMENTATION Regaining worldwide rights to Hexvix • Expected to be EBITDA1 accretive from full-year 2021 Financial growth highlights: • Positive growth rate in Q1, Hexvix/Cysview revenue growth of 6% – Some impact of Covid-19 during the las
Slide 12: Segment Performance First Quarter 2020
SEGMENT PERFORMANCE FIRST QUARTER 2020 Amounts in NOK million Commercial Franchise 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 13: Consolidated Income Statement First Quarter 2020
CONSOLIDATED INCOME STATEMENT FIRST QUARTER 2020 • Operating expenses, increase driven by Amounts in NOK million Q1 ‘20 Q1 ‘19 Change FY ‘19 – Significant FX impact, average approximately 8% – Planned investments in US commercial operations (sales & marketing) Hexvix/Cysview revenue 54.4 51.2 6% 213
Slide 14: Cash Flow First Quarter 2020
CASH FLOW FIRST QUARTER 2020 • Cash flow from operations Q1 improved mainly due to Amounts in NOK million Q1 ’20 Q1 ‘19 FY ’19 milestone payment of USD 1.5 million from Asieris as well Operations cash flow 3.0 -15.7 20.7 as improved working capital Earnings before tax -4.8 -6.0 45.9 – Other operatio
Slide 15: Balance Sheet 31 March 2020
BALANCE SHEET 31 MARCH 2020 31.12 31.12 Amounts in NOK million 2019 2019 • Non current assets – Investments of NOK 11.3 million in tangible and intangible assets Non current assets 54.6 70.5 is driven by investments in Cysview phase 3 project. This project Investments 11.3 13.6 will be fully amortiz
Slide 16: Expand and Acquire World Wide Rights to Hexvix
Expand and Acquire World Wide Rights to Hexvix
Slide 17: 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 18: 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 19: Large Untapped Potential in the EUR 150 Mill 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 and more than and more than 18,000 40% penetration 50,000 deaths deaths annually1 a
Slide 20: Historical Flat Trendlines = Significant EU Opportunity
HISTORICAL FLAT TRENDLINES = SIGNIFICANT EU OPPORTUNITY! 50% 90 000 43% 80 000 45% 41% 41% 41% 40% 70 000 39% 40% 38% 35% 60 000 35% 32% 50 000 30% 27% 40 000 25% 30 000 21% 20% 20 000 16% 16% 16% 16% 15% 14% 15% 13% 13% 10 000 12% 12% 11% 10% 8% 0 7% 5% 0% 2008 2009 2010 2011 2012 2013 2014 2015 20
Slide 21: 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 22: Positioned for Growth
Positioned for growth
Slide 23: 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 24: U.S. Accelerated Momentum: Recent Quarters' Installation Fuels Future Growth
U.S. ACCELERATED MOMENTUM: RECENT 8 QUARTERS’ INSTALLATION FUELS FUTURE GROWTH! Annual New Installations Cumulative install base continues strong trend * * Tower placements by year 24 *2012 – 17 of the 23 installations were converted clinical sites upon Cysview approval
Slide 25: 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 26: Global: Supportive Environment & Awareness
GLOBAL: SUPPORTIVE ENVIRONMENT & 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. • 8
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 Protection Strategy
IP Protection Strategy - ————
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 —_ es
Slide 34: 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 35: 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 36: 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 37: Q&A
Q&A