Photocure ASA · OSL:PHO
Photocure ASA — Q3 2013 Earnings Presentation
22 slides from Photocure ASA's earnings presentation, Oct 23, 2013
Slide 1: Building a Specialty Pharma Company: Results of the Third Quarter 2013
PHOTOCURE ASA BUILDING A SPECIALTY PHARMA COMPANY RESULTS OF THE THIRD QUARTER 2013 23 October 2013 Kjetil Hestdal, MD, President & CEO Erik Dahl, CFO
Slide 2: Disclaimer
DISCLAIMER The information included in this Presentation contains certain forward-looking statements that address activities, events or developments that Photocure ASA (“the Company”) expects, projects, believes or anticipates will or may occur in the future. These statements are based on various as
Slide 3: Highlights Third Quarter 2013
HIGHLIGHTS THIRD QUARTER 2013 • Hexvix/Cysview volume increased 11% in 3Q 2013 driven by strong customer demand across major markets – Own Hexvix/Cysview sales revenues in 3Q increased 29% compared to prior year – Partner sales revenues in 3Q decreased 14% compared to prior year impacted by inventor
Slide 4: Commercial Update
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Slide 5: Hexvix/Cysview Solid Performance in Own Sales Geographies
HEXVIX/CYSVIEW SOLID PERFORMANCE IN OWN SALES GEOGRAPHIES • PHO 3Q own sales revenues in the US and Nordics +29% v PY • Key drivers include strong customer demand, Own Hexvix/Cysview in-market unit sales increased BLC placements and price increases – Additional price increase planned in three Nordic
Slide 6: Hexvix/Cysview Encouraging Early Results in New Market Segment
HEXVIX/CYSVIEW ENCOURAGING EARLY RESULTS IN NEW MARKET SEGMENT • Following the initial diagnosis of bladder cancer, all patients are required to have frequent surveillance cystoscopic exams to monitor for recurrence and/or progression of disease – These exams are frequently performed in the outpatie
Slide 7: Hexvix/Cysview New Trial Results Show Improved Long Term Clinical Benefit
HEXVIX/CYSVIEW NEW TRIAL RESULTS SHOW IMPROVED LONG TERM CLINICAL BENEFIT • Long term bladder cancer recurrence data from Randers Hospital in Denmark – Retrospective data collected in >400 bladder cancer patients • The patients were either in an intervention group or historical control • Interventio
Slide 8: Ipsen Strong Partner in Europe
IPSEN STRONG PARTNER IN EUROPE • Partners driving robust customer demand in 3Q – Volume +10% v PY Hexvix Partner Unit Sales Per Quarter – Double digit growth in Germany, Italy, 10 000 other major markets 8 000 6 000 • PHO revenues from Partner -14% v PY 4 000 – Following transfer of production to 2
Slide 9: Pipeline Update
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Slide 10: Creating Value: Diverse Product Portfolio
CREATING VALUE DIVERSE PRODUCT PORTFOLIO Technology Indication Phase 1 Phase 2 Phase 3 Status Detection of • Worldwide license with Salix Lumacan® PDD colorectal • Clinical trial with various cancer formulations underway Treatment of • Positive Phase 2b results Visonac® PDT moderate to • SPA approve
Slide 11: Visonac Phase 3 Ready Asset
VISONAC PHASE 3 READY ASSET • High unmet need for novel treatments for moderate – severe acne • Positive Phase 2b results – Significant reduction in inflammatory lesions – Overall improvement in acne severity – Well tolerated regimen • Preparing for Phase 3 registration trials – SPA agreed in 2Q – R
Slide 12: Breakthrough Platform Technology Designed for Ease of Use
BREAKTHROUGH PLATFORM TECHNOLOGY DESIGNED FOR EASE OF USE • First fully integrated drug-delivery device in photodynamic technology • Novel single use, disposable intra-vaginal device developed for ease of use – Obviates clinical and commercial barriers • Simple application in office setting – Does n
Slide 13: Cevira a Major Opportunity
CEVIRA A MAJOR OPPORTUNITY • High unmet medical need for novel therapies to treat epidemic proportions of HPV/CIN populations – Fast track application for CIN 2 population submitted to FDA • Breakthrough technology allows for convenience and simplicity which can be integrated in even under-developed
Slide 14: Financials
Financials
Slide 15: Strong Volume Growth
STRONG VOLUME GROWTH • Revenue from own sales of Hexvix/ MNOK Q3 '13 YTD '13 Cysview up 29% in the quarter Hexvix own sales 8,3 25,2 – Nordic revenue increased 15%. In- YoY growth 28,6 % 27,0 % market unit sales to pharmacies up 9% Hexvix partner sales 9,7 28,3 – US revenue increased 85% driven by Y
Slide 16: Expense Reductions and Organizational Streamlining
EXPENSE REDUCTIONS AND ORGANIZATIONAL STREAMLINING 50 • R&D expenses at NOK 8.5 million in 3Q 40 – Main R&D activity Cevira and Visonac 30 drug/device manufacturing readiness for 20 Phase 3 10 • Quarter S&M expenses at NOK 15.4 0 million Q3 '12 Q4 '12 Q1 '13 Q2 '13 Q3 '13 – Decline from previous qua
Slide 17: Profit & Loss Third Quarter 2013
PROFIT & LOSS THIRD QUARTER 2013 MNOK Q3 '13 Q3 '12 Change YTD '13 YTD '12 Change Sales revenues 18,1 20,1 -10 % 54,1 55,4 -2 % Signing fee and milestones 1,1 2,9 -62 % 3,2 31,1 -90 % Total revenues 19,2 23,0 -17 % 57,3 86,5 -34 % Gross profit 17,7 20,0 -11 % 52,4 78,8 -34 % Operating expenses -32,6
Slide 18: Cash Flow Third Quarter 2013
CASH FLOW THIRD QUARTER 2013 MNOK Q3 '13 Q3 '12 YTD '13 YTD '12 Cash flow from: - Operations -17,7 -24,9 -82,0 -82,4 - Investments 1,0 2,9 3,6 7,4 - Financing activities 0,5 -1,7 -42,3 -6,3 Net change in cash -16,3 -23,7 -120,6 -81,3 Ending cash balance 182,2 273,9 182,2 273,9 • Quarter cash flow fr
Slide 19: Balance Sheet per 30 September 2013
BALANCE SHEET PER 30 SEPTEMBER 2013 • Non current assets includes MNOK 30.09 31.12 NOK 28.9 million in shares in 2013 2012 PCI Biotech Non-current assets 91,5 104,9 • Deferred tax asset of NOK Inventory & receivables 25,8 25,3 40.8 million Cash & equivalents 182,2 302,8 Total assets 299,5 433,0 • No
Slide 20: Summary and Outlook
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Slide 21: Executing Our Strategy
EXECUTING OUR STRATEGY • Build a speciality pharma company, focused on cancer and dermatology • Maximize the potential of the company's Photodynamic Technology Platform – Photocure Technology™ • Leverage our experience to develop, register and commercialize new products based on Photocure Technology
Slide 22: Key Milestones Q4 2013 – 1H 2014
KEY MILESTONES Q4 2013 – 1H 2014 Focus Drive growth of Cysview in the US Work closely in partnership with Ipsen to increase sales of Hexvix in Europe Progress partner discussions for Cevira Lumacan oral prototypes enter clinical development Progress partner discussions for Visonac 22