Photocure ASA · OSL:PHO
Photocure ASA — Q3 2015 Earnings Presentation
21 slides from Photocure ASA's earnings presentation, Oct 29, 2015
Slide 1: Building a Specialty Pharma Company
PHOTOCURE ASA BUILDING A SPECIALTY PHARMA COMPANY RESULTS OF THIRD QUARTER AND FIRST NINE MONTHS 2015 29 OCTOBER 2015 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: Progress on Key Objectives
PROGRESS ON KEY OBJECTIVES KEY OBJECTIVES 3Q2015 KEY ACHIEVEMENTS • Hexvix/Cysview global in-market unit sales growth of 10% • 8% growth in-market unit sales • Commercial franchise profitability 9.0 MNOK • Submit Special Protocol Assessment Request (SPAR) for • Achieved Special Protocol Agreement fo
Slide 4: Commercial Update
Commercial Update
Slide 5: Hexvix/Cysview a Significant Global Specialty Brand
HEXVIX/CYSVIEW A SIGNIFICANT GLOBAL SPECIALTY BRAND • Value of in-market sales of Hexvix/Cysview Global in-market unit sales (by Q) increased YoY 19% year to date to NOK 204 million LTM • Hexvix/Cysview global in-market volume increased YoY 8% in the quarter, and 7% year to date • Overall franchise
Slide 6: Hexvix/Cysview Solid Performance in Nordics and USA
HEXVIX/CYSVIEW SOLID PERFORMANCE IN NORDICS AND USA • Photocure own sales revenue in the US and Own Hexvix/Cysview in-market unit sales Nordics increased YoY 22% in 3Q and 35% year Nordic and US to date to NOK 42.1 million • US revenue increased year to date 84% – Driven by in-market volume growth o
Slide 7: Hexvix/Cysview Partner Progress
HEXVIX/CYSVIEW PARTNER PROGRESS • Partner revenue increased 4% in 3Q and 12% year to date to NOK 40.5 million – 3Q revenue driven by timing of inventory Hexvix Partner Unit Sales Per Quarter replenishments in 2014 • End user volume growth 8% in 3Q and 5% year to date • Double digit unit growth year
Slide 8: Pipeline Update
Pipeline Update
Slide 9: Creating Value: Clinical Development Programs
CREATING VALUE CLINICAL DEVELOPMENT PROGRAMS Technology Indication Phase 1 Phase 2 Phase 3 Status Positive Phase 2b results Treatment of SPA approved Cevira® PDT precursors of Exploring partnerships cervical cancer Treatment of Positive Phase 2b results Visonac® PDT moderate to SPA and PIP approved
Slide 10: Hexvix/Cysview Expanding into the Surveillance Segment
HEXVIX/CYSVIEW EXPANDING INTO THE SURVEILLANCE SEGMENT • Surveillance following initial diagnosis represents a significant growth opportunity of 2-3 times current TURB segment • First Patient, First Visit in Hexvix/Cysview Phase 3 market expansion study in October • Study including 360 patients to e
Slide 11: Cevira a Major Opportunity
CEVIRA A MAJOR OPPORTUNITY • Breakthrough single use and fully integrated drug-device technology to satisfy high need for novel therapies to treat global epidemic of HPV/CIN populations • A well tolerated non-systemic treatment option for patients which preserves fertility and avoids the morbidities
Slide 12: Cevira Significant Sales Potential
CEVIRA SIGNIFICANT SALES POTENTIAL • Large patient population based on biopsy confirmed histology of HSIL • ~1M cases HSIL annually in US & West EU1,2 detected through routine cervical screening programs; 50% of these are caused by HPV strain 16 or 183 • ~30% risk of progress to cervical cancer4 • U
Slide 13: Visonac Phase 3 Ready Asset with Considerable Sales Potential
VISONAC PHASE 3 READY ASSET WITH CONSIDERABLE SALES POTENTIAL • High unmet need for novel treatments for moderate/ severe acne • Positive Phase 2b results • Significant reduction in inflammatory lesions and improvement of overall acne severity • Well tolerated regimen • Phase 3 Ready with significan
Slide 14: Financials
Financials
Slide 15: Hexvix/Cysview Continued Growth Third Quarter 2015
HEXVIX/CYSVIEW CONTINUED GROWTH THIRD QUARTER 2015 • Revenue from own sales of Hexvix/ SALES - MNOK Q3 '15 YTD '15 Cysview increased YoY 22% in 3Q and Hexvix - Nordic 8,1 26,4 35% year to date YoY growth 11 % 17 % – Nordic 3Q revenue growth of 11% Cysview - US 5,3 15,7 – US 3Q revenue growth of 42%
Slide 16: Profit & Loss Third Quarter 2015
PROFIT & LOSS THIRD QUARTER 2015 MNOK Q3 '15 Q3 '14 Change YTD '15 YTD '14 Change Hexvix / Cysview revenues 27,0 24,1 12 % 82,6 67,2 23 % Other sales revenues 2,3 0,8 >100% 6,5 1,6 >100% Signing fee and milestones 6,6 31,9 -79 % 11,1 34,2 -68 % Total revenues 35,9 56,8 -37 % 100,2 103,0 -3 % Gross p
Slide 17: Segments Third Quarter 2015
SEGMENTS THIRD QUARTER 2015 MNOK Q3 '15 Q3 '14 YTD '15 YTD '14 LTM • Commercial franchise: Commercial Franchise – Continued improvement in Total revenues 35,9 26,1 100,2 72,2 126,2 revenues and EBIT Gross profit 33,9 24,5 94,0 67,1 118,2 – EBIT margin year to date at Operating expenses -24,8 -18,8 -
Slide 18: Cash Flow Third Quarter 2015
CASH FLOW THIRD QUARTER 2015 MNOK Q3 '15 Q3 '14 YTD '15 YTD '14 Cash flow from: - Operations -4,8 25,2 -19,2 -3,2 - Investments -3,9 0,9 -9,0 2,8 - Financing 1,5 0,0 2,4 0,0 Net change in cash -7,2 26,1 -25,8 -0,4 Ending cash balance 139,5 166,8 139,5 166,8 • 3Q cash flow from operations NOK -4.8 mi
Slide 19: Balance Sheet per 30 September 2015
BALANCE SHEET PER 30 SEPTEMBER 2015 • Non current assets includes NOK MNOK 30.09 31.12 8.6 million in shares in PCI Biotech 2015 2014 and deferred tax asset of NOK 19.8 Non-current assets 71,0 76,5 million Inventory & receivables 39,0 28,8 Cash & equivalents 139,5 165,2 • No interest bearing debt at
Slide 20: Outlook
Outlook
Slide 21: Outlook
OUTLOOK • Hexvix/Cysview global in-market unit sales growth of 10% in 2015 FINANCIAL • Initiate necessary documentation for the Cevira device to ensure readiness for the Phase 3 trial following the SPA approval CLINICAL • Reporting of clinical results of Hexvix/Cysview phase 3 market expansion study