Photocure ASA · OSL:PHO
Photocure ASA — Q2 2014 Earnings Presentation
24 slides from Photocure ASA's earnings presentation, Aug 26, 2014
Slide 1: Building a Specialty Pharma Company: Results of Second Quarter and First Half 2014
PHOTOCURE ASA BUILDING A SPECIALTY PHARMA COMPANY RESULTS OF SECOND QUARTER AND FIRST HALF YEAR 2014 26 AUGUST 2014 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 Second Quarter 2014
HIGHLIGHTS SECOND QUARTER 2014 • Hexvix/Cysview sales revenues increased 14% to NOK 23.8 million in 2Q 2014, driven by strong customer demand across major markets – Hexvix/Cysview global in-market sales value increased 14% to NOK 43 million – Partner sales revenues increased 22% to NOK 12.8 million
Slide 4: Commercial Update
Commercial Update sis ttt
Slide 5: Hexvix/Cysview Strong Growth in All Markets
HEXVIX/CYSVIEW STRONG GROWTH IN ALL MARKETS Global in-market unit sales (by Q) • Hexvix/Cysview global in-market volume growth 13% YTD • Value of in-market sales of Hexvix/Cysview increased YOY 14% in 2Q and 24% YTD Global in-market value NOK mill (LTM) 5
Slide 6: Hexvix/Cysview Solid Performance in Nordics
HEXVIX/CYSVIEW SOLID PERFORMANCE IN NORDICS • Photocure own sales revenues in the US and Nordics increased 6% in 2Q 2014 to NOK 11.1 Own Hexvix/Cysview in-market unit sales million and 19% YTD to NOK 20.0 million Nordic and US • Key drivers include strong customer demand and price increases • Nordic
Slide 7: Hexvix/Cysview Increased Momentum in US
HEXVIX/CYSVIEW INCREASED MOMEMTUM IN US • US 2Q 2014 revenue growth of 30%. YTD revenue growth of 33% • Key drivers include volume growth of 17% in 2Q and 15% YTD, price increases and FX • Despite limited 2014 CMS reimbursement policy, Blue Light Cystoscope placements increased to 47 in 2Q 2014, com
Slide 8: Hexvix: Ipsen Strong Performance in Europe
HEXVIX IPSEN STRONG PERFORMANCE IN EUROPE • Partner revenue increased 22% in 2Q 2014 Hexvix Partner Unit Sales Per Quarter to NOK 12.8 million. YTD growth of 25% to NOK 23.2 million • Strong customer demand with end user volume growth of 14% YTD • YTD double digit volume growth in France, Germany an
Slide 9: Pipeline Update
Pipeline Update
Slide 10: Creating Value: Diverse Product Portfolio
CREATING VALUE DIVERSE PRODUCT PORTFOLIO Technology Indication Phase 1 Phase 2 Phase 3 Status Detection of License agreement with Salix Lumacan® PDD colorectal terminated cancer Treatment of Positive Phase 2b results Visonac® PDT moderate to SPA and PIP approved severe acne Exploring partnerships Po
Slide 11: Visonac Phase 3 Ready Asset
VISONAC PHASE 3 READY ASSET • High unmet need for novel treatments for moderate/ severe acne – 1st Photodynamic treatment for inflammatory acne – Broad geographic fit • Positive Phase 2b results – Significant reduction in inflammatory lesions – Overall improvement in acne severity – Well tolerated r
Slide 12: Cevira: A Major Opportunity
CEVIRA A MAJOR OPPORTUNITY • High unmet medical need for novel therapies to treat global epidemic of HPV/CIN populations • Breakthrough single use and fully integrated drug-device technology • Results of the Phase 2b trial are significant – Significant overall response in CIN 2 – High clearance of H
Slide 13: Positive Scientific Advice Europe
POSITIVE SCIENTIFIC ADVICE EUROPE • Scientific Advice Meetings held with three Health Authorities during 2Q – All leading agencies in review of other HPV technologies • Advice was positive and consistent across the three – Cevira phase 2b results and proposed phase 3 plan discussed – Alignment that
Slide 14: Re-analysis Confirms Clinical Benefit of Cevira
RE-ANALYSIS CONFIRMS CLINICAL BENEFIT OF CEVIRA FDA requested re-analysis of the pathology data to include: • Blinded panel of three pathologists required to provide initial diagnosis and post treatment evaluation • Diagnosis of the patients with cervical intraepithelial lesions of cervix should be
Slide 15: Lumacan Partnership Terminated
LUMACAN PARTNERSHIP TERMINATED • Global development and commercialization rights licensed to Salix in October 2010 Received upfront and development payments of $8.5M to date • Following the proposed merger agreement between Salix and Cosmo Pharmaceuticals SpA – Agreed to terminate Salix license –
Slide 16: Financials
Financials
Slide 17: Hexvix/Cysview - Continued Growth Second Quarter 2014
HEXVIX/CYSVIEW - CONTINUED GROWTH SECOND QUARTER 2014 • Revenue from own sales of Hexvix/ SALES - MNOK Q2 '14 YTD '14 Cysview increased 6% in 2Q 2014 and 19% YTD Hexvix own sales 11,1 20,0 YoY growth 6% 19 % – Nordic 2Q revenue at level with last year, YTD growth of 15%. Hexvix partner sales 12,8 23
Slide 18: Operating Expenses Second Quarter 2014
OPERATING EXPENSES SECOND QUARTER 2014 MNOK Q2 '14 YTD '14 • Total OPEX at NOK 29.2 million in Research & Development 7,3 16,0 2Q. YTD at NOK 62.0 million, a YoY growth 11 % 2% reduction of 14% Sales & Marketing 13,5 27,6 YoY growth -30 % -28 % • R&D expenses at NOK 7.3 million in Other Opex 8,4 18,
Slide 19: Profit & Loss Second Quarter 2014
PROFIT & LOSS SECOND QUARTER 2014 MNOK Q2 '14 Q2 '13 Change YTD '14 YTD '13 Change Hexvix / Cysview revenues 23,8 20,9 14 % 43,2 35,4 22 % Other sales revenues 0,5 0,5 9% 0,7 0,7 11 % Signing fee and milestones 1,1 1,1 8% 2,3 2,1 10 % Total revenues 25,5 22,5 14 % 46,2 38,1 21 % Gross profit 23,5 20
Slide 20: Hexvix/Cysview Franchise Second Quarter 2014
HEXVIX/CYSVIEW FRANCHISE SECOND QUARTER 2014 • LTM (last twelve months) 2Q 2014 Hexvix Sales & Opr Result LTM (NOK mill) operating result for commercial activities at NOK +1.7 million compared to NOK -31.8 million LTM 2Q 2013 • Consistent quarterly improvements driven by both revenue increases as we
Slide 21: Cash Flow Second Quarter 2014
CASH FLOW SECOND QUARTER 2014 MNOK Q2 '14 Q2 '13 YTD '14 YTD '13 Cash flow from: - Operations -9,8 -37,5 -28,5 -64,2 - Investments 0,8 0,9 1,9 2,7 - Financing activities 0,0 -42,2 0,0 -42,8 Net change in cash -9,0 -78,8 -26,5 -104,3 Ending cash balance 140,7 198,5 140,7 198,5 • 2Q 2014 cash flow fro
Slide 22: Balance Sheet per 30 June 2014
BALANCE SHEET PER 30 JUNE 2014 • Non current assets includes NOK MNOK 30.06 31.12 41.5 million in shares in PCI Biotech 2014 2013 and deferred tax asset of NOK 49.1 Non-current assets 115,5 104,8 million Inventory & receivables 27,8 29,7 Cash & equivalents 140,7 167,3 • No interest bearing debt Tota
Slide 23: Summary and Outlook
Summary and Outlook
Slide 24: Good Progress Made Towards 2014 Goals
GOOD PROGRESS MADE TOWARDS 2014 GOALS KEY 2014 OBJECTIVES 1H ACHIEVEMENTS Hexvix/Cysview global in-market unit sales growth of YTD growth 13% ≥10% Obtain sustainable reimbursement solution in US Bill introduced to US Congress Secure partnership for development and Established high interest with comm