Photocure ASA · OSL:PHO
Photocure ASA — FY2013 Earnings Presentation
21 slides from Photocure ASA's earnings presentation, Feb 27, 2014
Slide 1: Building a Specialty Pharma Company: Q4 and FY 2013 Results
PHOTOCURE ASA BUILDING A SPECIALTY PHARMA COMPANY RESULTS OF THE FOURTH QUARTER AND FULL YEAR 2013 27 February 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 Fourth Quarter and Full Year 2013
HIGHLIGHTS FOURTH QUARTER AND FULL YEAR 2013 • Hexvix/Cysview sales revenues increased 28% in 4Q 2013, 16% for FY 2013, driven by strong customer demand across major markets – Photocure’s own sales revenues in US and Nordics increased 34% in 4Q 2013, 29% for FY 2013 – Partner sales revenues increase
Slide 4: Commercial Update
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Slide 5: Hexvix/Cysview Solid Performance in Nordics
HEXVIX/CYSVIEW SOLID PERFORMANCE IN NORDICS • Photocure own sales revenues in the US and Nordics increased 34% in 4Q 2013 and 29% for FY 2013 Own Hexvix/Cysview in-market unit sales • Key drivers include strong customer demand and price increases in Nordics • Nordic revenue growth of 33% in 4Q 2013
Slide 6: Hexvix/Cysview CMS Ruling Hinders US Growth
HEXVIX/CYSVIEW CMS RULING HINDERS US GROWTH • US 4Q 2013 revenue growth of 37% and 68% for FY 2013 – Volume growth of 19% in 4Q 2013 and 51% for FY 2013 • CMS packaged payment policy released in 4Q 2013 and includes Cysview into overall procedure payment without increasing payment for cost of drug –
Slide 7: Hexvix: Ipsen Strong Partner in Europe
HEXVIX IPSEN STRONG PARTNER IN EUROPE • Partner revenue increased 23% in 4Q 2013 and 5% Hexvix Partner Unit Sales Per Quarter for FY 2013 – Volume growth of 15% in 4Q 2013, and 10% for FY 2013 – Double digit growth in key markets – Strong customer demand – Germany represents 68% of total revenue • P
Slide 8: Pipeline Update
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Slide 9: 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 Phase 1 / 2 Clinical trial cancer underway Treatment of Positive Phase 2b results Visonac® PDT moderate to SPA approved severe acne Explorin
Slide 10: 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 11: Cevira A Major Opportunity
CEVIRA A MAJOR OPPORTUNITY • High unmet medical need for novel therapies to treat global epidemic of HPV/CIN populations • Single use and integrated drug-device – Breakthrough technology allows for convenience and simplicity which can be integrated in even under-developed healthcare systems • Result
Slide 12: Cevira Status of Regulatory Interactions
CEVIRA STATUS OF REGULATORY INTERACTIONS • In 4Q 2013 FDA transferred review responsibility to Division of Bone, Reproductive and Urologic Products (DBRUP) from Oncology Division • Photocure initiated discussion with DBRUP, focused on recently published diagnostic and clinical management guidelines
Slide 13: Financials
Financials
Slide 14: Strong Volume Growth
STRONG VOLUME GROWTH • Revenue from own sales of Hexvix/ Cysview SALES - MNOK Q4 '13 FY '13 increased 34% in 4Q 2013 – Nordic revenue increased 33%. In-market unit Hexvix own sales 13,0 38,1 sales to pharmacies increased 10% YoY growth 34 % 29 % – US revenue increased 37% driven by end user Hexvix p
Slide 15: Tight Fiscal Management
TIGHT FISCAL MANAGEMENT • R&D expenses at NOK 9.8 million in 4Q 2013 – Main activity related to development of Cevira and Visonac as well as ongoing regulatory work for Hexvix/Cysview • 4Q 2013 S&M expenses at NOK 14.8 million – In line with 3Q 2013 – A decline from 1H 2013 level due to cessation of
Slide 16: Profit & Loss Fourth Quarter 2013
PROFIT & LOSS FOURTH QUARTER 2013 MNOK Q4 '13 Q4 '12 Change FY '13 FY '12 Change Hexvix / Cysview revenues 24,5 19,1 28 % 77,9 67,8 15 % Other sales revenues 0,7 0,6 9% 1,4 7,3 -81 % Signing fee and milestones 1,1 27,6 -96 % 4,3 58,7 -93 % Total revenues 26,3 47,3 -44 % 83,6 133,8 -38 % Gross profit
Slide 17: Cash Flow Fourth Quarter 2013
CASH FLOW FOURTH QUARTER 2013 MNOK Q4 '13 Q4 '12 FY '13 FY '12 Cash flow from: - Operations -17,8 27,5 -99,7 -54,9 - Investments 0,9 1,7 4,5 9,1 - Financing activities 1,9 -0,2 -40,4 -6,5 Net change in cash -15,0 29,0 -135,6 -52,4 Ending cash balance 167,3 302,8 167,3 302,8 • 4Q 2013 cash flow from
Slide 18: Balance Sheet per 31 December 2013
BALANCE SHEET PER 31 DECEMBER 2013 • Non current assets includes NOK MNOK 31.12 31.12 32.6 million in shares in PCI Biotech 2013 2012 and deferred tax asset of NOK 49.1 Non-current assets 104,8 104,9 million Inventory & receivables 29,7 25,3 • No interest bearing debt Cash & equivalents 167,3 302,8
Slide 19: Summary and Outlook
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Slide 20: 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 21: Outlook & Targets 2014
OUTLOOK & TARGETS 2014 Hexvix/Cysview global in-market unit sales growth of ≥10% Obtain sustainable reimbursement solution in US Secure partnership for development and commercialization of Visonac Secure regulatory alignment on Cevira clinical development to progress partner discussions En