Photocure ASA · OSL:PHO
Photocure ASA — Q1 2013 Earnings Presentation
23 slides from Photocure ASA's earnings presentation, Apr 25, 2013
Slide 1: Building a Specialty Pharma Company: Results of the First Quarter 2013
PHOTOCURE ASA BUILDING A SPECIALTY PHARMA COMPANY RESULTS OF THE FIRST QUARTER 2013 25 April 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 First Quarter 2013
HIGHLIGHTS FIRST QUARTER 2013 • Positive final results of phase 2b study for Cevira in HPV diseases of the cervix – Significant and sustained lesion response and high HPV clearance in CIN2 patients • Total sales revenues of Hexvix/Cysview increased 2% to NOK 14.7 million driven by increased end user
Slide 4: Commercial Update
Commercial Update st Ce Ce
Slide 5: Volume Growth by Ipsen
VOLUME GROWTH BY IPSEN • Positive 1Q growth in end user sales in Hexvix Partner Unit Sales Per Quarter key markets 10 000 8 000 – Volume +6% vPY, driven by strong 6 000 performance in Germany, Italy, Austria, 4 000 Belgium 2 000 – Inventory reduced from prior year, initial 0 1Q 2Q 3Q 4Q inventory st
Slide 6: Hexvix/Cysview Mixed Performance in Own Sales
HEXVIX/CYSVIEW MIXED PERFORMANCE IN OWN SALES • PHO own sales revenues in the US and Nordics +5% vPY Own Hexvix/Cysview Unit Sales Per Quarter • Nordic end user volume down 8% vPY 3 000 due to inventory build at year end in 2 500 Denmark 2 000 – Solid performance in Sweden and 1 500 Norway 1 000 500
Slide 7: Pipeline Update
Pipeline Update 7
Slide 8: Creating Value: Diverse Product Portfolio
CREATING VALUE DIVERSE PRODUCT PORTFOLIO Technology Indication Phase 1 Phase 2 Phase 3 Status • $4.5M payment 4Q 2012 Detection of Lumacan® PDD • Oral prototypes in clinic in 2013 colorectal cancer • Worldwide license with Salix • Positive Phase 2b results • End of Phase 2 meeting complete Treatment
Slide 9: HPV - Need for Novel Treatment Options
HPV - NEED FOR NOVEL TREATMENT OPTIONS • HPV affects majority of women and risk of development of cervical cancer if not managed appropriately – Highly oncogenic subtypes 16 and 18 causal factor in • ~70% all cervical cancers • ~50% all high grade lesions • ~25% all low grade lesions • Current scree
Slide 10: 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 11: Cevira Demonstrated Significant and Sustained Efficacy in CIN2 Patients
Cevira Demonstrated Significant and Sustained Efficacy in CIN2 patients after 6 months CIN2 overall response 3 months after CIN2 overall response 6 months after last treatment (n=40) last treatment (n=40) 100 100 90 90 80 p=≤0.05 80 p=≤0.05 % responders % responders 70 70 60 60 50 50 40 40 30 30 20
Slide 12: Cevira Demonstrated Sustained Clearance of HPV including HPV 16/18
Cevira Demonstrated Sustained Clearance of HPV including HPV 16/18 at 6 months HPV16/18 clearance in CIN 2 patients • Several HPV subtypes can cause 90 6 months after last treatment (n=33) precancerous lesions which lead to cervical 80 cancer 70 % responders 60 50 • HPV 16 and 18 have the highest ri
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 • Breakthrough technology allows for convenience and simplicity which can be integrated in even under-developed healthcare systems • Results of the Phase 2b trial are signifi
Slide 14: Visonac Preparing for Phase 3
VISONAC PREPARING FOR PHASE 3 • 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 submitted in 1
Slide 15: Financials
Financials 15
Slide 16: Encouraging Underlying Volume Growth
ENCOURAGING UNDERLYING VOLUME GROWTH • Revenue from own sales of Hexvix/ MNOK Q1 '13 Q1 '12 Cysview up 5% in the quarter Hexvix own sales 6,4 6,1 – Nordic unit sales to pharmacies down YoY growth 4,8 % 8%, driven by inventory build at year end in Denmark, however solid Hexvix partner sales 8,1 8,1 p
Slide 17: Operating Expenses in Line with Previous Quarters and Expectations
OPERATING EXPENSES IN LINE WITH PREVIOUS QUARTERS AND EXPECTATIONS 50 • R&D expenses at NOK 9.1 million in 1Q 40 – Main R&D activity was phase 2b 30 study in EU/USA for Cevira 20 10 • S&M expenses increased to NOK 19.0 0 million in 1Q, an increase of 41% Q1 '12 Q2 '12 Q3 '12 Q4 '12 Q1 '13 – Increase
Slide 18: Profit & Loss First Quarter 2013
PROFIT & LOSS FIRST QUARTER 2013 MNOK Q1 '13 Q1 '12 Change Sales revenues 14,6 18,9 -23 % Signing fee and milestones 1,0 14,1 -93 % Total revenues 15,7 33,0 -52 % Gross profit 14,3 31,0 -54 % Operating expenses -38,0 -40,6 -7 % Operating profit/loss(-) -23,6 -9,7 >100% Profit/loss(-) before tax -21,
Slide 19: Cash Flow First Quarter 2013
CASH FLOW FIRST QUARTER 2013 MNOK Q1 '13 Q1 '12 Cash flow from: - Operations -26,7 -28,3 - Investments 1,8 2,5 - Financing activities -0,6 -3,4 Net change in cash -25,5 -29,1 Ending cash balance 277,3 326,1 • Quarter cash flow from operations NOK -26.7 million • Cash and cash equivalents on 31 March
Slide 20: Balance Sheet per 31 March 2013
BALANCE SHEET PER 31 MARCH 2013 • Non current assets includes MNOK 31.03 31.12 NOK 32.5 million in shares in 2013 2012 PCI Biotech Non-current assets 91,5 104,9 • Deferred tax asset of NOK Inventory & receivables 23,0 25,3 40.8 million Cash & equivalents 277,3 302,8 Total assets 391,9 433,0 • No int
Slide 21: Summary and Outlook
Summary and Outlook
Slide 22: 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 23: Key Milestones 2013
KEY MILESTONES 2013 2013 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 Visonac development and commercialization 23