Photocure ASA · OSL:PHO
Photocure ASA — FY2012 Earnings Presentation
22 slides from Photocure ASA's earnings presentation, Feb 28, 2013
Slide 1: Photocure ASA: Strategy on Track
PHOTOCURE ASA STRATEGY ON TRACK RESULTS OF THE FOURTH QUARTER AND FULL YEAR 2012 28 February 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 Fourth Quarter and Full Year 2012
HIGHLIGHTS FOURTH QUARTER AND FULL YEAR 2012 • Positive results of phase 2b study for Cevira in HPV diseases of the cervix • Hexvix®/ Cysview® commercial strategy on track – Own sales revenue continue strong growth trajectory, +37% in 4Q 2012 and +23% for full year – Gaining momentum in the US, with
Slide 4: Commercial Update
Commercial Update st Ce Ce
Slide 5: Hexvix Successful First Year with Ipsen
HEXVIX SUCCESSFUL FIRST YEAR WITH IPSEN • Full year of Ipsen partnership Hexvix Partner Unit Sales Per Quarter successful 10000 – Transition and MAA transfers 8000 successfully completed across all 6000 markets 4000 • Ipsen operational in major markets 2000 – Dedicated teams in place in Germany, 0 F
Slide 6: Hexvix/Cysview Strong Growth in Own Sales Operations
HEXVIX/CYSVIEW STRONG GROWTH IN OWN SALES OPERATIONS • PHO own sales revenues in the US and Nordics Own Hexvix/Cysview Unit Sales Per Quarter continue strong growth trajectory, +37% in 4Q 3000 2012 and +23% for full year 2500 2000 • Nordic end user volume growth 8% for full year 1500 • Nordic region
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: Cevira
CEVIRA Cancers induced by HPV • Cervical HPV infection highly prevalent and growing – 80% of all women have HPV infections during their lifetime – Represents 4-5 million women in US alone – At least 10% may become CIN 2/3 – May lead to cervical cancer without intervention • Potential alternative to
Slide 10: Cevira Showed a Significant Efficacy in CIN2 Patients
CEVIRA SHOWED A SIGNIFICANT EFFICACY IN CIN2 PATIENTS Overall response* in CIN2 patients Overall response* in CIN2 HPV positive** (N= 87) patients (N= 72) 100 100 90 90 % responders 80 80 70 70 60 60 50 50 40 40 30 30 20 20 10 10 0 0 HAL 5% HAL 1% HAL 0.2% Placebo HAL 5% HAL 1% HAL 0.2% Placebo p=0.
Slide 11: Cevira Eradication of the Leading Cause of Cervical Cancer (HPV16/18)
CEVIRA ERADICATION OF THE LEADING CAUSE OF CERVICAL CANCER (HPV16/18) • Several HPV strains can cause precancerous lesions which lead to cervical cancer HPV CLEARANCE RATE • HPV strain 16 and 18 has the Cevira* Placebo P value highest oncogenic risk CIN 2 PATIENTS HPV 16/18 (n=33) 83% 0% 0.02 • Cevi
Slide 12: Initial Results Generating Positive Interest
INITIAL RESULTS GENERATING POSITIVE INTEREST • Cevira at the optimal dose demonstrated significant efficacy in the CIN2 patients • Significant overall response • Significant clearance of high risk HPV16/18 • Cevira at the optimal dose showed a clear effect in overall response and HPV clearance in th
Slide 13: Visonac
VISONAC • 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 – End of phase 2 meeting with FDA – Finali
Slide 14: Financials
Financials 14
Slide 15: Driving Solid Revenue Growth
DRIVING SOLID REVENUE GROWTH • Total revenues up 12% in the quarter, MNOK Quarter FY 17% full year – Total Hexvix/Cysview sales up 4% in Q4 '12 2012 the quarter, 6% full year Hexvix own sales 9,7 29,5 YoY growth 37,7 % 22,8 % • Own sales of Hexvix/Cysview up 38% Hexvix partner sales 9,4 37,9 in the
Slide 16: Investing in Commercial Organization and R&D According to Plan
INVESTING IN COMMERCIAL ORGANIZATION AND R&D ACCORDING TO PLAN 50 • R&D expenses at NOK 13.3 million in 40 4Q and NOK 50.1 million full year 30 – Main R&D activity was ongoing phase 2b study in EU/USA for Cevira 20 10 • S&M expenses increased to NOK 18.7 0 Q4 '11 Q1 '12 Q2 '12 Q3 '12 Q4 '12 million
Slide 17: Profit & Loss Fourth Quarter 2012
PROFIT & LOSS FOURTH QUARTER 2012 MNOK Cancer Derm Q4 '12 Q4 '11 Change FY '12 FY '11 Change Sales revenues 19,1 0,6 19,7 19,0 4% 75,1 70,0 7% Signing fee and milestones 25,2 2,4 27,6 23,4 18 % 58,7 44,0 33 % Total revenues 44,3 3,1 47,3 42,4 12 % 133,8 114,1 17 % Gross profit 42,5 3,1 45,6 39,8 15
Slide 18: Cash Flow Fourth Quarter 2012
CASH FLOW FOURTH QUARTER 2012 MNOK Q4 '12 Q4 '11 FY '12 FY '11 Cash flow from: - Operations 27,5 17,4 -54,9 -34,5 - Investments 1,7 2,0 9,1 7,0 - Financing activities -0,2 -0,3 -6,5 -6,6 Net change in cash 29,0 19,0 -52,4 -34,1 Ending cash balance 302,8 355,2 302,8 355,2 • Strong operating cash flow
Slide 19: Balance Sheet per 31 December 2012
BALANCE SHEET PER 31 DECEMBER 2012 MNOK 31.12 31.12 • Other investments 2012 2011 includes NOK 46.7 million Non-current assets 104,9 127,7 in shares in PCI Biotech Inventory & receivables 25,3 26,3 Cash & equivalents 302,8 355,2 • Deferred tax asset of NOK Total assets 433,0 509,2 40.8 million Share
Slide 20: Summary and Outlook
Summary and Outlook
Slide 21: Executing Our Strategy
EXECUTING OUR STRATEGY • Build a speciality pharma company, focused on dermatology and cancer • 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 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 Final results from Cevira phase 2b clinical trial available enabling further partner discussions Lumacan oral prototypes enter clinical development