Photocure ASA · OSL:PHO
Photocure ASA — Q4 2014 Earnings Presentation
24 slides from Photocure ASA's earnings presentation, Feb 12, 2015
Slide 1: Building a Specialty Pharma Company: Results of Fourth Quarter and Full Year 2014
PHOTOCURE ASA BUILDING A SPECIALTY PHARMA COMPANY RESULTS OF FOURTH QUARTER AND FULL YEAR 2014 12 FEBRUARY 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: Delivering on Key Objectives
DELIVERING ON KEY OBJECTIVES KEY 2014 OBJECTIVES 2014 ACHIEVEMENTS • Hexvix/Cysview global in-market unit sales growth of 10% Growth ≥10% Bill with strong bipartisan support • Obtain sustainable reimbursement solution in US introduced to US Congress • Secure partnership for development and Establish
Slide 4: Key Highlights for Q4 2014 and FY 2014
KEY HIGHLIGHTS FOR Q4 2014 AND FY 2014 • Hexvix/Cysview franchise reached profitability in 2014 – Seven consecutive quarters of improved results – Global in-market sales growth of 11% in 4Q to NOK 49 million and 19% for the full year to NOK 180 million. Full year unit growth at 10%, in line with gui
Slide 5: Commercial Update
Commercial Update
Slide 6: Hexvix/Cysview a Significant Global Specialty Brand
HEXVIX/CYSVIEW A SIGNIFICANT GLOBAL SPECIALTY BRAND Global in-market unit sales (by Q) • Value of in-market sales of Hexvix/Cysview increased YOY 11% in the quarter and 19% FY 2014 to NOK 180 million • Hexvix/Cysview global in-market volume growth YOY 3% in the quarter and 10% FY 2014 • Overall fran
Slide 7: Hexvix/Cysview Solid Performance in Nordics
HEXVIX/CYSVIEW SOLID PERFORMANCE IN NORDICS • Photocure own sales revenue in the US and Nordics increased 13% in 4Q to NOK 14.6 million Own Hexvix/Cysview in-market unit sales and 20% FY 2014 to NOK 45.7 million Nordic and US • Key drivers include strong customer demand and price increases • Nordic
Slide 8: Hexvix/Cysview Increased Momentum in US
HEXVIX/CYSVIEW INCREASED MOMENTUM IN US • US 4Q revenue growth of 60% and FY • Continued positive data flow fuels forward 2014 of 49% momentum • Key drivers include 33% volume growth, – World Journal of Urology publication price increases and FX validating positive impact on overall and progression
Slide 9: Hexvix/Cysview Strong Performance in Europe
HEXVIX/CYSVIEW STRONG PERFORMANCE IN EUROPE Hexvix Partner Unit Sales Per Quarter • Strong customer demand with end user volume growth 3% 4Q, 10% FY 2014 • Partner revenue decreased 12% in 4Q – Timing of inventory replenishments in the 4Q 2013 • FY 2014 partner revenue increased 16% to NOK 46.3 mill
Slide 10: Hexvix/Cysview Near and Mid-Term Growth Drivers
HEXVIX/CYSVIEW NEAR AND MID-TERM GROWTH DRIVERS • Volume growth in existing markets – Increased penetration in the US – Incorporation in national guidelines (EU & US); publication of expert opinions • Improve profitability of Hexvix/Cysview franchise • Expand into new markets and territories – Surve
Slide 11: Pipeline Update
Pipeline Update
Slide 12: Creating Value: Diverse Product Portfolio
CREATING VALUE DIVERSE PRODUCT PORTFOLIO Technology Indication Phase 1 Phase 2 Phase 3 Status Positive Phase 2b results Treatment of Submit US SPA request by mid Cevira® PDT precursors of 2015 cervical cancer Exploring partnerships Treatment of Positive Phase 2b results Visonac® PDT moderate to SPA
Slide 13: 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 • Results of the Phase 2b trial are significant – Significant overall response in patients with CIN 2 – High clear
Slide 14: 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 15: Lumacan Strategy
LUMACAN STRATEGY • Global development and commercialization rights licensed to Salix in October 2010 – Received upfront and development payments of $8.5M • Following the proposed merger agreement between Salix and Cosmo Pharmaceuticals SpA Photocure and Salix agreed to terminate the license – Salix
Slide 16: Financials
Financials
Slide 17: Hexvix/Cysview Continued Growth Fourth Quarter 2014
HEXVIX/CYSVIEW CONTINUED GROWTH FOURTH QUARTER 2014 • Revenue from own sales of Hexvix/ SALES - MNOK Q4 '14 FY '14 Cysview increased 13% in 4Q and 20% FY – Nordic 4Q revenue growth of 2%, FY Hexvix own sales 14,6 45,7 YoY growth 13 % 20 % growth of 12% – US revenue increased 60% in 4Q and Hexvix par
Slide 18: Operating Expenses Fourth Quarter 2014
OPERATING EXPENSES FOURTH QUARTER 2014 MNOK Q4 '14 FY '14 • Total Opex at NOK 34.1 million in 4Q. FY at Research & Development 9,6 32,6 YoY growth 6% 1% NOK 127.6 million, a reduction of 9%. Sales & Marketing 13,9 54,5 YoY growth -6 % -20 % – FY reduction including one-off expenses 16% Other Opex 10
Slide 19: Profit & Loss Fourth Quarter 2014
PROFIT & LOSS FOURTH QUARTER 2014 MNOK Q4 '14 Q4 '13 FY '14 FY '13 Hexvix / Cysview revenues 24,8 24,5 92,0 77,9 Other sales revenues - 0,7 1,6 1,4 Signing fee and milestones 1,2 1,1 35,4 4,3 Total revenues 26,0 26,3 129,0 83,6 Gross profit 24,1 24,4 122,0 76,8 Operating expenses -34,1 -34,9 -127,6
Slide 20: Hexvix/Cysview Franchise Fourth Quarter 2014
HEXVIX/CYSVIEW FRANCHISE FOURTH QUARTER 2014 Hexvix Sales & Opr Result LTM (NOK mill) • FY 2014 operating result for commercial activities at NOK 10.4 million compared to NOK 8.7 million LTM 3Q 2014 – FY 2014 improvements of NOK 26 million compared to FY 2013 • Seven consecutive quarters with result
Slide 21: Cash Flow Fourth Quarter 2014
CASH FLOW FOURTH QUARTER 2014 MNOK Q4 '14 Q4 '13 FY '14 FY '13 Cash flow from: - Operations -2,9 -17,8 -6,1 -99,7 - Investments 0,6 0,9 3,4 4,5 - Financing activities 0,7 1,9 0,7 -40,4 Net change in cash -1,6 -15,0 -2,0 -135,6 Ending cash balance 165,2 167,3 165,2 167,3 • 4Q cash flow from operation
Slide 22: Balance Sheet per 31 December 2014
BALANCE SHEET PER 31 DECEMBER 2014 • Non current assets includes NOK MNOK 31.12 31.12 16.6 million in shares in PCI Biotech 2014 2013 and deferred tax asset of NOK 31.1 Non-current assets 76,5 104,8 million Inventory & receivables 28,8 29,7 • Photocure not participating in Cash & equivalents 165,2 1
Slide 23: Outlook
Outlook
Slide 24: Outlook
OUTLOOK • Hexvix/Cysview global in-market unit sales growth of ≥10% in 2015 FINANCIAL • Submit Special Protocol Assessment Request (SPAR) by mid-2015 • Initiate Phase 3 clinical trial to expand the use of Hexvix/Cysview CLINICAL into the surveillance market and fulfill the US post marketing commitme