Photocure ASA · OSL:PHO
Photocure ASA — Q4 2008 Earnings Presentation
27 slides from Photocure ASA's earnings presentation, Feb 27, 2009
Slide 1: Fourth Quarter and Full Year Results - 2008
Brilliance in photodynamic technology TM Fourth Quarter and Full Year Results - 2008 27 February 2009 Kjetil Hestdal, President & CEO and Christian Fekete, CFO
Slide 2: Sales revenues of MNOK 33.2 for Q4 (+41%)
Sales revenues of MNOK 33.2 for Q4 (+41%) Profit of MNOK -9.4 in Q4, up from MNOK -16.3 in Q4 2007 Sales revenues of MNOK 100.9 for 2008 (+31%) Profit of MNOK -64.4 in 2008, up from MNOK -75.0 in 2007 Significant progress in regulatory and clinical programs 2
Slide 3: Brilliance in photodynamic technology
Brilliance in photodynamic technology TM
Slide 4: Record sales in Q4 & 2008
Record sales in Q4 & 2008 Numbers in NOK thousand Q408 Q407 2008 2007 Sales revenue 33 190 23 587 100 917 75 252 Sales revenue growing Signing fee & milestone revenues 0 3 908 1 309 23 754 steadily Total revenues 33 190 27 495 102 220 99 006 Reduced losses Cost of products sold -5 914 -2 967 -19 074
Slide 5: Q4 2008 results by own sales and partners
Q4 2008 Q4 2007 Numbers in NOK thousand Own Partner R&D* Total % vs. 07 Own Partner R&D* Total Sales revenue Metvix/ Aktilite 7 421 12 223 19 644 33% 7 642 7 149 14 791 Sales revenue Hexvix 3 368 10 178 13 546 54% 1 988 6 807 8 795 Total sales revenues 10 789 22 401 33 190 41% 9 630 13 956 23 587 Mi
Slide 6: Full year 2008 results by own sales and partners
2008 2007 Numbers in NOK thousand Own Partner R&D* Total % vs. 07 Own Partner R&D* Total Sales revenue Metvix/ Aktilite 24 895 39 168 64 063 18% 23 053 31 168 54 221 Sales revenue Hexvix 10 190 26 664 36 855 75% 6 016 15 016 21 031 Total sales revenues 35 085 65 832 100 917 34% 29 069 46 183 75 252
Slide 7: Shares in PCI Biotech Holding ASA written down by NOK 9.4 million
Shares in PCI Biotech Holding Numbers in NOK thousand FY 2008 FY 2007 ASA written down by NOK 9.4 Non-current assets million in Q4 to NOK 11.5 million Intangible assets, software 534 779 Machinery & Equipment 3 939 3 436 Cash and cash equivalents of NOK 179.9 million Other investments 11 528 Total n
Slide 8: NOK 199.7 million in shareholders' equity
NOK 199.7 million in Numbers in NOK thousand FY 2008 FY 2007 shareholder s equity Paid-in capital 11 047 11 047 Other paid-in capital 15 467 10 984 No interest bearing debt Retained earnings 173 181 237 472 Shareholders equity 199 694 259 503 Minority interest 0 491 Total equity 199 694 259 994 Curr
Slide 9: Net change in cash during Q4
NOK -1.7 million in Net change Numbers in NOK thousand Q4 2008 FY 2008 in cash during Q4 due to strong Income/ loss before tax -9 426 -64 382 sales, cost control and one time Other operational items 16 805 4 704 effects Net cash flow from operations 7 559 -59 677 NOK 36 million improvement in net ca
Slide 10: Record sales in Q4 and FY 2008
Record sales in Q4 and FY 2008 Sales revenues growing steadily Manageable R&D expenses Demerged PCI Biotech Holding ASA in 2008 Increased Marketing & Sales expenses to boost sales further 20+ million in cash Significantly improved cash flow Financial freedom and strength to explore market opportunit
Slide 11: Hexvix - a breakthrough in bladder cancer diagnostics
Brilliance in photodynamic technology TM ® - a breakthrough in bladder cancer diagnostics
Slide 12: Hexvix unit sales increase
Hexvix® - sales increase of 41% in Q4 and 93% in 2008 in units Unit Sales 8 000 Q4: Partner sale of 6,240 units in 2008 vs. 4,570 units in 7 000 2007. 6 000 Q4: Own sale of 1,050 units in 5 000 2008 vs. 611 units in 2007. # units 4 000 Full year: Partner sale of 3 000 19,513 units in 2008 vs. 9,897
Slide 13: Hexvix - large phase III study in US/EU
Hexvix® - Large phase III study completed in US/EU with excellent results for detection and recurrence Hexvix cystoscopy was compared with standard white light cystoscopy in patients with non-muscle invasive bladder cancer (Ta/T1 tumors) 789 patients included at 28 centers in EU and USA included 9 m
Slide 14: Hexvix - phase III study in Denmark
Hexvix® - phase III study completed in Denmark in 2008 confirming the reduction in recurrence rates Hexvix cystoscopy was compared with standard white light cystoscopy in patients with non-muscle invasive bladder cancer 233 patients with bladder cancer at 2 centers in Denmark Started inclusion in Q3
Slide 15: Hexvix - roadmap
Hexvix® - roadmap Regulatory progress in the USA Constructive and progressive interaction with FDA in co- operation with GE Healthcare Submission to FDA planned in Q3 2009 Commercial process in Europe Promote Hexvix in co-operation with GE Healthcare EAU 2009 in Stockholm symposium and press meeting
Slide 16: Metvix - treatment of skin cancer without scarring
Brilliance in photodynamic technology TM ® ® - treatment of skin cancer without scarring
Slide 17: Metvix unit sales increase
Metvix® sales increase of 17% in Q4 and 16% in 2008 in units Unit Sales 23 000 Q4: Partner sale of 17,256 units in 2008 vs. 13,628 units 21 000 in 2007. 19 000 Q4: Own sale of 4,156 units in 17 000 2008 vs. 4,674 units in 2007. 15 000 13 000 Full year: Partner sale of 59,332 units in 2008 vs. 11 000
Slide 18: Metvix roadmap
® roadmap US launch in progress Improve payment/reimbursement conditions in co- operation with Galderma Establish new centers and increase use at established centers Improve procedure 18
Slide 19: Brilliance in photodynamic technology
Brilliance in photodynamic technology TM
Slide 20: Progress in the R&D programs
Progress in the R&D programs Clinical Products and Pipeline Explorative Phase I/II Phase IIb Phase III Submission Hexvix® USA PDD Bladder cancer diagnosis (USA) Visonac PDT Treatment of moderate to severe acne Cevira PDT Treatment of cervical premalignant lesions Lumacan PDD Colon cancer diagnosis =
Slide 21: Visonac - Phase II study in acne
Visonac - Phase II study demonstrated significant and sustained effect on treating moderate to severe acne vulgaris Median % reduction in inflammatory lesions Sustained improvement in lesion 100 count owing to bacteria killing effect and sebum reduction effect 80 64 of Visonac 60 60 60 40 Significan
Slide 22: Visonac - next steps planning phase III
Visonac - next steps planning phase III USA Guidance meeting held with FDA in January Positive feedback on Visonac documentation Discussions on the clinical development program Europe Guidance meeting scheduled in Sweden/EU in Q2 Plan to discuss the clinical development program in EU Plan to start p
Slide 23: Lumacan - growing health problem, colon cancer
- growing health problem, among most lethal cancers Over 500,000 cases of colon cancer are diagnosed each year in the US and EU combined Five years survival rate is 50 60%. Colonoscopy screening may prevent up to 80% of deaths from CRC Lumacan improves CRC diagnosis based on established technology 2
Slide 24: Lumacan - diagnosis of colon cancer
Lumacan - diagnosis of colon cancer Completed Phase I/II study in 2008; Proof-of- Concept with enema- early detection of premalignant conditions in the colon: open dose-finding 2 centres in Germany - 38 patients 37% improvement in detection over standard method Started Phase I/II study in 2009; Proo
Slide 25: Premalignant lesions in Cervix
Premalignant lesions in Cervix - HPV Infections and Cervical Abnormalities Clinical challenges: Patients with mild lesions (CIN1) - poor diagnosis (20-30% CIN2/3) - patient anxiety - no standard therapy - costly follow-ups - poor patient follow up Patients with severe lesions (CIN2/3) - invasive sur
Slide 26: Cevira - the Therapeutic Option
Cevira - the Therapeutic Option - PDT treatment of cellular abnormalities in the cervix Phase I/II dose-finding study: Interim results Lesion response rate %, Oslo 92 patients with CIN2/3 Oslo and Hannover 90 82 Complete response 80 73 Endpoint: 6 months response 70 Complete and partial Interim resu
Slide 27: Strategic and operational goals
Strategic and operational goals Maximize value of the existing product portfolio Continue Nordic leadership Support Galderma in strengthening Metvix/Aktilite follow-up on US Seek Hexvix approval in the US Develop new products Seek regulatory advice and start phase III in EU for Visonac Complete Proo