Photocure ASA · OSL:PHO
Photocure ASA — Q3 2008 Earnings Presentation
25 slides from Photocure ASA's earnings presentation, Oct 24, 2008
Slide 1: Third quarter report 2008
Brilliance in photodynamic technology TM Third quarter report 2008 October 24th, 2008
Slide 2: Q3 2008 financial, operational and R&D highlights
Financial: Sales revenues increased by 52 % to MNOK 23.6 Hexvix® revenue increased 69% to MNOK 7.8 (4.6) Metvix®/Aktilite® revenue increased 45% to MNOK 15.8 (10.9) Net profit improved by MNOK 11.5 to MNOK -12.1 (-23.6) Operational: Key events in the EU and US First sale of Metvix/Aktilite to Galder
Slide 3: Brilliance in photodynamic technology
Brilliance in photodynamic technology TM
Slide 4: P&L (group) unaudited
2008 2007 2007 Q3 2008 Q3 2007 1.1-30.09 1.1-30.09 1.1-31.12 23 629 15 565 Sales revenues 67 727 51 665 75 252 0 3 908 Signing fee and milestone revenues 1 303 19 845 23 754 23 629 19 474 Total revenues 69 030 71 511 99 006 -4 572 -3 374 Cost of products sold -13 160 -14 359 -17 326 19 058 16 100 Gr
Slide 5: Segment information Q3 2008
3Q 2008 % vs. PY 3Q 2007 Own Partner R&D* Total Own Partner R&D* Total Sales revenue 8 617 15 013 0 23 629 52 % 6 061 9 504 0 15 565 Milestone revenue 0 0 0 0 0 3 908 0 3 908 Total revenues 8 617 15 013 0 23 629 21 % 6 061 13 412 0 19 474 Cost of goods sold 493 4 079 0 4 572 36 % 559 2 815 0 3 374 G
Slide 6: Segment information 1-3Q 2008
1-3Q 2008 % vs. PY 1-3Q 2007 Own Partner R&D* Total Own Partner R&D* Total Sales revenue 24 296 43 431 0 67 727 31 % 19 439 32 227 0 51 665 Milestone revenue 0 1 303 0 1 303 0 19 845 0 19 845 Total revenues 24 296 44 734 0 69 030 -3 % 19 439 52 072 0 71 511 Cost of goods sold 1 621 11 539 0 13 160 -
Slide 7: Balance sheet (group) unaudited
30.09.2008 30.09.2007 31.12.2007 Intangible assets, software 564 1 921 779 Machinery & equipment 3 826 2 617 3 436 Other investments 12 397 Total non-current assets 16 788 4 538 4 215 Inventory 12 350 10 872 12 504 Receivables 24 412 27 917 32 222 Cash & cash equivalents 181 578 271 682 252 452 Tota
Slide 8: Hexvix - a breakthrough in bladder cancer diagnostics
Brilliance in photodynamic technology TM ® - a breakthrough in bladder cancer diagnostics
Slide 9: Hexvix - Recommended by NHS as standard care
Hexvix - Recommended by NHS as standard care Sales increase of 69 % to 7.8 (4.6) in Q3 The National Health Service in UK announced in September a program designed to promote the adoption of photodynamic diagnosis of bladder cancer as standard care. Hexvix is the only approved PDD product in the UK.
Slide 10: Hexvix partner and own sales in units
Hexvix partner sales in units 6 000 5 000 Partner sale of 4,575 units in Q3 4 000 2008 vs. 2,573 units in Q3 2007. 2006 3 000 2007 2008 2 000 1 000 - Q1 Q2 Q3 Q4 900 Hexvis ow n sales in units 800 700 600 Own sale of 808 units in Q3 500 400 2008 vs. 341 units in Q3 2007. 2006 300 2007 200 2008 100 -
Slide 11: Hexvix - Pivotal phase III study meets objectives
Hexvix - Pivotal phase III study meet objectives Inclusion Randomization/stratification Phase III clinical study in bladder cancer Time 0 Cystoscopy Hexvix instillation Cystoscopy white light Multi-centre at 28 clinics in EU/US Primary endpoint TURB Randomization White light FDA approved protocol (S
Slide 12: Metvix/Aktilite - treatment of skin cancer without scarring
Brilliance in photodynamic technology TM ® ® - treatment of skin cancer without scarring
Slide 13: Large market for Metvix/Aktilite in the US
Large market for Metvix/Aktilite in the US FDA approved Metvixia/Aktilite on June 26 2008 for use on Actinic Keratosis (AK), a precancerous skin disease caused by sun exposure AK affects more than 10 million Americans US dermatologists get over 4 million AK visits/year Metvixia is the tradename for
Slide 14: Launch of Metvixia/Aktilite in the US
Launch of Metvixia/Aktilite in the US -Galderma is the leading company in dermatology and skincare in the US. -Metvixia/Aktilite is one of a few new products ready for the market. -Galderma plan introduction of Metvixia/Aktilite to Key Opinion Leader centers in 2008. First shipment of 3,000 Metvixia
Slide 15: Metvix partner and own sales in units
Metvix partner sales in units Partner sale of 12,294 Metvix 16 000 14 000 tubes in Q3 2008, an increase of 12 000 29 % vs. 9,563 Metvix tubes in 10 000 2006 Q3 2007. 8 000 2007 6 000 2008 4 000 2 000 - Q1 Q2 Q3 Q4 Metvix ow n sales in units Own sale of 3,263 Metvix tubes 5 000 4 500 in Q3 2008 a dec
Slide 16: Progress in pipeline projects
Brilliance in photodynamic technology TM - progress in pipeline projects
Slide 17: 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 18: Visonac - significantly reduces total lesion count
Visonac - significantly reduces total lesion count US Study: Average Lesion Count for each time point 65 60 Red 55 Avg # lesions Light * P< 0.01 9 and 12 weeks after start of treatment Only 50 ** P< 0.05 18 weeks after start of treatment Red Light + 45 Visonac 40 ** 35 4 Treatments * * 30 0 2 4 6 8
Slide 19: Visonac is well tolerated in acne patients
Visonac - Visonac is well tolerated in acne patients VAS scale Mean and 95% Confidence interval 8 Severe Pain 7 6 Moderate Pain 5 4 3 Pain Mild 2 Pain No 1 80 mg/g Phase IIb 160 mg/g PoC study Visonac Metvix
Slide 20: Visonac - Improves patient's quality of life
Visonac - Improves patient s quality of life Treatment outcome: From severe acne to almost clear Before 12 weeks after treatment last treatment Before 12 weeks after treatment last treatment
Slide 21: Visonac - starting to prepare a phase III program
Visonac - starting to prepare a phase III program Meetings with authorities US: End-of-Phase II: Planned in Q1 2009 EU: Scientific advice: Planned in Q1 2009 Planned Phase III studies 2 placebo controlled phase III studies App. 400 patients per study 1 study in US and 1 study in Europe
Slide 22: US acne market for moderate to severe acne
Each year US doctors register ~3m 2007 Acne Retail Rx market (US visits concerning acne, app. 70% of and Europe Major 5) these have moderate to severe acne Topicals Market for topical treatment of Isotretinoin $250m Oral Antibiotics moderate to severe acne US$ 1.3 Other oral billion per year $400m E
Slide 23: Cevira - treatment of abnormalities in the cervix
Cevira - treatment of abnormalities in the cervix Phase I/II study: dose finding randomized in CIN 2/3 Norway and Germany Inclusion completed 92 patients 12 months follow-up Primary endpoint: 6 months response Results will be reported in November 2008 IND opened in the US 23
Slide 24: Lumacan phase I/II study in colon
Phase I/II study early detection of premalignant conditions in colon dose-finding 2 centres in Germany - 38 patients presented at DDW, California May 2008 Results: Detection rate Lumacan: 98% Detection rate white light: 72% Plan to start phase I/II study with the oral capsule formulation in 2008, op
Slide 25: Priorities going forward
Continue investing in Metvix and Aktilite Commercialise Hexvix Continue clinical development of Visonac, Cevira and Lumacan Secure licensing/co-development of pipeline projects 25