Photocure ASA · OSL:PHO
Photocure ASA — Q2 2008 Earnings Presentation
24 slides from Photocure ASA's earnings presentation, Aug 15, 2008
Slide 1: Second quarter report 2008
Brilliance in photodynamic technology TM Second quarter report 2008 August 15th, 2008
Slide 2: Financial, operational and strategic highlights
Financial: Sales revenues increased by 33 % to MNOK 22.7 Hexvix® revenue increased 108% to MNOK 8.2 (3.9) Metvix®/Aktilite® revenue increased 10% to MNOK 14.5 (13.2) Net loss of MNOK 23.0 (17.3) Operational: Metvix/Aktilite approved in the US Metvix/Aktilite approved by the FDA on June 26 for Actini
Slide 3: Brilliance in photodynamic technology
Brilliance in photodynamic technology TM
Slide 4: Demerger from Photocure
Demerger from Photocure IPO on Oslo Axess June 18th, 2008 Share issue of MNOK 60 Photocure ownership: 19.9% Accounting effect; Illustration of PCI Biotech s drug delivery technology P&L: Expenses of MNOK 4.8 in H1 2008 for endosomal release of drugs and nanoparticles Balance Sheet pr 30.6.2008: Othe
Slide 5: Income statement (unaudited)
2008 2007 2007 Q2 2008 Q2 2007 1.1-30.06 1.1-30.06 1.1-31.12 22 687 17 094 Sales revenues 44 098 36 100 75 252 0 12 028 Signing fee and milestone revenues 1 303 15 937 23 754 22 687 29 123 Total revenues 45 401 52 037 99 006 -4 087 -4 397 Cost of products sold -8 588 -10 985 -17 326 18 600 24 726 Gr
Slide 6: Income statement Q2 - own sales/partner sales
Income statement - own sales/partner sales (unaudited) 2Q 2008 % vs. PY 2Q 2007 Own Partner R&D* Total Own Partner R&D* Total Sales revenue 7 807 14 881 0 22 687 33 % 6 353 10 741 0 17 094 Milestone revenue 0 0 0 0 0 12 028 0 12 028 Total revenues 7 807 14 881 0 22 687 -22 % 6 353 22 770 0 29 123 Co
Slide 7: Income statement First Half 2008 - own sales/partner sales
Income statement First Half 2008 - own sales/partner sales (unaudited) 1H 2008 % vs. PY 1H 2007 Own Partner R&D* Total Own Partner R&D* Total Sales revenue 15 679 28 419 0 44 098 22 % 13 377 22 723 0 36 100 Milestone revenue 0 1 303 0 1 303 0 15 937 0 15 937 Total revenues 15 679 29 722 0 45 401 -13
Slide 8: Balance Sheet (unaudited)
Balance Sheet (unaudited - all amounts in NOK 1,000) 30.06.2008 30.06.2007 31.12.2007 Non-currrent assets Intangible assets, software 615 1 581 779 Machinery & equipment 4 021 2 584 3 436 Other investments 12 397 Total non-current assets 17 033 4 164 4 215 Currrent assets Inventory 11 941 11 478 12
Slide 9: Hexvix - a breakthrough in bladder cancer diagnostics
Brilliance in photodynamic technology TM ® - a breakthrough in bladder cancer diagnostics
Slide 10: Hexvix sales increase of 108% in Q2
Sales increase of 108 % to 8.2 (3.9) in Q2 Development in key value drivers: Establish reimbursement Ongoing Increase base of scopes Ongoing Train urologists Ongoing Increase use at established centres Ongoing 10
Slide 11: Hexvix partner and own sales in units
Hexvix partner sales in units 6 000 5 000 Partner sale of 5,235 units in Q2 4 000 2008 vs. 1,842 units in Q2 2007. 2006 3 000 2007 2008 2 000 1 000 - Q1 Q2 Q3 Q4 Hexvis ow n sales in units 700 600 Own sale of 595 units in Q2 500 2008 vs. 336 units in Q2 2007. 400 2006 2007 300 2008 200 100 - Q1 Q2 Q
Slide 12: Hexvix US FDA status and plan
Status: Discussion with FDA under the IND; Preclinical no outstanding issues Clinical depending on clinical results Equipment agreed process /working with partner Plan: Complete clinical phase III study in 2008 Submit complete response to FDA in 1H 2009 12
Slide 13: Phase III clinical study in bladder cancer
Phase III clinical study in bladder cancer Multi-centre at 28 clinics in EU/US FDA has approved protocol (SPA) Included ~750 patients Endpoints: detection of lesions/recurrence Implemented FDA requests: Independent panel read of histology Illustration of different types of bladder cancer Improved do
Slide 14: Metvix - treatment of skin cancer without scarring
Brilliance in photodynamic technology TM ® ® - treatment of skin cancer without scarring
Slide 15: FDA approved Metvixia/Aktilite for Actinic Keratosis
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 Metvix in the US.
Slide 16: US AK treatments
US AK treatments - US Topical AK treatments - Total visits 4M Total value $100M 13 % 15 % 25 % 87 % 60 % Topical Cryotherapy/other Aldara 5-FU Solaraze
Slide 17: 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.
Slide 18: Metvix partner and own sales in units
Metvix partner sales in units Partner sale of 14,897 Metvix 16 000 14 000 tubes in Q2 2008, an increase of 12 000 29 % vs. 11,543 Metvix tubes in 10 000 2006 Q2 2007. 8 000 2007 6 000 2008 4 000 2 000 - Q1 Q2 Q3 Q4 Metvix own sales in units Own sale of 2,731 Metvix tubes 5 000 4 500 in Q2 2008 a dec
Slide 19: Progress in pipeline projects
Brilliance in photodynamic technology TM - progress in pipeline projects
Slide 20: R&D programs
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 = completed = ong
Slide 21: Visonac - treatment of moderate to severe acne
Visonac - treatment of moderate to severe acne Phase IIb study: Moderate to severe acne ~190 patients in the US Dose finding Placebo controlled Endpoint: reduction of lesions New lamp developed Illustration of Photocure s novel acne treatment 21
Slide 22: 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 • Submitted IND in the US in July • New phase I/II study planned in 2008 • F
Slide 23: Lumacan - colon cancer diagnosis
• Finalized 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 Plan to start phase I/II study with the oral capsule formulation in 2008, open, dose finding 4 centres in Germany/Norway 50-70
Slide 24: Strategic priorities
Continue investing in Metvix and Aktilite • Strengthen Metvix/Aktilite in dermatology Commercialise Hexvix • Support GE Healthcare in introducing Hexvix • Secure Hexvix approval in the US Continue clinical development in acne, cervix and colon Secure licensing/co-development of pipeline projects 24