Photocure ASA · OSL:PHO
Photocure ASA — Q1 2009 Earnings Presentation
29 slides from Photocure ASA's earnings presentation, Apr 29, 2009
Slide 1: Brilliance in photodynamic technology
Brilliance in photodynamic technology TM April 29th, 2009 Kjetil Hestdal, President & CEO and Christian Fekete, CFO
Slide 2: Q1 2009 highlights
Sales revenue increased by 36 % to NOK 29.1 million (21.4) Operating profit of NOK -5.7 million (-22.5), an improvement of NOK 16.7 million Progress in R&D Visonac - Completed meetings with FDA and EU regulatory agencies Cevira - Started phase I/II proof-of-concept study in CIN I patients Lumacan -
Slide 3: Brilliance in photodynamic technology
Brilliance in photodynamic technology TM
Slide 4: Sales Revenue
NOKm 35 36 % 30 25 20 15 10 5 0 Q1 07 Q2 07 Q3 07 Q4 07 Q1 08 Q2 08 Q3 08 Q4 08 Q1 09 4 Sales Revenue
Slide 5: Sales revenue growing 36%, reduced losses, increased margin to 84%
Sales revenue growing 36% Numbers in NOK thousand (unaudited) Q1 09 Q1 08 FY 2008 FY 2007 Sales revenue 29 073 21 411 100 917 75 252 Increased margin to 84% Signing fee & milestone revenues 0 1 303 1 303 23 754 Reduced losses Total revenues 29 073 22 713 102 220 99 006 Lower R&D expenses due to Cost
Slide 6: Q1 2009 Own and Partner results
(unaudited) Q1 2009 Q1 2008 Numbers in NOK thousand Own Partner R&D* Total % vs. 08 Own Partner R&D* Total Sales revenue Metvix/ Aktilite 8 081 11 323 19 404 38 % 5 640 8 450 14 090 Sales revenue Hexvix 3 818 5 851 9 669 32 % 2 233 5 088 7 321 Total sales revenues 11 899 17 174 29 073 36 % 7 872 13
Slide 7: Shares in PCI Biotech written down by NOK 4.2 million
Shares in PCI Biotech Holding Numbers in NOK thousand (unaudited) 31.3.2009 31.12. 2008 ASA written down by NOK 4.2 Non-current assets million in Q1 to NOK 7.3 million Intangible assets, software 511 534 Machinery & Equipment 3 721 3 939 Cash and cash equivalents of NOK 161.9 million Other investmen
Slide 8: NOK 192.0 million in shareholders' equity
NOK 192.0 million in Numbers in NOK thousand (unaudited) 31.3.2009 31.12.2008 shareholder s equity Paid-in capital 11 047 11 047 Other paid-in capital 189 562 15 467 No interest bearing debt Retained earnings -8 611 173 181 Shareholders equity 191 997 199 694 Total equity 191 997 199 694 Current lia
Slide 9: Net change in cash during Q1
NOK 18.0 million in Net Numbers in NOK thousand (unaudited) Q1 2009 FY 2008 change in cash during Q1. Income/ loss before tax -8 611 -64 382 Other operational items -11 766 4 704 Other operational items include: Net cash flow from operations -20 378 -59 677 Inventory incr. MNOK -5.8 Reduced ST debt
Slide 10: Q1 2009 financial summary
Sales revenues growing 36 % to NOK 29.1 million Margin improved to 84% Lower R&D expenses due to few ongoing clinical trials Marketing & Sales expenses at 2008 level Operating income improved by NOK 16.7 million Nordic operating profit of NOK 0.6 million NOK 161.9 million in cash 10
Slide 11: Hexvix - a breakthrough in bladder cancer diagnostics
Brilliance in photodynamic technology TM ® - a breakthrough in bladder cancer diagnostics
Slide 12: Hexvix - the only licensed product of its type
® - the only licensed product of its type Enables doctors to carry out a more effective tumour removal Strong improvement compared to standard diagnostic procedures Hexvix results Detection of patients w/ bladder cancer 30% more1. Detection of patients w/ CIS lesions 28% more2. Detection of CIS lesi
Slide 13: Excellent feedback from urologists at EAU, Stockholm
Excellent feedback from urologists at EAU, Stockholm Presented phase III clinical study in 766 patients with non-muscle invasive papillary tumors (Ta/T1) Relative reduction in recurrence rate of 22 % (P=0.029) More lesions detected in 17 % of patients (P=0.0005) Representatives from GE Healthcare an
Slide 14: Hexvix key sales drivers
® Unit Sales 8 000 Key sales drivers: 60 % 7 000 Urologists acceptance 6 000 Equipment base 5 000 Use at established centres 4 000 Inflow of new centres 3 000 Reimbursement 2 000 Therapeutic area Geographical expansion 1 000 0 Q107 Q207 Q307 Q407 Q108 Q208 Q308 Q408 Q109 Units own Units partner 14
Slide 15: Hexvix priorities and US approval
Increase public awareness Improve reimbursement procedures Perform clinical studies to increase therapeutic indication and scope, and to develop new treatment options for follow up-patients Secure US approval Submission of NDA in Q3 2009 15
Slide 16: Metvix - treatment of skin cancer without scarring
Brilliance in photodynamic technology TM ® ® - treatment of skin cancer without scarring
Slide 17: Actinic Keratosis and NMSC
Actinic Keratosis (AK): Overall prevalence 11-25% 15 million diagnosed in EU/ US per year NMSC (Non Melanoma Skin Cancer): Most common malignancies in the Caucasian population > 1/3 of all adult cancers in the US Incidence increased 3-8% per year worldwide since 1964 17
Slide 18: Precisely directed treatment without scarring
® Precisely directed treatment without scarring Approved for AK, BCC and Bowen s (BD) PDT recommended as first-line treatment for AK/BCC/BD in international guidelines Physician-controlled - 100% compliance Clinically effective Limited & predictable side-effect profile Superior cosmetic outcome Non-
Slide 19: Metvix key sales drivers
® Unit Sales Key sales drivers: 25 000 11 % Placement/ sale of Aktilite lamps Train doctors and nurses 20 000 Use at established centres 15 000 Dedicated sales force Reimbursement 10 000 Therapeutic area 5 000 Geographical expansion 0 Q107 Q207 Q307 Q407 Q108 Q208 Q308 Q408 Q109 Units own Units part
Slide 20: Brilliance in photodynamic technology
Brilliance in photodynamic technology TM
Slide 21: Progress in the R&D programs
Progress in the R&D programs Clinical Explorative Phase I/II Phase IIb Phase III Submission Hexvix ® Preparing for submission to FDA Visonac Preparing for phase III Cevira Ongoing Proof-of-Concept study in patients with low grade dysplasia Lumacan Ongoing Proof-of-Concept with oral formulation = com
Slide 22: Visonac - need for new treatments
- need for new treatments Acne patient before treatment US doctors annually register ~ 3 million visits concerning acne ~70% of these have moderate to severe acne • Market for topical treatment of moderate to severe acne USD 1.3 billion per year Existing treatments have significant side effects Phot
Slide 23: Visonac regulatory meetings with FDA and EMEA
USA Guidance meeting held with FDA in January 2009 Positive feedback on Visonac documentation Discussions on the clinical development program Recommended that Photocure get additional clinical data on a patient population down to 9-12 years in combination with the acne lamp EUROPE Guidance meeting h
Slide 24: Cevira - clinical challenges
- clinical challenges Patients with mild lesions (CIN1) • Poor diagnostic sensitivity (20-30% CIN2+) • Positive HPV testing • No standard therapy • Patient anxiety • Time-consuming and costly follow-ups • Patients lost to follow up Patients with severe lesions (CIN2/3) • Invasive surgery • Requires
Slide 25: Cevira phase I/II study
IND opened in 2008 in the US Phase I/II study started in Q1 2009 • Focus on CIN1 • 5 centres in France, Germany and Norway • 6 months follow-up • Primary endpoint: 6 months response • 13 of 70 patients included per April 22nd • Initial results in Q1 2010 25
Slide 26: Lumacan - growing health problem
- growing health problem, among most lethal cancers Colorectal cancer - large and growing area Among the most lethal cancers > 500,000 cases diagnosed in US & EU per year Five years survival rate is 50 60% Colonoscopy screening may prevent up to 80% of deaths from Colorectal Cancer Use of colonoscop
Slide 27: Diagnosis of colorectal cancer
Diagnosis of colorectal cancer • Significant improvement of colorectal cancer diagnosis, based on established technology • Strong intellectual property 27
Slide 28: Lumacan phase I/II study
Started Phase I/II study in 2009 Proof-of-Concept with oral formulation: • Open, dose-finding • 4 centres in Germany and 50-70 patients • Sponsored by Norwegian Research Council • 6 of up to 70 patient included by April 22 • Planned completion in 2009 First PoC-study in Munich, Germany. One flat les
Slide 29: Continue to grow Metvix/Aktilite and Hexvix
Continue to grow Metvix/Aktilite • Support Galderma in strengthening Metvix/Aktilite in dermatology Continue to grow Hexvix • Support GE Healthcare in introducing Hexvix in EU • Secure Hexvix approval in the US Capture value through licensing deals for Visonac , Cevira and Lumacan 29