Photocure ASA · OSL:PHO
Photocure ASA — Q2 2009 Earnings Presentation
28 slides from Photocure ASA's earnings presentation, Aug 14, 2009
Slide 1: Brilliance in photodynamic technology
Brilliance in photodynamic technology TM August 14th, 2009 Kjetil Hestdal, President & CEO and Christian Fekete, CFO
Slide 2: Q2 highlights: revenue up 27%, NDA submitted for Hexvix
Increased sales revenue by 27 % to NOK 28.9 million (22.7) Improved operating profit to NOK -14.5 million (-17.7) Submitted NDA for Hexvix® in the USA Progress in R&D Visonac - Completed meetings with FDA and EU regulatory agencies Cevira - Ongoing phase I/II proof-of-concept study in CIN I patients
Slide 3: Brilliance in photodynamic technology
Brilliance in photodynamic technology TM
Slide 4: Sales revenue growing over 20% in the last 5 quarters
Sales revenue growing over 27 % 20% in the last 5 quarters 4
Slide 5: Sales revenue growing 27% in Q2 and 31% in H1
Sales revenue growing 27% Numbers in NOK thousand (unaudited) Q2 09 Q2 08 H1 2009 H1 2008 in Q2 and 31% in H1 Sales revenue 28 889 22 687 57 962 44 098 Signing fee & milestone revenues 0 0 0 1 303 Increased margin to 83% in Total revenues 28 889 22 687 57 962 45 401 Q2 and 84% in H1 Cost of products
Slide 6: Q2 2009 results by own and partner sales
(unaudited) Q2 2009 Q2 2008 Numbers in NOK thousand Own Partner R&D* Total % vs. 08 Own Partner R&D* Total Sales revenue Metvix/ Aktilite 5 816 11 166 16 982 17 % 5 838 8 688 14 526 Sales revenue Hexvix 4 531 7 376 11 907 46 % 1 969 6 193 8 162 Total sales revenues 10 347 18 581 28 889 27 % 7 807 14
Slide 7: H1 2009 results by own and partner sales
(unaudited) H1 2009 H1 2008 Numbers in NOK thousand Own Partner R&D* Total % vs. 08 Own Partner R&D* Total Sales revenue Metvix/ Aktilite 13 897 22 489 36 385 27 % 11 477 17 138 28 615 Sales revenue Hexvix 8 349 13 227 21 576 39 % 4 202 11 281 15 483 Total sales revenues 22 246 35 716 57 962 31 % 15
Slide 8: Cash and cash equivalents of NOK 150.6 million
Cash and cash equivalents of Numbers in NOK thousand (unaudited) 31.6.2009 31.12. 2008 NOK 150.6 million Non-current assets Intangible assets, software 472 534 Machinery & Equipment 3 449 3 939 Other investments 8 384 11 528 Total non-current assets 12 305 16 001 Current assets Inventory 19 013 12 7
Slide 9: NOK 181.9 million in shareholders' equity
NOK 181.9 million in Numbers in NOK thousand (unaudited) 31.6.2009 31.12.2008 shareholder s equity Paid-in capital 11 047 11 047 Other paid-in capital 190 416 15 467 No interest bearing debt Retained earnings -19 658 173 181 Shareholders equity 181 864 199 694 Total equity 181 864 199 694 Current li
Slide 10: Net change in cash during Q2
NOK 11.3 million in Net Numbers in NOK thousand (unaudited) Q2 2009 FY 2008 change in cash during Q2. Income/ loss before tax -12 095 -64 382 Other operational items -1 229 4 704 Net cash flow from operations -13 324 -59 677 Cash flow from investments 2 010 -12 865 Cash flow from capital transaction
Slide 11: Q2 summary: revenues growing 27% to NOK 28.9 million
Sales revenues growing 27 % to NOK 28.9 million Margin improved to 83% R&D; Hexvix NDA-filing and limited clinical activity Marketing & Sales expenses at 2008 level Operating income improved by NOK 3.2 million NOK 150.6 million in cash 11
Slide 12: Hexvix - a breakthrough in bladder cancer diagnostics
Brilliance in photodynamic technology TM ® - a breakthrough in bladder cancer diagnostics
Slide 13: 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 14: Phase III study in non-muscle invasive papillary tumors
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) Submitted NDA for Hexvix in the USA. 14
Slide 15: Hexvix key sales figures
® Key sales figures: +27 % 1,257 Hexvix units sold in the Nordic region, an increase of 111% vs PY 6,174 Hexvix units sold by GE Healthcare, an increase of 18% vs PY 15
Slide 16: Hexvix priorities: US approval, awareness, reimbursement
Secure 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 16
Slide 17: Metvix/Aktilite - treatment of skin cancer without scarring
Brilliance in photodynamic technology TM ® ® - treatment of skin cancer without scarring
Slide 18: Actinic keratosis and non-melanoma skin cancer prevalence
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 18
Slide 19: 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 20: Metvix/Aktilite key sales figures
® Key sales figures: 84 Aktilite lamps sold in Q209, +7 % an increase of 45% vs PY 3,418 Metvix tubes sold in the Nordic region, an increase of 25% vs PY 15,498 Metvix tubes sold by Galderma, an increase of 4% vs PY 20
Slide 21: Brilliance in photodynamic technology
Brilliance in photodynamic technology TM
Slide 22: Progress in the R&D programs
Progress in the R&D programs Clinical Explorative Phase I/II Phase IIb Phase III Submission Hexvix USA ® Application under review at 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 =
Slide 23: Visonac - need for new acne 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 Acne patient after treatment 23
Slide 24: Visonac development plan in USA and Europe
USA Start phase IIb study in August 2009 ~100 patients, including patients down to 9 years Using new acne lamp Planned completion second quarter 2010 Meet with FDA in second quarter 2010 (EoP2 meeting) Start phase III in 2010 EUROPE Start phase III in first quarter 2010 24
Slide 25: Cevira Phase I/II study in CIN1
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 30 of 70 patients included Initial results in Q1 2010 25
Slide 26: Lumacan - growing health problem in colorectal cancer
- 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: Lumacan Phase I/II study started in 2009
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 9 of up to 70 patient included Planned completion in 2009 First PoC-study in Munich, Germany. One flat lesion showing fluorescen
Slide 28: 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 Develop Visonac , Cevira and Lumacan and capture value through licensing deals 28