Photocure ASA · OSL:PHO
Photocure ASA — FY2002 Earnings Presentation
37 slides from Photocure ASA's earnings presentation, Feb 26, 2003
Slide 1: PhotoCure ASA Full Year Results Presentation 2002
PhotoCure ASA Full Year Results Presentation 2002 26th February 2003
Slide 2: Important Achievements
Important Achievements Metvix® – Launch started in Germany by Galderma – February 2003 – International roll out in progress– UK launch soon – Approvable letter from US FDA – September 2002 – NDA filed for BCC indication in the US – February 2003 – Recommended approval in Australia – February 2003
Slide 3: The financial profile to succeed
The financial profile to succeed % 2002 2001 change Comments Sales 25 223 2 330 983 % Substantial increase Cost of products sold 5 832 0 Gross Profit 19 392 2 330 732 % Other operating revenues 3 486 3 022 15 % Increase government grants Other operating expenses 132 404 133 218 -1 % Costs levelled o
Slide 4: Metvix – The Commercial Roll Out Gathers Momentum
Metvix® – The Commercial Roll Out Gathers Momentum PhotoCure 1st Photodynamic Therapy (PDT) Agent Rapid Growth in Revenues
Slide 5: Metvix – Galderma, the optimal marketing partner
Metvix® – Galderma, the optimal marketing partner Dermatology specialist – Sales + production + research Strong shareholders – Owned 50/50 by Nestlé and L’Oréal The only global company 100% focused on dermatology – reaching dermatologists in more than 70 countries – worlds largest sales force
Slide 6: Marketing Metvix – the German launch by Galderma
Marketing Metvix® – the German launch by Galderma Started launch 1st February 2003 Launch symposium in Berlin attended by 150 key opinion leaders Educational centres in place Metvix® and Light Sources with Galderma International roll out in progress
Slide 7: Marketing Metvix – the Galderma commitment
Marketing Metvix® – the Galderma commitment Metvix® subject to biggest launch investment ever Major international agency working to support product’s international roll out Dedicated international marketing team in place Metvix® could in time be Galderma’s biggest product
Slide 8: Marketing Metvix – progress in the Nordic region
Marketing Metvix® – progress in the Nordic region Metvix® available in all four countries Usage developing as planned Growing acceptance of benefits 130 centres now using technique routinely
Slide 9: Metvix – quick and easy treatment
Metvix® – quick and easy treatment Lesion preparation Metvix® application Red light illumination
Slide 10: Metvix – highly effective with superior cosmetic results
Metvix® – highly effective with superior cosmetic results
Slide 11: Metvix – highly effective with superior cosmetic results
Metvix® – highly effective with superior cosmetic results
Slide 12: Marketing Metvix – positive development of sales revenues
Marketing Metvix® – positive development of sales revenues Sales revenues 10 000 Sales revenues excl. 9 000 signing fee 8 000 Accrued signing fee 7 000 NOK 1000 6 000 5 000 4 000 3 000 2 000 1 000 - 1Q 2002 2Q 2002 3Q 2002 4Q 2002
Slide 13: Metvix – marketing in the Nordic area on track
Metvix® – marketing in the Nordic area on track Clinics with PhotoCure lamps 150 Target May 2003 Acc. number of clinics 125 Finland 100 Denmark 75 50 Norway 25 Sweden 0 Nov. Febr. May Aug. Nov. Feb. 01 02 02 02 02 02
Slide 14: Metvix – marketing in the Nordic area on track
Metvix® – marketing in the Nordic area on track Acc. number of light sources 250 Finland 200 150 Denmark 100 Norway 50 Sweden 0 Febr. May Aug. Nov. Feb. 02 02 02 02 02
Slide 15: Metvix – marketing in the Nordic area
Metvix® – marketing in the Nordic area Number of tubes sold to pharmacies 1600 1400 1200 1000 800 600 400 200 0 4Q 1Q 2Q 3Q 4Q 2001 2002 2002 2002 2002
Slide 16: Marketing Metvix – establishing clinical centers in Sweden
Marketing Metvix® – establishing clinical centers in Sweden Oct. 2001 Oct. 2002 Febr. 2003 N.A./N.I. 123 19 13 Interest 59 58 User 5 43 45 Big User 7 7 Big user: more than 5 treatments per week
Slide 17: Marketing Metvix – establishing clinical centers in Norway
Marketing Metvix® – establishing clinical centers in Norway Dec. 2001 Oct. 2002 Febr. 2003 N.A./N.I. 99 60 39 Interest 10 30 User 9 35 40 Big User 1 4 5
Slide 18: Marketing Metvix – establishing clinical centers in Denmark
Marketing Metvix® – establishing clinical centers in Denmark July 2002 Oct. 2002 Febr. 2003 N.A./N.I. 93 26 24 Interest 54 43 User 3 15 19 Big User 1 3
Slide 19: Marketing Metvix – establishing clinical centers in Finland
Marketing Metvix® – establishing clinical centers in Finland July 2002 Oct. 2002 Febr. 2003 N.A./N.I. 52 37 35 Interest 11 10 User 5 8 10 Big User 1 1
Slide 20: Marketing Metvix – the international roll out
Marketing Metvix® – the international roll out Launch started in Germany UK next country to launch Launch preparations are ongoing in 4 other countries
Slide 21: Germany – a significant potential
Germany – a significant potential The first major market adressed Enthusiastic response from opinion leaders to launch Dedicated product management Sales force consist of 50 sales representatives – of which 5 dedicated exclusively to Metvix® 6 educational centres in place Price and reimb
Slide 22: Metvix in the US
Metvix® in the US Approvable letter for AK received NDA for BCC now filed Pre-launch activities starting Opinion leader education started
Slide 23: Hexvix – A Breakthrough in Bladder Cancer Diagnosis
Hexvix® – A Breakthrough in Bladder Cancer Diagnosis PhotoCure’s 1st Photo-Diagnostic (PD) agent close to 1st launch
Slide 24: Hexvix – preparation finished
Hexvix® – preparation finished Hexvix 85 mg Powder for solution for intravesical use + 50 ml Solvent for Hexvix for intravesical use Hexvix® solution - Instilled 1 hour in the bladder - Start cystoscopy within 30 minutes
Slide 25: Hexvix – papillary lesion detected with Hexvix only
Hexvix® – papillary lesion detected with Hexvix only
Slide 26: Hexvix – CIS detected with Hexvix only
Hexvix® – CIS detected with Hexvix® only
Slide 27: Hexvix – papillary tumour
Hexvix® — papillary tumour PDD HAL URO Glib ’ HAL URO CC)
Slide 28: How Hexvix is used
How Hexvix® is used
Slide 29: Hexvix – excellent phase III results
Hexvix® – excellent phase III results Hexvix detected 97% of CIS lesions (CIS = Carcinoma in Situ) Hexvix® Standard white light cystoscopy cystocopy 97% 59%
Slide 30: Hexvix – 1st MAA already filed in Europe
Hexvix® – 1st MAA already filed in Europe Europe – Clinical phase III study completed with positive results – Marketing application for EU filed in Sweden - December 2003 USA – Investigational New Drug status obtained – Phase III studies on-going
Slide 31: Hexvix – the commercial opportunity
Hexvix® – the commercial opportunity Newly diagnosed patients, annually – Europe and North America: 200 000 Fourth leading cause of cancer in men Eighth leading cause in women Related to smoking, exposure to carcinogens
Slide 32: Hexvix – the cystoscopy market explained
Hexvix® – the cystoscopy market explained At first cystoscopy only 1/6 patients are diagnosed with bladder cancer Patients with suspicious or diagnosed bladder cancer will go through 1-2 cystoscopies for further diagnoses and treatment Thereafter patients will be followed up 1-4 times annually
Slide 33: Hexvix – cystoscopy market
Hexvix® – cystoscopy market 25% Operating Room cystoscopies 1/6 cancer 50% Follow-Up cystoscopies 25 % first cystoscopies 5/6 no cancer Suspected bladder cancer
Slide 34: Hexvix – pre-Launch activities underway
Hexvix® – pre-Launch activities underway Contract manufacturer selected Market research study completed Price and reimbursement preparations ongoing Out-licensing activities initiated – PhotoCure will retain the Nordic region as with Metvix®
Slide 35: Strong pipeline progressing well
Strong pipeline progressing well ALA derivatives R&D opportunities (excluding dermatology and urology) Barrets oesophagus – clinical pilot study initiated Colorectal cancer – clinical pilot study initiated Lesions in mouth, pharynx and larynx – clinical pilot study initiated Gynaecology (vul
Slide 36: We will continue to deliver – milestones for the next twelve months
We will continue to deliver – milestones for the next twelve months Metvix® – UK launch and further global roll out – 150 clinical centres established in the Nordic area – Final approval in the US and in Australia – Update regulatory dossier for remaining EU countries – Initiate clinical study for
Slide 37: Highlights
Highlights Metvix® – Launched in Germany by Galderma – February 2003 – International roll out has now started – UK launch soon – Approvable letter from US FDA – September 2002 – NDA filed for BCC indication in the US – February 2003 – Recommended approval in Australia – February 2003 – Increasing