Photocure ASA · OSL:PHO
Photocure ASA — Q1 2002 Earnings Presentation
18 slides from Photocure ASA's earnings presentation, May 7, 2002
Slide 1: PhotoCure ASA Results 1st quarter 2002
PhotoCure ASA Results 1st quarter 2002 May 2002 gm-November 2000 pres
Slide 2: Highlights
Highlights ! Metvix® – Commercialisation on track ! Hexvix® – On track for filing of marketing authorisation first half 2003 ! Strong R&D pipeline – Benzvix® cinical pilot studies on track gm-November 2000 pres
Slide 3: Metvix – Marketing Authorisations in many countries
Metvix® – Marketing Authorisations in many countries ! National authorisations issued in: – Sweden, Norway, Denmark, Iceland, Germany, UK, Ireland, Luxembourg, New Zealand ! Awaiting national authorisations in: – Finland, Belgium, Austria, Spain, Italy, Greece ! Application filed in Switzerland ! Ad
Slide 4: Marketing Metvix – Commercialisation in Sweden
Marketing Metvix® –Commercialisation in Sweden ! Regulatory approval June 2001 ! Reimbursed price of 1300 SEK per tube of Metvix® October 2001 ! Procedure fee negotiations ongoing ! Target group: 120 dermatology centers ! Training personell from 78 centres – 46 centers completed ! Provided 41 center
Slide 5: Marketing Metvix – Commercialisation in Norway
Marketing Metvix® –Commercialisation in Norway ! Final regulatory approval February 2002 ! Approved price of 1100 NOK per tube of Metvix® ! Reimbursement application filed for Metvix® ! Procedure fee negotiations ongoing ! Target group: 85 dermatology centers ! Focus on hospitals and opinion leaders
Slide 6: Marketing Metvix – Commercialisation in Denmark
Marketing Metvix® –Commercialisation in Denmark ! Final approval obtained ! Reimbursement application filed for Metvix® ! Target group: 90 dermatology centers ! Market introduction symposium this month ! Focus on hospitals and opinion leaders gm-November 2000 pres
Slide 7: Marketing Metvix – Commercialisation in Finland
Marketing Metvix® –Commercialisation in Finland ! Awaiting final national approval ! Target group: 100 dermatology centers ! Market introduction symposium this month ! Focus on hospitals and opinion leaders gm-November 2000 pres
Slide 8: Marketing Metvix – Galderma pre-launch preparations ongoing
Marketing Metvix® – Galderma pre-launch preparations ongoing ! Several meetings held between Galderma and PhotoCure executives on three continents – Co-operation established ! Steering comittee established between Galderma and PhotoCure ! Galderma hired dedicated strategic marketing manager ! Galder
Slide 9: New indications in dermatology – Several possible indications
New indications in dermatology – Several possible indications ! Positive data on acne – Pilot study completed – World wide acne market totals 1.7 bn USD per year ! Other areas of interest – Photoaging (skin rejuvenation) – Wound healing (pilot study planned) – Warts gm-November 2000 pres
Slide 10: Hexvix preparation
Hexvix® preparation Hexyl aminolevulinate 85mg + Phosphate buffer saline 50 mL " Hexvix® 8mM solution - Stable for 24h in refrigerator - Instilled 1 hour in the bladder - Start cystoscopy within 30 minutes gm-November 2000 pres
Slide 11: Hexvix in bladder cancer – positive results in phase II clinical trial
Hexvix® in bladder cancer – positive results in phase II clinical trial Four times more patients with CIS lesions detected (CIS = Carcinoma in Situ) Hexvix® White light 12 / 13 92% 3 / 13 23% Patients have one or more CIS lesions gm-November 2000 pres
Slide 12: Hexvix – phase III program ongoing
Hexvix® – phase III program ongoing ! Europe – Enrolment in first clinical phase III study completed – One additional study initiated ! USA – Investigational New Drug status obtained – Phase III study initiated ! First marketing application planned 1st half 2003 gm-November 2000 pres
Slide 13: Hexvix – pre-marketing activities ongoing
Hexvix® – pre-marketing activities ongoing ! Contract manufacturer selected ! Market research study completed ! Price and reimbursement preparations ongoing ! Out-licensing activities initiated – PhotoCure will at least retain the Nordic region gm-November 2000 pres
Slide 14: Research and development – strong pipeline
Research and development – strong pipeline ALA derivatives R&D opportunities (excluding dermatology and urology) ! Barrets esophagus – clinical pilot study initiated ! Colo-rectal cancer – clinical pilot study initiated ! Lesions in mouth, pharynx and larynx ! Gynegology (vulva, cervix, ovarian) ! B
Slide 15: PhotoCure – important milestones the next twelve months
PhotoCure – important milestones the next twelwe months As of May 2002 Metvix® ! Introduce the product in Norway, Denmark and Finland ! Submitt additional clinical data for AK and BCC in Australia, France, Portugal & Holland ! File new drug application for BCC in the US ! Initiate clinical study for
Slide 16: PhotoCure – important milestones the next twelve months
PhotoCure – important milestones the next twelwe months As of May 2002 Hexvix® ! Complete current ongoing phase III studies for PD of bladder cancer ! File first marketing authorisastion application for PD of bladder cancer Benzvix® ! Complete current ongoing clinical pilot studies PCI Biotech AS !
Slide 17: Financial Statements – Profit & Loss
Financial Statements – Profit & Loss Three months ended Twelve months ended 31.03.2002 31.03.2001 All figures in NOK 1,000 31.12.2002 3 697 402 Sales 2 330 124 625 Other revenues 3 022 3 821 1 027 Total operating revenues 5 352 3 845 5 095 Salaries & other pers. costs 25 737 23 536 12 820 External R
Slide 18: Financial statements - Balance sheet
Financial statements - Balance sheet Figures in NOK 1,000 31.03.2002 31.12.2001 Fixed assets 4 075 3 935 Receivables 18 445 10 456 Securities 241 556 283 564 Cash and bank deposits 116 640 21 614 Total assets 380 716 319 569 Shareholders' equity 233 108 259 398 Long term liabilities 17 447 17 362 Cu