Photocure ASA · OSL:PHO
Photocure ASA — Q3 2002 Earnings Presentation
35 slides from Photocure ASA's earnings presentation, Nov 6, 2002
Slide 1: PhotoCure ASA Results 3rd quarter 2002
PhotoCure ASA Results 3rd quarter 2002 November 2002
Slide 2: Highlights
Highlights ! Metvix® – Approvable letter from FDA – Increasing sales in the Nordic markets – Launch in Germany in February 2003 ! Hexvix® – Positive phase III results – On track for filing of marketing authorisation first half 2003 ! Benzvix® – Clinical pilot studies on track
Slide 3: Metvix – quick and simple treatment
Metvix® – quick and simple treatment Lesion preparation Metvix® application Red light illumination
Slide 4: Financial Statements – Profit & Loss
Financial Statements – Profit & Loss Three months ended Nine months ended 30.09.2002 30.09.2001 All figures in NOK 1,000 30.09.2002 30.09.2001 7 700 750 Sales revenues 15 991 1 682 - 86 Other operating revenues 130 2 772 7 700 836 Total operating revenues 16 121 4 453 3 009 - Cost of products sold 3
Slide 5: Metvix – positive development of sales revenues
Metvix® – positive development of sales revenues Sales revenues 9 000 8 000 Sales revenues 7 000 Milestones revenues 6 000 NOK 1000 5 000 4 000 3 000 2 000 1 000 - 1Q 2002 2Q 2002 3Q 2002
Slide 6: Metvix – marketing in the Nordic area on track (clinics)
Metvix® – marketing in the Nordic area on track Clinics with PhotoCure lamps 150 Target May 2003 125 Number of clinics 100 Finland 75 Denmark 50 Norway 25 Sweden 0 Nov. Febr. May Aug. Oct. 01 02 02 02 02
Slide 7: Metvix – marketing in the Nordic area on track (light sources)
Metvix® – marketing in the Nordic area on track Number of light sources 180 160 140 Finland 120 100 Denmark 80 Norway 60 Sweden 40 20 0 Febr. 02 May 02 Aug. 02 Oct. 02
Slide 8: Marketing Metvix – Sweden
Marketing Metvix® – Sweden ! Estimated market size: New cases per year Treatments per year – BCC 20 000 30 000 – AK 200 000 40 000 ! Reimbursed price of 1300 SEK per tube of Metvix® October 2001 ! Procedure codes private clinics – Procedure fee negotiations ongoing
Slide 9: Marketing Metvix – establishing clinical centers in Sweden
Marketing Metvix® – establishing clinical centers in Sweden Oct. 2001 Dec. 2001 Oct. 2002 N.A./N.I. 123 38 19 Interest 80 59 User 5 10 43 Big User 7 Big user: more than 5 treatments per week
Slide 10: Marketing Metvix – Norway
Marketing Metvix® – Norway ! Estimated market size: New cases per year Treatments per year – BCC 10 000 20 000 – AK 100 000 30 000 ! Approved price of 1100 NOK per tube of Metvix® ! Reimbursement application filed for Metvix® ! Procedure codes private clinics under negotiation
Slide 11: Marketing Metvix – establishing clinical centers in Norway
Marketing Metvix® – establishing clinical centers in Norway Dec. 2001 Oct. 2002 N.A./N.I. 99 60 Interest 10 User 9 35 Big User 1 4
Slide 12: Marketing Metvix – Denmark
Marketing Metvix® – Denmark ! Estimated market size: New cases per year Treatments per year – BCC 10 000 20 000 – AK 100 000 30 000 ! Metvix® commercially available July 2002, priced at 1100 DKK per tube ! Drug reimbursement routinely on a named patient basis ! Procedure codes private clinics under
Slide 13: Marketing Metvix – establishing clinical centers in Denmark
Marketing Metvix® – establishing clinical centers in Denmark July 2002 Oct. 2002 N.A./N.I. 93 26 Interest 54 User 3 15 Big User 1
Slide 14: Marketing Metvix – Finland
Marketing Metvix® – Finland ! Estimated market size: New cases per year – BCC 5 000 – AK 50 000 ! National approval May 2002 ! Metvix® priced at 148 Euro per tube ! Reimbursement application filed for Metvix®
Slide 15: Marketing Metvix – establishing clinical centers in Finland
Marketing Metvix® – establishing clinical centers in Finland July 2002 Oct. 2002 N.A./N.I. 52 37 Interest 11 User 5 8 Big User 1
Slide 16: Marketing Metvix – Galderma launch in Germany February 2003
Marketing Metvix® – Galderma launch in Germany February 2003 ! Pre-launch activities ongoing – Largest economical effort – pre-launch activity ever – Ready for major launch in Germany February 2003 ! Launch – Galderma will host launch symposium 1st of February 2003 ! Price and reimbursement – Negoti
Slide 17: Metvix – PhotoCure top down Marketing strategy
Metvix® – PhotoCure top down Marketing strategy SELLING PR KOL MARKETING Specialists GPs Patients and general population
Slide 18: Metvix – PhotoCure market strategy
Metvix® – PhotoCure market strategy Sales volume development Launch Year 5 (after launch)
Slide 19: Hexvix – preparation finished
Hexvix® – preparation finished Hexyl aminolevulinate powder + Phosphate buffer saline 50 mL " Hexvix® solution - Instilled 1 hour in the bladder - Start cystoscopy within 30 minutes
Slide 20: Hexvix – papillary lesion detected with Hexvix only
Hexvix® – papillary lesion detected with Hexvix only
Slide 21: Hexvix – CIS detected with Hexvix only
Hexvix® – CIS detected with Hexvix® only
Slide 22: Hexvix – single papillary tumour
Hexvix® – single papillary tumour
Slide 23: Hexvix – papillary tumour
Hexvix® — papillary tumour HAL URO CC)
Slide 24: Hexvix in bladder cancer – positive results in phase III clinical trial
Hexvix® in bladder cancer – positive results in phase III clinical trial Hexvix detected 97% of CIS lesions (CIS = Carcinoma in Situ) Hexvix® Standard white light cystoscopy cystocopy 97% 59%
Slide 25: Hexvix – phase III program ongoing
Hexvix® – phase III program ongoing ! Europe – Clinical phase III study completed with positive results – One additional study initiated ! USA – Investigational New Drug status obtained – Phase III studies initiated ! First marketing application planned 1st half 2003 – Preparations on track
Slide 26: Hexvix – bladder cancer market
Hexvix® – bladder cancer market ! Newly diagnosed patients, annually – Europe 75 000 – US 65 000 – ROW 100-150 000 ! Fourth leading cause of cancer in men ! Eighth leading cause in women ! Related to smoking, exposure to carcinogens
Slide 27: Hexvix – cystoscopy market
Hexvix® – cystocopy market ! Approximately 140 000 (2000) new cases of bladder cancer in Europe and the US per year (120 000 in 1990) ! 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
Slide 28: 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 29: Hexvix – commercial strategy
Hexvix® – commercial strategy ! Enter the market for patients who are in the operating room anyway – achieve high price ! Thereafter move into follow-up and confirmatory diagnostic procedures in clinics ! Eventually move into out-patient and private practice urology and early diagnosis ! Document He
Slide 30: 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
Slide 31: Research and development – strong pipeline
Research and development – strong pipeline ALA derivatives R&D opportunities (excluding dermatology and urology) ! Barrets oesophagus – clinical pilot study initiated ! Colo-rectal cancer – clinical pilot study initiated ! Lesions in mouth, pharynx and larynx – clinical pilot study initiated ! Gynae
Slide 32: PhotoCure – important milestones the next twelve months
PhotoCure – important milestones the next twelve months As of May 2002 Metvix® ! Expand the number of clinics in the Nordic countries – 150 clinics with light sources ! Submit additional clinical data in Australia, France, Portugal & Holland ! File new drug application for BCC in the US ! Initiate c
Slide 33: PhotoCure – important milestones the next twelve months
PhotoCure – important milestones the next twelve months As of May 2002 Hexvix® ! Complete current ongoing phase III studies for bladder cancer detection ! File first marketing authorisation application for bladder cancer detection ! Start clinical pilot study on treatment of bladder cancer Benzvix®
Slide 34: Financial statements - Balance sheet
Financial statements - Balance sheet Figures in NOK 1,000 30.09.2002 31.12.2001 Fixed assets 11 545 3 935 Stocks 20 813 4 287 Receivables 12 193 6 169 Securities 218 176 283 564 Cash and bank deposits 53 690 21 614 Total assets 316 417 319 569 Shareholders' equity 190 243 259 398 Long term liabiliti
Slide 35: Highlights
Highlights ! Metvix® – Approvable letter from FDA – Increasing sales in the Nordic markets – Launch in Germany in February 2003 ! Hexvix® – Positive phase III results – On track for filing of marketing authorisation first half 2003 ! Benzvix® – Clinical pilot studies on track