Photocure Asa · OSL:PHO
Photocure Asa — FY2001 Earnings Presentation
32 slides from Photocure Asa's earnings presentation, Feb 27, 2002
Slide 1: Presentation of Results 2001
PhotoCure ASA Presentation of Results 2001 Oslo 27th of February 2002 gm-November 2000 pres
Slide 2: Disclaimers
Disclaimers This document includes forward-looking statements. These statements are based on current expectations and projections about future events. Actual results could differ materially from those discussed in, or implied by, these forward-looking statements. This document does not constitut
Slide 3: 2001 - The Year to be Remembered
2001;- The Year to be Remembered Metvix® is being commercialised – Approved in 14 European countries and New Zealand – Launched in Sweden – Marketing applications filed in Australia, US & Switzerland – Licensed to Galderma S.A. outside the Nordic area – New lightsources developed and CE mark obtai
Slide 4: PhotoCure ASA - Mission
PhotoCure ASA – Mission Develop and market novel therapeutic and diagnostic products and related medical devices based on proprietary photodynamic therapy (PDT) technologies. gm-November 2000 pres
Slide 5: Broad technology platforms and advanced development programmes
Broad technology platforms and advanced development programmes Clinical Preclinical Explorative Phase I Phase II Phase III METVIX "High Risk" BCC APPROVED Primary BCC AK APPROVED HEXVIX BENZVIX NEW ALA DERIVATIVES PHOTOCHEMICAL SYNERGISM PHOTOCHEMICAL INTERNALISATION Completed Ongoing gm-November 20
Slide 6: Metvix - quick and simple treatment
Metvix® – quick and simple treatment Lesion preparation Metvix® application Curelight illumination gm-November 2000 pres
Slide 7: Metvix - new light sources
Metvix® – new light sources Curelight 128 Curelight 16 gm-November 2000 pres
Slide 8: Metvix - highly effective with superior cosmetic results
Metvix® – highly effective with superior cosmetic results gm-November 2000 pres
Slide 9: Metvix - highly effective with superior cosmetic results
Metvix® – highly effective with superior cosmetic results gm-November 2000 pres
Slide 10: Metvix - great market opportunities
Metvix® – great market opportunities BCC – Appr. 2 mill. new cases per year in EU, America & AUS – Current therapies give disfiguration / morbidity AK – Appr. 20 mill. new cases per year in EU, America & AUS – Current therapies give white spots, poor patient compliance Dermatologists view Metv
Slide 11: Marketing Metvix - Nordic sales force established
Marketing Metvix® – Nordic sales force established Launched in Sweden – Reimbursed price of 1300 SEK per tube of Metvix® – Two product specialists promotes Metvix® in Sweden – Trained and provided more than 40 centers with lightsources Final approval obtained in Norway – Price application filed
Slide 12: Metvix - market introduction
Metvix® – market introduction Old product New product ce Pe n ne Market ssa tra ai tion n Old Re Market Market development New gm-November 2000 pres
Slide 13: Metvix - sales volume development
Metvix® – sales volume development gm-November 2000 pres
Slide 14: Marketing Metvix - licensed to Galderma outside the Nordic area
Marketing Metvix® – licensed to Galderma outside the Nordic area Galderma preferred partner Owned 50/50 by Nestlé and L’Oréal World wide largest sales force – presence in more than 60 countries Exclusively dedicated to dermatology Galderma strategy ”We have choosen dermatology” Galderma corpor
Slide 15: Marketing Metvix - Galderma licensing agreement
Marketing Metvix® – Galderma licensing agreement Marketing and sales – Galderma will promote Metvix® & PhotoCure lightsources world wide outside the Nordic area Regulatory approvals – PhotoCure will be responsible for MAA in EU, US, AUS and NZ – Galderma will file MAA’s in other countries Rese
Slide 16: Marketing Metvix - significant payments from Galderma
Marketing Metvix® – significant payments from Galderma Up front payment of 12 mill Euro received Regulatory milestones: 18 mill Euro – Approval and launch in certain countries Sales milestones – For global sales level of 25 mill Euro per year and above Double digit royalty for existing and n
Slide 17: 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 Dedicated strategic marketing manager hired Galderma task forces established – More resources allocated than for any other
Slide 18: 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 19: Hexvix - great market opportunities
Hexvix® – great market opportunities Bladder cancer Significant medical problem: appr. 115,000 cases annually in the US & Europe > 2.5 million diagnostic cystoscopic procedures annually in Europe and the US On first diagnosis 70-80% of patients have superficial tumours Over 70% will have one
Slide 20: 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 21: Bladder cancer - detection of flat lesions (CIS) difficult
Bladder cancer – detection of flat lesions (CIS) difficult gm-November 2000 pres
Slide 22: Hexvix in bladder cancer - detects CIS lesions with blue light
Hexvix® in bladder cancer – detects CIS lesions with blue light gm-November 2000 pres
Slide 23: Hexvix in bladder cancer - positive results in phase II clinical trial
Hexvix® in bladder cancer – positive results in phase II clinical trial More patients with tumour lesions detected Hexvix® White light 44 / 45 98% 36 / 45 80% Histology positive = CIS, Ta, T1 Histology positive patients have one or more tumours gm-November 2000 pres
Slide 24: 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 25: Hexvix - phase III program ongoing
Hexvix® – phase III program ongoing Europe – Enrolment in clinical phase III study ongoing – One additional study initiated USA – Investigational New Drug status obtained – Phase III study started Marketing application planned 1st half 2003 gm-November 2000 pres
Slide 26: Research and development - strong pipeline
Research and development – strong pipeline ALA derivatives R&D opportunities (excluding dermatology and urology) Barrets esophagus Colo-rectal cancer Lesions in mouth, pharynx and larynx Gynegology (vulva, cervix, ovarian) Brain tumours Mammary tumours (breast conserving surgery) gm-Nove
Slide 27: PCI Biotech AS - focus on new transfection technologies
PCI Biotech AS – focus on new transfection technologies Increased focus on Photchemical Internalisation (PCI) – PCI Biotech AS established as a subsidiary of PhotoCure ASA PCI Biotech’s product development focuses on: – new transfection technology for the research market – improve existing techn
Slide 28: Financial Statements - Profit & Loss (Group)
Financial Statements – Profit & Loss (Group) Three months ended Twelve months ended 31.12.2001 31.12.2000 All figures in NOK 1,000 31.12.2001 31.12.2000 648 488 Sales 2 330 2 131 250 310 Other revenues 3 022 2 558 898 797 Total operating revenues 5 352 4 689 11 117 1 502 Labour costs 25 737 17 440 2
Slide 29: Balance sheet (Group) - strong financial position
Balance sheet (Group) – strong financial position Figures in NOK 1,000 31.12.2001 31.12.2000 Fixed assets 3 935 2 563 Receivables 10 456 2 604 Securities 283 564 366 009 Cash and bank deposits 21 614 33 674 Total assets 319 569 404 850 Shareholders' equity 259 398 357 360 Long term liabilities 17 36
Slide 30: PhotoCure - track record for achieving milestones
PhotoCure – track record for achieving milestones Milestones for next twelve months as of May 2001 Metvix® 9 File MAA’s for AK & ”High Risk” BCC in Australia & NZ- Q1 2001 9 Achieve marketing authorisation (MA) for AK in Sweden – Q2 2001 9 Achieve MA for “High Risk” BCC first EU country (Sweden) – Q
Slide 31: PhotoCure - track record for achieving milestones
PhotoCure – track record for achieving milestones Milestones for next twelve months as of May 2001 Hexvix® 9 Enter Phase III trial for PD of bladder cancer in Europe 9 Enter Phase III trial for PD of bladder cancer in US Benzvix® 9 Complete pre-clinical studies necessary for clinical trials PCI Biot
Slide 32: Key investment highlights
Key investment highlights Leader in photodynamic therapeutics and diagnostics Metvix® PDT new treatment in dermatology: – Launched for AK & BCC in first EU country (Sweden) – Approved in 14 European countries and NZ, pending in US & Australia Hexvix® in phase III for bladder cancer detection –