Photocure ASA · OSL:PHO
Photocure ASA — Q2 2004 Earnings Presentation
31 slides from Photocure ASA's earnings presentation, Aug 20, 2004
Slide 1: PhotoCure ASA Results Second Quarter 2004
PhotoCure ASA Presentation Results Second Quarter 2004 20th August 2004
Slide 2: Highlights
Highlights Metvix approved in the US Metvix launches initiated in Australia, Belgium and Switzerland Hexvix – pharmacokinetic study successfully completed and submitted – Approval expected in Sweden later this year – European filing planned later this year Number of Metvix units sold increas
Slide 3: Metvix roll out continues
Metvix® roll out continues
Slide 4: Metvix – commercialisation continues to progress
Metvix® – commercialisation continues to progress FDA approval for Actinic Keratosis received July – Will receive milestone payment of EUR 3 million from Galderma Launch initiated in 11 countries – PhotoCure: 5 Nordic countries – By partner Galderma: Germany, UK, Australia, Switzerland, Belgium,
Slide 5: Metvix – the patient friendly treatment
Metvix® – the patient friendly treatment Fast mode of action with superior cosmetic result Lesion preparation Metvix® application Red light illumination
Slide 6: Metvix – great market opportunities
Metvix® – great market opportunities Skin cancer (Basal cell carcinoma) App. 2 mill. new cases per year in EU, America, AUS & South Africa – Of which US 1 million, EU 500 000, Australia 200 000 Metvix the only light sensitive drug on the market Pre-cancerous skin lesions (Actinic Keratosis) Ap
Slide 7: Metvix – continued increase in clinics providing Metvix
Metvix® – continued increase in clinics providing Metvix® Clinics with PhotoCure lamps Initial target 180 achieved 160 Acc. number of clinics Q3 2003 140 120 Island 100 80 Finland 60 Denmark 40 Norway 20 0 Sweden 04 1 2 02 03 03 .0 .0 il. ay ay ct ov ov pr O M M N N A
Slide 8: Metvix – continued increase in sales in the Nordic area
Metvix® – continued increase in sales in the Nordic area Number of tubes sold to pharmacies 10000 9000 Moving annual total 8000 7000 6000 5000 4000 3000 2000 1000 0 01 02 02 03 03 04 20 20 20 20 20 20 4Q 2Q 4Q 2Q 4Q 2Q
Slide 9: Metvix – international roll out by Galderma
Metvix® – international roll out by Galderma Launches initiated in Belgium and Australia – Total number of actively marketed territories extended to 6 (i.e. Germany, UK, New Zealand and Switzerland) Launch preparations ongoing – Made available in Italy – To be launched in Spain later in 2004
Slide 10: Metvix – continued increase in sales in Galderma's area
Metvix® – continued increase in sales in Galderma’s area Metvix units sales - Moving annual total 10,000 8851 8,000 6769 U n i ts s o l d 6,000 4502 4,000 2573 2,000 1177 404 - 1Q03 2Q03 3Q03 4Q03 1Q04 2Q04
Slide 11: Metvix – successful expansion
Metvix® – successful expansion Metvix continues to gain approval in all its key markets Approved in 21 countries – 18 European countries – USA, Australia, New Zealand Pending applications in 11 countries – Europe: Holland, Portugal, Poland, Czech Republic, Slovakia, Estonia, Latvia, Lithuania –
Slide 12: Metvix – expanding the commercial potential
Metvix® - expanding the commercial potential US approval obtained – Marketing approval for AK received on 27th July – Amendment filed for BCC - FDA response expected by the end of 2004 Organ transplant study completed 2Q 2004 – All 80 patients enrolled – two years follow-up – Treatment response
Slide 13: 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 14: 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 blue light cystoscopy within 30 minutes
Slide 15: Hexvix – carcinoma (in situ) detected with Hexvix only
Hexvix® – carcinoma (in situ) detected with Hexvix® only This is what the Urologists This is what the Urologists sees with current procedure sees when adding Hexvix
Slide 16: Hexvix – cystoscopy market
Hexvix® – cystoscopy market More than 4 million 25% cystoscopies performed Operating Room every year in Europe & cystoscopies North America 1/6 cancer 50% Follow-Up cystoscopies 25 % first cystoscopies 5/6 no cancer Suspected bladder cancer
Slide 17: Hexvix – positive phase III results
Hexvix – positive phase III results Tree phase III studies completed with positive results – Two studies focused on detection of bladder cancer (CIS) – One study focused on change in patient management One additional study initiated – Detection of bladder cancer (papillary lesions) – Reduction i
Slide 18: Hexvix – closer to approval
Hexvix® – closer to approval Europe – Pharmacokinetic study with Hexvix completed and submitted in June – Marketing approval from Swedish Medicines Authority expected before year end 2004 – Approval in Sweden will pave way for approval from other EU/EEA countries - Filing planned later this year
Slide 19: Hexvix – Pre-launch activities underway
Hexvix® – Pre-launch activities underway General Health economy study ongoing Clinical data published in major urology journals Clinical trials ongoing in Germany, France, Netherlands, Denmark, Norway PhotoCure will continue to present Hexvix at key European urology meetings through exhibiti
Slide 20: Hexvix – Pre-launch activities underway (Nordic)
Hexvix® – Pre-launch activities underway Nordic Establishing key centres in each country: off-licence use to gain experience for future KOL role “Mapping” all major potential customers Establishing close cooperation with equipment distributors (local and central) Training sales force Devel
Slide 21: Research and intellectual property
Research and intellectual property
Slide 22: Detection of colon cancer – a significant market potential
Detection of colon cancer – a significant market potential Fourth most frequent cancer, and cause of death – Incidence 150.000 (US) – Mortality 57.000 (US) High risk patients – chronic bowel inflammation (ulcerative colitis) – Estimated prevalence: 4 mill world wide – Recommended yearly colonosc
Slide 23: Detection of colon cancer – positive initial data
Detection of colon cancer – positive initial data Fluorescence colonoscopy A feasibility study in 10 patients with colorectal cancer completed with positive results Larger studies in patients with ulcerative colitis planned
Slide 24: PCI Biotech AS – exploring novel drug delivery technologies
PCI Biotech AS – exploring novel drug delivery technologies PCI (Photochemical Internalisation) – – proprietary technology for site-specific delivery of drugs, e.g. to tumours – drug delivery induced by illumination PCI makes drugs more active, and only where desired – drug side effects can be r
Slide 25: PCI Biotech AS – significant progress made
PCI Biotech AS – significant progress made In animal models: – PCI specifically enhance the effect of anticancer drugs, curing animals under conditions where the drugs alone are inefficient – Promising results have been obtained in cancer gene therapy A proprietary photosensitser for use in the
Slide 26: Intellectual property
Intellectual property Ruling in patent dispute with DUSA pharmaceutical and Queens University in Australia expected later this year Mediation agreement signed between DUSA, Queens, Galderma and PhotoCure
Slide 27: Financial Statements (Group)
Financial Statements (Group)
Slide 28: Profit & Loss
Profit & Loss Three months ended Six months ended 2003 30.06.04 30.06.03 All figures in NOK 1,000 30.06.04 30.06.03 01.01-31.12 9,607 4,236 Sales revenues 19,786 10,753 23,380 3,908 20,048 Signing fee and milestone revenues 7,817 23,957 31,774 1,182 1,045 Other operating revenues 2,445 2,090 5,150 1
Slide 29: Balance Sheet
Balance Sheet Figures in NOK 1,000 30.06.04 30.06.03 31.12.03 Machinery & equipment 2,474 3,965 3,222 Financial fixed assets 8,013 7,850 7,832 Inventory 20,251 26,147 23,167 Receivables 15,344 16,734 13,335 Securities 129,000 181,949 170,309 Cash & cash equivalents 15,819 31,278 15,536 Total assets
Slide 30: Cash Flow Statement
Cash Flow Statement All amounts in NOK 1000 Six months Six months ended ended 2002 30.06.04 30.06.03 01.01 - 31.12. Cash Flow from operating activities -41,205 -41,341 -70,507 Cash Flow from investing activities -17 -101 -1,426 Cash Flow from finanscing activities 197 5,167 8,275 Net increase (decre
Slide 31: Progress towards sustained profitability
Progress towards sustained profitability Metvix – US approval for AK received July – Approved in 21 countries – Launch initiated in 11 countries – Amendment filed for BCC in the US – Response expected year-end – Continued sales growth in existing markets Hexvix – First marketing approval expecte