Photocure ASA · OSL:PHO
Photocure ASA — Q3 2004 Earnings Presentation
26 slides from Photocure ASA's earnings presentation, Oct 20, 2004
Slide 1: PhotoCure ASA Results Third Quarter 2004
PhotoCure ASA Presentation Results Third Quarter 2004 20th October 2004
Slide 2: Highlights
Highlights Hexvix received first marketing approval Hexvix application in other EU/EAA countries to be filed later this year Metvix approved in 8 new European countries Number of Metvix units sold increased with 96% (3Q 2004 vs. 3Q 2003) Sales revenues increased to NOK 8.1 million from NOK
Slide 3: Hexvix – A Breakthrough in Bladder Cancer Diagnosis
Hexvix® – A Breakthrough in Bladder Cancer Diagnosis PhotoCure’s 1st Photo-Diagnostic (PD) agent approved and close to 1st launch
Slide 4: Now you can see bladder cancer in a different light
Now you can see bladder cancer in a different light
Slide 5: Hexvix – improves detection of bladder cancer
Hexvix® – improves detection of bladder cancer
Slide 6: Hexvix – approved for bladder cancer detection
Hexvix® – approved for bladder cancer detection Marketing approval received in September from Swedish Medicines Authority – Filing in other EU/EEA countries planned later this year USA – Positive meeting held with the FDA as to filing based on current clinical data – A meeting addressing the NDA
Slide 7: Hexvix – pre-launch activities underway
Hexvix® – pre-launch activities underway Health economy study completed – Sufficient information for pricing decision gathered – Documentation important in future sales process Clinical data published in major urology journals PhotoCure continues to present Hexvix at key European urology meeti
Slide 8: Hexvix – targeting initially larger hospitals
Hexvix® – targeting initially larger hospitals Procedures for detecting bladder cancer is mainly hospital based in the Nordic countries Hexvix will first be launched in Sweden In the Nordic countries, PhotoCure is initially targeting appr. 50 centers – About 2/3 out of 615 urologists are worki
Slide 9: Hexvix – pre-launch activities ongoing
Hexvix® – pre-launch activities ongoing Nordic Establishing key centres in each country: – Enable Key opinion leaders to gain experience – Will play key role in training of other urologists Preparing for workshops and symposia Establishing close cooperation with equipment distributors (local a
Slide 10: Hexvix – significant market potential
Hexvix® – significant market potential Close to 5 million 25% cystoscopies performed Operating Room globally for bladder cystoscopies cancer 1/6 cancer 50% Follow-Up cystoscopies 25 % first cystoscopies 5/6 no cancer Suspected bladder cancer
Slide 11: Metvix roll out continues
Metvix® roll out continues
Slide 12: Metvix – commercialisation continues to progress
Metvix® – commercialisation continues to progress 5975 units sold in Q3 2004 – Increase of 96% from Q3 2003 Launch initiated in 12 countries – PhotoCure: 5 Nordic countries – By partner Galderma: Germany, UK, Australia, Switzerland, Belgium, Italy, New Zealand Launch preparations ongoing in co
Slide 13: Metvix – steady increase in annualised sales
Metvix® – but steady increase in annualised sales Number of tubes sold to Nordic pharmacies 12000 10000 Moving annual total 8000 6000 4000 2000 0 20 1 20 2 20 2 20 2 20 2 20 3 20 3 20 3 20 3 20 4 20 4 04 1Q 00 2Q 0 3Q 0 4Q 0 1Q 0 2Q 0 3Q 0 4Q 0 1Q 0 2Q 0 3Q 0 2 4Q
Slide 14: Metvix – continued increase in clinics providing Metvix
Metvix® – continued increase in clinics providing Metvix® Clinics with PhotoCure lamps 180 160 Acc. number of clinics 140 120 Island 100 Finland 80 Denmark 60 40 Norway 20 Sweden 0 1 2 04 02 03 03 4 .0 .0 .0 il. ay ay ct ov ov ct pr O M M O N N A
Slide 15: Metvix – steady increase in sales in Galderma's area
Metvix® – steady increase in sales in Galderma’s area Metvix units sales - Moving annual total 12,000 10,000 8,000 U n it s s o ld 6,000 4,000 2,000 - 1Q03 2Q03 3Q03 4Q03 1Q04 2Q04 3Q04
Slide 16: Metvix – successful expansion
Metvix® – successful expansion Metvix continues to gain approval in key markets FDA approval for Actinic Keratosis received July – Milestone payment of NOK 25.3 mill. (EUR 3 mill.) received from Galderma Approved in 29 countries – 26 European countries – 8 new countries in Q3 – Australia, New Ze
Slide 17: 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 Pre-cancerous skin lesions (Actinic Keratosis) App. 20 mill. new cases per year in EU, America & AUS –
Slide 18: Metvix – encouraging results in moderate/severe acne
Metvix® - encouraging results in moderate/severe acne Before After Before After
Slide 19: Metvix – encouraging results in moderate/severe acne
Metvix® - encouraging results in moderate/severe acne Before After
Slide 20: Financial Statements (Group)
Financial Statements (Group)
Slide 21: Highlights 3rd quarter 2004
Highlights 3rd quarter 2004 Sales revenues increased to NOK 8.1 million in 3Q 2004 from NOK 5.2 million in 3Q 2003 Milestone payment of NOK 25.3 million received from Galderma linked to US approval Costs reduced to NOK 21.9 million from NOK 24.3 million – Lower patent attorney costs Net prof
Slide 22: Profit & Loss – net profit in 3rd quarter
Profit & Loss – net profit in 3rd quarter Three months ended Nine months ended 2003 30.09.04 30.09.03 All figures in NOK 1,000 30.09.04 30.09.03 01.01-31.12 8,134 5,248 Sales revenues 27,920 16,001 23,380 29,228 3,908 Signing fee and milestone revenues 37,045 27,865 31,774 1,089 1,045 Other operatin
Slide 23: Cash Flow Statement – significantly improved first nine months of 2004
Cash Flow Statement – signficantly improved first nine months of 2004 Loss before taxes improved compared to 2003 (+ NOK 8.5 mill) – Significant increase in sales revenues (+ NOK 11.9 mill) – Milestone payment (+ NOK 9.2 mill) – Reduction in net financial income (- NOK 7.8 mill) No specials in o
Slide 24: Balance Sheet
Balance Sheet Figures in NOK 1,000 30.09.04 30.09.03 31.12.03 Machinery & equipment 2,155 3,548 3,222 Financial fixed assets 8,013 7,850 7,832 Inventory 19,172 24,816 23,167 Receivables 18,175 20,493 13,335 Securities 117,644 178,789 170,309 Cash & cash equivalents 35,815 15,724 15,536 Total assets
Slide 25: Accounting policies - IFRS to be implemented 1Q 2005
Accounting policies - IFRS to be implemented 1Q 2005 International Financial Reporting Standard (IFRS) Identified issues – Pension liabilities – Employee share options No significant impact on Profit & Loss or Equity estimated
Slide 26: Progress towards sustained profitability
Progress towards sustained profitability Metvix – Approved in 29 countries incl. US for Aktinic Keratosis (July 2004) – Amendment filed for BCC in the US – Response expected year-end – Launch initiated in 12 countries – Continued sales growth in existing markets Hexvix – First marketing approval