Photocure ASA · OSL:PHO
Photocure ASA — Q1 2004 Earnings Presentation
22 slides from Photocure ASA's earnings presentation, May 7, 2004
Slide 1: PhotoCure ASA Presentation Results 1 Quarter 2004
PhotoCure ASA Presentation Results 1 Quarter 2004 7th of May 2004
Slide 2: Progress towards sustained profitability
Progress towards sustained profitability Continued product roll out Metvix® – European sales continue to grow – Final US approval for Actinic Keratosis expected during 2Q 2004 – Patient enrollment in Tx study completed Hexvix® – Approval expected during 2004 - Pharmacokinetic study initiated – t
Slide 3: Metvix roll out continues
Metvix® roll out continues
Slide 4: Metvix – quick and easy treatment
Metvix® – quick and easy treatment Lesion preparation Metvix® application Red light illumination
Slide 5: Metvix – continued increase in clinics providing Metvix
Metvix® – continued increase in clinics providing Metvix Clinics with PhotoCure lamps 180 Initial target 160 achieved Acc. number of clinics 140 Q3 2003 120 100 Island 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 6: Metvix – continued increase in sales in the Nordic area
Metvix® – continued increase in sales in the Nordic area Number of tubes sold to pharmacies 9000 8000 Moving annual total 7000 6000 5000 4000 3000 2000 1000 0 1 Q 01 2Q 02 3Q 02 4Q 02 1Q 02 2Q 03 3Q 003 4Q 03 1Q 03 04 20 20 20 20 20 20 20 20 20 2 4Q
Slide 7: Metvix – expanding the commercial potential
Metvix® – expanding the commercial potential Approved in 19 countries - Hungary latest approval Pending applications in 6 countries Approvable letter for AK from US FDA – Final approval expected during second quarter NDA filed for BCC indication in the US – February 2003 – Non approval from
Slide 8: Metvix – international roll out by Galderma
Metvix® – international roll out by Galderma Launch initiated in Germany, UK and New Zealand in 2003 – Initial sales ongoing in Switzerland Launch preparations ongoing – Launch in Italy, Spain, Belgium, Australia and Switzerland during 2004 Continue to file new marketing authorisation applicat
Slide 9: Metvix – continued increase in sales in Galderma's area
Metvix® – continued increase in sales in Galderma’s area Overall Unit Sales of Metvix Cream 3000 2 6 71 2500 2000 19 2 9 Units sold 1500 13 9 6 1000 773 500 404 0 1Q03 2Q03 3Q03 4Q03 1Q04
Slide 10: 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 11: 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 12: Hexvix – CIS detected with Hexvix only
Hexvix® – CIS detected with Hexvix® only
Slide 13: Hexvix – excellent results in phase III studies on CIS
Hexvix® – excellent results in phase III studies on CIS Study No. pts. No. (%) Pts Hexvix included with CIS increment (%) 301 211 79 (37%) 27% 302 196 53 (27%) 20% 303 146 29 (20%) 16% TOTAL 553 161 (29%) 23%
Slide 14: Hexvix – excellent results in phase III studies on papillary tumors
Hexvix® – excellent results in phase III studies on papillary tumors Study No. pts. No. (%) pts Pts. (%) with included with Ta/T1 more Ta/T1 301 211 155 (73%) 38 (25%) 302 196 116 (59%) 34 (29%) 303 146 74 (51%) 15 (20%) TOTAL 553 345 (62%) 87 (25%) Improved bladder cancer detection changed patient
Slide 15: Hexvix – closer to approval
Hexvix® – closer to approval Europe – Clinical phase III studies completed with positive results – Marketing application for EU filed Dec. 2002 in Sweden - Clinical efficacy demonstrated - Pharmacokinetic study initiated - Approval expected 2004 USA – Investigational New Drug status obtained – A
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 – pre-launch activities underway
Hexvix® – pre-Launch activities underway Marketing collaboration with Karl Storz and other device manufactures Market research study completed Price and reimbursement preparations ongoing Clinical data accepted for publications in major urology journals and continued presentations at major s
Slide 18: Financial Statements (Group)
Financial Statements (Group)
Slide 19: Profit & Loss
Profit & Loss Three months ended 2003 2002 31.03.04 31.03.03 All figures in NOK 1,000 01.01-31.12 01.01-31.12 14 087 10 425 Sales and milestone revenues 55 154 25 222 1 263 1 045 Other operating revenues 5 150 3 486 15 350 11 470 Total operating revenues 60 304 28 709 3 999 3 830 Cost of products so
Slide 20: Balance Sheet
Balance Sheet Figures in NOK 1,000 31.03.04 31.03.03 31.12.03 Machinery & equipment 2,850 4,315 3,222 Financial fixed assets 8,013 7,850 7,832 Inventory 22,309 26,431 23,167 Receivables 16,337 17,208 13,335 Securities 147,336 197,687 170,309 Cash & cash equivalents 16,201 17,870 15,536 Total assets
Slide 21: Cash Flow Statement
Cash Flow Statement All amounts in NOK 1000 Three months ended 2003 31.03.04 31.03.03 01.01 - 31.12. Loss before taxes -16,214 -18,478 -42,767 Other operational items -6,274 -15,458 -27,740 Net cash flow from operations -22,487 -33,936 -70,507 Cash flow from investments -17 -10 -1,426 Cash flow from
Slide 22: Future prospects
Future prospects Metvix® – Sales growth in existing markets – New launches – New approvals - Final US approval for Actinic Keratosis expected during 2Q 2004 Hexvix® – First marketing approval in Sweden during 2004 – Marketing authorisation applications in Europe and US – Product launches Resea