Photocure ASA · OSL:PHO
Photocure ASA — FY2004 Earnings Presentation
27 slides from Photocure ASA's earnings presentation, Feb 24, 2005
Slide 1: PhotoCure ASA Full Year Results 2004
PhotoCure ASA Full Year Results 2004 24th of February 2005
Slide 2: Increased revenues
Increased revenues – Metvix® revenues up by 58 % – Metvix tubes increased 114 % – Metvix launched in Italy, Belgium, Australia and Switzerland – Milestone 3 million euro for AK in USA
Slide 3: Continued investment in R&D
Continued investment in R&D – Hexvix® approval in Sweden – Hexvix MRP application in 26 EU/EEA countries – Hexvix program for USA initiated – Metvix studies in Bowens and transplant patients continues – Metvix studies in acne initiated – Exploratory projects in bladder cancer, colon cancer and cervi
Slide 4: Financial Statements
Financial Statements
Slide 5: Revenues increased 37% from 2003
Revenues increased 37 % from 2003 2004 2003 2002 Sales revenues 36 855 23 380 10 892 Signing- and milestone revenues 40 954 31 774 14 331 Other revenues 4 597 5 150 3 486 Total revenues 82 406 60 304 28 709 Cost of Goods Sold 13 066 9 514 5 832 Salaries 34 684 27 756 18 795 Depreciation 1 530 1 677
Slide 6: Financial statements – profit & loss 4th quarter (group)
Financial statements – profit & loss 4th quarter (group) Three months ended 2004 2003 31.12.04 31.12.03 01.01 - 31.12 01.01 - 31.12 8 935 7 379 Sales revenues 36 855 23 380 3 908 3 908 Signing fee and milestone revenues 40 954 31 774 1 062 2 015 Other operating revenues 4 597 5 150 13 906 13 302 Ope
Slide 7: Financial statements - balance sheet (group)
Financial statements - balance sheet (group) 31.12.2004 31.12.2003 Plant & equipment 2 080 3 222 Financial fixed assets 1 750 7 832 Inventory 17 533 23 167 Receivables 16 146 13 336 Securities 111 219 170 309 Cash & cash equivalents 26 733 15 536 Total assets 175 460 233 402 Shareholders' equity 87
Slide 8: Financial statements - cash flow statement (group)
Financial statements - cash flow statement (group) 2004 2003 2002 Cash used in operating activities -47 103 -70 506 -50 906 Cash used in investing activities -387 -1 427 -8 906 Cash used/provided in financing activities -403 8 275 4 137 Net increase (decrease) in cash -47 893 -63 658 -55 675 Cash &
Slide 9: Financial statements – comments 4th quarter 2004
Financial statements – comments 4th quarter 2004 Metvix sales revenue increased 21 % vs Q4 2003 One time costs – Compensation to former CEO – NOK 6.4 million – Writedown of shares in Algeta AS – NOK 6.25 million Equity ratio 50 % at 31.12.2004 Cash & cash equivalents at 31.12.2004 – NOK 138
Slide 10: Metvix®
Metvix®
Slide 11: Metvix – sales in units increased 114% in 2004
Metvix – sales in units increased 114 % in 2004 Metxix Sales - Nordic 2001 - 2004 Metvix Sales - Galderma 2002 - 2004 4000 6000 3500 3000 5000 2500 4000 (units) U nits 2000 3000 1500 2000 1000 1000 500 0 0 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Per quarter Per quarter 2001 2002 2003 2004 Linear (2004) 2002 2003 20
Slide 12: Metvix – expanding the commercial potential
Metvix – expanding the commercial potential Approval for AK in US – Review of light device issues ongoing – will apply for Aktilite® in US Non approval NDA for BCC indication in December 2004 – Initiated discussions with FDA regarding new clinical studies New indications in non-melanoma skin c
Slide 13: Metvix – treatments in skin cancer (NMSC)
Metvix – treatments in skin cancer (NMSC) •• Surgical Surgical procedures procedures are are standard standard treatment treatment in in NMSC NMSC •• Cryotherapy Cryotherapy & & surgery surgery are are coded coded & & reimbursed reimbursed 35 PDT 30 Topicals 2% 25 % o f to ta l 22% 20 15 10 5 Proced
Slide 14: Metvix – topical treatment increasing 25%
Metvix – topical treatment increasing 25 % WORLDWIDE NMSC MARKET in $ $91 M, +25% ALDARA 21 954; 24% SOLARAZE 5-FU LEVULAN 16 005; 18% 52 049; 58% 55; 0% •Metvix not included in IMS market figures •Metvix sold for over $ 6 million ~ 6 % market share
Slide 15: Hexvix® – a breakthrough in bladder cancer diagnosis
Hexvix® – a breakthrough in bladder cancer diagnosis
Slide 16: Hexvix – key milestones reached in 2004
Hexvix – key milestones reached in 2004 Europe – Approved in Sweden – Initiated MRP procedure in 26 EU/EEA countries USA – New Drug Application (NDA) on EU/CIS data - Pre NDA meeting Dec 2004 – FDA accepted to review clinical data – Agreed final clinical development plan with FDA on papillary tu
Slide 17: Hexvix – bladder cancer market
Hexvix – bladder cancer market Newly diagnosed patients, annually Total Medicare payments from diagnosis – Europe 127 000 to death in the USA – US 67 000 60,000 57,629 – ROW ~150 000 55,000 51,865 50,448 48,684 50,000 TOTAL ~344 000 45,000 USD Related to smoking, 40,000 35,000 exposure to carcin
Slide 18: Hexvix – cystoscopies used in bladder cancer
Hexvix – cystoscopies used in bladder cancer First cystoscopy: 1/3 patients diagnosed with bladder cancer After confirmed diagnosis, patients will be followed up for years Within five years 50-70% of BC patients have one or more recurrences Estimated 3.8 million cystoscopies per year in Euro
Slide 19: Hexvix – ready for launch!
Hexvix – ready for launch! Improved detection of - More lesions in patients with flat (CIS) and papillary lesions - More patients with cancer Improved patient management Health economic cost savings at current price (SEK 3884) Quality of life is improved due to fewer surgical procedures (TURB
Slide 20: PCI Biotech AS
PCI Biotech AS
Slide 21: PCI Biotech – preclinical proof-of-concept
PCI Biotech –preclinical proof-of-concept PCI proven preclinical efficacy in vitro and in vivo – Enhanced efficacy of well known anti-cancer drug – Enhanced efficacy in gene therapy Strong patent protection in 4 patent families – PCI method of use – PCI alternative use – PCI in gene therapy – PC
Slide 22: Strategy and business update
Strategy and business update
Slide 23: New and strengthened management
New and strengthened management Kjetil Hestdal President & CEO Quality Assurance Britt Hanto QA Manager Research and Development Business Development Business Operations Sales & Marketing Finance Hilde Morris Pål Bråthen John Afseth Grete Hogstad Christian Fekete Vice President R&D Vice President BD
Slide 24: PhotoCure focuses on R&D in the value chain
PhotoCure focuses on R&D in the value chain Acquisition of new R&D Production/ Sales Nordic/ technology Incl. API Logistics Global Licensing Proof-of-concept: Development program designed and Regulatory Strategy close control by PC; monitored by PC globally; PC - Performance by collaboration with -
Slide 25: Strong IP position with 12 patent families
Strong IP position with 12 patent families Patent Family Priority Date 1) ALA –esters March/December 1995 2) Mucoformulations July 2000 3) ALA Esters II July 2000 4) ALA hexyl Esters April 1998 5) Design patent – lamp December 2001 6) Medical PDT lamp June 2001 7) Skin Preparation May 2001 8) Design
Slide 26: Industry trends in photodynamic therapy
Industry trends in photodynamic therapy Most companies are developing systemic photosensitizers combined with laser light sources In US, ”combination product” regulation forces development of specific drug-device combinations Mostly oncologic indications, but also other indications where PDT i
Slide 27: Strategic and operational goals
Strategic and operational goals Continue investing in Metvix – Galderma will launch in new countries – Seek Aktilite approval in US – Start BCC studies to support US NDA – Expand in NMSC indications – Initiate Acne program Launch Hexvix – Complete MRP procedure in EU/EEA countries – Launch in No