Photocure ASA · OSL:PHO
Photocure ASA — Q4 2009 Earnings Presentation
24 slides from Photocure ASA's earnings presentation, Feb 19, 2010
Slide 1: Presentation of fourth quarter 2009 results
Brilliance in photodynamic technology TM - from Biotech to Specialty Pharma Presentation of fourth quarter 2009 results 19 February 2010 Kjetil Hestdal, President & CEO Christian Fekete, CFO
Slide 2: Major steps towards a Specialty Pharma Company
Sale of Metvix/ Aktilite for EUR 51 million 30 September 2009 Received positive response to the Hexvix NDA from FDA on 30 December 2009 Payment of dividend of NOK 4 per share in December 2009 Cash of NOK 403.5 million as per 31 December 2009 Sales revenues of NOK 14.6 million in Q409 (33.2) Major st
Slide 3: We will create a unique Specialty Pharma Company
We will create a unique Specialty Pharma Company We will continue to focus on PDT based products We increase our commitment to the Dermatology market Capitalize on technological and commercial capabilities We remain committed to our Cancer portfolio Continue providing PDT products for diagnosis & tr
Slide 4: Creating value from strong IP position in Dermatology and Cancer
Creating value from strong IP position in Dermatology and Cancer Indication Status Peak sales potential EU/ US Approved in EU Hexvix® Detection of bladder cancer EUR 130 240 million Approval pending US Cevira Treatment of cervical cancer Phase I/II EUR 250 550 million Lumacan Detection of colon canc
Slide 5: Brilliance in photodynamic technology
Brilliance in photodynamic technology TM
Slide 6: Q4 and Full Year 2009
Q4 and Full Year 2009 Net gain on sale of Numbers in NOK thousand Q4 2009 Q4 2008 FY 2009 FY 2008 Metvix/Aktilite of MNOK Total revenues 14 566 33 190 98 798 102 220 369.3 in 2009 R&D expenses -27 289 -25 508 -79 492 -78 341 -8 012 -12 559 -41 640 -45 916 Reduced revenues and M&S Marketing & sales e
Slide 7: Continued vs discontinued operations 2009
(cont.) Continued vs discontinued operations 2009 Discontinued operations Continued operations Numbers in NOK thousand 2009 2008 2009 2008 Total revenues 50 370 65 366 48 428 36 854 Gross profit 40 443 50 667 42 887 32 480 Other income 0 0 11 652 3 580 Indirect manufacturing expenses -1 165 -1 694 -
Slide 8: Hexvix sales increased 8% in end user sales in Q4
(unaudited) Q4 2009 Q4 2008 Numbers in NOK thousand Own Partner R&D* Total % vs. 08 Own Partner R&D* Total Sales revenue Metvix/ Aktilite -307 2 913 2 606 -87 % 7 421 12 223 19 644 Sales revenue Hexvix 3 843 8 117 11 960 -12 % 3 368 10 178 13 546 Total sales revenues 3 536 11 030 0 14 566 -56 % 10 7
Slide 9: Hexvix sales increased 18% in end user sales in FY 2009
(audited) FY 2009 FY 2008 Disc. % vs. Disc. Numbers in NOK thousand Own Partner R&D* Total Own Partner R&D* Total op. 08 op. Sales revenue Metvix/ Aktilite 0 2 430 50 370 52 800 -18 % 0 0 64 063 64 063 Sales revenue Hexvix 16 908 29 090 0 45 998 25 % 10 190 26 664 0 36 855 Milestone revenue 0 0 0 0
Slide 10: NOK 403.5 million in cash year end
NOK 403.5 million in cash year end Numbers in NOK thousand (audited) 31.12.2009 31.12. 2008 Non-current assets No Metvix/Aktilite assets Intangible assets, software 365 534 Other investments includes1,040,000 Machinery & Equipment 1 772 3 939 shares in PCI Biotech valued at NOK 11.00/share Other inv
Slide 11: NOK 415.8 million in shareholders' equity or 91%
NOK 415.8 million in Numbers in NOK thousand (audited) 31.12.2009 31.12.2008 shareholder s equity or 91% Paid-in capital 11 047 11 047 Other paid-in capital 176 112 15 467 No interest bearing debt Retained earnings 228 624 173 181 No Metvix/Aktilite liabilities Shareholders equity 415 783 199 694 To
Slide 12: Q4 2009 and Full Year 2009 cash flow
Q4 2009 and Full Year 2009 NOK 263.2 million in Net Numbers in NOK thousand Q4 2009 FY 2009 FY 2008 change in cash during Q4 Income/ loss before tax -22 248 312 382 -59 562 Gain from sale of Other operational items 385 022 5 063 3 584 Metvix/Aktilite Net cash flow from operations 362 774 317 445 -55
Slide 13: Brilliance in photodynamic technology
Brilliance in photodynamic technology TM
Slide 14: Hexvix unit sales Q4 2009
® Unit sales Q4 2009: 1,362 Hexvix units sold in the +8 % Nordic region, an increase of 30% vs. Q4 2008 6,503 Hexvix units sold by GE Healthcare, an increase of 4% vs. Q4 2008 Unit sales 2009: 4,786 Hexvix units sold in the Nordic, an increase of 61% vs. 2008 22,962 Hexvix units sold by GE Healthcar
Slide 15: Hexvix - Nordic key performance indicators
Hexvix® - Nordic key performance indicators Nordic Hexvix units Nordic blue light Nordic Hexvix units/blue 1500 light 80 20 60 15 1000 40 10 500 20 5 0 0 0 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Hexvix Nordic market share in TURB 23% Equipment growth 18% in 2009 Growth in use 36% in 2009 15
Slide 16: Germany largest market over 50% of sales
® Germany largest market over 50% of sales New reimbursement from 1. January 2010 App. 600 blue-light scopes in market Established national and regional guidelines as well as EU consensus Focus on sales execution 16
Slide 17: Secure US approval, launch in US in 2010, increase use in Europe
® Secure US approval Recommended by FDA Advisory Committee and positive response, including action letter received from FDA in December 2009 Pending issues expected to be agreed during 1H 2010 Launch in US in 2010 Increase use in Europe Several programs for training/reimbursement/sales execution/equ
Slide 18: Effective treatment of moderate to severe acne
Effective treatment of moderate to severe acne 3 modes of action: Kills the acne bacteria Reduces sebaceous production Reduces inflammation Consistently high efficacy shown in 3 separate Phase II studies Treatments two weeks apart - sustained effect in reduction of lesions Limited side effects Signi
Slide 19: Status and road map
Status and road map Completed patient enrollment in multicenter phase II study in US/Canada in January 2010 Pediatric patient population (n=107) Preliminary results in March/April 2010 Study 2 months ahead of plan Results from phase II study will improve phase III program in EU/US Plan End-of-Phase
Slide 20: Improving facial skin appearance
TM Improving facial skin appearance Cosmetic product sold through dermatologists Finished pilot study in Q4 2009 with excellent results; Texture: Softened and smoothened skin Tone: Evened out skin color Fine lines: Diminished Pores: Reduced pore lines Initiation of consumer trial in US in Q2 2010 Pl
Slide 21: Diagnosis of colorectal cancer
Diagnosis of colorectal cancer Proof-of-Concept study using enema showed 39% increase in detection rate using Lumacan- colonoscopy. Improved oral formulation in development to optimize release in colon Scintigraphy testing of new oral formulations in Q2 2010 Ongoing phase I/II study on hold after 12
Slide 22: Treatment of HPV/precancerous lesions in cervix
TM Treatment of HPV/precancerous lesions in cervix Completed Proof-of-Concept study in 2009 - showed high efficacy in low grade pre-cancerous lesions Placebo-controlled multicenter phase II study ongoing in 5 countries in Europe All 70 patients enrolled Patient follow-up 6 months Initial results exp
Slide 23: Brilliance in photodynamic technology
Brilliance in photodynamic technology TM
Slide 24: Strategic, commercial and R&D priorities for 2010
Strategic: Create a Specialty Pharma Company in dermatology starting with the US Commercial: Improve commercial activities for Hexvix in Europe Secure Hexvix Approval in the US Hexvix launch in the US R&D: Start Visonac phase III program Finish Allumera consumer trial Cevira start phase II study wit