Photocure ASA · OSL:PHO
Photocure ASA — Q1 2005 Earnings Presentation
21 slides from Photocure ASA's earnings presentation, May 3, 2005
Slide 1: PhotoCure ASA Presentation First quarter 2005
PhotoCure ASA Presentation First quarter 2005 May 3, 2005
Slide 2: Obtaining milestones and building value
Obtaining milestones and building value Hexvix® – Approval in 27 EU/EEA countries, working on national approvals – Ongoing phase III study for extended indication in the US – Nordic pre-launch activities ongoing Metvix® – European sales continue to grow, launch in Holland – Discussions with FDA
Slide 3: Financial statements (Group)
Financial statements (Group)
Slide 4: Profit & Loss
Profit & Loss in accordance with IFRS 2005 2004 2004 All figures in NOK 1,000 01.01 - 31.03 01.01 - 31.03 01.01 - 31.12 Sales revenues 8 799 10 179 36 855 Signing fee and milestone revenues 3 908 3 909 40 954 Sales, signing fee and milestone revenues 12 707 14 087 77 809 Cost of products sold -3 903
Slide 5: Balance Sheet
Balance Sheet in accordance with IFRS 2005 2004 2004 Figures in NOK 1,000 31.03 31.03 31.12 Machinery & equipment 1 842 2 850 2 080 Financial fixed assets - 6 250 - Inventory 16 613 22 309 17 533 Receivables 15 023 16 519 16 146 Securities 97 839 147 336 111 219 Cash & cash equivalents 19 859 16 201
Slide 6: Cash Flow Statement
Cash Flow Statement in accordance with IFRS (all amounts in NOK 1,000) Three months ended 2004 31.03.05 31.03.04 01.01 - 31.12 Loss before taxes -13 094 -16 363 -45 323 Interest paid -20 -31 -103 Other operational items -7 449 -6 849 -4 822 Net cash flow from operations -20 563 -23 243 -50 248 Cash
Slide 7: Financial highlights
Financial highlights - increased Metvix sales offset by lower lamp sales and lower prices for Metvix to Galderma Nordic region – 3183 Metvix tubes sold in Q1 (+ 9 %) – Lower Aktilite sales in Q1 2005 of MNOK – 0.4 vs Q1 2004 – Inventory build-down of MNOK 0.3 Outside Nordic Region – 4991 Metvix
Slide 8: Hexvix – a breakthrough in bladder cancer diagnosis
Hexvix® – a breakthrough in bladder cancer diagnosis
Slide 9: Hexvix – approved in 27 EU/EEA countries
Hexvix® – approved in 27 EU/EEA countries MRP approval in 27 EU/EEA countries Working on national approvals Excellent reception at EAU, Turkey Nordic launch planned at NUF, - June 8-10 in Gothenburg Price SEK 3884 per kit (from pharm) Working with key opinion leaders Establishing refer
Slide 10: Hexvix – preparing the new drug application in the US
Hexvix® – preparing the new drug application in the US US – Agreement with FDA that existing clinical documentation can be submitted – Phase III multi-center study on- going in US and Europe Goal – Submit NDA in 2005 Urinary bladder with superficial cancer tumors.
Slide 11: Hexvix – building value
Hexvix® – building value Licensing activities ongoing – Negotiations with potential licensees – PhotoCure will retain the Nordic area – Australian court decision removed important obstacle. - Proves PhotoCure’s strong patent position - Proves that products based on derivatives of ALA are novel and
Slide 12: Metvix roll-out continues
Metvix® roll-out continues
Slide 13: Metvix – Galderma sales increase 85% in units
Metvix® – Galderma sales increase 85% in units Metvix Sales - Galderma 2002 - 2005 Sales increase in units of 85% vs Q1 2004 6000 5000 Launch in Holland in Q1 4000 2002 2003 Units 3000 2004 2000 2005 1000 0 Q1 Q2 Q3 Q4 Per quarter
Slide 14: Metvix – Nordic sales increase 9% in units
Metvix® – Nordic sales increase 9% in units Metxix Sales - Nordic 2001 - 2005 Sales increase in units of 9% in Q1 4000 vs 2004 3500 Metvix is medically accepted with 3000 2001 app. 200 clinics and app. 300 2500 2002 Aktilite lamps in market. (units) 2000 2003 1500 2004 Working on reimbursement
Slide 15: Metvix – regulatory update
Metvix® – regulatory update Approved in 29 countries including actinic keratosis (AK) in the US Pending applications in 3 countries Strengthening the position of Metvix in the treatment of non melanoma skin cancer by filing for Bowen’s disease in 22 EU/EEA countries AK in the US – Metvixia/C
Slide 16: Acne – a promising opportunity
Acne – a promising opportunity
Slide 17: Acne - an attractive market
Acne - an attractive market In the US over 17 million people are affected The lifetime risk for acne is about 85% The worldwide pharmaceutical anti acne market is USD 2.3 billion – (21% of worldwide dermatology market) The value of the worldwide pharmaceutical moderate to severe acne market
Slide 18: Acne - need for new treatments
Acne - need for new treatments Competitor Segment Therapeutic modalities Isotretinoin Oral • Highly effective (eg.Roaccutan) Vitamin-A • Long term treatment • Severe side effects • Risk management program US/EU Oral Oral • Moderate effect Antibiotics Antibiotics • Long term treatment • Resistance is
Slide 19: Acne – PhotoCure PDT – unique mechanisms of action
Acne – PhotoCure PDT – unique mechanisms of action Preclinical experience shows that PhotoCure PDT kills P.acnes bacteria International clinical experience shows a selective build-up of Photoactive porphyrins in sebaceous glands after PhotoCure PDT (Bissonnette, Canada) Clinical study showed m
Slide 20: Acne – further development
Acne – further development Proof of concept study with 30 patients with moderate to severe acne to be completed in Q3 2005 (Norway and Sweden) Establish close cooperation with Galderma Milestone – Start of phase II program in 2006 Illustration of PhotoCure’s PDT treatment
Slide 21: Goals and milestones
Goals and milestones Hexvix® – Sign licencing agreement – Secure national approvals in Europe – File new drug application (NDA) in the US – Nordic launches Metvix® – Sales growth in existing markets and new launches – File for approval of Bowen’s disease in the EU Research and development – Ac