Photocure ASA · OSL:PHO
Photocure ASA — Q2 2007 Earnings Presentation
21 slides from Photocure ASA's earnings presentation, Aug 16, 2007
Slide 1: Second quarter 2007
Brilliance in photodynamic technology TM Second quarter 2007 August 16th, 2007
Slide 2: Total revenues increased 49% to MNOK 29.1
Total revenues increased 49% to MNOK 29.1 (19.5) Hexvix commercialisation gaining momentum Milestones payments of Euro 1.0 million for price/reimbursement in France and Italy Hexvix revenue from GE Healthcare increased to MNOK 3.9 (0.8) Hexvix revenue increased to MNOK 1.3 (0.5) in the Nordic region
Slide 3: Brilliance in photodynamic technology
Brilliance in photodynamic technology TM
Slide 4: Sales revenues in Q2 increased by 47% to MNOK 17.1
2007 2006 2006 Q2 2007 Q2 2006 1.1-30.06 1.1-30.06 1.1-31.12 17 094 11 653 Sales revenues 36 100 24 938 61 667 12 028 7 843 Signing fee and milestone revenues 15 937 68 382 148 653 29 123 19 496 Total revenues 52 037 93 320 210 320 -4 397 -3 845 Cost of products sold -10 985 -7 409 -22 251 24 726 15
Slide 5: Income statement - geographical distribution
Income statement - geographical distribution (Amounts in NOK 1000) Q2 2007 Q2 2006 Nordic ROW R&D* Total Nordic ROW R&D* Total Sales revenue 6 353 10 741 0 17 094 4 149 7 504 0 11 653 Milestone revenue 0 12 028 0 12 028 0 7 843 0 7 843 Total revenues 6 353 22 770 0 29 123 4 149 15 347 0 19 496 Cost
Slide 6: Cash & cash equivalents of MNOK 301.9 per 30.6.2007
Balance Sheet (all amounts in NOK 1,000) 30.06.2007 30.06.2006 31.12.2006 Intangible assets, software 1 581 0 780 Machinery & equipment 2 584 2 879 2 178 Total non-current assets 4 164 2 879 2 958 Inventory 11 478 11 037 9 784 Receivables 27 025 29 110 27 595 Cash & cash equivalents 301 890 282 864
Slide 7: Net cash flow from operations of MNOK -17.5
Cash Flow Statement (all amounts in NOK 1,000) 2007 2006 2006 Q2 2007 Q2 2006 1.1-30.06 1.1-30.06 1.1-31.12 -17 257 -958 Income/loss(-) before tax -35 041 42 012 84 730 -244 -14 553 Other operational items -4 362 -25 351 -18 359 -17 501 -15 510 Net cash flow from operations -39 403 16 661 66 371 2 5
Slide 8: Hexvix - a breakthrough in bladder cancer diagnostics
Brilliance in photodynamic technology TM ® - a breakthrough in bladder cancer diagnostics
Slide 9: Development in key value drivers
Development in key value drivers: Establish reimbursement France/Italy Increase base of scopes Ongoing Train urologists Ongoing Increase use at established centers Ongoing Introduced in Germany, Austria, France, Spain, UK, Portugal, Baltics, Netherlands, Poland and Greece. European Hexvix awareness
Slide 10: Accomplishments
Accomplishments France: Full reimbursement for hospitals and out-patient clinics effective from medio 2007 ~ 33.000 TURB s per year Italy: Price approved June 2007 ~ 50.000 TURB s per year Nordic DRG procedure code from 2008 Denmark granted reimbursement from 2008 ~ 20.000 TURB s per year in the Nor
Slide 11: Discussion with FDA under the IND
Discussion with FDA under the IND; Preclinical no outstanding issues Clinical depending on clinical results Blue light equipment agreed process/working with partner Regulatory plan; Ongoing phase III study meets FDA requirements for clinical documentation 11
Slide 12: Adding a phase III study to the NDA
- adding a phase III study to the NDA Phase III clinical study for detection and recurrence of bladder cancer Multi-center phase III study at 28 leading clinics in EU/US Discussed with FDA agreed SPA ~750 patients Primary endpoints detection of lesions and recurrence Inclusion completed in Q3 9 mont
Slide 13: Metvix - treatment of skin cancer without scarring
Brilliance in photodynamic technology TM ® ® - treatment of skin cancer without scarring
Slide 14: Filed the Aktilite sNDA in June 2007
Filed the Aktilite sNDA in June 2007 Supplement to the approved New Drug Application for Metvixia in Aktinic keratosis submitted in June Expect first response from FDA in May 2008. Started preparation for launch in the US of Metvixia/Aktilite Facts about Aktinic keratosis (AK) in US: AK affects more
Slide 15: Congresses: World Congress on Cancers of the Skin, EADV
The 11th World Congress on Cancers of the Skin in Amsterdam Separate Metvix symposium The 16th European Dermatology and Venereology congress in Vienna New Metvix study presented showing Metvix efficacy in organ transplant patients Separate Metvix symposium
Slide 16: Acne, cervix, colon and PCI Biotech
Brilliance in photodynamic technology TM - acne, cervix, colon and PCI Biotech
Slide 17: Progress in the Phase IIb clinical study
Progress in the Phase IIb clinical study Moderate to severe acne Multi-center study in the US Dose finding - placebo-controlled 40/210 patients included First phase investigating safety profile completed Report scheduled for 2008 Lamp development on schedule First prototype produced in Q2 Preclinica
Slide 18: Phase I/II study ongoing
Phase I/II study ongoing: dose finding Norway and Germany 60/72 patients included plan to add 24 patients 6 month follow-up report scheduled for H2 2008 Development of new light source started Development new formulation ongoing Obtained regulatory guidance from the European authorities Conducting m
Slide 19: Phase I/II study ongoing
Phase I/II study ongoing: dose-finding 2 centres in Germany 25/33 patients included report scheduled for 2007 Hired new project director Started development of oral formulation Conducting market analysis with focus groups and KOL interviews 19
Slide 20: Preparing the first clinical study
Preparing the first clinical study Toxicology and safety pharmacology studies ongoing Clinical protocol finalized Updating business plan for to include siRNA Developing business models and strategy Developing actions to deliver the strategy and build value Patent applications for siRNA significantly
Slide 21: Continue investing in Metvix and Aktilite
Continue investing in Metvix and Aktilite Support Galderma in strengthening Metvix/Aktilite in dermatology Launch Metvixia/Aktilite in the US Commercialise Hexvix Support GE Healthcare in introducing Hexvix in EU Seek Hexvix approval in the US Continue clinical development in acne, cervix, colon and