PhotoCure - Third Quarter Results 2003
Oslo, Norway, 6 November 2003... Today PhotoCure presents its report for the third quarter, ending 30 September 2003. Highlights from the report include:
Financial highlights
Operating revenues in the third quarter 2003 totalled NOK 10.2 million, compared to NOK 7.7 million third quarter of 2002. Sales of Metvix are growing in the Nordic countries as well as in the Galderma territories. In the Nordic countries, Metvix sales to pharmacies in the third quarter 2003 increased with 95% compared to the corresponding quarter in 2002. Operating expenses decreased to NOK 26.4 million compared to NOK 28.5 million in the third quarter of 2002. Net loss amounted to NOK 14.8 million compared to NOK 17.2 in the third quarter of 2002. Liquid funds amounted to NOK 194.5 million as of 30 September 2003.
Continued Commercialisation of Metvix®
In September, an Advisory Committee to the US Food and Drug Administration (FDA), the Dermatologic and Ophthalmic Drugs Advisory Committee, evaluated PhotoCure's application for Metvix. The Committee did not recommend Metvix to be approved for first line treatment of primary nodular basal cell carcinoma(BCC), based on the efficacy results in the studies submitted. As members of the Committee stated that there is a medical need for Metvix in certain patient populations with BCC and as the Committee unanimously agreed that no safety concerns exist related to Metvix therapy, PhotoCure will proactively continue to work with the FDA, aiming at obtaining an approval for a BCC indication
Galderma continues the commercial expansion strategy for Metvix through pre launch activities in five new countries.
Hexvix® closer to first regulatory approval
First regulatory feedback for Hexvix marketing authorisation application was positive and PhotoCure will shortly respond to the outstanding questions.
Commenting on today's results, Professor Vidar Hansson, President and CEO of PhotoCure, says: "We are continuing our progress with Metvix, despite the temporary delay caused by the FDA Advisory Committee's recommendation. We are confident in receiving final approval for the treatment of both pre-malignant skin lesions (actinic keratosis) and basal cell carcinoma, also in the US. We are now focussing on the continued pan European launch of Metvix in order to maintain consistent growth of the Metvix sales."
The 3rd quarter report is available at the following link:
The 3rd quarter presentation is available at the following link: