Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Photocure ASA (Photocure), a in vitro diagnostics company, has reported total revenues of NOK102.2 million for the full year of 2008, compared with the total revenues of NOK99 million in the in the previous year-end. It has also reported a net loss of NOK64.3 million, or NOK2.91 per diluted share, for the full year of 2008, compared with the net loss of NOK74.9 million, or NOK3.39 per diluted share, in the in the previous year-end.
Subscribe to our email newsletter
Highlights
Sales revenues of NOK33.2 million in Q4 (+41%)
Profit of NOK-9.4 million in Q4, up from NOK-16.3 million in Q4 2007
Sales revenues of NOK100.9 million in 2008 (+31%)
Significant progress in regulatory and clinical programs
Financial results
Total revenue was NOK33.2 million in the fourth quarter 2008, compared to NOK27.5 million in the fourth quarter 2007. Profit after tax was NOK-9.2 million in the fourth quarter 2008 compared to NOK-16.3 million in the fourth quarter 2007.
The 2008 result includes NOK1.3 million in signing-fee and milestone revenue compared to NOK23.8 million in 2007. Profit after tax was NOK-64.4 million in 2008, compared to NOK-75.0 million in 2007.
Operating expenses was reduced with NOK19.0 million in 2008 compared to 2007, primarily due to reduced R&D expenses in 2008.
PCI Biotech AS was demerged from Photocure in 2008. Its accounts are included in the Photocure consolidated accounts up to 16 June 2008.
Cash flow from operations was NOK-59.7 million in 2008, compared to NOK-95.7 million in 2007. Liquid funds amounted to NOK179.9 million as of 31.12.2008.
President and chief executive officer of Photocure, Kjetil Hestdal, says in a comment to the results, “We are pleased to present a continued growth in sales of Hexvix and Metvix/Aktilite, both through own sales and through our partners. Some countries present a particularly impressive sale, showing that our products have a great market potential. The approval of the Aktilite lamp in USA is a regulatory milestone that gives access to the US market for Metvixia/Aktilite.
We have had significant progress in our regulatory and clinical programs in 2008. We look forward to finalizing the submission for Hexvix approval to FDA in 2009.”
Significant progress in regulatory and clinical programs
Metvix – Treatment of skin cancer
The Aktilite CL128 lamp was approved by the FDA in June 2008. Galderma have started the preparations for marketing and sales of Metvixia (US trademark for Metvix) and Aktilite for treatment of actinic keratosis in the USA.
Hexvix – Detection of bladder cancer
A large multi-centre phase III study was finalized in 2008, documenting that Hexvix significantly improves the detection and recurrence of bladder cancer. Hexvix cystoscopy was compared with standard white light cystoscopy in patients with non-muscle invasive bladder cancer. Additional tumours were detected in 16.9% of the patients receiving Hexvix (p=0.001). The improved detection of patients with flat lesions (carcinoma in situ) confirmed the earlier phase III studies. This study will be an important part of Photocures regulatory documentation which is planned submitted to the FDA in 2009.
Visonac – Treatment of moderate to severe acne
A US multi-centre phase IIb clinical study including 190 patients, was finalized in 2008 and reported very positive clinical results. Furthermore, two phase II clinical studies confirmed that the overall Visonac procedure could be simplified. Photocure has scheduled meetings with regulatory authorities in USA and Europe in 1st quarter of 2009, discussing the phase II results and the design of the phase III program.
Cevira – Treatment of precancerous lesions of the cervix
A phase I/II dose-finding study for treatment of precancerous lesions of cervix was finalized in 2008. The study included 92 patients from university hospitals in Oslo and Hannover. Interim results showed a high efficacy rate for patients with cervical precancerous lesions.
Photocure has filed a new drug/device patent related to the development of a new drug and light concept for the treatment of premalignant lesion in cervix.
Lumacan – Detection of early colon cancer
Photocure completed a phase I/II study of fluorescence-based photodynamic diagnostic for detection of early colon cancers in 2008. The study was performed at two hospitals in Germany and included 38 patients with suspected colorectal cancer. Results from the study showed a 37% improvement in detection of colon cancer compared to current standard colonoscopy.
Photocure has developed an oral capsule to improve the patient administration. A Proof-of-Concept study with the oral formulation has started in Germany in 2009.