Results 4th quarter and full year 2008

Published: 27 February 2009Financial Investment & Stock
Oslo, Norway, February 27, 2009

Photocure ASA (Oslo Stock Exchange: PHO) today presents its results for the fourth quarter 2008 and for the full year 2008. A presentation will take place today in Oslo, Norway, beginning at 08.15 am (CET) and webcast through the Company's website

The main items in the report are:

  • Sales revenues of MNOK 33.2 in Q4 (+41%)
  • Profit of MNOK -9.4 in Q4, up from MNOK -16.3 in Q4 2007
  • Sales revenues of MNOK 100.9 in 2008 (+31%)
  • Profit of MNOK -64.4 in 2008, up from MNOK -75.0 in 2007
  • Significant progress in regulatory and clinical programs
Hexvix® sales increased 54% in 4Q and 75% to NOK 36.9 million in 2008

The revenue from sales of Hexvix bladder cancer diagnostic increased to NOK 13.5 million in the fourth quarter 2008, an increase of 54% over the same period in 2007. Of these sales, NOK 3.4 million came from sales by Photocure in the Nordic region and NOK 10.2 million from sales by GE Healthcare, Photocure's commercial partner for Hexvix outside the Nordic region. Comparable figures for 2007 are NOK 8.8 million, NOK 2.0 million and NOK 6.8 million, respectively.

Revenue from Hexvix increased 75% to NOK 36.9 million in 2008 compared to 2007, split NOK 10.2 million from Photocure in the Nordic region and NOK 26.7 million from GE Healthcare outside the Nordic region. Comparable figures for 2007 are NOK 21.0 million, NOK 6.0 million and NOK 15.0 million, respectively.

Metvix® sales increased 33% in 4Q and 18% to NOK 64.1 million in 2008

Revenue from sales of Metvix®/Aktilite® for the photodynamic treatment of cancerous and precancerous skin lesions increased 33% to NOK 19.4 million in the fourth quarter 2008 compared to the same period for 2007. Photocure's sales of Metvix/Aktilite in the Nordic region decreased to NOK 7.4 million from NOK 7.6 million in 2007. The reduction in sales is an effect of the inventory variations due to price increases in Sweden and Norway in 2007.  Revenues from Galderma, Photocure's commercial partner for Metvix/Aktilite outside the Nordic region, increased 71% to NOK 12.2 million in the fourth quarter 2008 compared with the same period in 2007.

Revenue from Metvix/Aktilite increased 18% to NOK 64.1 million in 2008 compared to 2007. Revenue from Metvix/Aktilite from Photocure's own sales in the Nordic region increased by 8% to NOK 24.9 million and revenue from Galderma, increased by 26% to NOK 36.9 million in 2008.

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(TM) (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 tumors were detected in 16.9% of the patients receiving Hexvix (p=0.001). The improved detection of patients with flat lesions (carcinoma in citu) confirmed the earlier phase III studies. This study will be an important part of Photocure's regulatory documentation which is planned submitted to the FDA in 2009.

Visonac(TM) - 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(TM) 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(TM) - 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(TM) - 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.

Financial results
Total revenue was NOK 33.2 million in the fourth quarter 2008, compared to NOK 27.5 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.

Total revenue for the full year 2008 was NOK 102.2 million, compared to NOK 99.0 million in 2007. The 2008 result includes NOK 1.3 million in signing-fee and milestone revenue compared to NOK 23.8 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 NOK 19.0 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 NOK 179.9 million as of 31.12.2008.

President and CEO of Photocure, Kjetil Hestdal MD, PhD, 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."

Photocure ASA is a Norwegian pharmaceutical company founded in 1993 and listed on Oslo Stock Exchange. The company develops and sells pharmaceuticals and medical devices based on proprietary photodynamic technologies, targeting key dermatology and oncology markets.
Photocure has two products with sales and marketing approvals: Metvix®, which is a product developed for the treatment of skin cancer (basal cell carcinoma) and pre-cancerous skin lesions (actinic keratosis), and Hexvix®, which is developed for the detection of bladder cancer. Both products are based on the same photodynamic technology, combining the drug known as a photosensitiser with a light source that activates the photosensitiser. Photocure aims to develop a pipeline of follow-on products and technologies.
For further information, contact:
Photocure ASA
Attn. Kjetil Hestdal (President and CEO) or Christian Fekete (CFO)
Hoffsveien 48
NO-0377 Oslo, Norway

E-mail: or
Telephone: +47 22 06 22 10
Kjetil Hestdal mobile +47 913 19 535 - Christian Fekete mobile +47 916 42 938

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