Photocure ASA - Results for the second quarter and first half 2013
Oslo, Norway, 22 August 2013: Photocure (OSE: PHO), a Norwegian specialty pharmaceutical company focused on photodynamic technologies in dermatology and cancer, today announces its results for the second quarter and first half 2013.
Highlights include:
(Numbers in brackets are for the corresponding period in 2012)
· Total sales revenues of Hexvix/Cysview increased 27% to NOK 21 million (NOK 16 million) in the second quarter driven by continued strong underlying customer demand in key markets.
· Total revenues of NOK 22 million in the second quarter were lower than last year (NOK 31 million) due to lower milestone revenues. Total revenues for the first half year were NOK 38 million (NOK 64 million).
· Operating loss from continued operations before restructuring of NOK 14 million (NOK 10 million loss), which was higher than last year mainly due to lower milestone revenues. The operating loss for the first half was NOK 38 million (NOK 19 million loss).
· Optimization of organization in line with Photocure's development and commercialization strategy.
· Cash and cash equivalents of NOK 199 million.
· Photocure obtained Special Protocol Agreement (SPA) from the US FDA on the design of the phase 3 clinical registration program for Visonac, which is in development for the treatment of moderate to severe acne. The SPA defines the size, design and analysis of clinical trials that will form the primary basis of approval. Additionally on August 1 Photocure received a notice of allowance for its acne patent in USA.
· Photocure reported positive final results of the phase 2b study for Cevira. Cevira showed a statistically significant and sustained lesion response and high HPV clearance in CIN2 patients. Health economic models based on these positive results confirm the beneficial value of Cevira to the healthcare system.
Key figures:
| Figures in NOK million | 2Q 2013 | 2Q 2012 | Change | 1H 2013 | 1H 2012 | FY 2012 |
| Sales revenues Hexvix / Cysview | 20.9 | 16.4 | 27 % | 35.4 | 30.6 | 67.5 |
| Sales revenues API | 0.5 | -0.1 | 0.7 | 4.6 | 7.6 | |
| Signing fee & milestone revenues | 1.1 | 14.2 | -93 % | 2.1 | 28.3 | 58.7 |
| Total revenues | 22.5 | 30.5 | -26 % | 38.1 | 63.5 | 133.8 |
| Gross profit | 20.4 | 27.9 | -27 % | 34.7 | 58.9 | 124.4 |
| Research and development expenses | 6.5 | 9.7 | -33 % | 15.7 | 23.7 | 50.1 |
| Sales and marketing expenses | 19.2 | 17.2 | 12 % | 38.2 | 30.6 | 70.2 |
| Operating result (EBIT) recurring | -13.9 | -9.7 | -37.6 | -19.4 | -39.2 | |
| Operating result incl. non-recurring | -18.0 | -9.7 | -41.7 | -19.4 | ||
| Net profit/loss continued operations | -15.1 | -8.3 | -36.5 | -15.2 | -30.1 | |
| Earnings per share, diluted (NOK) | -1.01 | -0.65 | -1.01 | -1.19 | -2.24 |
President & CEO Kjetil Hestdal, M.D. Ph.D. comments:
"We are pleased to report robust organic growth of our underlying business in 2Q 2013. Hexvix/Cysview performance was strong across all of the key markets. The meta-analysis, confirming Hexvix/Cysview's importance in improving the detection and reduced risk of recurrence of bladder cancer, published during the 2Q in European Urology, validates the medical benefits of our flagship brand.
During the 2Q we continued to advance the development of our pipeline compounds. A significant milestone was achieved for Visonac in gaining agreement with the FDA on the design and analysis of the phase 3 registration protocols. Additionally, the positive results of the phase 2b study including the new health economic benefit for Cevira have generated substantial interest from prospective partners."
Please find the full financial report and presentation enclosed.
Photocure ASA will present its second quarter and first half 2013 report today at Hotel Continental, Oslo, Norway. The presentation will begin at 08.30 (CET) and representatives from the company will be Kjetil Hestdal, President & CEO and Erik Dahl, CFO.
The presentation will be publicly available at www.photocure.com. It will be possible to follow the presentation through a live webcast.
Photocure will additionally host an audio webcast and conference call today in English at 16.00 CET / 15.00 GMT / 10.00 EST.
Please make sure to dial in 5-10 minutes prior to scheduled conference call start time on one of the following numbers:
Confirmation code: 2390288
· NORWAY: +47 2350 0486
· UK: +44 (0)20 3427 1917
· USA: +1 212 444 0896
It is possible to listen to a replay of the conference call on the following numbers:
Confirmation code: 2390288
· NORWAY +47 2100 0498
· UK +44 (0)20 3427 0598
· USA +1 347 366 9565
For further information, please contact:
Photocure
President & CEO Kjetil Hestdal
Tel: + 47 913 19 535, Email: kh@photocure.no
CFO Erik Dahl
Tel: +47 450 55 000, Email: ed@photocure.no
Hume Brophy
Mary Clark, Hollie Vile
Tel: +44 20 3440 5653
Email: photocure@humebrophy.com
About Photocure
Photocure, headquartered in Oslo Norway, is a specialty pharmaceutical company and world leader in photodynamic technology. Based on our unique proprietary Photocure Technology(TM) platform, Photocure develops and commercializes highly selective and effective solutions within disease areas with high unmet medical need, such as bladder cancer, HPV and precancerous cervical lesions, colorectal cancer and skin conditions. Our aim is to provide solutions which can improve health outcomes for patients worldwide. Photocure is listed on the Oslo Stock Exchange (OSE: PHO). Information about Photocure is available at www.photocure.com.
All trademarks mentioned in this release are protected by law and registered trademarks of Photocure ASA.