Photocure ASA: Results for the fourth quarter and full year 2013
Oslo, Norway, 27 February 2014: Photocure (OSE: PHO), a Norwegian specialty pharmaceutical company focused on photodynamic technologies in dermatology and cancer, announces its results for the fourth quarter and full year of 2013.
(Numbers in brackets are for the corresponding period in 2012)
- Total sales revenues of Hexvix/Cysview increased 28% to NOK 24.5 million (NOK 19.1 million) in the quarter. Full year sales revenues increased 16% to NOK 77.9 million (NOK 67.8 million).
- Hexvix/Cysview global in-market value growth of 28% in the quarter and 18% to NOK 150 million for the full year. Global in market unit sales increased 11% for the year.
- Fourth quarter operating loss from continued operations before restructuring and one-offs was NOK 10.5 million, an improvement from the previous three quarters. Full year operating loss from continued operations before restructuring and one-offs was NOK 63.0 million (NOK 39.2 million loss).
- Cash and cash equivalents of NOK 167 million as per 31 December 2013.
- Photocure obtained freedom to explore potential partnerships for the continued development and commercialization of Visonac from Galderma.
- On 28 November, CMS (Centers for Medicare & Medicaid Services) in the US announced that Cysview will be included in a category which packages payment for the drug into the overall procedure reimbursement.
- On 27th December, the US FDA informed Photocure that its application for Fast Track Designation for Cevira cannot be granted at this time. Photocure is in discussions with the FDA on identification of the appropriate patient population for phase 3.
|Figures in NOK million||4Q 2013||4Q 2012||Change||FY 2013||FY 2012||Change|
|Sales revenues Hexvix / Cysview||24.5||19.1||28 %||77.9||67.8||16 %|
|Sales revenues API||0.7||0.6||1.4||7.3||-81 %|
|Signing fee & milestone revenues||1.1||27.6||-96 %||4.3||58.7||-93 %|
|Total revenues||26.3||47.3||-44 %||83.6||133.8||-38 %|
|Gross profit||24.4||45.6||-46 %||76.8||124.4||-38 %|
|Research and development expenses||9.8||13.3||-27 %||34.0||50.1||-32 %|
|Sales and marketing expenses||14.8||18.7||-21 %||68.4||70.2||-3 %|
|Operating result excl. restructuring & one-off||-10.5||2.5||-63.0||-39.2|
|Operating result incl. non-recurring||-19.1||2.5||-75.5||-39.2|
|Earnings per share, diluted (NOK)||-0.43||0.07||-2.77||-2.24|
President & CEO Kjetil Hestdal, M.D. Ph.D. comments:
"It has been a mixed year for Photocure in our commercial operations and R&D pipeline. Our flagship product Hexvix/Cysview continued a positive growth trajectory driven by strong performance in the Nordic and in partner territories. However, the recent CMS ruling will have negative impact on our sales growth and we are working to secure a long-term sustainable reimbursement solution for Cysview.
The successful completion of the phase 2b trial of Cevira in women with HPV related diseases of the cervix, was a significant achievement towards securing a strategic partnership. Although the change in diagnostic classification means we have not received fast track designation in the US at this time, we are confident in the potential of this innovative drug. Securing regulatory alignment on the phase 3 registration program for Visonac with the FDA and EU regulatory bodies, coupled with achieving agreement with Galderma, places Photocure in a strong position to explore potential partnerships for developing this promising acne treatment."
Please find the full financial report and presentation enclosed.
Photocure ASA will present its fourth quarter and full year 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.
A light snack will be served from 08:00 (CET). The presentation is scheduled to conclude at 09:15 (CET).
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:
· NORWAY: +47 2316 2771
· UK: +44 (0)20 3427 1906
· USA: +1 646 254 3365
Confirmation code: 2189017
It is possible to listen to a replay of the conference call on the following numbers:
· NORWAY +47 2100 0498
· UK +44 (0)20 3427 0598
· USA +1 347 366 9565
Confirmation code: 2189017
For further information, please contact:
President & CEO Kjetil Hestdal
Tel: + 47 913 19 535, Email: firstname.lastname@example.org
CFO Erik Dahl
Tel: +47 450 55 000, Email: email@example.com
Tel: +44 20 3440 5653
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.