AI Terminal

MODULE: AI_ANALYST
Interactive Q&A, Risk Assessment, Summarization
MODULE: DATA_EXTRACT
Excel Export, XBRL Parsing, Table Digitization
MODULE: PEER_COMP
Sector Benchmarking, Sentiment Analysis
SYSTEM ACCESS LOCKED
Authenticate / Register Log In

Photocure ASA

Earnings Release Feb 27, 2014

3714_rns_2014-02-27_388140f9-d5aa-4158-8473-1279e1c319fd.html

Earnings Release

Open in Viewer

Opens in native device viewer

Photocure ASA: Results for the fourth quarter and full year 2013

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.

Highlights include:

(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.

Key figures:

+--------------------------------+-------+-------+------+-------+-------+------+

|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 | 9.8| 13.3| -27 %| 34.0| 50.1| -32 %|

|expenses | | | | | | |

+--------------------------------+-------+-------+------+-------+-------+------+

|Sales and marketing expenses | 14.8| 18.7| -21 %| 68.4| 70.2| -3 %|

+--------------------------------+-------+-------+------+-------+-------+------+

|Operating result excl. | -10.5| 2.5|  | -63.0| -39.2|  |

|restructuring & one-off | | | | | | |

+--------------------------------+-------+-------+------+-------+-------+------+

|Operating result incl. non- | -19.1| 2.5|  | -75.5| -39.2|  |

|recurring | | | | | | |

+--------------------------------+-------+-------+------+-------+-------+------+

|Net profit/loss | -9.2| 3.3|  | -59.0| -47.9|  |

+--------------------------------+-------+-------+------+-------+-------+------+

|Earnings per share, diluted | -0.43| 0.07|  | -2.77| -2.24|  |

|(NOK) | | | | | | |

+--------------------------------+-------+-------+------+-------+-------+------+

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.

The presentation will be publicly available at www.photocure.com. It will be

possible to follow the presentation through a live webcast.

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:

Photocure

President & CEO Kjetil Hestdal

Tel: + 47 913 19 535, Email: [email protected]

CFO Erik Dahl

Tel: +47 450 55 000, Email: [email protected]

Hume Brophy

Mary Clark

Tel: +44 20 3440 5653

Email: [email protected]

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.

This information is subject of the disclosure requirements pursuant to section

5-12 of the Norwegian Securities Trading Act.

[HUG#1764917]

Talk to a Data Expert

Have a question? We'll get back to you promptly.