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 Dec 22, 2014

3714_iss_2014-12-22_77afae64-a00a-4b0e-ae52-954a7b75c831.html

Earnings Release

Open in Viewer

Opens in native device viewer

Photocure ASA - 2014 business performance goals update

Photocure ASA - 2014 business performance goals update

Oslo, Norway, 22(th) December 2014: Photocure ASA (OSE: PHO), a specialty

pharmaceutical company focused on photodynamic technologies in dermatology and

cancer, provides an update on business performance for 2014. The company is on

track to deliver on its objectives of successfully increasing sales of

Hexvix/Cysview and improving financial performance of the commercial franchise.

This, together with the payment from Salix, is expected to result in cash

reserves at the end of the year that are higher than previous guidance of NOK

145-155 million. For the pipeline progress has been made with the FDA designated

end of phase 2 meeting for Cevira., However, a strategic partnership for Visonac

is no longer expected to occur by the end of 2014.

Hexvix(®)/Cysview(®)

In line with the company's guidance for 2014, Photocure expects global

Hexvix/Cysview in-market unit sales for 2014 to grow at or above 10 per cent as

compared to the previous year (based on end user sales November 2014). The solid

performance is driven by continued growth in the Nordic region, strong results

from the strategic partnership with Ipsen, as well as increasing sales for

Cysview in the US.

Driven by solid customer demand, price increases supported by strong health

economic data, favourable currency fluctuations and cost containment; the

financial performance of the Hexvix/Cysview franchise has strengthened

significantly. The franchise attained profitability for the first-time during Q3

2014 and is expected to remain so through the end of the year.

In order to achieve a long-term sustainable reimbursement solution for Cysview

in the US, Photocure has continued to work closely with leading urology

associations, patient groups, other key stakeholders and members of Congress in

support of the proposed Congressional Bill, introduced in June 2014, which will

secure US senior cancer patients access to state of the art treatments,

including Cysview. The bill was not acted upon by the Congress before the year-

end recess. Photocure will continue its work to obtain reimbursement of Cysview

in the US, and expects that support of the bill will continue when Congress

reconvenes in 2015.

Visonac(®)

Visonac has successfully completed a phase 2b clinical trial and is phase 3

ready. Photocure's strategy is to establish a development and commercialization

partnership for Visonac prior to initiation of the phase 3 clinical program.

Photocure has engaged in discussions with potential partners, where the priority

is to secure an agreement demonstrating the full value of Visonac. Photocure's

initial expectation was to have a partnership in place before year-end 2014.

Obtaining alignment with a strategic partner on the value of the asset will

require additional time and therefore the discussions will need to continue into

Cevira(®)

A key objective in 2014 was to secure the regulatory pathway on a late stage

clinical development plan for Cevira prior to initiation of the phase 3 clinical

development.

As communicated earlier this year, discussions with Health Authorities in key

European markets have been completed and support has been achieved to continue

with the proposed phase 3 program, targeting women with high grade precancerous

lesions of the cervix (HSIL (CIN2)) as the first indication.

Additionally, Photocure completed the re-analysis of the clinical data, in

accordance with the new diagnostic consensus classification system and guidance

provided by US FDA, which demonstrated that Cevira provides improved treatment

efficacy compared to placebo among patients with HSIL.

After submission of the new results to FDA, Photocure discussed the results at

the FDA designated end of Phase 2 meeting held in early December. Photocure is

awaiting final minutes from FDA early 2015.

Photocure is in discussions with companies that are leaders in women's

healthcare to secure a strategic partnership to assist with the late stage

development and commercialization of Cevira.

Cash position

Based on the improved financial performance of the Hexvix/Cysview commercial

franchise as well as the $ 5 million payment received from Salix, Photocure has

increased its guidance on the expected cash reserves at the end of 2014 from in

excess of NOK 105 million to a range of NOK 145-155 million. Based on the

performance as of November 30, 2014 the company expects to end the year at or

above the higher part of this range.

The objectives for 2015 will be announced in the next financial report on 12

February 2015.

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]

Notes to editors

About Photocure ASA

Photocure ASA, 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.

This information is subject of the disclosure requirements acc. to §5-12 vphl

(Norwegian Securities Trading Act)

[HUG#1882495]

Talk to a Data Expert

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