Earnings Release • Dec 22, 2014
Earnings Release
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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]
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