Oslo, Norway, 22th 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
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 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 2015.
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.
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:
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, Email: firstname.lastname@example.org