“Our third quarter report demonstrates continued significant progress in our US business. The new reimbursement of Blue Light Cystoscopy with Cysview for Medicare patients, as well as the potential to expand Cysview’s label in the US show our commitment to this important market. It also confirms our desire to deliver patients better access to bladder cancer treatment. We expect the new reimbursement to drive significant growth in the future,” says Kjetil Hestdal, President and Chief Executive Officer of Photocure.
Photocure reported total group revenues of NOK 35.6 million in the third quarter of 2017 (35.2), with a recurring EBITDA of NOK -9.6 million (-1.6). Net profit was NOK -10.1 million (0.1), while the cash position ended at NOK 123.1 million. Global in-market unit sales of Hexvix/Cysview increased 3% in the third quarter, impacted by a reduction of the partner business of 1% in the quarter. The sales development in the US was strong with a unit sales increase of 39%. The EBITDA for the Hexvix/Cysview commercial franchise ended at NOK -0.2 million in the third quarter of 2017.
Photocure has built considerable experience in the urology sector through its Hexvix/Cysview franchise and sees significant long-term value creation potential in this market segment. The company aims to capitalize on the inclusion in the AUA guidelines, as well as the increased patient awareness and the changes to reimbursement of Cysview in the outpatient setting, to significantly increase penetration in the US market. CMS (United States Centers for Medicare & Medicaid Services) released in November the Final Rule stating that it will reimburse hospital outpatient departments for certain Blue Light Cystoscopy (BLC) with Cysview procedures from January 1, 2018.
“Photocure believes that in order to increase market shares in the US, an investment in the US commercial and medical infrastructure is required. As stated previously, the company plans to double its salesforce from 2016 and increase sales and marketing expenses towards the end of 2017. The goal of these efforts is to quadruple the revenues from the US operations by 2020 before the impact of Medicare reimbursement. The added reimbursement will have a positive effect on future revenues, however, the full implications of this positive change are not expected to be fully known before second half of 2018. Currently the company estimates that the added reimbursement will drive the US revenues in 2020 to a range of USD 20–25 million”, says Hestdal.
Photocure reported in May this year that the Phase 3 study of Hexvix/Cysview in the surveillance patient segment met its primary endpoint and other major endpoints. Based on this, the company submitted a supplemental New Drug Application (sNDA) to the US FDA, and in October FDA accepted for review and granted priority review status to the sNDA for Cysview. A decision on the approval by the FDA during the first half of 2018.
Photocure will present its third quarter report on Wednesday 8 November 2017 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 held in Norwegian.
The presentation will be publicly available at www.photocure.com. It will be possible to follow the presentation through http://webtv.hegnar.no/presentation.php?webcastId=67473710.
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 (http://webtv.hegnar.no/presentation.php?webcastId=67473875) the same day in English at 17:00 CET / 16:00 GMT / 11:00 EST.
Please join the event conference 5-10 minutes prior to the start time using the number and confirmation code below:
- NORWAY: +47 2350 0296
- UK: +44(0)330 336 9411
- USA: +1 323 794 2094
Confirmation code: 6929135
It is possible to listen to a replay of the conference call on the following numbers:
- NORWAY +47 2350 0077
- UK +44 (0)207 984 7568
- USA +1 719 457 0820
Confirmation code: 6929135
For further information, please contact:
President & CEO
Tel: + 47 913 19 535
Chief Financial Officer
Tel: +47 450 55 000