“Our second quarter report shows significant progress for our US business. US is a market of strategic importance for Photocure and we were delighted to present in May positive results from our Phase 3 study in the bladder cancer surveillance setting at the AUA meeting. These data formed the basis for our recent sNDA filing aimed at expanding the label for BLC with Cysview in the US to include the broader surveillance segment. Furthermore, after the quarter, we were very pleased to learn that CMS proposes to reimburse Blue Light Cystoscopy with Cysview from 2018, with a final decision expected later this year. We and our supporters have worked tirelessly to secure better reimbursement for Cysview in US and believe it will lead to increased access and allow better management for bladder cancer patients in the future,” says Kjetil Hestdal, President and Chief Executive Officer of Photocure.
Photocure reported total group revenues of NOK 39.3 million in the second quarter of 2017 (35.5), with a recurring EBITDA of NOK -4.4 million (-2.3). Net profit was NOK -4.7 million (18.1), while the cash position ended at NOK 137.0 million. Global in-market unit sales of Hexvix/Cysview decreased 2% in the second quarter, impacted by a reduction of the partner business of 6% in the quarter. The sales development in the US was strong with a unit sales increase of 37%. The EBITDA for the Hexvix/Cysview commercial franchise ended at NOK 4.7 million in the second 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 possible changes to reimbursement of Cysview, to significantly increase penetration in the US market.
Photocure reported in the second quarter 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 has submitted an sNDA to the US FDA, with a possible approval in 2018, for use of Blue Light Flexible Cystoscopy with Cysview in this out-patient surveillance setting.
CMS (United States Centers for Medicare & Medicaid Services) released in July the Proposed Rule outlining its 2018 plan to reimburse hospital outpatients departments using Blue Light Cystoscopy with Cysview. The comment period for the proposed rule closes in early September, and CMS is expected to issue a Final Rule in the fourth quarter of 2017 effective on 1 January 2018.
“Photocure believes that in order to increase market shares in the US, an investment in the US salesforce 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 to a range of USD 15 million by 2020. The company is fully funded for this market strategy”, says Hestdal.
Photocure will present its second quarter and first half year report on Wednesday 23 August 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=58634954.
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=58635101) 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 2100 2610
* UK: +44(0)330 336 9105
* USA: +1 719 325 2226
Confirmation code: 1923019
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: 1923019
For further information, please contact:
President & CEO
Tel: + 47 913 19 535
Chief Financial Officer
Tel: +47 450 55 000