"We are pleased to report strong growth in the U.S. sales with a year-over-year increase of 36%. The increase follows the accelerated investments in our U.S. commercial team, sales infrastructure and marketing. We believe these organizational changes will continue to drive execution of our growth plans throughout the year. Furthermore, we have this year received FDA approval of label expansion for Cysview and launched Cysview in combination with flexible cystoscopes in the surveillance of bladder cancer patients. With this as well as publication of new clinical data and new reimbursement in the U.S., we have significantly strengthened our ability to provide many more bladder cancer patients with improved management," says Kjetil Hestdal, President and Chief Executive Officer of Photocure.
Photocure reported total group revenues of NOK 41.6 million in the first quarter of 2017 (36.5), with a recurring EBITDA of NOK -4.0 million (-4.3). Net profit was NOK -3.0 million (-6.9), while the cash position ended at NOK 110.7 million. The sales development in the U.S. was strong with a unit sales increase of 29% in the quarter. Global in-market unit sales of Hexvix/Cysview decreased 3%, impacted by the loss of reimbursement in France and large deliveries to hospitals in Denmark in the fourth quarter of 2017. The EBITDA for the Hexvix/Cysview commercial franchise ended at NOK 0.9 million in the first quarter of 2018.
During the first quarter, Photocure experienced all time high increases in permanent blue light cystoscopes (BLCs), with 9 installations bringing the total to 113 at the end of the quarter. The company is gradually expanding the commercial and medical organization in the U.S. to increase the penetration of Cysview, and Photocure will continue this process throughout 2018.
In February 2018, the U.S. Food and Drug Administration (FDA) approved additional indications for BLC with Cysview to include flexible cystoscopes, which are used in the on-going surveillance of patients with bladder cancer. After the closing of the quarter, Photocure launched Cysview in combination with blue light enabled flexible video cystoscopes and the first bladder cancer patients underwent surveillance examination performed with flexible BLC with Cysview.
Photocure has built considerable experience in the bladder cancer market 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 TURBT procedures with rigid cystoscopes, to significantly increase penetration in the U.S. market. Furthermore, with the approval of the extension of the indication for BLC with Cysview to include flexible cystoscopies, a significant market opportunity has opened in the surveillance segment
"With 1.2 million surveillance cystoscopies performed annually in the US, this represents a significant opportunity for the company. We have an ambition to drive the US revenues in 2020 to a range of USD 20-25 million, however with upside potential driven by added reimbursement and penetration of the surveillance segment. The company will update the market on this outlook later in 2018 when there is better visibility of effects of the new reimbursement and initial market response in the surveillance segment", says Hestdal.
Please find the full financial report and presentation linked.
Photocure will present its first quarter report on Wednesday 23 May 2018 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=83489783
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=83490010) 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 2610UK: +44(0)330 336 9105USA: +1 323 701 0225
Confirmation code: 6005389
It is possible to listen to a replay of the conference call on the following numbers:
NORWAY +47 2350 0077UK +44 (0)207 660 0134USA +1 719 457 0820
Confirmation code: 6005389
For further information, please contact:
President & CEO
Tel: + 47 913 19 535
Chief Financial Officer
Tel: +47 450 55 000
Notes to editors
About Photocure ASA
Photocure, The Bladder Cancer Company, delivers transformative solutions to improve the lives of bladder cancer patients. Our unique technology, which makes cancer cells glow bright pink, has led to better health outcomes for patients worldwide. Photocure is headquartered in Oslo, Norway, and listed on the Oslo Stock Exchange (OSE: PHO). The US headquarters for Photocure Inc., are in Princeton, New Jersey. For more information, please visit us at www.photocure.com, www.hexvix.com or www.cysview.com