“2016 was a positive year for Photocure as we continued to build momentum in the US with Cysview. A significant milestone was reached by the inclusion and recommendations of Cysview in National treatment guidelines in the US. In addition, several papers including strong new clinical evidence supporting the use of Hexvix/Cysview were published during 2016. These events, together with the increase in installed base of Blue Light enabled Cystoscopes in the US and a higher level of patient awareness, provide us with confidence that our planned increase in investment in the US commercial urology franchise will create value for our shareholders in the future. Lastly, we are also looking forward to receiving results from our expanded use Phase 3 study in the US with the Karl Storz flexible scope in the surveillance setting in the middle of the year.” said Kjetil Hestdal, President and CEO.
Photocure reported total revenues of NOK 38.1 million in the fourth quarter of 2016 (34.5), with an EBITDA of NOK -0.3 million (-8.7). Net profit was NOK 17.9 million (-9.4), while the cash position ended at NOK 169.2 million. Hexvix/Cysview revenues grew 13% for the full year but declined 5% in the fourth quarter mainly due to inventory reductions at distributors, as well as a negative impact from foreign exchange rates. In-market unit sales increased with 3% in the quarter.
“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 has over the last years experienced a strong and growing penetration of Hexvix in key European markets and aims to capitalize on the inclusion in the AUA guidelines as well as the increased patient awareness to significantly increase penetration in the US market. Photocure does however believe that in order to increase market shares in the US to European levels, an investment in the US salesforce is required,” said Hestdal.
The company will therefore double its salesforce and increase sales and marketing expenses accordingly towards the end of 2017. The company believes these efforts will result in revenues from the US operations to quadruple to a range of USD 15 million by 2020.
“As a result of the increased activity level, the added operating expenses will contribute to an EBITDA decline for the group in 2017 and 2018. Photocure is fully funded for this market strategy. Photocure has also completed enrollment in its Phase 3 study of Hexvix/Cysview in the surveillance patient segment and expect to report clinical results in mid-2017. The company will then submit an sNDA to the US FDA, with a possible approval in 2018 for use of Blue Light Flexible Cystoscopy with Cysview in this setting,“ Hestdal concludes.
Photocure is continuing its discussions and due diligence processes with potential partners to establish strategic partnerships for its non-urology products, Visonac and Cevira.