Photocure ASA: Results for third quarter 2015

Oslo, Norway, 29 October 2015: Photocure (OSE: PHO), a specialty pharmaceutical company focused on photodynamic technologies in cancer and dermatology, announces its results for the third quarter 2015.

Highlights include:

(Numbers in brackets are for the corresponding period in 2014)

  • Total sales revenues of Hexvix/Cysview increased 12% in third quarter. Year to date sales revenues increased 23% to NOK 82.6 million (NOK 67.2 million)
  • Commercial segment EBIT increased 109% to NOK 23.1 million (NOK 11.1 million) with EBIT margin at 23% (15%) for the first nine-months
  • Global Hexvix/Cysview in-market unit sales growth of 8% in the third quarter year-over-year and 7% year to date
  • Agreement signed in August with BioSyent Pharma for the commercialization of Cysview in Canada with an upfront payment of USD 650,000
  • First patient enrolled in the Hexvix/Cysview Market Expansion Phase 3 study
  • Obtained alignment with US FDA on the design of Cevira phase 3 registration program
  • Strengthening of Cevira patent portfolio

Key figures:

Figures in NOK million 3Q 2015 3Q 2014 Change 9M 2015 9M 2014 Change FY 2014
Sales revenues 29.3 24.9 17 % 89.1 68.8 30 % 93.6
Signing fee & milestone revenues 6.6 31.9   11.1 34.2   35.4
Total revenues 35.9 56.8 -37 % 100.2 103.0 -3 % 129.0
Operating expenses 36.6 31.4 16 % 105.8 93.4 13 % 127.6
EBIT (Operating result) -2.7 23.8   -11.8 4.4   -5.6
  EBIT commercial franchise 9.0 5.7 59 % 23.1 11.1 109 % 15.9
  EBIT development portfolio -11.7 18.1   -34.9 -6.7   -21.5
Profit/loss(-) before PCI and tax 0.1 24.2   -7.3 6.9   1.5
Earnings per share, diluted (NOK) -0.23 1.13   -1.25 0.32   -1.16
Cash & cash equivalents 139.5 166.9         165.2

President & CEO Kjetil Hestdal, M.D. Ph.D. comments:

"In the third quarter of 2015, we continued to deliver growth. With the increased profitability of our commercial franchise we continue to make significant progress towards our goal of becoming a sustainable Specialty Pharma Company.

The new Hexvix distribution agreement with BioSyent Pharma, as well as the filing of the marketing authorization application in Australia by Juno Pharmaceuticals provides an additional foundation for the future growth of the Hexvix/Cysview brand as we work to ensure that bladder cancer patients gain access to improved patient management in regions outside the current territories.

Furthermore, we were pleased to announce after the quarter end that the first patient has been enrolled in our Phase 3 market expansion trial with Hexvix/Cysview. In this trial we will compare flexible blue light cystoscopy with Hexvix/Cysview with standard white light cystoscopy in the outpatient/surveillance setting. We expect to report results from this study in 2017.

In terms of our pipeline, we reached alignment with the FDA on the Cevira Phase 3 registration program through the SPA process and we were granted additional patent protection in Europe for Cevira which further strengthens the patent portfolio around this novel drug-device for HPV related cervical lesions".

Please find the full financial report and presentation enclosed.

Photocure ASA will present its interim report today 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 publicly available at www.photocure.com. It will be possible to follow the presentation through a live webcast.

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 today in English at 17:00 CET / 16:00 GMT / 11:00 EST.

Please make sure to dial in 5-10 minutes prior to scheduled conference call start time on one of the following numbers:

  • NORWAY:        +47 2316 2771
  • UK:                  +44(0)20 3427 1902
  • USA:                +1718 971 5738

Confirmation code: 4060187

It is possible to listen to a replay of the conference call on the following numbers:

  • NORWAY         +47 2100 0498
  • UK                   +44 (0)20 3427 0598
  • USA                 +1 347 366 9565

Confirmation code: 4060187

For further information, please contact:

Photocure
President & CEO Kjetil Hestdal
Tel: + 47 913 19 535, Email: kh@photocure.no

CFO Erik Dahl
Tel: +47 450 55 000, Email: ed@photocure.no

Trout International LLC
Lauren Williams
Tel: +44 20 3780 4972
Email:lwilliams@troutgroup.com

About Photocure

Photocure, headquartered in Oslo Norway, is a specialty pharmaceutical company and world leader in photodynamic technology. Based on our unique proprietary Photocure Technology(TM) platform, Photocure develops and commercializes highly selective and effective solutions within disease areas with high unmet medical need, such as bladder cancer, HPV and precancerous cervical lesions, colorectal cancer and skin conditions. Our aim is to provide solutions which can improve health outcomes for patients worldwide. Photocure is listed on the Oslo Stock Exchange (OSE: PHO). Information about Photocure is available at www.photocure.com.

All trademarks mentioned in this release are protected by law and registered trademarks of Photocure ASA.

This information is subject to the disclosure requirements pursuant to section 5-12 of the Norwegian Securities Trading Act.