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NOK 9.7 million) for the company. In 2026, Photocure expects product revenue
growth in the range of 7% to 11% on a constant currency basis and adjusted
EBITDA margin expansion.
“Photocure delivered a solid start to 2026, with strong growth across all
territories and continued execution across both our commercial and strategic
priorities. Revenue growth was robust in North America and Europe, reflecting
accelerating adoption of blue-light cystoscopy and increasing procedural
penetration in key markets,” says Dan Schneider, President & Chief Executive
Officer of Photocure.
The company continued to execute on its plan to expand blue-light cystoscopy
(BLC®) use in Q1 2026 with the installation of 11 new Saphira towers in the U.S.
- 4 new accounts and 7 blue light tower upgrades. Photocure had 413 active
accounts in the U.S. at the end of the quarter, an increase of 21% versus the
first quarter of 2025. Across Europe, a total of 75 Olympus Visera Elite III BLC
capable systems were installed since the launch in Q1 2025.
Total revenues ended at NOK 264.6 million in the first quarter of 2026, an
increase from NOK 125.3 million in Q1 2025. The total revenue in Q1 2026
includes recognized milestone payments of NOK 125.6 million for the approval of
Cevira in China and the acceptance of the marketing authorization approval
request in Europe. Reported EBITDA was NOK 128.3 million (NOK 1.8 million). EBIT
ended at NOK 120.7 million (NOK -5.6 million). Cash and cash equivalents were
NOK 192.7 million at the end of the period.
“As a very important regulatory and strategic update, the U.S. Food and Drug
Administration has provided clarity on the reclassification pathway for OAY
-related equipment (Diagnostic Endoscopic Light Source Systems) following its
response to the Karl Storz Citizen Petition and has confirmed plans to initiate
a proposed reclassification process in the second half of 2026. This marks an
important step towards a more structured and predictable regulatory framework
for BLC equipment in the U.S. market. For Photocure, reclassification has the
potential to be a step-change driver for the business, unlocking a significantly
larger commercial opportunity, as we move towards double-digit penetration
across the expanded market relative to where we are today,” Schneider adds.
Photocure’s partners Richard Wolf and Asieris achieved a significant milestone
with the April approval of the System blue BLC platform in China, which will be
commercialized alongside Hexvix following its prior approval by the National
Medical Products Administration (NMPA) in November 2024, enabling a fully
integrated drug-device offering. At the same time, the recent CE mark and early
commercial traction of blue light-compatible systems in Europe from the leading
global medtech company Stryker, reinforce the growing recognition of BLC as an
important standard in bladder cancer management and supporting broader adoption
over time.
“Cevira, originally developed by Photocure and out-licensed to Asieris, was
approved in China by the NMPA in March as a first-in-class non-invasive therapy
for cervical precancerous lesions. Shortly thereafter, Cevira was endorsed with
Level 1A evidence in expert consensus guidelines in China, reinforcing its
clinical adoption potential. In Europe, the European Medicines Agency accepted
the Marketing Authorization Application for Cevira during the quarter as well.
The approval of Cevira in China and the EMA acceptance serve as milestones with
contractual payments owed to Photocure in the amounts of 11.0 million and 2.0
million dollars respectively. The NMPA approval milestone is in dispute, with
Asieris having paid 6.6 million of the 11.0 million dollars owed. Photocure
believes its legal position to collect the full amount is strong and intends to
engage in discussions with Asieris to explore potential pathways forward,”
Schneider says, and continues:
“Furthermore, in addition to our Hexvix/Cysview base business and partnered
developments mentioned above, Photocure also remains committed to advancing a
strategy of building an integrated diagnostics platform and leveraging our
existing strong commercial footprints in North America and Europe. The uro
-oncology landscape is rapidly evolving toward more personalized and data-driven
care pathways, increasing the importance of multi-modal precision diagnostics
tools. During the quarter, we made a targeted 3.0 million dollar minority
investment in Vesica Health, a company within precision diagnostics, developing
and launching a multi-omic urine biomarker test for early detection of bladder
cancer with best-in-class performance. Our initiatives in flexible cystoscopy
with Richard Wolf, AI-enabled software with Claritas/ISC, biomarkers with Vesica
Health, and other innovations are progressing as planned, with the goal of
improving early detection, diagnostic confidence, surveillance and treatment
decision-making.”
Photocure sees multiple drivers supporting continued growth in its base
business, including sustained procedural adoption, expansion of installed
equipment, increased utilization across existing accounts, and continued upgrade
cycles to next-generation imaging systems. In addition, several strategic
catalysts will further enhance its trajectory, including FDA reclassification of
BLC to bring additional rigid equipment manufacturers to the U.S. and the
reintroduction of flexible BLC solutions.
“We remain confident in Photocure’s momentum and continued positive trajectory.
We expect strong underlying revenue growth across all regions, with product
revenue growth of 7% to 11% on a constant currency basis, supported by sustained
commercial execution. As operating leverage improves, we anticipate further
expansion in adjusted EBITDA margin, reflecting the scalability of our platform
and disciplined execution across the base business alongside a strategic
platform extension. Our focus remains on delivering consistent execution and
building long-term shareholder value,” Schneider concludes.
Please find the full financial report and presentation enclosed.
(Adjusted) EBITDA and other alternative performance measures (APMs) are defined
and reconciled to the IFRS financial statements as a part of the APM section of
the first quarter 2026 financial report on page 22.
The quarterly report and presentation will be published at 07:00 CET and will be
publicly available at www.photocure.com. Dan Schneider, CEO, Erik Dahl, CFO, and
Priyam Shah, VP of IR will host a live webcast at 14:00 CET.
The presentation will be held in English and questions can be submitted
throughout the event. The streaming event is available through:
Photocure Webcast Q1 2026 (https://qcnl.tv/p/xXUD8ZENOu17GeO0kLRJG
Q%20)
The presentation is scheduled to conclude at 14:45 CET.
For further information, please contact:
Dan Schneider
President and CEO
Photocure ASA
Email: ds@photocure.com
Erik Dahl
Chief Financial Officer
Tel: +47 450 55 000
Email: ed@photocure.com
Priyam Shah
Vice President Investor Relations
Tel: +1 7176815072
Email: priyam.shah@photocure.com
Geir Bjørlo
Corporate Communications (Norway)
Tel: +47 91540000
Email: geir.bjorlo@corpcom.no (geir.bjorlo@corpcom.no
)
About Photocure ASA
Photocure: The Bladder Cancer Company delivers transformative solutions to
improve the lives of bladder cancer patients. Our unique technology, making
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). For more information, please visit us at
www.photocure.com/news
All trademarks mentioned in this release are protected by law and are registered
trademarks of Photocure ASA.
This information is considered to be inside information pursuant to the EU
Market Abuse Regulation and is subject to the disclosure requirements pursuant
to section 5-12 of the Norwegian Securities Trading Act. This stock exchange
announcement was published by Tolv Hillestad, Photocure ASA, on 7 May 2026 at
07:00 CET.
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