{"success":true,"data":{"pressRelease":{"id":"24804","rtpr_id":"nPreXFYfTa","ticker":"PHO","exchange":"Oslo Børs","all_tickers":["PHO"],"title":"Photocure ASA: Results for the first quarter of 2026","author":"PR Newswire","published_at":"2026-05-07T06:25:15.869Z","article_body":"Photocure ASA: Results for the first quarter of 2026\nPR Newswire\n\nOSLO, Norway, May 7, 2026\n\nOSLO, Norway, May 7, 2026 /PRNewswire/ -- Photocure ASA (OSE: PHO) today\nreported Hexvix®/Cysview® revenues of NOK 139.0 million in the first quarter\nof 2026 (Q1 2025: NOK 125.3 million), and an adjusted EBITDA of NOK 15.3\nmillion (Q1 2025: NOK 9.7 million) for the company. In 2026, Photocure expects\nproduct revenue growth in the range of 7% to 11% on a constant currency basis\nand adjusted EBITDA margin expansion.\n\n\"Photocure delivered a solid start to 2026, with strong growth across all\nterritories and continued execution across both our commercial and strategic\npriorities. Revenue growth was robust in North America and Europe, reflecting\naccelerating adoption of blue-light cystoscopy and increasing procedural\npenetration in key markets,\" says Dan Schneider, President & Chief Executive\nOfficer of Photocure.\n\nThe company continued to execute on its plan to expand blue-light cystoscopy\n(BLC(®)) use in Q1 2026 with the installation of 11 new Saphira towers in the\nU.S. — 4 new accounts and 7 blue light tower upgrades. Photocure had 413\nactive accounts in the U.S. at the end of the quarter, an increase of 21%\nversus the first quarter of 2025. Across Europe, a total of 75 Olympus Visera\nElite III BLC capable systems were installed since the launch in Q1 2025.\n\nTotal revenues ended at NOK 264.6 million in the first quarter of 2026, an\nincrease from NOK 125.3 million in Q1 2025. The total revenue in Q1 2026\nincludes recognized milestone payments of NOK 125.6 million for the approval\nof Cevira in China and the acceptance of the marketing authorization approval\nrequest in Europe. Reported EBITDA was NOK 128.3 million (NOK 1.8 million).\nEBIT ended at NOK 120.7 million (NOK -5.6 million). Cash and cash equivalents\nwere NOK 192.7 million at the end of the period.\n\n\"As a very important regulatory and strategic update, the U.S. Food and Drug\nAdministration has provided clarity on the reclassification pathway for\nOAY-related equipment (Diagnostic Endoscopic Light Source Systems) following\nits response to the Karl Storz Citizen Petition and has confirmed plans to\ninitiate a proposed reclassification process in the second half of 2026. This\nmarks an important step towards a more structured and predictable regulatory\nframework for BLC equipment in the U.S. market. For Photocure,\nreclassification has the potential to be a step-change driver for the\nbusiness, unlocking a significantly larger commercial opportunity, as we move\ntowards double-digit penetration across the expanded market relative to where\nwe are today,\" Schneider adds.\n\nPhotocure's partners Richard Wolf and Asieris achieved a significant milestone\nwith the April approval of the System blue BLC platform in China, which will\nbe commercialized alongside Hexvix following its prior approval by the\nNational Medical Products Administration (NMPA) in November 2024, enabling a\nfully integrated drug–device offering. At the same time, the recent CE mark\nand early commercial traction of blue light–compatible systems in Europe\nfrom the leading global medtech company Stryker, reinforce the growing\nrecognition of BLC as an important standard in bladder cancer management and\nsupporting broader adoption over time.\n\n\"Cevira, originally developed by Photocure and out-licensed to Asieris, was\napproved in China by the NMPA in March as a first-in-class non-invasive\ntherapy for cervical precancerous lesions. Shortly thereafter, Cevira was\nendorsed with Level 1A evidence in expert consensus guidelines in China,\nreinforcing its clinical adoption potential. In Europe, the European Medicines\nAgency accepted the Marketing Authorization Application for Cevira during the\nquarter as well. The approval of Cevira in China and the EMA acceptance serve\nas milestones with contractual payments owed to Photocure in the amounts of\n11.0 million and 2.0 million dollars respectively. The NMPA approval milestone\nis in dispute, with Asieris having paid 6.6 million of the 11.0 million\ndollars owed. Photocure believes its legal position to collect the full amount\nis strong and intends to engage in discussions with Asieris to explore\npotential pathways forward,\" Schneider says, and continues:\n\n\"Furthermore, in addition to our Hexvix/Cysview base business and partnered\ndevelopments mentioned above, Photocure also remains committed to advancing a\nstrategy of building an integrated diagnostics platform and leveraging our\nexisting strong commercial footprints in North America and Europe. The\nuro-oncology landscape is rapidly evolving toward more personalized and\ndata-driven care pathways, increasing the importance of multi-modal precision\ndiagnostics tools. During the quarter, we made a targeted 3.0 million dollar\nminority investment in Vesica Health, a company within precision diagnostics,\ndeveloping and launching a multi-omic urine biomarker test for early detection\nof bladder cancer with best-in-class performance. Our initiatives in flexible\ncystoscopy with Richard Wolf, AI-enabled software with Claritas/ISC,\nbiomarkers with Vesica Health, and other innovations are progressing as\nplanned, with the goal of improving early detection, diagnostic confidence,\nsurveillance and treatment decision-making.\"\n\nPhotocure sees multiple drivers supporting continued growth in its base\nbusiness, including sustained procedural adoption, expansion of installed\nequipment, increased utilization across existing accounts, and continued\nupgrade cycles to next-generation imaging systems. In addition, several\nstrategic catalysts will further enhance its trajectory, including FDA\nreclassification of BLC to bring additional rigid equipment manufacturers to\nthe U.S. and the reintroduction of flexible BLC solutions.\n\n\"We remain confident in Photocure's momentum and continued positive\ntrajectory. We expect strong underlying revenue growth across all regions,\nwith product revenue growth of 7% to 11% on a constant currency basis,\nsupported by sustained commercial execution. As operating leverage improves,\nwe anticipate further expansion in adjusted EBITDA margin, reflecting the\nscalability of our platform and disciplined execution across the base business\nalongside a strategic platform extension. Our focus remains on delivering\nconsistent execution and building long-term shareholder value,\" Schneider\nconcludes.\n\nPlease find the full financial report and presentation enclosed.\n\n(Adjusted) EBITDA and other alternative performance measures (APMs) are\ndefined and reconciled to the IFRS financial statements as a part of the APM\nsection of the first quarter 2026 financial report on page 22.\n\nThe quarterly report and presentation will be published at 07:00 CET and will\nbe publicly available at www.photocure.com. Dan Schneider, CEO, Erik Dahl,\nCFO, and Priyam Shah, VP of IR will host a live webcast at 14:00 CET.\n\nThe presentation will be held in English and questions can be submitted\nthroughout the event. The streaming event is available through:\nhttps://qcnl.tv/p/xXUD8ZENOu17GeO0kLRJGQ\n\nThe presentation is scheduled to conclude at 14:45 CET.\n\nFor further information, please contact:\nDan Schneider\nPresident and CEO\nPhotocure ASA\nEmail: ds@photocure.com\n\nErik Dahl\nChief Financial Officer\nTel: +47 450 55 000\nEmail: ed@photocure.com\n\nPriyam Shah\nVice President Investor Relations\nTel: +1 7176815072\nEmail: priyam.shah@photocure.com\n\nGeir Bjørlo\nCorporate Communications (Norway) \nTel: +47 91540000\nEmail: geir.bjorlo@corpcom.no\n\nAbout Photocure ASA\n\nPhotocure: The Bladder Cancer Company delivers transformative solutions to\nimprove the lives of bladder cancer patients. Our unique technology, making\ncancer cells glow bright pink, has led to better health outcomes for patients\nworldwide. Photocure is headquartered in Oslo, Norway and listed on the Oslo\nStock Exchange (OSE: PHO). For more information, please visit us at\nwww.photocure.com/news\n\nAll trademarks mentioned in this release are protected by law and are\nregistered trademarks of Photocure ASA.\n\nThis information is considered to be inside information pursuant to the EU\nMarket Abuse Regulation and is subject to the disclosure requirements pursuant\nto section 5-12 of the Norwegian Securities Trading Act. This stock exchange\nannouncement was published by Tolv Hillestad, Photocure ASA, on 7 May 2026 at\n07:00 CET.\n\nThis information was brought to you by Cision http://news.cision.com\n\nhttps://news.cision.com/photocure/r/photocure-asa--results-for-the-first-quarter-of-2026,c4345662\n\nThe following files are available for download:\n\n https://mb.cision.com/Main/17498/4345662/4081231.pdf             Release                         \n https://mb.cision.com/Public/17498/4345662/8e3d393952501fed.pdf  Photocure Q1 2026 presentation  \n https://mb.cision.com/Public/17498/4345662/9f29f5bf9f8ed3ab.pdf  Photocure Q1 2026 report        \n\n \n\nView original\ncontent:https://www.prnewswire.co.uk/news-releases/photocure-asa-results-for-the-first-quarter-of-2026-302765194.html\n\n\n\nCopyright (c) 2026 PR Newswire Association,LLC. All Rights Reserved.","article_body_html":"","raw_payload":{"data":{"id":"nPreXFYfTa","title":"Photocure ASA: Results for the first quarter of 2026","author":"PR Newswire","ticker":"PHO","created":"2026-05-07T06:25:15.869Z","tickers":["PHO"],"exchange":"Oslo Børs","article_body":"Photocure ASA: Results for the first quarter of 2026\nPR Newswire\n\nOSLO, Norway, May 7, 2026\n\nOSLO, Norway, May 7, 2026 /PRNewswire/ -- Photocure ASA (OSE: PHO) today\nreported Hexvix®/Cysview® revenues of NOK 139.0 million in the first quarter\nof 2026 (Q1 2025: NOK 125.3 million), and an adjusted EBITDA of NOK 15.3\nmillion (Q1 2025: NOK 9.7 million) for the company. In 2026, Photocure expects\nproduct revenue growth in the range of 7% to 11% on a constant currency basis\nand adjusted EBITDA margin expansion.\n\n\"Photocure delivered a solid start to 2026, with strong growth across all\nterritories and continued execution across both our commercial and strategic\npriorities. Revenue growth was robust in North America and Europe, reflecting\naccelerating adoption of blue-light cystoscopy and increasing procedural\npenetration in key markets,\" says Dan Schneider, President & Chief Executive\nOfficer of Photocure.\n\nThe company continued to execute on its plan to expand blue-light cystoscopy\n(BLC(®)) use in Q1 2026 with the installation of 11 new Saphira towers in the\nU.S. — 4 new accounts and 7 blue light tower upgrades. Photocure had 413\nactive accounts in the U.S. at the end of the quarter, an increase of 21%\nversus the first quarter of 2025. Across Europe, a total of 75 Olympus Visera\nElite III BLC capable systems were installed since the launch in Q1 2025.\n\nTotal revenues ended at NOK 264.6 million in the first quarter of 2026, an\nincrease from NOK 125.3 million in Q1 2025. The total revenue in Q1 2026\nincludes recognized milestone payments of NOK 125.6 million for the approval\nof Cevira in China and the acceptance of the marketing authorization approval\nrequest in Europe. Reported EBITDA was NOK 128.3 million (NOK 1.8 million).\nEBIT ended at NOK 120.7 million (NOK -5.6 million). Cash and cash equivalents\nwere NOK 192.7 million at the end of the period.\n\n\"As a very important regulatory and strategic update, the U.S. Food and Drug\nAdministration has provided clarity on the reclassification pathway for\nOAY-related equipment (Diagnostic Endoscopic Light Source Systems) following\nits response to the Karl Storz Citizen Petition and has confirmed plans to\ninitiate a proposed reclassification process in the second half of 2026. This\nmarks an important step towards a more structured and predictable regulatory\nframework for BLC equipment in the U.S. market. For Photocure,\nreclassification has the potential to be a step-change driver for the\nbusiness, unlocking a significantly larger commercial opportunity, as we move\ntowards double-digit penetration across the expanded market relative to where\nwe are today,\" Schneider adds.\n\nPhotocure's partners Richard Wolf and Asieris achieved a significant milestone\nwith the April approval of the System blue BLC platform in China, which will\nbe commercialized alongside Hexvix following its prior approval by the\nNational Medical Products Administration (NMPA) in November 2024, enabling a\nfully integrated drug–device offering. At the same time, the recent CE mark\nand early commercial traction of blue light–compatible systems in Europe\nfrom the leading global medtech company Stryker, reinforce the growing\nrecognition of BLC as an important standard in bladder cancer management and\nsupporting broader adoption over time.\n\n\"Cevira, originally developed by Photocure and out-licensed to Asieris, was\napproved in China by the NMPA in March as a first-in-class non-invasive\ntherapy for cervical precancerous lesions. Shortly thereafter, Cevira was\nendorsed with Level 1A evidence in expert consensus guidelines in China,\nreinforcing its clinical adoption potential. In Europe, the European Medicines\nAgency accepted the Marketing Authorization Application for Cevira during the\nquarter as well. The approval of Cevira in China and the EMA acceptance serve\nas milestones with contractual payments owed to Photocure in the amounts of\n11.0 million and 2.0 million dollars respectively. The NMPA approval milestone\nis in dispute, with Asieris having paid 6.6 million of the 11.0 million\ndollars owed. Photocure believes its legal position to collect the full amount\nis strong and intends to engage in discussions with Asieris to explore\npotential pathways forward,\" Schneider says, and continues:\n\n\"Furthermore, in addition to our Hexvix/Cysview base business and partnered\ndevelopments mentioned above, Photocure also remains committed to advancing a\nstrategy of building an integrated diagnostics platform and leveraging our\nexisting strong commercial footprints in North America and Europe. The\nuro-oncology landscape is rapidly evolving toward more personalized and\ndata-driven care pathways, increasing the importance of multi-modal precision\ndiagnostics tools. During the quarter, we made a targeted 3.0 million dollar\nminority investment in Vesica Health, a company within precision diagnostics,\ndeveloping and launching a multi-omic urine biomarker test for early detection\nof bladder cancer with best-in-class performance. Our initiatives in flexible\ncystoscopy with Richard Wolf, AI-enabled software with Claritas/ISC,\nbiomarkers with Vesica Health, and other innovations are progressing as\nplanned, with the goal of improving early detection, diagnostic confidence,\nsurveillance and treatment decision-making.\"\n\nPhotocure sees multiple drivers supporting continued growth in its base\nbusiness, including sustained procedural adoption, expansion of installed\nequipment, increased utilization across existing accounts, and continued\nupgrade cycles to next-generation imaging systems. In addition, several\nstrategic catalysts will further enhance its trajectory, including FDA\nreclassification of BLC to bring additional rigid equipment manufacturers to\nthe U.S. and the reintroduction of flexible BLC solutions.\n\n\"We remain confident in Photocure's momentum and continued positive\ntrajectory. We expect strong underlying revenue growth across all regions,\nwith product revenue growth of 7% to 11% on a constant currency basis,\nsupported by sustained commercial execution. As operating leverage improves,\nwe anticipate further expansion in adjusted EBITDA margin, reflecting the\nscalability of our platform and disciplined execution across the base business\nalongside a strategic platform extension. Our focus remains on delivering\nconsistent execution and building long-term shareholder value,\" Schneider\nconcludes.\n\nPlease find the full financial report and presentation enclosed.\n\n(Adjusted) EBITDA and other alternative performance measures (APMs) are\ndefined and reconciled to the IFRS financial statements as a part of the APM\nsection of the first quarter 2026 financial report on page 22.\n\nThe quarterly report and presentation will be published at 07:00 CET and will\nbe publicly available at www.photocure.com. Dan Schneider, CEO, Erik Dahl,\nCFO, and Priyam Shah, VP of IR will host a live webcast at 14:00 CET.\n\nThe presentation will be held in English and questions can be submitted\nthroughout the event. The streaming event is available through:\nhttps://qcnl.tv/p/xXUD8ZENOu17GeO0kLRJGQ\n\nThe presentation is scheduled to conclude at 14:45 CET.\n\nFor further information, please contact:\nDan Schneider\nPresident and CEO\nPhotocure ASA\nEmail: ds@photocure.com\n\nErik Dahl\nChief Financial Officer\nTel: +47 450 55 000\nEmail: ed@photocure.com\n\nPriyam Shah\nVice President Investor Relations\nTel: +1 7176815072\nEmail: priyam.shah@photocure.com\n\nGeir Bjørlo\nCorporate Communications (Norway) \nTel: +47 91540000\nEmail: geir.bjorlo@corpcom.no\n\nAbout Photocure ASA\n\nPhotocure: The Bladder Cancer Company delivers transformative solutions to\nimprove the lives of bladder cancer patients. Our unique technology, making\ncancer cells glow bright pink, has led to better health outcomes for patients\nworldwide. Photocure is headquartered in Oslo, Norway and listed on the Oslo\nStock Exchange (OSE: PHO). For more information, please visit us at\nwww.photocure.com/news\n\nAll trademarks mentioned in this release are protected by law and are\nregistered trademarks of Photocure ASA.\n\nThis information is considered to be inside information pursuant to the EU\nMarket Abuse Regulation and is subject to the disclosure requirements pursuant\nto section 5-12 of the Norwegian Securities Trading Act. This stock exchange\nannouncement was published by Tolv Hillestad, Photocure ASA, on 7 May 2026 at\n07:00 CET.\n\nThis information was brought to you by Cision http://news.cision.com\n\nhttps://news.cision.com/photocure/r/photocure-asa--results-for-the-first-quarter-of-2026,c4345662\n\nThe following files are available for download:\n\n https://mb.cision.com/Main/17498/4345662/4081231.pdf             Release                         \n https://mb.cision.com/Public/17498/4345662/8e3d393952501fed.pdf  Photocure Q1 2026 presentation  \n https://mb.cision.com/Public/17498/4345662/9f29f5bf9f8ed3ab.pdf  Photocure Q1 2026 report        \n\n \n\nView original\ncontent:https://www.prnewswire.co.uk/news-releases/photocure-asa-results-for-the-first-quarter-of-2026-302765194.html\n\n\n\nCopyright (c) 2026 PR Newswire Association,LLC. All Rights Reserved."},"type":"article","timestamp":"2026-05-07T06:25:15.90678952Z","server_sent_at_ms":1778135115906},"received_at":"2026-05-07T06:25:15.969Z","source_url":"https://www.prnewswire.com/news-releases/photocure-asa-results-for-the-first-quarter-of-2026-302765168.html"},"analysis":{"id":"19408","press_release_id":"24804","analysis_json":{"industry":{"label":"Pharmaceuticals, Biotechnology & Life Sciences","sector":"Health Care"},"redFlags":["The NMPA approval milestone payment of $11.0 million is in dispute, with Asieris having paid only $6.6 million to date.","Reported EBITDA surge is largely attributable to one-time milestone payments rather than organic core business growth."],"eventType":"earnings","narrative":"Photocure reported Q1 2026 total revenue of NOK 264.6 million, more than doubling the prior year, driven largely by NOK 125.6 million in recognized milestone payments for Cevira.\n\nCore Hexvix/Cysview revenue grew 11% year-over-year to NOK 139.0 million, supported by a 21% increase in active U.S. accounts to 413 and continued installation of BLC systems in Europe.\n\nThe company secured significant regulatory and commercial milestones, including FDA clarity on OAY equipment reclassification and Cevira approvals in China and Europe, which triggered $13.0 million in contractual payments.","sentiment":"bullish","agentHooks":{"shouldPost":true,"suggestedAngle":"Q1 beat driven by Cevira milestones and strong Hexvix growth; FDA reclassification clarity unlocks U.S. market potential."},"keyFigures":{"revenue":"NOK 264.6 million","guidance":"product revenue growth in the range of 7% to 11% on a constant currency basis and adjusted EBITDA margin expansion","customDimensions":{"cash":"NOK 192.7 million","ebit":"NOK 120.7 million","ebitda":"NOK 128.3 million","hexvix_revenue":"NOK 139.0 million","adjusted_ebitda":"NOK 15.3 million","us_active_accounts":413,"hexvix_revenue_prior":"NOK 125.3 million"}},"quotedText":"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","namedEntities":{"people":[{"name":"Dan Schneider","role":"President & Chief Executive Officer"},{"name":"Erik Dahl","role":"Chief Financial Officer"},{"name":"Priyam Shah","role":"Vice President Investor Relations"}],"products":["Hexvix","Cysview","Cevira","Saphira","Visera Elite III","System blue"],"companies":[{"name":"Photocure ASA","ticker":"PHO"},{"name":"Karl Storz","relationship":"petitioner"},{"name":"Richard Wolf","relationship":"partner"},{"name":"Asieris","relationship":"partner"},{"name":"Stryker","relationship":"partner"},{"name":"Vesica Health","relationship":"investment target"},{"name":"Olympus","relationship":"supplier"}],"dollarAmounts":[{"amount":"$11.0 million","context":"Cevira NMPA approval milestone payment"},{"amount":"$2.0 million","context":"Cevira EMA acceptance milestone payment"},{"amount":"$3.0 million","context":"minority investment in Vesica Health"}]},"materialImpact":{"score":4,"reasoning":"Strong Q1 results with core product revenue growing 11% YoY and total revenue more than doubling due to significant milestone payments. Additionally, crucial regulatory clarity from the FDA regarding equipment reclassification and major partner milestones (Cevira approval in China/EMA acceptance) provide strong commercial catalysts."},"tickerRelevance":{"others":[],"primary":"PHO"},"globalImportance":25,"audienceRelevance":20,"eventTypeSecondary":["regulatory","partnership"],"importanceComponents":{"tickerTier":"small-mid-cap","eventGravity":"earnings-plus-regulatory-catalyst","sectorWeight":"Health Care"}},"event_type":"earnings","event_type_secondary":["regulatory","partnership"],"sentiment":"bullish","material_impact_score":4,"narrative":"Photocure reported Q1 2026 total revenue of NOK 264.6 million, more than doubling the prior year, driven largely by NOK 125.6 million in recognized milestone payments for Cevira.\n\nCore Hexvix/Cysview revenue grew 11% year-over-year to NOK 139.0 million, supported by a 21% increase in active U.S. accounts to 413 and continued installation of BLC systems in Europe.\n\nThe company secured significant regulatory and commercial milestones, including FDA clarity on OAY equipment reclassification and Cevira approvals in China and Europe, which triggered $13.0 million in contractual payments.","key_figures":{"revenue":"NOK 264.6 million","guidance":"product revenue growth in the range of 7% to 11% on a constant currency basis and adjusted EBITDA margin expansion","customDimensions":{"cash":"NOK 192.7 million","ebit":"NOK 120.7 million","ebitda":"NOK 128.3 million","hexvix_revenue":"NOK 139.0 million","adjusted_ebitda":"NOK 15.3 million","us_active_accounts":413,"hexvix_revenue_prior":"NOK 125.3 million"}},"named_entities":{"people":[{"name":"Dan Schneider","role":"President & Chief Executive Officer"},{"name":"Erik Dahl","role":"Chief Financial Officer"},{"name":"Priyam Shah","role":"Vice President Investor Relations"}],"products":["Hexvix","Cysview","Cevira","Saphira","Visera Elite III","System blue"],"companies":[{"name":"Photocure ASA","ticker":"PHO"},{"name":"Karl Storz","relationship":"petitioner"},{"name":"Richard Wolf","relationship":"partner"},{"name":"Asieris","relationship":"partner"},{"name":"Stryker","relationship":"partner"},{"name":"Vesica Health","relationship":"investment target"},{"name":"Olympus","relationship":"supplier"}],"dollarAmounts":[{"amount":"$11.0 million","context":"Cevira NMPA approval milestone payment"},{"amount":"$2.0 million","context":"Cevira EMA acceptance milestone payment"},{"amount":"$3.0 million","context":"minority investment in Vesica Health"}]},"model_name":"glm-4.7","prompt_hash":"sha256:f66160e0fe5301b2","schema_hash":"sha256:12363694422af5d9","created_at":"2026-05-07T18:23:33.638Z","global_importance":25,"audience_relevance":20,"importance_components":{"tickerTier":"small-mid-cap","eventGravity":"earnings-plus-regulatory-catalyst","sectorWeight":"Health Care"}},"durationMs":null,"modelName":"glm-4.7"}}