PHOTOCURE ASA - PHCUF STOCK NEWS

Photocure ASA reported NOK 81.4 million in Hexvix®/Cysview® revenues for Q1 2022, slightly lower than NOK 81.6 million in Q1 2021. The company faced challenges due to Covid-19, which impacted hospital operations, particularly in January and February. However, sales experienced a recovery in March, with a 12% increase in North America compared to last year. Total group revenues were NOK 81.6 million, while EBITDA was NOK -13.9 million. The company anticipates a boost in Blue Light Cystoscopy installations in the U.S. during the second half of 2022.

Photocure ASA's partner, Asieris Pharmaceuticals, has received approval from the Hainan Provincial Medical Products Administration to conduct a real-world evidence study for Hexvix^® in Hainan, China. This follows a Phase III study approval granted last month. Asieris holds exclusive rights to register and commercialize Hexvix in mainland China and Taiwan, entering a license agreement with Photocure in January 2021. The combined use of Hexvix and blue light cystoscopy is endorsed in major clinical guidelines, and this approval will support data collection from the Hainan pilot study.

Photocure ASA, known as the Bladder Cancer Company, announces presentations at two investor conferences in June 2021. CEO Daniel Schneider and CFO Erik Dahl will present at:

• The MicroCap Rodeo 2021: June 1, 3:00pm CET / 9:00am ET.
• Handelsbanken Nordic Mid/Small Cap Seminar: June 2, 4:15pm CET / 10:15am ET.

Both events include virtual one-on-one meetings for investors. Photocure focuses on innovative solutions for bladder cancer treatment, enhancing patient outcomes. For further details, visit their website.

Photocure ASA reported a strong performance in Q1 2021, with Hexvix/Cysview revenues of NOK 81.6 million, up 50% year-over-year. EBITDA improved to NOK 18.1 million, reversing last year’s loss of NOK -4.8 million. Total group revenues reached NOK 88.2 million, driven by unit growth in the U.S. and payments from Asieris for Hexvix licensing in China and Taiwan. Despite the ongoing impact of the Covid-19 pandemic, a rebound in procedure volumes is anticipated as access to care improves.

Photocure ASA announces that the Marketing Authorization Application (MAA) for Hexvix® has been accepted for regulatory review by the Chilean health authority.

Following this acceptance, Genotests SpA, the exclusive distributor for Hexvix in Chile, will prepare for the product's commercial launch, expected in the fourth quarter of 2021.

This partnership marks Photocure's first entry into South America, aiming to increase accessibility of Hexvix for bladder cancer patients in Chile, where there are approximately 1,500 new bladder cancer cases annually.

Photocure ASA (OSE: PHO) reported Hexvix/Cysview revenues of NOK 97.7 million for Q4 2020, up from NOK 58.8 million in Q4 2019. Overall, total group revenues reached NOK 97.9 million, a decrease from NOK 115.6 million in the previous year, with an EBITDA of NOK 15.2 million. Despite operational challenges due to the pandemic, the company achieved an 11% growth in U.S. sales and an 83.8% growth in European revenues. Guidance for 2023 is suspended amid ongoing uncertainty from Covid-19.

On Oct. 16, 2020, Photocure ASA presented data from the Nordic Flexible BLC registry at the BLADDR 2020 congress. The study highlights the efficacy of flexible Blue Light Cystoscopy (BLC) in managing non-muscle-invasive bladder cancer (NMIBC) in an office setting. The results showed that BLC enabled complete removal of suspicious lesions in 88% of cases without the need for further invasive procedures. This method potentially reduces healthcare costs while providing immediate treatment options for patients, offering a more efficient solution for NMIBC management.

On October 5, 2020, Photocure ASA announced that the European Patent Office granted patent EP 2983780 for the Cevira^® device, valid in Europe until April 9, 2034. Cevira is a photodynamic drug-device combination product for treating high-grade cervical dysplasia, a condition linked to HPV. In July 2019, the company licensed global development rights to Asieris Meditech. Asieris has since begun a global Phase III trial for Cevira following a China NMPA approval in July 2020.

Photocure ASA (OSE:PHO) has launched sales and distribution of Hexvix® in European markets previously managed by Ipsen Pharma. This transition is expected to fuel growth, as Photocure anticipates a revenue increase of around 3 times by 2021 compared to 2019 levels. The company has invested EUR 15 million to regain these rights and will pay earn-out fees based on sales performance. Furthermore, the European operations are projected to be EBITDA accretive from 2021 onwards, with a targeted annual revenue growth of 20-30% in the former Ipsen territories.