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Photocure ASA
Quarterly Report • May 8, 2025
3714_rns_2025-05-08_ae4a8d64-d95c-449e-984c-2be7b7fe1164.pdf
Quarterly Report
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Quarterly Report
Q1 2025
Highlights for first quarter 2025 and post-period news
(Numbers in parentheses and comparisons are for the corresponding period in 2024.)
- Hexvix®/Cysview® revenue in the first quarter of 2025 increased 7%, to NOK 125.3 million, compared to the same period last year (NOK 116.8 million). Year-over-year revenue growth was 11% in Europe and 2% in North America.
- The Company continued to execute on its plan to expand blue light cystoscopy use in Q1 2025 with the installation of 21 new Saphira™ towers in the U.S. — 8 new accounts and 13 blue light tower upgrades. There are now 337 active accounts in the U.S., an increase of 17% versus the first quarter of 2024.
- Across Europe, a total of 30 Olympus Visera Elite III blue light cystoscopy (BLC) capable systems were installed during Q1 2025.
- Growth of Cysview kits used for trans-urethral resection of bladder tumour (TURBT) procedures in the U.S. was more than offset by an expected decline in kits used for flexible cystoscopy and the negative impact of timing of sales of rigid kit orders of major accounts. Photocure estimates that U.S. flexible BLC unit sales declined YoY by 71%. Excluding flexible kits and adjusted for fluctuation of orders due to price increases in 2024, Q1 rigid kit sales increased in line with prior quarters.
- Commercial EBITDA, which excludes milestones and includes a small allocation for business development (BD) expenses, was NOK 6.8M, a decrease from NOK 11.7M in the same period last year.
- Photocure completed the buy-back programs which were initiated in December 2024 and March 2025 and repurchased a total of 500,000 of its own shares. The company now holds 514,148 or 1.9% of its own shares.
- On February 17, Photocure announced the availability of an interim flexible BLC solution in all countries where System blue and Richard Wolf reusable flexible cystoscopes are cleared.
- On March 14, a new publication from the BRAVO study in JU Open Plus emphasized the clinical benefits of BLC in reducing risk of bladder cancer recurrence.
- 7 Abstracts featured blue light cystoscopy and its key role as the precision diagnostic in bladder cancer patient care. Clinical data was presented at the 2025 American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO-GU) in San Francisco, the European Association of Urology (EAU) 2025 congress in Madrid, and the American Urological Association Annual (AUA) Congress 2025, that was held post-period in Las Vegas.
- Photocure expects product revenue growth in the range of 7% to 11% and YoY EBITDA improvement in 2025. While the Company is not providing a specific EBITDA guidance range, Photocure expects continued operating leverage flow-through in its core commercial business and significant growth in milestones this year.
| Figures in NOK million | Q1 2025 | Q1 2024 | Change | Change excl. FX |
FY 2024 |
|---|---|---|---|---|---|
| Hexvix/Cysview revenues | 125.3 | 116.8 | 7% | 4% | 487.9 |
| Other revenues | - | 1.3 | - | 37.5 | |
| Total revenues | 125.3 | 118.0 | 6% | 2% | 525.4 |
| Operating expenses | -114.4 | -102.4 | 12% | 8% | -445.5 |
| EBITDA * | 1.8 | 7.9 | 49.2 | ||
| EBITDA Commercial ** | 6.8 | 11.7 | 34.3 | ||
| EBITDA Development ** | -4.9 | -3.8 | 14.9 | ||
| EBIT | -5.6 | 0.7 | 20.4 | ||
| Net Earnings | -2.4 | -7.9 | -4.8 | ||
| Cash & cash equivalents | 259.5 | 258.3 | 293.8 |
* Refer to the Alternative Performance Measures on page 25 for more details on the calculation methodology
** Refer to Note 2 on page 17 for segment details
President & CEO Dan Schneider comments:
"We delivered another quarter of growth and positive EBITDA, driven by the strong performance from our European franchise. In parallel, our North American team continues the solid business development with an increased number of accounts adopting upgrades and new tower placements expecting to drive future revenue growth. We are able to offset the expected decline in flexible cystoscopy kits and expect the U.S. unit growth to accelerate in 2025 onwards. The completion of our share buy-back programme also highlighted our capital discipline commitment as the company continues to grow.
In the first quarter, 21 Saphira towers were installed in the U.S., including 8 new account placements and 13 accounts that upgraded to high-definition systems, and we increased the number of active accounts by more than 17% year- over-year for the rolling 12-month period. Additionally, our mobile BLC tower strategy continues to scale. At the end the quarter, 57 accounts had utilized Fortec's services, enabling these facilities to offer blue light cystoscopy to their patients due to the availability of mobile equipment. Several of those accounts have reordered Cysview, and we expect mobile tower use to be an important growth driver in 2025.
In Europe, we announced the availability of an Interim Flexible BLC solution to centers in all countries where System blue and Richard Wolf reusable flexible cystoscopes are cleared. The development process for an optimized solution is progressing on plan. We also are collaborating closely with Olympus on their recently launched highdefinition Olympus Visera Elite-III equipment featuring blue light cystoscopy. 30 Olympus systems have already been upgraded since launch, and we fully expect this new state-of-the art equipment to fuel Hexvix growth in the Nordic region and throughout continental Europe this year and beyond.
We believe BLC can play an important role in the fast-evolving bladder cancer market. The identification of patients with bladder cancer and the accuracy of the diagnosis is crucial for patient management and outcome. Consequently, there is a shift towards more precise diagnosis and personalized treatment in bladder cancer. Despite the evolving field of biomarkers and other technologies, the actual diagnosis still requires visualizing malignant lesions in the bladder and removing suspicious tumors during TURBT. This procedure combines diagnosis and tumor resection. At the major urology congresses this year a high volume of clinical data highlighted the important role of blue light cystoscopy in the early and accurate precision diagnosis in bladder cancer. Experts stress the importance of a BLC precision diagnosis, as its accuracy determines grading and staging, leading to better individual treatment decisions.
We remain focused on the growth of our business and investing in opportunities that can take Photocure to the next level in 2025. Supporting our expected growth this year, we expect continued strong growth in European momentum while our U.S. business continues to increase the base of active accounts using BLC. The mobile tower account expansion is anticipated to outweigh remaining declines in flexible BLC usage. New therapeutics entering the market to treat NMIBC are expected to continue raising the awareness of precision bladder cancer management further emphasizing the importance of better detection with BLC and Hexvix/Cysview. Additionally, the launch of Olympus' upgraded BLC equipment in Europe is now underway, and our partnership with Richard Wolf is progressing well with a flexible BLC interim solution available sooner than expected. Lastly, our license agreement with Asieris for Cevira has potential to trigger a significant milestone payment when it receives regulatory approval in China.
Photocure expects very limited tariff impact following a solid stock of units already shipped to the U.S., and no upcoming flagged tariffs to pharmaceutical products into the U.S. market while we monitor the situation closely.
In all, we delivered another quarter of growth and solid business development and reiterates our guidance of a product revenue growth in the range of 7% to 11% and YoY EBITDA improvement in 2025."
Operational review
Photocure ASA (Photocure or the Company) delivers transformative solutions to improve the lives of bladder cancer patients.
Photocure manufactures and commercializes Hexvix/Cysview, its flagship product, for more precise detection and resection of non-muscle invasive bladder cancer (NMIBC), reduction of disease recurrence and progression rates, and improved and cost-effective patient outcomes.
With established specialty commercial and medical teams in North America (U.S. and Canada) and Europe focused exclusively on the uro-oncology segment, Photocure has a solid foundation for the future growth of its breakthrough bladder cancer product, as well as the potential to expand its portfolio of solutions within the same uro-oncology domain.
Photocure continues to strive for ethical business operations, transparency and accountability in line with stakeholder expectations. In May 2021, the Company joined the UN Global Compact and in April 2025, Photocure published its sustainability (ESG) report for the year 2024, which can be accessed on the Company's website.
Commercial segment update
Photocure's first quarter revenue was favorably impacted by wholesaler order timing in Europe, higher average pricing in the U.S., and a positive impact from foreign exchange.
The Company continued to execute on its plan to expand blue light cystoscopy use in Q1 2025 with the installation of 21 new Saphira™ towers in the U.S. – - 8 new accounts and 13 blue light tower upgrades. In Europe, Photocure continued to facilitate image quality upgrades for existing accounts in key markets throughout the region. Across Europe, a total of 30 Olympus Visera Elite III BLC capable systems were installed during Q1 2025.
Revenues from Photocure's North American segment increased 2% in the first quarter of 2025, with unit sales decreased by 6% YoY. The increase in revenue was primarily driven by the favorable impact from foreign exchange of approximately NOK 2.6 million and higher average pricing but was offset by lower unit sales due to the expected further decline in flex kit sales and timing of customer orders of several major accounts.
Karl Storz's phase down of flexible blue light capital equipment resulted in lower flexible BLC kit sales, partly offsetting the positive unit sales development within the rigid segment. Photocure estimates that unit sales in the rigid segment increased 1% during the first quarter of 2025, year over year, while unit sales in the flexible BLC segment declined by 71% over the same period. Excluding flexible kits and adjusted for fluctuation of orders due to price increases in 2024, Q1 rigid kit sales increased in line with prior quarters.
Revenues from the Company's European segment increased 11% in the first quarter of 2025 year over year, with in-market unit sales increasing by 1% compared to the first quarter of 2024. Growth is mainly driven by Germany and Austria. Revenue growth was also driven by rebalancing of inventory levels at wholesalers. Foreign exchange favorably impacted the first quarter of 2025 for the European segment by NOK 1.8 million.
The consolidated YoY currency impact on sales revenue was NOK 4.4 million in the first quarter of 2025
| MNOK | Q1 '25 | Q1 '24 | FY '24 |
|---|---|---|---|
| North America revenues Europe revenues Partner revenues Hexvix/Cysview total YoY growth |
48.6 76.8 0.0 125.3 7% |
47.5 69.3 0.0 116.8 |
202.3 285.6 0.0 487.9 |
| Other revenues Total revenues YoY growth Gross profit Operating expenses |
0.0 125.3 7% 116.2 -109.4 |
0.4 117.1 109.8 -98.1 |
1.9 489.7 460.4 -426.1 |
| EBITDA EBITDA margin |
6.8 5% |
11.7 10% |
34.3 7% |
Total Hexvix/Cysview revenue increased 7% to NOK 125.3 million in the first quarter of 2025, from NOK 116.8 million reported in the same period in 2024. The results were mainly driven by unit growth in North America and Europe, and a NOK 4.4 million favorable impact from foreign exchange.
Other revenues in 2024 included sales to license partners and revenue from Hivec sales associated with the Company's distribution agreement with
Combat Medical in the Nordic region. The distribution agreement with Combat Medical was terminated in Q3 2024.
Operating expenses for the commercial franchise in the first quarter increased 12% YoY to NOK 109.4 million (NOK 98.1 million). The increase in operating expenses of the commercial franchise is primarily driven by the timing of expenses related to congresses and business meetings and expenses related to FTE adjustments. The negative impact of foreign exchange and inflation further contributed to the increase in operating expenses of the commercial franchise.
First quarter 2025 EBITDA for the commercial franchise was NOK 6.8 million, a decrease of NOK 4.9 million from the first quarter of 2024 (NOK 11.7 million).
Hexvix/Cysview
Global in-market unit sales volume in the first quarter of 2025 was level to the same period in 2024.
North America Cysview Segment
Q1 2025 Cysview revenues in North America increased by 2% YoY to NOK 48.6 million (NOK 47.5 million). The increase was driven by NOK 2.6 million benefit from foreign exchange and higher average pricing but was offset by 6% lower in-market unit sales mainly due to the timing of customer orders and an expected further decline in flex kit sales.
Going forward, growth in U.S. unit volume is anticipated to be driven by focused sales resources and further penetration of Cysview in the surgical setting, until new flexible blue light cystoscopy equipment enters the market. Photocure continues to expect the U.S. to be the fastest growing segment of its business over the next several years.
At the end of Q1 2025, the total number of active BLC accounts which ordered at least once in the last 12 months was 337, up 17% since Q1 2024. At the end of the first quarter of 2025, the total installed base of rigid blue light cystoscopes in the U.S. was 411, which includes 18 mobile towers operated by Fortec Medical for on-demand use. The installed base of new BLC equipment in the U.S. increased by 13%, or 47 towers, compared to the same period in 2024.
In early 2023, Karl Storz announced that it would no longer sell flexible BLC equipment for use in the surveillance setting and will cease servicing existing units when the availability of replacement parts has been exhausted. There were 69 flexible cystoscopy towers installed in the U.S. as of December 31, 2022, all of which were manufactured by Karl Storz. Photocure estimates that there were 18 flexible blue light cystoscopes remaining in the U.S. market at the end of Q1 2025.
Despite Karl Storz' decision, flexible BLC in the surveillance setting remains a strategic priority for Photocure. On July 15, 2024, Photocure announced that it had entered into a strategic agreement with Richard Wolf GmbH to develop and commercialize a next-generation 4K LED high-definition (HD) reusable flexible blue light cystoscope based on Richard Wolf's System blue technology. The agreement is focused on developing technologically advanced flexible blue light cystoscopy equipment for the global market so that physicians who treat patients with bladder cancer can offer the benefits of BLC with Hexvix/Cysview in the outpatient, or surveillance setting. On February 17, 2025, Photocure announced the availability of an Interim Flexible BLC solution to centers in all countries where System blue and Richard Wolf reusable flexible cystoscopes are cleared. The interim solution makes the Richard Wolf System blue platform compatible with one of its reusable flexible scopes. Until the new flexible BLC system is developed and approved in major markets, Photocure will focus its commercial efforts on the market for TURBT (Trans-urethral Resection of Bladder Tumor) surgeries using rigid blue light cystoscopes and on establishing BLC as standard-ofcare in this market segment.
European Hexvix Segment
In the first quarter of 2025, revenues in the Company's European segment increased by 11% to NOK 76.7 million (NOK 69.3 million). The increase was driven by in-market unit sales growth of 1% YoY. Revenue growth was also driven by rebalancing inventory levels at wholesalers. Revenues were favorably impacted by a NOK 1.8 million benefit from foreign exchange.
Since Photocure's acquisition of the European territories outside of the Nordic countries in October 2020, the Company has dedicated significant resources and focused on a strategy to re-engage with physicians, key opinion leaders, and capital equipment manufacturers to rebuild or enter major markets in continental Europe. Photocure's European commercial organization is focused on growing its business in established markets such as Germany and other countries in the DACH region. In addition, Photocure focuses on the growing demand for Hexvix
in large, underpenetrated countries such as the U.K., France, and Italy, referred to as the Company's "Priority Growth Markets".
In the fourth quarter of 2024, Olympus received final regulatory approval and launched its high-definition blue light cystoscopy upgrade for its state-of-the-art Viscera Elite III endoscopic visualization platform, which Photocure expects will increase the use of Hexvix in the Nordic markets and elsewhere in Europe. Across Europe, 30 Viscera Elite III towers were installed during Q1 2025.
As of January 1, 2025, Healthcare Reform in Germany went into effect. Photocure continues to see growth in its unit sales to German hospitals through the first quarter of 2025 and the Company will continue to monitor the Healthcare Reform situation in Germany as it evolves.
The Company intends to enter other large unpenetrated European countries such as Spain and Poland in the future as market conditions provide opportunity.
Hexvix/Cysview partner sales
Due to capital budget constraints and reimbursement challenges, partnership revenues in the first quarter of 2025 were limited.
In August 2021, Photocure announced that it regained commercial rights to Cysview in Canada from its licensee BioSyent. On January 3, 2022, Photocure announced that it had launched its own commercial operations in Canada, combining this territory with its U.S. business to form the Company's North American business segment.
In March 2022, the Company announced that it had terminated its distribution agreement with Juno Pharmaceuticals and simultaneously entered into an exclusive distribution agreement with Endotherapeutics Group to commercialize Hexvix in Australia and New Zealand. Endotherapeutics focuses on serving the urology market.
In September 2024, Photocure entered into an agreement with Equity Pharmaceuticals PTY Limited, part of the Clinigen group, to initiate a Named Patient Program (NPP) enabling bladder cancer patients in South Africa to access blue light cystoscopy with Hexvix. Equity Pharmaceuticals will administer the NPP, and shipping of product to South Africa is anticipated to begin in H1 2025.
In January 2021, Photocure entered into a partnership agreement with Asieris, a division of Jiangsu Yahong Meditech Co., Ltd., whereby Asieris obtained exclusive rights to register and commercialize Hexvix in Mainland China and Taiwan. The Company received an upfront payment of USD 750,000 from Asieris for the rights to Hexvix in the designated territories. Additionally, in the fourth quarter of 2024, Photocure also received a USD 1.1 million milestone payment for regulatory approval of Hexvix in China. Photocure will manufacture and supply Hexvix and receive a transfer price from Asieris representing a markup on product provided under the agreement and will also receive royalties on any product sales.
In December 2021, Asieris announced that Hexvix was put into pilot use in the Boao Lecheng International Medical Tourism Pilot Zone in Hainan Province. Additionally, in March 2022, Asieris announced that it had obtained approval from the National Medical Products Administration (NMPA) to conduct a real-world evidence (RWE) study for Hexvix in Hainan, China.
In February 2022, Asieris informed Photocure that it had obtained clinical trial application (CTA) approval from the National Medical Products Administration (NMPA) of China, enabling a Phase III clinical trial with Hexvix to be conducted in the region. In August 2023, Asieris announced that its Phase III Hexvix trial successfully met its primary endpoint. In October 2023 at the 43rd Congress of the Société Internationale d'Urologie (SIU) in Istanbul Turkey, Asieris presented the clinical results of the trial, which demonstrated that BLC with Hexvix outperformed white light cystoscopy in the detection of bladder cancer, particularly in cases of carcinoma in situ (CIS) and exhibited good tolerability.
The prospective, self-controlled, multi-center Phase III bridging trial evaluated the safety and detection benefits of blue light cystoscopy (BLC) with Hexvix compared to white light cystoscopy (WLC) in the diagnosis of non-muscle invasive bladder cancer (NMIBC) in a Chinese population. In the trial, 114 patients underwent BLC, and of the 97 patients diagnosed with NMIBC, a total of 42 patients (43.3%) had one or more additional lesions detected with Hexvix BLC compared to WLC (p<0.0001). Among the 114 patients, 11.4% (13/114) had CIS lesions, and among these, 11 patients (84.6%, 11/13) had additional CIS lesions detected under Hexvix BLC that were not found under WLC. The detection rates for tumor lesion types CIS, Ta, T1, and T2-T4 in the BLC
group were 94.7%, 100%, 98.2%, and 100%, respectively, while in the WLC group, they were 42.1%, 76.1%, 91.2%, and 100%, respectively.
The trial is the first randomized controlled clinical trial conducted with high-definition blue light capital equipment. The highly statistically significant results support previous studies with Hexvix/Cysview, including Photocure's pivotal Phase III trials, which were used for market approval in major international markets. In November 2023, Asieris announced that its new drug application for Hexvix in China was accepted by the NMPA, and the product received Chinese regulatory approval in November 2024. Commercialization is expected to take place after Richard Wolf's System Blue capital equipment receives approval in China. The System Blue capital equipment is currently undergoing regulatory review in China.
Additionally, Photocure has Hexvix marketing and distribution agreements with IGL Medical Ltd. in Israel, and Genotests SpA in Chile.
Publications and presentations in the quarter
During the quarter, new medical data highlighting the important role of blue light cystoscopy in the early and accurate precision diagnosis in bladder cancer was published or presented at 3 major urology congresses in North America and Europe:
On February 17, an abstract presentation at the 2025 American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO-GU), in San Francisco featured upstaging and risk mitigation with Blue Light Cystoscopy in NMIBC. The abstract discussed study results from Photocure's U.S. patient registry on the role of Blue Light Cystoscopy in identifying tumors undetected by WLC leading to necessary upstaging of patient pathology.
On March 14, a new BRAVO study publication reinforced the clinical benefits of BLC in reducing risk of bladder cancer recurrence: "Oncologic Outcomes of Blue Light Cystoscopy in an Equal Access Setting: Results of the BRAVO study", published in JU Open Plus. The research objective was to assess if blue light cystoscopy (BLC®) aided TURBT has an impact on the clinical outcomes of patients with NMIBC. Results of the real-world evidence study show that BLC was associated with a statistically significant 38% reduction in risk of recurrence compared to white light cystoscopy (WLC) use alone in a predominantly high-risk NMIBC patient cohort. These results are in line with prior results from multiple randomized controlled clinical trials. The BRAVO study (Bladder Cancer Recurrence Analysis in Veterans and Outcomes) is a propensity score matched, retrospective analysis evaluating clinical outcomes following BLC compared to WLC alone in patients from the Veterans Affairs Healthcare System. 626 patients were included in this study, 313 in each study arm (WLC versus BLC).
On March 21-24, clinical data presentations at the European Association of Urology (EAU) 2025 congress highlight the benefits of using Blue Light Cystoscopy in bladder cancer: two abstract presentations highlighting the benefits of Blue Light Cystoscopy (BLC®), notably its impact on recurrence risk and ability to help urologists make the best bladder cancer management choices for their patients:
- The impact of PDD on recurrence and progression in BCG-treated NMIBC* patients: a nationwide follow-up study: This nationwide cohort study investigates the association of PDD on recurrence and progression risk in BCGtreated NMIBC patients, using Danish registry data from 2009-2022 assessing patients treated with BCG for primary NMIBC.
- Trans Urethral Laser Ablation of bladder tumors under local anesthesia: A prospective study of pain and recurrences: This study investigated the short- and long-term oncology safety regarding recurrence and progression as well as perioperative pain after office-based Transurethral Laser Ablation (TULA) or fulguration by PDD-assisted flexible cystoscopy.
On April 26-28, 2025, at the American Urological Association Annual (AUA) Congress 2025, that was held post-period in Las Vegas, three abstracts were presented from Photocure's U.S. Blue Light Cystoscopy with Cysview Registry, a large multicenter bladder cancer patient registry of realworld data, established by Photocure in 2014 and projected to enroll 4,400 patients. In addition, the study protocol of a randomized controlled noninferiority trial comparing a multidisciplinary approach including PDD-guided primary TURBT to reduce the patients' burden of second resection
including a total of 327 patients has been presented at AUA 2025:
- Upstaging and Risk Migration with BLC for NMIBC: Results from a prospective multicenter registry
- Predicting Recurrence and Progression in Contemporary Patients with NMIBC Undergoing Blue Light Cystoscopy-Aided Transurethral Resection of Bladder Tumor
- Performance of the EORTC and CUETO Risk Prediction Models in Contemporary Patients Undergoing Transurethral Resection of Bladder Tumor with Blue Light Cystoscopy
- VI-RADS followed by Photodynamic Transurethral Resection of Non-muscle Invasive Bladder Cancer versus White-light Conventional and Second Resection: The CUT-LESS Randomized Trial
Development portfolio
The Company's development portfolio mainly consists of projects related to the development of Hexvix/Cysview and activities related to the agreement with Asieris for Cevira®.
| MNOK | Q1 '25 | Q1 '24 | FY '24 |
|---|---|---|---|
| Sales revenues | - | 0.9 | 1.9 |
| Signing fee & milestones | - - | 33.7 | |
| Total revenues | - | 0.9 | 35.6 |
| Gross profit | - | 0.5 | 34.3 |
| Operating expenses | -4.9 | -4.3 | -19.3 |
| EBITDA | -4.9 | -3.8 | 14.9 |
During the first quarters of 2025 and 2024, no milestones were received. Development revenue in Q1 2024 and full year 2024 includes milestone payments received from Asieris for the regulatory approval of Hexvix, the clinical development of Cevira, and revenue related to the sale of Cevira API to Asieris.
Operating expenses include business development expenses, R&D expenses related to the development of Cevira and Hexvix in China, and an allocation of overhead expenses.
Cevira® : in development for the non-surgical treatment of high-grade squamous intraepithelial lesions, including all HPV sub-types
Cevira is a photodynamic drug-device combination product candidate for the non-surgical treatment of high-grade cervical dysplasia.
In July 2019, the Company announced that it had entered into a License Agreement providing Asieris with a world-wide license to develop and commercialize Cevira (APL-1702) for the treatment of HPV-induced cervical precancerous lesions.
Subsequently, Asieris launched a global clinical development program initially focused on the Chinese market, based on Photocure's Phase IIb data for patients diagnosed with high grade lesions and Phase III study design elements discussed with the U.S. FDA. In late 2020, Asieris initiated patient enrollment in its global, multi-centered Phase III clinical trial for Cevira.
In August 2022, Asieris announced the completion of enrollment in the Phase III trial, accruing a total of 402 patients. The majority of patients in the study were enrolled in China, with the remainder enrolled in Europe. On September 20, 2023, Asieris announced that the Phase III trial met its primary endpoint, together with a robust safety profile. Results showed that the Cevira treatment group had a significantly higher response rate on the primary efficacy endpoint, with a response rate that is 89.4% higher than the placebo group (41.1% vs. 21.7%, p=0.0001). Additionally, Cevira treatment demonstrated a 103.9% improvement in the clearance rate of high-risk HPV16 and/or HPV18 compared to the control group (31.4% vs. 15.4%). These Phase III results were featured in oral presentations at the 2024 European Research Organization on Genital Infection and Neoplasia (EUROGIN) Congress and at the 2024 Society of Gynecologic Oncology (SGO) Annual Meeting.
Asieris is working toward market approval of Cevira in China, after announcing on May 12, 2024, that its NDA for Cevira was accepted by China's National Medical Products Administration (NMPA) for regulatory review. Asieris has also stated that it is actively exploring opportunities for overseas development partnerships for Cevira, and that it intends to submit a pre-submission to the European Medicines Agency and discuss with the U.S. Food and Drug Administration (FDA) the design of a pivotal clinical program for the North American market. In their 2024 annual report Asieris state: "In addition, the company received feedback from a communication meeting with the U.S. Food and Drug Administration (FDA) in December 2024 and reached
agreement with the FDA on the design of another Phase III clinical trial to support the U.S. marketing approval of APL-1702. Currently, the company is actively seeking overseas partners and preparing the application for this U.S. Phase III clinical trial."
Under the License Agreement with Asieris, Photocure has received USD 17.0 million in milestones to date including a signing fee of USD 5.0 million in 2019 and additional development milestone payments. Photocure is eligible for a USD 11.0 million milestone payment for the potential regulatory approval of Cevira in China. In addition, Photocure may also receive milestones of up to USD 31.0 million for regulatory submissions and approvals of Cevira in Europe and the U.S.
Initiation of patient dosing for a third indication of Cevira and approvals for such an indication in China, Europe, and the U.S. would trigger additional aggregate development and regulatory milestone payments of up to USD 16.0 million to Photocure. The Company is also eligible to receive royalties between 10% and 20% of global sales based on the achievement of certain sales thresholds, as well as cumulative milestone payments up to USD 190.0 million associated with global sales, with a significant portion of those milestones being triggered if the product achieves blockbuster status.
Financial review
(Numbers in parentheses are for the corresponding period in 2024; references to the prior year refer to a comparison to the same period 2024, unless otherwise stated).
| MNOK | Q1 '25 | Q1 '24 | FY '24 |
|---|---|---|---|
| Hexvix / Cysview revenues Total other revenues |
125.3 -0.0 |
116.8 1.3 |
487.9 37.5 |
| Total revenues | 125.3 | 118.0 | 525.4 |
| Gross profit | 116.2 | 110.3 | 494.7 |
| Research & Development Sales & Marketing Other Opex |
-1.2 -83.9 -29.3 |
-0.8 -77.6 -24.0 |
-3.6 -337.0 -104.8 |
| Operating expenses | -114.4 | -102.4 | -445.5 |
| EBITDA | 1.8 | 7.9 | 49.2 |
| Depreciation & amortization EBIT |
-7.4 -5.6 |
-7.1 0.7 |
-28.8 20.4 |
| Net financial items | -3.8 | -4.8 | -12.0 |
| Earnings before tax | -9.4 | -4.0 | 8.4 |
| Tax expenses | 7.0 | -3.9 | -13.2 |
| Net earnings | -2.4 | -7.9 | -4.8 |
Revenues
Hexvix/Cysview revenues in the first quarter of 2025 were NOK 125.3 million (NOK 116.8 million), a 7% increase versus Q1 2024. The sales increase is driven by a combination of a unit sales increase in Europe, higher average pricing in North America, and a favorable impact of foreign exchange but was offset by a unit sales decrease in North America due to the impact of customer order timing and the expected decline of flexible kit sales.
In 2024, Total other revenues mainly included milestone payments received from Asieris related to the development of Hexvix and Cevira.
Total revenues in the first quarter of 2025 increased 6% to NOK 125.3 million (NOK 118.0 million). The impact of foreign exchange on total revenues was circa NOK 4.4 million in Q1 2025.
Cost of goods sold (COGS)
First quarter 2025 COGS was NOK 9.1 million (NOK 7.7 million). COGS was 7% of sales revenue, in line with COGS for the full year 2024 (7%).
Operating expenses
Total operating expenses, excluding depreciation and amortization, were NOK 114.4 million (NOK 102.4 million) in the first quarter. The increase in expenses is driven by timing of project expenses, inflation and a negative impact of foreign exchange of circa NOK 3.9 million.
First quarter 2025 research and development (R&D) costs were NOK 1.2 million (NOK 0.8 million). The R&D costs relate mainly to regulatory work and the maintenance and expansion of Photocure's intellectual property.
Sales and marketing costs increased by 8% to NOK 83.9 million (NOK 77.6 million) in the first quarter of 2025. The expense increase was mainly driven by the timing of expenses related to congresses and business meetings and expenses related to FTE adjustments. The increase was further driven by an increase in merit and inflation, and the impact of foreign exchange of circa NOK 3.1 million.
First quarter 2025 other operating expenses, which include supply chain, business development, and general/administration costs, were NOK 29.3 million, compared to NOK 24.0 million in the same quarter of 2024. The increase is mainly driven by business development expenses, and expenses related to FTE
adjustments. The increase was further driven by an increase in merit and inflation, and the impact of foreign exchange of circa NOK 0.8 million. Business development expenses in the first quarter of 2025 amounted to NOK 1.8 million (NOK 0.8 million).
Financial results
EBITDA was NOK 1.8 million (NOK 7.9 million) for the first quarter of 2025. The consolidated positive impact of foreign exchange on EBITDA was circa NOK 0.2 million.
First quarter 2025 depreciation and amortization totaled NOK 7.4 million (NOK 7.1 million). The main cost item was the amortization of intangible assets related to the reacquisition of Hexvix sales, marketing and distribution rights in Europe and other markets previously controlled by Ipsen.
Net financial items in the first quarter of 2025 were NOK 3.8 million (NOK 4.8 million). Net financial costs were driven by foreign exchange losses, as well as accrued interest costs included for the deferred earnout liability due to Ipsen, offset by gains on foreign exchange and incurred interest income.
Net loss before tax was NOK 9.4 million in the first quarter of 2025 (net loss NOK 4.0 million). Net loss after tax was NOK 2.4 million for the first quarter of 2025 (net loss of NOK 7.9 million).
Cash flow and statement of financial position
Net cash flow from operations was NOK 4.1 million in the first quarter of 2025 (NOK 8.4 million). The cash flow from operations in Q1 is mainly driven by a net loss of NOK 9.4 million adjusted for non-cash items of NOK 10.8 million and a decrease in working capital of NOK 2.7 million.
First quarter 2025 net cash flow from investments was NOK 0.7 million (NOK 0.2 million).
First quarter 2025 cash flow from financing was NOK -39.0 million (NOK -9.8 million). First quarter cash flow from financing was mainly driven by the buyback of Photocure shares and the payment of the Ipsen Earn-out.
Net change in cash for the first quarter of 2025 was NOK -34.3 million (NOK -1.2 million). Cash and cash equivalents were NOK 259.5 million at the end of the first quarter 2025.
Long term liabilities were NOK 133.8 million at the end of the first quarter of 2025, including the capitalized value of expected future earn-out payments to Ipsen totaling NOK 113.4 million.
Shareholders' equity was NOK 471.8 million at the end of the first quarter 2025, representing an equity ratio of 67%.
As of March 31, 2025, Photocure held 472,691 of its own shares.
Risks and uncertainty factors
Photocure is exposed to risk and uncertainty factors, which may affect some or all the Company's activities. Photocure has commercial risk, financial risk, market risk, legal and regulatory risk, as well as operational risk related to geopolitical or environmental/climate issues, and risk related to the development of new products.
The Company is exposed to risks associated with market development for Hexvix/Cysview, progress of partnering activities, the availability and operating condition of capital equipment supplied by third-party companies, as well as financial risks related to inflation, interest rates, liquidity and currency fluctuations.
With regards to the U.S. tariff situation, the company expects limited impact in 2025 following a solid stock of units already shipped to the U.S. In addition, at time of writing, there are no upcoming flagged tariffs to pharmaceutical products into the U.S. market. The company continues to monitor the situation closely.
There are no other significant changes in the risks and uncertainty factors compared to the descriptions in the Annual Report for 2024.
Outlook
Photocure delivers transformative solutions that improve the lives of bladder cancer patients. Based on benefits of the Company's breakthrough product for the management of bladder cancer, Hexvix/Cysview, the Company has embarked on a stepwise approach for continued growth. Photocure sees significant long-term potential in the global bladder cancer treatment market and employs the following growth strategy:
- Acceleration Drive the breadth and depth of Hexvix/Cysview usage in key accounts
- Expansion Generate sales in new geographies and via product enhancements
- Acquisition Find and acquire or partner additional products used in the management of bladder cancer patients
- Transformation Acquire assets to strengthen the Company's uro-oncology product portfolio
North America and Europe are Photocure's primary markets for growth, given the Company's two direct sales organizations and a majority of the market still to be penetrated by Hexvix/Cysview with BLC. Photocure regained the sales and marketing rights to Hexvix in continental Europe in the fourth quarter of 2020 and regained the rights to Cysview in Canada in January 2022. As a result, the Company remains positioned to take advantage of the growth opportunities in these regions.
Photocure believes that the benefits of Blue Light Cystoscopy with Hexvix/Cysview offering superior detection and management of bladder cancer will continue to be adopted and become the standard of care. Indicators of continued growth in the Company's business are: (1) increased access to BLC through ongoing expansion of the installed base of rigid BLC towers in North America and increased interest in the mobile tower solution, (2) growing support behind the potential reclassification of BLC capital equipment from Class 3 to Class 2 in the U.S., which, if approved by the FDA, is expected to open the market for multiple manufacturers to offer BLC equipment (3) increasing momentum of BLC in the urology community and new NMIBC treatment options as observed at the European Association of Urology and American Urological Association congresses in 2024, (4) a high number of blue light image quality upgrades in targeted European accounts, and (5) the introduction of an interim flexible BLC solution from Photocure's collaboration with Richard Wolf to address the current unmet need and serve as a bridge to a new optimized highdefinition flexible BLC system for global distribution in the future. The Company plans to continue supporting its commercial efforts with additional clinical publications in scientific journals and data presentations at medical conferences to underscore the clinical benefits and cost-effectiveness of using BLC with Hexvix/Cysview.
Photocure expects product revenue growth in the range of 7% to 11% and YoY EBITDA improvement in 2025. While the Company is not providing a specific EBITDA guidance range, Photocure expects continued operating leverage flow-through in its core commercial business and significant growth in milestones this year.
Photocure – Results for first quarter 2025
6The Board of Directors and CEO Photocure ASA
Oslo, May 7, 2025
Dylan Hallerberg Chairperson
Ghizlane Tagmouti Director
Neal Shore Director
Dan Schneider President and CEO
Photocure Group Accounts for first quarter 2025
Photocure Group – Statement of comprehensive income
| 2025 | 2024 | 2024 | ||
|---|---|---|---|---|
| (all amounts in NOK 1,000 except per share data) | Note | Q1 | Q1 | 1.1 - 31.12 |
| Sales revenues | 125,335 | 118,035 | 491,675 | |
| Signing fees and milestone revenues | 4 | - | - | 33,713 |
| Total revenues | 125,335 | 118,035 | 525,387 | |
| Cost of goods sold | -9,141 | -7,743 | -30,716 | |
| Gross profit | 116,194 | 110,292 | 494,671 | |
| Indirect manufacturing expenses | 3 | -3,947 | -3,885 | -12,078 |
| Research and development expenses | 3 | -1,172 | -783 | -3,631 |
| Marketing and sales expenses | 3 | -89,663 | -82,341 | -355,038 |
| Other operating expenses | 3 | -26,987 | -22,537 | -103,524 |
| Total operating expenses | -121,769 | -109,546 | -474,271 | |
| EBIT | -5,575 | 746 | 20,399 | |
| Restructuring | - | - | - | |
| EBIT including restructuring | -5,575 | 746 | 20,400 | |
| Financial income | 5,198 | 6,523 | 24,892 | |
| Financial expenses | -9,010 | -11,275 | -36,901 | |
| Net financial profit/loss(-) | -3,811 | -4,752 | -12,010 | |
| Profit/loss(-) before tax | -9,386 | -4,006 | 8,390 | |
| Tax expenses | 5 | 6,975 | -3,883 | -11,729 |
| Net profit/loss(-) | -2,411 | -7,889 | -3,340 | |
| Other comprehensive income | -4,976 | 3,009 | 5,239 | |
| Total comprehensive income | -7,388 | -4,880 | 1,899 | |
| Net profit/loss(-) per share, undiluted | 6 | -0.09 | -0.29 | -0.12 |
| Net profit/loss(-) per share, diluted | 6 | -0.09 | -0.29 | -0.12 |
Photocure Group – Statement of financial position
| (Amounts in NOK 1,000) | Note | 3/31/2025 | 3/31/2024 | 12/31/2024 |
|---|---|---|---|---|
| Non-currrent assets | ||||
| Customer relationship | 7 | 91,697 | 108,369 | 95,865 |
| Goodwill | 7 | 144,000 | 144,000 | 144,000 |
| Intangible and fixed assets | 7 | 33,706 | 35,805 | 36,173 |
| Deferred tax asset | 5 | 47,000 | 45,604 | 39,070 |
| Total non-current assets | 316,403 | 333,778 | 315,107 | |
| Current assets | ||||
| Inventories | 38,212 | 33,307 | 39,536 | |
| Accounts receivable | 68,142 | 70,924 | 66,856 | |
| Other receivables | 26,260 | 18,333 | 23,737 | |
| Cash and short term deposits | 9 | 259,539 | 258,268 | 293,852 |
| Total current assets | 392,153 | 380,833 | 423,981 | |
| Total assets | 708,555 | 714,611 | 739,088 | |
| Equity and liabilities | ||||
| Equity | ||||
| Share capital | 10 | 13,560 | 13,560 | 13,560 |
| Other paid-in capital | 479,905 | 464,355 | 477,542 | |
| Retained earnings | -21,618 | 5,181 | 10,614 | |
| Shareholders' equity | 471,847 | 483,096 | 501,716 | |
| Long-term liabilities | ||||
| Earnout liability | 8, 9 | 113,406 | 126,072 | 117,126 |
| Other long-term liabilities | 20,435 | 25,245 | 22,530 | |
| Total long-term liabilities | 133,840 | 151,317 | 139,655 | |
| Accounts payable | 27,005 | 12,989 | 19,443 | |
| Other short-term liabilities | 75,863 | 67,208 | 78,274 | |
| Total liabilities | 236,708 | 231,514 | 237,372 | |
| Total equity and liabilities | 708,555 | 714,611 | 739,088 |
Photocure Group – Changes in equity
| 2025 | 2024 | 2024 | |
|---|---|---|---|
| (Amounts in NOK 1,000) | Q1 | Q1 | 1.1 - 31.12 |
| Equity at end of prior period | 501,716 | 482,848 | 482,848 |
| Capital increase | - | ||
| Share-based compensation (share options employees) | 4,826 | 5,128 | 16,970 |
| Own shares | -27,308 | - | - |
| Comprehensive income | -7,388 | -4,880 | 1,900 |
| Equity at end of period | 471,847 | 483,096 | 501,716 |
Photocure Group – Cash flow statement
| 2025 | 2024 | 2024 | |
|---|---|---|---|
| (Amounts in NOK 1,000) | Q1 | 01 | 1.1 - 31.12 |
| Profit/loss(-) before tax | -9.386 | -4.006 | 8.390 |
| Depreciation and amortisation | 7.395 | 7.119 | 28.798 |
| Share-based compensation | 4.826 | 4.904 | 16.970 |
| Interest income | -3,063 | -2.942 | -12,868 |
| Interest costs | 6,403 | 7,693 | 28,073 |
| Remeasured earnout | |||
| Unrealized currency (- gains) / losses | -1,277 | -437 | -65 |
| Changes in working capital | 2.668 | -6.977 | 2,976 |
| Other operational items | -3.496 | 3.031 | 4,476 |
| Net cash flow from operations | 4,070 | 8,385 | 76,750 |
| Net investments in fixed assets | -1,915 | -272 | -2.459 |
| Investments in intangible assets | -491 | -2.507 | -8,987 |
| Received interest payments | 3.063 | 2.942 | 12.868 |
| Cash flow from investments | 657 | 163 | 1,422 |
| Share capital increase employees | |||
| Paid earnout including interest | -9.474 | -8.666 | -37.135 |
| Payment of lease liability | -2.078 | -928 | -5,945 |
| Long term loan | |||
| Other financial payments and transactions | -27,486 | -187 | -742 |
| Cash flow from financing activities | -39,038 | -9,781 | -43,822 |
| Net change in cash during the period | -34,312 | -1,234 | 34,350 |
| Cash & cash equivalents at beginning of period | 293,851 | 259,502 | 259,504 |
| Cash & cash equivalents at end of period | 259,539 | 258,269 | 293,852 |
Notes to the accounts for first quarter 2025
Note 1 – General accounting principles
General information
Photocure ASA is a public limited company domiciled in Norway. The business of the Company is associated with development, production, distribution, marketing and sales of pharmaceutical products and related technical medical equipment. The Company's shares are listed on the Oslo Stock Exchange (OSE: PHO). The Company's registered office is Hoffsveien 4, NO-0275 Oslo, Norway.
Photocure Group (Photocure) comprises Photocure ASA and four wholly owned subsidiaries; Photocure Inc. registered in U.S, Photocure GmbH registered in Germany, Photocure SAS registered in France and Photocure Canada Inc. registered in Canada.
Basis of preparation
These condensed interim financial statements have been prepared in accordance with IAS 34 Interim Financial Reporting. These interim financial statements should be read in conjunction with the consolidated financial statements for the year ended December 31, 2024 (the Annual Financial Statements) as they provide an update of previously reported information.
The interim report has not been subject to an audit. The Board of Directors approved the interim financial statements on May 7, 2025.
Photocure performs the sales and distribution of Hexvix in the European markets. Photocure has established wholly owned subsidiaries in Germany (Photocure GmbH) and France (Photocure SAS) that provide marketing and promotion services. These entities have Euro (EUR) as functional currency. The sales, marketing and distribution in the U.S. and Canada are performed through Photocure's wholly owned subsidiary Photocure Inc. and Photocure Canada Inc., in both countries under the trade name Cysview. Photocure Inc. has U.S. dollars (USD) as functional currency while Photocure Canada Inc. has Canadian dollars (CAD) as functional currency.
Photocure ASA uses Norwegian kroner (NOK) as its functional currency and presentation currency. In the absence of any statement to the contrary, all financial information is reported in whole thousands. As a result of rounding adjustments, the figures in the financial statements may not add up to the totals.
Important accounting valuations, estimates and assumptions
IFRS 3
Photocure has in 2020 acquired back the Hexvix sales, marketing and distribution rights in Europe and other markets previously controlled by Ipsen Pharma SAS. The residual value in the acquisition constituted goodwill and is tested at end of 2024 for impairment. The deferred consideration was measured at fair value at the date of acquisition and is remeasured at fair value as of December 31, 2024. The changes in air value are recognized in profit or loss as financial income or expense.
Preparation of the accounts in accordance with IFRS requires the use of judgment, estimates and assumptions that have consequences for recognition in the balance sheet of assets and liabilities, the estimation of contingent liabilities and recorded revenues and expenses. The use of estimates and assumptions is based on the best discretionary judgement of the Group management.
Note 2 - Photocure Group – Segment information
Photocure reports two segments: Commercial Franchise and Development Portfolio. Commercial Franchise includes Hexvix/Cysview by geography (North America and Europe) and other sales (partners and other products including sales revenues for Hivec). Development Portfolio includes development of pipeline products.
| Q1 2025 | ||||||
|---|---|---|---|---|---|---|
| Hexvix | Cysview | Other | Total | Total | Grand | |
| (Amounts in NOK 1 000) | Europe | North Am | Sales | Sales | R&D | Total |
| Sales revenues | 76,751 | 48,584 | - | 125,335 | - | 125,335 |
| Milestone revenues | - | - | - | - | - | - |
| Cost of goods sold | -6,930 | -2,211 | - | -9,141 | - | -9,141 |
| Gross profit | 69,821 | 46,373 | - | 116,194 | - | 116,194 |
| Gross profit of sales % | 91% | 95% | 93% | 93% | ||
| R&D | -712 | -189 | -19 | -920 | -252 | -1,172 |
| Sales & marketing | -36,100 | -44,905 | -1,098 | -82,103 | -1,759 | -83,862 |
| Other & allocations | -14,055 | -11,869 | -500 | -26,424 | -2,915 | -29,339 |
| Operating expenses | -50,867 | -56,963 | -1,617 | -109,447 | -4,926 | -114,373 |
| EBITDA | 18,954 | -10,590 | -1,617 | 6,747 | -4,926 | 1,821 |
| Q1 2024 | ||||||
|---|---|---|---|---|---|---|
| Hexvix | Cysview | Other | Total | Total | Grand | |
| (Amounts in NOK 1 000) | Europe | North Am | Sales | Sales | R&D | Total |
| Sales revenues | 69,289 | 47,464 | 355 | 117,107 | 927 | 118,034 |
| Milestone revenues | - | - | - | - | - | - |
| Cost of goods sold | -5,886 | -1,358 | -56 | -7,300 | -443 | -7,743 |
| Gross profit | 63,402 | 46,106 | 298 | 109,807 | 484 | 110,291 |
| Gross profit of sales % | 92% | 97% | 84% | 94% | 52% | 93% |
| R&D | -313 | -86 | -12 | -411 | -372 | -783 |
| Sales & marketing | -31,991 | -41,708 | -1,256 | -74,955 | -2,107 | -77,062 |
| Other & allocations | -12,099 | -9,432 | -1,238 | -22,769 | -1,812 | -24,581 |
| Operating expenses | -44,403 | -51,226 | -2,507 | -98,135 | -4,292 | -102,427 |
| EBITDA | 19,000 | -5,119 | -2,209 | 11,672 | -3,808 | 7,864 |
1.1-31.12 2024 Hexvix Cysview Other Total Total Grand (Amounts in NOK 1 000) Europe North Am Sales Sales R&D Total Sales revenues 285,561 202,322 1,865 489,749 1,926 491,675 Milestone revenues - - - - 33,713 33,713 Cost of goods sold -23,236 -5,889 -225 -29,349 -1,367 -30,716 Gross profit 262,326 196,434 1,641 460,400 34,271 494,671 Gross profit of sales % 92% 97% 88% 94% 29% 94% R&D -2,724 -753 -108 -3,584 -47 -3,631 Sales & marketing -144,679 -178,339 -4,155 -327,173 -6,638 -333,810 Other & allocations -50,864 -38,458 -6,066 -95,388 -12,648 -108,036 Operating expenses -198,267 -217,550 -10,329 -426,145 -19,333 -445,478 EBITDA 64,059 -21,116 -8,688 34,255 14,939 49,193
Note 3 – Income statement classified by nature
| 2025 | 2024 | 2024 | |
|---|---|---|---|
| (Amounts in NOK 1 000) | 1.1 - 31.03 | 1.1 - 31.03 | 1.1 - 31.12 |
| Sales revenues | 125,335 | 118,034 | 491,675 |
| Signing fees and milestone revenues | - | - | 33,713 |
| Cost of goods sold | -9,141 | -7,743 | -30,716 |
| Gross profit | 116,194 | 110,291 | 494,671 |
| Payroll expenses | -74,344 | -69,944 | -285,700 |
| R&D costs excl. payroll expenses/other operating exp. | -230 | -372 | -47 |
| Ordinary depreciation and amortisation | -7,395 | -7,119 | -28,793 |
| Other operating expenses | -39,800 | -32,111 | -159,732 |
| Total operating expenses | -121,769 | -109,546 | -474,272 |
| EBIT | -5,575 | 746 | 20,399 |
Note 4 – Milestone Payments
Photocure has not received any milestone payments in the first quarter 2025. During the full year of 2024, Photocure received milestone payments from Asieris Pharmaceuticals related to the ongoing clinical development of Cevira of USD 2 million (NOK 21.6 million) and a milestone payment from Asieris related to the approval of Hexvix in China of USD 1.1 million (NOK 12.1 million).
Note 5 – Tax
| (Amounts in NOK 1 000) | 3/31/2025 | 3/31/2024 |
|---|---|---|
| Income tax expense | ||
| Tax payable | -955 | -1,323 |
| Changes in deferred tax | 7,930 | -10,406 |
| Total income tax expense(-)/income | 6,975 | -11,729 |
| Tax base calculation | ||
| Profit before income tax | -9,376 | 8,390 |
| Permanent differences | 3,885 | 12,008 |
| Temporary differences | 39,464 | -56,312 |
| Change in tax loss carried forward | -33,977 | 35,914 |
| Tax base | -4 | - |
| Temporary differences: | ||
| Total | -158,157 | -197,622 |
| Tax loss carried forward | 371,591 | 375,211 |
| Net temporary differences | 213,434 | 177,589 |
| Deferred tax benefit | 213,434 | 177,589 |
| Deferred tax asset | 47,000 | 39,070 |
Temporary differences are recognized for the parent company only and the note disclosure for the Group is of this reason identic to the disclosure for parent company.
The calculation of deferred tax asset March 31, 2025 and March 31, 2024 is based on a tax rate of 22%. The deferred tax asset is increased to NOK 47.0 million due to the loss and the movements in tax loss in the period. The deferred tax asset was NOK 39.1 million as of December 31, 2024. There is no expiry on losses to be carried forward in Norway. The basis for recognition of a tax asset in Norway are the expected future profits according to the business plan for all major markets and the assumption that temporary differences for the coming years will be reversed.
For further information refer to the consolidated financial statements for the year ended 31 December 2024 Note 11.
Note 6 – Earnings per share
Earnings per share are calculated based on the profit/loss for the year after tax but excluding other comprehensive items. The result is divided by a weighted average number of outstanding shares over the year, reduced by acquired treasury shares. The diluted earnings per share is calculated by adjusting the average number of outstanding shares by the number of employee options that can be exercised. Antidilution effects are not taken into consideration.
| 2024 | 2024 | 2024 | |
|---|---|---|---|
| (Figures indicate the number of shares) | 1.1 - 31.03 | 1.1 - 31.03 | 1.1 - 31.12 |
| Issued ordinary shares 1 January | 27,120,820 | 27,120,820 | 27,120,820 |
| Effects of share options excercised | - | - | - |
| Effect of treasury shares | -472,691 | -15,122 | -15,122 |
| Effect of shares issued | - | - | - |
| Weighted average number of shares | 26,826,706 | 27,105,698 | 27,105,698 |
| Effect of outstanding share options | - | 7,289 | 169 |
| Weighted average number of diluted shares | 26,826,706 | 27,105,698 | 27,105,867 |
| Earnings per share in NOK | -0.09 | -0.29 | -0.12 |
| Earnings per share in NOK diluted | -0.09 | -0.29 | -0.12 |
Note 7 – Intangible and Fixed Assets
| Customer | Registry | Other | Total fixed | ||||
|---|---|---|---|---|---|---|---|
| (Amounts in NOK 1 000) | Goodwill | relations | Right of use | Equipment Intangibles Intangibles | assets | ||
| Net book value 31.12.2024 | 144,000 | 95,865 | 16,273 | 4,532 | 13,298 | 2,070 | 36,173 |
| Net investments and revaluation 2025 | - | - | -564 | -30 | -400 | 1,753 | 759 |
| Termination leasing | - | ||||||
| Depreciation and amortization | - | -4,168 | -1,502 | -388 | -1,071 | -265 | -3,226 |
| Net book value 31.3.2025 | 144,000 | 91,697 | 14,207 | 4,114 | 11,827 | 3,558 | 33,706 |
Goodwill amounts to NOK 144 million and relate to the Hexvix sales, marketing and distribution rights in Europe previously controlled by Ipsen Pharma SAS (Ipsen) that were acquired by Photocure on October 1, 2020. The goodwill is not depreciated but was tested against impairment as of end December 2024. The impairment analysis carried out confirmed the goodwill value given the performance in 2024 and future growth opportunities that are expected to exceed forecasts prepared in connection with the transaction.
The customer relationships relate to existing customers in Europe which have previously been served by Ipsen. Customer relationships has been valued using a multiperiod excess earnings method and the value 1 October 2020 was NOK 166.7 million. Photocure has evaluated this asset to have an estimated value for 10 years and the intangible assets is depreciated on a straight-line basis over this period.
The right of use assets include the office rental agreements for Norway, US and Germany. In addition, a company car fleet related to the sales organization in Germany is included. The related lease liability is measured at the present value of the lease payments that are not paid at the commencement, discounted using the Groups incremental borrowing rate as the discount rate. The lease liabilities as of December 31, 2024, are NOK 14.7 million compared to NOK 16.8 million as of March 31, 2025 and the interest expense is NOK 0.178 million.
Photocure has the ownership of valuable patient registries with the treatment of blue-light diagnosis of bladder cancer. Photocure has decided to capitalize the registry costs from start of 2023, and as of March 31, 2025 it is capitalized NOK 16.7 million for amortization of a limited time period.
Note 8 – Earnout
Ipsen receives a deferred payment of 15% of net sales (years 1-7 post-transfer) and 7.5% of net sales (years 8- 10) in the former Ipsen major markets. The payments are made quarterly in Euro after the close of the quarter. The fair value of the remaining payments is classified as long term Earnout liability. Photocure has as of end March 2025 paid NOK 9.5 million including interest, compared to NOK 8.7 million as of March 2024. In 2025 the liability has been reduced by NOK 3.7 million based on the sales in the former Ipsen markets and the total liability is NOK 113 million as of March 31, 2025.
The fair value of the Earnout liability is driven by future expected sales and is remeasured on a yearly basis. There was no need for remeasurement as of December 31, 2024. To arrive at the remeasured fair value, Photocure has discounted the estimated earnout payments by an IRR equal to the IRR applied at license acquisition adjusted for later changes in the interest levels. This IRR has been deemed appropriate as a discount rate for the earnout payments since the level of the payments will be subject to the same risk factors as the cash flow prognosis for the acquisition.
Note 9 – Fair value financial assets
The table below details financial assets recognized in the balance sheet at fair value according to the valuation method. The different levels have been defined as follows:
Level 1: Noted prices in active markets for corresponding assets or liabilities
- Level 2: Available value measurements other than the noted prices classified as Level 1, either directly observable in the form of agreed prices or indirectly as derived from the price of equivalent
- Level 3: Value measurements of assets or liabilities that are not based on observed market values
| Market value hierarchy | ||||
|---|---|---|---|---|
| (Amounts in NOK 1 000) | Level 1 | Level 2 | Level 3 | Total |
| - Money market funds | 203,070 | - | - | 203,070 |
| - Earnout liability | -113,405 | -113,405 | ||
| Total | 203,070 | - | -113,405 |
Note 10 – Share capital
Registered share capital in Photocure ASA amounts to:
| No. of shares | Nominal value per share |
Share capital in NOK |
|
|---|---|---|---|
| Share capital at 31 December 2024 Share capital at 31 March 2025 |
27,120,820 27,120,820 |
NOK 0.50 NOK 0.50 |
13,560,410 13,560,410 |
| Treasury shares: | |||
| Holdings of treasury shares at 31 December 2023 | 15,122 | NOK 0.50 | 7,561 |
| Sale/Buy-back of shares | 458,543 | NOK 0.50 | 229,272 |
| Sale(-)/Buy-back of restricted shares | -974 | NOK 0.50 | -487 |
| Holdings of treasury shares at 31 December 2024 | 472,691 | 236,346 |
The table below indicates the status of authorizations as of March 31, 2025:
| (Figures indicate the number of shares) | Purchase, treasury shares |
|---|---|
| Authorisation issued at the General Meeting on 23 May 2024 Purchase of treasury shares after 23 May 2024 |
2,712,082 -458,543 |
| Remaining under authorisations at 31 March 2025 | 2,253,539 |
Shares owned, directly or indirectly, by members of the board, the President and CEO and senior management and their closely related associates as of March 31, 2025:
| Name | Position | No. of shares |
No. of subscription rights |
|---|---|---|---|
| Daniel Schneider | President & CEO | 99,689 | 457,500 |
| Erik Dahl | Chief Financial Officer | 32,750 | 278,750 |
| Geoffrey Coy | VP & General Manager North America | 15,207 | 221,250 |
| Anders Neijber | Chief Medical Officer | - | 164,000 |
| Anja Gossens-von der Heidt | Head of Global Human Resources | - | 66,750 |
| Jane Healy | VP & General Manager EMEA | - | 100,000 |
| Neal Shore | Board member | - | 9,097 |
| Ghizlane Tagmouti | Board member | 25,000 | 5,124 |
| Dylan Hallerberg | Chairperson of the board | 150,000 | 15,277 |
Note 12 – Share options
On March 31, 2025, employees in Photocure participated in the following share option schemes:
| Year of allocation | 2024 | 2024 | 2023 | 2022 | 2021 | 2020 |
|---|---|---|---|---|---|---|
| Option program | 2024 | 2023 | 2023 | 2022 | 2021 | 2020 |
| Number | 748,727 | 150,000 | 1,221,667 | 804 | 30,500 | 238,750 |
| Exercise price (NOK) | 59.57-69.36 | 61.92 | 57.14-61.03 | 115.70 87.39-139.41 | 78.65-81.41 | |
| Year of expiry | 2031 | 2029 | 2028 | 2027 | 2026 | 2025 |
The number of employee options, including conditional grants, and average exercise prices for Photocure, and development during the year:
| 3/31/2025 | 12/31/2024 | |||
|---|---|---|---|---|
| No. of shares | Average exercise price (NOK) |
No. of shares | Average exercise price (NOK) |
|
| Outstanding at start of year | 2,310,448 | 63.05 | 2,076,178 | 80.55 |
| Allocated during the year | 100,000 | 59.57 | 1,073,482 | 60.40 |
| Cancelled during the year | - | - | 509,900 | 127.39 |
| Become invalid during the year | 20,000 | 60.11 | 260,312 | 67.82 |
| Exercised during the year | - | - | - | - |
| Expired during the year | - | - | 69,000 | 54.70 |
| Outstanding at end of period | 2,390,448 | 62.93 | 2,310,448 | 63.05 |
| Exercisable options at end of period | 581,819 | 71.09 | 585,569 | 71.02 |
Note 13 – Shareholders
Overview of the major shareholders as of March 31, 2025:
| Name | Citizenship | Type of accountHolding | |||
|---|---|---|---|---|---|
| Morgan Stanley & Co. LLC | United States | Nominee | 5,469,775 | Stake 20.17% |
|
| Skandinaviska Enskilda Banken AB | Sweden | Nominee | 2,000,000 | 7.37% | |
| Skandinaviska Enskilda Banken AB | Ireland | Nominee | 938,100 | 3.46% | |
| Skandinaviska Enskilda Banken AB | Sweden | Nominee | 826,644 | 3.05% | |
| Nordnet Bank AB | Sweden | Nominee | 653,515 | 2.41% | |
| MP PENSJON PK | Norway | Ordinary | 618,418 | 2.28% | |
| The Bank of New York Mellon SA/NV | United Kingdom | Nominee | 547,730 | 2.02% | |
| J.P. Morgan SE | Sweden | Nominee | 527,328 | 1.94% | |
| PHOTOCURE ASA | Norway | Ordinary | 472,691 | 1.74% | |
| JPMorgan Chase Bank, N.A., London | United Kingdom | Nominee | 451,692 | 1.67% | |
| NORDNET LIVSFORSIKRING AS | Norway | Ordinary | 405,624 | 1.50% | |
| J.P. Morgan SE | Luxembourg | Nominee | 400,000 | 1.47% | |
| BNP Paribas | Luxembourg | Nominee | 287,500 | 1.06% | |
| VERDIPAPIRFONDET KLP AKSJENORGE IN | Norway | Ordinary | 279,890 | 1.03% | |
| Danske Bank A/S | Denmark | Nominee | 258,433 | 0.95% | |
| VOHRA | Norway | Ordinary | 217,148 | 0.80% | |
| Avanza Bank AB | Sweden | Broker | 211,254 | 0.78% | |
| BILLINGTON | Norway | Ordinary | 202,853 | 0.75% | |
| Skandinaviska Enskilda Banken AB | Luxembourg | Nominee | 202,775 | 0.75% | |
| VERDIPAPIRFONDET KLP AKSJENORGE | Norway | Ordinary | 195,630 | 0.72% | |
| Total 20 largest shareholders | 15,167,000 | 55.92% | |||
| Total Other shareholders | 11,953,820 | 44.08% | |||
| Total number of shares | 27,120,820 |
Photocure Group – Alternative Performance Measures
(Information provided based on Guidelines on Alternative Performance Measures (APMs) for listed issuers by The European Securities and Markets Authority - ESMA)
Photocure reports certain performance measures that are not defined under IFRS, but which represent additional measures used by the Board and management in assessing performance as well as for reporting both internally and to shareholders. Photocure believes that the presentation of these non-IFRS performance measures provides useful information which provides readers with a more meaningful understanding of the underlying financial and operating performance of the Company when viewed in conjunction with the IFRS financial information.
Photocure uses the following alternative performance measures.
EBITDA & EBIT
Photocure regards EBITDA as the best approximation to pre-tax operating cash flow and reflects cash generation before working capital changes and capex. EBITDA is widely used by investors when evaluating and comparing businesses and provides an analysis of the operating results excluding depreciation and amortization. The noncash elements depreciation and amortization may vary significantly between companies depending on the value and type of assets.
The definition of EBITDA is "Earnings Before Interest, Tax, Depreciation and Amortization."
The reconciliation to the IFRS accounts is as follows:
| 2025 | 2024 | 2024 | |
|---|---|---|---|
| (All amounts in NOK 1 000) | Q1 | Q1 | Full Year |
| Gross profit | 116,194 | 110,292 | 494,671 |
| Operating expenses excl depreciation & amortization | -114,373 | -102,427 | -445,478 |
| EBITDA | 1,821 | 7,865 | 49,193 |
| Depreciation & amortization | -7,395 | -7,119 | -28,793 |
| EBIT | -5,575 | 746 | 20,400 |
Revenue growth in constant currency
Photocure's business is conducted internationally and in respective local currency. Less than 5% of the revenue is conducted in Norwegian kroner, Photocure's functional currency. Fluctuations in foreign exchange rates may have a significant impact on reported revenue in Norwegian kroner. To eliminate the translational effect of foreign exchange and to better understand the revenue development in the various regions, Photocure provides calculated revenue growth information by region and in total for the Company. The average exchange rates used to translate revenues as per the reporting dates were as follows:
| 2025 | 2024 | 2024 | |
|---|---|---|---|
| Q1 | Q1 | Full Year | |
| USD (NOK per 1 USD) | 10.69 | 10.59 | 11.20 |
| EUR (NOK per 1 EUR) | 11.55 | 11.51 | 11.74 |
PHOTOCURE ASA
Hoffsveien 4 0275 Oslo, Norway +47 22 06 22 10 [email protected]
PHOTOCURE INC.
202 Carnegie Center, suite 101 Princeton, NJ 08540, USA +1 609 759 6500 [email protected]
PHOTOCURE GMBH
Breite Str. 27 40213 Düsseldorf, Germany [email protected]
