Photocure ASA

All right. Well, good morning. Good afternoon. This is Dan Schneider, CEO and president of PhotoCure. Welcome to PhotoCure ASA's third quarter 2026 results. With me today is Priyam Shah, our vice president of IR, and Dick Peters, our vice president of finance and IT. But also joining us today is a new member of our team, our new CFO, Dennis Camparelli. Dennis, maybe you'd like to say a few words. I know you won't be in so much speaking mode today, but at least introduce.

Sure, Dan. Thanks. So as Dan mentioned, I joined the team on Monday after 25 years in the healthcare investment banking and corporate finance world. Most recently, I led the life science tools and diagnostics practice at Canaccord Genuity. I've spent this week learning from Dick and the team, and I look forward to meeting many of you guys over the coming months. All right, great.

Welcome. Day three. All right, we'll get into the next slide. Disclaimers are in place for today's presentation. Next slide. So PhotoCure's strategy is built around the three priorities, and we continue to strengthen. It's strengthening the core by accelerating HEXFIX and SysView through expanded BLC installations, upgrades, mobile adoption, and market penetration. All of these are key accelerators to the current business. We also want to lead the standard, drive broader BLC adoption and non-muscle invasive bladder cancer detection, surveillance, and treatment monitoring through next generation systems, expanded market access, and flexible blue light cystoscopy. And the third, expanding on the platform. With a broader uro-oncology and precision diagnostic platform through biomarkers, AI, Strategic Partnerships, and Targeted M&A, building on initiatives such as the acquisition of Vesca Health and the AI collaboration with Claritas and Arterra. Together, these priorities drive near-term growth, expand our market opportunity, and strengthen our long-term value creation. Q3 highlights. Product growth. Overall, we had 7% product revenue growth, XFX. In North America, we delivered 9% product revenue growth, XFX, and a 9% unit growth in a rigid unit where rigid unit growth was 10%. The installed base of Sapphira upgraded blue light equipment continued to increase with nine new tower placements and four tower upgrades in the U.S. ForTech, the mobile solution, continues favorable impact on growth with 31 net hours up from 24 now in their national fleet of rentals, underscoring the growing demand for blue light cystoscopy across hospitals without capital budgets. And the number of active accounts increased 20% year over year to 454, setting the stage for continued momentum into the future. In Europe, European product revenue was up 6%, units up 8%. We continue to execute in EU with growth across all our key markets, driven by continued execution focus and tower upgrades. The Olympus Viscera III BLC equipment upgrades continue to gain momentum with now 87 Viscera installs in the field, and Stryker blue light enabled equipment has also commercially launched in EU as of Q2. Upgrades through the world have proven to increase the usage of BLC with HexFix and SysView. Encouraging accounts to upgrade remains a number one priority for PhotoCare. Adjusted EBITDA for the quarter was 14.2 million NOC, while reported EBITDA was 4 million NOC. The adjusted EBITDA margin in Q3 was 11%, while year-to-date 2026 adjusted EBITDA is 14% and comparable to last year. We continue forecasting improved operating leverage for 2026 while investing in key growth initiatives across the business. We had approximately $9.4 million knock in business development expenses in Q3 on various strategic initiatives and related expenses that bode well for our future. At the end of Q2, we had $162.4 million knock in cash and continue to have no interest-bearing debt on the books. Some key highlights from Q3. Dennis introduced himself. We're super excited to have Dennis join the team. He brings over 20 years of investment banking experience, med tech, diagnostics, and broader life sciences. He brings a valuable combination of industry insights, particularly in the space we're in, the financial expertise, and a strategic perspective to the company, which will be incredibly valuable as we continue to advance our growth strategy and broaden our reach to unlock the full potential. of our emerging portfolio. We also had the Vesca Health acquisition. Following the acquisition of Vesca Health and Q2, we continue to integrate AssureMDX into our portfolio as we prepare for commercialization. As a reminder, Vesca's acquisition included a $2.75 million equity milestone for the achievement of the ADLT or Advanced Diagnostic Laboratory Test designation by October 1st. or the amount rolls into a CMS reimbursement milestone as we are now prioritizing the Novitas LCD local coverage determination Pathway to Medicare Coverage for AssureMDX, the ADLT milestone no longer applies. Our focus remains on advancing our coverage and achieving Medicare reimbursement in line with the acquisition agreement. So said another way, that milestone that was tied to ADLT now becomes part of and added to the CMS milestone. FDA reclassification. On August 14th, the FDA published a proposed order in the Federal Register to initiate the process of reclassifying cystoscopy systems intended as an aid for the detection of bladder cancer from class three to class two. The FDA is initiating the proposed reclassification on its own initiatives following the review of available scientific, clinical, and post-market evidence. The FDA has stated that there is sufficient information to establish special controls that, together with general controls, will provide reasonable assurance of safety and effectiveness in these devices. The FDA closed the public comment period last week and will now begin their discernment. Reminder that there is no statutory required timeline, but given the level of interest and response, we remain optimistic on timing. The unlock has the potential to have a dramatic impact on the U.S. core business, opening up 65% of the market, which has otherwise been very difficult for us to access due to Carl Storrs not having access to those hospitals. In Savira news, Osiris entered into an exclusive licensing agreement with Theramex for Savira, subject to certain conditions. advancing the global development and commercialization of this first-in-class nonsurgical treatment for cervical precancerous lesions in Europe. The agreement is to cover all countries in Europe, as well as Australia, New Zealand, and Turkey. PhotoCure's economics continue to remain only based on the milestones and royalties as per the original agreement with Aceris, and we are not impacted by this new multi-party relationship. The first royalty payments were received this quarter related to the sales of Survivor in China and following the start of commercialization in late Q2 2026. In other publications and events, we had real-world economics and advancing the predictive models using blue light cystoscopy, so continuing to build the scientific and economic data around the use of blue light cystoscopy. Moving on to segment trends. There's been strong unit sales in both regions. Both North America and Europe delivered continued growth. In North America, product revenue increased 9%, XFX, with in-market unit sales increasing 9%, rigid growing at 10%. 13 new survivor towers were installed, nine new, four upgrades, adding to the active BLC account growth of roughly 20% year over year. Daniel Schneider, Anja Gossens-von der Heidt, Anders Neijber, Jane Healy, Priyam Shah, Tolv Hillestad, Dick Peters In Europe, product revenues increased 6% XFX and in-market unit sales increased 8%, driven primarily by 11% growth in the dock countries and 8% growth in the priority growth markets of France, UK, and Italy. There are now 87 Olympus Viscera III installs since launch and 29 upgrades of other equipment since year began. We continue to monitor the situation around the generic Hexfix from third parties as part of our normal competitive surveillance. We are aware of a filing in Europe, but at this stage, there's been no regulatory approval or commercial launch of the generic. And the timing and likelihood of any potential market entry remains uncertain. We do not have any information to assess impact on our business at the time, and we will continue to monitor it. Active accounts, particularly in the U.S., 20% growth in active accounts in the U.S., which are accounts that have ordered in the last 12 months. Over the past eight quarters, we have consistently seen strong year-over-year growth in accounts as ongoing trend fueled by Fortec and increased interest in importance of BLC. The Fortech program continues to exceed our expectations. Reactivated accounts with BLC upgrades along with new accounts remains an important initiative as upgrades provide double-digit uplift in sales. We continue to see momentum in the overall interest in adoption of BLC with SISU in the U.S., and I'll also comment that the Fortech mobile solution also is a good bellwether to the anticipation of additional OEMs in the U.S. market and the extreme interest in using BLC equipment for blue light cystoscopy using SysFu and HexFix. Moving on to growth initiatives. You've seen the slide before, but we can put a check mark on the FDA reclassification OEM expansion. The U.S. offers a significant growth opportunity with three key levers, that can materially expand our serviceable market. First, the FDA reclassification and additional OEM participation can unlock more of the rigid BLC market. The FDA has initiated the reclassification process as of August 2026, and as of last week, they have now closed the public comment period and will begin their discernment. Second, flexible BLC reentry into surveillance opens up a much larger reoccurring use opportunity. We expect to have the Richard Wolff Global Flexible Solution to be launch ready by the end of 2027. And third, improved reimbursement can reduce economic barriers and friction and accelerate the adoption, which we continue to work on with CMS. These opportunities build on a substantial underlying market, and approximately 85,000 new bladder cancer patients annually in the US, with more than 400 Daniel Schneider, Anja Gossens-von der Heidt, Another opportunity in expanding our presence in precision diagnostics. Historically, PhotoCure has operated primarily at the confirmed diagnosis and treatment stage, which is the green box on the right of the slide you see. Majority of HexFix and CystV today is used with rigid scopes in the OR setting and will be used in a clinical setting for regular bladder cancer surveillance using BLC Flex, which we're now co-developing with Richard Wolff and expect to be commercially ready by the end of 2027. With AssureMDX, the blue box to the left, which we acquired from Beska Health in a transaction back in June, we now move upstream. into the first point of clinical suspicion when patients present with signs or symptoms, primarily hematuria, that require further workup to confirm the diagnosis. Being upstream expands our relevance throughout the patient journey, from initial hematuria evaluation all the way through resection, surveillance, and treatment with our developmental partnerships with Cloridus and Arteria for AI enablement, and then the surveillance through the Richard Wolff co-developed flexible scope. We believe this creates a more integrated bladder cancer platform and strengthens our long-term competitive positioning in bladder cancer care and precision diagnostics. And updating on AssureMDx, we're in the preparation for commercialization. Up until now, we have primarily focused on explaining the AssureMDx clinical opportunity and the strategic rationale for bringing Vesca and PhotoCare together. ASURE MDX represents an opportunity for PhotoCure to extend its reach beyond cystoscopy into bladder cancer diagnostics pathway, addressing the need for better risk stratification and more informed clinical decision-making. Since closing the acquisition, our focus has moved very quickly from transaction and integration to now commercialization and execution. We're now focused on the commercial opportunity across Market access is progressing with the PLLA coding effective and the draft Novitas LCD supporting potential CMS coverage by mid-2027, while parallel pricing review is underway. We're also establishing the laboratory infrastructure, preparing our existing commercial team, and building the clinical and health economic evidence needed to support adoption. The key is to align reimbursement, operational capacity and readiness, and commercial execution so we can scale efficiently as Medicare coverage advances. This creates a pathway to bring AssureMDx to more patients while leveraging PhotoCure's existing relationships and expertise in bladder cancer. There's a significant breadth of activity underway. While many of our immediate milestones are in the U.S., particularly around Medicare reimbursements, this is very much a global strategy. Our product development work is being designed with potential U.S., European, and U.K. regulatory pathways in mind, and our clinical evidence generation already extends across both U.S. and Europe. and looking at one of our ongoing studies, ENABLE. The Cloridus PhotoCure co-sponsored AI cystoscopy study called ENABLE is an important investment in PhotoCure's future. Building the clinical evidence and imaging data set that can help enable the next generation of AI assisted blue light cystoscopy. We reached a significant milestone with our 100th patient now enrolled. Site activation is progressing across North America with 15 of the 16 sites expected to be activated by the end of October, supporting continued enrollment and excitement and momentum. Beyond the enrollment milestone, the strategic value is in the data we are building. By combining BLC imaging and clinical outcomes, Enable aims to create a foundation for AI-enabled tools that can enhance the utility of blue light cystoscopy, support clinical decision-making, and further differentiate PhotoCure's technology over time. This is about more than completing a study. It's about building an evidence base that can help shape the future of AI-assisted bladder cancer detection and strengthen PhotoCure's long-term competitive position and continued momentum. And with that, I'd like to turn over to Dick Peters for the financials.