Photocure ASA

OSE:PHO

Earnings Call Transcript 2024-Q3

[Daniel Schneider, executive]

All right. Well, good afternoon, good morning. My name is Dan Schneider, CEO and President of Photocure. Welcome to Photocure ASA's Third Quarter 2024 Results. With me today is Erik Dahl, our Chief Financial Officer; and David Moskowitz, Vice President, Investor Relations.

Next slide, please. So just a reminder, usual disclaimers are in effect for today's presentation.

Next slide, please. So I thought I'd like to start with our strategic priorities and initiatives. I think it's important that we kind of put this upfront so that you can see how all the activities and ultimately, the results are following behind.

In the first block of accelerate and expand, our strategic priority is to deliver our guidance for revenue, EBITDA and tower placements for the year, and we're well on track. As you know, after Q2, we did raise the bottom end of the range for the installations of blue light scopes in the U.S., and we feel very confident that we will come solidly within that range. Drive the Blue Light Cystoscopy mobile strategy through ForTec in the U.S. We now have all 18 towers placed out in the U.S. and then also increasing the penetration in our priority growth markets in Europe through image quality upgrades, new installations throughout the continent. And finally, expand and leverage our geographic distributor and distribution partners.

And the second block, positioning and access. Position BLC as a primary diagnostic tool to facilitate early and appropriate use of non-muscle invasive bladder cancer therapeutics. In Q2, we talked a lot about the trends. We talked about the number of companies trying to come to market with new therapeutics, bladder-sparing therapeutics, all intended to help patients avoid the ultimate muscle invasive bladder cancer. And Blue Light Cystoscopy can play a very important role and a growing role in that initiative.

We also want to support high-def blue light technologies entering the market. We've had Karl Storz launch their new blue light high-def technology. Richard Wolf has launched theirs. And I'm pleased to say that Olympus is in the final stages of their launch. We expect it here in the fourth quarter, which will be important, particularly in the Nordic region of Europe. We also will facilitate the reclassification of Blue Light Cystoscopy vis-a-vis the U.S. Citizen's Petition that was entered by Karl Storz. We continue to put pressure on the U.S. FDA, and we continue those efforts going forward. And then also, finally, reintroducing flexible Blue Light Cystoscopy with our partnership with Richard Wolf. In fact, the teams are meeting today to take a look at the development pathways and prototypes.

And then the third block, acquire and transform. Actively assess the opportunities in non-muscle invasive bladder cancer and other uro-oncology indications such as biomarkers, AI, new technologies, devices. Also leveraging -- all of this, leveraging our global commercial infrastructure in a broader uro-oncology segment. And examples of this are our recent collaborations with both Richard Wolf to reintroduce the world's only blue light flexible cystoscope and also our mobile strategy with ForTec in the United States.

Next slide, please. So some of the highlights for Q3. I'm very pleased with the quarter. It felt very solid, good momentum growing behind all the initiatives. We delivered 12% growth in Q3. We continue to expand the Saphira footprint and are on track to meet our guidance for new and upgraded tower placements in the U.S. We're executing on the EU priority markets. We had a 12% growth in the priority markets, growth markets of U.K., Italy and France. These are high-potential underpenetrated markets in Europe, and we'll continue to make progress and momentum there.

We had a recent meeting with Olympus. We believe the CE Mark in Europe will be issued soon. Equipment availability in certain countries will begin later this month or in early December. We continue to monitor those developments and are looking forward to collaborating with Olympus on this new product launch.

We also generated positive EBITDA, it's our sixth quarter in a row, and added cash to our balance sheet in the period. So I'm very pleased with the strength of our balance sheet.

And some on the important news flows, the ForTec mobile strategy is answering the challenge of access and capital costs in the U.S. We have 36 accounts as of today that have tried it or by the end of October have tried or evaluated the system, and we are starting to build a strong base of repeat customers. The contribution of mobile so far exiting out of October is greater than 3% of our U.S. business, is now coming out of the mobile segment. Blending that across the year is roughly 1%, but we expect that to continue to grow. And if you remember, when we talked about this in the prior quarters, the analogs used for mobile strategy by ForTec, looking at prior things like MRI fusion, et cetera, showed a slow continued growth and then often an acceleration later on around the 12-month marks or beyond. So we expect this to continue to grow and are excited about it.

The Richard Wolf Flex development is underway and puts the control back in our hands to relaunch into the largest cystoscopy market, that's the surveillance market. And then Hexvix was approved early in China. And we're very pleased with the regulatory body, noted that the high-quality Phase III data and NDA application that we had worked on with Asieris, it actually kind of, what they said to us, ranked in the top 1% of submissions they've seen in the Chinese -- by the Chinese NMPA. So that's fantastic. It was approved essentially 6 months ahead of schedule. It is not able to launch. We have to wait for the Richard Wolf equipment to go through its regulatory approvals, which are currently underway. We're hopeful that, that happens fairly quickly. We expect to launch in China probably late second half next year into 2026.

And then Cevira continues to undergo regulatory review, and we are told, and its public, by Asieris that they will file a pre-submission with European regulators later this quarter. So we look forward to seeing what that brings.

Next slide, please. So getting into segment trends. We'll move to the next slide, please. So each of our direct sales territories had solid unit sales growth in the quarter. In the U.S., we estimate that our unit growth of rigid towers grew in the low double digits, both year-over-year and sequentially. This more than offset the decline in Flex sales in the first half. In Europe, we had a strong quarter, mainly from Germany, growing at 11%. And if you remember, taking over the business from Ipsen, it was basically a flat to declining business. We've been delivering single -- mid- to high-digit growth. This put us in the double-digit growth for Germany. Most of this on the back of upgrades and efforts in particular regions of Germany that were underpenetrated like the Westphalia region. So we're very pleased with the development here.

And it was a 12% combined performance in our priority growth markets: Italy, France and U.K. with particularly strong growth in the U.K. We continue to expect to see good steady growth in Germany and other European territories. And the relaunch of Blue Light Cystoscopy throughout the continent will start with Olympus upgrades this quarter. So we're looking forward to that and particularly its impact on the Nordic region where Olympus has a stronghold.

Next slide, please. So trends in North America. Q2 revenue in the U.S. was up 12%. Market unit sales were up 6%, driven by a 10% growth in the first half and continued Flex discontinuation. The installed base was plus 12 for a total of 49 new and upgraded Saphira installations so far this quarter. This puts us on track to meet the 55 to 70 Saphira placements that we guided for on the year. Access to BLC equipment remains our top priority. The reclass efforts will continue and more pressure is mounting.

Meanwhile, ForTec is a powerful alternative strategy to expanding access to otherwise inaccessible accounts and patients. While we believe it will take some time for the awareness to get out there, the process, you have to get the champion within these accounts, so the top urologists or influential urologists who really want to bring blue light in. You got to take a look at the operations budget and get approvals through that, P&T committees for the drug to be brought into the hospital, the evaluation and the committed customers. So it does take time to move this through. And as I said, the analogs of the past from ForTec's efforts with other launches of mobile strategies show the same trajectory that we're on.

But the momentum and awareness are building, and it is in line with analogs of the past. And today, we have 36 accounts that use the service that otherwise would not have had access to it. I think that's an important thing to underscore. These are accounts that either, a, the capital was too costly; b, Karl Storz was not the primary vendor; or c, it just is an account that we just couldn't get to. So ForTec is accessing over 2,000 accounts or 2,200 accounts in the U.S., and we expect continued growth in this segment.

Next slide, please. So getting to the Saphira installed base, we now have 48% of the U.S. market is upgraded to the high-def system. It consists of 17 new accounts, 14 upgrades and 18 mobile towers that were delivered to ForTec in the third quarter this year. High-definition blue light equipment in the U.S. is now roughly 50% of the market. And as I said, keep in mind, Karl Storz roughly has about a 35% or so share of the U.S. market. So if you kind of take a look at the installations versus what Karl Storz's primary customers are, we actually have a high penetration, which bodes well for when we talk about entries of future manufacturers, whether it be a reclassification to a 510(k) pathway or other methods, will open up this market dramatically for us.

We also expect Karl Storz to continue the promotional program for Blue Light Cystoscopy to the end of the year. We think that will have impact on the fourth quarter and continue the momentum. And again, our main focus is to leverage the new high-def equipment through fixed and mobile towers and continue to improve their productivity.

Next slide, please. So looking at the European trends, there was strong performance in Q3. Germany continues to build momentum for us since we took it back from Ipsen. We have restored growth from mid-single-digit growth to now the 11% this quarter. Priority growth markets, U.K., France were major performers in this group. Italy is trending well -- also very well. Italy also has a challenge of a lot of outdated equipment from Karl Storz that is being upgraded as we work on it with the customer base. We also had one system and an example of this is in Italy, our largest customer equipment went down in Q3, and so that did have an impact on Italy's total unit sales, pushing them into the high single digits from strong double digits, but we expect that equipment back up here in the fourth quarter.

Italy received favorable position paper on guidelines in the third quarter. We had the DGU, the German urology conference, where we partnered with our partners on the bus, Karl Storz, and customers were quite excited about what they were seeing in terms of the new definition equipment. We expect the launch of Olympus blue light feature, state-of-the-art, VISERA III will have a positive impact on the Nordics who are dominated by Olympus and their aging standard definition blue light equipment that they currently have on hand, particularly in Denmark and Norway, but also throughout the rest of the Nordics.

Key initiatives throughout Continental Europe are having impact, continuing to execute on these. We've had 44 image quality upgrades in Q3 alone, 220 since 2023 and 29 new accounts added in the past 20 months, and this is fueling a lot of the resurgence in growth throughout Europe. So that is what we have in Europe.

So let's go to the next slide. So what do we have to look forward to: the growth initiatives, and this is where we get very, very excited. If we go to the next slide, Slide 11, while I'm very happy with the quarter's development in 2024, I believe the execution on these key growth initiatives will take the company to the next level. We're going to accelerate access vis-a-vis the ForTec mobile solution. As I said, there are 30 accounts by the end of September, 35 by the end of October. It's roughly 3% of our total U.S. sales to date, and that's -- given it's only launched in the last few months, I think that's fantastic. And again, it's following the analogs of prior launches by ForTec in other areas of devices that they've put on mobile trucks.

We have the reentry of surveillance in a market that's 3x the surgical market and growing. This is through the Richard Wolf agreement on developing a blue light surveillance flexible scope. The development is underway. We think roughly 2 years, we expect to bring this to market. But we continue to look for ways to expedite the reentry. The patients, physicians are increasingly needing better surveillance, determining what the next bladder cancer sparing treatment should be. So we believe that this will have a high impact once we launch back into the market. And again, we're looking for alternative ways to get to this market faster. So stay tuned.

Also, I think the final piece is the rapidly expanding treatment landscape needs complete and accurate diagnosis and follow-up and Blue Light Cystoscopy can play a central role in that. The wave of new therapeutics coming into the space has been traditionally underserved, but billions are being poured in into solving this problem. And to solve the problem, you have to see the problem and Blue Light Cystoscopy is the best technology for the diagnosis and determination of that patient's treatment forward.

Next slide. And talk about value-generating Asieris programs, two different types of deals. So I'll kind of make it a little more distinguished between the two to help everyone understand. The first one is the Hexvix commercial partnership with Asieris. I want to just state, so far, with our partnership with Asieris, we've taken in over NOK 18 million in milestones across both of these programs. It's added significant cash for us, operating cash and also future ambition cash, but also has potential to deliver more in the future to fuel our corporate ambitions.

On the commercial partnership on Hexvix, Hexvix got marketing authorization several months earlier. In fact, it's close to 6 months earlier. It was a high-quality regulatory application. Top 1% of Chinese NDAs have ever been approved in that speed. So a fantastic job by our friends in China. The potential for a Chinese approval for the Richard Wolf blue light system, we expect in the second half of 2025. It's under regulatory review. We understand it's going well so far. And we expect the commercial launch of the device, late '25, early '26.

On the Cevira out-license program for pre-cervical cancer product, the NDA remains under regulatory review for potential approval in China. Asieris has publicly disclosed that they will plan to file a pre-submission with EU regulators this quarter to see if the EU will accept their submission for review. If you recall, they have roughly 60, 65 patients that were in their Phase III trial that were of European descent. So they want to see if the European authorities will accept this as a submission. If they do, we'll receive milestones for both the filing and acceptance and approval of the EU if it's achieved. And then the Chinese regulatory decision for Cevira is expected to be in late 2025 event. And finally, the U.S. -- Asieris is working with the U.S. FDA, and we'll have more information on that as it becomes available.

All right. So with that, I'm going to turn it over to Erik Dahl, who will go through the Q3 financials. Next slide, please.

[Erik Dahl, executive]

Thank you, Dan. And please keep it at Slide 13. In this, we will review the consolidated income statement, segment reports for the 2 main segments as well as finally, the headlines from the cash flow and the balance sheet.

But first, a few words about the impact of foreign exchange. As everybody knows, we have negative movements from the Norwegian kroner in Q3 and year-to-date. Measured by unweighted monthly averages, the kroner in Q3 depreciated 2.2% against U.S. and 3.2% against euro. And year-to-date, the kroner depreciated 1.7% against U.S. and 2.1% against euro.

Looking at the financials, the year-over-year FX impact for Q3 revenue was positive, approximately NOK 2.4 million, while the year-to-date year-over-year impact on revenue was positive, approximately NOK 7.2 million. For EBITDA, the year-over-year FX impact for Q3 was positive, approximately NOK 0.5 million, while the impact year-to-date was positive, approximately NOK 1.9 million. And please, for the presentation, keep in mind that all amount mentioned will be in Norwegian kroner unless other currency is specified.

Next slide, please, Slide 14. So we're now looking at the consolidated income statement. Total revenue was NOK 120.2 million in Q3, an increase of 12% from Q3 last year. And main drivers were the unit sales growth of 6% in U.S. and 9% in Europe. We also had positive impact from average pricing in U.S. and FX in both regions. Year-to-date and including milestones, our revenue increased 7% year-over-year.

Consolidated Hexvix/Cysview revenue in Q3 increased 12% and year-to-date, 9%. Year-to-date is within the guidance given by -- at the beginning of the year. Consolidated in-market unit sales increased 8%, impacted negatively by the ongoing flexible BLC phase down in U.S.

Total operating expenses, excluding business development expenses was NOK 106 million, a year-over-year increase of NOK 9 million or 10%. However, of the NOK 9 million increase, NOK 5.2 million relates to a one-off accounting adjustment in Q3 last year for the capitalization of registry expenses in U.S. And the remaining part of the increase is driven by project expenses and FX. Sequentially, from Q2, operating expenses declined 2%. We also note that our operating expenses have been relatively level the last 11 quarters, adjusted for FX and inflation.

Business development expenses were minor in Q3, NOK 1.2 million. Operating expenses within business development are mainly related to life cycle management of Hexvix/Cysview. And the expense level, obviously, may vary from quarter-to-quarter, given the one-off nature of these expenses.

EBITDA in Q3 after business development expenses was NOK 5 million, and this compares to NOK 3.3 million, Q3 last year. We have achieved a positive quarterly EBITDA the last 6 quarters. The year-to-date EBITDA after business development expenses was NOK 40.7 million.

Depreciation and amortization was NOK 7.2 million in Q3. Main cost item is the amortization of intangible assets related to the return of the European business from Ipsen in 2020. The net financial items in Q3 were a net cost of NOK 2.8 million compared to a net cost of NOK 4.8 million, Q3 last year.

Tax expenses were a net income of NOK 1.5 million for the quarter compared to a net income of NOK 3.9 million, Q3 last year. And after tax, we have, for Q3, a net loss of NOK 3.7 million compared to a net loss of NOK 4.8 million same period last year.

And now to the segment performance. Next slide, please, Slide 15. For the segment reporting, we will focus on the 2 main segments, which is North America and Europe, and the North America segment includes U.S. and Canada.

Revenue for North America increased 12% in Q3, and the main drivers are volume increase of 6%, increased average prices and foreign exchange. This is partly offset by phase down of Cysview usage in the flexible BLC setting. Q3 direct costs increased year-over-year with NOK 8.5 million or 25% and the increase is driven by a NOK 5.2 million one-off accounting adjustment in Q3 last year. This is for the capitalization of registry expenses in U.S. And the remaining part of the increase is driven by project expenses, inflation and FX. In general, Q3 direct cost is level with the 2 previous quarters' current year. Q3 contribution was NOK 4.6 million compared to Q3 last year of NOK 8 million. Adjusting for the one-off accounting adjustment last year, the Q3 contribution increased year-over-year with NOK 1.8 million.

Our European business had year-over-year revenue increase of 12% in Q3, mainly driven by 9% volume growth and 3% FX. Direct costs increased year-over-year 3% in Q3, driven by inflation and FX. We ended Q3 with a contribution of NOK 35.1 million compared to NOK 29.1 million last year.

Now let's move to the cash flow and balance sheet. So it's next slide, Slide #16. Cash flow and cash flow from operations in Q3 was NOK 34.5 million compared to NOK 8.7 million last year, and the difference is mainly driven by improved EBITDA, noncash expenses and improved working capital, particularly accounts receivables in both regions.

Cash flow from investments in Q3 includes interest received, partly offset by investments in tangible and intangible assets. Q3 last year was negative NOK 2.5 million due to the one-off accounting adjustment for the capitalization of registry expenses in U.S. And cash flow from financing in Q3 was negative NOK 12.9 million, which is driven by the earn-out payments to Ipsen of NOK 9.8 million in the quarter. And the term loan from Nordea was fully repaid at the end of Q2 last year. So this gives a net cash flow in Q3 of NOK 24.1 million compared to negative NOK 3.9 million Q3 last year. The largest driver of this change is improved working capital. And with this cash flow, we ended Q3 with a cash balance of NOK 291 million.

Looking at the balance sheet, we ended the quarter with total assets of NOK 720 million. Noncurrent assets was NOK 322 million at the end of Q3. This included customer relationship with NOK 100 million, and customer relationship is the intangible asset identified in the purchase price allocation for the Ipsen transaction. Noncurrent assets also include goodwill from the Ipsen transaction of NOK 144 million and a tax asset of NOK 43 million.

Inventory and receivables were NOK 107 million at the end of Q3. The decrease from end of Q2 this year is driven by improved collection in both regions. Long-term liabilities of NOK 143.5 million include the earn-out liability related to the Ipsen transaction totaling NOK 120 million at the end of the quarter. And finally, equity at the end of the quarter, NOK 500 million or 69% of total assets.

This concludes the financial section. Thank you. Dan, it's back to you.

[Daniel Schneider, executive]

All right. Well, thank you, Erik.

Let's go to Page 17 -- well, actually, let's go to 18. So in summary. So you can tell, I'm quite pleased with the developments at the organization, particularly third quarter, solid quarter growth with 12% top line growth, positive EBITDA. This puts us multiple quarters in a row of positive EBITDA and also positive contribution from the commercial businesses. We had 12 new Saphira installations in the U.S. and now represents -- Saphira, the new high-def system represents about 50% of those installed base. And if you think about the way things are installed and as they replace, we're rolling into like the 2018, 2019 installations that are kind of up for upgrades. So we expect the final 50% of the Saphira that are out there that are standard definition to be upgraded over the next 24 or so months.

ForTec national rollout is gaining traction. As I said, month -- we're watching this month-over-month. We've got 36 accounts right now currently who have evaluated the service, used the service. Many have reordered the service. We're going to monitor it. It's roughly 3% of the business exiting out of October, which is really, really good to see as it offsets some of the declines that we've seen on the flexible side. And it also offers us access to accounts and patients that we otherwise would not be able to get to, whether it be the challenges with capital costs or the fact that they are not a primary vendor with Karl Storz or they just need another option, and they're more likely to do an operational budget expense than a capital budget expense. So I think this is a novel model. I'm really excited about where it's going. It's falling in line with the analogs of prior launches by ForTec, and we'll continue to report on it.

In Europe, extremely happy with work to date, 44 image qualities in the third quarter, 220, I think it was, in the last 20 months. The priority growth markets, which we promised would take time but would respond in due time, are now growing at double digits. And in particular, just noting that it would have been even, I think, a little bit higher had the one Italian large client not had equipment failures, but we expect to get them up online in the fourth quarter.

Despite the Flex phase down, Richard Wolf and Photocure continue on the joint development program to bring Flex back to the surveillance market. I will tell you that there is a growing -- increasingly growing need for Blue Light Cystoscopy in the surveillance market, particularly with this onslaught of new therapeutics, bladder-sparing therapeutics, that require us -- require physicians to determine whether or not a patient is eligible for continued therapy.

So Blue Light Cystoscopy can play a major role and Blue Light Cystoscopy flexible is the product that will be the difference maker there. We know in Europe, particularly in the U.K., there is a demand for it. The U.S. had 69 installed back when it started the discontinuation. And we knew at 69, we had roughly 30 with purchase orders into the first quarter. So we know that there will be a good demand for this when we bring it back to market. We expect it in the -- within the next couple of years, but we are looking at all alternatives to get it to market sooner.

We have a great presence at the conferences. We're gearing up for AUA and EAU. There are a lot of submissions on the importance of Blue Light Cystoscopy across all the different markets and different uses. So we're excited about what that could become as we look at the April time frame.

And our cash balance remains strong with NOK 291 million, up NOK 30 million at the end of the year 2023.

All right. Final next slide. So what are we looking forward to? And why am I super excited? The anticipated milestones and corporate objectives, we reiterate our 2024 financial guidance, 6% to 9% product growth in constant currency. I know that, right now, you're seeing 9% growth. But keep in mind, there is a slight FX impact there. Positive EBITDA, ex our BD spend, very strong there as well and U.S. Saphira tower placements in the range of 55 to 70. I believe we're currently at 49. So obviously, we feel very, very good about that range. And we'll see how far we can push it, particularly, given that Karl Storz is continuing their promotional program to the end of the year.

We'll continue to increase the Hexvix/Cysview kit throughput with tower upgrades and installations, collaborating with ForTec on the mobile tower national rollout, continue to put pressure there. And also, as I'm speaking here today, last week, our teams met with the Olympus teams to lay out an explicit plan for the Olympus relaunch or upgrade launch of their blue light capabilities throughout Europe. So that's exciting for the fourth quarter, and we'll see the impacts as we move through 2026.

We're going to continue to support the Citizen's Petition. The election in the U.S. has not changed our strategy. In fact, fortunately, a lot of what we had in play is still in play as it played out. We have legislative efforts and other things going on. So we feel really good about where we are. There is, again, no statutory requirement by the U.S. FDA to answer this Citizen's Petition in any particular time frame. But I think even with some of the recent appointments from President-elect Donald Trump, particularly this new department of efficiency with Vivek, and I'm going to mess up his last name, who comes from industry, we feel like there could be some positive wind in our sails for the Citizen's Petition. So we'll wait and see. Again, there's no statutory requirement, but we feel pretty good about that.

There's a lot of data that we'll be publishing through next year, a lot of it coming out of the real-world patient registries that we support, and that's very, very exciting, particularly in the context of coverage and reimbursement. We'll advance partnership with Richard Wolf, commercializing -- well, developing and then commercializing this next-generation flexible blue light system on a global scale. Again, we're going to look for every avenue to expedite this into all the markets, particularly the U.S. So more to come there if we're successful.

And then I think Asieris -- Hexvix was approved. They'll likely launch Hexvix in the second half of next year, and the Cevira program is undergoing regulatory review, which we understand is going quite well. And they're going to have a pre-MMA submission for Cevira in EU, and they're under -- and they want to engage in FDA discussions again as well. So that could produce a tremendous amount of milestone cash to Photocure to fuel our future ambitions.

So with that, I think we'll end on Slide 20. And I guess I'll turn it over to David, who is managing the Q&A for Erik and I.

[David Moskowitz, executive]

All right. Thanks, Dan. So we'll move to the Q&A portion of the call. Please send in your inquiries through the chat.

We'll start with the first question, which is about Olympus. Dan, are you able to give more clarity on the launch of Olympus's new blue light system? And how will you work with them on that launch to get the most out of it?

[Daniel Schneider, executive]

Yes. The teams met in Hamburg last week at the Olympus European headquarter. They were going through account by account throughout Europe, where they were going to, and how they were going to employ the tactics and strategies to get the upgrades in. The VISERA III system is a fairly simple system for them to upgrade to. It is a universal system. They can turn on the software and get it up as long as the VISERA system is in the accounts. We expect -- from what we hear from Olympus, they got their [ tooth ] a couple of weeks ago. We understand they're in the final stages of the CE Mark registration, and we expect them to launch here in the fourth quarter. We will report back out. I should say this, we will report out to everyone when we see the first commercial installation and use of blue light.

[David Moskowitz, executive]

Excellent. And just a follow-on to that question. How meaningful do you think the opportunity would be? How fast do you think you'll start seeing tangible results in terms of growth rates for...

[Daniel Schneider, executive]

Yes, it's going to be particularly -- well, I think it's going to be very impactful for Olympus. We know for a fact what they've told us is that their 2026 or 2025 aspirations in terms of revenue are impacted by the success of this launch. So if that tells you anything about how impactful and important it could be to them, certainly, it's going to be very impactful to us, particularly in the Nordics.

For those of you who have been with us for quite some time, the Nordics used to be a very strong market for us. But over the years, with outdated standard definition equipment by Olympus, who holds roughly 70% or more of the Nordic market, they were selling NBI against blue light because, obviously, the blue light was a standard definition inferior. They now have switched. They're going to be selling the blue light system as the premier system to have for the surgical -- for the staging, diagnosis and surgical resection of tumors. I think it will have a big impact, particularly in Norway, where they have a high concentration, Sweden and also Denmark.

Timing on this doesn't happen overnight. They got to get the systems in, upgraded and used. But I think, over the course of 2025, we'll continue to see building momentum and hopefully rebuild the Nordic markets. But the good news on the Nordic markets as currently as it sits is they're stable. We're not bleeding out anymore. I think most -- all the accounts are anticipating and are excited about this new Olympus system with blue light capabilities.

[David Moskowitz, executive]

Okay. Great. Recurring question, U.S. reclassification, are you able to give any update on the time line?

[Daniel Schneider, executive]

No. There's no statutory requirement. We keep putting pressure on them. The FDA and Karl Storz are the primary context in there. From what we understand, there hasn't been any dramatic initiatives so far. All we know is that the FDA is fully aware of this. And I think with the election and maybe the change in administration, maybe fresh eyes will take a look at this for us, and maybe we'll get a break. But we will let you know as soon as we see change here.

[David Moskowitz, executive]

Excellent. Okay. Moving to the Richard Wolf Flex agreement. You mentioned in the materials that as soon as possible, you'd like to get this to patients. So how is that partnership going? Are there any updates? And the other question on that would be, do you need U.S. down-classification to launch it in the U.S. if once successfully developed?

[Daniel Schneider, executive]

I think the relationship with Richard Wolf is extremely strong. If you take a look at our ambitions in China, it was -- Richard Wolf has stepped up. When you look in countries like Finland, where Olympus was selling against us in accounts and parts of Sweden, and we needed to counter that NBI initiative, Richard Wolf stepped up and went into those accounts and sold the System blue into those accounts for us. Again, they stepped up when we looked for partnerships to develop a surveillance blue light flexible system. Wasn't the only one we talked to, but they are the ones who stepped up with us. And their excitement and their eagerness to go after this is quite good.

Like I said, we met with them. We're meeting with them today. Several people on my staff actually apologize they're not on the call today to hear the quarterly presentation because they are in meetings with Richard Wolf, going through the development plans, the prototypes, et cetera. We have every intention of getting this to market as quickly as we can. That is a top priority. I think patients deserve it. So I'll have more information on that as far as that goes.

As far as the U.S. and Citizen's Petition and whether that is the gate or not, it is not the gate. There, we're looking at alternative ways to try to get ourselves to the U.S. quicker and not wait for Citizen's Petition. I think patients deserve it. I think we have a relatively strong case to the FDA. When there's -- when the only blue light system in the market has been withdrawn and yet the trends and the demands for better diagnosis and treatment are out there and continue to build, you need that solution. We are that solution. We'll be the only solution in the world, at least when we launch. So we will try to find our best way to the U.S. as quickly as possible. More to come on that as well.

[David Moskowitz, executive]

Okay. Excellent. Next question is on the U.S. scope placement. So of the 387 scopes in the U.S., 186 of them are Saphira, if you multiply out the 48%. That leaves 200 roughly older scopes, other legacy equipment. Are these scopes still active? And do you -- are you seeing higher kit utilization on the Saphira systems?

[Daniel Schneider, executive]

Yes and yes. So the ones that remain likely were bought -- I mentioned in my presentation, likely were bought in 2019, 2020, 2021. If you go back through our presentation, you'll see the numbers that were placed back in those days. Those are likely ones that will be up for end of life, end of service and replacement. And Karl Storz has every incentive to get those switched because they don't want to lose those accounts to Olympus or to Richard Wolf or anyone else. And since they do have the monopoly in the U.S., it's in their best interest to convert. So I think there'll be pressure over 2025 and 2026 to get the rest of those converted over. Most of them are still in operation. There are some that have died on the vine. Some of those accounts will switch to the mobile solution because capital budgets are tight. But one way or the other, we want to get those patients.

In terms of does it have an impact, I think I'd point to the impacts on Europe with 220 upgrades. And I think I mentioned, in Q2, Germany had 69 upgrades back then, 35 of those accounts had double-digit growth after the upgrade. In the U.S., a lot of it is degradation of sales with standard definition and stemming the tide, and then bringing sales back up again. So yes, it does have a positive impact, and it's very important. And I think anybody associated with the device world knows the importance of continuously upgrading systems and its impact on retaining customers.

[David Moskowitz, executive]

Excellent. Okay. So turning to ForTec. Questions here, one is, how big do you see ForTec getting in terms of the percentage of your business? You mentioned 3% exiting Q3. And how is the ramp going? Is it meeting your expectations, beating your expectations, in line?

[Daniel Schneider, executive]

It is -- yes, I'd characterize it's exceeding at this point, which is good because we expected a lot. And the 18 installations or purchases by ForTec and actually deployments happened later than what we thought was going to happen. It was a couple of late deliveries by Karl Storz. But in the end, they're exceeding our expectations. They're exceeding the expected plans. And if the expected plans expected those machines out 1 month or 2 or whatever earlier, we're already exceeding and we came into market later, so if you understand what I'm saying.

In terms of what can it mean to the U.S. business, it wouldn't surprise me for it to go up into the double digits in terms of our mix of business, if not even greater. We'll see where it goes. Some of the accounts that ForTec hits are going to be -- if you think about some of the largest accounts, the big academic centers, et cetera, those will probably always remain purchasing customers. They will own their systems and they will use them because they utilize them so much. They got huge patient bases. But for the smaller accounts that are out there, maybe they only have 100 TURBTs a year, this mobile solution is the right thing for them. It's an operational budget expense. So yes.

So I think we're accessing -- I think the key here is we're accessing customers that we otherwise would not have access to, at least in today's world. Now in the future, if there's multiple manufacturers out there and everybody has a blue light capability, and it's as simple as turning on software, then obviously, the world lights up with blue light, but we're not there today. So this is our counter strategy to the fact that we have limited access throughout the United States.

[David Moskowitz, executive]

Good. Financial question, you have roughly $300 million in cash -- I'm sorry, NOK 300 million in cash and positive cash flow from operations, positive EBITDA. What is your strategy for the cash that you have?

[Erik Dahl, executive]

I think you will find the answer looking at the growth initiatives that we're taking part of. Looking at Richard Wolf and the development of the Flex scope and maybe other developments as well and looking at the opportunities that are given now by other companies in the non-muscle invasive market, so it's kind of -- that's where you find the way that we might want to use this cash. Also one kind of maybe distant comment, but we should be aware that the risk level in the world has increased over the last few months. And I need to take that into consideration when I'm looking at the minimum cash balance I need.

[David Moskowitz, executive]

Okay. Excellent. Here's one on the priority growth markets, very strong in the third quarter, 12% growth. Do you expect this to continue?

[Daniel Schneider, executive]

Absolutely. Absolutely. It's going to continue. Extremely pleased with the progress and the efforts put in by the teams. We're increasing effort in Italy. We're extremely pleased with the U.K. and then France also has now picked up its momentum as well. So I see no change. In fact, I could see it continuing to strengthen over time across all those markets. Again, keep in mind, when we're talking about U.K. growing at significant double digits, they started with a pretty low base. So that growth rate might kind of trickle down a little bit, but that base business is growing with it and returning. So yes, so I don't see any stop to that.

[David Moskowitz, executive]

And related question to that is, in terms of utilization in both U.S. and Europe, on the image quality upgrades, so whether it's new Saphira systems or, in Europe, the incremental image quality upgrades. What can you tell us about the trends in utilization related to those?

[Daniel Schneider, executive]

I think we answered that earlier. I said -- I gave the example of Germany, 69 upgrades in -- when we talked about in Q2, 69 upgrades, 35 are in double-digit growth. U.S. reversing downward trends because standard definition breaks down. So yes.

[David Moskowitz, executive]

And on to Asieris. They -- Asieris did mention a spillover effect from the early approval of Hexvix and that it could relate to Cevira. Do you expect a spillover effect from that early approval?

[Daniel Schneider, executive]

I would say this, when you have a reputation of quality submissions, that does help. And I think the Chinese FDA or NMPA, as we call it now, will take that into account. Spillover in terms of will it expedite, I think, only in the sense that the data that is submitted is -- they'll feel like it's coming from a valid and reliable company versus somebody that they don't know, that will help. But at the end of the day, it is a different product with different data. So I can't estimate it, but I do think it has a positive overall impact first for Asieris. I will also say, Asieris, along with our team supporting as well, have done a phenomenal job in making sure these data packages are pristine and that the questions coming back -- in fact, there were no questions that basically came back on Hexvix, which is almost astounding. It was just that good of a package.

We're hoping for the same on Cevira, although it's not an approved product in the world versus Hexvix, which already is approved. Cevira is first to market in the world. So we expect some questions on that, but I think we're well prepared. And the key here on these is how quickly you can respond and how completely you can respond. And both teams worked extremely hard to be fast and complete.

[David Moskowitz, executive]

Excellent. Okay. And actually, last question is also on Cevira. Do you receive a milestone on the EU regulatory filing and approval? And what about this pre-submission filing that Asieris is talking about this quarter? Is that something we would receive a milestone on?

[Daniel Schneider, executive]

Not on the pre-submission or at least the conversation we have with the EU, we won't receive a milestone. But we will receive milestones if it's accepted by the EU for review and then if it's approved and it's significant. It's slightly more than the Chinese payout -- Chinese market payout. So yes, it's significant money. We're talking about -- if both of those were to come through, it'd double our -- come close to or getting closer to doubling our cash balance.

[David Moskowitz, executive]

All right. Very good. That is all the questions we have today. So Dan, I'll turn it back over to you.

[Daniel Schneider, executive]

All right. Well, great. Well, thank you, everyone. Look forward to seeing everyone on the Q4, I think, in February, I don't have the exact date, maybe Erik remembers. But thank you for joining us today. Have a great day. Bye-bye.