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And so we want to remain relevant in this space and we need to play. We want to support the high def VLC technologies entering the market both current and new capital equipment manufacturers. We've moved the needle on reclassification. Again, it is not something that we can predict per se, but I will say that I'm very pleased with the organizations push with the FDA, and we'll see how this plays out this year. Just as a side note, I mentioned in the last presentation, this is one way of getting additional technologies blue light technologies into the market. We are also pursuing with our partnership other alternative ways. The key is getting more there, more devices into the market, more manufacturers into the market. So more to come on that. And with the announcement earlier this week, we're focused on the Richard Wolf flexible system building adoption in Europe. As you recall, this is the largest segment [indiscernible] about $1,300,000,000 opportunity for us We had said that we were working on the development of LED high def blue light system with Richard Wolf and the development continues on time. But in the meantime, we were able to co develop and co investigate and discover a way to combine existing technologies that are already in the market into a flexible blue light cystoscopy.

This opens up the opportunity in Europe and for us to make sure that Flex is continuing to be relevant in the surveillance market, collecting the data and making sure that we can properly prepare the market for the full launch of the new Hi Def system in the next couple of years. And then third part is acquiring and transform, actively access opportunities in non muscle non muscle invasive bladder cancer and uro oncology indications things such as biomarkers, artificial intelligence and new technologies. Real time examples of that is some of the work we've been doing with Wolf Richard Wolf with the interim solution as well as the long term solution. And then also VorTeq, in the in the mobile systems But we continue to look for other opportunities to expand our in uro oncology space. So So some of the highlights on Q4. We had strong growth in the quarter with 13% revenue growth 11% unit sales growth in Q4. We generated 10% product revenue growth for the full year plus received $37,500,000 NOC milestone revenue from Osiris. We delivered 20% product revenue growth in The U. S. And 9% growth in our European business in the fourth quarter.

The installed basis of fiber blue light equipment continued to increase with six placements in Q4. I want to make a note here because some might not think that is great. But one of the things you got to keep in mind is we count towers when they are active in the market servicing patients. I will tell you that, there are multiple, many, I guess, POs, and we expect this is more of a phasing issue and you'll be happy with the first quarter of twenty twenty five. So again, don't get too caught up on six towers. The Richard the Karlstorz program with, for the Rigid Sephira upgrades is still in effect till the March 31. We continue to of The UK and France in the fourth quarter. Italy had a major center that has been down due to equipment failure. We expect that to be up and running and will return strong growth to Italy as well. This priority market space continues to build. And we're very pleased with the developments there. In addition, Germany had a very strong fourth quarter as well. And also, I think it's worth noting the Nordic region is now stable and starting initial signs of a turnaround.

And with Olympus, which is roughly 80% of that market, now upgraded to the Versa three Elite, we expect that to fuel growth for the Nordics beginning in 2025 and carrying forward into the future. We also generated positive EBITDA. It's our seventh quarter in a row and added cash the balance sheet in the period. We ended 2024 with $29.02 $94,000,000 NOC in cash and we have no term debt. On a new slow side, earlier this week, we announced Richard Wolf interim solution. Europe and rest of world where the System Blue and Flex components are approved. This puts a control in our hands to relaunch into the largest market segment in the world for cystoscopy. And we have that also, as you can see in our growth initiative slides later in the deck. The Forteck mobile strategy answers the challenge of access and capital costs. We're very pleased with the progress so far. With 44 accounts that have tried it by the end of twenty twenty four. We continue to see that building momentum, and it's following the analogs of prior devices and products that VorTeq has launched in the past. So we're very pleased that we're on track with that.

And our partnership with Osiris continues to advance. They presented survivor data at IPVC, with the clearance rates for different HPV types The product currently is under Chinese review. It's going from we understand pretty well. We think this the approval could come as early as third quarter this year, but we'll have to see. The PDUFA is for that is actually late fourth quarter. So we'll see how this develops but we're very excited about the possibilities. And of course, Hexfix already approved in Q4, and it's awaiting the Richard Wolf Capital Equipment approval through the NMPA in midyear this year. And then the launch. Next slide. All right, let's get into segment trends. Slide six, please. Okay, Q4. Each of our direct sales territories had solid unit sales growth in the quarter. In The U. S, we estimate that our unit volume growth at Rigid Towers continues to grow into the mid teens year over year. This is more this is more this more than offset the ongoing decline of flex throughout 2024, as you recall, we have about 25 flex towers left. I will tell you that they are aggregated. Most of the units are coming from a couple accounts.

They're very key. They're managed by world KOLs in The US. So there is, we continue to manage through that. I know that Karl Storrs doing everything they can to keep these customers up and running with Flex. But one of the key things about Flex as well is because it's near the end of life for these devices, they're being very selective in the patient patients they use it. So we'll continue to see downward pressure with flex declining throughout '25. In Europe, the strong growth in the quarter came from Germany. Our priority growth markets had a strong performance, up 9% for the year compared to 2.7%. In 2023. The UK has been a especially strong working off a low base, and France has been responding well to our work with the KOLs and image quality upgrades in the country. We continue to expect good growth in Germany and other European tear Cystoscopy throughout the continent with over 200 upgrades and 34 installation cystoscopies since we took the territory over [indiscernible] Next slide. So trends in North America, Q4 revenue was up 20%, mark in market units up 12%, driven by 17% rigid growth. In Q4, offsetting the continued flex discontinuation estimated to be down 16% in Q4.

In the installed base of plus six, three new, three upgrades for a total of 55 new and upgraded Sapphire installations. This meant the low end of a revised increase in guidance in the range. If you recall, we had original range and we upped it and we hit just came in on the the low end of the revised range. So well within the original guidance. And again, a lot of the Karl Storrs piece of this is in POs that should deliver in the first quarter of twenty twenty five. Karl's store's promotion program does remain in effect until the end of Q1. We also have rolled out a new metric for you to track our business one that we believe is a better indicator of our performance in The US and this is called active accounts, which are defined as accounts that have ordered at least once in the past twelve months. Based on this metric, we're up 11.3% year over year through the fourth quarter and we'll share that slide in a coming slide here in a moment. Access to blue light equipment remains our top priority. Reclass efforts will continue and more pressure has mounted.

We've invested significantly, in in working with congressional, US Congressional folks and through through our consultants in trying to move the needle on this. Meanwhile, VorTeq is a powerful alternative strategy to expanding asset access to other otherwise inaccessible accounts in patients. We believe it will take some time for the awareness to get out there, you got to get the champions, the operations budget, approval, P and T committee review, evaluation, and a committed customer, it does take time to go through that phase and we believe VorTeq can become a significant portion of our business. We think in excess of 15% to 20% could be higher. We'll see where it lands. I think what's also interesting with VorTeq on the subject is some of the accounts that started with VorTeq have decided that Blue Light is more important to them than they originally thought, and they've already started to begin to commit committing to acquiring their own equipment directly from Karl's store. So this is kind of what the hypothesis was that there will be accounts that will want it on the operating budget and want to use blue light, want access for the patients. There will be some accounts that want to try it.

And if it goes well, they will see a greater usage for it, and they'll end up buying the equipment. That is exactly what has beginning to play out over time. And we think this will continue through 2024. One note on this slide, you'll see on the picture there, there are about 16 different companies now involved with Beacon. Beacon is a patient advocacy group for bladder cancer patients. I will tell you that about four or five years ago, there was far less of these account. There's about five or six It goes to show you the amount of interest, investment, and overall companies that are involved in this space now. So it's a very exciting time to be in bladder cancer. Therapeutics diagnostics, [indiscernible] Next slide, please. So 55 SAFIRE systems were in installed in 2024 consisting of 20 new, 17 upgrades and 18 VorTeq towers. The high definition blue light equipment in The U. S. Is now roughly 50% of the market in Karl stores is highly dedicated to bringing this as close to 100% as it can, as quickly as it can. It's focused on pre 2022 installs. Anything in 2022 or before our standard definition.

That's the old systems. They are focused on upgrading them to the high def survivor system. Keep in mind, Karl's stores shares the equipment market with two other competitors holding roughly a 35% share. So we actually believe we have a relatively good penetration in Karlstor's Carl Sors has indicated that their focus is here will be on upgrading its base of existing accounts pre-twenty twenty two to Saphyrra, although we do anticipate placement of many new towers as well. In fact, there are instances, as I mentioned, where Forteq has started the account and the account has now committed to purchasing a Carl Storz tower. So that's actually good news. And on average, I've been asked this question, high def tower upgrades from standard def, what does that mean? We know that it means in excess of of 10% growth for those accounts, and there's a range Some of them go much higher, maybe a few a little bit lower, but we do know it has a positive impact on the business. So going forward, we're going to retire the slide for future earnings reports. You can see that we have worked for Carl Storrs, significantly grow the installed base of Blue Light Capital equipment in The U. S. Since we repositioned our U. S. Commercial organization in 2018, we've had three fifty five installations, 69 Flex the recent seven years versus 104 in the prior seven years.

But with we're very proud of the activity in the Rigid segment in addition to the 69 flexible towers. We've held place during the same period with Karl Storrs decided to cease the manufacturing of flexible equipment. Nevertheless, tower count is a real metric for Karl Storrs. But it's not a direct proxy of our performance. We look more at account penetrations. Additionally, Forte mobile towers now in the market and other equipment manufacturers potentially entering The US market will make this metric in incredibly difficult to track reliably. So the slide we want to share today is the growth in accounts actively using Sysu. We'll begin now exhibit this slide each quarter, which shows our active accounts in The U. S. Are those that have ordered on a rolling 12 basis. Through the current quarter. Importantly, this is a blend of all accounts with all types of towers. On the bottom of the slide, you can see our active accounts include those with rigid towers only, flex only, dual tower accounts, accounts with multiple rigid towers, mobile towers, rigid and mobile towers, and those that are evaluating equipment. Whether for installation or ongoing mobile use. We believe this is a more active and reliable metric for tracking our performance.

As you can see on the slide, we grew the number of active accounts through Q4 twenty twenty four on a rolling 12 basis from two ninety four to three sixteen, which an increase 11.3%. Keep in mind, there has been flex declines etcetera. So this is a moving number, but we believe this is a more accurate way to look at the business of what's really active out in the space. These data serve as an internal operating tool as we use to monitor our productivity and keep our accounts active And if they're not active, reactivate or move to a different type of platform like VorTeq. Taking a look at trends in Europe, had a 9% increase in revenue, which was primarily driven by strong performance in Germany and Austria and a good growth in UK and France, with continued stabilization in the Nordic regions. As I mentioned earlier, Italy had a major center that was down due to equipment failures, but we believe that we believe that will return here in the first quarter going forward through 2025. We had 79 image quality upgrades in 2024, which gives us over two since 2023 and 34 new accounts were added in just the past twenty months.

Key initiatives throughout Continental Europe have are having impact, and we continue to execute on these initiatives. We also sponsored the most successful EAU Euro webinar. There were over two ninety six live attendees and even more on the replay, and there were over 61 questions asking the session. We were told it was the most successful they've ever had. So that was quite an achievement for the marketing and medical teams. Late quarter four developments. So Olympus officially launched their new VISTARA three Elite system with a four ks blue light capability. We are closely working with Olympus team to expand VISTA three installs with this upgrade. We believe VIZIR III is currently in about 10% to 15% of the Olympus accounts of installed base endoscopy equipment in Europe. So adoption will take time to build that momentum As I mentioned earlier, it's extremely important and particularly in the Nordic region where Olympus has a very strong penetration rate. There's several new systems that have already been placed along with new blue light capability in The Nordics and Germany since late Q4. Both sales organizations are working very, very closely together. And as and finally, as of 01/01/2024, the German healthcare reform went into effect FotoCure continues to see growth in unit sales in German hospital through mid-twenty twenty five February or February February twenty twenty five, but we'll continue to monitor healthcare reform situation Germany has evolved and managed to it appropriately.

Next slide. So this is the slide that you generally will see on the annual report. It's our annual sales revenue. You can see it nice growth trajectory over the years. Each year, we generate this slide and display in our annual report. We continually show growth in Hexfix and SysVu. And despite several headwinds along the way, particularly with blue light equipment challenges in both markets. However, we have tailwinds. Olympus being the last of the three major blue light equipment manufacturers to upgrade to high def blue light system, VorTeq mobile solution now building momentum in The U. S. To combat capital budget and preferred equipment manufacturer constraints. And the potential for additional manufacturers to enter The US and EU markets in the future. We believe the growth of this curve will continue to accelerate going forward. Next slide. We're going to get into some growth initiatives. First, I want to mention the potential reclassification of blue light equipment in The U. S. Which is subject of Karl Storz's citizen petition, as I mentioned before. There are several capital equipment manufacturers that are willing, wanting to get into The U. S. Market. Under our five ks 10 application process, which takes three to six months for approval, expanding the basic capital equipment is key in terms of blue light availability.

Quality equipment and service and potentially more competitive pricing. Importantly, in this scenario, more investment in the segment, more salespeople selling blue light cystoscopy in the market, and account access would be expected to open up dramatically, fueling growth in procedures for SisVu. With Karl Storz's petition now officially closed for public comment, we expect our consultants our expert consultants have informed us that the next activity expected would be that the FDA would publish a notice for the next steps in The U. S. Federal Register. Which A Compendium Of Activities Undertaken By U. S. Government agencies and its don't have to tell everyone on this call. The US government is a little bit chaotic right now. So we'll have to see how that transpires, but that is the next step. We are hopeful that the FDA addresses the SIS petition very soon. We are very well aware that the FDA is very aware of this particular citizen's petition. It has been a tremendous amount of pressure on the FDA that we've mounted mounted on them. They have acknowledged that. And, we'll see where this goes. So let's go to the next slide, So just the key growth initiatives, I think two just real key upgrades updates on this.

We now have 44 VorTeq using accounts out there. The announcement on Monday evening of Richard Wolf interim solution for Flex, it is a System Blue light source blue light cystoscopy light source. This is a matter connecting it to an already approved flexible scope to perform procedures. System Blue is already deployed in many accounts throughout Europe. We're We don't have the exact number, but our our sales force who work at their sales force. We would believe it to be in a several hundred or less We want, we want blue lysisoscopy in surveillance to remain relevant. So it's important that we got this out to the market. I'm very, very pleased with how the organization's work with each other. We'll be able to build the data and experience behind the launch of the LED HD system in a couple of years. When we launch the full system, and it'll meet the demands of our customers right now in this evolving bladder cancer care landscape, so increase where we believe there'll be increasing outpatient procedures. We see this in particular in The UK where lasers are being used in the outpatient setting and blue light cystoscopy is under customer demand.

So we're very excited about potential opportunity there. Final comment, the moment the momentum and pressure continues to be built behind the notion of accurate diagnosis and complete resections in line with the precision pathway pathway for bladder cancer patient care. We believe blue light cystoscopy can play an essential part in determining the precision pathway You know, the precision diagnostic leading precision therapeutics is equivalent to the precision pathway that everyone's wanting to put these bladder cancer patients on. So we're excited about it. Next slide, please. Just a couple of comments. We talked about this earlier. This is our CYRIS programs. One is the partnership in China for Hexfix. They're awaiting Richard Wolf equipment approval. They expect it to come midyear this year and the launch late this year into 2026. And then on the out license program of Savira that's been submitted last March, March or May. It has an eighteen month to two year approval process, but we believe that they potentially could get, based on the recent feedback, an earlier approval this year. We'll wait on that. That comes with a significant milestone, dollars 11,000,000. We're really excited about how that program is developing. Regarding EU and US, they are continuing to work for alternative [indiscernible] pathways into both those markets.

And we'll give we'll update or they will update the market when they find find a pathway forward. Alright. I will turn it over to Eric Next slide. 15, Eric.

Yes. Thank you, Don.

Yes, in this section, we will review the consolidated income statement. We will review the segments report for the two main segments and finally, headlines from the cash flow and the balance sheet. We won't talk much about impact of foreign exchange this time. For the quarter, the impact was approximately 1% and for the full year, approximately [indiscernible] Just a final comment before we get started. Next slide, please. So we're now looking at the consolidated income statement. And I'll start with separate lines. Consolidated Hexfix C suite product revenue was €128,600,000 in the first quarter in the quarter, and which is 13% above 2023 and the highest ever. Full year HEXWEX Swiss revenue was €487,900,000 growing 10% year over year. And within the guidance for the year. Hexfix Sysvieu in market unit sales increased 12% in North America and 11% in Europe in Q4. And consolidated for the full year, the increase in volume was 6%. Obviously, the sales have been negatively impacted by the face down of the CISO View usage in the flexible BLC setting in U. S. On the positive side, however, we have seen strong development in the sale and distribution by our partner VorTeq. [indiscernible] Total revenue was $1,141,000,000 in the quarter and the decline from 2023 is due to the lower milestone revenue in 2024.

Full year tonn revenue was $525,000,000 which is an increase of 5%. Going to expenses, Total operating expenses excluding business development expenses was SEK120 million in Q4. Year over year increase was €13,500,000 or 12.6%. Increase included investments in medical programs, it included indirect inventory cost adjustments and obviously also merit inflation and foreign exchange. The increase was also driven by an accrual adjustment, which was reducing the expenses in the Q4 twenty twenty three. In total, one off accounting entries amounted to approximately €5,000,000 of the Q4 year over year expense increase. And adjusted for one offs, the year over year expense increase in Q4 was 8%. Excluding Merit, inflation and foreign exchange, the increase was approximately 3%. [indiscernible] If you look at the detail of the P and L, you will see that other other expenses, it's increasing, and this includes mostly G and A. And it includes within G and A, a reclass from sales and marketing costs. If I adjust for this movement, or this reclass, you will see that G and A is is mostly in line with previous quarters. [indiscernible] Business development expenses were €5,200,000 in fourth quarter. Operating expenses within Business Development are related to Life's cycle management for Hexvik Sysu.

Our cooperation with Richard Wolf on the flexible BLC system as well as business development efforts that can diversify our business and significantly increase our growth rate. The expense level within Business Development obviously may vary from quarter to quarter given the one off nature of these expenses. EBITDA in Q4 of the business development expenses was NOK8.5 million. And for the full year NOK49.2 million. Excluding milestones and business development, our core business had a full year EBITDA of DKK20 million. Which compares to €8,000,000 in 2023. So a 10% revenue increase drove more than 100% EBITDA increase. [indiscernible] Depreciation and amortization was €7,300,000 in Q4, Main cost items is amortization of the intangible assets related to the return of the European business from Ipsen in 2020. Net financial items was zero in Q4 compared to a net cost of €6,000,000 in 2023. Tax expenses, net cost of 7,000,000 for the quarter compared to a net income of SEK 3,400,000.0 in fourth quarter twenty And then after tax, we have for Q4 a net loss of $5,800,000 and for the full year, a net loss of $4,800,000 Next slide, please. We will look at the segment performance. And for the segment reporting, I will as always focus on the two main segments, which is North America and Europe.

And the North America segment includes U. S. And Canada. And revenue for North America increased 20% in the fourth quarter The main drivers are volume increase from 12% We had increased average prices of about 5% and never to about 2%. Foreign exchange. Revenue was always impacted by the also impacted by the face down of SysVu usage in the Flex [indiscernible] as I said earlier, on the positive side, we have seen strong development in the sale and distribution of our from our partner VorTeq. [indiscernible] Q4 direct cost increased year over year with $5,200,000 or 13%. And the increase is driven by project expenses, inflation and foreign exchange. And full year direct cost comparison is impacted by a $5,200,000 one off accounting adjustment in third quarter twenty twenty three. This was for the capitalization of registry expenses in U. S. Q4 contribution was 7,800,000.0 compared to Q4 twenty twenty three of 4,000,000. Full year contribution was $21,000,000 an improvement of $11,900,000 from last year. From 2023. Looking at the European business, they had year over year revenue increase of 9% in the fourth quarter mainly driven by 11% in market volume growth. But negatively impacted by a reduction of inventory at wholesalers.

Direct cost decreased 2% in the fourth quarter. We ended Q4 with a contribution of $31,700,000 compared to $25,200,000 in '20 As a conclusion on the segment report, and on the business in the two segments, we see significant growth and improved profitability in both of these regions. Now let us move to the cash flow and balance sheet. Next slide, please.

So cash flow from operations in Q4 was €15,400,000 And for the year, cash flow from operations was $76,800,000 compared to 2023, 48,300,000.0 highly driven by improved working capital. Cash flow from investments in Q4 includes interest received and paid as well as investments in tangible and intangible assets.

And cash flow from financing Q4 and full year was negatively driven by earn out payments to Ipsen.

The term loan from Nordea was fully repaid at the end of second Cash balance of $294,000,000 The balance sheet total assets $733,000,000 non current assets was $313,000,000 at the end of the year, This included customer relationship with $95,900,000 and customer relationship in the intangible assets is the intangible assets identified in the purchase price allocation for the IPS [indiscernible] Non current assets also include goodwill, from the Ipsen transaction of €144,000,000 and a tax asset of $3,737,000,000 euros Inventory and receivables were $125,900,000 at the end of 2024, The increase from $2,023,000,000 euros is €13,000,000 and is driven by increased revenue. Long term liabilities, $397,000,000 include the earn out liability related to the Ipsen transaction totaling $117,000,000 at the end of the year. And finally, Equinix. At the end of the year was €500,000,000 which is 68% of total assets. And this concludes the financial section. Thank you. Back to you. Thanks, Eric. Alright. Next slide. Summary. So let's just go to the summary of the twenty twenty four Q4 results. Overall, I believe it was a solid quarter with a 13% top line growth, positive EBITDA, which was our seventh quarter in a row, of positive EBITDA.

In addition to positive EBITDA that we generated, we continue to invest in key initiatives that we believe will generate future revenue growth and increase our operating leverage while remaining relevant in bladder cancer care.

We grew Rigidower growth an estimated 17% in Q4 as we continue outperform the phase down of Sysu usage in the flexible BLC setting. VorTeq is coming on and helping with the with the strong growth. We expect that to continue to accelerate. Richard Wolf and FotoCure joint development program is now bringing Flex back the market in the interim solution. It's great news. We'll continue we'll continue with more updates on this as we continue to launch it throughout Europe. And rest of world, including some of our partnerships. We also look for opportunities to bring it to The US. In the meantime, we'll continue the development of the high def system LED with them. We also grew our active accounts ordering Sysco in The U. S. By over 11% in Q4, and we believe that this measure is a good indicator of our overall performance. We continue to work with Karl Storffs on the growth on the installed base of BlueLight equipment in The U. S. The high definition systems now represent about half of all blue light equipment, and we expect this to continue to promotional program is extended till March 31. There's many POs that we expect to come to fruition in the first quarter.

We'll report on that in our first quarter results. Forteck national mobile rollout continues to gain traction and contribute to our growth. Through Q4, there are 44 accounts. Keep in mind, it really officially launched mid late third quarter. Already 44 accounts have used the service. Some have ordered Sysco kits more than once. We have some instances where accounts have liked it so much that they're going to purchase their own equipment, which is a really good, bellwether for the business and the interest in blue light cystoscopy, the number continues to grow. In Europe, we continue to facilitate image quality upgrades in our nearly 600 target accounts, and we believe that Olympus Blue Light upgrade will help us strengthen that initiative as that launches here in the first quarter twenty twenty five. Additionally, our priority growth markets grew significantly compared to the prior year, and we anticipate the growth to return to the Nordic region with the Olympus upgrades in 2025. Gearing up for this year's AUA and EAU, just interesting statistic. In general, the submissions that go into these organizations roughly 20 to 25% of those submissions for presentations, posters, etcetera, about 20% to 25% are approved.

We can tell you and quite proud of the fact we've had a 50% acceptance rate of our submissions. So we look forward to reporting on AUA and EAU at the Q1. Our cash balance remains strong at $294,000,000 NOC. Up from the $260,000,000 at the year end in 2023. And as Eric said earlier, the commercial business continued to contribute positive Q4 and prior May, adding operating leverage. So finally, last slide, the anticipated [indiscernible] We expect 7% to 11% product revenue growth with year over year EBITDA improvement in 2025 minus BD spend in milestones. We expect continued operating leverage flow through in the commercial businesses and a significant milestone this year, in particular, Icyrus and, and the Savira approval in China. We continue increasing Hexfix and SysPhU kit throughput and tower upgrades, both in The US and in Europe, The collaboration with VorTeq will continue to accelerate as we continue to roll out of mobile throughout The US. They are prepared and will invest more as this continues to increase. In adoption. And we're focused on the growth markets and the Olympus Equipment launch in Europe. We're advancing the partnership with Richard Wolf, We have the launch of the interim solution that we'll work on for Europe.

In addition, we'll continue the development of the LED high def blue light system flexible system for that we expect to come out with in the next eighteen to twenty four months. We'll continue to present and publish additional data from the real world evidence patient registries and other studies supporting the use of BLC with Hexfix and Sysu. Leveraging our registries with non muscle invasive bladder therapeutic companies. The systems petition, while it is unknown and no there's no statutory requirement on response, I I said earlier, the FDA is more than aware the pressure we've mounted on them. They're feeling it. We're excited about this, but this isn't, as I mentioned, not the only way to market. We're looking at alternative ways to market. The key here is whether it's the systems petition, the reclassification of blue light scopes or other ways to market the main thing we're working on is getting additional equipment into The US and that's and we're working with everyone on that. And finally, Osiris progress will continue to monitor that. Hopefully, the NDA for Savira will be approved this year as well as Richard Wolf Equipment, so they can launch XFIX in China.

And with that, I think we'll land on the last slide for Q and A and turn it over to David. To ask any questions there in the queue. All right. Thank you, Dan, and hello, everyone. Really nice Q and A queue, so thank you guys for interest and all your hard work on these questions.

So the first question really has to do with expenses.

What were the drivers of the higher operating expense in Q4? And should we expect this to continue? Hi, it's Eric.

I think I explained the drivers for the higher expenses in Q4 and also the variance between Q4 and this year and Q4 twenty twenty four and 2023. So let me focus on whether this will be the the standard going forward. I It would be wrong to use the fourth quarter and establish a forecast for 2025 based on the fourth quarter. We scrutinizing expenses all the time Discretionary spending are kept on a very low level. But on the other hand, we need to invest I want you to watch. I want you to check or look at the slide where we present the segments and you will see that Europe has an expense reduction while U. S. Have a significant Because we need to invest in the opportunities in The U. S. We're not we're also investing in Europe, definitely. But it's a different market, different scenario. And as a company, we have to do that. We have to utilize the opportunities we have. We have to stay relevant. That was my comment.

Okay. Excellent. It's a related question, but given those higher expenses in Q4, what are you doing to reduce costs? I think you may have answered that, but Just asking. It's the same it's really the same answer. We are scrutinizing. We are taping the spending as low as possible. But I can't stop investing. [indiscernible] as Eric said, are about relevance. All these therapeutics coming on the market doesn't automatically happen that blue light is going to be the center of attention. You have to work with that. You have to invest in it. We were asked to be part of a patient registry in The U. S. Hosted by [indiscernible] and that is in conjunction with the major therapeutic guys. We're being asked. And why that's important? Well, if you think about these guys have to find the patients that are BCG, unresponsive, [indiscernible] deserve a different type of treatment or have CIS, and the best way to define or detect those patients who is blue light cystoscopy. And that data is going to be extremely important and rich into the future of treating bladder cancer. To be able to go back and say, I used XYZ therapeutic because I used blue lights cystoscopy and here's all the data of why blue light cystoscopy got me there is so vitally important.

If you don't play in these places, you will be forgotten. And so, you know, we're at this unique point in time where this landscape of bladder cancer care has heated up at such a rate that we've got to stay relevant here. And we've got to invest in ourselves. Same goes with reclass. And reimbursement. I mean, it doesn't happen on its own. You've got to mount the pressure on Congressmen, Capitol Hill, CMS, FDA, and we're going after it as hard as we can because if when it's not even if. When we turn the page on that and things change, it opens up a whole opportunity of growth for us that we need to get. The Richard Wolf interim solution a $1,300,000,000 segment of market that we currently cannot access. You got to invest in it. You got to go after it. Otherwise, you're relegated to the $300,000,000 market.

And that's great. But I want more. And I think everyone deserves more and these patients deserve more. The Olympus launch, having these partnerships with Olympus, Wolf, Karl Storrs, being agnostic of being partners with them, and driving the uptake of blue light scopes, you know, that we're relying on. Is extremely important. VorTeq, mobile units, these this doesn't just happen. You have to work with these guys and helping, expand the usage of Blue Light Cystoscopy throughout The U. S. And as we kind of, you know, one of our theories early on was as they use the VorTeq equipment, the interest and the usage will go up to a point where the counts will decide, you know what, I'd mobile is great. It's not cheap. It's on my operating expense, but I think I will find room in my capital budget to buy my own blue light machine. And that is happening. But it doesn't happen without the investments. And so we're investing for the intermediate, long term future of the organization. And I think it's beginning to pay off. We, as we said in the Slide 13, I think. So Maybe related to your answer, you know, what are the potential opportunities that could increase 7% to 11% revenue outlook for 2025?

I think it's all the things I just I just mentioned. I think and I think the other thing is, it should should things change in the reimbursement landscape, particularly in the the outpatient setting in The U. S. The You know, the, god, why is my mind blank? This I just got over a call, so I apologize. In the David, help me with it, not the hospitals, but the step down from the hospitals. The ASCs. The ASCs and the inventory surgery centers.

Sorry.

Yeah. As we get access to those things, that may also be of time when we look at do we have the right effort there. Is it more centers, more locations? Do we have the right size sales force? Should we add two people three people? I mean, for every opportunity, we're going to meet it with the proper investment at the right time to drive usage and utilization.

Congrats on the early entry of the Richard Wolf flexible equipment. Can you discuss that opportunity further and whether you expect to get that equipment into The U. S?

Yeah. So I will I will give credit, to one of our country managers in Germany, who, along with a key physician and I believe also with the Richard Wolf folks, found this opportunity organically at on-site. They just tried something. It worked. They took it back. Richard Wolf took it back to the engineering team. They determined it not only did it work, it's actually a good interim solution to carry forward on it. We now have the availability for Europe and rest of world. We have a list of a bunch of countries, includes many of our partners where this opportunity could be utilized, Australia, Chile, Israel, China, So we will actually, lay this out for our partners as well. And it's exciting opportunity to get this into the market a year and a half to two years earlier than we thought. One of the things about about any therapeutic or any device or anything you use is you don't want the market to go cold. And so this is an opportunity to keep this market hot, engaged, generating revenue or generating data, I mean, not revenue. Well, it does generate revenue, but really it's about the data, the relevance, collecting, seeing how it's used, positioning it, market research around it.

It really sets us up for a very good launch in a year and a half. And reminding everybody, we are developing the world's only with with Richard Wolff, high def LED flexible blue light scope. [indiscernible] a little more, you know, have more bells and whistles, be a little bit more user friendly than the interim solution. But for the doctors who really want access to surveillance with blue light, they have a nice all alternative and it exists right now in two different components that need to be basically connected. To work if they own them.

Excellent. I'm going to ask a related question to that. So based on the statement that the interim the flex market is $1,300,000,000 and the interim solution is now available. Does this mean sort of the surveillance market is open in Europe?

Yeah. I mean, it's it's open in the sense that, it's accessible. Now you got to also look at country to country reimbursement scenarios to reimbursement scenarios trending etcetera. So the short answer is yes. We have something that we can sell in Europe. I think where it's been adopted so far has been the Nordics. We know there's strong interest in The UK, and then there are other parts of Europe where we think there'll be some opportunity as well. I'm not claiming this to be the be all and end all right now. I think we're working on all the other components of a proper launch. But in the meantime, this serves a a definite customer demand and customer need. Patient need. Yes.

And I'll just add to that.

Where Richard Wolf System Blue is available, there is now an option to buy another piece of equipment that you can use with the System Blue to turn it from rigid to flexible. So there is a capital equipment purchase. It's really a not a big number, but it still is a number and still a decision has to be made, has to be sold And then also in Europe, the infrastructure for flexible blue light or flexible, yeah, blue light cystoscopy is not quite there. So but this gives us that opportunity to start to build that infrastructure and that's what's going to be needed when the optimized solution comes out in a year or so. And I think the other one other comment too too, the therapeutics that are in The U. S. Are still still got to make their way to Europe. They're expensive. And so as The U. S. Sort of sets the tone and tenor on using blue lights cystoscopy to surveillance patients after they get TRBTs determine if therapeutics work or not work will lead into a European acceptance and adoption over time as well. So that's important. And now the other question you had is on The US.

Yes. We are looking at ways into The U. S. As well. So stay tuned there.

Great.

There are several exciting upcoming triggers with FDA reclass, HEXXAIC's launch in China, potential approval of SAVIRRA, and others. If some or all these come through, what impact does management believe this will have on EBITDA? [indiscernible] Frankly, because we're talking milestones, particularly for [indiscernible] I mean, it will obviously have a very positive impact but I cannot quantify it But just look at the development over the last couple of years, with the milestones and what happens to EBITDA.

Yeah. The Osiris along with the milestone any money they generate and and whatever they owe us goes straight to the bottom line. So it's a % leveraged in [indiscernible] So I'm going to take this next question, which seems to pivot off of that. And that is, Fotocure Photocure is trading at the lower end of the range last five years. Does Fotocure management view the current share price as fairly priced? And I'll answer that after you guys want to take it or You can take it. You can. Sure. Yeah. I mean, I think our view is no. No. We're trading from an EV to revenue basis of less than two times There's no value for Savira. Eric just talked about that, what that could do for our EBITDA. And Reclass is not in there. The new therapeutic trend, not in there. Any reimbursement upside, Olympus really kicking in and growing the Nordics and the rest of Europe.

And the upside from Forteck.

So I think, yes, maybe I think we're below the operating business as it is. In terms of fair value and then all these upsides which would be complete leverage because we're already generating a positive EBITDA with the base business without all these upsides [indiscernible] [indiscernible] When you guide for higher EBITDA in 2024, does this include any milestones? In 2025?

No. Great.

From this is a reclass question. From your experience, how long from public comment closure until the proposed order is published in the Federal Register.

No. No statutory requirement. No statutory determination. It could be any day, it could be days, it could be months. All I can say is that we the FDA has made us aware that they are fully aware about blue light cystoscopy and the OAY class of device. That's half the battle right there, because there's many petitions that go in. This has been a a blitz of stuff hitting them from all angles from manufacturers, from patients, from physicians, from other organizations, patient advocacy groups, all demanding access to blue light cystoscopy. So we're mounting a tremendous amount of pressure. We're not leading it just with the FDA. We're working with Congress as well. We just had a change administration. Fortunately for us, everybody we are working with retained their seats in Congress. So we, you know, we let the dust settle and we're pushing as hard as we can. Yeah. That's all I can say about it. It's just it's just one of those government things. But I do again, I know everyone gets really caught up on reclass. And that being the be all and end all. The ultimate goal here is more equipment manufacturers and more blue light accessibility in The U. S. Reclass is one way to get there.

We are pursuing other ways to find a way to help other all manufacturers get into this market space. So stay tuned on that as we progress through 2025.

Okay. Let's stick with the government for a minute, the U. S. Government. How would a potential import tariff to The U. S. Affect Photocure? And then the same question if a similar tariff would be introduced in the EU. That's kind of topical today. Yes, take U. S. We have a cost of goods sold in U. S. Which is around 3% So if you 25% if that is the alternative 25% on 3%. It's very small amount.

Thanks, Eric. When will the next generation flexible BLC from Richard Wolf The available to customers, NextGen.

The NextGen?

Yeah.

What we said when we announced it back in July, we said we'd take approximately two years for development. Through to approval. So somewhere in 2027, is where we think that would potentially launch.

Okay. [indiscernible] from accounts in Europe.

It's already start they've already started to implement a handful of accounts here early in the first quarter. I think it will continue to build throughout the year. And we'll report on it as we gain more momentum.

Okay.

Let me go back real quick on Bridger Wolf by the way. I said 2027. It could be late twenty twenty six too. It's just, you know, when I think about full on launch, everything working right, it's in my head, I'm thinking '27, but if we can get approval before that, we'll launch before On Osiris question, assuming approval of SAVIRON in China this year, when do you expect the product to be on the market? That's a question for Cyrus.

I would expect them to get to market within six to twelve months, but I can't speak for them. You'll have to go to their website and their Yes. I mean, I could say, the IPO of Osiris really, Savira was one of the centerpieces if not the centerpiece. They created a whole new women's health division around it. It's an important product. So I think they want to get it to market as soon as possible. [indiscernible] We're getting to the bottom here. What was the share of VorTeq of U. S. Sales in Q4? And what are the assumptions for VorTeq growth in 2025? Share of VorTeq in the fourth quarter was around 5% to 6%. We expect that to continue to grow throughout 2025. Excellent. Sorry to end abruptly, but it's, after a long, it was of questions, I think that's all we have. So appreciate the questions everyone out there and I'll turn it back to you.

All right.

Good. Well, thank you everyone for joining us. I think we have a lot of exciting things going on. I'm particularly excited about a lot of the investments we've made Already a couple have come through, such as the interim solution for BlueLight Flex Cystoscopy, As Well As VorTeq, Towers Being Deployed Throughout The U. S. And generating revenue and usage. And already kind of the hypothesis was that some accounts will convert and they already started converting. So good news there. I hope to report even better news as we move forward through 2025. So thank you for joining. Have a great day.