Photocure Asa

All right, well, good afternoon, everyone. Good morning here in the U.S. My name is Dan Schneider, President and CEO of PhotoCure. Welcome to PhotoCure ASA's first quarter 2024 results. Joining me today is Eric Dahl, CFO, and David Moskowitz, Vice President, Investor Relations. Next slide. Just a reminder, the usual disclaimers are in place for today's presentation. Slide three, please. Great, so first quarter highlights, product revenue, grew at 10%, unit sales 6% year over year. We had 17 Sapphira Towers placed in the US. There were six new accounts that were open. There were five upgrades from existing accounts. And then, and we'll get into this more today, we'll talk about the six mobile Sapphira towers that are now carried in the Fortex system. In Europe, we're executing on the priority growth markets. Both UK and Italy had significant double-digit growth. France is also coming on. The underpinnings of that business look very, very strong. We're expecting an increased momentum through the rest of the year. And the Nordics have stabilized, and some of the countries have actually increased slightly as they await the upgrade. All right. Well, good afternoon, everyone. Good morning here in the U.S. My name is Dan Schneider, President and CEO of PhotoCure. Welcome to PhotoCure ASA's first quarter. 2024 results. Joining me today is Eric Dahl, CFO, and David Moskowitz, Vice President, Investor Relations. Next slide. Just a reminder, the usual disclaimers are in place for today's presentation. Slide three, please. Great. So first quarter highlights, product revenue grew at 10%, unit sales 6% year over year. We had 17 Sapphira Towers placed in the US. There were six new accounts that were open. There were five upgrades from existing accounts. And then, and we'll get into this more today, we'll talk about the six mobile Sapphira Towers that are now carried in the Fortex system. In Europe, we're executing on the priority growth markets. Both UK and Italy had significant double-digit growth. France is also coming on. The underpinnings of that business look very, very strong. We're expecting increased momentum through the rest of the year. And the Nordics have stabilized, and some of the countries have actually increased slightly as they await the upgrade to Olympus blue light equipment in the second half of this year. We still face ongoing challenges with flexible BLC in the U.S. slowly eroding. Single manufacturer in the U.S., which plays into the citizen's petition, the hope that one day soon the product is classed down to a class two for a 510K pathway. We are fully aware that all the major manufacturers of blue light equipment across the globe are highly interested in the U.S. market and are queuing up for that day. And then, you know, we've had a slight delay in the Olympus upgraded blue light equipment. We expected it to be in the first half of this year. It is now pushed into what they're saying now is early second half of the year. So ongoing. From an EBITDA standpoint, we had nearly $8 million NOC, excluding business expenses was $8.6 million. It's been mostly stable for nine straight quarters. So we are getting our operating leveraged. We have a very strong balance sheet with 258 million NOC in cash. And as we announced recently, just the last couple of days, Savira has been entered into the Chinese NMPA for review by Osiris. And that brings a $2 million milestone to PhotoCure, which we expect to get in the coming week. Recent milestones, the Phase 3 data trial in China. using high-def equipment was presented at ASCO GU and at EAU. It was met with a lot of interest. In addition, I think probably one of the most significant presentations in quite some time was the VA Bravo data at AUA. It was a packed room. People were standing room only. There were only four questions, mostly intrigued and asking what this really means, understanding that what we are saying is that blue light technology in the era of all these new expensive therapies coming up can make a definitive decision in the diagnosis and treatment for bladder cancer patients. Said another way, patients who have blue light cystoscopy will get a better diagnosis and get on the right medications And if they don't work, they'll go to the next generation. So this was extremely exciting with not only recurrence, but progression, overall survival showing showing significance. There was an acceptance, I said, of the Osiris-Savira program. That is I know there's been various conversations on various platforms. That is a probable 18-month review. We'll wait to hear officially from Osiris as that continues through its pathway. And as you all know, HEXVIX for China was submitted last fall. That, too, is on an 18-month pathway. However, because of the data from Hainan, the medical tourism data from Real World Events, there is a thought that maybe the Chinese authorities may speed it up a little bit more. But both are on the typical 18-month review pathway. program. Fortech Mobile, we'll talk a little bit more about this strategy. It's probably maybe one of the worst kept secrets in the history of business. The definitive agreement is in process between Carl Storrs and Fortech. It has been ongoing negotiations for months. However, For anyone that's aware, you have probably seen it. Fortech has already begun the promotion and begun doing cases across the U.S. with their mobile platform. They created a special rack tray to carry this equipment mobile throughout the United States. They started in the In 2021, with the pilot program with one tower, they recently purchased five more. They have six in their possession. This is the beginning of where they intend to go with this. If you look at any of the past analogs of various mobile equipment that they've carried, whether it be the Fusion MRI or Galil's laser... prior ablation system, which I actually personally had experience with back in my past history, they make a significant impact on the market. And we'll talk a little bit more about how that makes that impact. But this is really exciting for us. And we're in the early, early stages of what this could mean to us. And finally, the reclassification of BLC, there was an additional supportive comments by Olympus to the citizens petition. We also had written into the Oncology Center of Excellence, and we'll continue the pressures there, both legislatively and regulatorily. All righty, next slide, please. So let's get into the segment trends. Slide five, please. All right, so for the U.S., we had strong trends in the commercial region picking up in March. We're still facing some of the headwinds of FLEX. If you remember back, flex was officially declared to be beginning the withdrawal or the lack of support basically beginning in March of last year. So for the first quarter of this year and second quarter of this year, we still face significant flex units that we had in prior years that we don't have now because we're down to 27 flex machines operating in the U.S. through the end of March. In Europe, there was a consistent growth. A lot of that is fueled by a good amount of business in Germany continues to grow at its mid-high single digits. And then we had significant growth now for several quarters in a row in both Italy and in the UK. This is fueled by the upgrades and the re-ignition of many of the old accounts as well as new accounts. And we expect France to pick up momentum as we move into second, third and fourth quarter this year. So very, very, very pleased with the developments. And I feel like the organization has got back on track after facing some things that weren't so much in our control, whether it be flex, COVID, the delay in the in the Sapphira launch, etc. So looking really forward to it. I think Europe in particular is looking forward to the Olympus launch, which is used in approximately 35% to 40% of the accounts throughout Europe and very heavily throughout the Nordics, which we intend to regain position on. Next slide, please. Slide six. So some of the key trends in North America, revenues increased 13% in market units, rose 2%. But I think what's most important, and this is sort of an estimate, is that the rigid growth was approximately 12%. And that is outpacing the flexible BLC phase down. We'll continue to see BLCs slowly erode through the market this year. Really where we're at today is the loyalists who really believed in flex and used it are trying to hang on to it. They are in many cases relegating it to the more severe cases. So usage may be dropping, but they're trying to keep it going for as long as they can. In the installed base of BLC Rigid, as I mentioned, there were 17 Sephira. We also had a temporary backorder on five new account POs for Q1 that will be placed here in Q2, awaiting certain pieces. This is a temporary backorder expected to be resolved. We had nine counts reactivated in Q1. We had 18 reactivated in 2023. Your question might be, what is reactivation? Reactivation are accounts that may have gone nine to 12 months without purchasing. And many times reactivation is a matter of a key user who's moved from one hospital to another. Could be the equipment has been down or they haven't upgraded it, or it could be a process snafu through the nursing staffs. But in any event, the accounts are being reactivated and back online. We also strengthened the label in Canada for reuse and CIS. And then we also launched our beginning launch of the Fortech mobile strategy that initiated in the first quarter. The 2024 AAUA was outstanding for us. Bravo 2 data was presented, as I mentioned. I think it's also important to note in this space, if you're wondering how important blue light might be The non-muscle invasive bladder cancer space has currently 29 registered trials in the U.S. Ten of those are phase three. In almost every case, these are trials seeking patients who have BCG failures or CIS. And if you look at what Blue Light does, that is exactly our spot. We are the best at detecting carcinoma in situ, and we're fantastic at detecting whether or not bcg has worked or not worked uh in the treatments and this opens up the opportunity for these second line therapeutics so as you can see there's a lot of interest from their side of it to see blue light cystoscopy uh rapidly adopted throughout the u.s and and eventually throughout europe as well as they make the registrations there as well um patient registry to that point is extremely viable we we uh we capitalized it last year uh it is uh it is uh uh Highly interesting to all the major manufacturers. I can't get into specifics of any of these things are under NDAs, but there's a lot of interest in looking at real world evidence and how their products are being used in the blue light, in a blue light case. And then also a lot of activities around reclassification, as I mentioned earlier, with all the major manufacturers now having weighed in on this. And in addition, the special controls, which is basically the recipe, has been put online by Carl Storrs. And so we are hoping that the FDA picks this up and begins the process. But at this point, we have not heard through Carl Storrs yet any official word on it. But we are hopeful and we continue as an organization to apply as much pressure as we can, despite it not being our our citizens petition, but we're doing everything we can to get this fixed. Next slide, slide seven. Right now in the US, 40%, 42% of the scopes in the US are from the new SAFIRE and we have five on back order and we'll continue to progress. Our range this year was 40 to 70 new SAFIRE. And again, this first quarter we had 17, so we're well on track for our guidance. Slide eight, please. So trends in Europe, revenues increased 9% year over year, and there was an 8% unit growth in Q1, heavily driven by Italy, UK, and Germany, and Belgium. We executed on a plan to increase penetration in those priority markets. As I said, UK and Italy, these are not small, single, double digit. These are actually very, very strong double digit growth in these countries. And so we're really looking forward to it. It's been consecutive quarters now, so we can claim that this is actually a path that we're on. And we know that in France, the underpinnings of the business from KOL engagement, key institutions, adoption, equipment upgrades, and new purchases, that all those things are in place now. And we expect France to start picking momentum up through the second quarter and through the second half of this year. All right. Two abstract presentations. There's pictures to the right. A lot of interest in PhotoCure and blue light cystoscopy. And we had many of the major KOLs across the globe who I met personally at the booth at EAU in Paris. All right, next slide, please. So I'm going to take a moment on this slide just to kind of talk through some of the markets in the DOC region, Germany, Switzerland. It's a gold standard. We have KOLs in place, good equipment. The upgrades that we do in Germany tend to be more minor because they've done a good job of keeping their equipment up. They have a high penetration rate in roughly 40, 45%. They continue to grow at mid-single digits. We don't see a change to that quarter to quarter. It's ranging in and around the 5% to 7%. So we expect that that good, strong middle single digit growth. In the Nordics, we had the issue with erosion due to outdated Olympus equipment. Olympus had the highest percentage of penetration throughout the Nordics as compared to the rest of Europe. So the solution for us was to stabilize this business, which we have done, and we are in process of co-launching. So working with Olympus, to co-launch in the Olympus new blue light equipment in the second half of this year. In the growth markets, which is France, UK, Italy, Benelux, we're seeing underlying critical business ignitions in place, the KOLs, access to accounts. Remember, we took over Europe in the midst of COVID. We didn't have access to many of the accounts for the first 12 to 18 months. We've gotten the equipment upgrades in full swing. I think we had 153 upgrades to date so far. The data and the interest in blue light cystoscopy is extremely high. The KLO engagement is extremely high. So country by country, the issue in France was equipment upgrades is critical. We also had some delays from Carl Storrs and some of their deliveries on upgrades. The solution is the deliveries are in place now as we've moved through first half and we expect growing impact for France coming into the later half of this, well, this quarter, second quarter. through the second half of the year. In the UK, we had issues with health systems striking, even though we've got new accounts up and running and upgrades taking place. But we expect increasing momentum through the UK. In Italy, a lot of outdated equipment. I think we've talked about in the past, we've got a similar mobile program piloting in Italy to offset some of the capital costs issues that they face, and also trying to get around some of the niching because of it. So we are now engaged with some of the leading cancer institutions throughout Italy. We have a very, very strong growth rate going on in Italy, and we expect that to continue forward. And then Benelux was our very first European countries to turn around And the first half was growing at roughly, you know, in the mid single digits as well. So very, very strong. The one other comment I'll make, we have the untapped markets. We have now started a pilot in Spain. Spain has a total addressable market similar to the UK, roughly 60,000 TRBT's. And it comes into the average price for all of Europe in terms of its average selling price. The reimbursement is in place. The issue was equipment. We've now convinced Carl Storrs to enter that market and start the pilot. So we will look forward to Spain contributing to the European results in the future. All right, next slide. So this one is the slide on OSIRIS and the two programs that we've outlicensed to them. First one is HEXFIX for China. As you know, it's been submitted to the Chinese NMPA. We expect that will continue. We know they're actively reviewing that file. Everything so far is on track as far as we know. So we could hear something at the end of this year, first half of next year. And then SAFIREA. was most recently submitted in the last few days. That is an 18-month review. We have a $2 million milestone payment due to us that should come in the next week or so. And then that will then start through its process. Upon approval of both of these products will be additional milestone payments. And then, of course, royalties and sales milestones into the future. So these are all likely 2025 events. All right. Next slide. I'm going to hand over to Eric for the Q1 financials.

Eric. Thank you. Thank you, Dan. Let's stick or stay on slide 11 for the time being, please. And what we're going to look at in the next slides is the consolidated income statement. We'll look at the segment report for the two main segments. And finally, we'll look at the cash flow and the balance sheet. A couple of words about foreign exchange first. As you've seen, the Norwegian kronor weakened also in the first quarter, year over year, and measured by unweighted quarterly average, the US dollar increased about 2.7%, and the euro increased 4% year over year. And measured in Norwegian kronor, the impact is on revenue, positive approximately 3.5 million, and on operating costs, negative approximately 2.8 million. So we have a net positive EBITDA impact of approximately half a million NOx. Final comment before we go to the numbers. Please keep in mind that unless other currency is specified, all amounts mentioned in this presentation are in Norwegian kronor. So next slide, please. Slide number 12. Yeah, what we're looking at now is the consolidated income statement. Starting up with revenue, it was 118 million in the first quarter. It's an increase of 11.8% or 10% for 11.8 million and 10% from Q1 last year. And the main driver was volume growth of 6%. But we also had impact from foreign exchange as well as increased average selling price. The revenue increase at constant currency in Q1 was 8% compared to the first quarter last year. So it's well within guidance. Total operating expenses, including business development expenses, was 102 million, which is an increase of 1.5 million from Q1 last year. An increase was driven by foreign exchange with a total of approximately 2.8 million, which is offsetting cost containment measures and timing of project expenses. EBITDA in Q1 after business development expenses, 7.9 million in total, This is an improvement. The EBITDA of 7.9 million is definitely an improvement of 9 million from last year's first quarter. And the improvement is revenue driven. Currency impact included in EBITDA is approximately 0.5 million positive for the quarter. Then we have depreciation and amortization, 7 million in Q1. Main cost item is the amortization of the intangible asset related to the return of the European business from Ipsen in 2020. And net financial items in Q1 were a net cost of 4.8 million compared to a net cost of 2.4 million Q1 last year. And the increase in net cost is driven mainly by foreign exchange. Tax expenses, 3.9 million for the quarter. The net tax expense is mainly driven by intercompany items in the parent company, as well as a minor amount for taxes paid in European subsidiaries. And after net financial items and tax, we have for Q1 a net loss of 7.9 million compared to a net loss of 11.7 million same period last year. And the main single driver of this improvement is improved revenues. Next slide, please. We're going to look at the segment performance. North America first. Revenue for North America increased 13% in Q1, driven by price increase. foreign exchange, and volume. The volume increase was 2% year-over-year, significantly impacted by a decline in flex volume due to ongoing flexible BLC phase-down in the U.S. And the rigid volume increase is estimated to 12%. Q1 direct cost declined year-over-year with 1.7 million, or 4%, in spite of a 2.7% strengthening of U.S. dollars compared to NOC. And the contribution was 4.3 million positive in Q1, an improvement of 7 million compared to the same quarter last year. The improvement is revenue as well as cost-driven. EBITDA in Q1, negative 5.1 million, reflecting an EBITDA margin of negative 11% compared to negative 28% Q1 last year. So we have a year-over-year improvement of 17 percentage points, or 6.5 million crowned. Looking at the European region, They had year-over-year revenue increase of 9%, which is mainly driven by in-market volume increase of 8% and by foreign exchange, partially tempered by stocking at wholesalers in the quarter. We were pleased to see significant growth in priority growth markets in the quarter. Direct cost decreased year-over-year 1.7 million or 6% in Q1. in spite of negative impact from FX as Euro appreciated 4% year over year. So we ended the first quarter with a contribution of 36 million compared to 29.6 million Q1 last year. And the improvement is driven by both revenue and operating costs. EBITDA for Q1 was 19 million, reflecting an EBITDA margin of 27% compared to 22% in Q1 last year, a year-over-year improvement of 5 percentage points, or 5.3 million crowning. Next slide, please, to look at the cash flow and the balance sheet. Net cash flow from operations 5.1 million positive in Q1 compared to negative 9.1 million Q1 last year. The improvement was mainly driven by EBITDA and working capital. Cash flow from investments was in first quarter positive 0.2 million and cash flow from financing in Q1 was negative 6.5 million, which was driven by the Ibsen earn out payment. The improvement from last year is driven by the repayment of 6.3 million kroner of the term loan from Nordea, which was fully repaid at the end of the second quarter 2023. So this gives a net cash flow in Q1 negative 1.2 million compared to negative 22 million in Q1 last year. The year-over-year improvement is mainly driven by improved EBITDA as well as working capital and last year repayment of the term loan. And with this net cash flow, we end first quarter 2024 with a cash balance of 258 million crown. Looking at the balance sheet, we end the quarter with total assets of 740 million. Non-current assets was 333 million at the end of Q1, and this included customer relationship with 108 million. Customer relationship is the intangible asset identified in the purchase price allocation for the Ipsen transaction. Non-current assets also include goodwill from the Ibsen transaction of 144 million and a tax asset of 45 million. Inventory and receivables, 122 million at the end of Q1, and the increase from last year is mainly driven by increased revenue. Long-term liabilities, 151 million, include the earn-out liability related to the Ibsen transaction of 126 million. And finally, equity at the end of the quarter, 483 million, which is 68% of total assets. And this concludes the financial section. Thank you. Dan, it's back to you. All right.

Thank you, Eric. Next slide. All right. Two slides left. We'll go to slide 16 on sort of a summary on Q1 2024 results, which I'm very, very pleased with. We had 10% product revenue growth, 6% unit. And I think what's most important year over year in the face of flex decline, but we're executing against the key initiatives. And our focus, as we said, coming out of fourth quarter is to drive utilization in the many, many upgraded towers and new towers that have been placed throughout the globe. We continue to build on our operating leverage. Commercial businesses contributed positively in Q1. We see that continuing into the future, which is what we all were striving for. We had 17 Sapphira towers installed, six new, five upgrade, and then we have the six mobile. I think excitingly, we're launching the Fortech mobile tower expansion. And to just kind of give you, I know there'll be questions on this, to give you some context on this, if you look at some of the the analogs that have been involved in these mobile strategies. I've seen somewhere when Fortech got involved market share in a five market player. So there were five different companies in the MRI fusion space. The folks at Fortech were able to drive 91% share because people liked the operating model better than having to buy the equipment. So I'm not saying we're gonna get 91% margin or share, but I also, I want to say that I think this is a significant growth opportunity for PhotoCure, especially if you think about today's world where interest rates have risen, capital equipment budgets and capital budgets in general have tightened. So this is a release valve and I think a clever way to continue the growth of blue light cystoscopy. The installed base of 154 Sapphire Towers throughout Europe now represents, I mean, in the U.S. now represents 42% of the towers in the U.S. And these towers are much more reliable. And what we see in general is that old machines slowly decay over time and usage. But these Sapphire systems are able to regain that momentum. The flex phase down continues to be a challenge. But the growth of the rigid market is outweighing that flex pressure. Like I said, first and second quarter this year still had pretty strong flex numbers, and then it started waning second half of last year. So we'll be up some significant comps here in the second quarter, but then they'll start declining. The priority growth markets in Europe are responding well. And like I said, UK and Italy are in very, very strong double-digit growth consecutive quarters in a row. There's strong momentum in the entire space of non-Muslim-based bladder cancer and BLC. We have strong support. And all these therapies are looking for an opportunity to work with us. And the cash balance remains strong. So slide 17, last slide, is anticipated milestones. We're going to reiterate our 24 guidance at this point. We'll revisit when we come back to you at the end of the second quarter presentation in August. But 6% to 9% product revenue growth, positive EBITDA, and 47% Sapphira installs, including both new and upgrades. And as I said, we had 17 this quarter, so we're well on our way. High focus on increasing HexFix SysView kit throughput through continuing to grow the BLC tower base in the U.S. and the use and leveraging of the Fortech mobile strategy, the penetration in the EU priority growth markets, and the pursuit of FlexBLC equipment. We didn't talk about that today, but that continues. Look forward to announcing that in the near term. but we intend to come out with a proprietary flexible system because that addresses approximately two-thirds of the total addressable market in which cystoscopies can be utilized. So we want to be in that space, especially in light of the fact that last year, first quarter in 23, the pipeline and the interest in flex was exploding. And I think that's testament, again, to the importance that blue light can play in the future of definitive care definitive diagnosis for all these expensive therapeutics that are hitting the markets. We'll continue to proactively support the Citizens Petition, doing absolutely everything we can. Data will continue to publish from real-world evidence, patient registries, as well as third-party sources. Again, exciting, exciting news at AUA when we presented Bravo 2 and we showed significance in recurrence, progression, and the holy grail of overall survival. And then finally, the Osiris assets will progress through the year. Again, these are Osiris' products. They will communicate. They're a public company themselves. We'll communicate when they communicate as best we can, but we anticipate that will continue to progress. What we are also aware of is they are going to have a pre-MMA application meet with EAU, EU authorities. The reason for that is they did have European patients in their phase three, and they want to see if the European Union or the European authorities would accept an application for an approval for Europe. If that is the case, they'll try to file by the end of this year. And then we understand that they are going to reenter discussions with the FDA based on the phase three results of Sevira being a different clinical design than what the FDA was requiring. They're going to see if they can get the FDA to agree to the way they had designed it. So, I think with that we can move to the last slide, which is Q&A and turn it over to David, who's probably going to have questions for us.

OK, thanks. And hello everyone and thanks for all your questions. Good good queue of questions today. And Dan, you're correct. A lot of questions on Fortech. So question one is the Fortech decision that you mentioned today. Is that the large order that you were expecting and Related to that, is there still a large order to come?

Yeah, I would call it the first phase tip of the spare of where they want to go. They start with one tower for their pilot in 21-22. They were negotiating from mid-year last year all the way to where we are today. For the extension, they purchased five more, which they've now deployed. So that gives them six in market today. they do have intentions to expand that significantly for the rest of the U S. And, and I think that's about as much as I better say without them having an agreement and announcement out themselves. Okay, great. But I think the good news is we, that a partial big order. So it's just the beginning. Yeah.

Okay, perfect. Excellent. Another question, a question on the guidance, actually, you know, some people are feeling that the guidance is conservative. Can you comment on that and also talk about the key factors that would drive the guidance to the higher end of the range for this year?

Yeah. I mean, we're in the first quarter and it looks very good. And I feel like we're in the range and very strongly in the range. I think Eric and I both agree. You can't come out first quarter and start adjusting your guidance. We can take a look at the mid-year. Why I What has to kind of happen to push this guidance even higher? I think for tech trans traction, this model is phenomenal, is all about utilization, is driving utilization. So if they have a tech in every procedure, that's different than what we can even do. They have hundreds of tech technicians in the U.S. that sit in operating rooms and make sure that the cases go off. They try to stack two, three, four cases a day. They're running towers all over the United States. They're getting to accounts that don't have capital equipment or don't have capital budgets, or maybe they're tied to Olympus, but they'd like to use blue light. I mean, this has so many different opportunities for us. I can't underscore kind of the excitement around what this potentially could mean for us. I think the Olympus launch in the second half for Europe is extremely critical. The sooner in the second half that happens, the better. We are in co-launch planning with them, in particular for the Nordics. We also are working on regaining ourselves in Denmark. We feel we have a very strong application to go into the Danish Treatment Council. So look forward to that. That'll be probably the late second half event, which then will lead into 2025. I think all of the excitement around non-muscle invasive bladder cancer and all these therapeutics, particularly in the U.S., are going to drive a lot of excitement around detecting and finding the patient's who are BCG unresponsive or may have CIS, but it's undetected under white light, but can only be seen under blue light. So I think that's going to fuel our tanks. I think the continued traction of the EU growth, now that they've had full access for well over a year now, you're starting to see the fruits of that labor with KOL engagement, key oncology institutions now adopting blue light, new equipment throughout Europe. So it's very, very good. So yeah, I think those are the, I think that's, you know, and then it's driving the operating leverage. You know, we've got a solid cost basis for our sales organizations, and I feel like we can drive more profitability. Yeah. Excellent.

A lot going on. And you answered a subsequent question about the Danish Treatment Council. When could that happen? And you talked about later this year, early 2025. Great. Cool. All right. Can you talk about the utilization of Sapphira Towers? How do you expect that utilization to trend over time? It's over trend.

You got to put in context of how institutions buy. And it's sometimes hard to pick up trends. You need a good time horizon on this. What we know so far is that in particular in Europe, especially Italy, now France, but U.K., Those equipment were very, very old and were all but abandoned. Getting new Sapphira, new equipment in there, whether it's Olympus Sapphira or Wolf, has actually had a dramatic impact on their business. So there is absolute increases. In the U.S., we saw a little bit of a different nuance to that. In the U.S., standard definition over time degrades. The light bulbs dim, the equipment breaks, they have issues with cleaning it, the cables are busted. And so the usage goes down over time. What we've seen with Sapphire is increased reliability, as we predicted, in usage of those machines. So, yeah, it's and I think the excitement, it's now in high def versus standard def. So I think the physicians are really enjoying the experience in blue light. And I think, you know, beyond those things, other things that those also impact is make sure the process in place, the users, you have multiple users on it, you know, using the blue light in each institution. So. I think it'll continue to improve.

Okay, excellent. With regard to the Fortec strategy, how will Fortec, Carl Storrs, and PhotoCure all work together on this initiative?

This is exciting, actually. All of us are 100% aligned. I'll say one thing. On the organizational side, there was organizational changes at Carl Storrs. I know the individual who leads the U.S. from the broad's perspective is an ex-Phillips guy. Phillips had experience with Fortec, very, very positive experience. So they are engaged and excited about it. The way this program works is Carl Storrs sells the equipment to Fortec. Fortec then deploys the equipment, and they charge a per-surgery case rate. And in that case, the disposables are used, and it's in those disposables that flow money back to Carl Storrs. For us, it's SysView. So we have an incentive. We want to see as many cases as possible go off. SysView is used. Carl Storrs makes money on both the capital equipment and the disposables or the reusables, not the reusables, disposables. And then the guys at Fortech make money on each procedure, you know, as an upcharge. So both us, Carl Storrs, and four tech reps have met on local levels to develop strategy plans on which accounts to go after, which ones make sense, which users, which urologists. Every account throughout the U.S. has put those plans together. And now with six towers deployed, some of those regions of the U.S. are already actively engaged. They're doing cases this week. They did them last week. The week before that, they continue to grow. The key here is trying to stack cases So if Fortec's going into Hospital A, they like to see Hospital A put two, three, four cases in a row so that they wheel in the blue light machine, the tech is there, the cases go well, they pack it back up, they put it back on the truck, they clean everything, and the next day they go to Hospital B and hopefully have two, three, four, five cases lined up. And they will do that every day of the week. That's different than if you own the machine at Hospital A. Then you're doing three or four cases, but it could be one on a Monday, two on a Tuesday, and one on a Thursday. And then that machine sort of sits dormant. In this case with Fortech, every machine can get to multiple accounts. They may get to four, five, six different accounts per machine, maybe more than that. We're going to see where this goes. And I think that's what they kind of learned is how to target, how to operationalize this as they were going through their pilot program in 2022. So we're there. And they're extremely, they are really excited about this. And as you've seen, if you get on their website, Their LinkedIn's, they had the dinner program at AUA. I mean, they are they are making a big deal of this. So with them promoting it, Carl Storrs promotes it and we promote it. I think we got to that's that's what three, four or five times the number of people on the street talking blue light in the in the world in which now, you know, non muscle invasive, non muscle invasive bladder cancer is exploding. Pretty darn good opportunity.

Excellent. Well, wide, uh, diversity of questions here. So, um, you mentioned in your, uh, prepared remarks, the co-launching of, um, with Olympus on their new blue light. Um, the question is, is there a cost to photocure to photocure to bear any costs with regard to co-launching with Olympus?

Now time, time, time to sit down with their territory reps, uh, to determine where the opportunities are. Um, prioritizing it but no the the cost i mean the cost is us going out and now talking that olympus has new you know blue light machine on the market but no you know typical i guess what someone's asking is launch costs like as if we were olympus ourselves that that's their money their their deal but we're there to assist and help and accelerate where we can particularly in the nordics where they have a 90 share yeah and i think probably the driver of the word co-launch is that

Recently, within the last several months, the two firms are really getting a lot more active and preparing for the market.

Yeah, if you think back, just reminding those who've been with us for a while, they have the MBI, which is not much different than Carl Storrs' Chroma system. It basically is a visualization of hypervascularization. When their blue light machine had aged to the point where it just wasn't very good throughout the Nordics, they strategized particularly through the Nordics mostly. that they would sell NBI as the answer over white light. And they knew in the back of their heads that this wasn't better than blue light, but it was the best they had because their blue light was very old. What we have today is them coming out and saying, you know what, docs, you got white light and you got enhanced white light with NBI. But if you want to do a proper procedure diagnosis into definitive care over time, you need to do a blue light TRBT. That's a very different message and they're pushing it.

Excellent. Okay. Next question is on reclass. Can you give us any update or indication on the timing for reclass, or is it just at this point totally unknown?

Totally unknown. I think we're making progress. We're seeing some tea leaves, but at this point, there's no official notice from the FDA. I will say that they have acknowledged that this is going on. They understand the petitions in there. I think the next step is for the FDA to actually make an answer to the citizens petition. That could happen tomorrow. It could happen next year. We don't know. But I think the amount of pressure we put on is really admirable, given who we are. And it's not even our citizens petition, but we have a lot to gain by it going through. So I remain optimistic on this. And again, we also are engaging legislators, congressmen, congresswomen across the U.S. to put pressure as well. So, you know, barring anything, you know, we had external consultants and legal firms, you know, taking a look at what we've done because we're always asking ourselves, what else can we do? And they've been amazed at how much we have done. And, you know, there's some tweaks and some ideas. You know, we put a letter into the Center of Excellence, the Oncology Center of Excellence as a way to kind of step up the pressure. But, you know, honestly, we just got to keep pushing on it. And eventually it'll happen, I'm sure of that.

Okay, excellent. Can you give us an update on the status of the proprietary flexible blue light system that you intend to bring out in the future?

Yeah. So where we are, we don't have the official agreement, but we do have more or less a green light that we're going to move forward with this. We do have a contracted manufacturer that will develop this reusable flexible system for us. We have been... over the last 12 months investigating with them multiple different models, development pathways, et cetera, so that we could land on a true path forward. Now we've landed on that path forward. It's a matter of time and money and development plans, et cetera, and agreeing on all that, which we pretty much are there. So look forward to making that announcement in the coming weeks.

Great. Okay, back to Fortech. Can you elaborate on the Fortech business model and the benefits of utilization and reach? I think you may have touched on this.

I think I've touched on that. I don't know if there's anything else I missed, David. I don't think so. I think I've hit it. I think they have a much larger sales force than ours. This is extremely exciting to them. You can see it on their web pages. You saw it at AUA. They are actively promoting this, and this is This is at a time when they only had one and then six, a total of six machines out there in the broadcasting on the national platform. They have hundreds of technicians, and these are the guys and gals that go into the procedures to make sure the procedures are going well, which means is the equipment set up? Is it working? Is the process in place? Is the patient instilled? All of this stuff that happens, our reps can only get to so many of those, and we wouldn't want them sitting in every case because then they're not selling. But they have people who are 100% dedicated to make sure the surgeries go off well. So I think that's exciting. I think all organizations, us, Fortec, and Carl Storrs have financial incentive aligned to utilization. You know, the more utilization, the more that everyone makes out. And I guess really the underlying thing to all this is the more patients that benefit. Now we're bringing access back. to a lot of places that they couldn't get blue light or they wouldn't spend the money for it. And now it's a very different model. And this flies under the radar. It goes onto the operating expense line for a hospital. It's much easier sometimes for them to absorb that than a capital expenditure.

Yeah. And I might add, in addition to getting around the capital budgeting issue, not having to purchase the equipment, you kind of touched on this, but I want to emphasize it, is, you know, Fortec has a vast customer network. It's in the thousands. And, you know, some hospitals and facilities are not used to buying Carl Storrs equipment. So Carl Storrs only has a certain percentage of the market. Fortech has their own base of customers. So this really is going to open up the market to other customers that don't have access to blue light or generally wouldn't be buying equipment from Carl Storrs. So I think it's a real advantage. Excellent. When do you expect the Fortech sales to begin contributing to growth in North America?

Perceptibly continuing to increase. I can tell you that there's a lot of cases happening through May and June. But when you took it in the totality of the total volume, it's probably not going to be totally perceptible. But as we continue through the second half of next year and certainly into 2025 with, you know, we have six towers today where they intend to go with this increases the volume opportunity. And I think it'll be more perceptible to everybody.

Yeah, I think when they scale up to the number of towers they intend to get to, that'll be when they launch it nationally. And then you'll start to see that, which we've said in our materials is the second half of this year. Great. And last question I have here is you're seeing a lot of activity in the non-muscle invasive bladder cancer space, a huge pipeline of bladder cancer treatment products. Some are launching. And the pipeline is just getting bigger and bigger. The excitement is there. And AUA was really all about non-muscle invasive bladder cancer. I mean, the secretary of the association said that himself. So the question is, how can you give an example of how, you know, photocure and blue light and these new therapies can work together? How does the company benefit from all these new therapies coming out? And how do we help?

I'll just give a hypothetical here. It's not so much hypothetical as real, but but I'll just, this might visualize it for everybody. Your patient and the physician found a hanging papillary under white light. They send you in, they give you BCG and they send you home. The papillary has been resected. They think they've got cured you of your cancer. You come back a year later, it's no longer non-muscle invasive, it's muscle invasive. Because guess what? They missed blue light. They missed CIS, the flat lesion, because they didn't use blue light. Well, Now it's too late. Now they're muscle invasive. So now that patient isn't even eligible for these expensive therapeutics. They're now going to a cystectomy. They're having their bladder removed. If I'm Merck, if I'm Immunity Bio, if I'm Faring, if I'm J&J, I want to get that patient before they go muscle invasive. Right? Because once they're muscle invasive, I'm no longer indicated for them. So how are you going to find them? You're going to want that doctor to use blue light to find that CIS patient. to find that BCG unresponsive patient before they end up muscle invasive. So it's in that space. So the patient will go through and probably, at least for now, will go through a BCG treatment. But when that fails, and it fails a lot more than I think people realize because they're not using blue light, they use white light, and they're not seeing that it failed. But when they find out it's failed, they have an opportunity to go to a step therapy. And they got a chance to go, there's a window there. So they could start on one therapeutic, at half a million dollars, and then transferred to a different one. The other interesting thing about these therapeutics, each is administered in different ways in different dosing regimes, and that also will play into choices for patients. But that window can only be opened up if you see cancer that isn't responding to BCG. And the best way to see it is with blue light cystoscopy. You know, underline it, bold it, it is what it is. And all the data lines up that way, and that's why the Bravo data came back the way it did, Because over time, it becomes obvious that blue light cystoscopy gets patients to a better place in terms of care. Faster, more aggressive if they need to be before the bladders are taken away. And their quality of life plummets and their life expectancy plummets. So there will be patients, and we did ask a lot of physicians, there are patients asking about these second-line therapeutics. You know, Dr. BCG doesn't seem like it's working. Can I go to the second-line products? Before that, it was, doctor, what day am I getting my bladder taken out? Because there was no second option for them. So now there is. But that window is going to be opened up using CystU HexFix blue light cystoscopy.

Yep. And keep in mind, many of those therapies are going to be multi-hundred thousand dollar therapies. So making sure that the BCG has failed, patient still has the tumors, blue light can help with that and help get those patients on the second line therapy. Whoops. Lights went out. Anyway, that's all we have. We're out of questions. So thanks, everyone. Dan, I'll turn it back to you.

All right. Well, thank you, everyone. It's really exciting times. I'm feeling really good about where we're at and where we're heading. Look forward to seeing you all in August at the Q2. Have a great day. Bye-bye.