Photocure ASA

OSE:PHO

Earnings Call Analysis

Earnings Call Transcript 2024-Q2

[Daniel Schneider, executive]

All right. Well, welcome, everyone. Good afternoon, good morning. Welcome to Photocure ASA's Second Quarter 2024 results. I'm Dan Schneider, President and CEO. With me today is Erik Dahl, our CFO; and David Moskowitz, Vice President of Investor Relations.

Next slide, Slide 2 disclaimers. Usual disclaimers are in effect for today's presentation.

Next slide. So a new slide for everyone, talking through the strategic priorities and initiatives. And the first block is the accelerate and expand. We want to deliver on our guidance for revenue, EBITDA, and we have now recently as of today, raised our tower placement guidance, and tightened it up. We want to drive additional image quality upgrades and account activations, we'll talk about that today, initiate Blue Light Cystoscopy Mobile strategy, the ForTec deal, we'll go into some details there, increased penetration in the growth markets and leverage our geographic partnerships.

In the positioning and access block, we want to position BLC as a primary diagnostic tool to facilitate early and appropriate use of non-muscle invasive bladder cancer therapeutics. And we're going to go into some detail there as well today. I think you'll get really excited about where the markets are going and the amount of interest and money flown into bladder cancer care and how Blue Light Cystoscopy is center stage.

We'll facilitate -- talk about the facilitation of the reclassification of Blue Light equipment and reintroduce flexible Blue Light in our Richard Wolf partnership agreement that we announced earlier this month.

And the final part, the acquire and transform. We're going to continue to actively assess opportunities in the non-muscle invasive bladder cancer space, biomarkers, AI, new technologies, things that will leverage our existing infrastructure in the broader uro-oncology segment. Example of that is the Richard Wolf and the ForTec deals.

Next slide. So some second quarter 2024 highlights. We expanded this Saphira footprint in the U.S. by 20, and we've raised our guidance upwards to 55 to 70. I want to also note that rigid growth is at 11% year-to-date, and Flex continues its downward disintegration. We expect it to continue to deteriorate through the rest of the year, what's left.

We're executing on the EU and the priority markets with double-digit growth in the priority markets and overall, Europe at plus 4% year-to-date. We have positive EBITDA and added cash further strengthening the balance sheet year-over-year.

Important news flow, we will talk more in depth about, as I mentioned, the ForTec Mobile strategy to answer the access and affordability challenges of Blue-Light Cystoscopy in the U.S. The Richard Wolf Flex agreement, putting control back in our hands to relaunch into the largest cystoscopy market. The VA Bravo data, and it's hitting 3 key elements in oncology care, recurrence, progression and overall survival. We will also talk a little bit about the Saphira submission to the Chinese NMPA, that now gives us 2 key products under Chinese review that will come with milestones in '25 upon approvals and launches.

Next slide. Okay, we'll talk about segment trends, slide 6. In U.S., we estimate that our unit volume growth at rigid towers grew in the low-double digits, both year-over-year and sequentially. This has more than offset the decline of Flex sales in the first half. In Europe, we are pleased with the momentum of Europe despite Q2 hospital strikes in the 6 largest academic centers in Sweden and a German buying pattern that shifted into July instead of June.

We expect to see good year-on-year growth in the second half of the year, with the initiatives that we've undertaken to effectively relaunch Blue Light Cystoscopy throughout the continent, with the engagement of capital equipment manufacturers and KOLs. So stay tuned.

And then keep in mind, one of the key drivers for Europe is the Olympus anticipated launch sometime in the second half, we believe, probably middle to end of the half of 2024. Olympus, reminding everyone, Olympus has about a 40% share throughout all of Europe. So when we talk about upgrades, reactivations, new installs, we're talking about Karl Storz and Wolf. But Olympus will have a significant impact, particularly in the Nordics when it launches later this year. We are currently in discussions with them and supporting their launch for the second half of the year.

And getting specific, next slide, to Europe, a more longitudinal view depicts the growth in H1 versus prior years. We believe momentum will strengthen in the back half of this year. We know how July came in. We feel very confident in saying that. And we especially think that Olympus could contribute if its launch comes sooner in the first -- in the second half. Third quarter is off to a strong start, and we know that the EU will contribute to us in our guidance range.

Slide 8, some key trends in the second quarter for North America, revenue up 9%, in-market sales up 1%, but I'd point out that rigid units were up 11%, offsetting the Flex discontinuation in the marketplace, which we expect to run out to the end of the year. The installed base of Saphira by 20. And so therefore, we have raised and narrowed our guidance, that gives us 39 on the year so far. We raised our guidance 55 to 70.

The ForTec Mobile strategy rollout is now underway. They now have 18 complete systems that are being deployed as we speak. That's -- we've had a couple that ran in the first half that have done quite I think, quite well, and we're really excited about the second half when all 18 are deployed.

And then the reclass initiatives continue. We continue to push legislatively and also regulatorily and also through many different stakeholders trying to get the FDA's attention. I still believe that this is not an if equation. This is a when. When is reclass going to happen. And I think we've put a tremendous amount of pressure on that.

Next slide. Just looking at the Saphira installed base is now at 46%. If you're looking at these charts, I think, think of it in terms of the older earlier installations are the ones that are first going to be upgraded. So anything installed in '20 -- standard definition installed in 2022 or 2021, probably not ready for upgrades. But anything prior to that is fair game. I know there's a heavy pressure by Karl Storz to get these upgrades. They've instituted, and I'll talk about second, they instituted a incentive program, a promotional program in the second half for both upgrades and new installations of Saphira. So we're very excited about that.

And the reason for this is, if you think back to the Asieris trials with -- on Hexvix in China, the high-definition studies had better results and a better surgical experience, and we believe that will translate into better outcomes and performance in the U.S. over time. We raised the guidance, as I mentioned, on the Saphira installs to the range of 55 to 70 versus 40 to 70.

Next slide. So let's talk about Europe, some key trends in Europe. Europe is now starting to come through. Strong performances in Q1. Q2 shows a continuation of momentum, keeping in mind that the Swedish strikes and the timing of purchases in Germany did shift some of the units. But overall, on the half, we're very pleased. We know how we're kicking into the second half.

Priority growth markets are responding per plan, particularly U.K. and Italy, France is coming on in the second half. Germany, our largest market also is performing well, and we expect a strong second half. I will say that there have been 69 upgrades in Germany, and over half of those upgrades are showing double-digit growth. So we know this matters to the European markets, in particular.

We had a strong presence at EAU. And again, like AUA, there was a major focus on non-muscle invasive bladder cancer, in particular, the therapeutics. We'll talk a little bit more about that in a moment. The key initiatives continue to make impact and 177 quality upgrade -- or 176 quality upgrades since 2023. And the way to think about this is there are 600 key targets for us in Europe. 40% of those are Olympus. So we really can't touch them until they launch their new Blue Light system. But the remaining 360, over half, have been now upgraded, and we believe that will have an impact over time on overall performance in Europe.

And we continue to support the Danish treatment council to reenter the Danish market. We feel pretty confident that what we've submitted is good and would hopefully have a conclusion later this year.

And next slide. So growth initiatives. I think it's important to take a moment here to talk about the gross initiatives and why I get particularly excited with what's going on in the business. But before I turn to the slides, I do want to mention the potential reclassification of Blue Light scopes in the U.S., which is a subject of Karl Storz assistance petition, which we've talked about.

I believe that when the FDA responds favorably to the system's petition and reclassifies Blue Light Systems to Class II, several things are going to happen. One, all the other [indiscernible] manufacturers, beyond even the other 2 that we currently know today, will enter the U.S. market under a 510(k) application process that takes about 3 to 6 months post the decision or post the 510(k) pathway being posted. This will expand the capital equipment base, providing availability. And we also believe because of the competitiveness, affordability and a better quality of equipment and service in the market.

Importantly, in this scenario, more investment in the segment, more salespeople selling Blue Light Cystoscopy because the capital equipment manufacturers will be supporting it as well, not just us and Karl Storz, will give us access to accounts and open up the market dramatically, fueling growth in procedures using Cysview. We are hopeful that the FDA addresses this petition soon. We'll keep you informed as Karl Storz informs us on the progress.

So next slide, let's talk about some of the other initiatives and opportunities underway. So we're not waiting on reclass alone to get affordability and accessibility into the U.S. market. This partnership and our involvement in bringing the 2 companies, the ForTec and Karl Storz together, is centered exactly on that aspect.

The Citizen's petition will definitely have its dramatic impact. But in the meantime, we believe we can move this market significantly through this partnership. And it's a new business model, but it's not an unheard of business model, but it is new for our cystoscopy or Blue Light Cystoscopy. And its intention is to gain access for patients and affordability through the collaboration with ForTec Medical.

The key points on the ForTec deal again, increasing access and utilization alignment of all 3 -- the alignment of all 3 companies of Karl Storz, ForTec and Photocure in terms of incentive. We're incentive because we sell Cysview, and ForTec and Karl Storz also have their individual incentives on a per procedure basis.

Having 3 companies drastically increases the firepower selling and the marketing resources deployed. If anyone's been on LinkedIn with ForTec, they've done an amazing job of promoting Blue Light Cystoscopy in the U.S. They're active in the marketplace. Now with 18 towers ready to go, they're reaching out proactively to well over 2,000 accounts that they currently are servicing. They have GPO contracts already established. So we believe that this will slowly build momentum through the second half of this year.

It also ensures that every account has access to high-definition equipment on site, and that is functional. Every procedure has a tech in attendance. And for those that are familiar with what happens in operating rooms, nothing always goes right. And having someone there on site to correct equipment issues, process flow, et cetera, is very, very important. So that's a key element to the ForTec business model.

They've been successful in other -- ForTec's been successful in other segments, and they have a large customer base. And I think the analog that I'd like to use is they had done the Philips MRI fusion system. There were 5 companies in that space. Bringing in this business model led by ForTec, they now, after 6, 7 years, have over 90% share of the market in that. So it does start slow, builds momentum and then takes off. We expect the comprehensive national launch in the second half with these 18 scopes.

So if that isn't exciting enough, let's go to the next slide and talk about the Richard Wolf agreement. And this one, I think, is particularly interesting, especially in the sort of near to midterm. What's exciting to me about this is we're gaining back control of the largest market opportunity through the partnership agreement with Richard Wolf to develop and commercialize a proprietary Flex Blue Light system to address the surveillance market, which is over 3x the size of the rigid opportunity.

It's a $1.5 million to $2 million investment to unlock and capitalize on a $1.3 billion market. It's going to take 2 to 2.5 years, I promise you. If there's ways to speed this up, we will, but we will not give away quality. I think we've learned lessons when equipment isn't up to standard, and it frustrates the users, causes breakdowns and ultimately, discontinuation of use. So we want to make sure we have a high-quality system.

And if you remember, prior to even me joining the company, Richard Wolf did have a Blue Light flexible system on market in Europe. It's actually deployed currently in the Nordics, and there's about 6 of those still out there in use. So we're really excited about Richard Wolf being the partner to work on this.

And I think without saying, we should be the first to market, should others want to join. And agnostic to that fact because at the end of the day, we are a pharmaceutical company selling Cysview or Hexvix. That's the most important thing to us. But having access to the market requires flexible Blue Light Cystoscopy.

So we will go to the next slide. So I think this is probably why the Richard Wolf deal in particular, and the timing of it, along with the Citizen's petition in the U.S. and the growing demand in Europe is becoming very, very interesting.

So remember, we talked about the past about how woefully underserved the bladder cancer market was? Well, not anymore. And I talked about this, I think, in the last quarter and prior quarters as well. There is a wave of new therapeutics coming in this space that has been traditionally underserved. Billions of dollars are being ported to solving the problem of patient care.

When I started here 6 years ago, there were only 3 products in development for bladder -- non-muscle invasive bladder cancer, and one of them failed very, very quickly, and that's the Vicinium, one of the, I think it's third from the bottom.

Now there are over 15 companies, 30 clinical trials, 10 different therapeutic targets and delivery systems, METAP2 slow-release gels, PD-L1s, PD-1s, gene therapy, adenoviruses, interleukin-5 superagonist, cellular delivery systems like the J&J Pretzel system, microenvironment work. All of this stuff is going to require something better than what we have today and been using. And that, going to the next slide, is why we get super excited.

The new non-muscle invasive therapeutics were the leading topic at AUA 2024. The fact is the earlier detection, and this is -- resonates with every surgeon and your oncologist out there. The earlier detection of CIS lesions, BCG refractory or recurrent disease will be key to a new therapeutic utilization. Said another way, those 15 therapeutics that will hit the market, 3 are on the market today, are going to require the absolute best detection system in the world. And we believe Blue Light Cystoscopy is exactly that.

It doesn't get away if the TRBTs are the cornerstone for non-muscle invasive diagnosis management and disease prognosis. A proper tumor resection, debulking the tumors, biopsies of pathology will continue to be required for definitive staging and grading. Missing early reoccurrence of high-risk tumors like high grade 1, T1 and CIS may delay the use of effective treatment, including newer second-line therapies. So the increased risk of progression to muscle invasive and poor survival outcomes. We believe by using Blue Light Cystoscopy, you can improve the pathway -- the precision pathways, precision diagnostic to precision therapeutic and the key to that to unlocking it is Blue Light Cystoscopy.

The position we play is kind of supporting a new bladder sparing approach. The British Medical Journal just recently published its abstract, basically talking exactly about this. And they point to enhance cystoscopies -- enhanced light cystoscopies, and Blue Light Cystoscopy being a key part of the future. It's highly sensitive, validated, guide recommended, technology to detect, confirm, monitor high-risk non-muscle invasive bladder cancer.

Multiple systematic reviews, including the [indiscernible] conclude the long-term benefits of Blue Light Cystoscopy. It's supported by the largest body of evidence in clinical data, including randomized control trials, large long-term real-world evidence, non-muscle invasive bladder cancer registries like the U.S. and the Nordics.

Dedicated studies supporting the ability to improve detection of BCG unresponsive tumors. Expert statements, as this is the best technology to adjudicate abnormal white light cystoscopic findings. Monitoring the response to novel bladder sparring, non-muscle invasive bladder cancer therapies is a regulatory requirement. The FDA recognizes CIS as a marker, tracking CIS morphology changes for therapeutic response.

Think about that, if Blue Light Cystoscopy is the best technology to detect patients with CIS, and the FDA in the U.S. and the EU is staying the same, then recognizing it, is using CIS as a marker, you can see where Blue Light Cystoscopy can play a major role, and we believe that's exactly where we're heading.

And finally, next slide, Slide 16. We'll talk about the Asieris programs. This partnership continues to progress favorably, and a couple of highlights. Both products are under regulatory review for potential approvals in China. Asieris has publicly disclosed recently that they're speaking to EU regulators this quarter about an EU Saphira filing.

I want to remind you that, that filing, if it happens, and it is received, we received milestones for the accepted filing as well as the approval on the same magnitude as what we're going to receive on the China submission. Both Chinese approval decisions for Hexvix and Saphira are expected to be 2025 events.

So with that, I'd like to turn it over to Erik Dahl, our CFO, to go through the financials.

[Erik Dahl, executive]

Thank you, Dan. What I will do is I will start with giving an overview of the second quarter financials and including the consolidated income statement. I will have a segment report with us and also finally, some headlines from the cash flow and balance sheet.

The first, a couple of words about foreign exchange. We have very small movements for the Norwegian kroner in Q2 and year-to-date. And measured by unweighted monthly averages in Q2 appreciated 0.4% against U.S. dollars and depreciated 0.8% against euro. And year-to-date, the kroner depreciated 1.5% against both currencies. So it's minimal.

Looking at the financials for the year-over-year FX impact. Q2 was -- the FX movements were immaterial. Year-to-date for sales revenue, the FX was positive, approximately NOK 3 million. And for COGS and operating expenses, negative approximately NOK 2.5 million. So take and give EBITDA impact of positive of approximately NOK 0.5 million. And so final remark, as always, all financials in the presentation are in Norwegian kroner unless I specify a different currency.

Now looking at the consolidated income statement. Total revenue in Q2 was NOK 145.4 million. It included Hexvix/Cysview revenue of NOK 122 million and milestones and other revenues of NOK 23 million. FX impact was not material for the quarter.

Hexvix/Cysview revenues in the second quarter increased 6% year-over-year, and the sales increase is mainly driven by a combination of volume increase and higher average pricing in North America. And to some extent, driven by wholesale shipment timing in Europe. Total market volume in Q2 was level with Q2 last year.

Volume and revenues, were in North America negatively impacted by the phase down of Cysview usage in the Flex segment, and in Europe by customer order fluctuation in DACH as well as the healthcare worker strike in Sweden.

Other revenues totaling NOK 23 million in Q2 is driven by a milestone payment of NOK 21.6 million related to the development of Saphira by Asieris. Q2 last year, other revenues of NOK 26.9 million, include milestone payment from Asieris for Saphira as well as Hexvix.

Due to total [indiscernible] excluding depreciation and amortization, but including business development, we're at NOK 110 million compared to NOK 114 million last year. And a decrease in expenses is driven by general cost containment measures as well as a significant reduction in business development spending. The impact of foreign exchange was not material.

Business development expenses are related to life cycle management for Hexvix/Cysview. The activities are within the business side of life cycle management, including potential collaborations. The expense level, obviously, may vary from quarter-to-quarter, given the one-off nature of these expenses.

EBITDA in Q2, including business development expenses, was NOK 27.8 million. This is an improvement of NOK 4.4 million from last year Q2, and the improvement is driven by increased Hexvix/Cysview revenue and lower operating costs, partly offset by less milestone revenue than last year.

Depreciation and amortization, NOK 7.2 million in Q2. The main cost items as previous quarters was the amortization of the intangible asset related to the return of the European business from Ipsen.

And net financial items in Q2, a net cost of NOK 4.5 million at level with last year, and our term loan was repaid at the end of Q2 last year.

Tax expenses, NOK 3.8 million for the quarter. The net tax expense is mainly driven by group results, but also intercompany items on the parent company.

And after net financial items and tax, we have for Q2, a net profit of NOK 12.3 million compared to a net profit of NOK 4.3 million same period 2023. And the main drivers of this improvement are increased Hexvix/Cysview revenue and lower operating costs, partly offset by less milestone revenue.

Now to the segment performance. Next slide, please. There we are. The segment reporting, we will focus on these, on the 2 main segments, which is North America and Europe. And starting with the North America segment, which includes U.S. and Canada. And revenue for North America increased 9% in Q2. The drivers are an increase of in-market volume for the rigid market as well as an increase in average sales price.

This is partly offset by the impact of the phase down of Cysview usage in the Flex segment due to direct cost were level with last year, and this drives a contribution of NOK 4.3 million compared to breakeven last year. The improvement is revenue driven, combined with flat direct operating costs, and North America has had positive contribution in the last 4 quarters. And EBITDA was negative NOK 5.1 million in Q2, which is an improvement of NOK 5.2 million from last year.

Looking at Europe. The European business experienced year-over-year an increased revenue of 3%. This is mainly driven by timing of wholesaler stocking. In-market volume was level year-over-year, due primarily to fluctuations in ordering by hospital customers in DACH countries as well as the healthcare worker strike in Sweden.

Direct cost in Q2 increased year-over-year NOK 2.2 million. The expense development is driven by different phasing of activities over the year and between years, year-to-date expenses are level with last year.

We ended Q2 with a contribution of NOK 36 million compared to NOK 37 million last year. EBITDA for Q2 was NOK 18.8 million, reflecting an EBITDA margin of 26%.

Now we change slides. Let's look at the cash flow and balance sheet. Thank you. Net cash flow from operations in Q2 was NOK 19.5 million compared to NOK 29.1 million last year. And year-to-date net cash flow from operations was NOK 27.7 million compared to last year NOK 20 million, which is driven by improved EBITDA.

Cash flow from investments was in Q2, positive NOK 0.5 million, and cash flow from financing, negative NOK 11.3 million. And the cash flow from financing is driven by the Ipsen earn-out payment, which was NOK 9.1 million in the quarter.

So this gives a net cash flow in Q2 of NOK 8.7 million compared to NOK 12.9 million in Q2 last year. Year-to-date, the cash flow was NOK 7.5 million, an improvement of NOK 16.6 million from same period last year. And with this cash flow, we ended Q2 with a cash balance of NOK 267 million.

Looking at the balance sheet. We ended the quarter with total assets of NOK 713 million. Noncurrent assets was NOK 326 million at the end of Q2. This included customer relationship with NOK 104 million. And customer relationship is the intangible assets identified in the purchase price allocation for the Ipsen transaction. Noncurrent assets also include goodwill from the Ipsen transaction of NOK 144 million as well as a tax asset of NOK 42 million.

Inventory and receivables were NOK 120 million at the end of Q2 compared to NOK 122 million at the end of first quarter. The increase from year-end last year is partly driven by increased revenue.

Long-term liabilities was NOK 147 million, which includes the earn-out liability related to the Ipsen transaction totaling NOK 123 million at the end of the quarter.

And finally, equity at the end of the quarter, NOK 500 million or 70% of total assets.

And this concludes the financial section. Thank you, and Dan, it's back to you.

[Daniel Schneider, executive]

Bringing home, we'll go to Slide 22. And just a quick summary of the Q2 2024 results. 6% product growth, unit sales are going to pick up in the second half. EBITDA of NOK 27.8 million. I think importantly, commercial businesses contributions have been positive in Q2 in the prior 3 quarters.

We had 20 Saphira installs in the U.S. and the ForTec rollout is now underway. The installed base of 174 Saphira towers since launch now represents nearly half of the towers in the U.S., with an emphasis on converting the remaining 50%, particularly leveraging the promotional program that Karl Storz has put in place starting August 5.

The phase down remains a challenge of Flex in the U.S., but the growth of rigid towers and kits sales have outweighed the Flex pressure throughout this period of time.

Priority growth markets in Europe are responding well to turnaround effects, in particular, U.K. and Italy have been in strong sustainable double-digit growth. There's strong momentum, as I talked extensively about the marketplace itself and the trends with therapeutics coming on, and the growing importance of Blue Light Cystoscopy could play in that role.

And finally, the cash balance remains strong and there is no term debt.

And we'll go to the final slide, anticipated milestones, the corporate objectives. Guidance remains 6% to 9% on product growth, with positive EBITDA. We did raise the 2024 tower guidance from -- range to 55 to 70, including new and upgrades. We anticipate that these upgrades will increase, along with ForTec, the throughput of Hexvix and Cysview. And the ForTec Mobile Tower, national rollout, we will be happy to report on it as it picks up momentum in the future. It's just early stage of the launch. There's really not a lot to report numerically at this time.

We're going to continue to proactively support the Citizen's petition, keep your eyes on that portal at the FDA. We have -- presenting more published data and real-world evidence from the patient registries. We intend to advance the partnership. And as I mentioned -- with Richard Wolf and as I mentioned, if we can expedite the development or the go-to-market Blue Light flexible system, we will do so, but we will not do it at the risk of quality.

And finally, our Saphira assets, Hexvix and Cysview. I mean, Saphira -- our Asieris assets had progressed. Hexvix and Cysview both are under review with the NMPA in China, and we expect those to be 2025 events, and they both come with milestones upon approval and then, obviously, royalties on sales and milestones.

And with that, I think it concludes today's presentation. We'll go to Q&A and turn it over to David. You're muted again.

[David Moskowitz, executive]

Well, technical difficulties. Good morning and good afternoon to everyone.

All right. We'll kick off the Q&A. We do have a number of questions here. First batch we have is from Rickard Anderkrans at Handelsbanken. When you say Q2 performance in Europe is not expected to affect the full year, what type of performance are you expecting out of Europe in terms of growth?

[Daniel Schneider, executive]

Erik, do you want to take that one?

[Erik Dahl, executive]

Yes. If I'm looking at -- looking at the numbers, it's clear that we had a positive development in the first half year. And we have improved EBITDA of our core business and measured financials, including measured by financial excluding milestones and business development expenses.

So I mean, the development has been positive. It had a couple of hiccups like movements of shipments to customers. But when we look into third quarter and we look into July, I think we have already in July, captured a lot of the drawbacks that we had in the second quarter. That's why we say it will not have an impact.

[David Moskowitz, executive]

I might also add, we have the guidance range on revenue of 6% to 9%. You should think of Europe contributing to that range. So think of a minimum of 6%. And year-to-date, we've driven 4% growth in Europe. So we've got some work to do in the back half of the year that we're confident in.

The next question is with regard to the high end and low end of your guidance, are you able to talk about the potential swing factors that get you between those 2 ranges?

[Daniel Schneider, executive]

On which one? The revenue or the [indiscernible]?

[David Moskowitz, executive]

On revenue.

[Daniel Schneider, executive]

On revenue?

[David Moskowitz, executive]

Yes.

[Daniel Schneider, executive]

Well, I think there's a couple of things, and I'll let you guys can add into it. Keep in mind, we're anticipating that Olympus will launch their system. It will have some impact, not a dramatic impact because it does take time to install and upgrade those systems throughout the Nordics.

We also have had all these upgrades. I mentioned Germany, 69 upgrades, over half of them are in double-digit growth. Now it takes time these things to -- once they're upgraded, to build the momentum up. We've had 176 upgrades throughout Europe. So we anticipate these all to be really contributing.

We've had 20 -- I think 23 something, I think, new installs in Europe as well, 8 in the last quarter. So I think that's, again, positive developments that are going to continue to contribute to the European growth.

And then in the U.S., of course, is the ForTec impact along with continued demand for Blue Light Cystoscopy as these therapeutics continue to roll out the back end.

[David Moskowitz, executive]

Excellent. That's a good segue into the next question, which is what -- or are you able to offer a growth contribution range for ForTec in the back half of the year?

[Daniel Schneider, executive]

Not at this time. It's too early. I mean 18 towers just getting deployed. It's going to take some time to do that. And I'm not prepared to do that publicly. We do have numbers in mind. I will say that, and we do expect them to be more productive than our existing base.

[David Moskowitz, executive]

Great. Question over on the Richard Wolf opportunity. You mentioned the TAM of $1.3 billion global opportunity for Blue Light Flex. Realistically, with Richard Wolf being the only provider of Flex Blue Light, once they come out to market, what do you think the real addressable market is for that?

And I can start on that one. So Rickard, we have -- 51% of the share in the U.S. is in physician offices. So if you just simply take the number of flexible procedures in the U.S., about 700,000 annually. You take that 51%, which is physician office only, and you multiply that by our list price in -- actually our net price of roughly $1,100 in the U.S.

Just the U.S. physician market alone, that's a $385 million calculation. So almost $400 million just in physician offices just in the U.S. So you can see how scalable this opportunity is. And globally, as you know, we really have to launch flexible Blue Light as a brand-new product over there. We're looking forward to undertaking that.

But I don't know, Dan or Erik, do you want to add any more to that?

[Daniel Schneider, executive]

No, I think that's good. I think it's all accessible market. If it is the one and only and if you're thinking about how they're treating bladder cancer, the diagnosis and the TRBT will take place. But then there's a surveillance aspect in using CIS as lesion markers. If there's no other option, if the best option is Blue Light flexible, then I think the barriers -- and also, I think there'll be an affordability to this as well that we're going -- that we are working towards as well. We don't want to come up with something that's not affordable, so to speak, to hospitals in Europe and U.S. So we're very, very conscious of what needs to get done. So I think it's -- the market is open for us to go after.

[David Moskowitz, executive]

And I'll also point out that we disclosed today the cost for the Richard Wolf development agreement, and Photocure is only going to bear $1 million to $1.5 million over that development period. So if you think about the opportunity relative to the cost of us entering into this, we hope that people out there can really appreciate the leverage we're getting out of this investment. So it's hopefully seen as a smart deal.

Following on to that is the estimated time line for Richard Wolf Flex development.

[Daniel Schneider, executive]

I think we state 2 to 2.5 years.

[David Moskowitz, executive]

Yes. Okay. Good. So 24 to 30 months. Okay.

Shifting over to the wave of therapeutics, that trend. With all the new therapeutics approved or in late-stage trials for non-muscle invasive bladder cancer, are you engaging with these manufacturers? And if so, how are you doing that?

[Daniel Schneider, executive]

We are. We are engaged, and we are currently engaged, and they are engaging us and they're proactive about it. And it's through the registry -- the patient registry. Reminding everyone what a tremendous body of evidence that is. It's 10 years in the making to have this data to access.

The second part is the FDA is stating, the European regulators are stating that to use these -- and I think the payers are going to be stating for sure, when you talk about, at least in the U.S., $0.5 million treatments, they're going to want to know for sure these patients, number one, are selected appropriately to give the treatment; and number two, did it work or did it not work? And if it didn't, why not? And we believe -- and they believe Blue Light Cystoscopy can play a significant role in helping them be successful. So I think that's very, very key. So we are currently talking and engaged with several.

[David Moskowitz, executive]

Excellent. A question on the EBITDA guidance. With EBITDA ex business development of $40 million year-to-date, given these first half results, are you able to give more specific EBITDA guidance for the full year?

[Erik Dahl, executive]

I think I mentioned it previously as well. Looking at the numbers, the company has had a positive development during the first half year, improved EBITDA of the core business and we got milestones and the business development expenses are down.

Now that does not imply that we should narrow our guidance on revenue and EBITDA. I remember the EBITDA guidance is open-ended. And I see no reason today to kind of shrink it down to a -- or give it a bandwidth.

So we actually see no reason to change the guidance with the exception of tower placements. So obviously, we will review this as we do in the third quarter and present the third quarter in October, November.

[David Moskowitz, executive]

Good. Here's an interesting one. Has the company considered initiating a strategic review to maximize shareholder value?

[Daniel Schneider, executive]

Strategic review of what?

[David Moskowitz, executive]

Of the business, I presume. That's the question..

[Daniel Schneider, executive]

We go through our annual strategic review every year and sit with the Board in the fall.

[David Moskowitz, executive]

Yes. Yes. We have ongoing processes in the company continuously. And that's part of the presentation, I believe we -- as you can see, there's a lot of things on the table. We are constantly looking for ways to improve the business and make -- enhance shareholder value. So...

And this seems to be the last question. Are you able to give more color around the potential submission in EU for the Asieris, the Saphira asset?

[Daniel Schneider, executive]

No. Only what -- I guess I want to remind everybody, this Asieris is also is a public company. So we are prohibited to talk about anything that they don't already release publicly. They've released publicly that they intend to have a conversation with the European authorities this -- hopefully, by the end of the third quarter, but certainly it is the second half. And as more information comes available, we'll share it upon their release as well.

One other thing I just want to say, I was thinking about this on the Richard Wolf question. Let me just say, throughout the development, where we can, we will update the market as it progresses through development. And as I said in my presentation, we're not looking for short cuts, but we are looking for places we can speed up to get to market sooner.

But right now, what we know on the development plan and look, let's use Karl Storz, let's even use Olympus, what it's taking for them to upgrade systems to get through regulatory filings and approvals, no good plan goes the way you want it to. So we didn't want to come out with something unreasonable and have you expect it in shorter time period than what I think is where it sits today.

So we are saying 2 to 2.5 years, 24 to 30 months, Believe me, we have -- we're incented, all those 15 therapeutic manufacturers are incented, Wolf is incented, the market is incented, urologists are incented, everybody wants Blue Light Flexible Cystoscopy back on the market. So we'll do our best.

[David Moskowitz, executive]

Yes. That's a good point. We will update investors on progress such as prototype development, validation, of course, regulatory filings and so forth. So there should be updates along the way.

And that is all we have today on the Q&A. So thank everyone for sending in your questions. We appreciate it.

[Daniel Schneider, executive]

Great. We will see everyone on Q3 and look forward to continued news flow coming out in the second half. That's it. Thank you.

[Erik Dahl, executive]

Thank you.