Photocure ASA

OSE:PHO

Earnings Call Analysis

Earnings Call Transcript 2023-Q4

[Daniel Schneider, executive]

Good afternoon and good morning, depending on where you are in the globe. This is Dan Schneider, President and CEO of Photocure. Today, we're presenting the Photocure Fourth Quarter 2023 Results.With me today is Erik Dahl, CFO; and David Moskowitz, Vice President of Investor Relations.Next slide, please. Just a reminder, the normal usual disclaimers are in place for today's presentation.Next slide, please. So fourth quarter highlights for 2023. We continued to see growth in execution on key initiatives despite flexible Blue Light Cystoscopy being discontinued worldwide by Karl Storz. Product revenue grew at 20%, unit sales 4% year-over-year. From a new tower installation standpoint, there were 10 new ones opened in the fourth quarter, 7 upgrades. We had 51 Saphira towers placed in 2023. This is the largest installation of rigid towers in any year since the launch of Blue Light Cystoscopy into the U.S.We're executing on our plan in Europe. There were over 146 image quality upgrades. What this means is that the equipment -- if you remember when we took over Ipsen, for Ipsen in Europe, much of the market had deteriorated. The equipment was quite old. The usage had really gone down. So one of the key initiatives for Europe is to get the equipment up and running, get patient selection expanded, get processes in the OR streamlined. So, so far, 146 image quality upgrades in 2023 and 23 new accounts opened in Europe, a lot of them in France and the U.K., but sprinkled throughout.Ongoing challenges. We do have the phase down of Blue Light Cystoscopy in the U.S. It was a growing market in the U.S. when we were informed by Karl Storz late February or early March of last year that Flex would be no longer supported and they were going to discontinue the brand. We are faced with the challenges of that being our only manufacturer approved in the U.S. with Blue Light Cystoscopy.We've also had a delay in Olympus' launch of Blue Light in Europe. That's due to an MDR approval that they're waiting on. But the good news for that is that Olympus, which is the final of the 3 large Blue Light Cystoscopy manufacturers, is in fact going to upgrade. And it is not a matter of if, but it is when. We believe it will be midyear of this year. That will be a significant impact for particularly the Nordic countries, where Olympus has a very strong hold, particularly Denmark and Norway.We had a positive EBITDA of NOK 29.9 million, NOK 29.6 million ex-BD expenses. Our OpEx has held mostly level for 8 quarters now in a row, as we said 2 years ago when asked that question, "Where are your cost basis and will you get leverage out of the business?" The answer is we believe we are, and we're able to hold steady. That doesn't preclude us if there's an opportunity in the market that we would need to invest in to get accelerated growth that we wouldn't do it. But at this point, we seem to be at a very solid OpEx level.Business development expenses were not material in the fourth quarter, and we remain with a very strong balance sheet at around NOK 260 million in cash and equivalents, and we have no debt.Key milestone events. There were 7 abstracts presented at major congresses in 2023. In Q4 alone, we had a presentation at SUO on real-world evidence showing a major decrease of bladder cancer reoccurrence, which is key to our story. And we also had the clinical results from the Hexvix Phase III trial in China presented at SIU. And reminding everyone, that's a very important trial for all of us as it was the first time that high-definition equipment was used in a randomized controlled trial and the data was very, very good. So we continue to find places to leverage that data to our benefit.Asieris on that data filed for their NDA in China. This is typically an 18-month approval process. They submitted in November. So we expect a second quarter 2025 answer from the Chinese authorities. It is possible because of the fact that we did with -- or Asieris did conduct a real-world evidence activities in Hainan, that, that data, along with some of the other data, they could expedite that review. But right now, we expect second quarter 2025.The large order for Blue Light Cystoscopy towers is delayed. This is a complex agreement. It is multi-partied. We are actually kind of brokering this deal. So it's not really 100% in our control. But what the good news is, is that it is moving forward. There will be co-training, et cetera, that will accompany this order. And we're excited about this. We believe it will materialize in the second quarter of this year. It could be by the end of this quarter as we're only in February. But really let's call it second quarter.And then in the Citizen's Petition, we had a recent additional comments by Pacific Edge. What's really important about this one, it is yet another type or a variety of stakeholders who are interested in support of a Blue Light Cystoscopy in the treatment of patients in the U.S.And why this is important as I get asked a lot of questions around biomarkers and how do they interrelate, are they competitive to Blue Light Cystoscopy. And I think this is answered by Pacific Edge very clearly. They are one of the largest biomarkers in the world. They believe that, yes, they have a role, but it works synergistically and complementary with Blue Light. So if the biomarker shows positive or positive signs of bladder cancer, the next step would be Blue Light Cystoscopy to visualize it, stage it and resect it.So that's exciting. We'll continue to push the Citizen's Petition. There is -- I think the key here to kind of note is the FDA is aware that the Class III designation in the U.S. prompted Karl Storz to withdraw Blue Light flexible equipment, and it is an important part in growing segment in bladder cancer care in the diagnosis and treatment of patients going forward, particularly for a lot of the therapeutic companies coming out. So we'll keep you updated on it. There is no statutory requirements by the FDA to answer this petition at any given time. But on average, it's somewhere between 18 months and 2 years. We're hopeful we'll hear something by the end of this year.Next slide, segment trends. We'll go to the next slide. A side-by-side view of North America and Europe. I think the thing to note is North America grew 3 out of 4 quarters despite the downturn of Flex that continues the road underneath the business. In Europe, same situation, 3 out of 4 quarters we had doubled -- we had growth. I think in particular, Europe, some of our high growth, what we consider our high-growth potential markets are now showing signs of high growth and sustained high growth, which is what we expect in the second half, particularly going into the fourth quarter. And those countries include Italy, U.K. and we think France as well.France experienced some difficulty last year with a lot of physician striking, but that has all been resolved and they're off to a good start. So both regions are off to a good start for first quarter this year in 2024.Next slide, please. So Saphira -- this is U.S. only. Saphira, the new high-def equipment in the U.S., now represents nearly 40% of the rigid installed base. There was 17 installations of Saphira in Q4, 10 of the new, 7 upgrades. Upgrades remain an important part of our strategy as we know better visualization, more excitement, better outcomes.It was the most installs in a rigid history with 51 on the year. We've also been able with Saphira to reactivate and accelerate dormant accounts, and we expect that strategy to continue carrying forward into 2024 and beyond. There are now over 352 towers placed throughout the U.S. And again, reminding everyone that this is a single manufacturer of Karl Storz, and it does have limitations on the market in terms of expansion, which is why that Citizen's Petition is so important to open up this market and bring in the competitive products, Olympus, Wolf and others.Next slide. A little deeper dive into Q4 '23 for North America. Revenues increased 21%. In-market unit sales rose 7%. Now keep in mind, again, we're in the headwinds of Flex, which at one point represented maybe 15% to 18% of our total business. So we're able to overcome that continued erosion. We'll continue to see erosion throughout '24. But we do see -- what I would say, the underpinnings of this business is double-digit growth in North America and it's outweighing the ongoing effects of flexible Blue Light Cystoscopy phase down.Karl Storz extended their tower promotion program through the end of 2023. That program is not in play right here in first quarter of 2024. And in Q2, if you remember, when the promo isn't in play, it does have an impact on the business. But despite that, we had 10 towers and 7 upgrades in the fourth quarter. Again, the highest number of rigid towers placed. And now with all these towers that are out there and 40% of them being in Saphira, it's time to harvest what we've planted.There continues to be extremely strong interest in the U.S.'s real-world evidence patient registry. It is a strategic asset for Photocure. We are engaged with multiple parties who are interested in the data, harvesting that data, using in publications for the purpose of Blue Light Cystoscopy. So that will continue to generate data going forward. In fact, AUA, EAU, you'll see, again, additional abstracts and presentations using that real-world evidence data as well as other real-world evidence data.The key initiatives in play to accelerate unit sales growth: increasing the kit usage by existing accounts, which includes upgrading the systems; streamlining the processes within the hospitals; and working on physician selection; expanding patient use because all patients could benefit from Blue Light Cystoscopy.Reactivating low users or inactive users through those upgrades is extremely important. The continued expansion and penetration of the VA system, particularly leveraging the VA BRAVO data. As you know, that's a 3-phase process. We had BRAVO 1. BRAVO 2 should come out midyear this year with the results of that. And then BRAVO 3, which focuses on the health economics aspects of patient care, will also -- intended to come out later this year. So that will be an important leverage because it is a very strong data set in the real-world evidence realm.There are approximately 27 remaining Flex accounts. We'll continue to see them erode throughout the year. And it is still our plan. We are in process, active conversations and negotiations and beyond, to be honest with you, with multiple opportunities for bringing flex back not only to the U.S., but on a worldwide basis. And I think that's exciting in the sense that we'll also have control -- better control of our own destiny in the situation. So more to come on that as that progresses.Citizen's Petition, we spoke about. It's important to expedite -- to get this down classification that would enable an expedited pathway to the number of Blue Light Cystoscopy equipment manufacturers in the U.S. I think it's -- the FDA being aware of the impact of this Class III designation on Flex surveillance, which is a growing need, especially with these therapeutics that are focused on patients who have failed on BCG or patients who are second line to chemotherapies and that aren't working. They need to identify these patients. We know Blue Light Cystoscopy is the best option, particularly for CIS patients. So I think there's adequate pressure and awareness. We'll continue to press it on our end, both regulatorily and legislatively.And I think the public comment always remains very, very important. And I think we've got a great variety of stakeholders that we've generated with KOLs, physicians, clinicians, the U.S. patient advocacy, Beacon, health systems, equipment manufacturers, and now most recently, a biomarker company in the sense of Pacific Edge. So more to come. We'll keep you updated as things progress.Next slide, please. So Q4 '23 Europe, like the U.S., the revenues increased 19% year-over-year. There was unit growth and a benefit from foreign exchange. Unit sales increased 4%. And as I said, the momentum was building to the second half. The growth markets of Italy and U.K. showed significant growth, strong double-digit growth. Germany was a little bit softer. It has a lot to do with timing of when they buy their inventories. We had a very strong kickoff in January. So that German effect did mask some of the ignition of these priority markets.There were significant image quality upgrades throughout Europe in 2023. They have a very strong pipeline. And we're expecting to yield similar durable turnaround double-digit trends in France in the coming months. I think it will start igniting here in the first quarter and we'll start seeing some really strong growth in the middle of the year.Blue Light continues to gain traction. The interest of the KOL community is high. EAU and AUA, we have currently 4 accepted abstract publications or abstracts that will be presented. There could be a fifth, we're waiting to hear. All strengthening our data around progression, meta-analysis -- I'm sorry, strengthening our data around the use of Blue Light Cystoscopy. The EAU guidelines is what I meant to say, were strengthened with progression data, meta-analysis and discounting the photo trial. So this continued engagement with the KOL community in Europe is reaping bigger rewards, longer-term rewards in the sense of guidelines and support of Blue Light Cystoscopy.In fact, in the congresses and our involvement with KOLs throughout Europe, there were over 165 different events we attended where Blue Light Cystoscopy was discussed and brought or presented or at least represented.So where we have key initiatives to improve growth? There are over 1,400 performing -- TURBT-performing centers. About half of them, 700, we've talked about this in the past, have Blue Light equipment in them. Much of that equipment was very, very old when we took over. Many of the users had stopped using it. The support had really waned. The processes had been broken down. We're actively targeting 590 hospital clinics which we believe are still underpenetrated.The key to this is the image quality upgrades. It could come in the form of small upgrades or major upgrades, including a replacement of the system. Again, a nice thing about Europe is they have access to all 3 major manufacturers. And since we took back Europe, all 3 major manufacturers have upgraded their Blue Light Cystoscopy equipment, which is, I think, testament to the demand that we have generated through the customer base throughout Europe that this has prompted the capital manufacturers to upgrade their equipment to the latest technology. So that is fantastic. And again, 23 new Blue Light accounts in 2023. We look forward to harvesting those.Next slide, please. So there's been significant progress with our partner Asieris. Two different programs. First one is Hexvix. That trial wrapped up. They have submitted for an approval. And as I mentioned in the kickoff of today's presentation, we expect 18 months or less review period. So we're thinking second quarter next year they'll hear back. Looking at the data, it would be hard to believe they wouldn't get an approval, but again, who knows. So if that's the case, they will then launch second half of next year in China.On Cevira, reminding this product was out-licensed to Asieris. So our involvement is very, very limited. We are required and bound to an agreement with them that we communicate only what they're willing to communicate or talk about. What I will say is they will be presenting this data at EUROGIN 2024. It's an HPV Congress, March 13th through 16th.I think it's kind of exciting. They are also, I know, engaging with regulatory authorities both in China and in Europe. Their intention, at least initially, is for sure a Chinese submission. I think they're assessing European. I know the question is, "What about the U.S.?" The U.S. will require additional studies. And that is on -- again, a part of their strategy deliberations.I think the other thing that's really important here is Cevira is the crown jewel in their crown. They recently announced the establishment of a women's health division and they found themselves a very accomplished commercial executive to lead that on a worldwide basis. So we're looking forward to the ongoing progress in this area. And reminding everyone, both of these programs come with significant milestones on both regulatory approvals and, down the line, with commercialization and sales revenues.Okay. I think I'll hand it over to Erik. Erik?

[Erik Dahl, executive]

Thank you, Dan. Okay. In this section, we will look at the financials, obviously, and we will review the consolidated income statement. We will look at segment report for the 2 main segments. And finally, headlines from the cash flow and balance sheet. And as always, please keep in mind that all amounts mentioned in this presentation are in Norwegian kroner, unless I specify a different currency.Looking at foreign exchange, high level for the full year, measured by unweighted monthly averages, the U.S. dollar increased 9.9% and euro increased 13.1%. And for Q4, U.S. dollar increased 6.3% and euro increased 12.1%.Next slide, please. Thank you. So we're now looking at the consolidated income statement. Total revenue was NOK 142.5 million in Q4, which is an increase of 37% from Q4 '22. Drivers of this increase were milestone revenues related to Cevira, a foreign exchange impact we had, and an increase of average selling price and volume growth. Full year revenue increased 27% to NOK 500 million and was impacted by the same drivers. Total operating expenses, excluding business development expenses, increased 2% to NOK 107 million in Q4 compared to Q4 2022.In constant currencies, the operating expenses decreased approximately 7%, which represents a continuation of the flat to negative expense development we have had in the last 8 quarters. Full year the year-over-year growth in our operating expenses, excluding business development expenses, was 10%, and in constant currencies the operating expenses decreased approximately 1%. We had no business development expenses in the quarter, but NOK 9.9 million for the full year, which is a decline of 57% or NOK 13 million from 2022.Now the 0 cost in Q4 on business development does not imply that we have stopped activities within business development, but you should expect that future business development activities continue to be as targeted as it has been in 2023.EBITDA Q4, NOK 29.9 million. This is an improvement of NOK 46.8 million from Q4 2022. And of this improvement, a total of NOK 28 million is driven by increased milestones and lower business development expenses, and the remaining NOK 18 million is the financial impact of the improved profitability of our core business, and it drives an improvement of EBITDA margin in Q4 of 16 percentage points compared to Q4 2022. Full year EBITDA, NOK 55.5 million, which is an improvement of NOK 80 million from 2022. Of this improvement, NOK 48.8 million is driven by increased milestones and lower business development expenses and NOK 31 million reflects improved profitability of our core business.Depreciation and amortization, NOK 7.4 million in Q4, and full year is NOK 27 million. Main cost item, as before, is the amortization of the intangible asset related to the return of the European business from Ipsen. And net financial items Q4, a net cost of NOK 5.9 million, and full year a net cost of NOK 18 million. And main cost items is the earn-out payment to Ipsen. We have no long-term loan or other long-term debt.Tax expenses, NOK 4.1 million in Q4, and full year NOK 9.5 million. And after tax, we have a net profit of NOK 12.5 million and full year a net profit of NOK 0.3 million, which compares -- is compared to a full year net loss of NOK 71.9 million in 2022. An improvement in net profit reflects significant improvements in core business as well as milestones received in the year.Next slide, please. So here, we're looking at the segment performance and we're looking at the 2 main segments, North America and Europe, and the North America segment includes U.S. and Canada. Now revenue for North America increased 21% in Q4. The drivers are foreign exchange, a volume increase of 7% and a price increase of 5% in U.S. This is partly driven by a decline in Flex volume due to the ongoing flexible BLC phase down in U.S.Q4 direct costs decreased year-over-year NOK 4.9 million or 11%. The decrease is driven by general cost containment, offsetting the 6% negative FX impact in the quarter. Contributing to the decrease is also a reclass of expenses related to patient registers. And these were previously expensed and now they are capitalized and amortized. The reduction in direct costs drove an improvement of contribution of NOK 12.5 million to NOK 4 million for the quarter, and full year contribution was NOK 9.1 million, which is an improvement of NOK 26 million from 2022.The European business experienced year-over-year revenue increase of 19% in Q4. This was driven by FX by increased volume and a combination of price increases and mix. Direct costs increased year-over-year with 26% in Q4, and this increase reflects the FX development and one-off expenses in the quarter. We ended Q4 with a contribution of NOK 25.2 million compared to NOK 22.6 million same quarter 2022, and full year contribution was NOK 121 million, an improvement of NOK 19.4 million from 2022. Full year contribution margin was 46%.Let's move to the next slide, cash flow and balance sheet. Thank you. So cash flow from operations in Q4, NOK 19.6 million compared to NOK 0.7 million in Q4 of 2022. And the difference is driven by the milestone from Asieris in the quarter and by improved profitability of our core business. Cash flow from investments in Q4, positive NOK 1.2 million, and this includes received interest payments, which are offsetting investments in tangible and intangible assets.Cash flow from financing in Q4 was negative NOK 16.4 million and includes earn-out payments to Ipsen. The term loan from Nordea was fully repaid at the end of the second quarter. So this gives us a net cash flow in Q4 positive NOK 4.4 million and compared to negative NOK 15.8 million in Q4 last year. And with this net cash flow, we ended 2023 with a cash balance of NOK 260 million.Looking at the balance sheet. We ended the year with total assets of NOK 711 million, noncurrent asset was NOK 339 million at the end of 2023. And this included customer relationship with NOK 112 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 and a tax asset at the end of the year, which was NOK 48.8 million.Inventory and receivables, NOK 113 million at the end of the year. The increase from year-end 2022 is mainly driven by increased revenue. And long-term liabilities, NOK 151 million, includes the earn-out liability related to the Ipsen transaction, totaling NOK 128 million at the end of the year. And finally, equity at the end of the year, NOK 482 million, which is 68% of total assets.And this concludes the financial section. Thank you. Dan, back to you.

[Daniel Schneider, executive]

Great. Thank you. All right. We'll go to the next slide, Slide 14, summary. We can move to the next slide, 15, a summary of Q4 results.So 20% revenue and 4% unit growth, but there are a lot of initiatives to accelerate unit sales momentum in 2024. Focus is going to be heavy on harvesting. While tower places still remain an important part of our strategy and in certain markets absolutely necessary, there are some markets that have towers and we need to improve the productivity of those towers. And so this is a harvest year. From a revenue standpoint, we make money on Cysview and Hexvix. We don't make money on the towers, but the towers are critical, obviously, to our overall success, long-term success.Some of the key things that we're doing this year beyond harvesting and getting more productivity out of our accounts, we expect the Citizen's Petition to continue to progress. We're hopeful that there'll be some sort of response by the FDA before the end of this year. We're doing everything we can from a stakeholder standpoint as well as regulatorily and legislatively.A large -- the large tower purchase that we spoke about is a new business model. This business model is brokered by us. It is meant to overcome some key challenges, particularly in the U.S., but also this transfers to some of the countries in Europe, such as Italy, where capital expense and the cost of the equipment is prohibitive. The time that it takes to get through the process is long. And in the case of the U.S., with only one choice of manufacturer, it makes it sometimes difficult for prime vendor situations, prime vendor being hospitals that are dedicated to one of the major device manufacturers. It's just another hurdle for us to try to come over. So this new business model that we hope to speak about the next time we get together, I think we'll address some of those key challenges we have in the U.S.The Flex proprietary system for Photocure is still onward. We're still making progress. There is work being done. There's testing being done. So we remain very optimistic there and hope to report out on that. And then the data from the patient registry is extremely valuable, as I mentioned, not only for Photocure and Blue Light Cystoscopy, but also for many other stakeholders in bladder cancer care.If you go back 7, 8 years ago and you went to EAU or AUA, there wasn't a whole lot of discussion on bladder cancer. It was all about prostate and things of that -- OAB, et cetera. That has changed drastically. And the influx of money and interest in development with all these therapeutic guys coming further underscores the critical importance of having a proper diagnosis and resections, and then staging, and then ultimately, a course of treatment. And Blue Light Cystoscopy remains the key in our minds to that overall patient journey.The Flex phase down in the U.S. will continue through the U.S. But I think you should note that even though when we get to guidance, it's high single-digit guidance growth, in reality the underpinning of the business is double digit. It's just overcoming the challenges of this erosion throughout '24. Key is that the priority markets in Europe are responding. Europe we got back. I would say that we re-launched in this year. This is a launch year, 2024, for Europe. All the things you would have done if you're preparing for a launch of a product have been done now. From the activation of the KOLs, to getting the equipment manufacturers to upgrade equipment and get reengaged and supportive and partnering with us, all is taking place. I think we're going to see some nice growth, particularly in the high-growth markets in Europe. Strong KOL support. Image quality continues to be a very important part of our overall strategy.Next slide, please. So continuing on with anticipated milestones and corporate objectives. I think from a guidance perspective, we're guiding 6% to 9% revenue growth, positive EBITDA and installations of 40 to 60. The 40 to 60 is -- I think we'll move to the high end for sure when this large order comes through. So it should be another great year for Saphira in the U.S. Europe will continue to do its upgrades. As we mentioned earlier, they had 146 upgrades last year. There will be more this year, as well as new accounts that get opened as Blue Life Cystoscopy continues to gain traction throughout all of Europe.We'll continue to proactively support the Citizen's Petition. The data will flow from the registries, not only our own registry, but the Danish registry, the Nordic registry. In this data, there is a whole host of publications. EAU, AUA, we have 2 presentations in each. There potentially will be a fifth. So we'll wait to see. And then as we get to the other major congresses, there will be additional data presented.We expect progress on Asieris' assets, particularly Cevira. They're going to present the data for the first time at EUROGIN in about 3 weeks, and we expect them to submit this for regulatory approval in 2024. And again, a reminder that there are additional milestones for each stage as they progress, not only Cevira, but Hexvix through to approval and then ultimately commercial launch.So with that, I think we can go to the last slide, 17, and turn it over for Q&A.

[David Moskowitz, executive]

Okay. Great. Thanks, Dan. And hello, everyone. And I would like to say thanks for all the questions that we've gotten in the queue. I'll start at the top here.First question is, when do you expect to see accelerating growth again in the U.S.? And I'll just add the related question is, when can we see double-digit growth again?

[Daniel Schneider, executive]

Well, as I mentioned in my presentation, there is underlying double-digit growth in the rigid space, but we're overcoming the erosion of Flex. It still remains probably roughly 10%, high single digits or 10% of the U.S. business. So until that headwind is eliminated, so to speak. You're not -- that growth isn't going to be as evident. But if you know the business well, you'll see it. I think once we can reintroduce Flex in this new -- we're very positive, we're optimistic about this new business model, I think will be interesting.And then in Europe, as I mentioned, it's been a couple of years, it's been tough. We took over Europe in the midst of COVID, launched into a market that was dormant, and Blue Light Cystoscopy was all that forgotten, equipment was old, processes broke down, KOLs abandoned. That has all been reengaged and reignited. And I'm excited about the way 2023 closed, particularly in the high-growth markets, growing at significant double digits. And I think as we turn the corner in '24, I think we'll be pleased as the year progresses.I think the key to the U.S., again, just to get the hyper growth, particularly with the way bladder cancer is evolving with the therapeutics coming out, bringing back Blue Light flexible cystoscopy and the key to this is the Citizen’s Petition, the reclassification, but bringing that back, we'll also have a very strong impact on accelerated growth in the U.S. But I think even without it, we're going to see growth.

[David Moskowitz, executive]

Okay. Excellent. Next question is, given the NDA acceptance for Hexvix in China with Asieris, when do you expect this product to get to market?

[Daniel Schneider, executive]

Which product?

[David Moskowitz, executive]

The Hexvix in China.

[Daniel Schneider, executive]

Oh, Hexvix. Come to the market second half of next year. If they get an approval somewhere between November this year to June of next year, I think what Asieris is saying is that it's an 18-month review. There are situations, as I mentioned in my presentation where that can go a little quicker. But at this point, let's assume they get an approval sometime in May, June and that they can get themselves launched in the second half of next year.

[David Moskowitz, executive]

All right. And you must have read my mind because the next question is, when could Cevira get to market?

[Daniel Schneider, executive]

I did read your mind. Cevira, it depends on when they submit. If they can submit by midyear this year, it's probably an 18-month review, I think the one -- again, I hate speaking for Asieris, this is their product at this point. But one of the things I do want to note on Cevira is a drug device combination. So it's a little more, always a little more complicated regulatorily. But typically 18 months review. So if they can get at least submission for China, say, by midyear, third quarter this year, then mark-out 18 months from there. They've already put in place a woman to run the women's health division who wants to launch this women's health division globally should be responsible for that.So I think the commitment is absolutely there and the #1 product, the sort of the crux of what's prompting all this is Cevira and their belief behind its success. So it's exciting as this develops.

[David Moskowitz, executive]

Yes. I think you answered this before in the presentation, but is Asieris applying for -- simultaneously for Chinese, European and U.S. approval of Cevira.

[Daniel Schneider, executive]

Well, I can confirm China, Europe, I think they're assessing. They did have European trial sites and whether or not that will qualify them for approval, I think they had to meet with the regulatory authorities of Europe. U.S., no, not at this point. We're going to -- they will need from what we understand 2 trials in the U.S. to support a submission into the FDA, slightly different design. The FDA was acquiring slightly different criteria. So more to come. But I know that they are extremely excited. I think the data was exciting to them. We haven't seen it, but they seem excited. So we'll see what the data looks like. And I think between that and what it requires to do the work, they'll progress it. But I think the fact they got someone -- they're building out the women's health division tells me that they're committed on a worldwide basis.

[David Moskowitz, executive]

Okay. Here's a little bit of a different question. Why is taking Blue Light equipment in the U.S. from Class III to Class II. Why is that a political process?

[Daniel Schneider, executive]

Why is it a political process?

[David Moskowitz, executive]

That's the question here?

[Daniel Schneider, executive]

What isn't a political process in the U.S.? It's not just political. There's -- it's government run. And I can't speak for every government in the world, but I think we've all had our challenges with some of the bureaucracy that goes into these things. What we're attempting to do is not only work through the bureaucracy through the channels and the processes. We're working through Karl Storz. So it's not even us directly. We can't even get a direct conversation with the FDA per se, but we're doing what we can. But we also can work the legislative side. And the interesting thing about the legislative side, it's a bit clever because if you can get the right legislators who enact the laws to put the right things in place in a bill that gets turned into a law that can change things very quickly.The other thing is politicians have a lot of influence, a lot of influence. And depending on what committees they sit on, et cetera, can have a significant impact or let's put it this way, if the FDA has got 20 things to look at and we can get the right legislator, put the right pressure to get them to look at the right thing, which is Blue Light Cystoscopy and the need for reclassing this thing. That's a good thing. So we are scrapping, and we are pushing as hard as we can, and then we continue to engage anybody and everybody in the bladder cancer space to support our initiative.And I think it's -- congratulations to the U.S. team who have been continuing to get people to jump in on our benefit for the most part. But they also translate that to the benefit for the patient. That's really ultimately what's at stake here is patients are not getting the best care because of old decisions made by the regulatory authorities in the U.S.I will tell you, interesting enough, after 2012, 2011-2012, the FDA had realized what they've done in some of these drug device combinations, particular with devices. And they are much more cautious on approving these things under Class III because they realize it creates a monopolistic situation, which is not in itself bad, but if it affects patient access to care, it's a problem. And that's ultimately what the FDA is trying to do is give people an opportunity for proper care. Long-winded answer to a short question.

[David Moskowitz, executive]

Yes. No. That's fair. I think a good answer. So sticking with Citizen's Petition, and this is really the last of the questions. There's 2 here. If the Citizen's Petition is granted, how long do you think it would take for Blue Light manufacturers to get their equipment to market?

[Daniel Schneider, executive]

Well, if it is -- so if the FDA picks up the Citizen's Petition, they're going to have to work with Karl Storz to design sort of what's the engineering specs and I won't get the technical side of all this, but what is it going to require someone to bring a Blue Light Scope to market? What are the technical engineering impact -- needs? Once they determine that, and that could take months they will then reclass it and they'll call it a Class II, at least is the way I understand the process. It will be a Class II device. At that point, the other manufacturers will have to match up the specs of their equipment to the specified requirements of the FDA's Class II and then submit. That submission is now on a 510(K) pathway, which is a 90-day review period.So all-in-all, I think on the -- at the moment the Citizen’s Petition turns into a down class, and they actually call Blue Light Cystoscopy a Class II device and a 510(K) pathway. I think you're probably looking at 6 to 9 months, maybe, could be sooner. I mean the -- it's not like someone is creating Blue Light from scratch. They have it. They have it in Canada. They have it in Europe. It's there. It's a matter of just matching up and submitting it, getting the paperwork in the FDA. So each one will work at their own pace. But I will say the interest is high, very high.And we know the 3 who are currently, you guys have also read through our Citizen’s Petition that Stryker has extreme interest in this process. So now you got another of the big guys wanting to knock on the door and come through and produce or provide Blue Light Cystoscopy on a worldwide basis. So more to come.

[David Moskowitz, executive]

And then a follow-on to that question is if the Citizen’s Petition is granted, how do you think about the revenue growth forecast under those conditions?

[Daniel Schneider, executive]

I'm not going to forecast it for everyone today. I will tell you that it does open up the market. We know, at least in the U.S., the Karl Storz has roughly 30%, 35% share. When I say share, they just have dominance in 30%, 35% of the accounts. The other ones, maybe 40%, I think they've had a little trouble recently, which by the way, is we're talking about Karl Storz, I don't know if anyone has seen this, but they have announced a major reorg in North America. And I think that's a response to customer communication, we'll call it, on how they're doing things. So I think that's a positive sign for Karl Storz.But if you think about 35%, 40% of the hospitals are Karl Storz dominated hospitals, the other 60% or 70% are dominated by the other manufacturers that is a hurdle sometimes that's hard to overcome. You're talking about accounts where if you buy all Karl Storz equipment, you get ex discount at the moment, you start bringing that volume down, you're losing volume discounts. So besides all the capital equipment processes and budget meetings you go to, you also have to overcome the fact that you're now taking something away from a volume discount arrangement.So I think opening this up to all manufacturers, it puts competition not only on an economic level because they're not -- there's just not one manufacturer. So price will be set by the market. But I think also technologically, you can't go out with equipment that is inferior to your competition. You're going to continually iterate that equipment. So what we will see is an acceleration in iteration of this equipment over time. So technologically and economically it will create a lot of opportunity for the U.S.

[David Moskowitz, executive]

Okay. There actually is one more question that came in. With regard to the large rigid tower order, it's been pushed back. What is your sense of the probability that this order will get done?

[Daniel Schneider, executive]

I would say it's near 100%. I think I know where we're at with it today. We've broken the deal. We're not buying the equipment. So that's one thing. But we are brokering this deal. It is a business model endeavor. I think it's exciting. I think it opens up a market that we can't get to because of the things I just mentioned around having a single manufacturer, the cost of capital equipment, the time it takes, the process, this is going to open it up for us to support. But at the end of the day, we are the ones bringing the parties together and brokering the deal. Obviously, one of the parties is Karl Storz. We can't identify the other party at their request. But when we're ready, we'll explain the model, what this means, why it's exciting to us and what we think that impact potentially be on the business in the U.S.

[David Moskowitz, executive]

Okay. Great. Well, that is all the questions...

[Daniel Schneider, executive]

2023 started out extremely strong. Flex is actually really strong in January, in early February, and then, of course, we were given the bad news for Karl Storz. But I think through all that, we continue to show the resilience of a company that will not give up on behalf of our patients that we treat so.