Welcome everyone. I'm Dan Schneider, President and CEO of Photocure. Welcome to our Fourth Quarter and Fiscal Year 2022 Results. With me today is Erik Dahl, CFO. Reminder, next slide, disclaimers are in effect for today's presentation. Next slide. Fourth quarter and fiscal year 2022 highlights, I think, you know, the highlight for the quarter is the launch of Saphira™ and the fact that we had a record number of installations, took tremendous amount of effort from the sales force in the customer servicing, support and training. I believe that also drew down some of their time in the U.S. from the typical balance in selling.
Our revenue growth was 10%. On a -8% unit sales, again, I think affected significantly by the amount of effort and energy that went into the installations, which bodes quite well for our future. As everyone knows from our past, the more installations brings on a momentum that carries ourself forward. Also, you know, the COVID and shortage, staff shortages still are out there, and we'll get into that shortly. There is signs of rebound.
I will be showing you a couple looks at both U.S., and EU in terms of first quarter and how it's progressing, and we're quite pleased that we can kind of partition quarter four as an anomaly affected by extraneous factors and also the record number of installations of Blue Light Saphira™ that were put into the market. EBITDA was NOK -16.9 minus business development expenses that are, you know, one-off in each quarter. If it happens, it's NOK -7.8. We continue to invest in the commercial. However, you know, our OpEx is for the most part gonna remain fairly stable. We'll increase investments. The quarter had increased investment in business development activities.
Of course, I'm not privy to disclose all that took place, but we continue to keep that as a very important part of our overall strategy in the inorganic developments of looking for synergistic and complementary assets to add to the offerings of Photocure. We also received a $1 million milestone from Asieris as they continue to make progress on the Saphira™ trial. On the news front, there was the advancement of the citizen petition. There were actually 13 public comments that were submitted. They were from large urology group practices, two manufacturers, multiple KOLs, and also the patient advocacy group, which is a very strong voice in the United States.
One thing about citizen petitions is they're not held to the same, or at least the process of reclassification is not held to a specific timeline, for the FDA. This amount of support, public support is very very important, in addition to what, you know, the final point, which is the Flex Tower situation. The installations going forward will be on hold. There were seven scheduled for first quarter this year. Those are on hold, KARL STORZ and us are assessing the situation, evaluating options to restore the equipment availability. That situation also will fuel the ability perhaps to speed up the attention or at least grab the attention of the authorities in the US FDA, to start a down class or a reclassification of the Blue Light system.
As a reminder, in the U.S., KARL STORZ has roughly 40% share of the market where they have full on access. The other 60%, of course, we can bring Blue Light into, but it takes a little more effort. This citizen petition would essentially, and the ultimate hope for a reclassification to a Class II device would open the market up for other manufacturers to come in, which we do know there is interest. We think that would have a dramatic impact on our ability to get Blue Light into all the accounts in the U.S. We think this is possible, could come this year. Again, there is no specific timeline given by the FDA on these types of things.
In fact, you know, that timeline can be anywhere from a few months to years. We believe we can get this current situation resolved quickly. All right. Segment trends, next slide. We'll go to slide 5. Q4 challenges in the post-pandemic environment. This affects both regions of the world. A couple snippets. You absolutely can go onto these various links and read about the impact of hospital volumes under pressure with labor crises, COVID-19 impact on staffing shortages, sick leaves in Germany. I mean, I don't wanna make the excuses over and over, but it is, it's still overhanging on anyone, I think, in the life science health system, and particularly procedural selling spaces. This continues to be something we deal with.
The good news, I think COVID as a pandemic and how to access accounts is not the problem now. It's more around the accounts themselves having the financial wherewithal and the staffing to support. The industry data suggests we get definitive data that TURBTs in the U.S. year-over-year were down a little bit. We have a little bit of headwinds. We believe the way we've set up with new installations and as things are developing here very early in quarter 1, that things will resolve very, very quickly as we get through 2023. Next slide. A couple trends in North America. You know, the revenues are up by 12%, although unit sales are off by 11%. Q1 have rebounded, and we'll share that slide shortly.
It is impacted by staffing shortages, lower procedural volumes, and of course, I think probably the number 1 thing is the amount of time and energy that went into placing 57 installations in quarter 4, and particularly towards the back half of quarter four was a lot of the time that normally is spent pulling through at its various accounts. This will remain a key strategy for us as we go forward. There are over 350 some odd accounts that have the old standard definition systems in them. It is our hypothesis and belief that getting those old systems into the new system of high-def Saphira™ will make an impact on utilization and reliability, increased usage by physicians in those institutions.
You know, new placements will remain you know, very, very high, but will also be at the same time, switching out old systems with KARL STORZ's support. We did have a record number. We had 57. We had 24 new ones, of Saphira™, seven flexible scopes, in the fourth quarter, we had 26, I believe, was the number on the number of obsolescence protection plan. Those were the accounts that had bought the old system, but with the insurance policy, so to speak, that when the new system was available, they would be switched out. We also are seeing existing accounts, large systems that are on standard definition now requesting Saphira™, those will be installed as we move through 2023, we think will have an impact on the future.
Demand for new Blue Light remains very, very strong. The pipeline is very strong. First quarter's gonna be good in terms of installations. We have no reason to believe that quarter 4 is a quarter that we would expect to repeat. We think that quarter 4 is an anomaly, and we'll move forward. Contracting and the CMS reimbursement remain an important driver for us, and I think the advocacy for the citizen petition, along with a four-pronged strategy to expedite the down-classification or declassification that we're putting into play will have an impact. Hopefully, we have good news as we move through the year. Next slide, please. I think this slide, just to show the atypical unit sales pattern, signs of rebound in Q1. I'd like to go to the next slide, if you could.
This is a quick glance at basically the first, you know, month and a half of the quarter. You can see that January is the highest over the last three years. In fact, January was the highest we've ever had in our history, so that's always a good sign. Then we moved into February. We're still, you know, six days left to the end of February, but at least from our perspective, projecting out, we look at dailies, weeklies, et cetera, and then the overall demand, we project that it'll be a double-digit growth in 2023 over 2022. Final numbers to be obviously coming out when we do the Q1 presentation later this year. Very good development.
Gives us great confidence in the business and the health of the business going forward. Next slide. In terms of the health of the business, I'd mentioned a couple things I wanna say about this slide. Record, obviously, number of installations for the quarter. We had 24 rigid, seven Flex in the upgrade of 26 obsolescence management plan. If you look at all the dark blue bars going backwards, and even some of the 59 of 2022, those are standard definition systems. Those systems are eligible, particularly ones that go from 2019 backwards. Those systems are end of life, end of service. They are subject to breakdowns. We've talked about this in the past and why this Saphira™ launch is so important.
We will be working vigorously with some, with the folks from KARL STORZ to get those 300 some odd old systems converted to the new platforms where we believe that the utilization will improve. Let's put it this way, it will not have a leaky bucket syndrome where things break down and the systems are pushed into the corner because they gotta wait for a repair. We believe the new systems will capture any losses of the past. This is a very important part of our strategy moving forward, and we're very optimistic of its impact on the business moving forward. Next slide. Moving into Europe, its unit sales were down 5%. Revenues were down 5%, and unit sales down 8%.
Again, affected by various things like staffing shortage and budget tightening. The other thing, we're gonna talk about this a little bit, is the German phasing of hospital ordering. You know, as we've gotten into Europe, we got Europe right on the cusp of the, or right in the midst of actually COVID. Our access to accounts and our understanding of the accounts continues to build, one of the key parts of this is the way the German market watches and responds and phases its ordering according to market dynamics, we'll get into that in a moment. I think 2023 is an exciting opportunity for the company. It'll be our first 12 months with complete open access to Europe.
If you recall, we had no access, for the most part, to Germany until about April or May of last year, or very limited access. Other accounts, majority of them throughout Europe, were not open until March and April. This year, 2023, will be the first year we have full on access. We're focusing on 80% of the existing accounts that we believe are under-penetrated. How will we attack them? Same way we're doing in the U.S. There's an opportunity to upgrade a lot of equipment out there, which will recapture and reinvigorate the business in Europe. You have to be present in those accounts to do these sorts of upgrades.
Getting, you know, new scopes, whether it be the Saphira™ system, which has also been upgraded in Europe, into those hospitals, or Richard Wolf, or in the future, we know Olympus is working on its upgrade and will launch later this year. Those are all key tactics to get those accounts back up and running and back to the levels we expect them to be and growing. The new system is gaining traction, and the upgrades are expected throughout 2023. We also expect new installations in Europe, particularly in the U.K., and France. We've already have some of those already taking place as new accounts are grabbing onto it. Of course, the Bladder Cancer Tour is highly is a high visibility in Germany there with over 20 stops throughout Germany and Austria showing demand.
We look forward to 2023 with Europe. We think the trends are going in the right direction. Next slide. You know, just looking back though at Germany, in particular and its reaction to the market, the three arrows you see on this slide are all German reaction to three things. First one, the dark blue, in 2020, was reaction to the Ipsen transfer to us. German hospitals anticipated this. They built inventory ahead of it, assuming there might be disruption. There wasn't disruption, therefore, they went in with some heavier inventory on the transfer. In 2021, they had budget headway or headroom they bought in. This is a typical buying pattern at the end of the year for many of the European countries.
If there's budget available, they will buy various products, devices, et cetera. We had that buy-in. This year in 2022, if you look at the second quarter, there was a buy-in ahead of the price increase in Germany, that then had to bleed out through Q3 and Q4. Again, we looked at Germany as a phasing effect on the overall European progress and performance. Next slide, please. Looking forward, the first six, seven weeks of 2023 looks very, very good for Europe. January, a little soft. Projecting February, looking at the dailies, weeklies coming in, it looks very, very strong. We look like we're back onto recovery. Momentum's building. Teams have 100% access, and we think we can really make the necessary changes.
I think, you know, one thing about Europe, putting in perspective, with COVID affecting access for the first two years of our ownership of that market, it also is a little bit longer process. We had to reengage and reenergize the KOLs. We're working on the guidelines. That feeds into reimbursement. You then go from reimbursement to getting funding and funding through pull-through. The process takes a little bit longer. I'm disappointed, to be honest with you, that we didn't have better access through COVID and could have accelerated the developments in Europe. I do have complete confidence that we can impact this market.
I think the 80% of the accounts that are under-penetrated and are gonna be focused on by the European sales team, with now access, I think will have a residual or have return for that effort in terms of performance in the future. Next slide. I think the untapped potential in the European market, key to this is France, U.K., and Italy. I mentioned new installations will be a part of it. A lot of old equipment out there, they're gonna be upgrading, so they're highly focused on it. These markets were also affected by staffing shortage, financial pressures, and equipment availability in the Q4 2022. Customer interest extremely high.
We believe that, you know, with our participation throughout Europe, 68 congresses, events, and workshops will be held in 2023, to really accelerate and ignite the business in Europe now that we have full access. I'm really excited about where that will be going in 2023. With that, I think I'd like to turn financials over to Erik. Erik?
Thank you, Dan. Well, I will give you a financial review, including the consolidated income statement. I'll give details about the two main segments, North America and Europe, finally, the headlines from the cash flow and the balance sheet. Before that, foreign exchange, it had a significant impact this quarter as well on our results. In short, the year-over-year FX impact in Q4 was for revenue positive approximately NOK 7 million, for EBITDA NOK -2 million. Full-year revenue impact was positive approximately NOK 14 million, for EBITDA negative about NOK 6 million. As we review the financial, please keep in mind that unless other currency is specified, all amounts that I mention in this presentation will be in Norwegian kroner. We're looking now at the consolidated income statement.
Total revenue was NOK 104.2 million in Q4, an increase of 10% from Q4 2021. Main drivers were the milestone revenues related to Cevira. It was foreign exchange impact, as well as an increase in average selling price. Full-year revenue increased 9% and was impacted by the same drivers. In addition, the comparison with 2021 was impacted by the upfront payment from Asieris of NOK 6.4 million in the first quarter of 2021. This payment was for the partnership agreement with Asieris for Hexvix in China and Taiwan. Total operating expenses, excluding business development expenses, increased NOK 16 million or 18% in Q4 compared to Q4 2021. The increase was mainly driven by FX, a total of NOK 9 million of the NOK 16 million increase. In addition, we had general inflation obviously, as well as investments in our commercial operations.
Full year, the year-over-year growth in our operating expenses, excluding business development expenses, was NOK 59 million or 19%. Contributing to this increase was FX with NOK 20 million, as well as the investments in Photocure's European commercial organization throughout 2021, which was required to support and grow the European sales. I actually received a few questions about the business development line or the business development expenses in the company. A couple of words around that. If you look at the report, the earnings report, the business development expenses is included in other operating expenses. On this slide, we have actually split it out as a separate line item. You can see that on the slide. Operating expenses within business development are related to the objective to increase our product offering.
As you know from the last many quarterly presentations, we have a clear ambition in this direction. May it be in licensing, may it be M&A, et cetera, et cetera. I have also received questions about the line item, other operating expenses, which you will not see in this line, but you will see it in the report. This line includes G&A and supply line, including manufacturing, and it also includes all business development costs, which was a total of NOK 20 million in 2022. I think I wanna explain the expense growth for the item, the line item, other operating expenses, and I'm using second half of 2021 as my baseline or starting point. The average cost per quarter in this period was NOK 17.5 million.
Compared to that, the average cost per quarter in 2022 has been NOK 24.3 million. However, excluding business development, we spent about NOK 20 million on business development, average NOK 5 million per quarter. Excluding business development, the average quarterly cost is therefore NOK 19.3 million. This is 10% above the 2021 average. The inflation has been on average 5%-7% year-over-year. Our average FX impact between the two years has been 5%. We have a NOK 20 million FX impact on the operating expenses on a cost base of NOK 400 million. Now, I can't run away from FX, but we can mitigate inflation to a certain extent. Overall, the 10% expense increase we have, excluding business development, is driven by FX and inflation. EBITDA in Q4.
After business development expenses of NOK 9.1 million was NOK -16.9 million. This is a decline from last year Q4, driven mainly by the business development expenses. Full year EBITDA, after business development expenses of NOK 20 million up was NOK 24.6 million. This is significantly different than the full year 2021, driven mainly by the investments in the European commercial operation during 2021 after the takeover from Ipsen end of 2020. Depreciation and amortization, NOK 6.2 million in Q4 and full year, NOK 24.4 million. Main cost item is the amortization of the intangible asset related to the return of the European business from Ipsen.
Net financial items in Q4 was a net cost of NOK 5.5 million, and full year a net cost of NOK 22.1 million. The comparison with 2021 is significantly impacted by the reevaluation of the earn-out liability end of 2021 and the net currency gain at the beginning of 2021. Tax expenses were an income of NOK 7.1 million in Q4 and full year an expense of NOK 0.7 million. The net tax expense for 2022 is driven by intercompany items. After net financial items and tax, we have full year a net loss of NOK 71.9 million compared to a net loss last year or in 2021 of NOK 30.9 million.
Main single driver is obviously the investments in the European commercial operations during 2021 after the takeover from Ipsen end of 2020. Just as a general comment to the OPEX and the operating expenses, when you try to understand the difference or the increase from 2021 to 2022, you first need to understand the increase within 2021. You will see that the costs increased significantly during 2022, and it has an obvious explanation. We acquired the Ipsen operation in Europe, and we had to feed the new people, and we had to incur spending in that operation. Next slide, segment performance. Thank you. Well, in the segment reporting, we will focus on the two main markets, obviously North America and Europe.
The North America segment includes Canada from the first quarter of 2022. In January, we launched our own commercial operation in Canada for the direct sales of Cysview, and this sale was previously partnered but to BioSyent. We have not restated 2021 financial segment number to include BioSyent in North America, as these were deemed not significant. Total revenue for the year 2021 was less than 1% of U.S. sales the same year. We have, however, restated in-market unit sales. In-market unit sales for North America in Q4 decreased year-over-year 11%, and U.S. unit sales alone decreased 10% year-over-year. Revenue increased 12% in Q4, of which U.S. had a growth of 10%. The revenue growth was mainly driven by significantly stronger U.S. dollar, as well as a price increase.
Full year volume in North America increased 1% and revenue increased 20%. The revenue growth was, as for the quarter, driven mainly by foreign exchange and the U.S. price increase. Q4 direct cost increased year-over-year with $12 million or 35%. This increase reflects, first of all, the strengthening of the U.S. dollar, but also operational items such as the investment in the launch in Canada, the launch of the new scope from KARL STORZ, and also medical programs and initiatives to develop relevant data which we need for selling purposes. The contribution was $-8.5 million in Q4 compared to $-0.5 million in Q4 2021. A year-to-date contribution $-16.9 million. EBITDA, which is here excluding allocated business development expenses, was $-17.5 million in Q4.
Looking at Europe, the European business experienced a year-over-year decline in revenue in Q4. This is driven by the phasing of the German business in the quarter and partly offset by a price increase in Germany in the second half of the year. In Q4, European volume declined 8%. Full year European volume increased 1%, with revenue declining 2%. The difference between volume and revenue development is mainly explained by foreign exchange. Direct costs increased year-over-year NOK 2.6 million or 10% in Q4. The increase is driven by the investments in the local European commercial structure.
As we got control of the Ipsen business in Europe in Q4 2020, we carefully increased staffing and cost during 2021, and we have continued to increase headcount and costs somewhat in 2022, given improved access, but also taking into consideration staffing shortages in the healthcare sector in Europe. We ended Q4 with a contribution of NOK 22.6 million compared to NOK 24.9 million in 2021. The EBITDA, again excluding allocated business development expenses for Q4, was NOK 5.6 million. Full year contribution was NOK 102 million, and EBITDA excluding the business development was NOK 42.4 million. Now let's look at the cash flow and the balance sheet. New slide, please. Thank you. Net cash flow from operations, NOK 0.7 million in Q4 and full year NOK -2 million.
The negative development from 2021 is mainly driven by EBITDA after business development expenses. Cash flow from investments was in Q4 NOK +0.8 million, and cash flow from financing in Q4 was NOK -17.3 million, and full year NOK -51.3 million, which was driven by repayment of the long-term loan from Nordea, as well as the Ipsen earn out payment. This gives a net cash flow in Q4 NOK -15.8 million and full year NOK -54.8 million. The net negative cash flow reflects the funding cost related to the long-term loan as well as the Ipsen earn out. With this cash flow, we end 2022 with a cash balance of NOK 268 million.
Looking at the balance sheet, we end the quarter with total assets of NOK 719 million. Non-current assets was NOK 360.8 million at year-end. This included customer relationship with NOK 129 million. The customer relationship is the intangible asset identified in the purchase price allocation for the Ipsen transaction. The non-current assets also include goodwill from the Ipsen transaction of NOK 144 million and a tax asset of NOK 55 million. Customer relationship is amortized over on a straight-line basis over 10 years, while the goodwill is subject to impairment testing. Inventory and receivables were NOK 90.2 million at year-end, at level with year-end 2021, of 2021 of NOK 90.3 million. This is mainly driven by increased revenue, but it's, you know. That's it.
Long-term liabilities is NOK 167 million. It does include the earn out liability of NOK 135 million, and the earn out liability represents the capitalized value of estimated future earn out payments to Ipsen. The liability is subject to a 10-year annuity. Finally, equity at the year-end was NOK 462.7 million, which is 64% of total assets. This concludes the financial section. Thank you. Dan, back to you.
All right, great. Thank you, Erik. Let's move to slide 19 with the summary results. Just reiterating, we see Q4 as an anomaly caused by staffing sicknesses throughout Europe that's well documented, budget impacts and limited access in the first three months in Europe. We believe proof of the rebound is showing very early in Q1 and also, you know, the fact, especially in the U.S., the number of installations literally towards the end of Q4 bodes quite well for the U.S., and its rebound. The pipeline of Saphira™ remains extremely strong still. We expect a good installation throughout 2023.
We expect Europe to benefit from you know, the European sales force to benefit from having full access to the Saphira™, to the accounts and also upgrades and new placements of Saphira™ and, you know, Richard Wolf's new equipment and Blue Light. We look forward and hope to have a potential down-classification of Blue Light equipment in the U.S. that would unlock the market in the U.S. going forward with more than one manufacturer. Next slide. Anticipated milestones and corporate objectives. The guidance, you know, we make this guidance with the, with the realization that there's still some uncertain times surrounding the business, whether it be, you know, the current hold, supply hold on Flex, the impacts of staffing shortages still exist, but we think they will slowly recover throughout 2023.
We make this guidance, you know, with that in mind, with 65-75 installations of Saphira™ , a positive EBITDA, and a 20% revenue growth minimum for next year. Or this year, 2023. We'll continue the geographic expansion, look for partnerships around the world, license agreements. You know, presenting and publishing additional data. There are over 16 active studies and 25 active publications that are in work for 2023 forward. I think, you know, that continues that ground swell of interest in Blue Light technology now that we have full worldwide rights to the product in a commercialization. And we'll continue to evaluate product or business opportunities, leveraging our organizational strengths across the globe. Our business development efforts will not stop.
With that, I think we can go to the final slide, which is Q&A, and open it up. David, I guess I think you're proctoring for us.
Hold on.
You're on mute, David.
Oh, there we go. Okay. Thanks. I have to just switch from the slides to the queue here. All right, great. I think Erik went over this in the presentation, but the first question we have is, the business development expenses of the NOK 9 million in 4Q, how do we see these expenses developing over the course of the year? There's a little, there's a, an follow-up to that question, but I'll get to it.
As a general comment, I mean, the NOK 9 million that we saw in fourth quarter is probably not gonna repeat itself. I mean, every quarter, definitely not. It was a high, high peak, and if you look at the remaining three quarters of 2022, we spent about NOK 10 million in those three quarters, so that's an average of NOK 3.3 million approximately per quarter. I mean, this is very hard to estimate. It's actually impossible to estimate, and that's why we, when we provide guidance, have to look at, let's name it normalized EBITDA. I need to take this out of the equation, otherwise I'm never gonna make an estimate. I'm never gonna be able to do an estimate. The estimate is without that expense line.
How much that expense line will be, well, I said I don't expect NOK 9 million to be the overall average. I also can't say that NOK 3 million will be the average. It's depending on the opportunities and what we're doing. Sorry.
Okay, thanks. The second part of that question was do you expect these expenses to decline going forward. I think you just answered that they may be volatile depending on the opportunities we're evaluating.
Yeah.
Is that right? Yeah.
I think, yeah, the keyword is normalized EBITDA.
Okay. All right, whoever asked that, we can follow up if... Hopefully we got to that, we answered that second part. Next question is will you report cystoscope upgrade placements in coming quarters and the impact on scope productivity?
Yeah. I... That's our intention, to start talking about the number of old or old KARL STORZ equipment in the U.S. that's been upgraded. As far as productivity, it's gonna take time to measure that. We do intend, at least internally we've begun the process of measuring the productivity. It's gonna be several quarters before we're able to get a good read on what, and to quantify that impact. We do expect, I think the hypothesis is solid, that more reliable, better equipment, with, you know, with better visualization will actually increase interest and usage of Blue Light technology.
I might add to that in terms of scope upgrade placements, I think we will report that. I mean, the focus on the chart obviously is on the growth of new accounts that we're adding to the spectrum. What's interesting about scope upgrade placements going forward, it's different than the OPP. The OPP, those accounts were asked to surrender. To upgrade, they had to surrender their old equipment. With upgrades going forward, the legacy accounts that kept their old equipment, we're starting to see upgrades there now, and those accounts are actually keeping their legacy equipment and bringing in the new Blue Light, the Saphira™ system. It's really interesting.
They, those accounts do intend to run two scopes or multiple scopes in their facility and keep running the old equipment, you know, until it is fully end of life. That's, I think, a really an interesting phenomenon. It brings up another point. The OPP accounts, keep in mind, when they were making that transition from their old equipment to new equipment, their old equipment went offline. They had to surrender it to KARL STORZ. There was a period of lack of productivity for those accounts in the fourth quarter. That's another thing to bring up and probably impacted the fourth quarter performance on kits.
Yeah. Good point.
A next question from Rikard. You mentioned focusing on the 80% of accounts that are under-penetrated. Can you talk a little bit about that, and do you have an absolute number of how many accounts that that means, that is?
I don't have the exact number, to be honest with you, at hand right here. We can get back to you, Rikard, with Susanne and answer that more directly for you.
Right. In terms of the 80% that are under-penetrated, yeah, the granularity on that essentially is, yeah. The 80% of the accounts that have towers from the Ipsen transaction, many of them are barely using it or they're not using it really at all, so it can even be un- you know, un-penetrated or kind of, you know, offline right now. There's a huge opportunity there, and as Dan mentioned before, throughout the pandemic and even a good part of last year with the flares of different variants of COVID, we weren't able to access those accounts. Yeah, we're excited to really get to that part of the business that we haven't been able to access.
I just, maybe, one qualifier for Rikard, but for everyone. When we say under-penetrated, you know, our expectation is 35%-40% penetrations in accounts. Anything less than that is under-penetrated, and David's point, you know, some of these accounts have equipment that is almost inoperable. Or maybe the person who used it at the time is gone or stopped using it. Getting those, you know, 1%-5% up to 35%-40% is a tremendous opportunity for us. Some of it, and I'll be honest with you, a lot of it has to do with the equipment specifically, but a lot of it is also activating the physician base to see the value of Blue Light technology, support them in the operating theater, and we, you know, begin helping their patients. All right.
I think a theme in Europe, and I think Susanne, who runs our European division, really was beating us over the head with the word image quality upgrades. It's somewhere in the presentation, but that really is the theme. There are a number of Saphira™ replacements that are gonna happen this year that are really upgrades of the existing base. That's really the, what we're going out with, as a marketing theme is you're not really seeing what you need to see in Blue Light until you upgrade. I think that's a big part of the momentum going forward. Another two questions for Rikard. One, what type of assets have you been assessing for in-licensing or M&A?
I won't say specifically what, but it's assets that would leverage our current commercialization footprints across the U.S. and Europe. You know, if you look at our corporate presentation, I believe, you know, we talk about the pathway of the patient, the non-muscle invasive bladder patient. We do look for assets that fit in that cycle. We also recognize that our call point is a uro-oncologist, and Uro-oncology treats more than just bladder cancer. We can get to that same physician and also sell other items, whether it's drugs, devices, or diagnostics. It's again, it's all about leveraging our footprint that we have today. I'm not looking, you know, to get into, you know, a completely different therapeutic area like cardiology or something like that, which require probably a different sales force.
We really wanna leverage our corporate capabilities, so we'll leave it right there.
Excellent. How many endoscope manufacturers, excluding KARL STORZ, Olympus, and Richard Wolf, are evaluating Blue Light launch, launches in the U.S.?
You know, it's interesting. I think I've answered that question before. It was like 12, including KARL STORZ, at one point, I believe. I now heard of two more. Some of these manufacturers are clip-on type devices that are agnostic to any scope that's out there. There's other ones that are full systems for the OR theater. You know, the big guys are obviously interested in the U.S., but there's a lot of others out there with, you know, anything from, you know, the big guys are interested in the big system, rigid stuff. There are a couple others on rigid. A lot of the other stuff is disposable flexes, et cetera, et cetera. I would say north of 12 that are interested, particularly in the U.S. market.
Of those 12, I would say maybe about a quarter of them also have worldwide or European interests as well, which is obviously very important to us equally, so.
Okay. Great. Last one from Rikard. When do you believe the Olympus scope will hit the market in Europe?
You know, I mean, we don't work for Olympus, but what they have indicated is their intention is to launch it later this year. These things are, you know, devices are, it's not always the easiest thing. There's engineering requirements, and there's a lot of testing that goes on. We thought the Olympus system would be out beginning of this year. It looks like it's gonna be later this year. We will update you and the market if and when Olympus gets that launch later this year, or.
Yeah, I believe there's still a regulatory approval that has to happen.
Mm-hmm. Yeah.
Very good. Here's a question. How much can you expand the revenue with the present cost base that you have?
Put it this way, the way I look at the revenue development is that I'm looking at the incremental contribution I can get out of the incremental revenue. I'm not gonna get 100% because that means that I have a total the same cost, but with increased revenue. Increased revenue, even with the same staffing, will require additional activities and will, in itself, drive cost. I do expect to see a significant positive incremental contribution out of the additional revenue that we get, the incremental revenue. It's not gonna be 100%, but I mean, it will not be zero. We will be able to increase the revenue significantly without adding incremental or adding significant cost, but there will be some.
Great. Since I have you on, here's another question for you, Erik. When will the Nordea loan be paid off?
30th of June this year. We have NOK 12.5 million left.
Okay. Very good.
David, I do have an answer for Rikard, 'cause Susanne just WhatsApp'd me, I might as well give you the answer live. I'm gonna just round it off. There's approximately 800 towers out there. About 640, we believe, are under-penetrated accounts, that's what we'll be targeting. She did confirm late this year, maybe early 2024, for Olympus launch. What I told you earlier was correct. It's probably later this year or into early 2024.
Got it. Okay. Is there any news about Cevira? That's C-E-V-I-R-A, not Saphira™-
Oh
... the new cystoscope. There's two Ceviras in her life.
Oh, yeah. Well, once the fire, God, now you got me saying it wrong. Is there any news? Still progressing. You know, they had their last patient in, the follow-ups are taking place. They expect a mid-year read on the data that could precipitate either, A, a filing, or B, they could decide to do another trial of some sort. We'll more to come on that as we get more information. That program is 100% under their, you know, pretty much under their control, although we do support and advise where they ask us to. Versus the Hexvix trial that's taking place in China, that trial we are the sponsor for, we are heavily involved on that one.
I will update you as they update us in our public... They are a public company, so we have to be conscious of what they make public as well when we're communicating to our investors.
Okay, great. Another Cevira question, but you answered it.
Is it Severe? Guys.
No, no, that was.
Or the-
Same question. Different participant. Next question is kind of similar, "What's the status of Hexvix in China? How is that going?
It's, they're enrolling as we speak. Multiple sites are up. Enrollment gonna continue. The intention, the plan, the expectation is that this trial's phase III is completed by third quarter, and packaged up for the FDA for an approval in 2024. There's no reason for us to believe that it, you know, obviously we're well, well-educated on Hexvix and how to, how it performs, et cetera. You know, provided that the investigators are, you know, doing the right things through the protocols, we should expect a 2024 launch.
Got it. Here's one from Thomas, our analyst, at Norne. Do you see staffing shortages improving, currently? What are you seeing in terms of that trend?
Yes. I think everyone's, I mean, I think we're in line with everyone else on this, that it's still an issue. You know, the staffing shortages, you know, also caused some of the budgetary constraints because people had to go out and get nursing staff or medical staff support, and they had to pay a premium for it, so that put more pressure on these systems. We do, like anything, it will resolve. You know, the medical world is not, is a sophisticated sales force. It requires education and training, so it's not like, you know, if you're out of nurses, you put an ad out and all of a sudden a bunch show up. They, they have to go through schooling and certifications, et cetera.
That is, we're hearing that, you know, there's a swell of future nursing and medical staff coming through the pipeline. We expect it to continue to resolve through 2023.
Yeah, it's simple supply and demand. I mean, with the prices that, or the salaries that nurses can earn these days, you can expect that it's attracting new people to the field.
Yeah.
It does take some time. That's right.
Yeah.
Okay, here's a question. "You stated that the TURBT volumes declined during Q4. What is your source? Can you elaborate on how much the volumes decreased?
Yeah.
I can jump-
Well, it's Definitive Healthcare. We pay for that data. You probably, the average person probably isn't going to have access to it unless you bought it. The decline was, you know, part of this with Definitive Healthcare data is you're looking at both commercial and government pay. Government pay lags in terms of its reporting, so, you know, by looking and triangulating to it, you know, we think it was probably a single-digit decline in the fourth quarter. David, you had actually a little closer analysis with that.
There's actually another source, which one of our investors pays for, so it may be something that is, it's called, Strata Decision Technology. This is actually urology procedure volumes. What it shows is, let me just pull this up again on my desktop.
About 4.6.
Yeah, it's about 4.8% decline sequentially from November to December, you sort of have to extrapolate on the chart, and it looks like it's about a 3%-4% decline from October to November. Just those two months alone, it looks like you had about an 8%-10% decline just over the back two months of the quarter. I think if I, if I just look at, you know, you look at the charts that we showed in the prepared remarks, both in the U.S., and in Europe, and you just see December just wasn't there. It wasn't there for the hospitals to exhaust their budget in Germany, and it just wasn't there for our U.S. customers.
Granted, we were running around putting, you know, putting in place new cystoscopes, the volumes just did not come through. Emergency surgeries or something that's life-saving versus a TURBT that can be postponed another month. The data really backed that up. It looks pretty drastic for the back half of the year, and as you can see, we're coming back in the first quarter. Thanks for that question. I think it's the last question I have. A good set of questions today. "How is the 20% minimum revenue growth projection comprised? What is assumed for the relative contribution new account installs?" Not sure if we give that level of granularity, Erik, you wanna take that?
Oh, you're muted, Erik.
Thank you. What I said is that I can only give a very high-level view of that. We're talking about 65-75 new installs during the year. That means on average about, let's say, 40 for the year average, and that compares to well over 300 installed base. The kind of the relative importance of the new installs for the year is, I mean, the value of that is less, significantly less than the installed base.
Yeah, I might just add to that. You know, you're getting to an important question, person that asked this question, is, you know, the U.S., I mean, there's significant growth in the U.S. I mean, if we were to break out the two territories, you know, Europe is moving slowly because, you know, Germany is a big contributor, that market historically is in the mid-single digit to the high single digit range. That kinda drags down the German, I'm sorry, the European performance as a whole. You know, if we were to look at U.S. performance, it's significantly north of 20%, and could be better assuming some of these restrictors come off.
You know, if we had Flex coming back to the market, or if the staffing shortages alleviate more significantly, you know, you could see growth rates in the 30% range in the U.S. Hopefully that's helpful.
I'll just add, let me add just additional one other piece to this. What became very obvious to us through the KARL STORZ transition from their old system to new system, we had limited installations, is this sort of uncovered what we call the leaky bucket syndrome, which was these old machines that go back to 2015, 2016, and 2017 were having breakdowns, and they weren't being utilized at the levels they were historically. That leakage at the bottom, and we have a rough idea of the you know, couple two, 3,000 units. With new installations, there weren't as many new installations to sort of cover up and overtake the losses on the bottom. That's why the Saphira™ upgrade system and getting these switchovers so critically important to us.
One, we get back the old business that was lost through equipment that was unreliable, broken, and maybe the, you know, the visual quality was low, so the high interest from a surgeon wasn't quite there. The other thing is just to get that back, but also then in the interest of new accounts coming on. 57 new installations, 26 new accounts, towards the last, you know, basically six weeks of the quarter bode well for the kickoff in 2023, which we're already seeing placing out in the numbers. Like I said, first quarter already interest is high, installations pipeline strong. You know, the new is great, it fuels the future, it's an important part of it.
Getting the old equipment upgraded will sort of seal off any of the losses of the past, and we think we can grow that business. We look forward to, you know, to reporting on that in the future once we get the analytics behind it over time.
Excellent. Okay, that's all the questions we have. We appreciate it. Dan, do you wanna wrap up with some final remarks?
Nope. I think that's it. It's been, you know, it's a challenging quarter. Fourth quarter, we believe is anomaly. We got proof in the first six, eight weeks of this quarter, 2023. We're looking forward to a strong 2023 going forward. A lot of good development, as we mentioned, from publications to hopefully a down-classification future capital equipment manufacturers coming into the U.S. market and actually on a global stage as well. With that, I wish you all a great day, and look forward to talking to you at the next quarterly update. Thank you