Thank you very much and hello everyone and thank you for joining us this morning. We would like to share our results for the Q1. And if we go to the next slide, the objective is to give you a business update, give you a sense in terms of what are we seeing in terms of the market, where are we with the performance of both our core and visualization business, how are our new launches doing, especially how we're doing with our entrance into urology and GI and also give you a sense in terms of what can you expect from Ambu for the next few years. And then Michael is going to talk about the financial results, give you an update in terms of the outlook, and we will take some Q and As at the end. So in terms of the key messages, first of all, we are very pleased with the results of the Q1, and I would like to thank you, the entire organization, for all their work share a dedication in what are still very difficult conditions.
But there are 3 key messages I would like to share with all of you. Number 1, the single use endoscopy market is one of the most track these medtech markets, and I will say that is becoming more and more clear as a month pass. The COVID-nineteen pandemic is making help our system more focus on infection control and avoiding cross contamination, and they are open to see single use endoscopy have a solution as they try to do elective procedures. And finally, medical authorities associations around the world are supporting the adoption of single use endoscopy. Now in terms of performance, it's, I would say, a remarkable first quarter.
We exceed BKK1 1,000,000,000 in sales. We reduced 39% on the back of our visualization grow in 101%. And we have all regions growing double digits. So this is not just driven by specific skip, but we actually see that across all geographies, we are able to drive our visualization business. Now in the case of Europe, where we had our visualization growing 194%, we did benefit from special orders from NHS England.
Basically, the NHS decided to bring show up their annual demand of single use pulmonology given how difficult is the situation right now with the pandemic. Now we have multiple growth drivers, and I would say this is one of the things which see it's important in the case of Fanbu that we do not depend on one specific product to fit our financial aspirations. But we, of course, enter into E and T and we have also recently entered into system. And I will share with you why we believe there is going to be widespread adoption of these technologies in these new endoscopy markets. And finally, I'm pleased also to share the progress with our ESCO launch have started and the feedback in terms of our strategy to target high volume segments is looking very promising.
When you look in terms of what does it mean in terms of profitability, the 39% organic growth have translated in an EBIT margin of 14.6 percent and a neutral cash flow before acquisitions of TKK 2,000,000. Now we are clear that we are emerging as the leading single use endoscopy player on the back of the rich pipeline that we have in front of us. And this year, we are going to achieve an important milestone, which
is the entrance
into GI. And in transition to GI. And in addition to the launch of Duo, we are entering into Colon and Gastro. But more importantly, if you look at our pipeline, our innovation engine, in the last 3 years, we introduced 5 new products. In the next 3 years, we are introducing 20 new products, which is basically allowing us to have the most complete single use endoscopy portfolio in all the segments where we compete.
Now this is a unique opportunity for Rambu. The market is developing very rapidly, we have a 1st mover advantage, the competitive superiority in terms of innovation and manufacturing and the momentum. So to make sure that we maintain our strategic and operational flexibility, we are also announcing that we are going to raise capital in an offering of newbie shares, and Michael will talk in more detail regarding that. So these are the key messages, and let's start with the market. So I mentioned that single is considered one of the most attractive new markets in medtech.
And I have to say, we had the JPMorgan conference a few weeks ago, and we had a chance to see all the landscape within MedTech. And something that was clear for us is that that drivers that are driving the adoption of single use endoscopy are becoming stronger and stronger as the time pass. There is more focus on contamination and infection control this last quarter than the previous quarter. The rapid technology advancements are actually making us be more certain regarding how more powerful our single use endoscopies are going to be. And that's because they are riding hold the investments and developments in other important sectors.
Our sensor, for example, are being powered by all the advancements in mobile and automotive. Our processors are actually being powered for all the investment in the gaming industry, the image enhancement software, the monitor hardware and all of that combined make us certain that as long as we continue to innovate, we are going to have single use endoscopy PROs that will have better clinical outcomes than reusable one. And finally, the attractiveness of the economic offering, if you price these products correctly, the benefits in terms of convenience make the transition much easier. And that's why we said this market is going from $500,000,000 last year to $2,500,000,000 in 2024. Now the case for single use endoscopy continue to strengthen.
And in 2020, we actually had the record year in terms of number of peer review studies regarding contamination and infection within GI. There were 26 studies looking at this issue and confirming that there is a problem and there is a need to improve the quality of care. The Spanish Pulmonology Association, for example, have decided after reviewing our single use bronchoscopy that single use should be the standard of care beyond COVID-nineteen pandemic. And this is very important because when the pandemic start it. Most pulmonology associations across key markets said, given the pandemic, if you need to do a bronchoscopy, you should use single use.
This is actually the 1st association that is saying, well, actually looking at everything we know right now regarding the performance of single use. Single use should be the standard of care going forward, and we expect that other pulmonology associations we'll achieve similar conclusions. In addition, we see medical authorities actually supporting more and more the creation of the single use endoscopy market. We know, for example, that CMS approve this special reimbursement for duanoscopy in outpatient procedures, and we believe that we are going to see something similar for inpatient procedures, which basically means that all health care systems in the U. S.
Not only have 2 safety recommendation from the FDA asking them to move away from traditional reducible scopes, but on top of that, they have an economic incentives to be able to do it and that will secure the creation of what is going to be a very important segment within single use endoscopy. And this is not just about the U. S. For example, a couple of weeks ago, Germany decided to approve a new procedure code for single use ERCPs to make sure they can track the performance of single use to endoscopy. And Germany is our most market in Europe and another example in terms of how we expect to see around the world, our solidities focusing and supporting the development of single use.
Now having seen the market, let's talk about our performance. And let me start first with our performance with our core business in terms of anesthesia and patient monitoring, and then we'll talk about our performance in visualization. So first of all, I think we are all see the impact of health care systems driven by COVID-nineteen and this continue. And I think most hospital medtech companies have indicated that today elective procedures are at around 85% to 90% of what was a normal size of the market. And our core business, it's driven by elective procedures.
So in Q1, we achieved 1%. Now there was a difference in terms of performance. Anesthesia grew 5% because the negative impact of the lower number of elective procedures is being offset by the higher demand of our resuscitators, which are being used in the treatment of COVID-nineteen patients. And then in the case of PMD, which correlates 100% with selected procedures. We saw a decline of minus 3%.
Now what we expect is as vaccines are being rolled out, as a number of cases in COVID-nineteen reduce, that our core business will go back to growth, and we expect that to happen in the second half of this year. Now with that background, let's talk about our visualization business, and it's an incredible performance. We grew 101% in Q1. Actually, our visualization business became the largest revenue contributor of the company in Q1 accounted for 55% of our revenues. Now as I mentioned during the introduction, we were benefit by the high demand of NHS England in the context of their cover COVID strategy to treat patients and build safety stocks.
So adjusted for this NHS special order, our visualization organic growth was 60%. And what we expect going forward is that the NHS England will not order, and we will continue to see that growth in the rest of the markets as per our plans. It's very encouraging that outside of Europe, we see North America growing at 35% and the rest of the growth the rest of the world growing at 35% as well. It's just an indication that in our most important market, which is the U. S.
And in all of our new emerging markets, the concept of single use endoscopy resonate, and we'll be able to create our business there. Now our strategy has been to embark on a rapid expansion across all endoscopy segments. And what we have done over the last 3 years, of course, is to move beyond pulmonology to get into ENT, SISTO and DUO. E and T, Sisto and Duo are combined about 19,000,000 procedures, which is 6x more than the 3,000,000 procedures that we have in ESCO Bronco. So it's very important for us to see what is show our performance in each of these segments.
So let me start with ESCO Bronco and then we will go through the other one. So in the case of Fesco Bronco, we continue to see the same positive dynamic we have see last year, we have increased the penetration and expanded our customer base. Pulmonologists' associations continue to recommend single use bronchoscopy. This is especially the case in Europe. And in the U.
S. Today, all major GPO contracts have selected Ambu ASCO 4 as their partner of choice in the treatment of single use bronchoscopy. And it is on the back of that, that we have won 150 new U. S. Customers and that our penetration rate in DOR and ICU already exceeded 30%.
So overall, our pulmonology business continue to carry a very strong momentum, and this is something that we believe will continue post the COVID-nineteen pandemic. Now if we look at ENT, this is important because, again, it was our first expansion beyond pulmonology, 11,000,000 procedures less concerned about contamination. So this was mainly driven by economics, convenience, flexibility and the technical performance of our product. And I'm pleased to share that our base in E and T is going very show it grew 280% versus last year. We grew 40% versus our previous quarter.
We are seeing a rapid penetration of ENT hospitals. Actually, 40 of the top 100 hospitals in the U. S. Have already been penetrated, and we won 120 new customers in the last quarter. And on the right hand side, what you can see is the monthly global unit sales since the launch, and it shows the impact of the start of the COVID-nineteen pandemic, but how after that, it has continued to rapidly grow and becoming a solution for all hospitals that wants to do ENT procedures safely.
Now having look at ENT, let's look at our bedding urology. And again, in the case of urology, I've been sharing with you the the initial positive performance, and this has continued during the Q1. We gained 150 new customers. So actually today, we have 240 accounts already closed in the U. S.
50 of the top 100 hospital have either converted or adding a trial phase for conversion. And actually, one of the things we have seen, especially in the case of SISTO, is that when we go into the trial phase, the probability of conversion is very high because of the superior technological technical performance of the product. Now more importantly, we also just start the commercial launch in Europe, and we are also seeing see the same potential that we are seeing in the U. S. For widespread adoption.
Now on the right hand side, you see the comparison of U. S. Unit sales for the 1st 8 months of launch between our ESCO Bronco, see ENT and SISTO. And what you are seeing is that actually SISTO is penetrating the market as fast as ENT. And this is very encouraging for us.
Cystoscopy is 6,000,000 Perseus in the market is twice bigger than pulmonology. And that basically shows that our bid in terms of entering with a direct commercialization, a model in urology is paying off that we have an important growth engine for the company. And more importantly, we will be able to leverage our urology customer base when we launch our ureteroscope. Now having talked about ENT and Sysco, let's talk about what is one of the most important bits of the company, which is our ESCO Duo. And as I have mentioned before, we consider duodenoscopy to be one of the largest segments in single use endoscopy.
When we say that in 2024, this market will be about $2,500,000,000 we assume that single use endoscopy is going to be a very important part of that. And our launch is underway. We have started our clinical trial, and we actually have expand the number of sites from 2 to 5. More importantly, one of our key priorities as part of a launch was to build a high profile, a key opinion leader network, one that help us to support our launch, but also with the future development of our DI portfolio. And what we have here are some quotes from 3 of our important KOLs.
We have Doctor. Tom Barron, for example, say I have now used the ESCoP duodenum in a handful of patients. I have been very impressed with how the scope has functioned. It's actually exceed my expectations. We have a quote from Doctor.
Frank Gress, once you become comfortable, 80% to 90% of ERCP cases could be done with the ESCOP duo. And we also have a quote from Doctor. Gutmann. Ambu has hit the mark on DISCOB Duo, and I look forward to the development of their entire GI line. These key opinion leaders basically have assessed the technical performance of our product have a say is the potential to be able to use Abaresco Duo across multiple levels of complexity in terms of procedure and have concluded that this is an attractive solution for ERCP hospitals.
They represent the base of the KOL community. They are former presidents of associations, chairs, members of editorial boards, and we are very pleased to have their support an endorsement during our launch. So with that as a start, less focus on our commercial on our progress with our commercialization. And I can share 3 things. Number 1, 3 of the major U.
S. GPOs have our ESCO Duo contract accounting for 90% of the U. S. Healthcare that basically means that if a U. S.
Hospital wants to order the Resco Duo, they are in the position to do it. More importantly, 370 ERCP accounts that represent about 30% of the total ERCP market have actually lined up to do the final evaluation for our scope duo. And today, we already have 30 ERCP accounts that have ordered our ESCO Duo and 5 of them are within the top 100 ERCP centers. Actually, one of them is within the top 5. And this is important because our commercialization strategy have focus on high volume ERCP centers.
Our measure of success is if we transition most of the reusable duodenoscopy into single use. So for us, it's very important not just to close a large number of accounts, but to close the accounts that drive most of the volume. So this is very encouraging, and we are looking forward to see how this is going to play out over the next few months. Now let's talk about the future. This year, in the second half, we will continue our rapid expansion into GI with a launch of COLUM and gastro, which are very important launches for the company.
They combine our €70,000,000 procedure. We believe based on all the research we have done, based on all of the interviews with hospitals and GI surgeons that there is a clear demand and need for our single use products, and we expect to see see similar levels of penetration to what we have seen in pulmonology, in ENT, in Sistra and what we are seeing in Duo today. And in addition to that, of course, we have a very important launch, which is the entrance into the bronco suite. The broncosuite segment is as big as the pulmonology segment. And with our ASCO-five, we are going to bring our most advanced technology to compete there.
Now we are going to emerge as a leading single use endoscopy player. In the last 3 years, we introduced 5 new products. And in the next 3 years, we have 20 new products. We basically are leveraging our R and D modular organization together with our highest scale low cost manufacturing to basically very rapidly bring the most complete portfolio of single use endoscopy across all the segments that we compete. And our strategy is to make sure that we not only introduce products, we not only complete the portfolio, but that we very rapidly move to the next generation of sensor some technology.
So we are always at the forefront in terms of clinical performance. All of this is going to create a very attractive ecosystem for health care systems, where they will be able to have the most complete folio monitors and console that can be leveraged across different single use endoscopies, which basically means that if I'm a hospital, I can do a pulmonology, endoscope procedure, then switch to do a cystoscope. Identify 1, go ahead and do a gastroscope, giving the hospital tremendous flexibility. This will also allow them, of course, to do endoscopy across different areas in the hospital and outside of the hospital. And GPOs are recognizing that.
That's why if you look at the contracts and what we are announcing in terms of our agreements with them, they are basically selecting Ambu as a partner of choice in the creation of the single use endoscopy market. So we are very excited with our performance. I'm very excited with the future. There will be a lot of volatilities throughout the year, but we are convinced that we are going to maintain our profile as one of the fastest growing major companies. And with that, let me pass you with Michael to talk about our financial results.
Thank you, Juan Jose. As already mentioned, we delivered an organic revenue growth of 39%, driven by visualization. The financial results for Q1 were significantly influenced by COVID, which led to an overall strong demand for our ASCO4 program. We have in the quarter seen a less impactful effect from the cancellation of elective procedures, but the overall performance of our core business continues to be impacted from this. In visualization, we experienced double digit growth rates across all geographies, leading to a growth of 101%.
The European growth was positively impacted by large orders of single use scopes to NHS in England as part of their COVID strategy. North America and rest of world both delivered 35% growth. And combined, for all regions, we sold 370 1,000 units of single use scopes, up 106% over last year. Our core business showed a growth of 1%. Anesthesia was driven by the increased demand for our resuscitators and growth of 5% growth, while PMD saw negative growth of 3% as COVID continues to cause shift in priorities at hospitals, leading to elective procedures being put on hold.
Lastly, we ended the quarter with an EBIT margin before special items of 14.6%. North America accounted for 39% of revenue with an organic growth of 13%. In America, visualization grew by 35% and continued the rapid growth we've seen since last quarter. Anesthesia posted growth of 2%, driven by high demand for resuscitators offsetting the reduced demand for other products in our anesthesia portfolio. See selective procedures being postponed, and our American PMD business decline by 13%.
Europe accounted for 53% of revenue with an organic growth of 79%. Visualization grew by 194%, and all major European markets posted double digit growth rates. European visualization growth was driven by ESCO-four, including the special orders to the NHS, which counts for approximately 50% of the to growth in visualization. Additionally, we have seen an increasing demand for our ENT and sister scopes, which have been very positively received on key European markets. Anesthesia grew organically by 17% and PMT by 2%.
Growth in anesthesia continues to be driven by demand for resuscitators, and we see some improvements in PMD with increased activity in electives. Rest of world contributed growth of 9%, this was with visualization at 35%, while anesthesia and PMD declined 2%, respectively 7%. So now let me go through the key numbers on our P and L. Revenue for Q1 was just above DKK 1,000,000,000. This corresponds to the organic growth of 39% and the reported growth of 33%.
This includes the mentioned impact from orders of Synclue scopes to the NSS. And excluding these orders, the growth would have been 23%. The gross margin for the quarter was 65.4%, up 5 percentage points over last year. This quarter's gross profit was positively impacted by a better product mix due to the volume growth in visualization and by scaling our manufacturing. As in previous quarters, negative effects from reduced average selling prices are minimal.
Total capacity costs for the quarter were DKK14 1,000,000 an increase of 41% compared to last year. The growth primarily come from increased sales and distribution costs, include continued costs for airfreight of all endoscopes out of Malaysia to meet demand. EBIT before special items ended at DKK148 1,000,000 in the quarter, leading to the mentioned 14.6 percent EBIT margin before special items. Free cash flow before acquisition totaled DKK 2,000,000 and was thus neutral to revenue. The milestone payment of DKK 298,000,000 or EUR 40,000,000 relating to the FDA clearance of the 2 Dinoscope was paid in October.
At the end of the year, our net working capital ended at DKK 636,000,000 corresponding to 17% of 12 month revenue and our equity total DKK 2,400,000,000 corresponding to an equity ratio of 47% of assets. Lastly, total net interest bearing debt was €1,700,000,000 which corresponds to a ratio of 2.5 of EBITDA before special items. Our overall rationale for the capital increase is to have full flexibility to execute on our strategy. Our strategy is all about building a high cadence of innovation, launch of innovative technologies into the market and take benefit from the market conversion when use shifts from reusable into single use endoscopy. As we are in the phase of building the market to Of zinc dilution endoscopy, time in metals and the potential slowdown would have a clear negative impact on future growth rates.
And it's on this basis, the intent to raise capital should be seen. So despite that our level of debt and leverage currently is at a reasonable level, We will, with the reduced leverage gain, freedom to commit the investments that are needed despite potential short term fluctuation in growth or EBITDA, And thereby ensure that our execution of the strategy is not being disturbed by how our leverage may evolve. It's in this light that We are now offering new Class B shares and existing treasury shares through an accelerated book building process with the aim to generate a proceed of approximately DKK 1,300,000,000. The aim is to reduce our leverage by end of the financial year to approximately 1.0, which we believe is a reasonable balance level that will give us freedom to execute on our strategic agenda. Now let's turn to the guidance for this year.
For 2021, our organic revenue growth is expected to be in the range of 17% to 20%, and this is unchanged compared to what we said at Q4. The growth will be driven by visualization, which will continue to see high double digit growth rates. And we expect our 2 new scopes, Sysco and Aesco Blue, to contribute sizable value to our organic growth. The anesthesia and PMD were negatively impacted by COVID in 2019 2020, but are expected to return to positive growth this year. The negative impact from COVID in 2019 2020 will cause anesthesia and PMD to exceed what is considered our normal growth rates for the long term.
The growth rates for these businesses will be relatively low early in the year, while we expect to see an increase towards the end of the year. In terms of EBIT margin, we continue to expect to be in the range of 11% to 12%. Endoscope units sold is expected unchanged to be between 1,300,000 1,400,000 units. Growth will be driven by the bronchoscopes, by the C scopes, cystoscopes and duodenoscopes are also expected to contribute to the overall unit growth. The quarterly development of the growth will, of course, be impacted by the high comparables in Q2 and Q3 last year.
And the buildup of the margin across quarters will be sensitive to the scale that we will achieve from the product launches this year. These were my comments to how the year is expected to play out. Thank you and back to you, Carlos.
Thank you very much, Michael. Why don't we open for Q and A?
And we have a few questions lined up already. The first is from the line of Katherine Tennyson of Bank of America. Please go ahead. Your line is open.
Hi, Jean. Thanks so much for taking my questions. I have 3, if I may. My first one is, could you just give me a little bit of help Understanding the timing and the rationale behind the equity raise, appreciate, Michael, you flagged us to be more flexible in executing the strategy. But Given very strong sales, GI launches, concomitant better profitability and reasonable enough leverage before all of this, Why do you feel you need this equity raise now?
And what part of the strategy do you feel needs most of this Firepower to you. Secondly, just on that 550 patient trial in the U. S, Can you update us? I appreciate it 30 days, but how many of those patients have you already tested using the Georgenoscope? And thirdly, on my quick math, I get the NHS boost to be around 90,000 scopes for the quarter.
Can you help us to understand the additional COVID benefit you had excluding the UK in your numbers this quarter? Thank you.
Catherine, this is Juan Jose. Thank you very much for your questions. First of all, I mean, your assessment in terms of the strength as a company is right. I mean, if you look at our Q1 results, we are growing very rapidly. This is a high margin business, basically, I mean, it's very profitable.
And as we drive growth, this is going to translate into higher levels of profitability and cash flow. Now if you look at it in terms of the creation of the single use endoscopy market, what we are seeing is that this market is developing much faster than what we saw. Everything I mentioned in terms of the impact of the COVID-nineteen pandemic, the higher focus on infection control, the actions from government authorities and associations, the adoption of our new launches beyond pulmonology. All just indicate that this is going to be a very large opportunity. And we are doing this capital raise for the simple reason that we want to make sure we have full strategic and operational flexibility to maximize our first mover advantage.
And that could be translated in many different ways, where it is new technologies in terms innovation that we want to bring into our portfolio sooner, whether it is a higher investment in terms of manufacturing capacity, in the case volumes are much larger where it is in terms of specific bets for some geographies. This just basically give us the flexibility to do it. And we think this is very important because from a value creation point of view, the higher the share we secure in the early years, the better we are going to be in the medium term. Now in terms of the 550 patients, let me just say that we are just starting. So we have some patients that have gone through the CMR, and I shared with you the quote from the KOLs.
This is basically see performance during human procedures. But in terms of the clinical, we are just starting. And in terms of the NHS, I think you asked what was our growth in visualization excluding the NHS, and it is 60%.
That's helpful. But just I was looking for the COVID benefits Across the world ex the United Kingdom, if at all you're able to give that number.
That's very difficult for us to calculate because the impact of COVID-nineteen varies depending on geographies and on procedures. There are some businesses that we have launched during COVID-nineteen, so we don't even have a reference point of what it means without COVID-nineteen. But I would say that the way we look at it is that the impact of COVID-nineteen is not temporary because what we are getting with COVID-nineteen is a more rapid penetration and expansion of our customer base, which is something that we are going to continue to carry post the COVID-nineteen pandemic. Start what we are saying. We will emerge from the COVID-nineteen pandemic as a stronger company with multiple growth beds across endoscopy.
That's super. Thank you.
Thank you, Catherine.
Thank you. Our next question comes from the line of Thomas Bowers Of Danske Bank. Please go ahead. Your line is open.
Yes. Thank you very much.
A couple of questions from me here. So I'll just kick off with the DUTENASCOB. So yes, you are in full commercial launch now. So maybe can you give us a little bit of color on the ERCP accounts that you have in the slide deck? So we have 30 accounts who have ordered the product.
But I'm just wondering, is this part of evaluating the scope? Or are these already done with the first evaluation? So what I'm trying here to find out is or trying to understand is what's the difference between those 30 accounts and those 370 accounts lined up for the valuation of the scope. And then second question, Just on just a little more color on the U. K.
Orders. So roughly on the 80,000 unit order. And I read In your statement that this was part of this was expected. So I guess I can assume that this is also part of Your current full year guidance. And again, well, secondly, you can say, was this more of a one off Like we saw last year, or is this contract with NHT, is this more of a, you would say, warm based nature the pandemic, so is there sort of a run rate in the coming quarters for keeping up the inventory levels in UK?
And is that also already reflected in your full year guidance? And then my last question just on the A Scope Systo. So I'm just wondering what's actually driving the strong uptake here. Is this primarily the beta deflection that makes a difference? Or is it Something else that we need to be aware of.
Thank you.
All right. Thank you very much, Thomas. And so let's just start with your question in terms of duoscopy. So we basically said that 30 ERCP accounts have already ordered. And this is actually a mix between accounts which are participating in CMR and accounts where we have gone through the evaluations, they have looked at the call and they have placed an offer.
And it just highlight the high receptiveness of ERCP Hospital to single use endoscopy with our value proposition. And this is very important because our economic offering allows hospitals to benefit from single use endoscopy and no risk of contamination at a neutral cost. And I would say that has been one of the drivers to see this level of penetration. Now in terms of the U. K.
NHS, so this is we have been working with the NHS since the pandemic started. So we knew the orders and the shipments by quarter. So this was expected. And what this means is that we should not expect to see more orders from NHS England for the remainder of the year. That basically means that when you look at our quarterly performance, we are going to have a very strong Q1 and Q4 and weaker Q2 and Q3.
And that's important because when you look at the comparables and everything, there will be a lot of volatility between our quarters. Now in terms of ESCO system, this is very important for us because we have bet the conversion from reusable to single use on the superior clinical, economic and operational flexibility of our products. And SISTO is the first time where the clinical performance of our probe is comparable or superior to reusable cystoscopy. And the main reason is because every time you take a reusable scistoscope through cleaning, washing and drying, the EMF resolution deteriorates. So if you are comparing a 1 year old reusable cytoscope with a brand new ESCOP system that would all of these actually feel they can have a better performance with our ESCO CYSOL than with our reusable.
And that's what we always preferred as a tipping point. To the moment when our technology is so superior that the surgeon feels they can have better clinical outcomes, of course, it's an attractive economic offering. There is no risk of contamination and give you all the operational flexibility that comes with single use. And that's really what is driving such a rapid level of penetration. And with 6,000,000 see those.
And what we have seen in the U. S. And what we are starting to see in Europe, we believe our sister scope is going to be a very important growth engine for us. So that hopefully gives you a little bit of context in terms of why we are seeing this level of uptake.
Yes, that's great. Thank you very much.
Thank you so much.
Thank you. Our next question comes from the line of Annette Luk of Handelsbanken, please go ahead. Your line is open.
Thank you so much. And from my side, congrats on the fairly impressive I'm sorry, Q1 performance. My first question would go to the time lines in the study you have just started on the duodenoscope. First of all, in respect to the smaller group of patients, when should we sort of expect any kind of Preliminary readout from that. Could that be at the virtual DJI in May?
Or would that be another event in Europe? And How do you feel about the completion date, saying 1st August in the study? Is that something you think is realistic? Or Should we add some sort of a buffer to that? Then my second question was go on the gross margin impact from Scope to Deno.
How would that be? Should we expect that to be lower or higher compared to The visualization average and how should we see the gross margin delta on E and T and Sisto as well Compare to bronco. That will be my questions. Thank you.
All right, Anete. Thank you very much, Ann. So let's just start with the clinical study. I mean, we will share the result of the 60 patients as soon as we have them. Of course, having it in time for the DDW conference will be ideal.
But this is something that we will just we plan to do the study in a very thoughtful way. And as soon as we have things, we will share them. And in terms of the fully study, we know that it will take about a year to do it. We plan to continue to expand the number of sites. But we are confident in terms of the completion of this study.
And again, it's important to remember that the commercialization of this growth is not tied to the results of the study. And based on what I shared in terms of the number of evaluations on total, we believe that all that is going to be finished well before we have the study results. Now the fair results are important for us in terms of our relationship with the GI community, in terms of deepening our relationship with key opinion leaders in terms of having materials to present at different conferences, that is more of a medium term type of activity. In terms of short term, that's really driven by the commercialization. And this product price point is 6x to 7x higher than pulmonology.
And therefore, the margin is higher. Now you have to see that we are entering into different platforms see different with different price points on different gross margins. So overall, what we are assuming see that our gross margin will remain stable as we move forward with some segment going up, some segment going down. But overall, the visualization margin remaining stable and of course, because it's much hire than the one we have for anesthesia and patient monitoring. The total gross margin of the company will continue to improve as we move forward.
Very good. Then my final question would be on you highlighted in your press release that The marketing expansion should come to an end by second half of this financial year. Would there be other investments that we are not aware of coming through in 2022? Or should we expect that the product mix that you highlighted from visualization to materialize to the EBIT margin in a year or 2.
Yes, so let me just start by saying that we believe Amu has the potential to be a high growth company and a high profitability company that once we have built all of our commercial infrastructure and back office and so forth, then there is significant leverage as we continue to grow the top line. Now what we mentioned is that at the end of Q2, we will finish with urology and GI investment we announced last year. We have completed it in the U. S, and we are going to finish with the OUS cell phones. Now going forward, we are entering into COLO.
We are entering into gastro. We are entering into the Bronco Suite. We are launching into our unitteroscope. There are 20 launches coming in, which basically means that you should assume that we will continue to expand our commercial infrastructure. It may be that it is not at the level that we have done in the previous 2 years, but we will continue to have an investment in our commercial infrastructure.
The best thing we can do is to make sure that we have enough reach to be able to maximize the value of these launches. And then you should assume that we will continue to be committed to our innovation agenda that our innovation as a percentage of sales will remain constant as we continue to grow very rapidly. And that's because our aspiration is to be the world's most innovative single use endoscopy player. But the way we compete against any player, large or small is on the technical performance of our products. And therefore, we need to ensure that we are always at the forefront of the later generations in technology.
And then in terms of manufacturing, we announced that we are building a single use endoscopy manufacturing plant in Mexico. We believe that with this investment, we will have what we need for the next few years. But I will say those are the investments that you should see from the company for the next 2 to 3 years.
Okay. Thank you so much.
Thank you. Thank you. Our next question comes from the line of Benjamin Silverstone at ABG. Please go ahead. Your line is open.
Thank you. And thank you, Juan and Mikael, for taking my question and congratulations on the strong quarter. I have a follow-up question to the NHS order, if I may. You mentioned that you started your relationship with them Back when the pandemic started and now obviously we are seeing them ordering for the full year, but do we have any sort of Color on how their ordering might look post the pandemic. So are they now a firm customer going forward for the single use?
Or how does that look within at NHS? And my second question is in regards to the capital raise. Michael, you mentioned that you would like to lower debt levels to make sure that you're able to take advantage of this Current momentum, which makes sense. But you will like to have the option to use this money on new Technologies, strengthen your conversations, etcetera. But how would that mean for the costs going forward?
Should we expect to see higher R and D expenditures or sales expenditures in the next couple of years? Or would this also perhaps entail potential external costs such as the acquisition of new technologies. If you could get any other color on that, that will be much appreciated. Thank you.
Benjamin, let me start with the NHS and then Michael will provide some additional details on the capital price. So first of all, we have had a long term relationship with the NHS. The NHS is not a new customer. What I was referring to is that when the pandemic started, the NHS took a more central role in the placement of offers and distribution on all key products in the treatment of COVID-nineteen patients. And that in our case included our resuscitators and our ESCO for Bronco.
And basically, we have been working with them very closely for the last year. And we see their orders, that how they are being used and so forth. What we can tell you is that we believe that this order should satisfy their demand until the end of the year. So we shouldn't expect many orders in Q2, Q3 and Q4. And that post pandemic, we actually expect the U.
K. To be to become one of the largest markets in Europe because what we have seen not yet in pulmonology but also in ENT and Sysco see that the U. K. Is leading in terms of the adoption of single use endoscopy. So we have penetration in nearly all major hospitals in the U.
S, the level of users and adoption of single use overreducible it's actually one of the highest in the world today, and that's why we consider that this is going to be a sustained momentum that one we will have. The only thing that will be different is that the NHS, rather than being the one place in the other, we will go back to the previous model where each of the NHS trust for each of the regions place the order. So let's talk about the capital raise, Michael. Okay. Thank you, Benjamin.
I think as we said, the reason why we do it is to gain flexibility to our operational and strategic execution of our overall plans. Northwest, Bronte was explaining, we always want to position our technology in the forefront because as the market is being created, share the share points that we can gain if we do it earlier rather than if we wait, will come at a much more attractive investment. So that's the reason why we are doing this, Benjamin, is that we want to have a balance sheet that can support our strategy And that we will be able to do the investments at the speed where we deem that they are required and without potentially coming into a situation where fluctuations in short term EBITDA could force us to change our priorities. So whether we are investing into engineers in our global innovation, whether we are acquire technologies that we can attach to our products or whether it's commercial expansion. I don't think the chemical rates are not going to change those priorities at all.
It's just going to bring us into a situation where our balance sheet will be very for that plan. I don't know if that explains your question.
It did. Thank you very much.
Thank you. Welcome.
Thank you. Our next question comes from the line of Neil Slev of Carnegie. Please go ahead. Your line is open.
Thank you. So if we dive into the growth numbers in the visualization division, you are telling us that The organic growth in Europe, excluding NHS, was approximately 60%. It should be compared with approximately 35% in the 2 other regions in the world. So is it fair to assume that The contribution from the COVID consumption of these scopes in Europe basically explains The momentum difference between the 60% and the 35% in the other regions. So that's my first question.
And my second question would be, so you say that NHS We'll not order for the rest of the year having ordered 80,000 scopes in the Q1. Would there be any other institutions In Europe, able to place orders of similar magnitude or would that only be NHS? They're telling us that NHS accounts for approximately 45% of the UK procurement of the single use scopes and their warehouses are Quite full with these products for the time being. So those would be my questions for now. Thank you.
Thank you. So Neil, just to clarify, the growth of visualization in Europe is 194%, and excluding the NHS, it's about 100%, not 60%. And this is very important because what we are seeing is that across all major markets in Europe, Germany, Italy, Spain, France, Benelux, in Nordics, we are seeing a very rapid expansion of our customer base and adoption of single use bronchoscopy for the treatment of COVID-nineteen show COVID-nineteen patients. And that's what is driving the growth. And that's why we say all regions, all markets are growing very rapidly.
And when the COVID-nineteen pandemic finish, we are going to emerge as a stronger company.
So is it fair to assume that Difference between the 100% and the 35% would be the COVID related growth coming out of Europe.
No, I wouldn't see it in that way. And it's very difficult because different markets are in different situations in terms of COVID. What COVID-nineteen does is it creates an overall positive environment for the adoption of single use endoscopy. Now in terms of this level of forwarding, we only are seeing it in the NHS. And what happened is that last year when COVID-nineteen started, we saw all these levels of panic buying.
But we show health care system that there was no need for that, that we could supply based on their demand at very high level of volumes. And that's why as we have gone through the Q1, outside of the NHS, we don't have any other organization ordering more see what they need and building inventory. Now first of all, the NHS can order and can continue to order. Organizations outside of NHS England, whether it is NHS Scotland or Ireland, they can all continue to order, of course. It's not a requirement.
It's just that based on what they have, we believe they should have enough for the remainder of the year.
So you wouldn't expect any other bulk orders from central Procurement offices, other places in Europe or North America for that matter?
No, no. It's not something that we have in our plans. Of course, nobody can predict how the pandemic will evolve, but we don't have any major bulk orders in the short term. Now if they come, of course, we doubled our manufacturing capacity when the pandemic start it, and we have continued to expand our manufacturing capacity. So we have a very high level of responsiveness.
But today, it's not part of the plan.
Okay. Thank you. And can you just repeat what you said earlier on about the quarterly development for this year? You mentioned, I think, that quarter 1 and quarter 2 would be the 2 strongest and weaker in the second half. Is that correctly understood?
No, Neil. So what I said was that Q1 and Q4 will be the quarter where you will see the strongest growth, and Q2 and Q3 will be the quarter with a lower growth, and that's actually mainly driven by the comparable from last year. If you remember all the panic buying and high order happening in Q2 and Q3.
Yes.
Okay, great. Thank you.
Thank you, Neil.
Thank you. Our next question comes From the line of Eui Cho at SEB. Please go ahead. Your line is open.
Hi, gentlemen. Thank you for taking my question. I have 3. And firstly, regarding the European approval on duodenoscope, could you please give us an indication on the time? And we understand that the CMS TBP payments has benefits the due to scope adoption in the U.
S. But without such additional reimbursement, would you consider your price is a bit too high outside the U. S. Market? And secondly, as we get close to the colonoscope and the gastroscope launch, could you please give us an indication on the average selling price And how should we look at its contribution margin when compared to ASCO Bronco?
And then third question is regarding ASCO 5 And we record that you already plan to penetrate the bronchosuit segment, so when launched the ASCO 4. So what was holding back the penetration so far and what would be the main technology upgrade with ASCO 5? Any comment would be very helpful. Thank you.
Thank you very much. And I got your question in terms of COLUMENTA STRO and then the ESCO V and the Bronco I just wanted to make sure that I understood correctly your first question regarding the pricing of our products. Would you mind just repeating that?
Yes. My question is, firstly, when do you expect to get European approval on duodenoscope? And then also without the additional reimbursement on duodenoscope in outside the U. S, would you consider your pricing is a bit too high?
Sure. Thank you for that. So first of all, I mean, we plan to expand into Europe as soon as we get the CE mark, and that's going to happen in the that's going to happen very soon. And of course, our European organization is fully engage already on preparing for that launch. Our pricing around the world is grounded on health care economics.
So we basically look at how much it cause a hospital to use a reducible duenoscope. And based on that, we come out with our pricing. And we don't expect significant differences between the U. S. And Europe.
Europe is tends to be slightly lower than the U. S, but I would say there are no major differences. Now in terms of Colon and Gastro, we are going to launch it in the second half. So as you can imagine, we are also in full preparations for what is going to be a very important milestone for the company. We cannot share with you the pricing today.
We will share it when we launch. The only thing that I can mention in terms of pricing is that again is going to be grounded on health care economics because our number one objective is, of course, to drive a significant transition from reducible into single use. Now the research that we are doing, and actually, I just had a chance to review a study we did in gastroscopy. It shows concerns around contamination and depending on the patient profile, high levels of concern, concerns in terms of availability, economics depending on the type of arthroscopy procedure. So we are actually very excited in terms of what we will be able to do in this segment.
And finally, with Abaresco saw we were not able to enter into the bronco suite because the image resolution requirements in the bronco suite are higher than in a normal pulmonology. And our ASCO 4 did not have that required technical performance to be able to be widely adopted. Now our ESCO 5 have our most advanced sensor. It's going to work together with our most advanced monitor, which is our ABO2 advanced. And together, we believe we are going to satisfy the needs in the bronchosuit.
And that's a very important launch because it will ensure that our bronchoscopy franchise will continue to grow for the foreseeable future.
Thank you. Can I just follow-up on the DoDensco pricing here? We understand the cost per posture is quite different from hospital to hospital. Is it also fair to assume your pricing will be quite different For different accounts.
I mean, we basically look at high volume accounts. That's really our reference in terms of pricing. And then we set a pricing in the market based on that. We cannot talk about our pricing strategy, so those are the main principles that we use when we set up pricing in the market.
Okay. Thank you.
Jump back to that.
Thank you
very much, Billy.
Thank you. Our next question comes from the line of Michael Healy at Berenberg.
Just want to look at maybe something we haven't spoke too much about is North American see growth in visualization. Obviously, this was hampered a bit last year given the COVID-nineteen headwinds and you've grown 35% And this year, maybe just some thoughts on that. Are you still experiencing COVID-nineteen headwinds? And what's kind of generated this growth? And how satisfied are you with this?
Maybe is it the other products? And then just touch on the NHS orders. Is that really just for bronchoscopes? And the reason I ask that is to elective procedures that are linked to maybe cystoscopy and ENT scopes have been postponed and there could be a backlog later on in the year. Is the NHS orders inclusive of any ENT and cystoscopes?
And then just a final question really on guidance. The results today are quite a bit Ahead of where I was thinking and I think the market as well, just your thoughts on maintaining or reiterating your guidance at this stage? Thanks a lot.
Yes, thank you very much. And so I would say in terms of North America, most hospital met tech companies add indicating that they have seen the elective procedures still at minus 15%, minus 10% during Q1 and that what they have seen is that after that recovery in October November, there was dip in December and that pretty much is following how the COVID-nineteen pandemic is developing. Within North America, there is a lot of volatility depending on the state and the cities in terms of how hospitals are being impacted. Right now, I will say California, for example, is under tremendous pressure. Now putting that as a context, a 35% growth in what is the most important market for single use endoscopy is very encouraging.
It's also very encouraging because I've been sharing with you the evolution of our new growth bets, ENT and SISTO and the reception of our ESCO duo from U. S. ERCP hospitals. And that basically means that for the U. S.
Region, as we move forward, we have not only a much larger customer base and penetration in pulmonology, put very powerful growth platforms that is going to ensure that our region continue to grow add very high growth rates. In terms of the NHS service, what we mentioned is exclusively Bronco. Now overall, when I look at the United Kingdom, there is a very rapid adoption of system ENT. And basically, the United Kingdom is leading the penetration within the European region. But it has not been translated into special NHS orders.
This is still the different hospitals placing orders after drying our products. And then listen, in terms of our guidance, we just finished our Q1. And for us, this is steal something which are important to know, especially how our recent launches are going to continue to develop. And it's very important for us that when we set our guidance, that is a guidance that we can stand for and that it reflects a thoughtful assessment of what will be our performance this year. For today, I think we need to take our guidance as it is.
Thank you. And we have a follow-up question from Thomas Powers of Danske Bank. Please go ahead. Your line is open.
Yes. Thank you very much. Just a quick follow-up here. Can you maybe give some color on, you could say, the aggregated competitive situation in So how are the competitors reacting to the perspective for the single use market opportunities As you see it right now. So what's happening out there right now?
Thank you so much. And I mean, we said I would say one of the first times that we met that it was very important for Ambu that we had more competitors, that we had large global competitors that could support the creation of a single that Ambu was not going to able to do it alone and that actually to meet our financial aspirations, we need competition. And what we are seeing playing out is as the market is getting more and more traction and more momentum that competitors are actually looking to participate from this growth. And I would say there has been no major change from what we saw in the last quarter. Boston Scientific, it's a player that plans to enter into high price, low volume endoscopy procedures.
So that will be the bronco suite, that will copy colangioscope, udetrescope. That's basically their focus. We have also seen Olympus talking about include in as part of the portfolio single use products. Of course, the strategy is not to create a market. Their strategy is if a segment move rapidly to single use.
They want to have a single use product as part of the offering so they can continue to participate. Outside of those 2 players, we don't actually see any other activity. We don't see Verathron make much inroads in the U. S. Actually, our assessment is that they might be going backwards during our Q1 on the back of the GPO agreements and the momentum that we have, and we don't see them outside of the U.
S. At this point. But going forward, our strategy assume that there will be competition for us to meet our financial operations. We don't need to be the only player in the market. There is room for more players.
What is critical for us is that we are competitive, and we are doing it by investing in our innovation, in our commercial infrastructure and leveraging our high scale, low cost manufacturing.
Thank you very much for that color. Thank you.
Thank you. Our next question comes from the line of Neil Sledd of Carnegie. Please go ahead. Your line is open.
Thank you. So could you just talk about the size of your commercial infrastructure investments that you expect to To do in the next 1 or 2 years in the area of colon and gastro. You talked That earlier in the call. And then secondly, I guess a question for the CFO. Can you just talk about your cash flow Development in the coming quarters, what should we expect here?
Thank you.
Thank you, Nils. And I cannot comment in terms of specific investments for COLUM and Gastro. But this I can tell you. First of all, we have created GI infrastructure that will commercialize all of our GI scopes. It will commercialize our duoscope, our Columbia scope, our Colon and Gastro and all the other GI launches we have in front of us.
And then in terms of our overall company commercial infrastructure, over the last 2 years, there has been some important investments that we have made. And going forward, we plan to continue to expand our commercial infrastructure, maybe not at that rate that we have done before. But basically, with the objectives to maximize the impact of the 20 launches that we have in front of us. And on the basis of that, if you look 5 years from now, we expect the company to have healthy levels of profitability because rapid top line growth with a high margin that we have in visualization and the levers of infrastructure once you have built translate into a rapid increase in our EBIT. So that to maybe you can take us a context and then I can pass Michael to talk about cash flow.
Thank you, and hi, Nils. 1st of all, we are not guiding on the cash flow, but I would love to give some color to it. And I think to start with, it's important to say that The capital base does not really change the way that we see our cash flows are going to evolve. So the impact that we will see to our cash flow as we move forward This is of course that it would be very closely related to how our EBIT margin is playing up. The big investments that are coming, the invest into innovation, which is more or less stacked across the quarter.
So that's not something that is changing very significantly. But And we have investments into the Mexican factory. And when we move out on the other side of this financial year, that would be the last milestone to be paid. On top of that, we are working on our working capital. And I think you appreciate that the levels that we have of working capital is actually Well managed and at a low level.
So there's not much more to say apart from that. But I think when you look at our growth and you look at our EBIT margin and you know the recurring level of investments, you get to that we would be reasonably schedule okay for this year.
So you still expect CapEx to sales of approximately 14%, I think you mentioned that in the full year report? 14%. Okay. Thank you.
Thank you. And at this time, we have one Final question in the queue. That's from the line of Jesper Ingulsom of DNB Markets. Please go ahead. Your line is open.
Yes.
Thank you. I just have a couple of questions. So on the slides, you say that you are now targeting 3 70 USP accounts, This accounts for 30% of the total USP market. I think last time you mentioned 300 accounts and accounting for 60% of the market. Can you just clarify the difference between the 30% and the 60%?
Is that because of last time you were speaking only in U. S. And now that you're referring to the entire to the global market? And then secondly, in terms of the full commercial launch of the Durdenascope, can you just clarify when actually that place how early December, considering that was the time line you originally gave us. And when can we expect sales of the Drudinoscope accelerate on the back of this, which quarter in particular could be to see that happen.
And then on the clinical trial for the Benelux Scope, there's been a few changes to The web page in terms of you recruiting and then all of a sudden not recruiting and then recruitment. Can any comments on what has happened there could be beneficial? And then lastly, just the NSS order. Can you just confirm that when you originally gave the guidance back in November that this was already part of the guidance? Thank you.
Yes. No, thank you for the question. I mean we it depends on how we are looking and segment in the market. I think that the most important thing for you to take is that these 370 ERCP accounts represent 30% of the total U. S.
ERCP market, and they are lined up for evaluation. So we are talking about note the previous stage, which is probe demonstrations and so forth, but the final, final one. Once they have passed the procurement committee, the discussion with the surgeons, and they are actually moving to use them aim human procedures at the hospital. That's why you have a difference in terms of percentages. Now we are moving down the funnel to the last step before they are actually placing the order.
In terms of the recruitment, your voice broke. So I'm not sure I got what you were talking in terms of recruitment, something about starting and stopping?
Yes. On the clinicaltrialdotcom page, you suddenly started to recruiting for the trial a few weeks ago At New York Hospital and then the following week, you are no longer recruiting at that place. And then the following week again, then you're all of a sudden recruiting At a different hospital. Just any comments around what happened there?
Yes. I mean, my understanding is that I think they were still finishing some paperwork. So when it was posted at the beginning that they had a starter recruitment, that was actually not accurate. We need to finish the paperwork. That's why that was changed.
And then when the paperwork the final paperwork was in place, then we posted what was the accurate status of the clinical, which was recruitment. But it's something that we have started. As you can imagine going from 2 sides to 5 sides when you look at the quotes of the key opinion leaders, reflect our confidence regarding the technical performance of the product and the ability to have successful outcomes on the clinical. And then in terms of the GNHS, do you mind expanding your question again?
Yes. So on the EnerSys order, can you just confirm that, that was already part of the guidance when you first provided the guidance in November?
Yes, this was part of the guidance. We again, with the NHS, we have been planning the support for the COVID-nineteen pandemic, so we knew the timing for the overall.
Okay. And then my 4th question was around the full commercial launch of the product, the plutinoscopy. When did that actually take place, the full commercial launch? I think last time you were talking about launching in December. When in December did it take place, if you could be a bit more specific.
And when can we expect sales to ramp up for the Usulina scope as a consequence of the full commercial launch?
Yes, I mean, it depends on what's your definition for commercial launch. I mean, what we are sharing now is that that's basically what we are doing. We are going against the high volume ERCP centers, and there was more activity in December, and there is far more activity in January. There will be even far more activity in the months to come. In terms of a material financial impact, we expect that our Duo will have more impact in the second half of the year, similar to what I have shared in terms of ENT and SISTO, it takes some time at the beginning to get traction, and then just start to get some more traction with our product, and that's basically how we are seeing it now.
Okay. Thank you.
Thank you, Jesper.
Thank you. As there are no further questions on the line at this time our hand back to our speakers for the closing comments.
Thank you. I mean, thank you very much. It has been a remarkable first quarter with our performance, with the way our launches are doing, with the development of our strategy, with our capital raise, hopefully, we are giving you confidence that we have everything that we need to make sure that we fulfill our aspiration of becoming the world's most innovative single use endoscopy player and in the process, one of the largest European based smelter companies. So thank you very much.