Ambu A S Ord

Hello everyone, this is Juan José González. Our apologies for the delay. Please assume that we are going to go for an hour from now. So let's do the following. There are many new investors joining this call. So I'm going to spend a few minutes talking about the AMBU equity story. Then we'll provide a business update and then we'll go through the update on the financials. So if we look at AMBU from an equity story point of view, there are basically three things which are important to know. Number one, what is the potential of a single use endoscopy market? Number two, what is the track record of AMBU both in terms of sales and in terms of driving profitability? And number three, what is the strategy of AMBU? And based on that, what can we expect in terms of the company's future performance? So let's start with the market. And if we look at the single-use endoscopy market, this market is today one of the most attractive medtech markets. It forecasted to go from $500 million last year to $2.5 billion by 2025. There are very few markets scaling up this rapidly. And there are basically three main drivers which are accelerating independently and that together make the transition from reusable to single-use a certainty. First of all, there is a much higher focus on infection control, both from regulatory bodies, public and private players and healthcare systems. The second thing is that in addition to infection control, there are significant benefits in terms of workflows and efficiency, basically the ability to do more procedures with the existing infrastructure. And finally, there are very rapid technological advancements, especially in terms of sensors, image resolution software, that basically makes the performance of single-use endoscopy continue to improve and become more and more competitive relative to reusable endoscopy. And these are the main drivers behind the creation of this new market. Now, if we look at AMBUS track record, let's start with our revenues. And what you have here on the right-hand side, is the evolution of our revenues in BKK from 2017 and 18 to last year. And basically the company went from 2.6 billion to over 4 billion BKK. The visualization business three years ago, it was only 32% of our sales. And we finished last year with that business being more than half of our sales. Our visualization business has grown at a compound growth rate of 37%. And if you look at it from a unit salt, last year we exceed 1.5 million scopes, which is triple from three years ago. And it's not only that, it's not only the fact that we are the largest, but we actually are the number one in single-use endoscopy in pulmonology, ENT, and urology. Now, when you look at it from a profitability point of view, what you have on the left-hand side is the evolution of the gross margin of the company from 2015-16 to today. And basically what you can see is a significant increase in terms of our gross margin. This is driven by the fact that our visualization business has a higher gross margin than the rest of the portfolio and is the one driving most of the growth. But we also have significant benefits in terms of scale of manufacturing and our cost of goods, and also the ability to leverage our commercial infrastructure once we complete to establish it across all the endoscopy procedures. So basically, we have a model that as a top line grows very rapidly on the back of a gross margin and the leverage of our commercial infrastructure and manufacturing will drive significant profitability growth. Now, our aspiration is very simple. We will be the number one player in single-use endoscopy. Our strategy is focused around three things. Number one, to build the most comprehensive and advanced portfolio and ecosystem in single-use endoscopy. That basically means that in every segment where we compete, we will have the most advanced scopes with a superior performance and the most complete offering. That will be in pulmonology, ENT, urology, and GI. Our second priority is to leverage our high-scale low-cost manufacturing. This actually supports our pricing strategy to drive the transition from reusable to single-use. And we have found that actually having the right economic offering is critical for the creation of this market, something that we have seen in our launch into ENT and cystoscopy. And finally, our strategy is to maximize our first-mover advantage by rapidly scaling our commercial infrastructure and getting it in position to execute on the accelerated launches. It is a combination of these three things, our significant innovation pipeline driven by the R&D modular engine, the high scale of manufacturing and a dedicated commercial infrastructure, which will ensure that we fulfill our aspiration of being the number one single use player. Now that we talk about the M-Wave with this story, let's talk about our business update. Since the last time that we worked together, we continue to see rapid progress both in terms of the market, our performance, and our future outlook. So if we look at the market, the support for the creation of a single-use endoscopy market continues to increase. we see significant support for the transition from reusable to single-use duonoscopy. This is driven by regulatory bodies, public and private payers, and healthcare systems. Today, we believe that on the back of all of this support, single-use duonoscopy is going to be one of the largest segments by 2025. But it's not only supporting duonoscopy. In pulmonology, we also saw for the first time a large-scale 14,000 patient real-world study. And this study actually highlighted not just the patient's safety benefits, but the economic benefits, mainly driven by the fact that we can reduce the level of readmissions by 53% if you use single-use scopes. and the cost of readmissions is about $15,000. So this is actually quite material, and on the back of that, we are more confident that pulmonology segmenting endoscopy should continue to transition, and we should see most of the pulmonology market move to single-use endoscopy. Now, that is in terms of the market. When you look at our visualization strategy, is actually continuing to drive rapid growth across all the platforms. And the key highlights are 31% growth in revenues last year, over 1.5 million units scopes, which represent a 41% growth over the previous year. Our broad single-use portfolio and economic offering is also making us a preferred partner among GPOs, and I will talk about some of the recent developments there. When you look at each of our segments within visualization, last year, Pulmonology reported double-digit growth over 2019-20, and it was on the back of what were record comparables. And that just shows the fact that we are able to continue to drive penetration of single use in this segment. And within that, we are able to maintain our leading share position. In terms of ENT and urology, we continue our accelerated growth and actually in terms of volume, after only 18 months of the launch of our ESCO system, we have become the number one player in single-use endoscopy in urology. And that just shows our ability to enter into an entirely new segment and on the back of our technology and superior offering drives a very rapid penetration. As you can imagine, we expect that some of our next 20 launches by 2022-23 show similar performance to Cisco. And finally, we also announced the positive early clinical results of our Xcode Duo 1.5, which shows 100% procedure success. And these early results are favorable to the clinical results of our competitors. And on the back of all of this, we are starting with a global commercialization with very strong key opinion leader support. So this is in terms of the market. This is the momentum that we are carrying into the new year. Let's talk about the future. And when we look at the future, we are very well positioned to lead the creation of a single-use endoscope market. We are maximizing our first-mover advantage. with strong investments in innovation, on manufacturing capacity, on the back of what will be the global largest single-use endoscopy plant in Mexico, and our commercial infrastructure. And all of this is reflected in our guidance. We are setting a guidance for this year with an organic revenue growth of 15% to 19%, and an EBIT margin of 7% to 9%. adjusted for last year's NHS England safety stock order, our revenue guidance would actually have been 3.5 points higher. And when you look at our profitability, it reflects the investments, the important investments we are doing in terms of manufacturing and commercialization, as well as the impact from the higher freight costs that we carried from last year, as well as raw material inflation. And part of the freight and raw material inflation we consider to be short-term in nature. So those are the key messages. And now let's get into interest transactions. So first of all, in terms of the market, from time to time, we share with you the progress in terms of the evidence on contamination. And on the left-hand side, you have the number of medical devices reports on reusable endoscopy-related contamination and infections. And in the third half of the year, we are already at 1,400 reports. which basically means that we'll finish this year above 2020. And that will be an increase versus 2014 of 13 to 14 times. It just showed a higher focus in terms of understanding what are the level of contamination and on the back of that, the awareness regarding what is the issue. And on the right-hand side, what you have is a cumulative number of studies looking at contamination and infection just in GI. And we wanted to give you an example in terms of how the understanding regarding contamination in GI across colonoscopy, gastroscopy, and colonoscopy has evolved. And basically, this year, we are going to exceed over 100 studies actually confirming that there is an issue in terms of contamination. As you can imagine, on the back of the FDA safety warnings asking for a much closer level of monitoring and report of this contamination and infections, this is going to increase. Now, let's look at the support for the creation of a single-use model. So we spoke about the FDA communication across bronchoscopy, urology, and duonoscopy. And in all of these cases, single-use endoscopy being highlighted as part of the solution. The most recent development is actually the strong economic incentive that is in place as of today to drive the transition from reusable to single-use endoscopy. Because in addition to Medicare giving a special reimbursement for outpatient procedures and inpatient procedures as of October, Now we actually have more evidence of private payers also providing a special incentive for any hospital that adopts single-use tonoscopy. That basically means that if hospital select AMBU as a single-use tonoscopy product for the DRCP procedures, they actually have a significant economic incentive and they will be better off in terms of financial if they were to do it. And finally, as I mentioned before, we have this 14,000 patient real world study showing the significant reduction in terms of the admission cost. It's on the back of this that we believe that the pulmonology of penetration will go from 30 to 35% to a significantly higher level and that this segment still has significant market expansion. We talk about the market. Let's talk about the evolution of our visualization volume. And basically we reached last year a record over 1.5 million scopes. That growth is across all of our platforms and represented a 41% growth. Now the most important development is that hospital access to single-use endoscopy is expanding rapidly. As of next year, all major GPOs will have created single-use endoscopy buying categories. And within a single-use endoscopy category, AMBU's breadth of portfolio, rich pipeline, and superior economic offering positions AMBU to be the preferred partner that GPOs support healthcare systems to transition to single-use. And all of AMBU's agreements has ensured hospital access to our existing portfolio, but more importantly, to our full scope pipeline. That basically means that that 20% that we are bringing to market by 2022-23 will be included in these GPO agreements and all hospitals will be able to have access to it. Now, let's talk about each of our segments. So let's talk about pulmonology. And basically, our pulmonology business showed double digit growth last year and is very well positioned for future growth. Last year, it played a very important role in the treatment of COVID-19 patients and continued to be the largest contributor in terms of revenue and growth. As of today, we have seen minimal impact from competitor launches with no impact on our pricing. based on the technical performance and pricing of our competitors, we do not expect our pricing is going to change for the foreseeable future. Now, in this new year, we expect the pulmonology demand to continue to be volatile and all this driven by uncertainty of COVID-19 and what can we expect during the winter season. Last year, there was no flu season. We expect this year to have a flu season, which also drives demand for our bronchoscopy products. But we expect to continue to go through a similar level of volatility that we experienced in the previous two years. And finally, our RISC-V high definition is on track to be launched this year. And with this launch, we will enter into the Bronco Suite that represents an expansion in terms of a total addressable market of over 70%. And together with the rest of the launches, ensure a very strong growth profile for this segment. Because it's not just the ESCO 5 into the Bronco Suite, it's also ESCO 5 for selected procedures, for smaller patients, It's also our Bronco sampler, and it's also our video laryngoscope 2.0, and all of these integrated with our AVOX and AV2 Advanced. So that is in terms of pulmonology. Let's look at the performance of our new visualization platforms. And what you have in the right-hand side is the evolution of our 12-week rolling average since the launch for ENT and Sisto. ENT is the red line and Sisto is the blue line. And as you can see, they continue to show very rapid growth and last year contributed to a sizable and increasing share of our growth and revenues. Both platforms are expected to contribute a large share of our organic growth this year. First of all, the penetration is very, very small. These markets combined account for 17 million procedures. And we are just starting, so the potential going forward is still significant. And the most important highlight is that in terms of volume, AMBU has become the largest single-use endoscopy player in the world. And we have achieved that after 18 months of launch of our ASCOP system, overtaking both from scientific that has been on the market for many years. And for me, this is a very good example in terms of the ability of FAMBU to enter across multiple endoscopy segments, the superior technology with a dedicated commercial infrastructure and drive a very rapid adoption. So that was in terms of pulmonology ENT and system. Now, in terms of our launch in Duo, I share with you the feedback in terms of our Duo 1.0 and the need to improve things like our elevator, our image resolution, our functionality to get ERCP surgeons comfortable to migrate to single use. So let me pass it to Basel Rifai. He's our chief marketing officer, and he will provide our latest view regarding the potential of single-use colonoscopy, the results of our clinical, of our controlled launch, and what can you expect in terms of our commercialization.

Thank you, Juan Jose. And before I give an update on Ambu's Duo 1.5 launch, Let me start by reminding everyone why Duo is going to be one of the largest segments in the $2.5 billion single-use market by 2025. For Duo, the conditions for moving from reusable to single-use are the most attractive across any endoscopy segment. Eighteen months ago, the FDA issued a safety warning asking healthcare systems to move from reusable to innovative devices with disposable components. Within those, evidence shows that disposable end caps are not the solution. The issue is not just in the TIP, but across the entire scope. And because of that, Medicare and private payers are giving additional reimbursement for transitioning to single-use endoscopes and not to disposable end caps. So the best option from a patient safety point of view and the best option from a hospital financials point of view is going to be single-use. Now, against that backdrop, last month we launched our A-scope Duo 1.5 and I'm pleased to share initial results from that launch today. I'll begin with our clinical study, and our clinical study is a multicenter study to evaluate ASCOPE Duo in a real-world setting. The study enrolls patients across all complexity grades, that's ASGE levels 1 through 4, and the primary outcome we're looking at is procedure success rate with ASCOPE Duo, which means that the procedure was completed using only AMBU's single-use stewarding scope without crossing over to a reusable scope. Up to yesterday, we've restarted seven of our clinical trial sites, and the site investigators have enrolled 29 patients. And across those 29 patients, the procedure success rate is 100%, meaning all cases were successfully completed using Duo 1.5, and zero cases were converted to reusable endoscopes. And that, of course, is a very positive result for Duo 1.5. Now, if we compare this to a competitor that used similar study methods and the same performance indicators, they had procedure success rates which were under 91% and almost 10% failure and crossover rate. So although it's not a head-to-head study, our results compare very favorably against that, and we are confident that based on these early results, Dual 1.5's technical performance will be best in class. And that, together with our more attractive pricing, will make Ascope Duo 1.5 the market leader over our competitor. Next, I'll turn to our controlled market release, or CMR, results. And our CMR was specifically designed to test the product in high complexity procedures. To put that into context, in the market, about 40% of cases are the most complex ones. That's the ASGE grades three and four. For our CMR, over half the cases were grades 3 and 4, so it was really meant to test the limits of the scope. Now, our CMR ran for 90 patients in 15 sites across the U.S. and Europe, and the results were that 98% rated Duo 1.5 as clinically acceptable, and 94% are willing to adopt Duo 1.5 clinically, which, again, is a positive result. And based on these results in this high-complexity patient group, we are confident in the product performance in even the most challenging situations. Now, on top of these metrics, it's encouraging to see the feedback from some top KOLs from around the world. KOLs like Dr. Ali Perti in the U.S., Dr. Eichhoff in Germany, and Professor Sexy in Australia. Reinforcing the Duo 1.5 is high-quality, safe, reliable, and easy to use, even for complex procedures and even for severely ill patients. I would say it's rare that after such a short launch timing, so many KOLs are willing to go on record supporting a product, and that's what we're seeing with Duo 1.5. So now that we've talked about technical and clinical performance, I'd like to talk about customer interest levels and single use. Now, just a few months ago, single use Duo was listed as a top five trend in all of GI in one of the biggest endoscopy journals. And I would say that as we launched Duo 1.5, we've also experienced very high levels of interest and engagement. I just returned from one of the largest GI congresses in the U.S. and had a chance to engage with over 30 clinicians. And when I asked them, what role will single-use Duo play in your practice, doctors already see a natural place where they'll begin to adopt single-use. The high-risk patients, infected, immunocompromised, the out-of-hours cases, nights and weekends, And many share the sentiment that partial conversion to single use is just for now. 100% conversion is just around the corner. And then when I ask doctors why they want to adopt single use, first and foremost, they mention that it's because of patient safety, because they believe it's in the best interest of their patients. Now, doctors also see that the economic incentive is favorable, especially in the case of Ambu's duodenoscopes, given our more favorable pricing. They like the workflow benefit, especially for emergent cases and for nights and weekends where they don't want to call staff in or keep them late just to reprocess a scope. And especially with the labor shortages their facilities are facing, that is giving an acute need for a simpler, lower overhead solution. And finally, the doctors point to specific product benefits of ANBU's ASCOPE Duo 1.5 over reusable and single use. Things like our lightweight scope, which causes less muscle strain when they hold it all day. or a radiolucent tip, which lets them see behind the scope using fluoro, and that's a feature no other scope reusable or single-use has, and they find it very useful clinically. In fact, we had doctors saying that that should be the standard of care in all next-generation duodenoscopes. And they like the maneuverability of our scope, the flexibility of the insertion tube, and that lets them safely navigate through the patient's anatomy, which we know is a challenge in some of the other offerings on the market. So that's a level of interest from the U.S. doctors. And as I've met with KOLs in Europe, it's also interesting to see how engaged they are in terms of evaluating single use. Now, Europeans are not subject to the same FDA guidance, but they are part of the same medical community. And more and more, they acknowledge the cross-contamination issue. And they also see a significant workflow benefit, potentially even more than in the U.S. In many countries that have staff shortages, hospital waiting lists, and capital constraints, they see single use as an attractive option to address those in Europe. So we have positive results in product performance and increasing customer demand for single use across our key markets. And with that, I'd like to share a short update on our global commercial launch of Duo 1.5, which is underway across the U.S., Europe, and Australia. And we basically have two main focus areas in our launch. The first one is gaining rapid adoption in high-volume centers. And the timing for this is very good. In fact, the highest volume ERCP center in the U.S. just came out with a publication in a top journal showing how they plan to adopt single use as part of their treatment algorithm and recommending how others can do the same. Our second focus is on full customer conversions in lower volume centers, the ones with the worst economics for reusable scopes and the biggest challenges in terms of scope reprocessing. And for those, we're already beginning to see them transition. The first one you can see here was Marietta Memorial Hospital in Marietta, Ohio. They just announced that they were the first hospital in the world to transition 100% to single-use Duo, and they are doing it with the A-scope Duo 1.5. Now, these full conversions are something we will see more and more of as we move forward with our global launch of Duo 1.5. Looking beyond Duo, we have an aggressive agenda overall in GI. We see it as a key part of the $2.5 billion single-use market in 2025. Duo is our first launch, and it will be followed up with Gastro, with Colon, Colangio, so that we build a full range of GI single-use scopes in our portfolio. And of those, our next step launch is going to be Gastro. And the Gastro market is a $20 million procedure market. And as we gear up for launch, we've tested our product with more than 50 KOLs. And based on that KOL feedback and the product's performance, they see potential to use our gastroshock in over half of the 20 million procedures. We especially see KOLs excited about the sterility and workflow benefits, so we expect those to be important drivers of adoption. And we've gotten feedback that our product might even outperform reusables in certain features, and that's something that could accelerate uptake. So we're confident that both the Duo 1.5 and Gasco are poised to be important growth engines for the company as we expand our presence in GI and unlock a major part of the $2.5 billion single-use market. And now to share more on our broader innovation pipeline beyond GI, I'm going to hand it back to Juan Jose.

Thank you very much, Basil. When we talk about what makes AMBU unique, at the core is our R&D modular engine. This ability to develop multiple products at the same time, bringing to market very rapidly, and then moving to the next generation, also at a scale which is unprecedented in medical devices. And our pipeline reflects that. We have the richest pipeline in single-use endoscopy. And we are on track to introduce 20 products by 2022-23. Many of them are going to be introduced this year. If you look at what will it mean for us as a company, our pulmonology portfolio will move into the Bronco Suite. We have a much stronger offering in terms of video laryngoscope. our emp will have an expansion in terms of indications but more importantly the launch of our next generation with a higher image resolution which will help us to accelerate the penetration if you look at urology with a rapid growth we are having we are going to introduce our system high definition that will further accelerate the penetration and of course we will enter into a the european segment which is a segment that actually should be already should most of you have transitioned to single use if it were not for the high pricing And then finally, we have our base in terms of GI, where we will have now the launch of our Duo 1.5, but by the end of the year, we'll be introducing our Duo 2.0, and then the launch of Gastro and Colon, and then our Colangioscope. And as you can imagine, we are investing every year on strengthening our R&D infrastructure. which basically means that our ability to develop roles from parallel continue to increase, and that will ensure that beyond 2022-23, we continue to be the most innovative single-use endoscopy company. Now, to make sure that we execute on this innovation pipeline, we continue to do prioritized investments as a company. First of all, for 2021-22, there will be increased investments in terms of launch activities and manufacturing capacity. And Mexico actually is probably the best example in terms of the expectations that we see in terms of future growth expectations, but also the benefits from a supply chain point of view of having a plant right next to what is our most important market. In terms of our US commercial organization, we actually have reorganized our visualization group into three organizations. Our pulmonology cell force, our ENT and urology cell force, and our GI cell force. And each of them will have a responsibility to execute on the key launches we have coming. The pulmonology cell force will focus on continue to drive penetration in pulmonology and enter into the bronchosuite. Our ENT and good ology cell phones will continue to drive penetration, move into their next generations in terms of technology and enter into the ureteroscope. And in terms of GI, the possibility will be to drive a rapid transition into anoscopy and enter into all the other major GI segments. And then outside of the US, We finished last year setting up our GI commercial infrastructure. And this year we are doing targeted investments in urology just to maximize the potential of our RISCO-4 system and to prepare for the launch of our ureteroscope and system high definition. And with that, let me pass it to Michael who's going to provide the financial update. Thank you Juan Jose.

I'll take you through the financial highlights for the year and the financial implications we have seen from supply chain disruptions. Finally, I'll elaborate on our guidance for 2021-22 and the assumptions that we have put behind. Let's start out with the key financial results for the year. On October 5th, we disclosed preliminary key figures for the full year 2021 and the actual financial performance is fully in line with this. Our revenue increased organically by 16% with revenue surpassing 4 billion DKK and combined for all regions we sold just above 1.5 million endoscope units. This corresponds to a volume growth of 41% over last year and three times as many units as we sold compared to three years ago in 2017-18. This also reflects the rapid expansion of our single-use endoscopy portfolio, which now covers multiple segments beyond pulmonology. Our growth margin ended at 62.4%. We saw a positive impact from a better product mix due to the volume growth in visualization, and we saw improved scale in our manufacturing with more output at almost unchanged indirect production costs compared to last year. Finally, EBIT earnings ended at 340 million DKK with a margin of 8.5, including additional trade costs that has hit in the second half of the year compared to the initial expectations, and these trade costs amounted to 75 million DKK or roughly 1.9% of revenues. First of all, visualization now constitutes 54% of the combined revenue, up from 48% in 2019-20, driven by a 31% organic revenue growth in 2021. The main growth driver behind the visualization growth continues to be our age group 4, which played an important role in the treatment of COVID-19 patients. However, our single-use ENT and sister scopes show rapid growth and are starting to contribute a sizable and increasing share of revenue. Our two other business segments, anesthesia and PMD, reached a combined organic growth of 3%. The growth is made up by a mixed effect from anesthesia posting a negative growth of 2% and PMD posting a positive growth at 9%. The negative growth in anesthesia is a result of high comparables from 1920 where our resuscitator were in strong demand and with elective procedures gradually improving over 2021. As for PMD, the 9% growth is a result of depressed comparables from 1920 and auto with elective procedures gradually improving over 2021. For anesthesia as well as PMD, The recovery has been at a slower pace than initially predicted going into 2021, and neither of the markets are yet to consider to be fully back at pre-COVID level activity yet. On slide 27, we show the geographical distribution of this year's revenue and organic growth rates. Across all geographies, we see a strong contribution from visualization. On the bank of high WGD growth in 2019-20, growth well above 25%. The performance contributed by anesthesia and PMD is more blurred as swing in elective activity impacts these businesses significantly. But all in all, we have seen steady signs of a recovery. North America accounted for 43% of revenue in 2021 and reported an organic growth of 17%. Growth in visualization came up strong with 33% growth, but with moderate uptake in energy sales. P&D showed improvements after the decline in sales during 1920. Europe accounted for 45% of revenue and grew organically 15%. On the bank of 96% growth in 1920, we continue to see 26% organic revenue growth in visualization, including the impact from the special orders delivered to the NHS in England. Like in the US, we see a nice pick-up in PMD on top of a depressed base in 1920 and we see negative growth in anaesthesia, partly due to the high comparable. The rest of the world poked at organic growth of 18% with visualisation at 47%, driven by Australia and Japan. The market dynamics were similar to Europe with regards to the anaesthesia and PMD business areas. Now allow me to comment on the financial effects on our supply chain and procurement activities that we have seen during the year. The situation with the disrupted supply chain has impacted AmpliCity significantly with higher lead times and higher costs of running the supply chain. With manufacturing in the Far East and the main markets in Europe and the US, the higher lead time has driven up the value of our inventories and created shortages that we have been forced to close by sending significant volumes by air freight. In addition, the rates on container freight has imploded, leading to an overall increase of our freight costs by 75 million, above what was expected, and this equals a 1.9% of revenue. In addition comes the higher inventory values that we now must carry for foreseeable future. All the additional threat costs has hit in the second half of the year and is thus significantly impacting our profit levels for Q3 and Q4 and coming into 21-22. We consider the main part of these disruptions to be temporary, but to remain throughout most, if not the full financial year 21-22. We therefore expect the cost of running our supply chain to remain at a high level and we expect an increasing impact from raw material inflation as fixed price contracts will start to expire and mitigations applied in 2021 are becoming exhausted. These factors are part of the reason why we expect our gross margin in 2021-22 to be slightly below 2021. The high growth from visualization that comes at margins well above the overall average will create positive leverage, but the raw material inflation will neutralize this positive impact. Finally, let me outline the financial guidance for 2021-22. With multiple product launches planned and our proven technology, we are well positioned to take on further market shares in single-use endoscopy as the markets convert from reusable. Over the last three years, we have committed significant investments in innovation, in commercialization and enabling functions to maximize our first mover advantages. We leave 2021 on a high note with 16% organic growth and 41% increase in endoscopes units sold. We also leave 2021 with an inflated cost base of almost 2% due to freight and 2.5% due to raw material inflation and capacity expansion in Mexico. We consider all these items to only be for the short to medium term and that most of the cost will revert to levels more in line with what has been seen historically. This includes our operation in Mexico as we've got scale to a cost level comparable to what we have on our other sites. For 21-22, however, these cost items will impact our overall financial performance. On this basis, the organic growth for 21-22 is expected to be in the range of 15-19%. Adjusted for the NHS order in the first quarter 2021, the guidance for the full year would increase by 3.5%. And because of the NHS orders, the organic growth in Q1 2021-2022 is expected to be close to 0%, and then gradually increase as we move through the year. The organic growth will be driven by visualization, which will continue to deliver high double-digit growth rates. Our recent launches of Ascope E4ENT and Ascope Sisto and Ascope Blue Dino are expected to contribute a large share of the organic growth as we create the markets and move through the year. The contribution to growth from products that will be launched in 2021-22 is expected to be modest during this first year of launch. The anesthesia and PUD businesses have in 2021 been negatively impacted by a slower than expected return of elective procedures. Both are in 2021-22 expected to gradually improve as the external market conditions return to pre-COVID levels and the backlog for many anesthesia products that was carried into 2021-22 is expected to have a positive impact on the growth in 2021-22. As for the EBIT margin, this is expected to be in the range of 7-9%, significantly impacted by raw material inflation, high freight rates and lack of transparency in the global supply chains, which drives the need for air freight to ensure we can continue to deliver. Again, we consider these levels to be for the short to medium term and eventually to reduce to a lower level. As we move into 2021-22, We have built a comprehensive commercial infrastructure that will ensure our ability to effectively launch and create the markets. You will therefore see that the OPEX ratio to revenue will be highest in the early part of the year and from here improve together with the EBIT margin as we move through the year. As a result, the EBIT margin for the first half 2021-2022 is expected to be low single digits and to gradually improve as we build further financial scale during the second half of the year. These were my comments for how we expect the year to play out.

And with that, I would like to give the word back to you, Francis. Thank you very much, Michael. I mean, just to summarize the environment of significant volatility. COVID is still with us. There are supply chain disruptions. In spite of all of that, we are 100% focused on executing on our strategy, on maximizing our first-mover advantage, on bringing to market our launches across all endoscopy segments and commercialize them very rapidly. And it is on the back of that that we expect to maintain our APICuro profile and derive significant improvements in terms of profitability. So why don't we move to have a short Q&A given the time. So we open it for questions.

Thank you. Ladies and gentlemen, if you do have a question for the speakers, please press 01 on your telephone keypad and you will enter a queue. After you're announced, please ask your question. Once again, it's 01 on your telephone keypad to register for a question. And our first question comes from the line of Thomas Biles from Danske Bank. Please go ahead. Your line is open.

Yes, thank you very much. A couple of questions from my side here. So just on the duodenoscope, so based on the quite positive feedback you have, so is there any additional upgrades planned for the version 2.0 other than what we already know about the sensor and the box connection? And then the 29 patient study interim data you have presented here today, should we still expect you to present interim data from 50 patients during the quarter, or will the next data disclosure will be when you have completed the trial here in 21, 22? And then just on the Bronco, so looking at the Q4 number, when you compare unit and growth for visualization, it seems like Bronco did have a, average of 2.4, assuming, of course, well, you highlight ENT and CISTO doing quite good, and then, of course, the ASP was somewhat lower as well. So any call on this, and then also taking ASCO 4 Bronco into the next fiscal year, so with the current guidance you have and all the impact you have from ENT back, Autodoc, TI, so where should we sort of think the ASCOPE 4 would be for the full year? Actually, basically, are we going to see X growth for this fiscal year? And then just finally, just on the ASCOPE 5, have you submitted to the FDA for approval now? Thank you.

Thank you very much, Thomas. So let me start with you. I think the next milestone is going to be to share the completed study and we are going to look at a GI industry forum to be able to do that. But given the number of sites we have active that we continue to expand, we expect to be able to present the full results in a non-distant future. Now, what Babson presented in terms of a technical performance of Duo 1.5 It shows that we have a product that can be used across all levels of complexity, and on the back of that, drives the transition to single use. Now, having said that, in the same way as we did with bronchoscopy, in the same way that we will do with ENT with a launch of our high resolution or system with our high definition, we will continue to innovate. And the idea is to make sure that at any point, we have the most advanced a product in the market i cannot get into details regarding 2.0 it will have a more advanced sensor it will have a connectivity to the airbox 2 advanced as where we have some columns but you should expect also to bring some of the strengths of 2.1.5 and to bring some additional enhanced functionality now in terms of bronco we don't really guide a by platform what i can tell you is this number one is going to be volatile and it's going to be probably one of the most difficult business to uh to forecast mainly driven by the uncertainty around the COVID-19 pandemic this winter season and the flu season. And in the case of COVID, we need to compare the relative size of the COVID pandemic this winter season versus last year winter season. And in the case of the flu season, there was no flu season last year, and we are expecting to have a flu season this year. Now, whatever is the size of the market, we expect the impact of competitors to be minimal. We expect the penetration of single use to continue to increase at the same rate as it has increased before. We expect our prices to remain constant and that we maintain most of our share. So that's as much as I can share. I don't know, Michael, if you have any other comments.

No, I think you have said it, Francie, that it has been a very volatile year that we have left and we enter into this year with a strong base. I think, as we also say in our guidance, we see very, very stable prices out there and we see increased penetration into geographies where we have not been as dominated before. So all these items are impacting how it's playing out, but I think overall volatility is probably the word that describes the situation the best.

Okay, great. And just on the ESCO 5?

On the ESCO 5, I mean, as we have so many launches going forward, we will share when we get the approvals. But have you submitted yet, or...? We will not comment in terms of when have we submitted or not, but you should expect this to be a global launch and that a launch will happen this year.

Okay, great. Thank you very much.

Thank you so much.

Thank you. Our next question comes from the line of Christian William from Nordea. Please go ahead. Your line is open.

Hi, good morning, and thank you for taking my questions. I have a couple as well. The first is going back to the announcement on the 5th of October. I understood that you expected some phasing of PMD and anesthesia products to slip from Q4 into Q1. So how should we understand sort of the relative size of sales for the core business in Q1 relative to Q4? So will core sales be higher in Q1? And therefore, should we expect visualization sales to... decline relative to Q4. That's my first question. And then my second question is whether you can give us some sort of soft guidance on the level of R&D capitalizations for the next year. I appreciate that the that you've had fairly high CapEx R&D spent this year. Should we expect those rates to come down relative to sales, or should we expect, say, similar 8% to 10% of sales in net capitalization also for the next year? Thank you.

Thank you, Christian. To your first question about the backorders and how Q1 played out and how we're entering into the first quarter, You're absolutely right that we said, and that was also how Q4 ended out, that we left Q1 with quite healthy backorders on especially core products. For Q1, we do expect those to be shipped. We are still in a very, I would say, volatile situation where it's very difficult to plan. We see that lead times for air freight is increasing, and we see that there's still significant congestions in the ports. I think that's probably the most I can say about it. I will not go into guidance specifically on how we expect the business units to perform in individual quarters, but you're right about your overall assumptions. With respect to the level of R&D capitalizations, I think you can assume that the level which we left in 2021 is how it's going to look also in 2021-22. So when you say around 10%, I would say that's probably a fair assumption to apply.

Great. Thank you very much.

Thank you. Our next question comes from the line of Benjamin Silverstone from ABG. Please go ahead. Your line is open.

Thank you. Good morning, Juan and Michael. I hope you are well. I have two questions, if I may. The first one is in terms of the timeline of your commercial infrastructure setup. Could you just give us an indication of when you expect this to be completed for all of your current segments? And also in terms of the growth for next year, you're guiding 15% to 19% organic growth. With such a strong portfolio of products to be launched next year, and also the Dudenoscope now starting to gain commercial traction, could you give some indication of which products you expect to drive to growth next year? Thank you.

Sure. And in terms of our commercial infrastructure, if you look at The investment we have done over the last three years, it has been to make sure we set up what is the core commercial infrastructure for commercialization. And that involves terminating distributors, going 100% direct, building the year organization globally, and now putting more focus in terms of urology. Going forward, we expect the investments in commercial infrastructure to be more moderate and lower to what we have experienced in the last three years. Of course, it will depend in terms of the performance of our launches and the opportunities we see in front of us, but overall, that is the assumption that we have. That basically means that out of next year, we should be able to start to see more laborers in terms of commercial infrastructure and see more benefit in terms of our profitability. In terms of our guidance of 15 to 19%, first of all, our guidance reflects the volatility we're seeing in the market in terms of COVID and elective procedures and so on. But putting that aside, you should expect that most of the growth is going to be driven by the pros we have in place together with Duo. Those are the ones that are going to drive most of the growth. We have high expectations in terms of pulmonology being able to continue to drive penetration in the market. ENT and CISTO, on the back of more dedicated resources, will continue to see a rapid growth. And I think Bustle made a very compelling case regarding the dual opportunity and what we believe we can achieve. We are being cautious in terms of the contribution of our new launches. These are, in most of the cases, launches in markets that don't exist, that we need to build from scratch. So we are not relying on them to be able to meet our guidance.

Thank you very much, Juan.

Thank you, Benjamin.

Thank you. The next question comes from Neil Flett from Carnegie. Please go ahead. Your line is open.

Thank you for taking my questions. I'll take them one at a time. So just to begin with your 550-patient study, which you have recorded in clinical trials, so have you changed the the structure of this trial. I'm just referring to the doctors that you quote in your press release and the presentations today. They don't seem to work in any of the centers which have been recorded in the clinical trial document except from one. That's my first question.

Yeah, thank you, Niels. I mean, we haven't changed We haven't changed it, and we just basically select just a couple of testimonials that can help to provide color regarding what is the feedback on the performance of the product. But if you want to get a more complete feedback regarding the KOL's views on the product, I think you can go to our LinkedIn page and just spend some time hearing what are they commenting on that.

So we should expect some of the centers which are currently recorded in the clinical trials not to participate in the trial.

Do you mind repeating your question?

Yeah, that's my question.

I mean, we have 10 centers. In the public, you can see on clinical trials, we have 10 centers planned. And so far, we've reinitiated seven of those sites Now, of course, when it comes to testimonials, you know, there's some level of bias we want to avoid by having those clinical trial sites who are doing more academic-type work to show the performance of our product from being the same customers that are doing, you know, sharing testimonials and the support for our product. And you can probably assume based on the, you know, performance, the level of feedback we're getting from the clinical trial sites in terms of the investigators.

Maybe, Neil, just to elevate the conversation a little bit, what you should be confident is around the technical performance of the probe that we are doing. We are sharing the early clinical data and that we will share the full clinical data at an industry forum. And we are sharing some feedback from customers. Now I have to say we're starting the global commercial launch and the most important thing is going to be what is the actual performance of the product. We are just positive in terms of the ability for the product to perform across different levels of complexity and together with our superior economics on our ability to also become the number one player in single-use endoscopy in GI.

And just a question on your slide 18 where you refer to the biggest ERCP center in the U.S. having converted to single-use or about to convert to single-use duodenoscopes. So did they actually adopt the amputee duodenoscope?

I think we don't, you know, we won't try to share individual feedback in terms of account adoption, but I can share that that's you know, that publication is a strong driver of adoption in high volume ERCP centers around the US and around the world.

Okay, and then a last question on the price inflation that most companies are experiencing right now. To what extent are you able to compensate for that by launching price increases on your existing products?

I mean, we are looking at pricing very carefully and there are certain things we can do in terms of pricing for existing products and for new products. But our pricing strategy is still focused on driving the transition from reusable to single use. And within that, we have some flexibility in terms of setting price points, but that's really our number one objective. Okay, thank you. Thank you very much, Niels.

Thank you. Our next question comes from the line of Yubai Su from SCB. Please go ahead. Your line is open.

Hi, thank you for taking my question. A couple questions from my side as well. I'll do one at a time. My first question is regarding the clinical trial. I understand the main focus on this study here is the procedure success rate. Is it possible to indicate a bit on the qualitative measures like ease of cannulation, which we understand from the doctors, this is also pretty important for them. Could you please put the color here?

Sure. And, you know, of course, when it comes to the clinical trial, we're going to ease of cancellation and other qualitative metrics will be part of the full report out that we do at an upcoming Congress. But I think I can share that from the controlled market release, that was not just focused on procedure success. that also was focused on the overall feedback across different performance attributes. And when we looked across all those, 98% of doctors were rating Duo 1.5 as clinically acceptable. And of course, ease of cannulation was a key part of that.

Is it possible to share some data on the measure, for example, like ease of cannulation?

Yeah.

Based on the data you already have. Yeah.

Yeah. I mean, you would have a chance to see the full data when we share the complete study. But what Vasily is saying is that you cannot get in a controlled market release 98% as clinically acceptable and 94% as willing to adopt Escort Duo 1.5 without having very high performance in terms of annulation. That's just not possible. So you should be confident that what we are sharing today, not only reflect that this product can be used across all levels of complexity, but also qualitative measures like annulation, this product is performing at very high level.

All right, fair enough. My second question here is on the urology and ENT, which you mentioned you have gained the number one position. So what measure have you sort of compared? Is it a unit sales or is the revenue?

We are using unit sales. What we are saying is that in terms of volume, we are number one in pulmonology. We were number one in ENT. and we became number one in urology last year.

And could you also, when you compare two, are you compared to the reusable scope, or is it compared to competitors' single-use scope?

I'm talking about number one single-use endoscopy player in urology. So I'm talking about relative to companies that have single-use urology problems.

Okay, clear. And my last question here is regarding the gastroscope. I recall you have submitted the FDA approval. So what is your expectation on the timeline for continued market release, full market launch, and clinical trial?

I mean, we are going through the process and waiting for the regulatory approval. So what we have committed is that the launch is going to take place this year and we are gearing towards the commercial activities. So that's as far as I can go. But as soon as we get the approval, we will let everybody know.

Is it fair to assume you will still go through the consumer market release then followed with the full market launch?

Yeah, in gastroscopy, because the volume is so large, the control marker release is actually much shorter than normal. There are 20 million procedures. So you can actually do over 100 procedures in less than a week and fully test approach before going into a commercial launch. But we are planning to do things properly and make sure that it is fully tested before we do the expansion. It's just that it's not going to be a very long process.

Okay, great. Thank you. I'll jump back to the queue. Thank you.

Thank you. Our next question comes from the line of Craig MacDonald from JP Morgan. Please go ahead. Your line is open.

Thanks so much. Good morning, everyone. My first question goes to Basil, and it was helpful hearing your strategy for the duodenoscope launch targeting lower volume and higher volume centres. I was wondering if you could give some colour as to the timeline for adoption in those two different types of centres. What's the typical timeline between the sales rep first knocking the door to adoption hitting 10 or 20 or 40%? Is there typically a trial period before you see meaningful adoption? And then sort of linked to that, to what extent are Salesforce measured or incentivized on GeoDynascope unit volume? And to what extent is it actual revenues? And then a second question. Apologies that I missed it, but can you just clarify whether you've seen any buying of bronchosclerotic pulmonology ahead of a potential fourth wave of pandemic and whether that's factored into your guidance for FY22? Thank you.

Thank you. Yeah, actually, let me just address both questions. First of all, in terms of Duo, I mean, what we can share right now is that given the conditions in terms of regulators, in terms of public and private payers, combined with the technical performance of our product and our economic offering, we believe that Duranoscopy is going to be one of the largest segments in 2025. I think we have No doubt that that's going to be the case. Now, in terms of the actual commercialization, you basically go through an evaluation where the healthcare system will test the product to make sure they are comfortable, that it works, as we say, across all the levels of complexity. And then you start the adoption. And it will vary whether it is a small center where we expect a more rapid adoption or a high-volume center that will start incorporating it into their practice and their transition in a way which is not that dissimilar to what we have seen in some of the other single-use endoscopy centers. Now, we have the commercial infrastructure to be able to cover most of the ERCP centers across all of our team projects globally. One of the good things is that this customer base is not fragmented. So you have the ability to go and introduce the product across most of the market relatively rapidly. Now, in terms of demand for our pulmonology across any next COVID-19 wave, I mean, there is still a lot of volatility, but we have shown over the last two years that we are actually able to supply at very high levels of demand without any disruptions. So healthcare systems have gotten accustomed that they don't need actually to build significant inventory, that they don't need to build significant inventory to be able to address and usually hide the amount of COVID-19 patients. We are assuming some level of COVID disruption, but nothing compared to what we have seen before.

Thanks very much. It's clear.

My pleasure. In the interest of time, with that, let me just close the Q&A. Thank you very much for staying with us. There is a lot of progress and discussions both in terms of the development of the market and how well Istanbul positioned to emerge as the number one player. And with that, I wish you all the best. Thank you.