Welcome to the Ambu earnings release Q2 2021-22 call. For the first part of this call, all participants will be in a listen-only mode, and afterwards there will be a question and answer session. As a reminder, this call is being recorded. Today, I am pleased to present Juan-José Gonzalez, CEO, Michael Højgaard, CFO, Bassel Rifai, Chief Marketing Officer. Please begin your meeting.
Thank you, and welcome everyone to our quarter two earnings call, and thank you for joining in such a short notice. If we can go to the agenda, what we will do is as similar to previous calls, we will provide a brief introduction on the company for investors who are not familiar with Ambu. We'll provide a strategic update on the main developments over the last three months. We'll go through the financial updates, and then we'll open for questions. When we look at Ambu, it's important to understand two things. One is the market attractiveness, and the second thing is Ambu's strategy and performance within this market. If we go to the next slide. Single-use endoscopy is one of the most attractive med tech markets.
The market is expected to grow from $500 million last year to $2.5 billion by 2025. There are three main drivers behind the creation of the single-use endoscopy market. Number one, an increased focus on infection control from both regulators, healthcare systems. Benefit around workflow and efficiency, a benefit which is important as healthcare systems are under more pressure to do more with less resources. The rapid technology advancement. The technologies powering single-use are moving very rapidly. Whether it is sensor technology, image enhancement software, that's basically making single-use endoscopy products more and more powerful relative to reusable endoscopy. It is a combination of these three drivers that is behind the transition from reusable to single-use. Now, if we go to the next slide.
Ambu is the number one player in single-use endoscopy. If you look at our performance over the last three years, we have an organic revenue growth of 15%, with a visualization, a growth of 37% and a volume growth of around 40%. Actually, our volume has tripled in the last three years. Last year we finished north of 1.5 million endoscope sales. At the same time, on the back of a visualization growth that have a higher gross margin, our overall company gross margin has improved by 8 points over the last five years. Now, our strategy in Ambu is very simple. We have created this R&D modular engine, and we are using it to build the most comprehensive and technologically advanced portfolio.
We are creating an ecosystem where different single-use scopes connect to monitors and processors, and are able to do different endoscopy procedures anywhere in a hospital. We are leveraging our high- scale, low- cost manufacturing setup to enable hospital to transition from reusable to single use in a cost- neutral way. Finally, we are maximizing our first- mover advantage by rapidly scaling up our dedicated commercial infrastructure. Those are the three key elements behind our strategy, and that's why we believe that as the market is created, Ambu will consolidate and strengthen its number- one position. Now, having said that, in terms of introduction, let's talk about the main developments in the market since the last time we got together. If we go to the next slide.
In terms of key messages, number one, the drivers creating the single-use endoscopy market continue to accelerate. We have had two of the most important U.S. organizations setting hospital quality and safety recommendations, increasing the requirements for reusable endoscopy reprocessing. We have had another product recall of a major reusable urology player, which is another example of the FDA focus on reducing endoscope-related contaminations. In terms of our performance, we have had a solid Q2 performance while advancing our visualization pipeline, which is putting Ambu in a strong position towards accelerated growth in the second half of the year. Adjusted by the NHS safety stock orders in Q2 last year, both visualization, anesthesia and PMD grew double digits.
We actually, in visualization, achieved a record volume growth of 444,000 unit sales in Q2, and 863,000 for the first half of the year. Our visualization growth is driven by ENT and cystoscope rapid penetration, which will further accelerate in the second half. As a result, we are increasing our ENT and cystoscope forecast for number of endoscope sales to approximately 800,000, versus above 700,000 last quarter. Our bronchoscopy demand is normalizing back to pre-COVID levels, but at a higher single-use penetration. I will spend a couple of minutes giving you more insight regarding that. Finally, we continue to advance our GI strategy with a global launch for our aScope Gastro. At the same time, we get ready to extend our leadership in pulmonology with introduction of aScope 5 Broncho into the bronch suite.
Those two are very important launches for Ambu and will be key growth engines going forward. Now, in terms of our full- year guidance, we are revising it down to reflect the lower- than- expected benefit from elective procedure pent-up demand and macroeconomic headwinds. Now, in the case of Ambu, our calendar year finished at the end of September. We had some expectations in terms of the recovery of the elective procedures, which we have seen. But at this point, we believe that the benefit of the pent-up demand is going to be later than what we expected on the back of labor shortages, which is limiting the ability of hospitals to be able to address more procedures. The macroeconomic headwind on the back of the Russia-Ukraine conflict, inflation, supply chain congestions are further increasing our production and distribution costs.
It is in the back of those two things that we are revising our full- year guidance to an organic revenue growth of 13%+ and EBIT margin of 5%+. This assumes that Ambu is going to grow over 20% in the second half of the year and finish the year as one of the fastest- growing med tech companies globally. Now, let's go one by one. If we go to the next slide. Market transition to single-use continues to accelerate. On the left-hand side, we see the most important announcement either from regulators or reusable endoscopy recalls in the last 12 months. And it's incredible when you actually step back and see all the announcements we have seen. 12 months ago, we had Olympus issuing a field safety notice on reusable duodenoscopes.
The FDA issue a warning letter on contamination levels in urology endoscopes. The FDA issue a recommendation for hospitals to consider single-use bronchoscopy due to the risk around contamination. CMS granted additional reimbursement for outpatient procedures for single-use duodenoscopy. We have KARL STORZ's recall of part of their reusable urology portfolio because of risk of contamination. We had one of the most important organizations setting quality and safety guidelines for hospitals, AAMI, updating guidelines for reprocessing. Shortly after, we had AORN, which is another very important organization, updating guidelines for reprocessing. This is just a very good example in terms of why we believe that the transition from reusable to single-use will happen.
We expect in the following years to see more focus from regulators, not just in the U.S., but outside of the U.S., increasing the requirements in terms of reprocessing of reusable endoscopy players, making the processes more complex and more expensive. We are going to see difficulties around reusable endoscopy players showing that they are able to be properly cleaned based on their current standards, and on the back of that, having to revise their standard. Now, let me just spend a couple of minutes talking about this, U.S. organization updating the, their guidance. And basically, AAMI and AORN have identified duodenoscopy, bronchoscopy, cystoscopy, and ureteroscopes as high-risk scopes, and they have put further reprocessing steps to address the contamination issues. The recommendation vary from sterilization, mandatory sterilization, cleaning verifications, enhanced drying.
Basically, this will add further complexity and cost and time to what were already complex reprocessing models. Depending on whether you are a hospital or a clinic, your ability to follow these guidelines is actually limited. These guidelines are of course following FDA communication on duodenoscopy and bronchoscopy while expanding into urology scopes, given the recent contamination issues. In the case of AORN, for the first time, they actually have a section on single-use endoscopy. One of the recommendations is that hospitals, as a first step, need to decide based on their ability to reprocess to do reprocessing and cleaning, whether they should take a reusable scope or a single-use scope. Hospitals follow these guidelines as a standard in terms of the way they operate.
We believe that as more healthcare systems adopt these guidelines, the overall attractiveness of single-use endoscopy will increase. Now, if we go to the next slide, let's talk about our performance in Q2. First of all, we basically saw the impact of Omicron in terms of depressing elective procedures in January. We saw a recovery in February, and then we saw in March the market rebounding. Within this environment, our anesthesia and PMD performance was very strong as it is driven by elective procedures. We posted in the quarter 12% growth in anesthesia and 14% growth in PMD. Now, part of this growth is also driven by the reduction of backlog orders that were coming from Q1.
Now, we expect to continue to see elective procedures to go above 2019 levels, but with less benefit from pent-up demand due to the hospital labor shortages. We also expect, especially in terms of PMD, that we will continue to gain share. As a result, we are maintaining our full- year double-digit growth expectation for anesthesia and PMD combined. Now, let's talk about our visualization business. If we go to the next slide. Adjusted for the NHS, our visualization revenue to continue to grow double digits with a record 444,000 units sold. The main highlights are, again, adjusted for NHS, a visualization growth of 10% in revenues and 25% in volume. If you look at our volume during the first half of the year, it's already above our full year volume in 2018 and 2019.
Our volume growth is mainly driven by the rapid penetration of ENT and cystoscope probes, in spite of an elective market that actually contracted in Q2. That is very encouraging and just shows the rapid penetration that we are having with these products. Now, let's talk about our most important businesses within visualization. If we go to the next slide. Our bronchoscopy franchise continues its long-term growth trend post COVID-19. And the graph on the left shows the quarterly global units sold since 2015, 2016, all the way to our Q2 this year. And you can see some important highlights. First of all, our bronchoscopy performance is declining in Q1 and Q2 due to the high comparables from last year's COVID wave.
That's why we say that the market is normalizing back to pre-COVID-19 levels, but at a higher single-use penetration. Our average selling price remains stable across all of our bronchoscopy products. The single and most important highlight is that on a multi-year basis, our bronchoscopy business continue to grow on the back of increased penetration. More importantly, going forward, we expect it to continue to grow driven by penetration and new product launches. As you can see from this chart, the impact from competition is really small. The reason why this is small is because competitors are also driving penetration of single-use endoscopy. Part of their growth is not coming from Ambu business, but from areas in the hospital where we are not present.
Again, going forward, when you look at our launches of aScope 5, new sizes, our aScope 5 BronchoSampler, we have significant innovation to be able to continue to drive this level of performance. Now, if we go to the next slide. Let's talk about ENT and cystoscopy. They basically continue the rapid acceleration, growing double digits quarter-over-quarter for the last seven quarters. This is a remarkable performance, and it is driven by all of our key markets globally. Actually, for the first half of the year, aScope 4 Cysto have already exceeded the full-year sales in 2020, 2021. The main adoption drivers continue to be convenience, flexibility, and superior product performance. This is because reusable ENT and cystoscopy products lose performance as they go through very complex reprocessing and cleaning processes.
If you are a hospital and you have a reusable cystoscope, for example, that it is one year old, that cystoscope have a performance which is already deteriorated. Single-use aScope 4 Cysto have a superior performance. This is more the case as we improve the image quality with our newest display monitor, aView 2 Advance. Our continued growth will be fueled by our dedicated ENT and urology commercial resources, the expansion into ENT and FEES, ENT FEES, which is a 1 million procedure market that have higher levels of reimbursement and that we were not addressing today. The recent product recall of a major urology reusable player. Allow me to spend a minute talking a little bit more about this recent product recall. If we go to the next slide.
KARL STORZ's recall represents a large opportunity to further accelerate our penetration for our aScope system in the U.S. Just in terms of context, KARL STORZ is the largest reusable cystoscope player in the U.S. with 40% market share. They have about 50% market share in clinics and 30% market share in hospital. They are covering 1.6 million procedures annually. Last year, the FDA requested KARL STORZ to conduct additional testing on the reprocessing methods, which identified failures following high-level disinfection in some selected scopes. Based on these test results, KARL STORZ issued a voluntary product recall at the beginning of April this year, requiring customers to move 100% to sterilization or to discontinue and return the products. We believe this recall will represent an important growth opportunity going forward.
The relative benefits of single-use cystoscope have increased as new requirements add significant burden to customers. For a clinic, this voluntary recall require them to invest more on capital. The cost of using reusable scopes is going to go up, and their ability is going to decrease as reusable scopes will have to go through longer reprocessing products. That's why relative now to single-use cystoscopy, we have an even more attractive value proposition. As a result, we have started to see over the last four weeks an even faster pace of adoption of our aScope system. That's why we're increasing our ENT and cystoscope forecast for the number of endoscopes sold this year to approximately 800,000 from 700,000 and above.
This is still unfolding, and we are taking a measured view in terms of what this means for us. We believe that most of the upside is going to be in Q4 and mainly into next year. It just position us in a very strong way to ensure a continued accelerated growth of this platform. Now, I talk about the developments in the market. We talk about our performance both in terms of anesthesia and PMD and then visualization. You have had a chance to see the evolution of our bronchoscope business and the one-off effects of the COVID-19 pandemic, but how we continue to drive penetration and growth in a market which is more normalized. Then you have seen the rapid growth of ENT and cysto.
Let's now move to talk about innovation, and I'm going to pass it to Bassel Rifai, our Chief Marketing Officer, who will give an update now.
Thank you, Juan-José. As Juan-José shared earlier, our visualization pipeline is putting Ambu in a very strong position toward accelerated growth, and that's driven by our innovation engine, which has become a clear competitive advantage for Ambu. If you go to the next slide. Today, I'm gonna share an update on our key launches, our GI bet with aScope Duodeno and Gastro and in pulmonology, our launch of aScope 5. I wanted to start by acknowledging the team behind it and what they've accomplished. Our innovation engine is a 500-person strong team across three sites in Denmark, in Germany, and in Malaysia. That represents the largest single-use endoscopy innovation infrastructure in the world. We believe it exceeds all of our major competitors combined.
Of course, one thing is the size and the other is the way that we're organized around modular innovation, which means that our full range of scopes benefit from each technology advancement we make, and the rapid launch cadence that we draw from consumer electronics. The result of that, the size and the organization of our innovation infrastructure, means that just over the past year, we've doubled our visualization portfolio. You can see on the left our current portfolio and what's been launched just in the past 12 months. Of course, two of our most exciting recent launches are aScope Gastro as part of our GI strategy in aScope 5, where we just received CE marks, and both of those I'm gonna talk more about.
In terms of future launches, we're looking forward to secure FDA clearance of aScope 5, and then next step after that will be aScope Duodeno 2.0. Starting with GI, if we move to the next slide, we have an aggressive innovation agenda in GI. It began with Duodeno, now it's continuing with Gastro, and it's gonna follow with Duodeno 2.0 colon and cholangio, so that we build a full range of GI single-use scopes in our portfolio. Today I'm gonna focus on Duodeno 1.5 and Gastro. For Duo, as we advance the Duodeno 1.5 launch, there are three main messages to take out from today. Number one is that this is going to be one of the largest single-use endoscopy markets in 2025 because the market environment for Ambu is continuing to become more attractive.
Basically, the two main developments we've seen over the past three months, first is that we're continuing to see expanding reimbursement coverage by private insurers in the U.S., and that's a driver towards single-use adoption. Then second, our main single-use competitor recently issued a safety notice in Europe related to injuries during scope insertion. We expect this to have a negative effect on their traction levels in Europe and be positive for our share within the single-use market. The second key message is that for aScope Duodeno 1.5, we continue to strengthen clinical evidence. In our last call, we shared that we submitted two abstracts on Duodeno 1.5 to DDW, and we're pleased to see that both were accepted to present in just two weeks.
One is gonna showcase the results of our 150-patient multi-site study, and the other is specifically focused on liver transplant patients, which is an immunocompromised population where sterile single-use is very important and where aScope Duodeno has shown excellent results. We're looking forward to be at DDW, you know, not just for that, but also to showcase all of our, you know, launches and our upcoming pipeline. The third key message is that as we advance the launch of Duodeno 1.5, we expect uptake to be gradual. That's because even as we move past Omicron, we see Duodeno as having a long-term attractive opportunity, but being driven by a longer selling process compared to some of our other scopes. Now, in terms of Gastro, as a reminder, this is a 20 million procedure market, more than pulmonary, cysto, and ENT combined.
It's a market which has very similar conditions to what is driving single-use adoption in those segments. You have procedures taking place at multiple sites in the hospital. You have a need to do more and more procedures going up against hospitals that face capital constraints and reprocessing that's getting more and more complex. Of course, you have the contamination risk with reusable scopes. Those are the conditions that support single-use penetration in gastroscopy as we launch Gastro and aBox 2 globally. Now, on the regulatory front, we've now secured clearances across all of our major markets. That's the U.S., Europe, and Japan. I've actually just returned from the U.S., where we completed our controlled market release these past two weeks.
Now, the goal of our CMR was to test the performance of the scopes across a range of customers, so we worked with endoscopists and surgeons, a range of sites of care, everything from academic hospitals to ambulatory surgery centers, and most importantly, across a range of procedures, everything from pre- and post-op checks to basic diagnostics, biopsies, balloon dilations, stent placements and removals, energy devices, and resections. Basically, a CMR which overall represents the vast majority of the case mix that we'd expect to see as we launch. For the CMR, we did 75 cases across 10 sites, and the results have been encouraging.
We saw a 98.5% clinical success rate and a 0% crossover rate to reusable, which means that the one case that wasn't completed, the patient had altered anatomy, so the physician didn't even try it with a reusable scope either. Beyond clinical performance, we also got encouraging customer feedback to very high satisfaction rates, especially among surgeons who gave the scope a 100% satisfaction rate and a 97% rating of image quality being acceptable. That was important because image quality is an area where customers have very high performance requirements in GI, and it shows that with our latest generation camera sensor in aBox 2, we're starting to meet those requirements and target procedures. Across all sites, you know, GI and surgery, 96% said insertion and maneuverability were on par or better than reusable.
In fact, 70% said those were superior to a reusable. That's of course because reusable scopes degrade over time, and so this is, you know, fresh and new right out of the box. Now, of course, beyond the quantitative results, some of the qualitative feedback was encouraging as we move into launch. You can see the quote from one of the surgeons in our CMR that aScope Gastro's ability to retroflex far exceeds any reusable scope I've used. You know, we had one site that did 11 cases in the morning before noon, and the feedback from the doctor was that my staff loved it today.
They said that, you know, word for word, that they feel like they're not worn out or dreading having to spend the rest of their afternoon cleaning the reusable scopes, and instead, they can be doing some other responsibilities. That's exactly the type of feedback that we heard and that we hear in cysto, that we're basically freeing up worn out staff. In a strained labor environment, that's becoming a more and more important purchasing factor. With those CMR results, we've now shifted to full commercial launch. We're targeting about half of the 20 million procedures out there. A key starting point for us is surgeons, non-GIs who are doing cases outside the endo suite, because those are two areas where we see some of the strongest pull from our customers. Then we expect to continue to expand our footprint from there.
To summarize in GI, we're confident that both Duodeno 1.5 and Gastro are set to be important growth engines for the company as we expand our presence. If we move to the next slide, now shifting to pulmonology. Earlier this week, we announced the CE mark of our aScope 5 Broncho HD, which is the fifth generation of our market-leading aScope platform. Now, we designed aScope 5 with one key purpose, and that was to perform at a high enough level that we can enter into and take share in the bronchoscopy suite. That's as a reminder, that's a new segment of 3 million procedures for us, and it's one where the three most important things are endoscope performance, workflow and availability, and number three is safety.
That actually is becoming even more important with the FDA guidelines towards sterilization of reusables as they and other organizations categorize it as a high-risk scope. If our design goal was to be able to enter into the bronch suite, we believe that we've achieved that and that aScope 5 is our highest performing bronchoscope yet. We've set a new bar in terms of high-performance imaging with a four times higher sensor resolution and four times greater processing power compared to aScope 4. We have robust and familiar mechanical performance and maneuverability. Of course, there's full compatibility with the Ambu ecosystem. In the development of this scope, we tested it with over 200 bronch suite KOLs globally in pre-clinical and bench-top settings. That's basically the largest ever customer engagement that we've done pre-launch. From that engagement, we've received very positive feedback.
We just finished a round of testing and feedback with a group of interventional pulmonologists, global KOLs, and 100% rated aScope 5 as acceptable based on pre-clinical testing. In some areas, they even rated it superior, areas like bending performance, especially with tools inserted. Now, that's an important factor because compared to competitor single-use scopes like EXALT, where they have a warning in their label against inserting tools while the scope is bent, we're showing high performance in that area, which we expect to be a strong competitive advantage on top of other advantages like image quality.
Compared to reusables, you know, one of the KOLs put it well when he said to me, "aScope 5 is a great bronchoscope, and it just happens to be single-use." That just shows how much we've closed the performance gap versus reusables for the bronch suite. Now, on top of the 100% saying aScope 5 is acceptable, 100% also said they would use it immediately when it's available. We're very pleased with the pre-clinical feedback. We're moving forward with product launch based on a European clearance, and we expect the clearance in the U.S. and other markets to follow. Now in terms of pricing, aScope 5 Bronch is gonna be priced at a premium versus aScope 4. Of course, with the long-term growth trend of aScope 4, we plan to keep both products in the market.
If we move to the next slide and just to round things out for pulmonology. In pulmonology, we have a strong leadership position, and our strategy is to extend that leadership through innovation. Now, against our main competitors in single-use, we have aScope 4, which is by far the market leader in bronchoscopy. We have BronchoSampler with its award-winning design and VivaSight 2, both of which are unique offerings. Now, we have aScope 5, which we believe will set a new bar for single-use bronchoscope performance, and all of those are compatible with our aView and aBox 2 ecosystem. Then, of course, on top of that, we have a future pipeline, which is two main things. Number one is to round out our aScope 5 Broncho with additional sizes and with a BronchoSampler.
Then later this year, we're going to introduce our next- generation video laryngoscope, and that's gonna close our only real portfolio gap in pulmonology and offer what we expect will be actually a superior option versus our competitors. All that means that we'll be exiting the year in an even stronger position to sustain our market leadership in pulmonology. To wrap up, we're again proud and thankful to our 500-person strong innovation engine that's doubled our portfolio this last year. We're excited about the recent launch of aScope Gastro and the clearance of aScope 5, and those together with our upcoming pipeline, we believe we're well-positioned to extend our spot as the number- one player in this rapidly growing single-use endoscopy segment. With that, I'm gonna hand it over to Michael to share a financial update.
Thank you, Bassel. I'm excited for this opportunity to take you through the key highlights for our second quarter and our first half of 2021, 2022. Thereafter, hand over for the guidance for the year to Juan-José Gonzalez. If we go to the next slide, I think it's slide 20. The organic growth in the second quarter came in at 8%. Adjusted for last year's NHS safety stock orders, the organic growth was 12%, with both visualization and anesthesia PMD growing double digits. Reported growth also came in at 12%. Combined for all regions, we sold 444,000 endoscope units, equal to a quarterly volume growth of 17% and 25% adjusted for the NHS.
The gross margin ended at 57.7% with a 4.5 percentage point decline over last year. The decline is driven by sales mix and increased production costs, including write-down of raw materials. The sales mix has a negative effect on gross profit due to the strong growth in anesthesia PMD relative to visualization. We estimate this impact to equal a decline of the gross margin of approximately 1 full percentage point. The EBIT earnings for the second quarter ended at DKK 47 million, with a margin of 4.2% compared to 10.9% in Q2 last year.
In addition to the impact that we saw on the gross margin, the reduction of the EBIT margin is driven by higher distribution costs for sea and for air freight, as well as amortization of products that has been launched over the last 12 months. If we go to the next slide, which shows the geographical distribution of the quarter's organic growth rates. Visualization delivered organic growth of 3% and 10% adjusted for the NHS. Anesthesia and PMD grew double digits due to recovery of elective procedure activities over last year, which were very depressed levels. The order backlog carried for the first to the second quarter has been lowered. North America reported an organic growth of 11%. Growth in visualization came out at 15%, driven by strong performance in ENT and urology.
Anesthesia PMD grew combined 6%, reflecting the continued return of elective procedures and some market shares. Revenue in Europe reported organic growth of 7% and adjusted for NHS, the region grew 16% in Q2. For visualization in Europe, the organic growth for the quarter went negative at 6%, but + 8% adjusted for NHS. Anesthesia PMD showed a remarkable comeback with 28% organic growth. Rest of world posted negative organic growth at -1% due to continued COVID- related restrictions on the main markets in Asia Pacific. Visualizations show 0% growth due to temporary market disruption, but with a strong underlying performance on the key markets. Anesthesia PMD showed negative growth of -3% as the region continues to suffer from COVID disruptions.
If we go to the next slide, where we have comments for the financial highlights for the quarter. Production costs increased 26% over last year's as we scale up, in fact, the factory in Mexico, paired with impact from raw- material inflation and labor shortages. Relative to revenue, these factors had a negative effect in the quarter of approximately 1.5 percentage point on gross margin. In addition, there's an impact from the DKK 19 million on a write-down of raw materials equal to a 2 percentage points impact. The write-down is related to a range of components that is becoming obsolete and according to policies, should be removed from the balance sheet. We continue to see that our global distribution costs are increasing relative to revenue.
For the first six months, we have seen an increase of DKK 80 million or 3.7 percentage points relative to revenue. The increase is caused by high freight rates as well as an increased need for use of air freight. Also the cost of warehousing is increasing, driven by the higher costs of energy. Finally, the milestone payment of EUR 20 million for the gastro scope that was conditional upon achieving the FDA clearance has been reversed. When we acquired Invendo Medical in 2017, the milestone payment was agreed upon FDA clearance no later than end of December 2021. Since the FDA clearance was obtained in February 2022, the milestone payment has lapsed and the provision of DKK 141 million has been reversed, which you can see in our net financials.
If we go to the next slide, where I'd like to say that we're happy to share that the construction of our new factory in Mexico has been completed, and we are now in the midst of setting up production lines. The plant will be more than double the size of our current site in Malaysia, and we are on plan to support the U.S. with selected single-use endoscopes out of Mexico starting in the fourth quarter. The capacity will gradually be expanded to include production of anesthesia and PMD products as well. The factory will give us a dual sourcing, which is an important risk mitigation. It will provide proximity to our largest market in the U.S., and it will enable more simple and less costly distribution into the U.S. compared to Malaysia.
With that, I'll hand the work back to you, Juan-José.
Thank you very much, Michael. I have to say it's an incredible achievement for the Ambu organization to be able to build this plant in record time in the midst of a COVID-19 pandemic. This is going to be a very important asset for us, not just to reduce our supply chain costs, but also to make sure that we have a dual sourcing strategy and be able to supply the world in case of any major events. Now, let's go to the next slide and let's talk about our revised financial outlook. There are three main highlights. Highlight number one, our fiscal year finished at the end of September. We had an expectation, not just in terms of elective markets recovering, but also seeing some of the benefits from the pent-up demand.
Based off our assessment today of the situation and driven by the hospital staffing shortages, we believe that the benefits in terms of pent-up demand will be more limited, and that we will see it in our following fiscal year. As 70% of our revenue come from elective procedures, we are adjusting our outlook for our organic revenue growth from 15%+ to 13%+. The macroeconomic headwinds on the back of the Russia-Ukraine conflict is also having sharp impact in terms of inflation, cost, and congestion of the global supply chain. That is further increasing our cost of production and distribution. If we look at the energy costs over the last two months, it has increased significantly, and we want to reflect that in our EBIT margin projection.
Now, we have a lot of measures that we are taking to be able to address the impact of inflation and supply chain costs. The Mexico plant is probably the most important one in terms of supply chain costs. By the end of next year, we expect the entire U.S. demand for Broncho, ENT, and Cysto to be supplied by our Mexico plant, which basically will reduce the need for sea freight and air freight from Asia. That's going to be a very important efficiency driver. Of course, it will reduce the inventory in transit and our working capital and so forth. We are also looking at our pricing and start taking price increases in selected products to address some of this inflation.
We're also looking at the pricing of our new products to ensure that we introduce products at a premium pricing to also be able to to address this, and we have a whole procurement program to reduce our raw materials. Having said all of that, over the next five months, we are going to have the impact of this deteriorated macroeconomic environment. Now, this revised guidance in terms of growth means that we expect to grow over 20% in the second half of the year. It's going to be driven by three things. Number one, the combined double-digit growth for anesthesia and PMD. Number two, the continued rapid adoption of ENT and cystoscope, aiming for a combined unit sale of 100,000. Number three, the benefit from recent product launches, especially in Q4.
This is important to know, the growth of ENT and cysto and the benefit coming from the KARL STORZ recall is going to be mainly in Q4, and the benefit from recent product launches is also going to be mainly in Q4. As a result, our Q4 revenues will be larger than Q3. This is in terms of our financial guidance. Let's go to the next slide because we also have two very important messages to give. Number one, I would like to thank Michael Højgaard for everything he has done over the last 10 years. To be the CFO of a high- growth company, creating a new market in a very volatile environment, is very difficult.
If I look at a track record during his tenure, when he joined, Ambu was a small company with DKK 1 billion revenues, one billion DKK in revenues. Today is over DKK 4 billion. When he arrived, Ambu was mainly a European company. Today, it's a truly global company. When he arrived, it was a company thinking about creating a new visualization business. Today, our visualization business is the largest business for Ambu, the number- one growth engine, and with a competitive advantage that will ensure the long-term success of the company. Michael has been an effective CFO, thoughtful partner. His work building not just a finance organization, but IT and legal, has been remarkable, and we are very grateful, and we wish him all the best in the future. Of course, we are also welcoming our new CFO, Thomas Schmidt.
Thomas will be our Chief Financial Officer as of June 1st, 2022. We are excited with his arrival. He has deep global finance and healthcare experience with the Roche Group. He was a CFO of their largest business outside of the U.S. in Germany. He was a global finance leader for Roche Professional Diagnostics, which is one of the largest med tech businesses globally. He was also a finance vice president for Roche Western Europe. He's a Danish national. He holds a Master of Business Economics and Auditing from Copenhagen Business School, and he will relocate back to Denmark after having lived abroad for over 20 years across Europe and Asia Pacific.
Thomas will have the journey of scaling up Ambu at an accelerated growth of globalizing it even further, of advancing our innovation, not just in terms of hardware, but also in terms of software. We are excited to be able to attract this quality of talent, and I'm sure he's going to be very successful as the new CFO. We finish our Q2 with very strong momentum. There are very few companies that can grow over 20%, and that is what Ambu is going to do. We do it facing significant volatility that we were not expecting, but volatility that we are prepared to be able to address effectively.
All these changes, this revised outlook doesn't change our view regarding the potential of single-use, and more importantly, our view regarding the potential of Ambu. Ambu will become one of the largest European med tech companies. With that, let's finish the presentation section and let's open for Q&A.
Thank you. If you have a question for the speakers, please press zero one on your telephone keypad and you'll enter the queue. After you're announced, please ask your question. Please limit your questions to two at a time. Our first question comes from Benjamin Silverstone from ABG. Please go ahead. Your line is open.
Thank you very much. Hi, Juan-José Gonzalez. I hope you are well. I just have a quick question in terms of the gross margin related to the Mexico plant impact. We do know that the overheads of ramping up the factory did have a negative drag this quarter. Could you just give us an indication of whether or not this is only due to us seeing the Mexico plant being put in place now, or if this sort of negative drag will continue after the summer when production is also starting up? The second question is in terms of the guidance for this year. Juan, you do mention the specific factors that you see as driving this quite back-end loaded year.
Could you just give us an indication of which things you're already seeing now in the beginning of Q3? You do mention in the report that you are seeing a more normalized access to hospitals, but any sort of indication of the current signs you're already seeing would be much appreciated. Thank you.
Thank you.
Hey, Benjamin, this is Michael. Maybe if I take the first question. What you see, the impact you see from Mexico, is very straightforward. It's simply a result of, you could say, idle capacity as you're building the platform. We started taking over the buildings. We're starting and installing equipment and so forth, and that is triggering some depreciations. Then we have staff doing, you know, all the qualifications, the testing and the measuring that needs to be set up. Soon in the next quarter, in the fourth quarter when we see output will be coming up, we will see that there will be a return on these investments here that we have from the factory. It's very straightforward.
Thank you. Benjamin, in terms of your question with the guidance, I mean, we are being prudent and reflecting everything that we are seeing as of today. In terms of the market in China, I think everybody is familiar with the lockdowns and I think this is something that we expect to continue all the way to the end of our fiscal year. Omicron is highly contagious, so we expect it to go from province to province and the country to go into opening and closing, opening and closing. Outside of China, for the most part, we see access back to normal. Again, we see elective procedures recovering. What we believe is that from now to the end of September, we will not see benefits in terms of pent-up demand.
This is just because of the labor shortages and the inability of hospitals to be able to absorb that level of volume. We see a more stable environment in terms of, in terms of elective markets and access. Again, our growth is driven by core growing double digits, ENT and Cysto continue its accelerated growth, and of course the introduction of our new products in GI and then our aScope 5.
Thank you very much.
Thank you, Benjamin.
Thank you. The next question comes from Thomas Bowers from Danske Bank. Please go ahead. Your line is open.
Yes. Thank you very much. A couple of questions from my side here. Just maybe sticking a little bit to the full year guidance. Just trying to sort of understand the moving parts here. It looks like you have a 3 percentage point lower impact from Broncho, especially assuming that the rebound on Cysto and ENT is, I don't know, around two percentage points to the upside. Anything driving Broncho expectations down in the second half or is this primarily reflected in a weaker Q2 than you expected?
I'm just trying to figure out whether you are maybe a little bit more conservative on Broncho going into the second half here. Then just on your EBIT guidance, your updated EBIT guidance. Assuming, well, the, let's say 5% for the full year, assuming that that would be around 6% for the second half. How should we see the development quarter-over-quarter? Maybe if you could comment a little bit on sort of the exit rate on the margin going into the next fiscal year, that would be very helpful. Then just lastly on NHS.
Starting the year, correct me if I'm wrong here, but you highlighted in at least your slides presentation with the Q4 that there was a 3.5 percentage point negative impact to your initial guidance. That's 15%-19%. That would be mainly hitting the Q1, and then maybe also impacting, that would be a modest impact in Q2. I'm just trying to figure out what is actually the full year impact. Is it still 3.5 percentage points or because to my calculations, you must be a little bit higher now with the impact you have in Q2. Maybe just clean up my memory here.
Just a very brief comment just on your pricing power. Have you actually been able to raise prices already in some of your products or is this something that will materialize in the relative near term? Anything that's included in your current fiscal year guidance or is this something for next fiscal year? Thank you.
Sure. Thank you so much. Let me take the first question and then Michael will take the next two. First of all, in terms of our broncho business, what we have seen over Q2 is a normalization of the market back to pre-COVID levels but at a higher penetration. That's why we wanted to share that graph so you can get a better feel for the evolution of our broncho business. I mean, right now our assumption is of course that we are not relying on any upside in terms of COVID waves going forward. One third of our bronchoscopy business is actually driven by elective procedures.
As we are more measured in terms of selective procedures, we are also more conservative in terms of what will be the development of our broncho business in the second half. In terms of pricing, we have started to take pricing already this year, especially in our core products. We are moving to continue to take price increases as our contracts expire with the hospitals and so forth. It's going to be a process that we will take over the next couple of years. One of the advantages that we have is that we have such a high cadence of innovation that we can also adjust the pricing of our new products to be able to drive an overall increase in terms of our average selling price.
Michael, do you wanna address the other?
Yeah, Thomas, but maybe could you just maybe reshape your question just as Juan-José answered it, just so I make sure what-
Yeah.
You're exactly asking about.
Yeah. Sure. If we just kick off with the EBIT guidance. With the updated 5%+.
Yes.
Assuming 6% for the second half, I'm just curious on how we should see development quarter-over-quarter. Maybe also if you could put a bit of color on the exit rate going into the next fiscal year.
Yeah. I think you got a very important piece of information for Juan-José Gonzalez, namely that our Q4 is going to be higher than our Q3. When you model out, you need to consider that. You also know that our financial scale, our level of EBIT is super dependent on our top line. We're investing for growth, and you will see the growth is coming quite strong in the second half with the 20% number that Juan-José Gonzalez also gave you. When you model that out, Thomas, you need to be sure that you take that into due consideration. I cannot give you the numbers, of course, but it all depends on the top line.
With the top line in the fourth quarter above the third quarter, you almost have the answer there.
Will it be sort of a very much hockey stick going into Q4, or would you also see improvement in Q3? Because I'm actually most curious about seeing what to expect for next year, basically.
No, definitely we will see improvements as we move into Q3. The point is that when you make your model, you need to make the allocation between the quarters in the second half.
Okay. Thanks.
Thank you.
On the NHS, just to understand fully on how you initially guided, you guided initially for 3.5 percentage points for the full year.
Yeah.
That was primarily Q1, and then you have a quite significant impact in Q2, which is at least for me a bit surprising.
Yeah. I think what we saw last year was that the NHS in general was very significant, and in isolation what we had in the second quarter was also significant. What we had in the first quarter was much, much more. I think that was what we talked about at that time. You're right, there's also an impact here in the second quarter.
The full year impact is still around 3.5 percentage points. Is that what you're saying or?
It's probably a little bit higher, Thomas. I don't have the exact number.
Okay. Maybe I can just ask where NHS is right now? I understand that there will not be any impact in Q3 and Q4. That of course should benefit your growth somewhat. Is it your impression that the inventory levels have normalized by now? Should we expect any new orders starting to come in, or is this not going to be until next year?
Yeah. Maybe I can take on that. After the safety orders in Q1 and Q2 last year, there have been no more NHS England orders in Q3 and Q4 last year. We don't expect to have anything this year. Actually, our growth is mainly going to be driven by the fact that we don't have the safety stock, high comparables basically in Q3 and Q4. We don't rely on NHS England to start ordering to achieve our targets.
Okay. Got it. Great. Thank you. Thank you very much.
Thank you very much, Thomas. Okay, one last question, and I just noticed we are at the end of our call.
Sure, sir. Next question is from Yiwei Zhou from SEB. Please go ahead. Your line is open.
Good morning. Thank you for taking my question. Actually, I have a couple question. I will try to limit. One question at a time. Firstly, on the gross margin, you mentioned there was 2 percentage point impact from the raw material write-down. Could you elaborate a bit on this item?
Yes, I can. It's of course a significant amount which we don't like, but when you look into it's a very operational issue. It's products from a range of suppliers that for one reason or another have proven to be in excess and where according to our policies, we simply just have to write it down. It's not a single explanation that you can iron out, but something that has been going on in our operation. It's probably the most I can say about it. It's really not very sexy, but extremely unfortunate.
Could you say which product is it relating to?
No, I'd rather not comment on that, but it's from a range of suppliers, so that's not one common denominator to it.
I also realized there was the DKK 7 million impairment due to the production line no longer in use you booked in this quarter.
Yeah.
Is it fair to assume it's relating to the raw material?
Um...
Is there any sort of correlation between these two?
No. Not necessarily. It related how we are updating our structures.
Okay. Okay. My second question here is also on the guidance. Just trying to understand the dynamics underlying the guidance change. Now you expect higher unit sales of ENT and Cysto. And so what is sort of lower your expectation, which product? Bronchoscope or is it, gastro or Duodeno? Or maybe you can also comment a little bit about the volume and the price.
Sure. No, thank you for the question. If you remember last quarter, we said that our target for ENT and Cysto combined was above 700,000 scopes. What we are doing today is we are confirming that that above is actually 800,000. But the adjustment we are making, it really reflects on our view today of the assumptions behind the pent-up demand this fiscal year. We are basically taking a more conservative view in terms of how that will be. That goes across most of our businesses. 70% of Ambu business is driven by elective procedures. That's why it's not that you have a kind of variance assumption for the product.
This is just reflecting our sense that we are going to execute our agenda, and that we should not rely on a, you know, much faster bounce back of the elective market than what we thought previously.
Is it fair to understand you have low expectation for bronchoscope, gastroscope, and also duodenoscope for this year?
I mean, all of these are elective procedures, ENT, Cysto, anesthesia, PMD. We are actually more prudent in terms of what we think the market is going to grow from now to the end of September.
Okay. Fair enough. Lastly, a follow-up question on the NHS order. For Q3 and Q4, you mentioned you don't expect any safety order, but how should we understand it? Do you still assume sort of sales to NHS of bronchoscope? Is this zero revenue from this channel?
Yeah. No, I mean, we basically last year in Q1 and Q2, NHS England ordered products, and in addition, ordered safety stock that they wanted to use to prepare for any emergency. Since last year, so starting in Q3, they stopped ordering, and they are using that safety stock. Basically we haven't had NHS England orders from last year Q3, Q4, this year Q1, Q2, and we are assuming not to have any NHS England orders Q3 and Q4. If I compare the second half of this year with the second half of last year, we are assuming no NHS England orders, which we also did not have last year. That's why there is no, you know. It's basically a neutral effect, basically, for the second half.
Okay. Clear. If I'm allowed, one last housekeeping question on the ASP level for aScope 5, could you maybe give us a range? You said, or you only said it's gonna be premium to the aScope 4.
Yes. Listen, we don't want to give our pricing ahead of starting the commercialization. Today you can assume that it is premium, and I think in our next quarter we'll be able to give you a view in terms of our ASP. You just need to wait a few more weeks to get that. No? Our pricing is hardly around parity to reusable to enable the transition. This is still the main principle behind our pricing.
Okay.
Thank you very much. Listen, first of all, thank you again for joining the call in such a short notice. If you look at the core drivers behind Ambu, if you look at the growth of our core business, if you look actually at the long-term growth of our bronchoscopy business, if you look at the accelerated penetration of ENT and Cysto, the pipeline that we have, we have doubled it in one year. The size of the market that we are entering, Ambu is in a very strong position, not just to deliver over 20% growth in the second half of the year, but to continue to grow at an accelerated rate in the future. We are doing it in the midst of significant volatility.
I think there are some reflections in terms of being prudent with our guidance that we are reflecting today and that we are going to reflect for the next few years. We are on our way to become one of the largest European-based med tech companies, and we are all very confident in terms of our ability to fulfill our vision. Thank you very much, and enjoy the rest of the day.
Thank you. This does conclude today's conference call. Thank you all for attending. You may now disconnect your line.