Royal Philips NV (PHG) Q2 2021 Earnings Call Transcript

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Royal Philips NV (PHG 3.15%)
Q2 2021 Earnings Call
Jul 26, 2021, 4:00 a.m. ET

Contents:

• Prepared Remarks
• Questions and Answers
• Call Participants

Prepared Remarks:

Operator

Welcome to the Royal Philips' Second Quarter and Semi-Annual 2021 Results Conference Call on Monday, July 26th, 2021. During the call, hosted by Mr. Frans van Houten, CEO; and Mr. Abhijit Bhattacharya, CFO, all participants will be in a listen-only mode. After the introduction, there will be an opportunity to ask questions. [Operator Instructions]. Please note that this call will be recorded and a replay will be available on the Investor Relations website of Royal Philips.

I will now hand the conference over to Mr. Leandro Mazzoni, Head of Investor Relations. Please go ahead, sir.

Leandro Mazzoni -- Head of Investor Relations

Good morning, and welcome to Philips Second Quarter 2021 Results Conference Call. Joining me today are our CEO, Frans van Houten; and our CFO, Abhijit Bhattacharya. Frans and Abhijit will take you through our strategic and financial highlights for the period and after that we will take your questions.

Our press release and the related information slide deck were published at 07:00 AM CET this morning. Both are available on our Investor Relations website. A full transcript of this call will also be made available today on the website. As mentioned in the press release, adjusted EBITDA is defined as income from operations, excluding amortization of acquired intangible assets, impairment of goodwill and other intangible assets, restructuring charges, acquisition-related costs and significant one-off items. Comparable growth for sales and orders are adjusted for currency and portfolio changes.

As of Q1 2021, the Domestic Appliances business is reported as discontinued operations. Sales and results from this business are no longer included in the results of continuing operations and relevant assets and liabilities are reported under assets and liabilities held for sale. All forward-looking projections exclude the Domestic Appliances business.

Over to you, Frans.

Frans van Houten -- Chief Executive Officer, Chairman of the Board of Management and the Executive Committee

Yeah, thanks. Hey, hello everyone and thank you for joining us today. I hope that you and your families are keeping safe and well. Let me upfront mention the upcoming field actions related to the component quality issue in our sleep apnea therapy devices that we announced back in June. Alright, I value to talk about that first, as you understand, because of the impact that it is having on patients as well as their well-being, which is at the heart of everything we do at Philips. I want you to know that we have mobilized the necessary resources across the Company to address this issue effectively, and I will come back later in this call with more details.

Zooming out, the COVID-19 pandemic is clearly not over, and our teams are very focused on delivering against what we call the triple-duty of care of meeting customer needs, safeguarding the health and safety of employees, ensuring business continuity. Despite the impact of COVID, we delivered actually strong performance momentum in all our businesses except for the sleep and respiratory care business. This resulted in 9% comparable sales growth and adjusted EBITA margin increased of almost 300 basis points and a free cash flow of EUR167 million for the Group in the second quarter.

We are very encouraged by the close to 30% comparable order intake growth for the Diagnosis and Treatment business with all major markets contributing, driven by the improvement of hospital capex and elective procedures and the very positive customer response to our innovation, innovative products and solutions. Order intake for the Connected Care businesses decreased, of course, following the exceptional growth of last year, as well as the headwinds in the Sleep & Respiratory Care business. Personal Health delivered strong 33% revenue growth in the quarter.

Now, I would like to provide some color on some of our initiatives to respond to the needs of today's hospital leaders across the globe as they plan for the future. Highlighting our strength in smart diagnostic systems, in the second quarter, we introduced a Spectral CT 7500. Let me spend a minute on this innovation as it is quite impactful.

With the launch of the IQon in 2016, we established a category of detector-based Spectral computed tomography. The Spectral CT 7500 is an important expansion to our portfolio and it delivers high-quality spectral images for the broadest patient base of any company, including cardiac, pediatric and bariatric patients. It's the only system that makes spectral data available on 100% of the scans allowing clinicians to adapt their protocols for different patients, thus eliminating the need of special workflows or multiple rescans. It is also the only system that provides spectral imaging for interventional procedures. The Spectral CT 7500 was extremely well received by customers and further expands our comprehensive CT portfolio, which is continuing its double-digit growth trajectory from last year.

We also launched IntraSight Mobile, a fully mobile interventional suite system to assist with coronary and peripheral artery disease procedures. IntraSight Mobile offers users in hospitals and office-based labs, the integration, flexibility and affordability for intravascular imaging, physiologist measurements and co-registration for seamless workflows and enhanced patient care.

Our Image-Guided Therapy devices portfolio continues to gain significant traction as we announced a series of important achievements in this business in the quarter. For example, the first structural heart repair procedure using our 3D intracardiac echocardiography catheter VeriSight Pro was performed at the Mayo Clinic. We also announced progress on several clinical studies, including the positive two-year clinical study results for the Tack Endovascular System for dissection repair, the first patient enrollment in the DEFINE GPS multicenter study to drive the adoption of iFR for percutaneous coronary interventions based on clinical evidence and the start of the WE-TRUST multicenter stroke study to shorten treatment times by identifying planning and treating ischemic stroke patients in the interventional suite.

Importantly, we continue to grow market share in our core businesses through deeper, more comprehensive customer partnerships. During the second quarter, we signed several new long-term strategic partnerships in countries ranging from North America, Europe, Latin America, and the Middle East. This builds from the strengths of our portfolio and demonstrates the trust that hospital leaders have in our ability to enhance health outcomes, lower the cost of care and improve patient and staff experience.

In Personal Health, we introduced Sonicare 9900 Prestige globally, which leverages AI to optimize user's brushing technique, ensuring full coverage of their mouth and instill brushing habits that improve oral health. We also expanded our leading male grooming portfolio with the introduction of the Shaver Series 9000 with SkinIQ technology in China, that leverages AI and sensors to offer a personalized shave, tailored to each unique skin and hair type and it will be launched in North America and in Europe in the second half of this year.

The integrations of the recently acquired BioTelemetry and Capsule businesses are progressing very well. The actions from customers to the expanded portfolio of end-to-end patient care management solutions from the hospital, all the way to the home have been very positive. We already see strong joint customer wins and funnel, including several major integrated delivery networks adopting these in the United States. We are also in the process of aligning assets, capabilities, and product roadmaps, which is a step toward joint R&D activity and platform development.

On a different angle, in line with our plans, on July 1, the Domestic Appliances business became a stand-alone entity and we are on track to complete the sale of this business to Hillhouse Capital in the third quarter, of course, subject to customary conditions. Also important, today we announced a new share buyback program for capital reduction purposes for an amount of up to EUR1.5 billion, and Abhijit will later on cover that in more detail.

Let me now speak about the planned field actions in Sleep and Respiratory Care. This is of course a major correction, and we take it very seriously. As mentioned, we have mobilized the necessary resources across the Company to address the issue. This is done due to possible risk of degradation of the sound abatement foam embedded in the devices. At the same time, we realize that the field action itself has temporarily also a significant impact to patients.

We are fully prepared to start with comprehensive repair and replacement actions for the affected units. We are still in discussions with the relevant regulatory authorities to obtain authorization to start deploying the repair kits and replacement devices that we are producing. For example, we have submitted the relevant applications to the FDA in June. We've already increased the overall production of DreamStation 1 and DreamStation 2 devices as well as repair kits from 30,000 units per week to 55,000 units per week as of the start of the third quarter. And we expect to reach 80,000 units per week in the fourth quarter, which underpins our expectation to address all devices in scope within 12 months of regulatory approval.

As a consequence of the prioritization of the repair and replace actions. We are currently not taking new orders for sleep therapy systems, while masks and other consumables, of course, continue to be sold. As a reference, before COVID-19, the annual revenue in our sleep business was close to EUR1.1 billion with approximately 60% from systems and 40% from masks and consumables.

In the longer term, we do not expect this issue to have a substantial impact on the fundamentals of our Sleep and Respiratory Care business, nor on the gross dynamics of this market. We have a market-leading innovative product portfolio in these businesses and continue to work closely and transparently with physicians, customers and patients to ensure that we address this issue as quickly as possible.

Following our voluntary field safety notice for which we have assumed a worst-case scenario, we are still conducting research and further tests to get insights, so that we are better able to scope possible patient risk. To be clear, we do not have data at this point such as preclinical or clinical study results, indicating that exposure to the particulates or emitted chemicals related to the sound abatement foam will lead to disease, while at this point we cannot exclude it either.

The various regulators around the world have made their own interpretation of the field safety notice in the data, also weighing the patient risks and benefits. As a result, we are seeing some variance in what regulators are advising patients in this matter. I would like to point you to the table in the investor presentation. As I know this is on your mind, I can say that some civil complaints and personal injury claims have been filed in courts against Philips. It is however far too early to draw any conclusion to talk about the merits of the claims or speculate about Philips' exposure.

In due course, we will be able to assess the merits of any claim and we intend to defend our position vigorously supported by the further test data that we are gathering. Obviously, the timelines that may apply to the handling of claims is not yet clear. I also want to talk about the broader context of quality across Philips. In the last few years, we have made strong progress in our quality culture and approach, improved design controls, improved post-market surveillance and improvements in the way that we handle corrective and preventative actions.

The effective products were designed and have been in full compliance with appropriate standards at the time of release and commercialization and the component issue was identified through our own post-market surveillance processes. Overall, the robustness of our processes has increased a lot. That doesn't mean, of course, that we are done, this journey remains a top priority for all of us at Philips. I want again to reiterate that patient well-being is at the heart of everything we do.

To round off, looking ahead, while we continue to see uncertainty related to the impact of COVID across the world and the impact of electronic component shortages, our overall financial guidance remains within the earlier guided range. I'm pleased with the progress that we're making on the strategic roadmap, as well as the strong performance momentum in all our businesses except for Sleep and Respiratory Care.

We are working hard on the field action and our journey to HealthTech leadership continues. We are executing on a clear strategy to help transform healthcare along the health continuum, combining smart systems devices, informatics, data and services. And I'm convinced, and I want to repeat that, that the growth and the margin profile of our Company remains very well underpinned.

And with that, I will turn the call to Abhijit.

Abhijit Bhattacharya -- Executive Vice President, Chief Financial Officer

Thank you, Frans, and thank you all for joining us today. Let me provide some color on the second quarter comparable sales growth of 9%, which was even 17% if you exclude the Sleep and Respiratory Care business. And let me remind you that our comparable sales growth does not include double-digit growth of BioTelemetry and Capsule, which we take into the comparable growth only after one year after acquisition.

The Diagnosis and Treatment businesses comparable sales growth was 16% in the quarter with double-digit growth across diagnostic imaging, ultrasound, Image-Guided Therapy and Enterprise Diagnostic Imaging Informatics. We were particularly pleased to see the very strong growth in our Image-Guided Therapy business, driven by traction in both systems and the devices businesses.

The volume of elective procedures continue to track above pre-COVID levels during the second quarter, and we expect this to continue as hospitals normalize their operations and also work through the backlog of patients. The sales for the Connected Care businesses declined 16% in Q2, driven by a substantial decline in the Sleep and Respiratory Care business on the back of a very strong Q2 last year, as well as the headwind related to the field action. Patient monitoring comparable sales grew mid-single digits as we continue to successfully convert the strong order book in this business and perform well above even the 2019 levels.

Personal Health delivered a comparable sales growth of 33%, driven by consumer demand for our new product innovations with good growth momentum across all geographies. All Personal Health businesses grew strong double-digit. It is important to note that two phasing factors also had a positive impact on the growth rate of Personal Health in the quarter. The first being the impact of the shift of Amazon Prime Day from Q3 last year, back to Q2 in 2021.

The second was the impact of the legal and fiscal disentanglement of Domestic Appliances as of July 1. This meant that our IT systems related to Personal Health had to be shut down in the first week of July, leading to some pre-deliveries in June, so as not to affect supplies during the cut over period. We estimate that these factors had a positive impact of 5 percentage points on the growth of Personal Health in the quarter.

Consumer sales through digital channels represents 45% of the total sales for Personal Health in Q2, and our shift to direct-to-consumer continues to gain momentum. With the strong performance in the second quarter, we closed the first half of the year with a 9% comparable sales growth and an adjusted EBITA margin increase of 330 basis points compared to last year. Excluding the Sleep and Respiratory Care business, comparable sales growth was 14% in the first half of the year.

Moving on to orders, I'm pleased to share that the Diagnosis and Treatment comparable order intake grew close to 30% in Q2, driven by strong double-digit growth in magnetic resonance, computed tomography, ultrasound and Image-Guided Therapy. This is due to positive market conditions, as well as the strong competitive momentum of our portfolio. As a result, we saw further increase of an already strong order book in these businesses in the quarter.

Comparable order intake in Connected Care declined over 50% on the back of around 170% growth in Q2, driven by the spike in COVID-19 generated demand. While we continue to expect demand for ventilators and patient monitors to normalize in the course of 2021, activity levels are expected to remain higher than in 2019 in these businesses. I'm pleased that we continue to experience very positive competitive momentum of our monitoring solutions in the ICU and in other care settings.

Let me now turn to the profitability development in the second quarter. Adjusted EBITA for the Group increased 280 basis points to EUR532 million, which is 12.6% of sales. In Diagnosis and Treatment, the adjusted EBITA increased 450 basis points to 13.2% of sales, mainly driven by sales growth and productivity. Connected Care delivered an adjusted EBITA margin of 11.3% of sales, mainly due to the impact from lower sales in the Sleep and Respiratory Care business, partly offset by results of our productivity programs.

In Personal Health, the adjusted EBITA was 17%, up from 5.6% last year, driven by sales growth, while we continue to execute on the planned higher investments in advertising in Personal Health. We continue to focus on driving productivity and are executing initiatives that will deliver on the cumulative net savings of EUR2 billion by 2025. These initiatives delivered EUR90 million savings in the second quarter, more specifically, EUR44 million through procurement programs, EUR30 million supply chain productivity and EUR16 million overhead cost reduction.

Restructuring, acquisition-related and other charges were EUR264 million, higher than guidance, mainly due to the EUR250 million provision increase related to the field action that we announced last month. Financial income and expenses were an expense of EUR7 million and included the positive impact from the increase in value of our minority participations.

The adjusted diluted EPS from continuing operations increased to EUR0.40 in Q2 compared to EUR0.27 last year. In the first half of the year, adjusted diluted EPS from continuing operations grew almost 70% to EUR0.69. Free cash was an inflow of EUR167 million in the quarter. In the first half of the year, free cash was an inflow of EUR336 million compared to an inflow of EUR197 million last year.

Let me provide some guidance for certain areas of our business. In the segment Others, we expect an adjusted EBITA loss of around EUR110 million for the full year 2021. This is EUR10 million better than our prior guidance due to lower costs year-to-date. The EBITA loss in this segment is expected to be around EUR290 million this year or EUR50 million worse than our prior guidance, mainly due to a loss related to the divestment recognized in the second quarter.

For Q3, we expect a net loss of around EUR45 million at the adjusted EBITA level and around EUR110 million at the EBITA level for segment Other. In line with our previous guidance, restructuring charges are expected to be 70 basis points to 80 basis points, and acquisition-related costs are expected to be around 70 basis points in 2021. We continue to expect one-time EU MDR and consent decree-related costs around EUR40 million in the year.

Financial income and expenses are expected to be a net cost of around EUR115 million in 2021. This is lower than our previous guidance of EUR140 million, largely due to the increase in value of our minority participation and assumes no one-off gains or losses in the rest of the year.

We currently expect effective tax rate to be in the mid-single digit in 2021. This is significantly lower than our previous guidance due to one-off tax benefits relating to business transfers which result in the recognition of some tax assets. Our mid-term guidance of 24% to 26% effective tax rate, excluding incidentals remain valid.

Today, we announced a new share buyback program for capital reduction purposes for an amount of up to EUR1.5 billion in line with our balanced capital allocation policy. At the current share price, the program represents a total of approximately 37 million shares or 4% of the total shares outstanding. We expect to start the program in the third quarter and to complete it within three years through forward purchase transactions and/or open market purchases. This new program reflects our confidence in the execution of our strategy and financial trajectory.

Moreover, under the ongoing EUR1.5 billion share buyback program for capital reduction purposes which was initiated in the first quarter of 2019, we repurchased shares in the open market and entered into a number of forward transactions. 2.5 million shares were delivered in June 2021 with an additional 18 million shares expected to be delivered via outstanding forward contracts through the remainder of the year.

These 20.5 million shares will be canceled by December 31st, resulting in a reduction of 2% of the outstanding shares and an estimated reduction of the total number of issued shares to 897 million compared to 917 million shares at the end of Q2. More details are available on our Investor Relations website.

To conclude, let me reiterate what we stated at the start of the year. Given the comparison base of 2020, we expected overall performance to be stronger in the first half of 2021, and this has been confirmed by our performance in Q1 and Q2. As Frans said, there is no change to our earlier guided range. Our adjusted EBITA margin outlook is a year-on-year step-up of 60 basis points with low to mid-single comparable sales growth. This will be driven by the momentum of a strong performance in all our businesses, offsetting to a significant decline in Sleep and Respiratory Care.

Overall, we expect double-digit growth in Diagnosis and Treatment, and Personal Health this year, while Connected Care sales are expected to decline in the high-teens range. Let me remind you that Connected Care faces a high comparison base from the spike in COVID-19 generated demand that resulted in 22% sales growth for the full year and 32% in the second half of last year. In addition, we have the negative impact on the Sleep and Respiratory Care business.

We expect performance in the second half of 2021 to be back-end loaded, given the comparison base of 2020 in Connected Care, the phasing impacts and the phasing impacts that I mentioned for Personal Health, and the estimated timing of installations of our very strong order book.

With that, I'm happy to take your questions along with Frans. Thank you.

Questions and Answers:

Operator

Thank you, sir. [Operator Instructions]. The first question comes from Veronika Dubajova from Goldman Sachs. Please state your question.

Veronika Dubajova -- Goldman Sachs -- Analyst

Hi, guys. Good morning, and I hope you're doing well. Two questions from me, please. The first one just is just an update Frans, and when do you think you will get the Emergency Use Authorization in U.S. to commence the repairs?

And I guess, maybe if you can comment on some of the other major markets, and what the time frame is looking like at this stage for you to commence the works, that would be really helpful. And if you've had any feedback so far from the regulatory agencies on the repair process and their thoughts on that. Apologies, I know it's pretty broad, but it's a big theme of focus.

And my second question is on the guidance just, Abhijit, wondering if you can narrow it down for us the low to mid-single digit is a pretty wide range. So just would love to understand, kind of where in that -- in that range you feel most comfortable? And maybe the kind of tweak to that margin guidance, you are no longer up to the 80 basis points. What has changed for you? Is it transport costs? Is it shortages? Is it raw materials or something else that's kind of leading you now toward the lower end of that 60 basis point to 80 basis point range?

Thanks, guys.

Frans van Houten -- Chief Executive Officer, Chairman of the Board of Management and the Executive Committee

Yeah, hi, Veronika. Good morning to you, and let me try to tell you as much as possible on all the ins and outs of the field action. And first of all, we have engaged with all the regulators around the world on the field safety notice, and it's interesting today observe differences in the risk-benefit interpretation that regulators didn't take, right. And that's why we have included the page that some regulators for inspection of -- guide for continued use while waiting for the repair and others point to the doctor.

Then on the repair procedures, let me point out that, there is multiple devices within the platform family of DreamStation 1. We have submitted multiple packages to the FDA for regulatory approval. That's so called 806 Form for the emergency field action. The FDA has engaged on these submissions, and we have already had several rounds of queries on those procedures which asks for more data and so on.

I cannot exactly predict when we get approval. I can only say that FDA is on top of it, and working very diligently. Let's say experience would show that kind of an eight-week approximate throughput time on an 806 could be expected. But that's out of prior experience, not necessarily related to this case.

In anticipation, we have already produced repair kits and we've also even placed stocks in bonded warehouses in a few countries in the world, so that we can move quickly out of the gate, alright? And, so we are all ready to go, alright? And I would expect that imminently, we should be able to give updates on that.

Does that answer your question on the upgrade process, Veronika, maybe let you react immediately on that?

Veronika Dubajova -- Goldman Sachs -- Analyst

No, that's really helpful. Thanks, Frans.

Frans van Houten -- Chief Executive Officer, Chairman of the Board of Management and the Executive Committee

Okay, good. Then Abhijit, the guidance with how many digits behind the comma.

Abhijit Bhattacharya -- Executive Vice President, Chief Financial Officer

Yeah, Veronika, I would love to do that. We have six months to go. There are -- as we've said, a lot of uncertainties, be it COVID, e-component shortage, etc. We have a strong order book and good demand. So I think, yes, if you take low to mid-single digit, it can be from zero to six. So I understand the range is wide, but somewhere in between is I think the fair indication of where we are likely to end.

The margin guidance is not really a change. So, I've seen different people reacting differently. Look, we've just seen where we are in the process. We are half a year down and we think the 60 basis point step up year-on-year with the issues that we have in Sleep and Respiratory Care, I think with what we know today is just a more accurate view of where we will end up. That's it.

Frans van Houten -- Chief Executive Officer, Chairman of the Board of Management and the Executive Committee

Yeah. Let me just reiterate, you know, the whole Company is completely geared up to compensate for the revenue loss in Sleep, alright. And there are so many opportunities that we are chasing and pursuing, that -- perhaps that creates the less, the lower-than-normal kind of ability to precisely nail, but don't read anything in it. We are all over it and we remain very confident around our ability to perform.

Veronika Dubajova -- Goldman Sachs -- Analyst

Excellent. Thank you, both. And Frans, if I can just quickly on the -- you sort of said, you've had some conversations with the FDA on the EUA. Just kind of curious anything surprising? I'm not familiar with how much back and forth happens on these things, but I'm just curious if you're hearing anything from them, that would make you less confident on that eight-week timeline for the EUA?

Frans van Houten -- Chief Executive Officer, Chairman of the Board of Management and the Executive Committee

I think all the questions are completely understandable and legitimate, and I think they point to the complexity of this whole area around VOCs, right. I'm sure that we'll get other questions during these calls. But let's say, the FDA has asked us to provide data that the replacement material is safe and sound, right? I mean, if you boil it all down, then everybody wants to ensure that if you go out with a repair and replace action on a couple of million of devices, that you do that in the full knowledge that it is a sound -- is a good solution. I think that, in my own words, if I put it like that, it describes it. And so I think it is diligent and the only unfortunate thing is it takes time. And patients are wanting to get this dealt with as soon as possible because not using the therapy is also giving a lot of discomfort and harm.

Veronika Dubajova -- Goldman Sachs -- Analyst

Understood. Thank you, guys so much. Super helpful.

Operator

Our next question comes from Patrick Wood from Bank of America. Please state your question.

Patrick Wood -- Bank of America -- Analyst

Perfect. Thank you very much. I'll just ask the two upfront, if that's all right. So I guess, tediously on the Sleep side as well, just curious how the order book sort of developed through the quarter and the revenue line.

Obviously, thank you, Abhijit, for commenting around the Group numbers with and without Sleep. Sort of playing around with that, I get the sense that toward the end of the month, presumably the Sleep hardware business was down like 90% or something, but I could be wrong with my math. I'm just curious how that business developed during the quarter, and whether you think that reflects just purely the repair action or a little bit the kind of consumer anger I guess on the issue?

And then the second one, I'm just curious -- Thank you, Frans for your commentary around the Group and the product qualities and those sorts of things. But do you feel that maybe internally how things are structured within Philips, how information gets fed up to the executive team. Is that something that you're looking at changing or considering to sort of help mitigate issues or surprises? Or is that an unreasonable expectation? Do you think things are kind of working all right as well?

Frans van Houten -- Chief Executive Officer, Chairman of the Board of Management and the Executive Committee

Okay. Abhijit, you take it first.

Abhijit Bhattacharya -- Executive Vice President, Chief Financial Officer

Yeah. No, overall, the Sleep business developed as we expected. Once we announced the repair action, then basically, we didn't sell any more of the systems, right? So the mask sales continued. Actually, mask sales were pretty good. So there, we don't have an issue. And normally, the Sleep Systems businesses toward the end of the quarter, bulk of the deals are done. So yes, you're right, Patrick, toward the end of the quarter, you really see the comparable decrease year-on-year. But not something that we were not expecting to happen. So no surprises there.

Frans van Houten -- Chief Executive Officer, Chairman of the Board of Management and the Executive Committee

Yeah, and then Patrick on your second question, already several years ago, as we moved from a conglomerate organization with a holding model toward an operating company focused on health technology, we did change our Q&R organization. At that time, and think of it, I don't know exactly or recall it exactly, but think of it like five years ago, we moved the reporting line of all quality and regulatory people to the functional leader of Q&R, right?

So we have a Chief Medical Officer, we have a Chief Quality and Regulatory Officer and the Chief Quality and Regulatory Officer reports directly to me, alright? And all the resources, all 4,000 of them in the Company, functionally report into the head of Quality and Regulatory. So that's my first point.

Second point, the learnings out of previous audits, 483s and inspections have pointed to the need to strengthen what is called Post Market Surveillance, right, PMS. And here, we have made actually a ton of progress. We've also implemented a Companywide information system called Trackwise, where all complaints are registered -- and thanks to IT, can also be analyzed more easily, alright? Now we get a couple of million data points into that system per year, alright? So you need to do a lot of analytics.

The post-market surveillance process has led us to detect the issue at hand here, right? So remember, we have since inception sold more than 10 million, 12 million of these devices. We track complaints coming in. And then at some point in time, you notice that there is a pattern instead of just incidents, alright? So in the beginning you get one complaint here, one complaint there. It's not a pattern, it doesn't get recognized as a pattern. But as more recently, we detected it as a pattern. We did an additional investigations like you are expected to, and that led us to come out in Q1 -- in Q2 with the information that you know.

So this is something we detected through our own PMS processes. And I would say that is to be expected from a HealthTech company and that process is working. Then you initiate your corrective and preventative actions, that leads to further insights, for example, around design controls and how robust these design controls are.

I think, and I claim that over the last several years we have made a ton of progress, right? That doesn't mean that the journey is over, but I feel good about how this will stand up to scrutiny, and for sure, we are anticipating that we will get regulatory investigations to please explain to us what exactly has happened. Also such a regulatory investigation is normal and should be expected with a field safety notice of this magnitude.

But, I think we are prepared for that. We -- I think with the -- to the best of our knowledge and integrity, we have acted in a way we should act. So therefore, I don't anticipate a need for a change of -- change of ways of working. And your specific point, how does information move? Well, we think that information gets reported up quickly and transparently in the Company. I have no other information at this time to assume the opposite to that. So, hopefully that helps you a bit.

Patrick Wood -- Bank of America -- Analyst

It does. Thank you for the commentary, guys.

Operator

The next question comes from Hassan Al-Wakeel from Barclays. Please state your question.

Hassan Al-Wakeel -- Barclays Capital Securities Ltd -- Analyst

Thanks for taking my questions. I have three please. Firstly, could you talk about current manufacturing capacity within Sleep, and where this sits relative to your 3.5 million installed base? What are the costs to increase capacity here?

Secondly, could you talk a bit about the momentum in North America, how did order intake within D&T fare, and what about MRI where I believe the number was plus 45% in Q1? And then finally following up on the guidance, could you talk about your confidence around topline guidance based on where your order book sits today. And then also on margins, given the quantum of higher margin Sleep sales that you will lose over the course of the year. And do you assume any impact to the mask business as part of this year's guidance?

Thank you.

Frans van Houten -- Chief Executive Officer, Chairman of the Board of Management and the Executive Committee

Great questions as usual, Hassan. Well, let me first reiterate what I said about manufacturing capacity, and I mentioned that we are ramping up capacity for the replacement and repair actions from 30,000 to already 55,000 a week currently aiming at 80,000 by the beginning of the fourth quarter, right? And now if you multiply that times the number of weeks, then you get to somewhere between 3.5 million or 4 million units, alright, and hence, the 12 months expected throughput time on this.

We have not, let's say, specifically mentioned the cost of increasing capacity. But I would reassure you that, that is not the big issue here. We would be able to go faster if, from a supply constraint point of view we would get our hands on the scarce materials from some of our suppliers.

So we have been helping our suppliers with mould capacity, etc, so that they can ramp up faster. And if we see that they can go faster, then we aim to shorten the 12 months, right, if possible. It's too early to speculate on that, but certainly, that would be our aim because that's better for patients. But obviously, the sooner we can resume sales, that's better for our own business.

Maybe on the back of it, I would like to share with you the feedback that we have been getting from distributors and doctors. They all say that the manner in which we deal with this issue is more important than the issue itself, alright? They realize that a technical component issue can happen, but the way we deal with it is important. And so far, we have only been getting positive feedback in the way we have been able to handle it. Also, the supplemental clinical information that was provided to doctors in a couple of weeks ago, I assume that you have seen it, it was very much appreciated.

What we also hear is that nobody has appetite for a monopolistic market situation, and they expect Philips to be able to quickly recover its position in the market and resume, let's say, our strong preference. What doctors also point to is the strong analytical capacity of the -- of our systems, helping them to understand the trend line of patients, so the whole informatics part of our devices, and as they provide information to the doctors is quoted as a strength, alright? So we are under the conviction that we will regain our market position or at least close to, pretty fast after we are able to resume production for commercial purposes, and as said, we will do that as fast as possible.

Now in the meantime, I think I have given my colleague Abhijit some time to look up all the numbers of the other questions. Abhijit?

Abhijit Bhattacharya -- Executive Vice President, Chief Financial Officer

Yeah, I think overall for North America, the order intake, especially in precision diagnosis was very solid, upwards of the 40%. MR was lower because, you know Hassan, we had a big order intake in Q1. So Q2 was low single-digit, but for the first half, very strongly in double-digit territory.

Our X-ray business had huge order intake. Our CT business, huge order intake and very nicely the ultrasound business also had a very, very strong order intake. So I think momentum in the U.S. is very good for us at this stage.

Frans van Houten -- Chief Executive Officer, Chairman of the Board of Management and the Executive Committee

And then the margin composition?

Abhijit Bhattacharya -- Executive Vice President, Chief Financial Officer

If you look at the impact on mask is to the extent that the masks went with the systems, we lose some of those sales, although we are -- we have programs in place in the third and fourth quarter to see how we can compensate for that. But it does have overall a negative impact on the mix in Sleep and Respiratory because, of course, Sleep is a high-margin business and some of the compensation is coming through oxygen concentrators, etc, which is a lower margin profile. But overall, for CC, that is a relatively small impact because patient monitoring is also growing.

Frans van Houten -- Chief Executive Officer, Chairman of the Board of Management and the Executive Committee

And then maybe if we take the question wider, Hassan, then, of course, the patient monitoring is a very beautiful profitable business, and that continues to grow strong throughout the year and continues to grow. Also, some governments are doing stockpile programs on monitoring and we continue to see the application of patient monitoring in other care settings. And also in D&T, strong growth in Image-Guided Therapy and the devices with a very strong margin profile by now also helps us to continue our margin trajectory, right? So that's it.

Operator

The next question comes from Michael Jungling from Morgan Stanley. Please state your question.

Michael Jungling -- Morgan Stanley -- Analyst

Thank you, and good morning. I have two questions, please. Firstly on the recall, you highlighted in your slide deck that 2.2 million people have registered out of the 3.5 million machines. Do you know what proportion of those 2.2 million are in the U.S.? How many patients highlighted that they actually have an issue with the DreamStation 1?

And are you surprised that it's no higher than the 2.2 million at this stage? And then question number two is also on the recall, but really focused on the foam of the DreamStation 1. Was that foam FDA approved by the vendor who you sourced it from? And are you able to tell us who the manufacturer is of that foam? Thank you.

Frans van Houten -- Chief Executive Officer, Chairman of the Board of Management and the Executive Committee

The 2.2 million registrations are more in the U.S. than the normal proportion of our business was, right? So over, what was it? [Speech Overlap] 65% of the expectedly affected devices are in U.S., but the proportion of registrations in the U.S. is higher. That's also because we were out of the gate faster with the patient engagement program and the network of DMEs is very strong in the U.S., whereas in some of the international markets, it takes a bit longer to reach people, but we expect that to catch up soon.

Obviously, most of the reports are with DS1 because that's by far the vast majority of devices affected. So unless I misunderstand your question, it's logical that the vast majority of these registrations are DS1 users. On the foam, I value to state that when the product DS1 was released, it was tested against all the standards in place, including VOC standards at that time, right? And the product, of course, met all those standards. Otherwise, it would never have been released.

The foam has been used for over ten years, and we never had any issue with it. Whether the manufacturer itself had its own approvals, I am over asked here at this moment. But I repeat that we have been using this foam for ten years in DreamStation 1 and prior generations and never had issues with it.

Michael Jungling -- Morgan Stanley -- Analyst

Okay. Thanks, Frans. Can I follow-up on the question that I asked about, of the 2.2 million patients who have registered, have you been able to collect data to see what the issue is, why they have filed or to register?

Frans van Houten -- Chief Executive Officer, Chairman of the Board of Management and the Executive Committee

We are still doing analytics on that database. The -- so I cannot give you more data than that. We have just done the first pass of analytics to take out duplicates, because that was the first issue that we needed to deal with. And now we are mapping it on registrations and when the products were produced and so on, I prefer to do a thorough job on analytics before I answer your question.

Michael Jungling -- Morgan Stanley -- Analyst

Okay. And Frans, you didn't answer the question about who the foam manufacturer is? Can you highlight that, please? Could you mention that?

Frans van Houten -- Chief Executive Officer, Chairman of the Board of Management and the Executive Committee

Yes, I realized that I didn't answer that. But -- so I'm not going to answer that.

Michael Jungling -- Morgan Stanley -- Analyst

Okay, thank you.

Operator

The next question comes from Kate Kalashnikova from Citi. Please state your question.

Kate Kalashnikova -- Citi -- Analyst

Hello, this is Kate Kalashnikova from Citi. I've got three questions on Sleep, I'm afraid. So firstly, Philips supplemental information sheet sent to doctors in July, it mentioned cytotoxicity was noted for the extraction concentration. And also the two genotoxicity assays showed a positive mutagenic response. What chemicals specifically is the document referring to? Because the chemical specifically mentioned in the release, such as CG, CGI and GEG, they're not proven carcinogens in humans. So it would be very helpful if you could clarify that.

And secondly, Philips changed the sound abatement foam in DreamStation 2 to silicon. Why have you made the decision if there are no safety risks identified or PE-PUR foam in DreamStation 1? And finally, what proportion of patients normally start sleep therapy and then discontinue perhaps even while in their first sleep device? And what proportion of users in the U.S. regularly use ozone cleaner? Thank you.

Frans van Houten -- Chief Executive Officer, Chairman of the Board of Management and the Executive Committee

Wow. Hi, Kate. The -- with regards to the characterization of the volatile organic compounds, that is a very complex matter and the supplemental information that we refer to indeed mentioned several gases, and we also observe that some people have misinterpreted the type of gases and therefore, took a more, let's say, serious interpretation than perhaps was justified.

We have also request of the regulators started a slate of additional tests to further characterize what gases are to be determined, and to how to characterize them. I can tell you that we have not detected TDI or TDA in those samples that were tested in the lab, alright? But as I said, further research is ongoing.

Now, with regards to the change of the foam from DreamStation 1 to DreamStation 2, you may recall that in June 2018, a new standard was published that had, let's say, heightened or different requirements on VOCs than the previous standard. The new standard did have a grandfather clause for existing equipment, and therefore, products that were already being produced in the past that were approved in past did not have to be retested against the new standard. Of course, that is provided that you don't have data and insights that your device would not be safe.

I can tell you that at the time of the release of that standard and -- that we did not have, in fact, the complaint rates coming out of our post-market surveillance, and therefore, we did not initiate a design change of the DS 1 at the time because there was no reason to, right?

And let's say, routinely in the medical device industry, you are faced with new standards being applied to new generations of products, and you're not going to retrofit old systems because that would be an impossible task, alright? You only do that when there is a safety concern, and as I said, when this new standard came out, we did not have that. And therefore, the grandfather clause in the standard of June 2018 applied.

Then the proportion of people using ozone cleaning is, of course, we don't know that exactly, but we can tell you that aggressive marketing has taken place even to the extent that the FDA issued their own warning in the beginning of 2020. Now, if we look at the correlation, or let's say, when did we start seeing complaints coming in United States, then the vast majority of the complaints are in 2020, right, and therefore -- and also geography-wise, we can, let's say, correlate to the regions where ozone cleaning was marketed more strongly. So that is where we stand.

Obviously, as we -- to the question of Michael as we get more data from the registration, we will be able to do more analytics and then maybe, Kate, we can come back to your question in due course.

Kate Kalashnikova -- Citi -- Analyst

Thanks for that. Just to clarify your answer to the first question. If you hopefully saw the TDA and TDI, they're not detected in the test done to date. DEG won't detect it, but it's not cytotoxic. So what chemicals is responsible for the potential -- reported potential cytotoxicity, if not TDI, TDA, and given that DEG is not cytotoxic. I'm just trying to understand if you can help us with this, it will be very helpful.

Frans van Houten -- Chief Executive Officer, Chairman of the Board of Management and the Executive Committee

I am now getting assistance here from Steve [Phonetic].

Steve

Hi. We need to further identify those compounds. So this was done on lab degraded foams, so that the foam was not, let's say, aged in the field. We artificially aged it to simulate the degradation. And then we did an extraction and we analyzed all the compounds in there. We could detect diethylene glycol. We -- there were a number of unidentified compounds that they are now further investigating, but we did not detect TDI or TDA.

Kate Kalashnikova -- Citi -- Analyst

Okay.

Operator

The next question comes from... [Speech Overlap]

Frans van Houten -- Chief Executive Officer, Chairman of the Board of Management and the Executive Committee

So let's say, rounding it up, Kate, I think it is way too early to conclude that you know the gases have really a severe health impact. We took a worst case approach back in April and June, because that is what is expected from, let's say, a responsible manufacturer, right?

If you don't know all the finite consequence, you go out first with a reasonably worst case scenario and then as data becomes available later, you can always reduce that rating, right. But it's -- that's what we need to do according to our own quality management system, alright?

And the supplemental, medical information already, let's say, gave a more balanced view on it, that was appreciated, and the further tests that we are conducting on a far bigger sample and also on aged -- normally and naturally aged products, will also determine whether the VOCs are more initially coming out of the machine, when they are coming from the production line or whether in the installed base, this is still an issue, alright?

I think this is one of the critical questions to answer, whether patients are really exposed to VOCs or not. So -- but taking a reasonably worst-case approach is, I think, the responsible way to go about it, and then we'll deal with the further information as it comes.

Kate Kalashnikova -- Citi -- Analyst

Thank you very much, Frans. And just very briefly, if I may, have you got any data that shows how ozone is accelerating foam degradation?

Frans van Houten -- Chief Executive Officer, Chairman of the Board of Management and the Executive Committee

Yeah, that we do. We have tested that, and we see a 40 times factor of acceleration of degradation when ozone is being used. And that's on an average use of ozone cleaning. And if people do that every day, of course, it goes even faster, right? But the acceleration factor caused by ozone cleaning is very, very significant, right? And otherwise, we would not call it out. It's a very aggressive cleaning method that should not be used on medical devices at all.

Operator

The next question comes from Scott Bardo from Berenberg. Please state your question.

Scott Bardo -- Berenberg -- Analyst

Yeah, thanks very much guys. Sorry, again to focus on the Sleep and Respiratory business, please. Frans, you mentioned a lot of volatile organic compounds and I understand why. I think this is potentially the bigger consideration as compared to a particular matter. The MHRA, in the UK, conducted the biological safety assessment and highlighted that they did not see any volatile organic compounds of concern after 24 hours, suggesting that this was a first out-of-the-box usage issue rather than something that was sort of sustainable over a prolonged period. I wonder if you could confirm in your initial safety assessment and clinical studies, whether you would agree with that observation, please.

Second question, please, Frans. I wonder if you could provide a little bit more details about how you intend to repair and replace. Can you give us some sort of split between repair and replacement? And does the alter between geographies, perhaps give us some sense of what you expect the profit impact as a result of no sales for CPAP devices to be for Philips, including mitigating factors.

And last question, please. Frans, you seem confident and pleased to hear about the ability to remediate this issue within 12 months or so. Am I right in saying then Frans, there is no reason at this point to deter from your 2022 provisional outlook for, say, 5%, 6% topline growth, 60 basis points to 80 basis points margin expansion? Thank you.

Frans van Houten -- Chief Executive Officer, Chairman of the Board of Management and the Executive Committee

Yeah, brilliant questions, Scott. Let me indeed cover them. Look, the MHRA test in the UK is very encouraging. And as I said, we have taken an initial worst case approach to it, because in the lab tests, our resident lab -- well not resident, but our partner that does the tests for our Sleep and Respiratory Care business, this is where we discovered the VOCs, and that's on a relatively small sample size, right?

And on that basis, we took the action, all right, because we could not do otherwise, right? We have found those gases in those -- in that limited sample, and consequently, we took a reasonable worst case approach. I told you that we have initiated a much wider sample testing, but also we've asked multiple labs to do the testing, because you know, we want to know the repeatability of the test in different test environments to exclude that potentially this one lab has a different approach, right. So all of that is still in the making.

Now you may say, why does it take so long? Well, these tests run for multiple weeks and then on multiple devices, and then all the molecules need to be characterized and measured for the, let's say, of the qualification. In a way that frustrates me as well, and because I would like to do this much faster and much better.

Steve, also just mentioned that in the initial tests, we have taken an accelerated aging approach, which these are also message that you -- that regulators will challenge us on too, say, maybe you should also consider other simulation environments. So in a way, it doesn't surprise me that if you -- in the UK, this sample test was done, and I find it encouraging that no VOCs were found, right?

But as I have not seen the raw data of the test, me not personally, of course, but our specialists, we cannot just draw conclusions on such a high level statement. We need to go into the reads of that assessment. But, rest assured that we're throwing all our analytics capacity to this, because clearly we need to characterize the risks and hopefully also come to insights that the worst-case approach was indeed what the word says worst-case.

Then, the repair and replace split, when we built the provision on the basis of our estimates of repair and replace, we assumed approximately 60-40.

Abhijit Bhattacharya -- Executive Vice President, Chief Financial Officer

Two-thirds/one-third.

Frans van Houten -- Chief Executive Officer, Chairman of the Board of Management and the Executive Committee

Thank you, Abhijit. Two-thirds/one-thirds of replace versus repair, right? And part of the 806 approval that we need from the FDA relates to the repair procedure and not just to the repair material, right? The repair procedure needs to demonstrate that after repair, you have a safe machine, right? So you can imagine that the amount of work that you need to do on a repair action is also to validate that after the repair, the machine is good to use.

And if you give the machine back to the original user, the standard there is lower than if you give a repair machine to a different patient, right? So all of this goes to the complexity of the repair process. And if we are optimistic, and then all our proposals on the repair procedure will work out and then the proportion of repair can actually go up, right? And we have also heard from DMEs, the distributors, that they actually prefer repair over replace in many instances. And you can imagine, I mean, you can make your own interpretation why they want that, but I think it's quite obvious.

And then, the revenue impact, so we are dedicating our production capacity in Sleep to the repair and replace action, right? And that takes also then into account this assumed proportion of repair and replace of: replace, two-thirds; repair one-third. If we can go faster there, of course, that would be helpful.

But for now, we have taken into account that we would lose the revenue for at least 12 months after the start of the field action. And Abhijit has, I think, at some point already said that, or we have said that the Sleep business is EUR1.1 billion, of which approximately 60% is systems and 40% is masks and consumables.

So then you can do your math and take out the 60% of the systems as lost revenue. Then -- and of course, we compensate that lost revenue by strength in our other businesses. On your last question, we believe that in 2022, we can maintain our Capital Market Day guidance of 5% to 6% revenue growth and 60 basis points to 80 basis points of profit expansion.

Scott Bardo -- Berenberg -- Analyst

Very fair answer. Thanks, Frans.

Frans van Houten -- Chief Executive Officer, Chairman of the Board of Management and the Executive Committee

You're welcome.

Operator

The next question comes from Ed Ridley-Day from Redburn. Please state your question.

Ed Ridley-Day -- Redburn -- Analyst

Hi, good morning, and thank you for the detailed answers. One follow-up please, on cost and obviously related to supply and freight. We have heard from some of your peers that have reported regarding the rising the costs, particularly with freight. Abhijit, can you speak to that a little? And while it seems that second quarter wasn't too badly affected, how do you see that panning out over the third and fourth quarter, both as I say, in regards to freight, but also electrical components? Thank you.

Abhijit Bhattacharya -- Executive Vice President, Chief Financial Officer

Yeah Ed, the second quarter was affected. Now, we have offset that with the productivity program, right, so the freight costs are at a heightened level in the first half. We'll also continue in the second half. But we are trying to mitigate as much as possible through our productivity programs. So that's why you don't see a big dent in the overall profitability.

So if you look at -- but also in the e-Components, you know, we have been hit by higher spot buy prices, which is also impacting profitability, but we try to offset that and a little bit more through productivity so that the profit trajectory keeps improving. That's how you should look at it. And in our guidance for the year, I think we have taken all these factors into account.

Ed Ridley-Day -- Redburn -- Analyst

Thank you. And just one quick follow-up. You gave us some color on the growth at BioTelemetry and then if you can give us more color on the growth that you're seeing in that business this year?

Abhijit Bhattacharya -- Executive Vice President, Chief Financial Officer

They still remain -- they remain strong. Actually, they performed slightly better than the plans that we had when we acquired the company. So, both are in strong double-digit territory with good profit expansion. So, so far, we are very pleased with the way it's progressing.

Frans van Houten -- Chief Executive Officer, Chairman of the Board of Management and the Executive Committee

Maybe just a good segue also to mention that early indications are that CMS comes out with an upward reimbursement on part of the monitoring to continue -- in the mobile continuous monitoring... [Speech Overlap]

Abhijit Bhattacharya -- Executive Vice President, Chief Financial Officer

MCOT.

Frans van Houten -- Chief Executive Officer, Chairman of the Board of Management and the Executive Committee

MCOT, sorry I got the abbreviation wrong. And so whereas, let's say, some analysts are worried about our reimbursement being cut. Here actually on MCOT, we see the opposite with a small, let's say, increase, but at least it can put some worries to rest. Of course, and earlier in the year, we already saw that the long-term holter was reinstated as a reimbursement.

So overall, the platform of BioTel looks very exciting and we are adding, let's say, therapies to it. We are growing this internationally. It looks very good.

Ed Ridley-Day -- Redburn -- Analyst

Great. Frans, thanks very much.

Operator

The next question comes from Julien Dormois from Exane BNP Paribas. Please state your question.

Julien Dormois -- Exane BNP Paribas -- Analyst

Hi, good morning, Frans. Good morning, Abhijit. Thanks for taking my questions. I will actually try to give you a break from the Sleep Care business. Could you just help us understand what was at stake in the margin trajectory for D&T in Q2, because when I compare the margin achievements to 2019, the gain you posted in Q2 was significantly below the gain you posted in Q1. So I'm just curious whether there is a phasing issue here or anything related to the product or the geographic mix maybe?

Abhijit Bhattacharya -- Executive Vice President, Chief Financial Officer

So, tell me once more, Julien, when you say you compare D&T?

Julien Dormois -- Exane BNP Paribas -- Analyst

Yes. The margin in D&T, and comparing that to the last normal year if I call it that way, which is 2019, if I'm right, the margin gain was about 100 BPs in Q2.

Abhijit Bhattacharya -- Executive Vice President, Chief Financial Officer

Yeah.

Julien Dormois -- Exane BNP Paribas -- Analyst

While it was 250 BPs in Q1. So it's significantly below. So I'm just curious whether there is something here or it's just phasing in the business.

Abhijit Bhattacharya -- Executive Vice President, Chief Financial Officer

I think you should look at it as primarily phasing. I think overall for D&T we are on a very good trajectory. You see that the bulk of the growth, of course, that comes is in equipment sales. So that to an extent comes at a lower margin than the service business. So the disproportionate growth in equipment has a slight dampening effect now. But of course, then going forward once we get the service contracts, you see then that the overall will keep improving.

Frans van Houten -- Chief Executive Officer, Chairman of the Board of Management and the Executive Committee

And Q1 2019 was relatively low, right?

Abhijit Bhattacharya -- Executive Vice President, Chief Financial Officer

Yeah.

Julien Dormois -- Exane BNP Paribas -- Analyst

Okay. Thanks for that. And maybe just as a follow-up in the broader approach or your discussions with hospital at this time and maybe on the geographic basis, how do you see things evolving? I mean, you obviously posted a strong order book development in Q2. But how would you qualify the current discussions you have and how willing the hospitals are from spending more on capex?

Frans van Houten -- Chief Executive Officer, Chairman of the Board of Management and the Executive Committee

Great question, Julien. Look, hospitals are in much better shape than half a year ago. Elective procedures are back, hospital finances are improving, backstops are being put in place. So we've seen a strong willingness to invest, and that of course, represents itself in the 29% order growth from -- in our D&T business. Much of that is market, although and we don't have market share numbers for Q2 yet, but I would expect perhaps some market share increase. But it also generally reflects the strength in the market.

Besides capital equipment, we see strong interest in telehealth and informatics. So that is also tracking very well. The stockpile programs that we referred to is more with regards to acute care and ICU related equipment, especially patient monitoring, which is good for us, given our market leading position there and higher margins.

And the geographical angle is basically all three market clusters for Philips do very well. So we see strengths across the world, North America, in particularly strong, Europe strong, Asia, China strong. I think we're -- and I would also say hospitals are now much better able to cope with the COVID pandemic. And so it looks good. I think we're on a good path for the rest of the year.

Julien Dormois -- Exane BNP Paribas -- Analyst

Okay.

Abhijit Bhattacharya -- Executive Vice President, Chief Financial Officer

[Speech Overlap] to also clarify, that if you look at Q1, the growth in our sales from 2019 was about EUR134 million, whereas in Q2 it was EUR54 million. So that also explains a bit the operating leverage between the two.

Julien Dormois -- Exane BNP Paribas -- Analyst

Makes sense. Thank you very much.

Frans van Houten -- Chief Executive Officer, Chairman of the Board of Management and the Executive Committee

Okay. Thank you.

Operator

Please limit your question to one question with one follow up only. The next question comes from Falko Friedrichs from Deutsche Bank. Please state your question.

Falko Friedrichs -- Deutsche Bank -- Analyst

Thank you. Good morning. I'll keep it to one question. It's on the share buyback program. So what led you to the decision to spend these EUR1.5 billion now for this program rather than use it for bolt-on acquisitions to strengthen your business? Is there simply a lack of good acquisition targets you currently see or what was the reason for that?

Frans van Houten -- Chief Executive Officer, Chairman of the Board of Management and the Executive Committee

Yeah, hi, good morning, Falko. Well, you know that in our Capital Markets Day, what is it 1.5 years ago, we reiterated that, in fact, we have a balanced capital allocation policy, right? Now, what does balance mean? Organic growth, M&A, dividend and share buyback. Now, I've always said, we will allocate a fair bit of capital to M&A, and we did that, right?

In Q1, we closed two acquisitions with approximately EUR3 billion worth of acquisitions BioTel and Capsule. And we continue to see good M&A opportunities. The share buyback program does not limit our ability to do acquisitions. In fact, it leaves us plenty of room for further acquisitions and bolt-ons, and we have every intention to also continue to evaluate opportunities as we go, alright?

Now, the share buyback program follows previous share buyback programs. The size is about the same as what we have done previously. And we have also astutely noticed the decline in the share price, which makes this an opportune moment to actually go into the market with a series of forward buys to take advantage of the situation, alright?

And finally, we can say that we have confidence in our ability to perform and to generate strong cash flow, strong profitability, and therefore, the share buyback program is a normal action in the sequence of things. And if you judge us over the last five to eight years or so, we have been doing this.

Falko Friedrichs -- Deutsche Bank -- Analyst

Okay, thank you.

Frans van Houten -- Chief Executive Officer, Chairman of the Board of Management and the Executive Committee

You're welcome.

Operator

The next question comes from Wim Gille from ABN ODDO. Please state your question.

Wim Gille -- ABN AMRO-ODDO BHF -- Analyst

Hi. Good morning. This is Wim Gille from ABN AMRO-ODDO. I got two questions. First on, let's say, the provisions that you've taken, about EUR511 million to date, can you give us a bit of a feeling how that number is split between repair, replace, use and any other costs, including legal and regulatory costs there?

And as a follow-up there, the ozone is clearly a part of the problem, the ozone cleaning. Is there a case to start legal action against the companies that have marketed ozone cleaning and try to recoup some of the costs that you are incurring for this thing?

And the second question is on the margins in Connected Care. If I look at kind of the revenue levels that we see in Q2 2021 versus Q2 2019, and then look at the margins, the margins are about 100 BPs lower than two years ago. How should I look at it? Is this -- can you maybe split kind of the impact from the acquisitions that you did?

What's the impact on the margins that we currently see versus kind of the normalized levels in 2019? Thank you.

Abhijit Bhattacharya -- Executive Vice President, Chief Financial Officer

I can take all of them. So the provision, as Frans mentioned, we've taken two-thirds/one-third on a repair/replacement basis. So, and in that, we have not included any provision for legal cases, right, so we are not able to estimate that, so we cannot take any reasonable estimate at this stage.

In addition to this, there are multiple other costs, a big chunk of that pertains to the whole communication cost as well as the follow-up and managing the database that will cost us a lot of money. There is of course, within each of those categories, there is material cost, there is labor cost and all of that. So it's quite an extensive calculation, but does not include any cost taken for legal claims.

On the margin split between 2019 and 2021, if you look, the sales levels are roughly the same. I think maybe EUR10 million more or so and/or EUR20 million more, if you take the percentage, 100 BPs more. Maybe we should have made EUR10 million more profit. But as I explained earlier, there is a mix effect and there are certain fixed cost, which you cannot reduce, or let's say, adjust out of the cost, which has a small dampening effect.

So I think overall, if you look, patient monitoring continues to do extremely well and actually grows profitability. The acquisitions continue to do well. They were not -- they help to mitigate some of the lost sales in Sleep. So that's why you see from a sales line we are flattish, so maybe we are missing about EUR10 million and that would come largely from the mix.

Frans van Houten -- Chief Executive Officer, Chairman of the Board of Management and the Executive Committee

And then on the question of the ozone manufacturers, really not this time in place to discuss our legal actions, maybe somewhere in the future, when we have studied it more and we know more of the details.

Wim Gille -- ABN AMRO-ODDO BHF -- Analyst

Thank you very much.

Operator

Unfortunately, we only have time left for one more question. The last question comes from Sezgi Ozener from HSBC. Please state your question.

Sezgi Ozener -- HSBC -- Analyst

Hi. Thanks for taking the time to taking my question. My question relates to, again, the first batches of repair and replacement kits that were shipped or already shipped out. As we're still waiting for the EUA to be approved, which material was used? And are you able to estimate a cost based on the replacement and repair cost in these devices? And how do these compare to the EUR500 million roughly of provisions that you've set aside?

And my second question is about a few of -- we saw a few positive one-offs this quarter, like a remeasurement of environmental liabilities and the favorable result in legal matters. I was just going to ask if you could elaborate a little bit on those. Thank you.

Frans van Houten -- Chief Executive Officer, Chairman of the Board of Management and the Executive Committee

Yeah, hi. Good morning. With regards to your first question, I'm afraid you may be reading too much into the first batches of repair kits that were shipped. I called it bonded warehouse because it's an extension of the Pittsburgh facilities in a foreign location. That is the only way to do it under the regulations. And we are obviously not kind of measuring cost on a per batch basis. I mean, that would go too far, but -- and certainly, have no intention to disclose the cost of every batch of repair kits. So, sorry I can't do much with your first question.

The second one, I think Abhijit, you want to talk to the provisions?

Abhijit Bhattacharya -- Executive Vice President, Chief Financial Officer

Yeah, I can. So two things. We had a legal case for which we had taken a provision in Q3 last year and that case was actually ended up being withdrawn against us, so we had to release that provision. So that came as a goodie now, but it came as a hit last year in Q3. And on the environmental provisions, we -- these are long-term environmental provisions we used to provide them on a 60-year basis and then you have to do a fair value calculation on those, and it causes a large amount of volatility, given the change in interest rates.

We have done an extensive benchmarking and actually most companies provide that for a maximum of 30 years. So in consultation with our auditors we have aligned to the market practice and now we have it for 30 years. So therefore, some of the provision was released. That's it.

Sezgi Ozener -- HSBC -- Analyst

Okay. And specifically, against what was -- were these, against what kind of environment threat or risk was -- were these provisions taken?

Abhijit Bhattacharya -- Executive Vice President, Chief Financial Officer

These are largely for businesses which we have sold actually many, many years ago where there were factories and we have to do clean up in the land and those kinds of things. So it takes years to do that, and therefore, you have to have a provision in your books to do those cleanup actions.

Sezgi Ozener -- HSBC -- Analyst

Thanks very much, Abhijit.

Abhijit Bhattacharya -- Executive Vice President, Chief Financial Officer

Welcome.

Operator

Thank you, Mr. van Houten, and Mr. Bhattacharya. That was the last question. Please continue.

Frans van Houten -- Chief Executive Officer, Chairman of the Board of Management and the Executive Committee

Yeah. Thanks very much everybody. Look, I fully appreciate the concern around all the open issues. I want to assure you that we are on top of it, as we take all the appropriate actions to deal with the patient situation as fast as we can. In the meantime, the business goes on, right? There is a lot of resilience in our other businesses, and that's also why we can maintain our guidance, and we look with optimism to the future.

I thank you very much for staying with us and covering us. Have a great day.

Operator

[Operator Closing Remarks].

Duration: 91 minutes

Call participants:

Leandro Mazzoni -- Head of Investor Relations

Frans van Houten -- Chief Executive Officer, Chairman of the Board of Management and the Executive Committee

Abhijit Bhattacharya -- Executive Vice President, Chief Financial Officer

Steve

Veronika Dubajova -- Goldman Sachs -- Analyst

Patrick Wood -- Bank of America -- Analyst

Hassan Al-Wakeel -- Barclays Capital Securities Ltd -- Analyst

Michael Jungling -- Morgan Stanley -- Analyst

Kate Kalashnikova -- Citi -- Analyst

Scott Bardo -- Berenberg -- Analyst

Ed Ridley-Day -- Redburn -- Analyst

Julien Dormois -- Exane BNP Paribas -- Analyst

Falko Friedrichs -- Deutsche Bank -- Analyst

Wim Gille -- ABN AMRO-ODDO BHF -- Analyst

Sezgi Ozener -- HSBC -- Analyst

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