Thank you very much. Welcome to today's earnings call. I have Lars Sandström with me as usual here, who will go through part of the detailed financials in a moment. But we can, I will start with a quick overview on some of the key takeaways, so we can
move over to page number two, please. So if we look at the key takeaways, from a performance perspective, the, on the top line, we continue to deliver sales growth, and we've ended the year right in line with our guidance, 3.9% for the full year. It's particularly good to see that we have had strong performance in our three largest markets in the quarter. That's the US, it's China, and it's Germany.
The only weak point we see is that the order intake for Surgical Workflows was slightly lower than the fourth quarter of 2018, and this is mainly related to a weak start to the quarter in America and in Asia Pacific. We still don't see any underlying change in the market, so we expect this to be temporary, and the quarter also ended on a much stronger note than it started, so that's positive. If you look at the total order bookings, they were also better than at the end of 2018. So for 2020, we enter with a stronger order book than what we entered 2019 with.
So we expect that our sales increase for 2020 will be in the range of 2% to 4%, as previously guided and in line with what the market -- underlying market growth. If you then look at the gross margin, the gross margin for the quarter was positively impacted by a favorable sales mix.
We had a good result from higher productivity in many parts of the company, and there was also a significant currency effect in the quarter. So all in all, this has contributed to a strengthened operating margin year on year. We come out with an adjusted EBITDA margin that is 1.4 percentage points higher than one year ago on an adjusted basis. So overall, a positive outcome from that perspective.
I also want to mention the cash flow. Our underlying cash flow was very healthy for the quarter, and the balance sheet strengthened as a consequence. And I think this is particularly good, since it really shows the work that we've been doing for almost two years now when it comes to, of course, accounts receivable, but also our inventory levels. To me, it's a sign that many of these underlying productivity measures that we've launched are actually gaining traction.
So we're very happy about that. When it comes to the balance sheet as such, we're now at 2.5% in leverage, which is, again, another piece of evidence that we're continuously moving in the right direction. From a dividend perspective, the board has proposed a dividend of SEK 1.5 per share, which implies a 50% increase versus the previous year.
We can then move over to page number three, please. I want to just outline some of the main events in the quarter. The key takeaways here. One is, sure, on the cost side, where we start to see positive effects from the restructuring efforts that we made in the first half of 2019. Some of these were also visible in the third quarter of 2019, as you may remember, and we expect that to have a full year effect, of course, in 2020.
If you look at OpEx, however, some of these savings were eaten up by, mainly by negative currency effects, but we also had remediation costs and the costs related to the European MDR preparations that are in full swing at the moment here.
There was also one expiring TSA from earlier, and we had some seasonally elevated personnel costs as well. So that gives kind of the whole picture from a cost perspective. It's also worth mentioning that we've strengthened our offering in the Life Science business area with the acquisition of Applikon Biotechnology, the leading company in the fast-growing area of advanced bioreactor systems for biopharmaceutical research and production.
We're very happy we closed this acquisition on the third of January, so they will be with us for the full year here. It's also worth mentioning, I think, in the quarter that we've decided and started to implement a number of important actions to improve the manufacturing footprint efficiency in surgical workflows. So one decision is moving the production of low-temp sterilizers from the manufacturing unit in Ankara, in Turkey, to our factory in Poznań, in Poland. This move is expected to be completed already by the end of 2020, with the manufacturing unit in Ankara closing entirely.
In terms of footprint rationalization, we're also in discussions with the workers' council on a project to transfer our endoscope washer production from Toulouse, France to Växjö, Sweden. So this will enable the Toulouse factory to focus entirely on our growing Life Science business and for Surgical Workflows, it becomes a much cleaner setup that will enable us to increase both productivity, but also competence. We will establish a disinfection competence center in our Växjö factory. So these are some of the main events during the fourth quarter, and we can then move over to page number four.
So if we look at the top line a little bit more in detail then, from an order intake perspective, our order intake rose 0.9% organically and 6.9% in actual numbers. We saw continued high order intake in Acute Care Therapies, mainly due to our Cardiopulmonary business, which delivered a double-digit growth in the quarter. We also see that Life Science is continuing to grow, primarily in sterilizers and in washer disinfectors. We had, as I mentioned initially, a little weaker order intake in Surgical Workflows, primarily due to a slow start of the quarter in Americas and Asia Pacific.
It's also worth noting that if we adjust for the cancellation of two low-margin orders in Acute Care Therapies and Surgical Workflows from back in 2017, the organic order growth amounted to 1.7%. So despite these cancellations, the order bookings are higher than a year ago. So if you want a proper comparison on the fourth quarter of 2018 with the fourth quarter of 2019, you can adjust for these.
We don't normally report any adjusted order intake, but since it's unusual with cancellations, we thought it would be worth mentioning this. If we then look at this from a sales perspective, we had 1.8% organic growth in the quarter, 7.7% in actual numbers.
Acute Care Therapies had good performance in all regions, accounted for the largest share of growth in absolute figures. We also see that Life Science showing very robust growth in both Americas and also EMEA. While organic net sales for Surgical Workflows declined in all regions, due in part to some deliveries that we made in the third quarter that normally maybe would have ended up in the fourth.
We can also see that from a consumer goods and capital goods perspective, sales of consumer goods are now growing faster than capital goods, which is generally positive for the growth model. We can then move over to page number five, please.
So if we dissect the order intake picture a little bit and look at the contribution from the different business areas, our organic order intake was a bit below market growth for the quarter, even with the adjustments that I mentioned earlier. We do expect this to be temporary, given the feedback that we have from customers and what we see in our pipeline.
As I mentioned earlier, the cancellation of the two lower margin orders from 2017 amounts to 57 million SEK, which takes away 0.8 percentage points from the growth figure for the quarter. So the adjusted figure then would be 1.7% if you want to compare quarter to quarter, from 2018 and 2019.
The Acute Care Therapies, then 2.9% organic growth in order intake, SEK 346 million in actual numbers. This is in line with market growth, and as I mentioned earlier, very strong order growth in our Cardiopulmonary business. Life Science also had good growth for the quarter, 2.3% organically, SEK 48 million in actual numbers.
Here we see an organic growth with a strong trend in capital goods for Asia Pacific. China is a very strong market for us in Life Science. Also generally favorable growth for disinfectors and for sterilizers, and a decline in Americas and EMEA, which we again expect to be temporary. The underlying growth dynamic in Life Science continues to be positive.
If we then look at Surgical Workflows, we had negative 2.4% organic order intake or order intake growth plus SEK 71 million in actual numbers. The weakness is attributable to Infection Control in Americas and in Asia Pacific, where, as I mentioned earlier, we had a slightly weak start. It's also worth mentioning that our smallest part of Surgical Workflows, Integrated Workflow Solutions, had organic growth of more than 20% in the quarter, so that's very positive. With that, we can move over to page number six, please.
If we look at this and below order intake and focus on our net sales, net sales for the quarter increased organically by 1.8%, in actuals by 7.7%, to in total SEK 8,498 million. In this, we had a positive currency impact of SEK 465 million, and as I mentioned earlier, consumables grow faster than capital goods for the first time in a rather long while. From a business area perspective then, Acute Care Therapies had 5.9% organic growth, or SEK 485 million in actual numbers.
This is outperforming the market a little bit with growth in all regions and most of our product categories. Very strong in Cardiopulmonary, as mentioned earlier. We also see continued robust performance in Critical Care. This is predominantly linked to high demand for our ventilators, and it's also encouraging to see that we have a good demand for our recently released product updates in Critical Care.
Life Science had a very favorable sales growth as well in the quarter, 13.9% organically, and SEK 143 million in actuals. This particularly driven by strong growth in EMEA, in sterilizers, and we also had higher sales in America, mainly attributable to capital goods in the US. Somewhat negative trend in Asia Pacific, but largely due to a challenging comp from the previous year, where we had over 46% growth in the fourth quarter of 2018.
In general, as well, sales and capital goods increased in Life Science. Surgical Workflows, on the other hand, we had minus 5%, 5.6% organic growth, the minus 20 million SEK in actual numbers. The organic decline here was attributable to factors like large deliveries taking place already in the third quarter, but also decline on products with lower margins, like, for example, our modular ward systems and some of the loading equipment related to CSD solution.
Organic sales in Infection Control and in Integrated Workflow Solutions were unchanged in the quarter. From a capital goods and consumables perspective, we had a decline of capital goods with 8.9% organically, while consumables grew by 2.7%.
With that, we can move over to page seven, please, and look a little bit at the gross margin development in fourth quarter 2019. So our adjusted gross profit increased by SEK 514 to 4,304 million in the quarter, driven mainly by Acute Care Therapies and, in general, support from currency. The currency support here was SEK 316 million. There was also an IFRS 15 effect of SEK 31 million positive in the quarter, important to know. If we compare with the preceding year's margin, the gross margin is 2.6 percentage points higher, driven by improvements in all of our business areas, which is encouraging to see.
This is supported, of course, by positive effects from currency, as I said, but also we can see a good mix between product and geography. We have some volume effects as well that are positive, and we have good absorption, and in general, also good productivity gains in our supply chain. So, a lot of good things happening there. With that, we can move over to page number nine, and I leave over to you, Lars.
Thank you, Mattias. As you can see, adjusted EBITDA increased by SEK 261 million, and the adjusted EBITDA margin improved 1.8 percentage points year-on-year. Currency effects had an impact of SEK 200 million on EBITDA and supported the EBITDA margin by 1.3 percentage points.
Adjusted gross profit impact on the margin amounted then to 1.3 percentage points, thanks to the positive product and geographical mix, and the other parts there, Mattias mentioned, yes. Looking at adjusted OpEx increase year-on-year, primarily due to currency and investments in compliance, quality, and remediation, including then also preparations for the EU MDR. Sequentially, the costs were higher following the seasonal pattern with higher costs in fourth quarter, and the higher OpEx had an EBITDA margin impact of negative 0.8%.
All in all, this resulted in an adjusted EBITDA of SEK 1,673 million, and an adjusted EBITDA margin of 19.7%. Over to page ten, please. Let's take a look at the BA contribution to adjusted EBITDA, which was impacted positively by currency tailwind of some SEK 200 million in the quarter. Starting with Acute Care Therapies, with a margin of 27.5%, which is an increase of 0.8 percentage points, and SEK 165 million in actuals. Here, the main increase of 0.8 percentage points was mainly due to increased sales volumes, higher gross margin and positive currency effect, which was partly offset by higher costs.
In Life Science, adjusted EBITDA rose by SEK 30 million, resulting in a margin increase of 0.5 percentage points, mainly attributable to higher gross margin compared with a year earlier, and also partly offset by some higher OpEx. SW, despite the lower sales volumes in Surgical Workflows, adjusted EBITDA increased by SEK 61 million, corresponding to a margin increase of 1.5 percentage points, due to improved gross margin, positive currency effects, and lower operating expenses here.
Over to page eleven, please. We continue to see improvements in the underlying OpEx development, which is tracking according to plan. And today, we are 10,538 FTEs, and we do see continuous underlying decline in the number of FTEs using the natural turnover, and only refill where it brings value to customers and the business.
However, we have increased the number of FTEs in the quarter, mainly attributable to sales, and also remediation and preparations for the MDR, and also some increases in the production, where we increased some of the production pace in some of our facilities.
This is generating value over time. At the same time, the number of FTEs within traditional back office areas are declining. Our work continues to bring OpEx in relation to net sales to a healthy level. As you can see in the graph to the right, adjusted OpEx in relation to net sales on a rolling 12-month basis has declined since the peak level in the first half of 2018. This is to some extent supported by positive price effects on net sales as well. Over to page 20.
On cash flow, before changes in working capital, it strengthened in relation to fourth quarter 2018, primarily due to improved EBIT, lower taxes paid, and also last year's payments for the investigation done in Brazil last year. During 2018 and 2019, we've been working intensely with improving our working capital.
And as you can see in the graph in the middle, we broke the trend in working capital days in the second quarter last year, following by a decline each quarter since. And we are now at some 112 working capital days. Also, working capital is decreasing 6.8% year-over-year, at the same time as our net sales is growing 1.8% organically.
Our efforts to improve working capital will continue, just as everything else we do in order to improve productivity, and thus, both underlying earnings and cash flow improve. Of course, you should expect this steep decline in working capital to slow down a bit as we get into comparisons that are tougher.
And as an example, you should expect some build-up in the safety stock, in inventories related to the transfer of production that is ongoing from Fairfield and Marana to Wayne in the US during 2020. Nevertheless, we still—we do still have many things to improve in this area. Net investment in the quarter amounted to SEK 261 million, compared to SEK 363 million previous year, and free cash flow then in total amounted to SEK 1.4 billion for the quarter. Let's move to page 13, please.
Let's take a look at our net debt situation, which has improved in the quarter following the strong cash flow. Interest-bearing liabilities declined by SEK 8.1 billion during the quarter, and net debt was reduced to SEK 12.3 billion. Our net debt, besides normal interest-bearing loans, as you find it in our financial report, include pension liabilities and impact from leasing liabilities under the new IFRS 16. When we exclude the IFRS 16 lease-related leases on the balance sheet and pension liabilities, and focus on the interest-bearing loans, we can conclude that they have been reduced by SEK 1.5 billion in the quarter.
The reduction in net debt, in combination with increasing operating profit, has contributed to a significant reduction of leverage. Net debt, including pensions and IFRS 16, is now at 1.7 times adjusted EBITDA. If we add pensions and IFRS 16 effect to the net debt, we are at 2.5 times adjusted EBITDA, which can be compared to 3.2 one year ago. Let's move to page 15, and back to you, Mattias.
All right. Thank you, Lars. So, just a few words on the outlook then. So, we continue to guide for 2% to 4% organic net sales growth for 2020. Nothing has really changed fundamentally on an overall level from our perspective.
From when we look at things from a customer perspective, we expect the overall positive demand pattern to continue, and this goes for both capital goods and consumer goods. We also get positive signals from customers on our newly launched products, which I think is very encouraging, and we expect the same with the ones that we have in the pipeline for 2020. So, that gives a bit of encouragement for the year in front of us.
We also enter this year with a stronger order book, in total compared to, when we started, 2019. However, we have been facing a decline in orders in Surgical Workflows for two quarters in a row now, mainly related to, Americas. So, this is something that we are very aware of and, addressing also internally with reinforcing the organization, here. And, yeah, we keep monitoring the, our activities closely and, really working hard to reverse the, the trend of the last two quarters. But all in all, if you weigh everything, together, we expect an organic growth in net sales of 2% to 4% for 2020.
With that, we can move over to page 17, and I'll just summarize briefly before we move to the Q&A part of the call. So if you look at the key takeaways when we summarize the fourth quarter of 2019, we continue to improve our business and deliver growth. So 2% to 4% expected for next year, in line with our predictions at the capital markets day in 2018. We see a positive margin development in all our business areas. The adjusted EBITDA for 2019 is 1.4 percentage points higher than the same comparison in 2018. Some of this improvement maybe came a little bit faster in 2019 than we expected.
We expected the main expansion to be in 2020, 2021, which was communicated at the Capital Markets Day, but I think it's good that things are a little front loaded in this sense. We continue as well to see positive development in underlying cash flows, and as I said, the thing to me and indicates that things are starting to work better from a productivity perspective is really all the activities that are getting traction and momentum when it relates to working capital, which is very sound for the company.
As a consequence as well, with the cash flows generated, our leverage has declined significantly, which again is another example of piece of evidence that we continue to move in the right direction. The board has also decided to propose to the AGM again that we will increase the dividend by 50% to 1.5 SEK per share.
Those are really the main takeaway, and so finally, overall, I'll just continue—we will just continue with our efforts to continue to work closely with our customers and really help them create value in their business and continue to strengthen our way of working in the coming quarters. So with that summary, I open up for questions. Thank you.
Thank you. Ladies and gentlemen, if you do wish to ask a question, please press zero and then one on your telephone keypad now. The first question is from Annette Lykke from Handelsbanken. Please go ahead, your line is now open.
Thank you so much. First of all, could you provide a little bit of color on the two order cancellations you had within acute care therapy? Where were these, and also on a regional, maybe product area as well, and also why these was canceled? Then you positively say that the FDA remediation program are on track, and you have unutilized provisions of around SEK 234 million, and you used about SEK 154 million in 2019.
So would it be fair to say that you have unutilized amounts corresponding something like 18 months? And is this in a timeline you also see as a finalization for the remediation program? Or, are we at risk that you will, during 2020, make a further FDA provisions as you, you know, on top of the already SEK 2 billion made there since 2014? Then I have some question on the FX afterwards.
Okay, good. Well, expect that when it comes to the cancellation, these are our two contracts that we've had since 2017, which are lower margin orders in the MEA part of EMEA. And where we've concluded that it doesn't make sense to continue to have it on our order book and finish supply this order. So the SEK 57 million in total, it's related to both Surgical Workflows and acute care, but that's the only time we deal with it.
When it comes to the FDA remediation, we do feel that the permission that we have is enough, otherwise we would have to change the course. And we do expect our program is running at full speed in all the relevant facilities. We expect this to continue in 2020, as we guided for, and we do expect that the remaining provision is enough for that work.
Okay. Then on the margin, and I know you, you're not so happy to talk about margin guidance, but if we look at the, and we strip out the effects of the SEK 200 million for the fourth quarter or SEK 400 million for the full year 2019, I think it's fair to say that your EBITDA, or just the EBITDA, like, if you strip out currency, is basically flat. And although you highlighted that you are gaining traction here, what should we expect for 2020 in this respect, as you also highlighted on your call, the effects you've seen have materialized already in 2019?
Yeah, well, you're absolutely right. We're not gonna change our view, and we will not provide deeper margin guidance. What you need to keep in mind, and what you didn't mention in your summary there, is that we've also had the headwind from expiring TSAs during the year. We've had remediation investments in addition to what we had the year before, and we have the preparations for EU MDR.
So when we talk about underlying margin improvement, it means offsetting these effects as well. So if you account for that, because these are things that we will get through during 2020, there is a better underlying margin expansion.
Okay. Thank you.
Next question is from Carina Elvin, from Danske Bank. Please go ahead, your line is open.
Hi, good morning. So just a few questions on the FX effects again. It was SEK 200 million only this in fourth quarter and SEK 400 million for the full year. Could you describe if you've had any hedging profits or losses during the year? And also, what is the value of the current cash flow hedges on the balance sheet, and how that potentially will impact profits going forward?
Yes, when you look at the current impact that we have in the fourth quarter of SEK 200 million.
You should also remember that the fourth quarter for us is the biggest quarter when it comes to profit, sales, and profit. So we get a proportionally higher share in the fourth quarter, so that is more normal in that sense. And when it comes to forward looking on our hedge putting, we have some hedges coming into next year, which are slightly negative, but there is not a big material impact, because we also have, of course, principles also coming in the other direction.
Okay, thank you. And also, no, sorry, that was all for me. Thank you.
And next question is from Kristofer Liljeberg from Carnegie. Please go ahead, your line is open.
Yeah, thank you. Three quick questions, if that's okay. The first one is for Surgical Workflows. How soon do you expect sales and order momentum to pick up again, and whether you see the weakness here in the last two quarters as temporary?
Second question about the margin, you have previously said that you expect a large margin improvement in 2020 versus 2019. Now, the currency impact, of course, helped the margin more than expected, I believe, in 2019. So how do you view that previous comment evolving here? And the third question about the tax rate, 34% in the quarter seems to be higher taxes in the US, so how should we think about the group tax going forward? Thank you.
All right. Thank you. When it comes to the Surgical Workflows, then we do—the reason we believe it's temporary is still that we see good activity levels from our customers. In the areas where we have the high market share, so outside the US, primarily, we don't see a big underlying weakness, especially not in our most important markets.
The main concern is in America, the US, specifically, and we've but worked both during the third and the fourth quarter with reinforcing our organization to move this in the right direction. So we do expect this to get some traction during 2020. So, that's the reason for our view on that as well.
When it comes to the margin expansion, we do expect still our underlying productivity improvement to continue in good steps in 2020. But you're absolutely right, that we've had a little bit more currency tailwind than we expected. So it's difficult to predict where we will end up. So the probability of a much bigger step has of course gone down a little bit, given that we made a bigger improvement in 2019. I can't really give any more detailed guidance on that. When it comes to the question on the tax rate as well, I didn't actually hear that, but I hope Lars picked it up.
Yeah. No, you asked about the higher tax rate. And yes, we have an impact from the geographical mix. We are making more money, growing in the US, that and some other geographies with higher tax rates. That impacts the tax rate pretty heavily. And also, US tax reform is impacting us from, again, PMD, and that is also contributing to the higher tax rate. And given this will also continue when we go into next year, so we will have a higher tax rate than we have had historically.
Do you think you will be able to compensate anything on the tax rate versus the 34% you had in 2019?
That is a work ongoing continuously, and we are working on that. I cannot give you more guidance on that today, but of course, we are not happy with that level, so we will work on that for sure.
Okay. But the current, what you think is the best guess? Because I think consensus is more closer to like 25% margin. It's a big difference if you have 34% versus 25%, so I guess it will be. I think you have...
Yeah
To give some sort of guidance there, since this is a higher level than in the past.
Well, as I said, in the tax rate we have now is in line with the result we have. So, and that is impacting us going forward. So that you should not calculate going back to that level. We are at 34% now, and so in the next year, we will work trying to bring it down from the 34%, but, not, I will not go give you a clear guidance more than that.
Okay. If you're very successful bringing it down, what, what are we talking about then, 30%, or is that a good assumption?
I will not give you any guidance on that. Sorry, Kris. Yes, sir.
Okay. I see. Thank you.
Next question is from Craig McDowell from JP Morgan. Please go ahead, your line is now open.
Thank you. Good morning, everyone. Just two questions from me, please. Firstly, please, can you give us an update on the progress of the mesh litigation? You previously said that trials would start early 2020. Have you had any further visibility on this, on where and when trials will start? And could you give an update on case numbers? And linked to that, please, could you give an indication of the cash out that you expect on the mesh provision in 2020? Thank you.
All right. Thank you. But yeah, unfortunately, only short answers on this one. We have no news when it comes to mesh. Nothing has changed there. As soon as we have any change that is material, we will, of course, disclose this, but there's nothing at the moment... and consequently, we can't give any guidance on the cash outflow because of this either. So we need to see what ends up here with the process milestones, and then we can maybe give a bit more guidance, but not today.
Okay. And just if we can follow up, the various sort of measures you're taking on adjusting the manufacturing footprint, can you give any indication on what restructuring charges you expect through 2020?
Well, there's not many restructuring charges in 2020 for the ones we've announced now. They were taken in 2019. What we have said when it comes to restructuring, over time, we have said a level of around SEK 200 million. Last year now in 2019, we are more, more towards SEK 300, and we should be moving, so say, may back to more normal maybe levels, but we don't give guidance for single years. But on the longer term, we say that around SEK 200 million has been.
Great. Thank you.
Next question is from Scott Bardo from Berenberg. Please go ahead, your line is now open.
Yeah, thanks very much for taking my questions. First one, just relates to you describing 2019 as an implementation year, previously with, you know, further underlying strides to from 2020 and beyond. You've made some comments here already, but can you please give us an update as to where you are with the SKU reduction and transfer of production warning letter appeasement in the US?
Just some sense of timescale and whether there's likely to be any quarterly disruption or near-term impact from any of those endeavors. Also, obviously, cash generation is coming relatively strongly, and your leverage position is better than I think most would have expected. Can you please just re-qualify your expectation for the Applikon acquisition now? Once you've absorbed that acquisition on a full year basis, where would you expect leverage ratios to be for the group for fiscal 2020? Thanks.
All right. Thank you, Scott. Yes, it's true. 2019 was a year of a lot of things being implemented, and we're starting to see the results from this. When it comes to the SKU reduction program, that's going according to plan. There's really no news with that. It's a healthy exercise that we're going through, and that's not been disruptive at all. It's been positive for the business. When it comes to the warning letters in Marana and Fairfield, we are in full swing when it comes to remediation, and I should reiterate what I said earlier, that 2020, we will spend on remediation these two factors as well.
And simultaneously, going through the move of the production from these two facilities to our Wayne facilities, and those projects are going according to plan, as well. On your question on leverage, then the Applikon acquisition will add just about 0.2 to the leverage, and we expect to be able to work that down again during 2020.
Okay, thank you. A couple of minors, please. I think historically the company in previous viral outbreaks like SARS or H1N1 have benefited from strong demand in ventilators. I just wonder whether you could comment at all whether you're seeing any increasing activity surrounding the coronavirus outbreak, please.
And also perhaps Mattias, you could give us some sense on the PMA for covered stents, which I think you've historically described as being you know one of the biggest swing factors to revenue growth in 2020. Where are we with this, please? When will we likely get some sort of answer here? Thanks.
Thank you. Well, when it comes to the virus outbreak, we already see increased activity. So our team in China is working intensely with our factories, not only for ventilators, though I would point out, but also our heart lung machines and the oxygenators required for this.
So we do see a pickup in demand for this, and we're really just trying to work as closely we can with the customers to help as many patients as we can, as well. It's an addition, I guess, to the normal influenza peak that we see this time of the year. On the PMA for covered stents, nothing has really changed since we talked about this in 2019. Again, we're still in the process of the dialogue with FDA on moving this forward. So no, no news at this stage.
Okay, thank you.
Yeah.
Next question is from Sten Gustafsson from Nordea. Please go ahead, your line is now open.
Yes, good morning. Sten Gustafsson from Nordea. A few questions. First on, could you give us a number of, well, how much of the provision you booked, related to the US mesh litigation, have you utilized in 2019? That would be helpful. That's my first question.
And, secondly, when it comes to the FX, you said, if I heard it correctly, that it would the hedging effect for 2020 would be negative. Is that correct? And if, can you give us some sort of guidance on what do you expect based on current currency situation and your sort of expected deliveries for 2020? That would be very helpful. Thank you.
Yes.
Starting with the first provision regarding mesh, as we have said before, we don't give any real information on that since we want to keep this not to disturb the process. But the full provision was made for possible outcomes and also the legal expenses. So it has only been used so far on connected to the legal expenses, so therefore minor impacts and changes to that.
And when it comes to FX, also, as I mentioned, there are minor impacts that are connected to FX hedging. As it looks, depending where we stand right now, then of course, you know, currency moves. When it comes to the translation, the normal translation impact, we don't see big impacts year over year, given the rates that we have at the moment, we don't expect big impact from that as it looks. I hope I've answered.
Well, does that mean then that the sort of SEK 400 million uplift this year will be basically zero, or around zero, for 2020? Is that how we should read it?
We don't give guidance on the transaction part. We will come back and give you more information when we come in the quarters going forward on currency development, as we do every time. But when it comes to pure translation, there is minor impact. Then translation, we cannot give you any guidance on this, depends on how it develops.
All right. Okay. Thank you.
We have a follow-up question from the line of Annette Lykke from Handelsbanken. Please go ahead, your line is open.
Yes, it was just on the first of all, on the restructuring cost, and that you say that long term, they're expected to be around SEK 200 million. Is it fair when you have such a, I mean, you have had a restructuring cost for a very, very long period, as long as I followed you, and now you're also expecting it not to be zero in the longer term. Wouldn't it be more fair to see those as a part of the operational cost if they have this kind of repeating nature?
On the MDR preparations, I might have understood what you've said before, but it was my impression that, once you have finalized this, you would allocate more resources into innovation from the cost you have within admin and the cost you have had within R&D, to prepare for the MDR, by May this year.
Starting with the restructuring, yeah, I think the reason why we show it is that it can be a significant amount in one quarter if you make a decision, so it will help you to see what kind of impact that has. And then if you want to decide to have it in or out, that is your decision. And when it comes to EU MDR, yes, it's an intensive period working on that.
And it, of course, takes some of the resources from the R&D organization, but also other parts of the organization. And when that phases out, some costs will disappear, what we can call external costs, and some costs can, of course, can be more moved back to the core R&D, you can call it.
There's been some general studies made that MDR preparations could be something in between 300 to 500 basis point of sales in Europe. Is that something you recognize, or will you be able to share with us how much of the MDR preparations, is it a 100 basis point, or how much of your margin has been allocated into this area?
Yeah, we don't disclose what the exact amount is, but it's significantly lower than the 500 basis points. We've heard the same benchmark figures as well, but we don't see the need for that. That comes from various consultants in the area, and we're doing a lot of this work ourselves, some help with externals, and that's the increase you can see really for it and what would disappear later on, but it's for sure not 500 basis points.
Okay. Thank you.
Another follow-up from Kristofer Liljeberg from Carnegie. Please go ahead, your line is open.
Yeah, two things. First, you talked about the currency effects for the full year. I'm sure I could calculate that myself, but the SEK 400 million mentioned, was that only the translation effect?
No, it's both translation and transaction together.
Okay. And the transaction part, how much was that?
The transaction part was SEK 132 million, and translation, SEK 68 million.
Sorry, how much was translation?
SEK 68 million.
Transaction, you said SEK 132 million, no?
Yes, and total, SEK 200 million.
Okay, but I mean, for the full year, wasn't it SEK 400 million for the full year?
But that I don't have on top of my mind. That I need to come back to you on.
Okay, that's fine. And then finally, on the PMA for the covered stents, you said you are in a dialogue with the FDA. Could you give some more clarity? Because I think you filed that quite a while ago. So has... Is there any problems that has emerged, or is the process going as good as you were hoping?
Yeah, there are no particular problem that have emerged. It's just a very drawn out process, that's it.
Okay. Thank you.
We have an additional follow-up from the line of Scott Bardo from Berenberg. Please go ahead, your line is open.
Yeah, thanks. I just want to come back to Kristofer's question on tax, please. I think Getinge's underlying tax rate has been around the 27% to 28% region for the last 13 to 14 years. So what I'm trying to understand is what has actually changed for a structurally higher tax rate? And do you expect that then to be coupled with higher cash out as it for taxes paid? So a bit more clarity there, please. That's, I think, needed. Thank you.
Yeah. Thank you, Scott. Yes, we are having a somewhat higher tax rate compared to historical, very stable, 27%. And from a cash out perspective, we still have tax loss carryforwards that we can utilize, so somewhat lower cash out is to be expected. And of course, that is depending on the possibility to utilize them, and that can vary a bit over years, but from a cash out perspective, over time, yes, it should be lower.
The reason for the increased tax rate is that because a lot of your business is coming from now, higher tax jurisdictions, or is it that you've now turned profitable or in the US market or something? Can you help explain what the structural difference is?
Well, it is mainly related to profitability or profits generated in higher tax regimes. That is the very short and simple answer.
Thank you. Could you give some examples of those regions for us, please, Lars?
Well, you have, as I mentioned in the beginning, there, US, impacting and also some European markets, and also that we are growing outside, so say, the old European market is also impacting. So that is... And the general trend is higher tax rates. If you look at the politicians, what they are working towards, and that is impacting us as well.
Okay. Thank you very much.
That was our final question for today, so I'll hand the call back to the speakers for any closing comments. Please go ahead.
Great. Thank you very much. I think I made the summary already before we started the Q&A. So, I just want to thank you for your attention and wish you a good rest of the day. Thank you very much.