Thank you very much. Welcome everyone to this call where we will go through CellaVision year-end bulletin and a little bit of background to CellaVision and the financial connectivity's for Q4. I'm calling in from a winter sunny and cold Lund. Lund is where we have the head office of CellaVision. My normal role is that I'm CFO for the company. Currently I'm doubling as acting CEO. For those of you who have called in the past, I'm sure that you recognize that it usually was Zlatko Rihter that presented these reports. He has left CellaVision in November and is currently heading up Mölnlycke Health Care as CEO for that organization. CellaVision has appointed a new CEO in Simon Østergaard. We are looking forward to welcoming him on board in March. In the meantime, I'm doubling as acting CEO. As usual, we will start with a short presentation of CellaVision and then continue with activities and financials for Q4 and also full year. At the end, there will be time for some questions and answers. Please move on to slide number three. Our vision, background to our story and what we do. CellaVision is a med tech company, and we're active in the field of digital morphology. To be more precise, we analyze blood cells, and we provide solutions for the blood lab in hospitals and commercial labs. Our vision is to replace the manual microscope and not only replace the image capturing parts, but also automating the analysis of the image and creating, with our technology, an efficient workflow in the blood lab. Since this is high volume, routine analysis, the value that we create when implementing our solutions is very good for the healthcare sector and for the patient in the end, a great value there. Please move on to slide number four. The first market that CellaVision approached around more than 10 years ago is the largest labs. That's where it makes the most sense to automate. We find about 17,000 really large labs around the globe, about 5,000 in Americas, 5,000 in the EMEA, and 7,000 in the APAC region. Our definition of a large lab is a lab where you do more than 130 blood samples per day. For this market, which is our original market, we created instruments, what we call our high- capacity instruments, and then they are well-suited for this market. I talked before about that this is a routine analysis. If you look at it on a global perspective, there is about 2.5 billion blood samples taken every year. The first step with a blood sample like this is that it goes through an instrument called a cell counter. It's a high- speed analysis. About 85% of the samples, they get analyzed and to a sufficient level in that instrument. In about 15% of the cases, a more in-depth analysis is needed, and this is where CellaVision instruments come into play, or you can use a manual microscope. Our market penetration today, let's say, is that we do globally, about 22% of these 380 million samples, they go through a CellaVision instruments, and still 78%, they go through the manual microscope. It's not homogeneous. In some areas, a lot more than 22% go through CellaVision instruments in our, what we call mature markets, and then other places, it's a lot less. On average, it's about 22%, meaning that there is a lot more to do on these large labs market that is our original market that we have approached. Slide number five, please. Last year, we launched a new system, where we could also analyze blood samples more suited for medium-sized and small-sized labs. It is lower in capacity and significantly lower in price. That's why it's not suited for the high lab sector, but more suited for the medium and low. Our definition is that if you do less than 130, it's a medium lab, and if you go even lower, so it's less than 30 samples per day, then we call that lab a small lab. In this sector, there's about 1.5 billion blood samples drawn every year. The process is very similar to the large labs, and about 15% of them are flagged out for in-depth analysis. Then you can choose to use either a manual microscope or, of course, CellaVision's new instrument, we call it the DC-1, which is well-suited then for this medium and small lab sector. Since it's a brand-new instrument, we haven't sold so many. If you count in percent, it's less than 1% of the world market that goes through our instruments, and by far, the majority goes through a manual microscope. As we launch this solution, we can see that we can gain big market share in this sector versus the manual microscope as well. Move on to slide number six, please. Okay, we do commercial operations in an indirect business model, and it's efficient and scalable for us to do it that way. On the sales side, we sell through partners, the benefit is that these partners, they have existing sales force and service technicians around the globe. They also work with the other instruments in the blood line. When a hospital or a lab exchange their blood line, they are looking at an array of instruments that needs to be replaced, these partners, they have the full assortment. From a selling point of view, it makes sense to replace everything at the same time. We have complemented this indirect sales model with local presence. Only a few persons, CellaVision employees in each country, they support and help our distribution partners in these countries when it comes to talking about the benefits of digital morphology, of doing it in our instruments instead of using a manual microscope. We have learned that it makes a big difference if you have these market support specialists in place or not. Currently, we have them in 18 countries, 18 markets, and we reach more than 40 countries with this. We still have some white spots on the map, but the coverage is starting to be pretty good, actually. When it comes to manufacturing, we have two approaches. One is a third-party manufacturer, and one is in-house. When it comes to our instruments, both large and small, we do that with a third-party manufacturer in Jönköping, north of Lund in Sweden. When it comes to reagents, stains, then we have a facility in Bordeaux, in France, where we do that manufacturing in-house. We are about 180 employees worldwide as a company here, and most of them are based here in Lund. At the bottom of the page, you see the names of all the partners that we use for sales and distribution. Well-known names, well-known players within the field of hematology. The top row, they are good at selling our large labs instruments, and the bottom line is for the smaller and mid-sized labs. Next slide, please. Slide number seven. Well, this is the CellaVision strategic agenda. We have five strategic agenda topics. If you look at the first one, geographic expansion, we still have some white spots on the map, and we find that this indirect business model that we have is very efficient in covering these white spots. What we do is add new market support presence, and with that, we can open up new markets and very fast grow and cover more countries around the globe. The solution that you use in a blood lab is the same if you do it in APAC, in EMEA, or in Americas. Geographic expansion is very important for us. Segment expansion is important as well. We started out in the large labs. We have instruments for small labs, small and medium-sized labs as well, and we also have instruments aimed for the veterinary market. The veterinary market is a lot smaller than the human market, we have developed instruments for that as well. Innovation is an important goal and strategic agenda for us, we continuously develop new systems, and new analysis systems, and we spend about 15% of our revenue, we're reinvesting innovation. That's an important part. Streamlined supply chain, well, both 3PM, third-party manufacturing, and in-house, we focus a lot on quality, and we focus a lot on cost control in this area. When you're a company like ours, work with partnerships for sales and for production, the partnership is important to maintain. We spend energy in making it easy and simple to interact and work with CellaVision when you're a partner to us. Please change for slide number nine. Here we have the hematology workflow. First, I'd like to talk a little bit about the workflow and the instruments that we have in what we call a blood line, it's a series of instruments. Secondly, we can talk about CellaVision part of that offering. As you see on the top line, we have the large labs described, and the bottom line is the small medium-sized labs. The first thing that happens when a blood sample comes into the blood lab is that it goes through a cell counter and about 85% of the samples are being analyzed and the result are sufficient in that step. 15% of the cases, you need a further analysis. The first step to do is actually to prepare a glass slide that can go under a microscope or into the CellaVision instrument, and you make a smear and you make a stain. These two instruments are called slide preparation instruments. Then the next step is to color the slide to get good contrast of the blood cells that are on the slide. CellaVision has also developed staining protocols, describing the procedure on how to do this in the best way. Then the final and last step is to put the slide in a CellaVision instrument to get the automatic analysis going. You could use a manual microscope as well to do that. For the large labs, you can see that the three first steps, those instruments are provided with our partners, the cell counter, the smear maker, and the stainer. They're part of our partners' assortment. What CellaVision can provide here is stains that goes into the stainer machine, and then stain protocols, to get the right procedures going. Of course, our large CellaVision instrument for digital morphology. If you look at the small and mid-size labs, CellaVision can take a bigger responsibility of the workflow. Our partners, they provide the cell counter still, a smaller version of it, a little bit lower capacity and cheaper, of course, as the rest of the instrument in this blood line here. CellaVision can also provide the smear maker to make the glass smear. We can provide the stainer, to stain the glass, and we can also provide, of course, then the liquid, the reagent that is sold or put into the stainer, and the stain protocol and the digital morphology system. Very similar workflows, but CellaVision can take a little bit larger responsibility for the small and medium-sized labs. Slide number 11, please. We're into financials and the fourth quarter highlights. We look at the three regions, Americas is usually our biggest region. We can summarize with that Americas has had a tough year. There is a slight improvement in Q4 compared to the previous two quarters. It's still negative, 43% versus last year, which was a very strong year then, so it's a tough comparison. The full year comparison year-over-year is negative 34%. We can conclude, though, and we're happy to see that the attachment rate, if there is a blood line being replaced in the Americas, the attachment rate or the ratio of these blood lines being sold with the CellaVision instrument, that's unchanged. Our conclusion is that when the market recovers, then our sales should recover with it. A few activities that we've had on the U.S. market, the DC-1, the small lower capacity instrument, got FDA clearance in October, and by that it's commercially available in the U.S. We continued to work with the launch of RAL stains, the product that are being produced in the factory in Bordeaux. We have previously been strong in Europe. RAL has a strong history in Europe, but not so strong in Americas and in APAC, and we are continuing to globalize that offering. The APAC region, it has had a strong Q4 and actually a very strong year as well despite the pandemic. We have 23% positive, versus last year in Q4, and the full year comparison is positive 29%. It's mainly driven by our two largest markets in Asia, China and Japan. In China, we haven't seen so much effects of the COVID pandemic. The business climate is basically normal and good activities, so strong sales in China. We also see good demand in Japan, and we see that some old technology is being replaced with CellaVision technology. That has given a special boost to the Japanese market during the year. Some areas in APAC are still affected by the COVID and the second wave of the COVID, like Australia, Korea, and India, and they're still affected and travel restrictions are in place. EMEA had a stronger quarter, the last quarter of the year, compared to the previous quarters. There was a +6% versus last year for the EMEA region. Full-year growth was 44%, but we acquired a company, RAL, last year in Q4. If we adjust for the structural effect of that, it was negative four full year for the EMEA region. We could see a few larger tenders in Q4 that helped the sales and also compensated a bit for the difficult business climate that we still have seen in Europe. In January, we established market support resource in Russia, and it's proceeding, and registrations of products have begun in Russia. That will be our next market in the EMEA region that we open up. Next slide, please. Slide number 12. Yeah. Continued key highlights. The CellaVision DC-1 we talked about, we got FDA clearance in October, and we have now information that our key partners are planning to launch in March already. As soon as the pandemic and the business climate allows, we expect to see increased sales from a low level, but increased sales of DC-1 instruments that is well suited for this market. Registrations are ongoing in China and they're continuing according to plan. We have the CE mark from before, so now it's only China that is left for registration. The whole world is open for DC-1 sales. Comments regarding the COVID situation. We continue to adapt to the COVID situation. Still travel restrictions, and we work digitally, both internally with meetings and also externally with meetings with customers and trainings and service technicians. We're happy to say and to see that we have not had to reduce our workforce at all. Our workforce is intact, and we are ready to accelerate. We have the staff in place, and as soon as the market recovers, we are ready to accelerate. We're waiting to see the positive signals in the market. Reagents distribution. We acquired the company RAL. RAL produces reagents, the stains, and we acquired RAL in October 2019. Historically, RAL has been strong in Europe, and now we are globalizing the assortment, and tests and evaluations are ongoing in the APAC region and in the Americas region. Last but not least, we're looking forward to welcoming Simon Østergaard as new president and CEO of CellaVision, and he will come on board in March. In a month's time, we will welcome him on board here at CellaVision. Okay, next slide, please. Slide number 13. Financial development and some key insights for Q4. You can see that we had a sale of SEK 131 million in Q4, that was a reduction with 13% compared to the last year, same period. The comment there is that we had negative FX effect. The Swedish krona has strengthened versus euros and dollars, the FX effect was about 6%, meaning that we had an organic growth of approximately 6% in the area. Stable gross margins and underlying operating expenses versus sales. We can see that we have 41% if we take the ratio of expenses versus sales, it's quite low, it's proving that our cost-conscious operations is preserving the margin for us. The EBITDA margin is 31%, we feel that under the circumstances, that's a good margin. We have a significant effect from COVID also effects from negative FX, still we have 31% EBITDA margin. Next slide, please. Slide number 14. Further comments on the Q4 results. Well, we commented already on the effect of the FX on the sales. If we look at the full year, we also have a structural effect. We did the acquisition in Q4 of RAL in Q4 2019, and if we deduct the structural and FX effects from the full year, it's not a 2% growth, but it's a - 10% the organic development on the sales. I talked before about the expenses and how we run a cost-conscious operation. We haven't had to lay off or reduce any workforce, but we have prioritized our projects and focused on the most important ones, and by that, we have been able to reduce our expenses. The organic reduction adjusted for structural and FX effect is -1 4% year-over-year. Development projects, that has increased. Our capitalized R&D has increased versus last year. The full year is SEK 25.5 million versus SEK 16 million last year's. It means that we have been able to prioritize our important development projects. There we have not reduced activities, which we think is important for the future of CellaVision. If we look at the cash flow, the full year cash flow for the company, the total cash flow was approximately zero. A couple of one-time effects on the cash flow is that we did not do any dividend like we have done in the past. Usually, we have had dividends, but no dividend this year due to the COVID. Also we had a slight increase to inventory due to a last-time buy of a critical component. That increase will continue into 2021, and then we will see reductions of inventory over four, five years. It's a temporary increase in inventory that we see related to this one-time buy. Next slide, please. Slide number 15. Here is the financial development year-over-year. If we look at the growth trend, we can see that 2020 is definitely a different year in the light of COVID-19. Growth here is 2% only compared to the previous periods here. A lot lower. Gross margin is around 66%, which is lower than previous periods as well. That's a product mix effect from the acquisition of RAL and adding the product group reagents has reduced the overall gross margin to this level, to 66%. Then we have the ratio operating expenses versus sales. We can see that the cost-conscious operations, we end up at 43% on this key KPI, which is quite low over an historic period as you can see. With this cost-conscious operation and scalable business model that we have, we've been able to preserve quite good profit margins. The EBITDA margin for the year is 30%. If we look at the chart down below here, we can see definitely that 2020 is a special year. There's less growth, and we can also see that operating expenses is down and EBITDA is down, but not as much as it would've been if we had kept our original plan for operating expenses. We think that we have balanced this special year, 2020, in a good way. That was the last slide. Thank you for that. We will now open up for questions. If you do wish to ask a question, please press zero one on your telephone keypad now. If you wish to withdraw your question, you may do so by pressing zero two to cancel. So, that is zero one to register for question. Our first question comes from the line of Ulrik Trattner from Carnegie. Thank you very much. I have a few questions. In the report, you sounded quite muted in the interim market recovery in the U.S., specifying that recovery is supposed to happen once vaccination program have had effect. Are we still to expect growth in the first half of this year in the U.S., or is this more on a negative stance that you're expecting growth to rebound first in the second half of this year? Yes. Exactly. U.S. being the largest market for us and a very important market. We follow the vaccination programs as careful as you can. We found some good websites where we can see the trends. If I have the right data, it looks like about 10% of the American population or the U.S. population has now been vaccinated. The vaccine program seems to be rolled out a little bit quicker there than average around the world, I would say, or quicker than in Europe at least. I think that's the most important factor to have the market go back to more normal conditions or normal business climate. Another factor is that we see that we are learning to do business, or businesses are learning to cope with the pandemic and using digital ways of doing business. There is a slight effect of that learning curve, we feel, but the most important factor is actually the rollout of the vaccines. Another comment to that is that we have rather long sales cycles. You can see that how you replace a blood line in a hospital, it is a rather long cycle from first visit to installment and training and that line being put into operation. Of course, when the pandemic hits, it slows down a little bit, it takes a little bit longer time to slow down, but then as the pandemic wears off. Since the sales cycle is long, it takes a little longer time to ramp back up again. We are confident, or we are optimistic, but it will take a little bit time before we are back into full swing, and it is really hard to judge and say. I think the best way is to actually follow the trends of the vaccinations, and also to keep in mind that the sales cycles are quite long for CellaVision. Would you say that it's more crucial that the society opening up, that you have the availability to go out to these labs, or is it more tied to the general health for diagnostics, as this is part of a blood line that is back up to capacity, back from where it's been shifted more towards COVID-19? Yeah. For the sales cycle for us, it's important to be able to actually visit the lab and to have access to the lab and to do the installments, do the trainings, do the quality systems, and get the new blood lines operational. That's important for us. To do that, you need to be able to travel, and you need to be welcome into the hospital. If the hospital is too busy taking care of other things that are more urgent, then it's hard to get the attention that you need, or it's hard to find the time slot. I guess it's a mix of the two things that you're mentioning. Okay, great. Just as the DC-1 was approved in October last year, how much did the DC-1 contribute to sales in the fourth quarter? Very small contribution so far. It's basically pre-launch systems that we have shipped, and we expect to see as the market recovers and as our partners focus more on this and work more actively with the DC-1, then we expect to see more increase in the sales. So far, the DC-1 has been hard to launch. It's a new technology, and new technologies are not that well-known, and it's part of nature that you need to talk a little bit more about it when it's a new instrument. That's even more difficult under a pandemic than to sell some technology that is somehow known, at least our large labs are a bit familiar with our instruments, I would say. It takes a little less physical meetings to get the sales going. For the DC-1, it's been more difficult. Okay, great. On to its operating expenses, you're talking about structural cost reduction. Year-over-year, 14% for the full year. As I look at the numbers, it seems like your capitalized R&D have gone up 37% year-over-year. Wouldn't it be more fair to look at adjusted numbers? By those numbers, it seems like there is simply close to zero. There is cost reduction year-over-year. Yes, I would say that's a valid point, actually, because capitalized R&D increased from SEK 16 million to SEK 25 million, and that is seen as a reduction, of course, of expenses. In one way, I think it's a fair comment, and then in another way, we can say that we have been more efficient with our R&D time spent. It's been spent on projects that we will live off in the future. In that sense, it's been more efficient this year. It was actually quite low last year because the DC-1, the new small instrument, was in the final stages. In the final stages, there was some fine-tuning and some commercialization and industrialization of the product. Those expenses, we were not able to capitalize. I'd say it was rather low last year, actually, and better spent this year. Okay, great. Last question before I get back into the queue. It's actually regarding to capitalized R&D and depreciation and how we should be able to decipher the gross margin between the different segments. Is there any way that you can specify RAL sales in the quarter, or at least specify what was the gross margin for your original morphology analyzers? Also, on RAL's gross margin development, it seems like it's down closer to six percentage points year-over-year, although we see a gradual recovery from last quarter, which was on a really low point. Any reason for RAL being at that level of the gross margin? Is that based on scale? I think the part of our business that has had less impact from the pandemic is actually the RAL business because it's not installation product, it's recurring business. We haven't had so much hiccups in the supply chain either. It's been working quite smooth under the circumstances. We have actually seen a bit of growth year-over-year on that segment. We're quite pleased with the development there. Long-term margin developments for RAL, well, we think that we can see that increased volumes in a factory usually leads to some improvements, but we also see that improvements are usually linked to hard work. It's not going to come overnight. It's probably hard work and gradual step-by-step improvements that we can expect. We also see that it will be hard to come up to the same level as we have for the instruments. I think the competition and the market climate makes that very difficult. Okay, great. Just if you can help us sort of decipher what RAL sales amounted to, or if you can specify the gross margin of your morphology analyzers ex RAL, what those numbers were? Yeah, I can give some hints on that. In the report, we have one table that is reconciling sales, and in there's a product group called reagents. Reagents is the largest part of RAL sales, almost 90% or in that area. By following that in the report, you can get a good sense of the development. What was the other question? It was- The gross margin development for the rest of the assortment. The rest of the assortment is quite stable actually, when it comes to gross margins. You can see smaller swings. I would say if you follow currency effects, because we have the sales in euro and dollar, and most of the costs are in Swedish krona. There is some leakage, like computer components and optics. We buy them in krona. There is a leakage from US dollars into the krona, with a bit of delay. I would say by following the exchange rate, you can follow the old gross margin development quite well. Okay, great. Just to be clear, a good proxy is that 10% of system sales is actually RAL systems as well, so capital goods. There is a bit of RAL systems that are being sold in the numbers, but it's quite small numbers so far. Great. Well, thank you very much, and I'll get back to the queue. Okay. Our next question comes from the line of Felix Wienen from SFO. Please go ahead. Hi, Magnus. Thank you very much for running us through the numbers this time. I really appreciate it. A couple of questions, please. The first one would be if you could add some more detail to the comment around the tenders in Europe, and whether these have translated into revenue already as it sounds in the fourth quarter, or whether these have been orders, and probably how they phase through the year, if you could add. That's the first question. Yes, part of this business is actually that you reply to tenders. I wouldn't say that it's extraordinary or a one-time effect, but we could pinpoint that a few of them probably fell into the Q4 period, and it was related to sales in Italy and sales in Germany and a bit in the U.K. A little bit of a mix there. We think that that helped the sales a little bit for the European region in Q4. We have a volatile business, so it's not unusual that you see swings between quarters. We just highlighted that in the report because during the circumstances and the pretty tough conditions that we see during the second wave of COVID in Europe right now, we thought it was appropriate to highlight that in the report. Sure. Thank you very much. The other question also comes back to R&D and capitalized R&D. Just for me to understand it better, does this increased capitalized R&D relate still to the DC-1 development or to other new projects? If it's to new projects, if you could give some more detail around the type of project. I think in the past we discussed about malaria or bone marrow analysis. Just some more detail would be fantastic and how you're getting ahead on these. Thank you. Yeah. The DC-1 is now launched on all markets except on the Chinese market, and as soon as our products are commercial in the market, all cost after that is expense. That's our accounting procedures to have it that way, and I think that's pretty much standard. The capitalized R&D is related to new developments, and it's both hardware and new platforms, new, more modern instrument platforms. Then it's related to software that you can load on the platforms and other software developments that are needed to have a competitive offering. You mentioned a few specific ones there. I won't do that, because usually we're not disclosing the pipeline of product development because it's sometimes an iterative process to move forward, and that could be reprioritization. Sorry. Over the period. We prefer not to comment on the specific ones, but large part of it is related to platforms for future instruments, I would say. That's fine. Thank you very much. Then just two more quick questions. The next one on leverage, please. I don't have the numbers in front of me right now. Where does net debt to EBITDA stand now, and where do you expect this to be at the end of 2021? The leverage. Sorry. Could you repeat that, please? Sure. On leverage is the question. The first point would be on net debt to EBITDA, where that stands at the moment, just because I don't have the numbers in front of me right now. Where do you expect that to end the year at? The year 2021, where do you expect net debt to EBITDA then? Yeah, I see what you mean. I have to pass on that. I don't have that numbers either in front of me or in my head. I have to pass on that one, sorry. We depreciate over five years on the loans that we have. That's the guidance at least. Okay. The loans are related to acquisition of the RAL that was done in Q4 2019. Okay, that's fine. Last question on RAL. I remember that in past conference calls, we discussed about the competitiveness of the product and competitors, I think Merck and others stepping up and maybe wanting to defend their market share instead of allowing RAL to scale. If you could share some anecdotal evidence of how that has developed, how competition has behaved over the last year. I think in a comment you also mentioned that competition is tough. Some more color would be fantastic. Thank you. I think when you look at products like reagents, you should look at the full cost, not just the cost per milliliter or per liter. You should look at the full cost of running your equipment. There's a part that's quality related, if you get good quality, because that saves time, and there is a part where that could save time in service and maintenance. There is, of course, the cost of the products. If you look at the whole perspective of all those parameters, we believe that the RAL offering is quite competitive actually. It has to be proven. It has been proven in Europe, and we think that we can prove it also in other parts of the world. We have some sales in Korea, for example, in APAC, and we are doing evaluations in both North America and in Asia to see if we can convince our partners and our customers that we have the best offering when it comes to this. I think also that the protocol, the staining protocol, the process description of how to use it, I think that's important too, as a factor. Will increase quality and save time in the labs. Okay, perfect. Thank you very much. That's it from me. I look forward to follow you over the next quarter and years. Thank you, Magnus. Thank you. I remind you that if you would like to ask a question, please press zero one on your telephone keypad now. We have a question from the line of Karl Oskar from Berenberg. Please go ahead. Hi, Magnus and everyone. I think most of my questions have already been answered, but I just wanted to tie a little bit back with what Ulrik was asking about in terms of the markets going forward. Obviously, I know it's a very different situation that we're in, but following on from the Q3 results, the communication from your end was that we're past the trough. Is this sort of a reiterated statement from your end? Do we think that we're past the trough, or should we expect more severe jumpy quarters going forward? Yeah, I expect it to be a rocky road still. I expect to see gradual improvements going forward. I also think it's a really difficult situation to predict what's going on because I think we're in hands of a lot of external factors when it comes to recovery in the markets, and quite closely related to supply and implementation of vaccine programs. I think we will see great improvements during the first half of this year. We won't be back to normal activities. That's the hypothesis that we're working from right now. We don't know if we're right or not. That's our view right now. Thank you, Magnus. That's all from me. There are no further questions registered, so I hand back to Magnus for any closing remarks. All right. Thanks very much for calling in, and thanks for your interest in CellaVision. Next time the report will be presented is in April. That's going to be our Q1 report, and then you will have a chance to meet Simon Østergaard, our new CEO, who will be presenting at that time. Thank you for now.
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