Earnings Call: Q1 2020

Apr 29, 2020

Yes. Welcome, everybody. It's really a great pleasure to have you here on the Sobeys call, knowing that we are competing with quite another quite a few other earning calls. So I go right into it. We'll start with the forward looking statement as per usual, and please take note of this. And then I come to the presenters of today, this is Henrik, our CFO and Mila, our Head of R and D, who will join me for this call. And with this having said, these are obviously unprecedented times, so I go to slide number 4, and very challenging times. So before we talk about our very significant top line and top and bottom line growth, just wanted to tell you that we absolutely take this situation very seriously and take charge. So for us, the first priority was to make sure that patients requiring any of our products get access to and we have achieved this. So we made sure that the supply chain has been ramped up in view of this new situation. For us, it was also important to make sure that our team is protected and we took the right measures at an early stage in terms of the quality of our office environment and also travel restrictions. But we also will make sure that we are staying in contact with our HCPs in a proper way and make sure that we respect obviously their priorities of today, but sort of make sure that we understand that we do care. In addition, we have been able to launch the bring on board the digital agenda for Sobe. We have launched Florio and Florio is really all about liberating and making sure that there are as few compromises for hemophilia patients as possible. I think this was an important strategic move for the group. And we have expanded our footprint internationally in China and we are on the way to do the same in Japan. And this bolstered by a very strong financial profile that Henrik is going to explain further this part. With this having said, what are the results? I mean, I think you have headline results, 42% growth on the top line, 44% earning growth. So pretty strong results. And when we go straight into the different business areas, you can see these results become pretty much alive. We had a very significant uptake also at constant currency with Kineret, driven by the correlated indications of the hyper inflammation as a result of the COVID-nineteen. We had spectacular growth with Synagis, so we ended the season very, very strongly and have been able to confirm our Q4 results with Synagis. So the product has performed extremely well under our ownership. And with Gamifant, I think it's important to note that we had 17% at actual currency, 11% at constant, but we had the strong quarter patient growth. And please remember that the Q4 results were very strong of 21% patient growth. And this current sales situation is basically a transition into a larger patient pool that we have followed with some concessions on pricing. So when we come to hematology, I'm very happy that we have been growing to drive this franchise at 30%, Obviously, driven by our hemophilia products and I will come back to in the later part implementation and we made our first strides with DOPTELET. Basically, when you think about on Page 6, how the group is developing, so basically what we have told you in the past is happening now and just by our results. The 2 core businesses have really grown exponentially and immunology has become an important second pillar in this franchise. It's very gratifying that basically our strategy is yielding the results. When you go to the next slide on Page 7, basically, the if you summarize this, we still have the appetite to grow hemophilia, and we see the positive momentum to do so. And I will talk about the some of the nuggets in a few moments. We have launched Cloriasis, for an example, With Doctor. Led, we have made our 1st imprint, the first 450 patients in ITP, so not insignificant already the impact in a very difficult environment. And COD, we are planning for launching in the EU and because recently also the COD indication approved in China. And basically, when you come then to immunology, we really want to further expand Gamifant, as we told you earlier, into secondary HLH indication and acute graft failure. Mila will talk about the clinical trials that we are currently ongoing and the clinical activities with Gamifant and also with Kineret. And obviously, for us, it's important that we continue to bring synergies. So basically, what we want to leave you with these challenging times really stimulate our appetite to do more and to do more in terms of supply chain ramp up, making sure that our products go through the clinical process and obviously that we make sure we are staying connected to our key customers and think about new tools and new ways of interacting with our customers and staying true to our values, whether about ambition, about urgency, ownership, but also about care. With this having said, I'll go straight to the hematology business review on Page 10. As you have seen on the report already, the hematology business has been doing extremely well. I just wanted to bring a little bit of life the first data points for DOPTELET. So SEK65 1,000,000 in the first quarter was quite gratifying for us, particularly as we were at the transition on the CLD location in the U. S. To transition out of Salix and taking charge ourselves. We think that with DOPTELET, we made the first impact. Obviously, it's not easy to launch a product in a more virtual access model, but we believe that we will have a stronger Q2 and be finally adjusting our commercial model accordingly. So going into the hemophilia products at 11, Elocta has made significant strides and the growth countries that the company is coming from is Spain, is CAE, but it's also it's Germany and Italy that have significantly contributed to the growth. One should also highlight that the largest part of this growth is really coming from patient acquisition and share gains. And Henrik will talk about more about this. And let's say there's a supply chain effect, But this is a minority part of these gains. With regard to Alprolix also here, it's a very strong demand growth. And this continues in key markets and it's quite nice to see that we have got Spain approved. With this having said, I just want to have a couple of words on our digital platform called Flowium. So as you can see here, this is a fully integrated platform that allows patients to basically know exactly what they can do at one given point of time and how they can adjust their life and basically in a position to have a very active life to manage the disease as opposed to forget about it. And on top, we are connecting the patient to physician. So we feel that this is a very relevant tool and we are now in the launch phase. We have set up a separate company to enable this technology and we think it will be very useful for the patient community. Coming to immunology, as you can see here on Page number 14, the immunology business has benefited from a fantastic season in this synergies, so significant uplift. And the product is really performing well. We had some initial topics with the supply chain. So we are now in the process to fix those and be even stronger for the next season. And so for us, this was a fantastic acquisition and supported the strong organic growth Kineret and Glated and so also for Gamifant, but overall the franchise has performed very well. And when you come to Kineret, the good news is we keep growing our existing business very well. This positive CHP opinion for the special indication called familiar Mediterranean Fever. Basically, our original, let's say, strategy to build this business based on rare disease indication, we continue. And now basically, we got on top the opportunity in the COVID-nineteen dynamic. And here we have fertility in the hyper inflammation of rhinosinusitis and already a few thousand patients have been treated and the product is in clinical research corporations over 500 patients and this number is bound to increase over the next couple of weeks. So very excited that Kineret can help patients in this very serious situation. Coming to Gamifant, I think it's important to have a relatively quick recap what the product is really all about. What we can say is there's a compelling evidence that interferon gamma contributes to clinical conditions seen in HLAH patients This is demonstrated efficacy in neutralizing interferon gamma. Our clinical development programs are continuing very well and Milan will talk about this, but only as much the MAS CEDJAR study enrollment has been completed. So we are on track with this study, very gratified that we were able to do so. The secondary HLH adult patient study is has been opened for enrollment, and we are also preparing the BRAF Telia study. So basically, what we announced some time ago, we are doing, and we are staying true to our strategy. In addition, interferon gamma now has very likely a significant role in the cytokine storm syndrome. And this led us to believe that we should study this and this we have been doing or we're doing currently in the Italian trial that Milan will talk about later. When you think about our dummy fund strategy, we are basically in the midst right now to evolve from an ultra niche rare indication, primary HLH in a narrowest definition to a primary HLH that basically according to the NACCHO definition that it covers in the U. S. A broader patient pool. And we are trying very hard to enable this move. And then basically, the 21% patient growth versus Q4 is the first proof point of this endeavor. But this will take some time during the next 12 to 18 months to basically take a fair share of this larger indication. MAS seizure is going to come after we have submitted our trial. And Mila can give you there an outline, but we are on track as we told you and expect to submit before end of year. And basically, then we will take this franchise internationally with these indications into Europe, Japan and China and followed by other indications that will open up the potential utility in CO potential utility in COVID-nineteen induced cytokine storm syndrome. We have we are on the way to show additional utility. That's the reason why this is more of a last terrific example that built upon what we have already announced, but we think that we may be able to do more for this product and would like to update you in due course. So at this point of time, I would like to refer now to Milan, who will share with you some of these exciting developments that we are currently doing in R and D and then has a particular, let's say, part of his presentation where he talks about the zekseidigine storm syndrome and the role of our products. Thank you. Milan, please? Thank you very much, Guido, and hello, everyone. On this slide, we're illustrating the role of the cytokine storm syndrome within patients with severe COVID-nineteen infection. So as you're probably well aware of, there's accumulating evidence now indicating that hyper inflammation caused by cytokine storm syndrome contributes to the complications of severe COVID-nineteen infection, which also includes the acute respiratory distress syndrome that significantly contributes negatively to the morbidity and also the mortality of the disease. What we find is that this disease has some characteristics that are similar to what we are seeing in HLH, including the elevated cytokines. If I can have the next slide, please. So this is what we're illustrating on this slide where essentially an overactivation of the immune system following the COVID-nineteen infection leads to an uncontrolled self stimulatory activation of the immune system some of the main culprits being IL-one and interferon gamma. And it's on this basis and also in response to a request from the Italian government that we initiated the clinical study looking at anakinra and emapalumab on top of standard of care in patients with known hyper inflammation and with a high risk of requiring ICU admission and also mechanical intervention. And our fundamental hypothesis is that inakenra and or imapalumab, these interventions would reduce the number of patients requiring mechanical ventilation. And if I can have the next slide. So this slide illustrates our R and D pipeline. As Guido mentioned and as discussed previously, we have made a significant effort to strengthen our pipeline within the areas of our core strengths being within hematology and immunology. So we have 2 ongoing Phase III studies, 1 with BIVOR 1 in collaboration with Sanofi and one for avatrombopak and chemotherapy induced thrombocytopenia. Then we have the Phase IIIII study with emapalumab in adults with nonprimary HLH, and we have the COVID-nineteen study that we just mentioned and the Phase II study where we recently completed enrollment in patients with MIS being treated with imaparamab. In the registration phase on the right hand side, we have the primary SLH indication with imapalumab in Europe. As Guido mentioned, we have favorable opinion from CHMP for familial Mediterranean fever with Anakinra. We have the chronic immune thrombocytopenia application with the Vetrumpak under review in Europe, and we plan to also file the or to submit to FDA the indication dura or deficiency of the interleukin-one receptor antagonist in the U. S. In 2020. So in addition to that, we have the option for the immune oncology Phase I asset on the left hand side, and we also have the financial rights to the follow on molecule within RSV virus, which is in Phase III now. So all in all, we have a very strong pipeline, I think, with the potential to really keep the company going also into the future. With that, I want to hand over to Henrik for the financial results. Thank you, Milan, and good afternoon, everyone. So let's start with the revenue bridge since Q1 'nineteen. Revenues for Q1 amounted to SEK4.639 billion, and that corresponded to an increase of 42% and 37% at constant currencies. SEK 179,000,000 of the reported number was related to the impact from positive FX movements. Our hematology franchise, consisting of hemophilia and DOPTELET, was the largest contributor to growth with $588,000,000 an increase of 34% at CER. Elocta and Alprolix both showed strong growth, 33% and 41% at CER, respectively. This growth was mainly driven by continued patient growth, but was also impacted by increased stocking due to the uncertainty of COVID. And for clarity, outside of hematology, we saw a limited stocking impact during the quarter. Furthermore, we also saw 1st full quarter of DOPTELET sales with reported revenue of $65,000,000 In immunology, we saw synergy sales of $1,196,000,000 corresponding to a growth of $471,000,000 at CER year on year. And as a reminder, the year on year growth was partially impacted by a full quarter of sales compared to Q1 'nineteen. AstraZeneca reported sales of $26,000,000 in Q1 2019 for the period before we took over the product. And since we need to evaluate synergies not on a quarterly basis, but rather over the RSV season, we should consider the season to date revenue number, which was $312,000,000 from Q3 to this quarter. And we do not expect any material sales in Q2, but this is anyway a double digit growth compared to the previous season. Generate sales for the quarter were SEK501 1,000,000, an increase of 39% at CER. And as we heard, we saw continued strong underlying growth fueled by the increased clinical interest related to the potential treatment in connection with COVID-nineteen. Gamifant sales of NOK 104,000,000 continues to show the volatility in the quarters to the nature of the disease and still small patient population. In the Specialty Care area, revenue for the quarter declined by 2% at CER to SEK445 1,000,000. And as we mentioned in Q4, we expect Specialty Care to decline by SEK300 1,000,000 to SEK400 1,000,000 in 2020 compared to 2019 as we are discontinuing various products now. And if we go to next slide, please. And move from move on from the revenue, we saw gross margin of 78% in Q1 compared to 76% in Q1 2019. And due to the seasonal product mix effect, primarily driven by synergies, gross margin will likely be slightly lower in Q2 and Q3. The adjusted EBITDA number reached SEK2.173 billion for the quarter, an increase of 48% and corresponding to a margin of 47%. Obviously, the margin in this quarter as well as in Q4 is impacted favorably by the seasonality that I just mentioned. Also the adjusted EPS adjusted for non recurring items the quarter was up 32%. Furthermore, operating cash flow of SEK 2,000,000,000 for the quarter, signaling continued strong operating cash flow, coming from a controlled working capital and a very strong underlying performance. And as a result of the strong operating cash flow, net debt decreased from SEK 15,400,000,000 at the end of last year to SEK 14,200,000,000 at the end of this quarter, which we will now take a look at on next slide, please. I'll return to the development of net debt per quarter. In 20 19, we completed the acquisitions of Synergis, Semapal and Mavendoba. With that, we levered up to a net debt of SEK 15,400,000,000. Now in Q1, we reduced net debt by SEK 1.2 billion due to the strong operating cash flow of SEK2 billion, partially offset by currency effects from our debt euro and dollars. And at the end of Q1, this gives us a pro form a leverage of well below 2.5 times and an available liquidity of about SEK 7,000,000,000 which provides us with opportunities going forward. And if we go to the next slide, please. Finally, I wanted to give a perspective of where we stand with our business during COVID times. And this relates to what we've seen in Q1, and we are, of course, aware of the considerably uncertainty related to this pandemic going forward. First of all, we continue to see an unchanged strong demand for our products, in some cases like even an increased demand. And next, thanks to our technical operations team and our partners, we continue to be able to supply product to customers. And furthermore, our strong cash flow relies on resilience being under control. We do get paid timely by our customers. And finally, we have very strong liquidity reserves with available liquidity of about SEK 7,000,000,000, which provides not only a safety net for our business, but also continue to invest in our business and look for new business opportunities. And with that, I say thank you and back to Gino again. Yes. Sorry, we have a technical glitch here. So I just wanted to share with you that we just to summarize, we have an appetite to further expand our position in hemophilia. We think that there are significant opportunities, and we see that we can still convert patients. When you think about it, we had a high single digit percentage growth of patient growth versus Q4 in Q1 for both products. And this does show that we are still relevant and we have a fantastic team to drive growth in this area. With our TrumboPark, we are obviously super excited to drive the product into the new indication here from most CIT. We have over 100 patients now recruited or enrolled in the study. And this means that we're actually well on track to meet our endpoints with the study. In ITP, we are filing in Europe. TLD, we got approved in China. So we think that this is going to be a significant product for us. With regard to immunology, as we explained, we have anakiniran and nopalumab now in COVID related hyper inflammation studies. In the pivotal environment, we have also quite numerous research collaborations that we would like to update you on this during the Q2. And we think that there's potentially quite a bit of utility beyond, particularly cegaatoemapalumab. Synagis, we obviously want to further improve our value chain and basically ensure that we have the correct dosing cycle reducing leakage. And obviously, we're quite gratified that we can further internationalize all business into relevant markets such as Japan and China for a rare disease player like us. And basically, with this having said, as you can see, we have a lot of very positive data points in from the business in Q1. We are quite bullish on the business. But given the uncertainty of today's environment, we didn't think it was appropriate at this time to increase the guidance. And that's the reason why we stick to the guidance and focus on the business and to keep driving this. And obviously, our ambition, let's say, remains unchanged. We want to drive double digit growth in our 2 core businesses, hematology and immunology. And our earning forecast or for earning guidance stays the same. And we still believe that with emapalumab and Doctolut, we have products in our hands that will make a very significant to the group over the years to come. And yes, basically with this, having said, I think we are open to questions. Thank you. I'm sorry for this little technical glitch. Thank you. The first question comes from the line of Lin Yang from Jefferies. Please go. Thank you. I have a few questions. 1 on hemophilia. So for the first quarter of this year and now, have you seen some extra buying of hemophilia products because of the pandemic? And also, are you seeing any impact from Hemlibra yet? And second question is on DOPTELET. I think on the slide about 400 patients are on the drug. I'm assuming it's a commercial Where these patients come from? Are they switching from other tipple mimetics or are they new patients? And the last question is on COVID-nineteen trial. Recently, Regeneron's IL-six data doesn't seem very promising. So when you look at your current trial assessing Gamifant as well as Kineret, do you have any view whether Gamifant could be more efficacious than Kineret? Thank you. Yes. Thank you, Eun. Maybe I start off and then hand over to Niran later for the COVID-nineteen trial. With regard to hemophilia, I think what we have seen is I mean, given this is not accurate science, but magnitudinally, probably around twothree demand, one third is the stocking effect or basically an effect where we make product available for patients who want to secure supply. And so there is an effect. But as Henrik pointed out, it's not the majority of effect. So the products are doing quite well, and we keep seeing conversions of patients even in the virtual environment, which is quite gratifying. So did we see an impact of Hemlibra? Yes, I mean, they are obviously a factor and they are there. But I think they are probably more focusing or their current conversion is probably more from other products. And let's say, the for us, let's say, we are focusing obviously on the benefits of our products. Hence, we enable patients now with this, with Fluorio, this is a digital solution to really manage the disease. Don't have to worry so much about compromises in terms of safety or side effects and having a liberating their lives. So this is our story. So we haven't really seen any material effect here on our business. With regard to Doctilid, It is basically, I mean, it's quite difficult for us to be really we have, I would say, a significant chunk are switches from other TPOs, really focusing on the TPO market and laundry. And this market is large enough for us. And then there are some new patients. But to quantify this, I think we is currently not we don't have this granularity of data and probably we'll look into this in the as part of the Q2. But it's quite nice to see that the product is actually considered relevant and there's an uptake. With regard to COVID-nineteen, maybe Milan, you want to share your thoughts on the efficacy? Absolutely. And thanks for your question. So I think we, as a company, are sort of affected also by the COVID pandemic and wanted to do as much as we could for the community. And it on that basis that we also initiated the trial in Italy also as a response to the government. I think it's too early to say whether we what that trial would have as a readout. But what I can say is that we have seen some similarities between the HLA phenotype and some of the characteristics that we see since that are most severely affected by COVID-nineteen. So these hyper inflammatory characteristics and this unperpetuated activation of the immune system. So we think there is potential to study and evaluate this disease, but I think it's too early to say what the readout would look like. The next question comes from the line of Christopher Yudi from SVB. Please go ahead. Hi there. So congrats on a good quarter, obviously. My first question is about the timing of the shift to higher royalty rate, the lower rate to them from you guys on Elocta and Alpro. It's what can you when should we expect for both products? And then what kind of a discount did you have to offer in Saudi Arabia to convert the entire market? And I guess last on on your slide, obviously, it's on your slide. Obviously, preclinical out there, 21 wasn't showing that. But can you give us any update on that? Yes. Maybe on the royalty, Henrik, you want to comment? Yes, sorry. Yes, but that is at the time of the launch of BIVV001. Yes. I think we are not increasing our loyalty now. I think that the royalties will increase when we have the BIF launch, but that's still a few years ahead. I thought they shift from 7% to 12% when you pay off the debt for the development of Alokta. No, that is not the case. And with regard to discounts in Saudi Arabia, I think we were quite gratified that in Saudi Arabia, people were thinking that there's a high utility obviously, of extended half life products, where those other therapies, new therapies. And actually, there was not a commercial stretch necessary. So it was mostly done on the strength of the product profile. And maybe with regard to the other question, Milan, do you want to come back to this? Absolutely. So with regards to BIVV-two, correctly, it's in the preclinical piece. And that's why we don't put it in our pipeline slide. We will give an update when and if it is correct, it's for hemophilia B. So it's a Factor IX based product, but it's truly to include it in the pipeline slide because it's we have set the lens to Phase I and onwards. Okay. And then on DOPTALID, so when should we actually expect top line for the CIT study? I mean, can you guide to that? And then can you also talk about the rationale for doing a pivotal trial without survival as an endpoint? Leon? Yes. So with regards to the CIC trial, enrollment is progressing well. We have just over 100 patients enrolled. So we are on track towards delivering top line results in the second half of twenty twenty. As we discussed, I think also on the previous call, the primary endpoint was agreed with the FDA. It is a composite endpoint, and it is not different from another compound in this class. So this is the primary endpoint that we are storing has been agreed to the FDA. Okay. Thanks. And lastly then, so for now on treating cytokine release syndrome in COVID-nineteen, So Gamifant and Kineret trials in Italy, I guess, obviously, the epidemic there is receding. So is there a risk that the trial will not be able to fully accrue similarly to the remdesivir in China? And can you comment on the timing of the planned CRS trial that was mentioned in the report? And I guess lastly would be, so yes, tocilizumab has read out positively in RCT. Can you perhaps give us some guidance around where we might see Gamifant fitting into and for that matter Kineret fitting into the treatment algorithm for severe COVID? Yes. So maybe yes, go ahead. So maybe if I start with the Italian Phase II trials. So at this point in time, we have enrolled 80 patients out of the 54 patients. We have 4 sites in Italy. We plan to enable more sites, and we may even go outside. I think you're right in the sense that the pandemic is decreasing, which is good, you can say, for the population as such. And I think what we are doing now is we are finding the size where we can see the right population. So actually, for us, we are less the length that we have applied in our trial is we want patients with hyper inflammation, but we don't want patients that are already mechanically ventilated. So I think there will be a switch in the population, but we see that we will be able to fulfill enrollment of the trial, and we have said that we expect to be able to have top line results in Q3 this year. I think when it comes to trucilizumab, I think I will probably answer the same way as I just did. I think we see some encouraging similarities in the underlying biology between what is being seen in these COVID-nineteen patients with severe respiratory distress that gives us reason to hope that this looks similar to HLA's and enabelumab, but it's too early to comment on what role either anakinra or enabapalumab would play. We have seen quite a lot of interest in enabapalumab in the medical community, and I think that's also reflected in the numbers. And anakinra is also included in a number of ISS studies that are ongoing right now. Okay. Thanks very much. I'll get back in the queue. Thank you. The next question comes from the line of Peter Sierstad from Handelsbanken. Please go ahead. Hi, it's Peter from Handelsbanken. Thank you for taking my question. I had a few. Back to the pricing of GaN FAN patients and you also said at the same time that quarter on quarter increased patients growth and the fact. Should we see this as sort of a new normal in terms to revenues to terms of lowering our price assumptions? Or could you just give us some hints as to how we should understand your comments regarding these patient volumes and cost because so far the volatility has been as due to the limited patient numbers, but also the high variation due to the weight dosing. So just to give us some Yes. Absolutely. I mean, basically, if you would have had the same weight of patients like in Q4, we would have seen a significant increase in this Q4 despite the let's say, despite price decrease. I mean, the price decrease essentially is in the magnitude is a little bit lower than what basically we have had as a volume increase. But the key driver was here that we have had lighter or younger patients. And basically, the for us now, and this is basically to come back to the Slide 17. I think that explains basically there is for us the prices now to say how can we reposition the product to a population which is essentially tenfold where we are today. And that's the reason why we had made some concessions. And basically now trying to appeal to this larger audience. And we are now in the transition. Obviously, COVID doesn't help. But even in this situation, what I wanted to say is, we have increased patient numbers quite considerably. So for us now, the key is really with our medical team and we have made some changes there to really propel growth towards this long indication and make a significant impact there. And then I think you will not see this volatility as much anymore because when you are fishing in a pond of 100, 150 patients, let's say 150, there is you can have different bias. And we obviously this is obviously influencing this. So but if you are able to get a significant share of 1300 patients, yes, then obviously the product will gain relatively quickly in terms of materiality. And this is what we are currently working on. So I hope that in the second half, we will get to a more you would see this effect of a lot of medical work, obviously, in the community and providing clarity on the data and that this will yield the right results. But the opportunity for the product is very significant here. It's so that it is basically we are now in this in between situation, but we want to enable this broader patient pool and then obviously relatively quickly then broaden it further with MAS and seizure. And then obviously hope to see already Europe approval by end of year or before end of year and then also go into the other geographies. So that basically then you should then get into this more upward spiral. Okay. Thank you. I just a couple of additional questions before I jump into the line. In terms of staying on Gamifant, I believe it was alongside the Q4 report you mentioned some interim data in macrophage activation syndrome study where you saw good responses in 6 patients. Could you give us an update there? And then I have a question for Henrik after that. Yes. Mila, you want to comment on the MAS CGL trial? Yes. So absolutely. So we continue to be encouraged by the evidence that we get out of the macrophage activation syndrome trial secondary to juvenile idiopathic arthritis. And once we have all data from the 14 patients that we have enrolled, we plan to meet with the FDA and discuss what could the next steps forward be, including a potential indication. We continue to be encouraged by the evidence with imapalumab here. Thank you. So my question for Henrik is looking at the I'm just trying to understand the underlying cost development. Looking at your cost development in Q1 of last year, just looking at costs, including depreciation and amortization, I see an increase of around €380,000,000 compared to Q1. I had some acquisitions since then, which is usually, but could you just give me a little flavor on this increase of €381,000,000 in total OpEx excluding depreciation and amortization, decomposing that and how much comes from the Dover acquisition, how much of this is related to SG and A, etcetera, etcetera, just to get a feeling for how we should how we should model this for the rest of this year, potentially also going into Henrik? Sorry, I was on mute, Peter. Thank you for the question. Well, if you're comparing Q1 with Q1 last year, I mean, obviously, we are comparing slightly different businesses because, first of all, we have full quarter of Synagis, which is a major product during the season. But then we also have the consolidation of Dova, where we are in launch phase and where we are running clinical trials. So it's difficult. It's almost 2 different animals. But if you look at Q1 and you compare it more with Q4, you see that it's actually a similar level. Having said that, we don't guide on a quarterly basis, but our OpEx base is likely to increase slightly in the quarters to come. Yes. I guess that's also, I guess, what is expected. My sort of basically what I'm trying to get at is you are mentioning that you have great opportunities with Gamifans since weather is also implies substantially higher costs than we currently anticipate to generate those opportunities. Now Maybe to help you further, if I repeat what we've said about Dostolet and how that will impact us. We said that DOPTELET would impact our earnings by about minus €500,000,000 during 2020, and that still stands. Perfect. Thank you very much. I'll jump back in the queue. Thank you. The next question comes from the line of Johan Univeros from Pareto Securities. Please go ahead. Thank you for taking my question. Yes, the understanding of the impression we get is that INREST, especially, I guess, is to some extent already used among severe COVID patients. Is that correct? Of course, they have very few alternatives medically. Yes. No, that's correct. Yes. It is used, let's say, by physicians upon their own decision, obviously, yes, because when you have these patients about to enter the ICU, you have to make some choices. And given the role of interleukin-one, there are quite a few choices made in favor of Kinetic. Thanks. That's helpful. And even if at this stage, it would be very anecdotal and not subject to any statistical relevance, but do you have any sort of flavor or feedback from that use? I think we have positive feedback. And but the proof is obviously in readouts of studies. And we think that there will be quite a bit of data for Kineret, in particular, coming up within the next couple of months. Thank you. That's all. You're welcome. The next question comes from the line of Victor Sandeep from ABG. Please go ahead. Yes. Hi, and thank you for taking my question. Yes. So do you see any different prescribing patterns among physicians that are prescribing synergies in the COVID-nineteen pandemic? Maybe that they prescribe that product more to protect patients? Or how do you think we should view the strong sales in Q1 and how to extrapolate that going forward? Thank you. Yes. I think the Q1 data are influenced by the fact that our hub that we have in place started working much better in Q1 even than Q4. So basically, we were able to improve compliance on the prescribed dosing scheme because we there was always an issue that patients would not get take the full cycle. And also what basically COVID has helped is that basically people don't want to make take any chances to protect preterm babies or their compromised babies. And I think that helps here. But I think it's primarily really the job of the team that really shaped up in Q1. And yes, and basically was able to work on some of these inefficiencies in the chain. But I don't I'm not aware that the product is used for our corporate related indications. Yes. Thank you. And on top of that also, the trajectory in the U. S. Is still quite flat. But how do you see that going forward in 2020? When do you expect a larger adoption of that product and more switches going forward? I think what we realize is the product was a little bit held back by some of the transition period on CLD. So we had a bit of more decline on CLD. Actually, the patient acquisition in ITP is quite positive. I think in the moment, we our teams can have direct face to face interaction again, which is now partially opening up. You will see material increases. Because we have seen that basically once we basically get really started on this, the product is responding well. So it is and we are now doing some other programs that basically are more in line to today's access realities. And let's see whether they bear fruits already. But I think the real impact you will see already when we have the team again in the field because the product has distinct advantages as we have discussed. And it will make it we'll find it today. I'm not and I'm not honestly, I think for the in this environment, I think the Q1 was a decent quarter. And I think we think that we can do better in Q2. Thank you. And just a final question. So you have some clinical trials now in Phase III, such as BIN-one, Nirsevimab and CIT for DOPTELET. Have you seen any impact on these trials due to the COVID-nineteen pandemic? Or could you give any update on recruitment for these studies? Thank you. I think maybe we start with the CIT trial. Milan has pointed out we have well above 100. We have now the first patient also coming in out of China. That basically makes us quite hopeful that we can deliver the goods in line with the time line that we have outlined. With regard to BIVV001, Milan, you want to comment? I don't think we have any indications yet, but maybe you want to give a perspective. So I think with the CIT trial, we have all sites up, and it's going well. And we have just enrolled about 100 patients, and we're on track towards delivering the results in the lab. I think when it comes to BIVV001, we have a few patients enrolled. It's too early to say whether there will be an impact of COVID. We have seen a decreased ability to initiate sites, but I think it's too early to say whether this would have an impact on timelines. Okay. Thank you very much. That's all for me. You're welcome. Thank you. Appreciate it. The next question comes from the line of Magnus Bona from Direct News. Please go ahead. Yes. Hello. I was wondering a little bit about the stocking effects. If you could tell me the magnitude of the stocking effect in the Q1, could it possibly be quantified as well? Also, Could you tell me a little bit about the revenue model behind it? And what do you see the potential for it? Thanks. Thank you. Maybe we start with the stocking effect. Henrik, you want to give it a little bit more color? Sure. Well, when it comes to stocking, we have observed stocking almost exclusively in the hemophilia product. So not really any measurable outside of that. We see that it's about 1 third percent, 40 percent of the elokta growth that we'll be stocking, which means that the major part of the growth compared to previous quarters is really demand growth. Yes. And so I think And in the case of Alprolix, it's similar that it's only a minor part with which it's talking. So maybe and I give you some color on Fluorio. So Fluorio is a platform which basically allows the patient to see quite a few parameters, I mean, that he inputs and basically that cover different areas of well-being and but also combines it with individualized PK profile. So essentially, the patient can see at any given point of time what his Factor activity level is. And this basically means that the patient knows if I want to play soccer now, then I need to have a certain activity level in order to avoid bleeding. So this and this is basically fully enabled for different devices like an iWatch or mobile phone. And basically, the revenue model, I mean, we have we make this available to the community. There is no for us, we believe that the best product and we think that this is a locked eye on our Alprolix, that they will benefit from this simply because they obviously have a dangerous profile and that basically patients will want to be basically know how they can actively live, let's say, manage their life and not believe that they are healthy and then start bleeding because they think it's so convenient to get maybe once a week subcut, but not realizing that their activity level is not high enough to cover the effect activity level to cover more active life. So that's basically the thought process behind this. And we think this will pay dividends, and we will see the hopefully, the payback and via increased revenues in our core products. Very well. Thank you. You're welcome. The last question comes from the line of Brian Balchin from Barclays. Please go ahead. Hi, thanks for taking the question. I only have one on the DOPTELET Phase 3 study in EIT. Can you just remind us of any trial design or patient recruitment differences versus the PROMACTOR trials that you think would favor a positive outcome in H2? Thank you. Sure. I mean, Dhemeen, you want to take it? Yes. So I think we're quite comfortable with the CIT indication with avatrombopag. I think there's a wealth of data that supports CPO agonists to increase data counts in patients that are undergoing chemotherapy induced or have chemotherapy induced thrombocytopenia. We've taken the learnings from the other programs and implemented that into our program. As we discussed before, we have a composite primary endpoint that I think is clinically meaningful and that has been agreed with the FDA, which essentially is proportion of subjects who do not require platelet transfusion, who do not require dose reduction and who do not have to have a chemotherapy delay. So and our patients essentially, they have to go through one cycle where we document that they have low platelet counts, and this is when we initiate treatment. So we think this trial has been optimized in order to show an effect of aortrombopag, but also something that is clinically meaningful for the patients and the medical community. Yes. So basically, what you can see in summary maybe is that the business is performing well. On the key endpoints that we are driving, we think that we can make substantial progress. Hence, we think that we are very equipped for the rest of the year. Any other questions? If not, then I would like to close this conference call. Really appreciate your interest in SORVI and wish you a great day. Talk to you soon. Bye.