Earnings Call: Q2 2021

Jul 21, 2021

Yes, it's a great pleasure to welcome you to the Q2 webcast today. As you probably have seen, we have some exciting news to share and very pleased that you have an interest in the company. With this said, let's go right into the theme of the session. Forward looking statement, please. Next slide. Yes, please just take note of this. And as per usual, didn't expect you to read it. I'm joined today by our CFO, Henrik Senpries and our Head of R and D, Ravi Raul. And with this, having said, let's go right into the numbers and the data points. So when you look at our performance during the Q2, we're very happy that we were back to double digit growth. We have 40% growth as reported. And we're quite gratified by this, particularly strong DOPTELET, the 42% growth is including the milestone payment that we received last year in Q2 and as reported. This was to the tune of SEK 100,000,000. So that taking this away is around 167% growth for DOPTELET, so strong growth there, 14% growth is Kinerel and 46% is Gamifant, shows a strong trajectory with our growth portfolio. But for us, very important is the patient growth with our hemophilia franchise and therefore most the 3% growth on the patient side with eloxtar and 16% is Alcolytics. And this basically that lays the foundation for solid profit development as we have shown this over SEK 900,000,000. Let's go to the next slide. Basically, you have to see the performance view of our strategic roadmap that we laid out at the Capital Market Day last year. And basically, in Q2, it's we have basically come back to after a challenging Q1 to a much more solid trajectory. And then I start from the core business. So what we have achieved is really strengthening again the consumption per capita, as I will show you later, for Elocta and Alprolase. We have continued growing the number of patients. So that solidified our core business. We have surfaced our growth project products with primarily the DOPTELET and with Gamifant. Notwithstanding this obviously performance of Kiena, it was very gratifying and I'll touch base on this later. And we're making great strides in building out our global footprint. And we're very happy that we got the reimbursement approval for Elocta in Russia and have got a couple of products now in approval the system and broader and are looking forward to further approvals in emerging markets by the end of the year. We'll touch base on this later today. Please go to the next slide. So let's go right into hematology. I think the numbers are clear. So 12% growth at constant currency on a franchise level was quite gratifying. Let's move to the next slide. And I think this is the bridge that we wanted to share with you. So what you can see is we had a ForEx impact of 5%. We have patient growth of $4,300,000 Now then we had the $90,000,000 is driven by the price reduction primarily in Germany, the destocking is the result that in Q1 last year, we had obviously an acceleration of sales. This one, we didn't have this year. As a consequence, we have normal stock levels mostly, I think, maybe a little flexibility, but mostly it is a normal vector normalization and that basically helped us. But I think it's important to note that the €81,000,000 the consumption per capita. That delta is now shrinking. We had a 4% increase of consumption per capita from Q2 to Q1. So we are closing the gap as we go along and as we have explained to you after Q1, and that basically makes us more optimistic for opportunities, all the reservations and that's what we will talk about also later. Next slide. With Alcolytics, I think these numbers are have a similar trend. And here, we have a stronger patient growth of 16.6 percent and that's quite gratifying. We had also a stocking effect as explained. But the overall, the growth story for Alcolysis holding nicely together. Next slide. And this is now doctor led. And if we take away the milestone payment as depicted nearly triple the product Q2 this year versus Q1. It's fair to say that we are not 100% where we want to be yet, but we like the trend in any case. And we think that this is going to be a very significant revenue driver for us and very happy with the changes that has been executed in the U. S. Organization to further propel our business. And it's also interesting to see that our product is doing quite well in China, which is promoted there by our partner Fozan. Next slide. Let's talk quickly about immunology. I think for us, important to notice that we still benefiting from COVID with Kineret, but to a not material or degree anymore. In the U. S, there's not any COVID impact anymore. That's a function of the disease. But overall, the product is obviously doing quite well with 40% growth at CER. And what we like is that we have been able to submit before the 9th July to EMA. We will take more study for approval. Ravi will talk a with more about it. And very happy to see that we are also in the R and D sector becoming more and more of the organization is delivering results and I think that's very gratifying. Next slide. And Gamifant, we talked about 46% growth. Here, we are still subjected to the weightage of the patient and the patient mix in terms of absolute number of patients, whether we are having we have a very significant increase with the wellness previous year. And so the product seems to be in a good trajectory. And we're obviously making strides with the RHLH trial to further expand the labor of Galifant. Next slide, please. So before I hand over to Ravi, just a couple of reflections. So when you think about us in the Q2, I think it's very positive that we have demonstrated now operationally to further propel the company. We had a couple of endpoints. Robin will talk about this more with Seif Mohit pointed out, we have also positive endpoints. Sometimes with our partners, like our pellets is print and is approved in the U. S. With BIVV001 and BIVV8897. And what it tells you is that in terms of probability, obviously, the company is making significant progress to progress its pipeline and that's to fulfill some price even though I think you will see this later with this Henrik, we are still conservative as far as the outcome is concerned because we don't want to get our heads on ourselves, particularly in times of uncertainty as we are facing them today. With this having said, Rausch, why don't you take it from here? Thank you, Guido. So I'll talk about the progress we've made in the last quarter and then highlights some short- and medium term catalysts looking forward. So As Guido mentioned, we were pleased with the ability to submit the Save More data to the EMA in July for the treatment of COVID-nineteen in adult patients who were at risk of severe respiratory failure. That's data that we announced and shared with you at the end of Q1. And the dossier has also gone to the MHRA in the UK, and we will be seeking emergency use authorization with the FDA. I think as we're seeing The pandemic continues to evolve, and we still feel there's a huge unmet need for patients in hospital to benefit from intervention with Kineret. And so we look forward to that review, and we've collaborated well with our investigator, Chief Investigator as well as with the agencies. Switching to other products, So BID-one or FNS Octacog Alpha is progressing well. And we've dosed the first patients In the pediatric study, which was dependent on completion of enrollment in the adult study. So those time lines and studies are progressing well. For well. For pegzetacoplan, we announced in collaboration with Apellis positive top line results from patients In the PRINT study, and these are patients who had not received C5 inhibitors and with treatment naive with PNH. And those data consistent with the PEGASUS study showed significant benefits of pegzidacoplan over standard of care. And then finally, over the last month or so, AstraZeneca and Sanofi have announced positive data from 2 trials with nocedevimab or MEDI-eight thousand eight hundred and ninety seven, The MEDLI Phase III trial, which met the primary endpoint in healthy infants And the MEDLI Phase twothree trial, which showed similar safety and tolerability of narseblimab compared to Synergous in patients who were preterm or infants who were preterm or who had concomitant conditions in the lung or the heart. So next slide, please. So looking forward, There are a number of near term catalysts that we anticipate within the pipeline. So for BIVV001, we will Expect in early 2022, the top line data from the adult study and thereafter data from the pediatric study. For pegzilacoplan, we expect EU approval by the end of the year. And in the follow on indication, There is good progress. For cold agglutinin disease, we will initiate a Phase III study in the second half of the year and similarly for C3gsmpgn for kidney disease. The ALS study should complete enrollment by the end of the year and will also commence a Phase II program in thrombotic microangiopathy by the end of the year. As Guido mentioned, we're still expanding in emopanumab, And we expect to dose the 1st patient in the rheumatologic HLH study soon with a readout of the first 16 patients in the middle of next year, and we expect decisions from China and Russia for the primary HLH dossier. Data from Cell 212 in chronic refractory gout will be out in the second half of next year, And we will see the full data from nesevimab early in 2022. So with that, I will hand over now to Henrik. Thank you, Robbie. Let's go to the financial summary for the quarter. So revenues of SEK 3,200,000,000 in the quarter was equivalent to a growth of 14% at CER. And that was driven mainly by strong growth of DOPTELET, particularly in the U. S. Market and a continued patient growth as we saw for Alprolix. The COVID impact was not as severe as in previous quarters, considering that Synagis was out of season, obviously, in Q2 and that the negative pressures from COVID on the Loxet Alprolix were less pronounced in terms of COVID infection rates and lockdowns, etcetera. If we move on to the gross margin, As we said in Q1, gross margin would normally be seasonally weak in Q2 and Q3, given the absence of material sales of Synagis during these quarters. The Q2 gross margin was 76% compared to 78% the previous year. And this decline is explained by the price reduction of the Nokcea Germany, the largest share of sales of lower margin business such as Tegsedi and WAYLIVRA from the agreement with Akcea and the sales adopted into our partner, Fosun, in China, But also the negative FX effects on revenue. And we would expect these factors to remain in Q3. Turning to EBITDA. EBITDA reached close to $922 for the quarter, corresponding to a margin of 29% versus 33% in Q1 2020. In addition to the lower gross margin that I just mentioned, SG and A increased by some 11% in CER, reflecting mainly increased efforts for Dovselet and launch preparations for PAGSEN CO plan as well as spend for the new Specialty Care products. R and D spend increased to SEK 484,000,000 for the quarter, corresponding to 15% of revenue as a result of the new programs for Exelco plan and FEL-two twelve as well as the efforts on Epipolumab. If we go to next slide. Operating cash flow in Q2 amounted to SEK 1,400,000,000, confirming the seasonal strength in cash flow in the Q2. And as a result, net debt at the end of the quarter amounted to SEK 11,200,000,000 corresponding to net debt to EBITDA of about 2x. The available liquidity at the end of the quarter was close to SEK 6,000,000,000. As you will have seen and in terms of the full year guidance, we stick to the previous outlook from Q1, That is revenues in the range of SEK 14,000,000,000 to SEK 16,000,000,000 and an EBITDA range of 30% to 35%. We believe that we are progressing very well, but there is still remaining risk related, not at least to COVID, that could particularly impact our 2 largest products, Enokta and Synagis. And with that, I hand over to Nino? Yes. Thank you, Eric. Let's go to the next slide. And Yes, basically, when you think about it, our pathway to drive the company into the future is really unchanged, yes? We obviously want to continue delivering on the core. We will continue driving our late stage pipeline. You've seen that we've got now quite a few data points confirming that we have made good choices with the selection of our late stage pipeline, good progress with spaxetaglutide, with BISH, is mediated by Severes making our strides for Gamifant. So overall, I think that this creates more confidence. We will obviously further take advantage of the global opportunities that we have with this franchise, making further strides in this regards to build the business in particular emerging markets. But for us, as we laid out at the Capital Markets Day, the opportunity in Japan, for instance, is going to be very significant. So we're building further this. And this basically is built upon strong cash flows that help us to reinvest and build the company that is to another level. So when you think about it, company is in a good shape, we're making strategic progress. But what we don't want and that's the reason why we haven't changed the guidance is getting ahead of also. The Q2 is additionally a softer quarter in absolute terms. So whilst we have the ability, we want to make sure that we have more data points. Also, when you look at the recent trends for COVID, I think we feel it would be not prudent now to already start getting ahead of ourselves and upgrade our guidance even though the exceptional that you have seen from the data are very positive. Next slide, I think we can then probably wrap it up. And for question and answer, it's because I think this was more to give you an insight from our side and you know, but we understand that today it's all it's much more about your questions and letting you in, in our thought process on the data. With this, maybe we open the floor for questions. If you can, Please limit your number of questions to 2 per speaker that will allow us to have a broader audience covered by the end of the session. Thank you. Thank Our first question comes from the line of Eun Yang from Jefferies. Please go ahead. Your line is open. Thank you. So I have two questions. By the way, good quarter. Congrats. So I under I appreciate it's too early to modify full year revenue guidance given the Limited data so far. But even assuming your high end of guidance and Synergies and seasonality, you are not really expecting any growth from The pipeline products besides the synergies, so two questions. One, can you talk about RSV season that you are expecting for upcoming year, Upcoming season? And secondly, for hemophilia product, so there was stocking in 2nd quarter after sales. But when you look at the sales last year, with the 1st quarter stocking, there was a destocking in 2nd on quarter. So should we expect that to happen in Q3? Thank you. Thank you, Basically, with regard to established synergies, let's say, the indicators when we follow the CDC publications are quite positive. So we see that the season that the RSV prevalence is coming back. And we have no indications at this stage, not but to believe that you have enormous season. Now this obviously could be significantly disrupted again, if we would have another reemergence or research of new COVID variants that could lead to more social distancing again, less international travel. And we could end up again into a bit of from a Synagis perspective, at least, this advantageous position. We think the indicators but the indicator that we have from the virology, also from our field activities are at this stage positive. It's just because it's such a big swing factor, it's just very difficult to predict now with some precision how it's coming out. That's the reason why we left the guidance, it will be a lot more flux in the guidance and maybe operational indicators and virology today would suggest so. With regard to hematology, I think the destocking effect that we have seen is primarily, let's say, is primarily in effect of Q2 last year. I don't expect this to let me see such a significant effect in the next quarters. What I would expect though is that, Okay, Q3 in Europe is always a bit of a challenging one given the vacation period. But normally, I would expect that we see further improvements with regard to consumption per capita clearly by the end of the year, and that's what we also explained to you, I think, in the Q1. So that basically the drivers of growth would be related to further patient gain, even though it's not a lot, but we're still gaining more patients. But we see that our competition is not a panacea doesn't have a panacea either. We see a space for us. We see a space with improvement of consumption per capita. We will have headwinds obviously from ForEx, we will have headwinds continue having headwinds from the price variance that we have now realized with the primarily with the German price reduction. And then as we the variance on the consumption per capita is not from 0 to 0. That will still take a while until you see the full benefit during the floor this year. But to your point, I don't anticipate that we will have a significant variance on growth in comparison versus last year and Q3. Thank you. Thank you. Thank you. Our next Question comes from the line of Christopher Ilesey from SEB. Please go ahead. Your line is open. Hi, there. Thanks very much and nice results. So my first question is related to this consumption improvement. So to what extent Is this due to lockdown relief? And to what extent is it potentially from a different approach by patients or Prescribers to the target trough. And my second question is, I guess for now, let's see, the China market access team, you have one in place ahead of The potential approvals you've got there, because I guess you have roughly a year or so after approval to get on the Reimbursement was right. Thanks. Yes. Thank you, Christopher. With the consumption per capita increase, it's obviously a little bit like a chicken and the egg question. I mean, we clearly benefit from the fact that the economy is opening, people are resuming a more active life. Consequently, they want to be better protected. Having said so, we have a significant step up of our activities in terms of medical education, the interaction of our MSLs and we had numerous seminars with KOLs talking about the subject of protecting patients and what could be the consequences, if you have an atrophy of your muscles and how this could affect joint leads and so on and so forth. So that is why I think it's a combination. I'm not I don't think we are in a position to really separate out both elements. But clearly, there's a benefit from more activity, But we have very materially stepped up our activity level and we felt that this was a subject matter that was considered to be relevant for many KOLs. So they quit there. They were heavily teamed up with us. They were supporting quite numerous medical events. And so that was clearly helpful. With regard to China, we have a team in place in China That is at this stage, obviously, more pre operational, but we have broadened market access team members. We're expecting obviously the approval for our Gummy funds end of this year, And we are working already very hard because we believe that this could be a very significant and important launch for us on how to basically unlock the reimbursement on a national level because we believe that the product would deserve to be covered nationwide. So we have the capabilities in place. And frankly, I mean, we have quite a bit of China experiences as a company and the people who wear their helmets in China used to be driving a business with 2,000 people in China in a different setting. So they know what they're doing. Terrific. Thanks so much. I'll get back in the queue. Thank you. Our next question comes from the line Raja Shammat from Deutsche Bank. Please go ahead. Your line is open. Hi. Thanks for the question. First one, if we could just go back So RSB revenues and just thinking ahead into 2022, is there a risk of lower RSB Revenues if nasevumab cannibalizes synergies before broader volumes kick in, in 2023? And then second question, just on the cost outlook for the second half of this year. How should we think about that given that you're already at the Top end of the range for full year EBITA margins? Thanks. Yes, thank you. Let's start with nirzumab. Very hard to make a forward looking statement obviously. When we look at it, we think that we will probably have a much more normal season in 2022, but it's too early to speculate. We are aware of the timelines that are publicly known, I think you can deduct nearly for yourself. What's the risk you guess is as nearly as good as ours on the launch schedule. But I think we say that we think that synergies will have a good place also next year. With regard to cost outlook, we think that we will obviously want to support the pre launch of pegzetagoplan. We want to support the launch phase of DOPTELET and we want to support the numerous clinical projects that we that Ravi has familiarized you. So we will stay with we think that we can stay within the remit of the guidance, I don't see that there are other things to record. Henry, do you want to comment on cost? No. I mean, that's right. And then this what Unigail said means that we expect somewhat higher spend level both in SG and A and R and D for the second half. But I think you need to just recognize that we expect that that will plan. We have a very significant part now stable and it just needs to be properly supported. Very good. Okay. Thank you very much. Thank you. Thank you. Our next question comes from the line of Rosy Turner from Barclays. Please go ahead. Your line is open. Hi, good afternoon. Can you hear me all right? Yes. Perfect. So I will stick to the 2 questions. Firstly, if it's good to understand a bit more around the drivers of specialty care growth. And Did I hear correctly that WAYLIVRA is margin dilutive? And then just one on the pipeline. Emapalumab, What are the actual economics behind the expected Russia and China approvals? What are the revenue dynamics there? Thank you. Thank you, No, let's start with Specialty Care Growth. I mean, the Specialty Care Growth, we have made a licensing agreement with Ionis on TEGSEDI and WAYLIVRA in Europe and for TEGSEDI in United States. And basically that influence our margin mix, particularly also because there were some setup costs, but you would expect as there was very limited payments involved that the gross margins would not reflect our average gross margin of our proprietary business, even though this is the gross margin of this business are clearly lower of what typically we had under partnering and that we basically downscaled considerably, but relatively speaking, still not comparable, which is no surprise. And therefore, let's say, the mentioning. But I think as we are evolving as a group, obviously, you think that the larger footprint will make us more attractive as we move forward for more partnering business and that it's a question on how profitable you can structure this and what is your level of commitment to these businesses. With regard to emapalumab, let's say, we have not guided on the economic relevance. But basically, just to give you some direction or to travel. I think emapalumab, obviously, in a broader HLH setting could be quite significant. In the primary HLH, you have seen the numbers in the U. S. This is in the strictest sense, it's an opportunity. But you look at the total populations of Russia and China, you come up obviously that this could be still material, but our hope would be, obviously, over time to as we try in the U. S. To expand the label. And then the question will be, that is an answer to this uncertainty to this, what will be the price that we were able to obtained in order to get, for instance, in China on the NRDL, while the numbers on the lower end would suggest in line with the population that there are quite a number of patients. I see data suggesting $5,600 is probably north of that for HOH. But then the question is, what will be the price level to enable this and over what time do you expect an HLA label and while initially people have a primary HLA label. So I'm afraid we are at an early stage and typically we will not guide on sales potential per region, but it gives you a little bit of a frame to think about it, that this is a significant opportunity, but we are not at a stage where we can basically already say that we have this opportunity in our hands. Perfect. Okay. That's very helpful. Understood. Thank you. Thank you. Our next question comes from the line of Victor Samba from ABG Sundal Kalia. Please go ahead. Your line is open. Yes. Hi, Eijan. Thank you for taking my questions, and congratulations on a solid quarter. So my first question Nes on Teixehta, Copeland. Could you highlight where you are in the process with the EMA? Have you entered a second clock stop, for example? Or any special questions From regulators or outstanding issues that have been discussed? And also, could you highlight perhaps how far developed your sales force is in Europe At the moment and how far you have left in the 1st countries where you will commercialize the product? Thank you. Yes. Thank you. I mean, Maybe I'll start with the easy bit and talk about our commercial readiness. And there we can we affirm that in the 1st wave countries, we have built considerable teams already, Whilst in the 2nd wave countries, we are about to do this. So we do this in a sequential way in order to minimize the impact on our results, obviously. But we will not compromise the launch readiness, and we have really stepped up our understanding of the first indication considerably, whether it's in various medical parts of the organization or whether it is commercially. With regard to the interaction with EMA, maybe Ravi, you want to comment. Yes. Thank you. I won't go into the detailed questions that we've received, but we have answered the major issues. So the progress the process is pretty well advanced. We're obviously in the summer recess clock from EMA, but we are confident, as I mentioned, that we would get approval by the end of the year. Okay. Thank you. And also, you didn't specifically mention any headwind in hemophilia due to competition. What is the Status from your point of view of Hemlibra competition, as I suppose, you can speculate that it will intensify when it's easier to reach physicians with less COVID In the second half, I'm guessing. Yes. I mean, with Semlibra, I mean, they're obviously a formidable competitor, and we recognize this. For us, it's important that we continue gaining more patients, mostly from other, let's say, 1st generation factor products at this juncture than from Ambre directly, but that we continue gaining more so that we have a net gain versus what we lose. And at this stage, that seems to be this is clearly in place and we have the business in a decent balance. But they will not rest and probably have not fulfilled the ambition yet. We have not fulfilled ours. So this will stay with us. Yes. And but what we can see is that with more activity, also maybe some of their data points will be put into perspective because clearly a trough level of 10 an equivalent level of 10 may not do it if you have more ambitions for an active life. So I think as we go along, you have obviously the early adopters, then you will have a next then you will have other patients who will want to seek this. On the other hand, you will have also patients who realize that this is not this treatment needs to be complemented if you want to be protected against bleeds. And as many of the patients who are in the studies got supplementary Factor VIII. So I think that basically rationalization and reasoning will set in When this new equilibrium will be established, who knows? I'm not making forward looking statements in this regard, but we will I can reassure you, we would make every effort to do so. And obviously, we have we are very gratified to have BIVS-one in our armament and any of the feedbacks we are receiving from the Phase III trials are very positive. Okay. Thank you. I'll jump back in the queue. Thank you. Thank you. Our next question comes from the line of Peter O'Thling from Pareto Securities. Please go ahead. Your line is open. Okay. Thank you. Two questions. One first for Eloct Then Alperics, if you look at the sales bridge and if you move 1 quarter ahead, the stocking effect, which has influenced it positively this quarter will go away. And some of the others will improve, for instance, the Consumption per patient. But what about the pricing factor? Will that still be around 10% year over year negative In Q3 and Q4? That's my first question. And then secondly, if you adjust for the sales To China of DOPTELET, the sales were essentially flat year over year for DOPTELET. So Just wondering, this EUR 58,000,000, how will that develop over the coming quarter? Did they build up the stock Now that they will sell down during Q3 and then maybe order a little bit more in Q4, how will The order pattern looked like going forward? Thank you. Yes. I'll start with the sales of DOPTELET. I mean, there is it's a little bit tough to separate this. And but when you have when you look at our performance Q2 last year and you take away the milestone, you have roughly SEK 100,000,000 of business at the same time. You basically and that basically is a comparator. So that's the reason why we say we nearly tripled on a sales basis because there was a milestone payment we obtained in that quarter. And when you look at the growth of the U. S. Business, excluding China, we have a very nice evolution of in average 30% compounded on a quarterly basis. Yes. Guido, but my question was about specifically the China number. Will that fluctuate over the Coming quarter? Yes. I mean, this is obviously export business, but the good news is that we don't think that the sales in Q2 is a one off. So we will have significant more sales as we It seems that these sales are reflecting the demand, granted that they can be because of the order pattern, always a quarter where you have less than a quarter where you have more. So I don't think that the what you have seen in Q2 is a one off. I think we can look forward to a significant more sales from China for this year and also for next year. Okay. But now they I understand that it wasn't a one off, but I reckon that the initial order was a little bit of Stocking ahead of launch that will be sold down during maybe Q3? No, they launched already earlier. So let's say, So I'm not making forward looking statements, obviously, what's in the order, but that is that was dimensionally to what the size of that business is, is not exaggerated. There may be some consumption of product in Q3. But when you look at it on an annual basis, I would be surprised if you would consider this Q2 as an extraordinary quarter. So you could essentially multiply this by 4 then? Well, I would not I'm not suggesting this now, Peter, but it will not be in a let's say, I just don't say that this an extraordinary quarter. But yes, I mean, there will be more significant more sales to come for us. Yes. But now the number is times 4 or whatever, let's say, I'm not saying, yes, but because we typically don't guide on this, but it's not an extraordinary sales number. And now we will not see anything till year end and consuming. That's clearly not the case. Okay, great. And then the price Component going forward year over year? The price component for HEPLIS, yes. Yes. They are basically The 90 millimeters is pretty much we don't expect for this year more price an aggravated price situation knowing for well that you cannot predict pricing, but we don't expect it. But what you see is pretty much on a relative basis what basically the impact of that primarily the German price impact is and that is something that we would carry forward with us during the course of the year. Okay, great. Thank you. Thank you, Peter. Thank you. Our next question comes from the line of Derek Helge from Carnegie. Please go ahead. Your line is open. Hi there. Thanks for taking my questions. I have 2, if I may. First on DOPTELET, going back a little bit on the previous question, Taking out the SEK 58,000,000 in sales in China for the quarter, it looks like the sales Performance in the U. S. Looks pretty flattish over the past 2, 3 quarters despite the launch in Europe. So I was wondering, are you sort of reaching a plateau in terms of market share in the U. S? Or what should get you back to growth In the second half in the U. S? Then secondly, on guidance. And If I'm correct, it looks like the Akcea deal Was expanded to include the U. S. In early April, so after your guidance was Announced. So my question is basically that are you just being conservative Because you're adding some SEK 200,000,000 in incremental sales in the U. S, but you're still keeping guidance Unchanged. Are you sort of conservative? Or are there any other headwinds That you didn't foresee earlier in the year. That was my 2 questions. Thank you. Yes. I think the Eric, I mean, when you look at the Doctolut, and you basically look at it quarter by quarter, and I just compare it on a patient basis, then I would have Q2 end of Q2 versus end of Q4, I have up to around, this is approximated now, close to 50% more patients. So in my books, that's not flattish. Yes. And so I there may be some Movements of sales, where you had an anticipation where you had an oversell in Q4 and as a consequence, lower Q1. But let's say, when I look at it, by all the yardsticks in the U. S. Business and maybe what we can do is have an offline discussion. That actually looks pretty decent to me the development and we that doesn't mean that we cannot do better, yes? And that's what we discussed with the team and we are working on this. But I'm not too pessimistic about it, in particular, now the More recent indicators, we have brought in a new team here that obviously wants to make a bigger impact. It is also an indication, to be honest, particularly in COVID, where a vertical launch was not possible. But I think not so bad. I mean, if somebody would have told me last year that this is going to be a sales evolution, I would have taken it any time. Yes. So, I think it's in terms of new patients, we will try to do better. There's still some opportunity. But the team is in terms of understanding that business, I think is quite positive. With regard to Akcea, the 200,000,000 impact that you are describing, I think consider it as conservatism, because We are not aware of any material adversity, otherwise we would have reported this. And secondly, but on the other hand, when you think about the swing factors that we are facing in today's world, that basically is something that we took, let's say, and But it is not something that we have already used for. But I think it's at least we don't want to disappoint, yes. That's our clear mantra. And as we go along in this CFS, some of the uncertainty around the environment is lifting. I think that we will make sure that we properly account for this. Okay, great. Thank you so much. Thank you. Thank you. Our next question comes from the line of Peter Joe from Handelsbanken. Please go ahead. Your line is open. Thank you. It's Peter from Air Dunken. Thanks for taking my questions and congratulations on the results. And furthermore, by the fact that the 2022 consensus or 2023 consensus are actually now below my number. So that means that there is Sorry to consensus and the negative revision cycle may be over, but let's not be take things to granted. So I have a couple of questions here. Firstly, just a follow on on DOPTELET. With the current run rate, you might be adding incremental sales of roughly SEK 600,000,000 Compared to last year, you are in the launch phase. And typically, there you see accelerating sales. So should we expect what is your expectations internally for DOPTELET? Should we see this as, let's say, a product that is still in an exponential growth phase and where we might see increasing incremental sales? Or should we take a more, let's say, standard view and just see this as a linearly growing product As you typically see from mature power products, that was number 1. With respect to nurvesimab, I guess the communication or at least the previous I heard of from MedImmune, Astra, etcetera, was that this product could be low priced in order to reach To have a mass market appeal, is there any update on how the strategy for diverse America is going to be set in terms of price and market access and accessibility? Thank you. Yes. Thank you, Peter. With regard to upside short and midterm versus consensus, I we have guided on what we have guided on. And let's say, with regard to DOPTELET, And let's say, at this stage, I think we should see during the second half an acceleration of growth. Yes. And let's say, because that's what we are working towards to I mean, is this now exponential? It's always a question on how you define exponential. But as we are now rolling up, let's say, the events, we think that we are clearly not done with Doctor. Let as we have guided to. And also, if you wanted to achieve our overall guidance for the products, you would expect that there will be an acceleration at one stage, and the team is gearing up for this. With regard to Nielsen, we are obviously due to our competitive situation, we are not in plugged into the commercial strategy of Sanofi as much at this juncture. So I don't have further updates I've then basically Sanofi has given to the market. And I think there is a good data point in the Capital Market Day last year. And I would not be able to share more than this because they don't share this with us and due to the competitive situation that we still have with Synagis. Thank you very much. Thank you. Thank you. Our next question comes from the line of Jon Bergin from Kepler Cheuvreux. Please go ahead. Your line is open. Hi. Thanks for taking my questions. I have 2. So you're running this study with amapalumab in malignancy driven HLH. So I didn't see the specific study on the R and D side you showed here in the presentation. So I was just wondering if you could give an update on the status or progress of the study. When will we see the first beta essentially? Then my other question is related to pexetico plan. So Apellis, they will offer this infusion system enable and they will have it available to patients already next year. So I was wondering if you also will offer this kind of infusion system in your territories. Thank you. Yes. Thank you. I start with the infusion system because I just discussed it actually with aphelacin. And there we will review this, the advance that we have right now selected and there is no common standard amongst geographies, let's say, I would say best in class infusion systems that has also is supported, but also has the right distribution. So that's our first step. And then we will look with SOPELIS and the decision has not been made to what degree we should use their own version. With regard to the malignant HOH study, I'd like to refer to Ravi because he's very close to this. Yes. Thanks, Guido. We've been conducting that study for some time. We've had a look at the results from the initial 10 patients. And it's a difficult area to work in. So we don't envisage progressing that particular indication with emapanumab simply because of the complexity of standard of care and the thickness of the patients. So we'll be focusing on other secondary HLH subtypes going forward. Good. I think maybe one more question and then we probably have to wrap it up. Yes. Our next question comes from the line of Christophe Jorde. It's a follow-up question. Christophe Jorde from SVB. Please go ahead. Your line is open. Yes. Thanks so much for taking my follow-up. So a question on pegcetacopalan in IgA nephropathy. I wondered why aren't you and Epellis going for this indication given the Iptacopan data? And I wondered, are you held back by the route of administration or the infusion reactions? Or is it something else on efficacy? Thanks. Ravi, do you want to talk do you want to take this? Yes. I think, Christopher, thanks very much for that. No, we're not being held back by anything. I think within both companies, I think we want to continue to expand the indication set for pegzetokopinib. As you can see, we are Really full in progress with 4 indications on top of PNH. So I think it's really a question of staging our investments and staging the indications that we do. Yes. I think, Christopher, we just have to recognize, you don't want to be a company that remain an opportunity, but never had the opportunity to make something out of it. I think on this note, thank you so much for your interest. I think it's we closed the session now because we reached 2 p. M. If you have further questions for us, please don't hesitate to reach out to our IR team and we will revert promptly. Thank you and wish you all a great day and a great week. Thank you.