Swedish Orphan Biovitrum AB (publ)

STO:SOBI

Earnings Call Transcript 2021-Q2

[Operator]

Ladies and gentlemen, welcome to the Sobi Q2 report. [Operator Instructions] I will now hand over to Guido Oelkers, CEO. Please go ahead with your meeting.

[Guido Oelkers, CEO & President]

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 session.Forward-looking statements, 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 Stenqvist, and our Head of R&D, Ravi Rao. And with this having said, let's go right into the numbers and the data points. So when you look at the -- at our performance during the Q2, we're very happy that we were back to double-digit growth. We had 14% growth, as reported. And we're quite pleased with 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 million. So that -- taking this away, it's about 167% growth for Doptelet, so strong growth there; 14% growth is Kineret; and 46% is Gamifant shows the strong trajectory with our growth portfolio.But for us, very important is the patient growth. So with our hemophilia franchise and therefore almost the 3% growth on the patient side with Elocta and 16% is Alprolix. And this basically then laid the foundation for the profit development as we have shown this over SEK 900 million.Let's go to the next slide. Basically, you have to see the performance in view of our strategic road map that we laid out at the Capital Markets Day last year. And basically, in Q2, we have basically come back to -- after a challenging Q1 to a much more solid trajectory. When I start from the core business, so what we have achieved in all is really strengthening again. The consumption per capita that I will show you later for Elocta and Alprolix, we have continued growing the number of patients. So that solidifies our core business.We have surfaced our growth project -- products with primarily Doptelet and with Gamifant. Notwithstanding this, obviously, performance of Kineret was very good to find, and I'll try and 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 the approval system 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 to 12% growth at constant currency on a franchise level was quite good to find.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 5%. We have patient growth of 4.3%. Then we had -- the SEK 90 million 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, and then there's a [indiscernible] but mostly, it is now back to normalization, and that basically helped us.But I think it's important to note that the SEK 81 million, 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 our future with all the reservations, and that's what we will talk about also later.Next slide. With Alprolix, I think these numbers are -- have a similar trend. And here, we have a stronger patient growth of 16.6%, and that's quite good to find. We had also stocking effect, as explained. But overall, the growth story for Alprolix is holding nicely together.Next slide. And this is now Doptelet, and you have the big take away. The milestone payment has [indiscernible] 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 a product is doing quite well in China, which is promoted there by our partner, Fosun.Next slide. Let's talk quickly about immunology. I think for us, important to notice that we're still benefiting from COVID with Kineret, but to a not material overall degree anymore. In the U.S., there's hardly 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 of July to EMA the SAVE-MORE study for approval. Ravi will talk a little bit more about it. And very happy to see that we are also in the R&D sector becoming more and more of an organization that is delivering results. And I think that's very good to find.Next slide. Then 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 over the -- we are having very significant increase as well as previous year. And so the product seems to be on a good trajectory. And we're obviously making strides with the RHLH trial to further expand the label of Gamifant.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 compare with [indiscernible]. We had couple of end points that Ravi will talk about this more with SAVE-MORE I pointed out. We have also positive end points sometimes with our partners as well as trends and the approval in the U.S. with this [indiscernible] and with 8897.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 Henrik, we are still conservative as far as the outlook is concerned because we don't want to get our head of ourself, particularly in times of uncertainty as we are facing them today.With this having said, Ravi, why don't you take it from here?

[Ravi Madduri Rao]

Thank you, Guido. So I'll talk about the progress we've made in the last quarter and then highlight 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-19 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 U.K., 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. 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 BIVV001 or Efanesoctocog alfa 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 pegcetacoplan, we announced in collaboration with Apellis positive top line results from patients in the PRINCE 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 a significant benefit of pegcetacoplan over standard of care.And then finally, over the last month or so, AstraZeneca and Sanofi have announced positive data from 2 trials with nirsevimab or MEDI8897, the MELODY Phase III trial, which met the primary end point in healthy infants; and the MEDLEY Phase II/III trial, which showed similar safety and tolerability of nirsevimab compared to Synagis in patients who were preterm or infants who are preterm or who had concomitant conditions in the lung or the heart.The 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 pegcetacoplan, we expect EU approval by the end of the year. And in the follow-on indications, 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 C3G MPGN for kidney disease.The ALS study should complete enrollment by the end of the year, and we'll also commence a Phase II program in thrombotic microangiopathy by the end of the year. As Guido mentioned, we're still expanding in emapalumab, and we expect to dose the first patient in the rheumatologic HLH study soon with the readout of the first 16 patients in the middle of next year. And we expect a decision from China and Russia for the primary HLH dossier. Data from SEL-212 in chronic refractory gout will read out in the second half of next year, and we will see the full data from nirsevimab early in 2022.So with that, I will hand over now to Henrik.

[Henrik Stenqvist, Chief Financial Officer]

Thank you, Ravi. Let's go to the financial summary for the quarter. So revenues of SEK 3.2 billion 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 Elocta and Alprolix were less pronounced in terms of COVID infection rates and lockdowns, et cetera.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 Elocta in Germany, a larger share of sales from lower-margin business, such as Tegsedi and Waylivra from the agreement with Akcea and the sales of Doptelet to our partner Fosun in China, but also the negative effects on revenue. We would expect these factors to remain in Q3.Further to EBITA. The EBITA reached close to SEK 922 million for the quarter, corresponding to a margin of 29% versus 33% in Q1 '20. In addition to the lower gross margin that I just mentioned, SG&A increased by some 11% in CER, reflecting mainly increased efforts for Doptelet and launch preparations for pegcetacoplan as well as plan for the new specialty care products. R&D spend increased to SEK 484 million for the quarter, corresponding to 15% of revenue as a result of the new programs for pegcetacoplan and SEL-212 as well as the efforts of emapalumab.If we go to next slide. Operating cash flow in Q2 amounted to SEK 1.4 billion, confirming the seasonal strength in cash flow in the second quarter. And as a result, net debt at the end of the quarter amounted to SEK 11.2 billion corresponding to net debt to EBITDA of about 2x. The available liquidity at the end of the quarter was close to SEK 6 billion.As you all 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 billion to SEK 15 billion and an EBITDA range of 30% to 35%. We believe that we are progressing very well, but there is still a remaining risk, risk related, not at least to COVID, that could particularly impact our 2 largest products, Elocta and Synagis.And with that, I hand over to Guido.

[Guido Oelkers, CEO & President]

Yes. Thank you, Henrik. Let's go to the next slide. And yes, basically, when you think about it in 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 have 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 pegcetacoplan, with BIVV, with MEDI8897, 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 on making further strides in this regards to build the business in particular emerging markets 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 on this. And this basically is built upon strong cash flows that help us to reinvest and build the company to another level.So when you think about a 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 those. Q2 is traditionally a softer quarter in the absolute -- in absolute terms. So while we have the ability, we want to make sure that we have more data for and ultimately when you look at the recent trends for COVID, I think we feel that would be not prudent now to already start getting ahead of ourselves and upgrade our guides, even though the [ sections ] that you have seen from the data are very positive.Next slide, I think we can then probably wrap it up and for questions and markers because I think this was more to give you an insight from our side and -- but we understand that today, it's all -- it's much more about your questions and letting you 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 cover by the end of the session. Thank you.

[Operator]

[Operator Instructions] Our first question comes from the line of Eun Yang from Jefferies.

[Eun Kyung Yang, MD & Senior Equity Research Analyst]

So I have 2 questions. By the way, a good quarter. Congrats. So 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 Synagis' seasonality, you're not really expecting any growth from the pipeline products besides the Synagis, so 2 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 second quarter ahead of the sales. But when you look at the sales last year, with the first quarter stocking, there was a destocking in second quarter, subsequent quarter. So should we expect that to happen in third quarter?

[Guido Oelkers, CEO & President]

Thank you, Eun. Basically, with regard to -- let's start with Synagis little bit. The indicators, when we follow the CDC publications, are quite positive. So we see that -- to see -- that the RSV probably is coming back. And we have no indications at this stage, but to believe that we will have a normal 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 in a bit of -- from a Synagis perspective, at least disadvantageous position.We think -- the indicators -- the indicators that we have from the virology also from our field activities are at that stage positive. It's just because it is such a big swing for us, it's just very difficult to predict and now with some precision how it's coming out. That's the reason why we left the guidance -- we allowed more flux in the guidance and maybe operational indicators and virology today would suggest so.On -- 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 -- that we see such a significant effect in the next quarters. What I would expect so 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 will see further improvement in the business 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 first quarter, 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. And we see that our competition is not a panacea and doesn't have a panacea either. So we see a space for us. We see a space there was 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 the variance on the consumption per capita is not from 0 to hero, that will still take a while until you see the full benefit that is going to flow of this year. But to your point, I don't anticipate that we will have a significant variance on the growth in comparison versus last year in Q3.

[Operator]

Our next question comes from the line of Christopher Uhde from SEB.

[Christopher Winston Uhde, Analyst]

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 say, 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 list, right?

[Guido Oelkers, CEO & President]

Yes. 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 the significant step-up of our activities in terms of medical education, the interaction of our MSLs, and we have 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 bleeds and so on and so forth.So that -- 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 is a benefit from more activity, but we have very materially stepped up our activity leverage. And we felt that this was a subject matter that was considered to be relevant for many KOLs. So they were happily teamed up with us, and we were supporting quite a 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 preoperational, but we have broadened market access team members. We're expecting obviously the approval for Gamifant 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 will deserve to be covered nationwide.So we have the capabilities in place. And frankly, I mean, we have quite a bit of China experiences in the company. And the people who were at the helm 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.

[Operator]

Our next question comes from the line of Rajan Sharma from Deutsche Bank.

[Rajan Sharma, Analyst]

Thanks for the question. First one, if we could just go back to RSV revenues and just thinking ahead into 2022. Is there a risk of lower RSV revenues if nirsevimab cannibalizes Synagis 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?

[Guido Oelkers, CEO & President]

Yes. Thank you. Let's start with nirsevimab. 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 time lines that are publicly known. I think you can deduct really for yourself. What's the risk you get is as nearly as good as ours on the launch schedule. But I think the -- we say -- we think that we -- that Synagis will have a place in also next year.With regard to cost outlook, we think that we will obviously want to support the prelaunch of pegcetacoplan. We want to support the launch phase of Doptelet. And we want to support the numerous clinical projects that Ravi has familiarized you. So we will stay with -- we think that we can stay within the limit of the guidance. Yes, I don't see that there are other things to report. Henrik, you want to comment on cost?

[Henrik Stenqvist, Chief Financial Officer]

No. I mean that's right. And this is what Guido said means that we expect somewhat higher spend level, both in SG&A and R&D for the second half.

[Guido Oelkers, CEO & President]

But, I think you need to just recognize that we expect pegcetacoplan will have a very significant product in our stable, and it just needs to be properly supported.

[Operator]

Our next question comes from the line of Rosie Turner from Barclays.

[Rosie Turner, Research Analyst]

Can you hear me right?

[Guido Oelkers, CEO & President]

Yes.

[Rosie Turner, Research Analyst]

Perfect. I will stick to the 2 questions. Firstly, if we could 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 on emapalumab. What are the actual economics behind the expected Russia and China approvals? What are the revenue dynamics there?

[Guido Oelkers, CEO & President]

Thank you. 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 the -- you would expect as there was very limited payments involved that gross margins would not reflect our average gross margin of our proprietary business, even though this year the gross margin of these businesses are clearly loss of what typically we had under partnering and that we basically don't scale 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 then 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 in order to emapalumab, obviously in a broader HLH setting could be quite significant. In primary HLH, we have seen the numbers in the U.S. This is, in a stricter 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 so there's uncertainty to this, what will be the price that we were able to obtain in order to get, for instance, in China on the NRDL. We know why the numbers on the lower end would suggest in mind with the population that there are quite a number of patients, I've seen data suggesting 5,600, it's probably north of that for HLH.But then the question is what will be the price level to enable this and over what time do you expect an HLH label, while initially, we would have a primary HLH label. So I'm afraid we are in early stage. And typically, we would not guide on sales potential to a 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.

[Operator]

Our next question comes from the line of Viktor Sundberg from ABG Sundal Collier.

[Viktor Sundberg, Research Analyst]

Congratulations on a solid quarter. So my first question is on pegcetacoplan. Could you highlight where you are in the process with EMA? Have you entered 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 first countries where you will commercialize the product?

[Guido Oelkers, CEO & President]

Yes. Thank you. I mean maybe I'll start with the easy bit and talk about our commercial readiness. And there, we can reaffirm that in the first wave countries, we have built considerable teams already whilst in the second 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?

[Ravi Madduri Rao]

Yes. Thank you. I will go into detailed questions that we've received, but we have answered the major issues. So 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.

[Viktor Sundberg, Research Analyst]

Okay. 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 could speculate that they will intensify when it's easier to reach physicians with less COVID in the second half?

[Guido Oelkers, CEO & President]

Yes. I mean with Hemlibra, 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, first-generation factor products at this juncture than from Hemlibra directly, but that we continue gain more gaining more that we would 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 you know they will not rest and probably have not fulfilled their ambition yet. We have not fulfilled ours. So this will stay with us. 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 or 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, the -- 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 were in the studies, who 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 this in our armament, and any of the feedback we are receiving from the Phase III trials are very positive.

[Operator]

Our next question comes from the line of Peter Östling from Pareto Securities.

[Peter Östling, Life Science Analyst of Equity Research]

Okay. Two questions. One first for Elocta and Alprolix. If you look at the sales bridge and if you move one 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. What about the pricing effect? 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 SEK 58 million, 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 look like going forward?

[Guido Oelkers, CEO & President]

Yes. I'll start with the sales of Doptelet. I mean 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 million 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 that 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.

[Peter Östling, Life Science Analyst of Equity Research]

Yes, Guido. But my question was about specifically the China number. Will they fluctuate over the coming quarter?

[Guido Oelkers, CEO & President]

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 as we -- it seems that these sales are reflecting the demand, granted that there can be because of the order pattern always a quarter where you have less than a quarter 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.

[Peter Östling, Life Science Analyst of Equity Research]

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.

[Guido Oelkers, CEO & President]

No, no, they launched already earlier. So let's say -- so I'm not making forward-looking statements, obviously, what they will order. But that is -- that was in 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.

[Peter Östling, Life Science Analyst of Equity Research]

So you could essentially multiply this by 4 then?

[Guido Oelkers, CEO & President]

Well, I would not -- I'm not suggesting this now, Peter, but it will not be -- it will not be -- let's say, I just didn't say that this is an extraordinary quarter. But yes, I mean, there will be more -- significantly more sales to come for us. Whether the number is times 4, whatever, let's say, I'm not saying 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.

[Peter Östling, Life Science Analyst of Equity Research]

Okay. Great. And then the price component going forward year-over-year.

[Guido Oelkers, CEO & President]

The price component for hemophilia, yes, basically, the SEK 90 million is pretty much -- we don't expect for this year, more price, an accurate price situation, knowing so 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 will carry forward with us during the course of the year.

[Operator]

Our next question comes from the line of Erik Hultgård from Carnegie.

[Erik Hultgård, Research Analyst]

I have 2, if I may. First on Doptelet. Going back a little bit on the previous question, taking out the SEK 58 million 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, 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 million in incremental sales in 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.

[Guido Oelkers, CEO & President]

Yes. I think the -- Erik, I mean, when you look at the Doptelet, 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 oversale in Q4 and as a consequence a lower Q1, but let's say, when I look at it by all yard sticks in the U.S. business and maybe what we can do is have an off-line 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 nor 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 COVID where 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 our sales evolution, I would have taken at any time. 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 SEK 200 million 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 -- 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 pocketed. 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. That's our clear mantra. And as we go along in this year, there is some of the uncertainty around the environment is lifting, I think then we will make sure that we properly account for this.

[Operator]

Our next question comes from the line of Peter Sehested from Handelsbanken.

[Peter Sehested, Research Analyst]

Congratulations on the results. And furthermore, by the fact that 2022 consensus or '23 consensus actually now below my numbers. So that means that there is upside to consensus and that the negative revision cycle may be over, but let's not be take things too 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 million 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 a, 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 for mature power products? That was number one.With respect to nirsevimab, I guess the communication or these are at least just I heard of from Medimmune, et cetera, 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 nirsevimab is going to be set in terms of price and market accessibility?

[Guido Oelkers, CEO & President]

Yes. Thank you, Peter. with regard to upside short and mid-term versus consensus, I mean we have guided on what we have guided on. And let's say, with regard to the Doptelet, let's say, at this stage, I think we should see during the second half an acceleration of growth. And let's say, because that's what we are working towards to. I mean, this is now exponential. It's always a question on how do you define exponential. But as we are now rolling up, let's say, the events, we think that we are clearly not done with Doptelet 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 nirsevimab, just we are obviously, due to our competitive situation, we are not plugged into the commercial strategy of Sanofi as much as its juncture. So I don't have further updates than basically Sanofi has given to the market. And I think there is a good data point in the Capital Markets 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 competitor situation that we still have with Synagis.

[Operator]

Our next question comes from the line of Jon Berggren from Kepler Cheuvreux.

[Jon Berggren, Equity Research Analyst]

I have 2. So you're running this study with emapalumab in malignancy-driven HLH. So I didn't see the specific study on the R&D slide 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 data essentially?Then my other question is related to pegcetacoplan. So Apellis, they will offer this infusion system called 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.

[Guido Oelkers, CEO & President]

Thank you. I start with the infusion system because I just discussed it actually with Apellis. And there, we will review this their advance. And we have right now selected and there is no common standard amongst geographies, let's say, I would say, best-in-class infusion system that has also supported but also has the right distribution. So that's our first step. And then we will look with the Apellis, and the decision has not been made to what degree we should use their own version. With regard to the malignant HLH study, I'd like to refer to Ravi because he's very close to this.

[Ravi Madduri Rao]

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 emapalumab 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.

[Guido Oelkers, CEO & President]

Good. I think maybe one more question, and then we probably have to wrap it up.

[Operator]

Yes. Our next question comes from the line of Christopher Uhde is a follow-up question. Christopher Uhde from SEB.

[Christopher Winston Uhde, Analyst]

So a question on pegcetacoplan in IgA nephropathy. I wondered why are you and Apellis 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?

[Guido Oelkers, CEO & President]

Ravi, you want to talk -- do you want to take this?

[Ravi Madduri Rao]

Yes. I think, Chris, 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 pegcetacoplan. But 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.

[Guido Oelkers, CEO & President]

Yes. I think we just have to recognize we 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 close 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.