Swedish Orphan Biovitrum AB (publ)

STO:SOBI

Earnings Call Transcript 2022-Q1

[Operator]

Ladies and gentlemen, welcome to the Sobi Q1 2022 report. [Operator Instructions]

I will now hand over to the company.

[Guido Oelkers, executive]

Yes. Hello, everybody. This is Guido Oelkers, CEO of Sobi. Welcome to the first quarter 2022 report and conference call for investors and analysts. The presentation was posted to sobi.com earlier. And with this going, let's go to Slide #2.

Slide #2 is the usual Safe Harbor statement, and we are making comments on our performance using constant exchange rates, or CER, and numbers used are in million Swedish krona for the first quarter of 2022, unless stated otherwise. Please turn to Page 3.

This is the agenda, where we plan to cover all key aspects and results today. We plan to review the presentation first and then do a quick Q&A until around 2:00 p.m. Swedish time. There are other companies reporting today and we want to be respectful of your time. If you keep questions short, we will try to keep the answers short too. [Operator Instructions] We propose to ask only 1 or 2 questions at a time, many thanks, in the interest of the audience.

In speaking order, I'm joined by Henrik, our CFO; Anders, our Head of R&D and Chief Medical Officer; and for later questions, we have also Armin, our Head of Medical and Scientific Affairs here. Let's turn to page -- also Slide #4.

Starting off the presentation, I'm pleased that 2022 has started well for Sobi despite quite a few uncertainties in the world around us. Revenue grew by 24%, or at constant currency 35%, with an element of phasing for Doptelet sales to the partner in China. Synagis ended the RSV season on a high note as patient stayed on medicine. Our newly -- our new launch medicines, Doptelet and now also Aspaveli and Gamifant combined grew 126%, and the global Sobi network continued to perform well with the launches.

The underlying EBITA margin landed at 40%. On a reported basis of 26%, we included a provision for expected credit loss in Russia of SEK 157 million restructuring costs related to the already communicated contract manufacturing closure with a cost of SEK 360 million, a simplification of SEK 72 million of our site structure and efficiency programs of another SEK 72 million. All items affecting comparability are detailed and fully transparent on Page 3 of the formal Q1 2022 report today. The efficiency programs will focus resources into core areas, simplify the organization, adjust our cost base to enable to continuously and sustainably grow the company and generate margin improvement over time.

The pipeline continued to deliver with the first Phase III data of efanesoctocog alfa. With this, we started a potentially transformative journey towards normalization of hemostasis in haemophilia A and which could live -- enable patients to live a life at the fullest. It is also an opportunity for Sobi to bridge the present with the future and anchor our leadership in hemophilia in the long run. We expect continued pipeline news flow in this year and in 2023.

With this performance, we underpinned the 2022 outlook today. Henrik will cover outlook later. Finally, I would like to thank my colleagues at Sobi for their dedicated work which made these results possible. We strive to make Sobi a great place to work. And with all due respect, we try to make it a great place to work in rare diseases. Slide #5, please.

Moving to disease areas and geographies. We had a strong growth amongst all disease areas, with hemophilia benefiting from lower comparisons in 2021. Haematology was boosted by Doptelet while growth in Immunology was driven by Gamifant and Synagis. From a regional perspective, we saw a higher growth in new markets or international markets, further adding on global expansion and increased geographic diversification of Sobi's business. All in all, this performance supports Sobi's quest to become a global leader in rare disease. Please turn to Slide 6.

Turning to haemophilia. We saw growth of 7%, but from a low base in first quarter 2021. As we move forward this year, we continue to see stabilization of sales. Given the lower base, Elocta advanced by 15%, supported by an increased number of patients and factor consumption. Alprolix also saw an increased number of patients but also a slight offset from the low consumption and some price adjustments. As we move ahead this year and while haemophilia remains competitive on tenders and price, remain cautiously optimistic to be able to continue growing this business or at least having a stable development.

Further in Haematology is Doptelet, a key growth driver in the future. On the next slide, quarterly revenues saw a significant jump from the phasing of sales to the partner in China which, of course, creates a higher comparison later in the year. In the U.S., we continue to see good uptake and we increased the focus on launch excellence and execution. In Europe, most revenue still came from Germany, but we have seen good progress elsewhere. We recently won a tender in a Nordic country with Doptelet, and now we're in first ahead of an oral competitor and the injectable competitor not part of the ranking. In many countries, we are the market leader in haemophilia. And as we expand in Haematology, we aspire to become a leader in ITP and make Doptelet the thrombin protein medicine of choice.

Let's turn to Slide #8. We are pleased to announce the first sales of Aspaveli for PNH in Europe, and the formal launches are now commencing. Please take note that the official launch in Europe was in April, but we had already some sales to the market. Initially, in the U.K., obviously, we launched and followed by Germany and then soon in France. We made some initial sales in the U.K. in March, and first commercial patient was dosed in the home care program last week. We have been granted early access authorization in France for EU labeled use in patients with hemoglobin levels below 10.5 gram per deciliter. Germany will start once eligible patients have been vaccinated as per the EU label.

As we move forward, we carefully track all relevant launch metrics, but we have some variance [ encouraging ] signals when -- particularly when you're looking at the number of patients who have been earmarked for this treatment. Please turn to Slide #9.

Turning to Immunology. Kineret revenues grew by 11%. Growth was driven by the use for COVID-19 in emerging markets, partially offset by lower spontaneous use for COVID in the U.S. Underlying sales outside of COVID-19 is estimated to have a growth in the single-digit percentage range. Gamifant revenue increased by 27%, which is less compared to the second half of 2021. While we continue to see growth in patient volume and duration, we also saw an offset from a number of patients who concluded their treatment, and we'll come later to this. There's also -- you have to take note of the Q4 results of Gamifant in 2021.

Please turn to Slide #10. Last in Immunology is Synagis, where we saw a strong sales growth of 31% driven by a lower base in 2021 caused by the reduced infection levels as well as patients continuing to get their monthly immunization this year despite the earlier part of the 2021, 2022 RSV season. Given the uncertainties heading into the quarter, we are pleased by how the total season has played out and very gratified by the success that the team has been able to achieve. As we look ahead with the RSV season at a low level during the part of this year, it's always difficult to predict the new season. Our assumption is that we will have the season -- that we will have a season for 2022, 2023, following a normal pattern.

I will now hand over to Henrik, our CFO, for the financials. Please go ahead, Henrik.

[Henrik Stenqvist, executive]

Thank you, Guido, and please turn to Slide 12. So hi, everybody. I will now take you through the financial performance for the first quarter of the year.

Starting with the quarterly revenue, and knowing that Guido just covered some of it, I'm showing quarterly amounts here over the past 5 quarters. In Q1, all disease areas showed growth over the same period last year. And if we look at it sequentially versus the first -- fourth quarter, the lower revenue in immunology was due to higher sales of Synagis and Kineret in the fourth quarter, as we reported in February.

Turning to the profit and loss on the right. For avoidance of doubt, the table has growth rates at actual exchange rates, the statutory view. Revenue for the first quarter was high, growing by 24% at CER, and it was elevated by the phasing of Doptelet sales to the partner in China. Doptelet sales to China are volatile due to the ordering pattern and do not carry the same value to Sobi due to a clearly lower margin. And as we move into the year, we also anticipate growth rates to moderate due to higher comparisons in 2021.

Gross profit included SEK 360 million of costs related to restructuring and asset impairment from the discontinuation of contract manufacturing as previously communicated. Excluding this, the gross margin declined to 77% in the quarter from 80% in the comparable period. The mix of business was the main reason for this, with sales of Doptelet to China representing the largest impact on gross margin.

SG&A expenses included SEK 249 million in costs related to restructuring, asset impairment and a provision for expected credit losses in Russia, and this provision alone was SEK 157 million. On an adjusted basis, excluding these costs, SG&A increased by 23% at CER and supported the launches of Aspaveli, Doptelet and Tegsedi in the U.S., and also our geographical expansion.

The R&D expenses included SEK 52 million in cost affecting comparability. And excluding these costs, the increase was a more modest 4% at CER. The reported EBITA margin, as we heard, was 26%, but when adjusted for the items affecting comparability, the margin reached 40%. And finally, earnings per share for the quarter ended at SEK 3.67 on an adjusted basis. For more details, look at Page 3 and further on Pages 22 and 23 in the Q1 report. If we go to next slide, please.

We turn to net debt and cash. Driven by the strong operating cash flow, we saw further material reduction in net debt to SEK 8.3 billion at the end of the quarter versus SEK 9.5 billion at the end of 2021. And as a consequence, the net debt to adjusted EBITA ratio reduced from 1.7x to about 1.3x at the end of the quarter. The reduction in net debt and improved credit metrics highlight once again the strong cash flow generation. Despite the continued investment in sales and marketing and development, we remain very cash generative. Please, next slide.

And finally, I'll turn to the financial outlook for full year 2022, which is on revenue growth at constant currencies and adjusted EBITA margin. As discussed in February, when the outlook was issued, we will continue to expand the presence in rare diseases and expand into new geographies. And as a result of this growth strategy, we expect revenue to grow by mid to high single-digit percentage at CER. This means that growth, compared to last year, is anticipated to moderate as we move further into 2022 due to the higher comparisons from the second half of 2021.

And furthermore, we will continue to invest in the pipeline and launches of new medicines to unlock the long-term value of the company. Despite these investments in the future, we maintain a favorable margin. EBITA margin is anticipated to be at the low 30s percentage of revenue, measured as adjusted EBITA margin.

And with this outlook covered, I now hand over to Anders for the pipeline. Thank you.

[Anders Ullman, executive]

Thank you very much, Henrik. For me, now having been in the job for 4 months, it's great to see our pipeline continue to deliver positive news and move forward and help deliver medicine to patients in need with -- in orphan and specialty care indications.

Looking at the pipeline -- next slide, please, yes -- at the pipeline news since February, a few highlights from my side. We were indeed very pleased to receive the regulatory approval with orphan status for Aspaveli in the U.K. in February for the treatment of PNH. This followed earlier approvals in the EU, Saudi Arabia and Australia. By being granted orphan status, Aspaveli will benefit from up to 10 years of market exclusivity from similar medicines in the approved orphan indication.

Gamifant was approved in China for use in primary HLH. This was a milestone for Sobi as the first approval awarded to our company in China. We have worked very hard on our geographical expansion, so it's quite nice to see real progress also from a regulatory and approval point of view.

In early March, Sobi and Sanofi announced the first Phase III results of efanesoctocog alfa or BIVV001. The XTEND-1 study met the primary endpoint, showing very clinically meaningful prevention of bleeds in people with severe haemophilia A, receiving weekly prophylaxis in addition. The Phase III studies in patients younger than 12 years of age, XTEND-Kids, achieved enrollment completion with data anticipated in 2023 to support the EU regulatory process.

In Japan, Doptelet was submitted for regulatory approval, and the filing was accepted for potential use in chronic liver disease. This is a small indication in Japan, but it marked a milestone for our company as this was the first regulatory submission even for Sobi in Japan. And as of today, we have also got the pegcetacoplan filing approved in Japan.

Our collaborator, Apellis, announced that they achieved enrollment completion in their Phase II study in ALS or Lou Gehrig's disease. And finally, we completed the promised U.S. regulatory submission for emergency use of Kineret in COVID-19, and we hope to hear back from the agency soon. Please turn to Slide 17.

The big news and very exciting news for us in the first quarter was the positive readout of the XTEND-1 Phase III study for efanesoctocog alfa in the treatment of haemophilia A. The study met very clearly the primary endpoint, showing a clinically meaningful prevention of bleeds or bleeding episodes in people with severe haemophilia A, receiving weekly prophylaxis with efanesoctocog alfa over a period of 52 weeks. The median annualized bleeding rate was 0, with a mean annual bleeding rate of 0.71.

A key secondary endpoint was also met, demonstrating once weekly efanesoctocog alfa was superior to prior prophylactic factors, factor VIII replacement therapy, showing a statistically significant reduction in annual bleed rates based on intrapatient comparisons. Efanesoctocog alfa was well tolerated and inhibitor development to factor VIII was not detected at all.

These data supported our confidence in the potential of efanesoctocog alfa to elevate protection in people with haemophilia A towards normal hemostasis. Sobi and Sanofi plan to present the detail data at forthcoming medical meetings, including data on physical health, pain and joint health. We believe once weekly efanesoctocog alfa has the potential to represent a new class of factor VIII therapy designed to provide high, sustained factor VIII activity levels near normal for the majority of the week, and with that, the potential to transform haemophilia A therapy. Please turn to Slide 18.

As we look ahead to the pipeline news flow in the remainder of 2022 and 2023, we expect more news from Aspaveli lifecycle program, and we anticipate delay last Phase III patients recruited for Selecta or SEL-212. In the second half of 2022, we anticipate collaborators to apply for U.S. approval for efanesoctocog alfa and nirsevimab as well as for Phase III program readout for SEL-212. We also expect to hear from the U.S. FDA on Kineret as well as seeing data for Gamifant in new indications. Looking ahead to next year, we also anticipate a good level of news from the pipeline, a list of events which will get longer as we move ahead.

Thank you for your attention and for the opportunity to talk about our science and clinical development in Sobi. And with this, I will hand back to Guido, who will now conclude.

[Guido Oelkers, executive]

Yes. Thank you so much, Anders. Please turn to Slide #20.

So when you summarize the -- our presentations, what we wanted to share with you, revenue grew by 24% with an element of phasing of Doptelet to our partner in China, our launch medicines delivered and -- 126%, very pleased with this result. EBITA margin landed at 40% on an underlying basis and including the one-time items of 26% on a reported basis as we outlined. And as we stated, the 2022 outlook has been renewed today, and the efficiency programs will help us to build the company into the future. I'm very proud of the pipeline progress, particularly on haemophilia A.

I think with this, let's turn to Page #21, and we are open up the floor for Q&A. [Operator Instructions] Can I please remind everybody to limit questions to 1 or 2 to be fair to other callers. Thanks in advance, and perhaps now we can take the first question.

[Operator]

[Operator Instructions] And the first question does come from the line of Adam Karlsson from ABG.

[Adam Karlsson, analyst]

Compliments on a strong quarter. Two questions, if I could. One on Doptelet and one on Elocta.

First on Doptelet, you attributed the strong growth in part to phasing of sales in China, as you said, but also continued launch progress in the U.S. And I was wondering if you could give an indication of the relative contributions of these 2 components to the growth. And for the China component specifically, how much was sort of a phasing of sales of stock versus true demand, please?

[Guido Oelkers, executive]

Yes. I mean basically, the China business was in Q1, give and take, half and the rest was attributed to U.S. and, let's say, obviously, launch success now in Europe primarily and a little bit in international markets given the phasing of the launches, but only so much. We spent quite a bit of time on Doptelet in the U.S. to unlock growth and we see that this is paying dividends now. And obviously, it helps us that we have now more face-to-face interaction with physicians.

[Adam Karlsson, analyst]

Great. And my second question on Elocta. Anecdotally, to be fair, but we've had indications of patients who have once switched to Hemlibra having switched back to Elocta. So while, I guess, net patient gains for Elocta, of course, predominantly the mix of short half-life factor replacement gains and Hemlibra losses. Can you give an indication of whether you're seeing any sort of meaningful gains from Hemlibra beyond sort of a very low number or anecdotal instances?

[Guido Oelkers, executive]

I think we have indications that there are quite a few patients, but the -- but it's not in terms of materiality. It is still a relatively moderate part. But as you can see also from the other presentation from the owner of Hemlibra, growth in Europe has pretty much flattened over the last quarters. That is an indication that we are on a good way and, obviously, we are excited now to have the strong data of BIVV001 that basically now, we know at least, many physicians are very excited of. And as we get closer to the launch, you can expect that more and more patients will be reserved already for BIVV001.

[Adam Karlsson, analyst]

Great. No, that's very helpful. I'll leave it there.

[Guido Oelkers, executive]

Yes. Maybe we turn back to the operator or to the next question. Viktor?

[Operator]

Our next question comes from the line of Viktor Sundberg from Nordea.

[Viktor Sundberg, analyst]

So first one on Doptelet as well. Maybe a bit old news, but back in September, you got an unfavorable reimbursement decision in France for ITP. And I just wonder if there -- is there any read across there to other European markets? Or did you see this as a one-off backlash in France only? And then I have a follow-up as well.

[Guido Oelkers, executive]

No, I think the -- there may be a misunderstanding. I think the main contribution, let's say, right now in Doptelet from Europe is coming from Germany. And obviously, we'll look forward now to roll it out at a more material level across Europe. So you can expect that Europe is gaining materiality. There's a price difference, obviously, versus U.S. that will not allow Europe to reach levels as you will see in the U.S. And then we basically will unlock over time markets, in international markets and the biggest opportunity internationally will be in Japan.

[Viktor Sundberg, analyst]

Okay. And then a second one on Gamifant. So as you mentioned, you will read out EMERALD in the second half of 2021. It's a bit difficult to interpret what kind of proportion of patients that would need a complete response on emapalumab to hit your primary endpoint. I just wonder if you could guide me a bit here.

And secondly, I see in your milestone slide that you don't have Gamifant in macrophage activation syndrome as a regulatory decision in 2023. So I just want to confirm if you still believe that Gamifant's label could be extended in 2023 for macrophage activation syndrome.

[Guido Oelkers, executive]

Maybe I refer these question to Anders as he is here, and...

[Anders Ullman, executive]

Yes. In terms of -- we still have relatively few patients in the hematological HLH study. So in terms of -- we -- based on previous observations, yes, we have good expectations that we will get a good response and many complete remissions. But I think it's too early to really speculate in what level of efficacy we will see.

The second question, I...

[Guido Oelkers, executive]

This was -- maybe I can take it, Anders. And this was regarding macrophage activation syndrome and regulatory approval. And this is more -- this is less owed to our confidence around the product. It's more owed to the way we're doing things here that we want to provide you with certainty. So we will only list regulatory decisions once we have the data in our hands and then we file it. So that is the reason why you don't find it. It's not that we have -- we are lacking confidence on the product.

[Viktor Sundberg, analyst]

Okay. And congrats again on a strong quarter.

[Guido Oelkers, executive]

Appreciate it. Thank you. Maybe we move on then to the next.

[Operator]

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

[Peter Östling, analyst]

Just a quick one on the guidance that the EBITA is now ex one-off items and you had 40% in Q1, but you still guide for low 30s. So what will happen in the next couple of quarters that still -- that you still believe that you will end up in the low 30s? Could you elaborate a little bit on this?

[Guido Oelkers, executive]

Maybe Henrik takes this question.

[Henrik Stenqvist, executive]

Yes, Peter. Well, the main difference is the much stronger comparisons with the second half of 2021, so that explains most of it. We also expect to see slightly higher spend, particularly on the R&D side, during the remainder of the year.

[Peter Östling, analyst]

Okay. That's helpful.

[Guido Oelkers, executive]

And then maybe just to add. Obviously, in the Q1, given the seasonality of Synagis is tend to be always a little bit higher as Q4 because of the more pronounced Synagis sales.

[Peter Östling, analyst]

But that should come back in Q4 this year as well, if you expect normal Synagis season?

[Guido Oelkers, executive]

Yes. In Q4, yes, and -- but then we have Q2 and Q3 also on an annualized basis, yes.

[Peter Östling, analyst]

Okay. Fair enough.

[Guido Oelkers, executive]

And it's obviously early, but we will be relentless, Peter.

[Operator]

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

[Christopher Uhde, analyst]

I appreciate seeing the geographic split of sales. Doptelet -- sorry, excuse me, Alprolix is my first question. What percent of performance was due to factor consumption and what's the driver of the reduced factor consumption that you mentioned? And then what price -- what percent is pricing? And was there any phasing given the blowout Q4? That's my first question.

My second question is thoughts around financing. If you could share your thoughts around financing and the changing rate environment, what would need to happen to make you change your approach to financing M&A?

[Guido Oelkers, executive]

Yes. I mean I think the -- when you look at the Alprolix performance, what we can see is we have good patient growth. We had some, let's say, some topics with still a little bit lower consumption that we carried forward. But I think -- when you look at the Alprolix performance, I'm just looking here at Slide #6, you can see, obviously, a very strong performance in Q4.

I think you have to partially see the Alprolix performance also in Q1 and look maybe it's a combination of the 2 quarters because we -- when you look at the underlying business factors, you have patient numbers, we got a little bit price here and there, but nothing in a material fashion that would explain this such a drop. So I think you need to -- there may be some carryovers, and you need to see both -- basically both quarters in combination, and that's the reason why we have guided on a more stable haemophilia business for the year.

[Christopher Uhde, analyst]

Great. So basically primarily phasing essentially, it sounds like.

[Guido Oelkers, executive]

Yes, yes. I think this is a very strong phasing effect, and therefore, the product is still making progress but not exponentially.

And with regard to the financing question, I'd like to refer to Henrik.

[Henrik Stenqvist, executive]

Yes. Christopher, can you repeat the question? Something about how to finance M&A or?

[Christopher Uhde, analyst]

Yes, in terms of approaching -- how you approach financing of M&A. Obviously, there's a changing macro environment that affects your interest expenses. What would need to happen to make you change? What has been your approach in terms of how to secure financing for your M&A?

[Henrik Stenqvist, executive]

I don't see any changes in approach. If we go into a period of higher interest rates, I think we have the capacity to stomach that. We have a significant debt capacity operating out of today's very moderate debt levels, so I don't see a change there.

[Guido Oelkers, executive]

And Christopher, I mean, for us, it's a matter of can we create value? And I mean, then basically with the interest rate hike, you have just the hurdle rate to perform. It's just elevated. So we keep going.

All right, maybe next question.

[Operator]

Our next question comes from the line of Mattias Häggblom from Handelsbanken.

[Mattias Häggblom, analyst]

Two questions, please, I'll take them one at a time. So firstly, on the productivity measures that caused some of the one-off cost elements in the quarter, help me think about the potential savings from this. And if possible, please quantify what that could relate to?

[Guido Oelkers, executive]

Henrik?

[Henrik Stenqvist, executive]

Yes. So what we are doing here with the one-offs is really, first and foremost, to get the resources into the core areas, and that is why we exit the contract manufacturing. We are also simplifying the company. We are consolidating the sites in Switzerland. We believe it's much better to operate out of one place than several places.

Then there are also efficiency programs ongoing and that is really broad. Our ways of working and our organizational structure is being developed. And of course, we do this also with the expectations to long term be able to support the growth, but long to mid-term improvements in the margin. We don't quantify any further than that at this point in time. But of course, that's an important piece of it.

[Mattias Häggblom, analyst]

Good. And then secondly, you raised the credit facility of SEK 2 billion in the quarter and a commercial paper program of up to SEK 4 billion. Should this be seen as normal balance sheet maintenance? Or should we view these activities as signs of your appetite for near-term deals and will tie in the status of your business development activities at the moment?

[Henrik Stenqvist, executive]

M&A is, of course, part of the business model. But what you're referring to is more diversification of the existing financing.

[Operator]

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

[Erik Hultgård, analyst]

I have 2, if I may, first on Aspaveli. You mentioned, Guido, in your comments that there is some patients that are already earmarked for this product. And I was wondering if you could quantify, or at least, put it -- put some perspective on if that's a significant number of patients and what this would imply for the uptick. Should we expect to boost the coming quarters than sort of a catch-up effect or is it less of a significance? And then I have a second question, if I may.

[Guido Oelkers, executive]

Sure. On Aspaveli, I mean we are not -- we have not yet gone public with the numbers because we are also referring -- the material size refers now to April, let's say, where we have seen a significant spike. And -- but the -- let's say, it is -- we are gratified by it, but just bear in mind with the Aspaveli product is you have a bit of a lag time. You have to get the patients vaccinated.

So until you get -- you see materiality of sales, it will take up to half a year. And that's also what you have seen, let's say, even though there you have a bit of a broader label in the U.S. This is what you have seen also with our colleagues from [indiscernible]. And -- but you will see a ramp up, let's say, that basically is a bit slower at the beginning, but then obviously, given the economic size, will be quite significant.

So with the numbers I have on hand, let's say, at least I can be quite confident that we are up for something good. But I cannot give you now -- and as we obviously have said, this is not a vertical launch simply because of the steps we have to go through, not because of the economic potential of the product lines.

Maybe next question.

[Erik Hultgård, analyst]

Great. And then on Alprolix, you mentioned unfavorable price adjustment in the quarter. Is that related to any specific market? And is this something that will stick the coming quarters, so you have basically lower price points on -- inside the market?

[Guido Oelkers, executive]

I think we try to precise is that the primary driver was really the comparability. You should look at Q4 and Q1 as one, and then price is more spread. There has not been any extraordinary pricing. It's more a competitive behavior because, obviously, you can appreciate that we are in a competitive situation. There was other factor IX suppliers, but nothing that sticks out or that has been, for us, a reason now to be worried, and not basically hold on to our outlook that this is more of a stable franchise for us this year.

Maybe we go to the next question.

[Operator]

Our next question comes from the line of Adam Karlsson from ABG.

[Adam Karlsson, analyst]

Just the one. On the -- of the SEK 660 million in one-offs or items affecting comparability, is it fair to assume that roughly 20% of that will be noncash, that component being the impairment of tangible assets related to the factor closure and restructuring costs? Or are there any other significant noncash components to be aware of?

[Henrik Stenqvist, executive]

No, Adam, it's actually probably less than 20% because part of the tangible asset impairments refer to capitalized rent to capitalized leases. So it's obviously mainly cash items here.

[Guido Oelkers, executive]

Maybe next question.

[Operator]

Our next question comes from the line of Eun Yang from Jefferies.

[Eun Yang, analyst]

I have one question on Doptelet and the other is on 212. So on Doptelet, last year, third quarter, half of the sales came from China, and then the fourth quarter sales were kind of low in China, less than third quarter. So first quarter this year, growth is driven by phasing of sales to China. Can you kind of quantify how much of first quarter sales came from China? And how should we think about quarterly growth for the remainder of the year? So that's question number 1.

And question number 2 is on 212. So recently, the horizon filed for sBLA combining KRYSTEXXA with methotrexate. So I want to ask you how that could change your efficacy bar for the data readout toward the end of this year as well as marketing position?

[Guido Oelkers, executive]

Very good. Regarding Doptelet, I'll start with, we have -- I mean we have around 50% of the business this quarter -- or last quarter in Q1 in -- related to sales to China. So we expect that there will be more sales to China, obviously. So it's not -- but maybe this is not a representative quarter, so to be also honest.

But there will be -- what we can expect there will be more sales given the fact that Doptelet is on the NRDL. And hence, they basically will ramp up now commercial further activities and we have -- but we have limited visibility on sellout in China right now, to be honest. And -- but we see that there is -- we can look forward to more business from them.

For me, the key is that we make good progress now in the U.S. foremost and which we are doing. Very encouraged by the more recent signals after we have done a couple of tweaks to the business and also now that we are ramping up Europe and international markets. But the product is in a good shape, and with very strong growth irregardless now of this variation that you have seen in China. And yes, there will be more business coming in from China. So Doptelet will become a very material product for us this year. There's no question.

And maybe with regard to SEL-212 and the recent development of KRYSTEXXA, maybe Anders, you want to comment. The -- on the methotrexate combination with KRYSTEXXA, and let's say, and whether this changes the bar. I'm just paraphrasing.

[Anders Ullman, executive]

So -- I mean we have been knowing about that program since some time, and we are still quite confident in the potential and advantages of the ImmTOR technology and SEL-212. And methotrexate have -- is a well-known compound with a lot of limitations in the utilities. So this is not any surprise to us, it's not changing our expectations on the product.

[Guido Oelkers, executive]

No. And I think, Eun, you need to also see this in a context that methotrexate is not indicated for many patients. And in particular, those who have a more frequent alcohol consumption, which is quite a significant chunk of those chronic refractory gout patients. In addition, I think the product will speak on the strength of dosing also and also by -- from what we have seen, particularly the effect on these more severe patients [indiscernible].

So I think we have the Phase III programs on the way, and we are looking forward to the readout of the second Phase III trial, and I think we accept that Horizon is a formidable competitor. But we hope that we are worthy of them and we can give them a good run for the money when we are.

[Armin Reininger, executive]

Eun, if I may add just on that one. I mean it's always more difficult approach to treat if you have to combine strong drugs and given also side effects and other aspects, particularly with methotrexate, whatever it is or it may be, need to watch out for liver and other things. So I think it's always more straightforward approach if you have one drug that really works on target.

[Guido Oelkers, executive]

Very good. Maybe next question.

[Operator]

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

[Christopher Uhde, analyst]

So I think -- just stick with SEL-212 for the moment here. Obviously, getting fairly close to pivotal readouts, but there's been little change to the R&D program, although it does seem that you need to do some work to reestablish your positioning after the COMPARE trial. So when and what might we expect to see in terms of augmenting that R&D program? And then I just wondered if you could detail the external expenses component of the restructuring costs?

[Guido Oelkers, executive]

Anders, do you want to talk about it?

[Anders Ullman, executive]

If I -- the external -- I'm not sure if I...

[Christopher Uhde, analyst]

No, sorry, that was the second part, separate. The first part was about SEL-212, and previously COMPARE was head-to-head against KRYSTEXXA. And although it was successful on most of the secondary endpoints, the primary missed. So what do you need to do to reestablish your positioning versus KRYSTEXXA in terms of your R&D program because nothing has changed in the interval.

[Anders Ullman, executive]

I think what we are doing is that we are running 2 largely well-designed studies with a significant part of these patients. And I think we have, from earlier studies and earlier observations and neutralizing effects of KRYSTEXXA, I think, we are -- altogether we are quite confident that we will see a clinical benefit in terms of the number of patients with remaining long-term efficacy in the Phase III studies, as that's what they designed for and what they powered for and what we are aiming for.

So in terms of your question regarding...

[Guido Oelkers, executive]

It was restructuring. This is basically the financial question probably, yes, where you basically say what to expect from the restructuring efforts, yes?

[Anders Ullman, executive]

You were asking about external costs?

[Christopher Uhde, analyst]

Yes, the SEK 72 million for external expenses, I just wondered what exactly that was? I mean I'm trying to understand how much would be potentially recurring given that you're talking about ongoing restructuring efforts or efficiency efforts.

[Anders Ullman, executive]

Yes. I mean the restructuring here is really almost complete. There could be smaller amounts in the next quarter, but it is virtually complete from a cost point of view.

[Guido Oelkers, executive]

I mean basically -- Christopher, these are basically design costs for organizational design because we undertook quite a bit of an effort looking at accelerating the business, building up capabilities, new functions and then, obviously, also designing organizational redesign, which we haven't announced yet and we see some savings.

So there is a second phase, but one-time events will not be at the level, obviously, as you have seen in Q1. And you know that we will do this in a sharp way, but it is designed -- these are design costs. So these are not yet cost for -- that you would typically have.

Next question?

[Operator]

The next question comes from the line of Caroline Banér from Danske Bank.

[Caroline Banér, analyst]

So a question on Synagis. Is there -- do you believe a change in clinical practice, as you mentioned, patients remained on treatment despite the early start of the RSV season. I was just wondering if you think there's a change in clinical practice here?

[Guido Oelkers, executive]

No, I think not really. I mean what we basically have to see is that when we acquired this business, this was a SEK 270 million business on a season basis. Now this season has -- when you account for what we have achieved last year in -- already starting a bit earlier in Q2 and then -- sorry, in Q3 and in Q4 and then this year in Q1, it's around SEK 330 million.

And let's say we have got better, obviously, let's say, in bringing patients along. We have talked about it that we have driven operational effectiveness in the organization and trying to build up the adherence because you used to have -- when we took the business, it was, I think, around -- patients got around 3.5 dosing per season. We have improved that and, let's say, sure enough, COVID was helpful.

But I think that would be too simple. I think it is a team that has done, over the years, a very consistent effort that was unfortunately blocked by the last -- Q1 last year by basically the absence of travel and the epidemic level. But I think this is now coming back. So I think we don't see a radical change, but if anything, there's a stronger adherence to the protocol.

Maybe next question.

[Operator]

[Operator Instructions] And the next question is from Viktor Sundberg from Nordea.

[Viktor Sundberg, analyst]

So I was wondering to get your take on nirsevimab, although it's a Sanofi natural program mainly, but I just want to get your take on the miss on hospitalization in the MELODY trial. What is your take on that in terms of the potential to [indiscernible] in the U.S.? I just wonder if you still are confident on the potential of that drug? Or is there more riskier that the nirsevimab could be more limited by, say, guidelines, reimbursement coverage or by the label?

[Guido Oelkers, executive]

Yes. I mean where we stand, based on what our knowledge base is, we don't think that basically the potential of nirsevimab appears to be impaired. If that would influence, we would obviously look forward to selling more Synagis, so that would not be the biggest problem at this juncture for us, let's say. So -- but I think we are reasonably well insulated. But I think that the other data of the product and based on some of the service that has been out, you have to -- we assume at least that there is confidence around the strength of nirsevimab.

And I think with this, maybe I just -- if you do -- if you allow me, I just want to maybe make a point. I would like to summarize. I think we started well. I mean at least this is what we feel. 25% growth at constant rate. Our launch products growing at 126% and on an adjusted basis, EBITA of 40%. I mean it makes us feel confident that we are on a good way to drive this business forward. It's early days. Hence, you can see us a little bit more cautious at this juncture given an uncertain world around us.

But it's really a pleasure to have you with us, and I would like to thank you for your interest in Sobi. And I would like to close the call and look forward to having interactions with you in the near-term feature. Thank you.

[Operator]

This now concludes our conference. Thank you all for attending. You may now disconnect your lines.