Swedish Orphan Biovitrum AB (publ)

STO:SOBI

Earnings Call Transcript 2021-Q4

[Operator]

Ladies and gentlemen, welcome to the Sobi Q4 and FY 2021 report. [Operator Instructions] I will now hand over to the company.

[Guido Oelkers, CEO & President]

Yes. Thank you so much, Keith. Hi, everybody. This is Guido Oelkers, CEO of Sobi. Welcome to the Fourth Quarter and Full Year 2021 Conference Call for investors and analysts. The presentation was posted to sobi.com earlier, and the IR team also sent it out by email. I go straight to Slide 2. And Slide 2, as usual, is our safe harbor statement. We will be making comments on our performance using constant exchange rates or CER and numbers used in million Swedish krone. And for the fourth quarter and full year, unless stated otherwise, comments will be mostly related to the fourth quarter performance. With this having said, please turn to Slide 3. This is the agenda where we plan to cover all key aspects of results today. We plan to review the presentation first and then do Q&A until 12:45 Swedish time, as we are respectful of your time and understand that there are also other companies reporting today. If you keep your questions short, we will try to keep the answers short too. [Operator Instructions] And in speaking order, I'm joined by Henrik, our CFO; and Anders, our new Head of R&D and Chief Medical Officer. A warm welcome, obviously, to Anders. And for questions later, we are going to have also Armin, our Head of Medical and Scientific Affairs and the IR team. So please turn with this to Page #4. Starting off the presentation, I'm pleased that the 2021 outlook was delivered with pipeline progress and that the 2022 outlook shows continued and consistent revenue growth. The 9% increase in quarterly revenues was boosted by extraordinary supply of Kineret for the use of COVID-19 patients at risk of developing severe respiratory failure. In the year, the revenue growth was 7% with a growth profile hence, throughout the year, taking full revenue growth to a sustainable level.Our new launch medicine, Doptelet and Gamifant grew by 75% in the year and by 31% in the quarter. This underpins our ability to commercialize products and take them to the next level. Overall, hemophilia stabilized with Elocta down and Alprolix up. And as you remember, the Elocta, the downfall was a result of price reductions as we have experienced the highest patient course during the year during the last quarter. This trend means that we stabilized our hemophilia business, and we continue seeing this into 2022. The EBITDA margin landed at 36% for the year, mostly due to slightly better fourth quarter, including the extraordinary supply of Kineret, as mentioned earlier. And in 2022, as we move forward, we anticipate to continue investing for the future and to unlock and optimize the net present value of the business. The pipeline continued to deliver with approvals of Aspaveli and PNH and the extension of the Kineret approval in Europe for the use of COVID-19 patients at risk of developing severe respiratory failure. And this supported our revenue growth today and more so tomorrow. We expect continuous pipeline news throughout the year and in 2023, as we will outline later. The 2022 outlook issued today confirms that the strategy is on track, and we see continued consistent revenue growth in 2022. Henrik will cover the full 2022 outlook later in the call. And before going into details on the business, I would like to thank our colleagues at Sobi for the dedicated and hard work in 2021 which made these results possible. We strive to make sure we're the greatest place to work for in rare diseases. So all in all, the 2021 outlook was delivered and the pipeline progress -- and so this pipeline growth and the 2022 outlook shows continued and consistent revenue growth. So let's turn to Page #5. We now take a deeper look into the business. Moving to disease areas and geographies. We had a solid growth and saw stabilization of hemophilia. Hematology grew, mostly supported by Doptelet and immunology grew because of Kineret in Gamifant.From a regional perspective, and I think this is quite important to note that there was growth in all areas in the fourth quarter. And Europe and North America, each up by 6%, while international grew by 59%, underpinning that our strategy to further diversify our geographic footprint is starting to pay dividends. This means that we are a more diversified company with revenues coming from more disease areas and more medicine. And it also means geographic diversification out of Europe into a global rare disease company in support of this strategy to become a leader in rare diseases. So please turn to Slide #6. Turning to hemophilia, we saw stabilization towards the end of the year with Elocta stable in the first quarter -- fourth quarter, but down in the year. Alprolix had a good fourth quarter and a slight growth in the year. We see a stabilization also continuing in 2022, as earlier mentioned, and with pressure on prices and tenders but some growth in patients and consumptions benefiting from the ongoing fuel geographic expansion, in particular, into Russia. In short, while hemophilia remains competitive, we are cautiously optimistic on the ability to continue the stable development as seen recently. Let's turn to Page #7. Further in hematology is Doptelet, a key growth driver now and in the future. And while sequential growth was impacted by the timing of supply to our partner in China, we saw a strong fourth quarter and continued progress with the ongoing launches in the U.S. and Europe. And in the U.S., we are more advanced as we started earlier, but there has been a good progress across the 2 approved indications. In Europe, most revenues were generated in Germany and the U.K., whilst we have some early positive signals from the Nordics. So where there's still quite a bit of potential with this product and personally, I'm very optimistic for it as we're moving forward.Please turn to Slide #8. Turning to immunology. Kineret saw a boost in the fourth quarter from supplies in Russia, Romania and Turkey related to COVID-19, partially offset by lower supplies in the U.S. We remind everybody that there can be some volatility in the supply related to COVID-19. I think as everybody understands, the underlying Kineret business is continue -- is expected to continue showing single-digit growth numbers.Gamifant had another strong quarter and will benefit from the approved indication in the U.S. where we saw more patients, more volume per patient and the longer duration of therapy and quite hopeful that this is an ongoing trend, even though, as you remember, Gamifant can be a little bit volatile on a quarterly basis, but with a very positive trend recently. Slide #9, let's say, the further in immunology is Synagis. And as you are aware, the -- this is -- we had an earlier start into the RSV season in 2021. Given the number of early patients starting in the third quarter, the fourth quarter continued very well, and the results are absolutely in line with what was delivered in previous years in considering the currency effect as well.Looking at RSV detection in the U.S., where the reduction into 2022 which can be seen from the official CDC control numbers, we estimate that the currency season is more or less a normal season, and this will refer to timing and revenues. While the development of the full season therefore remains still a little bit uncertain, we believe that the -- over the entire season '21/'22, we may expect an average season overall. So before I hand over to Henrik, a quick summary. The results achieved in 2021 and the continued and consistent revenue growth outlook for 2022 emphasize that our strategic decision to focus -- that we have outlined over the last years is proving to show benefit -- continuous benefit, and we are committed to continued durable and sustainable top line growth. With the increasing global revenue base, new medicine and pipeline, we remain fully on track. And with this, I turn now over to Henrik, who will talk about the financials. Henrik?

[Henrik Stenqvist, Chief Financial Officer]

Thank you, Guido. So please turn now to Slide 11 and I will now take you through our financial performance in the fourth quarter and full year on 2021. Starting with quarterly revenue and knowing that Guido just covered some of it, I'm showing quarterly numbers here over the past 2 years. And in the fourth quarter, as we heard, all disease areas showed growth over the same period last year. Sequentially, versus the third quarter, the lower revenue that you can see in hematology was due to the fluctuating supply of Doptelet to China, that we discussed in Q3.Turning to the profit and loss on the right. For the avoidance of doubt, this table has growth rate at actual exchange rates. That is the statutory view. Total revenue for 2021 came out higher than the refined outlook from October. We highlighted already the revenue uncertainties around the Doptelet to China and Synagis, and we also realized the extraordinary supply of Kineret in a couple of countries. Our gross margin declined to 79% in the quarter to 78% in the year, the decline in line with the expectations I had highlighted during the year. The price impact to Elocta and our mix of business were the main reasons for this. Some of the -- of our growing medicines have a lower gross margin than average, and this includes Tegsedi and [ Hemlibra ] and Doptelet to the Chinese market, all important divisions in 2021. The R&D expenses increased both in the quarter and in the year. They represented 11% of revenue in the quarter and 13% of revenue in the year. These increases were a result of the focused investment in the pipeline, including new and ongoing Phase III studies such as pegcetacoplan and SEL-212.SG&A expenses increased as well, driven by more investments in the launches of Doptelet and Aspaveli and the continued geographic expansion into Eastern Europe and Asia. And as a result of the investment into the future of the company, the EBITDA margin reduced to 41% in the fourth quarter and 36% for the year. The higher-than-expected margin in the fourth quarter benefited obviously from the extraordinary supply of Kineret mentioned earlier. Finally, earnings per share for the quarter ended at SEK 4.21 million and SEK 9.08 million for the year, corresponding to a decline of 6% on an adjusted basis. Please now turn to Slide 12 and turning to net debt and cash. We saw a large reduction in the net debt to SEK 9.5 billion at the end of the quarter compared to SEK 11.1 billion at the end of Q3 and SEK 13.7 billion at the end of December 2020. Our net debt-to-EBITDA ratio reduced from about 2x at the end of 2020 to 1.7x at the end of '21. The reduction in net debt and the improved credit metrics highlight, obviously, the strong cash flow generation in Sobi despite the continued investment in R&D and sales and marketing. And with our structure and business model, the company remains a very cash-generative business. If we now please turn to Slide 13. Finally, I'll turn to the financial outlook for 2022, which is on revenue growth at constant exchange rates and EBITDA margin. In 2022, so we will continue to expand our presence in hematology and immunology and expand into new geographic markets. As a result of this growth strategy, we expect solid revenue growth. Revenue is anticipated to grow by mid- to high single-digit percentage at CER. At the same time, we will continue to invest in the pipeline and launches of new products to unlock longer value of the business. With these investments in the future, we expect to maintain a favorable margin. So the EBITDA margin is anticipated to be at the low 30s percentage of revenue. I'm confident in the outlook provided today. This confidence is based on the success of our patient-centric strategy and our track record of commercial execution. And with that, thank you for listening, and I will hand over to you, Anders.

[Anders Ullman]

Thank you very much, Henrik. It's a great pleasure for me to having joined the management team in Sobi as the Head of Research and Development and the Chief Medical Officer as latest last month, actually. So I want to remind you that I'm basically still on the steep part of the learning curve to learn to know all our people, our processes and getting deeper into the projects in R&D. And I have to say I'm really excited to be part of the team and to help the Sobi organization to deliver medicines that really matter to patients in need within the orphan and specialty care areas. And I'm also very much looking forward to interacting with you today and, of course, also in the future.So turn, please, to Slide 15, where I wanted to take a look on the pipeline news since October with a few highlights from the busy schedule. We are, of course, very pleased to receive the regulatory approval for Aspaveli in the EU in mid-December for the treatment of PNH. We also obtained the first approvals for the medicine outside the European Union, first in Saudi Arabia and then in Australia under the name of Empaveli. Kineret was approved in the European Union for use in the COVID-19 patients at the risk of developing severe respiratory failure as determined by the suPAR biomarker. This was a great achievement which really emphasizes Sobi's the dedication to patients with significant unmet medical need. And Kineret was also approved for a couple of new indications in Russia, which is expanding the label and proving the benefit to more patients -- providing the benefit to more patients. Very recently, we also initiated the first of a series of new studies for Aspaveli, which is part of the life cycle program for this medicine outside the first indication, which is PNH as mentioned. The clinical development program for Aspaveli will keep us busy for quite some time to come with several studies in different indications and some of them starting already in the first half of 2022. EMERALD is a long-awaited new Phase III study for Gamifant in macrophage activation syndrome in rheumatological diseases. And here, we have the first patients induced by now, and I want to thank the study team to get EMERALD over the starting line. And finally, we announced the completion of recruitment in the first of 2 Phase III studies for SEL-212 in chronic refractory gout. And we are back for the Phase III data later this year. So please turn to Slide 16. At the ASH, the American Society of Hematology Medical Meeting in December last year, Sobi had quite a large presence across most of the portfolio in hematology and immunology. In hemophilia, building and expanding our leadership in this disease, we had new data from the approved medicines, Elocta and Alprolix as well data from the pipeline with BIVV001 or efanesoctocog alfa. We look forward to the first Phase III data during the first half of this year. Moving to Doptelet, we see data when switching patients from treatment with older thrombocytopenia medicines and being able to shift older medicines while maintaining durable and stable response is really key to make sure that more patients can benefit from the clinical profile of Doptelet into its strong safety profile. Aspaveli, we had the first patient of the PRINCE Phase III data to place. And a reminder, PRINCE was a C5 inhibitor treatment-naive patients with PNH. And there was also other data percentage supporting the use of Aspaveli in PNH. And last but not least, Gamifant. For Gamifant, there was data in HLH, the approved indication as well MAS or macrophage activation syndrome in systemic juvenile idiopathic arthritis. This data support the broadening of Gamifant use by being explored in the new EMERALD Phase III study, which just started. So please turn now to Slide 17, we'll -- looking at Aspaveli. As I mentioned, we are really thrilled to now have it approved across the European Union since December. And while we -- it will take some time to launch Aspaveli and bring this new medicine to patients in Europe, we think Aspaveli brings a very meaningful benefit to patients with PNH. In fact, Aspaveli is the first new medicine in the European Union since 2007 for the treatment of PNH with a novel mechanism of action providing expanded choice for treating this issue in patients.We estimate that there are more than 100,000 patients in the top 5 European countries that are not responding to treatment with C5 inhibitor. We also estimate that with 70% of all patients being treated for PNH remain anemic despite C5 treatment. In an even higher number of patients that we see some sort of impairment of daily life due to this chronic disease. While this high unmet medical need, we will start the first launch in the European Union during the quarter. We can launch in a few countries this year where reimbursement is granted quickly. In other countries. It will take more time to achieve reimbursement. And this is, of course, part of the normal process into the pharma markets today. So please turn to Slide 18, looking at the pipeline news flows that we can expect. So in addition, we anticipate a number of news from Aspaveli, including a study start as well as Aspaveli seeing the last patient induced in a Phase II study for Lou Gehrig's disease or ALS. For Kineret, we anticipate submitting and receiving validation for the application of emergency use in COVID-19 in the United States. We anticipate a regulatory decision on Gamifant in China, and we anticipate the last Phase III patients recruited in SEL-212. In the second half of '22, we anticipate collaborations to apply for the U.S. approval for efanesoctocog alfa or BIVV001 and nirsevimab as well as the Phase III program readout for SEL-212. Looking ahead to next year, we also anticipate a good level of news for the pipeline, a list of events, which will go longer as we move ahead. So with that, I really want to thank you for your attention and for the opportunity to talk about the science and clinical development in Sobi. And with this, I will hand back to Guido, who will now conclude.

[Guido Oelkers, CEO & President]

Yes, thanks, Andres. And so in summary, we are pleased that the 2021 outlook was delivered with pipeline progress and the 2022 outlook shows continued and consistent revenue growth. With the performance delivered today, so we have become a more diversified business with revenues coming from more disease areas, more medicine and more geographies. As a result, we are steadily expanding into a global rare disease company in support of the strategy to become a leader in rare diseases and being there for patients and for all colleagues. Please turn to Page #20, 21. I mean, just wanted to mention that we -- the patients, obviously, in PNH are not in the hundreds of thousands, but more in the thousands. So in Europe, we have around 2,600 patients currently treated with C5 inhibitors, and we will try to take a share in this European context. So -- but now, please, let's go to Page #21. So I think it is time, let's say, for question and answers. [Operator Instructions] Perhaps we can take the first question? Operator, are we good for Q&A?

[Operator]

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

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

This is Eun Yang from Jefferies. Can you hear me? Hello?[Technical difficulty]

[Operator]

Ladies and gentlemen, we thank you for your patience. The call will resume shortly. Our first question comes from the line of Eun Yang from Jefferies.

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

Can you hear me okay?

[Guido Oelkers, CEO & President]

Yes, absolutely. Apologies to everybody. The line collapsed and it felt very lowly actually. But I hope you are at least able to listen to our presentation till the end. I'm not sure of it. Were you able to listen or...

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

Yes. Yes. Yes, we were.

[Guido Oelkers, CEO & President]

All right. Perfect. Eun, please. We're all ears here. Apologies, anyway.

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

No problem. So this year, you have 3 major data readouts from BIVV001, Gamifant, 212. Seems to me, the clinical risks are relatively low for these programs. But I'd like to ask you what your expectations for each program is when the data reads out.

[Guido Oelkers, CEO & President]

Yes. Thanks, Eun for -- I think it's an excellent question. And I mean, basically, I guess, give you my personal expectation and then I'd like to refer to Anders and maybe also to Armin. I mean, when you think about efanesoctocog alfa, I would personally expect that we see data confirming, let's say, the earlier data that we have seen and confirming the profile of the product that we are so excited about and that this is a further important step to normalize patients. With regard to SEL-212. I would hope that we see a further confirmation of the efficacy of the product in serum uric acid removal. And with regard to the Gamifant, I would hope that we confirm the data that we have seen in the earlier cohort of the MAS patients demonstrating, really, a pristine efficacy of the product. I don't know how you see it, Anders.

[Anders Ullman]

And I just agree with everything you say. And I mean, this is why we are here. We are working with established efficacious drugs, and we moved the understanding of it forward to make sure that we really optimize how they can benefit patients in our -- with high medical need in rare diseases. So we, of course, have very positive expectations.

[Operator]

Our next question comes from the line of Brian Balchin from Barclays.

[Brian Balchin, Research Analyst]

This is Brian from Barclays. This has kind of partly just asked. Now I'm just hoping to probe a little bit more on BIV001 data expectations. Just hoping to get an understanding of the level of factor VIII activity that you'd be hoping to see at day 7. Just as well as anything you can give us on market share implications, particularly as it relates to Hemlibra. And just on 212 again, you're confident for a positive outcome because -- I ask this because in the -- compare Phase II statistical significance were achieved those patients with visible [ tachy ] baseline, but the primary endpoint is for the overall population. So just anything that you could [ provide ].

[Guido Oelkers, CEO & President]

Perfect. Maybe I'll just take the question on BIV quickly, and then we can have, later, Armin. But before -- and also Anders for SEL-212. Where we -- with BIV, what we expect is that looking at the profile that, actually, for the majority of a week that we have normalized a patient and achieve physiological level. I think this is very significant, very important. And then at the end after we -- on day 7, I would expect to see data in line with what we have published, let's say, in the -- from the Phase II results. Anders, maybe...

[Anders Ullman]

Yes. I think it's -- that's very correct, and I think we knew the pharmacokinetical profile. I think we have expectations on a positive outcome. And we hope that this will really prove that we, under a significant part of the week, can provide almost or near to normal physiological level of factor X and this, I think, will gradually give us the opportunity to raise the bar for the treatment goals from, yes, controlling bleedings to really control long-term outcome in this severe chronic illness.

[Guido Oelkers, CEO & President]

SEL-212, maybe you want to comment on that?

[Anders Ullman]

And this is also, I mean, a very high medical need. I -- we hope to see significant and sustained treatment results. And if it delivers what it promised, I think this will have a many positive impact for a large basic group of high medical need.

[Armin Reininger, Head of Medical & Scientific Affairs]

And, if I may, because the question, and thanks for the question, was very specific on the day 7. And you've heard Anders just said, and I just want to reinforce that, it is very important for negative outcomes hemophilia patient treatment, not just to focus on the trough level at the end of the interval, but really look also throughout -- in this case, throughout the full week of how much normalization of the clotting system has occurred. And I think that is something will be -- really become very much more important than just look at 1 data point at the end of a week. So therefore, we have very high hopes for BIV001 and also what it will do for patients and particularly, for joint disease.

[Operator]

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

[Peter Östling, Life Science Analyst of Equity Research]

Yes. I have a brief question on the outlook. In '21, you said that -- or the outlook was for '21, an EBITDA margin between 33% and 35%. And you guided earlier that the R&D costs would be between 13% and 15% of sales. It came in at below 13%. I was just wondering, since you are guiding for a lower EBITDA margin in 2022, are there any significant R&D costs that you had expected for '21 that is pushed into '22? Or what's the reason for guiding even below the '21 level on the EBITDA margin?

[Guido Oelkers, CEO & President]

I think it's a very good question. I think the main driver is the maturing of the pipeline with basically moving the product forward into the next stage. Therefore, the development cost becoming more expensive. And then secondly, let's say, the investment into the geographic footprint. And then thirdly, it's the launch cost, to be honest, for Aspaveli in Europe. Maybe next -- yes?

[Peter Östling, Life Science Analyst of Equity Research]

It will be maybe more on the selling and administrative line then that will expand.

[Guido Oelkers, CEO & President]

No, it's an overall envelope. We will also have an expansion of cost in R&D due to the fact that I alluded to, yes.

[Operator]

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

[Adam Karlsson, Research Analyst]

First one on peg or Aspaveli. You've thought and, obviously, received the May approval for second-line use unlike the broader label Apellis sought in the U.S. for reasons to do with the durations of market exclusivity, I assume, and of course, you're restricted to marketing on label. But I was wondering, given what we're seeing in the U.S. with Apellis' launch in the first-line setting, your thinking around potential off-label use in the third -- first-line setting, is it reasonable to assume that there might be some component of that for the European launch as well or your thinking there?

[Guido Oelkers, CEO & President]

No, I think we -- I mean, I don't think I need to speculate how much of those patients will get it off-line. We know that roughly in the EU5, you may have 1,100 patients that are not responding well. Just -- equate to 72% remain anemic despite C5 treatment. That's our target audience. We feel very comfortable in that patient pool. I mean, on a total European basis, these numbers are larger, as I quoted, around 2,600 finally treated with their new mix of meds. It's a larger number. So we will go after this patient pool. This actually allow us to be -- to show relevance and to make a meaningful difference to patients. Because despite the fact that the mortality has been obviously improved over the last years, that doesn't mean that these patients are totally well served. So that's really our approach and quite happy to be relevant to a large enough group of patients.

[Operator]

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

[Viktor Sundberg, Senior Analyst]

So first of all, could you just elaborate a bit how you view your M&A or licensing strategy going into 2022? Historically, you've had a high pace of new deals. Is that expected to continue in 2022? Or how do you plan to deploy your firepower from here on? And then I'd ask...

[Guido Oelkers, CEO & President]

Yes, absolutely...

[Viktor Sundberg, Senior Analyst]

Sorry, I can take -- just a quick second question as well. So maybe a specific question here also on Sanofi's Enjaymo approval that was approved for cold agglutinin disease. I just wonder where you see a differentiation compared to that versus -- as per BLA. Of course, you haven't read out your Phase III study here, but just curious how you're thinking of the competitive landscape.

[Guido Oelkers, CEO & President]

Yes. I mean -- maybe I'll start first with the M&A part. I mean, I think it's fair to say that when you are under offer, your ability to do deals is a little bit impaired. I mean, despite this, we were able to forge a partnership in Latin America at this point and basically signed the JAK inhibitor from Galapagos for a part of the Southern belt in Europe, so I'm quite happy with that. But I think it's fair to say that in terms of scale, we ask for something greater, and we have been working on this and feel energized now to look for these targets. We have a pipeline. And as we speak, we will focus on this because we are absolutely determined to build Sobi as a global leader in rare disease, and that means further diversification, let's say, in terms of portfolio. And we feel that as the leverage that Henrik has outlined, we are well positioned to do something and then God knows, maybe we can even do creative things beyond that remit. So with regard to CAD, I think this is probably not the largest indication for Aspaveli, to be quite frank, in our geography, given when we studied it. I -- to Anders, you want to comment on -- Anders or Armin, let's say, on the data from Sanofi. I mean, it's normally not our job to content. I mean for us, it's early days, simply because we have not even generated any data. So it's a bit premature maybe to comment there.

[Anders Ullman]

And I think it is to say that we are planning to start this study and get evidence, and then we can compare. And as Guido said, it's one of several life cycle management possibilities on top of the base case -- many cases here. So I think it's early to say, but that it's not a determining factor for the future success of the product.

[Operator]

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

[Mattias Häggblom, Research Analyst]

I have 2 questions. I'll take them 1 at a time. So first, a question around your existing franchises and how do you think about investment into perhaps, strategically, more important franchises possibly to be funded by divestitures and are seen as less core specific. I'm curious to hear if the RSV franchise, including Synagis and profit rights to this is as core for Sobi today as it was when acquiring the assets in 2018 since our profile has changed partly since, and...

[Guido Oelkers, CEO & President]

I think with this question, I mean, I've seen a lot of write-ups on those questions more recently and, let's say, I mean, [ named ] a lot of speculation around it. I mean, I think it is fair to say that for us, the RSV franchise is a backbone for the North American organization, which was important -- it is important to our -- to further diversification of the company and obviously important for the economic results of the overall group. Now the business is -- the RSV franchise, when we acquired it was probably even more important for us at that time than it is today because we are a more diversified company. And then the question is, is this -- is there an alternative to this? I think we have probably not made up our mind on this. But we're quite happy, to be honest with what we have. Let's say, because we are encouraged by the results of nirsevimab and also the commentary that will come from the -- that is coming from Sanofi, who obviously is very optimistic or, let's say, forward-looking to the launch. And frankly, if they are optimistic then I have no reason not to be optimistic because we are a financial beneficiary of this. And hence, I'm feeling quite good in my close today. Could I feel better in another close? I don't know, because I don't know how that close could look like, to be honest. But at this stage, I think it's -- it would be premature to speculate.

[Mattias Häggblom, Research Analyst]

Good. That's clear. Helpful. I have a second question, and I was late on the call, so apologies if it was covered but I was curious to hear if you could quantify the FX tailwind for the year. We see that you guide for constant exchange range, but we don't know exactly -- I don't know what the consensus is carrying. So is 200 to 300 basis points tailwind a fair assumption? Or if Henrik could comment on that?

[Operator]

Ladies and gentlemen, once again, apologies for the interruption. We have another technical issue. We will try to establish audio straightaway.[Technical Difficulty]

[Guido Oelkers, CEO & President]

Yes. So guys, apologies for this second interruption. As you can sense, life is sometimes not without challenges. And why don't we pick up the pace again with some questions.

[Operator]

Mattias Haggblom from Handelsbanken.

[Mattias Häggblom, Research Analyst]

I just had a second question around if Henrik could maybe quantify the tailwind from FX given where client FX spot rates are. I know they are moving all the time. But curious to hear if 200 to 300 basis points tailwind is the right way to think about that.

[Henrik Stenqvist, Chief Financial Officer]

Yes. Do you mean historical numbers? Or do you mean future?

[Mattias Häggblom, Research Analyst]

No, assuming FX would remain the same for the remainder of the year, would that be a 200 to 300 basis points tailwind on top of what you have guided in constant currency exchange rates? Obviously, FX can change, but I'm just curious to hear. It should be supportive and I'm just trying to quantify.

[Henrik Stenqvist, Chief Financial Officer]

Yes. I mean we refrain from speculating. That's why we're guide in constant currencies. So what we say is that we will have a mid to high single-digit growth on revenues, and that is assuming constant rates, which is the average rate for 2021. Then we know that currencies will take absolute numbers elsewhere, but we stick to the constant currencies.

[Mattias Häggblom, Research Analyst]

But could you confirm that if currencies remain where they are today, that will be a tailwind compared to 2021, given the strength of the dollar and the euro to the krone?

[Henrik Stenqvist, Chief Financial Officer]

Yes, I can confirm that, yes.

[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 Aspaveli, if you could sort of elaborate and give some more color on how we should model this over the next few years, given processes with market access. I assume early launches in Germany, but then top 5 markets, when do you expect those to come on board as well? And then the second question is on your long-term sales and margin targets that you put out late 2020. I was just -- wanted to hear your confidence level on these targets. Are you more or less confident in the 25 by 25 target? And also that margins should expand from '23 given sort of some pretty major opportunities and launches that you have over the coming years?

[Guido Oelkers, CEO & President]

Erik, thanks for the question. So to start off with Aspaveli, I think it's fair to say that the first launch countries will be Germany and U.K. in Q1. And then basically, given the usual European launch schedule, the others are following more in the later part of the year, mostly in Q4 and then in the next following year. What this also means is when you look at the product, given, let's say, the profile and it is and also the approval.[Technical Difficulty] Yes. Erik, sorry. We have here a bit of a play up with these systems. Yes, so maybe I just pick it up, I don't know where I was cut off, but...[Technical Difficulty]

[Operator]

Once again, we apologize for the technical difficulty. We will try to resume shortly.[Technical Difficulty]

[Guido Oelkers, CEO & President]

Yes, this video conference becomes a bit like a bad comedy. But let's say, anyway -- let's not lose the sense of humor today, and this was a good quarter. And -- but with regard to your question, so it's a gradual ramp-up based on geography and also the way you will launch it because it takes a while to get these patients on the product given the second line. Secondly, you need to get these patients vaccinated. And obviously, for me, but it's much more important when we have programs in this regard into place is to gain -- get patient experience because what we've been -- what we're expecting is that the product will speak for itself given its superior efficacy profile. When it comes to the long-term outlook for the company, 25 by 25, I mean I have obviously no memory loss, but I said, let's say, we allowed there for a range at the time but we will manage towards this. And that's the job of the team now to look for ways. Let's say, obviously, we haven't -- we have got some headwinds with the -- some of the pricing, for instance, in hemophilia, which we didn't see coming with such an effect. But this is -- we have also plenty of opportunities in the range. I would say it would be completely premature. We have plenty of time to pick up the pace and work towards this, and we will have a solid growth this year. And we'll feel encouraged to do whatever we can maybe to do better. With regard to the 2023 margin, I think that, let's say, we will have -- it's true that we're expecting there an improvement. I mean we are currently actually working on strategies that we will probably divulge during the later part of the year, let's say, actually maybe more like in the -- around Q2 that will help you to model this. So that basically, what we indicated to you is -- we can also fulfill and underpin with the right measures. So I think that we have -- so what basically conclusion is we are working towards what we have announced, and we have no memory loss. I mean, I have to say that this is a very difficult conference call. So what we could do is we have tomorrow, another, let's say, another obviously opportunity to do into this. If there is maybe 1 more question or 2, let's say, we can cover this now. Otherwise, we will cover it tomorrow at more length and we will make sure that we have a line that is durable. Maybe any question maybe for the final?

[Operator]

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

[Jon Berggren, Equity Research Analyst]

I have just 1 related to your geographic expansion. So during your last CMD, you said you were in for several launches in Japan during 2022 and 2023, 4 launches in total, I believe, for these 2 years. So I don't see anything related to this in the pipeline news flow, including reports. So please update us on these launches.

[Guido Oelkers, CEO & President]

Yes. I think the most important launch for Japan is going to be the Aspaveli launch, and this has a very significant potential. We're also thinking that we will get -- we can make some strides with regard to Japan. We can update this, let's say, in the overall news flow, let's say, when we're expecting approvals. But we are well on track here let's say, and we are basically -- what -- currently -- but normally, we are not commenting on, basically, country product, let's say, at that level. I mean, obviously, Japan is an important market. But we are building this business out. We have set our first foot there, and you'll [ know], we are confident about the fact that we can make a difference in this market.I think with this, probably what I'd like to do is I'd like to close the -- today's session, and basically say, I mean, even though we had a bit of a few challenges today. So I think I'm very happy that we have delivered in 2021 what we had set out. I think you please take away -- 2022, let's say, we see continuous growth. And we are, obviously, a more diversified business today, and this applies to the different disease areas. This applies to the number of products, but also to the geographies. And we will basically build this platform as a global leader in rare disease companies, [ further ] and this is our main thesis. So I'd like to thank you here for your interest, and I look forward to tomorrow, and then we will be more extensive and probably in a more technically stable environment. Thank you so much, and I wish everybody a great day.

[Operator]

This now concludes the presentation. Thank you all for attending. You may now disconnect.