Ladies and gentlemen, welcome to the Sobi Q4 and FY 2021 report. Throughout the call, all participants will be in listen-only mode, and afterwards there will be a question and answer session. I will now hand over to the company.
Yeah. 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. As I go straight to slide two, and slide two, as usual, is our safe harbor statement. We will be making comments on our performance using constant exchange rate or CER and numbers used in SEK million for the fourth quarter and full- year, unless stated otherwise. Comments will mostly relate to the fourth quarter performance. With that said, please turn to slide three. 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 your answers short too. For those on the phone, please join the queue for questions by pressing zero one. We propose you ask only one or two questions, many thanks in advance. In speaking order, I'm joined by Henrik, our CFO, and Anders, our new Head of R&D and Chief Medical Officer. Warm welcome, obviously, to Anders. For questions later, we are going to have also Armin, our Head of Medical and Scientific Affairs and the IR team. Please turn to page number four.
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. You know, this underpins our ability to commercialize products and take them to the next level. Overall, hemophilia stabilized with Elocta down and Alprolix up.
As you remember, the Elocta, the downfall was a result of price reductions, while we have experienced the highest patient cost during the year, during the last quarter. This trend means that we stabilize 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. 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 in PNH and the extension of the Kineret approval in Europe for the use of COVID-19 patients at risk of developing severe respiratory failure. This supported our revenue growth today and more so tomorrow.
We expect a continuous pipeline news flow 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. 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 Sobi the greatest place to work for in rare diseases. All in all, the 2021 outlook was delivered and the pipeline progress and so this pipeline grows and the 2022 outlook shows continued and consistent revenue growth. Let's turn to page five. 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 and Gamifant. From a regional perspective, I think this is quite important to note, there was growth in all areas in the fourth quarter. Europe and North America each up by 6%, whilst international grew by 59%, underpinning that our strategy to further diversify our geographic footprint is starting to pay dividends. This means that we are more diversified company with revenues coming from more disease areas and more medicines, and it also means a geographic diversification out of Europe into a global rare disease company in support of the strategy to become a leader in rare diseases. Please turn to slide number six.
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 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 consumption benefiting from the ongoing 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 seven. Further in hematology, Doptelet is a key growth driver now and in the future.
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. In the U.S., we are more advanced as we started earlier, but there has been a good progress across the two approved indications. In Europe, most revenues were generated in Germany and the U.K., while we have some early positive signals from the Nordics. There is 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 eight. 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 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 a longer duration of therapy. We are quite hopeful that this is an ongoing trend, even though, as you remember, you know, Gamifant can be a little bit volatile on a quarterly basis. With a very positive trend recently. Slide number nine. Let's say the further in immunology is Synagis. As you are aware, you know, 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. The results, you know, are absolutely in line with what was delivered in previous years 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 current 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 over the entire season, 2021, 2022, we may expect an average season overall. 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 continue durable and sustainable top-line goals. With the increasing global revenue base, new medicine and pipeline, we remain fully on track. With this, I turn now over to Henrik, who will talk about the financials. Henrik.
Thank you, Guido. Please turn now to slide 11. I will now take you through our financial performance in the fourth quarter and full- year of 2021. Starting with quarterly revenue and knowing that Guido just covered some of it, I'm showing quarterly numbers here over the past two years. 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 rates 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 uncertainty surrounding 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 and to 78% in the year. The decline was 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 our growing medicines have a lower gross margin than average, and this includes Tegsedi and Waylivra and Doptelet to the Chinese market, all important additions in 2021. The R&D expenses increased both in the quarter and in the year, and 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. 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 4.21 and 9.08 for the year, corresponding to a decline of 6% on an adjusted basis. Please now turn to slide 12.
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 2021. 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. 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, Sobi 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 a mid- to high single-digit % at CER. At the same time, we will continue to invest in the pipeline and launches of new products to unlock the long-term value of the business. With these investments in the future, we expect to maintain a favorable margin. The EBITDA margin is anticipated to be at a low 30s % 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.
With that, thank you for listening, and I will hand over to you, Anders.
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 late as last month, actually. I want to also 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. 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 matters to patients in need within the orphan and specialty care areas. I'm also very much looking forward to interacting with you today and of course also in the future.
Turn please to slide 15, where I wanted to take a look on the pipeline news since October with a few highlights from a 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 COVID-19 patients at risk of developing severe respiratory failure as determined by the suPAR biomarker. This was a great achievement which really emphasizes Sobi's dedication to patients with significant unmet medical need.
Kineret was also approved for a couple of new indications in Russia, which expanded the label, improving 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 the first half of 2022. EMERALD is a long-awaited new phase III study for Gamifant in macrophage activation syndrome in rheumatological diseases.
Here we have the first patients dosed by now, and I want to thank the study team to get EMERALD over the starting line. Finally, we announced the completion of recruitment in the first of two phase III studies for SEL-212 in chronic refractory gout. We are on track for the phase III data later this year. 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 as 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 show data when switching patients from treatment with older thrombocytopenia medicines and being able to shift older medicines while maintaining durable and stable responses is really key to make sure that more patients can benefit from the clinical profile of Doptelet including its strong safety profile. As for Empaveli, we had the first patient of the PRINCE phase III data took place. A reminder, PRINCE was a C3 inhibitor treatment-naïve patients with PNH, and there was also other data presented supporting the use of Aspaveli in PNH. Last but not least, Gamifant.
For Gamifant, there was data in HLH, the approved indication, as well in MAS or macrophage activation syndrome in systemic juvenile idiopathic arthritis. These data support the broadening of Gamifant use by being explored in the new EMERALD phase III study, which just started. Please turn now to slide 17. Looking at Aspaveli, as I mentioned, we are really thrilled to now have it approved across the European Union since December. While 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 physicians and patients.
We estimate that there are more than 100,000 patients in the top five European countries that are not responding to treatment with C5 inhibitor. We also estimate that over 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 their 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 reimbursements. This is of course part of the normal process in the pharma markets today. Please turn to slide 18.
Looking at the pipeline news flows that we can expect. In addition, we anticipate a number of news from Aspaveli, including a study start, as well as, Aspaveli seeing the last patient dosed 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 2022, we anticipate collaborations to apply for the U.S. approval for efanesoctocog alfa or BIVV001 and nirsevimab as well as the phase III 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.
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. With this, I will hand back to Guido, who will now conclude.
Yeah. Thanks, Anders. In summary, you know, 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, Sobi has become a more diversified business with revenues coming from more disease areas, more medicine and more geographies. As a result, Sobi is 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 our colleagues. Please turn to page number 2021. I mean, just wanted to mention that, you know, the patients obviously in PNH are not in the hundreds of thousands but more in the thousands.
You know, in Europe, you have around 2,600 patients currently treated with C5 inhibitors, and we will try to take a share in this European context. But now let's go to page number 21. I think it is time, let's say for question and answers. For those on the phone, please remember 01 to ask the question. Can I please ask everybody to limit the questions to one or two, and just to be fair to all the other participants? Thanks in advance, and because perhaps we can take the first question.
Thank you. Ladies and gentlemen, if you do wish to ask a question, you can do so by pressing zero one on your telephone keypad. Our first question comes from the line of
Are we good for Q&A?
Thank you. Ladies and gentlemen, if you do wish to ask a question, please press zero one on your telephone keypad. Our first question comes from the line of Eun Yang from Jefferies. Please go ahead. Your line is now open.
Do you mind initiating the Q&A now, please?
Hello. Hi, this is Eun Yang from Jefferies. Can you hear me? Hello.
Hello, Eun, this is Armin. I'm on a different line, so I hear everything, but obviously the line to the.
Ladies and gentlemen thank you for your patience the call will resume shortly with the Q and A session.Our first question comes from the line of Eun Yang from Jefferies. Please go ahead. Your line is now open.
Thank you. Can you hear me okay?
Yeah. Hi, Eun. Yes, absolutely. Apologies, actually to everybody. You know, the line collapsed and it felt you know, very lonely, actually. I hope you were at least able to listen to our presentation till the end. I'm not sure. Were you able to listen or?
Yes. Yes. Yes, we were.
All right. Perfect. Eun, please fire off. Yeah. Apologies anyway.
No problem. This year you have three major data readouts from BIVV001, Gamifant ten, SEL-212. It seems to me the clinical risks are relatively low for these programs. I'd like to ask you what your expectations for each program is when the data read out. Thank you.
Yeah, thanks, Eun Yang, for the question. I think this is an excellent question and, you know, I mean, basically, you know, I just give you my personal expectation and then I 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 and serum uric acid removal.
With regard to 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.
Yeah, but I just agree with everything you say. I mean, this is why we are here now. We are working with established, efficacious drugs, and we move the understanding of them forward to make sure that we really optimize how they can benefit patients with high medical need in our rare diseases. We of course have very positive expectations.
Very good. Jon, maybe we have another question.
Our next question comes from the line of Brian Balchin from Barclays. Please go ahead. Your line is now open.
Hi, this is Brian Balchin from Barclays. Thanks for the questions. This is kind of partly just asked now, but I'm just hoping to probe a little bit more on BIVV001 data expectations. Just hoping to get an understanding of the level of factor activity that you'd be hoping to see at day seven, just as well as anything you can give us on market share implications, particularly as it relates to Hemlibra. And just on SEL-212 again, your confidence on a positive outcome because I ask this because in the COMPARE phase II, statistical significance was only achieved in those patients with visible tophi at baseline, but the primary endpoint is for the overall population. Just anything you can-
Perfect. Maybe I just take the question on BIV quickly, and then we can have later Armin, but you know, beforehand, also Anders on SEL-212. Very brief, you know, with BIV what we expect is, you know, looking at the profile that actually, you know, for the majority of the week that we have normalized the patient and they achieve physiological level. I think this is very significant, very important. You know, at the end of the day after week on day seven, I would expect, you know, to see data in line with what we have published, let's say in or from the phase II results. Anders maybe-
Yeah. No, I think that's very correct. I think we know the pharmacokinetic 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 VIII. This, I think, will gradually give us the opportunity to raise the bar for the treatment goals from just controlling bleedings to really control long-term outcome in this severe chronic illness.
SEL-212, maybe you want to comment on that.
I mean, this is also a very high medical need. We hope to see significant and sustained treatment results and, if it delivers what it promise, I think this will have a major positive impact for a large patient group of high medical need.
Yeah, maybe next question
Anders, if I may, just because the question, and thanks for the question, was very specific on the day seven. You heard Anders just say it, and I just want to reinforce that. It is very important for negative outcomes in 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. I think that is something that will really become very much more important than just look at one data point at the end of a week. Therefore, we have very high hopes for BIVV001 and also what it will do for patients and particularly for joint disease.
Great. Maybe we come to the next question.
Our next question comes from the line of Peter Östling from Pareto Securities. Please go ahead. Your line is now open.
Yes. Thank you. I have a brief question on the outlook. In 2021, you said that the outlook was for 2021, an EBITDA margin between 33%-35%. You guided earlier that the R&D costs would be between 13%-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 2021 that is pushed into 2022? Or what's the reason for guiding even below the 2021-
Yeah.
Level of on the EBITDA margin? Thank you.
Yeah. Peter, I think it's a very good question. I think the main drivers is the maturing of the pipeline with basically moving the product forward into the next stage, therefore the development costs becoming more expensive. Secondly, let's say it is the geographic investment into the geographic footprint. Then certainly it's a launch cost, to be honest, for Aspaveli in Europe.
Okay. It
Maybe next. Yes.
It will be maybe more on the selling and administrative line than that will expand.
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. Yeah.
Okay, great.
Thank you, Peter.
Our next question.
Yeah. Maybe we go to the next question and.
Our next question comes from the line of Adam Karlsson from ABG Sundal Collier. Please go ahead. Your line is now open.
Hi. Thanks for taking my questions. First one on Aspaveli. You've sought and obviously received the MA approval for second line use, unlike the broader label that Apellis sought in the U.S. for reasons to do with durations of market exclusivity, I assume. Of course, you're restricted to marketing on label. 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 first line setting, is it you know, reasonable to assume that there might be some component of that for the European launch as well or your thinking there?
No, I think, you know, I mean, I don't think I need to speculate how much, you know, how much of those patients we get with off-label. We know that roughly in the EU5, you know, we have 1,100 patients that are not responding well. This equates to 27.2% remain anemic, you know, despite C5 treatment. That's our target audience. We feel very comfortable in that patient pool. I mean, you know, on a total European basis, these numbers are larger, you know, as I quoted, around 2,600 currently treated, so then you make the math. It's a larger number. We will go after this patient pool. This should actually allow us, you know, to be relat...
To show relevance and to make a meaningful difference to patients, because, you know, despite the fact that, you know, the mortality, you know, has been obviously improved over the last years, you know, that doesn't mean that these patients are totally well served. That's really our approach and quite happy to be relevant to a large enough group of patients.
Gotcha. Thank you.
Maybe-
Maybe just a-
Thank you.
... a q-
Yes.
Our next question comes from the line of Viktor Sundberg from Nordea. Please go ahead. Your line is now open.
Yeah. Hi. Thank you for taking my questions. 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 quite 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?
Yeah.
Add a quick follow-up also.
Yeah, absolutely. You know.
Oh, sorry.
Go ahead.
I can take just a quick second question as well. Maybe a-
Yes
... specific question here also on Sanofi's Enjaymo approval that was approved for cold agglutinin disease. I was wondering where you see a differentiation compared to that versus Aspaveli. Of course, you haven't read out your phase III study here, but just curious how you think of the competitive landscape. Thanks.
Thank you. I mean, maybe I start first with the M&A part. I mean, I think it's fair to say that when you are under offer, you know, 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 sign the JAK inhibitor from Galapagos for part of the southern belt in Europe, so quite happy with that. You know, I think it's fair to say that in terms of scale, we are up for something greater and we have been working on this and feel energized now to look for these targets.
We have a pipeline and, you know, as we speak, you know, we will focus on this because we are absolutely determined to build so we are as a global leader in rare disease, and that means further diversification, let's say, in terms of portfolio. You know, we feel that, you know, with the leverage that Henrik has outlined, you know, we are well positioned to do something, and then God knows maybe we can even do creative things beyond that remit. With regard to CAD, I think this is probably not the largest indication for Aspaveli, to be quite frank, in our geography, given. You know, when we studied it, to be honest, I. Would you comment on the data.
On Anders or Armin, let's say, on the data from Sanofi. I mean, it's normally not our job, you know, to comment. I mean, for us, it's early days simply because we have not even generated any data. It's a bit premature for you maybe to comment there.
I mean, I think just to say that we are planning to start a study and get evidence, and then we can compare. As Guido said, it's one of several lifecycle management possibilities on top of the base case indications here. I think it's early to say, but it's not a determining factor for the future success of the product.
Okay. Maybe the next question.
Great. Thank you.
Thank you.
Our next question comes from the line of Mattias Häggblom from Handelsbanken. Please go ahead. Your line is now open.
Thank you so much. I have two questions. I'll take them one at a time. First, a question around your existing franchises and how you think about investments into perhaps strategically more important franchises, possibly to be funded by divestitures in areas seen as less core. Specifically, I'm curious to hear if the RSV franchise, including Synagis and profit rights to nirsevimab, is as core for Sobi today as it was when acquiring the assets in 2018, since your profile has changed partly since then, shaped by other transactions.
I think it is a good question. There's been a lot of write-ups on this question more recently, and let's say, you know, 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 is important to the further diversification of the company, and obviously important for the economic results of the overall group. Now, the question 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. The question is there an alternative to this?
I think, you know, we have probably not made up our mind on this, but, you know, we're quite happy, to be honest, with what we have, let's say. I mean, because, you know, we are encouraged by the results of nirsevimab and also the commentary that is coming from Sanofi, who obviously is very optimistic, or let's say forward-looking to the launch. Frankly, if they are optimistic, then I have no reason not to be optimistic because we are a financial beneficiary of this. Hence, I'm feeling quite good in my clothes today. Could I feel better in another clothes? I don't know, because I don't know how that clothes could look like, to be honest.
At this stage, I think, you know, it would be premature to speculate.
Good. That's clear. Helpful. I have a second question, and I was late on the call, so apologies if this was covered.
Maybe the next question.
I was curious to hear if you could quantify the FX tailwind for the year. We see that you guide for constant exchange rates, but we don't know exactly. I don't know what consensus is carrying. Is 200-300 basis points tailwind a fair assumption, or if Henrik could comment on that?
Ladies and gentlemen, once again, apologies for the interruption. We have another technical issue. We will try to establish audio straight away.
Guys, you know, apologies for this second interruption. As you can sense, you know, life is sometimes not without challenges. Why don't we pick up the pace again with some questions, yeah.
Thank you. Mattias Häggblom from Handelsbanken, your line is now open again.
Thank you. I just had a second question around you know if Henrik could maybe quantify the tailwind from FX given where current FX spot rates are. I know they are moving all the time but you know curious to hear if 200-300 basis points tailwind is the right way to think about that.
Yeah. Do you mean historical numbers or do you mean future?
No, I, you know, assuming FX would remain the same for the remainder of the year.
Yeah.
You know, would that be a 200-300 basis points tailwind on top of what you have guided in constant currency, you know, ex-exchange rates?
No, no.
You know, obviously, FX can change, but I'm just curious to hear. It should be supportive. I'm just trying to quantify.
Yeah. I mean, we refrain from you know speculating. That's why we guide in constant currencies. 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 rates for 2021. We know that currencies will take that to the numbers elsewhere, but we stick to the constant currencies.
Could you confirm that if currencies remain where they are today, that would be a tailwind compared to 2021, given the strength of the dollar and the euro to the krona?
Yeah, I can confirm that. Yes.
Okay.
Thank you.
Next question maybe. Thank you.
Our next question comes from the line of Erik Hultgård from Carnegie. Please go ahead. Your line is now open.
Hi, Erik.
Thank you so much for taking my questions. I've two, if I may. First on Aspaveli, if you could sort of elaborate and give some 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 five markets, when do you expect those to come on, onboard 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 wanting to hear your confidence level on these targets. Are you more or less confident in this 25 by 25 target? Also, that margins should expand from 23%, given sort of some pretty major opportunities and launches that you have over the coming years.
Mm.
Thank you.
Hi, Erik Hultgård. Thanks for the question. Start off with Aspaveli. I think it's fair to say that the first launch countries will be Germany and the U.K. in Q1. Then basically, you know, 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 it also means is, when you look at the product, given, you know, let's say, you know, the profile and, you know, it is and also the. Erik, sorry. We have here, you know, a bit of a playback with these systems, you know.
No worries.
You know, maybe I just pick it up. I don't know where I was cut off, but.
Once again, we apologize for the technical difficulty. We will try to resume shortly.
This video conference becomes a bit like a bad comedy, yeah. Let's say, you know, anyway, let's not lose a sense of humor today. This was a good quarter. You know, with regard to your question, 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 it's second line. Secondly, you need to get these patients vaccinated. Obviously, for me, it is much more important, and we have programs in this regard in place to get patient experience, because what we're expecting is that the product will speak for itself, given its superior efficacy profile. Yeah.
When it comes to the long-term outlook for the company, 25 by 25, I mean, I have obviously no memory loss what I said. Let's say, you know, overly, you know, we allowed there for a range at the time, but, you know, we will manage towards this. You know, it's the job of the team, you know, to look for ways. Let's say, obviously we have got some headwinds with the pricing, for instance, and hemophilia, which we didn't see coming as with such an effect. You know, this is, we have also plenty of opportunities in the range. I would see it would be, you know, completely premature.
We have plenty of time to pick up the pace and, you know, work towards this. We will have a solid growth this year. You know, we 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 are expecting 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 and around Q2, that will help you to model this so that, you know, that basically what we indicated to you and is we can also fulfill and underpin with the right measures, yeah.
I think that we have the basic 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. What we could do is we have tomorrow another, let's say, another obvious opportunity to dive into this. If there is maybe one more question or two, let's say we can cover this now and otherwise we will cover it tomorrow at greater length, and we will make sure that we have a line that is that is durable. Maybe any question maybe for the final
Thank you. Our final question comes from the line of Jon Berggren from Kepler Cheuvreux. Please go ahead. Your line is now open.
Yes. Hi. Thanks for taking my question. I have just one related to your geographic expansion. During your last CMD, you said you were aiming for several launches in Japan during 2022 and 2023,four launches in total, I believe, for these two years. I didn't see anything related to this in the pipeline news flow you included in the report. Can you please update us on these launches? Thank you.
Yeah. I think the most important launch for Japan is going to be the Aspaveli launch. 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 you know we are well on track here. Let's say that. We are basically what we currently, but you know normally we are not commenting on basically country, product, let's say at that level.
I mean, obviously Japan is an important market, but, you know, we are building this business or we have set our first foot there and, you know, we are confident about the fact that we can make a difference in this market. I think with this probably what I like to do is I like to close today's session and basically say, you know, I mean, even though we had a bit of a few challenges today, so, you know, I think I'm very happy, you know, that we have delivered, you know, in 2021 what we set out. I think, you know, you please take away 2022, let's say we see continuous growth and, you know, we are obviously a more diversified business today. This applies to the different disease areas.
This applies to the number of products, but also to the geographies. We will basically build this platform as a global leader in rare disease companies. This is our main thesis. I 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. Yeah.
This now concludes the presentation. Thank you all for attending. You may now disconnect.