Swedish Orphan Biovitrum AB (publ)

STO:SOBI

Earnings Call Transcript 2020-Q4

[Operator]

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

[Guido Oelkers, CEO & President]

Yes. Thank you so much, and welcome to the Q4 webcast of Sobi. As per usual, I go straight to the forward-looking statement, and we just take note of it, not going to read it through, but just be aware. Today, I'm going to be joined by my colleagues, Henrik Stenqvist, the CFO; and Ravi Rao, the Head of R&D.And with this, let's go to the meet of the presentation on Slide 4. And basically, when you look at it, we had -- we have expanded our opportunity horizon for Sobi. I think it's fair to say that we are, this year -- that we have in 2020, but also in 2021, we are in a transition mode, and we are transitioning Sobi to a new reality. And during this transition, we are experiencing headwinds, foremost COVID, and we will talk about this more in the context of the guidance for 2021, but also the significant appreciation of the Swedish krona, which makes prior year comparisons more difficult forward-looking.So when you think about it and you come into the 2020, I think we were quite happy with the overall performance. We grew the top line for the year at 8% and at constant currency, and have an EBITDA margin of 41%. Q4, we had even an EBITDA margin of 48%. But I think, for me, as underlying indicators very important is that our core business, meaning the Haematology business and the Immunology business. Both businesses were growing double digit, 13%, hematology; and 16%, immunology. And basically, the consolidation of part of our discontinued Specialty Care business, respectively, the decline of Orfadin basically would compress the overall growth rate.At the same time, we were able to forge 2 strategic partnerships that propel our pipeline, but also allow us to further broaden our international footprint and prepare us for sustainable and long-term growth. And these partnerships are with our pellets regarding ex U.S. territories of systemic pegcetacoplan and the global rights of SEL-212.So when you go to the next slide, and we just elevate the discussion a little bit. How to think about Sobi also now moving in the future and how to measure progress of our strategy? Essentially, we have 2 vectors of growth. We have -- we want to obviously -- and this is regarding its portfolio dimension. And obviously, it's a geographic dimension. And when you think about it, our core business, until 2025, and we have provided guidance in this regard as part of the Capital Markets Day, we do not expect too much growth from it anymore. This is an important cash generator for the company, but we don't attach too much growth to it. Where we see growth is with regard to our late-stage pipeline and our launch products, in Europe and in North America, foremost. And we see significant growth opportunities on a relative scale, but also meaningful in absolute terms, in the, what we call international, meaning non-U.S., non-European markets, and we have set up quite a few new subsidiaries in this regard.So when you come to the progress that we have made in the area of pipeline, in the development of our portfolio. We have set out at the Capital Markets Day, as we said, we want to have 32 launches in key geographies, and we define those key geographies by North America, Europe and key international markets for us, meaning Russia, China and Japan. So -- and we basically also said at the Capital Market Day in December that we would have 4 of those launches next year, meaning in 2021. Now in the meantime, we have got -- we have retained the approval of Elocta in Russia and are in a good way to launch the product. We have obtained the approval as recently communicated for Kineret in Russia. We have retained the -- we have attained the approval of Doptelet in ITP and CLD. We submitted Doptelet in Russia and could expect or hope for an approval this year. And we have submitted pegcetacoplan in PNH in Europe with a potential approval also for this year.We are progressing SEL-212 in Phase III, as we have outlined. And for BIVV001, we completed the enrollment in partnership with our main -- with our partner, Sanofi, the enrollment of Phase III. We are -- let's say, what we can expect from us this year is going to be the commencement of our rheumatology HLH study, and that we have started enrollment also in the acute graft failure study. We have an ongoing study, which we think could be very interesting, which is an ISS, but of a large scale, with centers in Greece and in Italy called SAVE-MORE, that will have a readout in Q2 2021 and may or may not have implications for the indications of Kineret.Coming to the international expansion, eventually portfolio drives, obviously, also the further international expansion. And I think you should think about our international expansion in 3 phases that are overlapping, but in the first phase, now Russia, where we make significant progress already this year. China, let's say, is hopefully getting approvals this year, but then becoming more material in terms of economics the year after. And Japan, we will do -- retain approvals in '21 -- '22, sorry, and then becoming more material as of '23.Now with this having said, I would like to dive now into our portfolio, and we start with Haematology. And basically, I think important to notice, as I already outlined, the strong double-digit growth of our Haematology franchise and in difficult environment, Elocta strengthened its position in the key markets. And what it means is also that we retained our competitiveness. So we improved our share of -- in terms of patients by 10%. And we, let's say, in this -- in view of consumption reductions due to COVID, which makes the year-on-year comparison a little bit more tricky, and we made our first impact with Doptelet in 2020.So more specifically, let's go to the products and starting with Elocta. So when you think about it, 10% patient growth, obviously, this has been eaten up to a large degree by the reduction of consumption. And essentially, I think you need to think -- when you think about Elocta moving forward, and this is -- and I think this is important also when we talk about guidance, there are 3 vectors of growth, that drives this product. Obviously, patient growth. The second is consumption per capita. The third is price. And let's say, for -- and for now, let's say, in 2020, we have been aimed at constant currency to still drive growth by 3%, even though, let's say, the patient numbers have increased by 10%. So we have offset those, but the product is competitive. In the case of Alprolix, the difference is not as much, but not as high. Here, we have driven growth by 25% in terms of new patients. But we have also had an impact of decreased consumption per capita, given the fact though that Alprolix is a once-a-week therapy. That effect is on a relative scale less pronounced, but Alprolix is making good progress.Let's turn to Doptelet. And with Doptelet, I think -- I'm quite happy that we made a significant impact to the U.S. market. And first year sales essentially is full year sales anyway, is SEK 587 million. And we have now a 7% market share in the ITP market in the U.S. and we -- the product mix also good progress, even though it's a sales only 2 market in China. And we have obtained, as already outlined, ITP approval in Europe, and the first launch is going to be Germany, and hope that we can see more significant sales from international markets during the course of this year as, obviously, we want to see much more progress in the U.S.Now turning the page to Immunology. And here, they have, let's say, the overall Immunology franchise made also significant progress, 16% growth for the year at constant currency. And this, obviously, as you can see, Immunology very much affected or impacted by synergies. And I think it's fair to say that the incidence of RSV due to less international travel and also social distancing has been heavily impacted as an effect of COVID in the U.S. So we were very excited to end the year, let's say, with over $290 million, and let's say, in that -- but we think that this is something when you look forward, let's say, in particular to the second part of the season, where you have to be a little bit cautious.Kineret and Gamifant, as -- let's say, Gamifant, making significant progress also now particularly in Q4, and Kineret as well I will talk more about this.So coming to Kineret, we had a fantastic Q4 growth. And it's clear that Kineret, very -- many physicians see more benefits of Kineret in COVID-related indications, patients with hyperinflammation that are about to be admitted into an ICU setting. And there seems to be a benefit when you look at the recent publications. And that has basically propelled additional growth of this product and for the year with 32%. Very happy also that we made some progress with other indications, with DIRA and we imported on FMF earlier last year. This shows that, that Kineret is in a good way, and we are quite anxious to see how the ongoing studies that are currently being pursued will turn out. And there are 2 studies that are of primary importance, 00:26:22 [indiscernible] cooperation and SAVE-MORE that I alluded to earlier.Next slide, please, and to Gamifant. And with Gamifant, we had a very strong Q4. Washed out the pricing effect now to a large degree and have been able to strategically progress the product, increase the number of patients considerably, got also some benefits from the weight we have submitted in China and very satisfied with the progress of Gamifant. Let's say, even though it's still a little bit lumpy, but we hope that we can transition all the product into a new reality.On this note, I would like to ask now Ravi to share his thoughts on some of our R&D projects and bring them more alive. Thank you.

[Ravi Madduri Rao]

Thank you, Guido. So on this side, you see our pipeline, and you see the broad range of products that you've heard about over the last few minutes. Just a reminder that primarily focused in Immunology and Haematology and the overlap between the 2. And many of our medicines are being investigated in multiple indications. And since the last presentation, we had success for the approval of Kineret in Russia and the ITP approval for Doptelet in Europe. And we have pegcetacoplan and Gamifant under review. So all of those things demonstrate progress consistent with our strategic drivers and our future growth.For today, I'd like to focus primarily on pegcetacoplan and also on BIVV001. So if we go to the next slide, please. We recently commenced the partnership with Apellis for pegcetacoplan, which inhibits the C3 component of complement and really has the potential to elevate standard of care in paroxysmal nocturnal hemoglobinuria or PNH. And the PEGASUS trial reported out last year, and this was a head-to-head trial, which evaluated pegcetacoplan against the C5 inhibitor eculizumab. It consisted of 80 patients who had a suboptimal response to eculizumab. And after a run-in period were randomized in a one-to-one fashion to receive either pegcetacoplan or eculizumab, and the primary readout was after 16 weeks of randomized treatment. The patients were then able to cross over from eculizumab to pegcetacoplan, and the trial continued through to a total treatment period of 48 weeks. And I'll show you results from both parts of this study.Moving on to the next slide, please. So the results of the study at 16 weeks were highly significant and are summarized on this slide. The primary endpoint was to examine superiority of pegcetacoplan over eculizumab. And this was highly significant with a P-value of less than 0.0001. But not only that, there was a large increase in the hemoglobin of 3.8 grams per deciliter compared to that seen with eculizumab. In addition to the hemoglobin numbers, there were meaningful clinical improvements in those patients. 85% of patients were transfusion free versus 15% of patients on eculizumab. 71% of patients normalized their LDH, which is a good marker of underlying hemolysis versus 15% on eculizumab. And the patients felt better with a 12-point improvement over eculizumab in the FACIT-fatigue score. And so we were very excited by these results, which demonstrate significant improvement in response to pegcetacoplan over eculizumab.If we go to the next slide. As I mentioned, the patients were able to enter a long-term open-label extension, and the results of that are shown here. The graph shows hemoglobin over time through the run-in period, the initial randomized control period and then an open-label extension on the right-hand side, showing times from baseline to week 48. Pegcetacoplan is in orange and eculizumab and crossover to pegcetacoplan is in blue. The first thing to note is the rapid increase in hemoglobin on pegcetacoplan is maintained and very consistent over the subsequent 48 weeks of treatment. And I think this demonstrates that the effect seen is maintained, and that was reiterated by the patients also feeling better and having clinical improvement, as I mentioned earlier on. The blue line shows the patients who received eculizumab for the first 16 weeks and then crossed over to receive pegcetacoplan, and you can see that crossover period in the middle of this chart, in the gray. And it's very clear to see that the hemoglobin then rose to similar levels and was maintained once the patients received pegcetacoplan. I should note that there was sustained improvement in terms of transfusion, fatigue and biological -- other biological markers, and the safety profile was consistent between the 2 drugs and was maintained over time. So these data really form the basis of a recent submission. The drug is under priority review with the FDA with an expected action date in May, and we expect EMA approval later in the year.So if we move on to the next slide, I'd like to talk about BIVV001 or its new name, which we'll be referring to from now on, which is FS octocog alfa. As Guido mentioned, this is a collaboration with Sanofi. And this is a bioengineered Factor VIII, providing extended once week dosing and higher factor levels compared to existing therapies as well as nonfactor therapies. The program consists of an adult and adolescent study, which has recently completed recruitment as well as a pediatric study and the latter is required in combination with the AdHOC Study for approval in the European Union. The AdHOC Study is a 52-week study looking at annualized bleeding rate, and we expect data in the first half of 2022, and it has Fast Track designation in the U.S. with submission, hopefully, later in 2022. We expect the first children to be recruited into the pediatric study very shortly, enabling recruitment and then approval in the EU in 2023 or perhaps early in 2024.So in summary, there's very good progress with the pipeline, which are consistent with the growth drivers and the catalysts you heard about earlier on. And this is very positive, both short and medium term ambition. So with that, I'll hand over to Henrik to pick up the presentation.

[Henrik Stenqvist, Chief Financial Officer]

Thank you, Ravi, and good afternoon, everyone. So we go to the financial summary for the quarter and the full year 2020. So revenues for Q4, as said, amounted to SEK 4.581 billion. That corresponded to a decline of 2% at constant currencies. Full year revenues reached SEK 15.261 billion, corresponding to a growth of 8% at CER, with double-digit growth in both Haematology and Immunology franchises. Haematology consisted of the hemophilia Doptelet, showed a growth of 2% at CER for the quarter and 13% in 2020. In the quarter, Elocta declined by 10% at CER, while Alprolix grew at 8%. And we continue to see patient growth across both products, but for Elocta, a reduced consumption per patient due to the pandemic as we heard.Doptelet had a strong quarter with SEK 191 million in sales and a quarter-on-quarter growth of 24% in local currencies. And at the end of the year, we were in preparation for the European ITP launch in 2021. In Immunology, Q4 revenue increased by 6% at CER, with full year revenue increasing by 16%.Kineret sales increased by 59% in Q4 and 35% for the year. We continue to see increased underlying demand across all regions. And in addition, demand for COVID-19 had an impact in Q4 of roughly SEK 125 million and for the full year, roughly SEK 250 million. Synagis sales of the quarter, SEK 1.432 billion, a decline of 11% at CER due to very low virology levels as a result of COVID-19 measures. The decline was partially offset by improved dose adherance and improvements in the distribution system.And as we look into Q1 '21, the impact from the COVID-19 pandemic on the RSV virology levels remains an uncertainty for the sales of Synagis for the rest of this season.Gamifant sales picked up in the quarter with revenues of SEK 263 million compared to SEK 110 million in Q3. The growth was driven both by new patients and the increased duration of therapy offsetting the price reductions that we implemented earlier. And the Specialty Care revenue declined by 54% to SEK 218 million as a result, both of generic impact for Orfadin and the discontinuation of products during the year.As we move on from revenue, we saw a gross margin of 81% in Q4 and 79% for the year compared to 78% and 77%, respectively in 2019. And this is primarily driven by a favorable product mix, including the impact of synergies in Q4 as well as cost reductions. Adjusted EBITDA reached close to SEK 2.2 billion for the quarter corresponding to a margin of 48%. For the quarter, the margin was broadly in line with prior year of 49%. For the full year, the margin of 41% came up slightly behind last year's margin of 43%. This is -- was driven by our increase in SG&A, particularly the full year impact of the Dova commercial organization and launch efforts, as well as our international expansion in China, Japan and Russia. And then the adjusted EBITDA in Q4 excludes the positive impact from the reversal of the CVR liability of SEK 399 million, which was related to the acquisition of Dova.Looking now into cash flow and debt. Operating cash flow in the quarter amounted to SEK 858 million for the quarter, almost doubling the number from Q3. But also Q4 is a seasonally weak quarter, mainly due to the increased accounts receivable coming from synergies. And this becomes obvious when we look at the full year operating cash flow, which was SEK 5.2 billion.And finally, net debt increased by SEK 1 billion to SEK 13.7 billion, mainly because of the upfront payment of SEK 250 million related to the license agreement with Apellis for pegcetacoplan. And net debt of SEK 13.7 billion corresponds to leverage, which is just about 2x EBITDA, which is very comfortable. And we maintain available liquidity of close to SEK 5 billion, signaling continued position of financial strength for the opportunities ahead of us.And with that, I say, thank you, and back to you, Guido.

[Guido Oelkers, CEO & President]

Thank you so much, Henrik. Yes, I'd like to round it off with the outlook. And before I start, I would like to provide you with some of the key assumptions to bring this a little bit into context, but also into relationship to what we guided on at the Capital Markets Day. I think -- and I maybe start with Synagis. Let's say, on the next slide, yes. And basically, Synagis sales are very much skewed to the months of October, typically in March. Now these are the RSV season sometimes starts earlier and then lasts longer or is sometimes shifting. In December, we were still hoping that the virology would pick up during the second part of this season. Today, we do not see these indications, and hence, our forecast is much more cautious for this season, not for the next season, which will start in, again, September of this year.Regarding Elocta, I think we need to just recognize that the prolonged lockdown leads to 2 developments: A, patients have less activity, many working from home, offices. And on the other hand, we have less face-to-face interactions with our target audience as a consequence are less impactful to basically work alongside with physicians to make sure that patients are better protected and take advantage of the prolonged half-life of Elocta. Now when you think forward-looking, we also realize that given the pressure on health care systems and increased competition, this has an effect of prices and we anticipate price adjustments in various markets.So when we go to the next slide, in terms of financial outlook, what we can see is that we basically -- these 2 products on a 2020 basis, around 48% of our total business and obviously have, therefore, a significant impact on our -- also on our outlook. So we -- therefore, hence, we were more cautious and said, despite a lot of these positive developments with our launch products and our other portfolio, in Kineret, for instance, we thought that it is more prudent to be cautious, and therefore, we guided between SEK 14 billion and SEK 15 billion. And obviously, this happens at the same time, as Henrik pointed out, where the currency, the Swedish krona has appreciated and has, therefore, a negative effect on top line between 5% to 7%. So when you take the midpoint, this means that we are forecasting essentially at constant currency, a growth of -- from minus 2.5% to plus 4.5%.And as we are believing in our pipeline with 12 late-stage projects, with the expansion into international where we think that some of these new activities that we have in China and Japan could become extremely meaningful over the years to come, we basically felt -- if you feel compelled to invest into our business. And we gave you guidance already at the Capital Markets Day that we will invest into our R&D expense line between 13% to 15% on sales. And there are 2 main drivers, one of them being SEL-212 and the other one being the pegcetacoplan of the, let's say, that contribute, obviously, to these 12 late stage projects.So as I mentioned at the beginning, you see Sobi in a transition phase. But given the opportunities that are ahead of us, we think that we need to take these -- we cannot leave these opportunities behind, and we need to take advantage of them and invest into them. So the -- just to clarify this further, on Page 27, our revenue outlook, SEK 14 billion to SEK 15 billion, basically giving you here very simplistically what it means at constant currency and basically how to use this in view of our actual results in 2020.So very clear. We haven't lost confidence in our business, but we believe we need to invest into it. And yes, for 2021, we experienced 2 headwinds. It's a COVID-related effect, as I pointed out, and it's a currency effect. So just basically elevating the thought process, in conclusion. We think when you look at this, what we have done with this company, we have increased the company from '16 to '20 by 2.7x. We have increased our earnings by 3.8x in this period of time. We believe that we have established ourselves with a proven track record. We have now 2 robust and diversified therapeutic areas. Henrik pointed out, the cash flow, which we think is a very strong cash flow of our operating business. We have developed a significant pipeline. We have now today, 12 late-stage projects and 70 in Vietnam. And we have significant catalysts, as we pointed out, let's say, for sustainable value creation during the course already of this year. With this, I would like to open the floor for Q&A.

[Operator]

We have a question from Christopher Uhde from SEB.

[Christopher Winston Uhde, Analyst]

So I have a few questions. On -- I guess, I'll start on the guidance. And I might ask this in a couple of different ways to just try to triangulate here. But -- so I guess when it comes to -- if we start with Synagis. The prescription data -- sales tracking data suggests that there is an effect from -- potentially from wholesalers, is it possibly a stocking effect. So I guess is part of the reason for -- how you feel that we may see a phasing of that strong -- I mean relatively strong performance in Q4 -- in Q1 then? And then when it comes to Elocta, can you quantify -- well, I know you won't exactly do that, but can you give us some flavor on the impact of price pressure? How would you say what you've seen -- what you've done so far last year and so far this year in 2021? How would you say that compares with, let's say, what your predecessors did -- how they reacted when you came on the market with Elocta? And also, how does the outlook in terms of pricing seem this year versus last year? I mean another way to put this. You said that there was 10% patient growth over the year, but 3% sales growth. So how much of that delta was due to price cuts in the EU5? That's my first sort of question.

[Guido Oelkers, CEO & President]

Yes. Thanks, Christopher. I hope I can remember all of these different angles. No problem, no problem. It came rise to the occasion here. But let's start with the -- let's say, with Synagis. There is -- let's say, there was a stocking effect. We think it's around SEK 12 million, always difficult to understand all the elements of potential, let's say, of the different areas. So yes, but this compares -- I mean this is basically the kind of reflex that these wholesalers, respectively, now in this year or last year were special distributors. We don't have wholesalers anymore. So pretty much in line. A little bit less actually even than the year before. So yes, this is impacting, obviously, the first part now of the year. But I think the primary driver is here that when you look at the virology and you look at the CDC data, given that it's basically hardly any international trouble anymore and social distancing. There's really not much virology that you can point to -- I mean luckily, we are working only on 1% of the babies who are very exposed and fragile, and that's a consequence to better safe, I'm sorry. And that's the reason why we could be able to sell $290 million over the year. But what we see is that, obviously, there's an impact during this part of the season. Therefore, we want to be cautious and basically give you a cautious view here on how this is going to play out, whilst we think that in line with some of the epidemiologists that the -- during the second part of this year, there is a normalization effect. Yes. And let's say, so that's really our view on Synagis.With Elocta, the primary driver is indeed consumption. Pricing was a more smaller effect this -- last year. And let's say, this is a -- this was -- and this consumption effect, you can see it very clearly. There not is an effect that really kicked in primarily with the emergence of COVID because less activity level, and then also in some countries, earlier this year -- last year, the access and with this a more cautious behavior. And then basically, that has perpetuated itself. Physicians are obviously not in favor of this. So with them, we will try to, let's say, ensure that patients take advantage of the profile of Elocta and are better protected. But the -- sometimes if supplements joint bleeds, you don't see and you take effect of it, you only realize a few years later. So it's something that we are quite concerned about, and we're trying to correct. So for this year, we were -- let's say, part of our strategy is to try to take back part of this territory. I think it's realistic to see that the -- our patient growth, let's say, is going to become more difficult, but we still believe that we can grow Elocta on a patient basis because the franchise is competitive and there are patients who are -- who would like to stay in that paradigm and looking forward, primarily, also then to BIVV001, which has a great promise. And basically -- so we think we will continue growing patients, and we have no indications to believe any otherwise. But we have -- what we see is now that the unit recovery per patient is not happening right now. And let's say -- and as long as there's projected lockdown and we don't have access as much to the physicians, it's going to be tough. And what we also anticipate now is that pricing for this year will play a stronger role because we can anticipate price adjustments in a couple of markets, that will be quite material. So as a consequence, we will not have as much offsetting mechanism. And that's the reason why we have been cautious. But the -- but this is -- I mean I've just looked at some of the data also in the markets of our competitors by IMS. I mean this is not a unique Sobi phenomenon, yes. So it's just that the profit pool as such is also affected for factor consumption.

[Christopher Winston Uhde, Analyst]

But I mean so in terms of price pressure, I mean, is it possible to give us kind of like a ballpark idea? I mean should we be expecting double-digit price decreases, teens -- mid-teens, something like that for the year on average?

[Guido Oelkers, CEO & President]

Yes. I think it's -- I mean it's -- roughly, it could be double digit. It could be double digit. That's the reason why we have a more cautious approach.

[Christopher Winston Uhde, Analyst]

Okay. And what would you -- sorry, just last on that particular point. Would we expect to see that during the -- from the beginning of the year or sort of progressing over the course of the year?

[Guido Oelkers, CEO & President]

Yes. It will set in, let's say, now -- just some of these adjustments will set in as early as during the later part of Q1.

[Christopher Winston Uhde, Analyst]

Okay. Great. Then I guess, so my second question is about Gamifant. So how do you explain the sharp increase in new patients and duration of therapy that you referenced? I mean it's a very strong upswing in sales. And in the past, obviously, this has been a discussion, how much of this is just volatility from different patient sizes, weights, et cetera. I mean to what extent does this reflect something more stable than we've previously seen? And what does this -- what can you say about -- is this guidelines? Is this different patients besides just familial who are being treated? Are you getting more first-line patients, something like that? And I guess -- and then I think so...

[Guido Oelkers, CEO & President]

No, you first, sorry.

[Christopher Winston Uhde, Analyst]

Yes, sorry. Can we get a little bit more detail on the rheumatologic HLH data? And maybe when you -- or where you plan to present it? And I guess, finally, you -- is it possible to go for an EU decentralized pathway for approval for familial HLH? And if not, why not?

[Guido Oelkers, CEO & President]

Yes. Okay. So let's take it one step at a time. With regard to, let's say, this -- how to use this Q4. I mean as much as I want, I cannot already claim no victory. I think -- let's say, we had a couple of patients that came. What I can tell you is that our team is much more systematic now about it. And it's basically a changing a bit the paradigm we had also changed to be honest, the management. And as a consequence, now we act -- we basically work with the community and with physicians, so that the patient understands the opportunity of the product and people understand how better on how to diagnose primary HLH. Yes, because there were quite a few patients still missed and -- simply because they got the wrong diagnosis. And I think we are working with the community quite extensively now to improve this. And we haven't yet, let's say, I would say, been able to change guidelines, we have a number of projects ongoing, as I reported to earlier, but there is not -- this is not yet generating the traction. We have -- with regard to raw material, let's say, HLH, we have completed, as we reported, the MAS sJIA trial on that, and then we got feedback from FDA. As a consequence now, we are expanding the trial. And with this have a short on goal on a broader indication in rheumatological HLH. We are now feverishly working on the recruitment and how to accelerate this trial so that this may actually be more of a -- for us in the launch Phase 2022 reality, but we are not yet there.And regarding, let's say, Europe. Yes, we are working right now with a partner to understand how we could make Gamifant for patients and needs available despite the negative view of IMA, yes, because we think it is not responsible not to do so, yes, to make it very clear. And then maybe we have time for 3 more questions if there are. From someone else because I love this dialogue, but let's say -- but maybe we open the floor for some other, yes, for more. Yes, I will say surprised, yes. Thank you, Christopher. If you have more questions, we will take it -- we can pick it up offline. Yes, thank you.

[Operator]

We have a next question from Erik Hultgård from Carnegie.

[Erik Hultgård, Research Analyst]

I had a few. First, touching again on the expected price pressure that you see here in 2021 for Elocta. My question is basically, is this something that is isolated to selected markets? And should be seen more as sort of a one-off? Or is this happening more broadly? What is actually triggering this intensified price competition? Is it related to the fact that Hemlibra has gained a 22% market share in Europe now and that some of the companies operating feel more prone to be flexible on pricing? So comments on that would be really helpful.And then secondly, on the dynamic within hemophilia A and specifically on the launch of Hemlibra, have you identified any patterns on what patients that are more prone to stay on factor products? And what patients are more prone to switch? And whether that is something that is different from what you're seeing or what you've learned from the U.S. market? That would be all.

[Guido Oelkers, CEO & President]

Yes. Thank you, Erik. Yes, I mean, the good news is that, as you have seen, Roche didn't make so much progress in Q4 either, let's say. But the -- well I think, the pricing pressure back to that point is basically not the driver. The driver is more certain budgetary pressure right now by, let's say, payers and base business, the desire, let's say, to find opportunities for savings. And that basically then they open up. And so it's a more targeted approach. It doesn't affect the across the board. In this case, now we are primarily driven by 2 markets. So that's really -- so I don't think it's a general trend. But at this stage, I can say it's really related to a small number of markets. The other thing is that, obviously, the -- when you look at it, those patients who are more prone to stay on factor is -- are those who obviously want to have an active life and as such, want to control their life as opposed to forget about the disease. They are young patients because the data of Hemlibra are there limited, and then they are also compromised patients. So these are the 3 groups that -- and let's say, the difference is -- between us and the U.S. situation is that we, from the start, positioned Elocta as a protective agent, not as a convenience drug, and this has done us so far well. And let's say, so that's the reason why we still have met gains of patients even as we speak.

[Operator]

Our next question comes from Peter Sehested from Handelsbanken.

[Peter Sehested, Research Analyst]

Can you hear me?

[Guido Oelkers, CEO & President]

Yes. Absolutely.

[Peter Sehested, Research Analyst]

I have 3, and I have decided to jump into the helicopter and take a view from the above. With respect to your 2025 targets, at the CMD, you gave us some peak shares -- sorry, peak sales forecast for a couple of products. And you also sort of gave us an overall bridge that was sort of more high-level related. I just wondered if you could give us a little bit more product-specific details on that target? Secondly, in terms of your appetite for further business development. I mean according to my estimate, and I could be totally wrong, but I see double-digit growth in EPS, let's say, if you look at forward -- 4 years forward over the next 4 years. And would that growth only considerating to single digits as we get into sort of late '24, '25. So that does suggest that with the current assets, we should be able to do okay. Would it be fair to say that you are not in a hurry to do further business development over the next 3 to 4 years, let's say, and then you'll be able to harvest cash? Thirdly, in terms of R&D costs, could you give us a sense for given the current assets that you have in your portfolio right now, when do you see R&D expenses peaking in order to develop that portfolio? I guess by 2025, you must have, let's say, exhausted the opportunities of the current R&D portfolio. So just to get a sense as to, let's say, when your R&D cost expenses sort of might peak? And then just 1 -- perhaps one final remark. A key issue for investors has been the fact that consensus numbers have been ridiculously high for quite some time. And even though they have come down a bit now, I mean, they still look a bit high relative to my numbers. Wouldn't it be a good idea I mean just to take a big swing now, get the numbers washed up. So if we just say you've given guidance for sales in '25, what kind of EBITA margin are you looking for in '25 as well?

[Guido Oelkers, CEO & President]

Yes. Peter, thank you. Thank you for these questions. Well, I think the -- we stand by. Even though we have cautioned obviously for this year by the 25/25 logic, we have no reason to question this. The main drivers of growth is going to be the launch products, Doptelet and Gamifant and then pegcetacoplan, and then basically SEL-212 and on a -- and that, obviously, the launch, which we also kick in now probably more like a 24 -- early 24 launch, BIVV001, which will then expand again our hemophilia franchise. So that's basically -- and that basically are the primary drivers, of course. And then you have opportunities now with these new activities like Russia, Japan and China where you would expect load growth affiliates to clearly establish themselves well in the top 10, if not even, let's say, the one or the other in the top 5 of our subsidiaries, and just given the potential and I think the angle we have to them. So that basically underpins our quest for growth. So they will become -- so these are the products, pegcetacoplan, we think it's going to be a very material product, got nice accolades from FDA, and we will report later obviously on how we see the situation in Europe. But if anything, we are more confident that this could be a 2021 launch in Europe. And basically -- so this could be a -- this would be a very material product. But we also said that Doptelet will have peak sales of 500. We didn't see any reasons to million dollar -- to correct this. And we are in a good way now to develop this product. We think that we can make significant impact already this year and become quite sizable. And we also will see further internationalization that we have that we see also that this becomes 3 digits, yes, and in dollar. So that is -- so this, I think, gives you a bit of a flavor how we know that portfolio drives us. And yes, with the portfolio that we have 12 late-stage project, I mean, this is a midsized company. So you think that you have -- we have quite a bit of gas in the tank. We still think, when you look at value -- the way people value assets in this category, there's obviously -- there's a correlation between size and growth. That seems to correlate quite well with value. And so we still feel that we are not done. Let's say, doing something, but we don't feel the pressure. So we can be thoughtful about building the company and within the frame, obviously, that we have. So we are not in a hurry. And what we have told the market is also that there is a tipping point where we start deleveraging simply because also the company goes into a certain scale around 2023, yes. And let's say, when we would not expect -- I mean nobody can foresee what opportunities we come up with, but also on the R&D side. But typically, this is when you start deleveraging it. Maybe we have a another -- one more question, if this is okay? Sorry, Peter, if we can answer this probably more specifically if you wish in an off-line discussion. This gives you more like a high level. Maybe we refer to the next question.

[Operator]

A final question comes from Viktor Sundberg from ABG Sundal Collier.

[Viktor Sundberg, Research Analyst]

So maybe a quick follow-up here, again, on pricing. We've seen some price pressure in the U.S. on extended half-life factor treatments and IFA coming out quite aggressively saying that extended half-life factor is to expensive compared to its benefits, et cetera. The Europeans government agree with this? I guess I'm trying to understand this dynamic with the price pressure. Is it more that you compete more on price to get patients? Or how should we think about pricing, for example, in France or Germany, your key markets?

[Guido Oelkers, CEO & President]

Yes. I mean basically, the good news is that in Europe, the price pressure was exerted on EHLs from the start of launch because you -- basically the price premium you got over the short-acting was on a per unit basis, was basically most markets not existent. So you know what basically -- so what it meant is that the benefit of the prolonged half life was mostly passed on to the patient or the payer, depending on the usage already. Now where the price pressure is probably more coming from right now, I think, is probably more Germany than one of the other markets. But that is because they have -- the payers have certain -- see certain opportunities, okay?

[Viktor Sundberg, Research Analyst]

Okay. Yes. And just a quick one on Hemlibra as well. I mean to be more directed, do you see any switches from Elocta to Hemlibra at the moment? Or do you still feel very protected that you can push on...

[Guido Oelkers, CEO & President]

Yes. We see more switches from Elocta to Hemlibra than from Hemlibra back to Elocta at this stage. But we see more gains from other short-acting and -- but also some other EHLs back to Elocta. So that's the reason why we switch. And the good news is that, that Hemlibra, as pointed out, has just over 20% market share and that there is still a significant market out there where we can get patients.

[Viktor Sundberg, Research Analyst]

Yes. So just taking apart maybe COVID-19 effect price pressure, switching effects, is that a very minor part of the negative growth we saw here?

[Guido Oelkers, CEO & President]

Yes. I mean actually, our switching effect has been positive. So we have a net gain of patients. So that's a positive. The -- and what we lost, let's say, is in comparison to what we -- first of all, we gained more than we lost. But if you just look at losses in isolation, then the value of that losses is insignificant in comparison to the unit reduction per patient.

[Viktor Sundberg, Research Analyst]

Okay. And just very quickly on your guidance. I think maybe consensus has got a little bit surprised this morning with regards to our R&D Day, where you guided for single-digit growth, of course, not taking into account currency. But still, any comment -- anything that changed from your R&D Day that you realized in terms of competition, price pressure, et cetera, that made you be more cautious here?

[Guido Oelkers, CEO & President]

I think I just would allude, maybe to the earlier part of the presentation, where basically, what changed is really that we thought that the season would come back faster on the RSV side. And -- but the virology is just super low. And secondly, let's say, that, that basically we thought that we could already have more inroads into physicians offices, let's say, faster. But to be honest, I didn't expect that the lockdown now in many countries has been prolonged to March. And if I would have anticipated this in December, when we at the Capital Markets Day, I would have informed you. Thank you. I think we -- let's say, we -- is there still a question or no?

[Operator]

No.

[Guido Oelkers, CEO & President]

No. I think we are done now for today. It's a bit of a shorter question and answer, and I understand that you may have more questions. So please refer them to our IR department, and then we will try to answer them. But as you can see, we are a little bit more on the conservative side, but these are also pretty uncertain times. And so I hope you appreciate it, even though I understand that there are some concerns. Thanks a lot. Wish everybody a great day.

[Operator]

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