Ladies and gentlemen, welcome to the Sobi Q4 2022 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. Hello, everyone. This is Guido, CEO of Sobi. Welcome to the fourth quarter and full year 2022 conference call for investors and analysts. The presentation was posted to sobi.com earlier. Let's go to slide number two. slide number two has the usual safe harbor statement. As stated otherwise, we will be making comments that mostly relate to the fourth quarter performance in 2022 at constant exchange rates and in million SEK as per usual. Please turn to slide number three. This is the agenda. We plan to cover all key aspects of the report today. We plan to review the presentation first and then to go to the Q&A until around 2:00 P.M. Swedish time. If you keep questions short, we will try to keep the answers brief.
For those on the phone, please join in the queue for questions for pressing star one. Please note, here this is a new command. We propose you ask only one or two questions at a time. In speaking order, I'm joined by Henrik, the FO, and Anders, our Head of R&D and Medical Affairs and Chief Medical Officer. Armen, our senior scientific medical advisor, who usually joins us for Q&A, is in a medical meeting today. Armen is sending his apologies. Please turn to slide number four. Starting off, I'm pleased to say that 2022 was a good year for Sobi with a solid future ahead. We met the outlook for the year, and we also guide for further growth in 2023. In the quarter, revenue increased by 5% at constant exchange rate and by 8% in the year, fully met outlook.
We had a good end of year with revenues to launched medicines increased by 29% in the quarter and by 37% in the year, driven by Doptelet. Hemophilia continued relative stability and the Aspaveli launch is approaching SEK 100 million per quarter. Immunology was held back by high COVID comparison for Kineret in 2021, as well as lower sales of Gamifant. We saw slower cost growth in SG&A and moderate growth in R&D and medical cost. As a result, the EBITDA margin Adjusted landed at 41% in the quarter and at 35% in the year. The pipeline continued to deliver with Zynlonta EU approval, Doptelet submission in China for ITP and Kineret emergency use in the U.S. AstraZeneca and Sanofi have also announced the regulatory submission attempts for nirsevimab with a late 2023 approval expected.
New flow is set to increase in 2023. In summary, we met the 2022 outlook today and provide a solid outlook for 2023 with continued growth. Thanks to all my colleagues at Sobi, who made this progress possible. Let's turn to slide number five. Moving to disease areas and geographies, we saw good double-digit growth in Hematology, driven by Doptelet in all geographies, while Immunology was held back by tough comparisons for Kineret due to lack of COVID sales and lower Gamifant sales. From a regulatory point of view, we saw highest growth in rest of world, driven by Doptelet in China, but also increased presence and sales of other medicines. Growth in Europe and in the U.S. was held back by Kineret comparisons and Gamifant, but helped by Aspaveli and Doptelet launches.
We are pleased to see the increased proportion of revenues coming from rest of the world, or as we call it, international, as it helps to diversify the revenue base and also helps more people gain access to Sobi medicine. In 2023, we anticipate several approvals and launch in the region, further driving globalization. Let's turn to slide number six. Turning to Hemophilia, we saw continued relative stability. The performance here is spot on our expectation, and commitment to relative stability is set to continue this year. Elocta increased by 6%. Timing of orders boosted sales. There was growth in patients and higher factor consumption, but we also realized lower price across Sobi countries. We think factor consumption in 2022 in general reached pre-pandemic levels. Alprolix increased by 1%. More patient consumption offset by lower price.
We see relative stability continue in 2023, driven by new countries and offset by price. Doptelet had the best quarter with recent trends continuing. Up to 72% ex including China. In the U.S., trends continued. More new patients, new prescribers and a higher share, and longer duration of treatment are here the main reasons. Market share gains were mainly from the injectable competitor. In Europe, Germany continued to be the biggest driver supported by recent reimbursement. Sales reached more than SEK 300 million. Partner in China, we expect a tougher comparison this year with potential for lower sales depending on how the competitive situation looks. Let's turn to slide 8. The launch of Aspaveli continued well, with quarterly sales approaching SEK 100 million.
We have launched in Germany, the U.K., France, and parts of the Middle East, with early sales in a number of other countries where reimbursement is starting to come in one at a time. We increased to approximately 100 people on commercial supply by the end of December and in line with our commitment of a triple digit number shared at the last conference call. Turning to immunology, Kineret declined due to tough comparisons in 2021 due to COVID sales. In one quarter, Kineret will release the tough COVID comparison and move on. Gamifant sales were lower, but saw a sequential increase from the third quarter. Gamifant has reached high adoption in the U.S. and declined mainly due to lower use in adults. We focus on the lifecycle management work for Gamifant and recruitment into the EMERALD study with data later this year.
Let's turn to slide number 10. Now Synagis, we saw the RSV season start a little later than in 2021, but sales in the fourth quarter caught up with 2021. There's also an element of price benefit in the performance. U.S. RSV infection have decreased, so we still think it is realistic to expect an overall season that will follow the pattern closer to a normal season than in 2021, with a lower first quarter. I will now hand over to Henrik, our CFO, for the financials. Please go ahead, Henrik.
Thank you, Guido, and hello everybody. Please turn to slide 12. I'm pleased to take you through the key financials for the fourth quarter and full year 2022. Starting with the top line. Q4 revenue of almost SEK 6 billion was the highest ever as reported in SEK, with benefit both from performance but also currency. The reported growth was 22% and growth at CER, 5%, which gave a full year growth at CER of 8% in line with our full year guidance. Looking at the bars to the left, we saw continued sequential growth in hematology, driven by the strong performance of Doptelet, as well as the seasonal boost in immunology due to Synagis. Back to the table.
The gross margin in the quarter of 78% decreased slightly from a year ago due to the lower gross margin associated with sales of Doptelet to China, partly offset by FX. The EBITDA margin realized was 41%, equal to the same period last year, and there were no items affecting comparability in this quarter. Although operating expenses, as expected, increased in Q4 versus previous quarters, the EBITDA margin of 41% was supported by good cost control, with operating expenses growing by 4% at CER, excluding amortizations, and this compared with the revenue growth of 5% at CER for the quarter, as I just mentioned. Earnings per share for the quarter ended at SEK 4.68, representing a growth of 11% versus Q4 2021.
Operating cash flow was seasonally strong in the quarter and amounted to SEK 1.9 billion, reducing Net Debt by more than SEK 2 billion in the quarter to SEK 7.4 billion. This corresponds to a Net Debt to EBITDA ratio of about 1.1. For the full year, operating cash flow reached close to SEK 4.7 billion, which is close to 80% of reported EBITDA. As stated before, we anticipate milestone payments coming our way. For Q1, we expect to pay $175 million for nirsevimab and $50 million for the approval of loncastuximab tesirine. For details on items affecting comparability in the year, please see page three in the report or the appendix to this presentation.
We then move to slide 13, I will now turn to the financial outlook for 2023, which is on revenue growth at constant exchange rates and Adjusted EBITDA margin. The same principles as in 2022. We will continue to expand our presence in hematology, immunology and specialty care through ongoing launches, new medicines and geographic markets, and we anticipate sustained sales growth. Revenue is anticipated to grow by low to mid-single digit % at CER. As we continue to invest in launches and advance the pipeline on new medicines and emphasize the long-term value of the business.
We expect to keep a favorable EBITA margin. The EBITA margin Adjusted is anticipated to be at the low 30s% of revenue. This outlook continues to exclude any elements of our rights to the full share of US profits and losses for nirsevimab. With this outlook for 2023 covered, I now hand over to Anders for the pipeline. Thank you.
Thank you very much, Henrik. Hello, everyone. I will now take you through pipeline highlights and news flow. Turn to slide 15 please. When it comes to the pipeline, we saw more milestones reached in the fourth quarter. Doptelet was submitted for regulatory review in China for the ITP indication. It's already approved for chronic liver disease. Zynlonta, which is a new name for loncastuximab tesirine, was approved in the European Union and Kineret authorized for emergency use in COVID-19 in the United States. Finally, nirsevimab was accepted for regulatory review in the US, which was announced in January by AstraZeneca and Sanofi. As a reminder, Sobi has the right to AstraZeneca's full share of US profits and losses for nirsevimab. Please turn to slide 16. Staying on the science in Sobi, the ASH meeting in December displayed a breadth and depth of Sobi in hematology.
efanesoctocog alfa highlights included new data on physical functioning and pain from the XTEND-1 phase III study. Doptelet had data looking at length of therapy and persistence, areas where we see clear differentiation for our medicine versus competition. On Aspaveli, new data was shared on long-term safety in PNH and more intense dosing schemes. Study in progress in cold agglutinin disease. Zynlonta had new data shared from the latest development programs by ADC Therapeutics. On Gamifant, we had the first look at the REAL-HLH study providing details on the real clinical utility in HLH. As a head of research and development, it was nice to see the extensive presence at the meeting and being able to imagine the benefits that existing and new evidence can bring to people with rare and debilitating diseases. Please turn to slide 17.
Last month, the first phase III study for efanesoctocog alfa was published in the New England Journal of Medicine. Together with our partner, Sanofi, we were pleased with this milestone for the XTEND-1 study. The publication confirmed the clinical benefits of efanesoctocog alfa, and the editorial was very supportive of the benefit this new medicine can bring to people with hemophilia A. Next up is the data readout from the XTEND-Kids, the second phase III study in the first half of this year, and the EU and other Sobi regulatory submissions in the second half of 2023. Please now turn to slide 18. Now, looking ahead, we are into a new year with increasing news flow from the Sobi pipeline.
During the first half, we can expect regulatory decisions in the U.S. for efanesoctocog alfa, as well as the readout of the second phase III study required for the E.U. regulatory submission. Doptelet and Aspaveli are both awaiting regulatory decisions in Japan, and we are anticipate phase III data from Gamifant in a new setting, as well as two phase III studies for SEL-212. In the second half we will see some of the data readouts as mentioned convert into regulatory submissions as well as approach regulatory decisions in China for Doptelet and Kineret. We will also see if there is any utility of Aspaveli in ALS or Lou Gehrig's disease, as well as hear from AstraZeneca and Sanofi when nirsevimab is approved in the United States. In 2024, there is more to look forward to.
All in all, it's going to be busier for the pipeline in 2023, and we look forward to sharing the news with you and see how we can further help people with rare diseases. Before I close and hand back to Guido, I would like to say thanks to everyone in Sobi who have helped advance science and care for people with rare and debilitating diseases. Now back to Guido. Thank you.
Thanks, Anders. In summary, 2022 was a good year, and we can look forward ahead to a solid future here at Sobi. We are pleased about the progress we have made last year and the outlook provided for 2023. The business in a good shape and growing the pipeline of new opportunities continued to progress well with a busier news flow in 2023. As Anders said it so well, thanks to everyone at Sobi who made this possible, and we hope to continue to provide good news for patients also this year as we move forward with Sobi. Please turn to slide number two1. We now go to the Q&A. For those on the phone, please remember to press Star 11 or Star 11 to ask a question.
Can I please remind everybody to limit the questions to one or two to be fair to all callers. Thanks in advance. Perhaps now we can take the first question from the conference call.
Thank you very much. Our first question comes from Christopher from SEB. Hello, Christopher. Your line is open. Please go ahead now.
My questions. Christopher from SEB. Apologize if there's for you guys as well. My first question is related to pricing adjustments. Could you please give us a little more color on the retroactive pricing adjustments on hemophilia products? Also, I mean, I guess in the context of what we've heard about the EU market access reform impact. Particularly AMNOG and the U.K. rebate. That's my first question. Then the second question is related to Synagis. What can you tell us about your thoughts for Q1, given the drop-off in the season? I caught that you said that you expect a more normal Q1 than the prior year, but what factors give you confidence in that?
For Q4, given the likely launch of Beyfortus ahead of the quarter, what can you tell us about the impact of sales erosion on the product's gross margin? I guess, are you thinking, in a hypothetical scenario, let's say, where you lose half your sales, would we be talking on the order of a ten percentage point lower gross margin for Synagis, or would it be closer to two percentage points? Or what can you tell us that can help? Thanks.
Yeah. Thanks, Christopher. I mean, that's, start with the easy bit. I mean, you know, there was a retroactive price adjustment, but this is two years ago, and we don't anticipate a retroactive price adjustment from recent initiatives in Europe. What we expect, though, is some headwinds, and also is part of the reason why we are a little bit more cautious, because we obviously see continuous patient growth across the board, you know, also in hemophilia. We probably will face some headwinds there, and that's the reason why the outlook is covering this. I don't think we will provide here an in-depth outlook, we will see some headwinds in Europe that will obviously suppress, let's say sales. I think no doubt.
You mentioned quite a few of those initiatives, and this will affect us. You know, it's early stage, but what we can see, and we've scoped it out, that, you know, the momentum we have across the portfolio should compensate or overcompensate those effects. With regard to Synagis, I mean, you know, we went through quite extensive outside-in research and how, you know, to think about it. Basically what we can see is, you know, that, you know, the second part of the 2022, 2023 season is probably more following, you know, a normal pathway, you know, that you would have seen, you know, in the 2020 pre-COVID scenario in 2019 probably.
You know, where the second part of the season is always a little bit weaker than the first part. But, you know, we have granted that the virology is changing, but, you know, don't forget these are very, let's say, fragile babies, even in the, let's say, second part of the season. Obviously, there are quite a few newborn as such, so we don't expect here, let's say something in the extraordinary, just more following a normal pathway. You know, with regard to the... You know, basically, obviously, it's driven also by adherence, let's say, to the five cycles. You know, a lot of babies have been dosed now, so you know, the... You know, compliance in recent history was quite good.
I mean, if anything, you know, the epidemic levels of COVID and others have taught us that, you know, we should take those vaccinations seriously. I think, you know, that is, we are actually quite optimistic that we will have a decent finishing of the 2023 season. Hence, you know, we, you know, the impact on gross margin, at least, you know, for the first quarter, we don't see coming major deviation coming here from Synagis versus the right comparison. Moving forward, you know, and let's say on how this is going to play out.
I mean, we think that, let's say we will obviously maintain a large chunk of the Synagis business in 2023, given also the late launch of the new competitor, and we have done their various scenarios. I think maybe this is, I stop here and we open up for more questions and happy to come back to this another time. Thanks.
Thank you.
Thank you.
The next question comes from Eun Yang from Jefferies. Eun Yang, please go ahead.
Thank you very much. I have a question on Beyfortus, before that, I wanna ask you on SEL-212.
We are expecting phase III data in the first quarter this year.
Yep.
Can you remind us what are the kind of differentiating aspects of the product we'll see compared to Krystexxa in the trial, or the trial is compared to placebo? In the US, the Krystexxa size is running over $700 million annually. How do you see the European opportunity?
Yeah, I mean, maybe I start with the commercial element of your question and then also give an out to that, then maybe Anders can talk about the trial in a few seconds. With regard to SEL-212, obviously we'll have to wait, hold our horses. I mean, you will see an effect size, or let's say of SEL-212 that will be basically that even though the data are not comparative as you rightfully pointed out, I mean, we will still have a look at the absolute effect size and compare it obviously with what Krystexxa has achieved. I think for us, to be honest, this trial is all about meeting primary endpoint and, you know, which, you know, hopefully we are going to make.
I mean, otherwise, we have a problem. You know, that basically is the, is the main theme. You know, the question is gonna be what are we going to do with this data, and, how do we see our positioning then versus Krystexxa? I mean, you have seen the data from the phase II. You know, we got a little bit unlucky on the primary endpoint, but got some good, numerical data differences in various aspects. I think, you know, it's, we always said this is a commercial product, let's say that we can sell and, you know, and we can s- and we think that we can make a dent, but it's a bit early at this stage.
We would rather wait now to guide when we have seen the phase III data, and let's say and give you then a bigger, better picture. Anders, you want to quickly comment on the study design?
Yeah.
Yeah.
Yeah.
On the study.
I'm happy to.
phase III data.
I'm happy to. I mean, first of all, it, the product is the co-administration, this, of, 212, which is two components, which is urokinase regulated, in its same principles as Krystexxa. In addition, a select proprietary developed immunomodulator to give a better protection from neutralizing antibodies. The study, the two phase III studies, with more or less identical design are placebo-controlled studies, a study population that is similar to where we have said it before, and with a significant part of the population being tophaceous patients , et cetera.
The goal is of course to demonstrate safety and efficacy at a competitive level over placebo and document the tolerability of this combined treatment, which we are confident that we will meet. It's also pointed out that this is then a less frequent and therefore for patients, more convenient therapy. A relatively straightforward phase III program in my view.
I think, Yun, we are quite hopeful that we have a positive outcome, but we would like to wait for the data first and then guide you. You know, I mean, we always said this is a product that we can sell. At this point, we have no indication any otherwise. You had a question I think regarding Beyfortus, Yun.
Yes. Yes. Yeah. Sanofi said that PDUFA Date is third quarter, but they are hoping to get approval before the June CDC ACIP meeting schedule. In the event that it's approved earlier, and then Sanofi is able to launch pre-season, would you update your guidance for this year? Thank you.
Yeah. I mean, we, at this stage, you know, I mean, the, our guidance is obviously dependent a little bit on, you know, on how much, you know, you would expect from the product. You know, it's a bit of, you know, there are various scenarios that we played through, and that they are dependent on, you know, obviously on the launch. They are dependent on the time we have to those patients. They are dependent on the labor as such. When we asked people who used to be involved with those decisions, and then they are in a dependent obviously on their ability to basically manage this kind of very significant complexity of the launch. Now, this is the largest... Used to be the largest company. Let's say so, you know.
There are quite a number of factors that needs to be considered. I think it's a bit early for us, you know, to change any outlook. I think we will reassess this when we have a good grasp on how this will affect all those different parameters. Yeah. But, you know, we... The good news is that we actually quite insulated, and there's, there are scenarios where we could have end up with a significant upside. There are some scenarios where we have, which we think are unlikely, we could have a downside. What we used here in our assumptions is a base case, and let's see how it plays out. Yeah. We are not at this stage giving any indication on the new reassessment.
Maybe we move on then to the next person. Sorry. Yeah. Eun, let's move on to the next question.
Thank you.
Thank you.
Thank you very much. The next question comes from Sarita Kapila, from Morgan Stanley. Sarita, your line is open now. Please go ahead.
Hello. Hi, and thanks for taking my question. Similar in seeking on nirsevimab. If it's not approved in time for the start of the RSV season, so in late 2023, as you said, to what extent is your guidance conservative? Should we be thinking about a mid-30% margin in line with 2022? Secondly, just on Doptelet. Are you able to update us on the situation in China? How many generic players are pursuing Doptelet, and what level of sales erosion should we be factoring post-BCP inclusion?
Thank you.
Thank you. Yeah, no, let's, you know, let's come to Synagis and nirsevimab. Obviously, if there were to be a miss in the season, we have anticipated some effect on Synagis and, yeah. I mean, the point is, if you sell more Synagis, we're going to make more money. If they are not there for the season, I mean, there we have no indications why we should not have then a normal year. Yeah. That will do us well. Do we reach 2022 level? Well, we don't know here at this juncture because, you know, it will depend also on the virology as such, so it is again, you know, not the time now to give new guidance.
Clearly, just looking at the factors, it would do us well. Yeah. The other thing on Doptelet. Yeah, the ITP submission is, I think is opening up a very significant opportunity horizon for our partner, Fosun. Obviously, there's a risk which currently is not the case, that there will be generic competition affecting the business. To what degree? Well, it's speculative. I mean, you need to realize obviously that Fosun is a very formidable force in a Chinese context. The sales we are seeing in our books are the sales to Fosun, not the sales in market. You know, we will have to hold our horses to see.
You know, we just point out that there could be a negative effect, but there could be also obviously some positives if, you know, Fosun goes for a broader indication because the only indication that is currently approved is CLD. It's there's bit of uncertainty. You know, there could be some negative knock-ons because of a generic competition that may arise. Either there could be a positive, obviously, also from a broadening of the indication. You know, we are very confident, obviously, that we have a strong partner at our side who is who can manage this business very well. Maybe the next question.
Thank you. Our next question comes from Mattias Häggblom from Handelsbanken. Mattias, your line is open now.
Yep.
Please go ahead.
Good afternoon.
Thank you so much. I have two questions, please.
Sure.
Firstly, with regards to efanesoctocog alfa , and risk for development of inhibitors. I noted in the New England Journal of Medicine paper no trace of inhibitors in the XTEND-1. However, given the complexity of the molecule and potential exposure of new epitopes at the linker site, I'm curious to hear your thinking about the risk for inhibitors in the ongoing XTEND-Kids trial and to what extent the DSMB has already provided insight to this topic, given the open label nature of this trial. Then secondly, if Henrik could help us think of the Net Financials for the year. I have yet to see details on the maturity and structure of your debt from your upcoming annual report. Is the Q4 run rate a good way to think of Net Financials for 2023 per quarter?
To what extent do you have debt maturing and repriced at higher interest rates during 2023, making a more gradual increase also likely for 2023?
Yeah. Maybe we start, Mattias, thanks for your question. Maybe I refer to Anders and, you know, he can update us on what he expects on inhibitors from the children trial. I mean.
Yeah.
You know, Anders, maybe you fire off and then we-.
Yeah. I think that.
We can have Henrik. Yeah.
This is of course a ongoing, well-controlled, blinded, study where we. Of course, we are following safety, et cetera, as normal. That is. We have no reason to believe that it would be less safe or less efficacious in kids than in others from our understanding of the mechanisms, et cetera. We can of course not comment upon the trial outcome as it's still ongoing and not analyzed yet, so.
I think we don't expect anything in the unusual. Obviously, when you expose kids for the first time, there could be inhibitor development as it is with every other factor product, let's say. You know, it's too early to speculate. We think, you know, that FN's octocog alfa will sail through. Maybe, Henrik, you can comment on the Net Sales in Q4.
Yeah. Regarding the finance net, yes, we do have maturities in Q4, but we don't really expect any impact on financial net coming out of those maturities. I think Q4 is a reasonable proxy. We don't know what interest rates will do to us in 2023, but I think it's a reasonable proxy. We have, of course, an expected strong cash flow in 2023, but we also have significant milestones coming up during the year. Q4 reasonable proxy.
Yeah. Thanks, Mattias. Maybe then we go to the next caller. I think it's Lars from Danske. Yeah.
That's correct. The next question come from Lars Hevreng from Danske Bank. Please go ahead, Lars. Your line is open.
Yes. Thanks. I just wonder if you could tell a bit about the planned launch activities for Zynlonta. I mean, the recently in-licensed ADC product.
Yeah
... ADC Therapeutics. Tell us a bit about the launch priorities. Which countries will you launch in when, and what kind of pace up do you see on that product?
Yeah. I mean, we, the first launch country, it wouldn't surprise you, is Germany in Q2. Currently thinking about more May. I mean, it's gonna be a gradual ramp-up. I think we have, you know, also in terms of resources, we have a lot on the plate right now with, obviously with pegcetacoplan, with Doptelet launch in Europe. You know, manage this. You know, product is, as we always said, is a good opportunity that we consider more as an hematology product than an oncology product that we, let's say, that we see as a nice addition, but it's not a, let's say, you know, the main theme for us. Yeah. You know, we are quite hopeful for the product.
We had quite a number of KOL meetings, so there is a clear medical need. KOLs are waiting for the product. We think we can sell it. I think for this year, want to manage expectations. This is not gonna be the main commercial event. Anyway, we have to get, you know, also reimbursement in other markets as we follow.
Okay. Thanks. Can I just follow up on nirsevimab?
Yes.
I mean, disregarding when Sanofi's gonna launch, et cetera, and I assume whenever they will launch, will you incur your share of the results, so to say, on the product, irrespective of whether it's a profit or loss?
Yeah. I mean, this is, you know, as of launch, we will be in for the launch cost or commercial cost. You know, we will share, you know, we will, you know. Henrik can comment on this. We will consolidate this business on a gross basis. You know, we will. It could negatively affect our earnings, that's for sure. Considering the product and, you know, the simulations we made, you know, considering that it will very likely be a product for a very, very large target audience, we consider these investments as a happy problem in view of, you know, when you look at it from a discounted perspective. Yeah. Yeah. Maybe we go to the next caller.
I think it's Erik from Carnegie, if I'm not mistaken.
That's correct. Next question comes from Erik.
Hi there.
Erik, your line is open. Please go ahead.
Thank you so much. Thanks for taking my questions. I have two, if I may. First, on the guidance that you provided in the end of 2020, the 25 by 25. I was just wondering if how we should look at this guidance, if it.
It's still reasonable to believe you will hit this target. I know part of this guidance included accelerating growth and margins from 2023, including double-digit revenue growth from 2023. That seems to stand in contrast with the outlook provided today. Just curious to understand what sort of have been... What products or what parts of the guidance have performed better and what parts have underperformed since you provided that guidance.
Yeah, no, I mean.
Sorry. Finally, just on, maybe a question for Henrik on Capex. On top of the SEK 175.7, about 50% loans, what more should we expect for Capex, DD-driven Capex this year and potentially next year? Sorry, that was a long question, but-
Yeah. No
...thank you.
Appreciate it. No, I mean, if I'm not mistaken, Erik, when we, when we made this outlook, provided this vision, I mean, we said 25 by 25, and we had an error margin there of 10%. That we allowed for, and obviously granted that this was made at a time when nobody thought that Russia would invade Ukraine and COVID was not, was a very far away idea. Bottom line is we still have three years, yeah, to fulfill this mission. I appreciate that obviously on the earnings side, when you look at it today, you know that it and you know we have made a guidance and, you know, what can I say?
The guidance would not point you into leverage right now, yeah. That is a deviation versus what we said, let's say at the time. Let's say this was also at a time when we thought we had, as you know, the CIT indication in the bank. Let's say, so, you know, so a few things have changed. Overall, I think the business is doing quite well. I mean, when you think about, you know, a SEK 2.5 billion business for Doptelet, I don't feel actually ashamed, you know. I think it's a quite a nice uplift. At this stage, I think what we also need to see is to what degree can we give Gamifant an additional push now with the help of new data.
There we thought, obviously, at that time, probably that we were a little bit further ahead. You know, overall, the business has held quite nicely together. I mean, there were quite a few people who thought that we would not hold the fort in hemophilia, and were projecting a lot of Cassandra scenarios, what is gonna happen. I mean, it didn't happen. We grew the business, we increased the patients. You know, so I think this is how I would like to bring it into perspective. Give us a bit more time. This is where we are at this point of time. The good news is that we have a lot of opportunities to invest. Yeah. That's basically what we, what we are now doing, building a very strong future. Maybe to the other question, Henrik.
Yeah. Regarding the upcoming milestones, I mean, in addition to what I mentioned, regarding the nirsevimab payment in Q1 and the Lonca payment also in Q1, we have some milestones to Astellas related to Doptelet sales coming up. There is also a payment for the approval of nirsevimab. That's close to SEK 4 billion for 2023. In 2024, the major one expected to come up is, of course, the approval in Europe of efanesoctocog alfa.
Very good. Thank you.
Thanks a lot, Henrik. Just on Selecta, is there any payment to Selecta coming up, given that they're quite advanced in that program?
Yes, there are, but not so significant.
All right. Thank you so much.
Thank you. I mean, maybe we keep up the beat, you know, a move to Alistair from Royal Bank of Canada and straight away.
Yes, we do. Next, question from Alistair.
Thanks so much.
Alistair, your line is open.
Thank you. Just a couple. Thank you. First one is just on the specialty care segment. I know it's fairly small, but just in terms of the EBITDA margin there, which is down about 10 percentage points year-on-year. Just get a sense of how is that settled there? Can it recover? Or what's the outlook there? Just to follow up on Gamifant, you touched on the MAS approval. Maybe can you give us a sense of what sort of uplift that could be from the current indication in terms of sales potential? Thank you.
Yeah. Yeah. I mean, maybe I start with the easy bit, the Gamifant one. I don't think we really got the acoustics of your first question. Maybe Gamifant first, very quick. You know, let's say the patient potential for the indication at stake is give and take 3x of what basically the label in the strictest sense is what we have right now. It's quite substantial. To Henrik, maybe you can talk about the... I mean, or maybe you can refine your question because I think we didn't really get it. I think it was acoustically, it didn't come across, Alistair. Maybe you can repeat it.
Was that the first question?
The first question, I mean, we didn't get the first question properly, I think.
Yeah, sorry. It was just looking at the divisional EBITDA margin for the specialty bit, which is, you know, year-on-year down from about 32% to 22%. Just to get a sense of, you know, where that could go from here. Is that, I mean, did it improve or is that where it's gonna stick? I know that's a fairly small part of EBITDA.
Yeah. When it comes to the specialty care segment, that is, of course, under pressure and the decline of Orfadin has for sure an important EBITDA impact because that is still a profitable product. That's the main reason.
Yeah. Maybe, maybe with this we go to Peter from Pareto as the next one, given that we are running a little bit out of time.
Yes. Peter, please go ahead. Your line is open.
Thank you very much. Oh, that was quite the feedback.
Peter? Sorry.
Yeah. Can you hear me?
Yes, we can hear you.
Yeah. Okay. Just two quick ones regarding Beyfortus. Firstly, did you say that you included some cannibalization on Synagis in your 2023 outlook?
That's correct. Yeah.
Okay, great. Then you've been saying that you're working with different scenarios regarding the Synagis and the nirsevimab, how that pan out. Have you had any discussions with your auditors around the SEK 11 billion intangible that you have for Synagis on your book right now, how you would deal with that going forward?
With the first part, you know, we obviously had these discussions and, you know, basically feel that we understand the opportunities reasonably well. Maybe Henrik on the auditor discussion.
Yeah. Is, Synagis and its follow-up nirsevimab, as well as one item. It's one unit so it counts. It's not like we expect to an impairment of Synagis because of nirsevimab.
Yeah.
Okay. Do you expect that they will level out?
I mean, historically, we have guided, Peter, that we are more optimistic for the profit streams from nirsevimab in comparison to what we expect, what we realized from Synagis as a consequence. The answer is yes. Yeah.
Okay. Thank you.
You're welcome. Maybe we go to the next dial caller, is Victor, I think from Nordea.
That's correct.
Hi, Victor from Nordea. Congrats on the quarter. On nirsevimab, I just wanted to dig a bit into your agreement with AstraZeneca for the U.S. market. The agreement seemed to include that AstraZeneca is titled to an additional royalty from you if profits exceed a certain level in the U.S. Can you give any guidance how much headroom you have until that royalty component from AstraZeneca will kick in for you guys in the U.S. and maybe what's that all about also? Thank you.
Victor, I think we don't think that we have to pay royalties. No.
Okay. On the same topic, that is RSV, I also wanted to get some more color on your comment that favorable price effects helped you in the quarter. Is that price hikes you're talking about? Can you comment if that will follow you through into 2023? Then I have a quick follow-up as well.
price fights in with regard to which part of the portfolio? Sorry.
Sorry, for Synagis. You said that there were some favorable price effects that you talked about in your slide.
Yeah.
I just wanted to get some more color on that.
Victor, those price effects are mainly related to gross to net.
Yeah.
It's not in Q4, there are no price increases in Q4.
Yeah.
It's gross to net.
Yeah, because you make certain assumptions on the mix to whom you are selling.
Yeah.
You know, you have obviously, depending on how the mix is then turning out, you have variances.
Okay, great. yeah. Also on the EMERALD study here quickly, have you got any feedback from the agency, said anything about how many patients that you need to achieve a complete response for you in this study to be enough for supporting an added label?
Yeah. We got this feedback. Anders, you want to comment very quickly?
Yes. If you got any feedback from the FDA, how many patients that need to.
Yes.
reach a complete response in the study for you, for it to be enough for a supplementary label.
I don't think I have any numbers I can share there today.
Okay, thanks.
Yeah. Let's move to the next caller. This is Jon Berggren from Kepler, yeah?
That's correct. Jon Berggren from Kepler Cheuvreux. Jon, please go ahead. Your line is open now.
Thanks for taking my questions. I have two on Synagis. At the last ACIP meeting, Sanofi and AstraZeneca presented post-second season safety data from MEDLEY. This was in the cohort of, CLD and CHD patients. First, I was wondering if you could share your thoughts on that data. Secondly, if you could give us a rate of how many patients that received, Synagis in two seasons over just one season. Those were my questions. Thanks.
Yeah. I mean, Synagis, normally, let's say, you know, give and take 50,000 patients plus minus, yeah. This is what we have in a normal season. In MEDLEY, with regard to the MEDLEY study, I think the key question is there, you know, Because it's obviously safety data, no efficacy, and to what degree then and this was allowed in the European context, can those data be extrapolated to our study population or to our population that is on label, yeah? I think that's the main question with regard to Synagis, but we don't know how this question will be addressed. This is a privilege of the committee. Yeah.
I think we keep up the beat, and I think that maybe we end with the last question from Christopher from SEB.
Yes. Christopher is now on the stage. Please, Christopher, go ahead. Your line is open.
My question is, on the Gamifant lupus cohort, in the study, when would we expect to see that readout? 'Cause it's not on the table anymore. Then, with that, and the other cohort, what's the pathway look like for approvals for the EU and Japan? What's the current status in China? Thanks.
Good. Anders, you wanna take it?
Yeah. There was several questions there. I... First of all, our main focus and energy now is to get the patients requested to from the first cohorts in Still's disease to facilitate the submissions due to complete the remaining part for making the submission for secondary HLH in Still's patients. The second cohort is ongoing. We have the first patients recruited. SLE patients with SLE is a tough recruitment goal, but we are optimistic that we will move on. We have not communicated the same timeline on that. We... I think we will come back with that in later updates when...
Right now the main focus in European we are engaging first of all, we are getting a lot of interest and access requests, et cetera, from European key centers and we are looking of course forward both with additional data in due time to see if we can reconsider the primary situation in Europe. When we have the outcome of the secondary study also map out the regulatory strategy for other territories. We know that we will probably need slightly more patients.
Also the first cohort goes beyond what is requested for FDA in that process. We can't give you details there yet. Of course, we are committed to make Gamifant available for as many patients as possible, both with primary and secondary HLH in as soon as possible.
I think, you know, if you round it off, I mean, we think that we are not too far away anymore from where we need to be, let's say with the EMERALD study to have something to submit to FDA. Basically, when you look at it in summary for 2022, I think it was a good year. We can look forward to a solid future. You know, we're obviously quite gratified that we made good progress last year and, you know, have quite a bit of momentum now for 2023. Business in a good shape. We are growing the pipeline. You know, you've seen in a table there on the news flow. We think it's quite material to us, you know, what happens in the next half year.
A lot of good news are hopefully coming and new opportunities and that basically means we will be quite busy with the business but also with what we are going to do in the pipeline in 2023. Thank you so much for your interest and apologies that we overran a little bit in time. If you have any questions, you know who to call. You know Thomas is here and is happy to connect you, and we will address any information request that you may have. Thank you so much. Wish everybody a great day. Yeah. Thank you.
This now concludes our presentation. Thank you all for attending. You may now disconnect.