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Earnings Transcript for SOBI.ST - Q4 Fiscal Year 2023

Operator: Ladies and gentlemen, welcome to the Q4 2023 Report Conference Call and Live Webcast. I am Sandra, the Chorus Call Operator. I would like to remind you that all participants are in a listen-only mode and the conference is being recorded. [Operator Instructions] At this time, it is my pleasure to hand over to Guido Oelkers, CEO. Please go ahead, sir.
Guido Oelkers: Yes, thank you so much and hello everyone. This is Guido, CEO of Sobi. We are delighted to welcome you into the fourth quarter and full-year 2023 conference call for investors and analysts. Overall, we can say that we are pleased with our performance in 2023 and the year has exceeded our expectations. We posted this presentation to sobi.com earlier today. Let’s go to Slide #2. We would like to remind you as per usual of the forward looking statement and unless stated otherwise, we liked making comments that most related to the fourth quarter full-year performance in 2023 at constant exchange rate in million Swedish kroner. With that please turn to Slide #3. Today we plan to cover key aspects of our Q4 and full-year report. I’m joined by Henrik Stenqvist, our CFO and Lydia Abad-Franch, Head of R&D and Chief Medical Officer and during the Q&A session by Armin Reininger, our Senior Certificate Advisor. We plan to review the presentation first and then have Q&A until around 2
Henrik Stenqvist: Thank you, Guido, and hello, everyone. Please turn to Slide #15, and the key financials for the fourth quarter in 2023. Looking at the bars to the left, we see the consistent trend in hematology similar to last quarter with contribution to growth from Doptelet outside of China, Elocta as the valley and the addition of Vonjo. In immunology, Gami continues strong momentum with over a 100% year-on-year growth at the [Zynlonta] (Ph). Synergy sales declined due to later start of the RSV season as well as the launch of Beyfortus and the Beyfortus royalties of 890 million, mostly compensated for the lower synergy sales in the quarter. Over to the table on the right, revenue reached 6.8 billion and that was the highest quarter ever, as reported in SEK, as we continue to grow our strategic portfolio, reported growth was 14% and that corresponded to 15% at constant currencies. The adjusted growth margin in the quarter was 80% compared to 78% in the same period last year. The improvement is mainly due to the two, having no low margin opposite sales to China in the quarter. The gross margin was also improved by royalties from Beyfortus, but more somewhat offset by lower synergy sales, which is another high margin product for us. The adjusted the margin reached 38% below last year, or 41% and this is explained by the increase in operating expenses in the quarter. As a reminder, the CTI business was not included until Q3 of this year. And in addition to Vonjo costs the higher spend in marketing and sales related to the launches of Doptelet and Aspaveli and pre-launch activities for EfaAlfa, the increase in R&D spend relates mainly to Vonjo and EfaAlfa. For EfaAlfa, we are running additional Phase IIIb studies and also ramping up medical affairs and making geographic expansion efforts. The non-recurring cost or items affecting comparability of some 80 million in Q4 related to the ongoing integration following the CTI acquisition. We expect some further non-recurring cost in coming quarters, but at a lower level compared to Q4. For further details on items affecting comparability in the quarter, please see the page three in the Q4 report. Operating cash flow in the quarter was just above 1 billion, bringing net debt at the end of the quarter to 19.3 billion, corresponding to the net debt to EBTIDA ratio of about 2.5. As a reminder, we completed the SEK 6 billion rights issue in Q3. And if we go to Slide #16, and the financial outlook for the full-year 2024 for revenue growth at constant exchange rate and adjusted EBITDA margin. As we heard for 2024, revenue anticipated to grow by high single digit percentage at CER and adjusted EBITDA margin to be in the mid 30% of revenue. Expect the main drivers of growth in 2024 to be the uptake of Vonjo and including, of course, the full-year impact, the launch products Doptelet outside of China, Aspaveli, Gamifant and royalties for Beyfortus. Pending approval, if alfa will launch in Germany in the second half of 2024 with most other markets coming in 2025 following the customer reimbursement processes on a country by country basis. This makes 2025 the main launch year for EfaAlfa in our markets. On the other hand, we do not expect any sales Doptelet to our partner in China in 2024. Doptelet sales to China in 2023 were almost 600 million. In addition to the usual uncertainty and the timing and severity of the RSV season, we do expect that the successful uptake of Beyfortus will have an impact on sales of Synagis next season. The guidance on the EBITDA margin in the mid thirties reflects a slight increase in margin from 2023. Just as with revenue, we will have a full-year impact on Vonjo in 2024 in both SG&A and R&D costs. In SG&A, we will continue with a strong launch support for ongoing launches and also increase the investment into the launch and pre-launch of alfa in Europe, as well as continued geographic expansion. In R&D, we will increase our efforts related to studies and the ramp up of medical affairs activities for alfa, as well as the filing preparations for SEL - 212. The continued investments in bringing our assets to approval and launching them successfully are of course critical for unlocking the long-term value of these assets. And with the outlook covered, I will now hand over to Lydia. Thank you.
Lydia Abad-Franch: Thank you, Henrik. Hello everyone, and let’s start with the pipeline milestones on Slide 18 please. So we hit quite a few R&D milestones in the quarter. There are three notable developments for Aspaveli. In nephrology, we are making good progress. The VALIANT study, our pivotal Phase III clinical trials for Pegcetacoplan in C3G and IC-MPGN was fully recruited in December and we are looking forward to the data. And in November, we presented the positive Phase II novel results at the American Society of Nephology. We are very confident about the potential of Pegcetacoplan for these indications In nephrology. There are currently no approved targeted therapies that can prevent or reverse renal injury and failure for C3G or primary IC- MPGN as the only complement target therapy that can block the main pathophysiologic driver for these conditions, Pegcetacoplan has a convincing mechanism of action. For PNH in Europe, CHMP issued a positive opinion for Pegcetacoplan use in FirstLine treatment, and we terminated the Phase III study for Cold Agglutinin disease as part of realigning our joint activities with our partner Aspaveli. We are facing recruitment challenges due to availability of alternative therapeutic options that limited the number of patients eligible for this study. Important to note is that there are no safety concerns and efficacy has not been evaluated due to the blind design of the study. For Vonjo, the National Comprehensive Cancer Network issued new guidelines in December, and importantly, a new section on myelofibrosis associated anemia is now part of the guidelines and is included as an option for all aspects of management of patients with MF associated anemia. This NCCN update further supports pacritinib’s potential role in treatment of a broad range of MF patients. It is the preferred agent for its indication patient population of intermediate or high-risk MF patients with platelet counts below 50,000. And it is also noted as a potential option for high-risk patients with higher platelet counts. Finally, Kineret received its first approval in China, to which I will come back to on the next slide, please. So looking ahead, we have a lot of news to share. 2024 will be the year to launch efanesoctocog alfa. We believe that we have convincing and strong data and are preparing for the anticipated EU decision. The process has been going smoothly so far, and we answered the 120 questions we received certification for the device. We are also preparing for important U.S. submissions. First, for SEL- 212 chronic refractory gout for which Sobi now has the full responsibility after taking over the select team in November to keep the submission preparations on track. And we are still aiming to file with FDA in the first half of 2024. Later in the year, we will receive the full data from the Gamifant cohorts from the EMERALD study. This will enable us to file in secondary H&H for macro activation syndrome in steels disease in the second half of this year. And lastly, we continue our geographic expansion with anticipated Chinese decision for Doptelet in ITP and submission in Japan. And after receiving the FMS and CAPS indications for Kineret in China last year, we are also looking forward to the still syndication, which is the most significant of the three. As you can see, we are taking the momentum from 2023 and accelerating further in 2024. And with that, I would like to hand back to Guido. Next slide please.
Guido Oelkers: Yes. Thank you, Lydia. We are pleased with Sobi’s development as pointed out during Q4 and the full-year. And as we outlined, we saw 15% for the quarter growth, 12% for the full-year. This reflects a strong performance of our launch medicines and foundational business in all regions. In addition, obviously, we received a strong contribution from Beyfortus. Our R&D pipeline progressed with key milestones for efa, efanesoctocog alfa, Aspaveli and Doptelet. We have a strong momentum in the business and look forward to a successful 2024. And with this said, let’s move to the question-and-answer session. And maybe the Operator takes over.
Operator: [Operator Instructions] The first question comes from Eun Yang on from Jefferies. Please go ahead.
Eun Yang: I have a question on Vonjo first. So understanding that there was an integration phase that impacted the growth in 4Q, but focus sales are lower than 3Q, so you didn’t site integration issue in 3Q. And despite the fact that you have - but you had about 22% new patient starts in 4Q. I’m just wondering why [indiscernible] became lower than 3Q? And was there any impact from GSK launch? And another question is on hemophilia a royalty exchange rate with the Sanofi. It could be that I must be mistaken, but my understanding was that the royalty rate on ALTUVIIIO was negotiated to 8% range, a high single percentage range from 12% on a Elocta, was it renegotiated range or was it from the start that it was 8%??
Guido Oelkers: Yes. Thank you, Eun. Maybe we start with Vonjo. I mean, basically, where we are right now is Vonjo, given the fact that we have a stronger propensity to this more severe patients with platelet counts below 50,000. What we have right now, and obviously in also the way the product is used in the treatment algorithm, we have a shorter treatment period than other JAK inhibitors. And this is basically, right now it turns out that this is impairing obviously sales, but it is also an opportunity when this is corrected, particularly now with the new guidelines. But what it means is that essentially you have an average duration of treatment of eight months. With this you lose - if you don’t have replenish your new number of patients on time when this has an effect, obviously, overtime on the patient buildup. We haven’t seen this that much inQ3. That is correct. But we have seen it more in Q4, which because there is an accumulated effectofQ2 and Q3 and when we modeled this one out, and tried to really get to the bottom of this. So while it is I would agree. I mean, if it was the other way around and we wouldn’t have seen the patient grows in Q4, then I would’ve agreed with your suggestions that maybe this is related to GSK, but as we have seen the uptake in Q4. I mean, I’m not saying that we are completely free from GSK effect, but it is right now, it has more to do with our to be honest project, CTI lost a little bit with the eye of the ball in Q2 and we had quite a bit of we needed, there was a bit of a cultural alignment that needed to happen and think quite a few people actually left as also to deliver the synergies that we wanted to have. So that is really behind this. And then, we sure enough, we also clarified that we could improve the messaging, create more clarity here. But all of this has been agreed. And the team has a very clear target audience. So I think, what you see has more to do with us. And we had to do our housekeeping, sometimes in life you wished you could compress life into a spreadsheet and just extrapolate. Sometimes it is not the case. And let’s say we just have to accept that we now need to be - we need to give this time, give a bit of time. But from what we understand, we are in a good way and we should be able to demonstrate growth from here. And with regard to the royalty agreement, maybe Henrik, you share your views what has been agreed?
Henrik Stenqvist: Yes. Can you repeat the question, Eun?
Eun Yang: Sure. So the exchange royalty rate with Sanofi, my understanding is that locked rate is about 12% in both ways. But you was negotiated recently and we went down to 8%. So, question to you. Was it renegotiated down to 8% recently or was it 8% from the start?
Henrik Stenqvist: It was 8% from the start. It was not only a royalty that was negotiated, we made an early opt-in to the product. So, it was a larger deal than only the royal terms.
Guido Oelkers: And we can very well remember when we announced this we actually clarified this with 8% and 9%, 9% that we pay, 8% that they pay us, and we clarified that by the expanded market share that you would expect for efa on a total earnings side or revenue side for royalties, we should have a positive.
Operator: The next question comes from Charlie Mabbutt from Morgan Stanley.
Charles Mabbutt: Charlie Mabbutt from Morgan Stanley. I guess firstly just back to Vonjo, I guess it would be interesting to hear your thoughts on how the debate actually is playing out on the market in terms of the relative importance of thrombocytopenia and anemia, because I appreciate that you are on the NCCN guidelines for both, but obviously you are the preferred regimen for thrombocytopenia and momelotinib is preferred in anemia. So just thinking about the dynamics would be really helpful. And then, I don’t know if you can, but I think following the conversation we’ve been having today, if you could sort of help give any assurances on the level of growth we should expect, maybe through 2024, and how much of sort of the long-term revenue opportunity for the product you believe is in MF versus other indications outside of mf. I think those factors would all be very helpful.
Guido Oelkers: I mean, our ambition for 2024 is unchanged. We want to make this an important medicine. When you think about the market, and basically, and you segment it and let’s assume, you segment it according to two dimensions, hemoglobin level, and you say, okay, anemic below eight to 10 gram per deciliter and cytopenic below a hundred thousand, then that segment below a hundred thousand, regardless whether you are anemic or not, is more than 65% of the market. And this is where we believe we have a positive preference here based on market research and also now confirmed with the guidelines. Granted guidelines is not labeled, but - and I think the main topic is when you are a cytopenic patient, there is a large group, obviously of JAK inhibitor treated patients who are not getting a full dose. And if they don’t get full dose, they don’t get full effect. And the dosing is related to also to the mechanistic effect of JAK1 inhibition. We are JAK1 sparing a JAK2 inhibitor. So, logic would suggest that you basically, why would you use another JAK1 inhibitor if basically you are under dosing because of the mechanistic effect in the first place. And that basically, you know, makes us quite confident, obviously proof is in the pudding. I mean, I get it. I could have also lived with a higher number for Q4, very straightforward. Let’s say but, you know, but I think, you know, what you can sense is, you know, we think that we have the right product in our hands and we will, you know, make this a very significant product for Sobi this year. And nothing has changed I don’t think we have set out any specific target for the product for this year, but that this will be a material product. Let’s say, you know, until, and you have seen the expectations, you know, we will think that, you know, that this product will be an important contributor this year, period. Does this give you some flavor? Maybe Ahmed you can, because you know, historically you have, you have done quite a few interviews with some of the KOLs. You know, maybe you can give some color how you see the topic thrombocytopenia versus anemia
Armin Reininger: Yes. Happy to do so. Thank you very much, Charlie, for your question. I think it is a really important one because the way we look at this, and there is also discussions that we have a lot. Anemia clearly affects the wellbeing of the patient or fatigue and other things. But if you look at the real heavy outcome that is life expectancy, this is much less driven by low red cell counts, but clearly determined by the low platelet counts. And if you look at that aspect, and if you see that Vonjo really has positive effects, even in the worst patient group, platelet counts below 50,000, but has not only good effects on the platelets, but as well on the anemia. We feel strongly that we have shown in the worst patient group that this drug of our drug Vonjo is really helping those patients. And that should also be the case in the ones with higher platelet counts. So for us, we feel that if you compare the different aspects, particularly from the outcome and life expectancy, we feel that we have a great product. It is not a direct comparison that exists, but we feel that only looking at the anemia part doesn’t give justice of what the patients truly need. And that is more than just improved anemia.
Operator: The next question comes from Alexander Niall from Deutsche Bank.
Niall Alexander: It is Niall Alexander from Deutsche Bank. Thanks for taking my questions. So question on RSV percentages, we are seeing consensus forecast 35% decline in 2024, and then a 30% decline in 2025. And we, you know, we are seeing Beyfortus doing well in the U.S. so far with Sanofi commenting that they expect Beyfortus be blockbuster product. So question is, do you feel the 30 to 35% decline in synergies over the coming years is reasonable to assume? And that is the first question. And then just the second question is a quick one. Q4 2023, SG&A came in ahead of consistent estimates. So it’d just be good to get a feel of how we can expect SG&A to trend going forward. Thanks?
Guido Oelkers: Thank you. I mean, you would expect, you know, with an increase of obviously of Beyfortus in line with the guidance of Sanofi, that this will affect us and no matter what, let’s say, but, you know, we, I think a good I think a good indicator, because there is a bit of uncertainty. I mean, we obviously have two factors that has influenced synergies performance in Q4. Also, when you think about now the coming year, and the first factor was it is a season started late, which basically didn’t allow us to get enough doses administered. And then the second reason was that obviously there was a supply then in the end that I think was able, even though maybe not to be anticipated in the late stage of the quarter, which was then obviously was consumed and obviously affected also our ability to sell synergies. Now the question is where will we land? I think, that you will have to expect an effect on our business, You will have to expect, just by the virtue that we have a certain group of patients now that are using the product. There will be quite a few that will continue treatment, but it is clearly less than we had the year before synergies. And that basically will affect us to what degree will we be affected in the second [Indiscernible] as part of the year, meaning the 2024, 2025 season. I can’t tell you this is a bit part of the uncertainty, but what I can see is when you look at the dynamics of royalties from Beyfortus and our business, I mean, it is a bit like a [ying and a yang] (Ph). And it islet’s say, quite beautifully offsetting each other. We would not necessarily anticipate this decline of the franchise. Definitely not in terms of profitability. So I think that is how we are thinking about it. But there is an asymmetric element with Synagis where we obviously have higher sales in Synagis patients, and we get effectively then royalties from Beyfortus. So that basically creates a little bit of an uncertainty, and that is what basically also is included in our guidance. So I hope that gives you a little bit of some perspective on this.
Henrik Stenqvist: Then on your question on the SG&A., I mean, Q4 and reality, most of 2023 the SG&A is, of course, a reflection of our five ongoing launches. So we will, of course, continue in 2024 with strong launch support and also then, of course, intensify prelaunch and launch of efa. So that is what I can say about the trend in 2024.
Guido Oelkers: Yes. But I think it is - and this is basically what you have seen also in Q4. We saw the opportunity to invest into our pipeline and into our launches, which I think this is what we are supposed to do and what we should be doing, building the company out for the future. But we are also recognizing the fact that obviously, people want to see profit improvement and that is also incorporated as part of our guidance.
Operator: The next question comes from Alistair Campbell from Royal Bank of Canada.
Alistair Campbell: I guess two. First of all, obviously, we are now learning a lot more from Sanofi about Altuviiio launch in the U.S., and I just kind of wonder from what you have seen from those U.S. dynamics, what do you think will be similar in Europe? And what do you think actually may be different as that molecule comes to market? And then another question, if I may sort chance my luck a bit, if we look at the most recent consensus, it is got an EBITDA margin of about 43% by 2026. Now clearly, we are trying to wrestle with the positive impacts from a significant base water royalty against other things as well. But just get a sense of how realistic do you think that margin level can be in terms of attaining that level by that timeframe?
Guido Oelkers: I mean, what can we learn from Altuviiio in the U.S.? I think, obviously we have a larger relative franchise of a lobster, so basically and that may influence this, but what you can see is that there are certain -, which clearly would be the natural sources of growth for Altuviiio. There will be also quite a few patients from Hemlibra that may want to switch back to Factor VIII to alfa simply because they’re needing additional factor or they want to benefit from additional protection. And so these will be fully - but structurally when you think about it, where growth comes from factor and Hemlibra, maybe structurally it may not be so dissimilar. I mean, we look at our, let’s say, what is then the share of efa, of Elocta versus the share in the U.S., we will figure it. But I think that there is a certain amount that we are getting from short-acting and from the long-acting. And then obviously also getting some share back from [indiscernible] you will see how the momentum is built up, how the community is reacting, patient experience, they will be typically very much shared within the community. We know we have shared with you the anecdotal evidence, from patients who are on the product who really where the vast majority who of patients who have been in the clinical trials definitely want to stay on the product because they have such a wonderful experience. So, there is a lot of good things coming into this direction. And maybe later because - is just now actually at the ER conference, he can provide you maybe with some feedback on this. And then just a snapshot on EBITDA. EBITDA is going to be a function on how much we are going to invest into our future, obviously on the by forties. And it basically also, obviously how we are able to build up scale.. We unfortunately don’t provide guidance at this stage beyond 2024. But we understand that the more by far the royalties we have the more profitable the company becomes and that the more it allows us to make those educated choices. But we want to build, obviously, the company out for long term growth. And then hope, let’s see, where we stand at the end of the year, whether we have been conservative or we have been right on, but time will tell, but we want to make sure that we drive this for a strong growth despite obviously a few headwinds that are quite material on the scale of Sobi. Lydia, maybe you want to give the, let’s say, snapshot from [indiscernible] as you are right now there on the sentiments?
Lydia Abad-Franch: Yes, thank you. I think there is a lot of excitement here at Ehab with alfa. We have six abstracts that have been accepted. One is an oral presentation on the pediatric data, because that is the piece that we will be publishing this year as well. So it is generating a lot of interest in the community for not only for the adult treaters that we have published the data, but it is also very highly expected by the pediatricians. And what we hear is that that, there is still very high interest due to the fact that that for many factories still fundamental, that the expected levels of protections are something that have, has never been able to be achieved. And the one sharing the expertise from the clinical trials is really positive. So I think that here in our territories we will see switches from all the alternative treatment options that are currently available in the market, including factor and non-factor. So looking forward to having it approved and launched here.
Guido Oelkers: I think this gives you a bit of a flavor where we are at. Maybe we go to the next question.
Operator: The next question comes from Christopher Uhde from SEB.
Christopher Uhde: Hi there, Christopher Uhde. Thanks for taking my questions. So I guess I would like to start on OpEx going forward. So for 2024, does Q4, does the base there represent sort of a fully loaded SG&A that we can expect sort of going through 2024 on the existing portfolio? And then when it comes to synergies, are there any subgroups of patients where you have been more resilient to cannibalization from Beyfortus, and also how much can we sort of, how much can working capital improve as synergies decline? And then lastly on Vonjo, you have talked about potentially, you know, doing trials in the future expanding Pacifica for one thing, looking at other indications and also combinations with other Myelofibrosis drugs. But you had the asset for more than half a year, and so far we haven’t seen anything happening there. Have you changed your mind on this? And sort of as an aside to that, the anemia guidelines, the 2B recommendations, so it is not an easy ride for reimbursement there. Is that good enough or do you need a trial?
Guido Oelkers: Thanks. Yes, maybe, you know, thank you. I mean, thanks for asking only one question, Christopher. Very much appreciated. Let’s say, and, but you know with regard to Vonjo let’s say, you know, let’s start the other way around here because that was quite loaded. With Vonjo, we have obviously we are progressing quite a lot, but unfortunately for competitive reasons we can’t tell you right now, but that is the reason why we set due course. We haven’t changed our mind. And the NCCN guidelines is good enough for reimbursement. And let’s say, and that basically, so hence, you know, we, I mean, obviously it is we have to work for it, it needs to be understood. But we think that this is, this was an important milestone for the company, for the product. Yes. So we stand fully behind, there is nothing has changed. And then we maybe with the SG&A side, Henrik, you want to take this?.
Henrik Stenqvist: Yes. So on the question whether Q4 OpEx was fully loaded, and representative for 2024. Of course, there are ups and downs between quarters, but Q4 was, for sure, fully loaded. I can take also your question on you were expecting an improvement in cash flow when Synagis is switched to Beyfortus and that is not really the case because Beyfortus, we get paid after the quarter, whereas in the case of Synagis, when we’ve been invoicing ourselves, we have collected money before that. But of course, Beyfortus is, relatively speaking, much more profitable and will, from that point of view, generate a lot of cash.
Guido Oelkers: Does this give you - there was another element in your question, sorry...
Christopher Uhde: Those are great answers. Last element on the Synagis. Was there any subgroups of the patients where you are seeing more resilience to cannibalization?
Guido Oelkers: No. I think the subgroups is more driven by the profile at this stage of the physician. And there are some who were quite resilient and believe in the advantageous profile of the product and want to see more evidence. And as we historically have said, with increasing evidence, obviously, they grew quite a lot of evidence by the number of patients that are now on the product, that basically may or may not change. But for now, we have quite a large group still supporting the product. Good. Maybe we move to the next question?
Operator: The next question comes from Yifeng Liu from HSBC.
Yifeng Liu: I have one on the RSV specific your 2024 guidance and start both on revenue and margins. I was wondering how much sort of the share between Synagis and Beyfortus are you sort of penciling in from your implied margin and revenue? And secondly, on EfaAlfa, you mentioned that you are doing an additional Phase III trial and just trying to trying to understand what does it differ from your current data package and more value than that?
Guido Oelkers: I’m sorry that we have not provided, let’s say, the breakout of Synagis and also not of Beyfortus. And you are probably the best indicator on how we think about it, but we won’t tell you is what some of you are saying about Beyfortus revenues next year in the U.S. And with regard to, let’s say, with regard to efa, this is more long-term safety and Phase IIb. And Lydia, want to comment on it?
Lydia Abad-Franch: Yes. So it is a Phase IIb trial that we are running in our territories to collect additional data focusing on physical activities. So patients will have physical activity trackers and that will provide additional data that was not collected in a continuous way in the pivotal trials.
Guido Oelkers: But we are well on track.
Operator: The next question comes from Viktor Sundberg from Nordea.
Viktor Sundberg: One question here on Vonjo and your integration of CTI, could you quantify, maybe guide for us the synergy here? Do you think the product here will be highly margin creative going into 2024, for example, versus your mid thirties margin target for the combined sales of your products? I guess there is some overlap here between Dova and [indiscernible]. That is the reason for my question. And maybe as a very quick one on - and also study readout here, mid 2024, what is the commercial opportunity in your review for that indication?
Guido Oelkers: I start with - we said accretive in 2024 for the Vonjo, and we stick to it. And let’s say, it is not maybe massively accretive, but it is a very profitable product and it will make a contribution to the product, to the franchise.
Henrik Stenqvist: Yes. Viktor, obviously since we are speaking about an uptake here. The accretion will be building during the year.
Guido Oelkers: So we know that we have work cut out and we are not shy away from this. And anyway, we think we have enough what it takes to mix this with regard to variant. And this is obviously, when you think about the number of patients, you basically have substantially more patients in the nephrology indication for us per belly than you have for then you have for PNH. And in addition, it is what we can expect is, it is a two horse raise given the effect and one of the diseases even called C3G. So no surprise that you would expect a C3G inhibitor having a very direct effect, and therefore we are super excited. And also when you think about the deficit remover data and the images that were shown as part of the Phase II, we are really excited about this. So we think that, first of all, a lower number of competitors, secondly a very direct way. And certainly we think that the data, we can also look forward to this maybe, maybe quite positive. Yes. So, that is spurs our excite.
Operator: The next question comes from Erik Hultgard from Carnegie.
Erik Hultgård: On Aspaveli, this opportunity in renal diseases, could you talk a bit about how you see, obviously there is no approved therapy within C3G, but Novartis iptacopan announced positive headline data in, I think it was in December. So just curious to hear your thoughts there on potential differentiation looking at sort of earlier stage data, what we should anticipate there?
Guido Oelkers: Yes. Thank you. I mean we basically look at this market in terms of the following access. It is a pre, post-transplant and IC-MPGN and also the C3G. We think that - and basically, what you have to believe in or what you believe in is that by that time, we have a new applicator that Apellis has launched in the U.S. for the product that makes the administration of the product much easier and more convenient based on recent data points. So we think that this device twice a week, subcutaneous will then, you know, we compared obviously with twice a day oral. And then basically you say, okay, what will be the compliance with the oral? I mean, we have certain reference points, you know, on how compliant patients are with oral therapy in different settings and you know, and obviously non-compliance could lead to complications. And you know, and hence we think, you know, that there will be a fair share of physicians electing, you know, subcutaneous direct CC inhibition, particularly if the data will stack up. And we are actually quite positive, you know, based on the Phase II data that we will show some strong data also in Phase III so that, you know, that this will be a strong alternative treatment option for physicians. And, you know, we have, now quite a few patients or also in early access because it is there in such a desperate stage and that we make product available. We see really spectacular, you know, data from this. So, you know, we are really, you know, proof is in the pudding, but you know, the opportunity is very material and you know, and if you are in, and I think, you know, there may be a bias in the ICM PGN patient potential and for also post transplant. So you may have their strong, a strong target audience. Yes, I think this gives you, thank you Eric, and for your question. And so guys, I think we are a little bit ahead of time. So sorry that we were a bit extensive, but you know, as you can see, we don’t feel sorry with 12% growth. Yes. With and we are bullish about our future and we try to delight and make sure that we, you know, we can live up to your expectations. Appreciate it. I wish everybody a great week. Thank you.
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