The conference will stop being recorded for publication or broadcast. At this time, it's my pleasure to hand over to Guido Oelkers, CEO. Please go ahead, sir.
Yeah, thank you so much, and welcome, everybody. With this having said, you know, let's go straight to the first slide. It's really a pleasure to welcome you today to our Q1 report. And today I'm, you know, forward-looking statement as per usual. Today I'm joined by Henrik Stenqvist, our Chief Financial Officer, and Lydia Abad-Franc, our Head of R&D and CMO. And so during the Q&A session we will have also Armin Reininger, our Senior Scientific Advisor. Please go to the next slide. Good. I mean, you have seen the results this morning. I mean, results were excellent, from our perspective. It's plus 20% versus previous year.
I think this weighs even more when you consider that, we had to make up for SEK 880 million, roughly, of sales that we lost with Synagis. So we're quite, quite happy with the results in view of this.
But due to this erosion of Synagis and it was not made up, obviously, fully by the Beyfortus revenues, we had also a lower EBITDA margin. We will talk about this. But 37% still represents a 12% growth versus previous year. So when you think about, you know, our strategic portfolio, the strategic portfolio grew at 177%. There is our launch medicines and our new royalties that we received from our Beyfortus and for Altuviiio. This is quite significant. And this is making up for around 140% of our growth despite the fact that we had a pretty good year pretty good quarter with our Hemophilia franchise as well.
So, you know, when you see the slide, you know, with all the growth rates here, I mean, it's very substantial for Doptelet, Gamifant, and it's nice to see materiality with Aspaveli or Empaveli this quarter. We will talk about Vonjo a little bit because I'm sure this is on everybody's mind as well, you know, where we had more of a stable comparison versus previous quarter. With regard to key milestones that you achieved, I think it's very nice to see that we've got Fast Track designation for SEL-212. And this increases our confidence around the product. We have positive phase III data for Doptelet.
We had a positive CHMP opinion for first-line treatment of Aspaveli and Empaveli, which is also helpful to be more competitive, in view of future competitive entries. Outlook remains unchanged, simply because it's early in the year. You know, we have to make up also, for instance, for the one or the other topic and, you know, for most of the year, that we will have no gross sales in Q2. Let's move to the next slide. So when you basically look at the areas of business growth, as you can see, you know, the hematology being the growth leader with 46%, hemophilia sales very positive, you know, positively influenced by some of the international business, where we won some tenders, but also still strong growth in the more established markets.
This keeps us quite confident that we can competitiveness in Hemophilia, but overall hematology, the growth leader, immunology impacted by the Synagis development and specialty care, you know, in line, with what we expected, you know, because this business is something that we more manage for, for cash and earnings to support the growth in our core areas. When you look at the, regions, you know, Europe going very strongly with 15%, based on the, you know, strategic growth portfolio, but also supported by the growth in Hemophilia. And, the North American business impacted by the, erosion of Synagis. We are not adding here the royalties, in the North American number, but showing it below. So if you would add this, obviously, you know, the yin and the yang, then, this business is, would have done still very well.
International being our growth leader and, you know, becoming material. Our strategy to diversify in countries beyond North America and Europe is starting to pay dividends. Next slide. This is, you know, we spend a bit of time here to break out, you know, the strategic portfolio, which is really, you know, our royalties from the new product plus the products that we have recently launched or in this early stage of commercialization. And as you can see, you know, these are pretty significant growth rates. And I think we talked about it, you know, and if you exclude the Frozen business for Doptelet, you know, 59% at this point of time, makes us very confident that we have also more growth for this product. Let's go to the next slide. Here it's broken up.
So, you know, what you can see is really that the product portfolio that is relatively early is growing in significance and is now, well, for this quarter, 35%. And if anything, that part will grow whilst the foundation portfolio is also healthily growing. And this foundational portfolio does not include, obviously, Synagis, which is in the legacy portfolio. And, but, you know, the health status of the company is strengthened over time. And we're paying quite a bit of attention to this that we have a healthy portfolio of tomorrow's breadwinners and today's cash contributors. Next slide. This shows you that, you know, we are far not yet done, but there's still a lot of growth.
I think, you know, once we have submitted the SEL-212, we will talk a little bit more about the opportunity in chronic refractory gout if you see this be material. You know, Aspaveli, obviously waiting for the nephrology indications approval. Well, sorry, for the Phase III data first. But, you know, we believe that this is a material opportunity. And then, obviously, Altuviiio on the horizon. And, but, you know, also this Doptelet, you know, outside of the core regions, a lot of growth still to come. And, you know, we have just launched in Japan and making great strides. There's still a lot of opportunity ahead of us as well as for Aspaveli. And, Beyfortus is also an important growth driver.
Just, you know, when you think about the R&D franchise, as such, I mean, when you look at it because you have to look at it really not as a calendar year, but, you know, as a season, then the last, you know, for this season, which basically started in, October last year to through March, it's a SEK 3 billion region. I understand that you have difficulties to hear me. Is this correct? Can you hear me better now? Yeah? And, you know, when you think about the season, so it's a SEK 3 billion season, started a bit late, so not a, a season as we are used to, but by no means, let's say, reason for us to be less confident about RSV. Yeah, so the, maybe we move to the next slide.
You know, here you can see the hematology franchise, how it's, how it's growing, as an example of Doptelet. I think we talked about it. Next slide. Aspaveli and Empaveli, I'm quite happy with the acceleration of growth that we have seen in Q1. You know, we are now launching in more countries, Japan and China, you know, and becoming sizable, you know, more countries to come. We announced, you know, a joint venture in Korea. You would expect quite a bit from there. You know, we have Latin America emerging. So there's still a lot of new markets for us in, and then, obviously, the nephrology indication. So we stay quite positive about this franchise despite the fact that it will get more crowded. Next slide. And, Vonjo launch.
Yeah, so here, I think one needs to add a couple of points. When you look at it has been, I mean, not nearly perfectly flat from Q3 to Q1 this year. I think it's fair to say it took us some time to restructure the team and bring these two organizations together, understand, you know, what needed to be done in terms of messaging and strategy. Basically, you know, we were impacted, as we outlined in our report, by the Part D, meaning also unpaid patients as a crossover from last year to this year. You know, so it took us some time.
What we have seen, and this is, I think, the best yardstick, and this is that we have got very positive feedback from market research where physicians believe in the utility of the product. We have, obviously, very strong data. Lydia will show you some of them later. And so there's a strong preference share for Vonjo, but it needs some time until we make sure that this messaging is getting understood. We have seen some positive signals during the second half of the quarter. And what we see is, you know, this is what we announced because we wanted to give you a fair appraisal where we are and where we are not. And this is the 29% growth of March versus the average of Jan and February. So we are confident about this product.
It is not growing, you know, at the time, you know, at the pace we want to at this point of time, it's, I mean, needless to say. But the feedback that we get now and the indicators make us believe that we're on the right path. And that's what we said also in our report. Next slide. Yeah, strong demand in hemophilia. I think, you know, this is a reason to change our perspective on the franchise. We think this is a stable, growing business. You know, and obviously, we got a positive uplift for the reasons that I mentioned. You know, this is an important franchise. And we can't wait to add Altuviiio to this franchise. Next slide. This is the RSV season.
As you can see, you know, it's this when you look at this on a seasonal basis, which is not so obvious when you just look at the Q1 data. Yeah, the season was not the best season as we reported last year. It started a bit late. And you know, Beyfortus is obviously being a formidable product. And there is there's an asymmetry between the value of a Beyfortus patient, obviously, and Synagis. Therefore, it's a little bit difficult to predict this at times. But you know, we stay very positive about this franchise overall and think that you know, for when you look at it even on a calendar year basis, that there's a positive outlook. And clearly, there's a positive outlook once the new market dynamics have been established and we believe in the future of Beyfortus.
You know, don't forget that over time, our royalty percentage is also increasing. So we should get a, you know, a dual benefit from the increase of adoption, but also from the increase of our part participation in the earnings stream. Next slide. Gamifant strategy is working out. You know, we're very happy with the Q1, which is in line, you know, with previous quarters. And, you know, but overall, you know, it's obviously a massive change versus the Q1 that we had last year. And we believe in the future of this product. Secondary HLH, submission coming, new data coming for Gamifant. And hence, you know, we are quite bullish about this product, even though, you know, it's sometimes quite difficult to predict given the small number of patients and the relatively high value per patient.
Kineret, very gratifying to see this now, this evolution for the product and making good strides. You know, after we had the washout of the COVID business, you know, the product is now following a more normal pathway. Next slide. I think now it's time to hand over to Hendrik, who will update you on the financials.
Thank you, Guido. Hello, everyone. If we go to next slide, please. The key financials for the Q1 in 2024. As we heard, Q1 was a very strong growth quarter with a solid business performance. Revenue growth of 20% at CER and an adjusted EBITDA of 37%.
If we look at the bars to the left, we see the consistent trend in hematology, reflecting the 46% growth in Q1 through strong double-digit growth for both Elocta Alprolix, Doptelet, Aspaveli, and the additional Vonjo, and the lost revenue from the discontinued manufacturing of ReFacto. In immunology, which was down 11% versus Q1 2023, we saw Gamifant deliver 100% growth over Q1 last year, representing the fourth consecutive quarter with sales in excess of 400 million SEK. So the decline in immunology is explained by the new situation in RSV with the launch of Beyfortus and an earlier peak of the RSV season. Synagis declined by 63%, and this was only partly compensated by royalty revenues from Beyfortus, in the quarter.
But as the new dynamics settle in this market, we have a very positive view on the franchise, even if seasonal patterns of Beyfortus royalties could differ from those we have had for Synagis. And as you saw in the Q1 report, in order to adapt to a lower demand of Synagis in the quarter, we took the unfortunate but necessary decision to reduce the Synagis commercial organization by approximately 70%. So, over to the table on the right, revenues reached almost SEK 6.3 billion. And this was 20% at constant currencies. The lower adjusted gross margin in the quarter of 76% versus 80% in Q1 2023 was from the impact of lower RSV sales than the same period last year, including some inventory adjustments as well as other country and product mix effects.
The adjusted EBITDA margin reached 37%, below last year of 40%, of course, impacted by the lower gross margin that I just mentioned. Focusing now on the operating expenses in the quarter, we saw a growth of 17% at CER versus the same period in 2023. SG&A, excluding non-recurring costs, increased by 13%, mainly related to Vonjo, which was not there in Q1 2023, but also accelerated activities for launch products. R&D expenses, excluding non-recurring costs, increased by 24% at CER, mainly also due to the additional Vonjo, but also the filing activities for SEL-212. The non-recurring costs or items affecting comparability amounted to SEK 155 million in the quarter.
This resulted from costs related to the integration of CTI BioPharma of SEK 42 million, as well as the restructuring of Synagis commercial organization, which I just mentioned, amounting to SEK 85 million. Moving forward, we don't expect any material additional non-recurring costs from the acquisition of CTI, except for the adjustment to COGS related to the fair value of the acquired inventory. For details on these non-recurring items in the quarter, please see page 3 in the Q1 report. The operating cash flow in the quarter was SEK 2.3 billion, 14% higher than the same quarter last year, reflecting an improved working capital.
As a result, the net debt at the end of the quarter was SEK 18 billion, a reduction from SEK 19 billion at the end of Q4, corresponding to a net debt-to-EBITDA ratio of about 2.3 and reflecting our consistent cash flow generation. If we go to next slide, please. Had a look at the financial outlook for the full year. As usual for revenue growth at constant exchange rates and adjusted EBITDA margin. So we confirm the guidance for the full year, meaning that revenue is anticipated to grow by a high single-digit percentage at CER, and the adjusted EBITDA margin is anticipated at the mid-30s percentage of revenue. We expect the main drivers of growth in 2024 to be the same as we discussed in connection with giving this guidance the first time at the time of the Q4 report.
And those were the uptake of Vonjo, including, of course, the full-year impact, the launch products Doptelet, Aspaveli, and Gamifant, and the royalties for Beyfortus. In reflecting over the high single-digit full-year revenue forecast versus the 20% growth that we've seen in Q1, we should remember that we are early in the year and that there are a few factors that can be expected to be different for the rest of 2024 compared to Q1. First, Hemophilia product sales.
In the quarter, we had sales of close to SEK 2 billion, growth of about 15% at CER. This was driven in part by fulfillment of international orders. Due to the fulfillment of these orders, although we expect to maintain very strong position, we do not expect the same growth rates for the rest of the year. Second, as we heard, there was SEK 0.6 billion in sales of Doptelet to China in Q2 2023. As you probably know, we don't expect any further sales of Doptelet to China at this stage. We still expect material growth in our ex-China Doptelet sales for the rest of the year, but the growth rates will be impacted by the China sales from Q2 2023.
And third, Gamifant saw a significant step up in sales in Q2 2023 to more than 400 million SEK, which we have now maintained the last four quarters. And with the comp starting in Q2, it will be more difficult to show significant growth in percentage terms compared to the situation in Q1. And finally, we had the final Refacto manufacturing revenue of 375 million SEK in Q1. And there will be no more sales of ReFacto moving forward. So with the outlook covered, I will now hand over to Lydia. Thank you.
Thank you, Hendrik Stenqvist. Hello, everyone. So let's start with the pipeline milestone. From the next slide, please. We continued our steady pipeline progress in the Q1. In hematology, Doptelet is advancing in the pediatric ITP indication. And I will come to this in a minute. Aspaveli received positive CHMP opinion for the first-line treatment in PNH. Last week, the Committee for Orphan Medicinal Products confirmed the orphan drug designation. We terminated the Cold Agglutinin Disease program for Aspaveli, as communicated in February. Our immunology portfolio continues to advance this quarter in the U.S. and China.
SEL-212 received Fast Track designation from FDA, and we are on track to submit the BLA filing for chronic refractory gout. Kineret received approval for a Still's disease by the Chinese National Medical Product Administration. This indication is the largest of the three that we have applied in China. Next slide, please. Looking closer at the Doptelet pediatric ITP phase III study, this trial enrolled a total of 75 children between 1 and 17 years of age. It made its primary endpoint of durable treatment response in 28% of patients in the treatment arm compared to 0% for placebo.
All the secondary endpoints were met, as shown on the slide. Overall, very compelling data, and full results will be presented at an upcoming medical international conference. We plan to submit the pediatric ITP indication in the second half of this year to both FDA and EMA. Next slide, please. Let's look now into the exciting developments around pacritinib, which rapidly emerges as a backbone of myelofibrosis treatment with potential benefit also in other indications. Our strong belief in pacritinib is guided by a clear scientific rationale and existing unmet medical needs in MF. Cytopenias are a common feature of progressing myelofibrosis, with anemia being a common and challenging complication, often as an anticipated downside of current therapies. The prognosis is poor, with low survival rates for both severe thrombocytopenic and severe anemia populations.
The medical community has shown a strong interest in the potential of pacritinib. The National Comprehensive Cancer Network, NCCN, has set forth guidelines that endorse pacritinib as a first-line treatment option, not only for MF patients with severe thrombocytopenia but also as a potential option for high-risk patients regardless of platelet count. In addition, they now include pacritinib as a potential treatment option in patients with myelofibrosis-associated anemia. Pacritinib is increasingly seen as a differentiated agent in MF due to its unique mechanism of action as a JAK2 and IRAK1 inhibitor targeting multiple disease pathways. Additionally, it offers benefits, anemia benefits, likely related to ACVR1 inhibition.
We're also getting an important stream of requests for exploring further use of pacritinib in other indications beyond MF. Next slide, please. So we have convincing evidence to support the clinical value of pacritinib in chronic myelofibrosis. Pacritinib was more effective in cytopenic patients than best available therapy in reducing splenomegaly and symptoms.
It is generally well tolerated even in patients with severe cytopenia. It can be administered at full dose regardless of platelet counts, and we see an anemia benefit. Next slide, please. So our strategy for MS is designed to differentiate pacritinib based on its mechanism of action and to strengthen the therapeutic rationale. We are broadening the evidence based on a number of approaches. We are compiling preclinical data that will further enhance knowledge on pacritinib's mode of action. And we continue to strengthen the clinical evidence for pacritinib in MS. Of particular interest for investigators is pacritinib's efficacy for combination therapies. An example is pacritinib as a potential add-on to Selinexor monotherapy in JAK2 inhibitor naive participants, which Sobi supported. Besides pacritinib, this study also includes Ruxo and momelotinib as potential add-on JAK2 inhibitors.
Further studies explore its impact on disease progression, particularly in accelerated-phase myelofibrosis and its role in improving cytopenias and bone marrow fibrosis. As I say, there is a high interest in the community, and the studies you see on the right-hand side of the slide only reflect those that are already happening. Next slide, please. Our vision for pacritinib extends beyond myelofibrosis. We're actively supporting a range of studies, both as investigator-sponsored trials and in partnerships, to explore its use in a range of other hematological conditions. In malignant hematology, there are studies underway in myelodysplastic syndrome, CMML, Waldenström macroglobulinemia, and T-cell lymphoma. Other hemato-inflammatory diseases with potential use include recently published preclinical data in Castleman's disease and new clinical trials in Castleman's as well as chronic graft-versus-host disease.
As with myelofibrosis, we are in a number of discussions with investigators to support further studies in other hemato-inflammatory conditions. Next slide, please. Our news outlook remains strong. The CHMP is meeting these days to adopt an opinion on Altuviiio. So we anticipate sharing news very soon. As mentioned earlier, we plan to submit SEL-212 in chronic refractory gout in the US, now with the backing of the Fast Track designation. And we plan to submit Gamifant in secondary HLH for macrophage activation syndrome in Still's disease in the second half of the year. Doptelet's new pediatric ITP data will be used for filing in the pediatric indication in the U.S. and Europe.
And lastly, we continue our geographic expansion with anticipated Chinese decision for Doptelet in ITP and a submission in Japan. And with that, I would like to hand back to Guido. Yeah.
Thank you, Lydia. You know, maybe before we go into Q&A, a quick summary of what was presented. I think, you know, what you - what I what we want you to remember from this presentation, for sure, is 20% top line, 177% growth of our growth portfolio, strategic portfolio, 12% earnings growth. And, clearly, what we want to, what you do remember is that we are very confident now or increased confidence around SEL-212 based on Fast Track designation. And then there are obviously quite a few other, let's say, factors. But, you know, when you think about it, it's always difficult, you know, to anticipate what the future holds.
At this stage, we have a more conservative approach. We have a couple of headwinds. We may also have some upsides. But this is a good business, and we want to keep growing it, as fast as we can. But you know, at this early stage, there was no reason to change the outlook. Maybe with this, we open the floor for questions and answers.
We will now begin the question-and-answer session. Anyone who wishes to ask a question may press Star and one on the touch-tone telephone. You will hear a tone to confirm that you have entered a queue. If you wish to remove yourself from the question queue, you may press Star and 2. Questioners on the phone are requested to use only handsets and eventually turn off the volume from the webcast. Anyone who has a question may press Star and one at this time. Our first question comes from the line of Viktor Sundberg with Nordea. Please go ahead.
Yes. Hi. Viktor Sundberg from Nordea. I have a couple of questions, if I may. So you asked a question on guidance. So, guidance kept here despite a strong start. Any headwinds we should think about when we look at the full year that keeps you from increasing guidance even if it's early in the year? And maybe related to that also, I guess, people who are not that impressed with the report today point to that hemophilia was a strong driver, but ReFacto manufacturing phasing was a big part of that strength, which isn't as sustainable growth. So any guide on what the kind of underlying growth is in hemophilia in order to help us model this better? Thanks.
Yeah. Basically, you know, with regard to the guidance and headwinds, I mean, we will not have a frozen business for Doptelet in Q2. And that's to the tune of SEK 600 million. And then other than this, you know, there are other factors, as Hendrik pointed out, on comparability. It will be more difficult to continue growing, at the current growth rate, Doptelet Gamifant, simply because the base is getting larger. Then, you know, there will be other factors. But, you know, it's at this stage, it's pretty early. And we obviously hope that, you know, the Vonjo will become a driver. I think it's, there will be a couple of factors plus and minus. I don't think that we see now, any major change to our portfolio as such.
But, you know, we want to make sure that we don't get ahead of ourselves at this point of time, yeah? So, you know, there are a couple you know, there's not you know, Hendrik pointed it out.
So there are small things, you know, that makes it a little bit more difficult. But, you know, we hope obviously also that this early-stage portfolio is obviously making greater strides. I mean, it would not surprise you. And despite the fact that we will not have any frozen business for Doptelet, we still want to grow this at a material scale on a total basis as we have done last year, where we consolidated the first half. So with regard to hemophilia, I mean, that's really where we left it. You know, you have seen that Elocta and Alprolix has grown roughly around 15% versus previous year. And this was positively impacted by the, by some of the international business interfacing of some of these tenders.
But there is still a strong underlying growth, which is driven by patient expansion. And I think that will stay with us. And, you know, then there will be some erosion due to price, as we move forward. But, you know, we don't expect anything that we need to report here. So there are no significant shifts as we had in the past. So we just think that this, at this stage, is more of a stable to single-digit growth business for us. And, so in line with previous discussions, yeah? So that's really how we peg it, yeah? So maybe we move then to the next question. Thank you, Viktor. Thanks for your interest.
The next question comes from the line of Henrietta Boeg , Deutsche Bank . Please go ahead. Thank you. Yeah.
Two questions for me, please. The first on hemophilia. So what proportion of Q1 growth was phasing? And what is the pricing outlook? And how are you concerned about the potential competitive pressure from Novo's Mim8? And secondly, given comments for acceleration through Q1, is it still realistic that Vonjo will hit about SEK 2 billion this year, or should we expect slower recovery in growth over the coming quarters? Thank you.
Yeah. Let's start with hemophilia. I mean, we unfortunately will not provide guidance now on the percentage of the different components because it's a bit difficult. But, you know, I think if you take my earlier guidance into consideration, then I think you'll probably get a grasp direction of travel in this area. You know, we obviously take every competitor very seriously. But you may also understand that we are super excited about the efanesoctocog alfa launch. If nothing else, you know, we are quite reconfirmed our conviction by the recent announcement of growth from Sanofi, demonstrating that this compound is in high demand.
But you know, we just had two of our members here of the senior executive team members at WFH. And you know, there's a lot of anticipation for efanesoctocog alfa. So while we respect, obviously, Novo is, you know, a company that is, you know, a little bit larger than us. You know, I think we just need to acknowledge this. But you know, in hemophilia, we don't think that we can be outscaled or outmuscled by anybody. So we will we have come up with a very strong product, and we think that efanesoctocog alfa will make its pathway.
We think that this, that the Novo compound will primarily compete with the other non-factor product. Then time we will see. And obviously, they will have to show their phase III results first. And then we'll see, you know, we'll think about this newly. With regard to Vonjo, we don't give, you know, product guidance now for the year. But what you can expect is, you know, that we, that we obviously are confident about this product. That means that we will substantially want to grow this in the coming quarters. And that our confidence has grown about the product. And yeah. I mean, we have to acknowledge that sometimes, you know, this growth doesn't come in line with our extrapolation on a spreadsheet. You know, it took a while until Aspaveli was material.
Now with Vonjo, it will, you know, but we are confident that we made the right acquisition and shareholders will find - we'll get a good return on this product. So we, we will but, you know, we are not giving you a guidance or steer yet on the sales of Vonjo. Maybe we go to the next, sorry. Afterwards, obviously, that would be interesting, but we don't guide on per product. So maybe we can go to the next question.
The next question comes from the line of Alistair Campbell, RBC. Please go ahead.
Thanks very much. I've got a couple of questions, please. Just on Vonjo, you referenced some market research you've recently done. Maybe if I just sort of ask a bit more on that. Did you also ask in that piece of research physicians' views on anemia and how the product stacks up on that basis? And maybe did you also ask how they'd look at the product versus Ojjaara and any feedback and sort of competitive dynamic you're sensing between the two products there? And then if I could just turn to business development intentions, just a sense of, you know, what you're thinking right now. Are you more focused on fully integrating CTI and making Vonjo a success, or do you have room to think about sort of adding more to the business and doing more BD going forward from here? Thank you.
Yeah. Excuse me. The first part of your question was difficult to understand. I think it could have been a connection or maybe on our end. But could you repeat that first question? I mean, it was Ojjaara and then BD potential. But what was the first question with regard to the market research potential?
Yeah. Just, just really trying to understand obviously, you've been doing some market research, looking at Vonjo. Just to get a sense if you get sort of if there's more from that research you can discuss in terms of how physicians view the product referencing, patients with anemia or perhaps how they view Vonjo versus Ojjaara if you got that, level of information from research.
Yeah. I know we actually did I mean, as you would do, I mean, we did research not only, against Ojjaara and for obviously, for Vonjo but also understanding current perceptions on, Jakafi, which is, still serving the majority of patients.
I mean, basically, you know, what we, you know, we pointed this one out. I mean, we had some topics, I think, in the clarity of our messaging. And this took us a while. And we have now sorted this where we clearly wanted to position in line with physicians' recommendations. Vonjo for, you know, a little bit more than you roughly two-thirds of the patients. That means for patients who are cytopenic below 100,000, irregardless of whether they are anemic or not, in line with the guidelines from NCCN. And this is, you know, this messaging has been clarified. In the past, you know, the product is so good, you know, and it has so many elements, you know, and effects on different receptors, that message was probably not clear enough articulated.
You know, also, we obviously have to clarify that the cytopenia is a severe issue, and it's not going to get any easier over time. We basically, you know, see a clear opportunity for the product, particularly for patients that are currently underdosed, who can really benefit from the product profile. You know, and Ojjaara probably had an advantage in this way that they had a simpler message and clear. You know, it had also a few years of probably solid pre-marketing that we have to catch up. So, you know, we did some introspection, and we understand now what it takes. But, you know, sometimes these things take some time.
We believe in the product profile of Vonjo, you know, that we can get the preference share in this segment that I described, yeah, based on this research. But we need to live up to it. We work very consistently. And to be honest, it takes just some time until we can cover the universe at scale. And you know, in the meantime, obviously, our competitors will not wait for us. I mean, that's the nature of the thing. And we just have to acknowledge it. But we have a team that is extremely vigilant. And therefore, we are confident that we can solve this. With regard to BD, I mean, we want to demonstrate, obviously, that you know, it was the right decision to acquire CTI.
In the meantime, because it's part and parcel of our business model, we are, as we speak, exploring different opportunities. Hendrik has pointed out leverage has come down. That gives us opportunities. We also see opportunities for funding via different means. And, and, you know, we think that, you know, the company, you know, in doing the second half of this year, may be ready for some, activities on this external growth activities, whether it's a license or M&A. But, you know, that's part and parcel of our model.
And, while we are confident, you know and it's really gratifying to see, I think, not only, you know, Vonjo, the growth products, but also the endpoints that we will have this year, that, you know, the portfolio is rejuvenating further and increasing with regard to its profile.
But, you know, we believe that we've that we will constantly improve this profile and rejuvenate it, yeah? Thank you. Maybe we go to the next question.
Thank you.
The next question comes from the line of Christopher Uhde, SEB. Please go ahead.
Yeah. Thanks. No, you mentioned that it takes time for Vonjo. But I guess how much time is the most salient question? So maybe I think it, you know, it'd be really helpful if you could give more detail around, you know, and clarity around the, you know, new patient starts or other launch metrics for Vonjo, you know, beyond just what happened in a single month, given there can be volatility. And maybe, you know, what have you seen so far in Q2, for example? And then for my second question, so a 70% cut in the Synagis commercial organization cost. Is it correct that that relative difference includes cuts for all of selling medical and marketing costs or just the selling? And roughly, how much were the total costs for Synagis in 2023? Thank you.
Yeah. Thank you so much, Christopher. You know, you make it, you know, also pretty loaded question. You will understand that I can't give you any guidance on Q2, as much as I wanted, let's say. But you know, we let's put it this way. You know, we when we looked at the different indicators, you know, and obviously, they got a bit skewed because of this changeover from last, from the Part D in Q4 to this year. So, you know, we didn't have the strongest start in January as a consequence of this. But, you know, when we looked at the indicators, we looked at, you know, the direct feedback we get from physicians. And we're obviously quite, you know, receptive to any sort of feedback.
We have quite a number of; we have increased our activity level also materially as of February. We think that there is a correlation. Now, when is it going to happen? I mean, you know, you have seen the report where we just said that we are more confident about Q2. I think, you know, that I leave this up to you. I mean, more we can probably cannot say. You know, let's say, you know, the first; we have to earn it. And we are not making our forward-looking statement by quarter.
But, you know, that we didn't buy this product to be a flat liner, I think, is also fair to say. So we want to grow it. And, you know, and we will, we should experience growth. We know what consensus is. And we see this as a yardstick to live up to this. But, you know, whether we achieve this, we'll see. But, you know, we want to grow this product. And, you know, and indicators tell us that it is on the cards. With regard to the Synagis restructuring, this was referring to the headcount. And maybe, Hendrik, you want to add some additional flavor.
Yeah. So it's also marketing headcount. And it means that we now have a commercial force of about 40 people, working with Synagis going forward.
Yeah. You know, we have given you guidance, you know, on how many people we used to have. So that gives you a little bit of a sense, you know. And 70%, you know, gives you another direction, I hope. Yeah. Thank you, Christopher. Maybe we move to the next question. Thank you.
The next question comes from the line of Harry Gillis with Berenberg. Please go ahead.
Hi. Thank you for taking the questions. So just one quickly on SG&A. Obviously, you mentioned that Q4 last year came in sort of as perhaps higher than typical. And that's come down in Q1. I just wanted to think about how you expect SG&A spend to phase throughout the year and whether we should expect a similar pattern to last year, particularly as we consider the annualization of the CTI acquisition and then on top of that, just thinking about the Altuviiio launch, I just wanted to ask how we should think about the initial conversion of patients or the initial sales in Altuviiio and whether those early sales are more likely to come from a lot of patients and then a greater proportion from other factor products?
Or do you expect a high proportion of competitive products right from the beginning? Thank you.
Yeah. I mean, maybe I take the Altuviiio part, and then Hendrik can talk about the how to think about SG&A. So with regard to Altuviiio, I mean, obviously, you know, we have now the product available in some Middle Eastern countries. And we get very positive feedback. We have feedback, obviously, from these trials that were ongoing and the patient experience and physicians who have worked with this.
We have seen, obviously, the data point from Sanofi, and obviously, that which, you know, gives us another data point of robustness. Now, we will launch, let's say, mid of year, which we told you that in summer, European summer, it's not normally the easiest way to make sure, you know, that physicians and patients are meeting. And, you know, that switches can, but, you know, we will launch anyway. And there is a lot of anticipation of this. And the launch in Europe will be in Germany. And then other countries, another country, the U.K., following in the later part of the year. I think for us, beyond now sales, because, you know, it will, you know, basically, some of these physicians see their patient once a year.
And then, you know, and then it's a question: when do they see them during the course of this year to have this opportunity for changing therapy? And obviously, there will be some patients who will ask for it. So it's a little bit difficult to predict this. But what we want to see is that, you know, that by the end of the year, we want to have, you know, at least, you know, a significant number of patients that are on the product. We are not yet guiding on what this number should look like. But, you know, this is probably more of a marker for our success than being impressed now by significant sales numbers.
I mean, we are aware of the Sanofi number until we I mean, it will take a while until we have all Europe reimbursed, given just the sequence of reimbursement process. So, you know, the real first launch year for us is probably more next year, even though some of the countries will also come during the year on stream. So it's also not a complete full year. But, you know, you should see them also materiality in terms of sales. But we know that there's a significant interest. And when you think about, you know, the sources of growth, you know, historically, Sanofi gave some indication on what they were able to get from Hemlibra and let's say, and what they were able to switch from Elocta, and from other sources.
So we believe that, clearly, the vast majority will come from other factors. There will be a part which is unavoidable coming from Elocta. Whether we induce it or not is besides the point, simply because it's a better product with a better product profile. And then there will also be, we believe that, you know, non-factor patients switching to efanesoctocog alfa who will want to benefit from this. And, you know, I think, historically, Sanofi guided around 10% of their patients. I'm not sure whether it's 10% or more. We think that this is a very competitive product, let's say, that is in the position and with our team, that we should be able to take a material share again, yeah, from non-factor as well. I think this is really what we can say.
Maybe, Hendrik, you want to give some guidance on SG&A?
Yeah. On the phasing of SG&A. Of course, 2024 will be different to 2023 when we had the ramp-up of SG&A, because of the acquisition of CTI and the efforts on Vonjo. Now, this year, it's expected to be more of an even play, with probably slightly lower spend in Q3, which is, you know, relatively speaking, a low-activity quarter or lower-activity quarter.
Yeah. So maybe, being cautious, enough time we have 10 minutes, two more questions. And then what I would propose is because I recognize that we may not be able to answer all questions, that you otherwise contact Gerard or anybody else from our IR team.
You know, we make sure that we can answer them, give your questions within the next couple of days anyway. Yeah. Next question, please.
The next question comes from the line of Mattias Häggblom, Handelsbanken. Please go ahead.
Oh, good afternoon. Hi. Thanks so much for taking my questions. I have two, please. So, first, I'm sorry. I'm going to go for another try on Vonjo. So, your guidance that we will see quarter-on-quarter growth in Q2 is not very aggressive after being down in Q4 and now flat in Q1, but also taking into account what you said about March performance versus the average of January and February. So, I'm going to try to push you again. Using the March number you provided, did I get to roughly $12 million in revenues for March. So using that as a run rate for Q2, I get to $36 million with no added monthly growth. And Bloomberg Consensus seems to carry $41 million for the quarter.
So help us set the right expectations for Vonjo. Anything more you can add? And then I have a follow-up.
Yeah. No. I mean, this is, you know, I know it would be interesting. Mattias said, you know, "I would love to help you out here. But, you know, first of all, we have to deliver it in the first place." And let's say but, you know, we, yeah. We would be disappointed if we don't if we cannot grow the product. Very disappointed. But, you know, that is but we have to earn it. I mean, I would I was also hoping that, you know, we could have shown some growth earlier.
But you know, I just have to acknowledge that it takes some time and that we have to overcome a little bit of an inertia in a fragmented target audience. But there is - that is receptive, you know. And once you spend enough time with key physicians to the differentiated profile of our product and we have strong data, let's say, you know, but it just takes some time. Yeah. So apologies that I cannot give you the percentage, let's say, for the next quarter.
That's clear. And then I had a follow-up. When do you think it's time to help investors understand the potential of your factor eight franchise in your region, perhaps with a peak sales target in dollar terms like you did back in 2020 for some of your products at the Capital Markets Day?
Yeah.
When Sanofi provided an implied peak sales potential of Altuviiio, Consensus expectations moved accordingly, not least when they have now executed quarter by quarter. So I know you prefer to talk about patient share in the profit segment and what share gains the product may provide. But that doesn't seem to translate into high Consensus sales projections, at least not yet. So any thoughts on this would be helpful.
Yeah. I mean, you know, the I mean, what we I mean, we obviously need to launch in the first place. But we always said, you know, this is a leader in the segment. And we think a leader is, you know, between 30, you know and we historically said up to 40%. So it's not going to take it all. We gave guidance that, Elocta in this space is around, low 20s right now.
And so that gives you a dimensional shift. And that basically means, you know, that over time, you know, obviously, the share of Elocta will reduce. And basically, you know, then you look at this as a consolidated share. So the share in this category will be significantly larger. Then the question is, obviously, what is the size of the opportunity in this prophylactic market right now? If you basically look at the market, you know, you can deduct this by what we proposing. And let's say that basically now, the question is, what is how is the price evolution of this market? That's very difficult, to be honest, to predict. But that, you know, in our books, efanesoctocog alfa is a much larger product than what we have today with Elocta.
I think it has to be assumed. And that's basically, you know, that will not be a surprise. But how much larger, you know, that we have not projected yet. And we have not done this for the group. But we are not doing this now for Efa. So I'm a little, you know, we probably this is as much guidance as we can give at this stage. Yeah. But we are keen to launch. Yeah. But, you know, it's and that means, you know, we believe that this is a growth franchise. Yeah. Thank you, Mattias. Next question.
The next question comes from the line of Yifeng Liu, HSBC. Please go ahead.
Hi. Thanks for taking my question. I've got two very quick ones. The first one, could you briefly talk about the SEL-212 timeline for regulatory submission and also whether you have intention to file elsewhere? Second question is on these, Vonjo's additional studies you presented in the core. I just wonder, any R&D cost in the guidance in 2024, are they implied in guidance? Sorry. To know, in other words, are they baked in your guidance already? Sorry. Yeah.
Yeah. I'll do the easy part of your questions. And Lydia will do the tough part. Let's say the easy part is, you know, yes, the studies are in our guidance. You know, we are not projecting anything that we have not budgeted for. And as a consequence, you know, it's included. And basically, SEL-212 is a global product. We see opportunities for this product outside of North America or outside of the U.S. We launch it, too. How large the opportunity then will be, for instance, in Europe, will depend on our discussions with the different pricing authorities. But you know, we believe that there's a high unmet medical need also outside of the U.S. Lydia, maybe you want to talk about the filing?
Yes. And I think that we have communicated in previous reports that our plan is to submit in the first half of this year. And now, with the Fast Track designation, I think that that's going to support our submission timeline. So still, everything is on target for that. Yeah.
Very good.
Yeah. Thanks so much. Yeah.
Thank you. Yeah. I mean, basically, yeah. I think we probably covered it for now. So, apologies that not everybody was able to maybe ask a question. So please refer to our IR. And then we will address them swiftly. Thank you for your interest. So we don't, you know, as you can see, you know, 20% doesn't feel so bad as a start into the year. So makes us look forward to the following quarters. Thank you so much for your interest. Wish you a great day.
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