Swedish Orphan Biovitrum AB (publ)

STO:SOBI

Earnings Call Transcript 2024-Q1

[Operator]

Ladies and gentlemen, welcome to the Q1 Results 2024 Conference Call and Live Webcast. I am Alice the Chorus Call operator. [Operator Instructions]. The conference must not be recorded for publication or broadcast. At this time, it's my pleasure to hand over to Guido Oelkers, CEO. Please go ahead, sir.

[Guido Oelkers, executive]

Yes. Thank you so much, and welcome, everybody. And with this having said, 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 -- a forward-looking statement as the usual. Today, I'm joined by Henrik Stenqvist, our Chief Financial Officer; and Lydia Abad-Franch, our Head of R&D and CMO. And in the Q&A session, we will have also Armin Reininger, our Senior Scientific Adviser. Please go to the next slide.

So, I mean, you have seen the results this morning. And the result was excellent from our perspective is plus 30% versus previous year. I think this way even more up 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 happy with the results of [indiscernible] 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 at 37% and still represents a 12% growth versus previous year. When you think about our strategic portfolio, the strategic portfolio grew at 177%. And we know our launch medicines and our new royalties that we receive our Beyfortus and for Altuviiio.

This is quite significant, and it was making up for 140% of our growth despite the fact that we had a previous year, pretty good quarter with our hemophilia franchise as well. So -- and when you see the slide in hematology growth rates here, I mean, it's very substantial for Doptelet [indiscernible] candidate and it's nice to see materiality with Aspaveli and Altuviiio this quarter. We will talk about Vonjo a little bit because I'm sure this is on everybody's mind as well, we don't care we had more of a stable comparison versus previous quarter and there's more to say to this. And with regard to key milestones that we 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 product.

We have a positive Phase III data for Doptelet and we had a positive [indiscernible] for first-line treatment of Aspaveli/Empaveli, which has also helped probably be more competitive in your future competitive entries. Outlook remains unchanged, simply because it's early in the year, and we have to make up also, for instance, for the one or the other topic for most here that we will have no [ holdings ] in Q2. Let's move to the next slide.

So when you basically look at the areas of business growth, as you can see, the hematology being the growth leader that was 46%. hemophilia sales very positive positively influenced by some of the international business where we won some tenders, but also still strong growth in the more established markets and this makes us quite confident that we can competitive in hemophilia, but overall, in hematology, the growth leader immunology impacted by the Synagis development and Specialty Care line is what we expected because this business is something that we won't manage for cash and the earnings to support the growth in our core areas.

When you look at the regions, Europe growing very strongly it was 40% based on the strategic growth portfolio but also supported by the growth hemophilia. And the North American business impacted by the [ room ] of Synagis. We are not adding here the royalties in the North America number, but showing it below [indiscernible], then this business is to have done still very well. International being our growth leader and becoming material. So our strategy to diversify in countries beyond North America and Europe starting to pay dividends. Next slide.

So this is -- we spend a bit of time here to break out the strategic portfolio, which is really in our work with [ company ] products plus the products that we have recently launched or are in this early stage of commercialization. And as you can see, these are pretty significant growth rate. And I think we talked about it, if you exclude the [indiscernible] business for Doptelet, 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.

And here, it's broken up. So what you can see is really that the product portfolio that is relatively early is growing in significant and is now for this quarter, 35%. And if anything, that part will grow whilst the foundation portfolio is also healthily growing. And this foundation as portfolio does not include obviously Synagis, which is in the legacy portfolio and we help [ set ] as a company is strengthened over time. We have been paying quite a bit of attention to that if we have a healthy portfolio of tomorrow that [indiscernible] today cash contribution. Next slide.

This shows you that we are far, far not yet done, but there's been a lot of growth. I think once we have submitted the SEL-212, we will talk a little bit more about the opportunity and product [indiscernible] result if you see this [ material ]. Aspaveli obviously waiting for the nephrology indication approval -- sorry, for the Phase III data press and as you know, we believe that this is a material opportunity. And now [indiscernible] quarters. And -- but we are [ listed ] Doptelet outside of the -- for reasons a lot of growth still to come. And we just launched in Japan and making our great strides, but there's still a lot of opportunity ahead of us in Aspaveli and Beyfortus is also an important growth driver. And just when you think about the RSV franchise, as such, I mean, if you look at it because you have to look at it really other than calendar year. But as we see that the last for this season, which basically started in October last year to March, it is SEK 3 billion roughly [ reason ].

I understand that you have difficulties to hear me. Is that correct? Can you hear me better now? Yes? And when you think about the season, so it's a SEK 3 billion season, started a bit late, so not a season as we are used to, but by no means, let's say, reason for us to be less confident about RSV. Yes. So maybe we move to the next slide. And here, you can see the hematology franchise, how it's growing as an example of Doptelet. I think we talked about it. Next slide. Aspaveli, I'm quite happy with the acceleration of growth that we have seen in Q1. And we are now launching in more countries Japan and stream and becoming sizable and more countries to come.

We announced a joint venture in Korea. And you would expect quite a bit from there. Do we have Latin America emerging. So there's still a lot of new markets for us 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 the Vonjo launches. So here, I think what needs to add a couple of points. And when you look at it, it has been -- I mean, not nearly perfectly flat from Q3 to Q1 this year. And I think it's fair to say it took us some time to restructure the team and bring these 2 organizations together, understand what needed to be done in terms of messaging and strategy.

And basically -- and we were impacted as we outlined in our report by [indiscernible] meaning also unpaid patients at the crossover from last year to this year. And so it took us some time. What we have seen, and this is, I think, the best yardstick and this is that we have a, 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 this is what we announced because we wanted to give you a fair appraisal where we are, where we are not, and this is a 29% growth of March versus the average of Jan and February. And so that -- we are confident about this product. It is not growing at the pace we want at this point of time. I mean needless to say. But the feedback that we get now and the indicators make us believe that we have -- that we are on the right path, and that's what we said also in our report. Next slide. Yes, strong demand in hemophilia. I think this is a reason for us to change our perspective on the franchise. We think this is a stable growing business. And obviously, we've got a positive uplift for the reasons that I mentioned. This is an important franchise, and we can't wait to add [indiscernible] to this franchise. Next slide.

This is the RSV season. And as you can see, this -- when you look at this on a seasonal basis, which is not so obvious when you just look at the Q1 data the season was not the best season as we reported last year, started a bit late. And before just obviously being a formidable product and there is an asymmetry between the value of the Beyfortus patients, obviously, and Synagis. Therefore, it's a little bit difficult to predict at times. But we stay very positive about this franchise overall and think that 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.

And don't forget that over time, our royalty percentage is also increasing. So we should get a dual benefit from the increase of adoption but also from the increase of our participation in the earnings stream. Next slide. Gamifant strategy is working out. We're very happy with 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, our -- we are quite bullish about this product, even though it's sometimes quite difficult to predict given the small number of patients is a relatively high value per patient. And Kineret, very gratifying to see this now this evolution for the product and making good strides. And after we had the washout of the COVID business, the product is now following a more normal pathway. Next slide.

I think now it's time to hand over to Henrik, who will update you on the financials.

[Henrik Stenqvist, executive]

Thank you, Guido, and hello, everyone. So if we go to the next slide, please, and the key financials for the first quarter in 2024. So 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 Alprolix, Doptelet, Aspaveli, and the addition of Vonjo and the last revenue from the discontinued manufacturing of ReFacto. In immunology, which was down 11% versus Q1 '23, we saw Gamifant deliver 100% growth over Q1 last year representing the fourth consecutive quarter with sales in excess of SEK 400 million. 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 defer 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 the 20% at constant currencies. The lower adjusted gross margin in the quarter of 76% versus 80% in Q1 '23, 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 EBITA 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 '23. SG&A, excluding nonrecurring costs increased by 13%, mainly related to Vonjo, which was not there in Q1 '23, but also accelerated activities for launch products. R&D expenses, excluding nonrecurring costs, increased by 24% at CER, mainly also due to the addition of Vonjo, but also the filing activities for SEL-212. The nonrecurring costs or items affecting comparability amounted to SEK 155 million in the quarter. This resulted from cost related to the integration of CTI of SEK 42 million as well as the restructuring of the Synagis commercial organization, which I just mentioned, amounting to SEK 85 million.

Moving forward, we don't expect any material additional nonrecurring costs from acquisition of CTI except for the adjustment to COGS related to the fair value of the acquired inventory and for details on these nonrecurring 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. And 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-EBITA ratio of about 2.3 and reflecting our consistent cash flow generation. If we go to the next slide, please.

As a look at the financial outlook for the full year. As usual, for revenue growth at constant exchange rates and adjusted EBITA margin. So we confirm the guidance for the full year, meaning that revenue is anticipated to grow by high single-digit percentage at CER, and the adjusted EBITA margin is anticipated at the mid-30s percentage of revenue. We expect the main drivers of growth in '24 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 for Vonjo including, of course, the full year impact. The launch products Doptelet, Aspaveli and Gamifant and the royalties of 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 phasing of international orders. And due to the phasing 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 a SEK 0.6 billion sales of Doptelet to China in Q2 '23. And 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 '23.

And third, Gamifant saw a significant step up in sales in Q2 '23 to more than SEK 400 million, which we have now maintained the last 4 quarters. And with the comps 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 SEK 375 million in Q1, and there will be no more sales ReFacto moving forward. So with the outlook covered, I will now hand over to Lydia. Thank you.

[Lydia Abad-Franch, executive]

Thank you, Henrik, and hello, everyone. So let's start with the pipeline milestones on the next slide, please. We continued our steady pipeline progress in the first quarter. 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. And last week, the Committee of Orphan Medicinal Products confirm the Orphan Drug Designation. We terminated the [indiscernible] program for Aspaveli as communicated in February. Our immunology portfolio continues to advance this quarter in 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 Still's disease by the Chinese National Medical Products Administration, and this indication is the largest of the 3 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 20 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. And 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 [ PMA ]. Next slide, please.

Let's look now into the excitement 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 beds in MF. Cytopenias are a common feature of progressing myelofibrosis. With anemia being a common and challenging complication often as an anticipated down side of current therapies. The prognosis is poor with low survival rates for both severe thrombocytopenic and severe anemia population. The medical community has shown a strong interest in the potential of pacritinib. The National Comprehensive Cancer Network and CCM 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 increasing [ theme ] as a differentiated agent in MF due to its unique mechanism of action as a JAK2 + IRAK1 and ACVR1 inhibitor, targeting multiple disease pathways. Additionally, it offers benefit, anemia benefits likely related to AVCR1 inhibition. We are also getting an important stream of request for exploring further uses pacritinib in other indications beyond MF. Next slide, please.

So we have convincing evidence to support the clinical value of pacritinib in [ current ] myelofibrosis. Pacritinib was more effective in cytopenic patients and best available therapy in reducing splenomegaly symptoms. It is generally well tolerated even in patients with severe cytopenia. It can be administered a full dosing regardless of platelet counts, and we see an anemia benefit. Next slide, please.

So our strategy for MF 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 MF. Of particular interest for investigators is pacritinib efficacy for combination therapies. An example is pacritinib as a potential add-on to selinexor monotherapy in JAK inhibitor [indiscernible] participants which saw support. Despite pacritinib, this study also includes ruxo and [ momelotinib ] as potential add-on JAK inhibitors.

Further studies explore its impact on disease progression, particularly in accelerated pace myelofibrosis and its role in improving cytopenias and bone marrow fibrosis. As I said, there is a high interest in the community. And the stats you see on the right-hand side of the slide only reflects those that are already happening. Next slide, please.

Our vision for pacritinib expands beyond myelofibrosis. We are actively supporting a range of studies both as investigator-sponsored trials and in partnerships [ to stores ] is used in a range of other hematological conditions. In malignant hematology, there are studies underway in myelodysplastic syndrome, CMML, Waldenstrom’s 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 NIMs outlook remains strong. The CHMP is meeting these days to adopt an opinion on the Efanesoctocog alfa. So we anticipate sharing NIMs very soon. As mentioned earlier, we plan to submit SEL-212 in chronic refractory gout in the U.S., now with the backing of the fast track designation and we plan to submit [indiscernible] 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 and ITP and a submission in Japan. And with that, I would like to hand back to Guido.

[Guido Oelkers, executive]

Yes. Thank you, Lydia. And maybe before we go into Q&A, a quick summary of what was presented. I think what we want you to remember from this presentation for sure is 20% top line. 177% growth of our gross portfolio, strategic portfolio, 12% earnings growth. And clearly, what we want to -- what you do remember is that we are very confident of -- our increased confidence around SEL-212 based on fast track designation. And then there are obviously quite a few other, let's say, factors. But when you think about it, it's always difficult 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 upside. But this is a good business, and we want to keep growing it as fast as we can. But at this early stage, there was no reason to change the outlook. Maybe with this, we'll open the floor for questions and answers.

[Operator]

[Operator Instructions]. Our first question comes from the line of Viktor Sundberg with Nordea.

[Viktor Sundberg, analyst]

Viktor Sundberg from Nordea. I have a couple of questions, if I may. So I have a question on guidance. So guidance kept 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 reported day points to that hemophilia was a strong driver, but refractory manufacturing phasing was a big part of that strength addition sustainable growth. So any guide on what the kind of underlying growth is in hemophilia in order to help us model this better?

[Guido Oelkers, executive]

Yes. Basically, with regard to the guidance and headwinds, I mean we will not have a [indiscernible] Business for Doptelet in Q2, and that's to the tune of SEK 600 million and other than this, there are other factors, as Henrik pointed out, on comparability will be more difficult to continue growing at the current growth rate, Gamifant simply because the base is getting larger, then there will be other factors. But at this stage, it's pretty early and we obviously hope that one day we'll become a driver. I think it's -- there will be a couple of factors, plus or minus. I don't think that we see now any major change to our portfolio as such but we want to make sure that we don't get ahead of ourselves at this point of time. So there are -- there's not -- Henrik pointed it out.

So there are small things that makes it a little bit more difficult, but we hope obviously also that this early stage portfolio is obviously making greater strides, I mean we were not surprised you despite the fact that we will not have any force 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 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 and the phasing of some of these tenders, but there is a strong -- still a strong underlying growth, which is driven by patient expansion.

And I think that will stay with us. And that there will be some erosion due to price as we move forward. But we don't expect anything that we should -- that we need to report here. So there are no significant shift as we had in the past. So we just think that this is at this stage, is more of a stable to single-digit growth business for us. And so in line with the previous discussions. So that's really how where we pack it -- so maybe we can then to the next -- Thank you, Viktor. Thanks for your interest.

[Operator]

The next question comes from the line of [indiscernible], Deutsche Bank.

[Unknown Analyst]

2 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 capacity pressure from [indiscernible] and secondly, given comments for acceleration through Q1, is it still realistic that Vonjo will hit about SEK 2 billion this year. What should we expect slower recovery in growth over the coming quarters?

[Guido Oelkers, executive]

Yes. Let's start with hemophilia. I mean, we, unfortunately, will not provide guidance on the percentage of the different components because it's a bit difficult. But I think if you take my earlier guidance into consideration, then I think you probably get a grasp direction of travel in this area. 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, we are quite reconfirmed our conviction by the recent announcement, of course, from Sanofi, demonstrating that this compound is in high demand but we just had 2 of our members here of the senior executive team members at WFH, and there's a lot of anticipation for Efanesoctocog alfa. So whilst we respect, obviously, [ Novo ] company that is a little bit larger than us.

I think we just need to acknowledge this, but in hemophilia, we don't think that we can be outscaled or [ amused ] by anybody. So we have come up with a very strong product, and we think that the Efanesoctocog alfa will make its pathway, and we think that this -- that the Novo compound will primarily compete with the other nonfactor product. And then time we will see. And obviously, they will have to show the Phase III results first. And then we'll see think about this newly -- with regard to [indiscernible] , we don't give product guidance now for the year. But what you can expect is 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 yes, I mean, we have to acknowledge that sometimes this growth doesn't come in line with our extrapolation on the spreadsheet.

It took a while until Aspaveli was material. And now with Vonjo -- but we are confident that we made the right acquisition and share we'll find -- we'll get a good return on this product. So we will but we are not giving you a guidance or steer yet on the sales of Vonjo. Maybe we go to the next -- sorry, -- so obviously, that would be interesting, but we don't guide on per product. So maybe we can go to the next question.

[Operator]

The next question comes from the line of Alistair Campbell.

[Alistair Campbell, analyst]

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 little more on that. Did you also ask in that piece of research. Physician's views on anemia and how the product stacks up on that basis? And maybe did you also ask how they look at the product versus [indiscernible] And any feedback competitive dynamic you're sensing between the 2 products there. And then if I could just turn to business development intentions, just a sense of 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?

[Guido Oelkers, executive]

Yes. 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 [ Vonjo ] and then the potential, but also was the question with regard to the market research potential.

[Alistair Campbell, analyst]

Yes. Just really trying to understand, obviously, you've been doing some market research looking at Vonjo. Just to get a sense if you got 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 [indiscernible] If you got that level of information.

[Guido Oelkers, executive]

No, we actually did -- I mean, as you would do, I mean, we did research, not [ only ] against [indiscernible] And for obviously, for Vonjo, but also understanding currently perceptions on [ Jakafi ] which is still serving the majority of patients. And I mean, basically, what 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 a little bit more than roughly 2/3 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 -- this messaging has been clarified.

In the past, the product is still good. And it has so many elements, effects on different receptors. That message was probably not clear enough, articulated. And also, we obviously have to clarify that the cytopenia is a severe issue and it's not going to get any easier over time. And we basically see a clear opportunity for the product, particularly for patients that are currently underdosed who can really benefit from the product profile. And in [indiscernible] probably had an advantage in this way that they had a simpler message and clear and had also a few years of probably solid premarketing that we have to catch up. So we did some introspection and we understand now what it takes. But sometimes, these things take some time. We believe in the product profile of Vonjo and that we can get the preference share in this segment that I described based on this research.

But we need to live after it. We work very consistently and to be honest, it takes just some time until we can cover the universe at scale. And 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 this, but we have a team that is extremely vigilant. And therefore, we are confident that we can solve this. With regard to [indiscernible] I mean, we want to demonstrate obviously that 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. Henrik has pointed out, leverage has come down. That gives us opportunities. We also see opportunities for funding, we have different means.

And we think that the company during the second half of this year may be ready for some activities on the external growth activities, whether it's a license or M&A, but that's part and parcel of our model. And while we are confident and it's really gratifying to see, I think, not only Vonjo the growth products, but also the endpoints that we will have this year that the portfolio is rejuvenating further and increasing with regard to this profile, but we believe that we will constantly improve this profile and rejuvenated. Thank you. Maybe we go to the next question.

[Operator]

The next question comes from the line of Christopher Uhde, SEB.

[Christopher Uhde, analyst]

And you mentioned that it takes time for Vonjo. But I guess how much time is the most salient question. So maybe I think it'd be really helpful if you could give more detail around and clarity around new patient starts or other launch metrics for Vonjo beyond just what happened in single month, given there can be volatility. And maybe 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 the force in 2023?

[Guido Oelkers, executive]

Thank you so much, Christopher. You make it was a 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 we -- let's put it this way. We -- when we looked at the different indicators, and obviously, they got a bit skewed because of this changeover from the [ Part D ] part in Q4 to this year. So we didn't have the strongest start in January as a consequence of this. But when we looked at the indicators, we looked at the feedback -- direct feedback we get from physicians and we obviously quite receptive to any sort of feed. We have quite a number of increased our activity level also materially as of Feb. We think that there is a correlation. Now when is it going to happen? I mean you have seen the report where we just said that we are more confident about Q2.

I think that I leave this up to you. I mean more we can probably cannot say let's say, the first we have to earn it, and we are not making our forward-looking statement by quarter. But that we are -- that we didn't buy this product to be flat line. I think it's also fair to say. So we want to grow it and we should experience growth. We know what consensus is. And we see this as a [ uptake ] to live up to this, but whether we achieve this, we will see. But we want to grow this product. And we -- and indicators tell us that it is on the card. With regard to the synergies restructuring, this was referring to the headcount. And maybe, Henrik, you want to add some additional flavor.

[Henrik Stenqvist, executive]

Yes. So it's sales and marketing headcount, and it means that we are now have commercial force of about 40 people working with Synagis going forward.

[Guido Oelkers, executive]

And we have given you guidance on how many people we used to have. So that gives you a little bit of a sense and 70% gives you another direction. Yes. Thank you, Christopher. Maybe move the next question.

[Operator]

The next question comes from the line of Harry Gillis with Berenberg.

[Harry Gillis, analyst]

So just one quickly on SG&A. Obviously, you mentioned that Q4 last year came in sort of was 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 cells in Altuviiio and whether those early sales are more likely to come from a [ lock ] to patients and then a greater proportion from other factor products? Or do you expect a high proportion of competitive products right from the beginning.

[Guido Oelkers, executive]

Yes. I mean, maybe I'll take the Altuviiio part and then Henrik can talk about how to think about the SG&A. So with regard to Altuviiio, I mean, obviously, 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 gives us another data point of robustness. Now we will launch, let's say, mid of year, which -- and we told you that in summer, European summer, it's not normally the easiest way to make sure that physicians and patients are meeting. And that switches can -- but we will launch anyway. I mean there is a lot of anticipation uncertainty.

The launch in Europe will be in Germany and then the other countries -- other country, U.K. following in the later part of the year. I think for us, beyond our sales because it will -- basically, some of these physicians see their patients once a year. 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 by the end of the year, we want to have at least a significant number of patients that are on the product. We are not yet guiding on what this number should look like.

But this is probably for more a marker for our success than being impressed now by significant sales numbers when we are aware of the Sanofi number until -- I mean it will take a while until we have all Europe reimbursed, given just the sequence of reimbursement process. So the real first launch here 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 should see them all the materiality in terms of sales. But we know that there's significant interest. And when you think about the sources of growth, historically, Sanofi gave some indication on what they were able to get from the [indiscernible] and let's say, in what they were able -- what they were switching from Elocta and from other sources. So we believe that clearly the vast majority will come from other sectors.

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 more -- it's a better product with a better product profile. And then there will be also -- we believe that nonfactor patients switching to Efanesoctocog alfa who will want to benefit from this. And I think historically, Sanofi guided around 10% of the patients. I'm not sure that it's 10% or more. We think that this is a very competitive product let's say, that is in the -- with our team that we should be able to take material share again yes, from a nonfactor as well. I think this is really what we can say. Maybe, Henrik, you want to give some guidance on SG&A.

[Henrik Stenqvist, executive]

Yes, on the phasing of SG&A of course, '24 will be different to '23, where we had the ramp-up of SG&A because of the acquisition of CTI and the efforts of Vonjo. Now this year, it's expected to be more of an even play with probably slightly lower spend in Q3, which is relatively speaking, a low activity quarter or lower activity quarter.

[Guido Oelkers, executive]

So maybe being [indiscernible] Time, we have 10 minutes, 2 more questions. And what I would propose is because I recognize that we may not be able to answer all questions that you otherwise contact [ Gador ] anybody else from our IR team. And we make sure that we can answer them your questions within the next couple of days anyway. Next question, please.

[Operator]

The next question comes from the line of Mattias Häggblom, Handelsbanken.

[Mattias Häggblom, analyst]

I have 2, please. So first, I'm sorry, I'm going to go through a try on volumes. So your guidance that we will see quarter-on-quarter growth in Q2 is not very aggressive after being down in Q4, now flat in Q1, but also taking into account what you said about March performance versus the average of Jan and February. So I'm going to try to push you again, using the March number you provided I get to roughly $12 million in revenue for March. So using that as a run rate to Q2, I get the $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.

[Guido Oelkers, executive]

Yes. No, I mean this is -- I know it would be interesting. I would love to help you out here. But first of all, we have to deliver it in the first place. And let's say, but we -- yes, we would be disappointed if we don't -- we cannot grow the product, very disappointed. But you know that is -- but we have to earn it. I mean I was also hoping that we could have shown some growth earlier. But I just have to acknowledge that it takes some time and that we have to come -- overcome a little bit of an inertia in a fragmented target audience but that is receptive. And once you spend enough time with key physicians to the differentiated profile of our product. And we have strong data, let's say, no. But it just takes some time. Yes. So apologies that I cannot give you the percentage, let's say, for the next quarter.

[Mattias Häggblom, analyst]

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 ReFacto franchise in your region, perhaps with a peak sales target in dollar terms like you did back in 2024 for select of your products at the Capital Markets Day. When Sanofi provided and implied tax sales potential of our 2-wheel contentious expectations moved accordingly at 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 see it translate into high consensus sales projections, at least not yet. So any thoughts on this would be helpful.

[Guido Oelkers, executive]

Yes. I mean we -- I mean what we -- I mean we obviously need to launch in the first place. But we always said this is a leader, leaders in the segment. And we think the leader is [indiscernible] , and we historically said up to 40%. And so it's not going to take it all. We gave guidance that Elocta in the space is around low 20s right now. And so that gives you a dimensional shift. And that basically means that over time, obviously, the share of Elocta will reduce. And basically -- and 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 can deduct this by what we're proposing.

And let's say -- so that basically -- the question is what is all the price evolution of this market. That's very difficult ones to predict. But that in our books, Efanesoctocog alfa is a much larger product than what we have today with Elocta, I think it has to be assumed that that's basically that will not be a surprise. But how much larger that we have not projected yet, and we have not done this for the group, but -- and we have been not doing this now for Efa. So I'm a little -- we probably this is as much guidance as we can give at this stage. We are keen to launch, yes. But and that means we believe that this is a growth franchise.

[Operator]

The next question comes from the line of Yifeng Liu, HSBC.

[Yifeng Liu, analyst]

I've got 2 very quick ones. The first one, could you briefly talk about the SEL-212 time line for regulatory submission and also whether you have intention to file elsewhere? Second question is on the Vonjo additional studies you presented in the call. I just wondered any R&D costs in the guidance of 2024. Are they implies guidance or -- sorry, in other words, are they baked in your guidance already, sorry.

[Guido Oelkers, executive]

I do the easy part of your question, and Lydia will do the tough part. And let's say, the easy part is, yes, the studies are in our guidance. We are not projecting anything that we have not budgeted for. And as a consequence, it's included. And basically, SEL- 212 is a global product and we see opportunities for this product outside of North America or outside of the U.S. And we launched it to how large the opportunity then will be, for instance, in Europe will depend on our discussions we see, different pricing authorities, we believe that there's a high unmet medical need outside of the U.S. Lydia, maybe you want to talk about the filing?

[Lydia Abad-Franch, executive]

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 time line. So still everything is on target for that. And yes.

[Guido Oelkers, executive]

Yes. I mean, maybe we have -- yes, 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 the swiftly. Thank you for your interest. So we don't -- as you can see, 20% doesn't feel so bad at the start into the year. So it makes us look forward to the following quarters. Thank you so much for your interest. Wish you a great day.

[Operator]

Ladies and gentlemen, the conference is now over. Thank you for choosing Chorus Call, and thank you for participating in the conference. You may now disconnect your lines. Goodbye.