Swedish Orphan Biovitrum AB (publ)

The conference will 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.

Yeah, thank you so much and welcome everybody. And 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 the statement as per usual. Today I'm joined by Henrik Sennquist, our chief financial officer, and Julia, our head of R&D and CMO. And in the Q&A session, we will have also Armin Greininger, our senior scientific advisor. Please go to the next slide. Good. I mean, you have seen the results this morning. I mean, the 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 880 million roughly of sales that we lost with synergies. So we're quite happy with the results from the offset. But due to this erosion of synergies, and it was not made up obviously fully by Fortis revenues, we had also a lower EBITDA margin. We will talk about this. So this previous year, when you think about, you know, our strategic portfolio, the strategic portfolio grew at 177%. This is our launch medicines and our new royalties that we received for our bisphortis and for our tubio. This is quite significant, and this is making up for around 140% of our growth despite the fact that we had a pretty good quarter with our hemophilia franchise as well. So, you know, and when you see the slide and all the growth rates here, I mean, it's very substantial for Dr. Lett. Come in front and it's nice to see materiality with Astavelli and Netavelli this quarter. We will talk about Wonju 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. 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 SEL212, and this increases our confidence around the product. We have positive Phase III data for Doctellate, and we had a positive CHMP opinion for first-line treatment of Aspavelli and Alpavelli. which is also helpful to 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 one or the other topic and foremost here that we will have no closing 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 course leader with 46%, hemophilia sales very positive, you know, positively influenced by some of the international business where we want some tenders, but also still strong growth in the more established markets. It makes us quite confident that we retain competitiveness in hemophilia, but overall hematology is the growth leader. Immunology impacted by the synergist development and specialty care in line with what we expected because this business is something that we manage for cash and earnings to support the growth in our core areas. When you look at the regions, Europe is growing very strongly with 15% based on the strategic growth portfolio but also supported by the growth in Australia. And the North American business is impacted by the erosion of still nitrogen. We are not adding here the royalties in the North American number If you would ask it to the yin and the yang, then this business would have done still very well. International being our goals leader and becoming material, so our strategy to diversify in countries beyond North America and Europe is starting to pay dividends. Next slide. spend a bit of time here to break out the strategic portfolio, which is really our work with company products plus the products that we have recently launched on this early stage of commercialization. And as you can see, these are pretty significant growth rates, and I think we talked about it, and if you exclude the frozen business for Doctella, 59% at this point in time, makes us very confident that we have also more goals for this product. Let's go to the next slide. And 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 also this quarter 35%. And if anything, that part will grow, while the foundation portfolio is also healthily growing, and this foundation portfolio does not include all the seed images, which is in the legacy portfolio. But the health figures of the company is strengthened over time. We pay 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 2.2, we will talk a little bit more about the opportunity and product respect in regard to this new material. You know, I was very, obviously, waiting for the nephrology indication to Google, sorry, for the page 3 database. And, you know, we believe that this is a material opportunity. And then, obviously, F&S Octocop Alpha, Antiportus. But we are also this top talent, you know, outside of the four regions. A lot of growth is still to come. And, yeah, we just launched in Japan. And, you know, great strides. There's still a lot of opportunity ahead of us in suicide fidelity. 540 is also an important gross driver. And just, you know, when you think about the R3 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. And the last, you know, for the season, which basically started in October last year to March, it's a three-year than roughly SEC region. I understand that you have difficulties to hear me. Is this correct? Can you hear me better now? And, you know, when you think about the season, so it's a 3 billion SEC season, started a bit late, so not a season as we are used to, but by no means, let's say, a reason for us to be less confident about RSV. Yeah, so maybe we move to the next slide. And, you know, here you can see the hematology franchise, how it's growing. It's an example of Doctelid. I think we talked about it. Next slide. Aspavelli and Pavelli, I'm quite happy with the acceleration of growth that we have seen in Q1. And, you know, we are now launching in more countries, Japan and Stream, you know, and becoming... sizable and more countries to come. We announced a joint venture in Korea and you would expect quite a bit from there until 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 Wonder Launch, I think one needs to add a couple of points. When you look at it, it has been 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 to bring these two organizations together, understand what needed to be done in terms of messaging, and strategy and basically, you know, and we were impacted as we outlined in our report by the Part D, meaning also unpaid patients at the crossover from last year to this year. And, you know, so it took us some time. What we have seen, and this is, I think, the best yardstick, And this is that 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, 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 January and February. And so we are confident about this product. It is not growing, you know, at the pace we want at this point of time, I mean, needless to say. but to the feedback that we get now and the indicators make us believe that we have, 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, is this a reason to change our perspective on the franchise? We think this is a stable, growing business, you know, and obviously we get a positive We got a part of this uplift for the reasons that I mentioned. This is an important franchise, and we can't wait to add FNS Octocock Alpha to this franchise. Next slide. This is the RSV season, and as you can see, 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. Started a bit late. And, you know, Bay Fortis obviously being a formidable product and there is an asymmetry between the value of a Bay Fortis patient obviously and synergies. 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 they're 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 Bay Fortis. And don't forget that over time, our royalty percentage is also increasing, so we should get it. a dual benefit from the increase of adoption, but also from the increase of our participation in the earnings stream. Next slide. Tami Fund's strategy is working out. We're very happy with the Q1, which is in line with previous quarters. But overall, 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 Gummy Fund. And hence, we are quite bullish about this product, even though it's sometimes quite difficult to predict given the small number of patients and the relatively high value per patient. And Kineret, very gratifying to see this now. They see evolution for the product and making good strides. And after we had to wash out 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 Hendrik, who will update you on the financials.

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 Nocta and Alperix, Dr. Letzesta Valley, and the additional Wonjo, 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 400 million SEC. So the decline in immunology is explained by the new situation in RSV with the launch of Bay Fortis and an earlier peak of the RSV season. Stimulus declined by 63%, and this was only partly compensated by royalty revenues from Bay Fortis in the quarter. But as the new dynamics settled in this market, we have a very positive view on the franchise, even if seasonal patterns of Bay Fortress royalties could differ from those we have had for synergies. And as you saw in the Q1 report, in order to adapt to a lower demand of synergies in the quarter, we took the unfortunate but necessary decision to reduce the synergies commercial organization by approximately 70%. So over to the table on the right, revenues reached almost 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 in 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. FT&A, excluding non-recurring costs, increased by 13%, mainly related to VONJO, which was not there in Q123, but also accelerated activities for launch products. R&D expenses, excluding non-recurring costs, increased by 24% at CER, mainly also due to the addition of VONJO, but also the filing activities for SAL212. The non-recurring costs or items affecting comparability amounted to $155 million in quarter. This resulted from cost related to the integration of CTI of 42 million as well as the restructuring of the synergies commercial organization which I just mentioned amounting to 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. And 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 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 18 billion, a reduction from 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 the next slide, please. Add 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 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 Bonjo, including, of course, the full year impact, the launch product Stop to Let, Aspa Valley, and Gamifunds, and the royalties for May 40s. 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 2 billion, growth of about 15% at CER. This was driven in part by facing of international orders. And due to the facing 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 0.6 billion sales of Dobson to China in Q2-23. And as you probably know, we don't expect any further sales of Dobson to China at this stage. We still expect material growth in our ex-China Dobson sales for the rest of the year. But the growth rates will be impacted by the China sales from Q2-23. And third, Gamifan saw a significant step up in sales in Q2-23 to more than 400 million SEC, 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 in Q1, and there will be no more sales of refactos moving forward. So with the outlook covered, I will now hand over to Lydia. Thank you.

Thank you, Henrik, and hello, everyone. So let's start with the pipeline milestone from the next slide, please. We continued our steady pipeline progress in the first quarter. In hematology, Doctelet is advancing in the pediatric ITP indication, and I will come to this in a minute. Astabeli received positive CHMP opinion for the first-line treatment in PNH. And last week, the Committee of Orphan Medicinal Products confirmed the orphan drug designation. We terminated the colaglutinin disease program for Aspabelli as communicated in February. Our immunology portfolio continues to advance this quarter in U.S. and China. Cell 212 received fast-track designation from FDA, and we are on track to submit the BLA filing for chronic respiratory gout. Kineret received approval for a SEALS disease by the Chinese National Medical Product Administration, and this indication is the largest of the three that we have applied in China. Next slide, please. Looking closer at the Doctelet 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. 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 EMA. Next slide, please. Let's look now into the excitement development surrounding pacretinib, which rapidly emerges as a backbone of myelofibrosis treatment with potential benefit also in other indications. Our strong belief in pacretinib is guided by a clear scientific rationale and existing unmet medical needs in MS. Cytopenias are a common feature of progressing myelofibrosis. With anemia being a common and challenging complication, often as an anticipating 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 pacretinib. The National Comprehensive Cancer Network, NCCM, has set forth guidelines that endorse pacretinib as a first-line treatment option, not only for MS patients with severe thrombocytopenia, but also as a potential option for high-risk patients regardless of platelet count. In addition, they now include pacretinib as a potential treatment option in patients with myelofibrosis-associated anemia. Pacretinib is increasingly seen as a differentiated agent in MS due to its unique mechanism of action as a JAK2R1 and ACBR1 inhibitor targeting multiple disease pathways. Additionally, it offers benefits, anemia benefits, likely related to ABCR1 inhibition. We're also getting an important stream of requests for exploring further uses of pacretinib in other indications beyond MS. Next slide, please. So we have convincing evidence to support the clinical value of pacretinib in chronic myeloma fibrosis. Pacretinib 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 count, and we see an anemia benefit. Next slide, please. So our strategy for MF is designed to differentiate pacretinib 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 pacretinib's mode of action. And we continue to strengthen the clinical evidence for pacretinib in MF. Of particular interest for investigators is pacretinib efficacy for combination therapies. An example is pacritinib as a potential add-on to salinexor monotherapy in JAK inhibitor-naive participants, which SOVI supports. Besides 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-phase myelofibrosis, and its role in improving cytopenia 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 pacretinib 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, CMNL, Waldstrom myelodysplasia, and T-cell lymphoma. Other hematoinflammatory diseases with potential use include recently published preclinical data in Castelmans disease and new clinical trials in Castelmans as well as chronic RAP versus Holtz disease. As with myelofibrosis, We are in a number of discussions with investigators to support further studies in other hematoinflammatory conditions. Next slide, please. Our news outlook remains strong. The CHMP is meeting these days to adopt an opinion on efamisoctococcalpha. So we anticipate sharing news very soon. As mentioned earlier, we plan to submit cell 212 in chronic refractory gout. in the U.S., now with the backing of the fast track designation. And we plan to submit full refund in secondary HLH for macrophage activation syndrome in still disease in the second half of the year. DOPTELIS 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 DOPTELIS in ITP and a submission in Japan. And with that, I would like to hand back to Guido.

Thank you, Julia. 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 growth portfolio, strategic portfolio, 12% earning growth, And clearly what you do remember is that we are very confident now or increased confidence around SEL212 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 upsides. 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 opened 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 1 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 1 at this time. Our first question comes from the line of Victor Sundberg with Nordea. Please go ahead.

Yes, hi. Victor 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 points to that hemophilia was a strong driver, but refractory manufacturing phasing was a big part of that strength, which is a 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 Fosun business for Dr. Lett in Q2. And that's to the tune of 600 million sec. And then other than this, you know, there are other factors as Henrik pointed out on comparability. will be more difficult to continue growing at the current growth rate, GAMIFund, simply because the base is getting larger. Then, you know, there will be other factors. But, you know, at this stage, it's pretty early. And we obviously hope that, you know, Wonjo will become a driver. I think 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, you know, we want to make sure that we don't get ahead of ourselves at this point of time. So, you know, there's not, you know, Henrik 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 in spite of the fact that we will not have any FOSM business for Dr. Lett, we still want to go 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 Alpolix has grown roughly around 15% versus previous year. And this was positively impacted by some of the international business and the facing 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 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 is 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 where we pick it. So maybe we move then to the next question. Thank you, Victoria. Thanks for your interest.

The next question comes from the line of Henrietta Berg, Deutsche Bank. Please go ahead.

Thank you. Yeah, two questions for me, please. The first on haemophilia. 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 MIMEI? And secondly, given comments for acceleration through Q1, is it still realistic that Bondo will hit about 2 billion this year? Or should we expect a recovery in growth over the coming quarters? Thank you.

Yeah, let's start with Simphilia. I mean, we unfortunately will not provide guidance 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... to get a grasp on the 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 FNS-Oxacog IFA launch. If nothing else, we have quite reconfirmed our conviction by the recent announcement, of course, from Sanofi, demonstrating that this compound is in high demand. But we just had two of our members here of the senior executive team members at WFH, and there's a lot of anticipation for F&S OctoCock Alpha, so why do we respect, obviously, a 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 out-muscled by anybody. So we have come up with a very strong product and we think that the FNS OctoCock RFM will make its pathway and we think that the Novo Compound will primarily compete with the other non-factor product and then time will see. We will see and obviously they will have to show their phase three results first and then we'll think about this newly. With regard to Wonjo, 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. We have to acknowledge that sometimes this growth doesn't come in line with our extrapolation on a spreadsheet. It took a while until Asper Belli was material, And now with Wanzhou, it will, you know, but we are confident that we made the right acquisition and shareholders will find that we'll get a good return on this product. So we will, but, you know, we are not giving you a guidance or steer yet on the sales of Wanzhou. Maybe we go to the next, sorry, after us, obviously, that would be interesting, but we don't guide on a 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. May I just ask a bit more on that? Did you also ask in that piece of research physicians use on anemia and how the product stacks up on that basis? And maybe did you also ask how they look at the product versus Ajara and any feedback and sort of the 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 Vonjur 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. Excuse me, the first part of your question was difficult to understand. I think it could have been a connection or maybe from our end, but could you repeat that first question? I mean, it was OJAR and then BD potential, but what was the first question with regard to the market research potential?

Yeah, just really trying to understand. Obviously, you've been doing some market research looking at Vonjo. Just to get a sense 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 Ojarra, if you've got that level of information.

We actually did, as you would do, I mean, we did research not only against Ojarra and obviously for Vonjo, but also understanding currently perceptions on Jakafi, which is still serving the majority of patients. And 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 end line with physicians' recommendations. One drew for, you know, a little bit more than 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 messaging has been clarified. In the past, the product is so good, and it has so many elements and 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, you know, see a clear opportunity for the product, particularly for patients that are currently underdosed who can really benefit from the product profile. And, you know, and Yojira probably had an advantage in this way that they had a simpler message and clear and, you know, had also a few years of experience 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 Bonjo and, you know, that we can get the preference share in this segment that I described 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 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 BD, I mean, we want to demonstrate, obviously, that it was the right decision to acquire HCTi. 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. It gives us opportunities. We also see opportunities for funding via different means. And we think that the company, 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 once we are confident, you know, and it's really gratifying to see, I think, not only, you know, Wando, 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 this profile, but we believe that we will constantly improve this profile and rejuvenate it. Thank you. Maybe we go to the next question.

The next question comes from Christopher Ude, SEB. Please go ahead.

Yeah, thanks. 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 would be really helpful if you could give more detail around and clarity around the new patient starts or other launch metrics for Vonjo beyond just what happened in a 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 Synergis 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? Thank you.

Yeah. Thank you so much, Christopher. 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 put it this way. 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, 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 feedback, direct feedback we get from physicians and we obviously quite, you know, receptive to any sort of feedback. We have quite a number of, we've 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 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 it's also fair to say we want to grow it and we should experience growth. We know what consensus is and we see this as a yardstick to live up to this. But whether we achieve this, we'll see. But we want to grow this product and indicators tell us that it is on the cards. With regard to the Synergist restructuring, this was referring to the headcount. And maybe, Henrik, you want to add some additional flavor?

Yeah, so it's SELSA marketing headcount, and it means that we now have a commercial force of about 40 people working with Synergist going forward.

Yeah, and we have given you guidance on how many people we used to have. So that gives you a little bit of a sense, you know, and 70% gives you another direction, I hope. 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.

Thank you for taking the questions. So just one quickly on SG&A. Obviously, you mentioned that Q4 last year came in sort of 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 Altuvio launch, I just wanted to ask how we should think about the initial conversion of patients or the initial sales in Altuvio 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 Artuvio part, and then Henry can talk about how to think about SG&A. So with regard to Artuvio, 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 the trials that were ongoing and the patient experience and physicians who have We have seen obviously the data point from Sanofi, which gives us another data point of robustness. Now, we will launch, let's say, mid of year, 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. We will launch anyway, and there is a lot of anticipation of this. The launch in Europe will be in Germany, and then another country, the UK, following in the later part of the year. I think for us, beyond now sales, because 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 more of a marker for our success than being impressed now by significant sales numbers. We are aware of the Sanofi number. It will take a while until we have all Europe reimbursed, given just the sequence of reimbursement process. 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 know you could 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 the Libra and and let's say 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 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 more, it's a better product with a better product profile. And then there will be also, we believe that, you know, non-factor patients switching to FNS octococcal alpha 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 with our team that we should be able to take material share again. Yeah, from non-factor as well. I think this is really what we can say. Maybe, Henrik, you want to give some guides on SG&A?

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

So maybe being focused 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 us, Jared or anybody else from our IR team. And we make sure that we can answer your questions within the next couple of days anyway. Next question, please.

The next question comes from . 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 bond yields. 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 of it, 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 volume. 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. But here's that, you know, I would love to help you out here, but... First of all, we have to deliver it in the first place. Let's say we would be disappointed if we cannot grow the product. Very disappointed, but we have to earn it. I was also hoping that we could have shown some growth earlier, but you 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 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, but it just takes some time. 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 VIII franchise in your region, perhaps with a peak sales target in dollar terms like you did back in 2020 for select of your products at the Capital Markets Day? Yeah. When Sanofi provided an implied peak sales potential, our two real 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 head projections, at least not yet. So, 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 say, you know, this, this is a leader, leaders in the segment. And we think a leader is, you know, between 30, 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. That gives you a dimensional shift and that basically means that over time, obviously the share of Elocta will reduce 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 that basically Now the question 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, evidence of the coca-alpha 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 That we have not projected yet, and we have not done this for the group, and we are not doing this now for AFA. So probably this is as much guidance as we can give at this stage. We are keen to launch. And that means we believe that this is a growth franchise. Thank you, Matthias. Next question.

The next question comes from the line of Yifan Liu, HSBC. Please go ahead.

Hi, hi. Thanks for taking my question. I've got two very quick ones. The first one, could you briefly talk about SEL212 timeline for regulatory submission and also whether you have intention to file elsewhere? Second question is on these, Vong Zhou's additional studies you presented in the call. I just wonder, any... R&D costs in the guidance in 2024? Are they baked in your guidance already?

I do the easy part of your questions and Lydia will do the tough part. 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, you know, it's included. And basically, and SEL212 is a global product. And we see opportunities for this product outside of North America or outside of the U.S. And we launch it to 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 medical need also outside of Julia, 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 flash track designation, I think that that's going to support our submission timeline. So still everything is on target for that. Yeah.

Very good.

Thanks so much.

Thank you. 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. As you can see, 20% doesn't feel so bad as a 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.

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