Swedish Orphan Biovitrum AB (publ) / Earnings Calls / April 29, 2025

    Operator

    Welcome to the Sobi Q1 2025, report, conference call and live webcast. I'm Sandra the conference call operator. [Operator Instructions]. At this time, it's my pleasure to hand over to Guido Oelkers, CEO. Please go ahead, sir.

    Guido Oelkers

    Thank you. Sandra, hello everyone. This is Guido Oelkers CEO of Sobi. We are delighted to welcome you to the first quarter video conference of 2025 call for investors and analysts. We posted this presentation to sobi.com earlier today, and you know, straight to the forward looking statement, we would like to remind you of the usual provisions on the statement about expectations, projections or future events. Unlike stated otherwise, we will be making comments that most relate to the first quarter at constant exchange rate in million Swedish krona. Let's move to the agenda, and today, we plan to cover the following key aspects of the Q1 report. I'm joined by Henrik Stenqvist, our CFO, and Lydia Abad-Franch, Head of R&D, and Chief Medical Officer. We plan to review the presentation first and then have Q&A until around 4

    30 Swedish time. For those on the phone, please join the queue for questions by pressing star one, we propose that you only ask one maximum two questions at a time. Let's go to slide number four. I mean, we, as you have seen, you know, this has been a pretty strong quarter with solid performance that we started in 2025 you know. And the stats are as follows, you know, 3% total growth, but we will talk more a little bit about it, and an EBITDA margin of 36% but the portfolio grew 23% if you exclude the RSV seasonal product and the discontinued refactor manufacturing revenues. This reflects a solid performance across the strategic portfolio that grew at 46% is now close to 50% of our entire business. And hematology was driven by continued growth of top talent, Aspaveli and the launch of auto worked, and that generated 455 million in the first quarter. We continue to build and deliver on our clinical development milestones, and look forward to seeing the progress of our pipeline with the exciting potential for Gamifant and Aspaveli. And you know, when you go a little bit more deeper into the different business areas, you know, obviously we look forward to continue driving the out of work launch. We'll talk more about it. And you know, when you think about, you know, immunology, and also a little bit more later, I mean, Gamifant, with over 30% in kinder, it have performed extremely well. So in terms of pipeline, I think, you know, we our progress with filing Gamifant for HLH MAs and still disease in the US, receiving a priority review with the PDUFA date late June was clearly a highlight. And Aspaveli, was submitted to EMA [ph] for the potential treatment of C, 3g, and ICMPG and we'll continue the discussion with health authorities, and look forward to bringing this product to the market pretty soon. And so overall, it's a combination of strong business momentum whilst hitting important milestones in development and filing. Let's move to slide number 5, and just when we go look into the performance in more detail, as you can see here, by business area, very strong momentum in hematology, hemophilia here, slightly reduced by. The discontinuation of the manufacturing. But you know, when you think about hemophilia, a products growing at 29%. I think this speaks for them, for itself, and immunology, let's say down, but if you take away the synergist sales that we have now consolidated de facto in Q1 due to the change, due to the obviously incoming by 40s, no, basically, immunology is growing over 20% and this shows you know that there's robustness across board. When you think about, you know, the geographic split Europe having obviously a fantastic quarter with 19% and if you take away the synergist effect on North America growing at 24% and international at 38%. I mean, these are very strong numbers and speak for a very strong commercial execution. Let's move to the next slide number 6, focusing more a bit on the portfolio and, you know, and I, I just like to highlight, you know, the performance of auto work, the performance of Doppler with 47% the performance of Aspaveli was 39 the performance of Kineret with 16% and the performance of gummy one with 31 so very strong quarter, and we'll talk about, you know, the performance of one joint in a moment. So let's move to the next slide and a more specific review by product. We are pleased with the continued strong growth of Ultra Vac and, you know, the rapid adoption in quite a few markets, but foremost in in Germany, and there, we have achieved a market share position of 57% after nine months in within the launch phase. And you know, this shows you know what is possible with this product. This is over 24% market share gained within the space of time. And you know, we and we see very promising trends also in other markets. So we look forward to bringing this important medicine to more markets across Europe and other so be territories. Let's move to Aspaveli. And you know, rights we are facing with us by value, obviously, quite a bit of competition from new Orle medicines. We continue seeing significant growth. And you can see that we had a pretty strong Q1 and this is more primarily driven by progress in international markets. But I think the, as we always said, you know, the primary story for us is really about the nephrology indication that we are looking forward to, and, you know, and, and, and we are very keen now, let's say, to bring this product to the market, because the combination of very significant reduction in proteinuria, clearance of C3 staining and from the kidney in high percentage of patients, and the stabilization of EGFR at the at such an early point of time, make us really excited. And, you know, make us believe that this is an important product for in those two indications. So we look forward to working with the regulatory authorities to move this forward in parallel and being, let's say, building an inter internal infrastructure in nephrology to prepare the launch. And this is what we are currently doing across the organization. Let's talk about Vonjo, you know, and so the demand for one job grew quarter on quarter, even though, you know, you see here a minus six in q1 versus previous year. Let's say, however, you know, these sales were pretty much impacted primarily by stocking and partially by gross to net adjustment, including Medicare Part D reform in the US, and this led to a decline of six, 6% in revenues. And we aim to resolve this in the coming quarters. Our ambition remains unchanged in our near term focus to continue growing in myelofibrosis, leverage the guidelines, the NCCN guidelines, and ultimately see growth outside of the restricted area of below 50,000 plate lengths that we have on label. So and you know the growth strategy is more explicit than on the next slide. So as you can see, you know, our glass for one year is clearly not even half full, and there's clearly a thirst for expansion. So looking at over, looking at Vonjo overall. We still see significant potential to be unlocked in my fibrosis. But Leo realized also that leapfrogging in terms of performance will really take a change of guidelines and label expansion, and we are working on this. This year will be will launch in some of the additional smaller countries outside of the US, but ultimately, we need the Pacifica phase three study for both full approval in the US and filing in Europe and Japan. The next step is also to broaden the use of Vonjo. And we have started, you know, a phase three study for Vonjo assessing its potential in vectors. And let's an area with currently no approved treatments, and we have a strategy with CMML, and we believe that there's a very strong mechanistic rationale for one during the space and there's also broad overlap of prescribers with myelofibrosis. So let's move to Beyfortus, As the headline describes. Beyfortus Now follows much more the seasons of or the seasonal sales pattern of vaccines. And, you know, and as, as illustrated in the graph, the sales predominantly occur in Q3 and Q4 and you know, this is new for us at so we because, you know, it with synergies. We obviously had also always a very strong q1 but given that this product is only given once a season and not five times. Obviously, the sales pattern has changed, so important to note that our share of sales of by 40s goes from 25% in 2024 by a tiered rate starting this year until 28% reaching a range of 30% to 35% of net sales beyond 2028 the royalty rates will remain fixed at these levels. So, you know, we obviously here very much dependent on the performance of Sanofi but for us, you know, we, we may be benefiting not only from the business growth, but also from a royalty improvement. So let's move to immunology and to Kineret and Gamifant and you know, and as the headline suggests, you know, our immunology review revenues grew 22% in q1 when you exclude the RSV revenues. So outside of RSV in immunology, both Kineret and Gamifant have shown strong and sustained performance. Gamifant continues to exhibit significant growth despite high penetration the primary HLH market, and we are looking very much forward to the launch of secondary HLH indication with a regulatory decision to be expected by the end of June. So far, we have seen no delays and the filing spares all on track to meet the PDUFA date of June 27. Let's move to the next slide. So when you think about, you know us or so be moving into the future, I think it's nice to just think of a very simple Formula, 234, because when you think about us right now, you have two major launches ongoing, one of them displaying exuberant growth. With Ultra rock, as you have seen, one Jew still. You know, we have some work cut out for it. But we have very important filings ongoing with Gamifant, entering secondary HLH, With Aspaveli, let's say entering into, or we have filed for the really primary indication for us in nephrology, in the two nephrology indications and Nast, which will be also very material product to us, as we believe, in chronic refractory guard. And then we have four projects in development, and here we taking a stand that we take our existing compounds into settings of high unmet medical need, into IDS, interferon gamma, given sepsis, into one [indiscernible] into CMML and taking [indiscernible] [Technical Difficulty] [Audio Gap] affected by the loss of lower margin refactor sales as well as product and country mix in various products, and it was partially upset, offset by lower RSV sales and royalties. And I said the adjusted beta margin reached 36% compared to 37% last year. Looking at operating expenses for the quarter, we observed an 8% growth at CER compared to the same period in 2024. SG&A, excluding non-recurring items and amortization, increased by 10% at CER in the quarter, driven by launch and pre-launch costs for Altuvoct, Aspaveli, Nephrology and NASP. R&D expenses increased by 3% at CER excluding non-recurring items, mainly due to post approval activities for Altuvoct and development programs in Gamifant and [indiscernible], we now see lower costs in NASP related programs compared to in 2024. Operating cash flow for the quarter was 2.3 billion, slightly more than in June 2024. Net debt continues to go down, ending the quarter at 12.7 billion, corresponding to the net debt to EBITDA ratio of 1.3 times compared to 1.6 times at the end of the previous quarter. So please turn to slide 16 and financial outlook for the full year 2025 as usual. This outlook is based on revenue growth at constant exchange rates and adjusted EBITDA margin. For the full year 2025 our outlook is unchanged. We anticipate revenue to grow by a high single digit percentage at CER, and an adjusted the data margin in the mid-30s, percentage of revenue. On the revenue guidance, the drivers are the same as when we presented this guidance in connection with the Q4 release first for Altuvoct, we've seen a strong launch in Germany and Switzerland. Early launch sales in Spain, and we look forward to continuing to launch the product into new markets in 2025. We also expect continued progress with our existing commercial portfolio, and we continue to expect a strong contribution from the Fortis royalties, although this is a factor where we do not control the outcome ourselves. In regards to our data margin guidance, we will start to ramp up investments in our pre-launch assets, specifically NASP and Aspaveli in nephrology, starting later this year. In R&D. We will also continue with post approval studies for Altuvoct and new studies for Vonjo [indiscernible] and CMML, as well as the registration of Air Force for Aspaveli, Gamifant and NASP. Please turn to slide 17. And finally, I wanted to spend a few minutes on currency exposure on our P&L considering the recent appreciation of the Swedish krona, the chart gives an illustrative view on our exposure and the split between currencies for revenue, as well as OpEx and COGS. Our revenue is dominated by sales in us, dollars and euros, with only a minimal share in Swedish krona. So anytime there is a currency movement, this will have an almost one to one impact on revenue in SEK. The cost of goods sold and OpEx, around 15% to 20% is in SEK, with the remainder primarily in dollars and euros, and this means that the impact from currency movements on a beta would be slightly larger, relatively speaking, than the impact on revenue due to the cost we have SEK. In fact, overall, the absolute numbers of revenue and costs will fluctuate with currency movements, but the EBITDA margin is relatively protected from changes in FX rates due to the natural hedging that comes from the composition of currencies in our business. With that, I hand over to Lydia. Thank you.

    Lydia Abad-Franch

    Thank you, Henrik, and hello everyone. We will start with the pipeline milestones on the next slide, please, and can you move to the next slide please. Thank you. We have a very productive first quarter, seeing important regulatory filings and clinical progress. In February, we successfully submitted the EU application for us. Aspaveli in C3g and ICMPGN, which has since been confirmed by EMA, and it's now making steady progress. Gamihan received FDA priority review for our HLH mas us application with a PDUFA date at the end of June, On the clinical side, we initiated a research collaboration to explore Gamifant from in interferon gamma driven sepsis, also known as IDS, the [indiscernible] in hemophilia started enrolling patients, and the next as proof of concept study with pacritinib, which we discussed at the last quarterly call, is starting up. Finally, our Japanese study with Kineret still deliver positive top line data, paving the way for a submission later in the year. As Guido said, we are maximizing the opportunities to innovate and expand the use cases for our medicines, the synovitis and the IDs. Sepsis studies demonstrate this well, so I would like to explain them a bit more in depth. Next slide, please. Thanks. Starting with Gamifant, interferon gamma driven sepsis, which could address a significant unmet medical need with important burden to healthcare systems. Sepsis is a life threatening medical condition which arises when the body's response to infection causes injury to its own tissues and organs. This can lead to shock, multi organ failure, disability and death, especially if it's not recognized early and treated promptly. It is a leading cause of death worldwide, responsible for about one in five deaths. Almost 50 million people suffer from this condition, and 14 million died from it. It also leads to high health care costs with an estimated $60 billion in the US alone. Recently, an endo type of sepsis has been identified, which is characterized by elevated interferon gamma and CX CL nine, referred to as interferon gamma driven sepsis IDs. This endotype represents an increased risk for 28 day mortality, irrespective of the type of infection, comorbidities or organ dysfunction. Since [indiscernible] neutralizes interferon gamma and block signaling that leads to hyperinflammation, we have initiated a research collaboration with the Hellenic Institute for the Study of Sepsis, the phase two a embrace proof of concept study in patients with IDs will explore if [indiscernible] can improve outcomes in IDs. The study has started, is actively enrolling, and the first patients have been dose. It has two treatment arms and one placebo arm each with 295 patients, and we expect top line data in the second half of this year which will inform next steps for this indication. Next slide, please. The China Study for Altuvoct in patients with synovitis is building on the ability of Ultrabook to maintain factory levels in the non-hemophilia range for most of the week. This changes the treatment paradigm for this chronic condition, allowing for unprecedented levels of protection. Increasingly targeting non hemophilia levels is seen as achievable and recommended, for example, by the German Society of thrombosis and hemostasis. Joint Health is becoming a focus. It is a key concern for hemophilia patients and their physicians, because most patients experience joint deteriorations from microbleeds, which cannot heal without adequate hemostasis. In hemophilia patients, bleeding inside a joint lead to blood accumulation in the joint space. This repeated bleeding irritates the lining of the joint called synovium. It becomes inflamed and thickened over time. And treated synovitis involves two irreversible chronic arthropathy, and between 22 and 55% of people on prophylactic treatment have synovitis, making it the most common complication in hemophilia. The medical community is very keen to know if the high, sustained factory levels provided by Altuvoct can contribute to prevent and improve synovitis and joint damage. The shine study aims to analyze 100 joints with synovial hypertrophy from approximately 35 patients. Additionally, our partner, Sanofi is conducting a twin study in their territories with the same setup, allowing us to perform post hoc analysis with combined data from the two studies and evaluate up to 200 joints with synovial heat parasitic Next slide please. So looking ahead, we continue to be busy with the submissions to the major regulatory agencies, FDA, Ema and PMDA for our key assets, Gamifant, Aspaveli and Nast in the US. The focus will be on the approval of Gamifant for HLH mas in steel species, and on finalizing the submission of NAS for uncontrolled gout in Europe, the focus will be on the approval of Aspaveli for the nephrology indications, C3g, and ICMPGN. And in Japan, we will be submitting three dossiers game for HLH mass in a stealth disease, kidnapped in a stealth disease. And Aspaveli for the nephrology indications, the Aspaveli submission in Japan will now include the 52 week data, which moves the submission timeline to the second half of this year. And with that, I would like to hand back to Guido Next slide, please.

    Guido Oelkers

    So hi, yeah, thanks. Really, I mean, and let's go straight to the summary. You know, as you can see, you know, we were very pleased with service development. During the first quarter, we saw significant top line growth of 23% excluding the seasonal RSV revenues and the final manufacturing sales from q1 last year, the overall strategic portfolio is delivering well and growing at 46% our R&D pipeline has shown tremendous progress with the continued successful Launch of out of work in Europe, the filing and granting of a priority review for Gamifant in the US for secondary HL age and the filing of in the EU for us by valiant nephrology. We will continue this pace with the planned completion of the Nast filing of uncontrolled guard in the US by q2 building on these, we have four areas that we are going to leverage in our portfolio with the studies, as you just saw, in synovitis, in hemophilia, interferon gamma, sepsis, gamma del sepsis, vexes and CMML. This will open tremendous opportunities for so will be in the coming years. And we are actively preparing of these new launches in 2025 and continuing the expansion of ongoing launches with the strategic portfolio products. We have some momentum in this business, in our business, and obviously momentum also in the pipeline development. And we are continuing, looking forward to continue this journey with our colleagues and stakeholders around the globe. And now please move to slide number 23. We now open the floor for questions. [Operator Instructions].

    Operator

    [Operator Instructions]. The first question comes from Shirley Chen from Barclays Bank.

    Shirley Chen

    Hi, thanks for taking my question. Congratulations on Altuvoct to achieve 57% share in Germany. Just wondering if this would adjust your expectations for the market share of Altuvoct in haemophilia market a market across Europe? And also, can you perhaps share some initial feedback from Switzerland and Spain markets? Thank you so much.

    Guido Oelkers

    Yeah, thank you. I mean the 50% sorry, it should be precise, includes also a locked, wider majority now coming, the vast majority coming from I to work. So it's our hemophilia, a share primarily driven by out of work, and the 24% gain on the haemophilia class in Germany, is driven, obviously, by by the out of work expansion. But, you know, is this now an example? I mean the the launch successes in Switzerland also look very promising, you know. And in fact, the trajectory doesn't, you know, it's earlier, but it doesn't look less impressive, just less. There's a lower number, obviously, of patients in in Switzerland, in Germany, and, you know, in Spain, it will take it. We have some very strong signaling already, but it takes a little bit of time, because you need to get the reimbursement accepted by the regions. And this is currently ongoing, but we are very optimistic that, you know, I mean, 57% is very strong. This is ahead of our expectations. To be quite, quite frank. I mean, we always said 30 to 40 would be a good ambition on a consolidated share. As you can see. You know, we can break through this, but it is. We'll have to see whether this is already indicative. That's not this high number, but, uh, but I'm sure that, you know, our country managers and other countries don't work, don't, don't to look too shy. But you know, if anything, you know, we are more confident about the product in our in our territory.

    Operator

    The next question comes from Mattias Haggblom from Handelsbanken.

    Mattias Haggblom

    Two questions, please. So firstly, your partner, Sanofi stated last week that, due to lower immunization rates in the US during Q1 before to shift in Q4 may be stored and used for RSVCS in 25-26 so question goes, as your partner quantified the [indiscernible] they think remains in stock, and how, if at all, has that informed your outlook for '25 and then secondly, if you could remind us of your appetite for M&A in light of the very rapidly deleveraging balance sheet. And if there is appetite, what profiles are you looking for? And if there is no appetite, why not? Thanks so much.

    Guido Oelkers

    Yeah, thank you, Matthias for the two questions. So the first one, I mean, you know, basically our annual ambition for the product is unchanged because, you know, we have also no indication from Sanofi that they revised their annual ambition. Yes, they stock, but, you know, the essay pointed will out, but you know, frankly, I mean, we know this from, from our own experience, you know, there's always an overhang of stock in the trade and then the question is, can this be digested and at what rate? But you know, the fact remains, you know that the majority of the sales are there, you know, but not very long ago, I think Sanofi mentioned also that, you know, given the relatively low immunization last year, 55% - 60% Let's say they feed us as a growth opportunity will have to find out, you know, in this environment, how this works. We feel reasonably insulated, given the Dow so royalty rate is going to increase, so we'll figure, we'll figure, but we have no indication from Sanofi in this, let's say, to dampen our expectations for the year. And one has to say also that you know, Sanofi can only share things with us within reason, yeah. I mean, given the residual competitiveness with synergies, and with regard to M and A, you know, it would surprise you that we are very vigilant right now and thinking how we can intelligently expand. I mean, use. See from the portfolio that we have, that we have quite a bit to do now, very near term, and, you know, and therefore we are now thinking how we can develop the company, you know, on a going concern basis, also into the mid in longer term, and looking for products that are, you know, giving us leverage and are suitable to our existing portfolio and this process is ongoing, and we're looking currently for various opportunities.

    Operator

    The next question comes from Christopher Uhde from SEB.

    Christopher Uhde

    Thanks for taking my questions. I think my thing I'm wondering most about is, what are the gating factors for launching Altuvoct in France and UK? Now left. That's my first and my second is just with Aspaveli competition. We saw this kind of, I mean, decent performance last quarter, but definitely missed expectations now, well ahead of expectations and very good growth. How should we think about the dynamics in P&H and let's say, are there specific patient groups where you feel or niches where you feel more, I don't know, insulated or stronger relative to the competition, could we see price pressure, or was that a factor in Q4 '24? Thank you.

    Guido Oelkers

    Yeah. Thank you. Christopher, so maybe, with regard to the easy one, yeah, no. In the UK, we are currently operationalizing this. We have got their positive [indiscernible] working on this now, we don't see there any more problems. And in France, we are in active discussion with the transparency commission and to resolve this and look forward to a launch during the course of this year. But we don't want to be put under, you know, don't want to put under ourselves, under too much pressure, because, you know, we have strong momentum in any case, and we have enough countries currently on the plate already. But you know, we want to launch, obviously, in line in France, and to make this product available everywhere, but in our territory, as far as Aspaveli is concerned, yeah, it's good that, as you see, you know, we had a pretty satisfactory Q1 I mean, primarily, let's say, you know, driven by the launch in, by the launches in the International region. And what we can see is also that we are now getting, also patients back from the orals, because it seems you know that sometimes you know, a more central, you know, effect on the C3 inhibition for certain patients, not for all, may be more beneficial than to be more proximal and, you know, but we have not yet deciphered, you know, major patterns, but we know that the product is is very suitable. And we also think you know that the launch, you know, by by end of the year in various countries of the new device will make the administration easier, take away the burden of administration and will make will strengthen our competitive offering in P&H.

    Operator

    The next question comes from Harry Gillis from Berenberg

    Harry Gillis

    Thank you for taking the questions. You mentioned some operational improvements relating to Bonjour. I was just wondering if you could please expand on those and what they entail as perhaps some of some of the measures you're taking to help drive growth of that product. And then just a quick one on the gamma indication expansion. So obviously the doofus end of June. Just wondering, should we see some sort of sales inflection in the second half of this year? Will this be more of a gradual increase over the next couple of years? Thank you.

    Guido Oelkers

    Thank you. You know. Let's start with operationally, this Vonjo. I mean, we have, we have had two of two pronged approach. We have significantly strengthened our medical area, and we have with Jamie Freeman, from previously Gen head of medical at Genetec in the US. And we have also recruited, quite, you know, we have now retained a very strong K well in the field and on a permanent basis. And we have also, we are also, let's say, improving the medical organization as such as we speak. Then we also realized, you know, that. Because we needed to be, needed to have a stronger outreach to the key centers. Again, we are working. Obviously, the two studies that we are currently working on will help us also to reconnect to the academic centers and bring us back in on top of mind. And then, you know, we, we are working through the metrics with our with our team. And, you know, there we saw some softening, and we have taken and we have introduced some change at leadership levels. So this is what we are doing for Vonjo and with regard to Gamifant sales. I mean, you know, we you know the product is utilized already in other indications, as physicians indicate. So this will probably be a gradual but you know, we expect that, you know this obviously will enable Gamifant you know, we indicated in the past that we expecting to double the product, essentially. So this will, but this will not be, you know, from zero to hero. It's more, you know, a gradual build up now of the product over time.

    Operator

    The next question comes from Yifeng Liu from HSBC.

    Yifeng Liu

    Thanks for taking my question. I was wondering if you could comment on the sort of environment of BD, and given all the macro volatility and unknowns etc, and has anything changed on your approaches to BD? And secondly, perhaps you could comment on some of the changes we see, maybe with the FDA, and how do you see that affect your regulatory activities? Thanks.

    Guido Oelkers

    Thank you. I think you know every you know, in a way, crisis is you know, a threat and obviously an opportunity. At the same time, as we know, many you know, companies are running right now out of funding and you could argue that some of the companies who run out of funding probably should run out of funding. Some others, you know, become obviously significant opportunities. Those value of cash is clearly more pronounced. Why it's for good assets. We always, you know, there's always competition, but it's clear that, you know, there the environment for buyers right now is more favorable than it was maybe a year ago. And so this opens up for opportunities for a sourcing company and therefore we are quite encouraged to look for this because, you know, there's more uncertainty baked in, but if you have a, would say, more level headed view then and the longer term you and you believe in this industry you should be. We are undeterred with regard to the changes of the FDA. You know, we, we have not, you know, felt, you know. I know that there have been reports recently out, but we have not felt this, yeah, we, we have seen, you know, that say that the, you know, we have got the priority review for Gamifant and we are working towards these timelines. So we cannot comment that we have any, you know, let's say, any changes to the FDA. But obviously, we also read about those changes in terms of employment structure, but so far, we cannot comment anything either in either direction. I think we, and we look forward to launching Gamifant pretty soon.

    Operator

    The next question comes from Natalia Webster from RBC.

    Natalia Webster

    Thanks for taking my questions. I have two follow ups. The first on Vonjo, given Q1 was also impacted by some stocking effects. You expecting this product to grow on a full year basis given the operational improvements you talked about. And my second question following up on BD, is there a desire to add not novel molecules to the pipeline, as apart from Nast, the development pipeline looks to be predominantly focused on line extensions for marketed drugs at the moment. Thank you.

    Guido Oelkers

    Thank you. Yeah, no, it's clear, we will. I mean, we are absolutely convinced that we can grow Vonjo during the course of the year. Anything less would be, would be big disappointment. I mean, you know, frankly, I mean, we had a couple of disappointments with product already. And I wish it would be whether we would have made faster progress. It's clearly not a lack of effort. It's tough. We obviously, you know, guide a further guideline change and a label change would make it much easier. And they were working on this and, you know, but, but we are undeterred, and even without we should be able to grow this product, is no question. And with regard to now a novel comp, you know, absolutely we will focus. We are focused on a new a new compounds, to further, to further innovative, innovate our portfolio, and, you know, and really move up further the way you change. And that's what we have currently in mind and we are currently looking at some situations in this regard.

    Operator

    [Operator Instructions]. We have a follow up question from Christopher Uhde from SEB.

    Christopher Uhde

    Thank you very much for taking my follow up. It's on Vonjo and just understanding the dynamic in Q1 here. Because, of course, we know that there's been a lot of catastrophic impact that is new for oncology drugs. So I'm just wondering, Can you can you help us understand it sounded like the stocking was the bigger effect on the catastrophic. Is that correct? And then how much for the remainder of 2025. Is it really improvement in strategy that you're working on and execution, versus just sort of more passive from volume growth on the current efforts? Thank you.

    Guido Oelkers

    Yeah, thank you. I mean, basically, when you think about it the [Technical Difficulty] [Audio Gap]

    Christopher Uhde

    In the US, you know how exposed, if so, be, which products are affected, which products you know that you sell in the US have to enter US manufacturing. And you know, any sense of, you know, in the sensitivity at your [indiscernible] line or earnings about what, let's say, a 20% tariff could do. I appreciate this as speculation, and you might not be able to give exact numbers. Thank you.

    Guido Oelkers

    Thank you. I mean, you know, maybe what we what, I start quickly with the with the [indiscernible] part, and then I refer to the tariff impact to our CFO. With regard to Altuvoct and [indiscernible] in the Q1 from these effects, and [indiscernible] benefiting. So the on an overall Haemophilia part for these two products together, the impact is more like a single digit effect. And you know, clearly less, much less material, for instance, then you know the effect that we have incurred from in by 40s, in the season effect. So, you know, yes, so they have so the Altuvoct number looks better than they should. Let's say when you can argue, because these tenders, they come as they come. But let's say the Altuvoct number should have looked better. And clearly, by for this probably also. So this is basically how we think about it. In this regard to the terrorists, maybe Henrik, you want to comment on this?

    Henrik Stenqvist

    Yeah. So with regards to potential, we should say tariffs. Of course, we in Sobi, we have product flows of both finished goods and intermediates, predominantly between the US and Europe, both ways, we think that any impact on potential tariffs would be manageable to us, but we really want to refrain from the speculations on you know, if and when and how and how much any tariffs would, you know, be imposed. So we refrain from speculating.

    Guido Oelkers

    Yeah, so maybe we go to the next question. But as you can see, this is more be more of a manageable effect for us right now, and we'll think about it when there are more issues, when it's clearer.

    Operator

    Ladies and gentlemen, that was the last question. I would now like to turn the conference back over to Guido Oelkers for any closing remarks.

    Guido Oelkers

    Yeah, as a note I would like to thank you for your interest in Sobi and stay tuned. I know that we are in competition with many other companies right now. So very much appreciate your attention. And if you had any questions, please refer to our IR team for most obviously, and they will be extremely happy to either directly answer or connect you with the right expert. Appreciate it. Wish you everybody a great week. Thank you so much.

    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.

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