Swedish Orphan Biovitrum AB (publ)

STO:SOBI

Ladies and gentlemen, welcome to the Sobi Q1 2025 Report Conference Call and Live Webcast. I'm Sandra, the Chorus Call operator. [Operator Instructions] The conference is being recorded. [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.

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 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 mostly 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. [Operator Instructions]



Let's go to Slide #4. I mean we -- as you have seen, this has been a pretty strong quarter with solid performance that we started in 2025. And the steps are as follows: 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 products and the discontinued ReFacto 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 the haematology was driven by continued growth of Doptelet, Aspaveli and the launch of Altuvoct, and that generated SEK 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, Aspaveli and NASP. And when you go a little bit more deeper into the different business areas, obviously, we look forward to continue driving the Altuvoct launch. We'll talk more about it. And when you think about immunology and also a little bit more later, I mean, Gamifant with over 30% and Kineret have performed extremely well.



So, in terms of pipeline, I think we -- our progress with filing Gamifant for HLH/MAS and steroid disease in the U.S., receiving a priority review with a PDUFA date late June was clearly a highlight and Aspaveli was submitted to EMA for the potential treatment of C3G and IC-MPGN. And we continue the discussion with health authorities and look forward to bringing this product to the market pretty soon. So overall, it's a combination of strong business momentum whilst hitting important milestones in development and filing.



Let's move to Slide #5. And when we go look into the performance in more detail, as you can see here by business area, very strong momentum in haematology. Haemophilia here slightly reduced by the discontinuation of the manufacturing. But when you think about haemophilia A products growing at 29%, I think this speaks for itself. And Immunology, let's say, down. But if you take away the Synagis sales that we have now consolidated ReFacto in Q1 due to the obviously incoming Beyfortus, basically, Immunology is growing over 20%. And this shows that there's robustness across board. When you think about the geographic split, Europe having obviously a fantastic quarter is 19%. And if you take away the Synagis 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 #6, focusing more a bit on the portfolio. And I'd just like to highlight the performance of Altuvoct, the performance of Doptelet with 47%, the performance of Aspaveli with 39%, the performance of Kineret with 16% and the performance of Gamifant with 31%. So very strong quarter, and we'll talk about the performance of Vonjo 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 Altuvoct and the rapid adoption in quite a few markets, but foremost in Germany. And there, we have achieved a market share position of 57% after 9 months within the launch phase. And this shows what is possible with this product. This is over 24% market share gain within this space of time. 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 Sobi territories.



Let's move to Aspaveli. And whilst we are facing with Aspaveli, obviously, quite a bit of competition from new oral medicines, we continue seeing significant growth, and you can see that we had a pretty strong Q1. And this is primarily driven by progress in international markets. But I think the -- as we always said, the primary story for us is really about the nephrology indication that we are looking forward to. 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 C3c staining and from the kidney in a high percentage of patients and the stabilization of eGFR at such an early point of time make us really excited and make us believe that this is an important product in those 2 indications. So, we look forward to working with the regulatory authorities to move this forward in parallel and being, let's say, building an internal infrastructure in nephrology to prepare the launch, and this is what we are currently doing across the organization.



Let's talk about Vonjo. And so, the demand for Vonjo grew quarter-on-quarter, even though you see here a minus 6% in Q1 versus previous year. Let's say, however, these sales were pretty much impacted primarily by stocking and partially by gross to net adjustment, including Medicare Part D reform in the U.S. And this led to a decline of 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 platelets that we have on label. And the growth strategy is more explicit than on the next slide. So, as you can see, our glass for Vonjo is clearly not even half full, and there is clearly a thirst for expansion.



So, looking at Vonjo overall, we still see significant potential to be unlocked in myelofibrosis, but we realize 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, we will be -- we'll launch in some of the additional smaller countries outside of the U.S. But ultimately, we need the PACIFICA Phase III study for both full approval in the U.S. and filing in Europe and Japan. The next step is also to broaden the use of Vonjo. And we have started a Phase III study for Vonjo assessing its potential in VEXAS, and that's an area with currently no approved treatment, and we have a strategy with CMML, and we believe that there is a very strong mechanistic rationale for Vonjo in this space, and there's also a broad overlap of prescribers with myelofibrosis.



So, let's move to Beyfortus. As the headline described, Beyfortus now follows much more the seasons of -- or the seasonal sales pattern of vaccines. And as illustrated in the graph, the sales predominantly occur in Q3 and Q4. And this is new for us at Sobi because with Synagis, we obviously have always a very strong Q1. But given that this product is only given once a season and not 5 times, obviously, the sales pattern has changed. So important to note that our share of sales of Beyfortus 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, we obviously here very much dependent on the performance of Sanofi, but for us, 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 as the headline suggests, our immunology revenues grew 22% in Q1 when you exclude the RSV revenues. So outside of RSV and Immunology, both Kineret and Gamifant have shown strong and sustained performance. Gamifant continues to exhibit significant growth despite high penetration in the primary HLH market. And we are looking very much forward to the launch of secondary HLH indications 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 -- 27th of June.



Let's move to the next slide. So, when you think about us or Sobi moving into the future, I think it's nice to just think of a very simple formula, 2, 3, 4. because when you think about us right now, we have 2 major launches ongoing. One of them displaying exuberant growth with Altuvoct, as you have seen. Vonjo still, 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, we have filed for the really primary indication for us in nephrology, in the 2 nephrology indications. And NASP, which will be also a very material product for us, as we believe, in chronic refractory gout. And then we have 4 projects in development. And here, we've taken a stand that we take our existing compounds into settings of high unmet medical need, into IDS, interferon-gamma-driven sepsis, into Vonjo, into VEXAS, as you pointed out, Vonjo into CMML. And taking Altuvoct into synovitis, which has been an unsolved problem for many hemophilia patients, and I'm sure that Lydia will talk more about it.



So, we're taking bold steps going into areas of high unmet medical needs without fundamentally changing the risk profile of the company. And as you can see, we have a lot of work for us cut out in 2025 and '26, and can look forward to a very prosperous future. On this note, I'd like to hand over to the CFO, Henrik.

Please turn to Slide 15. And we will now take a look at some key financial metrics for the quarter. So, in Q4, our revenues of SEK 6.5 billion corresponded to a revenue growth of 3% at constant currencies. And if you exclude the seasonal RSV products as well as the discontinued refractory manufacturing revenue, growth for the quarter was 23% at constant currencies. So, if we look at the bar chart on the left with revenues by quarter and business area, we see a solid growth in haematology of 13% in the quarter. Haemophilia A sales, including Elocta and Altuvoct, increased by 29% at CER. We continue to see strong momentum for Altuvoct in the launched markets. And in addition, we have continued strong growth in Doptelet and Aspaveli.



Vonjo demand was stable in the quarter, but was negatively impacted by stocking issues and, to a smaller extent, gross-to-net adjustments. Immunology experienced a decline of 21% in the quarter as a result of the expected decline of Synagis and seasonal shift in Beyfortus royalties. On the other hand, Gamifant and Kineret grew in strong double digits. Referring to the table on the right and the adjusted gross margin of 77% in the quarter, compared to 76% in Q1 2024. Gross margin was positively impacted by the loss of lower-margin refractory sales as well as product and country mix in various products, and this was partially offset by lower RSV sales and royalties. And as said, the adjusted EBITA 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 nonrecurring items and amortization, increased by 10% at CER in the quarter, driven by launch and prelaunch costs for Altuvoct, Aspaveli nephrology and NASP. R&D expenses increased by 3% at CER, excluding nonrecurring items, mainly due to post-approval activities for Altuvoct and development programs in Gamifant and Vonjo. We now see lower costs in NASP-related programs compared to in 2024. Operating cash flow for the quarter was SEK 2.3 billion, slightly more than in Q1 2024. Net debt continues to go down, ending the quarter at SEK 12.7 billion, corresponding to a net debt-to-EBITDA ratio of 1.3x compared to 1.6x at the end of the previous quarter.



So please turn to Slide 16 and the 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 high single-digit percentage at CER and an adjusted EBITDA 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 Beyfortus royalties, although this is a factor where we do not control the outcome ourselves. In regards to our EBITDA margin guidance, we will start to ramp up investments in our prelaunch 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 the new studies for Vonjo in VEXAS and CMML, as well as the registrational efforts 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 U.S. dollars and euros, with only a minimal share in Swedish krona. So, any time there is a currency movement, this will have an almost 1:1 impact on revenue in SEK. For 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 EBITDA will be slightly larger, relatively speaking, than the impact on revenue due to the cost we have in SEK. Overall, the absolute numbers of revenue and costs will fluctuate with currency movements, but the EBITA margin is relatively protected from changes in FX rates due to the natural hedging that comes from the composition of currencies in our business.



And with that, I hand over to Lydia. Thank you.

Thank you, Henrik, and hello, everyone. We will start with the pipeline milestones on the next slide, please. Can you move to the next slide, please? Thank you. We had a very productive first quarter, seeing important regulatory filings and clinical progress. In February, we successfully submitted the EU application for Aspaveli in C3G and IC-MPGN, which has since been confirmed by EMA and it's now making steady progress. Gamifant received FDA priority review for our HLH/MAS U.S. application with a PDUFA date at the end of June. On the clinical side, we initiated a research collaboration to explore Gamifant in interferon gamma-driven sepsis, also known as IDS. The synovitis SHINE Phase IV study with Altuvoct in haemophilia started enrolling patients. And the VEXAS proof-of-concept study with Pacritinib, which we discussed at the last quarterly call, is starting up. Finally, our Japanese study with Kineret in Still's disease delivered 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.



Starting with Gamifant interferon-gamma-driven sepsis, which could address a significant unmet medical need with important burden to health care 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 5 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 U.S. alone.



Recently, an endotype of sepsis has been identified, which is characterized by elevated interferon gamma and CXCL9. 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 emapalumab 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 IIa EMBRACE proof-of-concept study in patients with IDS will explore if emapalumab can improve outcomes in IDS. The study has started, is actively enrolling and the first patients have been dosed. It has 2 treatment arms and one placebo arm, it's with 25 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 SHINE study for Altuvoct in patients with synovitis is building on the ability of Altuvoct to maintain Factor VIII levels in the non-haemophilia range for most of the week. This changes the treatment paradigm for this chronic condition, allowing for unprecedented levels of protection. Increasingly, targeting non-haemophilia levels is seen as achievable and recommended, for example, by the German Society of Thrombosis and haemostasis. Joint health is becoming a focus. It is a key concern for haemophilia patients and their physicians because most patients experience joint deteriorations from microbleeds, which cannot heal without adequate haemostasis. In haemophilia patients, bleeding inside the joint lead to blood accumulation in the joint space. This repeated bleeding irritates the lining of the joint called synovium. It becomes inflamed and thicken over time. And treated synovitis evolves to irreversible chronic arthropathy. And between 22% and 55% of people on prophylactic treatment have synovitis, making it the most common complication in haemophilia.



The medical community is very keen to know if the high sustained Factor VIII 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 2 studies and evaluate up to 200 joints with synovial hypertrophy. Next slide, please.



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 NASP. In the U.S., the focus will be on the approval of Gamifant for HLH/MAS in Still's disease and on finalizing the submission of NASP for uncontrolled gout. In Europe, the focus will be on the approval of Aspaveli for the nephrology indications, C3G and IC-MPGN. And in Japan, we will be submitting 3 dossiers: Gamifant for HLH/MAS in Still's disease, Kineret in Still's disease and Aspaveli for the nephrology indications. The Aspaveli submission in Japan will now include the 52-week data, which moves the submission time line to the second half of this year.



And with that, I would like to hand back to Guido. Next slide, please.

Yes. Thanks, Lydia. I mean, and let's go straight to the summary. As you can see, we were very pleased with Sobi's 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 Altuvoct in Europe, the filing and granting of a priority review for Gamifant in the U.S. for secondary HLH, and the filing in the EU for Aspaveli in nephrology.



We will continue this pace with the planned completion of the last filing of uncontrolled gout in the U.S. by Q2. Building on these, we have 4 areas that we are going to leverage in our portfolio with the studies, as you just saw in synovitis in haemophilia, interferon-gamma-driven sepsis, VEXAS and CMML. This will open tremendous opportunities for Sobi 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 #23.



We now open the floor for questions. [Operator Instructions] And perhaps we can take the first question.

The first question comes from Shirley Chen from Barclays.

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 A market across Europe? And also, can you perhaps share some initial feedback from Switzerland and Spain market?

Thank you. I mean, the 50%, sorry, I should be precise, includes also Elocta, the vast majority coming from Altuvoct. So, it's our haemophilia A share primarily driven by Altuvoct, and the 24% gain on haemophilia A in the haemophilia A class in Germany is driven obviously by the Altuvoct expansion. But it is now an example. I mean, the launch successes in Switzerland also look very promising. And in fact, the trajectory it's earlier, but it doesn't look less impressive, there's a lower number, obviously, of patients in Switzerland and Germany. And in Spain, 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, I mean, 57% is very strong. This is ahead of our expectations to be quite frank. I mean, we always said 30% to 40% would be a good ambition on a consolidated share. As you can see, we can break through this. But we'll have to see whether this is already indicative this high number. But I'm sure that our country managers in other countries don't want to look too shy. But if anything, we are more confident about the product in our territory. Maybe the next question.

The next question comes from Mattias Häggblom from Handelsbanken.

Two questions, please. So firstly, your partner, Sanofi, stated last week that due to lower immunization rates in the U.S. during Q1, before to shift in Q4 may be stored and used for RSVs in '25, '26. So, question goes, has your partner quantified to Sobi how much 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 an appetite, what profiles are you looking for? And if there is no appetite, why not?

Thank you, Mattias, for the 2 questions. So, the first one, I mean, basically, our annual ambition for the product is unchanged because we have also no indication from Sanofi that they revised their annual ambition. Yes, there is stock, but as they pointed out. But frankly, I mean, we know this from our own experience, there's always an overhang of stock in the trade. And then the question is, can this be digested and at what rate. But the fact remains that the majority of the sales are there. But not very long ago, I think Sanofi mentioned also that given the relatively low immunization last year of 55%, 60%, let's say, they see this as a growth opportunity. We'll have to find out in this environment, how this works. We feel reasonably insulated given that our royalty rate is going to increase. So, 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 Sanofi can only share things with us within reason. I mean, given the residual competitiveness with synergies. And with regard to M&A, it would surprise you that we are very vigilant right now and thinking how we can intelligently expand. I mean, you see from the portfolio that we have that we have quite a bit to do now, very near-term. And therefore, we are now thinking how we can develop the company on a going concern basis also into the mid- and longer-term, and looking for products that are giving us leverage and are suitable to our existing portfolio. And this process is ongoing, and we are looking currently for various opportunities. And then maybe move to the next question.

The next question comes from Christopher Uhde from SEB.

I think my thing I'm wondering most about is what are the gating factors for launching Altuvoct in France and U.K. 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 PNH? 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?

Yes. Thank you, Christopher. So maybe with regard to the easy one, yes, in the U.K., we are currently operationalizing this. We have got the positive from NICE and 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 -- don't put ourselves under too much pressure because we have strong momentum in any case, and we have enough countries currently on the plate already. But we want to launch, obviously, in France and to make this product available everywhere in our territory.



As far as Aspaveli is concerned, yes, it's good. As you see, we have a pretty satisfactory Q1. I mean, primarily, let's say, driven by the launches in international region. And what we can see is also that we are now getting also patients back from the orals because it seems that sometimes a more central effect on the C3 inhibition for certain patients, not for all, may be more beneficial than to be more proximal. But we have not yet deciphered major patents, but we know that the product is very suitable. And we also think that the launch 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 strengthen our competitive offering in PNH. Maybe go to the next question.

The next question comes from Harry Gillis from Berenberg.

You mentioned some operational improvements relating to Vonjo. I was just wondering if you could please expand on those and what they entail and perhaps some of the measures you're taking to help drive growth of that product? And then just a quick one on the Gamifant indication expansion. So obviously, the PDUFA is 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.

Let's start operationally with Vonjo. I mean, we have a 2-pronged approach. We have significantly strengthened our medical area. And we have with Jamie Freedman from previously Head of Medical at Genentech in the U.S., and we have also recruited quite -- we have now retained a very strong KOL in the field and on a permanent basis. And we are also, let's say, improving the medical organization as such as we speak. Then we also realized that because we needed to have a stronger outreach to the key centers again. We are working, obviously, the 2 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 we are working through the metrics with our team. And 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, the product is utilized already in other indications as physicians indicate. So, this will probably be gradual, but we expect that this obviously will enable Gamifant. We indicated in the past that we are expecting to double the product essentially. So, this -- but this will not be from zero to hero. It's more a gradual buildup now of the product over time. Next question please.

The next question comes from Liu Yifeng from HSBC.

I was wondering if you could comment on the sort of environment of BD and given all the macro volatility and unknowns, et cetera? 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?

I think every -- in a way, crisis is a threat and obviously, an opportunity at the same time. As we know, many 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 become obviously significant opportunities. So, the value of cash is clearly more pronounced. Whilst for good assets, there's always competition. But it's clear that the environment for buyers right now is more favorable than it was maybe a year ago. And so, this opens up opportunities for a sourcing company. And therefore, we are quite encouraged to look for this because there is more uncertainty baked in. But if you have, I would say, a more level-headed view and a longer-term view and you believe in this industry, we are undeterred. With regard to the changes of the FDA, I know that there have been reports recently out, but we have not felt this.



We have seen that we have got the priority review for Gamifant, and we are working towards these time lines. So, we cannot comment that we have any, 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 in either direction. I think and we look forward to launching Gamifant pretty soon.

The next question comes from Natalia Webster from RBC.

I have 2 follow-ups. The first on Vonjo. Given Q1 was also impacted by some stocking effects, are 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 novel molecules to the pipeline as apart from NASP, the development pipeline looks to be predominantly focused on line extensions for marketed drugs at the moment?

Yes. No, it's clear. I mean, we are absolutely convinced that we can grow Vonjo during this course of the year. For us, anything less would be a big disappointment. I mean, frankly, we had a couple of disappointments with the product already, and I wish we would have made faster progress, it's clearly not a lack of effort. It's tough. We obviously, a further guideline change and a label change would make it much easier, and we're working on this. But we are undeterred and even without, we should be able to grow this product. There's no question. And with regard to, now absolutely, we are focused on new compounds to further innovate our portfolio and really move up further the value chain, and that's what we have currently in mind, and we are currently looking at some situations in this regard.

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

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 help us understand. It sounded like destocking was the bigger effect than 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?

Yes. Thank you. I mean, basically, when you think about it, roughly 2/3 is more driven by the stock impact, 1/3 by the gross to net adjustments as a part also of the changes to Medicare. And let's say, so it is so far manageable thing. We should be able to outgrow the situation irregardless, as a consequence. And basically, the operational improvements should allow us to bring the product back to a growth trajectory as we have seen it over 3 quarters. And then we are very keen, obviously, to see when we can get an improvement on guidelines already and then what are the pathways for us to come to a label change.

The next question is also a follow-up from Harry Gillis from Berenberg.

Just a quick one on Elocta. I was wondering if you could quantify the phasing benefit you saw from that one in Q1. And perhaps I think you had a negative phasing effect, if you could also quantify that. I guess no one's discussed it yet, but sorry to go there. But if we're going to think about potential tariffs, I appreciate there's lots of unknowns at the moment and it's all speculation. But just to give us a sort of sense if pharmaceutical tariffs were to be introduced in the U.S., how exposed is Sobi? Which products are affected, which products that you sell in the U.S. to U.S. manufacturing? And any sense of the sensitivity at your EBITA line or earnings about what, let's say, a 20% tariff could do. I appreciate this is speculation and you might not be able to give exact numbers.

I mean, maybe I'll start quickly with the haemophilia part and then I refer to the tariff impact to our CFO. With regard to Elocta and Alprolix, we had 2 effects. Alprolix not benefiting in the Q1 from these effects and Elocta benefiting. So, on an overall haemophilia part for these 2 products together, the impact is more like a single-digit effect. And clearly much less material, for instance, than the effect that we have incurred in Beyfortus in the seasonal effect. So yes, so the Elocta 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 Alprolix number should have looked better. And clearly, Beyfortus probably also. So, this is basically how we think about it. And with regard to the tariffs, maybe, Henrik, you want to comment on this?

Yes. 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 U.S. and Europe, both ways. we think that any impact on potential tariffs would be manageable to us, but we really want to refrain from further speculations on if and when and how and how much any tariffs would be imposed. So we refrain from speculating.

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

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.

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

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.