Ladies and gentlemen, welcome to the Sobi Q1 2025 Report Conference Call and Live Webcast. I'm Sandra, the Chorus Call Operator. I would like to remind you that all participants are in listen-only mode and the conference is being recorded. The presentation will be followed by a Q&A session. You can register for questions at any time by pressing star and one on your telephone. For operator assistance, please press star and zero. 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. 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. Unless stated otherwise, we will be making comments that mostly relate to the first quarter at constant exchange rate in million SEK. Let's move to the agenda. 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 4:30PM 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, as you have seen, this has been a pretty strong quarter with solid performance that we started in 2025. The stats are as follows: 3% total growth, we will talk more a little bit about it, and an EBITDA margin of 36%. 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. The hematology 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. 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. When you think about immunology and also a little bit more later, I mean, Gamifant with over 30% in Kineret have performed extremely well. In terms of pipeline, I think our progress with filing Gamifant for HLH, MAS, and Still's disease in the U.S. receiving a priority review with the PDUFA date late June was clearly a highlight. Aspaveli was submitted to EMA for the potential treatment of C3G and IC-MPGN.
We will continue the discussion with health authorities and look forward to bringing this product to the market pretty soon. Overall, it is a combination of strong business momentum while hitting important milestones in development and filing. Let's move to slide number five. When we look into the performance in more detail, as you can see here by business area, very strong momentum in hematology. Hemophilia here is slightly reduced by the discontinuation of the manufacturing. When you think about hemophilia A products growing at 29%, I think this speaks for itself. Immunology is, let's say, down. If you take away the Synagis sales that we have now consolidated de facto in Q1 due to the obviously incoming Beyfortus, basically immunology is growing over 20%. This shows that there is robustness across the board.
When you think about the geographic split, Europe having obviously a fantastic quarter with 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, number six, focusing more a bit on the portfolio. And I 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. 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.
There we have achieved a market share position of 57% after nine months within the launch phase. This shows what is possible with this product. This is over 24% market share gain within the space of time. We see very promising trends also in other markets. We look forward to bringing this important medicine to more markets across Europe and other Sobi territories. Let's move to Aspaveli. Whilst we are facing with Aspaveli, obviously quite a bit of competition from new oral medicines, we continue seeing significant growth. You can see that we had a pretty strong Q1. This is primarily driven by progress in international markets. I think, as we always said, the primary story for us is really about the nephrology indication that we are looking forward to.
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 such an early point of time make us really excited and make us believe that this is an important product in those two indications. 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. This is what we are currently doing across the organization. Let's talk about Vonjo. 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. This led to a decline of 6% in revenues. We aim to resolve this in the coming quarters. Our ambition remains unchanged in our near-term focus to continue growing in myofibrosis, leverage the NCCN guidelines, and ultimately see growth outside of the restricted area of below 50,000 platelets that we have on label. The growth strategy is more explicit than on the next slide. As you can see, our glass for Vonjo is clearly not even half full. There is clearly a thirst for expansion. Looking at Vonjo overall, we still see significant potential to be unlocked in myofibrosis. Realize also that leapfrogging in terms of performance will really take a change of guidelines and label expansion.
We are working on this. This year, we'll launch in some of the additional smaller countries outside of the U.S. 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. We have started a phase III study for Vonjo assessing its potential in VEXAS. That's an area with currently no approved treatments. We have a strategy with CMML. We believe that there's a very strong mechanistic rationale for Vonjo in this space. There's also broad overlap of prescribers with myofibrosis. Let's move to Beyfortus. As the headline describes, Beyfortus now follows much more the seasons of or the seasonal sales pattern of vaccines. As illustrated in the graph, the sales predominantly occur in Q3 and Q4.
This is new for us at Sobi because with Synagis, we obviously had also always a very strong Q1. Given that this product is only given once a season and not five times, the sales pattern has changed. It is important to note that our share of sales of Beyfortus goes from 25% in 2024 by a tiered rate starting this year until 2028, reaching a range of 30%-35% of net sales. Beyond 2028, the royalty rates will remain fixed at these levels. We are very much dependent on the performance of Sanofi. For us, we may be benefiting not only from the business growth, but also from a royalty improvement. Let's move to immunology and to Kineret and Gamifant. As the headline suggests, our immunology revenues grew 22% in Q1 when you exclude the RSV revenues.
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. 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 is all on track to meet the PDUFA date of June 27. Let's move to the next slide. When you think about us or Sobi moving into the future, I think it's nice to just think of a very simple formula: two, three, four. Because when you think about us right now, we have two 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.
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. NASP, which will be also a very material product for us, as we believe, in chronic refractory gout. We have four projects in development. Here we're taking a standard. We take our existing compounds into settings of high unmet medical need into IDS, interferon-derived sepsis, into Vonjo, into VEXAS, as we pointed out, Vonjo into CMML, and taking ALTUVOCT into
affected by the loss of lower margin ReFacto sales, as well as product and country mix in various products. This was partially offset by lower RSV sales and royalties. As said, the Adjusted EBITDA 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. FG&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 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 1.3 times compared to 1.6 times at the end of the previous quarter. 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 a high single-digit percentage at CER and an Adjusted EBITDA margin in the mid-30s % 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. We look forward to continuing to launch the product into new markets in 2025. We also expect continued progress with our existing commercial portfolio. 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 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 the new studies for Vonjo in VEXAS and CMML, as well as the registration of efforts for Aspaveli, Gamifant, and NASP. Please turn to slide 17. 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. Anytime there is a currency movement, this will have an almost one-to-one impact on revenue in SEK.
For cost of goods sold and OpEx, around 15%-20% is in SEK, with the remainder primarily in dollars and euros. 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 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.
Thank you, Henrik. 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 hemophilia started enrolling patients. 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. Thanks. Starting with Gamifant in 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 die from it. It also leads to high healthcare 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 blocks signaling that leads to hyperinflammation, we have initiated a research collaboration with the Hellenic Institute for the Study of Sepsis. The phase II-A 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 two treatment arms and one placebo, each with 25 patients. 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-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 the joint leads 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. Untreated synovitis evolves to irreversible chronic arthropathy. 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 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-op analysis with combined data from the two 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. In Japan, we will be submitting three dose years: 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 timeline to the second half of this year. With that, I would like to hand back to Guido. Next slide, please.
Hi. Yeah, thanks, Lydia. I mean, and let's go straight to the summary. You know, as you can see, you know, 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 NASP filing of uncontrolled gout in the U.S. by Q2. Building on these, we have four areas that we are going to leverage in our portfolio with the studies that you just saw in synovitis, in hemophilia, interferon-gamma-driven sepsis, VEXAS, and CMML. This will open tremendous opportunities for Sobi in the coming years. We are actively preparing for 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.
We are continuing, looking forward to continue this journey with our colleagues and stakeholders around the globe. Please move to slide number 23. We now open the floor for questions. For those on the phone, please remember to press star one to ask the question. Can I ask everybody, please, to limit questions to one or two to be fair to all callers? Thanks in advance. Perhaps we can take the first question. Back to the operator.
Thank you, sir. The first question comes from Shirley Chen from Barclays. Please go ahead.
Hi. Thank you for taking my question. Congratulations on ALTUVOCT to achieve a 57% share in Germany. Just wondering if this would adjust your expectations for the market share of ALTUVOCT in hemophilia A market across Europe. Also, can you perhaps share some initial feedback from Switzerland and Spain markets? Thank you so much.
Yeah. Thank you. I mean, the 50%, sorry, should be precise, includes also Elocta, while the majority now coming, the vast majority coming from ALTUVOCT. So it's our hemophilia A share, primarily driven by ALTUVOCT. And the 24% gain on a hemophilia A in the hemophilia A class in Germany is driven, obviously, by the ALTUVOCT expansion. Is this now an example? I mean, the launch successes in Switzerland also look very promising. In fact, the trajectory does not—it's earlier, but it does not look less impressive. It's just less—there's a lower number, obviously, of patients in Switzerland and Germany. In Spain, it will take—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. This is currently ongoing.
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 30-40% would be a good ambition on a consolidated share. As you can see, we can break through this. We will have to see whether this is already indicative, this high number. I am sure that our country managers in other countries do not want to look too shy. If anything, we are more confident about the product in our territory. Yeah. Maybe the next question.
The next question comes from Mattias Häggblom from Handelsbanken. Please go ahead.
Yeah, good afternoon. Mattias Häggblom, Handelsbanken. Two questions, please. Firstly, your partner, Sanofi, stated last week that due to lower immunization rates in the U.S. during Q1, they thought shifting Q4 may be stored and used for RSV disease in 2025-2026.
The question goes, has your partner quantified the SoVI, how much they think remains in stock, and how, if at all, has that informed your outlook for 2025? Secondly, if you could remind us of your appetite for M&A in light of the very rapidly deleveraging balance sheet. If there is appetite, what profiles are you looking for? If there is no appetite, why not? Thanks so much.
Thank you, Mattias, for the two questions. 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, as they pointed out, but frankly, I mean, we know this from our own experience. There is always an overhang of stock in the trade.
The question is, can this be digested and at what rate? The fact remains that the majority of the sales are there. Not very long ago, I think Sanofi mentioned also that given the relatively low immunization last year of 55%-60%, they feel there is a growth opportunity. We will have to find out in this environment how this works. We feel reasonably insulated given that our royalty rate is going to increase. We will figure. We have no indication from Sanofi in this to dampen our expectations for the year. One has to say also that Sanofi can only share things with us within reason. I mean, given the residual competitiveness with Synagis. With regard to M&A, it would not 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. 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. This process is ongoing, and we are looking currently for various opportunities. Thank you. Thank you. Maybe move to the next question.
The next question comes from Christopher Uhde from SEB. Please go ahead.
Yeah, there. Thanks for taking my questions. I think the 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. 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? Let's say, are there specific patient groups where you feel or niches where you feel more, I do not know, insulated or stronger relative to the competition? Could we see price pressure, or was that a factor in Q4 2024? Thank you.
Thank you, Christopher. Maybe with regard to the easy one, no, in the U.K., we are currently operationalizing this. We have got the positive votum from NICE and working on this now. We do not see there any more problems.
In France, we are in active discussion with the Transparency Commission to resolve this and look forward to a launch during the course of this year. We do not want to put ourselves under too much pressure because we have strong momentum in any case, and we have enough countries currently on the plate already. We want to launch, obviously, in France and to make this product available everywhere in our territory. As far as Aspaveli is concerned, yeah, it is good that, as you see, we had a pretty satisfactory Q1. I mean, primarily, let's say, driven by the launches in the international region.
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. We have not yet deciphered major patterns, but we know that the product is very suitable. 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. Please go ahead.
Thank you for taking the questions. 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. Just a quick one on the Gamifant indication expansion. Obviously, the PDUFA's end of June. Just wondering, should we see some sort of sales inflection in the second half of this year, or will this be more of a gradual increase over the next couple of years? Thank you.
Thank you. Let's start operationally with Vonjo. I mean, we have a two-pronged approach. We have significantly strengthened our medical area. We have Jamie Freedman, previously head of medical at Genentech in the U.S. We have also recruited quite a—we have now retained a very strong KOL in the field and on a permanent basis.
We are also, let's say, improving the medical organization as such as we speak. We also realized that because we 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 on top of mind. We are working through the metrics with our team. There we saw some softening, and we have taken and we have introduced some change at leadership levels. This is what we are doing for Vonjo. With regard to Gamifant sales, I mean, the product is utilized already in other indications, as physicians indicate. 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. This will not be from zero to hero. It is more a gradual build-up now of the product over time. Next question, please.
The next question comes from Liu Yifeng from HSBC. Please go ahead.
Thank you.
Hello. Hello. 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. Has anything changed on your approaches to BD? 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.
Thank you. 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. 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. The value of cash is clearly more pronounced. Why? It's for good assets. There's always competition. It is clear that the environment for buyers right now is more favorable than it was maybe a year ago. This opens up for opportunities for a sourcing company. Therefore, we are quite encouraged to look for this because there's more uncertainty baked in. If you have a, I would say, more level-headed view and a longer-term view, and you believe in this industry, you should be undeterred.
With regard to the changes of the FDA, we have not felt, I know that there have been reports recently out, but we have not felt this. We have seen, let's say, that we have got the priority review for Gamifant, and we are working towards these timelines. We cannot comment that we have any, let's say, any changes to the FDA. Obviously, we also read about those changes in terms of employment structure. So far, we cannot comment anything in either direction. I think we—and we look forward to launching Gamifant pretty soon.
Thank you.
Thank you. Next question, please. The next question comes from Natalia Webster from RBC. Please go ahead.
Hi there. Thanks for taking my questions. I have two 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? 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? Thank you.
Thank you. Yeah, 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, I mean, 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.