Ladies and gentlemen, welcome to the Q2 2024 report conference call and live webcast. I am Sandra, the Chorus Call operator. I would like to remind you that all participants have been placed 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. Hello, everyone, this is Guido Oelkers, CEO of Sobi. We are delighted to welcome you to the second quarter 2024 conference call for investors and analysts. We posted this presentation to sobi.com earlier today. We would like to remind you, please go to slide 2 of the usual provisions on statements about expectations and projections of future events. Unless stated otherwise, we will be making comments that mostly relate to the second quarter at constant exchange rates in SEK million. Please turn to slide 3. Today, we plan to cover the key aspects of our Q2 report. I'm joined by Henrik Stenqvist, our CFO, Lydia Abad-Franch, our Head of R&D and Chief Medical Officer. During the Q&A session, we will be joined by Armin Reininger, our Senior Scientific Advisor as well.
We plan to review the presentation first and then have a Q&A until around 3 P.M. Swedish time. For those on the phone, please join the queue for questions by pressing star one. We propose to ask only 1 or maximum 2 questions at a time. With this said, you know, let's go right to the beef of the presentation. Please turn to slide number 4. We are very pleased with the performance in the second quarter and overall strong first half, which has been driven by successfully executing on our strategy and growth of our strategic portfolio. We saw a significant top-line growth of 11% in Q2, and an EBITDA margin adjusted for was 28%. Please bear in mind that we consolidated the business to Vonjo. Taking away this effect, our top-line growth would have been 26%.
Hematology growth was driven by continued growth of Doptelet and Aspaveli sales and the addition of Vonjo. We saw growth of Elocta and Alprolix, mainly driven by geographic expansion, but also by some phasing in tender markets. We continue to build the launch of Vonjo, which has taken time, and while we see progress, we believe that the product offers a broader potential than we currently yield. Given our strong scientific profile... Sorry, given the strong scientific profile of the product and the feedback of physicians, we remain confident to change the trajectory by our new strategic initiatives and the broader and higher reach of our target audience during H2. Immunology reflects strong Gamifant sales of SEK 522 million, where no Synagis sales in the quarter as we are now out of the RSV season.
In terms of the pipeline, we have seen tremendous progress in the first half, thanks to our strong development teams, with the approval of Altuvoct in Europe for hemophilia A and the filing of SEL-212 to FDA under Fast Track Designation for the potential treatment of chronic refractory gout. Additionally, we received Fast Track Designation for Gamifant for the potential treatment of secondary HLH, which we intend to file in H2. We have a very strong momentum in the Sobi business, both commercially and in the development, and are pleased to update our guide, update our guidance for 2024. We expect double-digit growth, previously high single digit, and mid-thirties for the adjusted EBITDA margin. Please turn to slide number 5. Let's look at the overall performance in more detail. Our growth of 11% was driven by both hematology and immunology sales.
We saw a strong performance of hematology with 13%, and the more gratifying is when we look at the underlying growth, you know, as I highlighted earlier, of 26%, excluding the effect of sales to Fosun Pharma. Growth came from all regions, with the US growing at 38% and international, excluding Doptelet China, grows impressively 73%. We look forward to continuing the delivery of our global strategy in 2024. Please go to slide 6. Our growth strategy has led to strong results, which primarily driven by our strategic growth portfolio, which includes our medicines listed here, Enbrel, Beyfortus, and Synagis royalties in the US, contributing to 41% of our total business in Q2....
Here you see the five medicines from our portfolio, which impressively grow year-on-year growth, delivering significant growth to our business now, and most importantly, will be the future growth drivers of our business. We are excited to include Altuvoct sales as of now, based on the recent approval in the US, sorry, in, in Europe, and will further enrich our strategic growth portfolio in the second half of the year. Please turn to slide number seven. Another look at the strategic portfolio. This is a graphical visualization, and it shows, you know, the other representation of growth in the quarter, again, demonstrating the growth of our strategic portfolio of 74%, whilst the vast majority of the strategic portfolio is driven by our own medicines.
We have built this one on top of a strong foundation portfolio, which grew 9%, driven by Elocta, Alprolix, and Kineret, all showing double-digit on a year-to-date basis. Our legacy portfolio is expected, it is expected shrinking, particularly this quarter, with no RSV revenues and our manufacturing of ReFacto now closed as of the first quarter. Based on high growth rates at the early stage in lifecycle medicines in the strategic portfolio, we expected to demonstrate continuous growth, fueled by geographic expansion and the new indications as illustrated on the next slide. Please turn to slide number 8. So we have been pushing growth across 2 dimensions as part of our overall strategy. Pipeline development, meaning bringing new products to market and extending indication. Geographic expansion, meaning expanding the market coverage of our medicines.
For the pipeline, it has been a very productive first half of the year. Altuvoct will now be launched in Europe, first in Germany in H2. This medicine has a tremendous first launch in the U.S. with our partner, Sanofi, and we look forward to bringing this important medicine to patients in Europe and our territories. For SEL-212, we are very gratified that the FDA has granted fast-track designation, and we now have initiated the submission to the U.S. FDA. Fast-track designation will allow us more access and support to the FDA during the filing and the recognition of the unmet medical need in chronic refractory gout.
We are also very happy that we have received a second fast-track designation this year in Q2, this time for Gamifant in secondary HLH, which reflects the importance of our innovative potential medicine and what they can bring to patients. We are on track for filing this indication in the second half. At the same time, we continue building our geographic footprint with launches of Aspaveli, Doptelet, Zynlonta, and Gamifant in new markets, and for Vonjo as of 2035 at scale. This puts forward Sobi into a new phase of sustained growth, driven by new products, execution on our development commitments, and we look forward to the data of Aspaveli in nephrology and the filing of Gamifant in secondary HLH during the second half of the year. Please turn to slide 9.
Doptelet has had another strong quarter, with 61% growth, excluding sales to China in Q2. Sales growth was driven by increased uptake in the U.S., ongoing launches in regions Europe and international. In the U.S., there's a continued positive evolution of patients, new prescribers, higher market share, and duration of treatment. There's also accelerated growth in Europe and international, driven by our ongoing launches and continued increased market share in the earlier launched markets. Please turn to slide 10. The launch of Aspaveli continued well, with quarterly sales of SEK 251 million and 77% growth, continuing a solid launch trajectory. We have strong growth momentum across Europe, International, and Canada, as more patients switch from C5 inhibitors to Aspaveli, Empaveli, seeking optimal control of their PNH.
In the quarter, the EU approved the broad label to include first-line treatment of PNH, enabling our teams to talk broadly about the benefits of this important medicine. We will see the next inflection point for Aspaveli later this year, with the data for the potential new indication in nephrology. We look forward to seeing the Valiant phase 3 study results in second half of this year. Please turn to slide 11. Vonjo sales were SEK 347 million in the quarter. We have seen continued momentum from March, and Vonjo is establishing its place, especially in the below 50,000 microliter platelet patient population. However, we still have not seen the inflection point we want to see in terms of market penetration. Of note, in the first half, we have seen from several sources that the overall volumes in the market, myelofibrosis market-...
have been flat and is expected to grow during the later part of 2024. Currently, we have approximately 8% market share in the myelofibrosis market. Further progress hinges on broader acceptance of the, on the unmet medical needs in these patients, with less than 100,000 platelets and vital knowledge and acceptance of the NCCN guidelines. We are working hard with our enlarged teams on focused messaging and increasing our coverage and reach in the market. We firmly believe we have the best-in-class medicine, as outlined on the next slide. Please turn to slide 12. As mentioned, we still have ample opportunity for Vonjo, not only in the U.S. myelofibrosis market, but where we have a lot of potential, but also in terms of internationalization and new indications.
We are progressing well with Pacifica, with the phase 3 trial, which is important in two fronts. It is confirmatory study to get full approval in the U.S., and it will allow us to file ex-U.S. in more territories. Currently, we will have early access programs in-country utilizing the FDA label, such as in the Middle East. However, Pacifica will be needed for Europe and Japan. We are also continuing our work on new indications and have advanced two indications, and we'll give some update later in the year. Please turn to slide number 13. There's a tremendous unmet medical need in myelofibrosis, and Vonjo represents an important advancement. You can see from the numbers shown here that the median survival with low platelet counts, for instance, below 50,000 platelets per microliter, is only 1.25 years.
While with severe anemia, the median survival is almost 70% longer. When considering Vonjo's effect on platelets, we are convinced that Vonjo could play a much broader role in clinical practice. Along with the strong KOL support we have seen and the updated NCCN guidelines, with additional data emerging on various aspects of Vonjo benefits, such as fast and durable clinical response, symptom reductions, and real-world evidence, which Lydia will cover in more detail later on. We continue to generate new data and build upon the strong clinical rationale for Vonjo in the treatment of myelofibrosis. We have made significant changes to the U.S. setup, with new leadership in the sales management and expanded the overall structure, both commercially and medically.
We are increasing our targeting and digital approaches to reach more HCPs and patients, and building on the education work around the benefits of Vonjo and the unmet medical needs in myelofibrosis treatment. Please turn to slide number 14. Our foundation business continues to be driven by our hemophilia medicines in the second quarter, especially for Elocta. We are expanding the leading presence of Elocta and Alprolix to more patients and in the new territories. This confirms the community's confidence in these treatments and has been able to overcompensate for price developments that we experience, especially in Europe. We saw some additional order phasing driving growth in Q2.
We are very excited and look forward to introducing Altuvoct in Europe in the coming months, and in this important therapy area for Sobi, and building on the great legacy we have built with the hemophilia community in Europe. Please turn to slide number 15. We see continued growth for Gamifant in Q2, with sales of SEK 522 million. Growth becoming more difficult in view of the strong Q2 in 2023. Overall, this positive development is a result of an enhanced go-to-market model, more experience with Gamifant, and the belief of interferon gamma in this setting. We see increased interest from both existing physicians and new prescribing centers, who are increasingly prescribing it for their patients, as well as a better-balanced patient mix, including adolescents and adult patients.
As far as Kineret is concerned, Kineret shows strong growth of 11% in Q2, further reinforced by the elevated interest in the IL-1 mechanism. Demand is coming from all regions. Please turn to slide number 16. I now hand over to Henrik for the financials. Thank you.
Thank you, Guido, and hello, everyone. Please turn to slide 17, and we will now review some key financial metrics for Q2. As said by Guido, Q2 was a strong growth quarter with a very solid business performance, reflected in 11% revenue growth at constant currencies and adjusted EBITDA margin of 28%. Two quick notes: first, and as we heard, there were significant sales of Doptelet to our partner in China last year. Excluding this, our revenue growth in the quarter at CER would have increased to 26%. Second, our EBITDA margin in Q2, and Q3 for that matter, is typically impacted by the lack of RSV sales, leading to a lower margin in these quarters than the average for a full year of business. Looking at the bar chart on the left, all our therapeutic areas exhibited a strong performance.
Specifically, hematology reported a 13% increase, immunology grew by 7%, and specialty care saw a 12% rise. Within hematology, hemophilia grew in the double digits in Q2. We see continued momentum in Doptelet, with a growth of 61%, excluding China, and we see Doptelet growth in all regions. Then we have the addition of Vonjo, contributing SEK 347 million in the quarter, and this is a slight quarter-on-quarter growth. In immunology, we continue to see a strong momentum with Gamifant, and this is the fifth quarter, starting in Q2 2023, that we have delivered more than SEK 400 million in revenue, and the first quarter with sales in excess of SEK 500 million, an all-time high for the product. Also, Kineret continued to grow at double digits, surpassing SEK 700 million in the quarter.
Referring to the table on the right, the revenue of over SEK 5.4 billion corresponds to 11% at constant currencies. Doptelet outside of China, Vonjo, Elocta, Aspaveli, are the key growth drivers in this quarter. The improved adjusted gross margin of 77% in the quarter, compared to 71% in Q2 2023, is mainly due to the absence of low-margin Doptelet sales to China in the quarter, but also to other positive products and country mix effects in the business. The adjusted EBITDA margin reached 28%, up from 26% last year, influenced by the high growth margin just mentioned. Looking at the operating expenses for the quarter, we observe a 22% growth at constant currencies compared to the same period in 2023.
SG&A, excluding non-recurring items and amortization, increased by 7% at CER in the quarter, primarily due to Vonjo, which was not materially included until Q3 2023, and accelerated activities for launch products. We've managed to partly offset the impact of Vonjo on the SG&A line through savings in the Synagis organization, as we reported in Q1. But R&D expenses are the main driver in overall OPEX increase in the quarter, and this is about SEK 350 million of increased spend, reflecting the efforts to file SEL-212 for FDA approval. The additional volume, of course, and clinical and medical affairs activities related to Altuvoct. Non-recurring costs or items affecting comparability amounted to SEK 30 million in the quarter, resulting from the adjustment to COGS related to the fair value of acquired inventory in the CTI acquisition.
Other than this item, we do not expect any significant additional non-recurring costs from the acquisition of CTI moving forward. For detailed information on items affecting comparability in the quarter, please refer to page 3 of the Q2 report. The operating cash flow for the quarter was SEK 2.3 billion, compared to SEK 0.4 billion in Q2 last year. The very strong cash flow is due to higher operating profits, but also a lower net working capital buildup. This net working capital reduction is primarily due to lower gross-to-debt settlements in the U.S. for Synagis. Net debt at the end of the quarter was SEK 16 billion, corresponding to a net debt to EBITDA ratio of approximately 2x. In the first six months of 2024, we have reduced net debt by SEK 3.2 billion, reflecting our solid cash flow generation.
If we now turn to slide 18, and we discuss the financial outlook for the full year, 2024. This is, as usual, based on revenue growth at constant exchange rates and adjusted EBITDA margin. We're upgrading our revenue guidance for the full year, anticipating a low double-digit revenue growth at constant currencies, and we are reiterating an adjusted EBITDA margin in the mid-thirties% of revenue. The upgrade of the revenue guidance comes from the strong momentum that we've seen in H1 of this year, where we expect the main drivers of growth in H2 to continue to be Doptelet, Aspaveli, Vonjo, and the royalties for Beyfortus. Naturally, overall growth rates in H2 are expected to decline versus H1 due to the more difficult comps from H2, 2023.
The margin guidance remains unchanged at the mid-thirties % of revenue, considering the continued efforts in R&D, mainly related to the FDA filing of SEL-212, which is a rolling submission, and Gamifant. In addition, we have the nephrology indications of Aspaveli, C3G and IC-MPGN, as well as accelerated clinical and medical activities for the recently approved Altuvoct. With the outlook covered, I will now hand over to Lydia. Thank you.
Thank you, Henrik, and hello, everyone. So let's start with the pipeline milestones on the next slide, please. We have continued our solid pipeline progress in the second quarter of this year. In hematology, we received European approval for Altuvoct in hemophilia A, as well as for Aspaveli and Empaveli in first line for paroxysmal nocturnal hemoglobinuria. Both medicines are also retained their orphan drug status.... No other factor VIII product has managed to maintain their orphan designation at the time of marketing authorization, which underlines Altuvoct's significant patients' benefit. We are very happy to be able to offer these new options for patients with PNH and hemophilia A. In immunology, we initiated the rolling submission BLA for the SEL-212 in chronic refractory gout at the end of June, and FDA granted Fast Track designation for Gamifant in secondary HLH MAS in Still's disease.
Additionally, very promising data for SEL-212, Altuvoct, and Vonjo was also prominently presented at the recent EULAR, ISTH, and ASCO congresses, and I would like to give you a glimpse of it. Let's start with the SEL-212 on the next slide, please. The SEL-212 submission is based on the results of the DISSOLVE-1 and 2 pivotal studies. We have been developing SEL-212 for chronic refractory gout. The DISSOLVE program consisted of two double-blind, placebo-controlled studies of SEL-212 with 265 dosed patients. Here is the data from the recent EULAR Congress, for the first time showing the pooled data from both DISSOLVE-1 and 2 studies. As you see on the left graph, there was a statistically significant higher response rate for SEL-212 versus placebo, with the majority of chronic refractory gout patients treated with the dose chosen for the BLA submission being responders.
On the right-hand graph, we see that the reduction of serum urate from baseline in treated patients was profound, with a reduction of 5.53 milligrams per deciliter, which represented 60.8%. These are clinically meaningful reductions with unexpected effect on tophi. It is notable that treated patients have no difference in the number of gout flares within the first three months of therapy. As you might know, during the initial treatment period of these patients, other serum urate lowering therapies increased gout flares in this patient population. Finally, no new safety signals were observed, and the overall safety profile of SEL-212 was consistent with previously conducted studies. This is the data FDA used to grant Fast Track designation and which we are basing the BLA on. Next slide, please.
Moving to efanesoctocog alfa, the results from the EXTEND and EXTENDED studies were presented at ISTH with four oral presentations. EXTENDED is the open label extension study to the pivotal EXTEND-1 and EXTEND-Kids, evaluating the long-term safety and efficacy of EFA, and will continue until 2027. The primary endpoint is occurrence of inhibitor development. Secondary endpoints shown here include annualized bleeding rate, treatment of bleeding episodes, and safety. The results confirm EFA's ability to change the treatment paradigm for hemophilia A. 217 participants roll over to the EXTENDED study, 146 adults and 71 kids. Importantly, factor VIII inhibitors did not develop. On the left side of the graph, you see the benefits of EFA prophylaxis. The median annual bleed rate remained at zero, as in the pivotal studies.
Over 94% experience zero spontaneous bleed over 2 years in adults and adolescents and over 35 weeks in the children population. Once-weekly prophylaxis resulted in very high compliance, as you see in the lower left side. If we look at the right-hand side graph, we see the high efficacy of EFA when bleeds occur. A single injection was sufficient to resolve a bleed in 94% of cases, and a large majority of patients, 88%, evaluated their response to treatment of bleed as excellent or good. The mean total dose of EFA required to treat a bleed was 48.2 units per kilogram. Next slide, please. Joint health outcomes in adults and adolescents were also presented at ISTH, showing that all 132 evaluable target joints were resolved during the study, as shown on the left graph.
The investigators who completed the surgical procedures, on the right-hand side, you see the outcomes of the 49 major surgeries, and the investigators completing the procedures assessed the participants' response during the surgery and during the postoperative period. All except one procedure were rated as excellent or good and did not require blood transfusion. Importantly, the cumulative median consumption for major surgeries was 162 international units per kilogram over a period of 16 days, starting the day before the surgery. This consumption is unprecedentedly low for major surgeries in hemophilia and is similar to the 150 international units per kilogram dose of EFA for the routine prophylaxis during the same time period. You can see why we believe that EFA will make such a significant difference to how hemophilia A is treated. Next slide, please.
Moving into myelofibrosis, emerging data on Vonjo highlights a strong rationale for its use in the treatment of this disease. A recently published manuscript analyzed patients treated with pacritinib across the phase three persist studies. Strikingly, the benefit of pacritinib on both spleen volume and symptoms was consistent regardless of baseline platelets or hemoglobin subgroups, as shown on the left side of the slide. In other words, its effect is maintained regardless of baseline blood counts. Symptoms improvement was actually greatest in the patients with severe anemia who had baseline hemoglobin less than eight grams per deciliter. This subgroup also experienced improvement in hemoglobin after starting pacritinib, as shown on the right upper graph, and there was a correlation between symptoms improvement and anemia improvement. In other words, pacritinib has demonstrated efficacy across MF patients, in particular in patients with severe anemia.
Furthermore, our clinical trial data has now been confirmed by the first real-world evidence analysis of Vonjo, recently presented at ASCO, and based on its use for treatment of MF in the US. This real-world data shows that cytopenic patients who receive Vonjo experience a stable or increasing platelet counts and hemoglobin levels, with the greatest anemia benefit experienced by patients with the most severe baseline anemia, as shown on the right lower graph. Next slide, please. Summing up, the first half year, we have delivered on all our major milestones, as you can see on the left-hand side of the slide. Our outlook for the second half of 2024 remains strong. We plan to submit for Gamifant secondary HLH for macrophage activation syndrome in Still's disease in the second half of the year to the FDA.
Doptelet continues its geographic expansion with a planned ITP filing in Japan, and we also will file for the pediatric indication based on the data from earlier this year. We will have the Aspaveli Valiant phase 3 data on C3G and IC-MPGN, which we expect to open the path to new nephrology indications for pegcetacoplan. Our momentum will continue in 2025. Next slide, please. We continue to generate data for Altuvoct, and next year we expect the first year interim data from the Freedom phase 3B study. This will give us insights into physical activity changes for people using once weekly prophylaxis with EFA, and this is a highly relevant indicator for quality of life of patients. For Aspaveli, we aim to submit our nephrology application in Europe and Japan.
Gamifant will see both FDA decision and the Japan submission in secondary HLH MAS, and we will prepare our European filing strategy. We also expect a U.S. regulatory decision for SEL-212 in chronic refractory gout. And finally, we also expect Kineret to be ready for submission in a Still's disease in Japan. And with that, I would like to hand back to Guido. Thank you.
Thank you, Lydia. You know, let's maybe provide you with a summary on the next slide, slide 28. So in summary, we are very pleased with Sobi's development in first half of the year and the performance in Q2. We saw significant top-line growth of 11% in the quarter, 26%, excluding Doptelet China. This reflects the strong performance in our strategic portfolio and our foundational portfolio in hematology and immunology, and continued growth in our key products around the world. This has led us to upgrade our revenue guidance from high single-digit to low double-digit revenues for the full year, and we maintain the guidance of mid-30s Adjusted EBITDA margin. Our R&D pipeline showed tremendous progress with the approval of Altuvoct in Europe for hemophilia A and Aspaveli in first-line PNH in Europe.
We initiated the filing of SEL-212, as you just heard, for chronic refractory gout based on fast track designation in the U.S., and received fast track designation for Gamifant in secondary HLH. In summary, we have a strong momentum at Sobi and in the business, as well as in pipeline development, and we look very much forward to the second half of the year. With this, I think, you know, we would like now to open the floor for questions. For those on the phone, please remember to press star one and to ask a question. Can I remind everyone to limit questions to one or two, to be fair to all callers? Apologies in advance that we are a little bit, we had to stretch it a little bit today, but we had so many areas to cover.
Shows, you know, how busy we are. You know, with this, let's go straight into the question, question and answer session, to give you a maximum time.
We will now begin the question and answer session. Anyone who wishes to ask a question may press star and one on the touch-tone telephone. You will hear a tone to confirm that you have entered the queue. If you wish to remove yourself from the question queue, you may press star and two. Questions on the phone are requested to use only the handset, and please turn off the volume of the webcast. In the interest of time, please limit yourself to one question only. The first question comes from Brian Balchin from Jefferies. Please go ahead.
Hey, thanks for the one on Vonjo. So Guido, you said you're currently penetrating around 8% of the US MF market. So how confident are you in penetrating up to 30%, just in light of the strategic initiatives you've implemented? I guess, have you seen a shift in physician prescribing behavior more towards NCCN guidelines, or is it still kind of in line with the label? Cheers.
Yeah. Thank you. You know, we are currently seeing that we are probably more, you know, we get the vast majority in line with label. There's a lot of work that is cut out for us. We also see that once, you know, we are having the right interactions with physicians, that there's an opportunity to change. That makes us hopeful and, you know, when you look at the data and also we looked at some data from patients, what patients expect, it's clear that they're expecting more than just symptom relief. And that makes us hopeful if we can get this correct connection right, that we can also penetrate into other segments, so below 100,000, primarily.
Got it. Thank you.
Thank you.
The next question comes from Viktor Sandberg, from Nordea. Please, go ahead.
Yes. Hi, thanks for taking my questions. I have two FMA. So also on Vonjo here, I just wondered a bit, you know, about the difference here between the outcome of these couple of quarters versus what you envisioned for the product when you acquired it. I guess you must have known that you would lay off, you know, part of the CTI team to reap the Synagis here. But just wondered what kind of, yeah, what the reasons behind, you know, the kind of sluggish uptake we see right now versus what you expected when you acquired the products and the reason behind that.
I also appreciate if you can relate that to the SEK 36 million you provided here at the final week of the quarter, if that's a reasonable uptake for Q3. And a quick second one, also on Altuvoct and the dynamics there with Elocta. How do you think we should view the erosion of Elocta sales in Europe going forward? I note that in the U.S., Elocta has lost quite a lot of sales, I believe around 35% in the quarters after Altuviiio was approved, but consensus figures in Sobi remain quite flat in 2025 versus 2024 for Elocta. So should the market perhaps factor in higher erosion of sales for Elocta when Altuvoct gains market share?
Or should we have anything in the back of our mind when we model sales for Sobi, in the Sobi territory versus the U.S.? Thank you.
Thank you. Yeah, no, let's start with Vonjo. You know, I mean, it's fair to say that we would have hoped for, you know, better sales. You know, and whilst we clearly expected, you know, to see efficiencies out of the merger with, out of the integration of CTI, it's fair to say that we also lost a few sales management, salesmen leaders and camps, we would not necessarily like to have lost. Yeah. And that's the competition, and, you know, we need to just accept it and... But, you know, we have now, let's say, rebuilt the team. We have everybody understands, you know, what is at stake. That we have some learnings for sure, in targeting and segmentation as well.
But I think, you know, we had, we had the messaging earlier this year as we reported that we needed to improve. And obviously, we have a formidable competitor. We had more time to prepare the market, but the rationale for the product remains the same. So we think, you know, we are delayed, but, you know, when you elevate yourself, you still have, obviously, to deliver Aspaveli, to roll it out broader internationally, but we will have significant launches next year. And then we will obviously bring it also in some new indications. So, you know, we remain very confident that we can do this. Yeah, we are delayed, but we are not derailed. Yeah? And I think this is important, and we will keep pushing this product very hard.
As far as the guidance is concerned for the year, we don't do this on a product basis, but, you know, let's put it this way: We stay confident that we will see some growth in H2, which is more material than whatever we have shown so far. As far as Altuvoct is concerned, you know, we look really at Altuvoct and Elocta, you know, as one area. I mean, we will obviously try to penetrate and reclaim territories from, you know, areas that also Hemlibra have taken, and, you know, obviously consolidate more of the factor VIII market. But as you have seen from the data from Lydia, I mean, this product is fantastic. I mean, very rarely have we seen so much anticipation of the product.
Anyway, as part of Q3, then we can update you on the progress. I mean, it's-- But, you know, so far, it is a lot of anticipation and very positive momentum. We just have the product a few days in the market in Germany, and it's fantastic, you know. So this is... But, you know, we see this Altuvoct and Elocta really as one hemophilia A franchise.... For me, the more patients we switch over time to Altuvoct, the better for Sobi, because and the better for patient, because they have access to the best possible product. So we will see some erosion. I don't think it's gonna be, you know, a landslide.
You know, it's more gradual, but, you know, don't forget that Elocta's patient growth will also come from international territories where, you know, Altuvoct is not gonna be launched in the first place. So, you know, I'm not commenting now on Elocta forecast. I'm just saying that we believe that we can expand our franchise. Yeah.
Thank you.
Thank you.
The next question comes from Mattias Häggblom from Handelsbanken. Please go ahead.
Yeah, thank you so much. Two questions, please. Firstly, there were a number of products that exceeded consensus expectations in the quarter, including Doptelet, Elocta, and Kineret. Could you talk about to what extent there were any one-off tenders or orders that drove the peak by the, by those products, or if their performance reflected underlying dynamics in the quarter? And then secondly, on Gamifant, based on consensus expectations, the product will approach SEK 2 billion in revenues this year. Back in 2020, at the CMU, you called out the peak sales potential of SEK 4 billion-SEK 5 billion. So can you remind me the importance of the potential approval in secondary HLH for Gamifant in order to accomplish this peak sales?
Yes. Thank you, Mattias, for your questions. So with regard to, you know, with regard to Doptelet and Kineret, they are no one-offs. It's just, it's really a reflection of the underlying performance of the business, because, you know, we are experiencing exponential growth as we go along, in particular with Doptelet in the growth phase, and sorry, with Kineret, not exponential, but double-digit growth for a product that obviously has a bit of tenure. This is really growing interest of the product, but it's not affected by vendors. As far as Elocta is concerned, this growth is really there has been some favorability in H1 due to tenders, but it's not as material, yeah.
So there's really a strong, underlying, healthy growth of Elocta, primarily driven by the by emerging markets in the international markets where we have access to the license, Eastern Europe, North Africa. In Turkey, we have an unbelievable momentum. So that's really what's driving Elocta, but there has been some favorability. So you know, we are not projecting, I would not project double-digit growth for Elocta for the full year, particularly as Altuvoct is gonna be launched now. But you know, it is not, you know, it's not like this is flat. I mean, there's the product in itself grows very substantially, yeah. So that's really... But this is really an effect of internationalization. With regard to Gamifant, yeah, you do the math. You know, the Gamifant is up for very significant growth.
We have unlocked now this new potential of Gamifant, as you can see in Q2. And we will, you know, build upon this. The secondary HLH indication, as we have highlighted, is going to be very material for us, and that's the reason why we are showing here so much tenacity, even though this was not the most straight pathway, as you know. You know, it took us a while, but you know, now in second half, we will submit, and we will be able to build this business next year, well, as of next year.
By virtue of the data and by all the publications, you know, that are coming out also from the real-world evidence, we think that the product has much more, you know, to go for. You know, so we are very excited about Gamifant as a very significant revenue driver for the company in the future.
Thank you so much.
Maybe next question. Thank you.
The next question comes from Elliot Campbell, from Redburn Atlantic. Please go ahead.
Thanks so much. Two questions, please. First of all, just to go back to, Vonjo, I mean, it's sort of striking that, your key competitor, GSK, with Ojjaara, is, has been launching very well and gaining traction, pretty nicely there. So just to get a sense of why you think that's happening for Ojjaara versus Vonjo in terms of the competitive dynamic. Does that come down to, a broader label for them or perceived efficacy advantage, or is it maybe something to do with tolerability? Just a sense of how those two drugs stack up. And then maybe just one for Henrik in terms of R&D.
Obviously, R&D is stepping up this year as you integrate CTI, but, you know, as we look forward into 2025, not sort of specific guidance, but just broadly, how should we think about the moving parts in terms of perhaps some trials completing versus others coming on, like additional Vonjo studies? Is it gonna still gonna be upward tension for R&D in 2025? Thank you.
Yeah. Maybe I'll start with Ojjaara versus Vonjo. I think you know what you need to bear in mind is, you know, that, GSK had probably around two years of market shaping this medical organization ahead of us before they launched the product. And they got, you know, a label which is very broad versus, Vonjo's label. We got them end of year, end of last year, the NCCN guidelines, so they have a head start. And I think, you know, when you, when you think about the medical education, would probably have more pronounced anemia as an issue than-...
and maybe myelofibrosis and, but you know, by the same token, you know, as you have seen from the mortality data, we feel very strong that basically the that, you know, that the thrombocytopenia is a much bigger issue. And maybe let's say, after Henrik has completed his... Or maybe, no, I think it's good, maybe Armin because I think it's the essence to come back, you know, myelofibrosis versus anemia. What is here the issue? And then Henrik talks about RDMA. Yeah, Armin?
Yeah, and thank you very much. Hello, everyone. I think one needs to recognize that in myelofibrosis, the end is always fatal, and for the physicians, they really want to treat the patients so that they feel good along the way. And if the patients come, and the biggest concern, taking out all the other aspects, which are less so, is fatigue. And textbook knowledge says, well, fatigue is linked to low red cell counts, to anemia. But a lot of people forget that also low platelet counts could cause fatigue. And if you look at the survival rates, it means that if you have a drug that works in the least favorable population with platelet counts below 50,000, and they have a survival rate, as Guido showed, of 1.25 years median, versus anemia. Severe anemia has what? 2.1 years.
That, I think, tells me as a physician, and this is something that we need to communicate even more to the physicians out there, if they really want to treat their patients, it should not just be the anemia aspect, number one. And number two, the anemia aspect in the Ojjaara data are not really in the lowest platelet count patients, because along myelofibrosis development, both go down. It's cytopenia, meaning the platelets go down, the red cells go down, and if you really want to look at which product serves both areas, we have strong data and more emerging for the pacritinib and Vonjo, and I think this is why we really need to push much, much more and get more, communication going with the physician, even than what we have had before.
Yeah. So maybe I think that gave you maybe a bit of a spell. Henrik, why don't you comment on the R&D expenses?
Yeah. So on the R&D, while you're right, that, activity level has been high and will continue to be high during this year, and when it comes to 2025, we don't guide specifically on 2025 right now, but it's fair to believe that we will continue with high R&D activities also in 2025. Even if some studies come to an end, there is also a lot, a whole set of important medical activities for all these products that will come to launch.
Thank you.
Thank you. Maybe the next question.
The next question comes from Harry Guild from Berenberg. Please, go ahead.
Hi, thank you very much. So I also just have a couple of questions on Vonjo, please. So I was wondering, you know, of, of, of the 8% share that you have today, whether it would be possible for you to provide, you know, some information on how much of that, as it stands today, is coming from the, the less than 50,000 platelet group and those with between 50,000 to 100,000. And then any sort of feedback you're, you're hearing from physicians today about how they decide between Vonjo and Ojjaara, and how confident you are that you can ultimately, highlight the, the benefits of Vonjo and, and start accelerating, that sales ramp.
And then just looking to the longer term, you know, clearly the sales have been a bit, a bit slower than you'd hoped, but has this impacted the longer-term potential in myelofibrosis specifically? Thank you.
Yeah, thank you. You know, with disregard to the 8%, share, you know, we don't break it down. I mean, I mentioned that the vast majority of this share is coming from below 50,000, and we are underrepresented in the other two segments, meaning below 100 and above 100. Now, we know that from the work that we have done, once we have a consistent approach, and we are coming through with a new messaging, that we can change opinions. And that makes us hopeful, you know, particularly when you think about the connection that Armin laid out earlier and the data that were presented by Lydia earlier, that we can do this. So in terms of long-term potential, nothing has changed.
You know, and I think when you think about the other vectors of growth, we will update you that we stand by what we have communicated to the market. There's absolutely no reason for us. Yes, we are not happy. Yes, we had a fair share of learnings, but, you know, we are not, by any stretch of imagination, feeling that we have now to, you know, revise our ambition for the product. You know, we go back in there and we will try to convince, let's say, physicians about the merits of our product. Now, that's what we're doing, and there's a ton of data that we are accruing, you know, in very various different aspects. I mean, you have seen the anemia data from really earlier presented.
We were evidence so very strong. I mean, you know, so, you know, as people will get more accustomed to this, we just have to understand that we have to—we had some headwinds that were larger than we were hoping for, but that doesn't mean that we don't believe in the place of the product. You know, and I think, you know, once we get into a different rhythm, I think, you know, there will be, you know, we will take our fair share. Yeah, next question.
In the interest of time, please limit yourself to one question only. The next question comes from Christopher Uhde from SEB. Please go ahead.
Hi there. Thanks very much for taking my question. So, I might have misunderstood this from before, but I believe that you have said in the past that you're really targeting the community or local office setting with Vonjo rather than the institutional setting and where, let's say, GSK maybe is more focused. Which strikes me as a little unconventional. Is that the correct strategy? Why do you think that's the better route than the usual sort of institutional KOL-led launch? And if I could squeeze in a second one. I... You've previously talked about on Vonjo having lifecycle management trials. None has been announced yet, and I just wondered why the delay, is it the organization or is it something else?
Thank you.
Yeah. Thank you, Christopher. Very much appreciated. No, I think we probably were not clear enough. I mean, of course, we are focusing on KOLs and making sure that we get it top-down right. And, but we also cover, community accounts, and that's, that's correct, you know, where, where we have seen some, some positive feedback. And it, and it's fair to say that, you know, the—when you, when you think about the, the launch dynamics, you know, the, in the first wave, before we got the hemophilia guidelines, it's clear that, you know, Ojjaara probably had taken some share in second line, also in other segments. And, you know, we now, in the process to correct this. Yeah, so basic—but, you know, when, when it...
So we are clearly too focusing also on top-down, the top-down strategy on key accounts. With regard to the lifecycle management or new indications, the thing is that, you know, we have made decisions, and we have progressed those, let's say, quite nicely. Traditionally, we have only announced those studies once we have first patient in, and sometimes this takes some time. Yeah. And that's the reason why you haven't heard from us. But, you know, H2, we come out, and we will share this with you, and I hope you will be happy with the choices that we have made. And you know, there's a much broader, let's say, story that we want to tell you, let's say, in the next couple of months, and we will not shy away.
So it is not that we, we are not, daring, we are wavering, or we are slow. It's sometimes it takes a while, and it's true that, you know, let's say that, you know, it took us a while, maybe last year, but, you know, we are absolutely determined to get this one going, and we have made arrangements already and, you know, signed contracts, agreements, to get this one off the ground. But we wanted to make sure that we come out of the blocks, also to make sure that we don't give too much lead time to our competitors. And, and that's the reason why you haven't heard from us.
Thanks so much.
Thank you.
The next question comes from Erik Hultgård from Carnegie. Please go ahead. Mr. Hultgård, your line is open. You may proceed with your question.
Sorry, I was on mute. Thanks a lot for taking my question. Regarding Vonjo, I guess it's quite obvious that you haven't been successful enough to get your message out to physicians to change sort of prescriber behavior. So how much of that is just a question of time, that it takes time to get the messaging out? And how much is actually related to sort of investments behind the product? So are you considering increasing the number of sales reps or investing more behind other type of channels to get the message out? Thank you.
Thank you. I mean, it is both. It's time, because, you know, when we lost quite a few people in the field, then obviously we lost also context, so that needs to be rebuilt. That takes time. And it is also a question of quantity, and we have addressed this as well. So we have significantly upgraded the team, and, you know, we have changed the sales management.
Thank you so much.
Thank you.
The next question comes from Alex Neil from DB. Please go ahead.
Hi, it's Alex Neil from Deutsche Bank. Thanks for taking my question. It's one on margin outlook. So you've historically provided some guidance for FY 2025. So thinking of hemophilia's momentum and the slow start to Vonjo, can your profit margins get to north of 40% in the midterm? And then if I can squeeze in a very quick one, do you have any appetite for further acquisitions going forward? Thanks.
Thank you. I think you know the north of 40%, if we keep growing at the pace we are currently growing. It's probably, you know, with the programs that we are currently supporting, is probably not quite realistic. I mean, you know, we're expecting a significant boost from the royalty income, and that will clearly give us an uplift, and we'll have to see, you know, Sanofi will give you guidance next week, as far as I understand. But, you know, I think, you know, right now, I think we need to double down on this, on our portfolio and on our pipeline, as you've seen. I mean, we have fantastic pipeline in our stable.
I mean, I know that there is still some reservations with SEL-212, and, you know, there's also, you know, a bit of a struggle, yeah. But, you know, now to get fast-track designation and to finally submit, I mean, I was very excited. We were yesterday together with the team, that it has been newly formed for this product. I mean, there's so much excitement around this product. And, you know, the way they're thinking about it, we're thinking that this is a very material product for the company. I mean, it worked. We had a launch conference just a few days ago as well.
So you want us to really exploit the opportunity that are related to our portfolio, and therefore, you know, I'm probably more cautious on the earnings, but I'm bullish on the prospect of the company in terms of driving double-digit growth. You know, that's what we are trying to do, and obviously, building this business in a very sound way. With regard to new deals, I think, you know, we are currently, obviously, looking at this. We have our hands full, as you can see. You know, it's a very rich program. I mean, if the nephrology data will look as good in a few weeks as the phase two data looked like, I mean, we will have another very happy problem, yeah, to tackle this very important indication, and we think the opportunity is there.
This is a spectacular place also for Sobi. In sum, you know, I mean, we believe in this business and building it up. I mean, obviously, we understand that we want to improve margins, but whether this is the time now to think already about 40, I think it's probably premature. Henrik, you want to comment on margins? This is your area.
No, I think you've covered it. It's premature with all the activities that we have ongoing, driving the pipeline, but also all the launches that are ongoing and upcoming. It is not a short-term realistic scenario.
Yeah. Thank you. Maybe another question?
The last question for today's call is from Yang Liu from HSBC. Please, go ahead.
Hello, thanks for taking my question. I just got one in there. You commented on the overall, sort of myelofibrosis, market, and first-time remission was flat. And how should we think about moving forward part of it in terms of going to H2 and maybe 2025? And do you see any sort of upside and trends? Any color you can provide on that, please? Thank you.
Yeah. Thank you. I mean, when you look at the Evaluate data and, you know, they, they're expecting, you know, the, a recovery of this, in around 5% for the year. I think, you know, that's- I would have a better data point myself. Yeah, so I think you, while you see this a momentary weakness in Q1, sorry, in Q2, I don't see this as a permanent, situation. But yeah, so I think, you know, this will even out, and, over the next, quarters, and also driven by the fact, you know, of the new launches and taking share and building the market and awareness. So I don't see this as a permanent.
I'm mindful now of time, and, you know, apologies that we had so much to cover, but, you know, which is also good, you know, this is a company that has a lot of things currently ongoing. I would propose, if you are okay with this, that we stop now the earnings call, respecting everybody's, time. And, if you have questions, please, refer to, our IR team, and we will try to schedule also meetings with, with other experts of the company as you, as you feel like. You know, we want to make sure that you get the, the best possible information on our business, and we, we don't shortchange anybody. So very much appreciate your time. Thank you for, for staying tuned during the summer period, and, wish you a great, great week and, talk to you soon.
Thank you.
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 the lines. Goodbye.