Swedish Orphan Biovitrum AB (publ)

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 listened only mode and the conference has been 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 number two, of the usual provisions on statements about expectations and projections of future events. And unless stated otherwise, we will be making comments that mostly relate to the second quarter at constant exchange rates in million Swedish kronor. Please turn to slide number three. Today, we plan to cover the key aspects of our Q2 report. I'm joined by Henrik Stenqvist, our CFO, Lydia Abad-Franzsch, our head of R&D and chief medical officer. During the Q&A sessions, we will be joined by Armin Reiniger, 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 one or maximum two questions at a time. With this said, let's go right to the beef of the presentation. Please turn to slide number four. 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 full zone. Taking away this effect, our top line growth would have been 26%. Hematology growth was driven by continued growth of Dopdelen and Asparvilli sales and the addition of Wonjo. We saw growth of Elocta and Alpolix, mainly driven by geographic expansion, but also by some phasing in tender markets. We continue to build the launch of Wonjo, which has taken time, and while we see progress, we believe that the product offers a broader potential than we currently yield. 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 gamifan sales of $522 million. sex sales where no synergist 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 Altowalked in Europe for hemophilia A and the filing of SEL212 to FDA under fast-track designation for the potential treatment of chronic refractory gout. Additionally, we received fast-track designation for Gummy Fund 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 guidance for 2024. We expect double-digit growth, previously high single-digit, and mid-30s for the adjusted EBITDA margins. Please turn to slide number five. 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 FOSO. Growth came from all regions with the U.S. growing at 38% and international excluding adopted at China grows impressively 73%. We look forward to continuing the delivery of our global strategy in 2024. Please go to slide number six. Our growth strategy has led to strong results. which primarily driven by our strategic growth portfolio, which includes our medicines listed here, and Befortus and our two view royalties in the U.S., 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 Altovox sales as of now, based on the recent approval 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 the other representation of growth in the quarter, again, demonstrating the growth of our strategic portfolio of 74%, while 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 Alokta, Alkorex, and Kinneret, all showing double digits on a year-to-date basis. Our legacy portfolio is expected shrinking, particularly this quarter with no RSE 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 eight. So we have been pushing growth across two 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. Altuvox 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 Cell 212, we are very gratified that the FDA has granted fast-track designation, and we now initiated the submission to the US FDA. Fast-track designation will allow us to 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 Gummy Fund 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 Asper Valley, Doctolet, Celonta, and Gamifund in new markets, and for Wonjo as of 2035 at scale. This puts Poho Zobi into a new phase of sustained growth driven by new products, execution on our development commitments, and we look forward to the data of Asper Valley in nephrology and the filing of GAMI Fund in secondary HLH during the second half of the year. Please turn to slide nine. Dr. Lett has had another strong quarter with 61% growth excluding sales to China in Q2. Sales growth was driven by increased uptake in the US, ongoing launches in regions Europe and international, In the U.S., there's a continued positive evolution of patients, new prescribers, higher market shares, 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 number 10. The launch of Aspavelli continued well with quarterly sales of 251 million sec 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 Aspavelli and Pavelli 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 ASPA Valley later this year with the data for the potential new indication in ufology. We look forward to seeing the Valley and Phase III study results in the second half of this year. Please turn to slide number 11. Wonjo sales were 347 million sec in the quarter. We have seen continued momentum from March and Wonjo 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 myofibrosis market have been flat and is expected to grow during the later part of 2024. currently we have approximately eight percent market share in the myofibrosis market further progress hinges on broader acceptance of the on the unmet medical needs in these patients with less than 100,000 platelet 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 Wonjo not only in the U.S. myofibrosis market, 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 III trial, which is important in two fronts. It is a confirmatory study to get full approval in the U.S., and it will allow us to file ex-US and 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 will give some update later in the year. Please turn to slide number 13. There's a tremendous unmet medical need in myofibrosis and Bonjoe represents an important advancement. You can see from the numbers shown here that the medium 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 Wonjo's effect on platelets, we are convinced that Wonjo 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 Wonjo 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 Wonjo in the treatment of myofibrosis. We have made significant changes to the US 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 WONJO and the unmet medical needs in myofibrosis 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 Alprolex 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, autophasing driving growth in Q2. We are very excited and look forward to introducing Altoworked 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 Gamifund in Q2 with sales of 522 million SEG, growth becoming more difficult in view of the strong Q2 in 2023. Overall, this positive development is a result of an enhanced whole-to-market model, more experience with Gamifund, and the belief of Interphone Gamma in the 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 of constant currencies and adjusted EBITDA margin of 28%. Two quick notes. First, and as we heard, there were significant sales adopts led 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 dopsulate with a growth of 61%, excluding China, and we see doplet growth in all regions. Then we have the addition of Vonjo, contributing 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 400 million SEC in revenue, and the first quarter with sales in excess of 500 million, an all-time high for the product. Also, Kinrate continued to grow at double-digit, surpassing 700 million in the quarter. Referring to the table on the right, the revenue of over 5.4 billion corresponds to 11% at constant currencies. Topselet outside of China, Vonjo, and Loxan as the value of the key growth drivers in this quarter. The improved adjusted gross margin of 77% in the quarter compared to 71% in Q2-23 is mainly due to the absence of low-margin docile sales to China in the quarter, but also to other positive product and country mix effects in the business. The adjusted EBITDA margin reached 28% up from 26% last year, influenced by the high gross margin just mentioned. Looking at the operating expenses for the quarter, we observed 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 Bonjour on the SG&A line through savings in the synergies 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 350 million of increased spend reflecting the efforts to file cell 212 for FDA approval. The additional volume of costs and clinical and medical affairs activities related to out-of-box. Non-recurring costs or items affecting comparability amounted to 30 million in the quarter, resulting from the adjustment to COGS related to the fair value of acquired inventory in the CTI acquisition. And 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 $2.3 billion compared to $2.4 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 net settlements in the U.S. for synergies. Net debt at the end of the quarter was 16 billion, corresponding to a net debt to EBTA ratio of approximately two times. And in the first six months of 2024, we have reduced net debt by $3.2 billion, reflecting our solid cash flow generation. If we now turn to slide 18, we discuss the financial outlook for the full year 2024. And this is, as usual, based on revenue growth at constant exchange rates and adjusted EBITDA margins. We're upgrading our revenue guidance for the full year, anticipating a low double-digit revenue growth at cost of currencies, and we are reiterating an adjusted beta margin in the mid-30s percentage 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 Doctonet, Asta Valley, Bongeo, and the royalties for Bay Fortis. 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-30s percentage of revenue, considering the continued efforts in R&D, mainly related to the FDA filing of cell 212, which is a rolling submission, and gun default. In addition, we have the nephrology indications of Aspen Valley, C3G, and ICMPGM, as well as accelerated clinical and medical activities for the recently approved Outlooks. And with the Outlook covered, I will now hand over to Lydia. Thank you.

Thank you, Heinrich. 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 Altuvox in hemophilia A, as well as for Astavelli and Pavelli in first line for paroxysmal nocturnal hemoglobinuria. Both medicines also retain their orphan drug status. No other factor VIII product has managed to maintain their orphan designation at the time of marketing authorization. which underlines out of a significant patient's 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 VLA for the cell 212 in chronic resumptory gout at the end of June. And FDA granted fast-track designation for igamifant in secondary HLH mass in Stills disease. Additionally, very promising data for SALT212, ALTVOGT, and BONJOE was also prominently presented at the recent EULER, ISTH, and ASCO Congresses. And I would like to give you a glimpse of it. Let's just start with the SALT212 on the next slide, please. The SALT212 submission is based on the results of the DISSOLVE 1 and 2 pivotal studies. We have been developing Cell 212 for chronic refractory gout. The DISSOLVE program consisted of two double-blind placebo-controlled studies of Cell 212 with 265 dose patients. And here is the data from the recent Euler Congress for the first time showing the pool data from both DISSOLVE 1 and 2 studies. As you see on the left graph, there was a statistically significant higher response rate for SALT212 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 5.3 milligrams per deciliter, which represented 60.8%. These are clinically meaningful reductions with unexpected effects on TOFI. 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 urinary lowering therapies increased gout flares in this patient population. And finally, no new safety signals were observed. and the overall safety profile of SEL2 and 2 was consistent with previously conducted studies. This is the data FDA used to grant fast track designation and which we're basing the BLA on. Next slide, please. Moving to efanesoctocogalpha, 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 rolled 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 two years in adults and adolescents, and over 35 weeks in the children population. And once weekly prophylaxis resulted in very high compliance, as you see in the lower left side. If we look at the right-hand side graphs, 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 participant's 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 searches 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 Bonjoe highlights a strong rationale for its use in the treatment of this disease. A recently published manuscript analyzed patients treated with pacretinib across the phase 3 persist studies. Strikingly, the benefit of pacretinib 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 group also experienced improvement in hemoglobin after starting pacretinib as shown on the right upper graph. and there was a correlation between symptoms improvement and anemia improvement. In other words, Pacuritinib 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 Bonjo recently presented at ASCO, and based on its use for treatment of MF in the U.S. This real-world data shows that cytopenic patients who receive Bonjo experience 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. Coming 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 gamifan in secondary HLH for macrophage activation syndrome in stills 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. And we will have the Astaveli Valiant Phase III data on C3G and ICMPGN, which we expect to open the path to new nephrology indications for pexetacoplant. And our momentum will continue in 2025. Next slide, please. We continue to generate data for all two walks. 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 Astabelli, we aim to submit our nephrology application in Europe and Japan. GAMIFAN will see both FDA decision and the Japan submission in secondary HLH mass, and we will prepare our European filing strategy. We also expect a U.S. regulatory decision for SALT212 in chronic refractory gout. And finally, we also expect Kineret to be ready for submission in a stills disease in Japan. And with that, I would like to hand back to Guido. Thank you.

Thank you, Lydia. And, you know, let's maybe provide you with a summary on the next slide, slide 28. So, in summary, we are very pleased with SOVI's development in the first half of the year and the performance in Q2. We saw significant top-line growth of 11% in the quarter, 26% excluding Dr. LeChina. This reflects a 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 maintained the guidance of mid-30s adjusted EBITDA margin. Our R&D pipeline showed tremendous progress with the approval of Altuvox in Europe for Haemophilia A and Aspar Valley in first-line P&H in Europe. We initiated the filing of SEL212, as you just heard, for chronic refractory gout based on fast-track designation in the U.S. and received fast-track designation for a gummy fund in secondary HLH. In summary, we have a strong momentum in the business as well as in pipeline development, and we look very much forward to the second half of the year. And 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 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 with only handsets and eventually 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 Balkin from Jefferies. Please go ahead.

Hey, thanks for the question. Just one on Vonjo. So, Gidi, as 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.

Thank you. You know, we are currently seeing that we are probably more, you know, we get the vast majority in line with the 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 for 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 symptomatic. And that makes us hopeful if we can get this conjunction right, that we can also penetrate into other segments below 100,000 primarily.

Got it. Thank you.

Thank you. The next question comes from Victor Sandberg from Nordea. Please go ahead.

Yes, hi. Thanks for taking my questions. I have two FMAs. So also on Bongeo 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 read the synergies here but just wondered what kind of 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 and also appreciate if you can relate that to the 36 million provided here at the final week of the quarter if that's a reasonable uptake for Q3. And a quick second one also on Altevoxt and the dynamics here with Alokta. How do you think we should view the erosion of Alokta sales in Europe going forward? I note that in the US Alokta has lost quite a lot of sales, I believe around 35% in the quarters after L2V was approved. But consensus figures in Sobe remain quite flat in 25 versus 24. for Elocta, so should the market perhaps factor in higher erosion of sales for Elocta when Alaltovox gains market share or should we have anything in the back of our mind when we model sales for Sobe in the Sobe territory versus the US? Thank you.

Thank you. Let's start with one, Joel. It's fair to say that we would have hoped for better sales. And whilst we clearly expected to see efficiencies out of the merger with or out of the integration of VTI, it's fair to say that we also lost a few sales management leaders and camps we would not necessarily like to have lost. And that's a competition and we need to just accept it. But we have now let's say rebuilt the team. We have Everybody understands, you know, what is at stake. There were some learnings for sure in targeting and segmentation as well. But I think, you know, we had the messaging earlier this year as we reported that it needed to improve. And obviously we have a formidable competitor. We have 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, you know, Pacifica to rule 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 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 AltaWalk is concerned, we look really at AltaWalk and Alokta as one area. We will obviously try to penetrate and reclaim territories from you know, areas that also Libra has taken, and also, you know, and obviously consolidate more of the Factor VIII market. As you've seen from the data from Ludi, I mean, this product is fantastic. I mean, very rarely have we seen so much anticipation of the product. And, you know, as part of Q3, then, we can update you on the progress. I mean, but, you know, so far, there's 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. So this is, but you know, we see this, Altorock and Elocta really as one Haemophilia A franchise. For me, the more patients we switch over time to Altorock, the better for SOVI, and the better for patients, because they have access to the best possible product. So we will see some erosion. I don't think it's going to be, you know, a landslide. you know, it's more gradual, but don't forget that Elocta's patient growth will also come from international territories where, you know, Altowalk is not going to 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 A franchise. Thank you. Thank you.

The next question comes from Mattias Hegelblom from Handelsbanken. Please, go ahead.

Thank you so much. Two questions, please. Firstly, there were a number of products that exceeded consensus expectations in the quarter, including Doctelet, Deloctate, and Kinret. Could you talk about to what extent there were any one of tenders or orders that drove the beat 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 2 billion krona in revenues this year. Back in 2020 at the C&D, you called out the peak sales potential of 4 to 5 billion krona. So can you remind me the importance of the potential approval in secondary HLH for Gamifant in order to accomplish these peak sales?

Yes. Thank you, Mattias, for your question. So with regard to Dopilot and Kineret, they are no one else. It's really a reflection of the underlying performance of the business because we are experiencing exponential growth as we go along. In particular, we stopped in the growth phase. Sorry, with Kinneret, 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. So there's really a strong underlying healthy growth of Elocta, primarily driven by emerging markets, 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 Elokta, but there has been some favorability. So, you know, we are not projecting, I would not project double-digit growth for Elokta for the full year, particularly as AltaWood is going to be launched now. But, you know, it is not, you know, it's not like this flat. I mean, the product in itself grows very substantially, yeah. So that's really, but this is really an effect of internationalization. With regard to GAMI Fund, yeah, you do the math. You know, the GAMI Fund is up for very significant growth. We have unlocked now this new potential of GAMI Fund, 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, it took us a while, but now in the second half, we will submit, and we will be able to build this business as of next year. And we've learned by the virtue of the data And all the publications that are coming out also from the real-world evidence, we think that the product has much more to go for. So we are very excited about Gaffey Fund as a very significant revenue driver for the company in the future.

Thank you so much. Thank you.

The next question comes from Elisir Campbell from RSD. 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 Ajara, 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 Ajara 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? There's 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 there still going to be upward tension for R&D in 2025? Thank you.

Yeah. Maybe I'll start with Ojiro versus Vonjo. I think, you know, what you need to bear in mind is, you know, that And GSK had probably around two years of market shaping with a medical organization ahead of us before they launched the product. And they got, you know, a label which is very broad versus Von Joe's label. We got then end of year, end of last year, the NCCN guidelines. So they have a head start. And I think, you know, when you think about the medical education, what probably have more pronounced anemia as an issue than maybe myofibrosis. But, you know, by the same token, you know, as you have seen from the mortality data, we feel very strong that basically the, you know, that the thrombocytopenia is a much bigger issue. And maybe, let's say, after Henrik has completed his, or maybe, you know, I think it's good Maybe Armin, because I think it's the essence to come back, you know, myofibrosis versus anemia. What is here the issue? And then Henrik talks about RMA.

Armin? Yeah, and thank you very much. Hello, everyone. I think one needs to recognize that in myofibrosis, the end is always fatal. And for the physicians, they really want to treat the patient so that they feel good along the way. And if the patients come and the biggest concern is, taken 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 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 OJARA 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 Percritin and Bonjo, 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 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, well, 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 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 Gill from Burenburg. Please go ahead.

Thank you very much. So I also just have a couple of questions on Bonjo, please. So I was wondering, you know, 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 less than 50,000 platelet group and those with between 50 to 100,000. And then any sort of feedback you're hearing from physicians today about how they decide between Bonjo and Ajara? and how confident you are that you can ultimately highlight the benefits of Vonjo and start accelerating that sales ramp. And just looking to the longer term, clearly the sales have been a bit slower than you had hoped, but has this impacted the longer term potential in myelofibrosis specifically? Thank you.

Yeah, thank you. With regard to the 8% share, You know, we don't break it down. 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 have coming through with the 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. And, you know, 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. That's what we're doing. There's a ton of data that we are accruing in various different aspects. I mean, you have seen the anemia data from Julia earlier presented. We were at evidence. So it's very strong. I mean, as people will get more accustomed to this, we just have to understand that 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. And I think once we get into a different rhythm, I think we will take our fair share. Next question.

In the interest of time, please limit yourself to one question only. The next question comes from Christopher Ude 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 Bon Jo, rather than the institutional setting and where it is, let's say GSK maybe is more focused, which strikes me as a little 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. You previously talked about On Bon Jo 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.

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, but we also cover community accounts, and that's correct, where we have seen some some positive feedback, and it's fair to say that, you know, when you think about the launch dynamics, you know, in the first wave, before we got the anticipating guidelines, it's clear that, you know, OJARA probably had taken some share in second line, also in other segments, and, you know, we now in the process to correct this. So we are clearly focusing also on the top-down strategy on key accounts. With regard to the lifecycle management on new indications, the thing is that we have made decisions and we have progressed those, let's say, quite nicely. Traditionally, we have only announced those studies once you have, we have first patient in. And sometimes this takes some time. 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 are not daring, we are wavering, or we are slow. Sometimes it takes a while, and it's true that, you know, let's say that it took us a while maybe last year, but we are absolutely determined to get this one going, and we have made arrangements already and 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 that's the reason why you haven't heard from us. Thanks so much. Thank you.

The next question comes from Eric Hultgaard from Carnegie. Please go ahead. Mr. Hultgaard, your line is open. You may proceed with your question.

Sorry, I was on mute. Thanks a lot for taking my question. Regarding Vono, I guess it's quite obvious that you haven't been successful enough to get your message out to physicians to change prescriber behavior. 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 all the context. So that needs to be rebuilt. That takes time. And it's 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 Alexander Niel from DB. Please go ahead.

Hi, it's Neil Alexander from Deutsche Bank. Thanks for taking my question. It's one on margin outlook. So you've historically provided some guidance for FY25. So thinking of hemophilia's momentum and the slow start to Vonjo, do you feel profit margins can get to north of 40% in the midterm? And then if I can squeeze in a very quick one, if so, do we have any appetite for further acquisitions going forward? Thanks.

Thank you. I think, you know, the north of 40%, if we keep growing at that pace, we are currently growing. It's probably, you know, with the programs that we are currently supporting, it's probably not quite realistic. I mean, you know, we will get a significant boost, obviously, from expecting a significant boost from the royalty income, and that will clearly give us an uplift, and we'll have to see, you know, some of you will give you guidance next week, as far as I understand. But, you know, the 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 a fantastic pipeline in our stable. I mean, I know that there's still some reservations with SEL212, and, you know, this is 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, I, too, 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. And, 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 look is, as a phase two data look like. I mean, we will have another very happy problem, yeah, to conquer 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. Yes.

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 malfibrosis market in first-time remittances flat. And how should we think about moving part of it in terms of going to H2 and maybe 2025? And do you see any sort of upside and trend 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're expecting, you know, the recovery of this in around 5% for the year, I think, you know, I would have a better data point myself. So I think once you see this momentary weakness in Q1, sorry, in Q2, I don't see this as a permanent situation. Yeah? So I think this will even out over the next quarters and also driven by the fact 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 apologies that we had so much to cover, but which is also good. This is a company that has a lot of things currently ongoing. I would propose... If you are clear with this, that we stop not the earning 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 other experts of the company as you feel like. We want to make sure that you get the best possible information on our business and that we don't shortchange anybody. So very much appreciate your time. Thank you for staying tuned. during the summer period and wish you a great week and talk to you soon. Thank you.

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