Swedish Orphan Biovitrum AB (publ)

Ladies and gentlemen, welcome to the Q2 2023 reports conference call and live webcast. I am Alice, the Coruscant operator. I would like to remind you that all participants have been listed on remote 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 1 on your telephone. For operator assistance, please press star and 0. 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.

Yeah, thank you so much, and welcome, everybody. This is Guido Oelkers, CEO of Solvi. As you can see from the Q2 report that we published earlier this morning, we're obviously super excited about the performance in 2023 so far and delighted to welcome you to the second quarter 2023 conference call for investors and analysts. We posted this presentation on our website, SUBI.com, and we would like to, and, you know, let's go to the next slide, you know, the safe harbor statement as per usual. We would like to remind you of the usual provisions. Unless I state it otherwise, we will make comments that most relate to second quarter performance in 2023 at constant exchange rate in million Swedish krona. Today we plan to cover the key aspects of our quarterly report. I'm joined by Henrik Stenqvist, our CFO, and Armin Reidinger, Swedish scientific and medical advisor and a member of the EXCOMM. We plan to review the presentation first and then open up for Q&A at around 2 p.m. Swedish time. And for those on the phone, please join the queue for questions by pressing star 1. we propose that you ask only one or two questions at a time as per usual. So let's go right to the beef and go to the first slide. You know, we successfully delivered on our strategy in the last quarter. We saw significant top-line growth of 16% at constant rate and 26% at actual rate for the quarter. And this brings us to 6% growth at constant rate for H1, respectively, 15% as reported. This reflects a strong performance both in hematology and immunology, and in particular, our launch medicines, which have been growing over 80% for the quarter at constant rate. Hematology revenues were growing at 18%, and the growth was mainly driven by Our launch product stopped delayed in Asper Valley, whereas we had stable sales from our foundation business with Elocta and Alprolix. Our stronghold position in hemophilia provides us with an excellent platform ahead of the expected launch of FNS Octococc Alpha and confirms our strength in rare hematology. Immunology reflected strong growth of Kineret and Gamifront. Our ambition to build a leading rare hematology franchise was evidenced by the closing of the CTI Wonjo acquisition. The acquisition offers considerable strategic opportunities by capitalizing on our hematology expertise and on Wonjo's potential for patients worldwide. Our R&D pipeline progressed with two milestones. We submitted FNS Octococc Alpha to the European Medical Medicine Agency. FNS Octococc has great potential to become the new standard of care for hemophilia A. Hence, this was a very important milestone for our company. Yesterday, the FDA approved nilcivimab for RSV, and this has been a big or an important milestone for our company as well as we are benefiting from royalties. in the U.S. We have strong momentum in the SOBI business, taking together with the CTI platform. We have raised our revenue guidance for the year to high single-digit growth accordingly. So all four elements of our SOBI strategy contribute to this performance. It's about building our leadership in rare hematology, building our pipeline and allowing us to capture value from it, building an immunology franchise and growing it, and this is evidenced by the strong leap of Gamifan performance and our regional expansion and becoming a true global player in rare disease. Moving to the next slide, please. And we are very excited to have enclosed this transaction with CTI because it provides us with a range of benefits, both immediately and in the long term. WONJO is a very promising medicine. It is well differentiated as it targets JAK2 and IRAC and ACVRV1 while sparing JAK1. It therefore addresses an unmet medical need in severe thrombocytopenic myofibrosis. WONJO complements SOVI very well. Myofibrosis is a blood cancer. SOVI has extensive experience in thrombocytopenia with stop-to-let In addition, the CTI team has developed formidable expertise in hemato-oncology, which will expand our collective capabilities and create new opportunities for the future. It will be highly accretive to revenue margins. We already recorded the first sales in June at 36 million kroner. And as I said, we are raising our guidance for 2023 partially because of the acquisitions. Please turn to page number six. So when integrating CTI, we make sure that we fully capture, you know, Wanzhou's value. In the first weeks, we seamlessly, the seamless continuation of Wanzhou operation has been our focus. We successfully retained key talents and started the cultural and business integration. There's a lot of energy and engagement on both sides. which makes me very optimistic. We also started the lifecycle management planning to define how we expand into new indications and territories beyond the U.S. It is one of the areas that CTI has not been able to fully embark on due to their size. With our experience and capabilities, we can add a lot of additional dimensions to unleash WANJO's potential. All in all, that we are very thoughtful about building Onjo's franchise up to its potential and creating leverage with a newly formed SOBI organization comprising of top talents from CTI and SOBI professionals. This goes beyond the realization of savings. We have ambitious near-term goals for our hematology franchise and see exciting opportunities in the area of lifecycle management and development. Let's turn to page number seven. So just to share a little bit of excitement on Prakritinib. Prakritinib is a well-positioned for growth, and we will explore its further benefits to patients with myofibrosis and beyond. Real-world insights into benefit of Wonjo in different patient population to extend its benefits and enable a wider patient access. We also want to embark on the following, therefore, very strong scientific rationale for the benefit of paracetamol in other diseases with underlying inflammation-driven pathophysiology, regulatory submissions in international markets. So these are the key drivers. It's insight into new opportunities. It's providing a new strategic rationale into other indications, and then obviously taking advantage of our global footprint. We want to share our excitement about CTI, and in particular Bonjo, or Prakritinib, or it's called generically, to provide you with additional insights. Hence, we host an event with Professor John Mascarenas from Mount Sinai tomorrow. He is one of the foremost experts in the field and will give you an overview on latest data and possibilities, He will be joined by Sarah Buckley, who is our new global medical lead for the franchise at Sobe, who will provide an in-depth understanding on the subject matter as well. Now it's time to turn to slide number eight, and Henrik, would you like to take this?

Sure. Thank you, Guido. Hello, everyone. So as many of you will have seen, Sobe today called for an EGM, on August 15th for the purpose of carrying out the rights issue of approximately $6 billion with preferential rights for existing shareholders. The proceeds will be used to partly finance the CTI acquisition of approximately $17.3 billion, corresponding to about one-third of the equity value. Considering SOBE's momentum, this quantum gives us an appropriate starting point post the acquisition for further deleveraging and financial flexibility. Following an authorization by the EGM, the intention is to launch the rights issue soon thereafter, and the terms of the rights issue will be set by the Board shortly before the launch. And as previously announced, Investor B, our main shareholder, has undertaken to subscribe for their pro-rata share of the rights issue, corresponding to about 36.2% of the shares. In addition, Fjärde Oppe Fonden, Polar Capital, Handelsbanken Fonden, and Swedbank Rover, together representing about 12.8% of the shares, have expressed an intention to subscribe for their respective pro-rata share. So altogether, shareholders representing about 49.1% of the shares have undertaken to subscribe or expressed their intention to subscribe to their respective pro-rata share of the rights issue. I think I now hand back to Guido.

Yes, thank you, Henrik. You know, let's turn back to our quarterly performance, and, you know, we provided now with a with a perspective on page 9 on our performance by franchise and regions. As stipulated before, our growth of 16% was driven by both hematology and immunology, especially our launch brands, over 80% growth, just to bring this back alive. And that brings us to a revenue growth at a constant rate of 6% for the first six months. and the constant rate. And, you know, basically what you can see is, you know, very strong growth, underlying growth. If you would, this 6% would be around taking away the COVID effect for Kinneret and our business with the Chinese partner, Fuzun, for Doctoled, we would have grown at 9%. So that gives you a little bit of a of guidance on the underlying goals of the company. So both regions, North America and international, grew very significantly in the quarter, whereas Europe was pretty stable. So in the first half, all regions grew high single-digit rate. Let's turn to slide number 10. And I think this is, you know, we wanted to show you a little bit the sources of growth and why we are so excited about you know, SOVI's future as well as we are about our Q2. This is a schematic chart for illustration purposes only. And what you can see is today's growth is fueled by a rich portfolio of growth and launch products, namely Dr. Lead, Asper Valley and P&H, Gummy Fund, Cilantro, and Bonjo. All products have one common theme. there's still a lot of headroom to reach full potential. And that means that there's a lot left on the table to grow the company in the forthcoming years. What is exciting for us is that during the second half of this year, this portfolio of five growth products will economically be joined by the expected royalty stream from Bifortis in the U.S., by the launch of EFRA in the first launch countries, likely in the Middle East. And when you think about the other portfolio, why is SEL212 and ASPA Valley and nephrology indications are not too far off from launch either? It gives you a perspective that this portfolio of late-stage pipeline, launch products and gross products, is very much de-risked at this point of time. In summary, SUBI is looking forward to a period of sustained growth driven by a lot of new products. Let's turn to page number 11. Obviously, our bread and butter business, you know, hemophilia, and it is important, particularly also in view of our new launch of FNS OctoCock Alpha. So our business is continues to be underpinned by stable hemophilia growth of 2% at age 1. We expand the leading presence of ALOCTA and operates to more patients in new territories. This confirms the community's confidence in these treatments. For ALOCTA, we see underlying unit growth in international markets, while the facing is less favorable in Q2. government interventions, compressed prices in various European markets, while we see a positive evolution on consumption and patient expansion in Europe. As a result, Elocta grew at 2%. Alpolix was impacted by this quarter by the phasing in the Middle East, but grew 8% for the first half. Let's turn to slide 12. And this is the doctor-led chart, you know, And here, what you can see, obviously a very nice evolution in the US and Europe accelerating growth in the second quarter, very significantly, mainly driven by Spain, UK, Germany, and Italy. And this expected trend, it makes us confident to grow the product double digit for the rest of the year, despite the early patent expiry in China, and just a note on the side is that we are going to launch Doctolet in the second half of this year also in Japan. Let's turn to slide number 13. And, you know, we are very gratified that we made good progress with Aspavelli. On a quarterly basis, we sold 144 million SEC, and we have launched the product now in Germany, the U.K., and France, parts of the Middle East and Australia. And in the second quarter, we are going to add Canada and more countries in Europe. With early sales in a number of other countries, well, reimbursement is starting to come in one at a time. We are also expecting to launch Asper Valley in Japan, which represents our largest single market opportunity. So we increased considerably the number of patients on commercial supply. We have quite a number of patients also in various trial initiatives as we move on. So let's move, turn to page number 14. And, you know, Gummy Fund, let's say, has been the most prominent evolution, you know, in this quarter. You know, it was a big spike. This is a result of an enhanced outreach, more experience with Gummy Fund, and recent publication of new data. We introduced a new go-to-market model, which better reaches new institutions. We have now around 200 patients treated with Gummy Fund, and there's more real-world data and experience available. So physicians have gotten more comfortable with the benefit-risk profile of Gummy Fund and are increasingly prescribing it for their patients. They are doing this now for longer too, and this results in the sales evolution that you have seen. Is this new normal? Probably not yet, but clearly the Q1 is also not indicative of where Gummy Fund stands today. So the product is making a lot of strategic progress. All contributed anyway to a very strong growth of 73% for the quarter. And more than half of it is coming from new patients. 60% comes from higher dosing, which adds volatility because it depends also on the patient's body weight. Kineret has now flushed out the COVID-related effects in Q2 and returns to a normal growth pattern, which is really related to the elevated interest in the IL-1 mechanism. Growth is driven by the U.S. and internationally. and the H1 sales are still down because of the COVID-related impact, whilst we had moderate growth when you exclude this. On this note, I'd like now to hand over to Henrik, who will take you through the financials.

Thank you, Guido, and let's turn to slide 16. We go to the key financials for the second quarter. So starting with the top line, Q2 was another good quarter with a solid business performance, with revenue of almost $4.9 billion, was the highest Q2 ever, as reported in SEC, benefiting from both underlying performance but also currency tailwinds. So reported growth was 26%, corresponding to 16% at CERN. Explained mainly by Doptalet in all regions, a very strong quarter as we heard for Gamifant, but also Kinret in the US and some international markets. The newly acquired Bongeo contributed to revenue with 36 million from the period June 26th to June 30th. Looking at the bars to the left in hematology, driven by the strong performance of Doptalet, we see the highest ever quarter sales. In immunology, we see the impact in the quarter of the seasonal pattern of synergies, however, mitigated by strong gamifund sales and the kin rate performance. If we go back to the table, the adjusted gross margin in the quarter of 71% was below last year of 74%, mainly due to the high doctorless sales to China in the quarter, which is a low margin business. The adjusted EBITDA margin excluding non-recurring items of 236 million reached 26%, slightly better than last year's 25%. The non-recurring costs or items affecting comparability of 236 million in Q2 relate almost exclusively to transaction and restructuring costs in connection with the CTI acquisition. And we do expect some further non-recurring costs in coming quarters, but at lower amounts than in Q2. The operating expenses, excluding amortization and non-recurring items, came in slightly higher than the previous quarter and also increased versus Q2-22 by 5% at CER, driven by the increased marketing and sales spend related to Aspen Valley, Doctolet, Synlonta, which wasn't there a year ago, and the pre-launch of Isanis Optical Alpha, whereas the R&D spend was reduced compared to last year at CER. The adjusted earnings per share for the quarter ended at 148, well above the adjusted EPS of last year, an increase of 63%. The operating cash flow in the quarter at $357 million reflected the seasonal weakness of our cash flow in Q2, but increased slightly versus last year. But of course, the main event in Q2 was the CTI acquisition, which explains the jump in net debt to $27 billion, which is the status before the rights issue and corresponds to a net debt to EBITDA ratio just below four times. For further details on the items affecting comparability in the quarter, please see page 3 in the Q2 report. And if we then go to slide 17, to the financial outlook for the full year 23. And as usual, it's for revenue growth at constant exchange rates and adjusted EBITDA margin. We will continue to expand in hematology, immunology, and specialty care through ongoing launches, new medicines, and geographic markets, and we anticipate a sustained sales growth. We increased the guidance for revenue for the full year 2023 as follows. Revenue is anticipated to grow by a high single-digit percentage at CER, where the previous outlook was low to mid single-digit growth. And as we continue to invest in launches and advance our pipeline of new medicines and emphasize the long-term value of the business, we anticipate an adjusted EBITDA margin at the low 30s percentage of revenue, which is unchanged compared to the previous outlook. This outlook now includes the expected impact from the newly acquired CTI and the product Bonjour, but also Sobeys rights to royalties to New Savvy Bub. And as already communicated, Bongeau is expected to be created to solve this adjusted EBITDA margin in 2024. And with the outlook covered, I will now hand over to Armin for the pipeline. Thank you.

Thank you very much, Henrik. Hello everyone. Well, it's my pleasure to also talk about pipeline milestones. And as Guido alluded to before, we have two key milestones that we hit for our late-stage pipeline this quarter on FNS-OCTO-COG-ALPHA for hemophilia A, as well as nircevimab for RSV. In May, the EMA, the European Medicines Agency, validated our marketing authorization application for FNS-OCTO-COG-ALPHA. This puts us on a path towards potential approval in Europe in 2024. We also continue to see high interest by physicians and are convinced that FNR-Dr. Koch has the potential to change the treatment paradigm for hemophilia patients, as we also learned at the recent ISTH Congress. This is also exemplified by the presentation of the latest data at this Congress of our pediatric study, the Extend Kids, at a late-breaker session at ISTH. And also, as said already before, as just yesterday, the FDA approved Sanofi's and AstraZeneca's Bay Fortis for the prevention of RSV. Please turn to the next slide. The increasing R&D pipeline news flow that we want to make you aware of for H2 is clearly on . ICP regulatory decision in China. Most important for us also, or most significantly, is the gamifent progress that we are making. We are preparing for submission of gamifent in macrophage activation syndrome, MAS, in the U.S., and this is dependent on the interim data from the MREL Phase III study, which we will see later in the year. And the next regulatory submission after that will be for Cell 212 in chronic refractory gout, so after the positive dissolved data from earlier this year. And on the right-hand side, you see that we also have quite some things coming for Aspavelli and Pavelli on kidney aspects, TA, TMA, and also several additional aspects for doptellate in ITP, and also some additional regulatory decisions in China. So with that, please turn to slide 21. and I hand back to Guido. Guido, I think you're on mute.

Sorry. Yeah, no, so to sum it up, and, you know, what I want to leave you with is, you know, is really the background of our current strengths is, you know, aside of from having obviously medicine that matter for rare disease patients or people suffering from rare diseases, The first successful of our successful is really our strategy that was built in 2017. And it's about leading in hematology, growing our immunology franchise and specialty care franchise, capturing the value from our pipeline and having global ambitions. And as you can see from the results, we are delivering on all aspects. Toby's strengths lie in evaluating, developing clinical projects, commercialization, and bringing medicine. To do this, we build a strong performance culture. This is based on our company values. They keep us united, keep us focused on working for patients, and all of this is in an ethical and responsible way. We have a very cohesive senior management team, including the executive committee with a significant tenure. This creates a high degree of trust, which in turn helps us to make better and faster decisions. So moving to the next slide. As you can sense, you know, we are very pleased with the second quarter and the first half a year at SOVI. We successfully delivered on our strategy in the last quarter with significant top line growth and expansion of our pipeline. Just to summarize, we saw significant top line growth, 16% in the quarter, 26% reported, 6% for the first half year, 15% reported, and we continue to build our leading rare disease hematology franchise with the CTI acquisition. Our R&D pipeline progressed with two key milestones for F&S OctoCock Alpha and Nils Siverma. We have a strong momentum in the SOBI business, taking together with the CTI acquisitions that we are raising our revenue guidance for the year to high single-digit growth. I think it's now a good time to open the floor for questions and answers.

We will now begin the question and answer session. Anyone who wishes to ask a question may press star and 1 on the touchtone 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 2. Questioners on the phone, I request you choose only answers and eventually turn off the volume from the webcast. Anyone who has a question may press star and 1 at this time. Our first question comes from the line of Charlie Mabbott with Morgan Stanley. Please go ahead.

Thank you.

Hi, it's Charlie Mabbott from Morgan Stanley. Thanks for taking my questions. Two questions, please. So firstly, on the CTI deal, I'm just wondering how you expect Bonjo to ramp in the US. The product clearly has a niche in the market where there is an unmet need, as you said. So was there a case of CTI simply being unable to fully invest in the launch? And now could we see the product grow more rapidly over the next 18 months as you broaden awareness? And secondly, could you talk about how you see the cost lines trending through this year and next, given the divergence in trends across SG&A and R&D for the quarter? I believe CTI had SG&A costs of around $20 million and R&D of around $10 million in Q1. So how much of this should we expect to be taken on by SOBI over the coming quarters? Thanks very much.

Yeah, thank you. Let me start with the first part and then on the cost side, I refer to Henrik. You know, basically, You look at CTI purely philosophically, I think they have done a tremendous job, the team, with a lot of expertise to bring the business where it is today. But it's also quite clear, you know, when you are a one-trick pony, you have one product, it's not very efficient to build an infrastructure competitive enough to be, you know, in an area where you have quite a few already very significant players today, but more to come. So we think that we can take this to the next level. And this basically relates to the fact, you know, and we've spoken about this at an earlier presentation. We have a team with Doc Teller that basically has, you know, a 90% overlap in target audience with the CTI organization. The combination of the two will give them a very strong foothold in this market. We keep the two teams at this juncture separate because we think that there is benefit from harvesting synergies by losing reminder positions in each team and definitely leveraging the overall medical organization. So we think that we will be more competitive together than CTI alone. And then obviously, you know, this should yield some results. We think that we should be up for significant growth. In addition, I think you need to also realize that the NCCN guidelines were recently expanded. So we, where the product has reason to believe, you know, we have a reason to believe to sell the product beyond severe thrombocytopenic patients in a more, in a broader fashion. And, you know, the combination of this, I think, is basically the reason why we believe that we can significantly accelerate growth of the product and why we are very optimistic for the future. And then obviously in the next phase, we want to take it international. And we are working now with the team very closely together let's say, from ex-CTI now, obviously driving this as part of the SOBI organization. And you will see tomorrow, I mean, when Sarah Buckley will talk about opportunities with regard to Vonjo, I mean, she is a clinical oncologist, has a really in-depth knowledge of the subject matter, how we're basically trying to create a symbiosis of domain knowledge from CTI to And coupling this with, I think, very strong processes and commercial experience in our North, particularly at this stage in our North American organization, that this should yield significant impact. Maybe on the cost side, Henry, do you want to comment?

Yeah, Charlie, I think your question was about SQ&A, yeah? Yeah, and R&D just sort of, yeah. Yeah. Yeah. Yeah. Well, when it comes to SG&A, of course, there is a degree of immediate impact because of the fact that we are obviously combining the two companies. But in the short term, there is so much more focus on finding the right go-to-market model and focus on the top line. And that's also reflected by by the guidance that we stick to the low 30s margin, whereas we've said that we expect an accretion in 2024. But obviously, the focus is on top line growth in the short term. For R&D, of course, the confirmatory trial continues.

And we know we will come back to our board and then we will obviously make the right announcements. We are working right now on a comprehensive set of lifecycle management initiatives and indication expansions for the product. We want to take this product to the next level. The outcome of this, and that's the reason why we haven't quantified yet synergies, because we obviously ring fencing synergies and we have realized quite a bit already But, you know, we want to make sure that we give you then a complete view on this, where we see the product going, but also, let's say, you know, with new indications, but also then basically making account for what we see in terms of efficiencies. Yeah, maybe we moved on to the next slide. Oh, to the next question, sorry.

The next question comes from the line of Christopher Ude, SCB. Please go ahead.

Hi there. Yeah, thanks for taking my questions. So my first one is on EFINALPHA and the EMA process. You previously indicated we should expect a, we could probably expect a pretty quick process given how well the mechanism is understood and how clear the data is and so on. Does that mean that there is scope to, for the EMA to give you the 180-day questions ahead of the 180-day? time, or should we still expect the 180 days to be in place? And then I think, so does the financing increase or decrease the odds, or does it impact the odds of you monetizing the NIRSEVIMAB royalty stream? And then, especially in the short term, and then thirdly, So, Vonjo, coming back to the ramp and potential, so obviously any sort of uptake, you know, there's the usual work to be done to get physicians aware and patients aware and whatnot. But beyond that, just looking at the projections, this could, you know, this has the potential to be an absolutely massive

drug for you guys what do you need to overcome to get as many patients you know on to therapy within the label population alone to start with thanks thank you Christopher you know very very quick you know so let's start with the financing I mean a silver mark we were obviously we are looking forward to a great performance of Sanofi in the overall ISV area, whilst we're obviously trying to do a good job with synergies and trying to be a product of choice for these very compromised babies. But, you know, we are looking forward to monetizing this. Financing provides us with a solid position, so we don't need to monetize the royalty stream. And that basically, you know, the company is in a very solid foundation. With regard to wonder potential, we will obviously make sure that we harvest this. I'm glad you see this. Yes, we share your excitement around the product, and yes, we think that this is a very material opportunity in terms of market penetration given its mode of action and see the data that are clinically differentiated, and we'll share more on this. and the excitement tomorrow. I mean, maybe then we can go into more detail. With regard now to the AMR approval process, Armin, you want to comment on this? Yeah.

Christopher, as you know, with accelerations, you have it when you have it. So I want to be very careful with making some forward-looking statements here. But I think what we see and what we heard at the ISTH is a huge interest in all physicians from the U.S., from Europe, And they really are just waiting desperately to get that product into their hands and treat their patients. So I think whenever we can do some accelerating moves, we will definitely let everyone know ASAP. But with the authorities, we just need to wait for the process and what they announce to us.

So it's too early for us to speculate whether there's any earlier approval. But we are looking forward to the first launch countries pretty soon in the Middle East and then you know, than the usually launch sequence around Europe. Thank you. Next question, please.

The next question comes from the line of Yin Yang with Jefferies. Please go ahead.

Thank you. On gamifant, you laid out the factors that drove strong sales into Q. The question is, what's the duration of treatment on average on gamifant? And then should we assume second quarter sales is the runway for the remainder of the year? Thank you.

Yeah, I think, you know, obviously the way to see this is we have improved our organization. We have new data. We have, you know, the probability of getting prescribed when a patient is presenting themselves is increased versus the past, and that is evidenced by a higher number of patients. Now, in which form and shape these patients are coming, we can hardly, you know, we don't influence as much. But, you know, I would think, you know, that let's say, will we have another, is the Q2 now the new normal? I would not be so daring at this stage. If we would have secondary HLH approved, clearly, you know, you would expect even more than that. Yeah. But at this juncture, I think, you know, to think something that is on a higher, significantly higher level than what you had in Q1 and in between, you know, what we have, you know, in Q2, I think that is probably more how we think about this product because, you know, you could be unlucky in a quarter again, you know, because patients go off therapy. And then we have, I mean, you want to talk, you want to comment on the duration of therapy right now? I mean, we have very different patients also right now. I mean, the product is also, you know, the benefit of the product is also seen even with certain CAR-T patients at this stage here, so one should say. Amit, you want to comment?

Yes. As you know, as per label, it's the primary HLH patients. And those patients, when they are on gamifent, they're usually treated until they go to the treatment, the curing attempt, which is the stem cell transplant. That is dependent on several factors. Also, as you know, dependent on to get the right donor and those kind of things. It may be several weeks to months. But at the same time, physicians, as Kira said before, gain more and if they, as we also know, because we get a lot of requests in Europe for managed access programs or to compassionate use of the drug, there are physicians who see the benefit beyond that very strict primary HLH label that we have in the U.S. So it's very hard to then say the average time treatment period is such and such because it has a quite wide span, but I would believe that we can really unlock with what you have seen on the news flow with the macrophage activation syndrome. And if we get successful with the MRL study data and also with the submission in the US, I think we can have a much clearer view on this. And also what we thought initially that those patients are probably more small children with a certain weight. We have seen over the years that the weight ranges quite dramatically all the way and early adulthood, and they may be very heavy. So there's quite a fluctuation that we cannot predict.

Okay. Thank you.

Thank you. Thank you, Yun. Next question, please.

The next question comes from the land of Gonzalo Atiak with ABG Sundar Kalia. Please go ahead.

Hi. Thank you for taking my questions. I will continue with the GAMI Fund also. on the reasons for the sales being higher this year. I mean, you're mentioning that physicians are more comfortable with it, and the patient character has a lot of influence here also. But I was wondering if this spike in growth is also partly justified by its use in an off-label setting in secondary HLH. Could that be the case? I mean, do you have any words on that?

I mean, to be honest, we are strictly promoting the product on label, in line with the label, which is primary HLH. But we know from real-world evidence that, you know, physicians, at their decision, use the product also in other indications. And, you know, there's quite a bit of body of evidence right now suggesting that interferon gamma is also, you know, if you inhibit interferon gamma, you can mitigate whisker T, so that it's a at least heavily debated by various physicians. So, you know, there is broader usage, which, you know, which makes it very difficult for us to predict, you know, have an accurate prediction on the product. But therefore, we said, you know, once we have things more on label, then this makes it much easier to predict. But, you know, we're promoting strictly on label, but there is a lot of interest in interferon gamma products, in the science community.

Okay, great. And a second one, if I can, on the city map. Following the approval yesterday, a new ACIP meeting has been announced for August 3rd. Could you give us your thoughts on having the approval and recommendations already placed or in place by August with a few months before the season starts? Do you think they will have an impact on Synergy sales, and if this would happen later in Q3? Thank you very much.

Thank you. I mean, it's beyond us to speculate what the committee will say. We believe in Synergy with more than a million lives of a safety database. And we know it's the guidelines, the committee, there will be people, you know, who will have different views on this. You know, how far, will it be like Abel said now, all babies, irregardless, or will there be a room? I mean, we know that there will be some who will be advocating to take a stepwise approach, but, you know, we cannot, we have no influence on this, and the Let's assume it is in line with what was announced yesterday during the night in Europe. And then it is a question of to what degree will it influence it. I think for this year, you will probably see some impact, but you will see also obviously the other fight on the royalty stream. Now, the question is, how quickly can they penetrate on the total patient population? And that's everybody's guess. You know, if you basically can afford a longer perspective, let's say 2025, we know that in any of those scenarios, you will be better off than you are today. This is our conviction anyway. But what will be the situation now this year, I mean, there is a bit of uncertainty. Perfect. Thank you very much. To be honest, we believe in synergies. Absolutely. Thank you so much. Maybe next question.

The next question comes from the line of Matthias Hegblom with Helmholtz Banken. Please go ahead.

Yeah, thank you so much. Two questions, please. So firstly, on the revenue guidance uplift from low to mid single digit growth to now high single digit growth, which is roughly a billion kroner in additional sales. The new outlook includes near similar up royalties and CTI by former revenues that the previous outlook did not, as I understand it. And when I look at consensus, This has had roughly 200 million krona in instrument royalties for this year, and sell-side models sit there by far to show revenue of 700 million krona second half based on Bloomberg forecasts, which combined almost bring me to the uplift of the guidance. So what does the new outlook imply for the rest of the business, not least in light of the very strong second quarter, including the Chinese shipment of Doctelet? And then secondly... Drilling into Kinneret a bit more with regards to the strength we saw here in the quarter, you provided some additional details in the report, but is it possible to expand and help us understand the durability of this strength? Thanks so much.

Thank you. You know, when it comes to the revenue guidance, I mean, basically what we see is that the underlying business is doing quite well. Obviously, and therefore, we are probably more optimistic on our existing business than we, let's say, than we have been at the beginning of the year. So there we see an improvement. And then we obviously see an opportunity with Bonjo, material opportunity. And then basically you have this scenario synergist and uh and the orgy stream from their civil map and there could be effects that cancel each other out and that provides a certain and we have taken certain assumptions that we you know we believe are reasonable and that in in some we think it is uh you know we don't lean too much forward by basically saying it is a high single digit revenue goals yeah so we we don't break it out uh more And with regard to Kineret, I think what we see now is, you know, that the product is gaining a little bit more traction. We see some good growth in international. The larger international becomes our organizations, the more momentum we have also with Kineret. We still see some good growth coming from the U.S. while it's more stable in Europe. But it is really the interest in the product and we're making the product obviously available in more countries, international. that is really driving the underlying momentum. We would not, you know, we cannot provide at this stage more guidance. But, you know, that's the reason why we think, you know, the product is going to be for us a gross product. Is it going to be a double-digit gross product? Maybe not. But it is a product that we, you know, once we have flushed out the COVID impact, that we can grow, yes, moderately grow. That's basically what we see here. And, you know, this is where it used to be. So, basically, and basically, if you, and COVID gave us an bolus that is now flushed out and then, you know, but we're taking it from there. It still remains a very interesting topic for many physicians around the globe. Henrik, you want to give more color to the guidance?

No, I think you put it well. um obviously we uh we have slightly increased the expectations of the underlying uh of the underlying business uh not at least when it comes to uh to adopt it after the strong performance uh but other than that no uh i think you said it you know yeah yeah we have obviously as you can see you know we have really exponential growth particularly now in europe right now

And we don't see this coming down too quickly. All right. Perfect. Thanks so much. Thank you. Thank you, Mattias. Maybe we'll open up.

The next question comes from the line of Peter Östling with Pareto. Please go ahead.

Yes. Thank you. Just a single one. Most of my questions have already been answered. You mentioned, regarding Vonjo, you mentioned that there have been some expansion when it comes to guidelines. Does that mean that the basic population of around 7,000 patients in the U.S. will expand?

Yeah, I mean, when you follow the guidelines, which is not labeled, but you follow the guidelines, the NCCN guidelines, they cover all myofibrosis patients at this stage.

Okay, so... Okay, thank you. Thank you.

The next question comes from the line of Alistair Campbell with RBC. Please go ahead.

Thanks so much. I've got two questions, if I may. The first one is on .Telet. I just really want to be clear on this. Obviously, a very large China sales number in Q2, but if I were to assume No more China sales this year, second half this year, or next year, but the underlying run rate for Doctellate X China. I'm probably getting to a number that looks like broadly year-on-year you'd be flat for Doctellate. Is that reasonable, or do you think you can do better than that? And then the second question is on L2VO. A couple weeks ago, Sanath, you were talking about the launch in the U.S. and saying it's going ahead of expectations. They're taking about 10% of patients from Hemlibra, so quite an optimistic outlook from them, and I'm sure we'll hear more from them next week. Just how good a proxy do you think the U.S. launch role to VOA is when we think about your launch in Europe, albeit it will be slower and sort of market by market? Thanks.

Yeah. Let's start with the easy one on Doctelit. And basically what we see here, I think there's an echo maybe some of us could go on mute here. And basically, you know, when you think about Doctelit, you know, you have, we think that we can do better than what you think. Because, you know, we think that we can even, we are optimistic to show double-digit growth for Dr. Littles here. Because, you know, the momentum is so powerful. And, you know, with the business that we have now consolidated from foregoon and with the underlying momentum that we see, we think we should be significantly year. So let's see. Exponential growth is obviously always difficult to project, but that we are going to grow over and above last year, we see very strongly because there we are also launching in Japan, so we should be pretty bullish about doptility. And we had to increase our orders, so you know, We'll make sure that we sell it also. And with regard to the second part of the question, the – sorry, can you just give me – The Antuvio launch. The Antuvio launch, yeah, you have 10%. You know, what we have seen historically was, you know, that obviously when you launch in the U.S., you have access to a much larger patient population on day one. but we have to earn our stripes and getting reimbursement in a more sequential way. We try to be fast with this. And what we saw with Elocta was once we had reimbursement in all countries, then we were actually more effective than BioVerity was at that time. and gained, obviously, a significantly higher market share, even though the economics, because of the price, were initially small. What we think is that, given the high expectations, we believe that this has really the make-up to become best-in-class and standard therapy. and and you know but you know how quickly can we take amoeba patients we will obviously try to take amoeba patients but don't forget also that him lever has been much more successful in the us than they have been in you know there's a significant opportunity for us and you know we will not discriminate where we take the the share from we are very optimistic and share this optimism But we are now obviously really keen to get this on the schedule in all the relevant markets and starting obviously next year and then penetrating from there. So you will have to be a little bit more patient with us just giving the reimbursement approvals. But once we have reimbursement approval, we hope that we will demonstrate similar uptake curves than what Sanofi is experiencing right now. Yeah, maybe is this giving you some favor, yeah? And maybe we open up for one more question, yeah?

The next question comes from Victor Sundberg with Nordea. Please go ahead.

Thank you.

Yes, hi. Thank you for taking my questions. I have three maybe quick ones, if I may. So given the acquisition was finalized quite close to the end of Q2, should we model any more one-offs here in terms of cost for Q3? That was my first question. Secondly, on Doptalet, you highlighted here, of course, that generic competition will be introduced in China this year. So I just wonder if there's an impact here on your ambition in ITP as well in China, or if you can give your rationale for going off the debt indication in China, given the high price pressure. on both the VBP and the NRDL. And my final question was also here on the label extension for gamifantasecondary HLH. I guess it has been some uncertainty previously if you're going to have enough data in your package to the FDA, but I just want to understand if you had more interactions with the FDA and how confident you are that the Phase II trial, MRLD, and real-world evidence together will be a strong enough data package for the label extension. Thank you.

Thank you, Victor. You know, let's start from the back. You know, we need to hold our horses. I mean, we will have an interim, as Amin said, pretty soon on the MRL data for the first cohort of patients. Then we will judge whether this is already sufficient. Really, we'll consult FDA. So it's speculative at this stage, you know, whether we need to recruit the entire study or whether we can already go with the interim cohort, and that basically we will have to assess when the data are there with us. Regarding, you know, ITP China, I mean, this is a discussion that we have as Fosun, you know, and figure out, you know, obviously ITP could be the big opportunity. It doesn't seem in China to be, you know, a promotion, but I mean, there seems to be utility of our product, irregardless of the label that has been approved. Clearly, it will further stimulate growth. And we will see, you know, whether we can find in this new situation with FUSO, maybe an economic arrangement that could be beneficial also for SOBI, but it is too early to, let's say, provide you with any guidance on this, you know, We'll come back when we have something at this stage. Don't account for it anyway. There's strong with the rest of the business. With regard to the one-offs, Henrik, you want to comment? What do you expect in terms of one-offs?

Yes, Victor. We do expect some more one-off costs in coming quarters. However, smaller than we saw in Q2.

Thank you very much. Thanks.

Thank you. Maybe one last question and then there may be some opportunity after the Wonjo discussion for some questions and answers as well tomorrow. Is there one last question?

Our last question comes from the line of Neil Alexander with Deutsche Bank. Please go ahead.

Thank you.

Hi, guys. It's Neil from Deutsche Bank. Very quick one. Just wondering if you can give your takes on direction of margins midterm and confidence of delivering margin improvement next year given the CTI deal. Thanks.

Yeah, thank you. You know, I mean, basically, you know, this is when you take a step forward, clearly with what we have now on board with the launch product, with the operating leverage that we will create out of it, If you look at it midterm, clearly we need to yield margin improvement. And Wonjo is obviously no surprise. Being a small molecule is going to be over time accretive. Then we have, you know, the situation synergies versus royalties. So when you say midterm, also there, you know, the royalties should be very accretive because by definition it's 100% yes of a smaller molecule. It's a smaller percentage, but, you know, it's very material. It refers to a much larger, obviously, patient group. And as we grow our other launch products and ghost products, they are also mostly very accretive source of supply for Dr. Lead that is also very positive for us. So there are a lot of positive factors, and that should, let's say, help us. Now, what does it mean for next year? You know, I think, you know, that would be premature for me now to give you guidance already. That's something that we typically do, you know, at another stage. But, you know, we think that we have a lot of opportunity to improve the business. And, you know, and obviously we will update you once we know how much additional money we want to invest into studies and lifecycle management with regard to Bonjour shortly. But overall, we will not get obviously overboard. We believe in this business. We think it's on an excellent shape. There's a lot of opportunity for growth. So I'm afraid that I cannot give you now a guidance already for next year. But when you have a bit of a perspective on the business, then there are a lot of factors that should help us. over time, yeah? And is this now for the next year? I would not provide you with a guidance at this point of time. So maybe what I do is I wrap it up. Really like to thank you for your interest. You know, as you can sense, you know, we are upbeat about the company. It's, you know, quite nice to see how a lot of these things coming into place and really like to thank you for your interest. We have to be respectful that there are also other earning calls as we speak today. Thank you for your interest and for those who have an interest to learn more about one's communities and may have a question tomorrow is the time. Thank you so much. Wish everybody a great day. Thank you.

Ladies and gentlemen, the conference is now over. Thank you for choosing Coruscant. Thank you for participating in the conference. You may now disconnect your lines. Goodbye.