Ladies and gentlemen, welcome to the Q2 2023 reports conference call and live webcast. I am Alice, the Chorus Call operator. I would like to remind you that all participants will be in listen-only mode, and the conference is being recorded. The presentation will be followed by a Q&A session. You can register for questions at any time by pressing star and one on your telephone. For operator assistance, please press star and zero. The conference must not be recorded for publication or broadcast. At this time, it's my pleasure to hand over to Guido Oelkers, CEO. Please go ahead, sir.
Thank you so much, and welcome, everybody. This is Guido Oelkers, CEO of Sobi. As you can see from the Q2 report that we published earlier this morning, we are 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, sobi.com, and we would like to go to the next slide. The safe harbor statement as per usual, we would like to remind you of the usual provisions. Unless, as stated otherwise, we will make comments that mostly relates 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, our sweet new scientific and medical advisor and a member of the ExCom. We plan to review the presentation first and then open up for Q&A around 2:00 P.M. Swedish time. For those on the phone, please join the queue for questions by pressing star one. We propose that you ask only one or two questions at a time, as per usual. 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. This brings us to 6% growth for 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 by 18%, and the growth was mainly driven by our launch products, Doptelet and Aspaveli. Whilst 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 efanesoctocog alfa and confirms our strength in rare hematology. Immunology reflected strong growth of Kineret and Gamifant. Our ambition to build a leading rare hematology franchise was evidenced by the closing of the CTI Vonjo acquisition. The acquisition offers considerable strategic opportunities by capitalizing on our hematology expertise and on Vonjo's potential for patients worldwide. Our R&D pipeline progressed with two milestones.
We submitted efanesoctocog alfa to the European Medicines Agency. efanesoctocog has great potential to become the new standard of care for hemophilia A. This was a very important milestone for our company. Yesterday, the FDA approved nirsevimab for RSV, 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. 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.
This is evidenced by the strong leap of Gamifant performance and our regional expansion and becoming a true global player in rare disease. Moving to the next slide, please. You know, we are very excited to having closed this transaction with CTI because it provides us with a range of benefits, both immediately and in the long term. Vonjo is a very promising medicine. It is well differentiated as it targets JAK2 and IRAK and ACVR1, while sparing JAK1. It therefore addresses an unmet medical need in severe thrombocytopenic myelofibrosis. Vonjo complements Sobi very well. Myelofibrosis is a blood cancer. Sobi has extensive experience in thrombocytopenia with Doptelet. 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 and margins.
We already recorded the first sales in June with at SEK 36 million krona. As said, we are raising our guidance for 2023, partly because of the acquisition. Please turn to page number six. When integrating CTI, we make sure that we fully capture, you know, Vonjo's value. In the first weeks, we seamlessly the seamless continuation of Vonjo 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 life cycle 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, a lot of, you know, additional dimensions to unleash Vonjo's potential. All in all, we are very thoughtful about building Vonjo's franchise up to its potential and creating leverage with the 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 life cycle management and development. Let's turn to page number 7. Just to share a little bit of excitement on pacritinib. pacritinib is a well-positioned for growth, and we will explore its further benefits to patients with myelofibrosis and beyond. Real-world insights into benefit of Vonjo in different patient population to extend its benefit and enable a wider patient access.
We also want to embark on the following, therefore, a very strong scientific rationale for benefit of pacritinib in other diseases with underlying inflammation-driven pathophysiology, regulatory submissions in international markets. These are the key drivers. It's insight into new opportunities. It's providing a new strategic rationale into other indications then obviously, taking advantage of our global footprint. We want to share our excitement about CTI and in particular, VONJO or pacritinib, how it's called generically, to provide you with additional insights. Since we hosted an event with Professor John Mascarenhas 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 Sobi, who will provide you an in-depth understanding on the subject matter as well. Now it's time to turn to slide 8. Henrik, would you like to take this?
Sure. Thank you, Guido. Hello, everyone. As many of you will have seen, Sobi today called for an EGM on August 15th, for the purpose of carrying out the rights issue of approximately SEK 6 billion, with preferential rights for existing shareholders. The proceeds will be used to partly finance the CTI acquisition of approximately SEK 17.3 billion, corresponding to about one third of the equity value. Considering Sobi'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 right issue will be set by the board shortly before the launch.
As previously announced, Investor AB, 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 AP-fonden, Polar Capital, Handelsbanken Fonder and Swedbank Robur, together representing about 12.8% of the shares, have expressed an intention to subscribe for their respective pro rata share. 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 you.
To Guido, yeah.
Yes. Thank you, Henrik. You know, let's turn back to our quarterly performance. You know, we provide, you know, with a perspective on page nine on our performance by franchise and regions. You know, 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. You know, this brings us to a revenue growth at constant rate of 6% for the first six months at a constant rate. You know, basically what you can see is, you know, very strong growth, it's underlying growth. If you would, this 6% would be around.
taking away the COVID effect for Kineret and our business with the Chinese partner, Fosun, for Doptelet, we would have grown at 9% so t hat gives you a little bit of a guidance on the underlying growth of the company. Both regions, North America and International, grew very significantly in the quarter, whereas Europe was pretty stable. In the first half, all regions grew high single-digit rate. Let's turn to slide number 10. 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, Sobi's future as well as we are about our Q2. This is a schematic chart for illustration purposes only.
What you can see is today's growth is fueled by a rich portfolio of growth and launch products, namely Doptelet, Aspaveli in PNH, Gamifant, Zynlonta and Vonjo. All products have one common theme. There's still a lot of headroom to reach full potential. You know, that means, you know, that there's a lot of 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 Beyfortus in the US and by the launch of efa in the first launch countries, likely in the Middle East.
When you think about the other portfolio, why is SEL-212 and Aspaveli in 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 growth products is very much de-risked at this point of time. In summary, Sobi 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, haemophilia, and it is important, particularly also in view of our new launch of efanesoctocog alfa. Our business continues to be underpinned by stable haemophilia growth of 2% at H1 . We expand the leading presence of Elocta and outreach to more patients in new territories. This confirms or the community's confidence in these treatments.
For Elocta, we see underlying unit growth in international markets, while the phasing 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%. Alprolix 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 Doptelet chart, you know, and here what you can see are obviously a very nice evolution in the U.S. and Europe, accelerating growth in the second quarter very significantly, mainly driven by Spain, U.K., Germany, and Italy.
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. Just a note on the side is that we are going to launch Doptelet in the second half of this year, also in Japan. Let's turn to slide number 13. You know, we are very gratified that we made good progress with Aspaveli. On a quarterly basis, we sold SEK 144 million, and we have launched the product now in Germany, the U.K. and France, parts of the Middle East and Australia. In the second quarter, we are going to add Canada and more countries in Europe. There was early sales in a number of other countries where reimbursement is starting to come in one at a time.
We are also expecting to launch Aspaveli in Japan, which represents our largest single market opportunity. 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 on to page 14. You know, Gamifant 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 Gamifant 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 Gamifant, and there's more real-world data and experience available. Physicians have gotten more comfortable with the benefit-risk profile of Gamifant 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 a new normal? Probably not yet, but you know, clearly it is the Q1 is also not indicative of where Gamifant 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, you know, 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 not flushed out the COVID-related effects in Q2, and it returns to a normal growth pattern, which is really related to the elevated interest in the IL-1 mechanism.
Growth is driven by U.S. and international, and the H1 sales are still down because of the COVID related impact. While we had moderate growth when you exclude this. On this, in 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. Starting with the top line, Q2 was another good quarter with a solid business performance, with revenue of almost SEK 4.9 billion, was the highest Q2 ever, as reported in SEK. Benefiting from both underlying performance but also currency tailwinds. Reported growth was 26%, corresponding to 16% at CER, explained mainly by Doptelet in all regions, a very strong quarter, as we heard, for Gamifant, but also Kineret in the U.S. and some international markets. The newly acquired Vonjo contributed to revenue with SEK 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 Doptelet, we see the highest ever quarter sales.
In immunology, we see the impact in the quarter of the seasonal pattern of Synagis, however, mitigated by strong Gamifant sales and the Kineret 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 Doptelet sales to China in the quarter, which is a low-margin business. The adjusted EBITDA margin, excluding non-recurring items of SEK 236 million, reached 26%, slightly better than last year's 25%. The non-recurring costs or items affecting comparability of SEK 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 2022 by 5% at CER, driven by the increased marketing and sales spend related to Aspaveli, Doptelet, Zynlonta, which wasn't there a year ago, and the pre-launch of efanesoctocog alfa, whereas the R&D spend was reduced compared to last year at CER. The adjusted earnings per share for the quarter ended at SEK 1.48, well above the adjusted EPS of last year, an increase of 63%. The operating cash flow in the quarter at SEK 357 million reflected the seasonal weakness of our cash flow in Q2, but increased slightly versus last year.
Of course, the main event in Q2 was the CTI acquisition, which explains the jump in net debt to SEK 27 billion, and which is the status before the rights issue and corresponds to a net debt to EBITDA ratio of just below 4x . For further details on the items affecting comparability in the quarter, please see page three in the Q2 report. If we then go to slide 17, to the financial outlook for the full year 2023, 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 high single-digit % at CER, where the previous outlook was low to mid-single-digit % growth. 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 % 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 Vonjo, but also Sobi's rights to royalties to nirsevimab. As already communicated, Vonjo is expected to be accretive to Sobi's adjusted EBITDA margin in 2024. 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. As Guido alluded to before, we have two key milestones that we hit for our late-stage pipeline this quarter on efanesoctocog alfa for hemophilia A, as well as nirsevimab for RSV. In May, the EMA, the European Medicines Agency, validated our marketing authorisation application for efanesoctocog alfa. 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 efanesoctocog 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 XTEND-Kids, at a late-breaker session at ISTH.
Also, as said already before, as just yesterday, the FDA approved Sanofi and AstraZeneca's Beyfortus, nirsevimab, 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 Doptelet ITP regulatory decision in China. Most important for us also, or most significantly, is the Gamifant progress that we are making. We are preparing for submission of Gamifant in macrophage activation syndrome, MAS, in the U.S., this is dependent on the interim data from the EMERALD phase III study, which we will see later in the year. The next regulatory submission after that will be for SEL-212 in chronic refractory gout after the positive DISSOLVE data from earlier this year.
On the right-hand side, you see that we also have quite some new things coming for Aspaveli and Empaveli on kidney aspects, TA, TMA, and also several additional aspects for Doptelet in ITP, and also some additional regulatory decisions in China. With that, please turn to slide 21. I hand back to Guido. Guido, I think you're on mute.
Sorry. Yeah, no. 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. As you know, aside of from having obviously medicine that matter for rare disease patients or people suffering from rare diseases, the first success of our success strategies are really our strategy that was built in 2017, it's about leading in hematology, growing our immunology franchise and specialty care franchise, capturing the value from our pipeline and having global ambitions. As you can see from the results, we are delivering on all aspects. Sobi'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. Certainly, 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. 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 Sobi. 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. We continue to build our leading rare disease hematology franchise with the CTI acquisition. Our R&D pipeline progressed with two key milestones for efanesoctocog alfa and nirsevimab. 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 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. Questioners on the phone are requested to choose only answers and eventually turn off the volume from the webcast. Anyone who has a question may press star and one at this time. Our first question comes from the line of Charlie Mabbutt with Morgan Stanley. Please go ahead.
Thank you.
Hi, it's Charlie Mabbutt from Morgan Stanley. Thanks for taking my questions. Two questions, please. Firstly, on the CTI deal, I'm just wondering how you expect Vonjo to ramp in the U.S. The product clearly has a niche in the market where there is an unmet need, as you said. 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? 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 SGA costs of around $20 million and R&D of around $10 million in Q1.
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, 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 build, to bring the business where it is today. It's also quite clear, you know, when you are a one-trick pony, yeah, 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, more to come.
We think that we can take this to the next level, this basically relates to the fact, you know, we've spoken about this at an earlier presentation. We have a team with Doptelet 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, you know, separate because we think that there is benefit from harvesting synergies by, you know, using the reminder positions in each team, definitely leveraging the overall medical organization. We think that we will be more competitive together than CTI alone. 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. Where the product has reason to believe, you know, or we have a reason to believe, to sell the product beyond severe thrombocytopenic patients in a more, in a broader fashion. 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.
obviously in the next phase, we want to take it international. 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. You will see tomorrow, when Sarah Buckley will talk about opportunities with regard to Vonjo. She is a clinical oncologist, has a really in-depth knowledge of the subject matter, how we basically trying to create a symbiosis of domain knowledge from CTI 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, Henrik, you want to comment?
Yeah, Charlie, I think your question was about the SG&A, yeah?
Yeah, 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. In the short term, there is so much more a focus on finding the right go-to-market model and, you know, focus on the top line. That's also reflected by the guidance that we stick to the low thirties margin, whereas we've said that we expect a creation in 2024. Obviously, the focus is on top-line growth in the short term. For R&D, of course, the confirmatory trial continues.
Yeah. We know we will come back to our board, we will obviously make the right announcements. We are working right now on a comprehensive set of life cycle 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, you know, we obviously ring-fencing synergies, and we have realized quite a bit already. 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 taking account for what we, what we see in terms of efficiencies.
Yeah, maybe we move then to the next slide or to the next question. Sorry.
The next question comes from the line of Christopher Uhde at SEB. Please go ahead.
Hi there. Yeah, thanks for taking my questions. My first one is on efanesoctocog alfa and the EMA process. You previously indicated 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 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? Does it impact the odds of you monetizing the nirsevimab royalty stream? Especially in the short term. Thirdly, Vonjo, coming back to the ramp and potential.
Obviously, any sort of uptake, you know, there's the usual work to be done to get physicians aware and patients aware and whatnot. 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 on, you know, onto therapy within the label population alone to start with? Thanks.
Thank you, Christopher. You know, very, very quick. You know, let's start with the financing. I mean, at nirsevimab, we were obviously, we are looking forward to a great performance of Sanofi in the overall RSV area. Sobi obviously trying to do a good job with Synagis, and trying to be a product of choice for these very compromised babies. 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. That basically, you know, company is in a very solid foundation. With regard to Vonjo potential, we will obviously, you know, make sure that we, you know, we harvest this. I mean, I'm glad you see this.
You know, we yes, we share your excitement around the product. Yes, we, you know, we think that this is a very material opportunity in terms of market penetration, given its mode of action and the data that, you know, that are clinically differentiated. You know, 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 EMA approval process, Armin, you want to comment on this?
Yeah. Christopher, as you know, with accelerations, you have it when you have it. I want to be very careful with making some forward-looking statements here. I think what we see and what we heard at the ISTH is a huge interest in all physicians from the US, from Europe, and they really are just waiting desperately to get that product into their hands and treat their patients. I think whenever we can do some accelerating moves, we will definitely let everyone know ASAP, but with authorities, we just need to wait for the process and what they announce to us.
We it's too early for us to speculate whether there's any earlier approval, but we are looking forward, you know, to the first launch countries pretty soon in the Middle East and then, you know, then the usual launch sequence around Europe. Thank you. Next question, please.
The next question comes from the line of Eun Yang, with Jefferies. Please go ahead.
Thank you. On Gamifant, you laid out the factors that drove strong sales in 2Q. The question is, what's the duration of treatment on average on Gamifant? Then should we assume second quarter sales is the runway for the remainder of the year? Thank you.
I think, you know, obviously, the way to see this is we have improved our organization, we have new data. We have, with this, you know, the probability of getting prescribed when a patient is presenting themselves is increased. Whereas the past, that is evidenced by a higher number of patients. In which form and shape these patients are coming, we can hardly, you know, we don't influence as much. 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.
At this juncture, I think, you know, to think something that is on a, 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 to, how we think about this product. You know, the, you could be unlucky in a quarter again, you know, because patients go off therapy and then, and then we are. Armin, you want to talk, you want to comment on the duration of therapy right now?
Yeah.
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 with even with certain CAR-T patients at this stage here. One should say. Armin, you want to comment?
Yes. Eun, as you know, as per label, it's the primary HLH patients. Those patients, when they are on Gamifant, 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. At the same time, physicians, as Guido said before, gain more confidence 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 US.
It's very hard to then say the average time treatment period is such and such, because it has a quite wide span. I would believe that we can really unlock with what you have seen on the news flow with the macrophage activation syndrome. If we get successful with the EMERALD study data and also with the submission in the U.S., I think we can have a much clearer view on this. 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 into adolescence and early adulthood, and they may be very heavy. There's quite a fluctuation that we cannot predict.
Okay. Thank you.
Thank you.
Thank you. Next question, please.
The next question comes from the line of Gonzalo Artiach with ABG Sundal Collier. Please go ahead.
Hi. Hi, thank you for taking my questions. I will continue with the Gamifant 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 characteristic has a lot of influence here also. 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, what do you have any words on that?
I mean, you know, 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. Yeah. There's quite a bit of a body of evidence right now suggesting that interferon gamma is also, you know, if you inhibit interferon gamma, you can mitigate with CAR-T, so that it's at least heavily debated by various physicians. There is broader usage, which, you know, which makes it very difficult for us to predict, you know, to have an accurate prediction on the product.
We said, you know, once we have things more on label, then this makes it much easier to predict. You know, we're promoting strictly on label and, but there is a lot of interest in interferon gamma in the science community.
Okay, great. A second one, if I can, on nirsevimab. 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 few months before the season start? Do you think they will have an impact on Synagis sales, rather than if this would have happened later in Q3? Thank you very much.
No, this is, yeah, thank you. I mean, this is, you know, I mean, it's beyond us to speculate what the committee will say. You know, we will, you know, we believe in synergies, you know, with more than 1 million lives of a safety database. We know it's, 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, it was 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 it in a stepwise approach, but, you know, we cannot, we have no influence on this.
Let's assume it is in line with with the with what was announced yesterday or during the night in Europe. You know, then it is a question, to what degree will it influence it? I think for this year, you will probably see some impact, but, you know, you, the more you, but you will see also, obviously, the other side on the royalty stream. The question is, how quickly can they penetrate in the on the total patient population? 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.
Great.
Yeah, what will be the situation now this year? I mean, there is a bit of uncertainty, yeah.
Perfect.
we believe-.
Thank you very much.
To be honest, we believe in synergies. Yeah, absolutely. Thank you so much. Maybe next question?
The next question comes from the line of Mattias Häggblom, with Handelsbanken. Please go ahead.
Yeah, thank you so much. Two questions, please. Firstly, on the revenue guidance uplift from low to mid single-digit growth to now high single-digit growth, which is roughly SEK 1 billion in additional sales. The new outlook includes Nirsevimab up royalties and CTI BioPharma revenues that the previous outlook did not, as I understand it. When I look at consensus, because it had roughly SEK 200 million in Nirsevimab royalties for this year, and sell side model CTI BioPharma to show revenue of SEK 700 million second half, based on Bloomberg forecast, which combined almost bring me to the uplift of the guidance. 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 Doptelet?
Secondly, drilling into Kineret a bit more, with regards to the strength we saw here in the quarter. You provided some additional details in the report, is it possible to expand and help us understand the durability of this strength? Thanks so much.
Thank you. You know, I mean, when it comes to the revenue guidance, I mean, basically what we see is that the underlying business is doing quite well. Yeah. Obviously, 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. There we see an improvement. We obviously see an opportunity with Vonjo, material opportunity.
Basically you have this scenario, synergies and the royalty stream from nirsevimab. There could be effects that cancel each other out, that provides a certain. We have taken certain assumptions that we, you know, we believe are reasonable, and that in some, we think it is, you know, we don't lean too much forward by basically saying it is a high single-digit revenue growth. Yeah, we don't break it out even more. 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., whilst it's more stable in Europe. It is really the interest in the product, and we 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 growth product. Is it going to be a double-digit growth product? Maybe not. 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. You know, this is where it used to be.
Basically, and basically, and COVID gave us and 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?
I think you put it well.
Mm.
Obviously, we have slightly increased the expectations of the underlying business, not at least when it comes to Doptelet after the strong performance. Other than that, no, I think you said it, Guido.
Yeah. Yeah, we have obviously, as you can see, you know, we have really exponential growth, particular now in Europe right now. We don't see this coming down too quickly. All right.
Perfect. Thanks so much.
Thank you. Thank you, Mattias. maybe we open up.
The next question comes from the line of Peter Oehling with Pareto. Please go ahead.
Yes, thank you. Just, a single one. Most of my question has already been answered. You mentioned, regarding Vonjo, you mentioned that, there had been some expansion when it comes to guidelines. Does that mean that the basic population of around 7,000 patients in the US will expand?
Yeah, yeah, I mean, the when you follow the guidelines, which is not label, but you follow the guidelines, the NCCN guidelines, they cover all thrombocythemia patients. all myelofibrosis patients at this stage.
Okay.
All doing well.
Oh, your own credit. Okay. Thank you.
Thank you.
The next question comes from the line of Alistair Campbell with RBC. Please go ahead.
Thanks so much. Got two questions I may. The first one is on Doptelet. Just really want to be clear on this. Obviously, a very large China sales number in Q2. If I were to assume no more China sales this year, second half this year or next year, but the underlying run rate for Doptelet ex-China, I'm probably getting to a number that looks like broadly year on year, you'd be flat for Doptelet. Is that reasonable, or do you think you can do better than that? The second question is on ALTUVIIIO. A couple of weeks ago, Sanofi were talking about the launch in the US 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 for ALTUVIIIO is when we think about your launch in Europe, albeit it'll be slower and sort of market by market? Thanks.
Let's start with the easy one on Doptelet. Basically, what we see here, and I think there's an echo, maybe for some of us to go on mute. Basically, you know, when you think about Doptelet, 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 Doptelet this year. Because, you know, the momentum is so powerful, and obviously, with the business that we have now consolidated from four to one, and with the underlying momentum that we see, we think we should be significant here. Let's, you know, let's see where.
Exponential growth is obviously always difficult to project. In our, but that is it, that we are going to grow, over and above last year, we see very strongly, because, you know, there we are also launching in Japan, so we should be. We are pretty bullish, about Orfadin, yeah. We, we had to increase our orders, so you know, to make sure that we sell it also. With regard to the second part of the question, the... Sorry, can you just repeat the question?
The ALTUVIIIO launch.
The ALTUVIIIO launch.
Or-
Yeah, you said 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 1, whilst we have to earn our stripes in getting reimbursement in a more sequential way. We try to be fast with this, so that, you know, and what we saw in with Elocta was once we had reimbursement in all countries, then we were actually more effective than Bioverativ was at that time. Gained, obviously, a significantly higher market share, even though the economics because of the price, were initially small. What we think is that with given the high expectations for ALTUVOCT, we believe that this is, you know, has really the.
the makeup to become best in class and standard therapy. and, you know, but, you know, how quickly can we take Hemlibra patients? We will obviously try to take Hemlibra patients, but don't forget also that Hemlibra has been much more successful in the U.S. than they have been. Still, there is a significant opportunity for us, and, you know, we will not discriminate where we take 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, you know, doing the and starting obviously next year, and then penetrating from there.
Yeah, it will, you will have to be a little bit more patient with us, just giving the reimbursement approvals. You know, once we have reimbursement approval, we hope that we will demonstrate similar uptake curves than what Sanofi is experiencing right now.
Sure.
Yeah, maybe, is this giving you some flavor, yeah? Maybe we open up for one more question, yeah.
The next question comes from the line of Viktor 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. 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 Orfadin, you highlighted here, of course, that generic competition will be introduced in China this year. 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 after that indication in China, given the high price pressure-
Mm-hmm.
on both the VBP and R&D, and RDL. My final question was also here on the label extension for Gamifant secondary HLH. I guess it has been some uncertainty previously if you're going to have enough data in your package to the FDA. I just want to understand if you had more interactions with the FDA and how confident you are that the phase two trial, EMERALD, and real world evidence-
Mm-hmm.
together will be a strong enough data package for the label expansion.
Mm-hmm.
Thank you.
Thank you, Viktor. You know, let's start from the back. You know, you know, we need to hold our horses. I mean, we will have an interim, as Armin said, pretty soon, on the EMERALD data for the first cohort of patients. We will judge whether this is already sufficient. Clearly, we'll consult the FDA. 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 with Fosun, you know, and we are, you know, obviously ITP could be the big opportunity.
It doesn't seem in China to be, you know, a promotion, but, you know, 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 DN, new situation with Fosun, maybe an economic arrangement that could be beneficial also for Sobi. 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.
Mm-hmm.
There's strong under with the rest of the business. With regard to the one-offs, Henrik, you want to comment what you expect in terms of one-offs?
Yes, Viktor, we do expect some more one-off costs in coming quarters. However, smaller than we saw in Q2.
Okay, thank you very much. Thanks.
Thank you. Maybe one last question, and then, there may be some opportunity after the Vonjo discussion, to open for some questions and answers as well, tomorrow. Is there one last question?
Our last question comes from the line of Niall Alexander with Deutsche Bank. Please go ahead.
Thank you.
Hi, guys. It's Niall 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, 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. Vonjo is obviously no surprise, being a small molecule, is going to be over time, being accretive. We have, you know, the situation synergies versus royalties. When you say midterm, also there, you know, the royalties should be very accretive because by definition, it's 100%, yes, of a smaller, it's a smaller percentage, but, you know, it's very material. It refers to much larger, obviously, patient group.
As we grow our other launch products and and growth products, they are also mostly very accretive source of supply for Vonjo, that is also very positive for us. 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. You know, we think that we have a lot of opportunity to improve this the business. You know, and obviously, we will update you once we know how much additional money we want to invest into studies and life cycle management with regard to Vonjo shortly.
Overall, we will not get obviously overboard. You know, we believe in this business. We think it's on an excellent shape. You know, there's a lot of opportunity for growth. I'm afraid that I cannot give you now a guidance already for next year. You know, when you have a bit of a perspective on the business, there are a lot of factors in favor that should help us over time. Yeah. This is now for the next year. I would not provide you with a guidance at this point of time. 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 pleased about the company.
It's, you know, quite nice to see how a lot of these things coming into place. 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 Vonjo opportunities and may have another question tomorrow is the time. Thank you so much. Wish everybody a great day. Thank you.
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