Swedish Orphan Biovitrum AB

Please note, anyone who wishes to ask a question during the conference may press star and 1 on the touch-tone telephone. You will hear a tone to confirm that you've entered the queue. If you wish to remove yourself from the question queue, you may press star and 2. Participants are requested to use only hands as well as connect questions. Please hold the line. The conference will begin shortly. Thank you. Please note, anyone who wishes to ask a question during the conference may press star and 1 on their touch-tone telephone. You will hear a tone to confirm that you've entered the queue. If you wish to remove yourself from the question queue, you may press star and 2. Participants are requested to choose only hands as well as in a question. Please hold the line. The conference will begin shortly. Thank you. Orphan Biovitrum AB Please note, anyone who wishes to ask a question during the conference may press star and 1 on the touch-tone telephone. You will hear a tone to confirm that you've entered the queue. If you wish to remove yourself from the question queue, you may press star and 2. Participants are requested to use only hands as well as connect questions. Please hold the line. The conference will begin shortly. Thank you. Please note, anyone who wishes to ask a question during the conference may press star and 1 on their touch-tone telephone. You will hear a tone to confirm that you've entered the queue. If you wish to remove yourself from the question queue, you may press star and 2. Participants are requested to choose only hands as well as any questions. Please hold the line. The conference will begin shortly. Thank you. Orphan Biovitrum AB Please note, anyone who wishes to ask a question during the conference may press star and 1 on the touch-tone telephone. You will hear a tone to confirm that you've entered the queue. If you wish to remove yourself from the question queue, you may press star and 2. Participants are requested to use only hands as well as connect questions. Please hold the line. The conference will begin shortly. Thank you. Please note, anyone who wishes to ask a question during the conference may press star and 1 on their touch-tone telephone. You will hear a tone to confirm that you've entered the queue. If you wish to remove yourself from the question queue, you may press star and 2. Participants are requested to use only hands as well as in a question. Please hold the line. The conference will begin shortly. Thank you. Orphan Biovitrum AB Please note, anyone who wishes to ask a question during the conference may press star and 1 on the touch-tone telephone. You will hear a tone to confirm that you've entered the queue. If you wish to remove yourself from the question queue, you may press star and 2. Participants are requested to use only hands as well as connect questions. Please hold the line. The conference will begin shortly. Thank you. Please note, anyone who wishes to ask a question during the conference may press star and 1 on their touch-tone telephone. You will hear a tone to confirm that you've entered the queue. If you wish to remove yourself from the question queue, you may press star and 2. Participants are requested to use only hands as well as in a question. Please hold the line. The conference will begin shortly. Thank you.

Ladies and gentlemen, welcome to the SOBI Q2 Results 2026 Conference Call and Live Webcast. I am Valentina, 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 Oerker, CEO. Please go ahead.

Yeah, thank you. Hello, everyone. This is Guido Oerker, CEO of Sobi. We are delighted to welcome you to the second quarter and half year of 2026 conference call for investors and analysts. Our presentation was posted on Sobi.com earlier today. Please turn to slide number two. We would like to remind you of the usual provisions on statements about expectations and projections of future events. Unless stated otherwise, we are making comments that mostly relate to the second quarter at constant currency exchange rates and a million Swedish krona. Please turn to the next slide. Today, we plan to cover the key aspects of our Q2 report. I'm joined by Henrik Stenqvist, our CFO, and Lydia Barth-Franzsch, head of R&D and chief medical officer. We plan to review this presentation first and have Q&A until around 3 p.m. today, Central Eastern European time. For those on the phone, please join the queue for questions by pressing star 1. If joining on HD Audio, please use a virtual keypad and press star. We propose that you ask only one, maximum two questions at a time. Please turn to slide number four. It's about the key takeaways for Q2. Let me start with the key messages from what has been a very strong quarter for Solvi. In Q2, we delivered revenue growth of 29%, at constant exchange rates alongside adjusted EBITDA margin of 35%, which clearly demonstrates both the strength of our portfolio and the quality of our execution. This performance was broad-based, driven by our strategic portfolio, supported across all regions, which again highlights the resilience and scalability of our business model. We are pleased with the progress with our latest new newest launches such as ASPA Valley in Europe, and at the same time, we delivered positive data from the REDUCE-2 trial for POTS to itinerate. We continue to make tangible progress across the entire pipeline. We are advancing gamifant and interferon gamma-driven sepsis with EMBRACE-2, expected to initiate it in the second half of this year. Additionally, while we received a complete response letter from NASP related to manufacturing, the path to submission is clear and we are taking the necessary steps to address the concerns of the agency. Importantly, based on the strong first half performance, We are increasing our full-year outlook, which reflects both the momentum of what we are seeing today and our confidence in continued delivery. So overall, the message for the quarter is very clear. We are delivering strong growth, making consistent progress in the pipeline, and building further confidence in our trajectory. Please turn to the next slide. Let's take a closer look at the Q2 performance. Growth was very well diversified across regions and segments. We delivered total net sales of just under 7.8 billion SEC in the quarter, corresponding to growth of 29% at constant exchange rates. which is particularly important here is the quality of that growth. It is driven primarily across our strategic portfolio which accounts around two-thirds of our group sales in Q2 and continues to grow significantly faster than the rest in the rest of the year. From our geographic perspective, the growth was very well diversified across all regions north, America delivered growth of 33%, international markets grew by 45%, and Europe contributed 23%. At the product level, we continue to see strong contributions from Dopdelet, Altuwacht, and Gamifund, whilst newer launches such as Asper Valley are building momentum and expanding their contribution. Taken together, this is a gross profile that is diversified, sustainable, and increasingly driven by high-value innovative medicine. Please turn to the next slide. Let me now turn to our pipeline and development progress. We continue to execute against a focused and disciplined development strategy, which with multiple programs advancing in parallel and delivering important During the quarter, we announced positive plotline results of REDUCE-2 with poitinorad, which demonstrated meaningful urate reduction alongside its favorable efficacy and tolerability profile. At the same time, we are progressing Gamifront in interferon gamma-driven sepsis, where we are aligning closely with regulatory authorities and preparing to initiate the EMBRACE-2 study in the second half of the year. Across the broader portfolio, we continue to see steady progress in regulatory filings, lifecycle management, and new indication development, which together underpin a strong and balanced pipeline. Overall, this pipeline represents a diversified set of launches throughout 2028, supporting our ambition to reach approximately 55 billion SEC in revenues by 2030. Let's look at a few products in more detail. Altovoct, next slide, please. Altovoct continues to perform extremely strongly and is establishing itself as a best-in-class product in Haemophilia A prophylaxis. In Q2, Altowalk delivered very strong growth with sales increasingly significantly on a year-to-year basis, supported by both new patient uptake and continued geographic expansion. We have now launched in 30 markets, including key European markets. We are progressing a three-wave launch strategy, allowing us to increasingly expand our share of the total market potential in the segment. During the quarter, our combined Haemophilia A sales grew by 41% at constant exchange rate. This performance reflects the strong clinical profile of Altowogt and the disciplined launch execution. Please turn to the next slide. The launch strategy in nephrology is progressing well across markets, and we are seeing incongruently early momentum supported by an expanding evidence base. During the quarter, we continued to expand access, including approval in the UK, and we are seeing increasing uptake in markets where reimbursement is already in place. National reimbursement is now in place in Spain or by coming towards the end of Q2. We have introduced the ENFUSE on-body delivery system with the first patient now dosed and very positive initial feedback which reinforces the differentiation of the product. Importantly, the new term outlook, long-term outlook and real-world data continue to support the clinical profile in line with a strong pivotal variant data. We are well on track to reach our 2026 target of four to 500 patients in nephrology, which underpins our confidence in the long-term potential of this franchise. Please turn to the next slide. So Dr. Lett continues to deliver consistent performance and is now firmly established as a leading global franchise. Growth is being diversified and is built on a differentiated product portfolio, including strong efficacy, pure dietary restriction, combined with an excellent execution. We are also continuing to expand internationally with the recent launches across Asia, Latin America, and other regions contributing to an increasing ex-US contribution over time. Overall, this remains a highly attractive asset with continued strong growth performance and a growing significant potential in international regions. Let's turn to the next slide. and speak about Gamifan in HLH and MAS. The US launch in MAS continues to perform well, with strong momentum driven by increasing physician awareness and new patient demand. Growth is also being supported by the expansion in international markets following the FDA label. In parallel, we have now completed filing in both Europe and Japan with a regulatory decision expected in Japan in H2, providing additional future growth opportunities for the product. Let's move to the next slide. Regarding gamifant in interferon-driven sepsis, this represents a significant opportunity both medically and strategically and we are making good progress in defining the development pathway. We had our first meeting with the Emergency Task Force on the design of the IDS program and based on the feedback, we are pursuing a large registrational Phase IIb III study in Europe through the EMBRACE II study, which we expect to initiate in the second half of this year. This study will be conducted in collaboration with the Hellenic Institute for the Study of Sepsis. Based on the data, we will then decide on the regulatory pathway. This provides a clear fast-to-market approach in the area of significant unmet medical need. While there's a lot of work still to be done, we believe that this represents a very meaningful opportunity to address in a high unmet medical need and further strengthens our pipeline. Let's move to the next slide. Turning to our gout franchise. We are building a leadership position across multiple segments in the gout market. For NASP, we received a complete response letter in June related to manufacturing. Not the outcome we obviously would have wished for. However, it is important to note that this is not related to clinical safety or efficacy concerns, and we have a clear plan to resubmit within the next 6 to 12 months. For POTS degenerate, the positive reduce-to data represent a significant milestone demonstrating strong efficacy and a favorable safety profile. We are pleased with the data that we have seen so far. We are on track for further data readouts and plan to progress towards filing in 2027. Together, these assets provide the foundation for meaningful and variable franchise with significant long-term potential. Slide number 13, please. Let me now turn to guidance. Based on our strong performance in the first half of the year, we are increasing our full-year outlook. We delivered outstanding first-half growth of 26% at constant exchange rate alongside strong margin development. At the same time, we have made significant progress across our pipeline. while continuing to execute on multiple key launches. Taken together, this gives us increasing confidence in our ability to deliver both growth and profitability for the full year. Now, I'd like to hand over to Luria.

Thank you, Guido, and hello, everyone. I will start with the pipeline milestones on the next slide, please. We continued our strong run during the second quarter. We received the top-line data for poditinirab in its first of the two pivotal studies, and the results confirm our excitement. I will come back to this in a minute. For NASP, the FDA issued a complete response letter which lays out a clear and actionable path towards resubmission, and I will share more details on that too. The results on the second-line combination, LOTIS-5 study of synlontha and rituximab, became available in June. Based on the study outcome, we will use the LOTIS-5 results to convert the current third-line conditional approval to full approval for synlontha monotherapy, especially in region-international countries like Brazil, Australia, and the Middle East region, where we see a strong potential to help patients. New positive string ulcer data from Core and Core 2 studies was presented at EAS, which I will detail later on. The certification of infused device for Aspavelli in the EU paves the way for home use by people 12 years and older. The initial feedback from patients and physicians highlights the greater convenience compared to the previous solution. Kineret was approved in Japan for Stills disease, making another medicine now available for our growing presence in Japan. And we completed enrollment in the Pacifica trial of Bonjo in chronic myelofibrosis, which we already discussed at the last earning call. Next slide, please. Turning to gout. Clinical results for Potatinorab strengthened our decision to make this asset part of the SOVI portfolio and our ambition to build a gout franchise. We reported positive top-line results from the pivotal Phase III Reduce II study. Both the 75 and 50 mg doses met the primary efficacy endpoint with 69 and 56.6%, of patients respectively achieving serum uric acid level below six milligram per deciliter at six months, compared with 8% of placebo. Importantly, poditinura was overall well tolerated with a safety profile consisting with previous studies. We expect to present detailed data at the Congress later this year, and we continue to expect the Reduce-1 top-line readout in the fourth quarter. On NASP, we received a complete response letter from FDA. The CRI is related to CMC and contract manufacturing facility topics, which are addressable. The feedback provides a clear and actionable path forward, and we're actively engaging with the FDA and manufacturing partners as we work towards the submission. Importantly, the FDA identified no concerns regarding clinical efficacy or safety profile of NASP that impact a probability. So we remain confident in the long-term potential of NAS and committed to bring this treatment option to patients with uncontrolled gout. Next slide, please. While Tringolsa is under EU review for severe hypertriglyceridemia above 880 milligram per deciliter, new data were presented at the EAS Congress. This pool analysis of the pivotal core and core two studies looked at patients with severe hyperthyroidemia defined as TG levels of at least 880. This threshold is recognized by European guidelines as requiring urgent intervention to reduce the risk of acute pancreatitis. And this is the population we are aiming for with the European submission. The analysis included 455 patients and focus on those at highest risk of acute pancreatitis. Tringolza demonstrated an 85% reduction in the relative risk of acute pancreatitis events and a 66 placebo-adjusted reduction in TG levels with the 80 milligram dose after six months of treatment. Importantly, 85% of treated patients achieved TG levels below 880. What we find particularly encouraging is that these data further strengthen the growing body of evidence linking TG reduction with meaningful clinical outcomes. Acute pancreatitis is one of the most serious complications of severe hypertriglyceridemia, and these results reinforce the potential value of Tringolsa beyond biomarker reduction only. Overall, we believe these data support the efficacy and safety profile of Tringosa inferior hypertriglyceridemia above 880. This is strengthening our confidence in its potential to address a significant medical need. Next slide, please. Looking ahead, we continue to see a strong and diversified stream of pipeline milestones across this and next year, spanning nephrology, immunology, hematology, and specialty curves. In the second half of 2026, we expect several important regulatory and clinical data events. These include regulatory decisions in Japan for Aspavelli in C3G and primary ICMP-GM, as well as gamifan in HLH-MAS. In gout, we expect the Reduce-1 top-line data readout for potatinerad. And in severe hypertrophic seridemia above 880, we anticipate CHMP opinion for Tringulza. Moving into 2027, we expect continued momentum across the portfolio. Key anticipated milestones include the planned FDA submission for POD detenerate and the resubmission for NASP, regulatory progress for gamifan in HLH mass in Europe, and important phase three readouts for Bonjo in both myelofibrosis and dexed syndrome. Taken together, these milestones illustrate the breadth of our development portfolio and our continued focus on delivering innovation for patients living with rare and debilitating diseases. And with that, I would like to hand over to Henrik. Next slide, please.

Thank you, Lydia. Hello, everyone. Please turn to slide 20. We will now take a look at some key financial metrics for the quarter. Looking on the table to the right, We see a revenues of 7.8 billion, corresponding to a growth of 29% at constant currencies. The adjusted gross margin of 77% in the quarter is in line with last year, and this is due to a mix of offsetting products and country mix effects. operating expenses excluding non-recurring items and amortization for the quarter increased by 24% at CER compared to Q2 2025. FG&I also excluding non-recurring items and amortization increased by 15% at CER driven by launch and pre-launch costs for Aspa Valley in the prodigy NASP and Trigonsa, and these costs were partially offset by lower costs for Bonjo and Topsinet. R&D expenses increased by 47% at CR, excluding non-recurring items, mainly due to the addition of the Atrosi development programs. And as a reminder, we had only a part of a quarter of those costs in Q1. And as a result, the adjusted EBITDA for the quarter amounted to 2.8 billion, equal to a margin of 35% compared to 34% for the same period last year. Operating cash flow for the quarter was 1.9 billion compared to 1.4 billion in Q2 last year. This increase reflects higher operating profits, but also partially offset by inventory buildup to support our launches. and that gave a net debt at the end of the quarter just above 16 billion and a net debt to EVTA ratio of 1.3 times compared to 1.5 times in the previous quarter. Please now turn to slide 21 and the financial outlook for the fall year 2026. As usual, this is based on revenue growth at constant exchange rates and adjusted EBITDA margin. So for the full year 26, we have raised the outlook for both revenue and adjusted EBITDA margin. We anticipate revenue to grow at mid to high teens percentage at CER and previously low double digit percentage. And we anticipate EBITDA margin to be in the mid to high 30s percentage of revenue and previously mid 30s percentage of revenue. Now to add some color to this guidance upgrade, Related to revenue, we saw 26% growth at CER in H1, and we expect momentum to continue with Outerbox, Dopslet, and Gamifant being the main growth drivers in full year 2026. However, on a percentage basis, we're up against high comps in H2, which will naturally bring down the revenue growth in H2 compared to the situation in H1. And this is how we come to growth of mid to high teens for 2026. Bay Fortis, although not expected to be a major growth driver, remains difficult for us to forecast, but we don't believe the fundamentals have changed with regards to recommendations and reimbursement. Related to adjusted EBITDA margin and that guidance, our margin in H1 was 37%. In the second half of the year, we will have the benefit of Bay Fortress seasonal royalties on our bottom line, as well as some NASP costs that we move now from 26 to 2027. And at the same time, we will advance Gamifund in IDS, as we heard, and plan to initiate the Phase 2b-3 study in the second half of 26. We will also have increased costs for the launch of Aspen Valley Nephrology as we continue the rollout in Europe. as well as in Trengosa, where we will ensure a strong and well-prepared market entry to address the larger patient opportunity in SHGG, which we expect to launch next year. And finally, and as usual, we will continue to be diligent with cost containment in the rest of our business. So with this, I hand back to Guido. Thank you.

Peter, you're on mute.

Sorry. To conclude, and maybe we can go to the next slide, SUBI continues to execute across all dimensions. We are delivering robust financial performance. is one of the leading companies in the world. It is one of the leading the second half of the year with a strong momentum and increasing confidence about our growth trajectory. With this, I would like to hand over to Q&A.

Thank you. We will now begin the question and answer session. Anyone who wishes to ask a question may press star and one on their 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. Questionnaires on the phone are requested to disable the loudspeaker mode and eventually turn off the volume from the webcast while asking a question. Anyone who has a question may press star and one at this time. The first question comes from Christopher Yudi from SED. Please go ahead.

Hi there. Thank you very much for taking my questions. Christopher Udy from SEB. Probably for Guido and maybe Lydia. So Arrowhead has a few trials reading out in Q3 that include acute pancreatitis as endpoints. So what do you see as or perhaps hear from your stakeholders as the bar in terms of magnitude of pancreatitis reduction for them to hit that would threaten tringles as chances of being the clear preferred therapy in Europe? And my second question is basically on why the NASP CRL came and what the impact is. So specifically for Lydia, I think the NASP BLA was originally delayed by about a year as the team worked to get CMC right. So what detail can you share to help us understand the extent to which what happened here was foreseeable? or that it was out of your hands, such as because of regulator bandwidth and related to the uptake in CRLs that we've seen. So obviously then obviously this feeds into what you can say about your confidence in terms of being able to fully address all the outstanding issues within the timeframe you've mentioned. Thank you.

Yeah, thank you. Maybe we start with the competition with Arrowhead and then I hand over to Lydia. I mean, you look at the situation, Arrowhead being behind us. We are now already in the market with FCS. And obviously, you know that we are preparing the approval and the launch for the broader indication as early as beginning of next year. So from this perspective, we are the lead. we have very strong data on SHCG reduction which is probably more comparable with the Arrowhead product and we have when you account for these data properly and then you have the we have the data in AP reduction which obviously the bar is super high now These are not comparative trials. A lot of things can happen, but for them to beat or meet is not going to be evident. In any case, we have a time advantage, and we have not obviously insinuated that we take the entire market. We just said that we are exploiting the lead position, and we will be up. You know, we don't underestimate the competitor, but we think that we have here an edge. And we are building these teams out. This is for us a key priority launch. And we are well on the way, you know, in terms of building these teams. I mean, it's one of our foremost points. So, yes, they will come, but, you know, the market is large enough. We think that we are in the lead. And it's... and it's for them to try to meet our efficacy level in AP and the bar is super high. And these are non-comparative trials, obviously. So, Julia, you want to comment maybe on what you expect in these trials and maybe then talk about NAS?

Yeah, so when it comes to Redemplo, basically, We always need to be very cautious, as Guido says, if you cannot compare head-to-head the trials because you can find differences in the patient population. We need to be also aware that, for example, we already have a head start also with an auto-injector that is something that for this type of chronic treatment is bringing a lot of value to patients. So I think that we want to see the data first It's not only about efficacy, we need to look at also the safety profile. So there are many nuances here, but we remain very confident that Tringosa is going to be a very strong asset for this indication. So I think that let's wait and see the data first when it comes. Yes, probably soon. And then we can comment more based on the facts. But we are remaining very confident on what Tringolsa can deliver. And maybe I can touch briefly on the CRL. And yes, you're right. We had already previous discussions with FDA. And as you know, some of the manufacturing facilities outside the US that have been resolved. So there are now CMC questions and data that we need to address. And I think the most accurate thing I can say is what we are doing now after receiving the CRL is that we will be meeting with FDA to map exactly timelines and we plan to resubmit. because what is clear is that there is a very clear path and actionable that we can deliver. And, yeah, that's what we will be doing in the next month, being this obviously a high priority for us. Thank you very much.

Thank you. Next slide.

The next question comes from Kirstie Ross-Stewart from BNP Paribas. Please go ahead.

Hello, thank you. It's Kirsty O'Stuart from BNP Paribas. So maybe just a quick one on AltaVox growth, obviously very impressive in the quarter. So just as you progress through your three-wave launch plan, can you provide a bit of colour on the opportunity associated with kind of each wave of the launch plan relative to your 10 billion sec guidance? And bigger picture, just how long can you sustain or do you think you can sustain double-digit growth post-2026? And then on the sepsis phase two, three program, based on some relatively rudimentary statistical analysis, I think that the 1800 patient target across three arms of the trial implies that you're powering this trial for a kind of high single digit delta versus placebo, which would imply a little bit of a step down from the 12% delta you saw in phase two trial. So Firstly, maybe is that a fair assumption? And can you just explain how you're thinking about your expectations for the placebo arm as you go into the registration or trial? Thank you.

Yeah, thank you for your question. Maybe I'll start quickly with the work. We think that we can sustain this for quite a while. I mean, if you extrapolate the sales numbers that we already achieved in the quarter, The product is on a good way. We are clearly on track to make this 10 billion mark. No question. We don't know yet when we will achieve it, but there's a lot of growth opportunities still in Europe. There's obviously significant growth in some of the international markets. as you will see. So, you know, we are not worried about this. This is, you know, it is, you know, and also the, when you think about I2VoCT in combination with Elocta, the number will already be this year, extremely substantially. So maybe I refer now to Lydia on the Zepsys tribe.

Yeah, so yes, you are absolutely right that that's the plan to have these 800 patients recruited. We recently received the feedback from EMA and the emergency task force and that's what we are now reviewing and implementing in the protocol. So it's a bit early to comment on details on the statistical power, arms, design, etc. And we will be very happy to come back to all of you once we have finalized the protocol based on all this feedback that has been positive because it's really allowing us to go to a registrational phase 2b3 trial. So at this point in time, no more details that I can provide, but the good news is that we have this feedback very clear that we are now working to implementing our protocol.

And I think, Kirstie, it's fair to say that we, and Lillia, that we will not power the study for a single-digit difference. I think that's it. Yes, I think this is clear. Why would we do that? Next question. Thank you.

The next question comes from Mitchell Kapoor from HC Wainwright. Please go ahead.

Hi, this is Ahmed on for Mitchell. Thank you for taking your questions and congrats on the strong quarter. Just two questions, one on the NASP CRL. I was wondering if the post-CRL FDA meeting has already been scheduled and if the six to 12-month resubmission estimate is based on direct FDA feedback or is that SOBE's internal estimate? And are there any milestones between now and resubmission we should be looking out for? And the second question on the guidance I guess, what level of sales growth are you modeling in the second half to reach that midpoint of the revised range, and what do you expect to drive this growth? Where have you embedded the most conservatism?

Thank you. Maybe, Lidia, you start.

Yeah, sure. So the meeting with FDA has not been scheduled yet. We have 90 days to align with FDA on that. But this is something that we are planning, and it will be scheduled soon. So that's the first question related to that meeting. And then the second part on the six to 12 months, this is still our estimate. You know, we have 12 months to resubmit and we are looking into every way to accelerate and to make it the closed to six as possible, but it's a little bit early to be more precise on that. So it's something that is based on our assumptions, and we have not yet had that discussion with FDA to really fix the next resubmission date. But in the meantime, we will be working, and the CMC team already has started internally and with the external manufacturing facilities to address the issues.

Yeah. So the team in the technical operation know exactly what needs to be addressed. They're working on this, and this prompted our advice, you know, with regard to the timeline. You know, normally we are not so precise on guidance, but I understand. Henrik has a good day. Maybe you can elaborate on your guidance.

Yes, I can. Of course, H2 will naturally come down in terms of growth rates because of the high comps that we had from H2 last year. But I think you were asking for a number, and it's obviously an H2 growth of some low to mid-double-digit growth. But we won't give any exact number.

Got it, thank you. And I guess just for the NASP CRL, just the last part of the first question was, are there any particular milestones we should be looking for between now and the resubmission, kind of other than obviously the FDA meeting?

No, not really. We just need to meet with FDA and agree on the next plan for the resubmission, but nothing in between that we will need to communicate.

Got it, thank you. The next question comes from Harry Gillies from Barenburg. Please go ahead.

Thank you very much for taking the questions. Could you please let us know what were the biggest drivers of the top line guidance range? So which drugs had the biggest difference in H1 versus your prior expectations? And then number two, could you please discuss how you're thinking of the GammaFant sepsis opportunity in terms of the US? I believe this is an ex-US or just European-only trial. How are you thinking about the opportunity there? Will Sobe go alone or perhaps look for a partner? And if I could ask a third question, as we try and model Tringolza sales next year in Europe, in the larger HTG indication. You know, how should we think about that piece of launch, you know, somewhere between Altivox and Aspavelli, or is this more of an Aspavelli-type launch? Just considering it's obviously a new area, but the drug is already on the market. You're already speaking to physicians in the smaller indication. Thank you.

Thank you. Yeah, now with regard to the growth drivers versus guidance, it's clearly Dr. Lett and I2Walked. I2Walked because it's an exceptional performance and obviously Dr. Lett was not obvious that we can still retain such a strong growth momentum also in markets like the U.S., and they've been internationally anyway booming and so this clearly was sticking out but you know the performance is obviously driven by a cross board and very pleased also with the Kinneret performance. With regard to the Gummy Fund and IDS I mean this is a decision that we have taken it's only driven by speed because we felt that the emergency task force was giving, was understanding what we tried to achieve and we basically have to set up and our goal is to make the drug available as fast as possible and obviously we will update you then on our approach to the US. We will democratize access obviously to the product but we thought if we get to a kind of fast-track approach in Europe, and we believe it's a product that will pave the way for other geographies. Julia, do you want to comment?

Yeah, sure. So you're absolutely right. The objective is, based on the feedback from EMA and the emergency task force, we have a path for, let's say, the fast market, but the ultimate goal remains to get an approval for GAMI fund in this indication globally, but it will be a stepwise approach.

Yeah. And, you know, this was, it's just speed that prompted us. This is a torch. And then with regard to Twingo also, I mean, we have not set this out, but, you know, you have seen the global ambition. It's, you know, it's one of our biggest, it's going to be one of our biggest products. And, you know, I think you have to see this in this light. I mean, it's always, you know, tough because, you know, you will, over time, you will have this uptake. And, you know, and it is probably an uptake commercially. I mean, if it... It may take more time than, let's say, the uptake and then I do work. But, you know, it's a very large area. So we are optimistic, but we have not yet provided detailed guidance. So we but, you know, we have given you an idea where we see the thing globally, you know, turning out and it is it's going to be a very huge product to us. Thank you. And the next question.

The next question comes from Gonzalo Arteag from Danske Bank. Please go ahead.

Hi, and thank you for taking my questions, Gonzalo Arteag from Danske Bank. I have a couple of them. The first one is from Rana Spavelli. We see that sales went slightly down versus Q1. I was wondering if you could give us some color on the launch trajectory in kidney rare diseases and why we have not seen signs of growth in Q2. How should we see this drug in this launch period going forward in terms of looking forward estimates? And the second question is following the previous one on gamifant on sepsis. Just so I understand, have you spoken with the FDA on this opportunity already or only with EMA? And is this decision of going only for Europe also driven by study design or more stringent longer endpoints required by somehow?

Maybe, Luia, you start with sepsis and then we follow. Yeah, so...

Yeah. Thank you, Gonzalo. And I will start with this IDS piece. And yes, the answer is yes. We're talking now only with EMA. And that is based on this speed to market and really having a clear path towards a registrational trial in Europe. Having said that, that does not mean that we are not talking to experts in the U.S. because this is not... We have a long-term plan for Gamifon, as I mentioned before, and it's an ambition of having a global asset for IDS. So we've started some conversations with the U.S. experts, but not yet with FDA.

Okay. And, you know, it's again, we have a very high attention level in EMA. We didn't want to lose this momentum. It's a time decision. And with regard to Asparvalli, let's say, you know, the, you know, this is, the variance is more driven by P and H than by EMA. TCG, when we say that we are very confident with our patient numbers, that basically tells you that we have a very good uptake in terms of number of patients in comparison to what we sent out to the market. Obviously, Spain came on board a little bit late. You see an effect in Germany. It always takes some time to bring these patients on. but the launch is well on the way and obviously that patient numbers ultimately have to translate into sales and we have stabilized this P&H business but that means also that there should be an accumulation effect. So there's nothing wrong with the launch. We are clearly confident to exceed or meet at least our guides in terms of number of patients. So product is in a wide trajectory and you will see this in the later quarters.

Great, thank you.

You're welcome.

The next question comes from Johan Junerus from SB1 Markets. Please go ahead.

Thanks for taking my questions and well thanks for plenty of good questions before but to go back to the NASP and details just for the framework of the process could you once you will have the timetable more established following the next meeting will you communicate that and also will that communication provide more substance into the details that is at hand what you do using contract manufacturing in the process and also please remind us about once you submit the box timeline to be expected after this submission.

So, and I'm sorry because I could not hear the end. So you were asking when we submitted?

Yes, the last bit was once you do submit 12 months or a bit short, nearer, what's the timeline afterwards we can expect? That was the last bit.

Okay, so we submitted in June last year, we were expecting, so we had our pedophilia, it was June this year. Now we have this up to 12 months to resubmit, and then we will try to shorten. I don't think that we can provide very detailed information on exactly the timelines for each of the parts, but once we submit, we have six months for the review of FDA of the resubmission this year.

Yes, and following the meeting that will take place, then you will have a better view on the timelines. And will you at that stage communicate that? And will you also provide some more details regarding what's the issues?

I think that that's a piece that we need to decide once we meet with FDA. So probably in the next quarterly call, we can bring more details, but it will be high-level detail information.

Yes. Well, very useful. Thank you. Thank you.

Are there more questions?

No, that was the last question. Back over to you for any closing remarks.

Yeah, thank you so much for your interest. I know it's summer season, so the more we appreciate that you're dialing in. As you can see, we feel quite bullish about this business. 29% growth is giving us a lot of confidence for the coming months and for the rest of the year, and with strong earnings supporting this business and progress, obviously. in the portfolio, in the pipeline, even though not everything has worked out according to plan, but, you know, that's life. But, you know, the majority of things that's important projects clearly prevail. And I think this is what matters. Thank you so much and wish you a great week. Look forward to reconnecting with you. Thank you.

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