Yeah, thank you. Hello, everyone.

This is Guido Oelkers, 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 in million Swedish kroner.

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 Abad-Franch, Head of R&D and Chief Medical Officer. We plan to review this presentation first and have Q&A until around 3:00 P.M.

today, Central Eastern European time. For those on the phone, please join the queue for questions by pressing star one.

If joining on HD audio, please use the 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 Sobi. In Q2, we delivered revenue growth of 29% at constant exchange rates alongside adjusted EBITA 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 newest launches, such as Aspaveli in Europe, and at the same time, we delivered positive data from the REDUCE 2 trial for pozdeutinurad.

We continue to make tangible progress across the entire pipeline. We're advancing Gamifant in interferon-gamma driven sepsis with EMBRACE II 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.

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 SEK 7.8 billion in the quarter, corresponding to growth of 29% at constant exchange rates.

What 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 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%, Europe contributed 23%.

At the product level, we continue to see strong contributions from Doptelet, ALTUVOCT, and Gamifant, whilst newer launches such as Aspaveli are building momentum and expanding their contribution. Taken together, this is a growth 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, with multiple programs advancing in parallel and delivering important milestones. During the quarter, we announced positive top-line results of REDUCE 2 with pozdeutinurad, which demonstrated meaningful urate reduction alongside its favorable efficacy and tolerability profile.

At the same time, we are progressing Gamifant in interferon-gamma driven sepsis, where we are aligning closely with regulatory authorities and preparing to initiate the EMBRACE II study in the second half of the year. Across the broader portfolio, we continue to see steady progress in regulatory filings, life cycle 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 SEK 55 billion in revenues by 2030. Let's look at few products in more detail.

ALTUVOCT. Next slide, please.

ALTUVOCT continues to perform extremely strongly and is establishing itself as a best-in-class product in hemophilia A prophylaxis. In Q2, ALTUVOCT delivered very strong growth, with sales increasing significantly on a year-over-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 hemophilia A sales grew by 41% at constant exchange rate. This performance reflects the strong clinical profile of ALTUVOCT and the disciplined launch execution.

Please turn to next slide. The launch strategy in nephrology is progressing well across markets, and we are seeing encouragingly early momentum supported by an expanding evidence base.

During the quarter, we continued to expand access, including approval in the U.K., 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 long-term outlook and real-world data continue to support the clinical profile in line with the strong pivotal VALIANT 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.

Doptelet 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 it internationally with the recent launches across Asia, Latin America, and other regions, contributing to an increasing ex-U.S. 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 Gamifant in HLH and MAS.

The U.S. 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 II-B/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 decide on the regulatory pathway. This provides a clear path-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 presents a very meaningful opportunity to address 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 6-12 months.

For pozdeutinurad, the positive REDUCE 2 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 a meaningful and valuable 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.

I'd like to hand over to Lydia.

Thank you, Guido. 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 pozdeutinurad in its first of the two pivotal studies, 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.

I will share more details on that too. The results on the second-line combination LOTIS-5 study of Zynlonta 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 Zynlonta monotherapy. Especially in regional international countries like Brazil, Australia, and the Middle East region, where we see a strong potential to help patients.

New positive Tryngolza data from CORE and CORE2 studies was presented at EAS, which I will detail later on. The certification of enFuse device for Aspaveli in the E.U.

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 Still's disease, making another medicine now available for our growing presence in Japan. We completed enrollment in the PACIFICA trial of VONJO in chronic myelofibrosis, which we already discussed at the last earning call.

Next slide, please. Turning to gout, clinical results for pozdeutinurad strengthen our decision to make this asset part of the Sobi portfolio and our ambition to build a gout franchise.

We reported positive top-line results from the pivotal phase III REDUCE 2 study. Both the 75 mg and 50 mg doses met the primary efficacy endpoint with 69% and 56.6% of patients respectively achieving serum uric acid level below 6 mg per deciliter at six months, compared with 8% of placebo.

Importantly, pozdeutinurad was overall well-tolerated with a safety profile consisting with previous studies. We expect to present detailed data at a congress later this year.

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 CRL is related to CMC and contract manufacturing facility topics, which are addressable. The feedback provides a clear and actionable path forward.

We are 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 approvability.

We remain confident in the long-term potential of NASP and committed to bring this treatment option to patients with uncontrolled gout. Next slide, please.

While Tryngolza is under E.U. review for severe hypertriglyceridemia above 880 mg/dL, new data were presented at the EAS Congress.

This pool analysis of the pivotal CORE and CORE2 studies looked at patients with severe hypertriglyceridemia, 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 focused on those at highest risk of acute pancreatitis. Tryngolza demonstrated an 85% reduction in the relative risk of acute pancreatitis events and a 66% placebo-adjusted reduction in TG levels with the 80 mg 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 Tryngolza beyond biomarker reduction only. Overall, we believe these data support the efficacy and safety profile of Tryngolza in severe hypertriglyceridemia above 880.

They strengthen our confidence in its potential to address a significant unmet 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 care. In the second half of 2026, we expect several important regulatory and clinical data events.

These include regulatory decisions in Japan for Aspaveli in C3G and primary IC-MPGN and PNH, as well as Gamifant in HLH/MAS. In gout, we expect the REDUCE 1 top-line data readout for pozdeutinurad.

In severe hypertriglyceridemia above 880, we anticipate CHMP opinion for Tryngolza. Moving into 2027, we expect continued momentum across the portfolio.

Key anticipated milestones include the planned FDA submission for pozdeutinurad and the resubmission for NASP, regulatory progress for Gamifant in HLH/MAS in Europe, and important phase III readouts for VONJO in both myelofibrosis and VEXAS 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.

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 our revenues of SEK 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 product and country mix effects. Operating expenses, excluding non-recurring items and amortization for the quarter increased by 24% at CER compared to Q2 2025.

SG&A, also excluding non-recurring items and amortization, increased by 15% at CER, driven by launch and pre-launch costs for Aspaveli in nephrology, NASP, and Tryngolza. These costs were partially offset by lower costs for VONJO and Doptelet.

R&D expenses increased by 47% at CER, excluding non-recurring items, mainly due to the addition of the Arthrosi development programs. As a reminder, we had only a part of a quarter of those costs in Q1.

As a result, the adjusted EBITA for the quarter amounted to SEK 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 SEK 1.9 billion, compared to SEK 1.4 billion in Q2 last year.

This increase reflects higher operating profit, partially offset by inventory buildup to support our launches. That gave a net debt at the end of the quarter just above SEK 16 billion and a net debt to EBITA ratio of 1.3x, compared to 1.5x in the previous quarter.

Please now turn to slide 21 and the financial outlook for the full year 2026. As usual, this is based on revenue growth at constant exchange rates and adjusted EBITA margin.

For the full year 2026, we have raised the outlook for both revenue and adjusted EBITA margin. We anticipate revenue to grow at mid-to-high teens percentage at CER, previously low double-digit percentage, we anticipate EBITA margin to be in the mid-to-high 30s percentage of revenue, 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 ALTUVOCT, Doptelet, and Gamifant being the main growth drivers in full year 2026. However, on a percentage basis, we are up against high comps in H2, which will naturally bring down the revenue growth in H2 compared to the situation in H1.

This is how we come to growth of mid-to-high teens for 2026. Beyfortus, 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 EBITA margin and that guidance, our margin in H1 was 37%. In the second half of the year, we will have the benefit of Beyfortus seasonal royalties on our bottom line, as well as some NASP costs that we move now from 2026 to 2027.

At the same time, we will advance Gamifant in IDS, as we heard, and plan to initiate the phase II-B/III study in the second half of 2026. We will also have increased costs for the launch of Aspaveli nephrology as we continue the rollout in Europe, as well as in Tryngolza, where we will ensure a strong and well-prepared market entry to address the larger patient opportunity in sHTG, which we expect to launch next year.

Finally, as usual, we will continue to be diligent with cost containment in the rest of our business. With this, I hand back to Guido.

Thank you. Guido, you're on mute.

Sorry. Maybe we can go to the next slide.

Sobi continues to execute across all dimensions. We are delivering robust financial performance, driving successful launches, and advancing a differentiated pipeline.

At the same time, we are making disciplined strategic choices that position us well for long-term value creation. With this positive readout of pozdeutinurad REDUCE 2, we have significantly de-risked this asset and look forward to continue to progress it towards approval.

Overall, we are entering 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.

Hi there. Thank you very much for taking my questions, Christopher Uhde from SEB.

Probably for Guido and maybe Lydia. Arrowhead has a few trials reading out in Q3 that include acute pancreatitis as endpoints.

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 Tryngolza's chances of being the clear preferred therapy in Europe? My second question is basically on why the NASP CRL came and what the impact is.

Specifically for Lydia, I think the NASP BLA was originally delayed by about a year as the team worked to get CMC right. 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 uptick in CRLs that we've seen.

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 time frame you've mentioned. Thank you.

Yeah. Thank you.

Maybe we start with the competition with Arrowhead, then I hand over to Lydia. You look at the situation, Arrowhead being behind us.

We are now already in the market with FCS, obviously, you know that we are preparing the approval and the launch for the broader indication as early as beginning of next year. From this perspective, we are the lead.

We have very strong data on sHTG reduction, which is probably more comparable with the Arrowhead product when you account for these data properly. Then we have the data in AP reduction, which obviously the bar is super high.

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. We have not obviously insinuated that we take the entire market.

We just said that we are exploiting the lead position. We will be up.

We don't underestimate the competitor, we think that we have here an edge. We are building these teams out.

This is for us a key priority launch, we are well on the way in terms of building these teams. It's one of our foremost points.

Yes, they will come, but the market is large enough. We think that we are in the lead.

It's for them to try to meet our efficacy level in AP, the bar is super high. These are non-comparative trials, obviously.

Lydia, you want to comment maybe on what you expect in these trials and maybe then talk about NASH?

When it comes to Redemplo, basically, we always need to be very cautious. As Guido says, 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 the auto-injector. That is something that for this type of chronic treatment is bringing a lot of value to patients.

I think that we want to see the data first. It's not only about the efficacy, we need to look at also the safety profile.

There are many nuances here, but we remain very confident that Tryngolza is going to be a very strong asset for these indications. I think that let's wait and see the data first when it comes, yes, probably soon, then we can comment more based on the facts.

We are remaining very confident on what Tryngolza can deliver. Maybe I can touch briefly on the CRL.

Yes, you are right, we had already previous discussions with FDA, as you know, some of the manufacturing facilities outside the U.S. that have been resolved.

There are now CMC questions and data that we need to address. 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 exact timelines, we plan to resubmit.

What is clear is that there is a very clear path and actionable that we can deliver. That's what we will be doing in the next month, being this obviously a high priority for us.

Thank you very much.

Uhde, thank you. Next slide.

Next question, sorry.

Hello. Thank you.

It's Kirsty Ross-Stewart from BNP Paribas. Maybe just a quick one on ALTUVOCT growth, obviously very impressive in the quarter.

Just as you progress through your kind of three-wave launch plan, can you provide a bit of color on the opportunity associated with kind of each wave of the launch plan, relative to your SEK 10 billion guidance? Bigger picture, just how long can you sustain, or do you think you can sustain double-digit growth, post 2026?

Then on the sepsis phase II-III program, based on some relatively rudimentary statistical analysis, I think that the 1,800 patients 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 the phase II trial. Firstly, maybe is that a fair assumption?

Can you just explain how you're thinking about your expectations for the placebo arm as you go into the registrational trial? Thank you.

Thank you for your question. Maybe I'll start quickly with ALTUVOCT.

We think that we can sustain this for quite a while. 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 SEK 10 billion mark. No question.

We don't know yet when we will achieve it, but there's a lot of growth opportunity still in Europe, there's obviously significant growth in some of the international markets as you will see. We are not worried about this.

Also when you think about ALTUVOCT in combination with Elocta, the number will already be this year extremely substantial. Maybe I refer now to Lydia on the sepsis trial then.

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, that's what we are now reviewing and implementing in the protocol.

It's a bit early to comment on details on the statistical power, arms, design, et cetera. 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 through a registrational phase II-B/III trial.

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 implement in our protocol.

I think, Kirsty, it's fair to say that we, and Lydia, that we will not power the study for a single-digit difference. I think this is clear.

Why would we do that? Yeah.

Okay.

Next question.

Thank you.

Yeah. Thank you.

Hi, this is [Emran] for Mitchell. Thank you for taking our 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, if the 6-12 month resubmission estimate is based on direct FDA feedback or is that Sobi's internal estimate.

Are there any milestones between now and resubmission we should be looking out for? The second question on the guidance, 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 Lydia, you start with NASP.

Yeah. Sure.

The meeting with FDA has not been scheduled yet. We have 90 days to align with FDA on that.

This is something that we are planning, and it will be scheduled soon. That's the first question related to that meeting.

The second part on the 6-12 months, this is still our estimate. We have 12 months to resubmit, and we are looking into every way to accelerate and to make it close to six as possible.

It's a little bit early to be more precise on that. 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.

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. More on that.

The team in the technical operation know exactly what needs to be addressed. They're working on this, and they've prompted our advice with regard to the timeline.

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 have from H2 last year.

I think you were asking for a number, and it's obviously an H2 growth of some low to mid double-digit growth. We won't give any exact number.

Got it. Thank you.

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 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.

Nothing in between that we will need to communicate.

Got it. Thank you.

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?

Which drugs had the biggest difference in H1 versus your prior expectations? Number two, could you please discuss how you're thinking of the Gamifant sepsis opportunity in terms of the U.S.?

I believe this is an ex-U.S. or just European-only trial.

How are you thinking about the opportunity there? Will Sobi go alone or perhaps look for a partner?

If I could ask a third question. As we try and model Tryngolza sales next year in Europe in the larger HTG indication, how should we think about that pace of launch?

Somewhere between ALTUVOCT and Aspaveli, or is this more of an Aspaveli 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. With regard to the growth drivers versus guidance, it's clearly Doptelet and ALTUVOCT.

ALTUVOCT because it's an exceptional performance, obviously. Doptelet was not obvious that we can still retain such a strong growth momentum also in markets like the U.S., and internationally anyway booming.

This clearly was sticking out. The performance is obviously driven by across board, and very pleased also with the Kineret performance.

With regard to Gamifant and IDS, this is a decision that we have taken. It's only driven by speed because we felt that the Emergency Task Force was understanding what we tried to achieve, and we basically have the setup and our goal is to make the drug available as fast as possible.

Obviously we will update you then on our approach to the U.S. We will democratize access, obviously, to the product.

We thought if we get to a kind of fast track approach in Europe, and we believe in the product, that will pave the way for other geographies. Lydia, you want to comment?

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-to-market, but the ultimate goal remains to get an approval for Gamifant in this indication globally, but it will be a stepwise approach.

It's just speed that prompted us with this approach. With regard to Tryngolza, we have not set this out, but you have seen the global ambition.

It's going to be one of our biggest products. I think you have to see this in this light.

It's always tough because over time you will have this uptake, and this is probably an uptake commercially. It may take more time than, let's say, the uptake than rituximab, but it's a very large area.

We are optimistic, but we have not yet provided detailed guidance. We have given you an idea of where we see this thing globally turning out, and it's going to be a very huge product for us.

Thank you.

Maybe next question.

Hi, thank you for taking my questions, Gonzalo Artiach from Danske Bank. I have a couple of them.

The first one is on Aspaveli. 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?

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?

Is this decision of going only for Europe also driven by study design or more stringent longer endpoints required by some? Thank you very much.

Maybe, Lydia, you start with sepsis and then we follow.

Yeah.

We talk about that. [audio distortion]

Thank you, Gonzalo. I will start with this IDS piece.

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 does not mean that we are not talking to experts in the U.S.

because we have a long-term plan for Gamifant, as I mentioned before, and it's an ambition of having a global asset for IDS. We've started some conversations with the U.S.

experts, but not yet with FDA.

It's again, we have a very high attention level at the left in EMA. We didn't want to lose this momentum.

It's a time decision. With regard to Aspaveli, let's say, the variance is more driven by PNH than by C3G.

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 said out to the market. Obviously, Spain came on board a little bit late.

You see an effect in Germany. It will always take some time to bring these patients on.

The launch is well on the way, and obviously that patient numbers ultimately have to translate into sales. We are stabilized this PNH business, but that means also that there should be an accumulation effect.

There's nothing wrong with the launch. We are clearly confident to exceed or meet at least our guidance in terms of number of patients.

Product is in a right trajectory, and you will see this in later quarters.

Great. Thank you.

You're welcome.

Thanks for taking my questions, well, thanks for plenty of good questions before. To go back to the NASP and details just for the framework of the process, once you will have the timetable more established following the next meeting, will you communicate that?

Also, will that communication provide more substance into the details that is at hand? Of course, you're using contract manufacturing in the process.

Also please remind us about once you submit, what timeline to be expected after the submission.

Lydia?

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

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

We submitted in June last year. Our PDUFA date was June this year.

We have this up to 12 months to resubmit, then we will try to shorten. I do not think that we can provide very detailed information on exactly the timelines for each of the products.

Once we submit, we have six months for the review of FDA of the resubmission this year.

Yes. Following the meeting that will take place, you will have a better view on the timelines.

Will you at that stage communicate that, will you also provide some more details regarding what are the issues?

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

Yes. Well, very useful.

Thank you.

Thank you. Are there more questions?

Thank you so much and for your interest. I know it's summer season.

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. 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, that's life.

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.