3/18/2026

speaker
Operator
Conference Operator

Good day and thank you for standing by. Welcome to Volneva's full year 2025 results and business update conference call and webcast. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, please press star 1 1 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 1 1 again. Please note that today's conference is being recorded. I would now like to hand the conference over to your speaker, Joshua Drum, VP of Global Investor Relations.

speaker
Operator
Conference Operator

Please go ahead.

speaker
Joshua Drum
VP of Global Investor Relations

Hello, and thank you for joining us to discuss Velneva's financial results for the full year 2025 and corporate update. It's my pleasure to welcome you today. In addition to our press release and analyst presentation, you can find our consolidated financial results for the year ended December 31st, 2025, which were published earlier today, available within the financial report section on our investor website. I'm joined today by Velneva's CEO, Thomas Lingelbach, and our CFO, Peter Buehler, who will provide an overview and update on our business as well as our financial results. There will be an analyst Q&A session at the conclusion of the prepared remarks. Before we begin, I'd like to remind listeners that during this presentation, we will be making forward-looking statements which are subject to certain risks and uncertainties that could cause actual results to differ materially from those expressed or implied by these forward-looking statements. You can find additional information about these risks and uncertainties in our periodic filings with the Securities and Exchange Commission and with the French Market Authority, which are listed on our company website. Please note that today's presentation includes information provided as of today, March 18, 2026, and Valmiva undertakes no obligation to revise or update forward-looking statements except as required by applicable securities laws. With that, it's my pleasure to introduce Thomas to begin today's presentation.

speaker
Thomas Lingelbach
CEO

Thank you, hello, and thank you for joining us today. As we reflect on 2025, I'm proud to say that Balneva once again demonstrated resilience, discipline, and an unwavering sense of purpose. In a year marked by geopolitical uncertainty, rising vaccine hesitancy, and further consolidation in the biotech sector, we stayed focused, remained agile and continued strengthening our position as an innovative and recognized vaccine company. Our financial performance was solid. Total revenues exceeded €170 million, slightly above 2024 levels, including almost €160 million in product sales. This result reflects not only foreign exchange headwinds and the planned reduction in third-party product sales, but also growth in our proprietary travel vaccines. We closed the year with a cash position of nearly 110 billion euros and further enhanced our financial flexibility through a successful debt refinancing. We also achieved more than a 20% reduction in operating cash burn driven by our continuous distributed cash management. Most importantly, though, together with our partner Pfizer, we further advanced our Lyme disease vaccine candidates. This program represents an important opportunity for Valneva and for the millions of people at risk of Lyme disease. And we are looking forward and crossing fingers for the pivotal phase three results. Turning to how we see Valneva's strategic evolution. Our strategy is geared towards becoming the leading vaccine biotech company based on three important pillars. On the one hand side, we expect to further grow our commercial business and to optimize the cash generation through the commercial business. We will certainly continue maximizing R&D upside for our investors, leveraging our proven track record in R&D progression, in our ability to bring products from bench to global licensure And we will do so by leveraging our integrated business model on the one hand side, commercial, manufacturing, and development, which can be beneficial to advance and document programs in our R&D pipeline. Let's look a little bit at the different programs in our portfolio. And I'm now starting, of course, with the leading Lyme disease vaccine candidates in the world, the LA-15. So if you look at page eight of the presentation, this is a summary that shows you the growing and emerging problem that Lyme disease represents. There is currently no vaccine available to prevent Lyme disease, and also treatments are somewhat suboptimal. We are seeing a growing annual burden of the disease with reported almost 500,000 cases in the United States annually. And in Europe, it's probably going to be the same amount of magnitude. Also, the reported and the officially reported cases are a bit more than 130,000 annually. The important thing about Lyme disease is its severe clinical manifestations. 10 to 30% of cases develop, you know, many different clinical manifestations, which can be categorized in three packets. Ganytis, neuroborreliosis, and atributis. And most importantly, 5 to 10% of the cases continue to have persistent symptoms following treatment with antibiotics. We are evaluating VLA-15 right now in a placebo-controlled field efficacy study called VALOR. This study includes approximately 10,000 individuals. It's a study that is randomized one-to-one placebo against vaccine, two-to-one U.S. versus European sites, or to be precise, North American versus European sites. And the primary endpoint is disease prevention after three plus one doses, namely in season two, which we have also tested as part of this study. We completed last year all vaccinations and we are now in the process of testing and evaluating the data. As I said earlier, we hope that we're going to get, of course, good data and we have guided for data in the first half of this year. So in summary, VLA15 is a compelling opportunity in a really underserved market. It will be definitely the first vaccine, if approved, to address this disease. It is a highly differentiated vaccine, state of the art, when it comes to the vaccine composition addressing the main and predominant serotypes of Lyme borreliosis in the northern hemisphere. It is really representing a compelling target population and a use case with a broad addressable population. We have tested in the study people about five years of age. And we see really an opportunity here to address a very, very large target population. Of course, there is also a strategic fit within Pfizer's vaccine franchise, and we are very pleased to have a strong partner with Pfizer for the future commercial opportunities ahead for this vaccine. And of course, you know, there is a clearly attractive commercial dynamic. Prophylactics are always cheaper than therapy. And a potential inclusion in some of the routine immunization schedules for high-risk areas would really be a perfect opportunity. So with that, we see a unique and compelling opportunity that, of course, could be transformational for Waliba. So, again, we are looking forward to the data. Fingers crossed. So, if we turn to XCHIC, you know that we are still investing in the further development of what we call the LA-1553 or the marketed trade name XCHIC. Currently, we have three major R&D activities on Ixchic. We are very glad that we have been able to initiate a pilot vaccination campaign, which is ongoing in Brazil. We launched it in February with our partner Instituto Putantan in selected municipalities in Brazil. age range currently licensed by Anvisa in Brazil, namely 18 to 59 years of age. And the objective is really to achieve a 20 to 40% coverage within the target population. And right now, the vaccination uptake is quite compelling. We are further investing in post-marketing effectiveness studies to confirm the effectiveness and to optimize the correction of the safety profile. And this is a pragmatic, randomized, controlled, effective mental safety study in adults and adolescents in endemic countries. And of course, we continue to work on ensuring greater access to address the unmet medical needs in endemic countries. And we are in the process of expanding our network of manufacturing and distribution partners in low- and middle-income countries. So overall, I would say Ixchic did not have a great start in the travel segment, but we have been able to refine our labels and percussion, and we are now focusing mainly on post-marketing effectiveness and global market access. Turning to Shigelosis. So our program called S4V2 is a vaccine that targets shigellosis. It's a tetravalent shigella vaccine candidate that we in-licensed from Lima Tech. And it's currently the clinically most advanced shigella vaccine candidate. And therefore, we see here an opportunity to develop a first-in-class vaccine in a really life-threatening disease. When you look at the market opportunity and, more importantly, the clinical and medical need, you need to recognize that it is currently representing the second leading cause of fatal diarrhea, especially in children. And therefore, it has been identified as a priority vaccine by WHO. Vannevar has worldwide commercial rights upon potential approval. And we see here really two major markets. On the one hand side, travel. This is certainly a vaccine that could complement our travel portfolio in the adult sector. And probably more importantly, children in low-medium income countries. We launched two parallel studies, two phase two studies, one in infants. The other one is a combined immunogenicity and challenge study, a so-called controlled human infection model. Both are right now ongoing, and we expect for both data mid of the year. So again, a very important milestone for the company and subject to data, we're going to decide on the program development pathway forward. With that brief update on our portfolio and our key activities, I would like to turn over to Peter to provide us with the financial report.

speaker
Peter Buehler
CFO

Thank you, Thomas. Good morning or good afternoon to all of you. Now moving on to the financial review, starting with details on our top line on slide 16. Total product sales reached €157.9 million, in line with our guidance, and decreasing by minus 3.3% over 2024, or minus 1.3% at constant currency. The decrease in sales is primarily a result of the planned reduction of third-party sales and to a lesser extent of adverse currency impacts. As mentioned by Thomas at the beginning of the call, proprietary product sales excluding currency effects grew by plus 9% year-over-year. Ixiara sales reached 98.4 million euros compared to 94.1 million euros in 2024, representing a growth of 4.6% or 7.2% as constant currency. The growth in Ixiara sales was driven by the travel segment. Tukeral sales were essentially flat at €31.9 million compared to €32.3 million in the previous year, a decline of minus 1.2%. At constant currency, Tukeral sales grew by plus 1.8% year-over-year. Growth in sales was impacted by distributed change in Germany, a key indirect market. XTRIX sales reached €8.4 million compared to €3.7 million in the prior year. This includes the supply of 40,000 doses to the French island La Réunion in 2025. Finally, we reduced our third-party sales substantially year-over-year from 33.2 million euros to 19.2 million euros. As discussed previously, this decrease was the result of planned termination of our existing distribution contract for third-party products in order to focus on our proprietary products. Moving on to slide 17, looking at the P&L. Other revenues increased from €6.3 million to €16.8 million. The increase is driven by a €10 million revenue recognition related to the line agreement with Pfizer. These €10 million were previously included in refund liability on our balance sheet and represent the amount Valneva no longer expects to owe through future payments to Pfizer. Looking at our expense, cost of goods and services increased by 8.6 million euros. Cost of goods in the fourth quarter were adversely impacted by an 8.5 million euro inventory write-off, mainly related to extreme determination of the contract with the Serum Institute of India. We're talking here about an accounting write-down. The product is still available and could potentially be used for supply under future contracts in the pandemic market. Cost of goods also include approximately 10.8 million euros of idle cost. XCRO cost of goods remained stable versus prior year, while Ducorral gross margins deteriorated due to the failure of manufacturing batches in the fourth quarter. Research and development expenses increased from 74.1 million euros in 2024 to 85.3 million euros in 2025. This increase is in line with our guidance and is driven by higher spend on our Phase 2 Shigella vaccine candidate. And additionally, we increased our investment in our Chikungunya vaccine as we are executing on our post-marketing obligations. Marketing and distribution expense amounted to 37.4 million euros compared to 62.4 million euros in 2024. This significant decrease is the result of a reduced extra expense compared to significant investment in prior launch years. G&A expenses decreased from 42.8 million euros to 37.3 million euros as a result of our continued initiative to decrease administrative spend across the company. In 2024, VALNIVA sold the priority review voucher obtained with the approval of ixtric in the United States, which, net of expenses, resulted in proceeds of €90.8 million. Other income and expense decreased year-over-year by roughly 60% as a result of lower R&D tax credits and to a lesser extent due to low grant income in Scotland. In 2025, VALNIVA reports an operating loss of €82.1 million compared with an operating profit of 13.3 million euros. The operating profit in June 2024 was substantially driven by the non-recurring income statement of the sale of the Priority Review voucher. Finance expense includes the cost to refinance our debt with Deerfield and Robymed with a new five-year borrowed loan with Pharmacon. Valneva's loss for the period reached 115.2 million euros, while the adjusted EBITDA is reported at minus 51.4 million euros. Now, moving on to the financial outlook. In 2026, we expect total product sales of 145 to 160 million euros, and total revenues of 155 to 170 million euros. The overall decrease versus 2025 is related to further plant reduction in third-party product sales, offsetting continued growth from our proprietary products. We expect to progress in enhancing our RD pipeline of differentiated vaccine candidates, and cash will continue to be a focus with an emphasis on reducing our operating cash burn. Subject to a successful Lyme disease vaccine approval and commercialization, we expect to become financially self-sustainable and potentially profitable. With that, I hand the call back to Thomas to look at our future value drivers.

speaker
Thomas Lingelbach
CEO

Thank you so much, Peter. Yeah, well, let me turn to page 21 and talk a little bit about the future. Of course, you know, it will heavily depend on life. And what is the significance of the phase three results for Vannevar? Well, positive results could be transformational. delivering substantial commercial milestone and royalty revenue to fund further pipeline development and value creation. It would also further validate Varneva's position as a leading vaccine biotech company to potentially becoming the fourth vaccine we have developed from bench to market. When we look at our key initiatives and what we really would like to do going forward, On the one hand side, we would like to build scale in our R&D pipeline. This includes potential strategic in-licensing to augment our in-house pipeline, while creating a risk-balanced portfolio of innovative specialty lifecycle and high-value vaccine assets. We created Valneva 13 years ago, with an investment theme and focus on vector-borne diseases. We would like to expand now beyond vector-borne diseases, targeting assets based on defined criteria. We have a couple of quite interesting programs in preclinicals. They are all, you know, kind of, or some of them associated with AMR, but we have also a very interesting EBV program. All of that we expect to accelerate and bring into clinical development subject to positive line data. And of course, there is room to optimize our integrated operations, to control our value chain by investing in enhancing our end-to-end capabilities, and to structure our commercial model to optimize and maximize cash. With that outlook, Hopefully, an outlook based on positive data. I would like to turn back to the operator to take your question.

speaker
Operator
Conference Operator

Thank you. As a reminder, to ask a question, please press star 1 1 on your telephone and wait for your name to be announced. To withdraw your question, please press star 1 1 again. Once again, please press star 1 1 to ask a question and wait for your name to be announced. To withdraw your question, please press star 1, 1 again. Thank you. We are now going to proceed with our first question. The questions come from the line of Maury Raycroft from Jefferies. Please ask your question.

speaker
Maury Raycroft
Analyst, Jefferies

Hi. Thanks for taking my questions. Looking forward to seeing the LIME data soon. I know guidance is for first half 26. but you recently said you expect the data soon. Do you still see potential for readout by end of first quarter, or is it likely, could it get pushed to the second quarter? And also, can you talk about your involvement in the data analysis? I'm wondering if you have access to the data room and can see real-time updates on the number of adjudicated Lyme cases. And do you see the split between the vaccine and placebo?

speaker
Thomas Lingelbach
CEO

So, Maury, The sponsor for the phase three study is Pfizer. Pfizer are in total control with regard to the execution of the study, and we are at this point fully blinded. There is an official guidance from Pfizer with regard to the data readout in H1, and of course, we can't say anything different. We are hoping, though, that the data will come around mid of H1, whenever this mid is. But I would like to remind everyone that there is only one official guidance, and that's the one from Pfizer.

speaker
Maury Raycroft
Analyst, Jefferies

Got it. Understood. And can you comment on when the last time was that you spoke with Pfizer on the program, and what's the latest they're communicating to you based on status and timing?

speaker
Thomas Lingelbach
CEO

So we have a joint development structure. We have a governance as per contract, which includes a couple of formalized bodies. And I would say we have weekly interaction, frequent interaction, and so far, so good.

speaker
Maury Raycroft
Analyst, Jefferies

Got it. Okay. Maybe just last question, just if you can remind us what gives you confidence that VLA-15 will be equally efficacious in serotypes two through six versus serotype one. Wondering if you tested serotypes two through six in preclinical challenge models similar to the 2024 publication that you had.

speaker
Thomas Lingelbach
CEO

Yes, so first of all, this is an excellent question. So in preclinical models, different preclinical models, some of which have been published, others not yet. We have done passive and active immunization and tested against all serotypes. What we don't know is whether the immunological protection levels in humans will be identical across different serotypes. We have a lot of grounds to believe that, but of course, as you know, Maury, outside of serotype one, which was shown through Limerick and Imolime, there is no data in humans today that bridges immunological response with efficacy and even For Limerick, there was never a formal correlate of protection established, but there has been a publication that summarized correlation factor of 0.8, so 80% correlation in between immunological titers and protection. And of course, we hope to see the same. What gives us confidence is that in different models, different animal models, we have compared VLA15 against, I would call it, a limerick biosimilar. And this has been shown and published in different publications that have said not everything has been published. And we have seen across the border non-inferiority or superiority after three doses. And I think that that is mainly what gives us confidence, in addition, of course, to the immunological profile that we have observed across many different clinical studies. By the end of the day, data will tell, and data will hopefully come soon, and then we will know.

speaker
Maury Raycroft
Analyst, Jefferies

Got it. All helpful. Thanks for taking my questions.

speaker
Operator
Conference Operator

We are now going to proceed with our next question. And the questions come from the line of Brandon Foulkes from HC Wainwright. Please ask a question.

speaker
Brandon Foulkes
Analyst, HC Wainwright

Hi. Thanks for taking my questions and congratulations on all the progress. You know, maybe just staying on LIME, how do you think about capital allocation going forward if LIME is successful? That obviously changes your capital profile potentially quite significantly. So how should we think about that aspect of the business?

speaker
Peter Buehler
CFO

Yeah, Brandon. Hey, this is Peter. Well, look, I think it's important maybe to remind everyone that, you know, upon positive phase three data, we will not get any milestones under the program. The next milestones will be due upon first commercial sales. Essentially, it's first commercial sales in Europe and in the U.S., and it's a combined milestone of $143 million. But that's about, I would say, you know, probably a year and a half away from now at least. so so i mean in terms of capital profiles on the short term it's not really going to change and then i think you know we would certainly want to again accelerate and potentially augment our pipeline and this will of course take time to do that and we'll consider carefully how we do that great thanks very much and then maybe just on shigella s4v2

speaker
Brandon Foulkes
Analyst, HC Wainwright

When we see the phase two data later this year, how should we think about the threshold there for Vannevar moving forward with full development responsibility or sort of perhaps other development paths on that program? Thank you.

speaker
Thomas Lingelbach
CEO

Very good question, Brandon. So I would say the thing that we like about this program is that it includes controlled human infection models in adults. So this means we will have adults challenged at least with one strain, namely sonar, and we will see what we call pilot efficacy. So we will see whether people are protected and to which level they are protected, and more importantly, if there is an indication around what level of immunogenicity is required for them to be protected. This gives us, based on prior data, also a first hint to the children population, because there, of course, we don't challenge, but we will have also a good understanding about the immunological threshold, provided that we're going to see pilot efficacy. provided that we're gonna see a decent level of, let's say, correlation, also it's not a statistical correlation, in between immunological titer, immunological response, and protection, we will progress this program further. If not, we have failed, and we have failed rather cheap, which is the advantage of you know, a program where you can really use a challenge model and see pilot efficacy ahead of expensive Phase III studies. Of course, we are planning for success. We are working on, you know, the development pathway going forward. And as I mentioned earlier, we expect data from both studies mid-this year. And then, you know, we will, of course, inform the market about the next development steps.

speaker
Brandon Foulkes
Analyst, HC Wainwright

Great. Thank you very much.

speaker
Vannevar

We are now going to proceed with our next question. And the questions come from the line of Damien Chaplin from Stifel.

speaker
Operator
Conference Operator

Please ask your question.

speaker
Damien Chaplin
Analyst, Stifel

Yes. Hello. Congrats on the good results, and thank you for taking my question. The first one is on the NCIP recommendation. So when do you expect to receive an NCIP recommendation for VLF15 if approved? And do you believe a broad recommendation is achievable for this vaccine? And if so, what would be the key criteria to get such recommendation? Thank you.

speaker
Thomas Lingelbach
CEO

So first of all, I think it's fair to say Currently, to predict ACIP meetings, to predict ACIP outcomes, to predict ACIP dynamics is probably a mission impossible given the geopolitical environment in the United States. Having said that, we believe that Pfizer will progress fast post-approval into the ACIP process. And ACIP, at least in the past, have reviewed a couple of major criteria. One, risk-benefit. This considers, of course, the safety profile that we're going to see as part of the Phase III study. And on the other hand, the benefit of vaccination, which will be heavily driven also by the final efficacy we're going to see in the different target groups and probably also importantly against serotype 1, which is the most prevalent serotype in the United States. The other criteria is the health economic benefits. Well, we know that the cost of treating Lyme are very, very high. And therefore, we believe that the health economic benefits will be very favorable for that. Now, favorable for people living in high-risk areas. So we know that there is a huge difference in line incidents based on different geographies. And we hope that we will get a broad recommendation for people living in high-risk areas and representing a high-risk population in those areas. You know, what this means in detail, hard to predict at this point in time, but we are very positive about broad recommendation provided, data deployed, of course.

speaker
Damien Chaplin
Analyst, Stifel

Okay. Thank you very much.

speaker
Operator
Conference Operator

We are now going to proceed with our next question. And the questions come from the Landon family. Stephen from Guggenheim, please ask your question.

speaker
Stephen
Analyst, Guggenheim

Great. Thanks so much for taking our questions. One back on Lyme and then one other topic. So on the Lyme, I appreciate everything you said around your Pfizer running trial here. Just curious if you know what actually it would be in the top line press release. What should we expect in terms of what, you know, endpoint or information is planning to be disclosed? So anything you could share would be helpful just ahead of a release. And then the second one is on Xero. And this was a specific question here just around the DOD contract. because that has been an important source of revenues for that vaccine in the past. Do you have any information on sort of, you know, where that might stand in terms of a contract for this year or looking forward?

speaker
Thomas Lingelbach
CEO

Well, of course, let me start with Lyme. So we have previously communicated that we expect Pfizer to release top-line data. Well, top-line data, as you know, is something that is not clearly defined what it really means. What it means definitely is the primary endpoint. It is safety. Whether Pfizer will decide to announce more than that, this is at their discretion, and Valneva is currently not in any possession of information regarding what else may or may not be included in the top-line release. When it comes to DOD, yes, we are expecting a new contract. It is a vaccine broadly used in the Army in that we are under a sole supplier contract with the DOD. It's the only licensed GE vaccine in the United States. And yes, we can expect a new contract this year.

speaker
Stephen
Analyst, Guggenheim

Okay. Is there any timing around that, like when that might happen or too early to say?

speaker
Thomas Lingelbach
CEO

I don't want to predict the timing because, again, we are talking government, and we have intentionally not guided on any timeline associated with this.

speaker
Stephen
Analyst, Guggenheim

Okay.

speaker
Operator
Conference Operator

All right. Thank you.

speaker
Operator
Conference Operator

We are now going to proceed with our next question. And the questions come from the line of Reg and Sharma from Goldman Sachs. Please ask your question.

speaker
Reg Sharma
Analyst, Goldman Sachs

Hi. Thanks for taking my question. Actually, first one for Peter. Could you maybe just help us understand the gross margin progression in 2026? Feels like there are a few moving parts in 2025. What are the pushes and pulls in 2026? how much of that 10 million or so in idle capacity costs are likely to reoccur in 2026? And also in licensing and M&A that you mentioned as part of the strategy to rebuild the R&D pipeline, could you just discuss what that could look like in terms of size, structure, and if there are any specific areas or segments of the market that you're likely to focus on, whether that's travel or otherwise? And then just one very quick follow-up on the DOD contract from the prior question. Is that assumed within your revenue guidance for 2026? Thank you.

speaker
Thomas Lingelbach
CEO

So where shall we start? Maybe we start off, I start off with the pipeline evolution, and then I let Peter talk about all the financial questions that you had. As I mentioned previously, We have also last year already initiated a process to look at external opportunities in the same way we are looking at internal opportunities. This resulted, for example, in the licensing of our Shigella vaccine candidate, and we will continue doing that. As I mentioned, we will definitely now go above and beyond vector-transmitted diseases, and we will certainly go above and beyond travel because we believe, and again, planning for success, of course, that there are many, many potential vaccine-preventable diseases that are currently not covered by the big vaccine players. And we have already given a focus area around enteric diseases in the context of AMR. But we have also started with our EVV program to build around a potential herpes franchise. And these are the key areas that we are currently contemplating. And again, we have a dedicated team screening, scouting, evaluating, and we will decide, you know, on, you know, progressing internal or bringing in external opportunities in the coming months and years.

speaker
Peter Buehler
CFO

Peter. Yeah, so on gross margin, Rashaan, yes, there were a couple of things. going on in 2025. I mean, I think the best way to look at it is by product. So when we look at Ixionaro, it is relatively stable versus 2024. What happened in 2025 is it was a bit adversely impacted by the change from the Manson facility over to the Almeida facility, so a new manufacturing site in Scotland. And also related to that, because of this transfer a bit lower volume in manufacturing, which, of course, leads them to a bit less effective overhead absorption. I think on Duke Coral, we had a very good gross margin up until the end of Q3. And then what we saw in Q4 is we had a couple of patch write-offs, which you know, quickly had quite a significant impact, and this adversely impacted our gross margin . And I think on XGIC, you know, it's primarily that is, of course, a big hit on the cost of goods overall. It's the write-off we took on drug substance following the termination of the SII contract. And as I said, those doses are still available. I mean, the product is good. It has quite a long shelf life. And if we manage to build a business in an endemic market in Asia, those doses could still be written back, basically, and then sold. To your question on idle capacity, yeah, I would say the 10 million is probably a number that will, unless there is a major change in how we make usage of our manufacturing facilities, which we right now don't see, it's probably going to stay for a while. because we have all the capacities in both Sweden and Scotland. Oh yes, so military. What was your question on the DOD and RACHA?

speaker
Reg Sharma
Analyst, Goldman Sachs

It's just whether that's in your guidance for 2026.

speaker
Peter Buehler
CFO

Absolutely. So it's included in the guidance in 2026, you know, with the volume that we assume right now. So they order, you know, they have a right to order additional doses within their 12-month period, which they did, and it's then shipped after the 12 months. which is also why, you know, it's not because there's no new contract that there is no shipment. So, shipments are continuing under the old one. And then, as Thomas said, we expect a new contract, and that's all included in the guidance.

speaker
Operator
Conference Operator

Thank you. We are now going to proceed with our next question.

speaker
Operator
Conference Operator

And the questions come from the line of Simon Scholes from First Berlin. Please ask your question.

speaker
Simon Scholes
Analyst, First Berlin

Yes, good afternoon. I've just got two questions. The first is on chikungunya, on the chikungunya vaccine and the status of 1555, which I think is the candidate for local manufacturer in Brazil. And then secondly, following the suspension of the SII licensing deal, I was wondering if you could outline your next steps in Asia with regard to XCHIC.

speaker
Thomas Lingelbach
CEO

So, both excellent questions, I would say. So, let me start with 1555. I mean, of course, the whole regulatory processes have slowed down the approval of 1555 by at least Now that we have concluded all the updates with the different regulatory authorities, including Anvisa, meaning sharpening the pencil on age ranges, sharpening the pencil on warnings and precautions, contraindications, and all of that, there's no reason anymore for Anvisa to further slow down or wait for 1555 approval. Hence, we are expecting it quite soon. When it comes to our NMIC strategy in Asia, we decided to take control over the commercialization but also manufacturing of the product in Asia, the growing medical needs outside of the Indian territories. And we are currently in the process of evaluating potential chains of custody, evaluating potential partners, evaluating potential commercialization structures, and evaluating potential manufacturing strategies. And we hope that we will be able to you know, progress and denounce that in the later part of this year.

speaker
Simon Scholes
Analyst, First Berlin

Okay, thanks very much. That's very helpful.

speaker
Operator
Conference Operator

We are now going to proceed with our next question. And the questions come from the line of Susan Van Vunterhuizen from VLK. Please ask your question.

speaker
Suzanne Van Vunterhuizen
Analyst, VLK

Hi, it's Pauline on for Suzanne. I have two questions regarding LIME. For LIME, could you clarify if the first cohort of participants in the phase three received a booster prior to the last kick season? And also, what about the second cohort of participants? And we're also wondering at what point in time there will be booster data and will the data be part of the filing? Thank you.

speaker
Thomas Lingelbach
CEO

So we have currently not included a so-called second booster or dose five, because I'm assuming that you are referring to that. But we will, in a success case, augment and provide an additional booster dose. And our current hypothesis as we presented I think already a while ago at our R&D day in New York, that we will not be part of the initial licensure process, but for example a supplemental DLA.

speaker
Operator
Conference Operator

Thank you so much.

speaker
Operator
Conference Operator

We have no further questions at this time, so I'll hand back to you for closing remarks.

speaker
Thomas Lingelbach
CEO

Thank you very much for having joined us today. It's been a pleasure. And as I said, we are looking forward to our line data. So again, fingers crossed. I think Vannevar has great prospects, great opportunities. With that, stay tuned. Thank you so much.

speaker
Vannevar

This concludes today's conference call.

speaker
Operator
Conference Operator

Thank you all for participating. You may now disconnect your lines. Thank you.

Disclaimer

This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.

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