Valneva SE (VALN) 2025 Q4 法說會逐字稿

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  • Operator

  • Good day and thank you for standing by. Welcome to Valneva's full year 2025 results and business update, conference call and webcast. (Operator Instructions)

  • Please note that today's conference is being recorded. I would now like to turn the conference over to your speaker, Tshu Adram, VP of Investor of Global Investor relations. Please go ahead.

  • Joshua Drumm - Investor Relations

  • Hello and thank you for joining us to discuss Valniva's financial results for the full year 2025 and corporated. 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 30, 2025, which were published earlier today, available within the financial report section on our investor website.

  • I'm joined today by Valneva's CEO, Thomas Lingelbach and our CFO Peter Beller, 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 Valeva 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.

  • Thomas Lingelbach - President, Chief Executive Officer, Director

  • Thank you. Hello, and thank you for joining us today.

  • As we reflect on 2025, I'm proud to say that Balniva 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 EUR170 million slightly above 2024 levels, including almost EUR160 million in product sales.

  • These results reflect not only foreign exchange headwinds and the plan production in third-party product sales, but also growth in our proprietary travel vaccine portfolio.

  • We closed the year with a cash position of nearly EUR110 million and further enhance our financial flexibility through a successful debt refinancing.

  • We also achieved more than a 20% reduction in operating cash burn driven by our continuous disciplined cash management.

  • Most importantly though, together with our partner Pfizer, we further advanced our Lyme disease vaccine.

  • This program represents an important opportunity for Boniva and for the millions of people at risk of Lyme disease, and we are looking forward and crossing fingers for the pivotal phase 3 results.

  • Turning to how we seevalniva's strategic evolution.

  • Our strategy is geared towards becoming the leading vaccine biotech company.

  • Based on 3 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 would 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 augment.

  • 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 candidate in the world, VLA 15.

  • So if you look at page 8 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.

  • Which reported almost 500,000 cases in the United States annually.

  • And in Europe it's probably going to be the same order of magnitude. Also, the reported, and the officially reported cases are a bit more than 130,000.

  • The important thing about Lyme disease is its severe clinical manifestations.

  • 10% to 30% of cases develop, many different clinical manifestations which can be categorized in three buckets, di, neuroorliosis andtritis.

  • 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 Paloa.

  • This study includes approximately 10,000 individuals. It's a study that is randomized 1 to 1 placebo or against vaccine, 2 to 1 US versus European sites, or to be precise, North American versus European sites, and the primary endpoint is disease prevention after 3 1 doses, namely in season 2.

  • 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 and 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, But VLA 15 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 above 5 years of age, and we see really an opportunity here to address a 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 Baliba.

  • So again we are looking forward to the data, fingers crossed.

  • So if we turn to ICHC, you know that we are still investing in the further development of what we call VLA 1,553 or the marketed trade name exchick.

  • Currently we have three major R&D activities, on exchic.

  • 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 Institute of Bhutanan in selected municipalities in Brazil. We covered the age range currently licensed by Avisa 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 uptake is quite compelling.

  • We are further investing in post-marketing effectiveness studies, to confirm the effectiveness and to optimize the description of the safety profile, and this is a pragmatic randomized controlled effectiveness and 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 Ichic, did not have a great start, in the travel segment, but we have been able to refine our labels and percussions.

  • And we are now focusing mainly on postmarketing effectiveness and global market access.

  • Turning to, sugarosis.

  • So our program called S4V2, is a vaccine that, targetshigelosis. It's a tetravalent, Shigella vaccine candidate that we licensed, from Limatech 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.

  • Boniva 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 2 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 proposed 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.

  • Peter Bühler - Chief Financial Officer

  • Thank you, Thomas, and 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 EUR157.9 million in line with our guidance and decreasing by 3.3% over 2024 or 1.3% at constant currency.

  • The decrease in sales is primarily a result of the planned reduction in third-party sales and to a lesser extent of adverse currency impact. As mentioned by Thomas at the beginning of the call, proprietary product sales excluding currency effect grew by 9% year over year.

  • IR sales reached EUR98.4 million compared to EUR94.1 million in 2024, representing a growth of 4.6% or 7.2% as constant currency.

  • The growth in kara sales was driven by the travel segment.

  • Tar sales were essentially flat at EUR31.9 million compared to EUR32.3 million in the previous year, a decline of 1.2%. As constant currency, Turo sales grew by 1.8% year over year.

  • Growth in in sales was impacted by distributed change in Germany, a key indirect market.

  • Latris sales reached EUR8.4 million compared to EUR3.7 million in prior year.

  • This includes the supply of 40,000 doses to the French island La Reignion in 2025.

  • Finally, we reduced our third-party sales substantially year over year from EUR33.2 million to EUR19.2 million.

  • As discussed previously, this decrease was the result of planned termination of our existing distribution contracts for third-party products in order to focus on our proprietary products.

  • Moving on to slide 17, looking at the P&O.

  • Other revenues increased from EUR6.3 million to EUR16.8 million. The increase is driven by a EUR10 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 Valva no longer expects to owe to future payments to Pfizer.

  • Looking at our expense, cost of goods and services increased by EUR8.6 million. Cost of goods in the fourth quarter were adversely impacted by an EUR8.5 million inventory write-off, mainly related to extric following the termination 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 endemic markets.

  • Cost of goods also include approximately EUR10.8 million of idle cost.

  • IRO cost of goods remained stable versus prior year, while Dal gross margin deteriorated due to the failure of manufacturing batches in the 4th quarter.

  • Research and development expenses increased from EUR74.1 million in 2024 to EUR85.3 million in 2025.

  • This increase is in line with our guidance and is driven by higher spend in our phase 2 Shigella vaccine candidates and additionally, we increased our RD investment in our chikungunya vaccine as we are executing our post-marketing obligations.

  • Marketing and distribution expense amounted to EUR37.4 million compared to EUR52.4 million 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 EUR42.8 million to EUR37.3 million as a result of our continued initiative to decrease administrative spend across the company.

  • In 2024, Valniva sold a priority review voucher obtained with the approval of the Exchequer in the United States, which massive expenses resulted in proceeds of EUR90.8 million.

  • Other income and expense decreased year to year by roughly 50% as a result of lower R&D tax credits and to lesser extent due to low grant income in Scotland.

  • In 2025, V Nva reports an operating loss of EUR82.1 million compared with an operating profit of EUR13.3 million. The operating profit in 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 gear for the buildingmen with a new five-year loan with Parmacom.

  • Boniva's loss for the period reached EUR115.2 million while the adjusted EBTT reported at EUR51.4 million.

  • Now moving on to the financial outlook.

  • In 2026, we expect total product sales of EUR145 million to EUR160 million and total revenues of EUR155 million to EUR170 million.

  • The overall decrease versus 2025 is related to further planned reduction in third-party products, offsetting continued growth from our proprietary products.

  • We expect to progress in enhancing our R&D pipeline of differentiated vaccine candidates.

  • And cash will continue to be a focus with an emphasis on reducing or 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 had to call back to Thomas to look at our future value drivers.

  • Thomas Lingelbach - President, Chief Executive Officer, Director

  • Thank you so much, Peter. Yeah, well, let me turn to page 21, and talk a little bit, about the future.

  • Of course, it will heavily depend.

  • Online.

  • And what is the significance of the Phase 3 results for Vera? Well, positive results could be transformational.

  • Delivering substantial commercial milestones in royalty revenue to fund further pipeline development and value creation.

  • It would also further validate Veva's position as a leading vaccine biotech company to potentially becoming the 4th 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 a potential strategic in licensing to augment our in-house pipeline.

  • While creating a risk balanced portfolio of innovative specialty life cycle and high-value vaccines.

  • We created Veva 13 years ago.

  • Was 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 preclinical.

  • They are all, kind of, well, 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 land 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 questions.

  • Operator

  • Thank you.

  • (Operator Instructions) Maury Raycroft, Jefferies

  • Maury Raycroft - Equity Analyst

  • Hi, thanks for taking my questions. Looking forward to seeing the live 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 lime cases. And do you see the split between the vaccine and placebo?

  • Thomas Lingelbach - President, Chief Executive Officer, Director

  • So, Maury, the sponsor, for the phase 3 study, is Pfizer.

  • Fizer are in self control, with regards to the execution of the study, and we are at this point fully blinded.

  • There is an official guidance from Pfizer with regards to the data readout in H1.

  • And of course we can't say anything different.

  • We are hoping so that the data will come around mid of H1 whenever this myth is.

  • But we, I would like to remind everyone that there is only one official guidance.

  • And that's the one from Piper.

  • Maury Raycroft - Equity Analyst

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

  • Thomas Lingelbach - President, Chief Executive Officer, Director

  • So we have a joint development structure. We have the 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.

  • Maury Raycroft - Equity Analyst

  • Got it. Okay. And.

  • Thomas Lingelbach - President, Chief Executive Officer, Director

  • Maybe just.

  • Maury Raycroft - Equity Analyst

  • Last question, just if you can remind us what gives you confidence that VLA 15 will be equally efficacious in serotypes 2 through 6 versus serotype 1, Wondering if you, tested serotypes 2 through 6 in preclinical challenge models similar to.

  • Thomas Lingelbach - President, Chief Executive Officer, Director

  • The.

  • Maury Raycroft - Equity Analyst

  • 2024 publication that.

  • Thomas Lingelbach - President, Chief Executive Officer, Director

  • You.

  • Maury Raycroft - Equity Analyst

  • Had.

  • Thomas Lingelbach - President, Chief Executive Officer, Director

  • 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, stereotypes.

  • What we don't know.

  • Is whether the immunological protection levels in humans.

  • Will be identical across the different stereotypes. We have a lot of ground to believe that.

  • But of course, as 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 summarize a correlation factor of 0.8 to 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, VLA 15, Against, I would call it a limerick biosimilar.

  • And this has been shown in, and published, in different publications as that not everything has been published.

  • And we have seen across the border noninferiority or superiority, after, 3 doses.

  • And I think 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, they will tell and data will hopefully come soon and then we will know.

  • Maury Raycroft - Equity Analyst

  • Got it, all helpful. Thanks for taking my questions.

  • Operator

  • We are now going to proceed with our next question.

  • And the questions come from the land of Brandon Fuls from HC Wainwright. Please ask a question.

  • Brandon Folkes - Equity Analyst

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

  • Peter Bühler - Chief Financial Officer

  • Yeah, Brandon, hey, this is Peter. Well, look, I think it's important maybe to remind everyone that, upon positive phase 3 data, we will not get any milestones, under the program. The next milestones will be due upon first commercial sales. It's essentially it's first commercial sales in Europe and in the US, and it's a combined milestone of $143 million. But that's about, I would say, probably a year and a half away from now at least. So.

  • I mean in terms of capital profiles in 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 and this will of course take time to do that and we'll consider carefully how we do that.

  • Brandon Folkes - Equity Analyst

  • Great, thanks very much. And then maybe just on Shigele S4V2.

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

  • Thank you.

  • Thomas Lingelbach - President, Chief Executive Officer, Director

  • Very good question, Brandon. So I would say, the thing that we like about this program.

  • Is that it includes a controlled human infection model in adults.

  • So this means we will have Adal challenged, at least with one trade namelyhonai.

  • 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.

  • In 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 going to see a decent level of let's say, correlation, although it's not a statistical correlation in between immunological tiger, 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, a program where you can really use the challenge model and see pilot efficacy, ahead of extensive phase 3 studies. Of course we are planning for success, we are working on, 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.

  • Brandon Folkes - Equity Analyst

  • Great, thank you very much.

  • Operator

  • We are now going to proceed with our next question.

  • And the questions come from the line of Damien Chaplain from STL. Please ask your question.

  • Damien Choplain - Analyst

  • Yes, hello, congrats on the good results and thank you for taking my question. The first one is on the ACIP recommendation. So, when do you expect to receive an an SCIP recommendation for the EFF 15 if approved? And do you believe a broad recommendation is achievable for for this vaccine? And if so, what would be the key criteria to get such recommendation?

  • Thank you.

  • Thomas Lingelbach - President, Chief Executive Officer, Director

  • So, first of all, I think it's fair to say that, currently to.

  • Predict ACIP meetings to predict ACIP outcome, 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.

  • Past, post approval, into the ACIP process.

  • And ACRP at least in the past.

  • Have reviewed, a couple of, major, criteria.

  • One, risk benefit.

  • It considered of course the safety profile that we're going to see as part of the phase 3 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 real life.

  • The other criteria is the health economic benefits.

  • Well, we know that the costs of treating Lyme are very high.

  • And therefore we believe that it has economic benefits.

  • Would be very favorable for that, Now favorable for people living in high risk area.

  • So we are, we know that there is a huge difference in lime incidence, based on different geography.

  • 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 a broad recommendation provided data support.

  • Peter Bühler - Chief Financial Officer

  • Of course.

  • Okay, thank you very much.

  • Operator

  • We are now going to proceed with our next question.

  • And the questions come from the Vamil Divan, Guggenheim

  • Vamil Divan - Equity Analyst

  • Great, thanks so much for taking our questions. So 2, if I could 1 on back online and then one other topic, so on the line, I appreciate everything you said around your Pfizer running, the trial here. Just curious if you know what actually would be in the top-line press release, which we expect in terms of what, endpoint or information is planning to be disclosed. So anything you could share would be helpful just ahead of us send that release. And then the second one is on XCRO, and this is 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, where that might stand in terms of a contract for this year or or looking forward?

  • Peter Bühler - Chief Financial Officer

  • Well, of course, let.

  • Thomas Lingelbach - President, Chief Executive Officer, Director

  • Me start with lime. So we have previously communicated that we expect Pfizer to release topline data.

  • Well, topline data, as 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 Veva 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 DD. It's the only licensed JE vaccine in the United States.

  • And yes, we can expect a new contract this year.

  • Vamil Divan - Equity Analyst

  • Okay, is there any timing around that, like when that might happen or not too early to say.

  • Thomas Lingelbach - President, Chief Executive Officer, Director

  • I don't want to predict the timing because again we are talking government.

  • And we have intentionally not guided on any tent associated with.

  • Vamil Divan - Equity Analyst

  • Okay. All right, thank you.

  • Operator

  • We are now going to proceed with our next question.

  • And the questions come from la landa Bridge and Sharma from Goldman Sachs. Please ask a question.

  • Rajan Sharma - Analyst

  • 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 2006 and How much of that 10 million or so in idle capacity costs are likely to reoccur in 2026, then also on the in licensing and M&A that you mentioned is 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 of all 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.

  • Thomas Lingelbach - President, Chief Executive Officer, Director

  • 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 candidates, and we will continue doing that.

  • As I mentioned, we will definitely now go above and beyond bacterial 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, 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 EBD 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, on, progressing internal or bringing in external opportunities, in the coming months and years.

  • .

  • Peter Bühler - Chief Financial Officer

  • Yeah, so on gross margin, Racha, yes, there were a couple of things going on in 2025.

  • When I, when we, I mean, I think the best way to look at it is by product. So when we look at ICCaro, it is relatively stable versus 2024. What happened in 2005 is it was a bit adversely impacted by the change from the Manson facility over to the Almeda facility. So a new manufacturing site in Scotland.

  • And also related to that because of this transfer, a bit of lower volume in manufacturing, which of course leads them to a bit, less effective overhead absorption. I think on Duorral, 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 batch write-offs which. Quickly has a quite a significant impact and this adversely impacted our gross margin of coal, and I think on the exchequ is is, 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 their product is good. It it has quite a long shelf life.

  • And if there, if we are, if we manage to build a business in endemic market in Asia, those doses could still be written back basically and then 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 a while for a while, because we have all the capacities in both Sweden and Scotland.

  • Oh yes, so military, what was your question on the DD and Russia? I'm sorry.

  • Absolutely. So it's included in the guidance in 2026, with the volume that we assume right now. So they order, they have a right to order additional doses, within the 12 month period, which they did and it it's then shipped after the 12 months. Which is also why 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 promises that we expect the new contract and that's all included in the guidance.

  • Operator

  • We are now going to proceed with our next question.

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

  • Simon Scholes - Analyst

  • Yes, good afternoon. I've just got two questions. The first is on chikungunya, on the chikungunya vaccine and the status of 1,555, which I think is the candidate for the 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 ICHC.

  • Thomas Lingelbach - President, Chief Executive Officer, Director

  • So, both excellent questions, I would say, so let me start with 1,555.

  • I mean, of course.

  • The whole regulatory processes, have slowed down the approval of 1,555 by ALISA.

  • Now that we have concluded all the updates with the different regulatory authorities, including ANISA, meaning, sharpening the pencil on age ranges, sharpening the pencil on warnings and percussions, contraindications, and all of that, there's no reason anymore for UNISA.

  • To further slow down or wait for 1,555 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 products in Asia given the growing medical needs outside of the Indian territory.

  • 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, progress and announce that in the latter part of this year.

  • Simon Scholes - Analyst

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

  • Operator

  • We are now going to proceed with our next question.

  • And the questions come from the line of Susan van Wunterhausen from VLK. Please ask your question.

  • Suzanne Van Voorthuizen - Analyst

  • Hi, it's Pauline on for Suzanne. I have two questions, regarding Lyme. For Lyme, could you clarify if the first cohort of participants in the phase 3 received a booster prior to the last kick season, and, also, what about the second cohort of participants? And we were also wondering at what point in time there will be booster data and will the data be part of the filing.

  • Thank you.

  • Thomas Lingelbach - President, Chief Executive Officer, Director

  • So we have currently not included a so-called second booster or those 5 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 is, 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 deal.

  • Suzanne Van Voorthuizen - Analyst

  • Thank you so.

  • Operator

  • Much.

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

  • Thomas Lingelbach - President, Chief Executive Officer, Director

  • Thank you very much for having joined us today, been a pleasure, and, as I said, we are looking forward to, our line data, so again, fingers crossed, I think, Veva has great prospects.

  • Great opportunities, and with that, stay tuned.

  • Thank you so much.

  • Operator

  • This concludes today's conference call. Thank you all for participating. You may now disconnect your lines.

  • Thank you.