Valneva Full Year 2025 Earnings Call - Lyme Phase 3 Readout Imminent, Could Be Transformational
Summary
Valneva closed 2025 with steady top line and a sharpened focus on its proprietary vaccines, while waiting for a potentially company changing Phase 3 readout from its Lyme vaccine program run by partner Pfizer. The company recorded product sales of EUR 157.9 million, total revenues just above EUR 170 million, a year-end cash balance near EUR 110 million, and a successful debt refinancing, even as it reported an operating loss driven by nonrecurring impacts and higher R&D spend.
The call centered on three themes. First, the VALOR Phase 3 Lyme trial is complete on vaccinations and Pfizer guides a readout in H1 2026, a result that could materially alter Valneva’s capital plans but will not produce near-term milestones until commercial sales. Second, management is pruning third-party sales, cutting operating cash burn and redirecting resources to IXIARO, IXCHIQ post-marketing work, chikungunya and the newly in-licensed Shigella program. Third, 2026 guidance reflects lower third-party revenue, continued R&D investment, and persistent manufacturing idle costs, leaving execution and upcoming clinical readouts as the primary drivers of upside and downside risk.
Key Takeaways
- Valneva reported total product sales of EUR 157.9 million for 2025 and said total revenues exceeded EUR 170 million.
- Year-end cash was nearly EUR 110 million and the company completed a debt refinancing, improving financial flexibility.
- Operating loss for 2025 was EUR 82.1 million versus an operating profit of EUR 13.3 million in 2024; net loss was EUR 115.2 million and adjusted EBITDA was -EUR 51.4 million. The 2024 numbers benefited from a one-time sale of a priority review voucher that generated EUR 90.8 million.
- Valneva reduced operating cash burn by more than 20% in 2025 through disciplined cost control. Marketing and distribution spend fell to EUR 37.4 million from EUR 62.4 million year over year. G&A fell to EUR 37.3 million from EUR 42.8 million.
- R&D spend increased to EUR 85.3 million in 2025 from EUR 74.1 million in 2024, driven by higher investment in the Shigella S4V2 program and post-marketing commitments for the chikungunya vaccine IXCHIQ.
- VLA15, the Lyme disease vaccine in the VALOR Phase 3 field efficacy trial, completed vaccinations in ~10,000 participants. Pfizer is the trial sponsor and controls the data; Pfizer guides a top-line readout in the first half of 2026. Valneva remains blinded and says interactions with Pfizer are frequent.
- A positive Phase 3 readout would be transformational in commercial potential, but Valneva will only receive the next contractual milestones upon first commercial sales, a combined amount of USD 143 million, likely more than a year away.
- VLA15 targets the main serotypes in the Northern Hemisphere. Preclinical data and immunogenicity data give confidence across serotypes, but no formal human correlate of protection exists outside limited historical data, so efficacy per serotype remains an open question.
- Shigella S4V2, in-licensed from LimmaTech, is now the company’s most advanced enteric candidate. Two Phase 2 studies are underway, including an infant study and a controlled human infection model. Valneva expects data from both studies mid-2026 and says pilot efficacy in the challenge model would enable an efficient go/no-go decision.
- IXIARO sales grew to EUR 98.4 million (4.6% YoY, 7.2% at constant currency). The company expects a new DoD contract this year and says DoD volumes are included in 2026 guidance. IXIARO gross margin was stable but impacted by manufacturing transfer and lower overhead absorption.
- IXCHIQ sales rose to EUR 8.4 million in 2025. Valneva launched a pilot vaccination campaign in Brazil with Instituto Butantan targeting 20% to 40% coverage in the licensed 18 to 59 age group, and is prioritizing post-marketing effectiveness and safety studies to refine label and access.
- Dukoral sales were essentially flat at EUR 31.9 million, but Dukoral gross margin deteriorated after manufacturing batch failures in Q4. Cost of goods was also hit by an EUR 8.5 million inventory write-down related to Zika drug substance following termination of the Serum Institute of India contract, though the product remains usable for future supply.
- Third-party product sales were deliberately reduced from EUR 33.2 million to EUR 19.2 million as Valneva exits distribution agreements to focus on proprietary products. 2026 guidance assumes a further reduction in third-party sales.
- Valneva provided 2026 guidance of EUR 145 million to EUR 160 million in product sales and EUR 155 million to EUR 170 million in total revenues, reflecting continued proprietary growth offset by planned third-party contraction and ongoing R&D investment.
- Manufacturing idle costs were approximately EUR 10.8 million in 2025 and management expects similar idle cost pressure to persist in 2026 until capacity utilization improves.
- Strategic shift: Valneva plans to augment its pipeline via in-licensing and internal programs, expanding beyond vector-borne diseases and travel vaccines into enteric diseases tied to AMR, EBV and other specialty vaccine areas, with acceleration contingent on positive Lyme data.
Full Transcript
Operator: day, and thank you for standing by. Welcome to Valneva’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 11 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 11 again. Please note that today’s conference is being recorded. I would now like to hand the conference over to your speaker, Joshua Drumm, VP of Global Investor Relations. Please go ahead.
Joshua Drumm, VP of Global Investor Relations, Valneva: Hello, and thank you for joining us to discuss Valneva’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 31, 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 Bühler, 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 Autorité des marchés financiers, which are listed on our company website. Please note that today’s presentation includes information provided as of today, March 18, 2026, and Valneva 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, Chief Executive Officer, Valneva: Thank you. Hello, and thank you for joining us today. As we reflect on 2025, I’m proud to say that Valneva 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 EUR 170 million, slightly above 2024 levels, including almost EUR 160 million in product sales. This result reflects not only foreign exchange headwinds and supply reduction in third party product sales, but also growth in our proprietary travel vaccine portfolio. We closed the year with a cash position of nearly EUR 110 million 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 disciplined cash management. Most importantly, together with our partner, Pfizer, we further advanced our Lyme disease vaccine candidate. 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 3 results. Turning to how we see Valneva’s strategic evolution. Our strategy is geared toward 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.
We will do so by leveraging our integrated business model. On the one hand side, you know, 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, VLA15. 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, with reported almost 500,000 cases in the United States annually. In Europe, it’s probably gonna be the same order of magnitude also.
The reported and officially reported cases are a bit more than 130,000 annually. The important thing about Lyme disease is its severe clinical manifestation. 10%-30% of cases develop, you know, many different clinical manifestations, which can be categorized in three buckets, gastritis, neuroborreliosis, and arthritis. Most importantly, 5%-10% of the cases continue to have persistent symptoms following treatment with antibiotics. We are evaluating VLA15 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. The primary endpoint is disease prevention after 3 + 1 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 gonna get, of course, good data, and we have guided for data in the first half of this year. 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 above five years of age.
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. Of course, you know, there is a clearly attractive commercial dynamic. Prophylactics are always cheaper than therapy. A potential inclusion in some of the routine immunization schedules for high-risk areas would really be a perfect opportunity. With that, we see a unique and compelling opportunity that of course could be transformational for Valneva. Again, we are looking forward to the data being approved.
If we turn to IXCHIQ, you know that we are still investing in the further development of what we call VLA 1553, or the marketed trade name IXCHIQ. Currently, we have three major R&D activities on IXCHIQ. 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 Butantan, in selected municipalities in Brazil. We covered the age range currently licensed by Anvisa in Brazil, namely 18 to 59 years of age. The objective is really to achieve a 20%-40% coverage within the target population. 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 description of the safety profile. This is a pragmatic, randomized, controlled effectiveness and safety study in adults and adolescents in endemic countries. Of course, we continue to work on ensuring greater access to address the unmet medical needs in endemic countries. We are in the process of expanding our network of manufacturing and distribution partners in low and middle income countries. Overall, I would say IXCHIQ did not have a great start in the travel segment, but we have been able to refine our labels and precautions. We are now focusing mainly on post-marketing effectiveness and global market access. Turning to shigellosis. Our program called S4V2 is a vaccine that targets shigellosis.
It’s a tetravalent Shigella vaccine candidate that we in-licensed from LimmaTech, and it’s currently the clinically most advanced Shigella vaccine candidate. 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. Therefore, it has been identified as a priority vaccine by WHO. Valneva has worldwide commercial rights upon potential approval. 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. Probably more importantly, children in low- and medium-income countries.
We launched 2 parallel studies, 2 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 for both data mid of the year. Again, a very important milestone for the company and subject to data, we’re gonna 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, Valneva: 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 EUR 157.9 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. IXIARO sales reached EUR 98.4 million compared to EUR 94.1 million in 2024, representing a growth of 4.6% or 7.2% at constant currency.
The growth in IXIARO sales was driven by the travel segment. Dukoral sales were essentially flat at EUR 31.9 million compared to EUR 32.3 million in the previous year, a decline of -1.2%. At constant currency, Dukoral sales grew by +1.8% year-over-year. Growth in sales was impacted by a distributor change in Germany, a key indirect market. IXCHIQ sales reached EUR 8.4 million compared to EUR 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 EUR 33.2 million to EUR 19.2 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&L. Other revenues increased from EUR 6.3 million to EUR 16.8 million. The increase is driven by a EUR 10 million revenue recognition related to the license agreement with Pfizer. These ten 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 EUR 8.6 million. Cost of goods in the fourth quarter were adversely impacted by a EUR 8.5 million inventory write-off, mainly related to Zika, 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 the endemic markets. Cost of goods also include approximately EUR 10.8 million of idle costs. IXIARO cost of goods remains stable versus prior year, while Dukoral gross margin deteriorated due to the failure of manufacturing batches in the fourth quarter. Research and development expenses increased from EUR 74.1 million in 2024 to EUR 85.3 million in 2025. This increase is in line with our guidance and is driven by higher spend on our phase 2 Shigella vaccine candidate. Additionally, we increased our R&D investment in our chikungunya vaccine as we are executing on our post-marketing obligations. Marketing and distribution expense amounted to EUR 37.4 million compared to EUR 62.4 million in 2024.
This significant decrease is a result of our reduced IXCHIQ spend compared to significant investments in prior launch years. G&A expenses decreased from EUR 42.8 million to EUR 37.3 million as a result of our continued initiatives to decrease administrative spend across the company. In 2024, Valneva sold a priority review voucher obtained with the approval of IXCHIQ in the United States, which net of expenses resulted in proceeds of EUR 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 lower grant income in Scotland. In 2025, Valneva reports an operating loss of EUR 82.1 million compared with an operating profit of EUR 13.3 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 BioPharma Credit with a new five-year product loan with Pharmakon. Valneva’s loss for the period reached EUR 115.2 million, while the adjusted EBITDA is reported at -EUR 51.4 million. Now moving on to the financial outlook. In 2026, we expect total product sales of EUR 145 million-EUR 160 million, and total revenues of EUR 155 million-EUR 170 million. The overall decrease versus 2025 is related to further planned reduction in third-party product sales, 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 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’ll hand the call back to Thomas to look at our future value drivers.
Thomas Lingelbach, Chief Executive Officer, Valneva: 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 Lyme and what is the significance of the phase 3 results for Valneva. 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 Valneva’s position as a leading vaccine biotech company, 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 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 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 preclinical. They are all, you know, 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 Lyme data. 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. As a reminder to ask a question, please press star one one on your telephone and wait for your name to be announced. To withdraw your question, please press star one one again. Once again, please press star one one to ask a question and wait for your name to be announced. To withdraw your question, please press star one one again. Thank you. We are now going to proceed with our first question. The question comes from the line of Maury Raycroft from Jefferies. Please ask your question.
Maury Raycroft, Analyst, Jefferies: Hi. Thanks for taking my questions. Looking forward to seeing the Lyme data soon. I know guidance is for first half 2026, but you recently said you expect the data soon. Do you still see potential for a 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?
Thomas Lingelbach, Chief Executive Officer, Valneva: Maury, the sponsor for the phase 3 study is Pfizer. Pfizer are in total 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. 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. I would like to remind everyone that there is only one official guidance, and that’s the one from Pfizer.
Maury Raycroft, Analyst, Jefferies: Got it. Understood. 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?
Thomas Lingelbach, Chief Executive Officer, Valneva: We have a joint development structure. We have a governance as per contract, which includes you know, a couple of formalized bodies. I would say we have weekly interaction, frequent interaction, and so far, so good.
Maury Raycroft, Analyst, Jefferies: Got it. Okay. Maybe just last question, just if you can remind us what gives you confidence that VLA15 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 the 2024 publication that you had.
Thomas Lingelbach, Chief Executive Officer, Valneva: Yes. First of all, this is an excellent question. 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, you know, outside of serotype one, which was shown through LYMErix and ImuLyme, there is no data in humans today that bridges immunological response with efficacy. Even for LYMErix, there was never a formal correlate of protection established.
There has been a publication that summarized a correlation factor of 0.8, so 80% correlation between immunological titers and protection. 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 an LYMErix biosimilar. And this has been shown in, you know, and published in different publications. As I said, not everything has been published. And we have seen across the board non-inferiority or superiority after, you know, 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.
Maury Raycroft, Analyst, Jefferies: Got it. All helpful. Thanks for taking my questions.
Operator: We are now going to proceed with our next question. The question comes from the line of Brandon Folkes from H.C. Wainwright. Please ask your question.
Brandon Folkes, Analyst, H.C. Wainwright: Hi. Thanks for taking my questions, and congratulations on all the progress. You know, maybe just staying on Lyme, how do you think about capital allocation going forward if Lyme is successful? That obviously changes your capital profile potentially quite significantly. How should we think about that aspect of the business?
Peter Bühler, Chief Financial Officer, Valneva: 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. I mean, in terms of capital profiles over the short term, it’s not really gonna change. 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.
Brandon Folkes, Analyst, H.C. Wainwright: Great. Thanks very much. Maybe just on Shigella, S4V2. When we see the phase 2 data later this year, sort of how should we think about the threshold there for Valneva moving forward with full development responsibility, or sort of perhaps other development paths on that program? Thank you.
Thomas Lingelbach, Chief Executive Officer, Valneva: Very good question, Brandon. I would say the thing that we like about this program is that it includes a controlled human infection model in adults. This means we will have adults challenged at least with one strain, namely Sonnei, and we will see what we call pilot efficacy. 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 into 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 gonna 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 three studies. Of course, we are planning for success. We are working on, you know, the development pathway going forward. As I mentioned earlier, we expect data from both studies mid this year. You know, we will of course inform the market about the next development steps. Great. Thank you very much.
Operator: We are now going to proceed with our next question. The question comes from the line of Damien Choplain from Stifel. Please ask your question.
Damien Choplain, Analyst, Stifel: Yes, hello. Congrats on the good results, and thank you for taking my question. The first one is on ACIP recommendation. When do you expect to receive an ACIP recommendation for VLA15 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.
Thomas Lingelbach, Chief Executive Officer, Valneva: First of all, I think it’s fair to say that 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. 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 gonna see as part of the phase 3 study. On the other hand, the benefit of vaccination, which will be heavily driven also by the final efficacy we’re gonna see in the different target groups. Probably also importantly, against serotype 1, which is the most prevalent serotype in the United States.
The other criteria is the health economic benefit. Well, we know that the costs of treating Lyme are very, very high and therefore, we believe that the health economic benefit will be very favorable for the vaccine. Now favorable for people living in high-risk areas. We know that there is a huge difference in Lyme incidence based on different geographies. 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 supports, of course.
Damien Choplain, Analyst, Stifel: Okay, thank you very much.
Operator: We are now going to proceed with our next question. The question comes from the line of Ami Fadia from Guggenheim. Please ask your question.
Ami Fadia, Analyst, Guggenheim: Great. Thanks so much for taking our question. Two if I could, one on back on Lyme and then one other topic. On the Lyme, appreciate everything you said around Pfizer running, you know, the trial here. Just curious if you know what actually 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. Anything you could share would be helpful just ahead of the release. The second one is on IXIARO. This is a question-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 contract for this year or looking forward?
Thomas Lingelbach, Chief Executive Officer, Valneva: Well, of course. Let me start with Lyme. 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 JE vaccine in the United States.
Yes, we can expect a new contract this year.
Ami Fadia, Analyst, Guggenheim: Okay. Is there any timing around that? Like when that might happen or no? Too early to tell.
Thomas Lingelbach, Chief Executive Officer, Valneva: I don’t want to predict the timing because, again, we are talking government. We have intentionally not guided on any timeline associated with this.
Ami Fadia, Analyst, Guggenheim: Okay. All right. Thank you.
Operator: We are now going to proceed with our next question. The question’s come from the line of Rajan Sharma from Goldman Sachs. Please ask your question.
Rajan 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, and how much of that EUR 10 million or so in idle capacity costs are likely to reoccur in 2026? Also on the 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 of all segments of the market that you’re likely to focus on, whether that’s travel or otherwise?
Just one very quick follow-up on the DoD contract, and from the prior question, is that assumed within your revenue guidance for 2026? Thank you.
Thomas Lingelbach, Chief Executive Officer, Valneva: 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 co-opportunities. This resulted, for example, in the in-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.
We have already given a focus area around enteric diseases in the context of AMR. We have also started with our EBV program to build around a potential herpes franchise. These are the key areas that we are currently contemplating. 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. Peter.
Peter Bühler, Chief Financial Officer, Valneva: Yeah. On gross margin, Rajan, 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. When we look at IXIARO, it is relatively stable versus 2024. What happened in 2025 is it was a bit adversely impacted by the change from the Manson building over to the Almeida 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 to a bit, you know, less effective overhead absorption. I think on Dukoral, we had a very good gross margin up until the end of Q3.
Then what we saw in Q4 is we had a couple of batch write-offs, which, you know, quickly had a quite a significant impact. This adversely impacted our gross margin in Dukoral. I think on IXIARO, you know, it’s primarily, and 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. As I said, those doses are still available. I mean, the product is good. It has quite a long shelf life.
If we manage to build a business in endemic market in Asia, those could still be written back basically and then sold. To your question on idle capacity. Yeah, I would say the EUR 10 million is probably a number that will, unless there is a major change in, you know, how we will make use of our manufacturing facilities, which we right now don’t see, it’s probably gonna stay a while, for a while, because we have over capacities in both Sweden and Scotland. Oh, yes. On military, what was your question on the DoD again? Sorry.
Rajan Sharma, Analyst, Goldman Sachs: It’s just whether that’s in your guidance for 2026.
Peter Bühler, Chief Financial Officer, Valneva: Absolutely. It’s included in the guidance in 2026, you know, with the volume that we assume right now. 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. Shipments are continuing under the old one. As Thomas said, we expect the new contract and that will include a new guidance.
Rajan Sharma, Analyst, Goldman Sachs: Thank you.
Operator: We are now going to proceed with our next question. The questions come from the line of Simon Scholes from First Berlin. Please ask your question.
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 VLA1553, which I think is the candidate for local manufacture in Brazil. Secondly, following the suspension of the SII licensing deal, I was wondering if you could just outline your next steps in Asia with regard to IXCHIQ.
Thomas Lingelbach, Chief Executive Officer, Valneva: Both excellent questions, I would say. Let me start with VLA1553. I mean, of course, the whole regulatory processes have slowed down the approval of VLA1553 by Anvisa. Now that we have concluded all the updates with the different regulatory authorities, including Anvisa, meaning, you know, 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 VLA1553 approval. Hence, we are expecting it quite soon. When it comes to our LMIC strategy in Asia, we decided to take control over the commercialization but also manufacturing of the product in Asia, given the growing medical needs outside of the Indian territory.
We are currently in the process of, you know, evaluating potential change of custody, evaluating potential partners, evaluating potential commercialization structures, and evaluating potential, you know, manufacturing strategies. We hope that we will be able to, you know, progress and announce that in the latter part of this year.
Simon Scholes, Analyst, First Berlin: Okay, thanks very much. That’s very helpful.
Operator: We are now going to proceed with our next question. The questions come from the line of Susanne van der Laan from VLK. Please ask your question.
Brandon Folkes, Analyst, H.C. Wainwright0: Hi, it’s Pauline on for Susanne. I have two questions regarding Lyme. For Lyme, could you clarify if the first cohort of participants in the phase three received a booster prior to the last tick season? Also, what about the second cohort of participants? 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.
Thomas Lingelbach, Chief Executive Officer, Valneva: We have currently not included a so-called second booster or dose five because I’m assuming that you are referring to that. We will in a success case augment and provide an additional booster dose. 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 BLA.
Brandon Folkes, Analyst, H.C. Wainwright0: Thank you so much.
Operator: We have no further questions at this time, so I’ll hand back to you for closing remarks.
Thomas Lingelbach, Chief Executive Officer, Valneva: Thank you very much for having joined us today. Been a pleasure. As I said, we are looking forward to our Lyme data. Again, fingers crossed. I think Valneva has great prospects, great opportunities. 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.