VALN

Image source: The Motley Fool. Thursday, Aug. 13, 2026 at 9:00 a.m. ET VP of Investor Relations-Joshua Drumm Chief Executive Officer-Thomas Lingelbach Chief Financial Officer-Peter Buhler Operator: Good day, and thank you for standing by. Valneva presents its half year 2026 financial results. [Operator Instructions]. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Joshua Drumm, VP of Investor Relations. Please go ahead. Joshua Drumm: Hello, and thank you for joining us to discuss Valneva's financial results for the first half 2026 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 6 months ended June 30, 2026, which were published earlier today available within the Financial Reports section on our Investor website. I'm joined today by Valneva's CEO, Thomas Lingelbach; and our CFO, Peter Buhler, 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 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, August 13, 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: Thank you so much, Josh. Good day, everyone. Let me start off with a couple of introductory remarks. The first half of 2026 has certainly been marked on our efforts to focus on enhancing our financial position, especially after the initial Lyme Phase III VALOR results and the resulting uncertainty. And we have been able to generate a strong cash position with more than EUR 120 million in cash. This is a result of our disciplined cash management and the proceeds from the recent offering. We also included a broad restructuring program, and we expect the positive P&L and cash flow impact in the second half of this year and, of course, beyond. This included a reduction in our workforce, a reprioritization of projects, activities and a focus on our core operational business. When we look at our general commercial business performance, we generated more than EUR 60 million in total product sales. We have reaffirmed the guidance because the half year sales performance is in line with our anticipated pacing of product sales throughout the year 2026. We have had a number of adverse EBIT impacts in the first half of the year. Peter will explain those in greater detail. Most of them are really one-off effects and are non-recurring. But the most important thing and the most exciting thing is that Pfizer continues to be very positive about the prospect of the Lyme disease vaccine, and they recently announced during their earnings that they expect regulatory decisions for the Lyme disease vaccine candidate in the next 12 months, which is really great news. Now turning to our general business update. And of course, I would like to start with Lyme. You know that the vaccine showed a very strong point efficacy, greater than 70%, a very good safety profile. And as we discussed multiple times, we had a miss on the lower bound of the 95% confidence interval. However, we have to note that we see here with this product candidate a very significant clinical meaningful efficacy. And we had also 95% confidence interval lower bound greater than 20% in the second pre-specified analysis. All of that in combination with the huge unmet medical need, the totality of clinical evidence and the fact that we really expect a positive health economical benefit for a potential prophylactic solution increases our confidence in the future prospects of a potential Lyme vaccine. There is a huge unmet medical need, we have discussed this many times in the past. The annual burden of disease is increasing. And we have been noting recently close to 500,000 cases in the United States. Europe, I mean, numbers are kind of still significantly underreported because not all countries have respective surveillance systems, but certainly north of 100,000 cases every year. Some of them come along with very severe manifestations in the order of 10% to 30%, carditis, neuroborreliosis, arthritis. And unfortunately, 5% to 10% of cases continue to have persistent symptoms even following treatment. As such, we really believe that LB6V, how it's called now, is a compelling opportunity in a highly underserved market. We could really leverage a first-mover advantage. The perception around a need for Lyme vaccination is high. We are the only Lyme disease vaccine candidate in late-stage clinical development. And it could become, if licensed, the first potential Lyme vaccine in nearly 30 years. The vaccine is based on a proven mode of action. We cover the six key serotypes prevalent in the Northern Hemisphere. And the technology is based on modern state-of-the-art recombinant protein technology. We have a broad addressable population. At this point in time, we showed in the study results for people above 5 years of age. I mentioned already that we see a growing disease burden. And of course, with global warming, the tick population across all the high-risk areas of Lyme disease are steadily increasing. We have a excellent partner, and there is a huge strategic fit with Pfizer's vaccine franchise. And hence, we anticipate a very attractive commercial prospects and dynamics. So all in all, we share Pfizer's positivity on the prospects of that vaccine, and we really hope that we can get this vaccine to licensure on both sides of the Atlantic. On IXCHIQ, as part of our overall restructuring process and also reprioritization of our key strategic focus areas, we shift more and more toward the IXCHIQ access in countries where there is highest risk for chikungunya infection, meaning primarily low and medium-income countries. And we are currently executing on a significant number of post-marketing activities, all supported by our great partner, CEPI. We have a Pilot Vaccination Campaign ongoing in Brazil. We have more than 50,000 people already vaccinated today. These are adults 18 to 59 years of age. We have a study ongoing to confirm effectiveness and optimize description of the safety profile, which, of course, over time, could potentially even lift the highly restrictive warnings, precautions and other indications we have right now in our label for travel. All of that, of course, to ensure greater access, and we are focusing a lot right now on expanding our network of manufacturing distribution partners in low and middle-income countries. And we hope that we will be able to even announce something toward the latter part of the year. The locally manufactured vaccine in Brazil by our partner Butantan has now been approved and is expected to be incorporated into Brazil's public health system in the near future. We in-licensed an interesting candidate against shigellosis. It's the most clinically advanced tetravalent Shigella vaccine candidate. Right now, we are running two studies, one in infants, the other one in adults. One is an immunogenicity and safety study. The other one is a controlled human infection model study, so pilot efficacy through human challenge. We expect for both studies, results in the coming months. And of course, based on the results, we will decide on the next development steps for that vaccine. Of course, there is still a significant market opportunity for shigellosis, especially given that it's the second leading cause of fatal diarrheal disease and estimated with 165 million cases and 600 deaths annually, mostly, of course, in children in LMIC countries. But there is also a very interesting opportunity to -- either in a stand-alone setting or in a combination vaccine setting to work toward a broader covering diarrheal vaccine for travelers. With this short update on our core R&D activities and general business development, I would like to hand over to Peter to provide you with the financial report. Peter Buhler: Yes. Thank you, Thomas. So first, looking at product sales. Product sales reached EUR 64 million compared to EUR 91 million in the first half of 2025. Sales, excluding third-party products, decreased by minus 18.3% versus prior year at constant currency. This decrease was primarily due to product-specific effects, which I will discuss shortly. IXIARO sales reached EUR 44 million compared to EUR 54.7 million in the prior year's first half. The year-over-year decrease primarily reflects the transition to a new distributor in Germany in January 2026 as well as product sales phasing, notably the timing of deliverables to the U.S. Department of Defense. Shipments to the U.S. Department of Defense in the first half of 2026 continued under the 1-year contract signed in January 2025. We expect to sign a new contract in the coming months and beginning to recording sales under this new contract in the second half of the current fiscal year. Foreign currency fluctuation also had an adverse impact of EUR 1.5 million on IXIARO sales during the first half of 2026. DUKORAL sales reached EUR 14.7 million compared to EUR 17.4 million in the first half of 2025. Prior year sales benefited from onetime sales associated with the supply of DUKORAL doses to Mayotte in response to a cholera outbreak. In addition, sales in the first half of 2026 were adversely affected by the distributor transition in Germany in January, 2026. Similar to the first quarter, existing inventory transferred from the previous distributor was sufficient to meet market demand during the period. Furthermore, there was a slight weakening of the travel market in certain geographies due to geopolitical factors. IXCHIQ sales reached EUR 4.4 million compared to EUR 7.5 million in the first half of 2025. While current year sales include the first shipment of drug substance to our Brazilian partner, Instituto Butantan, the prior year benefited from 40,000 doses sold to the French Island La Reunion in response to a major chikungunya outbreak as well as travel sales in the United States. In light of the slow product uptake in travel, the company is currently evaluating its future commercial strategy for IXCHIQ, including the potential focus on the endemic markets. Third-party products decreased substantially from EUR 11.4 million in the first half of 2025 to EUR 1 million in the first 6 months of 2026. This planned reduction is the result of the key third-party distribution agreements that ended in December 2025 without renewal. Moving on to the income statement on the next slide. Total revenues reached EUR 65.8 million versus EUR 97.6 million in the first half year of 2025. The decrease is mostly related to the lower product sales. Last year's other revenues also included a one-off upfront payment related to the licensing agreement with the Serum Institute of India for our single-shot chikungunya vaccines. Looking at expenses. Cost of goods and services for the first half of 2026 reached EUR 59.5 million compared to EUR 47.2 million during the same period last year. Cost of goods in the first half of 2026 were impacted by a number of non-recurring and exceptional effects. In particular, a provision of EUR 9.7 million in cancellation fees related to external manufacturing commitments for IXCHIQ and the EUR 4.5 million non-cash impairment of excess IXCHIQ inventory resulting from lower-than-anticipated sales. In addition, cost of goods were adversely impacted by changes in manufacturing schedule and volumes and related adverse variances as well as higher idle costs following the transfer of manufacturing to our Almeida facility. IXIARO's gross margin reached 56.4% compared to 65.5% in the prior year. The decrease is mainly related to lower volumes and an unfavorable change in the manufacturing schedule. Last year's IXIARO gross margin was exceptionally high due to high manufacturing volumes and related favorable overhead absorption. DUKORAL generated a gross margin of 24.7% compared to 52.9% in the first half of 2025. The gross margin of DUKORAL in the first half of 2026 was adversely impacted by higher than usual failed batch costs and inventory revaluation. In contrast, the prior year gross margin benefited from a favorable overhead absorption due to manufacturing timing and higher volumes. The IXCHIQ gross margin was negative due to the onetime cancellation fees provisioned in the second quarter as well as the inventory write-down mentioned previously, which importantly had no cash impact. Research and development expense decreased from EUR 32.4 million in the first half of 2025 to EUR 30.2 million in the first half of 2026. That increase -- that decrease is mainly a result of reprioritization and rescheduling of R&D activities. Marketing and distribution expenses decreased significantly from EUR 20.3 million in the prior year to EUR 13.5 million in the first half of 2026. The decrease is related to a planned reduction in advertising and promotion related to IXCHIQ as well as reduced personnel, warehousing and distribution costs. G&A expenses decreased to EUR 15.4 million compared to EUR 19 million in the first half of 2025. The reduction was a result of lower personnel costs and savings in advisory and professional fee services. The company implemented the restructuring program in June 2026, and operating expenses in the first half year included onetime cost of EUR 3.2 million related to that program. Savings are expected in the second half year and beyond. In the first half of 2026, Valneva reported an operating loss of EUR 49.9 million compared to EUR 16.8 million in the prior year. Adjusted EBITDA loss in the first half of 2026 reached EUR 40.1 million compared to EUR 6 million in the prior year. Before moving to the outlook and guidance, a word on cash. As mentioned by Thomas at the beginning of the call, cash at June 30th was EUR 121.5 million compared to EUR 109.6 million at the end of fiscal year 2025. Cash used in operations in the first half of 2026 was EUR 13.7 million compared to EUR 10.9 million in the first half of the prior year. Now moving to the next slide, moving to Slide 18. We confirm our financial guidance for the fiscal year 2026 with product sales of EUR 135 million to EUR 150 million and total revenues of EUR 145 million to EUR 160 million. We expect the signing of a new contract with the U.S. Department of Defense for the supply of IXIARO in the coming months. We expect our commercial business to continue generating positive cash flow and the restructuring program implemented in June will have a positive impact on the P&L and cash flow in the second half of the current fiscal year and beyond. We expect product-related gross margin to improve in the second half following the non-recurring effects in the first half of the year. We continue to see potential to become financially self-sustainable starting in 2026, pending successful regulatory approval of the Lyme disease vaccine and subsequent commercialization by Pfizer. With this, I hand the call back to Thomas. Thomas Lingelbach: Thank you so much, Peter. The 2026, we mean 2027, of course, also it would be nice to be already in 2026 financially self-sustainable. Yes, let me close by giving a little bit prospect on how we see the future of Valneva, of course, provided and subject to Lyme success. Going forward, we would really like to leverage the company's core strengths in vaccine development to deliver greater long-term value. We would like to build scale in the R&D pipeline once Lyme has been out of pipeline and hopefully successfully brought to market. We see here a clear opportunity for strategic in-licensing to augment our clinical stage pipeline. And what we would like to do is really to create a risk balanced portfolio of innovative specialty life cycle and high-value vaccine assets, which are attractive and go very much beyond our prior focus on vector-borne diseases. We are working with the team to target new assets based on defined criteria and new targeted disease areas. In parallel, we are advancing our internal earlier-stage candidates such as EBV or ETEC/a broader enteric disease covering candidate program. And we would like to put also emphasis on focusing on reducing antimicrobial resistance targets. All of that will be flanked by further optimizing our integrated operations. We have kicked off a number of initiatives already as part of our restructuring program this year. And this mainly focuses on adapting and adjusting our value chain, changes of custody, make versus buy external manufacturing partners, but also a continuous focus on optimizing our commercial models, all of that with one clear objective, namely to maximize cash from our integrated operations and commercial business in particular. So all in all, we see a very nice prospect for Valneva going forward. But for now, we -- it's all about Lyme, and we have to wait until we hopefully see further positive development on the Lyme vaccine candidate, while executing thoroughly on our base business and continue our focus on strong cash management and disciplined cash management. With that, I would like to conclude the presentation and hand back to the operator to take your questions. Operator: [Operator Instructions] This question comes from Tara Bancroft from TD Cowen. Tara Bancroft: I was hoping maybe you could give us a little -- any more detail or thoughts or feelings that you have on a regulatory update? I know Pfizer still sounds optimistic about it and a decision in the near to midterm over the next 12 months. But is there anything else that you can add to the discourse that you've had with Pfizer and our regulators? That would be really appreciated. Thomas Lingelbach: Pfizer are making very good progress with the regulatory agencies. And we hope that we will be able to announce next steps soon. That's all we can say at this moment in time specific. Tara Bancroft: I see. Okay. So then maybe -- totally understood on that kind of commentary. So maybe then I can ask a little bit more detail about some of the scenarios that could possibly come up. One in particular that might be really helpful to get your thoughts on is the potential for you and Pfizer to maybe run another Phase III program or even a post-marketing surveillance study. What I'm hoping you can help us understand is maybe the economics of those avenues, like what you would be responsible for? And how does that factor into your capital allocation plans? Thomas Lingelbach: Yes. It's a good question, Tara. So the existing agreement with Pfizer included or includes that Valneva has -- is sharing development costs to licensure. Everything that comes beyond licensure is currently not part of the contractual agreement with Pfizer. Whether or not, we will further invest in Lyme on the points you mentioned, is something that may be discussed at a later point in time, but definitely not before we see the product being licensed -- hopefully being licensed in the respective jurisdictions. Operator: We are now going to take our next question, and this one comes from Maury Raycroft from Jefferies. Maurice Raycroft: Congrats on the progress. I was going to ask one on Shigella. So wondering if you can provide more color on what is gating the update? Is it operational related to the clinical study or data analysis? Or are you awaiting additional regulatory clarity on the potential development path? And then when the data are disclosed, should we also expect clarity on the path forward? And what are the latest scenarios that you're considering there? Thomas Lingelbach: Yes. Thanks for your question, Maury. So yes, let me -- so first of all, we have had a few delays on the program. You know that the studies are still conducted by LimmaTech. LimmaTech recently got acquired by Lilly. So there are a couple of key cleanup steps right now, but we are in the last and final steps on data validation and putting the conclusions together, final analysis, et cetera. So this is not going to take a long time until we will be able to disclose. Now, what do we expect? I mean, please remember what we said at the very beginning, we like the fact that we run a controlled human infection model, meaning a human challenge. And the human challenge will give us a very clear understanding about the efficacy of the vaccine. Of course, it cannot be decisive or conclusive, but it's highly indicative. And it will also provide us with a view on what is the immunological threshold that we need to achieve to see a level of protection and to which level -- at which level of protection. The flanking immunogenicity study in children will clearly provide us, a, with safety, which is very important. And it would also give us a first feel for how is the immunological profile in children as compared to adults. And of course, also it's not a direct head-to-head comparison possible, but it will also provide us with a good indication. We will take those two data packages together. And then we will see whether this is already good enough to proceed to the next development stage or if there is a need to optimize. And this could be an optimization on dose, schedule, formulation. But our objective is to announce the next development steps either with the data or very shortly thereafter. I hope this answered your question. Maurice Raycroft: Yes. Do you need some regulatory feedback to do that then or... Thomas Lingelbach: Say it again? Maurice Raycroft: Do you need some regulatory feedback to... Thomas Lingelbach: Yes. We have a group of regulatory advisors with whom we are working. We are currently not expecting to seek a direct regulatory advise from the relevant regulatory bodies because we had prior discussions. And I think for us, it's pretty clear what the potential expectations would look like. Maurice Raycroft: Got it. Okay. Maybe just one quick one for Lyme. I know you can't say a whole lot about where Pfizer is at with the process. But I'm just wondering for the U.S. regulatory path versus the European regulatory path, can you say if those are both moving in parallel? Or is it more sequential where you want some clarity from the U.S. before you can do an update for European status? Thomas Lingelbach: I think both activities are progressing very nicely. These are two independent processes. And there is -- at this moment in time, I would assume that Europe probably goes first. And -- but Pfizer is working closely with the FDA in support of its planned BLA submission for the Lyme disease vaccine candidate. Operator: We are now going to move to our next question. And this question comes from the line of Vamil Divan from Guggenheim Securities. Unknown Analyst: This is Edward from -- on for Vamil. Just maybe a couple of more questions online, if I may. First, it sounds like Pfizer told us that they have filed with -- in Europe, but not yet with the FDA. They're still in conversations. So I'm wondering if you can share any details on your learnings on why they decided to proceed that way? And then the second question is, are there any differences in how the European agency and the FDA look at vaccine data in general and VLA15 specifically that you can kind of highlight for us that would be pertinent here? And then maybe to what extent the European filing do you think that would derisk actually the FDA filing? Thomas Lingelbach: Yes. So first of all, yes, we can confirm that Pfizer filed with the European Medicines Agency. They disclosed that with two analysts after their last earnings. As such, we are, of course, very happy about this step. As I mentioned, following the data, they clearly advanced the regulatory processes. And as I mentioned earlier, these are two independent agencies. Also, we know from the past and our own history that there are, of course, close interactions and communications in between those agencies. I would not speculate right now about why one earlier, the other later. I would say, let's celebrate this progress. And as we said in the past many, many times, there is a huge medical need on both sides of the Atlantic. There is a significant commercial opportunity on both sides of the Atlantic. In one of the recent analyst reports, it was clearly articulated that the market is expected to be probably the same size, which is what we have been stating for years as it being the Valneva expectation. So as such, we are quite pleased about progress. And as I said, we are looking forward to how Pfizer are going to conclude with the FDA in support of their planned BLA submission for the Lyme disease vaccine candidate. Unknown Analyst: And maybe just on just how your understanding of how European versus FDA regulators look at sort of the vaccine data and maybe VLA15, if there's anything we should be aware of in how -- just how these two different agencies approach the data and what the bar is, how they think about the efficacy, safety bar there? Thomas Lingelbach: I -- you know I don't know specifically how -- whether there are any differences in how they're going to look at the data. I mean the data are what the data are, right? I mean we have safety data, we have efficacy data, we have immunogenicity data and the data are the same. And of course, all agencies, and this is not Lyme specific, and I say this is to someone who has been now in vaccine development for more than 30 years. I mean they all look at the same. They look at the totality of clinical evidence. They look at risk benefit, health economical benefits, underlying mode of action, scientific fundament. So I'm not necessarily assuming that they look differently at the data. There are nuances, and we know it from, for example, our Chik vaccine, which was the last vaccine that we brought from bench to licensure that, of course, when it comes to details on statistical analysis, on -- to details on potential post-marketing commitments or post-marketing pediatric development routes, there are slight differences here and there. But I have never seen in my history that there were material differences in how the two regulatory bodies you cited were handling applications. Operator: We are now going to take our next question, and this one comes from Suzanne van Voorthuizen from Kempen. Suzanne van Voorthuizen: This is Suzanne. I have one on the Valneva ambition from here. It seems like that you are gravitating to more R&D or biotech-driven identity rather than a commercial focus. Can you elaborate to what extent this strategic direction depends on Lyme being successful? Or phrased differently, how do you envision to walk this future path independent of the state of the Lyme program? And then I have a small question on the sale of the site in France next to the EUR 6 million in proceeds. Does this also bring an ongoing cost reduction of a certain degree? Thomas Lingelbach: Yes. Suzanne, yes. So you are absolutely right that we see our -- we have always seen and we see our commercial business in a way being subscale, right? It is important to have a fully integrated model because the capabilities that we have on the commercial side, on the industrial side, are clearly beneficial for the vaccine development. And we have seen this across many, many different programs. And as such, we see a value in staying fully integrated. But at the same time, the key purpose of our commercial business is not to focus on top line growth or augmenting strategically. By the end of the day, we would like to take the cash out of our commercial business and reinvest it in R&D. And therefore, our focus will be really to maximize cash generation from the commercial business going forward. We believe we are one of the very, very few remaining pure-play vaccine companies that have a proven expertise in bringing vaccines -- novel vaccines from bench to licensure, and we would leverage that. Now the capacity, I would say, we have to invest, of course, it depends heavily on Lyme success, because you know that the economics from the deal with Pfizer are favorable. And that besides milestones, the royalties are -- from Lyme would, of course, go straight down to the bottom line and as such, it could allow us to invest significantly in enhancing our pipeline, both organically as well as strategically, while even potentially being completely financially self-sustainable. And we believe that this is a very appealing strategy. It's a very appealing strategic outlook. But as you know that many, many times, it's all about Lyme. And of course, it depends on the licensure, be it Europe, U.S., both or just one, and the commercial success of this vaccine then later on. But we believe overall, strategically, yes, there is a benefit. Coming to your question on Nantes, yes, we -- as part of our restructuring program that Peter mentioned earlier, and I mentioned it too, we have also consolidated all of our R&D operations into Vienna. So which means that all R&D is now centralized in Vienna, and we shut down the R&D operations we had in Nantes. This consolidation brings efficiency and cost reduction. And this is something that, of course, we don't see immediately because it comes over time. We have significant redundancy costs and restructuring costs, but this is certainly something where we see a significant benefit in the future to come besides the fact that we disclosed in the half year report, of course, we get also some proceeds from the sale of the building that we have -- that we are now executing on. Operator: We are now going to move to our next question, and this question comes from Shyam Kotadia from Goldman Sachs. Shyam Kotadia: Two on the modeling side of things. So you mentioned your ongoing restructuring program. So I just wanted to check how should we be thinking about SG&A and R&D for the remainder of the year, especially knowing SG&A came in lower than expectations? And I can see that linked to that, you no longer call out the 25% to 35% reduction in OpEx versus 2025 that you did in your prior release. So does that hold? So that's the first question. And then the second question is on what is the realistic expectation for gross margin in second half '26? I realize you're not guiding on it specifically, but could you help us understand how it could compare to last year given that you're mentioning an uptick there? Peter Buhler: Yes. Thanks for the questions. So no -- let me first get into your questions on the restructuring and the impact on R&D and SG&A. So you saw on SG&A, in particular, a trend that started already last year when we did some efficiency improvements, it continues this year. And we expect clearly continued efficiency in SG&A spend. So I think what you see in the first half year is in a way where we will continue to see the future. And as I said, there were some -- also some one-off costs in there that we will, of course, not have anymore, and we eliminated a number of positions. And of course, in H1, you don't see an impact of that, and you will see that going forward. I think similarly on R&D, we would expect to see in the second half year a decrease in cost. And to your point, yes, we did provide a guidance in the last press release about overall rough guidance on where we see costs going versus last year, and that still holds true. We have not confirmed it. We have also not revised it, which means it still holds true. On gross margin, yes, so as you understood, there was a lot of one-off events and also some non-cash effect in the first half year. So in the second half year, we clearly expect a much better gross margin than in the first half year. And I would say, overall for the year, we will probably not get exactly to where we were last year, but we will get certainly much closer to the full year gross margin we have -- we recorded last year. And then I would also expect a positive trend getting into 2027. Operator: We are now going to take our next question, and this will come from Simon Scholes from First Berlin. Simon Scholes: Just got a question on IXCHIQ. So the local version of the IXCHIQ vaccine has now been approved in Brazil. I was wondering if you could give us some indication of how long it might be before the start of commercial sale of the vaccine in Brazil? Thomas Lingelbach: Yes. So basically, the -- our partner, Butantan are currently in the midst of the launch planning. Therefore, I would consider it a bit too early to really talk about, I would say, commercial prospects. There is a clear desire to include chikungunya vaccine into the healthcare system. There is a significant opportunity, both public as well as private markets in Brazil. And you know that when we look at the demand that we have seen or we are seeing from our drug substance supplies to Butantan, and we recorded in the first half the first revenues from drug substance sales because remember, the locally produced product means we are shipping drug substance and they turn it into drug product and final products. And just by the way of what you see there, we really expect this to become a very significant opportunity. But it's too early, and I won't -- I don't want to throw out numbers here without having a clear confirmation from our partner. Simon Scholes: And just a supplementary on the Pilot Vaccination Program. I think you've delivered -- you've vaccinated 50,000 persons so far. And how long do you expect this Pilot Vaccination Program to continue for? Thomas Lingelbach: Yes. It's a good question. So we have -- remember, this is a program that is owned by the Ministry of Health, so by the government. The government's objective is to have a minimum of 100,000 people vaccinated because what we are generating there is also a so-called active pharmacovigilance, especially given that chikungunya is a live attenuated vaccine, and we have been discussing in the past all the issues that arose from that. It is important that before they include it in a very, very broad public vaccination schedule, they need to see active pharmacovigilance. They need to see how this all works out. And that's why their internal target has been a minimum of 100,000 doses vaccinated, which could be reached, I think, by the latter part of the year. But -- yes, so that's all I can say to that. Operator: There are no further questions for today. I will now hand the call back to Thomas Lingerbach for closing remarks. Thomas Lingelbach: Thank you so much for your questions today. Thank you so much for following Valneva so closely, and of course, Lyme in particular, right now. As I said, we share the positivity that you could see across Pfizer's different communications. We are very happy about the progress that is currently being made. And we are optimistic that we're going to see approvals for the vaccine in the next 12 months and as such, enabling a nice strategic prospects, as I responded to following Suzanne's question earlier. So with that, thanks again, and have a good remainder of the day. Goodbye. Operator: Thank you. This concludes today's conference call. Thank you for participating. You may now disconnect. Before you buy stock in Valneva Se, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and Valneva Se wasn’t one of them. The 10 stocks that made the cut could produce monster returns in the coming years. 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Track your investments for FREE with Simply Wall St, the portfolio command center trusted by over 7 million individual investors worldwide. Pfizer stock has delivered a roughly 28% decline over the past five years, yet recent gains and a mixed set of valuation checks mean the current price is not an obvious bargain or clear bubble. With fresh product news and shifting expectations around its portfolio, investors are weighing whether the recent rebound leaves enough room for attractive long term returns. The share price is down about 28% over five years. This points to a company that has yet to fully reward long term holders despite a stronger showing in the last year. Progress on Pfizer and Valneva's Lyme disease vaccine candidate can support confidence in future cash flows, while legal and product related risks such as the Chantix settlement may limit how much of a premium the market is willing to put on the stock. The broader checks give Pfizer a mixed read on value, with the company scoring 3 out of 6 on Simply Wall St's valuation framework, so it does not stand out as clearly cheap or clearly expensive. The issue now is whether the current price for Pfizer properly reflects that mixed valuation picture or pushes the stock too far in either direction. Find out why Pfizer's 14.0% return over the last year is lagging behind its peers. The P/E ratio is a useful way to look at Pfizer because earnings are still the main anchor for how investors value this large pharmaceutical business. Pfizer currently trades on a P/E of 35.2x, which is more than double the pharmaceuticals industry average of 16.9x and also below the peer group average of 52.5x. That places the stock at a premium to the broader sector, even if it does not sit at the very top of the peer range. Simply Wall St's fair P/E for Pfizer, which adjusts for its specific growth outlook, margins, size and risk profile, is 24.6x. The current 35.2x multiple is therefore meaningfully higher than this tailored estimate. Despite the recent Lyme disease vaccine progress and stronger non Covid revenue mix, the P/E still indicates investors are paying a higher valuation for Pfizer shares relative to what this framework suggests is justified. On this P/E yardstick, Pfizer stock appears overvalued. See what the numbers say about this price — find out in our valuation breakdown. Simply Wall St Narratives pick up where Pfizer's valuation puzzle leaves off and spell out which combinations of future growth, margins and earnings would need to play out for the stock to be worth meaningfully more or less than today's price. Rather than focus on a single multiple or model output, each narrative lays out the assumptions behind its view of fair value so you can compare those expectations with Pfizer's reported results over time. Community views on Pfizer sit on opposite sides of the fence, with one camp leaning into the pipeline story and the other focused on pressure from pricing and patents. Bull case: 8% undervalued Read the full Bull Case to see why Pfizer could be undervalued Bear case: 7% overvalued Read the full Bear Case to see why Pfizer could be overvalued Do you think there's more to the story for Pfizer? Head over to our Community to see what others are saying! Pfizer looks overvalued on current market multiples, which suggests the recent optimism already prices in a fair amount of good news. With broader valuation checks sitting in a mixed range, the stock does not screen as a clear bargain or an obvious bubble. The key question from here is whether Pfizer can deliver enough durable earnings growth from its pipeline to make the current premium feel routine rather than stretched, especially in the face of pricing and legal pressures highlighted by recent events. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Companies discussed in this article include PFE. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email [email protected]

Total product sales of €64.0 million Solid cash position of €121.5 million as of end June 2026 Regulatory decisions for Lyme disease vaccine candidate expected in the next twelve months2 Lyon (France), August 13, 2026 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today reported its condensed consolidated financial results for the first half of the year ended June 30, 2026, provided key corporate updates, and reaffirmed its financial guidance for 2026. The half year financial report, including the condensed consolidated interim financial report and the half year management report, is available on the Company’s website (Financial Reports – Valneva). Valneva will provide a live webcast of its half year 2026 results conference call beginning at 3 p.m. CEST / 9 a.m. EDT today. This webcast will also be available on the Company’s website. Please refer to this link: https://edge.media-server.com/mmc/p/zd7jniit/lan/en First-half 2026 Financial Update Total revenues were €65.8 million, including €64.0 million in product sales, compared with €97.6 million and €91.0 million, respectively, in the first half of 2025. The year-over-year decrease primarily reflects the planned wind-down of third-party sales (down €10.5 million versus the first half of 2025) and the expected phasing of product sales, including the distribution transition in Germany and timing of IXIARO® shipments to the U.S. Department of Defense (DoD). Cash position was €121.5 million as of June 30, 2026, compared with €109.7 million as of December 31, 2025. This strong cash position reflects the positive impact of restructuring initiatives, disciplined cash management and €37 million in gross proceeds from the successful reserved offering completed in the second quarter of 2026. Net loss of €63.3 million compared with a net loss of €20.8 million in the first half of 2025, reflecting lower gross margin due to lower sales and manufacturing volumes as well as one-off impacts on cost of goods sold, including IXCHIQ®-related contract termination costs and inventory write-offs. Financial Outlook Despite the continued adverse impact of the geopolitical environment on travel, Valneva reaffirmed its 2026 guidance with expected product sales of €135 million to €150 million and total revenues of €145 million to €160 million. Product gross margins are expected to improve in the second half of the year following one-off effects in the first half of 2026 Valneva successfully implemented a global restructuring initiative4 to reduce its cash burn through a significant workforce reduction, the reprioritization and rescheduling of R&D activities and the streamlining of its global operations. As part of this initiative, the Company also agreed to sell its Nantes site in France for €6.2 million. A preliminary sale agreement has been signed with Nantes Métropole, and the transaction is expected to close in September 2026. Peter Bühler, Valneva’s Chief Financial Officer, commented, “Our focus over the past few months, following the Lyme VALOR results has been to restructure and refocus our operations. The successful financing completed in April has enabled us to build and maintain a strong cash position, allowing us to prioritize resources on our core business and key strategic priorities while preserving the flexibility to accelerate growth should the Lyme program progress successfully toward licensure and commercialization.” Financial Information(Unaudited results, consolidated per IFRS) Clinical Stage ProgramsLYME DISEASE VACCINE CANDIDATE – LB6V (formerly VLA15) Regulatory decisions expected in the next twelve months In March 2026, Valneva and Pfizer announced topline results from the Phase 3 VALOR “Vaccine Against Lyme for Outdoor Recreationists” clinical trial (NCT05477524) evaluating their investigational six valent OspA-based Lyme disease vaccine candidate LB6V6.Since then, Pfizer has been engaging with regulatory authorities to align on potential pathways to licensure and has expressed optimism regarding the vaccine candidate's regulatory approval prospects7. Regulatory decisions are expected in the next twelve months8.LB6V is currently the only Lyme disease vaccine candidate in late-stage clinical development. The program has received PRIME designation from the European Medicines Agency (EMA) and Fast Track designation from the U.S. Food and Drug Administration (FDA).If approved, LB6V has the potential to address a significant unmet medical need, with more than 80 million people in the United States and over 200 million people in Europe estimated to live in areas at elevated risk of Lyme disease. CHIKUNGUNYA VACCINE - IXCHIQ® / VLA1553Ongoing post-marketing commitments activities, including Pilot Vaccination Campaign in Brazil Several post-marketing commitments activities for IXCHIQ® are ongoing. These include the ongoing Pilot Vaccination Strategy (PVS) in Brazil. This is the first large-scale public vaccination campaign using IXCHIQ® in a real-world setting, conducted by the Brazilian Ministry of Health with support from Valneva and its local partner, Instituto Butantan. To date, approximately 50,000 adults aged 18 to 59 years have already been vaccinated as part of this campaign.The PVS, together with several studies that are ongoing or in preparation9,10,11,12, will serve as the basis for current and planned post-marketing Phase 4 studies evaluating the effectiveness and safety of IXCHIQ® to generate real-world evidence in larger and more specialized populations. SHIGELLA VACCINE CANDIDATE – S4V2First Phase 2 results expected shortly S4V2 is the world’s most clinically advanced tetravalent vaccine candidate against shigellosis, the second leading cause of fatal diarrhea worldwide. Two clinical trials of S4V2, a Phase 2 infant safety and immunogenicity trial13, and a Phase 2b Human Challenge trial (CHIM)14, sponsored by LimmaTech Biologics AG, are ongoing. Results from both studies are expected in the third quarter of 2026. Based on the outcome of these studies and the future R&D strategy, Valneva will determine the appropriate next steps, including whether to assume responsibility for the vaccine candidate's late-stage clinical development15.No approved multivalent Shigella vaccine is currently available outside of Russia or China, and the development of Shigella vaccines has been identified as a priority by the World Health Organization (WHO)16. In October 2024, the U.S. FDA granted Fast Track designation to S4V2, recognizing its potential to address a serious condition and fill an unmet medical need17. The global market opportunity for a vaccine against Shigella is estimated to exceed $500 million annually18. First-Half 2026 Financial Review                         (Unaudited, consolidated under IFRS) Revenues Valneva’s total revenues were €65.8 million in the six months ended June 30, 2026, compared to €97.6 million for the same period in 2025. The decrease was primarily attributable to the planned discontinuation of the majority of third-party sales, the expected phasing of product sales, including the timing of IXIARO® shipments to the U.S. DoD, the distributor transition in Germany as well as non-recurring outbreak-related sales of DUKORAL® and IXCHIQ® recorded during the first half of 2025 that did not repeat in 2026. Other revenues, including revenues from collaborations, licensing and services, amounted to €1.8 million in the first half of 2026 compared to €6.5 million for the same period in 2025, which included revenues recognized under the exclusive license agreement with the Serum Institute of India for IXCHIQ®, which was terminated in 2025. Product Sales Total product sales amounted to €64.0 million in the first half of 2026, compared to €91.0 million in the first half of 2025. In line with Valneva’s strategy and prior communications, third-party distribution activities have significantly decreased following the expiration of the Company’s main distribution agreement in 2025. Consequently, third-party product sales decreased by €10.5 million, or 91.6%, to €1.0 million in the first half of 2026 and are expected to represent less than 5% of product sales by the end of the year.Valneva’s commercial portfolio comprises three vaccines: IXIARO®/JESPECT®, DUKORAL® and IXCHIQ®. Japanese Encephalitis Vaccine IXIARO®/JESPECT® Sales of IXIARO®/JESPECT® were €44.0 million in the first half of 2026, compared with €54.7 million in the first half of 2025. The year-over-year comparison primarily reflects the transition to a new distributor in Germany in January 2026 as well as the product sales phasing, notably the timing of deliveries to the U.S. DoD. Deliveries under the contract signed in January 2025 continued during the period, and Valneva expects to make additional IXIARO® deliveries to the DoD during the remainder of 2026, including under a new contract expected in the third quarter. Foreign currency fluctuations had an adverse impact of €1.5 million on IXIARO®/JESPECT® sales during the first half of 2026. Cholera / ETEC19-Diarrhea Vaccine DUKORAL® DUKORAL® sales were €14.7 million in the first half of 2026, compared with €17.4 million in the first half of 2025. The prior-year period benefited from one-time sales associated with the supply of vaccine doses to Mayotte in response to a cholera outbreak. Sales in the first half of 2026 were also affected by the transition to a new distributor in Germany in January 2026. Existing inventory held by the previous distributor remained sufficient to meet market demand during the period, temporarily reducing product shipments, while the geopolitical situation continued to adversely affect travel. Deliveries under the new distribution arrangement are gradually resuming. Foreign currency fluctuations had an adverse impact of €0.4 million on DUKORAL® sales during the first half of 2026. Chikungunya Vaccine IXCHIQ® IXCHIQ® sales were €4.4 million in the first half of 2026 including initial shipments of the vaccine’s drug substance to Instituto Butantan, compared with €7.5 million in the first half of 2025. The prior-year period benefited from sales in the U.S. and from 40,000 doses provided to the French island of La Réunion in response to a chikungunya outbreak. In light of the product uptake in travel, the Company is currently evaluating its future commercial strategy for IXCHIQ® including a potential focus on endemic markets. Operating Result and adjusted EBITDACosts of goods and services sold were €59.5 million in the first half of 2026, compared to €47.2 million in the first half of 2025. As a result, gross profit decreased to €6.3 million. The decrease in gross profit was primarily attributable to lower sales and manufacturing volumes across the portfolio, adverse cost impacts related to IXCHIQ® inventory provisions and third-party manufacturing, supply contract termination costs, and higher idle manufacturing costs that were neither capitalized nor allocated to products. As a result, product-level gross margin before unallocated costs decreased to €14.7 million in the first half of 2026 from €54.4 million in the first half of 2025. Gross profit was further reduced by €9.4 million in unallocated manufacturing costs, including idle capacity and other costs not allocated to products, compared to €6.0 million in the first half of 2025. * as % of total revenues * as % of total revenues IXIARO® gross margin was 56.4% in the first half of 2026, compared to 65.5% in the first half of 2025. The decrease mainly reflects lower volumes and adverse changes in manufacturing costs, partly offset by a favorable average selling price and product/country mix effect. The prior year gross margin had benefited from a particularly high manufacturing volume and related cost absorption.DUKORAL® gross margin was 24.7% in the first half of 2026, compared to 52.9% in the first half of 2025 and 33.3% for the full year 2025. Gross profit decreased to €3.6 million in the first half of 2026 from €9.2 million in the first half of 2025, mainly due to lower volumes. In the first half of 2025, production timing and the prior-year manufacturing shutdown resulted in favorable absorption and inventory valuation effects. By contrast, the first half of 2026 was adversely impacted by inventory valuation and revaluation effects, as well as higher failed batch costs. Gross margin for IXCHIQ® was negative, mostly impacted by one-time cancellation fees related to external manufacturing commitments of €9.7 million and a €4.5 million non-cash impairment of excess inventory, both resulting from lower than anticipated sales. The financial impact reflects the company’s decision to shift its commercial focus for chikungunya to endemic territories where the risk of chikungunya virus infection is highest. Third-party product gross profit was €0.2 million in the first half of 2026, compared to €4.5 million in the first half of 2025. The decrease reflects the planned wind-down of third-party distribution activities. Cost of services amounted to €0.8 million in the first half of 2026 compared to €4.6 million in the first half of 2025, which included revenue recognition from the IXCHIQ license agreement with Serum Institute of India, terminated in December 2025. Research and development expenses declined to €30.2 million in the first half of 2026, compared to €32.4 million for the same period in 2025. The decrease was largely attributable to the reprioritization and rescheduling of R&D activities. Marketing and distribution expenses totaled €13.5 million in the first half year of 2026, down significantly from €20.3 million in the first half year of 2025. The decrease primarily reflects lower advertising and promotional expenses related to IXCHIQ® as well as reduced personnel, warehousing and distribution costs. General and administrative expenses decreased to €15.4 million in the first half of 2026, from €19.0 million in the same period of 2025. The reduction was primarily driven by lower personnel costs and savings in advisory and professional services. In the first half of 2026, €3.2 million of expenses were recognized across the affected functions in connection with the workforce reduction and restructuring program initiated in the second quarter of 2026. Other income, net of other expenses, decreased to €2.9 million in the first half of 2026 from €4.6 million in the same period of 2025. The decrease was primarily attributable to lower R&D tax credits, partially offset by higher grant income. Valneva recorded an operating loss of €49.9 million in the first half of 2026 compared with an operating loss of €16.8 million in the same period of 2025. The increase in operating loss was mainly driven by lower product sales and one-time charges related to IXCHIQ® recorded in the first half of 2026, which were not incurred in the prior-year period. Adjusted EBITDA loss (as defined below) was €40.1 million in the first half of 2026, compared with an adjusted EBITDA loss of €6.0 million in the corresponding period of 2025. Operating Loss and Net Result Operating loss was €49.9 million in the first half of 2026 compared to €16.8 million in the first half of 2025. In the first half of 2026, about 50% of the operating loss was generated by IXCHIQ®.Net loss was €63.3 million in the first half of 2026 compared to a net loss of €20.8 million in the first half of 2025. The increase was primarily driven by lower gross profit, reflecting lower product sales and higher COGS, including IXCHIQ®-related manufacturing contract cancellation fees, inventory charges and idle capacity costs. The loss was partly offset by lower R&D, marketing and distribution, and G&A expenses. Finance expense and currency effects resulted in a net finance expense of €13.1 million in the first half year of 2026, compared with a net finance expense of €2.7 million in the first half year of 2025. The increased expenses were mainly attributable to unfavorable movements in the USD/EUR exchange rate, resulting in a foreign currency loss of €3.9 million in the first half of 2026 compared with a foreign currency gain of €7.8 million in the first half year of 2025. Cash Flow and Liquidity Net cash used in operating activities amounted to €13.7 million in the first half of 2026 compared to €10.9 million in the same period of 2025. The increase in the first half of 2026 was primarily driven by increased losses during the period, partially offset by lower net working capital requirements. Cash inflows from investing activities amounted to €0.6 million in the first half of 2026 compared to cash outflows of €1.6 million in the same period of 2025. Cash inflows in the first half of 2026 were largely attributable to proceeds from investments in money market funds. By contrast, cash outflows in the first half year of 2025 were mainly related to the purchase of equipment, partially offset by interest income. Net cash generated by financing activities amounted to €24.5 million in the first half of 2026 compared to a net cash inflow of €9.3 million in the same period in 2025. Cash generated during the first half of 2026 included net proceeds of €34.3 million from a capital raise completed in the second quarter of 2026. By comparison, cash inflows in the same period of 2025 included net proceeds from capital raises of €20.1 million. Both quarters included interest payments, amounting to €8.9 million in the first six months of 2026 and €9.5 million in the same period of the prior year. Cash and cash equivalents were €121.5 million as at June 30, 2026, compared to €109.7 million at December 31, 2025. Non-IFRS Financial Measures Management uses and presents IFRS results as well as the non-IFRS measure of Adjusted EBITDA to evaluate and communicate its performance. While non-IFRS measures should not be construed as alternatives to IFRS measures, management believes non-IFRS measures are useful to further understand Valneva’s current performance, performance trends, and financial condition. Adjusted EBITDA is a common supplemental measure of performance used by investors and financial analysts. Management believes this measure provides additional analytical tool. Adjusted EBITDA is defined as earnings / (loss) for the period before income tax, finance (income)/expense, foreign exchange (gain)/loss, amortization, depreciation, and impairment. A reconciliation of Adjusted EBITDA to net loss for the period, which is the most directly comparable IFRS measure, is set forth below: Product sales (excluding third-party sales) at constant exchange rate: References to changes in net sales at constant exchange rate (CER) indicate that currency fluctuation effects have been removed. Net sales for the period in question are recalculated using the exchange rates applied in the prior period, as detailed below: About Valneva SEWe are a specialty vaccine company that develops, manufactures, and commercializes prophylactic vaccines for infectious diseases addressing unmet medical needs. We take a highly specialized and targeted approach, applying our deep expertise across multiple vaccine modalities, focused on providing either first-, best- or only-in-class vaccine solutions.We have a strong track record, having advanced multiple vaccines from early R&D to approvals, and currently market three proprietary travel vaccines.Revenues from our growing commercial business help fuel the continued advancement of our vaccine pipeline. This includes the only Lyme disease vaccine candidate in advanced clinical development, which is partnered with Pfizer, the world’s most clinically advanced Shigella vaccine candidate, as well as vaccine candidates against other global public health threats. More information is available at www.valneva.com. Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 and securities laws in France. These statements may be identified by words such as “aims,” “anticipates,” “believes,” “could,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,” “plans,” “possible,” “potential,” “seeks,” “will” and variations of these words or similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these words. All statements other than statements of historical facts contained in this press release are forward-looking statements, including, but not limited to, statements with respect to: future financial performance and financial guidance including projected product sales, total revenue and total R&D investments; Valneva’s plans for investment in future growth; the timing of orders for commercial products; plans and expectations regarding the development, commercialization and commercial prospects of Valneva’s product candidates and commercial products, including the prospects and timing of actions relating to clinical studies and trials and product approvals, such as study initiations, study advancements, data readouts, submissions, filings, approvals, and label expansions; the expected benefits and availability of Valneva’s commercial products and product candidates; and potential growth opportunities and trends, including the assumptions and expectations regarding total market opportunity targeted by Valneva’s product candidates and commercial products. These forward-looking statements are based on Valneva’s expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties that could cause Valneva’s business, strategy, future results or performance to differ materially from those expressed or implied by the forward-looking statements. Many factors may cause differences between current expectations and actual results, including: Valneva’s success in the commercialization of its commercial products; uncertainties and delays involved in the development and manufacture of vaccines; the potential that success in preclinical testing and earlier clinical trials does not ensure that later clinical trials will generate the same results or otherwise provide adequate data to demonstrate the efficacy and safety of a product candidate; the impacts of macroeconomic conditions, including tariffs and other trade policies, the conflict in Ukraine and the conflict in the Middle East, fluctuations in inflation and uncertain credit and financial markets, on Valneva’s business, clinical trials and financial position; unexpected safety or efficacy data observed during preclinical studies or clinical trials; clinical trial site activation or enrollment rates that are lower than expected; Valneva’s ability to realize the benefits of its collaboration and license agreements; changes in expected or existing competition; changes in the regulatory environment; the uncertainties and timing of the regulatory approval process; the impact of the global and European credit crisis; the ability to obtain or maintain patent or other proprietary intellectual property protection and unexpected litigation or other disputes. Other factors that may cause the Company’s actual results to differ from those expressed or implied in the forward-looking statements in this press release are identified in the section titled “Risk Factors” in Valneva’s Annual Report on Form 20-F for the year ended December 31, 2025 filed with the U.S. Securities and Exchange Commission (“SEC”) and the Autorité des marchés financiers (“AMF”) on March 18, 2026, and in other filings made with the SEC and AMF from time to time. Valneva is providing this information as of the date of this press release and expressly disclaims any intention or obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by law. 1 Valneva Announces the Successful Completion of an €84 million Reserved Offering - Valneva2 https://s206.q4cdn.com/795948973/files/doc_financials/2026/q2/Q2-2026-Earnings-Charts-FINAL.pdf3 https://s206.q4cdn.com/795948973/files/doc_events/2026/Jun/08/PFE-USQ_Transcript_2026-06-08.pdf4 Valneva Reports First Quarter 2026 Financial Results and Provides Corporate Updates - Valneva 5 For additional information on Adjusted EBITDA, please refer to the “Non-IFRS Financial Measures” section at the end of the PR6 2026_03_23_Lyme-Phase-3-Data-Read-out_PR_EN_FINAL.pdf7 https://s206.q4cdn.com/795948973/files/doc_events/2026/Jun/08/PFE-USQ_Transcript_2026-06-08.pdf8 https://s206.q4cdn.com/795948973/files/doc_financials/2026/q2/Q2-2026-Earnings-Charts-FINAL.pdf9 Study Details | NCT07347002 | Observational Study to Assess the Effectiveness of VLA1553 Vaccine in Preventing Chikungunya During a Pilot Vaccination Strategy in Brazil | ClinicalTrials.gov10 Study Details | NCT07414524 | VLA1553-403 Pregnancy Surveillance Study | ClinicalTrials.gov11 Study Details | NCT07254702 | Prospective Safety Cohort Study After VLA1553 Vaccination in Municipalities Selected for Participation in the VLA1553 Pilot Vaccination Strategy in Brazil | ClinicalTrials.gov12 CEPI, Chikungunya13 Valneva and LimmaTech Announce First Vaccination in Phase 2 Infant Study of Tetravalent Shigella Vaccine Candidate S4V2 - Valneva14 Valneva and LimmaTech Announce First Vaccination in Phase 2b Human Challenge Study of Tetravalent Shigella Vaccine Candidate S4V215 Valneva and LimmaTech Enter into a Strategic Partnership to Accelerate the Development of the World’s Most Clinically Advanced Tetravalent Shigella Vaccine Candidate - Valneva16 Immunization, Vaccines and Biologicals (who.int)17 Valneva and LimmaTech Awarded FDA Fast Track Designation for Tetravalent Shigella Vaccine Candidate S4V - Valneva18 LEK analysis19 Indications differ by country - Please refer to Product / Prescribing Information (PI) / Medication Guide approved in your respective countries for complete information, incl. dosing, safety and age groups in which this vaccine is licensed; ETEC = Enterotoxigenic Escherichia coli (E. Coli) bacterium. Attachment 2026_08_13_VLA_H1_2026_PR_EN_Final

Interested in Valneva SE Sponsored ADR? Here are five stocks we like better. First-half performance weakened: Revenue fell to €65.8 million from €97.6 million, while the operating loss widened to €49.9 million, partly due to IXCHIQ-related provisions and inventory impairments. Valneva maintained its 2026 outlook for product sales of €135 million–€150 million and total revenue of €145 million–€160 million, supported by €121.5 million in cash and restructuring measures expected to improve second-half cash flow. Lyme vaccine regulatory progress remains pivotal: Pfizer has filed with the European Medicines Agency and expects regulatory decisions within 12 months, with potential financial self-sustainability beginning in 2027 if the vaccine is approved and commercialized. Novavax’s dispute resolution and upcoming earnings call Valneva (NASDAQ:VALN) reported lower first-half revenue and wider losses for 2026, while maintaining its full-year sales outlook and emphasizing its cash position, restructuring measures and expectations for regulatory progress on its Lyme disease vaccine candidate with Pfizer. CEO Thomas Lingelbach said the company ended the period with more than €120 million in cash following disciplined cash management, a recent offering and a restructuring program that included workforce reductions, project reprioritization and a focus on core operations. Cash at June 30 was €121.5 million, compared with €109.6 million at the end of 2025. → AST SpaceMobile Earnings Just Reminded Investors How Risky Space Can Be Product sales totaled €64 million in the first half, down from €91 million a year earlier. Total revenue fell to €65.8 million from €97.6 million, largely reflecting lower product sales and the absence of a prior-year upfront payment tied to a licensing agreement with the Serum Institute of India for Valneva’s single-shot chikungunya vaccine. CFO Peter Bühler said IXIARO sales declined to €44 million from €54.7 million. The decrease reflected a transition to a new German distributor in January, the timing of deliveries to the U.S. Department of Defense and a €1.5 million adverse foreign-exchange effect. The company expects to sign a new U.S. Department of Defense supply contract in the coming months and begin recognizing sales under that agreement in the second half. → Nebius’ Q2 Beat Shows the AI Bottleneck Is Capacity, Not Demand DUKORAL sales declined to €14.7 million from €17.4 million. The prior-year period benefited from one-time doses supplied to Mayotte during a cholera outbreak, while 2026 sales were affected by the German distributor transition and some weakening in travel markets due to geopolitical factors. IXCHIQ sales were €4.4 million, compared with €7.5 million in the first half of 2025. While the current period included the first shipment of drug substance to Brazilian partner Instituto Butantan, the prior-year period included 40,000 doses sold to La Réunion during a chikungunya outbreak and U.S. travel sales. Bühler said Valneva is evaluating IXCHIQ’s future commercial strategy, including a potential greater focus on endemic markets because of slow travel-market uptake. → On Holding's Price Stumble May Be an Opening for a Company Built to Run Third-party product revenue fell to €1 million from €11.4 million after distribution agreements ended in December 2025 without renewal. Valneva reported an operating loss of €49.9 million for the first half, compared with a €16.8 million loss a year earlier. Adjusted EBITDA loss widened to €40.1 million from €6 million. Cost of goods and services rose to €59.5 million from €47.2 million. Bühler attributed the increase partly to exceptional IXCHIQ-related charges, including a €9.7 million provision for cancellation fees on external manufacturing commitments and a €4.5 million non-cash impairment on excess inventory following lower-than-expected sales. Research and development spending declined to €30.2 million from €32.4 million due to reprioritization and rescheduling of activities. Marketing and distribution expense fell to €13.5 million from €20.3 million, while general and administrative expense declined to €15.4 million from €19 million. The first-half figures included €3.2 million in one-time restructuring costs. The company expects its restructuring actions to produce favorable profit-and-loss and cash-flow effects in the second half and beyond. Bühler said Valneva expects gross margin to improve in the second half as first-half nonrecurring items do not repeat, though full-year gross margin may remain below the prior year’s level. Lingelbach said Pfizer continues to be positive about the outlook for the Lyme disease vaccine candidate, referred to during the call as LB6V. Pfizer has said it expects regulatory decisions within the next 12 months, according to Valneva. Valneva said the vaccine showed point efficacy above 70% and a favorable safety profile, though the lower bound of the 95% confidence interval missed the targeted threshold in one analysis. Lingelbach noted that the lower confidence-interval bound exceeded 20% in a second prespecified analysis and said the company believes the totality of evidence, disease burden and potential health-economic benefit support the program. During the question-and-answer session, Lingelbach confirmed Pfizer has filed with the European Medicines Agency and said European and U.S. regulatory activities are independent processes. He said he expects Europe could move first, while Pfizer continues to work with the FDA in support of a planned biologics license application submission. Valneva shares development costs with Pfizer through licensure under the existing agreement. Lingelbach said any further investment in the program after licensure, including potential post-marketing work, would be addressed later and is not currently covered by the contract. For IXCHIQ, Valneva is supporting a Brazilian pilot vaccination campaign in adults ages 18 to 59, where more than 50,000 people have been vaccinated. Lingelbach said Brazil’s government aims to vaccinate at least 100,000 people as part of active pharmacovigilance before broader public-health deployment. Butantan’s locally manufactured version of the vaccine has been approved and is expected to be incorporated into Brazil’s public health system. The company also expects results in coming months from two studies of its in-licensed tetravalent Shigella vaccine candidate: an adult controlled human infection study and an infant immunogenicity and safety study. Lingelbach said Valneva plans to determine next development steps based on the data, including whether potential optimization of dose, schedule or formulation is needed. Valneva reaffirmed 2026 guidance for product sales of €135 million to €150 million and total revenue of €145 million to €160 million. Management said the commercial business is expected to continue generating positive cash flow. Lingelbach corrected an earlier statement on timing for potential financial self-sustainability, saying the company sees potential to reach that position beginning in 2027, subject to Lyme vaccine approval and subsequent commercialization by Pfizer. Valneva SE is a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases. Headquartered in Saint-Herblain, France, the company applies inactivated whole-cell and recombinant technology platforms to address public health needs. Valneva's research and development efforts span a range of viral and bacterial pathogens, with an emphasis on travel-related and emerging infectious diseases. Among its marketed products, Valneva offers IXIARO®/JESPECT® for the prevention of Japanese encephalitis and DUKORAL® for the prevention of cholera and diarrhea caused by enterotoxigenic Escherichia coli. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "Valneva Q2 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for August 2026.

This article first appeared on GuruFocus. Product Sales: EUR64 million in H1 2026, down from EUR91 million in H1 2025. Ixiaro Sales: EUR44 million, down from EUR54.7 million year-over-year, impacted by distributor transition in Germany and timing of US Department of Defense shipments. Ducoral Sales: EUR14.7 million, down from EUR17.4 million in H1 2025, affected by prior-year one-time outbreak supply and distributor transition. Ixchiq Sales: EUR4.4 million, down from EUR7.5 million, including first shipment to Brazilian partner Instituto Butantan. Third-Party Product Sales: EUR1 million, down from EUR11.4 million, due to planned expiration of distribution agreements. Total Revenues: EUR65.8 million versus EUR97.6 million in H1 2025. Cost of Goods and Services: EUR59.5 million, up from EUR47.2 million, including EUR9.7 million in cancellation fees and EUR4.5 million inventory impairment. Ixiaro Gross Margin: 56.4%, down from 65.5% in the prior year. Ducoral Gross Margin: 24.7%, down from 52.9% in H1 2025. Research and Development Expense: EUR30.2 million, down from EUR32.4 million. Marketing and Distribution Expense: EUR13.5 million, down from EUR20.3 million. G&A Expense: EUR15.4 million, down from EUR19 million. Operating Loss: EUR49.9 million, compared to a loss of EUR16.8 million in H1 2025. Adjusted EBITDA Loss: EUR40.1 million, compared to a loss of EUR6 million in the prior year. Cash Position: EUR121.5 million at June 30, 2026, up from EUR109.6 million at end of fiscal year 2025. Cash Used in Operations: EUR13.7 million in H1 2026, compared to EUR10.9 million in H1 2025. FY 2026 Guidance: Product sales of EUR135 million to EUR150 million and total revenues of EUR145 million to EUR160 million. Warning! GuruFocus has detected 6 Warning Signs with INRLF. Is INRLF fairly valued? Test your thesis with our free DCF calculator. Release Date: August 13, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Valneva SE (INRLF) ended the first half of 2026 with a strong cash position of over EUR120 million, bolstered by disciplined cash management and proceeds from a recent offering. Pfizer remains highly positive on the Lyme disease vaccine candidate, expecting regulatory decisions within the next 12 months, which could unlock significant value. The company has implemented a broad restructuring program expected to generate positive P&L and cash flow impacts in the second half of 2026 and beyond. Valneva SE (INRLF) reaffirmed its full-year 2026 guidance for product sales of EUR135-150 million and total revenues of EUR145-160 million, indicating confidence in its base business. The locally manufactured Chikungunya vaccine in Brazil by partner Butantan has been approved, with over 50,000 people already vaccinated in a pilot campaign, opening a significant market opportunity. The company is advancing its Shigella vaccine candidate, with results from two key studies expected in the coming months, potentially expanding its pipeline. Valneva SE (INRLF) reported a significant operating loss of EUR49.9 million in the first half of 2026, a sharp decline from the EUR16.8 million loss in the prior year. Total product sales decreased to EUR64 million from EUR91 million in the first half of 2025, driven by distributor transitions, product phasing, and geopolitical factors. The company recorded non-recurring charges, including a EUR9.7 million provision for cancellation fees and a EUR4.5 million non-cash impairment of excess inventory, impacting gross margins. Gross margins for key products like Ixiaro and Ducoral declined significantly due to lower volumes, manufacturing schedule changes, and higher failed batch costs. The future strategic direction and potential for financial self-sustainability are heavily dependent on the successful regulatory approval and commercialization of the Lyme disease vaccine. Sales of the Chikungunya vaccine (Ixchiq) remain slow in the travel market, prompting the company to evaluate a strategic shift towards endemic markets. Q: Can you provide any more detail on the regulatory update for the Lyme disease vaccine, given Pfizer's optimism about a decision in the next 12 months?A: Thomas Lingelbach (CEO): Pfizer is making very good progress with the regulatory agencies, and we hope to announce next steps soon. That's all we can say at this moment in time specifically. Q: Could you elaborate on the potential scenarios for the Lyme program, such as running another Phase 3 program or post-marketing surveillance, and how that would factor into capital allocation?A: Thomas Lingelbach (CEO): The existing agreement with Pfizer includes Valneva sharing development costs to licensure. Everything beyond licensure is currently not part of the contractual agreement. Whether we will further invest in Lyme on those points may be discussed later, but definitely not before we see the product licensed. Q: Can you provide more color on what is gating the Shigella update, and should we expect clarity on the path forward when data is disclosed?A: Thomas Lingelbach (CEO): We've had a few delays on the program, as the studies are still conducted by NEMATech, which was recently acquired by LIDI. We are in the final steps of data validation and analysis. The human challenge study will give us a clear understanding of efficacy, and the immunogenicity study in children will provide safety data. We will take both data packages together and decide on next development steps, announcing them either with the data or very shortly thereafter. Q: For the U.S. and European regulatory paths for Lyme, are they moving in parallel or sequentially?A: Thomas Lingelbach (CEO): Both activities are progressing nicely and are independent processes. At this moment, I would assume Europe probably goes first, but Pfizer is working closely with the FDA in support of its planned BLA submission. Q: Can you share any details on why Pfizer decided to file in Europe first, and are there differences in how the European Agency and FDA look at vaccine data?A: Thomas Lingelbach (CEO): We can confirm Pfizer filed with the European Medicines Agency. I would not speculate on why one is earlier than the other. The data are the same, and all agencies look at the totality of clinical evidence, risk-benefit, and health economic benefits. I have never seen material differences in how the two regulatory bodies handle applications. Q: It seems you are gravitating toward a more R&D-driven identity. To what extent does this strategic direction depend on Lyme being successful?A: Thomas Lingelbach (CEO): The key purpose of our commercial business is to maximize cash generation and reinvest in R&D. The capacity to invest depends heavily on Lyme's success, as royalties would go straight to the bottom line, potentially making us financially self-sustainable. It's a very appealing strategy, but it's all about Lyme and depends on licensure and commercial success. Q: Regarding the sale of the site in France, does this bring ongoing cost reduction beyond the proceeds?A: Thomas Lingelbach (CEO): As part of our restructuring program, we consolidated all R&D operations into Vienna and shut down operations in Nantes. This consolidation brings efficiency and cost reduction over time, with significant benefits to come, besides the proceeds from the building sale. Q: How should we think about SG&A and R&D for the remainder of the year, and does the 25-35% reduction in OpEx guidance still hold?A: Peter Buehler (CFO): We expect continued efficiency in SG&A spend, and what you see in the first half is what we will continue to see. On R&D, we expect a decrease in costs in the second half. The guidance on cost reduction versus last year still holds true; we have not revised it. Q: What is the realistic expectation for gross margin in the second half of 2026?A: Peter Buehler (CFO): There were many one-off and non-cash effects in the first half. In the second half, we clearly expect a much better gross margin. For the full year, we will probably not get exactly to last year's level, but we will get much closer, with a positive trend into 2027. Q: How long might it be before the start of commercial sales of the locally manufactured Chikungunya vaccine in Brazil?A: Thomas Lingelbach (CEO): Our partner is in the midst of launch planning, so it's too early to discuss commercial prospects. There is a clear desire to include the vaccine in the healthcare system, and we expect this to become a very significant opportunity, but it's too early to provide numbers. Q: How long do you expect the pilot vaccination program in Brazil to continue?A: Thomas Lingelbach (CEO): The program is owned by the Ministry of Health. The government's objective is a minimum of 100,000 people vaccinated to generate active pharmacovigilance data. This target could be reached by the latter part of the year. For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Lyon (France), July 22, 2026 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that it will report its first half 2026 financial results on Thursday, August 13, 2026. The Company will host a live webcast beginning at 3 p.m. CET/9 a.m. ET to discuss the financial results and provide a business update. The live webcast will be accessible on the Company’s website and made available as an archive after the event concludes. Please refer to this link: https://edge.media-server.com/mmc/p/zd7jniit/lan/en About Valneva SEWe are a specialty vaccine company that develops, manufactures, and commercializes prophylactic vaccines for infectious diseases addressing unmet medical needs. We take a highly specialized and targeted approach, applying our deep expertise across multiple vaccine modalities, focused on providing either first-, best- or only-in-class vaccine solutions.We have a strong track record, having advanced multiple vaccines from early R&D to approvals, and currently market three proprietary travel vaccines.Revenues from our growing commercial business help fuel the continued advancement of our vaccine pipeline. This includes the only Lyme disease vaccine candidate in advanced clinical development, which is partnered with Pfizer, the world’s most clinically advanced Shigella vaccine candidate, as well as vaccine candidates against other global public health threats. More information is available at www.valneva.com. Forward-Looking Statements This press release contains certain forward-looking statements relating to the business of Valneva, including with respect to business partnerships and the progress, timing, results and completion of technology transfer and regulatory approvals in additional markets. In addition, even if the actual results or development of Valneva are consistent with the forward-looking statements contained in this press release, those results or developments of Valneva may not be sustained in the future. In some cases, you can identify forward-looking statements by words such as “could,” “should,” “may,” “expects,” “anticipates,” “believes,” “intends,” “estimates,” “aims,” “targets,” or similar words. These forwardlooking statements are based largely on the current expectations of Valneva as of the date of this press release and are subject to a number of known and unknown risks and uncertainties and other factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievement expressed or implied by these forward-looking statements. In particular, the expectations of Valneva could be affected by, among other things, uncertainties and delays involved in the development and manufacture of vaccines, unexpected clinical trial results, unexpected regulatory actions or delays, competition in general, currency fluctuations, the impact of the global and European credit crisis, and the ability to obtain or maintain patent or other proprietary intellectual property protection. Success in preclinical studies or earlier clinical trials may not be indicative of results in future clinical trials. In light of these risks and uncertainties, there can be no assurance that the forward-looking statements made in this press release will in fact be realized. Valneva is providing this information as of the date of this press release and disclaims any intention or obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise. Attachment 2026_07_22_H1_2026_Results_Curtain Raiser_EN

Interested in Valneva SE Sponsored ADR? Here are five stocks we like better. Valneva’s Lyme disease vaccine VLA15 delivered strong Phase 3 efficacy above 70% and showed no safety concerns, but it missed the first pre-specified statistical endpoint because fewer Lyme cases occurred than expected. Pfizer still plans regulatory submissions, making the program the company’s biggest near-term catalyst. First-quarter 2026 results were weaker, with revenue falling to 30.9 million euros and net loss widening to 32.1 million euros as sales declined across IXIARO, DUKORAL and IXCHIQ. Lower margins were also pressured by manufacturing issues, inventory provisions and higher costs tied to the Almeida facility transfer. Valneva cut full-year guidance and launched a restructuring plan that includes a 10% to 15% global workforce reduction to preserve cash and reduce operating expenses. Management said the company is focusing on its core portfolio and key programs, including IXCHIQ, Shigella and the potential Lyme vaccine launch. Novavax’s dispute resolution and upcoming earnings call Valneva (NASDAQ:VALN) reported lower first-quarter revenue and a wider loss for 2026, while management said the company is focused on conserving cash as it awaits the next regulatory steps for its Lyme disease vaccine candidate being developed with Pfizer. Chief Executive Officer Thomas Lingelbach said the quarter was “certainly dominated” by the Phase 3 readout for the Lyme disease vaccine candidate VLA15, also referred to by Pfizer as LB6V. He said the study showed “strong efficacy,” but that the first pre-specified statistical criterion was not met, while a second pre-specified analysis met its criterion. → Rocket Lab Just Hit a New All-Time High—Time to Buy or Let It Breathe? “Overall, the efficacy, as you can see, on the slide, is above 70%, which is really strong,” Lingelbach said. He added that the vaccine was well tolerated and that “no safety concerns” had been identified at the time of analysis. Lingelbach said the statistical issue was tied to fewer Lyme disease cases than anticipated over the study period, which led to a wider confidence interval. Still, he said Pfizer is planning regulatory submissions because of the clinically meaningful efficacy and the second pre-specified analysis. → MercadoLibre Boldly Invests in Growth: Discount Deepens Chief Financial Officer Peter Bühler said product sales totaled 30.5 million euros in the first quarter of 2026, down from 48.6 million euros a year earlier. Total revenue was 30.9 million euros, compared with 49.2 million euros in the first quarter of 2025. IXIARO sales were 20.2 million euros, compared with 27.5 million euros a year earlier. Bühler said the decline was primarily due to the phasing of scheduled deliveries to the U.S. Department of Defense under the contract signed in January 2025. → MP Materials Is Quietly Building a Rare Earth Powerhouse DUKORAL sales fell to 8.6 million euros from 12.3 million euros. Bühler said the prior-year period included one-time sales tied to supplying doses to Mayotte after a local cholera outbreak. He also cited the impact of a change in distribution partner for certain European Union countries, mainly Germany, where residual inventories were sufficient to satisfy first-quarter demand. He said new product deliveries are expected to resume in the second quarter. IXCHIQ sales were 1.6 million euros, down from 3 million euros in the prior-year quarter, which had benefited from initial doses supplied to the French island of La Réunion in response to a major outbreak as well as travel sales in the U.S. Third-party product sales declined to 100,000 euros from 5.8 million euros as Valneva intentionally winds down distribution of third-party products to focus on its proprietary portfolio. Valneva reported an operating loss of 23.7 million euros in the first quarter, compared with a smaller loss a year earlier, driven by lower sales and gross margin. The company’s net loss was 32.1 million euros, compared with 9.2 million euros in the first quarter of 2025. Cost of goods and services rose to 26.2 million euros from 21.3 million euros despite lower sales. Bühler cited several factors, including higher idle costs following the manufacturing transfer to the new Almeida facility, failed batches, inventory provisions and onerous contracts related to IXCHIQ. He also said the first quarter of 2025 benefited from a positive standard cost adjustment. The gross margin on commercial product sales, excluding IXCHIQ, was 45.2%, compared with 62.7% a year earlier. IXIARO’s gross margin was 50.8%, down from 72.6%, due to higher manufacturing costs, increased batch write-offs and lower overhead absorption. Bühler said IXCHIQ’s gross margin was negative, impacted by cancellation fees related to external manufacturing commitments after lower-than-anticipated sales. Research and development expense was stable at 15.2 million euros, mainly reflecting investments in IXCHIQ, Shigella and a preclinical Epstein-Barr virus project. Marketing and distribution expense fell to 7 million euros from 10.4 million euros, mainly due to lower IXCHIQ spending, particularly in the U.S. General and administrative costs declined to 8.2 million euros from 9 million euros. Valneva ended March with 105 million euros in cash and cash equivalents, compared with 110 million euros at the end of the prior fiscal year. Bühler said the figure does not include initial proceeds from the company’s reserved offering completed in April 2026. The company lowered its 2026 outlook, citing “emerging adverse trends in travel vaccine uptakes” in key markets driven by geopolitical factors. Valneva now expects product sales of 135 million euros to 150 million euros and total revenue of 145 million euros to 160 million euros for fiscal 2026. Management also said Valneva initiated a restructuring plan in April to streamline operations and focus resources on key projects. The plan includes a global workforce reduction of about 10% to 15% and is expected to reduce operating expenses by 25% to 35% compared with 2025 levels. In response to an analyst question, Bühler said the full payback from people-cost reductions would occur next year because of legal processes and notice periods, particularly in Austria. He said external spending reductions have already started and are expected to generate meaningful savings during the remainder of 2026 and into 2027. Most of the savings, he said, are expected in research and development. Lingelbach said Lyme disease remains a major medical need and market opportunity, noting that no human vaccine is currently available to prevent the disease. He said nearly 90 million people in North America and more than 200 million in Europe live in high-risk areas, with reported annual disease burdens of about 500,000 cases in the U.S. and more than 100,000 in Europe. He added that reported figures are likely underreported. During the question-and-answer session, analysts repeatedly asked about Pfizer’s regulatory plans. Lingelbach said Pfizer is preparing for meetings with regulatory authorities but declined to provide more detail. Asked whether Valneva has insight into Pfizer’s FDA discussions, he said Valneva is not actively involved in preparations or discussions between Pfizer and regulators, but is informed through existing steering structures at different time points than the broader market. Lingelbach said Pfizer has stated it will present the full Lyme dataset at a forthcoming conference, though he said the specific conference had not been confirmed to his knowledge. He also said Valneva’s current assumption is that acceptance of a filing would be disclosed. Valneva also highlighted ongoing work for IXCHIQ, its chikungunya vaccine. Lingelbach said a pilot vaccination campaign is underway in Brazil for adults ages 18 to 59, targeting 20% to 40% coverage across various municipalities. More than 30,000 people have been vaccinated to date, with the company aiming for more than 100,000 overall. He also said Butantan’s locally produced chikungunya vaccine, Butantan-CHIK, achieved licensure in Brazil. Lingelbach described the milestone as a major achievement in an effort supported by CEPI to advance vaccine access in countries that can benefit from it. On Shigella, Lingelbach said Valneva’s candidate is among the most advanced tetravalent vaccine candidates against shigellosis, targeting the four most common pathogenic Shigella bacteria. Two studies are ongoing: one in children in Africa and another controlled human infection model assessing immunogenicity and pilot efficacy. Readouts are expected over the summer. Lingelbach said the company will review the Shigella data before deciding next development steps. He said there has been no strategic change to the program because of restructuring, though the pace or phasing may differ from earlier assumptions. Looking ahead, Lingelbach said Valneva will focus on its base business, key strategic projects and cash preservation while planning for a successful Lyme outcome. If the Lyme vaccine is approved and commercialized, he said it could create “very significant strategic growth opportunities” for the company. Valneva SE is a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases. Headquartered in Saint-Herblain, France, the company applies inactivated whole-cell and recombinant technology platforms to address public health needs. Valneva's research and development efforts span a range of viral and bacterial pathogens, with an emphasis on travel-related and emerging infectious diseases. Among its marketed products, Valneva offers IXIARO®/JESPECT® for the prevention of Japanese encephalitis and DUKORAL® for the prevention of cholera and diarrhea caused by enterotoxigenic Escherichia coli. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "Valneva Q1 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for May 2026.

On Wednesday, Valneva (NASDAQ:VALN) discussed first-quarter financial results during its earnings call. The full transcript is provided below. This transcript is brought to you by Benzinga APIs. For real-time access to our entire catalog, please visit https://www.benzinga.com/apis/ for a consultation. The full earnings call is available at https://edge.media-server.com/mmc/p/xbkzgkz7 Valneva SE reported first-quarter revenues of approximately €30 million, with a decline from the previous year attributed to changes in business setup, supply phasing, and one-off expenses. The company is focused on cash management and announced a workforce reduction of 10-15% to achieve a 25-35% reduction in operating expenses. Valneva SE is advancing its Lyme disease vaccine candidate in partnership with Pfizer, observing strong efficacy but facing statistical challenges; Pfizer plans regulatory submissions. The Chikungunya vaccine is progressing well, with a significant pilot vaccination campaign in Brazil and ongoing efforts to expand access in endemic countries. Valneva SE is adjusting its 2026 product sales guidance to €135-150 million due to adverse travel vaccine uptake trends, with a restructuring plan to streamline operations. The company continues to advance its Shigella vaccine program with ongoing studies and plans for further development based on upcoming results. Management expressed confidence in the long-term prospects of its key vaccine candidates and strategic growth opportunities. OPERATOR Hello and thank you for joining us to discuss Valneva's financial results for the first quarter 2026 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 three months ended March 31, 2026, which were published earlier today, available within the Financial Reports section on our investor website. I'm joined today by Valneva's CEO Thomas Lingelbach 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 and 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, May 13, 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 Lingelbach to begin today's presentation. Thomas Lingelbach (Chief Executive Officer) Thank you, Josh. Good day everyone. Yeah. Our first quarter was certainly dominated by the Lyme phase three readout with the strong efficacy observed the first pre-specified statistical criterion was not met, but the second one was met. Pfizer is planning for submissions to regulatory authorities on financials. We reported a top line of approximately €30 million a year. On year quarter to quarter comparison is however with regards to this first quarter not really meaningful because of various factors including a different business setup, supply facings, one off effects on the expense side. All of that will be elaborated by Peter during his respective financial report. Given the level of uncertainty around Lyme, our strong focus is on cash containment and management. We reported a strong cash position with which excludes the proceeds from the recent financing more than 100 million total cash at the end of the first quarter and launched a comprehensive program to reduce our operating expenses which also includes reduction of global workforce by approximately 10 to 15% and aims to result in a significant 25 to 35% reduction in our operating expenses as compared to to last year. With that, let me turn to our programs and to our key business activities. I reported already about the statistical miss and the fact that the second pre-specified statistical criteria met the lower bound. Overall, the efficacy as you can see on the slide, is above 70%, which is really strong. The vaccine was well tolerated. There were no safety concerns identified at the time of analysis. The reason for all of that is that we have observed fewer than anticipated Lyme disease cases that were accrued over the study period. Given, however, the clinically meaningful efficacy and the fact that the 95% confidence interval lower bound was above 20 in the second pre specified analysis, Pfizer is confident in the vaccine's potential and hence, as mentioned earlier, is planning submissions to regulatory authorities. Lyme represents a major medical need and hence market opportunity. There is no vaccine currently available to prevent Lyme disease in humans and we see a continuous rise of the annual burden of disease. We have here in this slide reported the numbers of people who live in high risk areas of lyme disease. Almost 90 million in North America, more than 200 million in Europe and an annual disease burden of a reported 500,000 cases in the US, more than 100,000 in Europe. Also, we all acknowledge that those reported numbers are probably heavily under reported clinically. Lyme comes with different clinical manifestations. 10 to 30% of the individuals develop either carditis, neuroborreliosis or arthritis and some, namely 5 to 10% of the cases continue to have persistent symptoms even following treatment. As Such, we see VLA15 or LYME6.3 using the Pfizer terminology as a compelling opportunity in a highly underserved market. It is the only Lyme disease vaccine candidate in such a stage of development in nearly 30 years. It's highly differentiated. We built on a proven mode of action, but with a broad coverage addressing all the prevalent serotypes prevalent on both sides of the Atlantic. It is a modern, state of the art recombinant protein based subunit vaccine. We tested individuals in the study aged five years and above and as I mentioned, we continue seeing a growing disease burden across high risk areas and some of you have recently seen again articles in this regard. There is of course a strong strategic fit with Pfizer's existing business and franchise and overall we really see a prophylactic solution as the solution of choice for this disease. As such, we remain confident. We remain confident in the prospect of this vaccine to ultimately make its way to patients or to people who are in need of it. Turning over to Chikungunya, our IgG product is continuing its path through different R&D activities. Besides limited commercial sales in travel, the overall market evolution, market development and access in emerging markets and low medium income countries is however quite remarkable and is progressing quite nicely. We have a very significant pilot vaccination campaign ongoing in Brazil. The vaccine is being given to adults 18 to 59 years of age and the objective is to reach a 20 to 40% coverage within this target population across various municipalities in Brazil. We have already vaccinated more than 30,000 people to date and we are aiming for much more than 100,000 overall. There is also additional work ongoing to prepare for post marketing effectiveness in Brazil and in other jurisdictions. Currently we are focusing on creating a strong safety database with our study 406 which is well advanced and is nearing completion of the enrollment. We are working on ensuring greater access to this vaccine in endemic countries. We have a project ongoing to expand the network of manufacturing and distribution partners in those countries and we are making good progress. We reported very recently through our different social media channels that the locally produced Chikungunya vaccine by Butantan called ButantanChic achieved licensure in Brazil. This has been a major, major achievement in the endeavor that is supported by CEPI and for which we are grateful in advancing this vaccine and advancing access into countries and for countries who can really benefit from it. Few words on Shigella and our Shigellosis program. It is certainly one of the most advanced, if not the most advanced tetravalent vaccine candidate against Shigellosis. We are targeting the four most common pathogenic Shigella bacteria and previously our partner Limatech reported positive initial phase 1/2 data. We have currently two studies ongoing, one in children in Africa and the other one is an immunogenicity and pilot efficacy study, so called controlled human infection model. For both we are expecting the first readouts or the readouts over the summer. And then as we discussed and reported previously, we will decide on next development steps for this program and for this program addressing a global market that is expected north of half a billion dollars annually given the severity of shigellosis, especially the fact that it is the second leading cause of fatal diarrhea in children and it therefore has been prioritized by WHO and other funding institutions. So overall, a lot going on on our key R and D and business activities. And with that I would like to hand over to Peter to provide us with the financial report. Peter Buehler (Chief Financial Officer) Thank you, Thomas. Yes, so looking at the financial report for the first quarter of fiscal year 2026, product sales reached 30.5 million euros compared to 48.6 million euros one year ago. IXIARO sales were 20.2 million euros compared to 27.5 million euros in the first quarter of 2025. The year over year decline is primarily a result of a difference in the phasing of scheduled deliveries to the US Department of Defense. Deliveries in the first quarter of 2026 have continued under the current contract signed in January 2025. Dukoral sales reached 8.6 million euros compared to 12.3 million euros in the first quarter of last year. The prior year included one off sales related to the supply of doses to Mayotte following a local cholera outbreak. In addition, Dukorall sales in the first quarter were adversely impacted by the change in our distribution partner for certain EU countries, mainly Germany, which represents a substantial traveler's market. This change took effect from January 1st and included the transfer of residual inventories which in the case of Dukorall were sufficient to satisfy the demand for the current first quarter. We expect new product deliveries to resume in the second quarter of 2026. IXIChick sales reached 1.6 million euros compared to 3 million euros in the first quarter of 2025 which had benefited from first shipment of doses to French islander La Reynie in response to a major outbreak. As well from travel sales in the United States, third party products were reduced to €100,000 compared to 5.8 million euros in last year's first quarter and this decline reflects the intentional wind down of third party product distribution to increase the focus on our proprietary products. Now moving on to the income statement, we reported total revenues of 30.9 million euros versus 49.2 million euros in the first three months of 2025. Other revenues remained largely unchanged year over year. Cost of goods and services were 26.2 million euros versus 21.3 million euros in the prior year. The increased cost of goods despite lower sales were a result of several factors. Idle cost increased compared to one year ago following the completion of the manufacturing transfer to the new Almeida facility. The cost related to failed batches and inventory provisions in addition to onerous contracts related to IXIChick significantly exceeded the cost observed in the first quarter of the prior year. Additionally, cost of goods in the first quarter of last year were particularly low due to positive impact related to standard cost adjustment. In the first quarter of 2026, the gross margin on commercial product sales excluding ixchig was 45.2% compared to 62.7% for the three months ended March 31, 2025, or approximately 50% for the full year of 2025. XIAR's gross margin reached 50.8% compared to 72.6% in the first quarter of 2025 and the decline was driven by higher manufacturing cost following the transfer of production to the Almeida facility, increased batch write offs and lower overhead absorption due to lower sales. In addition, as already mentioned, last year's first quarter had a significant positive impact related to standard cost revaluation. For the full year of 2025, the IXIARO gross margin reached 59.6%. The gross margin of IXIChick was negative, impacted by cancellation fees related to external manufacturing commitments following lower than anticipated sales. Additionally, cost of goods include idle capacity cost and cost not allocated to products of 5 million euros. We expect gross margin to normalize and improve following one off effect in the first quarter of 2026. Research and development expense for the first quarter remained stable year over year at 15.2 million euros, mainly representing investments into Ixchik and Shigella as well as our preclinical EBV project. Marketing and distribution expenses in the first quarter reached 7 million euros compared to 10.4 million euros in the prior year. The decrease is mainly related to lower spend on Ixchic. In particular, in the United States, general and administrative costs decreased to 8.2 million euros compared to 9 million euros in the prior year. The decrease is related to lower people cost as well as savings in professional services. The operating loss for the first quarter of 2026 is reported at minus 23.7 million euros driven by lower sales and gross margin. Net finance and income tax expense is reported at 8.4 million euros compared to 3.3 million euros in the prior year. The increased expense is driven by a foreign exchange loss of 3 million euros compared to foreign exchange gain of 3.7 million euros in the prior year. With this, the loss of the first quarter of fiscal year 2026 reached 32.1 million euros compared to 9.2 million euros in the prior year. A Word on Cash as mentioned at the beginning of this presentation, total cash and cash equivalents at the end of March were 105 million euros compared to 110 million euros at the end of the prior year. Fiscal year in the first quarter of 2025, we continue to reduce the cash used in operations compared to the prior year. Cash at the end of March does not yet include initial proceeds from our successful reserved offering completed in April 2026. Now moving to the next slide to review our guidance for the fiscal year in light of emerging adverse trends in travel vaccine uptakes across our key markets driven by geopolitical factors, we adjust our product sales guidance to 135 to 150 million euros for the fiscal year 2026 and total revenues to 145 to 160 million euros. In April 2026, we initiated a restructuring plan to streamline our business operations and focus our resources on key projects. As a result, we plan a global workforce reduction between 10 and 15% and expect an overall reduction in our operating expense of about 25 to 35% compared to the level of 2025. This concludes the final section of this call and I would like to hand back to Thomas. Thomas Lingelbach (Chief Executive Officer) Thank you so much, Peter. Yeah. To conclude our presentation, talking a little bit about the future of course, and as I mentioned during the introduction and Peter reiterated this during the financial report, while we are living through the period of uncertainty regarding the Lyme vaccine candidate, we will of course do everything to focus on our base business to make sure that we advance the key strategic projects and activities and that we contain cash to the maximum level possible. However, we plan for Lyme success and we plan for a successful outcome of the Lyme process that will be run by Pfizer with the respective regulatory authorities and if successful, it would offer for Valneva very significant strategic growth opportunities. In such a case, we want to leverage our core strengths in vaccine development because this is where we believe we will be able to deliver greater long term value. Our focus will be to build scale in the R&D pipeline post VLA15 and post successful approval and commercialization. We'll do this by combination of organic and inorganic, meaning strategic growth in the pipeline. We clearly would like to expand and extend beyond our initial investment thesis when we created the company, namely vector borne diseases. And you have seen that some of our preclinical activities, especially EBV and also the enteric disease focus point already in this direction. And of course we will continue as we have done last year and we will do so this year again to optimize our business operations. Be it on the commercial, but also be it on the manufacturing and supply side, all to generate as much cash with the commercial business as possible. With this I would like to conclude our updates and give back to the operator to take your questions. OPERATOR Thank you. To ask a question, you will need to press Star one and one on your telephone and wait for your name to be announced. To withdraw your question, please press Star one and one again. One moment for our first question and this question comes from the line of Maurie Reichroft from Jefferies. Please go ahead. Maurie Reichroft (Equity Analyst) Hi, thanks for taking my questions. I'll ask a couple on the Lyme program. I know there's a degree of uncertainty there, but wondering if there's any perspective you can provide on the status of Pfizer's pre Biologics License Application (BLA) meeting request with FDA (Food and Drug Administration) and whether a meeting date's been scheduled and potentially what timing for that meeting could look like. Hi Mauri, thanks for the question. Pfizer are preparing for respective meetings more we cannot state and say at this point in time, unfortunately. Okay, understood. And wondering if you can help us understand how Pfizer plans to present the totality of clinical evidence to fda, including cases that were adjudicated out and whether there's been any discussion around reevaluating outcomes under less restrictive clinical clinical criteria. We've discussed how you guys have used the astringent definition and so wondering if there's any perspective on that. Thomas Lingelbach (Chief Executive Officer) Maury? Unfortunately I can't comment to that. Understood. Maurie Reichroft (Equity Analyst) Okay. And maybe one other quick clarification question. Once Pfizer has the BLA meeting scheduled, they have the BLA meeting. Do you know if there will be a disclosure around the BLA acceptance or how logistics could work going forward? Our current hypothesis is that file acceptance will be disclosed. Got it. Okay. Thanks for taking my questions. I'll hop back in the queue. OPERATOR Thank you. Our next question comes from the line of Suzanne Van Hofartuzen from Kampen. Please go ahead. Hi, this is Romy on for Susana. Thanks for taking our questions. The first is on Xario Growth Dynamics. So I was wondering if the decline we saw for Q1 of this year was solely driven by phasing with the US DoD or was there also contributions from the private travel markets and then a follow up there for the full year 26 guidance adjustments. Is this primarily based on your thinking of the general travel dynamics expected this year? Thank you. Romy So let me take the question first and then possibly Peter can compliment. So I think as we said during our report, it's a combination of various Thomas Lingelbach (Chief Executive Officer) factors and certainly the major contributing factor as reported by Peter has to do with phasing of supplies to the DoD, our single largest customer. For example, you know, the supply schedule and the phasing is different year over year and it's very hard to predict the exact supply schedule. That makes always this quarter to quarter comparisons really difficult. There is however also a contributing point around reduced travel and Peter presented very clearly that this is the root cause for and the major cause for why we have been taking a prudent stand and revised the guidance down by 10 million. It is not that we see already a huge impact in in Quarter one. But what we are observing is really a reduced level of travel into the geographies which are very important for our travel vaccines. And this is also supported by airline data. And we see this trend emerging and that's I think all we can say with regards to the dynamic of Xiao and Peter. Please jump in if you want to add anything. Peter Buehler (Chief Financial Officer) Yeah, I think the only other thing to add is to a lesser extent than the shipments to US military there is this impact on the indirect markets with the shifting of distributor where we see a slight impact, not as much as on Dukara, but we see a little impact also on. On Ixiara. But this is more just, you know, technically the switch over from to a new partner. Right. OPERATOR Thank you. Thank you. We will now take our next question and this question comes from the line of Pamel Diwan from Guggenheim Partners. Please, please go ahead. Pamel Diwan (Equity Analyst) Thanks for taking my questions and maybe a couple more on the Lyme front and appreciate you may not be able to answer all these fully right now. But one, I'm curious when we would actually. When you think the full data would be released for us to review it in totality. Second, I'm wondering are there other examples you can point us to with vaccines where there's been this situation where the. The first primary endpoint of the trial was not met in terms of the confidence interval and the vaccine was still approved. Are there any sort of comps that you can point us to to give confidence on the. On the. Still getting through and then just on the event rate. I'm curious if you can comment on the event rate being lower than what you saw or what you expected? And does that in any way sort of impact what you think in terms of the commercial opportunity for this vaccines or the interest in the, in the amount of events that are about happening in the community? Is there any change to your views based on what you saw in terms of how many people are, you know, acquiring the disease during the trial? Thank you. Thomas Lingelbach (Chief Executive Officer) Yeah, so let me start from the back to the front here a little bit. So yeah, I mean as we reported in the press release, the total end meaning the total number of reported and adjudicated cases was certainly lower than anticipated, which resulted in this wide spread confidence interval lower and upper. We don't necessarily see this with regards to what is happening in the high risk areas of Lyme and this is certainly something that we will need to look into and Pfizer are certainly doing that as we speak. With regards to other vaccines, there are a few reports and publications that were made in two different channels, including social media analyst reports where people focused on situations that may have been not similar but probably comparable. I mean, there were reports around a flu vaccine called FluMist. There were reports around one of the Respiratory Syncytial Virus (RSV) vaccines. There were also references made to the, you know, immunobridging in the pneumo development areas. You know, we don't think that, I mean, all of that is certainly, probably indicative, but by the end of the day I don't think that there is something that one can really compare like, for, like in the world of vaccine development, you need to really review whether the results are clinically meaningful and this is certainly the case. And then it's a review of the totality of clinical evidence and data that would certainly be facilitated by Pfizer in the best possible and optimal way. To your question about where and when will the data in totality be presented? Pfizer stated that they will present the full data set at a forthcoming conference. To my knowledge, it has not yet been confirmed which one this is going to be. Pamel Diwan (Equity Analyst) Okay, thanks for the information. Thanks. OPERATOR Thank you. Our next question comes from the line of Damen Chaplain from Stifle. Please go ahead. Damen Chaplain (Equity Analyst) Thank you for taking my questions. I have a couple questions on the restructuring plan. So can you elaborate on how the savings will phase through the year and how should we think about the savings between RND and sgna and the last one, when do you anticipate achieving full payback from the program? Thank you very much. Peter Buehler (Chief Financial Officer) Yeah, thanks for the question, Damian. So in terms of timing, you know, as we, you know, a lot of the redundancy we're looking at. So when we look at people cost, a lot of the redundancy we're looking at are in Austria and there's a clear legal process. So actually this will continue for a while. And then of course, you know, similar to other European countries, there will be notice period. So the full payback will certainly only be that next year. On that we initiated the process now with the Austrian authorities and I think information to staff will occur approximately in a month from now. I think when it comes to external spend, this is actually initiated now and we do expect a significant savings for the remainder of 2026 and then of course carried over into 2027 and between R&D and SGA, sorry, most of the savings we would expect in R and D as opposed to, if we compare to 2025. Right. In sales and marketing, it's going to be more or less cosmetic in line with Kind of the adjustments we did to the top line and then in G and A, in a way a continuation of savings we've already seen in 2025 versus prior year. And we will add on some savings, but it's not going to be as substantial as an R and D, of course. Damen Chaplain (Equity Analyst) Thank you very much, Peter. OPERATOR Thank you. Our next question comes from the line of Rajan Sharma from Goldman Sachs. Please go ahead. Rajan Sharma (Equity Analyst) Hi, I've got a couple of questions and sorry to labour the point on the Pfizer part, but I was just wondering what level of insight do you actually have into Pfizer's FDA discussions? Is it essentially the same as everybody else in the market where you get the update when Pfizer discloses it? And then I had a couple of financial questions which I can follow up with. Thomas Lingelbach (Chief Executive Officer) So we are not actively involved in the, in the preparations or discussions in between FISA and regulatory authorities, but we have a process to be informed through existing steering structures at different time points as compared to the market. Rajan Sharma (Equity Analyst) Okay, got it, thank you. And then a couple on the financials. So Peter, I think well, you guided to normalize growth margin for 2026. Could you just help us understand what a normalized gross margin is for Valnava and what the impact of idle capacity costs might be? In 2025 you had 10 million of idle capacity costs and you've reported 5 million already in 1Q26. I think at full year results you mentioned that idle capacity costs in 26 would be similar to 2025. So is that still the case? And then secondly, just on the outlook for revenues, can you just help us understand or reassure that there's no further downside there? Looking at the midpoint of your new guidance range, that implies around a 12% decline versus 25. In Q1, 26 you've seen a 26% decline and I think third party products will trend down and it sounds like the travel market slowdown that you mentioned was not fully realized in Q1. So. Peter Buehler (Chief Financial Officer) Yeah, could you just help us with understand those dynamics and provide some reassurance that there's not further downside there? Yeah, thank you, Rajan. So on gross margin, normalized gross margin. So I, you know, and it's, it's of course it's work in progress in a way, but we would expect that we probably get close to where we were for the full year, 2025 for the rest of the year in terms of idle capacity it is a bit higher than last year. It's not the full 5 million. So we said the 5 million is idle plus some unallocated cost. So Most of the 5 million is idle and it is higher than last year just because we transitioned over to Almeida and are now fully utilizing the Almeida facility, which increased part of the idle capacity because of the pure size of this manufacturing site. When it comes to revenues, I mean, we think we have a realistic guidance. Now the range we gave 130 to 150. Where we will land in this range, we can't say. Of course, that's why we gave the range. But right now we feel comfortable that it's appropriate what happens for the remainder of the year. In terms of geopolitical situation, we can of course not give any guarantee. I mean, if the overall situation, especially in the Middle east gets worse and the travel market gets affected, you know, we cannot exclude it will have an impact. But as from where we stand today, we think it's a realistic assumption. You know, the range. OPERATOR Thank you. We are now going to take our next question. And this question comes from the line of BRANDON Fox from H.C. wainwright. Please go ahead. BRANDON Fox (Equity Analyst) Hi. Thanks for taking my questions. Just changing gears here a little bit and focusing on the Shigella phase two readout. What are you looking for in this readout? How will you assess the go forward decision? And has that bar changed given the focus on OPEX reduction? And then maybe just looking a bit further out on this. If you were to commercialize that product, would you be selling to the same call points as Ducaroll? Can you just talk about the commercial Thomas Lingelbach (Chief Executive Officer) synergies of a Shigella and cholera product? Thank you. Thank you so much. Glad that we are able to talk a little bit about Shigella for a change. Yeah. So first of all, The thing that we really like about this program is that through the controlled human infection model that is currently run at Johns Hopkins, we will get pilot efficacy. We are challenging people with one strain, namely the Shigella sonnei strain. And what we hope to see is a that the challenge model works, meaning that people above a certain immunological titer are being protected and others not that we see really an effect on placebo versus vaccine in this model and ideally a first indication about the immunological threshold that needs to be reached in order to see protection on the children's side. We hope to see that we see a solid immunogenicity profile, good serial response rates, and that we have a first idea about the schedule and whether this to those schedule in children will be sufficient or not. So this is what we expect to see from those studies and then we gonna take. It's hard to say to predict right now what the outcome is going to be. But the good thing is you have a huge de risking in case of positive data. And therefore once we see the data we are currently anticipating that we will need to turn an additional round around, optimizing probably dose schedule and so on and so forth and anticipate those things to commence literally next year. I think there is currently no strategic change with regards to the Shigella program in connection with our restructuring activities. I would say there is probably a bit of a different facing or pace associated with it as compared to previous hypothesis. But strategically and focus wise we don't see a real difference. Now coming back to your question around commercialization, which is a very good one. You know, Shigella and Shigellosis has two key potential markets. By far the largest medical need and commercial opportunity sits in emerging countries and in low medium income countries where this is a disease with a huge mortality burden and therefore a very, very relevant risk benefit and health economical benefit. Here in the ideal world one would target step by step a multivalent vaccine covering more than just shigellosis. So combination vaccines that could potentially also include E tec, cholera and other components. But as a second step, and I think those combination vaccines in the enteric disease field would certainly represent a huge commercial opportunity. And we see the introduction in those emerging markets as a first step, really as a stepping stone. The second part is travelers. There is a clear need for Shigella vaccine in travelers. Again, you know, in the ideal world you would have a combination vaccine to create more and more coverage in order to be able to provide a quote unquote travelers diarrhea vaccine. And in order to present the traveler's diarrhea vaccine, you will need to add additional antigens above and beyond even you know, cholera and E tech. But again, it's a stepwise approach. Whether or not Shigella standalone will be, you know, directly license and commercializing travelers or whether we're going to focus on combination right away is something that we are exploring and it will be part of our review in connection with the future development plan for Shigella. And please keep in mind that we announced previously that we are working on enteric diseases. Also in our preclinical arena, we are working on a prod covering ETEC vaccine candidate for example covering both LT as well as st. And of course with that plus our cholera vaccine in hand, we in a way set ourselves up for Potential combination vaccines in the traveler's diarrhea environment. I hope this answered your question. Yes, that was very helpful. BRANDON Fox (Equity Analyst) Thank you very much. OPERATOR Thank you. As a reminder to ask a question, you will need to press star one and one on your telephone. We are now going to take our next question. And this question comes from the line of Simon Scholz from First Berlin Equinity Research. Please go ahead. Simon Scholz (Equity Analyst) I've just got one question. You wrote in the 2025 20F that you'd received a letter from the FDA preventing you from using the Almeida facility to produce Xiaro for distribution in the U.S. i was just wondering if you could outline current measures to mitigate that and also give us some idea as to whether this will impact sales of IXIARO or your capacity supply the Department of Defence with IXIARO. Thomas Lingelbach (Chief Executive Officer) So first of all, yes, you're right. We received 483 as part of the pre approval inspection and the complete response letter with regards to the pre approval supplement of Almeida as an alternative site for Xiaro manufacturing. We have however, received approvals for the new manufacturing site from all the other regulatory bodies. Now we were kind of smart enough to file Almeida as an additional manufacturing site and the existing facility is still active. And I think this is important to note. And we are releasing product out of the previous facility or the existing facility called Menson into the US market as we speak. And of course we are working with the FDA to address their concerns articulated in the 483 and will resubmit the pre approval supplement process, you know, as soon as we can. Simon Scholz (Equity Analyst) Okay, so you don't expect any impact from temporary inability to use Almeida on Ixiara sales in the us? Thomas Lingelbach (Chief Executive Officer) Not at this point in time. Simon Scholz (Equity Analyst) Okay, thanks very much. OPERATOR Thank you. That was our final question for today. I will now hand the call back to Thomas Dingerbach for closing remarks. Thomas Lingelbach (Chief Executive Officer) Thank you so much for your attendance today. Great questions and for following Valneva. And as we said during the call today, we are looking forward especially to the next steps in connection with the Lyme vaccine. I confident in the prospect of not only Lyme, but also Valneva. Thanks a lot. Disclaimer: This transcript is provided for informational purposes only. While we strive for accuracy, there may be errors or omissions in this automated transcription. For official company statements and financial information, please refer to the company's SEC filings and official press releases. Corporate participants' and analysts' statements reflect their views as of the date of this call and are subject to change without notice. UNLOCKED: 5 NEW TRADES EVERY WEEK. Click now to get top trade ideas daily, plus unlimited access to cutting-edge tools and strategies to gain an edge in the markets. Get the latest stock analysis from Benzinga: VALNEVA (VALN): Free Stock Analysis Report This article Transcript: Valneva Q1 2026 Earnings Conference Call originally appeared on Benzinga.com © 2026 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.

This article first appeared on GuruFocus. Release Date: May 13, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Valneva SE (INRLF) reported strong efficacy in their Lyme disease vaccine candidate, with an efficacy rate above 70%. The company maintains a strong cash position, with over $100 million in total cash at the end of the first quarter. Valneva SE (INRLF) is actively working on a comprehensive program to reduce operating expenses by 25% to 35%, including a global workforce reduction. The Chikungunya vaccine program is progressing well, with significant pilot vaccination campaigns ongoing in Brazil. Valneva SE (INRLF) is advancing its Shigella vaccine program, with two studies ongoing and expecting readouts over the summer. Valneva SE (INRLF) reported a decline in product sales, reaching EUR 30.5 million compared to EUR 48.6 million one year ago. The company experienced a significant operating loss of EUR 23.7 million in the first quarter of 2026. Gross margins have decreased, with a notable decline in the gross margin of commercial product sales from 62.7% to 45.2%. The company is facing challenges with the FDA regarding the use of its Almeida facility for manufacturing, impacting its ability to supply certain products. Valneva SE (INRLF) has adjusted its product sales guidance downward due to emerging adverse trends in travel vaccine uptakes, driven by geopolitical factors. Warning! GuruFocus has detected 6 Warning Signs with INRLF. Is INRLF fairly valued? Test your thesis with our free DCF calculator. Q: Can you provide any updates on Pfizer's pre-BLA meeting request with the FDA regarding the Lyme vaccine? A: (Thomas Lingelbach, CEO) Pfizer is preparing for the respective meetings, but we cannot provide further details at this time. Q: How does Pfizer plan to present the clinical evidence to the FDA, especially regarding cases adjudicated out? A: (Thomas Lingelbach, CEO) Unfortunately, I cannot comment on that. Q: Once Pfizer has the BLA meeting scheduled, will there be a disclosure around the BLA acceptance? A: (Thomas Lingelbach, CEO) Our current hypothesis is that file acceptance will be disclosed. Q: Regarding Exario's growth dynamics, was the Q1 decline solely due to phasing with the USDOD, or were there contributions from private travel markets? A: (Thomas Lingelbach, CEO) The decline was primarily due to the phasing of supplies to the DOD, but reduced travel also contributed. We have revised our guidance down by $10 million due to these factors. Q: Can you elaborate on the financial outlook, particularly regarding gross margins and revenue guidance? A: (Peter Buehler, CFO) We expect gross margins to normalize close to 2025 levels. Idle capacity costs are slightly higher due to the transition to the Almeida facility. We believe our revenue guidance range of EUR 135 to 150 million is realistic, but geopolitical factors could impact this. For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Total product sales of €30.5 million Cash position of €105.3 million as of end March 2026, excluding proceeds from successful reserved offering completed in April 20261 Program launched in April to further reduce operating expenses Pfizer expected to file regulatory submissions for Lyme disease vaccine candidate Lyon (France), May 13, 2026 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today reported its financial results for the first quarter ended March 31, 2026, provided key corporate updates, and updated its 2026 financial guidance. The condensed consolidated interim financial results are available on the Company’s website (Financial Reports – Valneva). Valneva will provide a live webcast of its first quarter 2026 results conference call beginning at 3 p.m. CEST/9 a.m. EDT today. This webcast will also be available on the Company’s website. Please refer to this link: https://edge.media-server.com/mmc/p/xbkzgkz7 First quarter 2026 Financial Update Total revenues were €30.9 million, including €30.5 million in product sales, compared with €49.2 million and €48.6 million, respectively, in the first quarter of 2025, mainly reflecting the planned wind-down of third-party sales (-97.6% versus the first quarter of 2025) and a different shipment phasing to the U.S. Department of Defense Operating cash burn continued to decline, improving to €0.3 million in the first quarter of 2026, compared to €8.1 million in the first quarter of 2025 Cash position of €105.3 million as of March 31, 2026, compared to €109.7 million as of December 31, 2025 Excludes €37.0 million in gross proceeds from recent successful reserved offering1 Net loss of €32.1 million, compared with a net loss of €9.2 million in the first quarter of 2025 mainly impacted by one-off effects in cost of goods (termination of contracts, standard cost adjustment, inventory write-offs), in addition to idle cost and lower sales. Financial Outlook Valneva is adjusting its 2026 sales and revenue guidance partially as a result of an emerging adverse trend in travel vaccine uptake across key markets, driven by geopolitical factors. The Company is therefore revising its product sales guidance to €135 million to €150 million from €145 million to €160 million previously Other revenues are reconfirmed – resulting in a new total revenue guidance of €145 million to €160 million As part of the Company’s continued focus on diligent cash management, and following the recent consolidation in France2, Valneva has initiated a further restructuring plan designed to streamline its global business operations: Focus resources on its base business and key strategic projects, including a reduction of its global workforce by 10-15% Together these initiatives are expected to result in significant ~25-35% reduction in 2026 operating expenses compared to 2025 Product gross margins are expected to normalize following one-off effects in the first quarter of 2026 Peter Bühler, Valneva’s Chief Financial Officer, commented, “Our first‑quarter sales reflect the sharp decline in third party products and our planned focus on proprietary products. We also see the first indications of the geopolitical situation adversely affecting travel. We continued to reduce our operating cash burn meaningfully and, combined with further cost saving measures and our strengthened balance sheet following the successful financing completed in April, we expect a solid cash position through the potential regulatory approvals of our Lyme disease vaccine.” Financial Information(Unaudited results, consolidated per IFRS) Commercial Portfolio Valneva’s commercial portfolio comprises three vaccines: IXIARO®/JESPECT®, DUKORAL® and IXCHIQ®. The Company’s main third‑party product distribution contract concluded in 2025 and, as previously communicated, this activity is now intentionally winding down. As a result, third‑party product sales were reduced by 97.6% in the first quarter of 2026 to €0.1 million. This strategic initiative is expected to result in improved overall product gross margins. JAPANESE ENCEPHALITIS VACCINE IXIARO®/JESPECT® In the first quarter of 2026, IXIARO®/JESPECT® sales were €20.2 million, compared with €27.5 million in the first quarter of 2025. The year‑over‑year decline primarily reflects a difference in the phasing of deliveries to the U.S. Department of Defense (DoD). Deliveries have continued under the current contract signed in January 2025, and Valneva expects to deliver further IXIARO® doses to the DoD in 2026. CHOLERA / ETEC3-DIARRHEA VACCINE DUKORAL® In the first quarter of 2026, DUKORAL® sales reached €8.6 million versus €12.3 million in the first quarter of 2025, which included one-off sales related to the supply of doses to Mayotte following a cholera outbreak. First quarter 2026 sales were adversely impacted by the distributor transition in Germany in January 2026, as residual supply transferred from the previous distributor was sufficient to satisfy the demand for this quarter. Product deliveries are expected to resume in the second quarter of 2026. CHIKUNGUNYA VACCINE IXCHIQ® In the first quarter of 2026, IXCHIQ® sales amounted to €1.6 million, compared with €3.0 million in the first quarter of 2025, which had benefited from sales in the United States and shipments of doses to the French island of La Réunion following a chikungunya outbreak. Clinical Stage Programs LYME DISEASE VACCINE CANDIDATE – LB6V (formerly VLA15) Regulatory submissions expected In March 2026, Valneva and Pfizer announced topline results from the Phase 3 VALOR “Vaccine Against Lyme for Outdoor Recreationists” clinical trial (NCT05477524) of their investigational six valent OspA-based Lyme disease vaccine candidate LB6V4.LB6V demonstrated more than 70% efficacy in preventing Lyme disease in individuals aged five years and above. The investigational vaccine candidate was well tolerated with no safety concerns identified. Overall, results strengthen confidence in the vaccine candidate and Pfizer is planning submissions to regulatory authorities.VLA15 is the only Lyme disease program in late-stage clinical development today and has received Fast Track designation from the U.S. Food and Drug Administration (FDA). CHIKUNGUNYA VACCINE - IXCHIQ® / VLA1553Pilot vaccination campaign ongoing in Brazil In February 2026, Valneva and Instituto Butantan announced the initiation of a Pilot Vaccination Strategy (PVS) in Brazil using Valneva’s single-shot chikungunya vaccine, IXCHIQ®. The vaccination campaign will serve as the basis for post-marketing commitments. To date, over 30,000 adults, aged 18 to 59 years, have already been vaccinated as part of this campaign which evaluates the effectiveness and safety of IXCHIQ® in a real-world setting. In early May 2026, the Brazilian Health Regulatory Agency (ANVISA) authorized Instituto Butantan to locally manufacture a version of Valneva’s chikungunya vaccine5. With this authorization, the vaccine – developed in partnership with Valneva and supported by the Coalition for Epidemic Preparedness Innovations (CEPI) – is approved for use in Brazil in individuals aged 18 to 59 and can be incorporated into the Unified Health System. SHIGELLA VACCINE CANDIDATE – S4V2First Phase 2 results expected mid-2026 S4V2 is the world’s most clinically advanced tetravalent vaccine candidate against shigellosis, the second leading cause of fatal diarrhea worldwide. Two clinical trials of S4V2, a Phase 2 infant safety and immunogenicity trial6, and a Phase 2b Human Challenge trial (CHIM)7, sponsored by LimmaTech Biologics AG, are ongoing. First Phase 2 results are expected mid-2026. Subject to positive results for both trials, Valneva will assume responsibility for all further development8.No approved multivalent Shigella vaccine is currently available outside of Russia or China, and the development of Shigella vaccines has been identified as a priority by the World Health Organization (WHO)9. In October 2024, the U.S. FDA granted Fast Track designation to S4V2, recognizing its potential to address a serious condition and fill an unmet medical need10. The global market opportunity for a vaccine against Shigella is estimated to exceed $500 million annually11. First Quarter 2026 Financial Review (Unaudited, consolidated under IFRS) RevenuesValneva’s total revenues were €30.9 million in the three months ended March 31, 2026 compared to €49.2 million for the same period in 2025. The decrease was primarily attributable to the discontinuation of third-party product distribution, differences in the schedule of shipments to the U.S. Department of Defense, the distributor transition in Germany, as well as one off outbreak-related sales of DUKORAL® and IXCHIQ® in 2025 that did not recur in 2026.Other revenues, including revenues from collaborations, licensing and services remained largely unchanged and amounted to €0.4 million in the three months ended March 31, 2026 compared to €0.6 million for the same period in 2025. Operating Result and adjusted EBITDACosts of goods and services sold (COGS) were €26.2 million for the three months ended March 31, 2026. The gross margin on commercial product sales, excluding IXCHIQ®, was 45.1% compared to 62.7% for the three months ended March 31, 2025. The positive impact of lower third-party product sales was offset by higher manufacturing expenses following the transfer of manufacturing to the new Almeida facility in Scotland, and by additional one-time effects.Gross margin for IXIARO® was 50.8% compared to an exceptionally high 72.6% achieved in the first quarter of 2025 (full-year 2025 IXIARO® gross margin of 59.6%). The decline was primarily driven by higher manufacturing costs at the Almeida facility, increased batch write-offs, and lower sales volumes. Gross margin for DUKORAL® reached 33.6% compared to 52.2% in the first quarter of 2025, with the decline primarily attributable to batch write-offs. Gross margin for IXCHIQ® was negative, mostly impacted by cancellation fees related to external manufacturing commitments following lower than anticipated sales. Additionally, COGS included €0.2 million attributable to the third-party distribution business, €5.0 million related to idle capacity and costs not allocated to products, and €0.3 million related to services. By comparison, total COGS in the first quarter of 2025 were €23.0 million, comprising €21.3 million of cost of goods and €1.8 million of cost of services.Research and development expenses remained stable at €15.2 million for the three months ended March 31, 2026.Marketing and distribution expenses totaled €7.0 million in the first three months of 2026, down from €10.4 million in the first three months of 2025. The decrease primarily reflects lower advertising and promotional spending related to IXCHIQ® as well as overall lower personnel costs and reduced warehousing and distribution expenses.General and administrative expenses decreased to €8.2 million in the three months ended March 31, 2026, from €9.0 million in the same period of 2025. The reduction was primarily driven by lower personnel costs and savings in advisory and professional services.Other income, net of other expenses, decreased to €1.9 million in the three months ended March 31, 2026, from €2.2 million in the three months ended March 31, 2025. Lower R&D tax credits were partially offset by higher grant income.Valneva recorded an operating loss of €23.7 million for the three months ended March 31, 2026 compared with an operating loss of €6.0 million in the same period in 2025. The increase in operating loss was mainly driven by lower product sales in the first three months of 2026, compared to the prior-year period.Adjusted EBITDA loss (as defined below) was €18.2 million in the three months ended March 31, 2026, compared with an adjusted EBITDA loss of €0.6 million in the corresponding period of 2025. Net ResultIn the three months ended March 31, 2026, Valneva generated a net loss of €32.1 million, compared to a net loss of €9.2 million in the first three months of 2025. The increase in net loss was primarily driven by lower sales in the first three months of 2026.Finance expense and currency effects resulted in a net finance expense of €7.6 million in the first three months of 2026, compared with a net finance expense of €1.8 million in the first three months of 2025. The increase was mainly attributable to unfavorable movements in the USD/EUR exchange rate, which led to a foreign currency loss of €3.0 million in the first quarter of 2026, compared with a foreign currency gain of €3.7 million in the first quarter of 2025. Cash Flow and LiquidityNet cash used in operating activities amounted to €0.3 million in the three months ended March 31, 2026 compared to €8.1 million in the same period of 2025. The reduction in the first quarter of 2026 was primarily driven by lower net working capital requirements.Cash inflows from investing activities amounted to €0.3 million in the three months ended March 31, 2026 compared to cash outflows of €1.0 million in the three months ended March 31, 2025. Cash inflows in the first quarter of 2026 were largely attributable to proceeds from the investment of liquidity into money market funds. Cash outflows in the first quarter of 2025 were mainly related to the purchase of equipment, partially offset by interest proceeds.Net cash used in financing activities amounted to €4.7 million in the three months ended March 31, 2026 compared to a net cash outflow of €5.6 million in the same period in 2025. Cash outflows in both periods primarily reflected interest and lease payments.Cash and cash equivalents were €105.3 million as at March 31, 2026, compared to €109.7 million at December 31, 2025. Non-IFRS Financial MeasuresManagement uses and presents IFRS results alongside the non-IFRS measure of Adjusted EBITDA to evaluate and communicate its performance. While non-IFRS measures should not be construed as alternatives to IFRS measures, management believes they provide useful additional insight into Valneva’s current performance, performance trends, and financial condition. Adjusted EBITDA is a common supplemental performance measure among investors and financial analysts. Management believes this measure provides additional analytical tools. Adjusted EBITDA is defined as earnings / (loss) for the period before income tax, finance (income)/expense, foreign exchange (gain)/loss, amortization, depreciation, and impairment. A reconciliation of Adjusted EBITDA to net loss for the period, which is the most directly comparable IFRS measure, is set forth below: Product sales at constant exchange rates:References to changes in net sales at constant exchange rates (CER) indicate that currency fluctuation effects have been removed. Net sales for the period in question are recalculated using the exchange rates applied in the prior period, as detailed below: About Valneva SEWe are a specialty vaccine company that develops, manufactures, and commercializes prophylactic vaccines for infectious diseases addressing unmet medical needs. We take a highly specialized and targeted approach, applying our deep expertise across multiple vaccine modalities, focused on providing either first-, best- or only-in-class vaccine solutions.We have a strong track record, having advanced multiple vaccines from early R&D to approvals, and currently market three proprietary travel vaccines.Revenues from our growing commercial business help fuel the continued advancement of our vaccine pipeline. This includes the only Lyme disease vaccine candidate in advanced clinical development, which is partnered with Pfizer, the world’s most clinically advanced Shigella vaccine candidate, as well as vaccine candidates against other global public health threats. More information is available at www.valneva.com. Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 and securities laws in France. These statements may be identified by words such as “aims,” “anticipates,” “believes,” “could,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,” “plans,” “possible,” “potential,” “seeks,” “will” and variations of these words or similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these words. All statements other than statements of historical facts contained in this press release are forward-looking statements, including, but not limited to, statements with respect to: future financial performance and financial guidance including projected product sales, total revenue and total R&D investments; Valneva’s plans for investment in future growth; the timing of orders for commercial products; plans and expectations regarding the development, commercialization and commercial prospects of Valneva’s product candidates and commercial products, including the prospects and timing of actions relating to clinical studies and trials and product approvals, such as study initiations, study advancements, data readouts, submissions, filings, approvals, and label expansions; the expected benefits and availability of Valneva’s commercial products and product candidates; and potential growth opportunities and trends, including the assumptions and expectations regarding total market opportunity targeted by Valneva’s product candidates and commercial products. These forward-looking statements are based on Valneva’s expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties that could cause Valneva’s business, strategy, future results or performance to differ materially from those expressed or implied by the forward-looking statements. Many factors may cause differences between current expectations and actual results, including: Valneva’s success in the commercialization of its commercial products; uncertainties and delays involved in the development and manufacture of vaccines; the potential that success in preclinical testing and earlier clinical trials does not ensure that later clinical trials will generate the same results or otherwise provide adequate data to demonstrate the efficacy and safety of a product candidate; the impacts of macroeconomic conditions, including tariffs and other trade policies, the conflict in Ukraine and the conflict in the Middle East, fluctuations in inflation and uncertain credit and financial markets, on Valneva’s business, clinical trials and financial position; unexpected safety or efficacy data observed during preclinical studies or clinical trials; clinical trial site activation or enrollment rates that are lower than expected; Valneva’s ability to realize the benefits of its collaboration and license agreements; changes in expected or existing competition; changes in the regulatory environment; the uncertainties and timing of the regulatory approval process; the impact of the global and European credit crisis; the ability to obtain or maintain patent or other proprietary intellectual property protection and unexpected litigation or other disputes. Other factors that may cause the Company’s actual results to differ from those expressed or implied in the forward-looking statements in this press release are identified in the section titled “Risk Factors” in Valneva’s Annual Report on Form 20-F for the year ended December 31, 2025 filed with the U.S. Securities and Exchange Commission (“SEC”) and the Autorité des marchés financiers (“AMF”) on March 18, 2026, and in other filings made with the SEC and AMF from time to time. Valneva is providing this information as of the date of this press release and expressly disclaims any intention or obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by law. 1 2026_04_30_Financing_PR_EN_Final.pdf 2 Valneva to Further Consolidate its Operations in France - Valneva 3 Indications differ by country - Please refer to Product / Prescribing Information (PI) / Medication Guide approved in your respective countries for complete information, incl. dosing, safety and age groups in which this vaccine is licensed, ETEC = Enterotoxigenic Escherichia coli (E. Coli) bacterium. 4 2026_03_23_Lyme-Phase-3-Data-Read-out_PR_EN_FINAL.pdf 5 https://butantan.gov.br/noticias/anvisa-autoriza-producao-nacional-da-vacina-contra-a-chikungunya-pelo-instituto-butantan?utm_source=linkedin&utm_medium=social&utm_campaign=site-not%C3%83%C2%ADcia&utm_term=ead%20da%20esib&utm_content=ead%20da%20esib 6 Valneva and LimmaTech Announce First Vaccination in Phase 2 Infant Study of Tetravalent Shigella Vaccine Candidate S4V2 - Valneva 7 Valneva and LimmaTech Announce First Vaccination in Phase 2b Human Challenge Study of Tetravalent Shigella Vaccine Candidate S4V2 8 Valneva and LimmaTech Enter into a Strategic Partnership to Accelerate the Development of the World’s Most Clinically Advanced Tetravalent Shigella Vaccine Candidate - Valneva 9 Immunization, Vaccines and Biologicals (who.int) 10 Valneva and LimmaTech Awarded FDA Fast Track Designation for Tetravalent Shigella Vaccine Candidate S4V - Valneva 11 LEK analysis Attachment 2026_05_13_Q1_Results_PR_EN_Final