Q2 2026 Valneva SE Earnings Call

August 13, 2026

Operator: Good day and thank you for standing by. Valneva presents its H1 2026 financial results. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star one and one on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star one and one again. 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.

Speaker #1: Good day, and thank you for standing by. Valneva presents its half-year 2026 financial results. At this time, all participants are in a listen-only mode.

Speaker #1: After the speaker's presentation, there will be a question-and-answer session. To ask a question during the session, you will need to press star 1 and 1 on your telephone.

Speaker #1: You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 1 and 1 again. Please be advised that today's conference is being recorded.

Speaker #1: I would now like to hand the conference over to your speaker today, Joshua Drumm, VP of Investor Relations. Please go ahead.

Speaker #2: Hello, and thank you for joining us to discuss Valneva's financial results for the first half of 2026 and our corporate update. It’s my pleasure to welcome you today.

Joshua Drumm: Hello, and thank you for joining us to discuss Valneva's financial results for H1 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 six months ended 30 June 2026, which were published earlier today, available within the financial report section on our investor website. I am joined today by Valneva CEO, Thomas Lingelbach, and our CFO, Peter Bühler, who will provide an overview and update on our business as well as our financial results. There will be an analyst Q&A session at the conclusion of the prepared remarks.

Speaker #2: In addition to our press release and analyst presentation, you can find our consolidated financial results for the 6 months and the June 30, 2026, which were published earlier today, available within the Financial Reports section on our Investor website.

Speaker #2: 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.

Speaker #2: 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.

Joshua Drumm: Before we begin, I would 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, 13 August 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.

Speaker #2: 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.

Speaker #2: 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.

Speaker #2: With that, it's my pleasure to introduce Thomas to begin today's presentation.

Speaker #3: 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 by our efforts to focus on enhancing our financial position, especially after the initial Lyme Phase III VALOR results and the resulting uncertainty. We have been able to generate a strong cash position, with more than $120 million in cash.

Thomas Lingelbach: Thank you so much, Josh. Good day, everyone. Let me start off with a couple of introductory remarks. H1 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. 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 impacts in H2 of this year, and of course, beyond. This included a reduction in our workforce, a reprioritization of project activities, and a focus on our core operational business.

Speaker #3: 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 positive P&L and cash flow impacts in the second half of this year and, of course, beyond.

Speaker #3: 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 $60 million in total product sales, we have reaffirmed the guidance because the half-year sales performance is in line with our anticipated facing of product sales throughout the year 2026.

Thomas Lingelbach: 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 H1 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 H1 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 continue 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.

Speaker #3: 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.

Speaker #3: But the most important thing, and the most exciting thing, is that Pfizer continued to be very positive about the prospect of the Lyme disease vaccine. In their recently announced earnings, they stated that they expect regulatory decisions for the Lyme disease vaccine candidate in the next 12 months, which is really great news.

Speaker #3: 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.

Thomas Lingelbach: You know that the vaccine showed a very strong point efficacy, greater than 70%, a very good safety profile. 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, meaningful efficacy. 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 prospect of a potential Lyme vaccine. There is a huge unmet medical need. We have discussed this many times in the past.

Speaker #3: However, we have to note that we see here with this product candidate a very significant leaning for meaningful efficacy and we had also 95% confidence interval lower bound greater than 20% in the second pre-specified analysis.

Speaker #3: All of that, in combination with the huge unmet medical needs, the totality of clinical evidence, and the fact that we really expect a positive health economic benefit for a potential prophylactic solution, increases our confidence in the future prospect of a potential Lyme vaccine.

Speaker #3: 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 and Europe. I mean, numbers are still significantly underreported because not all countries have respective surveillance systems, but certainly, there are north of 100,000 cases every year.

Thomas Lingelbach: The annual burden of disease is increasing, and we have been noting recently close to 500,000 cases in the United States. Europe, numbers are 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. 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 have 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.

Speaker #3: Some of that then come along with very severe manifestations in the order of 10 to 30% candidiasis, neuroboriosis, arthritis, and unfortunately 5 to 10% of cases continue to have persistent symptoms even following treatment.

Speaker #3: 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.

Speaker #3: We have 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.

Speaker #3: The vaccine is based on a proven mode of action, we cover the six key serotype prevalence in the Northern Hemisphere, and the technology is based on modern state-of-the-art recombinant protein technology.

Thomas Lingelbach: 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 five years of age. I mentioned already that we see a growing disease burden. Of course, with global warming, the tick population across all the high-risk areas of Lyme disease are steadily increasing. We have an excellent partner, and there is a huge strategic fit with Pfizer's vaccine franchise. Hence, we anticipate a very attractive commercial prospect and dynamic. 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.

Speaker #3: We have a broad addressable population at this point in time, we showed in the study results for people above five 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.

Speaker #3: We have an excellent partner, and there is a huge strategic fit with Pfizer's vaccine franchise. Hence, we anticipate a very attractive commercial prospect and dynamics.

Speaker #3: 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.

Speaker #3: On Xtic, as part of our overall restructuring process, and also reprioritization, of our key strategic focus areas, we shift more and more towards the Xtic 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 encryption 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.

Thomas Lingelbach: On IXCHIQ, as part of our overall restructuring process, and also reprioritization of our strategic focus area, we shift more and more towards the IXCHIQ access in countries where there is highest risk for chikungunya infection, meaning primarily low and medium income countries. 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.

Speaker #3: 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 towards the latter part of the year.

Thomas Lingelbach: We are focusing a lot right now on expanding our network of manufacturing distribution partners in low and middle income countries. We hope that we will be able to even announce something towards the latter part of the year. The locally manufactured vaccine in Brazil by our partner, Instituto 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 is 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.

Speaker #3: The locally manufactured vaccine in Brazil, our partner Butantan, has now been approved and is expected to be incorporated into Brazil's public health system in the near future.

Speaker #3: We in-license an interesting candidate against Shigelosis, 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.

Speaker #3: 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 Shigelosis, 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.

Thomas Lingelbach: 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 is 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 standalone setting or in a combination vaccine setting to work towards a product 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.

Speaker #3: But there is also a very interesting opportunity, either in a standalone setting or in a combination vaccine setting, to work towards a broader-covering diarrheal vaccine for travelers.

Speaker #3: 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.

Speaker #2: Yeah, thank you, Thomas. So, first, looking at product sales, product sales reached €64 million compared to €91 million in the first half of 2025.

Peter Bühler: Yeah. Thank you, Thomas. So first looking at product sales. Product sales reached EUR 64 million compared to EUR 91 million in H1 2025. Sales excluding third-party products decreased by -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 H1. 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 H1 2026 continued under the one-year contract signed in January 2025. We expect to sign a new contract in the coming months and begin recording sales under this new contract in H2 of the current fiscal year.

Speaker #2: 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.

Speaker #2: Xiara sales reached €44 million compared to €54.7 million in the prior year's first half. The year-over-year decrease primarily reflected 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.

Speaker #2: Shipments to the U.S. Department of Defense in the first half of 2026 continued under the one-year contract signed in January 2025. We expect to sign a new contract in the coming months and begin recording sales under this new contract in the second half of the current fiscal year.

Peter Bühler: Foreign currency fluctuation also had an adverse impact of EUR 1.5 million on IXIARO sales during the H1 2026. DUKORAL sales reached EUR 14.7 million compared to EUR 17.4 million in the H1 2025. Prior year sales benefited from one-time sales associated with the supply of DUKORAL doses to Mayotte in response to a cholera outbreak. In addition, sales in the H1 2026 were adversely affected by the distributor transition in Germany in January 2026. Similar to the Q1, existing inventory transferred from the previous distributor were 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 H1 2025.

Speaker #2: Foreign currency fluctuation also had an adverse impact of €1.5 million on Xiara sales during the first half of 2026. Dukoral sales reached €14.7 million compared to €17.4 million in the first half of 2025.

Speaker #2: Prior year sales benefited from one-time 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.

Speaker #2: 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.

Speaker #2: Xtic sales reached €4.4 million, compared to €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 of La Réunion in response to a major chikungunya outbreak, as well as travel sales in the United States.

Peter Bühler: 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 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 a potential focus on the endemic markets. Third-party products decreased substantially from EUR 11.4 million in the H1 2025 to EUR 1 million in the first six 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 H1 2025.

Speaker #2: In light of the slow product uptake in travel, the company is currently evaluating its future commercial strategy for Xtic including a potential focus on the endemic markets.

Speaker #2: Third-party products decreased substantially from €11.4 million in the first half of 2025 to €1 million in the first six months of 2026.

Speaker #2: 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.

Speaker #2: Total revenues reached 65.8 million euros versus 97.6 million euros in the first half year of 2025. The decrease is mostly related to the lower product sales.

Peter Bühler: 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 vaccine. Looking at expenses, cost of goods and services for the H1 2026 reached EUR 59.5 million compared to EUR 47.2 million during the same period last year. Cost of goods in the H1 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 a EUR 4.5 million non-cash impairment of excess IXCHIQ inventory resulting from lower than anticipated sales.

Speaker #2: Last year's other revenues also included a one-off upfront payment related to the licensing agreement with the Serum Institute of India for a single-shot chikungunya vaccine.

Speaker #2: Looking at expenses, cost of goods and services for the first half of 2026 reached 59.5 million euros compared to 47.2 million euros during the same period last year.

Speaker #2: 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 9.7 million euros in cancellation fees related to external manufacturing commitments for Xtic and the 4.5 million euro non-cash impairment of excess Xtic inventory resulting from lower than anticipated sales.

Speaker #2: 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.

Peter Bühler: 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 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 H1 2025. The gross margin of DUKORAL in the H1 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.

Speaker #2: Xiara 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.

Speaker #2: Last year's Xiara 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.

Speaker #2: 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 favorable overhead absorption due to manufacturing timing and higher volumes.

Speaker #2: The Xtic gross margin was negative due to the one-time cancellation fees provisioned in the second quarter, as well as the inventory write-down mentioned previously, which importantly had no cash impact.

Peter Bühler: The IXCHIQ gross margin was negative due to the one-time cancellation fees provisioned in Q2, as well as the inventory write-down mentioned previously, which importantly had no cash impact. R&D expense decreased from EUR 32.4 million in H1 2025 to EUR 30.2 million in H1 2026. 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 H1 2026. The decrease is related to a planned reduction in advertising and promotion related to IXCHIQ, as well as reduced personnel, warehousing, and distribution cost. G&A expenses decreased to EUR 15.4 million compared to EUR 19 million in H1 2025.

Speaker #2: Research and development expense decreased from €32.4 million in the first half of 2025 to €30.2 million in the first half of 2026.

Speaker #2: That decrease is mainly a result of reprioritization and rescheduling of R&D activities. Marketing and distribution expenses decreased significantly from 20.3 million euros in the prior year to 13.5 million euros in the first half of 2026.

Speaker #2: The decrease is related to a planned reduction in advertising and promotion related to Xtic, as well as reduced personnel, warehousing, and distribution costs.

Speaker #2: G&A expenses decreased to 15.4 million euros compared to 19 million euros in the first half of 2025. The reduction was a result of lower personnel costs and savings in advisory and professional fee services.

Peter Bühler: 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 include a one-time cost of EUR 3.2 million related to that program. Savings are expected in the second half year and beyond. In H1 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 H1 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 30 June was EUR 121.5 million compared to EUR 109.6 million at the end of fiscal year 2025.

Speaker #2: The company implemented the restructuring program in June 2026 and operating expenses in the first half year include a one-time cost of 3.2 million euros related to that program.

Speaker #2: Savings are expected in the second half year and beyond. In the first half of 2026, Valneva reported an operating loss of 49.9 million euros compared to 16.8 million euros in the prior year.

Speaker #2: Adjusted EBITDA loss in the first half of 2026 reached €40.1 million compared to €6 million in the prior year. Before moving to the outlook and guidance of World on Cash, as mentioned by Thomas at the beginning of the call, cash at June 30 was €121.5 million compared to €109.6 million at the end of fiscal year 2025.

Speaker #2: Cash used in operations in the first half of 2026 was 13.7 million euros compared to 10.9 million euros in the first half of the prior year.

Peter Bühler: Cash used in operations in H1 2026 was EUR 13.7 million compared to EUR 10.9 million in H1 of the prior year. Now moving to the next slide, to slide 18. We confirm our financial guidance for the fiscal year 2026 with product sales of EUR 135 to 150 million and total revenues of EUR 145 to 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 H2 of the current fiscal year and beyond. We expect product-related gross margin to improve in H2 following the non-recurrent effect in H1 of the year.

Speaker #2: Now moving to the next slide to slide 18, we confirm our financial guidance for the fiscal year 2026 with product sales of 135 to 150 million euros and total revenues of 145 to 160 million euros.

Speaker #2: We expect the signings of new contracts with the US Department of Defense for the supply of Xiara in the coming months. We expect our commercial business to continue generating positive cash flow and the restructuring program intimately 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.

Speaker #2: We expect product-related gross margin to improve in the second half following the non-recurrent 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.

Peter Bühler: 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.

Speaker #2: With this, I hand the call back to Thomas.

Speaker #1: Thank you so much, Peter. Peter said 2026 we mean 2027, of course. Also, it would be nice to be already in 2026 financially self-sustainable.

Thomas Lingelbach: Thank you so much, Peter. Peter, the 2026, I mean 2027, of course. Also, it would be nice to be already in 2026 financially self-sustainable. Let me close by giving a little bit prospects 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. What we would like to do is really to create a risk-balanced portfolio of innovative specialty lifecycle and high-value vaccine assets, which are attractive and go very much beyond our prior focus on vector-borne diseases.

Speaker #1: Yeah, let me close by giving a little bit prospects on how we see the future of Valneva of course, provided and subject to Lyme success.

Speaker #1: 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.

Speaker #1: We see here a clear opportunity for strategic indicing to augment our clinical stage pipeline and what we would like to do is really to create a risk-balanced portfolio of innovative specialty lifecycle and high-value vaccine assets which are attractive and go very much beyond our prior focus on vector-borne diseases.

Speaker #1: We are working with a 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, stroke, and a broader enteric disease-covering candidate program. We would also like to put emphasis on focusing on reducing anti-microbial resistance targets.

Thomas Lingelbach: We are working with a 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 EVD or ETEC/Shigella, a broader enteric disease-covering candidate program. 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. This mainly focuses on adapting and adjusting our value chains 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.

Speaker #1: 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 adopting and adjusting our value chains, chain 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 cash from our integrated operations and commercial business in particular.

Speaker #1: So all in all, we see a very nice prospect for Valneva going forward. But for now, it's all about Lyme and we have to wait until we hopefully see further positive developments on the Lyme vaccine candidates while executing thoroughly on our base business and continue our focus on strong cash management and disciplined cash management.

Thomas Lingelbach: But for now, 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.

Speaker #1: With that, I would like to conclude the presentation and hand back to the operator to take your questions.

Speaker #3: 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.

Operator: Thank you. To ask a question, you will need to press star 1 and 1 on your telephone and wait for your name to be announced. To withdraw your question, please press star 1 and 1 again. One moment for our first question. This question comes from Tara Bancroft from TD Cowen. Please go ahead.

Speaker #3: To withdraw your question, please press star one and one again. One moment for our first question. And this question comes from Tara Bancroft from TD Cowen.

Speaker #3: Please go ahead.

Tara Bancroft: Hi. Good morning, everyone. Thanks for hosting this call and taking our questions. I was hoping maybe you could give us 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. Is there anything else that you can add to the discourse that you've had with Pfizer and/or regulators? That would be really appreciated. Thanks.

Speaker #4: Hi, good morning everyone. So thanks for hosting this call and taking our questions. I was hoping maybe you could give us a little any more detail or thoughts or feelings that you have on a regulatory update.

Speaker #4: 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 no regulators that would be really appreciated.

Speaker #4: Thanks.

Thomas Lingelbach: Pfizer are making very good progress with the regulatory agencies. We hope that we will be able to announce next steps soon. That's all we can say at this moment in time, specifically.

Speaker #1: 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 specifically.

Speaker #4: 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.

Tara Bancroft: I see. Okay. Totally understood on that kind of commentary. 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? Thanks.

Speaker #4: 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 three program or even a post-marketing surveillance study.

Speaker #4: 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.

Speaker #4: Thanks.

Thomas Lingelbach: Yeah. It's a good question, Tara. The existing agreement with Pfizer includes that Valneva 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 hopefully being licensed in the respective jurisdictions.

Speaker #1: Yeah. 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.

Speaker #1: 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 jurisdiction.

Speaker #4: Great. Thanks so much.

Tara Bancroft: Great. Thanks so much.

Speaker #3: Thank you. We are now going to take our next question. And this one comes from Maureen Raycroft from Jefferies. Please go ahead.

Operator: Thank you. We are now going to take our next question. This one comes from Maury Raycroft from Jefferies. Please go ahead.

Maury Raycroft: Hi. Congrats on the progress and thanks for taking my questions. I was going to ask one on Shigella. 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? When the data are disclosed, should we also expect clarity on the path forward? What are the latest scenarios that you are considering there?

Speaker #5: Hi. Congrats on the progress, and thanks for taking my questions. I was going to ask one on Shigella, so I'm wondering if you can provide more color on what is gating the update.

Speaker #5: 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 you're considering there?

Speaker #1: Yeah. Thanks for your question, Maureen. So yeah, let me so first of all, we have had a few delays on the program. You know that the studies are still conducted by Nematec.

Thomas Lingelbach: Yeah. Thanks for your question, Maury. 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 Eli 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. This is not going to take a long time until we will be able to disclose. What do we expect? 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. 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 is highly indicative.

Speaker #1: Nematec 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, etc.

Speaker #1: 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.

Speaker #1: 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.

Speaker #1: 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 at which level of protection.

Thomas Lingelbach: 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 at which level of protection. The flanking immunogenicity study in children will clearly provide us, A, with safety, which is very important. It will also give us a first feel for how is the immunological profile in children as compared to adults. Of course, although it is not a direct head-to-head comparison possible, 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. This could be an optimization on dose, schedule, formulation.

Speaker #1: 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.

Speaker #1: 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 those schedule formulation but our objective is to announce the next development steps either with the data or very shortly thereafter.

Thomas Lingelbach: Our objective is to announce the next development steps either with the data or very shortly thereafter. Hope this answers your question.

Speaker #1: Hope this answered your question.

Speaker #5: Yeah. That's helpful. Do you need some regulatory feedback to do that then or?

Maury Raycroft: Yeah, that is helpful. Do you need some regulatory feedback to do that then or?

Speaker #1: Say it again?

Thomas Lingelbach: Say it again.

Speaker #5: Do you need some regulatory feedback to?

Maury Raycroft: Do you need some regulatory feedback to-

Speaker #1: Yeah. We have a group of regulatory advisors with whom we are working. We are currently not expecting to seek direct regulatory advice 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.

Thomas Lingelbach: Yeah, we have a group of regulatory advisors with whom we are working. We are currently not expecting to seek a direct regulatory advice from the relevant regulatory bodies, because we had prior discussions, and I think for us it is pretty clear what the potential expectations would look like.

Speaker #5: Got it. Okay. Maybe just one quick one for Lyme. I know you can't say a whole lot about where Pfizer's at, what the process, but I'm just wondering for the US 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 US before you can do an update for European status?

Maury Raycroft: Got it. Okay. Maybe just one quick one for Lyme. I know you cannot say a whole lot about where Pfizer is at with the process, but I am just wondering for the US 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 US before you can do an update for European status?

Speaker #1: 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 plan BLAs admission for the Lyme disease vaccine category.

Thomas Lingelbach: I think both activities are progressing very nicely. These are two independent processes. There is, at this moment in time, I would assume that Europe probably goes first. Pfizer is working closely with the FDA in support of its planned BLA submission for the Lyme disease vaccine candidate.

Speaker #5: Got it. Okay. Thank you for taking my questions.

Maury Raycroft: Got it. Okay. Thank you for taking my questions.

Speaker #3: Thank you. We are now going to move to our next question. And this question comes from the line of family one from Guggenheim Securities.

Operator: Thank you. We are now going to move to our next question. This question comes from the line of Vamil Divan from Guggenheim Securities. Please go ahead.

Speaker #3: Please go ahead.

Speaker #6: Hey guys. Good morning. This is Edward from Fervamo. Just maybe a couple more questions online if I may. So first, it sounds like Pfizer told us that they have filed with in Europe but not yet with the FDA.

[Analyst] (Guggenheim Securities): Hey, guys. Good morning. This is Edward from Vamil. Just maybe a couple more questions on line, if I may. First, it sounds like Pfizer has told us that they have filed in Europe, but not yet with the FDA. They are still in conversation. I am wondering if you can share any details on your learnings or on why they decided to proceed that way. 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 highlight for us that would be pertinent here? Then maybe to what extent the European filing do you think that would de-risk the FDA filing? Thanks.

Speaker #6: They're still in conversation. So I'm wondering if you can share any details on your learnings or on why they decided to proceed that way.

Speaker #6: 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 BLA 15 specifically that you can kind of highlight for us that would be pertinent here?

Speaker #6: And then maybe, to what extent do you think the European filing would de-risk the actual FDA filing? Thanks.

Speaker #1: Yeah. 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.

Thomas Lingelbach: Yeah. 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. 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 us celebrate this progress. As we said in the past 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.

Speaker #1: 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 between those agencies.

Speaker #1: 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. 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 being the Valneva expectation.

Thomas Lingelbach: 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. 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.

Speaker #1: 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.

Speaker #6: Okay. Thanks. And maybe just on just how your understanding of how European versus FDA regulators look at sort of the vaccine data and maybe VLA 15 if there's anything we should be aware of and how just how these two different agencies approach the data and what the bar is how they think about the efficacy safety bar there.

[Analyst] (Guggenheim Securities): Okay, thanks. Maybe just on how your understanding of how European versus FDA regulators look at the vaccine data and maybe VLA15, if there is anything we should be aware of in 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 do not know specifically whether there are any differences in how they are going to look at the data. I mean, the data are what the data are, right? We have safety data, we have efficacy data, we have immunogenicity data, and the data are the same. Of course, all agencies, and this is not Lyme specific, and I say this as someone who has been now in vaccine development for more than 30 years. They all look at the same. They look at the totality of clinical evidence. They look at risk benefits, health economical benefits, underlying mode of action, scientific fundamentals. So I am not necessarily assuming that they look differently at the data.

Speaker #1: No, I don't know specifically 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?

Speaker #1: 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.

Speaker #1: And I say this as someone who has been now in vaccine development for more than 30 years. I mean, they all look at the same.

Speaker #1: They look at the totality of clinical evidence. They look at risk benefit, health economic benefit, underlying modes of action, scientific fundament. So I'm not necessarily assuming that they look differently at the data.

Speaker #1: There are nuances and we know it from, for example, our tick 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.

Thomas Lingelbach: There are nuances and we know it from, for example, our tick vaccine, which was the last vaccine that we brought from bench to licensure that, of course, when it comes to details on statistical analysis, 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.

Speaker #1: But I have never seen in my history that there were material differences in how the two regulatory bodies you cited were handling applications.

Speaker #6: Great. Thank you so much.

[Analyst] (Guggenheim Securities): Great. Thank you so much.

Speaker #3: Thank you. We are now going to take our next question, and this one comes from Suzanne van Vertuizen from Kempen. Please go ahead.

Operator: Thank you. We are now going to take our next question, and this one comes from Suzanne van Voorthuizen from Kempen. Please go ahead.

Speaker #7: Hi team. This is Suzanne. Thanks for taking my questions. I have one on the Valneva ambition from here. It seems like that you are gravitating to a more R&D or biotech driven identity rather than a commercial focus.

Suzanne van Voorthuizen: Hi, team, this is Suzanne. Thanks for taking my questions. I have one on the Valneva ambition from here. It seems like 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 fate of the Lyme program? 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? Thank you.

Speaker #7: 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 fate of the Lyme program?

Speaker #7: And then I have a small question on the sale of the site in France, next to the 6 million in proceeds does this also bring an ongoing cost reduction of a certain degree?

Speaker #7: Thank you.

Speaker #1: Yeah. Hi Suzanne. Yeah. So you are absolutely right. That we see our we have always seen and we see our commercial business in a way being a subscape, right?

Thomas Lingelbach: Yeah. Hi, Suzanne. You are absolutely right. That we have always seen, and we see our commercial business in a way being a top scale, 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. 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. Therefore, our focus will be really to maximize cash generation from the commercial business going forward.

Speaker #1: 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.

Speaker #1: 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.

Speaker #1: 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.

Speaker #1: We believe we are one of the very, very few remaining pure peer vaccine companies that have a proven expertise in bringing novel vaccines from bench to licensure.

Thomas Lingelbach: We believe we are one of the very, very few remaining pure-play vaccine companies that have a proven expertise in bringing novel vaccines from bench to licensure, and we would leverage that. Now, the capacity, I would say, we have to invest, of course, depends heavily on Lyme success because you know that the economics from the deal with Pfizer are favorable. You know that besides milestones, the royalties from Lyme would, of course, go straight down to the bottom line. As such, could allow us to invest significantly in enhancing our pipeline, both organically as well as strategically, while even potentially being completely financially self-sustainable. We believe that this is a very appealing strategy. It is a very appealing strategic outlook. But as you know that many, many times, it is all about Lyme.

Speaker #1: And we would leverage that. Now, the capacity I would say we have to invest of course depends heavily on Lyme success. Because you know that the economics from the deal with Pfizer are favorable.

Speaker #1: And that besides milestones, the royalties from Lyme would of course go straight down to the bottom line. And as such, could allow us to invest significantly in enhancing our pipeline both organically as well as strategically while even potentially being completely financially self-sustainable.

Speaker #1: And we believe that this is a very appealing strategy it's a very appealing strategic outlook. But as you noted, many, many times it's all about Lyme.

Thomas Lingelbach: Of course, it depends on the Lyme licensure, be it Europe, US, 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, 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. 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. This is something that, of course, we do not see immediately because it comes over time. We had significant redundancy costs and restructuring costs.

Speaker #1: And of course, it depends on the Lyme licensure, be it Europe, US, both. Or just one. And the commercial success of this vaccine then later on.

Speaker #1: But we believe, overall, strategically, yes, there is a benefit. Coming to your question on that, 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.

Speaker #1: 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.

Speaker #1: And this is something that of course we don't see immediately because it comes over time. We had significant redundancy costs and restructuring costs. But this is certainly something where we see a significant benefit in the future to come.

Thomas Lingelbach: 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 that, of course, we get also some proceeds from the sale of the building that we are now executing on.

Speaker #1: Besides of the fact that we disclosed in the half-year report that of course we get also some proceeds from the sale of the building.

Speaker #1: That we have that we are now executing on.

Speaker #3: Thank you. We are now going to move to our next question. And this question comes from Shyam Kotadia from Goldman Sachs. Please go ahead.

Operator: Thank you. We are now going to move to our next question. This question comes from Shyam Kotadia from Goldman Sachs. Please go ahead.

Speaker #6: Hi there. Thank you for taking my question. Two on the modeling side of things. So you mentioned you're 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?

Shyam Kotadia: Hi there. Thank you for taking my questions. Two on the modeling side of things. You mentioned your ongoing restructuring program. 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? 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 priorities. Does that hold? That is the first question. The second question is on what is the realistic expectation for gross margin in H2 2026? I realize you are not guiding on it specifically, but could you help us understand how it could compare to last year, given that you are mentioning an uptick there? Thank you.

Speaker #6: Especially noting SG&A came in lower than expectations. And I can see that, linked to that, you no longer call out the 25 to 35 percent reduction in OPEX versus 2025 that you did in your priority.

Speaker #6: So, does that hold? That's the first question. And then, the second question is: what is the realistic expectation for gross margin in the second half of '26?

Speaker #6: 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?

Speaker #6: Thank you.

Speaker #1: Yeah, hey, thanks for the question. So let me first get into your questions on the restructuring and the impact on R&D and SG&A. You saw on SG&A in particular a trend that started already last year, when we did some efficiency improvements, and continues this year.

Peter Bühler: Yeah. Hey, thanks for the question. Let me first get into your questions on the restructuring and the impact on R&D and SG&A. You saw on SG&A the particular 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. I think what you see in the H1 is in a way what we will continue to see in the future. As I said, there were some also one-off costs in there that we will, of course, not have anymore. We eliminated a number of positions. Of course, in H1, you do not 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 H2 the decrease in cost.

Speaker #1: 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 what we would continue to see in the future.

Speaker #1: And as I said, there were also some one-off costs in there that we will, of course, not have anymore. And we eliminated a number of positions.

Speaker #1: 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.

Speaker #1: And to your point, yes, we did provide a guidance in the last press release about over rough guidance on where we see costs going, versus last year.

Thomas Lingelbach: To your point, yes, we did provide a guidance in the last press release about over 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. Yeah. As you understood, there was a lot of one-off events and also some non-cash effects in the H1. In the H2, we clearly expect a much better gross margin than in the H1. 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 recorded last year. Then I would also expect positive trends getting into 2027.

Peter Bühler: To your point, yes, we did provide a guidance in the last press release about over 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. Yeah. As you understood, there was a lot of one-off events and also some non-cash effects in the H1. In the H2, we clearly expect a much better gross margin than in the H1. 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 recorded last year. Then I would also expect positive trends getting into 2027.

Speaker #1: 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, yeah, so as you understood, there was a lot of one-off events and also some non-cash effect in the first half year.

Speaker #1: So in the second half of the year, we clearly expect a much better gross margin than in the first half of the year. And I would say overall for the year, we will probably not get exactly to where we were last year, but we will certainly get much closer to the full-year gross margin we recorded last year.

Speaker #1: And then I would also expect a positive trend going into 2027.

Speaker #6: Thank you.

Speaker #3: Thank you. We are now going to take our next question, and this one comes from Simon Scholz from First Berlin. Please go ahead.

Operator: Thank you. We are now going to take our next question, and this one comes from Simon Scholes from First Berlin. Please go ahead.

Simon Scholes: Yes, good afternoon. I have just got a question on IXCHIQ. 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 sales of the vaccine in Brazil.

Speaker #7: Yes, good afternoon. I just have a question on XCheck. The local version of the XCheck 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 sales of the vaccine in Brazil?

Speaker #1: Yeah. So basically, 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.

Thomas Lingelbach: Yeah. Our partner, Instituto Butantan, are currently in the midst of the launch planning. Therefore, I would consider it a bit too early to really talk about 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. You know that when we look at the demand that we have seen, or we are seeing from our drug substance supplies to Instituto Butantan, and we recorded in the H1 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 product. Just by the way of what we see there, we really expect it to become a very significant opportunity.

Speaker #1: 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.

Speaker #1: 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 product.

Speaker #1: Just by the way of what we see there, we really expect this to become a very significant opportunity. But it's too early. And I don't want to throw out numbers here.

Thomas Lingelbach: But it is too early, and I do not want to throw out numbers here without having a clear confirmation from our partner.

Speaker #1: Without having a clear confirmation from our partner.

Speaker #7: Okay. That's very helpful. 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?

Simon Scholes: Okay. That is very helpful. Just a supplementary on the pilot vaccination program. I think you have vaccinated 50,000 persons so far. How long do you expect this pilot vaccination program to continue for?

Speaker #1: Yeah. It's a good question. So we have a remember, this is a program that is owned by the Ministry of Health. So by the government.

Thomas Lingelbach: Yeah, good question. Remember, this is a program that is owned by the Ministry of Health, so by the government. The government 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 broad public vaccination schedule, they need to see active pharmacovigilance. They need to see how this all works out. That is 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. So that is all I can say to that.

Speaker #1: The government 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 life-attenuated vaccine and we have been discussing in the past, all the issues that arose from that.

Speaker #1: 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.

Speaker #1: 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.

Speaker #1: But yeah, so that's all I can say to that.

Speaker #7: Okay, thanks very much. That's very helpful.

Simon Scholes: Okay, thanks very much. That is very helpful.

Speaker #3: Thank you. There are no further questions for today. I will now hand the call back to Thomas Lingelbach for closing remarks.

Operator: Thank you. There are no further questions for today. I will now hand the call back to Thomas Lingelbach for closing remarks.

Speaker #1: 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.

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. We are optimistic that we are going to see approvals for the vaccine in the next 12 months. As such, enabling a nice strategic prospect, as I have responded to following Suzanne's question earlier. So with that, thanks again, and have a good remainder of the day. Goodbye.

Speaker #1: As I said, we shared the positivity that you could see across Pfizer's different communications. We are very happy about the progress that is currently being made.

Speaker #1: And we are optimistic that we're going to see approvals for the vaccine in the next 12 months. As such, this enables a nice strategic prospect, as I responded to following Susanna's questions earlier.

Speaker #1: 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.