Half Year 2024 Valneva SE Earnings Call

Buhler, Peter Buhler.

Operator: Good day, and thank you for standing by. Welcome to the Valneva Presents Its Half Year 2024 Financial Results Conference Call. At this time, all participants are in a listen-only mode.

Operator: 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 1 on your telephone. You will then hear an automated message advising that your hand is raised.

Speaker Change: Good day and thank you for standing by. Welcome to the Valneva Presents its half year 2024 financial results conference call.

Speaker Change: At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session.

Speaker Change: To ask a question during the session you will need to press star 1 1 on your telephone You will then hear an automated message advising your hand is raised to withdraw your question Please press star 1 1 again. Please be advised that today's conference is being recorded

Operator: To withdraw your question, please press star 1 1 again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your first speaker today, Joshua Drumm, VP, Global Investor Relations. Please go ahead. Thank you, operator. Hello, and thank you for joining us to discuss Valneva's first half 2024 results and corporate update. It's my pleasure to welcome you today.

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

Joshua Drumm: In addition to our press release and analyst presentation, you can find our consolidated financial results for the 6th month ended June 30, 2024, which were published earlier today, available in 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 key financial results for the first half. There will be an analyst Q&A session at the conclusion of the prepared remarks.

Joshua Drumm: Thank you, Operator.

Joshua Drumm: Hello and thank you for joining us to discuss Del Nivo's first half 2024 results and corporate update. It's my pleasure to welcome you today.

Speaker Change: In addition to our press release and analyst presentation, you can find our consolidated financial results for the sixth month ended June 30th, 2024, which were published earlier today, available within the financial reports section on our investor website.

Speaker Change: 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 key financial results for the first half. There will be an analyst Q&A session at the conclusion of the prepared remarks.

Joshua Drumm: 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 the 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.

Speaker Change: 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 the actual result to differ materially from those expressed or implied by these forward-looking statements.

Speaker Change: 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.

Joshua Drumm: Please note that today's presentation includes information provided as of today, August 13th, 2024, 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. Thank you, Josh. Good day, everyone.

Speaker Change: Please note that today's presentation includes information provided as of today, August 13th, 2024, 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: It's a pleasure to present to you, together with my colleagues, the great achievements that we have been able to deliver on in the first half of this year, most notably in R&D and strategic development. Peter will develop the financials more in detail, but the product sales of 68.3 million euros included the first recognized sales for X-Shake, and we're overall in line with our anticipated supply and sales phasing, and hence we have reiterated our set of full year financial guidance.

Thomas: Thank you, Josh. Good day, everyone. It's a pleasure to present to you, together with my colleagues, the great achievements that we have been able to deliver on in the first half of this year.

Thomas: most notably in R&D and strategic development.

Thomas: Peter will develop the financials more in detail, but product sales of 68.3 million euros included first-recognized sales for xShake.

Thomas: and we're overall in line with our anticipated supply and sales phasing and hence we have reiterated our set of full year financial guidances.

Thomas Lingelbach: The successful sale of our priority review voucher and the deferral of our loan reimbursement in the first quarter allowed us to maintain a solid cash position, and now that we have completed our payment for the Lyme disease program, we anticipate a significantly lower cash burden for a little part of the year.

Peter: The successful sale of our priority review voucher and the deferral of our loan reimbursement in the first quarter allowed us to maintain a solid cash position and now that we completed

Peter: for the Lyme disease program, we anticipate a significantly lower cash burn towards the latter part of the year.

Thomas Lingelbach: We achieved major things in R&D, as I mentioned at the beginning. And the first one, of course, was the new Shigella vaccine. Most recently, we entered into a strategic partnership to accelerate the development of the world's most advanced tetravalent Shigella vaccine. Additional exempted approvals in Canada and Europe were obtained even slightly ahead of our planning, which allows us to launch in the first market in the last quarter of this year, and we have pending approvals in the UK and Brazil.

Peter: We achieved major things in R&D, as I mentioned at the beginning, and the first one, of course, the new Shigella vaccine. Most recently, we entered into a strategic partnership to accelerate the development of the world's most advanced tetravalent Shigella vaccine.

Peter: Additional extreme approvals in Canada and Europe were obtained even slightly ahead of our planning, which allowed us to launch in first market in the last quarter of this year, and we have pending approvals in the UK and Brazil.

Thomas Lingelbach: We are very grateful that we have been able to extend our partnership with TIPI, who awarded us a new more than $40 million grant to support product access, post-marketing, and labor extension trials for. We reported positive phase 3 HD data in adolescents, which will all be used to support our label extension submissions in the second half of this year. We also published two-year antibody persistence data in The Lancet, which are also expected to support further label extensions.

Peter: We are very grateful that we have been able to extend our partnership with TIPI who awarded us a new more than 40 million grant to support product access post marketing and label extension trials for xChick.

Peter: We reported positive phase 3 X-ray data in adolescents, which will all be used to support our label extension submissions in the second half of this year.

Peter: We also published two-year antibody persistence data in Lancet, which are also expected to support further label extensions.

Operator: Good day and thank you for standing by.

Operator: Welcome to the Valneva Presents, It's Half Year 2024 Financial Results Conference School. At this time, all participants are in a listen-only mode.

Thomas Lingelbach: And as you know, the study is going on for roughly. We completed enrollment in the Phase 2 study of x-chick in children 1 to 11 years of age, completed the primary vaccination in our Phase 3 evaluation study for Lyme disease, and hence we are fully on track for the first readout at the end of 2025. And as you know, and as reported already in the last quarter, we initiated the Phase 1 for our second generation Zika vaccine candidate with data expected in the first half of 2025.

Peter: And as you know, this study is going on for roughly five years.

Operator: 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, one on your telephone. You will then hear an automated message advising your hand is raised. To destroy your question, please press star one, one again.

Peter: We completed the enrollment in Phase 2 study of x-check in children 1 to 11 years of age.

Peter: completed the primary vaccination in our phase 3 valor study for Lyme disease and hence we are fully on track.

Operator: Please be advised that today's conference is being recorded.

Joshua Drumm: I would now like to hand the conference over to your first speaker today, Joshua Drumm, VP Global Investor Relations. Please go ahead. Thank you, operator. Hello and thank you for joining us to discuss Valneva's first half 2024 Results 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 sixth month ended June 30, 2024, which were published earlier today, available within the financial report section on our investor website.

Peter: for the first readout at the end of 2025. And as you know, and as reported already at the last quarter, we initiated the phase one for our second generation Zika vaccine candidate with data expected in the first half of this year.

Joshua Drumm: I'm joined today by Valneva's CEO, Thomas Lingelbach, and our CFO Peter Bueller, who will provide an overview and update on our business as well as our key financial results for the first half. 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 the actual result 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.

Thomas Lingelbach: Let me draw your attention to page number six of the presentation, which is a recap of Valneva's strategy. You know that our aim is to become a globally recognized vaccine company in line with our vision of contributing to a world where no one dies or suffers from a vaccine preventable disease. Our strategy is based on three pillars. On the one hand, driving commercial growth.

Speaker Change: Let me draw your attention to page number six of the presentation.

Speaker Change: which is a recap of our NEVA strategy. You know that our aim is to become a globally recognized vaccine company in line with our vision contributing to a world where no one dies or suffers from a vaccine preventable disease.

Speaker Change: Our strategy is based on three pillars. On the one hand side, driving commercial growth.

Thomas Lingelbach: Here, we see clearly X-JIG and the possibility to unlock the X-JIG value by building awareness and market, capitalizing on the bundling effect with the existing travel path business, and expanding globally, reaching more LMRC territories via strategic partnership. And this commercial business is expected to become cash flow positive from 2025 onwards. The second pillar is our R&D, and here we would really like to capture R&D upside and provide upside to our investors by leveraging our proven R&D engine and existing strategic partners, continue to focus on vaccines that can make a difference, as you know, being technology agnostic, striving for first-only or best-in-class solutions, and execute efficiently to generate meaningful clinical catalysts.

Speaker Change: Here we see clearly x-check and the possibility to unlock the x-check value by building awareness and market.

Joshua Drumm: Please note that today's presentation includes information provided as of today, August 13, 2024, and Valneva undertakes no obligation to revise or update forward-looking statements, except as required by applicable securities laws.

Speaker Change: capitalizing on the bundling effect with existing travel paths business and expanding globally, reaching more LMRC territories via strategic partnerships.

Speaker Change: And this commercial business is expected to become cash flow positive from 2025 onwards. The second pillar is our R&D.

Speaker Change: And here we would really like to capture R&D upside and provide upside to our investors by leveraging our proven R&D engine and existing strategic partnerships.

Speaker Change: We continue to focus on vaccines that can make a difference, as you know, technology agnostic, striving for first-only or best-in-class solutions.

Thomas Lingelbach: With that, it's my pleasure to introduce Thomas to begin today's presentation. Thank you, Josh. Good day, everyone.

Thomas Lingelbach: The new example Chigella is a vaccine where we expect phase three to enter once Lyme, hopefully, will be successful. From the third pillar, it's really the maximization of our integrated biotech. You know, we are one of the very few pure play vaccine companies that have a fully integrated model from research to sales. And we build on continual value from R&D and commercial.

Thomas Lingelbach: The pleasure to present to you, together with my colleagues, the great achievement that we have been able to deliver on in the first half of this year. Most notably in R&D and strategic development. Peter will develop the financials more in detail, but the product sales of 68.3 million euros included first recognized sales for X-Shake, and we're overall involved in that. We're aligned with our anticipated supply and sales phasing, and hence, we have reiterated our sets of fully-year financial guidance.

Speaker Change: and execute efficiently to general meaningful clinical catalysts.

Speaker Change: The new example, Chigella, is a vaccine where we expect phase 3 to enter once Lyme hopefully will be successful. The third pillar is really the maximization of our integrated biotech model.

Speaker Change: You know, we are one of the very few pure play vaccine companies that have a fully integrated model from research to sales. And we build on continual value from R&D and commercial execution.

Thomas Lingelbach: Of course, we support timely Lyme approvals, and on the back of that, we may achieve sustained profitability with potential VLA-15 commercial revenues from our partner, Pfizer. When you look at our pipeline, you see that the introduction of the Shigella program through the strategic alliance with LIMATEC has helped us really to build a very coherent pipeline with strong and advanced clinical candidates, of course, with Lyme as number one in our pipeline and clearly the most attractive value player.

Thomas Lingelbach: The successful sale of our priority review outer and the deferral of our loan reimbursement in the first quarter allowed us to maintain a solid cash position, and now that we completed our payment for the line disease program, we anticipate the significantly lower cash burn towards the latter part of the year. We achieved major things in R&D, as I mentioned at the beginning, and the first one, of course, the new Shigella vaccine.

Speaker Change: Of course, we support the timely LIME approvals, and on the back of that, we may achieve sustained profitability with potential VLA-15 commercial revenues from our partner, Pfizer.

Speaker Change: When you look at our pipeline you see that the introduction of the Shigella program through the strategic alliance with LIMATEC has helped us really to build a very coherent pipeline with strong and advanced clinical candidates

Speaker Change: Of course, with Lime as the number one in our pipeline and clearly the most attractive value player.

Thomas Lingelbach: Most recently, we entered into a strategic partnership to accelerate the development of the world's most advanced tech surveillance Shigella vaccine. Additional Shigella vaccines in Canada and Europe were obtained, even slightly ahead of on planning, which allowed us to launch in first-market in the last quarter of this year, and we have pending a poll in the UK. Devani. We are very grateful that we have been able to extend our partnership with Teddy, who awarded us a new more than 40 million grant to support products as post-marketing a labelled extension trial for EXJIC.

Thomas Lingelbach: Then Chikungunya with ongoing clinical activities, BEAD phase three, BEAD phase two pediatric, BEAD phase three adolescents, and also phase four with Shigella, which I'm going to develop more in detail, but with a first phase two GYM study-controlled human infection model and pediatric studies to begin in the second half of this year. And then there is Zika, which could be a very nice plug and play within our existing travel vaccine portfolio.

Speaker Change: then Chikungunya with ongoing clinical activities, speed phase three.

Speaker Change: BeatFace2 Pediatric, BeatFace3 Adolescents, and also Face4.

Speaker Change: with Shigella, which I'm going to develop more in detail, but with a first phase two CHIM study, controlled human infection model, and pediatric studies to begin in the second half of this year.

Speaker Change: And then with Zika, which could be a very nice plug and play within our existing travel vaccine portfolio.

Thomas Lingelbach: And as we have reported in the past, our key focus areas in preclinical are circled around EBV and various enteric disease programs. When we look at X-Chic, the world's first and only Czechongonia vaccine license today, we really have a very unique product here. We expect to benefit by being first to market, and we believe we have a differentiated and competitive product characterized by a very strong and durable immunological response following a single injection, and, very importantly, we have shown that there is no difference in immunogenicity between younger and older adults.

Thomas Lingelbach: We reported positive phase 3 exit data and other lessons, which will all be used to support our labelled extension submissions in the second half of this year. We also published two-year antibody persistence data in Lancet, which are also expected to support further labelled extensions. And as you know, this study is going on for roughly five years. We completed the enrollment in phase 2 study of EXJIC in children 1 to 11 years of age.

Speaker Change: And as reported in the past, our key focus areas in preclinical are circled around EBV and various enteric disease programs.

Speaker Change: When we look at X-Check, the world's first and only chikungunya vaccine license today.

Speaker Change: We have really a very unique product here. We expect to benefit by being first to market.

Speaker Change: and we believe we have a differentiated and competitive product characterized by very strong and durable immunological response.

Thomas Lingelbach: Completed the primary vaccination in our phase 3 study for Lyme disease, and hence, we are fully on track for the first readout at the end of 2025. And as you know, and as reported already at the last quarter, we initiated to phase 1 for our second-generation CECA vaccine candidate with data expected in the first half of this year.

Speaker Change: following a single injection.

Speaker Change: And, very importantly, we have shown that there is no difference in immunogenicity between younger and older adults.

Thomas Lingelbach: The vaccine has been generally well tolerated amongst the more than three and a half thousand adults and more than 700 adolescents evaluated for safety. When we look at the U.S. launch success and where we are right now, we have made some recent achievements. We launched the Unbranded Traveler campaign to build consumer awareness, the BHA, and IHD adopted the CDC recommendations, and published the chikungunya virus and vaccine guidance.

Speaker Change: The vaccine has been generally well tolerated amongst the more than three and a half thousand adults and more than 700 adolescents evaluated for safety thus far.

Thomas Lingelbach: The majority of your attention to page number 6 of the presentation, which is a recap of Geneva's strategy. You know that our aim is to become a globally recognized vaccine company in line with our vision, contributing to a world where no one dies or suffers from a vaccine preventable disease. Our strategy is based on three pillars. On the one hand side, driving commercial growth. Here, we see clearly EXJIC and the possibility to unlock the EXJIC value by building awareness and market, capitalizing on the bundling effect for existing travel pass business, and expanding globally, reaching more LMRC territories via strategic partnerships.

Speaker Change: When we look at the U.S. launch success and where we are right now, we made some recent achievements. We launched the Unbranded Traveler campaign to build consumer awareness.

Speaker Change: the DHA IHD adopted the CDC recommendations and published the chikungunya virus and vaccine guidances. And we are continuously growing our customer base, distributors and customers reordering xChik already.

Thomas Lingelbach: And this commercial business is expected to become cash flow positive from 2025 onwards. The second pillar is our R&D. And here, we would really like to capture R&D upside and provide upside to our investors by leveraging our proven R&D engine and existing strategic partnership. We continue to focus on vaccines that can make a difference, as you know, technology, agnostic, striving for first on your best and last solutions. And execute efficiently to general meaningful clinical catalyst.

Thomas Lingelbach: And we are continuously growing our customer base, distributors, and customers reordering xChik already. What's coming up? Of course, this is... a challenging endeavor because we are talking about a brand new disease, a brand new vaccine. So we are investing significantly in building awareness, building recommendations, and building adoption. And as next steps, we see really the publication of the Chikungunya vaccine recommendations in MMWR, which is still pending. Continue working with CDC to raise awareness of global threats, including recent significant cases in Brazil. And the ACIP is expected to discuss guidelines for endemic island regions, i.e., Puerto Rico.

Speaker Change: What's coming up? Of course, this is a quite challenging endeavor because we are talking about a brand new disease.

Speaker Change: brand new vaccine. So we are investing significantly in building awareness, building recommendations.

Speaker Change: Building a Doctrine.

Speaker Change: And as next steps, we see really the publication of the Chikungunya vaccine recommendations in MMWR, which is still pending. Continue working with CDC to raise awareness of global threats, including recent significant cases in Brazil.

Speaker Change: And the ACIP is expected to discuss guidelines for endemic island regions, i.e. Puerto Rico. And the review is planned for October this year with a vote in February of 2025.

Thomas Lingelbach: And the review is planned for October this year with a vote in February of 2025. And when you look at the territory expansion, you see on slide 11 that we have already ticked many boxes. U.S. done, of course, label extension for adolescents, pediatric patients, but also antibody persistence is coming up. Canada, we got the approval, and their label extensions will also follow.

Thomas Lingelbach: The new example, Chigella, is a vaccine where we expect phase three to enter once a line hopefully will be successful. From the third pillar is really the maximization of our integrated biotech model. You know, we have one of the very few pure-play vaccine companies that have a fully integrated model from research to sales. And we build on continual value from R&D and commercial execution. Of course, we support the timely line of provost.

Speaker Change: And when you look at the territory expansion, you see already on slide 11 that we have many boxes ticked. U.S. done, of course, label extension for adolescents, pediatric, but also antibody persistence is coming up.

Speaker Change: Canada, we got the approval, also their

Thomas Lingelbach: In Europe, everything so far achieved according to plan, slightly ahead of plan, as I said, MHRA approval still outstanding for the U.K., and then also here as next steps post licensure label extension. We have the Brazilian licensure process ongoing, and we are targeting additional markets with established traveler's markets, but also additional LMIC territories, including on the basis of WHO pre-qualification. When we look at the ongoing clinical activities, which as I mentioned at the beginning, are supported by the new more than 40 million dollar CEPI grant, we have the post-marketing effectiveness study, phase four, which are in reality two studies, one observational effectiveness study in participants greater than 12 years of age in Brazil, and so-called practice of age in Brazil, and so-called pragmatic randomized controlled effectiveness and safety study in adults in an endemic country with roughly, The label extensions I mentioned already, we completed the phase three successfully for adolescents and the phase two for children 1 to 11 years of age is already fully enrolled.

Speaker Change: In Europe, everything so far achieved according to plan, slightly ahead of plan, as I said. MHRA approval still outstanding for the UK, and then also here as next steps post-licensure labeled extension submission.

Thomas Lingelbach: And on the back of that, we may achieve sustained profitability with potential VLA-15 commercial revenues from our partner Pfizer. When you look at our pipeline, you see that the introduction of the Chigella program through the strategic aligns of Tima Tech has helped us really to build a very coherent pipeline with strong and advanced clinical candidates. Of course, with Lime as the number one in our pipeline and clearly the most attractive value player, then Shikungunya with ongoing clinical activities, bead phase three, bead phase two, pediatric bead phase three, adolescents, and also phase four, with Chigella, which I'm going to develop more in detail, but with a first phase two, gym study, controlled human infection model, and pediatric studies to begin in the second half of this year.

Speaker Change: We have the Brazilian licensure process ongoing and we are targeting additional markets with established travelers markets.

Speaker Change: but also additional LMIC territories, including on the basis of WHO prequalification.

Speaker Change: When we look at the ongoing clinical activities, which, as I mentioned at the beginning, are supported by the new more than $40 million TEPI grant.

Speaker Change: We have the Post-Marketing Effectiveness Study.

Speaker Change: Phase IV, which are in reality two studies, one observational effectiveness study in participants greater than 12 years of age in Brazil, and a so-called pragmatic randomized controlled effectiveness and safety study in adults.

Thomas Lingelbach: And then with Tika, which could be a very nice black and play within our existing travel vaccine portfolio. And as reported in the past, our key focus areas in pre-clinics are circled around EBD and various enteric disease post. Williams. When we look at X-Chic, the world's first and only Czechongonia vaccine license today, we have really a very unique product here. We expect to benefit by being first to market, and we believe we have differentiated and competitive product characterized by a very strong and durable immunological response, following a single injection.

Speaker Change: an endemic country with roughly 20,000 people.

Speaker Change: The label extensions I mentioned already. We completed the phase 3 successfully for adolescents and the phase 2 for children 1 to 11 years of age is already fully enrolled.

Thomas Lingelbach: The ongoing antibody persistence and long-term safety study in adults is a very important study because it will further substantiate our hypothesis that this vaccine, after a single shot, will protect at least for five years. And then we have another study that we have been working on in potentially immunocompromised patients. When we look at LIME, as I said, we consider LIME the single largest value driver for Valneva.

Speaker Change: The ongoing antibody persistence and long-term safety study in adults is a very important study because it will further substantiate our hypothesis that this vaccine after a single shot will protect at least for five years.

Speaker Change: And then we have another study that we have been working on in potentially immunocompromised adults.

Speaker Change: When we look at LIME, as I said, we consider LIME the single largest value driver in Vannevar.

Thomas Lingelbach: And very importantly, we have shown that there is no difference in immunogenicity between younger and older adults. The vaccine has been generally well tolerated among the more than three and a half thousand adults and more than 700 adolescents evaluated for safety so far. When we look at the US launch success and where we are right now, we made some recent achievements. We launched the unbranded traveler campaign to build consumer awareness. The BHA, IHD adopted the CDC recommendations and published the Czechongonia virus and vaccine guidance and we are continuously growing our customer base, distributors and customers reordering X-Chic already.

Thomas Lingelbach: It's the only Lyme disease program in advanced clinical development today. You know, you have heard it many, many times, but it's a multivalent recombinant protein-based vaccine covering the six most prevalent serotypes of Lyme borreliosis in the Northern Hemisphere. It's based on an established mode of action, out-of-surface protein A and antibodies able to basically kill the spiresides in the mid-gabbit of the tick.

Speaker Change: It's the only Lyme disease program in advance clinical development today.

Speaker Change: You know, you have heard it many, many times, but it's a multivalent recombinant protein-based vaccine covering the six most prevalent serotypes of Lyme borreliosis in the Northern Hemisphere.

Speaker Change: It's based on an established mode of action, autosurface protein A and anti-osteohantibodies able to...

Speaker Change: basically killed the spirocytes in the midst of the tick.

Thomas Lingelbach: And the single largest achievement in the first half of this year has been the completion of the primary vaccination enrollment, a great achievement by the joint teams at Pfizer and Valneva. You remember that we have estimated the market to be above $1 billion in sales, and, as you also know, Valneva will be eligible for upfront and milestone payments, up to more than $400 million, of which we have received thus far $165 million. There's a tiered royalty model in place subject to sales levels between 14 and 22.

Speaker Change: And the single largest achievement in the first half of this year has been the completion of the primary vaccination enrollment. Great achievement by the joint teams at Pfizer and Vannevar.

Speaker Change: You remember that we have estimated the market to be above 1 billion in sales and as you also know, Barneva will be eligible for up-front and milestone payments.

Thomas Lingelbach: What coming up, of course, this is a try-challenging endeavor because we are talking about a brand new disease, brand new vaccine, so we are investing significantly in building awareness, building recommendations, building adoption, and as next steps we see really the publication of the Czechongonia vaccine recommendations in MMWR, which is still pending. Continue working with CDC to raise awareness of COVID threats, including recent significant cases in Brazil. And the ACIP is expected to discuss guidelines for endemic island regions, EIE, Puerto Rico, and the review is planned for October this year with a vote in February of 2025.

Speaker Change: up to more than $400 million, of which we received thus far 165. There's a tiered royalty model in place, subject to sales levels in between 14 and 22 percent.

Thomas Lingelbach: There are a couple of key important milestones coming up. We completed our cost contribution to the LIME program in the first half of this year, as I mentioned during my introduction. And we expect the two-year antibody persistence and booster results in the third quarter this year. This is just by way of reminder; this is immunogenicity data post-second booster. So it will give us an indication about the necessity for annual boostering, and of course, with all of that, we are on track for three readouts at the end of 2025, with regulatory findings expected in 2020. Page number 15 shows, again, the overall study design of Phase 3, a secrecy study which was a placebo-controlled randomized study, one-to-one randomized against placebo, two-to-one North America versus European sites.

Speaker Change: There were a couple of key important milestones coming up. We completed our cost contribution to the LIME program in the first half of this year, as I mentioned during my introduction.

Speaker Change: and we expect the two-year antibody persistence and booster results in the third quarter this year. This is just by way of reminder, this is immunogenicity data post second booster.

Thomas Lingelbach: And when you look at the territory expansion, you see already on slide 11 that we have many boxes picked. US done, of course, labeling tension for adolescents, PDI-trake, but also antibody assistance is coming up. Canada, we got the approval. Also, they are labeling tensions with follow. In Europe, everything so far achieved according to plan, slightly ahead of plan, as I said, MHRAFU will still outstanding for the UK and then also here as next steps post-licensure labeling tension submissions.

Speaker Change: So it will give us an indication about the necessity for annual boostering.

Speaker Change: And of course, with all of that, we are on track for the phase three readout at the end of 2025.

Speaker Change: with regulatory findings expected in 2026.

Speaker Change: Page number 15 shows again the overall study design of the phase 3 efficacy study, which is.

Thomas Lingelbach: We have the Brazilian licensure process ongoing and we are targeting additional markets with established travelist markets, but also additional LMIC territories, including on the basis of WHO pre-qualification. When we look at the ongoing clinical activities, which as I mentioned at the beginning, are supported by the new more than 40 million dollar tech grants. We have the post-marketing effectiveness study, phase four, which are reality two studies, one observation on effectiveness study and participants greater than 12 years of age in Brazil, and so-called practice of age in Brazil, and so-called pragmatic randomized controlled effectiveness and safety study in adults, and then demicountry with roughly 12 years of age.

Speaker Change: placebo-controlled randomized study, one-to-one randomized against placebo, two-to-one North America versus European sites, and the primary endpoint is the rate of confirmed Lyme disease cases after two consecutive tick seasons, meaning

Thomas Lingelbach: And the primary endpoint is the rate of confirmed Lyme disease cases after two consecutive tick seasons, meaning Primary Immunization plus First Booster with a secondary endpoint including efficacy after the first Lyme season, meaning after the completion of the primary. So overall, we are very excited about the progress around Lyme, and we are very grateful to our partner, Pfizer, that we will be able to run the study according to our guidance and plan.

Speaker Change: primary immunization plus first booster with a secondary endpoint including the efficacy after the first Lyme season, meaning after the completion of the primary series.

Speaker Change: So, overall, we are very excited about the progress around Lyme, and we are very grateful to our partner Pfizer that we will be able to manage the study according to our guidance and plan.

Thomas Lingelbach: When we look at Shigella, as I mentioned during my introduction, it is a wonderful opportunity that we have generated here through the Strategic Partnership for Slima Tech. The product candidate is called S4B, and it is really a unique opportunity to develop a first-in-class vaccine for a life-threatening disease. It is the most advanced tetravalent Shigella program in the world. It's based on a so-called bioconigation technology, and has the potential to cover up to 85% of the Shigella, the license that we have entered into as part of our strategic partnership with Lima Tech is the global one, and the vaccine candidate is, as I said, a four-valent covering the most Lima Tech already reported positive phase 12 clinical data, including robust immunogenicity and, We estimate the market opportunity for Shigella vaccine to exceed half a billion dollar annually.

Speaker Change: When we look at Shigella, as I mentioned during my introduction, it is a wonderful opportunity that we have generated here through the strategic partnership with LIMATEC.

Thomas Lingelbach: 20,000 people. The label extensions, I mentioned already, we completed the phase three successfully for the lessons and the phase two for children one to 11 years of age is already fully enrolled. The ongoing antibody persistence and long-term safety study in adults is a very important study because it will further substantiate our hypothesis that this vaccine after a single shot will protect at least for five years. And then we have the another study that we have been working on in potentially immunocompromised adults.

Speaker Change: The product candidate is called S4V, and it is really a unique opportunity to develop a first-in-class vaccine for a life-threatening disease.

Speaker Change: It is the most advanced tetravalent Shigella program in the world. It's based on a so-called bioconjugation technology and has the potential to cover up to 85% of the Shigella infections.

Speaker Change: The license that we have entered into as part of our strategic partnership with LIMATEC

Thomas Lingelbach: When we look at Lyme, as I said, we consider Lyme the single largest value driver in Valneva. It's the only Lyme disease program in advanced clinical development today. You know, you have heard it many, many times, but it's a multivalent component protein-based vaccine covering the six most prevalent stereotypes of Lyme Boraliosis in the northern hemisphere. It's based on an established mode of action out of surface protein A and anti-ospei antibodies able to be basically kill the spirocides in the mid-gabbit of the tick.

Speaker Change: is a global one, and the vaccine candidate is, as I said, a four-valent covering the most pathogenic Shigella bacteria serotypes.

Speaker Change: Limatech already reported positive phase 1-2 clinical data, including robust immunogenicity and favorable safety and tolerability data.

Speaker Change: We estimate the market opportunity for El Shigella vaccine to exceed

Thomas Lingelbach: And it's a wonderful plug and play because we are seeing here a very similar commercial footprint, namely travelers, military from high income countries, but LMICs as well. And here specifically, children living in endemic areas. It is the second leading cause of fatal diarrheal disease, with up to estimated more than 150 million cases and more than 600,000 deaths are attributed annually to Shigana.

Speaker Change: half a billion dollars annually.

Speaker Change: and it's a wonderful plug-and-play because we are...

Thomas Lingelbach: And the single largest achievement in the first half this year has been the completion of the primary vaccination enrollment grade achievement by the joint teams advisor and Valneva. You remember that we have estimated the market to be about one billion in sales. And as you also know, Valneva will be eligible for upfront and milestone payments up to more than $400 million of which we received as far 165. There's a TS Royal Team model in place subject to sales levels in between 14 and 22%.

Speaker Change: seeing here a very similar commercial footprint, namely travelers, military from high-income countries, but LMICs as well, and here specifically children living in endemic countries.

Speaker Change: It is the second leading cause of fatal diarrheal disease. Up to estimated more than 150 million cases and more than 600,000 deaths are attributed annually to Shigella.

Thomas Lingelbach: Therefore, it has been identified as a priority vaccine by WHO. In terms of upcoming milestones, I mentioned at the very beginning of this call, we will soon start phase two, the first phase two, gym studies, gym means controlled human infection models or it's a human challenge study in the US, in adults and phase two, a pediatric study in LMI Cs, both will be let and conducted by Lima Tech before then, and Valneva will take over further activities. We will start already, you know, working The page number 18 shows the overall key terms of the strategic partnership with CMATEC, and here you see basically how the partnership works.

Speaker Change: and therefore it has been identified as a priority vaccine by WHO.

Speaker Change: In terms of upcoming milestones, I mentioned at the very beginning of this call, we will soon start the first Phase II GEM study. GEM means Controlled Human Infection Models, so it's a human challenge study.

Thomas Lingelbach: There are a couple of key important milestones coming up. We completed our cost contribution to the Lyme program in the first half of this year, as I mentioned during my introduction. And we expect the two-year antibody persistence and booster results in the third quarter this year. This is just by way of reminder, this is immunogenicity data post-second booster. So it will give us an indication about the necessity for annual boostering. And of course, with all of that, we are in track for the say three readout at the end of 2025 with regulatory findings expected in 2026.

Speaker Change: in the U.S., in adults, and Phase II pediatric study in LMICs. Both will be led and conducted by LIMATEC.

Speaker Change: Before then, Vaneva will take over further activities.

Vaneva: We will start already, you know, working on a couple of things immediately, like CMC and regulatory activities.

Vaneva: And of course, given the exclusive global license nature, we will be responsible for worldwide commercialization if approved.

Vaneva: The page number 18 shows the overall key terms of the strategic partnership with Simatec.

Thomas Lingelbach: So, LIMATEC receives an upfront payment, and it's a little eligible for future milestone and royalty payments. The upfront payment is 10 million euros, and all the further development, regulatory, and sales-based milestones will go up to 40 million. There's a low double-digit royalty on net sales and a travel segment, and additional payments, and single-digit royalties based on commercialization in NM.

Vaneva: and here you see basically how the partnership works.

Thomas Lingelbach: Page number 15 shows, again, the overall study design of the phase three efficacy study, which is placebo controlled, randomized study, one-to-one randomized, against placebo, two-to-one, North America versus European sites. And the primary endpoint is the rate of concern on climate disease cases after two consecutive tick seasons, meaning Primer immunization plus first booster was a secondary endpoint including the efficacy after the first line season, meaning after the completion of the primary series. So overall, we are very excited about the progress around line and we are very grateful to our partner Pfizer that we will be able to manage the study according to our guidance and plan.

Vaneva: So Lima Tech receives an upfront payment, is eligible for future milestone and royalty payments.

Vaneva: The upfront payment is 10 million euros.

Vaneva: and all the further development, regulatory and sales-based milestones will go up to $40 million. There's a low double-digit royalty on net sales in the travel segment, and additional payments and single-digit royalties based on commercialization in NMICs.

Thomas Lingelbach: As I mentioned, it's a true partnership. So we collaborate through phase two. LIMATEC conducts the first phase two human challenge study, which is a challenge with the SONI serotype and the pediatric immunogenicity study.

Vaneva: As I mentioned, it's a true partnership.

Vaneva: So we collaborate through the phase two. Limatech conducts the first phase two human challenge study, which is a challenge with...

Thomas Lingelbach: Then, you know, Valneva will take the lead and initiate a second phase two GYM study against the second serotype, namely FLEX2A. And, of course, LIMATEC and Valneva have already started working on tech transfer, and the IND will be transferred to Valneva once all phase two studies are fully in place. And then, you know, Valneva will lead and manage all future developments.

Vaneva: sonai serotype and the pediatric immunogenicity study. Then Valneva will take the lead and initiate a second phase two GYM study against the second serotype namely FLEX2A.

Thomas Lingelbach: When we look at Shigella, as I mentioned during my introduction, it is a wonderful opportunity that we have generated here through the Strategic Partnership for Slima Tech. The product candidate is called S4B and it is really a unique opportunity to develop a first-in-class vaccine for a life-threatening disease. It is the most advanced tetravalent Shigella program in the world. It's based on a so-called bioconigation technology and it has the potential to cover up to 85% of the Shigella infections.

Vaneva: and of course Lima Tech and Valneva have already started working on tech transfer and the IND will be transferred to Valneva once all phase two studies are fully enrolled.

Speaker Change: And then, you know, Waldnehmer will lead and manage all future development activities.

Thomas Lingelbach: So overall, we are really excited about this fantastic opportunity. You may recall that enhancing our R&D pipeline has always been one of our strategic objectives. And therefore, we are thrilled that we have found an opportunity for a potential first-in-class vaccine for a life-threatening disease, so fully in line with our mission and vision. So, when we talk a little bit about Tika, you know that we started a phase one study with our so-called optimized second generation vaccine candidate, VLA-1601. It should, in reality, be called VLA-1601.2 because it's the second generation.

Speaker Change: Peace.

Speaker Change: So overall, we are really excited about this fantastic opportunity. You may recall that augmenting our R&D pipeline has always been one of our strategic objectives.

Speaker Change: and therefore we are thrilled that we found an opportunity for a potential first-in-class vaccine for a life-threatening disease so fully in line with our mission and vision.

Thomas Lingelbach: The license that we have entered into as part of our Strategic Partnership with Slima Tech is a global one and the vaccine candidate is, as I said, a four-valent covering the most pathogenic Shigella bacteria-zero types. Slima Tech already reported positive phase one, two clinical data including robust immunogenicity and favorable safety and tolerability data. We estimate the market opportunity for Shigella vaccine to exceed half a billion dollar annually and it's a wonderful black-and-play because we are seeing here a very similar commercial footprint, namely, travelers, military from high-income countries but LMICs as well and here specifically children living in endemic countries.

Speaker Change: So when we talk a little bit about Zika, you know that we started a phase one study.

Speaker Change: with our so-called optimized second-generation vaccine candidate, VLA-1601. It should in reality be called VLA-1601.2 because it's a second generation.

Speaker Change: activated, inactivated whole virus.

Thomas Lingelbach: Active-ended, inactivated whole virus; we are a platform that we originally developed for Xero, then further optimized for our COVID vaccine, VLA-2001, and upscaled. So, we use, like for like, a technological approach here. And as you know, the Tika virus is coming back. It's reemerging, and it's another mosquito-transmitted disease with devastating clinical attacks, and there are no vaccines or specific treatments available. It's also worth noting that Sika is a P.R.V.

Speaker Change: We are leveraging here the platform that we originally developed for Xero, then further optimized for our COVID vaccine VLA-2001 and upscaled. So we use like-for-like.

Speaker Change: technological approach here and as you know the the Zika virus is coming back it's re-emerging

Thomas Lingelbach: It is the second leading cause of fatal diarrhea disease, up to estimated more than 150 million cases and more than 600,000 deaths are attributed annually to Shigella and therefore it has been identified as a priority vaccine but WHO. In terms of upcoming milestones, I mentioned at the very beginning of this call, we will soon start the phase two. The first phase two, gym studies, gym means controlled human infection models or it's a human challenge study in the US, in adults and phase two, pediatric study in LMICs.

Speaker Change: and it's another mosquito transmitted disease with devastating clinical effects. And there are no vaccines or specific treatments available. Also worth noting that Zika is PRV eligible.

Thomas Lingelbach: eligible, and many different organizations are currently discussing potential funding mechanisms around tick. In terms of upcoming milestones, of course, we are currently executing the phase one study, and, subject to data, we will then consider the future development strategy in the first half. With this remarkable progress on our R&D and strategic development front, we come to the financials, and it's a pleasure to hand over to Peter. Thank you, Thomas, and good morning and good afternoon to all of you.

Speaker Change: and many different organizations are currently discussing potential funding mechanisms around Zika.

Speaker Change: In terms of upcoming milestones, of course, we are currently executing the phase one study and subject to data we will then consider the future development strategy in the first half of next year.

Thomas Lingelbach: Both will be let and conducted by Llima Tech before then Valneva will take over further activities. We will start already working on a couple of things immediately, like CMC and regulatory activities and of course given the exclusive global life and nature, we will be responsible for work by coming to the day soon.

Speaker Change: year.

Speaker Change: With this remarkable progress on our R&D and strategic development front we come to the financials and it's a pleasure to hand over to Peter.

Peter: Thank you, Thomas, and good morning and good afternoon to all of you.

Thomas Lingelbach: Product sales for the first half year reached 68.3 million euros and, on a comparable basis, grew 7% over the prior year. However, including last year's sales of the COVID-19 vaccine, sales declined by minus 2%. The impact of currency fluctuation is negligible.

Peter: Product sales for the first half year reached 68.3 million euros and on a comparable basis grew 7% over prior year. Including last year's sales of the COVID-19 vaccine, sales declined by minus 2%. The impact of currency fluctuation is neglectable.

Thomas Lingelbach: and Peter Buhler. The page number 18 shows the overall key terms of the strategic partnership with HEMA Tech, and here you see basically how the partnership works. So, HEMA Tech receives an upfront payment. It's a little eligible for future milestone and royalty payments. The upfront payment is 10 million euros, and all the further development, regulatory and safe spend milestones will go up to 40 million. There's a low double digit royalty on net sales, and a travel segment, and additional payments, and single digit royalties based on commensalization in NMICs.

Peter Buhler: Total Xero sales reached 41.9 million euros and increased by 38% over the prior year. The strong year-over-year growth was primarily driven by sales to the U.S. military that were low in the first half of 2023. Xero sales into the travel market also delivered growth over the first half year, despite supply constraints experienced during the first quarter. XER's supply constraints were fully resolved in the second. Ducroix sales declined year-over-year by minus 13 percent and reached 14.9 million euros in the first half of 2024.

Peter: Total Xero sales reached 41.9 million euros, an increase by 38% over prior year. The strong year-over-year growth was primarily driven by sales to U.S. military that were low in the first half of 2023.

Peter: The Xearo sales into the travel market also delivered growth over the first half year despite supply constraints experienced during the first quarter.

Peter: XCR supply constraints were fully resolved in the second quarter.

Peter: Ducorol sales declined year over year by minus 13 percent and reached 14.9 million euros in the first half of 2024.

Peter Buhler: The decrease is mainly related to reduced marketing investment, as our new manufacturing site in Sweden underwent regulatory evaluation and approval. In terms of our ongoing launch of our new chikungunya vaccine, X-Chik, we reported sales of 1 million euros by June 30th in the United States. As a reminder, the ACIP recommendation for X-Chik was adopted by the CDC in March of this year. In line with our expectations, third-party products declined by minus 37 percent year-over-year to reach 10.5 million euros as a result of supply constraints.

Thomas Lingelbach: As I mentioned, it's a two partnerships. So, we collaborate through the phase two. Lema Tech conducts the first phase two human challenge study, which is a challenge with Sonya, Syritide, and the pediatric immunogenicity study, then Valneva will take the lead and initiate a second phase two gym study against a second Syritide, namely Flex2A, and of course, Lema Tech and Valneva have already started working on tech transfer, and the IND will be transferred to Valneva once all phase two studies are fully involved. And then Valneva will lead and manage all future development activities.

Peter: The decrease is mainly related to reduced marketing investment, as our new manufacturing site in Sweden underwent regulatory evaluation and approval.

Speaker Change: In terms of our ongoing launch of our new Chikungunya vaccine, X-Chik, we report sales of 1 million euros by June 30th in the United States. As a reminder, the ACIP recommendation for X-Chik was adopted by the CDC in March of this year.

Speaker Change: In line with our expectations, third-party products declined by minus 37 percent year-over-year to reach 10.5 million euros as a result of the supply constraint.

Peter Buhler: Moving on to the income statement. Total revenues reached €70.8 million versus €73.7 million in the first half of 2023. This decrease of 4% is driven by, as I already mentioned, last year's revenue related to the COVID-19 vaccine and lower revenues recognized from R&D collaborations, as well as our prior year revenues related to the closure of our clinical trials material manufacturing site in Sweden. Looking at expenses, we observe a significant decrease in the cost of goods and services from 53.8 million euros in the first half of 2023 to 45.6 million euros in the current first half year.

Speaker Change: Moving on to the income statement.

Peter Buhler: Ixiaro gross margin reached 57.5% of Ixiaro product sales compared to 40.2% in the first half of 2023. In the prior year, the Xero cross-margin was adversely impacted by batch write-offs. Duke Royal generated a gross margin of 34.8%, while third-party products yielded a gross margin below 30%.

Speaker Change: Total revenues reached 70.8 million euros versus 73.7 million euros in the first half year of 2023.

Speaker Change: The decrease of 4% is driven by, as already mentioned, last year's revenue related to COVID-19 vaccine and lower revenues recognized from R&D collaborations, as well as our prior year revenues related to the divestiture of our clinical trials material manufacturing site in Sweden.

Thomas Lingelbach: So, overall, we are really excited about this fantastic opportunity. You may recall that augmenting our R&D pipeline has always been one of our strategic objectives, and therefore, we as well that we found an opportunity for a potential first-in-class vaccine for a life-threatening disease, so fully in line with our mission and vision.

Speaker Change: Looking at expenses, we observe a significant decrease in cost of goods and services from €53.8 million in the first half of 2023 to €45.6 million in the current first half year.

Thomas Lingelbach: So, when we talk a little bit about TICA, you know that we started a phase one study with our so-called optimized second-generation vaccine candidate, VLA-1601. It should, in reality, call VLA-1601.2 because it's a second-generation, activated inactivated whole virus. We are leveraging here the platform that we originally developed for Xiaro, then further optimized for our COVID vaccine, VLA-2001, and upscaled. So, we use a light-for-like technological approach here. And as you know, the TICA virus is coming back, it's reemerging, and it's another mosquito transmitted disease with devastating clinical attacks, and there are no vaccines or specific treatments available. It's also worth noting that TICA is BRV eligible, and many different organizations are currently discussing potential funding mechanisms around TICA.

Speaker Change: Xero gross margin reached 57.5% of Xero product sales, compared to 40.2% in the first half of 2023. In the prior year, the Xero gross margin was adversely impacted by batch write-ups.

Speaker Change: Ducoral generated a gross margin of 34.8% while third-party products yielded a gross margin below 30%.

Peter Buhler: The total gross margin excluding X-TRIC grew to 47.7% from 40% in the first half year of 2023. However, the total gross margin is also adversely affected by X-TRIC-related overhead costs as well as idle costs related to our new manufacturing size. In the second half of the year, we expect further cross-margin improvements as supply shortages have been resolved. Research and development expenses increased from €26 million in the first half of 2023 to €29.7 million in the first half of fiscal year 2023.

Speaker Change: The total gross margin excluding ex-CHIC grew to 47.7% from 40% in the first half year of 2023.

Speaker Change: However, the total gross margin is also adversely affected by x-check related overhead costs as well as idle costs related to our new manufacturing site.

Speaker Change: In the second half of the year, we expect further cross-margin improvements as supply shortages have been resolved.

Speaker Change: Research and development expenses increased from 26 million euros in the first half of 2023 to 29.7 million euros in the first half of fiscal year 2023.

Peter Buhler: That increase mainly relates to tech transfer costs for the transfer of our XTRO and XTRIG manufacturing operations to our new Almeida site in Scotland, as well as higher R&D spend for XTRIG as we continue to execute ongoing studies. Furthermore, marketing and distribution expense increased by approximately 15% to reach 23.2 million euros. The increase is related to increased launch costs related to our X-Chick vaccine that also include higher personnel costs as we expanded our commercial team. G&A expenses were reported at 22.8 million euros and remained stable year over year.

Speaker Change: That increase mainly relates to tech transfer costs for the transfer of our XTRO and X-Chick manufacturing operations to our new Almeida site in Scotland, as well as higher R&D spent for X-Chick as we continue to execute ongoing studies.

Thomas Lingelbach: In terms of upcoming milestones, of course we are currently executing the Phase One study and subject to data, we will then consider the future development strategy in the first half of next year.

Speaker Change: Marketing and distribution expense increased by approximately 15% to reach 23.2 million euros. The increase is related to increased launch cost related to our X-Chick vaccine that also include higher people cost as we expanded our commercial team.

Peter Buhler: With this remarkable progress on our R&D and strategic development front, we come to the financials and the pleasure to hand over to Peter. Thank you Thomas and good morning and good afternoon to all of you. Product sales for the first half year reached 68.3 million euros and on a comparable basis grew 7% over the prior year, including last year sales of the COVID-19 vaccine sales declined by minus 2%.

Speaker Change: G&A expense were reported at 22.8 million euros and remained stable year over year.

Peter Buhler: The sale of the PRV generated net other income of 90.8 million euros, which contributed to an operating profit of 46.8 million euros versus an operating loss of negative 35 million euros in the prior year. Adjusted EBTA improved from minus 28 million euros to positive EBTA of 56 million euros. Now moving to slide 25. As discussed during our full year 2020 earnings release, we expect revenues to double by the time Line is launched.

Speaker Change: The sale of the PRV generated net other income of 90.8 million euros, which contributed to an operating profit of 46.7 million euros versus an operating loss of negative 35 million euros in the prior year.

Speaker Change: Adjusted EBTA improved from minus 28 million euros to positive EBTA of 56 million euros.

Peter Buhler: The impact of currency fluctuation is neglectable. Total exearo sales reached 41.9 million euros and increased by 38% over the prior year. The strong year over year growth was primarily driven by sales to US military that were low in the first half of 2023. Exearo sales into the travel market also delivered growth over the first half year despite supply constraints experienced during the first quarter. Exearo's supply constraints were fully resolved in the second quarter. 2 crores sales declined year over year by minus 13% and reached 14.9 million euros in the first half of 2024.

Speaker Change: Now moving to slide 25.

Speaker Change: As discussed during our full year 2023 earnings release, we expect revenues to double by the time LIME is launched.

Peter Buhler: The main driver of this anticipated sales growth is, of course, the addition of sales derived from our Xtrick vaccine but also the expected continuous growth of Xero. Next slide, please. We confirm our guidance for fiscal year 2024 with product sales of 160 to 180 million euros, other income of 100 to 110 million euros, and R&D expense of 60 to 75 million euros. It should be noted that the edition of the Shigella program does not change our RD expense guidance for the year.

Speaker Change: The main driver of this anticipated sales growth is of course the addition of sales derived from our X-TRIG vaccine, but also expected continuous growth of Xero.

Speaker Change: Next slide, please.

Speaker Change: We confirm our guidance for fiscal year 2024 with product sales of €160-180 million, other income of €100-110 million and R&D expense of €60-75 million.

Peter Buhler: The decrease is mainly related to reduced marketing investments as our new manufacturing sites in Sweden underwent regulatory evaluation and approval. In terms of our ongoing launch of our new Chikunguni vaccine, EXTIC, report sales of 1 million euros by 2 and 30th at the United States. As a reminder, the ACIP recommendation for EXTIC was adopted by the CDC in March of this year.

Speaker Change: It is to be noted that the addition of the Shigella program does not change our R&D expense guidance for the year.

Peter Buhler: As we have completed our contribution to the budgeted Lime Phase III trial, we expect a significantly lower cash burn in the second part of the year. We also confirm our midterm guidance, including double-digit CAGR growth of XER over the next three years and X-Trick sales exceeding 100 million euros in year three of launch. With that, I hand the call back to Thomas.

Speaker Change: As we completed our contribution to the budgeted LIME Phase III trial, we expect a significantly lower cash burn in the second part of the year.

Speaker Change: We also confirm our midterm guidance, including double-digit CAGR growth of XCR over the next three years.

Peter Buhler: In line with our expectations, third-party products declined by minus 37% year over year to reach 10.5 million euros as a result of supply constraints. Moving on to the income statement, total revenues reached 70.8 million euros versus 73.7 million euros in the first half year of 2023. The decrease of 4% is driven by, as already mentioned, last year's revenue related to COVID-19 vaccine and lower revenues recognized from R&D collaborations as well as our prior year revenues related to the vestiture of our clinical trials material manufacturing sites in Sweden.

Speaker Change: and Xtrick sales exceeding 100 million euros in year three of launch. With that I hand the call back to Thomas.

Thomas Lingelbach: Thank you so much, Peter. Yeah, let me conclude. Our presentation was slide 28. I mentioned all the key news flow items during my update on the individual programs and activities, but this is a summary of what we have still to expect. Onchic, the upcoming potential approvals in Brazil and the UK, submission for label extensions related to adolescence, antibody persistence data, and the initiation of the phase 4 clinical activities. Lyme, of course, a very important data set in the third quarter with the phase two, two-year antibody persistence and booster results.

Thomas: Thank you so much, Peter. Yeah, let me conclude our presentation with slide 28. I mentioned all the key news flow items during my update on the individual programs and activities, but this is the summary of what we have still to expect.

Speaker Change: ONCHIC, the upcoming potential approvals in Brazil and the UK

Speaker Change: The submission for label extensions, you know, related to adolescence, antibody persistence data, and the initiation of the Phase IV clinical activities.

Peter Buhler: Looking at expenses, we observe a significant decrease in cost of goods and services from 53.8 million euros in the first half of 2023. To 45.6 million euros in the current fat first half year. XERO Gross Marching reached 57.5% of XERO product sales compared to 40.2% in the first half of 2023.

Speaker Change: Lyme, of course, a very important data set in the third quarter with the phase two, two-year antibody persistence and booster results.

Thomas Lingelbach: Then, of course, we hope that we will be on time to complete all booster vaccinations ahead of the tick season 2025 and then the primary data readout at the end of 2025. It says here study completion, but it's not study completion because, of course, the study continues for a longer time, but this is the primary endpoint readout and the secondary endpoint.

Speaker Change: Then, of course, we hope that we will be on time to complete also all booster vaccinations ahead of the tick season 2025.

Peter Buhler: In the prior year, the XERO Gross Marching was adversely impacted by batch-ride drops. Two coral generated a gross margin of 34.8% while third-party products yielded a gross margin below 30%. The total gross margin, excluding X-trick, grew to 47.7% from 40% in the first half year of 2023.

Speaker Change: and then the primary data readout at the end of 2025. It says here, study completion is not study completion because of course study continues for a longer time, but this is the primary endpoint readout and secondary endpoint readout.

Peter Buhler: However, the total gross margin is also adversely affected by X-trick-related overhead costs as well as idle costs related to our new manufacturing sites.

Thomas Lingelbach: Then, the additional new flow around the Department of Defense; we expect a new supply contract for Xero in the last quarter of this year. And now, with the newly augmented program, the initiation of the phase two studies, both the first chimpanzee study, as well as the pediatric immunogenicity study in LMSC. And then, you know, look a little bit into the earlier part of next year for the phase one data for our second generation CKB.

Speaker Change: Then the additional new flow around the Department of Defense, we expect a new supply contract for Xero.

Peter Buhler: Bart. In the second half of the year, we expect further cross-marching improvements as supply shortages have been resolved. Research and development expenses increased from 26 million euros in the first half of 2023 to 29.7 million euros in the first half of fiscal year 2023. That increased mainly related to tech transfer costs for the transfer of our XTRO and XTRO manufacturing operations to our new Almeida site in Scotland, as well as higher R&D spend for XTRIC as we continue to execute ongoing studies.

Speaker Change: in the last quarter this year.

Speaker Change: and now with the newly augmented program, the initiation of the phase two studies, both the first CHIM study as well as the Pediatric Immunogenicity Study in LMSC.

Speaker Change: and then, you know, go looking a little bit into the earlier part of next year, the phase one data for our second generation Zika vaccine.

Thomas Lingelbach: This concludes the presentation, and I would like to hand it back to the operator to take questions. Thank you. As a reminder, to ask a question, you will need to press star 11 on your telephone and wait for your name to be announced. To withdraw your question, please press star 11 again. We will now take our first question. Please stand by. And the first question comes from the line of Suzanne Van Voorthuizen from Van Lanschot Kempen.

Speaker Change: This concludes the presentation and I would like to hand back to the operator to take the questions.

Peter Buhler: Marketing and distribution expense increased by approximately 15 percent to reach 23.2 million euros. The increase is related to increased launch cost related to our XTRIC vaccine that also includes higher people cost as we expanded our commercial team. G&A expense were reported at 22.8 million euros and remains stable year over year. The sale of the PRV generated net other income of 90.8 million euros, which contributed to an operating profit of 46.8 million euros versus an operating loss of negative 35 million euros in the prior year. A trusted EBTA improved minus 28 million euros to positive EBTA of 56 million euros.

Speaker Change: Thank you. As a reminder to ask a question you will need to press star 11 on your telephone and wait for your name to be announced. To withdraw your question please press star 11 again.

Speaker Change: We will now take our first question. Please stand by.

Speaker Change: And the first question comes from the line of Suzanne Van Voorthuizen from Van Lanschot Kempen. Please go ahead, your line is now open.

Operator: Please go ahead; your line is now open. Hi, team. Thanks for taking my questions. Maybe to start off on the xCheck launch, now with many approvals in the pocket in your first full quarter of sales, can you walk us through which markets xCheck is available today to the end customer? And can you expand on which territories you expect to be the most important contributors to sales in the future?

Speaker Change: Hi, team. Thanks for taking my questions.

Speaker Change: Maybe to start off on the xCheck launch, now with many approvals in the pocket and your first full quarter fills in.

Speaker Change: Can you walk us through which markets ICTiC is available today to the end customer? And can you expand on which territories you expect to be the most important contributors to sales in the future? And, yeah, providing the path to your...

Peter Buhler: Now moving to slide 25. As discussed during our full year 2023 earnings release, we expect revenues to double by the time line is launched. The main driver of this anticipated sales growth is of course the addition of sales derived from our XTRIC vaccine, but also expected continuous growth of XTRO.

Speaker Change: guidance of over 100 million within three years and then I have a follow-up. Good. Okay, so let me start off by the... so basically right now the vaccine is only available in the United States.

Thomas Lingelbach: And yeah, providing the path to your guidance of over $100 million within three years. And then I have a follow-up. Okay. Okay, so let me start off by saying...

Peter Buhler: Next slide please. We confirm our guidance for fiscal year 2024 with product sales of 160 to 180 million euros, other income of 100 to 110 million euros and R&D expense of 60 to 75 million euros. It is to be noted that the addition of the Shigella program does not change our R&D expense guidance for the year. As we completed our contribution to the budgeted line phase 3 trial, we expect a significantly lower cash burn in the second part of the year. We also confirm our midterm guidance, including double digit Kager growth of XTR over the next three years and XTRIC sales exceeding 100 million euros in year three of launch.

Thomas Lingelbach: So basically, right now, the vaccine is only available in the United States. We got the approvals in Canada and Europe, as you know, slightly ahead of our own expectations. You may recall that we originally said we would launch the vaccine outside the US at the very beginning of 2025. We hope that we are now in a position to launch the vaccine in selected European countries and Canada, already in the fourth quarter.

Speaker Change: We got the approvals in Canada and Europe, as you know, slightly ahead of our own expectation. You may recall that we originally said

Speaker Change: We would launch XUS at the very beginning of 2025.

Speaker Change: We hope that we are now in a position to launch in selected European countries and Canada already in the fourth quarter.

Thomas Lingelbach: So all the preparatory activities are ongoing. You know that there's a lot to be done post-approval, country-specific, and this is currently in the process. So to manage expectations, we expect..., of course, failed to be very moderate in the ex-U.S. countries in the fourth quarter because there will be a launch in the fourth quarter. We have not yet finally decided where we are going to launch first in Europe, but this is currently under evaluation, and there are, of course, the typical, you know, key travel vaccination countries in Europe, and there are also countries in Europe which have a higher, you know, base awareness around chikungunya than others.

Speaker Change: So all the preparatory activities are ongoing. You know that there's a lot to be done post-approval, you know, country specific.

Thomas Lingelbach: With that, I hand the call back to Thomas. Thank you so much Peter.

Speaker Change: and this is currently in the make. So to manage expectations, we expect.

Thomas Lingelbach: Yeah, let me conclude our presentation with slide 28. I mentioned all the key news flow items during my update on the individual programs and activities, but this is the summary of what we have still to expect. On tick, the upcoming potential approvals in Brazil and the UK, the submission for label extensions, you know, related to other lessons, antibody persistence data, and the initiation of the phase 4 clinical activities. Line, of course, a very important data set in the third quarter with the phase 2 two-year antibody persistence and booster results.

Speaker Change: Of course, sales to be very moderate in the ex-U.S. countries in the fourth quarter because

Speaker Change: There will be a launch in the fourth quarter. We have not yet finally decided where we are going to launch first in Europe.

Speaker Change: But this is currently under evaluation and there are, of course, the typical, you know, key travel vaccination countries in Europe.

Speaker Change: And there are also countries in Europe which have a higher, you know, base awareness around chikungunya than others. All of that is currently under consideration.

Speaker Change: and hopefully we will be able to communicate around that very soon. When we talk about the sales expectation, we are still very confident about the...

Thomas Lingelbach: Then of course, we hope that we will be on time to complete also all booster vaccinations ahead of the tick season 2025, and then the primary data readout at the end of 2025. It says here study completion is not study completion because of course study continues for longer time, but this is the primary endpoint readout and tick in the ring, and what do we know? Then the additional news law around the Department of Defense, we expect a new supply contract for Xiaro in the last quarter of this year. And now with the newly augmented program, the initiation of the phase two studies, both the first chim study as well as the pediatric immunogenicity study in NMSC.

Thomas Lingelbach: All of that is currently under consideration, and hopefully, we will be able to communicate around that very soon. When we talk about the sales expectation, we are still very confident about the overall market size and the growth projection that we gave, the midterm growth projection that we gave for X-CHIC. It is a bit too early to say, you know, how it's really gonna play out.

Speaker Change: overall market size and the growth projection that we gave, the midterm growth projection that we gave for xChick.

Speaker Change: It is a bit too early.

Speaker Change: to say, you know, how it's really gonna play out.

Thomas Lingelbach: You may recall, we discussed it in the past; all travel vaccines in the past have shown an S-curve at the beginning. And so, you know, we have to see at which point we're really gonna see the steep increase. As I mentioned during the presentation, we still have a couple of things outstanding in the United States, MMWR being one, for example, very critical in order to facilitate X-CHIC growth from a U.S. perspective. And then, of course, all the respective recommendations for the ex-U.S. countries and then the introduction in the LMR. Got it, that's very helpful. And then my second question online.

Speaker Change: You may recall, we discussed it in the past, all travel vaccines in the past have shown an S curve at the beginning. And so the...

Speaker Change: You know, we have to see at which point we're really going to see the speed increase.

Speaker Change: As I mentioned during the presentation, we have still a couple of

Thomas Lingelbach: And then, you know, going looking a little bit into the earlier part of next year, the phase one data for our second generation TCA vaccine.

Speaker Change: Things outstanding in the United States, MMWR being one, for example, very critical.

Operator: This concludes the presentation and I would like to hand back to the operator to take a question. Thank you. As a reminder to ask a question, you will need to press star one on your telephone and wait for your name to be announced. To assure your question, please press star one one again. We will now take our first question. Please stand by. And the first question comes from the line of Suzanne Van Voorthuizen from Van the Landshopped Campaign.

Speaker Change: in order to facilitate the exit growth from a U.S. perspective, and then, of course, all the respective recommendations for the ex-U.S. countries, and then the introduction in the LMS.

Speaker Change: Got it. That's very helpful. And then my second question online, I wanted to follow up regarding the phase 2 two-year antibody persistence data that is expected in the next quarter.

Thomas Lingelbach: I wanted to follow up regarding the phase two year antibody persistence data that is expected in the next quarter or in this quarter, actually. Gave clarify what data sets we're expecting here. This is the second booster compared to no second booster, or yeah, can you remind us what the expectations are basically?

Speaker Change: or in this quarter, actually. Can you clarify what data set we're expecting here? Is this a second booster compared to no second booster? Or can you remind us what to expect, basically?

Operator: Please go ahead. Your line is not open. Hi, team. Thanks for taking my questions. Maybe to start off on the extra launch now with many approvals in the book in your first full quarter of sales. And can you walk us through which markets extra is available today to the end customer? And can you expand on which territories you expect to be the most important contributors to field in the future and yeah, providing the boss to your guidance of over 100 million within three years.

Thomas Lingelbach: Basically, it's the same as we reported after the first booster. So basically, you have the vaccination schedule 0-2-3. Then one year later, we measured the immunological response pre and post booster. And you may recall that after the first booster, we saw a very, very significant anamnestic response. So the immunological response post the first booster was by a substantial factor higher than the immunogenicity after priming.

Speaker Change: Basically, it's the same that we reported after the first booster. So basically, you have the vaccination schedule 0 to 6.

Speaker Change: Then you have, one year later, we measured the immunological response pre- and post-booster.

Speaker Change: And you may recall that after the first booster, we saw a very, very significant anamnestic response. So the immunological response post the first booster was by a substantial factor higher than the immunogenicity after priming.

Operator: And then I have a follow-up. Good. Okay, Suzanne, let me start off by the, so basically right now the vaccine is only available in the United States. We got the approvals in Canada and Europe. As you know, slightly ahead of our own expectations, you may recall that we originally said we would launch X-US at the very beginning of 2025. We hope that we are now in a position to launch in selected European countries and Canada already in the fourth quarter.

Thomas Lingelbach: Now we're going to look at the same situation one year later, so this means month 30, which is the second booster, so the immunogenicity data pre-booster, and then month 31, the immunogenicity data post the second booster. And here we will see what the immunological responses look like. We haven't seen the data yet, so it's hard to tell. But as you know, our current working hypothesis is that the Lyme vaccine will require an annual booster shot.

Speaker Change: Now we're going to look at the same situation one year later, so which means month 30, which is the

Speaker Change: the second booster, so that's the immunogenicity data pre-booster, and then month 31, the immunogenicity data post the second booster.

Speaker Change: and here we will see how the immunological...

Operator: So all the preparatory activities are ongoing. You know that there's a lot to be done post approval. You know, countries specific and this is currently in the make. So to manage expectations, we expect, of course, sales to be very moderate in the X-US countries in the first quarter because it will be a launch in the fourth quarter. We have not yet finally decided where we are going to launch first in Europe.

Speaker Change: you know responses look like. We haven't seen the data yet so it's it's it's hard to tell but as you know our current working hypothesis is that the Lyme vaccine will require an annual booster shot.

Thomas Lingelbach: And, of course, this immunogenicity data will give you a very good hint. Got it. And then, allow me to squeeze in one more online.

Speaker Change: And, of course, this immunogenicity data will give you a very good hint around this.

Thomas Lingelbach: Can you remind us of the phase two data and phase three set up how you expect the immunogenicity levels to translate into the primary endpoint of preventing cases and appreciating a fixerate rate very across different types of diseases that are prevented by vaccines? What a fixerate percentage do you think is good for marketing? These are two very complex and very challenging questions.

Speaker Change: Got it. And then allow me to squeeze in one more on Lyme. Can you remind us on the Phase 2 data and the Phase 3 setup, how you expect the immunogenicity labs to translate into the primary endpoints of preventing cases? Thank you.

Operator: But this is currently under evaluation and there are, of course, the typical, you know, key travel vaccination countries in Europe. And there are also countries in Europe which have a higher, you know, faith awareness around Chikungunya than others. All of that is currently under consideration and hopefully we will be able to communicate around that very soon. When we talk about the sales expectations, we are still very confident about the the overall market size and the growth projection that we gave, the midterm growth projection that we gave for X-Chic, it is a bit too early to say you know how it's really gonna gonna play out.

Speaker Change: appreciating efficacy rates vary across different types of diseases that are prevented by vaccines. What efficacy percentage do you think is good for marketing a Lyme vaccine?

Speaker Change: These are two very complex and very challenging questions. So let me start with the first one. I mean, unfortunately, there is nothing like an immunological correlate at this point in time.

Thomas Lingelbach: So let me start with the first one. I mean, unfortunately, there is nothing like an immunological correlate at this point in time. But as we have reported in the past, we see the immunological results, definitely in line with what prior vaccines have shown also. However, there is no direct comparability possible because of different FAs, and different vaccine constructs. But we feel confident, also based on all the published animal data, that our immune responses are definitely in line.

Speaker Change: So, but as we reported in the past,

Speaker Change: We see the immunological results.

Speaker Change: You know, definitely in line with what prior vaccines have shown. Also, there is no.

Speaker Change: direct comparability possible because of different essays, different

Speaker Change: vaccine constructs, but we feel confident also based on all the published, you know, animal data that our immune responses

Operator: You may recall we discussed it in the past, all travel vaccines in the past have shown an S-curve at the beginning and so that you know we have to see at which point it's really we're really gonna see the steep increase. As I mentioned during the presentation we have still a couple of things outstanding in the United States, MMWR being one for example very critical in order to facilitate the X-Chic growth from US perspective and then of course all the respective recommendations for the X-US countries and then the introduction in the elements.

Thomas Lingelbach: I think the other part on prevention of the disease is, we have discussed this a couple of times. We are in the efficacy study. We are measuring Lyme disease cases. Hence, we are measuring again a clinical endpoint. So the rate of confirmed Lyme cases in the vaccine group as compared to the placebo group. I mean, what is good?

Speaker Change: are definitely in line with or even better than what has been shown in the past. I think the other part on...

Speaker Change: The prevention of

Speaker Change: the disease. We have discussed this a couple of times.

Speaker Change: We are in the efficacy study. We are measuring Lyme disease cases. Hence, we are measuring, again, a clinical endpoint. So, rates of confirmed Lyme cases in the...

Speaker Change: vaccine group as compared to the placebo group. I mean, what is a good, what is a bad efficacy result? I would say...

Thomas Lingelbach: What is the bad efficacy result? I would say, any results that would give a strong recommendation I would consider a success. Don't push me for a percentage number; I'm not allowed. We got it. Thank you. Thank you. We will now take our next question. Please stand by, and the next question comes from the line of Evan Wang from Guggenheim Securities. Please go ahead. You'll understand.

Operator: Got it that's very helpful and then my second question online, I wanted to follow up regarding the phase two-year antibody persistence data that is expected in the next quarter or in this quarter actually gave clarify what data sets we're expecting here this is the second booster compared to no second booster or yeah can you remind us what the expected basically. Basically it's the same as we reported after the first booster so basically you have the vaccination schedule zero to six then you have one year later we we measured the immunological response pre and post booster and you may recall that after the first booster we saw a very very significant and amnestic response so the immunological response post the first booster was by the potential factor higher than the immunogenicity after priming now we're gonna look at the same situation one year later so which means month 30 which is the second booster so the immunogenicity data pre-booster and then month 31 the immunogenicity data post the second booster and here we will see how the immunological you know responses look like we haven't seen the data yet so it's hard to tell but as you know our current working hypothesis is that the line vaccine will require an annual booster shot and and of course this immunogenicity data we give you a very good hints around this.

Speaker Change: Any result that would give a strong recommendation, I would consider a success. Don't push me for a percentage number, I'm not allowed to say so.

Speaker Change: Thank you. We will now take our next question. Please stand by.

Speaker Change: And the next question comes from the line of Evan Wang from Guggenheim Securities. Please go ahead, your line is now open.

Operator: Hey guys, thanks for the question. To you from me, first on Bigg's Check, did you provide an update on some of the launch metrics in the US, just any additional commentary you can provide on the degree of, you know, how access and reimbursement progress is going, and what we're seeing in terms of, you know, some of the initial restocking and active accounts you have? and then on Chigella, appreciate, you know, or are happy to see that life and share.

Evan Wang: Hey guys, thanks for the question. Two for me. First on xCheck, can you provide an update on some of the launch metrics in the U.S.?

Evan Wang: Just any additional commentary you can provide on the degree of, you know, how access and reimbursement progress is going What we're seeing in terms of, you know, some of the initial restocking and active accounts you have

Speaker Change: And then on Shigella, appreciate, you know, or happy to see, you know, that licensure. You know, can you just talk about some of the upcoming trials you have planned? I know

Thomas Lingelbach: You know, can you just talk about some of the upcoming trials you have planned? I guess, first, you know, with the Lima Tech reported 40 results, when will we see that, you know, full data, either in publication or at an American conference? And then with your planned phase two immunogenicity study, can you remind us maybe how she thinks about that trial design relative to... The results that we saw from Kenya? Thanks.

Speaker Change: I guess first, you know, with the Limitech-reported S4G results, when will we see that, you know, full data either in publication or in a Velcro conference?

Speaker Change: And then with your planned phase two immunogenicity study, can you remind us maybe how we should think about that trial design relative to the results that we saw from Kenya? Thanks.

Thomas Lingelbach: So many questions; hopefully, I was able to capture those. So, on xChick, we are really seeing, as you rightly pointed out, that we are having customers reordering xChick, which is good because it means that slowly, slowly, the vaccine is being taken up. I think it's a bit too early to really talk about this in detail.

Speaker Change: So many questions, hopefully I was able to capture those. So I think on xshake...

Speaker Change: We are really seeing, as you rightly pointed out, that we are having customers reordering xChick, which is good because it means

Speaker Change: It's slowly, slowly, the vaccine is being taken up.

Speaker Change: I think it's a bit too early to really talk about this in detail. I think we have continued to grow the awareness of chikungunya and x-chik among HDPs.

Operator: Got it and then allow me to squeeze in one more on line can you remind us on the phase two data and phase three set up how you expect the immunogenicity loves to translate into the primary endpoint of preventing cases and appreciating a fixed rates vary across different types of diseases that are presented by vaccines what a efficacy percentage do you think is good for marketing and line vaccine. These are two very complex and very challenging questions so let me start with the first one I mean unfortunately there is nothing like an immunological correlate at this point in time so but as we reported in the past we see the immunological results you know definitely in line with what prior vaccines have shown also there is no direct comparability possible because of different essays different vaccine constructs but we feel confident also based on all the published you know animal data that our immune responses are definitely in line with or even better than what has been shown in the past I think the other part on the the prevention of the disease we have discussed this a couple of times we are in the efficacy study we are measuring Lyme disease cases hence we are measuring again a clinical endpoint so rates of confirmed Lyme cases in the vaccine group as compared to the placebo group I mean what is a good what is the bad efficacy result I would say Any results that would give a strong recommendation, I would consider success.

Thomas Lingelbach: I think we have continued to grow the awareness of Chikungunya and xChick amongst healthcare professionals. We have also started to engage with customers. We have now sold doses across each of our sales channels, including a growing number of reorders, as I mentioned earlier.

Speaker Change: who also started to engage with customers.

Speaker Change: We have now sold those across each of our state channels.

Speaker Change: including a growing number of re-orders as I mentioned earlier, the number of customer accounts we are engaging with is growing as well. Additionally we continue to see travelers proactively asking about checks.

Thomas Lingelbach: The number of customer accounts we are engaging with is growing as well. Additionally, we continue to see travelers proactively asking about Chik, which is a fantastic achievement already right now. And across access to and coverage of xChick continues to improve. We had approximately 25 percent coverage last quarter, and now it's over 50 percent.

Speaker Change: which is a fantastic achievement already right now and across and excellent coverage of x-ray continues to improve. We we had approximately 25% coverage last quarter and now it's over 50%.

Thomas Lingelbach: And I think this is really an important step forward, and as I said, there are a couple of things still outstanding, and there are some gating factors worth noting, including the fact that the ACIP recommendations for chikungunya have still not been published in the MMWR, which is important for driving broader reimbursement and prescribing of the vaccine by HDPs. So that's a little bit about where we are on the I When it comes to Shigella, I mean, we are at this point in time, so I will start with the latter part of your question.

Speaker Change: and I think this is really an important step forward.

Speaker Change: And as I said, there are a couple of things still outstanding.

Speaker Change: And there are some gating factors worth noting, including the fact that the ACIP recommendations for chikungunya have still not been published in the MMWR.

Speaker Change: which is important for driving broader reimbursement and prescribing of the vaccine by HTPs.

Speaker Change: So that's a little bit where we are on the on the on the x-shift front.

Speaker Change: When it comes to Shigella, I mean...

Speaker Change: We are at this point in time, so I'll start with the latter part of your question. I think the LIMATIC team is preparing for a respective

Thomas Lingelbach: I think the LIMATEC team is preparing for the respective publication of their data pre-deal, meaning the Phase I-II study. I don't have the details, but you can easily reach out and ask them directly. Then when it comes to the development plan going forward, at this point in time, we have the deal clearly presented that we expect the two phase, two human challenge studies, so the CHIM studies against the two most relevant serotypes, the next steps in parallel to the immunogenicity study and safety study in PEATS in LMIC.

Speaker Change: publication of their data pre-deal, meaning the Phase 1-2 study.

Speaker Change: I don't have the details, but you can easily reach out and ask them directly. Then when it comes to the development plan going forward, at this point in time, we have...

Speaker Change: clearly presented with the deal that we expect the two phase, two human challenge studies, so the CHIM studies against the two most relevant serotypes.

Operator: Don't push me for a presentation number, I'm not allowed to say it. Thank you. We will now take our next question. Please stand by. And the next question comes from the line of Evan Wang from Guggenheim Securities. Please go ahead, your line is not open. Hey guys, thanks for the question. Two from me, first on Bigg's check. Could you provide an update on some of the launch metrics in the US? Just any additional commentary you can provide on the degree of how access and reimbursement progress is going?

Speaker Change: The next steps in parallel to the immunogenicity study and safety study in PEATS, in LMIC,

Thomas Lingelbach: And then from there, we have, of course, a first development plan, but we would like to get further validation through the regulatory agencies. Therefore, we hope that we will have a more precise potential development plan for licensure at our planned investor day in October. And this is where we plan to present this development plan. Thank you. We will now take our next quiz; please stand by. And the next question comes from the line "Oscar Hafenlam" from Brian Garnier. Please go ahead; your line is now open.

Speaker Change: And then from there, we have, of course, a first development plan, but we would like to get further validation through the regulatory agencies.

Speaker Change: and therefore we hope that we will have a more precise...

Speaker Change: potential development plan to licensure at our planned investor day in October this year and this is where we plan to present this development plan in detail.

Operator: We're seeing in terms of some of the initial restocking and active accounts you have. And then on Chigella, appreciate, you know, or happy to see, you know, that life and share. You know, can you just talk about some of the upcoming trials you have planned? I know, I guess first, you know, with the Lima Tech reported at 40 results. When will we see that, you know, full data, either in publication or in American conference?

Speaker Change: Thank you.

Speaker Change: Thank you. We will now take our next question.

Speaker Change: Please stand by.

Speaker Change: And the next question comes from the line of Oscar Hafenlam from Brian Garnier. Please go ahead, the line is now open.

Operator: And then with your planned phase two immunogenic study, can you remind us maybe how she think about that trial design relative to the results that we saw from Kenya? Thanks. So many questions, hopefully, are able to capture those. So I think on XChig, we are really seeing, as you rightly pointed out, that we are having customers reordering XChig, which is good because it means it's slowly, slowly the vaccine is being taken up.

Operator: Hi guys, thank you for taking my question. So regarding X-Check, I understand that the current focus and guidance are basically based on the trade risk markets, and I was just wondering if we could also expect in the near future some major contracts to kick in, similar to what happened to Xerio a few years back.

Oscar Hafenlam: Hi guys, thank you for taking my question. So regarding xCheck, I understand that the current focus and guidance is basically based on the travelers markets, and I was just wondering if we could also expect in the near future some major contracts to kick in, similar to what happened to Xero a few years back. Thank you guys.

Thomas Lingelbach: Thank you. Yeah, so I think that's an excellent question. And quite frankly speaking, we are not yet entirely clear how the US military process is going to work, but most likely not in the same way we used to have it with Ixiaro because the military is not doing those kind of contracts anymore. But definitely the military part, and you saw that we already had a good achievement in that the Department, the Defense Health Agency, adopted the CDC recommendations, which is already a great achievement.

Speaker Change: Yeah, so I think that's an excellent question. And quite frankly speaking, we are not yet entirely clear how the...

Speaker Change: U.S. military

Speaker Change: process is going to work, but most likely not in the same way we used to have it with Xearo.

Operator: I think we, it's a bit too early to really talk about this in detail. I think we have, we have continued to grow the awareness of Chigongunya and XChig amongst HTPs. We also started to engage with customers. We have now sold doses across each of our stage channels, including a growing number of reordered. As I mentioned earlier, is the number of customer accounts we are engaging with is growing as well. Additionally, we continue to see travelers proactively asking about Chig, which is a fantastic achievement already right now.

Speaker Change: because the military is not doing those kind of contracts anymore.

Speaker Change: So, but definitely the...

Speaker Change: military part and you saw that

Speaker Change: that we had already a good...

Speaker Change: achievement in that department, the Defense Health Agency adopted the CDC recommendations, which is already a great achievement, and therefore we expect the U.S. military to become a major

Thomas Lingelbach: And therefore, we expect the US military to become a major customer for Ixia in the United States. Okay, very clear. Thank you. Thank you. We will now take our next question. Please stand by. And the next question comes from the line of Rajan Sharma from Goldman Sachs. Please go ahead, your line is not open.

Speaker Change: a customer in the United States.

Speaker Change: Okay, very clear. Thank you.

Speaker Change: Thank you. We will now take our next question.

Operator: And across and access and coverage of XChig continues to improve. We had approximately 25% coverage last quarter, and now it's over 50%. And I think this is really an important step forward. And as I said, there are a couple of things still outstanding. And there are some gating factors worth noting, including the fact that the ACRP recommendations for Chigongunya has still not been published in the MMWR, which is important for driving further investment and prescribing of the vaccine by HTPs.

Speaker Change: Please stand by.

Speaker Change: And the next question comes from the line of Rajan Sharma from Goldman Sachs, please go ahead, your line is now open.

Operator: Hi, thanks for taking my question. First of all, on Ducrol, I just wanted to clarify the regulatory approvals that you're waiting for, are they now resolved, so we should expect kind of a normal supply of Ducrol and normal marketing in the second half of the year? And I guess just related to that, do you expect Ducrol to grow in 2024? I'm given that sales are down 13% year-to-date, and then I just have a follow-up on that straight. Yeah, maybe I'll take the first part and then I'll hand over to Peter to talk a little bit more about Dukkarat's performance.

Rajan Sharma: Hi, thanks for taking my question. So firstly, just on Ducrol, I just wanted to clarify the regulatory approvals that you're waiting for, are they now resolved? So we should expect kind of normal supply of Ducrol and normal marketing in the second half of the year. And I guess just related to that, do you expect Ducrol to grow in 2024, given I think sales are down 13% year to date? And then I just have a follow up on extractive.

Operator: So that's a little bit where we are on the on the on the exit front. When it comes to Chig, I mean, we are at this point in time. So I start with the letter part of your question. I think the limited team is preparing for respective application of their data, preview, meaning the phase one to study. I don't have the details, but you can easily reach out and ask them directly.

Speaker Change: Maybe I take the first part and then I hand over to Peter to talk a little bit more about Dukkarat performance. Just to avoid a misunderstanding here, we had

Thomas Lingelbach: Just to avoid a misunderstanding here, we had some issues around stucco rail sales because we were waiting for the approval of the new Fylfinnish site in Sweden. We built a new Fylfinnish site in Sweden as part of our COVID endeavor, and we replaced the old filling side with this brand new filling side, and this required certain regulatory approvals in all the markets where Desperals has been licensed.

Speaker Change: some facing issues around stucco rail sales because we were waiting for the approval of the new FinFinish site in Sweden.

Peter: We built a new Finnish site in Sweden as part of our COVID endeavor.

Operator: Then when it comes to the development plan going forward, at this point in time, we have clearly presented with the deal that we expect the two phase two human challenge studies. So the gym studies against the two most relevant stereotypes. The next steps in parallel to the immunogenicity study and safety study in P in LMI C. And then from there we have, of course, a first development plan, but we would like to get further validation through the regulatory agencies.

Peter: and we replaced the old filling site with this brand-new filling site and this required certain regulatory approvals in all the markets where Ducoral has been licensed.

Thomas Lingelbach: Therefore, we were also cautiously investing in, you know, marketing, sales, and everything around that. And we had some issues associated with the sales of Ducoral. That's just to avoid, we are not expecting anything anymore. We got all the approvals, everything is clear. And this will lead us to the full year. Peter, do you want to say something about that? It's a pleasure, Thomas. Hey, Rajan.

Peter: Therefore, we were also cautiously investing in, you know, marketing, sales, and everything around that, and we had some facing issues associated with

Peter: the sales of Ducorral. That's just to avoid, we are not expecting anything anymore. We got all approvals, everything is clear, and this will lead us to the full year. Peter, you want to say something about this?

Peter Buhler: So, you know, just also to remind you, in Q1, we, docorral, did grow, right? And we did say in the past, we do expect docorral to continue to grow year over year. And we haven't provided a specific number, but this has not changed, given, you know, the H1 result.

Peter: It's a pleasure, Thomas. Hey, Ratchan. So, you know, just to remind you, in Q1, do coral did grow, right? And we did say in the past, we do expect do coral to continue to grow year over year. We haven't provided a specific number, but this has not changed.

Operator: And therefore, we hope that we will have a more precise potential development plan to life and share at our plans investor day in October. Pierre, and this is where we plan to present this development plan in BC. Thank you. We will now take our next question. Please stand by. And the next question comes from the line of Oscar, Hafen Lamm from Brian Garnier. Please go ahead. The line is not open. Hi, guys.

Peter: given the H1 result, so we do expect growth and to grow up.

Peter Buhler: So we do expect growth on docorral. Okay, thank you, that's clear. And then just going back to Ixtric, just wondering if you could provide a sense of how many doses have been administered to date or kind of how much of that revenue number that you've reported is in stocks. Peter, do we have the numbers on that? I don't think so.

Speaker Change: Okay, thank you, that's clear. And then just going back to Ixtric, I'm just wondering if you could provide a sense of how many doses have been administered to date or kind of how much of that revenue number that you've reported is stocking?

Speaker Change: [inaudible]

Operator: Thank you for making my question. So regarding this check, I understand that the current focus in guidance is basically based on the troubles markets. And I was just wondering if we could also expect in the near future some major contracts to kick in, similar to what happened to exterior viewers back here. Thank you. Yeah, so I think that's an excellent question. And quite frankly, speaking, we are not yet entirely clear how the US military process is going to work, but most likely not in the same way we used to have it with Xiaro, because the military is not doing those kind of contracts anymore.

Peter Buhler: Well, you know, Rajan, the way we account for xChick for now is we really account for on a sell-through basis. So we only account when sales are made to the retailer or to the provider, which means there is little to no stock in the channel. So we do not book as we ship to distributors. We chose that just to avoid potential returns.

Speaker Change: Peter, do we have the number on that? I don't think we do. You know, Rachan, so basically, the way we account for xChick for now is we really account for on a sell-through basis, so we only account when sales are made to the retailer or to the provider, which means there is little to no stock in the channel. So we do not book as we ship into distributors.

Speaker Change: We chose that just to avoid potential returns.

Peter Buhler: Okay, that makes sense. Thank you. You're welcome. As a reminder, to ask a question, you will need to press star one, one on your telephone and then wait for your name to be announced. To ensure that your question is answered, please press star one, one again. We will now take our next question. Please stand by. And the next question comes from the line of Maury Raycroft from Jeffreys. Please go ahead; your line is now open.

Rachan: Okay, that makes sense. Thank you.

Speaker Change: You're welcome. Thank you.

Speaker Change: As a reminder, to ask a question you will need to press star 11 on your telephone and then wait for your name to be announced. To ensure your question, please press star 11 again. We will now take our next question. Please stand by.

Operator: But definitely the military part and you saw that we had already a good achievement in that department, the Defense Health Agency adopted the CDC recommendations, which is already a great achievement. And therefore, we expect the US military to become a major customer for the United States. Thank you. You will now take our next question. Please stand by. And the next question comes from the line of Rajan Sharma from Goldman Sachs. Please go ahead.

Speaker Change: And the next question comes from the line of Maury Raycroft from Jeffreys, please go ahead your line is now open

Operator: Hi, congrats on the progress, and thanks for taking my question. For xChick, I'm wondering if you can talk about any unique strategy for what you're doing during this time to gain an advantage or insulate your launch ahead of potential competitor entry. And as a follow-up to an earlier question, do you have any insight into whether the Department of Defense would want to contract for one or two ChickB vaccines, or how will

Maury Raycroft: Hi, congrats on the progress and thanks for taking my questions.

Maury Raycroft: For xChick, I'm wondering if you can talk about any unique strategy for what you're doing during this time to gain advantage or insulate your launch ahead of potential competitor entry.

Speaker Change: And as a follow-up to an earlier question, do you have any insight into whether the Department of Defense would want to contract for one or two chickpea vaccines, or how will that work?

Operator: Yeah, well, I mean, that's a good one. I would say, first of all, when it comes to the military, you will appreciate that this is a different disease than Japanese encephalitis, so it's very difficult to draw a direct comparison.

Speaker Change: Yeah, well, I mean, that's a good one.

Speaker Change: I would say, first of all, when it comes to the military, I mean, you will appreciate that this is a different disease than Japanese encephalitis, so it's very difficult to draw a direct comparison.

Operator: Your line is not open. Hi, thanks for taking my question. So, firstly, just on decry, I just wanted to clarify the regulatory appeals that you're waiting for. Are they now resolved? So we should expect kind of normal supply of decry, and normal marketing, in the second half of the year. And I guess just related to that, do you expect decry, to grow in 2024? I'm given, I think, sales are done. 13% here today.

Thomas Lingelbach: So our goal is to ensure that the military has full access to the Ixchic vaccine and that they are stocking it in preparation for our. In addition, and as I reported earlier, they are evaluating the data from the current outbreak to determine if it fits in their protocol the way XCR-O-Dose does right now. And therefore, you know, we believe that we could play a very important first mover, a first mover advisor It's difficult to say at this point in time, but I would say there's a good chance that we could really play a first mover game here with the U.S. military, for sure.

Speaker Change: So, our goal is to ensure that military has full access to the Ixchic vaccine and that they are stocking in preparation for outbreaks.

Operator: And then I just have a follow-up on the extractive. Yeah, maybe I take the first part and then I hand over to Peter to talk a little bit more about decry performance, just to avoid a misunderstanding here. We had some facing issues around decry, because we were waiting for the approval of the new fill finish site in Sweden. We built a new fill finish site in Sweden on as part of our COVID endeavor.

Speaker Change: In addition, and as I reported earlier, they are evaluating the data in current outbreaks to determine

Speaker Change: if it fits in their protocol the way Xerodos does right now. And therefore, you know, we believe that we could play a very important first mover here, a first mover advantage.

Speaker Change: So, difficult to say at this point in time, but I would say there's a good chance that we could really play a first mover game here with the U.S. military, for sure.

Operator: And we replaced the old filling site with this brand new filling site, and this required certain regulatory approvals of in all the markets where the parole has been licensed. Therefore, we were also cautiously investing in marketing, sales, and everything around that. And we had some facing issues associated with the sales of Tukaral. That's just to avoid, we are not expecting anything anymore. We got all the approvals, everything is clear. And this will lead us to the full year, Peter, you want to say something about, with Fajr Thomas, Hey, Rajan.

Thomas Lingelbach: Got it. Understood. And anything else you're doing commercially for EXCHEC, just to help insulate your launch ahead of competitor entry? Then I have one. I think nothing on top of what I reported earlier. I think for us, the most important thing is that we get the label extensions done so that we have a product that is licensed for everyone above 12 years of age. We want to make sure that we get the antibody persistence data into the label, at least the ones that we have reported on thus far.

Speaker Change: Got it, understood. And anything else you're doing commercially for X-Check, just to help insulate your launch ahead of competitor entry? I think nothing on top of what I reported earlier. I think for us the most important thing is that

Speaker Change: we get the label extensions, you know, done.

Speaker Change: so that we have a product that is licensed for everyone above 12 years of age.

Speaker Change: We want to make sure that we get the antibody persistence data into the label that at least the ones that we have reported on thus far. These are all, you know, major potential competitive advantages.

Operator: So, you know, just so to remind you, Q1, we do call it did call, right? And we did say in the past, we do expect to call to continue to grow year over year. We haven't provided a specific number, but this has not changed given, you know, the H1 result, so we do expect growth and to call. Okay, thank you that's clear. And then just going back to X trick, just wondering if you could provide a sense of how many doses have been administered to date or kind of how much of that revenue number that you've reported is stocking.

Thomas Lingelbach: These are all major potential competitive advantages. And that's what we are currently aiming for, and this is what we are doing in addition to what I reported earlier on the commercial front and building awareness, getting it into the channel, and working with HTPs. Makes sense. And for the ICSIRO Department of Defense contract in the fourth quarter of this year, can you remind me if you're saying what the amount or range of that contract you're expecting?

Speaker Change: And and that's what we are currently aiming for. And this is what we are doing in addition to what I reported earlier on the commercial front and building awareness and.

Speaker Change: getting it into the channel and working with HTTPs and so on and so forth.

Speaker Change: Got it. Makes sense. And for the ICSIRO Department of Defense contract in fourth quarter of this year, can you remind me if you're saying what the amount or range of that contract you're expecting?

Thomas Lingelbach: Peter, I'm not sure what we reported in the past. And it's an ongoing discussion, so right now, Maury, we don't know. I think what, you know, generally speaking, what we saw last year is that the Department of Defense, compared to the contract in 2019, they're building less stock. So we would, my best guess right now, it would be at a similar level than what we had last year.

Operator: Peter, do we have a number on that? I don't think so. Well, you know, Rajan, so basically the way we account for X trick for now is we really account for on a sell through basis, so we only account when sales are made to the retailer or to provider, which means there is little to no stock in the channel. So we do not book as we ship into distributors. You know, we chose that just to avoid potential returns.

Speaker Change: Peter, I'm not sure what we reported in the past.

Peter Buhler: But again, it's early discussion. Got it. Okay, thanks for taking my question. Thank you. We will now take on the next question. Please stand by. And the next question comes from the line of Samir Devani from Rx Securities. Please go ahead, Joanna Thode.

Speaker Change: Do you recall? Well, it's an ongoing discussion, so right now, Maury, we don't know. I think what, you know, generally speaking, what we saw last year is that the Department of Defense, compared to what they contracted in 2019, they're building less stock.

Speaker Change: So we would, my best guess right now would be at a similar level than what we had last year, but again, it's already discussed.

Speaker Change: Got it. Okay, thanks for taking my questions.

Operator: Yeah, okay, that makes sense. Thank you. You're welcome. Thank you. As a reminder to ask a question, you will need to press star one, one on your telephone, and then wait for your name to be announced. To ensure your question, please press star one, one again. We will now take our next question. Please stand by. And the next question comes from the line of Maury Raycroft from Jeffries. Please go ahead. Your line is not open.

Speaker Change: Thank you. We will now take our next question. Please stand by.

Speaker Change: And the next question comes from the line of Samir Devani from RX Securities. Please go ahead, your line is now open.

Operator: Thank you, guys. Thanks for taking my question. It's just a quick follow-up on Xero.

Samir Devani: Hi guys, thanks for taking my question. It's just a quick follow-up on Ixsiaro. I was wondering if you could just give us a breakdown of what you're seeing from a travel sales perspective versus military sales perspective in terms of growth rates. Thanks very much.

Thomas Lingelbach: I was wondering if you could just give us a break from what you're seeing from a travel cell. Thank you very much. Yeah, thanks, Samir. Well, you know, we have not disclosed the details between the military and travel.

Operator: Hi, congrats on the progress, and thanks for taking my questions. For X trick, I'm wondering if you can talk about any unique strategy for what you're doing during this time to gain advantage or insulate your launch ahead of potential competitor entry. And as a follow-up to an earlier question, do you have any insight into whether Department of Defense would want to contract for one or two chickpea vaccines, or how will that work?

Speaker Change: Yeah, thanks Samir. Well, you know, we have not disclosed the details between military and travel. As we said, both segments are growing.

Peter Buhler: As we said, both segments are growing. Travel sales, we had relatively small growth, so the majority of the year-over-year growth is really coming from the U.S. military, where, as I said during the call last year, in the first half of 2023, we had, you know, very, very low sales, and this year it was much more substantial, but we have not disclosed the exact data. Okay, thanks very much. Thank you. As there are no further questions, I would like to hand back to Thomas Lingelbach for any closing remarks. Thanks a lot for your questions.

Speaker Change: travel sales, we have a relatively small growth, so the majority of the year-over-year growth is really coming from US military where

Operator: Yeah, well, I mean, that's a good, that's a good one. I would say, first of all, when it comes to the military, I mean, you will appreciate that this is a different disease than Japanese insularitis. So it's very difficult to draw direct comparison. So our goal is to ensure that military has full access to the X trick vaccine, and that they are stocking in preparation for outbreaks. In addition, and as I reported earlier, they are evaluating the data and current outbreaks to determine if it fits in their protocol the way Xiaro does right now.

Speaker Change: As I said during the call

Speaker Change: Last year, in the first half year of 2023, we had, you know, very, very low sales and this year it was much more substantial, but we have not disclosed the exact data.

Speaker Change: Thanks very much.

Speaker Change: Thank you.

Speaker Change: As there are no further questions, I would like to hand back to Thomas Lingelbach for any closing remarks.

Thomas Lingelbach: Thanks a lot for your questions. As you've seen...

Thomas Lingelbach: As you have seen, the first half-year, especially on the R&D and strategic development front, has been quite remarkable, and we see really great growth opportunities for Valneva, including that we have reiterated that we see a pathway to sustain profitability upon successful licensing and commercialization of the Lyme vaccine. Therefore, thanks to all of you, thanks to our shareholders, employees, partners, and I wish you a very good remainder of the day. Thank you.

Thomas Lingelbach: The first half year especially on the R&D and strategic development front has been quite remarkable and we see

Speaker Change: really great growth opportunities for Vannevar.

Operator: And therefore, you know, we believe that we could play a very important first mover here, a first mover advantage. So it's difficult to say at this point in time, but I would say there's a good chance that we could really play a first mover game here with the US military, for sure. I got it. Understood. And anything else you're doing commercially for XXX just to help insulate your launch ahead of competitor entry?

Speaker Change: including that we have reiterated that we see a pathway to sustain profitability upon.

Speaker Change: successful licensure and commercialization of the Lyme vaccine. And therefore, you know, thanks to all of you, thanks to our shareholders, employees, partners, and I wish you a very good remainder of the day.

Thomas Lingelbach: This concludes today's conference call. Thank you for participating. You may now disconnect. Speakers, please stand by. [music] I'm sorry, I'm sorry, I'm sorry, I'm sorry, I'm sorry, I'm sorry, I'm sorry, I'm sorry, I'm sorry, I'm sorry, I'm sorry, I'm sorry, I'm sorry, I'm sorry, I'm sorry, I'm sorry, I'm sorry, I'm sorry, I'm sorry, I'

Speaker Change: Thank you. This concludes today's conference call. Thank you for participating. You may now disconnect. Speakers please stand by.

Operator: .. .. .. .. ....

Operator: I think nothing on top of what I reported earlier, I think for us the most important thing is that we get the label extensions done so that we have a product that is licensed for everyone about 12 years of age. We want to make sure that we get the antibody persistence data into the label that at least the ones that we have reported on thus far. These are all major potential competitive advantages.

Operator: And that's what we are currently aiming for. And this is what we are doing in addition to what I reported earlier on the commercial front and building awareness and getting it into the channel and working with HCTs and so on and so forth. Got it, make sense. And for the XERO Department of Defense contract in fourth quarter of this year, can you remind me if you're saying what the amount or range of that contract you're expecting?

Speaker Change: and many more. Thank you.

Peter Buhler: and many more. Thank you. Thank you.

Operator: Peter, I'm not sure what we reported in the past. And it's ongoing discussion, so right now, Mori, we don't know. I think what generally speaking, what we saw last year is that the Department of Defense compared to what the contract in 2019, they're building less stock. So my best guess right now would be similar at a similar level than what we had last year, but again, it's discussion. Got it. Okay, thanks for taking my question.

Operator: Thank you. We will now take our next question. Please stand by. And the next question comes from the line of Samir Devani from Rx Securities. Please go ahead, you'll end up open. Hi guys, thanks for taking my question. It's just a quick follow-up on XERO. I was wondering if you could just give us a breakdown of what you're seeing from a travel sales perspective versus military sales perspective in terms of growth rates.

Speaker Change: and many more. Thank you. Thank you.

Operator: Thanks very much. Yeah. Yeah, thanks, Samir. Well, you know, we have not disclosed the details between military and travel. As we said, both segments are growing. Travel sales, we have a relatively small growth. So the majority of the year of review growth is really coming from US military where, as I said, during the call last year, in the first half year of 2023, we had, you know, very, very low sales. And this year was, it was much more substantial, but we have not disclosed the exact data.

Operator: Thanks very much. Thank you. As there are no further questions, I would like to hand back to Thomas Linglebach for any closing remarks. Thanks a lot for your questions. As you've seen, first half year, especially on the R&D and strategic development front has been quite remarkable. And we see really great growth opportunities for Vanneva, including that we have reiterated that we see a pathway to sustain profitability upon successful licensure and commercialization of the line vaccine.

Operator: And therefore, you know, thanks to all of you. Thanks to our shareholders, employees, partners. And I wish you a very good remainder of the day. Thanks. This concludes today's conference call. Thank you for participating. You may now disconnect. I think it's please stand by. Thank you. James Stamos, Peter Buhler, Simon Scholes, Thomas Lingelbach, Peter Buhler, Simon Scholes, Thomas Lingelbach, James Stamos, Peter Buhler, Simon Scholes, Thomas Lingelbach, Peter Buhler, Simon Scholes, James Stamos, Peter Buhler, Simon Scholes, Thomas Lingelbach, James Stamos, Peter Buhler, Simon Scholes, Thomas Lingelbach, James Stamos, Peter Buhler, Simon Scholes, Thomas Lingelbach, Peter Buhler, Simon Scholes, Thomas Lingelbach, James Stamos, Peter Buhler, Simon Scholes, Thomas Lingelbach, James Stamos, Peter Buhler, Simon Scholes, Thomas Lingelbach, James Stamos, Peter Buhler, Simon Scholes, Thomas Lingelbach, James Stamos, Peter Buhler, Simon Scholes, Thomas Lingelbach, Nicholas Lamm, Max Herrmann, Peter Buhler, Simon Scholes, Thomas Lingelbach, Peter Buhler, Thomas Lamm, Max Herrmann, Peter Buhler, Simon Scholes, Thomas Lingelbach, Peter Buhler,[inaudible] Simon Scholes, Thomas Lingelbach, Peter Buhler, Simon Scholes, Thomas[inaudible] Peter Buhler, Simon Scholes, Thomas Lingelbach, Peter Buhler, Simon Scholes, Thomas Lingelbach, Peter Buhler, Simon Scholes, Thomas Lingelbach,[inaudible] . . [inaudible][inaudible] John Scholes, John Scholes, John Scholes, John Scholes,[inaudible]

Speaker Change: Thanks For Watching!

Speaker Change: Noah Nassar Trevor White Dylanork Michonne Taylor Chase Tiles Thanks for watching!

Speaker Change: and many more. Thank you. Thank you.