NASDAQ:VALN Valneva Q2 2025 Earnings Report $10.47 -0.69 (-6.18%) Closing price 08/14/2025 04:00 PM EasternExtended Trading$10.84 +0.37 (+3.52%) As of 04:30 AM Eastern Extended trading is trading that happens on electronic markets outside of regular trading hours. This is a fair market value extended hours price provided by Polygon.io. Learn more. ProfileEarnings HistoryForecast Valneva EPS ResultsActual EPS-$0.16Consensus EPS -$0.27Beat/MissBeat by +$0.11One Year Ago EPSN/AValneva Revenue ResultsActual Revenue$54.84 millionExpected Revenue$46.28 millionBeat/MissBeat by +$8.56 millionYoY Revenue GrowthN/AValneva Announcement DetailsQuarterQ2 2025Date8/12/2025TimeBefore Market OpensConference Call DateTuesday, August 12, 2025Conference Call Time9:00AM ETConference Call ResourcesConference Call AudioConference Call TranscriptSlide DeckPress Release (6-K)Press ReleaseInterim ReportEarnings HistoryCompany ProfileSlide DeckFull Screen Slide DeckPowered by Valneva Q2 2025 Earnings Call TranscriptProvided by QuartrAugust 12, 2025 ShareLink copied to clipboard.Key Takeaways Positive Sentiment: Achieved near €100 million in H1 revenues (+37.8% YoY) and maintained a strong cash position (>€160 million) while reducing operating cash burn. Positive Sentiment: The Phase 3 Lyme disease vaccine trial is on track with over 9,000 participants across three tick seasons, aiming for regulatory submissions in 2026. Positive Sentiment: FDA and EMA have lifted temporary age-related restrictions on the single-shot chikungunya vaccine, reaffirming its safety profile and long-term antibody persistence for outbreak response. Neutral Sentiment: The tetravalent Shigella vaccine candidate advanced into a Phase 2 infant study and an ongoing Phase 2b controlled human infection model, with efficacy data expected early next year. Neutral Sentiment: Despite an operating loss of €16.8 million, adjusted EBITDA improved by 80% YoY (ex-PRV sale) and 2025 guidance was reaffirmed with product sales projected at €170–180 million. AI Generated. May Contain Errors.Conference Call Audio Live Call not available Earnings Conference CallValneva Q2 202500:00 / 00:00Speed:1x1.25x1.5x2xThere are 7 speakers on the call. Operator00:00:00and thank you for standing by. Welcome to the Valneva Presents its Half Year twenty twenty five Financial Results Conference Call and Webcast. At this time, all participants are in a listen only mode. After the speakers' presentation, there will be a question and answer session. Please note that today's conference is being recorded. Operator00:00:30I would now like to hand the conference over to your first speaker, Joshua Drum, Vice President, Global Investor Relations. Please go ahead. Speaker 100:00:39Thank you, operator. Hello, and thank you for joining us to discuss Bellneva's first half twenty twenty five 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 six months ended 06/30/2025, which were published earlier today, available within the Financial Reports section on our Investor website. I'm joined today by Valneva's CEO, Thomas Lingelbach and our CFO, Peter Bruhler, who will provide an overview and update on our business as well as our key financial results for the first half. Speaker 100:01:14There will be an analyst Q and A session at the conclusion of the prepared remarks. Before we begin, I'd like to remind listeners that during this presentation, we will be making forward looking statements, which are subject to certain risks and uncertainties that could cause actual results to differ materially from those expressed or implied by these forward looking statements. You can find additional information about these risks and uncertainties in our periodic filings with the Securities and Exchange Commission and with the French Market Authority, which are listed on our company website. Please note that today's presentation includes information provided as of today, 08/12/2025, and Velineva undertakes no obligation to revise or update forward looking statements, except as required by applicable securities laws. With that, it's my pleasure to introduce Thomas to begin today's presentation. Speaker 200:02:01Thank you, Josh. Good day, everyone. It's a pleasure to present our first half twenty twenty five financial results and key business highlights. A first half of the year that has been quite eventful and marked by excellence in execution. We achieved total revenues close to €100,000,000 a very significant year over year growth, and a cash position of more than a €160,000,000, which also marks not only a strong additional cash influx through ATM transactions, but also a significant reduction in operating cash burn, which again shows you that we are focusing on investing into the right things and and really making sure that we retain a strong cost cash position as we go into the period of line data readout. Speaker 200:03:09We have further pipeline and regulatory progress around Lyme, ex chick, and shigella, and I'm gonna go into those in more detail. When we look on page five, what we have really seen or what we are seeing is our key highlights. In line with our mission ambition, we have really addressed unmet medical need in the first half of the year. We finalized a new supply agreement for its CRO with the US Department of Defense, and we responded to the French government's call for X shaped to combat chikungunya outbreaks in La Rignon and Mayotte. We also responded to the cholera outbreak in Mayotte by supplying doses of ducorale. Speaker 200:03:55So really by addressing those unmet medical needs, ensuring that we make a change to people's lives. On the regulatory and commercial achievements, we secured additional marketing authorizations for XGIC in The United Kingdom, in Brazil, and label extensions for XGIC in Europe for adolescents 12 years of age and and older. We also announced an exclusive vaccine marketing and distribution agreement for Germany with CSL Securius. We are happy about this partnership. We had to undergo a very comprehensive safety assessment with the two key regulatory authorities, FDA and EMA, in connection with XGIC safety signals observed during mainly during the vaccination campaign on La Viegnion. Speaker 200:04:49And we were able, through this collaborative interactions and approach with the agency, to lift the temporary age related restrictions again. Online, we are very happy that the VALOA study is progressing to plan. The entire program is progressing to plan, and that's very recently announced by by Pfizer during its earnings call. We completed the vaccination in the current VALOA phase three study. On XGIC, we have seen a high sustained one year immune response in adolescents, which again reconfirms what we have seen in adults, namely the key differentiation of this product, long term antibody persistence and protection. Speaker 200:05:37We also achieved positive phase three pediatric safety and immunogenicity results for XG. On Shigella, we have been progressing our first controlled human infection model study, and we initiated vaccinations in a dedicated phase two infant study. When we look at the programs one by one, of course, we would like to start with our Lyme disease vaccine candidate, which is clearly the world's leading candidate in that field. And as we reported many occasions, Lyme disease represents a major medical need and market opportunity. There's currently no vaccine available to prevent Lyme disease in humans, and also the treatment options are very limited. Speaker 200:06:29The annual burden of disease is constantly increasing, and the most updated numbers show that we are approaching in the Northern Hemisphere more and more numbers that gear towards one million cases on an annual basis. Many of those cases result in severe manifestations, catitis, neuroborgnosis, arthritis. And unfortunately, many people experience persistent symptoms. And in those even persistent following treatment with antibiotics. So therefore, there is a clear medical need and a clear objective to find a suitable, meaning efficacious, and safe preventative solution. Speaker 200:07:25When we look at the phase three study that is ongoing, this is a study that, for operational reasons, as reported many times in the past, has been split into two cohorts, but it's one study spanning over three tick seasons, tick season 2023, '4, and five. We included in this study more than 9,000 participants aged 12 years and older. And the study is randomized one to one vaccine against placebo, two to one North America versus Europe. The primary endpoints and what we try to achieve here is prevention of the disease. Therefore, we are measuring as part of the primary endpoint, the rate of confirmed Lyme cases after two consecutive tick seasons, meaning after completion of the full vaccination series priming with three doses and first booster, therefore, at three plus one or four doses. Speaker 200:08:28This is the primary endpoint. With regards to secondary endpoints, of course, we will report, and we aim to report the number of Lyme disease cases and efficacy after the first tick season, and many other immunological endpoints as defined in the phase product phase three protocol. On the slide on page nine, you can see that now all the little syringes here are marked green. And this is the key progress. And with this progress, Pfizer reconfirmed that they aim to submit regulatory applications in The United States and Europe in 2026. Speaker 200:09:14And this is in line with the timeline that reported that we have reported, Pfizer reported in the past, namely that we aim to launch in the 2027, subject to positive data to have people protected for the 2028 tick season. We are going to monitor this year the Lyme cases until the October. This is the end of the Lyme season. Then thereafter, Pfizer will undergo case adjudication, you know, database cleaning, and all of that. So everything is on track, and we are looking forward to this data and, hopefully, to a nicely efficacious and safe vaccine that will be able to make a substantial change to people's lives and represent a major catalyst for Vyleva going forward. Speaker 200:10:10Turning to chikungunya, our single shot chikungunya vaccine, X shape or VLA fifteen five three. We mentioned already that FDA and EMA have now lifted again the temporary restrictions against youth in elderly. You know that we had reports of serious adverse events in fray elderly individuals, primarily among elderly with multiple underlying health conditions, and most of it resulted and was observed through the mass vaccination campaigns in La Vignon in response to a very severe chikungunya outbreak. EMA and FDA therefore imposed temporary restrictions while they investigated together with us the reported SAEs. I mentioned already twice that those restrictions have now been lifted, and all the labels have been updated. Speaker 200:11:16What has been updated primarily are the use conditions and the safety sections, precautions, and warnings, either on the prescribing information in The United States or the summary of codec characteristics, SMPC in Europe. And and this reaffirms what we have been saying from the very beginning. A life attenuated vaccine has a clear advantage, for an outbreak disease, which is unpredictable in terms of timing. And and it is coming with a very, very long antibody persistence and protection. And we are monitoring in a follow-up study antibody persistence for up to ten years. Speaker 200:12:07And most importantly, XTRK remains indicated for the prevention of disease caused by the chikungunya virus in individuals 18 years of age and older in The United States, 12 years and older in Europe, who are at high risk exposure to chickpea. So it remains an excellent vaccine solution if given to the right people in the right setting. Of course, we are continuing to focus expanding access, label extensions, and furthermore, the overall product profile for XGIC. We have a very robust clinical program that is supported by more than $40,000,000 grant by Tippi. And we are grateful that Tippi continues to support this program and the company as a whole. Speaker 200:13:02The phase four aim to confirm effectiveness and basically is a key post marketing commitment since the vaccine got its initial approval to an immunological surrogate of protection, so called accelerated approval pathway. There will be observation effectiveness study in Brazil, pragmatic randomized controlled effectiveness safety study in adults and adolescents to be to be confirmed in other endemic countries. And we expect also further prospective safety cohort studies. On the label extension, we aim to expand access to the vaccine for all age groups, and will gradually develop it accordingly. On the product profile, I think it's very important that we confirm the long term durability of the immune response that we have that we can show that the vaccine following a single shot has a very long zero response rate and, hence, effectiveness. Speaker 200:14:17And this ongoing antibiotic assistance, as I said earlier, is a study that would monitor people for up to ten years. We reported positive three month results to date with four months with four years results coming up later this year. Now turning to Shigella, which is the world's most clinically advanced tetravalent Shigella vaccine candidate. We are targeting to cover with the four serotypes up to eighty five percent of the Shigellosis infections. And these infections are really life threatening, especially in young children, and therefore also identified as a priority vaccine by WHO. Speaker 200:15:11We are aiming to develop the vaccine both for children living in low medium income countries, but also for travelers who are exposed to the disease. We our partner, Limatec, reported positive phase one data previously in this program, which got awarded FDA passport designation. As I said at the very beginning, we launched a phase two infant study with data expected towards the latter part of this year. And we have the ongoing phase 2b controlled human infection model study aiming to provide an early look at potential efficacy with efficacy data expected very early next year. Those studies are still led by Nematec. Speaker 200:16:05And Vanneva would assume all further regulatory R and D, CMC and future commercialization activities in the near term. As we reported earlier, we are working on a novel Zika virus candidate. This is a candidate that we optimized against the first generation candidate that we had pre COVID. It leverages our inactivated whole virus platform that we further advanced and developed as part of our COVID endeavor. And previous results showed already excellent immunogenicity safety. Speaker 200:16:49And now in this phase one study, we look at safety and immunogenicity with an enhanced process and optimized vaccine formulation. As we reported earlier, we believe that a vaccine solution against this flaviviral disease transmitted by the aedes mosquitoes is needed because of the devastating effects those infections can have. But at the same time, we will need to evaluate future development strategy strategies based on the phase one results, external non dilutive funding and the resulting market potential and to see where we really are at the point of data readout. With this update on our primarily R and D programs here, I would like to turn over to Peter to provide you with the financial Speaker 300:17:48report. Thank you, Thomas, and good morning and good afternoon to all of you. Now moving to the financials of the 2025. Product sales reached €91,000,000 compared to €68,300,000 in the 2024, an increase of 33.3%. Foreign currency fluctuation had an adverse impact of €500,000 VIXiaro sales reached €54,700,000 increasing 30.6% over prior year. Speaker 300:18:17The strong year over year growth was equally driven by sales to travelers and to the Department of Defense. Xiara sales during the 2024 were adversely impacted by supply constraints. Dukorat sales grew year over year by 16.4% and reached €17,400,000 in the 2025. The growth in Dukorat sales was supported by a €1,100,000 sale to the French island of Marriott to combat a local cholera outbreak. XJIC sales reached €7,500,000 compared to €1,000,000 in the 2024 when the product had been launched in The United States. Speaker 300:18:55XJIC sales in the 2025 benefited from a supply of 40,000 doses to the French island La Reignon as the island experienced a major chikungunya outbreak. Third party products increased by 8.8% year over year to reach €11,400,000 This increase is primarily a result of supply constraints in the first half of the prior year, and we continue to expect a gradual decrease of third party products. Moving on to the income statement. Total revenues reached €97,600,000 versus €70,800,000 in the 2024. The increase of 37.8 is driven by higher product sales and an increase in other revenues related to the licensing agreement with the Serum Institute of India for Vyleva single shot chikungunya vaccine. Speaker 300:19:46Looking at expenses, cost of goods and services for the 2025 reached €47,300,000 compared to €45,600,000 during the same period last year. The gross margin on commercial products, excluding XCHIC, reached 59.2% in the 2025 compared to 47.7% in the prior year. The improvement in gross margin was driven by better manufacturing performance. IXIARO gross margin reached 65.5% compared to 57.5% in the 2024, And DUKORAL generated a gross margin of 52.9% compared to 34.8% last year. Cost of goods related to XTRK amounted to €2,500,000 or a gross margin of 66%. Speaker 300:20:37Cost of goods also includes a EUR 5,900,000.0 idle capacity cost. Research and development expense increased from EUR 29,700,000.0 in the 2024 to €32,400,000 in the 2025. That increase is driven by costs related to the Shigella vaccine candidate following the R and D collaboration with Limotech Biologics. We expect another acceleration of our R and D costs in the 2025, in particular driven by the Ixtric Phase IV program. Marketing and distribution expense decreased from €23,200,000 in the prior year to €20,300,000 in the 2025. Speaker 300:21:19The increase is related to a planned reduction in the advertising and promotion spend related to XJIC following the launch in early twenty twenty four. The decrease was partially offset by higher costs related to warehousing and distribution. G and A expense decreased to €19,000,000 compared to $20.22 euros $2,020,800,000.0 in the 2024. At the 2024, the company ran a program to increase operational efficiency, and the reduction in G and A spend is a direct result of this initiative. In the 2025, Valneva reported an operating loss of €16,800,000 compared to an operating profit of €46,700,000 in the last year. Speaker 300:22:04Last year's operating profit was the result of the sale of a Priority Review Voucher for a total net proceeds of €90,800,000 Adjusted EBITDA in the 2025 reached minus €6,800,000 minus €6,000,000 compared to a positive EBITDA of €66,200,000 last year. Excluding the one off PRV sale in the prior year, adjusted EBITDA improved by 80% year over year. Before moving to the outlook and guidance, a word on cash. As mentioned by Thomas at the beginning of the call, cash at June 30 was reported at €161,300,000 compared to €168,400,000 at the 2024. Cash used in operations was reported at €10,900,000 compared to €66,300,000 in the 2024. Speaker 300:22:55Now moving to Slide 21. We confirm our financial guidance for the fiscal year 2025 with product sales of 170,000,000 to €180,000,000 and total revenues of EUR 180,000,000 to 190,000,000. We continue to project R and D expenses of EUR 90,000,000 to 100,000,000. The R and D expenses will be partially offset by grant funding and the anticipated R and D tax credits. As confirmed in the first half year results, we expect a significantly lower use of cash in operations, targeting a year over year reduction of more than 50%. Speaker 300:23:32Cash flow remain a key focus in order to ensure sufficient runway to reach key inflection points. In the midterm, we expect continuous growth in our product sales, focus on strategic investments into R and D and continuous improvement in gross margin. We continue to expect VONNEO to be sustainably profitable post successful approval and commercialization of the Lyme disease vaccine. With this, I hand the call back to Thomas for the outlook. Speaker 200:24:00Thank you, Peter. Yeah. When we look at the 2025 guidance, of course, it is important that we look at the growth drivers. And the growth drivers primarily are, as Peter mentioned, life. I think the the VLA 15 program or the Lyme disease program with Pfizer is not only the single largest catalyst for the company and its future development and strategic optionality, but it's also the vaccine that could make the single largest impact to people's lives. Speaker 200:24:46As such, it is very highly matching with our purpose, our vision, and mission. Of course, in the near term, as Peter said, we will focus on growing commercial revenues, and we will reposition XShake as the right vaccine against chikungunya for the right setting in the right population in the right also geographical area. With regards to future pipeline, we have our two early stage or mid stage clinical assets, Shigella and Zika. And our goal is to not only progress those programs, but possibly even further augment our pipeline post phase three successful life. As such, we have really a great opportunity to become on the back of a positive line outcome, the leading vaccine biotech in the world. Speaker 200:25:54And with that, I would like to hand back to the operator to take the question. Operator00:26:00Thank you, We are now going to proceed with our first question. And the questions come from the line of Maury Raycroft from Jefferies. This Speaker 400:26:35is Amin on for Maury. Congrats on the progress. Questions. Couple of questions from us. Regarding the 40,000 doses you sold to the French government, should we expect any additional revenue recognition in Q3? Speaker 400:26:51Also, could you share your perspective on demand scenarios for ex check through year end considering the evolving chickpea outbreak in Indian Ocean and now looks like China? Speaker 200:27:08Yeah. So let me start with the second part of your question, and then I hand over to Peter to take the first part of your question. So you're absolutely right. I mean, we are seeing right now very critical and devastating epidemiological dynamic around chikungunya. We are in contact with all the respective governance governments where currently outbreaks are occurring. Speaker 200:27:46As I mentioned earlier, we believe that especially for those countries, you know, our vaccine proposition represents a very good vaccine solution. It's too early to to state at this point in time where and how we will be able to respond. We have no supply constraints. We have sufficient material available for for, you know, addressing those potential response strategies. But we also would like to make sure that that we stay in control over those vaccination or potential vaccination campaigns given the experience that we had with La Reunion. Speaker 200:28:39So, therefore, bear with us that at this point in time, we don't wanna promise anything other than we will be at most responsive. Speaker 300:28:49Peter? Yeah. So on the 40,000 doses, they they were all shipped in the first half year, and the the revenue will still be recognized in the first half year. So nothing nothing related to that 40,000 to come in the second half. Great. Speaker 500:29:06Thanks. Operator00:29:08We are now going to proceed with our next question. And the questions come from the line of Sebastian Vandishot from Van Lanschotcampen. Please ask your question. Speaker 500:29:20Hi, guys. Thank you for taking our questions. I'm on for Susan. For the Lyme vaccine, could you maybe provide some insight on how the reporting of the data readouts will transpire at year end? Will the doc disclosures only, report top line data, or can we also expect some detailed results? Speaker 500:29:39And then, maybe would you be able to position the vaccine in terms of immunogenicity towards vaccines of the past? Thank you. Speaker 200:29:51Again, vaccine setup. We couldn't Sebastian, we couldn't hear the second part of your question. You were breaking up your your part of the question. I'm sorry for that. Speaker 500:30:04Sure. It's it's regarding the immunogenicity profile of the vaccine versus past COVID COVID, I'm sorry, Lyme vaccines in the past from the nineties. Speaker 200:30:15Yeah. Okay. So let us, first of all, address the first part of the question. Of course, the reporting of the phase three results is under the sole responsibility and accountability of Pfizer. We are currently expecting that the data readout will come in two steps, namely a report on the so called top line data, which primarily will include efficacy numbers, and then a subsequent data communication on all the other, you know, endpoints given that, as you know, the study has many endpoints and many, you know, primary, secondary, exploratory. Speaker 200:31:07You know, there are many things that will need to be reported. And and as we said in the past and as many of you have it already included in the respective reports, we expect, you know, all data to be out probably by the end of the first quarter, but definitely in time to support the anticipated regulatory submissions, you know, around mid next year. When it comes to the immunological profile, it is very difficult to compare what was observed from an immunological profile back in the days from vaccines that had undergone phase three studies like Limerick or ImoLyme because they had very different schedules. The entire formulation was different. The antigen contract construct was different. Speaker 200:32:14The assays were different. What we can say is that we have tried to compare the those previous full length serotype one antigen to our modern recombinant subunit and multivalent fusion protein BLA 15 in different animal models. We have published those results in the direct comparison against what we call in parenthesis at the full length of a serotype one biosimilar. And we have seen that across the border, we could really identify noninferiority or, in many cases, also superiority. Any other, you know, comparison right now, you know, would just not be scientifically sound. Speaker 200:33:22And by the end of the day, the efficacy readout will tell us, sir. Great. Speaker 100:33:29Thank you so much. Speaker 200:33:30You're welcome. Operator00:33:33We are now going to proceed with our next question. And the questions come from the line of Damian Choplin from Stifel. Please ask your question. Speaker 500:33:47Yes. Hello. Congrats on the good publication, and thank you for taking my questions. I have first one on ICSIK. So could you please elaborate a bit on what might trigger an acceleration in sales uptake within the traveler market? Speaker 500:34:02And, are you still in discussion with the states in The U. S. For potential stockpiling? And my second question is on distribution agreements with CSL. What should we expect in terms of financial impact on top line and, potentially EBITDA? Speaker 500:34:17Thank you. Speaker 200:34:19Yeah. So let me let me start with the second part of your question first. You know, we have been collaborating with the Bavarian Nordic for a number of years now in Germany. And and, you know, for reasons that we all understand, you know, we we have to change, and we have been extremely pleased that we were able to find with CSL, from our perspective, an excellent partner with an excellent base infrastructure in Germany. The commercial terms under the agreement are very similar to what we used to have. Speaker 200:35:04And and, therefore, we do not expect an immediate, you know, difference in, you know, the prospects around Germany in the mid to long term, you know, as CSL gear further up with in in Germany, we may even see a potential, you know, upside. When it comes to XGIC and future market access, you would certainly appreciate that the uncertainty that we have experienced and had to experience following all those safety investigations had an impact on the market uptake for that vaccine. At the same time, we know that the vaccine profile, and especially the the profile of a live attenuated single shot vaccine, has distinct advantages when it comes to future outbreak preparedness. And and, therefore, we are expecting that now that all those restrictions got lifted, the investigations got concluded, the the the prescribing information, then s p SMPC has got updated, we will see a new momentum. And and we expect, as I mentioned earlier, hopefully, to be able to respond to some of the emerging outbreaks across the globe right now. Speaker 200:36:45And and all the other discussions will hopefully resume now in the latter part of this year. Speaker 500:36:56Thank you very much. Operator00:37:09We are now going to proceed with our next question. And the questions come from the line of Rajin Sharma from Goldman Sachs. Please ask your question. Speaker 600:37:21Hi. Thanks for taking my questions. So, a couple on Lyme and the VALORE trial. So on clinicaltrials.gov, the entry suggests that the primary completion date of the trial is December 26. So just wanted to double check your confidence that that Phase three headline data will be coming in in 2025, or is there potential that this could spill into 2026? Speaker 600:37:46And then just on the trial specifically, what do you consider to be the bar for success here? And I know you kind of talked about, the inability to kind of do cross trial comparisons with the the previous sets of vaccines that were approved, but I think Limericks demonstrated a forty nine percent efficacy rate after two priming doses. And I think you've talked previously about potentially showing better efficacy. So is that what you're looking for? And if you have any color, it would be helpful to understand what the FDA's bar for approvability is as well. Speaker 600:38:17Thank you. Speaker 200:38:18So let me hi, Rajan. Let me start with the second part of your question first. So you rightly pointed out that the direct comparison to Limerick and ImoLyme is very difficult. And, you know, that the schedule was different, but also the efficacy readouts of the two vaccines were very different. You know, the and the Limerix after two doses, you know, as you mentioned, a bit below 50, ImoLyme above 60, and then, you know, both, you know, very substantially increased up to three doses. Speaker 200:39:04You know, we have a different setup right now. We have a with zero two six and then a booster after one year. We have a very different immunological profile. And, hence, we are also expecting a very different, you know, efficacy profile as compared to those vaccines that were developed at the time. There is a reason for why we concluded with the authorities to set the primary endpoint after three plus one doses, And and we are and as I said earlier, you know, all the, you know, the models that were run and published in animals to show a non inferiority or superiority, you know, after, you know, the final dosage. Speaker 200:39:57And this is what we are expecting, of course. That is what we are hoping for. There is no communicated or aligned bar for approval with the FDA or the European Medicines Agency, but there are precedents on certain efficacy levels that you can certainly point and and and filter out. But I don't want to mention here specifically any number. When it comes to the data readout, you know, price.gov always includes safety follow-up periods and follow-up period. Speaker 200:40:41This is what all, you know, notifications on trial.gov show. Trial.gov show where it shows very clearly that that we have to do case counts until the October. And, thereafter, as I mentioned at the beginning, Pfizer will go through their case adjudication process and their database cleaning. And it will take as long as it will take. For us, the more important thing is that Pfizer reaffirms the submission timeline and whether we will receive the top line data a month earlier or a month later, a, it is not in our control, and, b, it is not material for us. Speaker 200:41:28And, therefore, I don't wanna comment on you know, and put, you know, execution time line at this moment in time into into Pfizer here. It would not be appropriate for me to do that. Speaker 600:41:44Okay. Thank you very much. Operator00:41:48We have no further questions at this time, so I'll hand back to you for closing remarks. Thank you. Speaker 200:41:54Yes. Thank you so much for your attendance today, for your good questions and for following Vannevar. I hope you share with us the exciting prospects that we see in the company, in our vision, in our business, in our mission and fit ambition. Thank you so much, and have a great day. Operator00:42:17This concludes today's conference call. Thank you all for participating. You may now disconnect your lines. Thank you, and have a great day.Read morePowered by Earnings DocumentsSlide DeckPress Release(6-K)Press ReleaseInterim report Valneva Earnings HeadlinesA Vaccine for a Mosquito-Borne Disease Fuels Valneva Stock Rally1 hour ago | bloomberg.comValneva SE 2025 Q2 - Results - Earnings Call PresentationAugust 12 at 3:21 PM | seekingalpha.comTrump’s national nightmare is herePorter Stansberry and Jeff Brown say a new U.S. national emergency is already underway — and it could trigger the biggest forced rotation of capital since World War II. They reveal why Trump is mobilizing America’s tech giants… and name the two stocks most likely to soar as trillions shift behind the scenes. | Porter & Company (Ad)Valneva Shares Gain After Results, OutlookAugust 12 at 4:48 AM | marketwatch.comValneva Reports Half Year 2025 Financial Results and Provides Corporate UpdatesAugust 12 at 2:00 AM | globenewswire.comValneva SE (VALN) Q2 2025: Everything You Need To Know Ahead Of EarningsAugust 11, 2025 | finance.yahoo.comSee More Valneva Headlines Get Earnings Announcements in your inboxWant to stay updated on the latest earnings announcements and upcoming reports for companies like Valneva? Sign up for Earnings360's daily newsletter to receive timely earnings updates on Valneva and other key companies, straight to your email. Email Address About ValnevaValneva (NASDAQ:VALN) SE, a specialty vaccine company, develops, manufactures, and commercializes prophylactic vaccines for infectious diseases with unmet needs. It offers IXIARO, an inactivated Vero cell culture-derived Japanese encephalitis vaccine indicated for active immunization against Japanese encephalitis; DUKORAL, an oral vaccine for the prevention of diarrhea caused by Vibrio cholera and/or heat-labile toxin producing enterotoxigenic Escherichia coli bacterium; IXCHIQ, a single-dose, live-attenuated vaccine for the prevention of disease caused by chikungunya virus; and VLA2001, an inactivated whole-virus COVID-19 vaccine. The company also develops VLA15, a vaccine candidate, which is in Phase III clinical trial against Borrelia, the bacterium that causes Lyme disease; VLA1553, a vaccine candidate, which is in Phase III clinical trial against the chikungunya virus; VLA1554, a vaccine candidate targeting human metapneumovirus; and VLA2112, a vaccine candidate to treat patients with epstein-barr virus. It sells its products in the United States, Canada, Germany, Austria, Nordics, the United Kingdom, France, rest of European countries, and internationally. Valneva SE has collaborations with Pfizer, Inc. to co-develop and commercialize its Lyme disease vaccine; and Instituto Butantan for the development, manufacturing, and marketing of single-shot chikungunya vaccine. The company was founded in 1998 and is based in Saint-Herblain, France.View Valneva ProfileRead more More Earnings Resources from MarketBeat Earnings Tools Today's Earnings Tomorrow's Earnings Next Week's Earnings Upcoming Earnings Calls Earnings Newsletter Earnings Call Transcripts Earnings Beats & Misses Corporate Guidance Earnings Screener Earnings By Country U.S. Earnings Reports Canadian Earnings Reports U.K. Earnings Reports Latest Articles Brinker Serves Up Earnings Beat, Sidesteps Cost PressuresWhy BigBear.ai Stock's Dip on Earnings Can Be an Opportunity CrowdStrike Faces Valuation Test Before Key Earnings ReportPost-Earnings, How Does D-Wave Stack Up Against Quantum Rivals?Why SoundHound AI's Earnings Show the Stock Can Move HigherAirbnb Beats Earnings, But the Growth Story Is Losing AltitudeDutch Bros Just Flipped the Script With a Massive Earnings Beat Upcoming Earnings Palo Alto Networks (8/18/2025)Medtronic (8/19/2025)Home Depot (8/19/2025)Analog Devices (8/20/2025)Synopsys (8/20/2025)TJX Companies (8/20/2025)Lowe's Companies (8/20/2025)Workday (8/21/2025)Intuit (8/21/2025)Walmart (8/21/2025) Get 30 Days of MarketBeat All Access for Free Sign up for MarketBeat All Access to gain access to MarketBeat's full suite of research tools. 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There are 7 speakers on the call. Operator00:00:00and thank you for standing by. Welcome to the Valneva Presents its Half Year twenty twenty five Financial Results Conference Call and Webcast. At this time, all participants are in a listen only mode. After the speakers' presentation, there will be a question and answer session. Please note that today's conference is being recorded. Operator00:00:30I would now like to hand the conference over to your first speaker, Joshua Drum, Vice President, Global Investor Relations. Please go ahead. Speaker 100:00:39Thank you, operator. Hello, and thank you for joining us to discuss Bellneva's first half twenty twenty five 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 six months ended 06/30/2025, which were published earlier today, available within the Financial Reports section on our Investor website. I'm joined today by Valneva's CEO, Thomas Lingelbach and our CFO, Peter Bruhler, who will provide an overview and update on our business as well as our key financial results for the first half. Speaker 100:01:14There will be an analyst Q and A session at the conclusion of the prepared remarks. Before we begin, I'd like to remind listeners that during this presentation, we will be making forward looking statements, which are subject to certain risks and uncertainties that could cause actual results to differ materially from those expressed or implied by these forward looking statements. You can find additional information about these risks and uncertainties in our periodic filings with the Securities and Exchange Commission and with the French Market Authority, which are listed on our company website. Please note that today's presentation includes information provided as of today, 08/12/2025, and Velineva undertakes no obligation to revise or update forward looking statements, except as required by applicable securities laws. With that, it's my pleasure to introduce Thomas to begin today's presentation. Speaker 200:02:01Thank you, Josh. Good day, everyone. It's a pleasure to present our first half twenty twenty five financial results and key business highlights. A first half of the year that has been quite eventful and marked by excellence in execution. We achieved total revenues close to €100,000,000 a very significant year over year growth, and a cash position of more than a €160,000,000, which also marks not only a strong additional cash influx through ATM transactions, but also a significant reduction in operating cash burn, which again shows you that we are focusing on investing into the right things and and really making sure that we retain a strong cost cash position as we go into the period of line data readout. Speaker 200:03:09We have further pipeline and regulatory progress around Lyme, ex chick, and shigella, and I'm gonna go into those in more detail. When we look on page five, what we have really seen or what we are seeing is our key highlights. In line with our mission ambition, we have really addressed unmet medical need in the first half of the year. We finalized a new supply agreement for its CRO with the US Department of Defense, and we responded to the French government's call for X shaped to combat chikungunya outbreaks in La Rignon and Mayotte. We also responded to the cholera outbreak in Mayotte by supplying doses of ducorale. Speaker 200:03:55So really by addressing those unmet medical needs, ensuring that we make a change to people's lives. On the regulatory and commercial achievements, we secured additional marketing authorizations for XGIC in The United Kingdom, in Brazil, and label extensions for XGIC in Europe for adolescents 12 years of age and and older. We also announced an exclusive vaccine marketing and distribution agreement for Germany with CSL Securius. We are happy about this partnership. We had to undergo a very comprehensive safety assessment with the two key regulatory authorities, FDA and EMA, in connection with XGIC safety signals observed during mainly during the vaccination campaign on La Viegnion. Speaker 200:04:49And we were able, through this collaborative interactions and approach with the agency, to lift the temporary age related restrictions again. Online, we are very happy that the VALOA study is progressing to plan. The entire program is progressing to plan, and that's very recently announced by by Pfizer during its earnings call. We completed the vaccination in the current VALOA phase three study. On XGIC, we have seen a high sustained one year immune response in adolescents, which again reconfirms what we have seen in adults, namely the key differentiation of this product, long term antibody persistence and protection. Speaker 200:05:37We also achieved positive phase three pediatric safety and immunogenicity results for XG. On Shigella, we have been progressing our first controlled human infection model study, and we initiated vaccinations in a dedicated phase two infant study. When we look at the programs one by one, of course, we would like to start with our Lyme disease vaccine candidate, which is clearly the world's leading candidate in that field. And as we reported many occasions, Lyme disease represents a major medical need and market opportunity. There's currently no vaccine available to prevent Lyme disease in humans, and also the treatment options are very limited. Speaker 200:06:29The annual burden of disease is constantly increasing, and the most updated numbers show that we are approaching in the Northern Hemisphere more and more numbers that gear towards one million cases on an annual basis. Many of those cases result in severe manifestations, catitis, neuroborgnosis, arthritis. And unfortunately, many people experience persistent symptoms. And in those even persistent following treatment with antibiotics. So therefore, there is a clear medical need and a clear objective to find a suitable, meaning efficacious, and safe preventative solution. Speaker 200:07:25When we look at the phase three study that is ongoing, this is a study that, for operational reasons, as reported many times in the past, has been split into two cohorts, but it's one study spanning over three tick seasons, tick season 2023, '4, and five. We included in this study more than 9,000 participants aged 12 years and older. And the study is randomized one to one vaccine against placebo, two to one North America versus Europe. The primary endpoints and what we try to achieve here is prevention of the disease. Therefore, we are measuring as part of the primary endpoint, the rate of confirmed Lyme cases after two consecutive tick seasons, meaning after completion of the full vaccination series priming with three doses and first booster, therefore, at three plus one or four doses. Speaker 200:08:28This is the primary endpoint. With regards to secondary endpoints, of course, we will report, and we aim to report the number of Lyme disease cases and efficacy after the first tick season, and many other immunological endpoints as defined in the phase product phase three protocol. On the slide on page nine, you can see that now all the little syringes here are marked green. And this is the key progress. And with this progress, Pfizer reconfirmed that they aim to submit regulatory applications in The United States and Europe in 2026. Speaker 200:09:14And this is in line with the timeline that reported that we have reported, Pfizer reported in the past, namely that we aim to launch in the 2027, subject to positive data to have people protected for the 2028 tick season. We are going to monitor this year the Lyme cases until the October. This is the end of the Lyme season. Then thereafter, Pfizer will undergo case adjudication, you know, database cleaning, and all of that. So everything is on track, and we are looking forward to this data and, hopefully, to a nicely efficacious and safe vaccine that will be able to make a substantial change to people's lives and represent a major catalyst for Vyleva going forward. Speaker 200:10:10Turning to chikungunya, our single shot chikungunya vaccine, X shape or VLA fifteen five three. We mentioned already that FDA and EMA have now lifted again the temporary restrictions against youth in elderly. You know that we had reports of serious adverse events in fray elderly individuals, primarily among elderly with multiple underlying health conditions, and most of it resulted and was observed through the mass vaccination campaigns in La Vignon in response to a very severe chikungunya outbreak. EMA and FDA therefore imposed temporary restrictions while they investigated together with us the reported SAEs. I mentioned already twice that those restrictions have now been lifted, and all the labels have been updated. Speaker 200:11:16What has been updated primarily are the use conditions and the safety sections, precautions, and warnings, either on the prescribing information in The United States or the summary of codec characteristics, SMPC in Europe. And and this reaffirms what we have been saying from the very beginning. A life attenuated vaccine has a clear advantage, for an outbreak disease, which is unpredictable in terms of timing. And and it is coming with a very, very long antibody persistence and protection. And we are monitoring in a follow-up study antibody persistence for up to ten years. Speaker 200:12:07And most importantly, XTRK remains indicated for the prevention of disease caused by the chikungunya virus in individuals 18 years of age and older in The United States, 12 years and older in Europe, who are at high risk exposure to chickpea. So it remains an excellent vaccine solution if given to the right people in the right setting. Of course, we are continuing to focus expanding access, label extensions, and furthermore, the overall product profile for XGIC. We have a very robust clinical program that is supported by more than $40,000,000 grant by Tippi. And we are grateful that Tippi continues to support this program and the company as a whole. Speaker 200:13:02The phase four aim to confirm effectiveness and basically is a key post marketing commitment since the vaccine got its initial approval to an immunological surrogate of protection, so called accelerated approval pathway. There will be observation effectiveness study in Brazil, pragmatic randomized controlled effectiveness safety study in adults and adolescents to be to be confirmed in other endemic countries. And we expect also further prospective safety cohort studies. On the label extension, we aim to expand access to the vaccine for all age groups, and will gradually develop it accordingly. On the product profile, I think it's very important that we confirm the long term durability of the immune response that we have that we can show that the vaccine following a single shot has a very long zero response rate and, hence, effectiveness. Speaker 200:14:17And this ongoing antibiotic assistance, as I said earlier, is a study that would monitor people for up to ten years. We reported positive three month results to date with four months with four years results coming up later this year. Now turning to Shigella, which is the world's most clinically advanced tetravalent Shigella vaccine candidate. We are targeting to cover with the four serotypes up to eighty five percent of the Shigellosis infections. And these infections are really life threatening, especially in young children, and therefore also identified as a priority vaccine by WHO. Speaker 200:15:11We are aiming to develop the vaccine both for children living in low medium income countries, but also for travelers who are exposed to the disease. We our partner, Limatec, reported positive phase one data previously in this program, which got awarded FDA passport designation. As I said at the very beginning, we launched a phase two infant study with data expected towards the latter part of this year. And we have the ongoing phase 2b controlled human infection model study aiming to provide an early look at potential efficacy with efficacy data expected very early next year. Those studies are still led by Nematec. Speaker 200:16:05And Vanneva would assume all further regulatory R and D, CMC and future commercialization activities in the near term. As we reported earlier, we are working on a novel Zika virus candidate. This is a candidate that we optimized against the first generation candidate that we had pre COVID. It leverages our inactivated whole virus platform that we further advanced and developed as part of our COVID endeavor. And previous results showed already excellent immunogenicity safety. Speaker 200:16:49And now in this phase one study, we look at safety and immunogenicity with an enhanced process and optimized vaccine formulation. As we reported earlier, we believe that a vaccine solution against this flaviviral disease transmitted by the aedes mosquitoes is needed because of the devastating effects those infections can have. But at the same time, we will need to evaluate future development strategy strategies based on the phase one results, external non dilutive funding and the resulting market potential and to see where we really are at the point of data readout. With this update on our primarily R and D programs here, I would like to turn over to Peter to provide you with the financial Speaker 300:17:48report. Thank you, Thomas, and good morning and good afternoon to all of you. Now moving to the financials of the 2025. Product sales reached €91,000,000 compared to €68,300,000 in the 2024, an increase of 33.3%. Foreign currency fluctuation had an adverse impact of €500,000 VIXiaro sales reached €54,700,000 increasing 30.6% over prior year. Speaker 300:18:17The strong year over year growth was equally driven by sales to travelers and to the Department of Defense. Xiara sales during the 2024 were adversely impacted by supply constraints. Dukorat sales grew year over year by 16.4% and reached €17,400,000 in the 2025. The growth in Dukorat sales was supported by a €1,100,000 sale to the French island of Marriott to combat a local cholera outbreak. XJIC sales reached €7,500,000 compared to €1,000,000 in the 2024 when the product had been launched in The United States. Speaker 300:18:55XJIC sales in the 2025 benefited from a supply of 40,000 doses to the French island La Reignon as the island experienced a major chikungunya outbreak. Third party products increased by 8.8% year over year to reach €11,400,000 This increase is primarily a result of supply constraints in the first half of the prior year, and we continue to expect a gradual decrease of third party products. Moving on to the income statement. Total revenues reached €97,600,000 versus €70,800,000 in the 2024. The increase of 37.8 is driven by higher product sales and an increase in other revenues related to the licensing agreement with the Serum Institute of India for Vyleva single shot chikungunya vaccine. Speaker 300:19:46Looking at expenses, cost of goods and services for the 2025 reached €47,300,000 compared to €45,600,000 during the same period last year. The gross margin on commercial products, excluding XCHIC, reached 59.2% in the 2025 compared to 47.7% in the prior year. The improvement in gross margin was driven by better manufacturing performance. IXIARO gross margin reached 65.5% compared to 57.5% in the 2024, And DUKORAL generated a gross margin of 52.9% compared to 34.8% last year. Cost of goods related to XTRK amounted to €2,500,000 or a gross margin of 66%. Speaker 300:20:37Cost of goods also includes a EUR 5,900,000.0 idle capacity cost. Research and development expense increased from EUR 29,700,000.0 in the 2024 to €32,400,000 in the 2025. That increase is driven by costs related to the Shigella vaccine candidate following the R and D collaboration with Limotech Biologics. We expect another acceleration of our R and D costs in the 2025, in particular driven by the Ixtric Phase IV program. Marketing and distribution expense decreased from €23,200,000 in the prior year to €20,300,000 in the 2025. Speaker 300:21:19The increase is related to a planned reduction in the advertising and promotion spend related to XJIC following the launch in early twenty twenty four. The decrease was partially offset by higher costs related to warehousing and distribution. G and A expense decreased to €19,000,000 compared to $20.22 euros $2,020,800,000.0 in the 2024. At the 2024, the company ran a program to increase operational efficiency, and the reduction in G and A spend is a direct result of this initiative. In the 2025, Valneva reported an operating loss of €16,800,000 compared to an operating profit of €46,700,000 in the last year. Speaker 300:22:04Last year's operating profit was the result of the sale of a Priority Review Voucher for a total net proceeds of €90,800,000 Adjusted EBITDA in the 2025 reached minus €6,800,000 minus €6,000,000 compared to a positive EBITDA of €66,200,000 last year. Excluding the one off PRV sale in the prior year, adjusted EBITDA improved by 80% year over year. Before moving to the outlook and guidance, a word on cash. As mentioned by Thomas at the beginning of the call, cash at June 30 was reported at €161,300,000 compared to €168,400,000 at the 2024. Cash used in operations was reported at €10,900,000 compared to €66,300,000 in the 2024. Speaker 300:22:55Now moving to Slide 21. We confirm our financial guidance for the fiscal year 2025 with product sales of 170,000,000 to €180,000,000 and total revenues of EUR 180,000,000 to 190,000,000. We continue to project R and D expenses of EUR 90,000,000 to 100,000,000. The R and D expenses will be partially offset by grant funding and the anticipated R and D tax credits. As confirmed in the first half year results, we expect a significantly lower use of cash in operations, targeting a year over year reduction of more than 50%. Speaker 300:23:32Cash flow remain a key focus in order to ensure sufficient runway to reach key inflection points. In the midterm, we expect continuous growth in our product sales, focus on strategic investments into R and D and continuous improvement in gross margin. We continue to expect VONNEO to be sustainably profitable post successful approval and commercialization of the Lyme disease vaccine. With this, I hand the call back to Thomas for the outlook. Speaker 200:24:00Thank you, Peter. Yeah. When we look at the 2025 guidance, of course, it is important that we look at the growth drivers. And the growth drivers primarily are, as Peter mentioned, life. I think the the VLA 15 program or the Lyme disease program with Pfizer is not only the single largest catalyst for the company and its future development and strategic optionality, but it's also the vaccine that could make the single largest impact to people's lives. Speaker 200:24:46As such, it is very highly matching with our purpose, our vision, and mission. Of course, in the near term, as Peter said, we will focus on growing commercial revenues, and we will reposition XShake as the right vaccine against chikungunya for the right setting in the right population in the right also geographical area. With regards to future pipeline, we have our two early stage or mid stage clinical assets, Shigella and Zika. And our goal is to not only progress those programs, but possibly even further augment our pipeline post phase three successful life. As such, we have really a great opportunity to become on the back of a positive line outcome, the leading vaccine biotech in the world. Speaker 200:25:54And with that, I would like to hand back to the operator to take the question. Operator00:26:00Thank you, We are now going to proceed with our first question. And the questions come from the line of Maury Raycroft from Jefferies. This Speaker 400:26:35is Amin on for Maury. Congrats on the progress. Questions. Couple of questions from us. Regarding the 40,000 doses you sold to the French government, should we expect any additional revenue recognition in Q3? Speaker 400:26:51Also, could you share your perspective on demand scenarios for ex check through year end considering the evolving chickpea outbreak in Indian Ocean and now looks like China? Speaker 200:27:08Yeah. So let me start with the second part of your question, and then I hand over to Peter to take the first part of your question. So you're absolutely right. I mean, we are seeing right now very critical and devastating epidemiological dynamic around chikungunya. We are in contact with all the respective governance governments where currently outbreaks are occurring. Speaker 200:27:46As I mentioned earlier, we believe that especially for those countries, you know, our vaccine proposition represents a very good vaccine solution. It's too early to to state at this point in time where and how we will be able to respond. We have no supply constraints. We have sufficient material available for for, you know, addressing those potential response strategies. But we also would like to make sure that that we stay in control over those vaccination or potential vaccination campaigns given the experience that we had with La Reunion. Speaker 200:28:39So, therefore, bear with us that at this point in time, we don't wanna promise anything other than we will be at most responsive. Speaker 300:28:49Peter? Yeah. So on the 40,000 doses, they they were all shipped in the first half year, and the the revenue will still be recognized in the first half year. So nothing nothing related to that 40,000 to come in the second half. Great. Speaker 500:29:06Thanks. Operator00:29:08We are now going to proceed with our next question. And the questions come from the line of Sebastian Vandishot from Van Lanschotcampen. Please ask your question. Speaker 500:29:20Hi, guys. Thank you for taking our questions. I'm on for Susan. For the Lyme vaccine, could you maybe provide some insight on how the reporting of the data readouts will transpire at year end? Will the doc disclosures only, report top line data, or can we also expect some detailed results? Speaker 500:29:39And then, maybe would you be able to position the vaccine in terms of immunogenicity towards vaccines of the past? Thank you. Speaker 200:29:51Again, vaccine setup. We couldn't Sebastian, we couldn't hear the second part of your question. You were breaking up your your part of the question. I'm sorry for that. Speaker 500:30:04Sure. It's it's regarding the immunogenicity profile of the vaccine versus past COVID COVID, I'm sorry, Lyme vaccines in the past from the nineties. Speaker 200:30:15Yeah. Okay. So let us, first of all, address the first part of the question. Of course, the reporting of the phase three results is under the sole responsibility and accountability of Pfizer. We are currently expecting that the data readout will come in two steps, namely a report on the so called top line data, which primarily will include efficacy numbers, and then a subsequent data communication on all the other, you know, endpoints given that, as you know, the study has many endpoints and many, you know, primary, secondary, exploratory. Speaker 200:31:07You know, there are many things that will need to be reported. And and as we said in the past and as many of you have it already included in the respective reports, we expect, you know, all data to be out probably by the end of the first quarter, but definitely in time to support the anticipated regulatory submissions, you know, around mid next year. When it comes to the immunological profile, it is very difficult to compare what was observed from an immunological profile back in the days from vaccines that had undergone phase three studies like Limerick or ImoLyme because they had very different schedules. The entire formulation was different. The antigen contract construct was different. Speaker 200:32:14The assays were different. What we can say is that we have tried to compare the those previous full length serotype one antigen to our modern recombinant subunit and multivalent fusion protein BLA 15 in different animal models. We have published those results in the direct comparison against what we call in parenthesis at the full length of a serotype one biosimilar. And we have seen that across the border, we could really identify noninferiority or, in many cases, also superiority. Any other, you know, comparison right now, you know, would just not be scientifically sound. Speaker 200:33:22And by the end of the day, the efficacy readout will tell us, sir. Great. Speaker 100:33:29Thank you so much. Speaker 200:33:30You're welcome. Operator00:33:33We are now going to proceed with our next question. And the questions come from the line of Damian Choplin from Stifel. Please ask your question. Speaker 500:33:47Yes. Hello. Congrats on the good publication, and thank you for taking my questions. I have first one on ICSIK. So could you please elaborate a bit on what might trigger an acceleration in sales uptake within the traveler market? Speaker 500:34:02And, are you still in discussion with the states in The U. S. For potential stockpiling? And my second question is on distribution agreements with CSL. What should we expect in terms of financial impact on top line and, potentially EBITDA? Speaker 500:34:17Thank you. Speaker 200:34:19Yeah. So let me let me start with the second part of your question first. You know, we have been collaborating with the Bavarian Nordic for a number of years now in Germany. And and, you know, for reasons that we all understand, you know, we we have to change, and we have been extremely pleased that we were able to find with CSL, from our perspective, an excellent partner with an excellent base infrastructure in Germany. The commercial terms under the agreement are very similar to what we used to have. Speaker 200:35:04And and, therefore, we do not expect an immediate, you know, difference in, you know, the prospects around Germany in the mid to long term, you know, as CSL gear further up with in in Germany, we may even see a potential, you know, upside. When it comes to XGIC and future market access, you would certainly appreciate that the uncertainty that we have experienced and had to experience following all those safety investigations had an impact on the market uptake for that vaccine. At the same time, we know that the vaccine profile, and especially the the profile of a live attenuated single shot vaccine, has distinct advantages when it comes to future outbreak preparedness. And and, therefore, we are expecting that now that all those restrictions got lifted, the investigations got concluded, the the the prescribing information, then s p SMPC has got updated, we will see a new momentum. And and we expect, as I mentioned earlier, hopefully, to be able to respond to some of the emerging outbreaks across the globe right now. Speaker 200:36:45And and all the other discussions will hopefully resume now in the latter part of this year. Speaker 500:36:56Thank you very much. Operator00:37:09We are now going to proceed with our next question. And the questions come from the line of Rajin Sharma from Goldman Sachs. Please ask your question. Speaker 600:37:21Hi. Thanks for taking my questions. So, a couple on Lyme and the VALORE trial. So on clinicaltrials.gov, the entry suggests that the primary completion date of the trial is December 26. So just wanted to double check your confidence that that Phase three headline data will be coming in in 2025, or is there potential that this could spill into 2026? Speaker 600:37:46And then just on the trial specifically, what do you consider to be the bar for success here? And I know you kind of talked about, the inability to kind of do cross trial comparisons with the the previous sets of vaccines that were approved, but I think Limericks demonstrated a forty nine percent efficacy rate after two priming doses. And I think you've talked previously about potentially showing better efficacy. So is that what you're looking for? And if you have any color, it would be helpful to understand what the FDA's bar for approvability is as well. Speaker 600:38:17Thank you. Speaker 200:38:18So let me hi, Rajan. Let me start with the second part of your question first. So you rightly pointed out that the direct comparison to Limerick and ImoLyme is very difficult. And, you know, that the schedule was different, but also the efficacy readouts of the two vaccines were very different. You know, the and the Limerix after two doses, you know, as you mentioned, a bit below 50, ImoLyme above 60, and then, you know, both, you know, very substantially increased up to three doses. Speaker 200:39:04You know, we have a different setup right now. We have a with zero two six and then a booster after one year. We have a very different immunological profile. And, hence, we are also expecting a very different, you know, efficacy profile as compared to those vaccines that were developed at the time. There is a reason for why we concluded with the authorities to set the primary endpoint after three plus one doses, And and we are and as I said earlier, you know, all the, you know, the models that were run and published in animals to show a non inferiority or superiority, you know, after, you know, the final dosage. Speaker 200:39:57And this is what we are expecting, of course. That is what we are hoping for. There is no communicated or aligned bar for approval with the FDA or the European Medicines Agency, but there are precedents on certain efficacy levels that you can certainly point and and and filter out. But I don't want to mention here specifically any number. When it comes to the data readout, you know, price.gov always includes safety follow-up periods and follow-up period. Speaker 200:40:41This is what all, you know, notifications on trial.gov show. Trial.gov show where it shows very clearly that that we have to do case counts until the October. And, thereafter, as I mentioned at the beginning, Pfizer will go through their case adjudication process and their database cleaning. And it will take as long as it will take. For us, the more important thing is that Pfizer reaffirms the submission timeline and whether we will receive the top line data a month earlier or a month later, a, it is not in our control, and, b, it is not material for us. Speaker 200:41:28And, therefore, I don't wanna comment on you know, and put, you know, execution time line at this moment in time into into Pfizer here. It would not be appropriate for me to do that. Speaker 600:41:44Okay. Thank you very much. Operator00:41:48We have no further questions at this time, so I'll hand back to you for closing remarks. Thank you. Speaker 200:41:54Yes. Thank you so much for your attendance today, for your good questions and for following Vannevar. I hope you share with us the exciting prospects that we see in the company, in our vision, in our business, in our mission and fit ambition. Thank you so much, and have a great day. Operator00:42:17This concludes today's conference call. Thank you all for participating. You may now disconnect your lines. Thank you, and have a great day.Read morePowered by