Good day and thank you for standing by. Welcome to the Valneva Presents its Q1 2023 financial results conference call. At this time, all participants are in a listen only mode. After the speaker's presentation, there'll be a Q&A session. To ask a question during the session, you will need to press star one and one on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star one and one again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your host today, Joshua Drumm, Vice President of Global Investor Relations. Please go ahead. Thank you, Sharon. Hello, thank you for joining us to discuss Valneva's first quarter 2023 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 quarter, which were published earlier today, available within the financial reports section of our investor website. I'm joined by Valneva's CEO, Thomas Lingelbach, and CFO, Peter Bühler, who will provide an overview and update on our business as well as our key financial results for the quarter. 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 the 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 information about these risks and uncertainties in our periodic filings with the Securities and Exchange Commission and with the French Market Authority, which are listed on our company website. Please note that today's presentation includes information provided as of today, May 4th 2023. 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 so much, Josh. Good day to everyone. Great pleasure to present a couple of updates with regards to our quarter one and later Peter to present the financial report. We have a very good momentum right now, driven on the one hand side by our strong sales performance, but also increasing clarity on our key catalysts. Our product sales in the first quarter nearly doubled year-over-year. It was primarily driven by our proprietary product, IXIARO and DUKORAL, both of which more than quadrupled from quarter one 2022. We maintain a position of financial strength with a cash position of more than $250 million at the end of quarter one. We have reiterated our guidance with regards to expected product sales reaching or exceeding pre-pandemic levels this year. We have also a clear pathway towards our key transformative catalysts. Our chikungunya vaccine, which we expect to become the world's first chikungunya vaccine if approved, is still on track for its PDUFA date, confirmed after the mid-cycle review, towards the end of 2023. August 2023, sorry. We expect to commence further additional ex U.S. regulatory processes in 2023. For Lyme, we have decided after careful evaluation of risk and benefits, to keep the phase III design and the endpoint as previously agreed with regulators. We will have additional enrollment for primary immunization to begin in the second quarter, and will include the 2025 tick season, which in turn means that we are expecting to file in 2026. Pfizer will bear the current projected incremental cost due to the agreed additional enrollment. I will go into more details during the R&D update. Let us turn to page six of the presentation. Chikungunya, you know that our chikungunya vaccine is a live attenuated vaccine candidate under FDA priority review. It is the first and only chikungunya vaccine candidate that reported positive phase III data. It was the first one to submit a Biologic License Application to the FDA for potential approval. To remind everyone about the key benefits of a live attenuated vaccine approach, it is targeting a very long-lasting protection. Thus far, we have seen excellent antibody persistence data over time. Overall, our results demonstrated not only long-lasting but on a high zero response rates after a single shot. We are now preparing full steam for our launch of VLA1553, which perfectly fits within Valneva's existing infrastructure. In terms of target populations, we are looking at the non-endemic countries, you know, travelers, military, but also outbreak preparedness in key countries. Of course, the endemic use in low, middle income countries where we have partnered with Instituto Butantan, which includes also local manufacturing. To remind everyone about our key dates here and key KPIs. PDUFA date, as mentioned earlier, this point in time confirmed for the end of August 2023. In first company to achieve BLA approval will be eligible to a PRV. We are estimating that we could potentially sell this PRV if we got it at around $100 million. We have right now an adolescent trial ongoing because the initial approval will be in adults 18 years and older. We expect top-line results mid-year, which will then support also some of the regulatory filings. As I mentioned earlier, we expect to commence additional regulatory processes for Canada, EMA, and U.K. this year. We are super excited about our chikungunya program, and we are looking really forward to launch this product in an area of a very high unmet medical need. On page seven of presentation, Lyme, our Lyme disease vaccine candidate VLA15, is the only one in advanced clinical development today worldwide. It is a multivalent recombinant protein-based vaccine candidate, which has undergone a quite substantial number of phase I, II, and two studies. We initiated the phase III study as planned last year. This is basically the status until we had to discontinue a substantial amount of study subjects that were integrated in the study due to uncovering GCP violations by a third-party operator, CRO in this case. To remind everyone again, this program is partnered with Pfizer. Pfizer is the sponsor for the phase III study. Of course, we have received a substantial number of milestones, including also our equity investment that Pfizer did in June 2022. All the other features of this vaccine, we have presented many times, you know, multivalent, six-valent, because this covers the predominant serotypes in the Northern Hemisphere, established mode of action. We have mentioned already the fast track designation that was granted for this program. Now you are all interested in, you know, how are we going forward with the phase III study and page eight shows the current status of the phase III efficacy study called VALOR. We plan to enroll around 9,000 participants, five years and older, at high risk of Lyme disease in the U.S., Canada and Europe. There will be a one-to-one randomization in between VLA15 and placebo, and roughly a two-to-one randomization U.S. versus Europe. The primary endpoint is the rate of confirmed Lyme disease cases after two consecutive tick seasons and after completion of the three doses of priming plus booster. The secondary endpoint is linked to the Lyme confirmed Lyme disease cases after the first Lyme season, which means after three doses or after the so-called priming. This is illustrated now with the two different cohorts in the graph below. What you see on the upper part of the graph is the current participants, which we call now the cohort 1. These are the ones that were enrolled last year, where unfortunately we could not enroll the full necessary cohort because of the GCP issue. This is the so-called cohort 1 which will now receive or very soon receive the first booster. We have the cohort 2, which are the incremental number of study subjects that will be recruited soon. This cohort 2 will then start with this redozes priming and the 18 months booster as well. Therefore, as mentioned earlier, you have the tick season 2023 and 2024 literally for the first cohort, and 2024 and 2025 for the second cohort. This allows us to retain the initial protocol and the initial design. All of that means that we are now aiming to submit regulatory applications in the U.S. and Europe in 2026 as compared to 2025 before we had and Pfizer experienced the GCP issues. When we look at R&D as a whole and pipeline and what's next, there are a couple of quite interesting remarks to be made. Besides of chikungunya and Lyme, we are currently working on Zika. We are evaluating it to potentially re-enter the clinic at the end of 2023, early 2024, given the overall status of medical need around Zika. Given the fact that the WHO expressed a very clear preference in a position paper for an inactivated whole virus approach, given the potential target population, meaning women in childbearing age or even pregnant women. We are working on hMPV and have concluded now the initial preclinical PoC. As we mentioned during the last call, the overall respiratory environment is kind of moving towards a future RSV hMPV combo. Therefore, we see our asset as an interesting asset for potential partnering. We have the other, you know, three preclinical candidates with a clear priority on EBV, where we expect to have our antigen education completed by the end of 2023 in Campylobacter and Pavlov for both. We are currently working on certain work packages in order to facilitate the respective skating reviews. With that overview about primarily our R&D activities, I would like to hand over to Peter to provide you with the financial report. Thank you, Thomas, and good morning or good afternoon to all of you. Let's discuss our first quarter 2023 financials. Total revenues reached EUR 33.5 million, an increase of 53.4% compared to the first three months of 2022. While product sales increased by 98.6% to reach EUR 32.1 million. This increase is driven by the continued recovery of the international travel market. Product sales, excluding the COVID-19 vaccine sales in the first quarter of last year, increased by 159.7% over prior year. On the right side of the slide, you can see the composition of product sales with small sales to U.S. military in the first quarter of 2023. Discussions with the U.S. Department of Defense are ongoing, we expect to sign a new contract in the coming months. Direct sales reached 71.6%, which is lower than usual. As a comparison, for the full year of 2022, direct sales reached 91%. The decreased ratio of direct sales is a result of high sales to Bavarian Nordic for distribution in the German market. Moving on to slide 12 to look at the details of our product sales. Sales of IXIARO quadrupled versus prior year, and the same is true for Dukoral. Again, this reflects the strong recovery of the travel market that directly impacts the sales of our travel vaccines. We see a solid year-over-year growth across all markets and managed to increase prices for IXIARO and Dukoral in most markets. Third-party product sales decreased by almost 20% as a result of supply constraints of products sold under the distribution agreement with Bavarian Nordic. Foreign currencies had no significant impact on the product sales performance versus prior year. Moving on to slide 13 and looking at the P&L. We already covered the over 50% growth in total revenues. Cost of goods and services increased by 48% year-over-year. Gross margin of commercial products excluding COVID somewhat deteriorated to reach 48.4% compared to 68% in the first quarter of last year. However, the prior year gross margin was positively affected by one-off effects. Research and development costs reached EUR 14.1 million compared to EUR 20.7 million, a decrease of 32% as our Chikungunya vaccine candidate progresses towards licensure. Also, in Q1 of prior year, we reported more significant R&D expenses related to VLA2001, our COVID-19 vaccine. Sales and marketing expense increased from EUR 2 million in Q1 of 2022 to EUR 9 million in Q1 of the current fiscal year. Costs related to the pre-launch activities of our Chikungunya vaccine, including related staff increase, is a major driver of the increase in sales and marketing costs. Sales and marketing costs in Q2 of last year were particularly low due to an impact of our share-based compensation. G&A costs in the first quarter increased significantly over prior year and reached EUR 10 million. In the first quarter of 2022, all expense lines were favorably impacted by an adjustment of EUR 11.7 million related to the impact of the company's share price development on the employee share-based compensation. Without that favorable impact in the first quarter of last year, G&A costs would be roughly flat. Other income, net of other expenses, is reported at EUR 3.5 million, compared to EUR 2.1 million in the first three months of 2022. This increase is driven by the revenue recognition of a grant in Scotland. Operating loss for the first quarter reached negative EUR 16.6 million versus negative EUR 18.4 million one year ago, while adjusted EBITDA reached negative EUR 12.3 million versus EUR 13.3 million one year ago. Before we move on to the guidance, a word about cash. Total cash and cash equivalents amounted to EUR 254.5 million at the end of March, compared to EUR 289.4 million at the end of December. Now, moving on to the next slide on guidance. We reconfirm the guidance for the total fiscal year of 2023, with EUR 130 million-EUR 150 million in product sales, EUR 90 million-EUR 110 million in other income, representing the PRV mentioned by Thomas at the beginning of the call. R&D investments are still expected between EUR 70 million and EUR 90 million. With this, I would like to give the call back to Thomas. Thank you so much, Peter Bühler. Yeah, to summarize, where we see our key upcoming catalysts and news flows for the remainder of the year. Chikungunya, as mentioned, first adolescent study results expected, mid-2023. The potential BLA approval and first launch of the product in the United States alongside with the potential PRV sale immediately after the granting of the BLA. As mentioned earlier, three additional submissions planned, namely Canada for this year, Canada, EMA and the UK, and those will happen this year. On Lyme disease, VLA15, of course, it is critical that we get the enrollment right. That the enrollment for the additional, now new second cohort, for primary immunization begins in the latter part of the second quarter. We will see as part of our general program to review antibody persistence, also some further data in the second half of this year. When it comes to news flow outside of chikungunya and Lyme and of course, a potential DoD contract for IXIARO in the coming months, this is certainly something that we should expect here. We have talked in the past about the fact that we would probably evaluating implementing the clinical pipeline through a program acquisition or partnering in order to have more, you know, clinical and earlier clinical stage assets that could provide substantial, you know, catalysts in the future while we are kind of accelerating our preclinical programs towards clinical entry. With that, I would like to go to the page 18 of the presentation to conclude. Here, you see the slide that we have shown in the past a couple of times. This is just illustrating to you how we see the growth over the coming years, with today's main value driven by IXIARO, Dukoral and third-party products, you know, adding, you know, Chikungunya to our commercial part and then, you know, later, you know, coming up with VLA15 and the first, you know, monetizations around the Lyme program in our partnership with Pfizer. All in all, Valneva is poised for substantial growth in the years to come. With that, I would like to hand back to the operator to take the questions. Thank you. To ask a question, you will need to press star one and one on your telephone and wait for your name to be announced. To withdraw your question, please press star one and one again. We will now go to your first question. Your first question comes to the line of Maury Raycroft from Jefferies. Please go ahead. Hi, this is Kevin on for Maury. Congrats on the update, and thanks for taking my questions. Just a couple on Lyme to start. Could you clarify what the ultimate size of each cohort is going to be? Just maybe if you could talk about what potential options you were considering and what ultimately led you to keep the current protocol. Then just finally, with filing now in 2026, does that change how you think at all about, you know, your overall strategy or anything with the competitive landscape? Okay. Let me try to answer your questions in this regard. First of all, we are not permitted at this point in time to disclose the exact numbers of the different cohorts. You have seen that pre the GCP issue, we had said 6,000-7,000 was the end. Pfizer reported that around 50% of the study subjects had to be abandoned. Now you see on the slide an end of 9,000, which answers your question. When we talk a little bit about the strategy going forward. I think, yes, it is unfortunate that we are facing a one-year delay for the Lyme program as compared to where we were. Let's not forget that the underlying science, the underlying strength of this product candidate, is certainly still something that has not changed. Even if someone started tomorrow with a clinical development for a Lyme disease vaccine, it would still be the same clinical development program that would be needed, and we know how long it takes. Therefore, we don't see necessarily any change on strategy in connection with that. What were the other options? Of course, when you think about what has happened, it was primarily U.S.-focused. We have evaluated, of course, you know, going, you know, for a subcourse, e.g., Europe first and then U.S. later and/or, you know, changing primary versus secondary versus primary. All of that has been a long process, in excellent collaboration and consultation in between the two parties and supported also by external parties. Ultimately we decided to keep everything as is and just add an additional cohort. Great. Thank you. On chikungunya, for the mid-cycle review, you mentioned that there's no significant review or safety concerns. Just wondering if there's any other points that were discussed that you could comment on that have implications for the review process label or post-approval studies. Thanks. Not at this point in time. Great. Thanks. I'll hop back in the queue. Thank you. We'll now go to your next question. Your next question comes to the line of Max Cameau from Stifel. Please go ahead. Hi. Great. Thanks very much for taking my questions and congrats on the quarter. Just wanted to understand a little bit about the pre-commercial activities for the tick vaccine. What are you doing? What are your plans? Also on the tick in terms of ACIP meeting in February, should we be expecting a few phases of an ACIP review or do you think you can get a clear decision with one meeting? That's the first question. Second, just on following up on the question with regards to Lyme. I just wanted to make sure that 9,000 is excluding the 9,000 subjects is excluding any of the GCP kind of patients that or subjects that were recruited by that one IXIARO. Final question on commercial. Notice usually you have a strong fourth quarter and a strong first quarter with the travel vaccine business. I noticed obviously, that the IXIARO and other vaccine areas were down quarter-on-quarter, fourth quarter to first quarter. I just wanted to get an understanding of that, you know, stocking patterns or what was the cause of that, given clearly we're still, seeing a recovery in travel. Thank you. Yeah. Very good questions, Max, as usual. Hi. Basically, try to go to address them as good as I can. The 9,000 on Lyme exclude, of course, the ones that were executed from the study. For tick launch, I mean, you know that, we are investing heavily. We are investing in people, processes, infrastructure, market access, activities, all the stuff that you would expect for a pre-launch phase. You know, really getting everything ready in time to get to make the launches success and ensure that we see then over time a rapid uptake of the vaccine. Awareness is key around all of that. This requires resources, you know, human resources, but also other resources. I mean, you see this already in the increase in sales, marketing expenses, which will continue. On the whole ACIP thing. I mean, right now the vote date is set for February. There have been already a couple of steps, and there are still a couple of additional steps planned. You know, more we cannot predict at this point in time. Doesn't mean that we may not see, you know, additional steps here and there, but this is as far as we can tell at this moment in time. On the commercial dynamics, please keep in mind, quarter one has still been affected by supply shortages on the Valneva side, and not only on the Valneva side, also on third-party products. It is at this moment it is very difficult to predict or to draw a conclusion on the pattern that you've seen this year to prior years. Therefore, you know, we would like just to remind everyone that we have again reiterated the product sales guidance for this year to reach EUR 130 million-EUR 150 million. Great. Thanks very much. More than welcome, Max. Thank you. We will now go to your next question. Your next question comes to the line of Ed White from H.C. Wainwright. Please go ahead. Hi. Thanks for taking my questions. Just on hMPV, you had mentioned today and before that, you could partner looking at an RSV combo. I'm just curious as to if you've actually had any interest in that if that's something we can expect to see, you know, this year, or is this just sometime down the road that we should be thinking about this opportunity? Excellent question. Basically, we are having active discussions around hMPV, but it is by far too early to promise a partnering deal. You know, we are, we clearly see that, you know, for example, the mRNA companies strive towards RSV hMPV combos. We also see the clear medical need for RSV hMPV combos. There are only a certain number of RSV companies that could have a potential differentiation by adding an hMPV component to the vaccine. As I said, it is too early. This is why we are saying we are evaluating the partnering, but we are not promising the partnering at this point in time. Okay. Thank you. Just on, tick, how should we be thinking about a potential for you know, a DoD contract or the size of perhaps the stockpiling for, you know, outbreak preparedness? How are you thinking about this opportunity? Is it immaterial or it's a material opportunity for the company? This is a very difficult to answer question. We have, I mean, you know that we have been pretty clear about the expected market opportunity in the travel segment and in the LMIC countries. We have not been specific at all around the size of a potential, you know, military business, nor have we been specific to size around stockpiling. We have discussions both with U.S. military as well as with certain countries or states potentially interested in stockpiling. At this point in time, those segments do not represent a major chunk of our overall projections. It is too early to really give a guidance or give a range for these opportunities. I think we should probably postpone this to next year, same time or so. Once this product is approved, hopefully, and in the market, then we will have a much, much better understanding about those opportunities I think. Okay. Thank you. My last question is just regarding the two different cohorts for the tick study now. Are you considering these, and Pfizer are considering these cohorts as different studies or the same study? You know, can you release the data from the cohort 1 prior to cohort 2, or do you have to wait for both cohorts to finish to release the data? No, first of all, this is one study. Second, we are currently expecting to release it all together. Okay, great. Thanks for taking my questions. More than welcome. Thank you. We'll now go to our next question. Your next question comes from the line of Evan Wang, Guggenheim Securities. Please go ahead. Hi, guys. Thanks for taking the question. I have one on Lyme and then one on chikungunya. With Lyme, you know, as we're thinking about the additional cohorts being enrolled, will that be entirely U.S. focused or majority U.S. focused, just given the CRO patients? For chikungunya, just following up on the stockpiling opportunity there. I believe you have had or early conversations. Are there any color you can provide in terms of, you know, the feedback you've gotten? Is there any kind of additional studies or bottlenecks that, you know, may need to be addressed first? Thanks. On Lyme, additional cohorts, U.S. and Canada. No additional enrollment in Europe. For chikungunya and the whole stockpiling, as I mentioned, we have discussions ongoing. At this point in time, we do not expect further studies than the one that we have already planned. Please keep in mind, we have planned, you know, besides the pivotal studies that we have concluded, adolescent, or pivotal phase III in adults. We have planned, of course, the adolescent, then later pediatric. We have also planned studies in immunocompromised. We have planned, you know, co-vaccination studies. We are not necessarily expecting those to become a prerequisite for a potential stockpiling. I think it would more be a question once the final, you know, recommendations will be there, the final approvals will be there. I think that would be the moment where we're gonna get more clarity and that's certainly important. Got it. If I could just squeeze one more in. you know, in terms of potential business development or in-licensing, is 2023 realistic or is that more a longer term? I mean, yeah, for us it is a 2023 objective and, but it depends on the opportunity, right? We have clearly set this objective for this year for the organization, for ourselves, and we hope that we will be able to achieve that. You know, at this point in time, we have, you know, multiple things that we are reviewing and evaluating. As I said, you know, a deal is done when the deal is done, right? I mean, we cannot be sure that this is gonna materialize this year. Great. Thank you. Thank you. We'll now go to your next question. Your next question comes from the line of Rajan Sharma from Goldman Sachs. Please go ahead. Hi, thanks for taking my questions. I just had a couple. I guess firstly, just, given the strong start for the travel vaccines in, you know, in 2023 and given the quarterly performance, I was just wondering how confident you are in reaching the upper end of your sales guidance. Secondly, just on Japanese encephalitis, given that there was a competitive vaccine which was acquired by a private company who kind of talked about expanding global registrations of that vaccine. I was just wondering how you know, if you could discuss your thoughts on the market and how you are kind of able to defend your position there. Thanks. Let me take the second question, and then I will give to the first part to Peter. Look, I mean, at this point in time, we have not seen any competitor for JE initiating the necessary clinical studies for a registration in Europe and U.S. There is no way, you know, you can register this competitive product without a respective clinical study. Those will, you know, take time and I think we're gonna deal with it, when we see, you know, a potential competitor entry. In terms of positioning, our vaccine has more than 10 years history. It is a vaccine that is marked by excellent effectiveness and safety. It is a very well-known and established brand. As such, we feel strong about this product. We feel strong about its prospects, and we would also feel strong about it if we had a competitor entry, which is not on the horizon at this point in time from where we stand at this point. Peter, you wanna say something about guidance? Yeah. Well, thanks, Rajan, for the question. Look, I think we're very optimistic when it comes to our sales. I think with, as you said, with a very strong first quarter, actually in line with pre-pandemic level in euro terms. Of course this is great for the rest of the year also. As Thomas said, we still have some supply constraints in Q1. We're very optimistic with regards to reaching our guidance. Whether it will be the upper part of the guidance, I think it's too early to tell, but we certainly had a good start. Thank you. Thank you. Once again, if you would like to ask a question, please press star one one on your telephone keypad. We will now take your next question. Your next question comes from the line of Samir Devani, Rx Securities. Please go ahead. Yeah. Hi, guys. Thanks for taking my questions. I think I've got a couple. Just going back to the successful mid-cycle review, Thomas. I just wanted to get whether you got any more color as to whether there was likely to be a VRBPAC meeting or not. Just that's the first question. The second one is really just on the Pfizer Lyme collaboration. You haven't booked any recognized any revenue in the P&L this quarter. I was just wondering if you could help us understand whether we should still expect you to recognize anything for the remainder of the year, and if so, what sort of magnitude. I think last, in the last call you talked about your contribution coming out of refund liabilities. There doesn't seem to have been much change in your refund liabilities on the balance sheet. Could you just confirm whether there's been a significant payment made to Pfizer during the quarter for that R&D contribution? Thanks. Okay. Samir, again, mid-cycle review, we have not mentioned anything about a VRBPAC, and we have not mentioned anything about any roadblock. This should be giving you the right answer, I think. On the revenue recognition contribution liabilities, I hand over to Peter and his team. Yeah. Thank you. Hey, Samir. On the revenue recognition, you're right, we have not recognized any revenue. There could still be, going forward, some revenue that we could recognize potentially, which we've decided not to do so far as long as the phase III trial is still, you know, in a relatively early stage and ongoing. But, we certainly have some amounts that we could potentially recognize going forward. I think on the refund liability, I think your observation is very good. There was, I think with, you know, with the overall situation, the Lyme, I think there were some, I would say, delays in issuing invoicing. We indeed have not paid as much in Q1 as we would have anticipated, and that's why probably you haven't seen a lot of movement in the refund liability. There will be a catch up in the later part of the year. It doesn't change the overall cost base we had estimated earlier on. Okay. That's very helpful. Let me just actually sneak in one more. Just on your third party product sales, they were quite a lot lower than what they were in Q4. Could you just explain to us what's going on there and what we should expect for the rest of the year? Thanks. Yeah. Look, as I said before, I think, when I look at it, we're in euro terms, in line with where we were pre-pandemic. I think it's a very strong quarter. I think it's in line with our expectations, and we're optimistic for the rest of the year to deliver product sales within guidance, EUR 130 million-EUR 150 million. Okay. That's great. Thank you very much. Thank you. We'll now go to your next question. Your next question comes to the line of Simon Scholes, First Berlin. Please go ahead. Your line is open. Yes. Hello. I've got two questions. I remember in the last call, you were discussing that a creative solution might have with the FDA, might have allowed you to submit documentation already as early as 2025, despite the loss of trial participants. I would just be very curious to if you could discuss what that creative solution might have entailed. Secondly, can you give us any indication, I mean, can you tell us whether you expect the supply constraints which hit your travel vaccine business in Q1 to ease in the current quarter? Thanks. First of all, not so sure whether I recall having said creative. I think you did. Yeah. Well, I mean, as I mentioned, I answered the same question earlier on, right? I think we have evaluated the possibility to take special sub-cause earlier. After a careful risk-benefit evaluation, we have decided that it is not in the interest of this program to increase its risk profile. That's why we have said, we keep the original protocol as is. On the supply constraint side of things, you know, yes, we have had supply issues in, still in the first half of the year because demand has just exceeded what we had anticipated. You know, we have a long lead time to produce the vaccines. When we saw last year that there was a beginning recovery, we immediately started, but it takes time. We are currently anticipating no further supply constraints going forward from where we are today. Okay, thanks very much. Thank you. There are currently no further questions. I will hand the call back to you. I think with that, we would like to thank you, for your participation today. Thank you for your support, and for following, Valneva. It's been a pleasure to provide you today's update. Have a good remainder of the day. Bye-bye. Thank you. This concludes today's conference call. Thank you for participating. You may now disconnect.