Valneva - Earnings Call - Q4 2024
March 20, 2025
Transcript
Operator (participant)
Good day, and thank you for standing by. Welcome to Valneva's Full Year 2024 Results conference call. At this time, all participants are in listen-only mode. After the speaker's presentation, there will be the question-and-answer session. To ask a question during the session, you need to press star one one on your telephone keypad. You will hear an automated message advising your hand is raised. To withdraw a question, please press star one one again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to our first speaker today, Joshua Drumm. Please go ahead.
Joshua Drumm (VP and Global Investor Relations)
Thank you. Hello, and thank you for joining us to discuss Valneva's Full Year 2024 Results and corporate update. It's my pleasure to welcome you today. In addition to our press release and analyst presentation, you can find our consolidated financial results for the 12 months ended December 31, 2024, which were published earlier today, available within the financial reports section on our investor website. I'm joined today by Valneva 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 2024. There will be an analyst Q&A session at the conclusion of the prepared remarks.
Before we begin, I'd like to remind listeners that during this presentation, we'll 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, March 20, 2025, and Valneva undertakes no obligation to revise or update forward-looking statements except as required by applicable securities laws. With that, it's my pleasure to introduce Thomas to begin today's presentation.
Thomas Lingelbach (CEO)
Thank you so much, Josh. Good day to everyone. Yeah, Valneva had another successful year in 2024, thanks to no small part to the dedication and skill of our in-house teams and lawyer partners. When we look at the key highlights of the year, we achieved our targeted double-digit year-on-year sales growth with sales above EUR 160 million, aligned with our 2024 guidance. We managed to have a very solid cash position at year-end, close to EUR 170 million, with a significantly lower operating cash burn. Of course, all augmented by our successful placement of almost EUR 60 million and the sale of our priority review voucher. Peter is going to provide more details, of course, on all the financial performance indicators. We had a very strong regulatory execution with three additional IXCHIQ approvals and a very significant number of upcoming label extensions around IXCHIQ.
Of course, we achieved one of our strategic objectives to augment our pipeline with a leading phase II Shigella program. When we really look at what have we achieved and what are we expecting for 2025, this is all shown on page five of the presentation. As I said, substantial clinical and regulatory progress, as well as financial strengths, are really the headlines for 2024. When we look at 2025 ahead, we expect multiple data readouts. We expect product approvals. We expect label extensions. When we look at this a little bit more in detail, we expanded access to IXCHIQ. We have launches underway in Canada, Europe, and the United Kingdom. We entered into new Asian partnerships for key endemic markets. You know, especially the low-medium-income countries are very important for this product.
We reported further key clinical findings that supported the label extensions for IXCHIQ into adolescence. We have clearly, with this product, again confirmed its product differentiation, primarily when it comes to antibody persistence. We have the VLA product profile has been confirmed through additional key news flows and results that we reported in 2024, primarily the phase II booster results that we reported. As I mentioned earlier, we have a strong financial position, which allows us to continue R&D investments. We showed solid cash, continuous double-digit revenue growth, and we got an additional grant funding that supports our key IXCHIQ R&D activities. Looking ahead, we see, of course, the transformative potential for the Lyme vaccine candidate VLA15, which is right now in the phase III study. We are on track for the study for a first data readout expected by the end or at the end of the year.
This will then result in regulatory filings anticipated for 2026. Hopefully, if everything goes well, first approvals in 2027. We have further expanded and will further expand access to IXCHIQ. We expect a product approval in Brazil, which will be our very first endemic market for this product. I mentioned already the adolescent label extensions in key markets. Of course, we are still waiting for quite a number of national vaccination recommendations outside of the United States, which hopefully will support the uptake of that vaccine in the respective markets. We have further meaningful clinical milestones that we anticipate for 2025, the results from the phase II studies for Shigella, but also the phase I results for our novel Zika vaccine candidate. What are the key growth drivers for 2025 and beyond? Of course, the most important one, VLA15, our Lyme vaccine candidate.
We have clearly articulated many times that if successful, meaning successful data, successful regulatory approvals, successful commercialization, this product will have the potential to drive Valneva into sustained profitability, driven by milestone payments and royalties expected to start in the success case towards the latter part of 2027. We will, in the meantime, continue to grow our commercial revenues in the near term, of course, continue the growth trajectory for IXIARO and DUKORAL, augmented by further growth of IXCHIQ that gains more and more global traction. When we look at the future pipeline value, it is, of course, Shigella and Zika that are the next clinical assets in the pipeline. Our goal, as articulated in the past, is to have a next phase III program ready to go into phase III post-Lyme success.
When we look a little bit at the Lyme disease candidate, again, giving the background to Lyme, Lyme disease represents a major medical need and hence market opportunity. There's currently no vaccine available to prevent Lyme disease in humans, and the annual disease burden is substantially at a rise. CDC reported almost 500,000 cases in the United States. In Europe, given that there is not a very comprehensive reporting system, there are definitely confirmed cases of about 130,000. When we look a little bit into the clinical manifestation, and I think this explains also the severity of Lyme disease, 10%-30% of people develop really severe clinical manifestations, including Lyme carditis, neuroborreliosis, or Lyme arthritis. 5%-10% of those remain with persistent symptoms, and those continue to have persistence really over years.
Therefore, this is really a major issue, and therefore a preventative solution would have a huge health economical benefit. When we look at people living in areas of risk and Lyme risk, we have around 80 million people in the United States living in defined Lyme endemic regions and about 200 million in Europe. Therefore, our current guidance agreed with Pfizer is that we expect the market to exceed $1 billion at peak. We are currently in the middle of, oh, the latter part of the phase III study called VALOR. You know that this phase III study has been spanning over three tick seasons. We are now in tick season number three or just about to enter the tick season 2025. We reported last year in our joint press release the completion of the primary vaccination series.
We have still, for the second cohort, the booster vaccination to be done. By way of reminder, we have about 9,000 participants in the study, greater than five years of age. The study is a placebo-controlled randomized study, one-to-one randomized vaccine against placebo, two-to-one randomized North America versus Europe. The primary endpoint of the study is the rate of confirmed Lyme disease cases after the respective primary series plus booster, so after the so-called three plus one vaccination. Secondary endpoints include, amongst others, the Lyme disease cases after the primary series. There were a whole bunch of other secondary endpoints that we have been discussing in the past. All in all, we need to see, of course, the right level of cases and the right level of efficacy.
All of that will be shown once we have the final data readout for the prevention of the disease here, which we anticipate towards the end of 2025. When we look at chikungunya, and again, this is a reminder for all of you, we believe that our product is a highly differentiated vaccine. It is the first vaccine that got licensed against chikungunya. It provides a strong and persistent immune response with only one dose. We have shown close to 100% seroresponse, and we have seen a sustained seroresponse at that level up to now. After three years, we have an antibody persistence study that is going to monitor the persistence up to 10 years. We expect that we're going to see a very high level of persistence for a long time.
It is also important that we have seen a similar level of seroresponse in all age groups tested thus far, meaning adolescents, 18-64 years of age, and 65+. As I said, it is a true one-shot vaccine. We have a number of key R&D activities associated with IXCHIQ. They are all focused on expanding access, label extension, or confirmatory studies to support the product's effectiveness in real life. I mentioned at the very beginning that this program is supported by a new more than $40 million grant from CEPI, extending our existing and very successful partnership with CEPI. We have the post-marketing effectiveness study, the phase IV study to confirm the effectiveness following the licensure process around the so-called accelerated approvals. It is an observational effectiveness study that we will conduct in Brazil.
We will have pragmatic randomized control effectiveness safety study in adults in endemic countries and a prospective safety cohort study and practices surveillance in Brazil. This forms the package around our phase IV activities. When we look at label extension to expand access to the vaccine for all age groups, of course, we have the phase III randomized control study in adolescents, age 12 to 17 years of age, and we reported positive data up to month 12 already. This is an ongoing regulatory process right now. We expect to enter into a phase III study for children below 11 years of age. We anticipate to start the study in the last quarter this year, pending, of course, all positive results. Those were already reported to a very large extent.
When we look at the product profile, I mentioned already the ongoing persistence study and the last data point that we reported after 36 months. When we look at Shigella, the program that we brought in, it is the world's most clinically advanced tetravalent Shigella vaccine candidate called S4V2. It got exclusively licensed from our partner, LimmaTech. It includes the four most common pathogenic Shigella bacteria serotypes. LimmaTech, in the past, reported positive phase I two clinical data. This program got awarded FDA Fast Track designation. We have explained already during our R&D day that we expect the market opportunity for Shigella to exceed $500,000,000 annually. The segments for this product are, of course, the low-medium income countries, and here especially children in low-medium income countries, because there it is the second leading cause of fatal diarrheal disease, estimated 165 million cases and 600,000 deaths annually.
A major unmet medical need. Therefore, it got also prioritized by the World Health Organization. Of course, we have the segments like chikungunya or like Japanese encephalitis in travelers and military. When we look at the current development program, we are basically here at the phase II CHIM study that is currently ongoing. In parallel, we're going to run a phase II pediatric study. The start of this phase II pediatric immunogenicity study is imminent. Both studies are being conducted by LimmaTech. We assume all further R&D, CMC, regulatory activities from LimmaTech in the course of the coming months. We are in a transition process to take over the lead on all of that. When we look at the Zika virus candidate called VLA1601, we expect the phase I results by the end of this year.
It is a novel adjuvanted inactivated whole virus vaccine candidate. We are leveraging the platform that we developed for our COVID vaccine called VLA2001. We are testing double adjuvantation here and a large-scale production platform that, of course, would be needed for a vaccine like a vaccine against the Zika virus. I mean, we all remember well that Zika virus infections can be quite devastating. Microcephaly, severe brain defects in newborns, Guillain-Barré syndrome in adults, all of that is well in our memories, I think. We see more and more Zika outbreaks coming back. There is currently no vaccine or specific treatment available. It is a PRV-eligible disease, and there is potential significant funding from public institutions. We have articulated previously that we are going to execute this phase I study.
We will take a look at the overall immunological profile, including antibody persistence, and then we'll further study the further pathway to a potential licensure. This will also in part depend on our views at the time around medical need, market potential, and the opportunity for non-dilutive external funding. With that, I would like to hand over to Peter.
Peter Bühler (CFO)
Thank you, Thomas. Good morning or good afternoon to all of you. Moving on to the financial review, starting with details on our top line on slide 20. Total product sales reached EUR 163.3 million, in line with our guidance and growing 13% over 2023. Excluding COVID-19 vaccine sales in 2023, product sales grew by 18% year-over-year. IXIARO sales reached EUR 94.1 million, compared to EUR 73.5 million in 2023, representing a growth of 28%. Sales to travelers grew 19% year-over-year, and sales to US military also recorded a strong growth as the US Department of Defense opted to purchase additional doses under the September 2023 contract. As a reminder, in January 2025, we announced a new one-year contract with the U.S. Department of Defense. DUKORAL sales reached EUR 32.3 million, compared to EUR 29.8 million in the previous year, a growth of 8%.
The main driver for this growth came from Canada, as well as from the indirect markets, where improved availability of products drove stock replenishments. IXCHIQ was launched in 2024 in the United States, and at the end of the year in Canada and France, and we recognized initial sales for the financial year 2024 of EUR 3.7 million. Finally, third-party sales decreased year-over-year by EUR 2.5 million to EUR 33.2 million as a result of third-party supply constraints in the first half year. As discussed in the past, we expect these third-party sales to continue to decrease in the future as we focus on our proprietary products. The decrease of third-party products will support our goal to improve our overall gross margin. Moving on to slide 21, looking at the P&L. Other revenues decreased from EUR 9.1 million to EUR 6.3 million.
The decrease is primarily related to lower revenues recognized from our chikungunya collaboration with CEPI and Butantan. In 2023, other revenues also included some residual revenues related to our COVID-19 vaccine program. Looking at expenses, we reduced our cost of goods by EUR 2.4 million, with a decrease in both cost of goods and cost of services. The overall gross margin of commercial products, excluding IXCHIQ, reached 50.6%, compared to 46% in 2023. This improvement is primarily related to better manufacturing performance, including improved yields in our Scottish manufacturing site. As mentioned in previous earnings calls, our gross margin is adversely impacted by idle cost in our new manufacturing sites in Scotland and Sweden. IXIARO reached a gross margin of 61%, compared to 52.3% in 2023. DUKORAL's gross margin has directly been lower than IXIARO, and there reached 38.7%, compared to 42.4% in the prior year.
Third-party sales reached a gross margin of 32.8%, and IXCHIQ cost of goods were EUR 7.2 million, exceeding sales driven by manufacturing overhead. Research and development expenses increased from EUR 59.9 million in 2023 to EUR 74.1 million in 2024. The increase of 24% is in line with our guidance and is driven by the tech transfer of IXIARO and IXCHIQ production to our new facility in Scotland, as well as by our newly licensed phase II vaccine candidate for Shigella. Furthermore, we increased our investment in preclinical activities. R&D investments in our chikungunya vaccine were stable year-over-year as we execute further clinical studies, in particular in pediatrics, and started preparing for our mandatory phase IV activities. In 2024, we strengthened our R&D team in line with our strategy to continue focusing on innovation.
Marketing and distribution expenses are reported at EUR 52.4 million, compared to EUR 48.8 million in 2023. This increase is primarily due to higher staff costs as we strengthened our commercial organization to support our sales growth, including the launch of IXCHIQ. G&A expenses decreased from EUR 47.8 million in 2023 to EUR 42.8 million in 2024. This decrease is related to lower external spend, but also to structural changes to our G&A organization. In 2024, Valneva sold a Priority Review Voucher obtained with the approval of IXCHIQ in the United States. The voucher was sold at $103 million, which, net of expenses related to the sale of the voucher and translated into euros, resulted in net proceeds of EUR 90.8 million.
Other income and expense remained stable versus prior year at EUR 20.7 million and mainly consist of grants as well as tax credits related to R&D activities in Austria and France. In 2024, Valneva reports an operating profit of EUR 20.7 million, compared with an operating loss of EUR 82.1 million in the prior year. The operating profit in 2024 was substantially driven by the non-recurring income related to the sale of the priority review voucher. After financial expense and income taxes, Valneva's loss for the period reached minus EUR 12.2 million, while the adjusted EBITDA is reported at plus EUR 32.9 million. Now, moving on to the financial outlook. In 2025, we expect total product sales to reach EUR 170-180 million and total revenues to EUR 180-190 million.
We expect the growth in product sales to come primarily from increased sales of IXCHIQ driven by the United States, but also expansion into additional new territories. We expect IXIARO and DUKORAL to continue to grow, while we assume third party, as previously mentioned, to continue to decrease significantly. We expect our investments into R&D to reach between EUR 90 million and EUR 100 million as we continue to advance our clinical and preclinical assets. These investments into R&D are supported by external grant funding as well as R&D-related tax credits, which will be recorded in other income. As mentioned by Thomas, we report a solid cash basis at the end of 2024 with EUR 168 million in cash and cash equivalents, and we expect to decrease our operational cash burn by more than 50% from over EUR 60 million in 2024 to around EUR 30 million in 2025.
We will continue to manage our cash carefully to have sufficient runway to reach key inflection points. We will continue to grow our commercial revenues and focus on strategic R&D investments. We're targeting one clinical program to enter phase III post-Lyme data, and we will look for additional non-dilutive funding for our clinical programs. As mentioned in the past, we expect to continue improving our gross margin as we focus on our proprietary products and finalize the tech transfer into our new manufacturing site in Scotland. From 2020, based on a successful Lyme disease vaccine approval and commercialization, we have the opportunity to become sustainably profitable. With that, I hand the call back to Thomas to look at our future value drivers.
Thomas Lingelbach (CEO)
Many thanks, Peter, for this comprehensive financial report for the full year 2024. Let me remind you one more time where we see really the growth drivers for 2025 and a little bit beyond 2025. It's about Lyme. As we mentioned in this presentation, again, it is certainly a very, very important asset for the company. With an expected first readout by the end of the year, this is, of course, something that's going to have an enormous impact on the future development and prospects of the company. We have our commercial business, which has delivered quite nicely over the past years, and we see this really continuing. As Peter mentioned, the shift from lower third-party product sales, primarily given that our commercialization partnerships with BN will come to an end, and more focus on our proprietary vaccines will substantially increase cost margin.
Hence, the overall commercial business already this year is expected to be cash generative and will continue to provide cash that we can reinvest in R&D. We have very nice R&D assets that we would like to progress, and we expect some meaningful clinical data readouts this year, especially around Shigella and Zika. With that, I would like to hand back to the operator to take your questions.
Operator (participant)
Thank you, dear participants. As a reminder, if you wish to ask a question today, please press star, one, one on your telephone keypad and wait for your name to be announced. To withdraw a question, please press star, one, one again. Please stand by while we compile the Q&A roll studies. It will take a few moments. Now we are going to take our first question. It comes from Suzanne van Voorthuizen from Van Lanschot Kempen. Your line is open. Please ask your question.
Suzanne van Voorthuizen (Head of Life Sciences Equity Research)
Hi, this is Suzanne from Kempen. Thanks for taking my question. Peter, can you elaborate a bit on the cash burn guidance that is going down by over 50%? What are the main drivers behind this? With that, can you also give some context to the R&D expenses going up for the coming year? Another question for Thomas, more of a vaccine sentiment question. What risks or opportunities do you see stemming from RFK's role now in the administration? We've seen some changes implemented at the CDC and the ACIP, but on the other hand, he also specifically mentioned his experience with Lyme. Can you elaborate on this, please? Thank you.
Peter Bühler (CFO)
Yeah, so I can start with the cash burn. Hey, Suzanne, by the way. Thanks for the question. I will start with your question on cash. I think there are various reasons why, and you saw also the, of course, with the sales growth, et cetera, that will contribute. I think we will focus on cost containment in 2025. Also, we will look at, we will work on our working capital clearly. We have a couple of initiatives. With the end of the COVID program, for instance, the collection of the R&D tax credits took a little longer. In 2025, we expect to have the exceptional year where we will actually collect two years worth of R&D tax credits. All these are reasons why we actually will see a much lower cash burn.
Of course, as Thomas mentioned, also the commercial business returning to profitability will, of course, help our cash.
Thomas Lingelbach (CEO)
Does it answer your question, Suzanne?
Suzanne van Voorthuizen (Head of Life Sciences Equity Research)
Yes, for sure. Maybe in R&D going up, can you also elaborate on that?
Peter Bühler (CFO)
Yeah, so R&D going up, I mean, a very significant contribution, of course, to that is the chikungunya phase IV trial, the mandatory trials that we need to do under the approval we have in the U.S.. That is really going to, these costs are really going to ramp up in 2025. Of course, also the rest of the pipeline that we're accelerating and also our new Shigella program that is adding on to the R&D activities. Thank you.
Thomas Lingelbach (CEO)
Good. It was mentioning, Suzanne, that we will have the phase IV program will also be augmented by the phase III initiation in pediatrics, which is also mandatory, the mandatory post-licensure activity. All that peaks a little bit in the later part of this year. This is why you see this relatively high R&D cost. As Peter said, this is the potential offset through the CEPI grant as well as the R&D tax credits that Peter mentioned. On RFK, you gave us, of course, the question that we are receiving all the time. First of all, our position is, let's not speculate. I think it is important that we monitor the situation quite carefully. Of course, all vaccine companies have been concerned about ACIP getting delayed, necessary things that were supposed to be discussed at ACIP could not be discussed.
We need to really evaluate the impact. We need to see how this is going to go and develop further going forward. With regards to our existing vaccines on the market, these are mostly vaccines that are being paid out of pocket. They are currently not subject to, I would say, articulated criticism around vaccination. They are targeting areas of very high unmet medical need. The health economical analysis for those vaccines is very favorable. On Lyme, the situation is that the ACIP, the draft ACIP agenda had the formation of a Lyme working group on its agenda. We hope that this is going to come very soon. In our view, and you and I had this discussion before, my personal view is science will prevail.
If there was an efficacious and safe vaccine against a devastating disease like Lyme disease, why should it not be used and given to people who can benefit most of it?
Suzanne van Voorthuizen (Head of Life Sciences Equity Research)
Got it. Thank you very much.
Operator (participant)
Thank you. Now we're going to take our next question. The question comes from Samir Devani from Rx Securities. Your line is open. Please ask your question.
Samir Devani (Managing Director)
Hi guys. Thanks for taking my questions. Let me just kick off perhaps with some number questions. Can you just confirm whether you took any price rises on IXIARO and DUKORAL at the beginning of this year? I guess that's question one. I guess the only other one on the numbers is, or maybe two on the numbers. There was an intangible spend up to end of September of about EUR 10 million, and it seems to have gone down to EUR 2.5 million in the cash down. I was just wondering what happened in the last quarter to do that. You mentioned about the R&D tax credits that you're expecting. Could you just maybe quantify that for us? Thanks very much.
Thomas Lingelbach (CEO)
I start with the first part of your question. Hi, Samir, by the way. We had no material price increases in 2024 for any of our products. You have almost a like-for-like volume comparison. I'm sure that was your question.
Samir Devani (Managing Director)
Actually, Thomas, it was about 2025 rather than 2020. Was it at the beginning of the year you've taken it?
Thomas Lingelbach (CEO)
No. No, it's 2025. Sorry, Samir. This is what I meant. Yeah.
Samir Devani (Managing Director)
Yeah. Okay.
Thomas Lingelbach (CEO)
Basically nothing at this point in time. Peter, to the other part of the question.
Peter Bühler (CFO)
Yes. Your question on intangible, Samir. That was basically an upfront payment we had made for the in-licensing of the Shigella program. As our partner LimmaTech is executing some of the R&D work, we then brought some of the, there was basically the cost that they're contributing to the phase II right now, we actually moved out of the intangible. That is why this became.
Samir Devani (Managing Director)
Okay. Makes sense. Yeah. Okay. Makes sense. And then just the one on the R&D tax credits, Peter, that you mentioned, what sort of quantity is that, if you maybe can tell us that?
Peter Bühler (CFO)
Yeah, we do not give guidance on the R&D tax credit. When you look at our 2024 financial statements, you will see that out of the EUR 20 million that you see in other income, about half of it is R&D tax credit, and the other half is grants. That gives you a rough idea of what the tax credit was that we collected in 2024. As I said, for 2025, we have not given the detailed guidance.
Samir Devani (Managing Director)
Okay. And then just maybe if I can sneak one final one in, just on the application for approval of IXCHIQ in Brazil, is there any update as to when we might see that? Thanks very much.
Thomas Lingelbach (CEO)
Yeah. On Brazil, you know that we had anticipated the approval in Brazil in the first quarter. We have been seeing some delays on the process. Basically, we have not received any further list of questions, which means the review process is very close to its end. I mean, our partner Butantan are pushing hard on Anvisa right now. All the other steps have been successfully completed, like pre-approval inspections and so on and so forth. You know that the approval, also, it is a delay right now. The approval is not yet on the critical path. We need this approval to start the pilot vaccination program that we anticipate and will combine then with the phase IV requirements, which is necessary to start in the rainy season, which means we have a bit of buffer.
Therefore, we hope that we're going to get the approval very soon.
Samir Devani (Managing Director)
Right. Thanks very much.
Thomas Lingelbach (CEO)
You're welcome.
Operator (participant)
Thank you. Now we're going to take our next question. Just give us a moment. The question comes from Lane of Rajan Sharma from Goldman Sachs. Your line is open. Please ask your question.
Rajan Sharma (Executive Director of Pharma and Biotech Equity Research)
Hi. Thanks for taking my questions. Just relating to IXCHIQ, and maybe just following up on that policy question from earlier, do you think the postponement of the February ACIP meeting could actually be beneficial for you near-term, given there was supposed to be a vote on your competitor's chikungunya vaccine as well, I believe? Secondly, just again following up on IXCHIQ, could you just talk to the market dynamics that you're seeing so far? Appreciate it's still relatively early, but in terms of the revenues that you have generated and the traction that the vaccine's got, where is that coming from based on what you're able to see? Thank you.
Thomas Lingelbach (CEO)
Let me start with the later part because there's not a lot I can say to the first part of your question. Let's talk a little bit about IXCHIQ dynamic. First of all, we are absolutely convinced that the chik market will develop over time. We discussed it in the past. We were initially a bit too optimistic with regards to the ramp-up, but we are absolutely convinced that this product will lead to a good commercial opportunity. Why is that? Because chikungunya is a severe disease, and the more we see in terms of outbreaks, the more we see in terms of clinical manifestations, the more we get to the point of saying that and seeing that chikungunya is not just a flu-like symptom disease, but it comes with pretty severe health impairments, some of them pretty long-lasting.
What we see right now is that there is more and more disease awareness. All the investments that we have been doing, that our competitors have been doing, are really driving the general understanding around chikungunya. On top of that, we see outbreaks. I mean, you have all noticed that there is a pretty severe outbreak on La Réunion right now with more than 2,000 cases in a single week. We have published a health economical analysis in a very renowned journal, which also shows that the health economical situation for chikungunya vaccination is very favorable. All in all, there is clearly a growing awareness. The growing awareness comes with growing demand. We see, of course, substantial prospects in the low-medium income countries.
Both of our partners have signaled quite substantial initial demands for their respective launch years, which in reality will be next year, but we will supply already a drug substance to them this year. In the United States, we are still waiting for the MMWR. You heard Suzanne's question at the beginning. I mean, there were many things that were supposed to be discussed at ACIP. We have been this delay of MMWR does not help access to the retail channel. All of that will hopefully be resolved soon and then drive uptake. The initial situation that we see in Europe, and thus far, we have launched in France. We have launched in Canada. We are going to launch in the U.K. The initial signs look good.
Everyone can, based on our guidance and based on what we have said about the decline of third-party products and the increase of IXIARO and DUKORAL, everyone can make the math of what we have assumed in terms of IXCHIQ sales this year. From there, we have to see how it's further going to develop. I think this is all I can say at this point in time about the IXCHIQ dynamic and the market dynamic around chikungunya.
Rajan Sharma (Executive Director of Pharma and Biotech Equity Research)
Okay. Thank you.
Operator (participant)
Thank you. Now we're going to take our next question. Just give us a moment. The question comes from Lane of Oscar Haffen Lamm from Bryan, Garnier. Your line is open. Please ask your question.
Oscar Haffen Lamm (Senior Associate of Biotechnology Equity Research)
Hi, team. Oscar from BG. I believe most of my questions have been taken in, but maybe on Zika. I was curious what your view was on the evolution of the epidemiology and ultimately how this would affect the potential continuation of the program into phase II. When would you expect the phase II to start and your estimated cost on that one? Thank you.
Thomas Lingelbach (CEO)
You're talking about Shigella phase II?
Oscar Haffen Lamm (Senior Associate of Biotechnology Equity Research)
The Zika phase II.
Thomas Lingelbach (CEO)
The Zika phase II. No. Basically, on the Zika, at this moment in time, we are with Zika in the phase I, as you know. We have a first data readout expected by the end of the year. This will then be followed by an antibody persistence period. We want to really understand antibody persistence since this has been an issue in the past. Basically, then we will take it from there and talk to the authorities about the clinical development pathway. I would say the earliest we could start a phase II study, if we decided to progress into phase II, would probably be at the end of 2026, early 2027. This is the current time horizon.
Oscar Haffen Lamm (Senior Associate of Biotechnology Equity Research)
I got it. Thank you.
Operator (participant)
Thank you. Now we're going to take our next question. The question comes from line of Vamil Divan from Guggenheim Securities. Your line is open. Please ask your question.
Vamil Divan (Managing Director)
Great. Thanks for hosting the call and taking my question. A couple—I apologize that I missed this—but on the IXCHIQ, just the—you've talked previously about your midterm guidance and kind of being relooked at. I'm wondering, just kind of given all the dynamics, when do you think is an appropriate time for us to expect that to be announced? Second, on Lyme, I know Pfizer, as you mentioned here, Pfizer aims to submit the application next year, assuming positive data. I'm just trying to get clarity on the exact timing for the data readout because Pfizer actually doesn't list it as sort of a key event on their catalog page for this year. I know you guys think it's coming. I'm just trying to clarify.
Do you expect the data this end of this year, or do you think the actual data readout itself may go into next year and just kind of how we should think about that? Thank you.
Peter Bühler (CFO)
Yeah, thanks for the questions. On IXCHIQ, we did give indeed the midterm guidance in the past. We did say earlier on that we might have to revise that, and indeed, we think we have to revise it. As you saw, the ramp-up of sales was lower than we had anticipated. We still believe in the potential of the product, and we still think that the guidance we gave in terms of level of sales is achievable, but it will certainly take a little longer. As we said, we need a few more data points. The 2025 started, right? We just had two months now where we have more data points, and we're launching a new territory. I think we still need a bit of time to really confirm by when we will get to the critical number.
This is also why we have not decided to give a new midterm guidance at this stage. We may in the future come back and give more indication, but it just took us a bit more time. Thomas, on the timing of the data readout for Lyme?
Thomas Lingelbach (CEO)
Yep. I mentioned at the beginning of the call and throughout the presentation that we are expecting the first data readout at the end of 2025. This will be followed by further analysis, further secondary endpoint readouts in the earlier part of 2026. We have previously, in our joint press releases, Pfizer said that we're going to submit the regulatory submissions in 2026 and that we anticipate to ideally bring the product into the market in time so that people can benefit from it for the 2028 [audio distortion].
Vamil Divan (Managing Director)
Okay. All right. Thank you.
Peter Bühler (CFO)
You're more than welcome.
Operator (participant)
Thank you. Dear participants, as a reminder, if you wish to ask a question, please press star one one on your telephone keypad and wait for your name to be announced. To withdraw a question, please press star one one again. We are going to take our next question. The question comes from line of Maury Raycroft from Jefferies. Your line is open. Please ask your question.
Maury Raycroft (Equity Research Analyst)
Hi. Congrats on the priority. Thanks for taking my questions. I'm just going to ask one on chikungunya. With Bavarian Nordic recently approved, maybe just talk about that and how you plan to leverage your first mover advantage and accelerate the launch in 2025. I'm also wondering if you still expect that the CDC will publish the MMWR this year and around July and how we should think about that as well.
Thomas Lingelbach (CEO)
First of all, we are very careful right now in predicting any timelines when it comes to MMWR, CDC, ACIP processes because, I mean, realities have shown that we have big unknowns here. We have to see really how this is going to evolve. Yes, our internal planning is still assuming that we're going to get MMWR this year. When it comes to Bavarian, of course, I mean, you know what I said in the past, we're not going to talk about competitor products and their dynamic and what it will do or not do. The point is I believe that there is a strong share of voice because I mentioned a couple of times that for chikungunya, disease awareness is key.
I think the more we see their really work around further increasing the awareness of the disease, the better it is.
Maury Raycroft (Equity Research Analyst)
Understood. That makes sense. I just wanted to see if there's any additional perspective you can share related to the vaccinated subjects that were hospitalized after getting IXCHIQ and what your expectations or some scenarios that could come out of the discussion at the upcoming ACIP meeting.
Thomas Lingelbach (CEO)
Yeah. I think what we are seeing here is a normal process. Cases were reported under the VAERS system. The causality of those cases with the vaccination is being assessed. We have provided all the necessary information to ACIP, CDC, as well as FDA. We do not want to speculate, and we do not want to say anything right now about how they conclude on the causality. We have, of course, our own opinion around that, but let the process prevail. I think we take it from there, whatever the outcome is going to be.
Maury Raycroft (Equity Research Analyst)
Makes sense. Okay. Thanks for taking my questions.
Peter Bühler (CFO)
You're more than welcome, Maury.
Operator (participant)
Thank you. Dear participants, as a last reminder, if you wish to ask a question, please press star one one on your telephone keypad. Dear speakers, we'll just give a moment to our participants. There are no further questions for today. I would now like to hand the conference over to the management team for any closing remarks.
Thomas Lingelbach (CEO)
Yeah. Thanks a lot for your attendance today. Thanks a lot for your great questions, as usual. We are looking ahead with confidence. We are looking ahead into a great 2025, knowing, of course, that 2025 is a transitional year for the company as we are moving towards Lyme data, which will be very critical for the further strategic development of the company. As such, we are looking forward to some very interesting further readouts this year, as mentioned. Again, thank you so much for your attention. Thanks so much for your interest and support of the company and wishing you all the best for the rest of the day. Thank you.
Operator (participant)
This concludes today's conference call. Thank you for participating. You may now disconnect. Have a nice day.