Q1 2025 Valneva SE Earnings Call
[music].
Operator: Good day and thank you for standing by.
Good day and thank you for standing by welcome to the Bel never first quarter of 2025 financial 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 will need to press star one one on the telephone keypad.
Operator: Welcome to the Valneva First Quarter 2025 Financial 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.
Operator: To ask a question during the session, you will need to press star 1 1 on your telephone keypad. You will then hear an automated message advising your hand is raised. To withdraw a question, please press star 1 1 again.
Speaker Change: Yeah, Yeah, I'm not somebody that message advise and you had this race to withdraw your question. Please press star one again.
Operator: Please be advised that today's conference is being recorded.
Please be advised that today's conference is being recorded.
Joshua Drumm: I would now like to hand the conference over to our first speaker today, Joshua Drumm, Vice President, Global Investor Relations. Please go ahead. Thank you. Hello, and thank you for joining us to discuss Valneva's first quarter 2025 results and corporate update. It's my pleasure to welcome you today.
Speaker Change: I would now like to hand, the conference over to your first speaker today, Joe should drop as the President of Global Investor Relations. Please go ahead.
Speaker Change: Thank you.
Speaker Change: Hello, and thank you for joining us to discuss <unk> first quarter 2025 results and corporate update.
Speaker Change: My pleasure to welcome you today.
Joshua Drumm: In addition to our press release and analyst presentation, you can find our consolidated financial results for the three months ended March 31st, 2025, which were published earlier today, available within the financial reports section of our investor website.
Speaker Change: In addition to our press release and analyst presentation, you can find our consolidated financial results for the three months ended March 31, 2025, which were published earlier today available within the financial reports section of our Investor website.
Joshua Drumm: I'm joined today by Valneva CEO Thomas Lingelbach and CFO Peter Buhler, who will provide an overview and update on our business, as well as our key financial results for Q1 2020.
Speaker Change: I'm joined today by Bill Niebur, CEO, Thomas Lingelbach, and CFO, Peter Buhler, who will provide an overview and update on our business as well as our key financial results for Q1 2025 that.
Joshua Drumm: There will be an analyst Q&A session at the conclusion of the prepared remarks. Before we begin, I'd like to remind listeners that during this presentation, we will be making forward-looking statements, which are subject to certain risks and uncertainties that could cause the actual results to differ materially from those expressed or implied by these forward-looking statements. You can find additional information about these risks and uncertainties in our periodic filings with the Securities and Exchange Commission and with the French Market Authority, which are listed on our company website.
Speaker Change: There will be an analyst Q&A session at the conclusion of the prepared remarks.
Speaker Change: Before we begin I'd like to remind listeners that during this presentation, we will be making forward looking statements, which are subject to certain risks and uncertainties that could cause the actual 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.
Speaker Change: <unk>, which are listed on our company website. Please note that today's presentation includes information provided as of today may seven 2025, and <unk> undertakes no obligation to revise or update forward looking statements, except as required by applicable securities laws.
Joshua Drumm: Please note that today's presentation includes information provided as of today, May 7, 2025, and Valneva undertakes no obligation to revise or update forward-looking statements, except as required by applicable securities laws.
Thomas Lingelbach: With that, it's my pleasure to introduce Thomas to begin today's presentation. Thank you, Josh, and good day to all of you. Pleasure to provide the update during today's earnings call. Yeah, the first quarter, 2025, was a solid quarter with strong overall financial performance. Total revenues reached almost 50 million euros. The reduction in operating cash burn is reflecting our continuous focus on cash. and Cash Management. And this is also shown in a cash position north of 150 million euros, excluding the recent proceeds from our April ATM transaction. And in quarter one, we also made progress on the regulatory front, predominantly around xChick label extensions and further approval.
Speaker Change: With that it's my pleasure to introduce Thomas to begin today's presentation.
Thomas Lingelbach: Thank you, Josh and good day to all of you.
Thomas Lingelbach: Pleasure to provide the update during.
Thomas Lingelbach: During today's earnings call.
Thomas Lingelbach: The first quarter 2025, with a solid quarter with strong overall financial performance.
Thomas Lingelbach: Total revenues reached almost $50 million.
Thomas Lingelbach: <unk>.
Thomas Lingelbach: The reduction in operating cash burn is reflecting our continuous focus on cash and cash management.
Thomas Lingelbach: And this is also shown in our cash position north of 150 million Euro excluding the recent proceeds from our April ATM transaction.
Thomas Lingelbach: And in quarter. One we also made progress on the regulatory front predominantly around shake.
Thomas Lingelbach: Label extensions and <unk>.
Thomas Lingelbach: And for the approvals.
Thomas Lingelbach: When we look a little bit more into the details of the first quarter, 2025, we got a new Xero contract awarded by the U.S. Department of Defense. We responded to the French government's call for ICSICC to combat the chikungunya outbreaks in La Réunion and Mayotte. and we responded to the cholera outbreak in my yacht by supplying doses of Ducoral, so all in line with our mission to address unmet medical needs. With regards to the key regulatory achievements that I mentioned earlier, we got the marketing authorization for xJIC in the UK in individuals 18 years of age and older, and we also submitted the respective adolescent label extension application.
Thomas Lingelbach: When we look a little bit more into the details of.
Thomas Lingelbach: The first quarter 2025.
Speaker Change: We got a new <unk> contract awarded by the U S Department of defense.
Speaker Change: We responded to the French government call for <unk> to come back the chikungunya outbreaks in Latvia, and the all in my yard.
Speaker Change: And we responded to the Colorado, breaking my yacht by supplying doses of doukhobor. So all in line with our mission to address unmet medical needs with regards to the key regulatory achievements that I mentioned earlier.
Speaker Change: We got the marketing authorization.
Speaker Change: <unk> in the UK and individuals 18 years of age and older and we also.
Speaker Change: Submitted to the respective adolescent label extension application.
Thomas Lingelbach: We got the X-CHIC label extension in Europe for individuals 12 years of age and older by the European Medicines Agency. And the X-CHIC marketing authorization in Brazil represents the first approval of a chikungunya vaccine in an endemic country. On clinical data and pipeline progress, we reported high sustainable response in adolescents one year after X-ray vaccination with a single dose and as part of our phase three. We reported positive phase 2 pediatric results for X-Trich and as such could decide the dose for the planned phase 3 study in the pediatric population. And we initiated the first vaccination in the phase 2 infant study in Africa of our tetravalent Shigella vaccine candidate.
Speaker Change: We got the label expansion in Europe for individuals 12 years of age and older by the European Medicines Agency.
Speaker Change: And the <unk> marketing authorization in Brazil yield represents the first approval opportunity <unk> vaccine in in endemic countries.
Speaker Change: On clinical data and pipeline progress.
Speaker Change: We reported high sustained immune response in adolescence, one year after X rig vaccination with the single dose and as part of our phase III.
Speaker Change: We reported positive phase II pediatric results.
Speaker Change: And as such could decide the dose for the planned phase III study in.
Speaker Change: <unk> in the pediatric population.
Speaker Change: And we.
Speaker Change: We initiated the first vaccination in the phase two infant study in Africa of our Tetravalent Shigella vaccine candidate.
Thomas Lingelbach: F4, V2.
Paul Mitchell: As Paul Mitchell.
Thomas Lingelbach: Turning our attention a little bit to Lime. Um... You all are very aware of the Lyme program and the medical need that Lyme disease represents globally. There is no vaccine available to prevent Lyme disease in humans, and we see a growing annual burden of disease with almost half a million cases reported and confirmed cases reported in the United States, more than 100,000 cases reported in Europe, and those numbers are heavily impacted by under-reporting or not even existing reporting systems in some of the countries. When we look at the clinical manifestations, 2 to 30 percent develop really severe clinical manifestations, including cauditis, neuroporiosis, or arthritis, and 5 to 10 percent have persistent symptoms. and even following tweets.
Thomas Lingelbach: Turning our attention a little bit to line.
Thomas Lingelbach: You all are very aware of the <unk> program and the medical need that Lyme disease represents.
Thomas Lingelbach: Globally.
Thomas Lingelbach: There is no vaccine available to prevent Lyme disease in humans, and we see a growing annual burden of disease.
Thomas Lingelbach: With almost half a million cases reported a confirmed cases reported in the United States.
Thomas Lingelbach: More than 100000 cases reported in Europe in those numbers.
Thomas Lingelbach: Heavily impacted by under reporting or Nordics, even existing reporting systems in some of the countries.
Thomas Lingelbach: When we look at the clinical manifestations, 2% to 30%.
Thomas Lingelbach: Develop really severe clinical manifestations, including diet is new report real estate or have tried it and.
Thomas Lingelbach: And 5% to 10% have persistent symptoms.
Thomas Lingelbach: Even following treatment.
Thomas Lingelbach: Therefore, we see a huge unmet medical need for a preventative solution, enhanced commercial opportunity for Valneva, especially given that we are talking about almost 90 million people in the US and more than 200 million people in Europe who live in endemic regions where Lyme represents a major risk. You all know that we are in year three or in the third tick season of the ongoing phase three study Valor, and we are expecting first data at the end of this year. This is a study that includes more than 9000 participants, five years of age and above, who are at high risk of Lyme disease.
Thomas Lingelbach: Therefore, we see a huge unmet medical need for preventative solution enhance commercial opportunity for <unk> NEVA, especially given if we are talking about almost 90 million people in the U S and more than 200 million people in Europe, who live in endemic regions.
Thomas Lingelbach: Lime represents a major risk.
Thomas Lingelbach: I don't know that we are in year three or in the third tick season.
Thomas Lingelbach: Of the ongoing phase III study by lower.
Thomas Lingelbach: <unk>.
Thomas Lingelbach: We are expecting first data at the end of this year.
Thomas Lingelbach: This is a study that includes more than 9000 participants five years of age in the past.
Thomas Lingelbach: Who are at high risk of Lyme disease.
Thomas Lingelbach: We are measuring here against the placebo control setting, randomized one-to-one, against placebo two-to-one North America, Europe, and the primary endpoint is the rate of confirmed Lyme disease cases. So prevention of the disease after the second consecutive tick season. And right now we have the second cohort undergoing the booster vaccination. And then we have quite a significant number of secondary endpoints, including the rate of confirmed Lyme disease cases after the first season, after the primary series. So, very exciting year, and we hope to see the first data is set by the end of the year, which will be followed by a significant number of secondary endpoints and other data associated with the study and provided positive data, we expect filing with the regulatory authorities next year.
Thomas Lingelbach: We are measuring year against the placebo controlled setting randomized one to one.
Thomas Lingelbach: Against placebo two to one North America Europe, and the primary endpoint is the rate of confirmed Lyme disease cases, so prevention of the disease. After the second consecutive peak season.
Thomas Lingelbach: And right now we have the second chord undergoing the booster vaccination.
Thomas Lingelbach: And then we have.
Thomas Lingelbach: Quite significant number of secondary endpoints, including.
Thomas Lingelbach: The rate of confirmed Lyme disease cases after the first season after the primary serious.
Thomas Lingelbach: So very exciting year.
Thomas Lingelbach: And.
Thomas Lingelbach: And we hope to see the first data set by the end of the year, which will be followed by.
Thomas Lingelbach: A significant number of secondary endpoints and other data associated with the study and provided positive data.
Thomas Lingelbach: We expect.
Thomas Lingelbach: Filing.
Thomas Lingelbach: With the regulatory authorities next year.
Thomas Lingelbach: With that, let me turn over to Ixtchic. You know that our chikungunya vaccine is a highly differentiated vaccine, and we are glad that we have been able to report strong clinical data thus far across all the studies and across all the target populations that we have been evaluating and got licensed by now. At the same time, we have experienced recent changes to ICT recommendations in response to reports of serious adverse events in frail elderly individuals. As such, ACIP recommended precaution for use in 65-plus. EMA cautioned against use in frail older adults, especially those with comorbidities and in trans-Hispanic recommendation for use in 65 plus.
Thomas Lingelbach: With that let me turn over to Rick.
Thomas Lingelbach: Rick.
Thomas Lingelbach: That our chikungunya vaccine, it's a highly differentiated.
Thomas Lingelbach: Vaccine and <unk>.
Thomas Lingelbach: And we are flat.
Thomas Lingelbach: We have been able to report a strong clinical data thus far across all the studies and across all of the target population.
Thomas Lingelbach: That we have been evaluating and licensed by now at.
Thomas Lingelbach: At the same time, we have experienced recent changes to execute recommendations in.
Thomas Lingelbach: In response to reports of serious adverse events in frail elderly individuals.
Thomas Lingelbach: As such.
Thomas Lingelbach: ACI Pea recommended precautions for use in 65 plus.
Speaker Change: EMR cautioned against us.
Speaker Change: In frail older adults, especially resources Comorbidities.
Speaker Change: <unk>.
Speaker Change: <unk> suspended recommendation for use in 65, plus all of that.
Thomas Lingelbach: All of that, you know, pending ongoing investigations. As we stated in our different publications and communications, we are highly committed to standards of safety and appreciate, therefore, these precautionary decisions. All investigations into SAEs remain ongoing, and it's worth noting that causality has not been definitely established at this point in time. We will, of course, continue to closely monitor all reported adverse events and cooperate fully with health authorities while working proactively on a potential update of the product. We have now a bit more than 40,000 doses administered, so doses of Xtrick that landed in people's arms. And we continue to see a positive risk benefit in the vast majority of people with potential exposure to the disease.
Speaker Change: Pending ongoing.
Speaker Change: Investigations.
Speaker Change: As we stated in our different applications and.
Speaker Change: In communications, we are highly committed.
Speaker Change: To standards of safety and depreciate. Therefore, these precautionary decision.
Speaker Change: All investigations into SaaS remain ongoing and it's worth noting that facility has not been definitely established that this complaint in time, we will of course continue to closely monitor all reported adverse events and cooperate fully with health authorities, while working proactively on a potential update of <unk>.
Speaker Change: Product indication.
Speaker Change: We have now a bit more than 40000 doses administered so doses of X strict Atlanta and people Tom.
Speaker Change: And we continue to see a positive risk benefit and the vast majority of people with potential exposure to the disease and.
Thomas Lingelbach: And we would like to remind one more time that it must not be given to people who are immunodeficient or immunosuppressed due to disease or treatment. When we look at the further development of X-CHEC that we are currently conducting, we are preparing for the post-parketing effectiveness phase four program. This is a program to confirm the effectiveness following licensure based on an immunological surrogate of protection, the so-called accelerated approval pathway, and to further help optimizing the description of the safety program. We are planning an observational effectiveness study in Brazil, pragmatic randomized controlled effectiveness and safety study in endemic countries, and prospective safety court study and pregnancy surveillance in Brazil.
Speaker Change: And we would like to remind one more time that mass.
Speaker Change: Must not be given to people, who are immuno deficient or immuno suppressed due to disease or treatment.
Speaker Change: When we look at the further development of <unk> debt.
Speaker Change: Debt that we are currently conducting.
Speaker Change: We are preparing for the post marketing effectiveness phase III program.
Speaker Change: This is a program to confirm the effectiveness following licensure based on an immunological historic rate of protection that so called the accelerated approval pathway.
Speaker Change: And to further house optimizing description of the safety profile.
Speaker Change: We are planning an observation of effectiveness study in Brazil are dramatic randomized control effectiveness and safety study in endemic countries and prospective safety cost study in pregnancy civilians in Brazil.
Thomas Lingelbach: We have ongoing label extensions to expand access to the vaccine for all age groups. And we reported already the data, phase three data in adolescents, which landed in some countries and some regulatory jurisdictions already in a label extension. Others are still under review.
Speaker Change: We have ongoing label extensions to expand access to the vaccine for all age groups.
Speaker Change: And.
Speaker Change: We reported already the data phase III data in adolescence, which landed in some countries and some regulatory jurisdictions already in a label extension others are still under review.
Thomas Lingelbach: And we plan to start a phase three study in children aged one to 11 years of age. On the product profile, all of that, and across all programs, we would like to confirm the long-term durability of the immune response to further differentiate our vaccine.
Speaker Change: And we plan to.
To start a phase III study in children, aged one to 11 years of age.
Speaker Change: On the product profile.
Speaker Change: All of that and across all programs, we would like to confirm the long term durability of the immune response to further differentiate our vaccine.
Thomas Lingelbach: Turning to Shigella, which is really the most advanced program right now in the tetravalent bioconjugate vaccine space targeting shigellosis infections. It's a program that we have partnered with LIMATEC. It includes the four most common pathogenic shigella bacteria serotypes. LIMATEC in the past reported positive phase 1, 2 clinical data, and the program got awarded FDA designation. We expect a huge unmet medical need, of course, primarily in children living in low medium income countries, but also a substantial added value for travelers and military personnel. And the shigella disease and the work around shigella vaccines has been identified as a priority by the World Health Organization.
Sheila: Turning to Sheila.
Speaker Change: The year, which is.
Speaker Change: We are the most advanced program right now in the tetravalent bi.
Speaker Change: <unk> conjugate vaccine space.
Speaker Change: Targeting shigellosis infections.
Speaker Change: It's a program that we have partnered with <unk>.
Speaker Change: It includes the four most common.
Speaker Change: Pathogenic should get out of a tiered serotypes.
Speaker Change: You might take in the past reported positive phase one two clinical data and the program got awarded FDA fast track designation.
Speaker Change: We expect a huge unmet medical need of course, primarily in <unk>.
Speaker Change: Children living in low medium income countries, but also.
Speaker Change: A substantial added value.
Speaker Change: For travelers and military personnel.
Speaker Change: And D shigella disease, and the work around Chagall vaccines have been identified as a priority by the World Health organization.
Thomas Lingelbach: As mentioned at the beginning, we launched a phase 2 infant study this year, and we expect data already for the latter part of this year. We have an ongoing phase 2b so-called controlled human infection models. This is a study that goes in two steps. The first step is to optimize dose and schedule. Second is to challenge and get with the challenge a first idea around pilot efficacy. We announced that we have slightly extended the immunogenicity phase, so the so-called step one.
Speaker Change: As mentioned at the beginning we launched a phase II study.
Speaker Change: This year and we expect.
Speaker Change: Data already so that's a part of this year.
Speaker Change: We have an ongoing phase two b.
Speaker Change: So called.
Speaker Change: Controlled human infection models.
Speaker Change: This is a study that.
Speaker Change: It goes in two steps the first step is to optimize.
Speaker Change: Dose and schedule, our second is to challenge.
Speaker Change: To get with the challenge of first idea around pilot efficacy we announced.
Speaker Change: We have extended the immunogenicity face so that's step one.
Thomas Lingelbach: And as such, we are not expecting the pilot efficacy data as previously announced in the second half of this year. And of course, we will work continuously on this exciting program and make sure that we progress towards the next development phase.
Speaker Change: And as such.
Speaker Change: <unk>.
Speaker Change: I'm not expecting the.
Speaker Change: Part of the efficacy data.
Speaker Change: The previously announced in the second half of this year, but in the first half next year and of course.
Speaker Change: We will work continuously on this exciting program and make sure that as we progress.
Speaker Change: The next development phases.
Thomas Lingelbach: Turning to Zika, we expect phase one results later this year on our second generation optimized vaccine candidate against the Zika virus. It's an inactivated whole virus vaccine-based vaccine that leverages our technology that we developed and further optimized as part of our COVID work and our COVID vaccine during the pandemic, VLA 2001. And of course, we hope to see positive data that would enable further development against the disease that can have quite devastating effects.
Speaker Change: Turning to <unk>.
Speaker Change: We expect phase.
Speaker Change: Phase one results later this year.
Speaker Change: On our.
Speaker Change: Second generation optimized vaccine candidate against the Zika virus.
Speaker Change: It's inactivated hold virus vaccine based vaccine that.
Speaker Change: <unk> Leverages, our technology that we developed and further optimized as part of our corporate work and our Covid vaccine.
Speaker Change: During the pandemic BLA 2001.
Speaker Change: And of course, we hope to see positive data that would enable further development.
Speaker Change: Against the disease that can have quite devastating effects and.
Thomas Lingelbach: And please be reminded that there is currently absolutely no vaccine or specific treatment available. And as such, we hope also for support of public institutions, for example, to help advance a potential vaccine against the Zika virus.
Speaker Change: Please be reminded that there is currently absolutely no vaccine a specific treatment available.
Speaker Change: And as such we hope also for support of public institutions for example.
Speaker Change: To help advance our potential vaccine against Zika.
Peter Buhler: With that, I would like to hand over to Peter to provide us with the financial report. Thank you, Thomas, and good morning and good afternoon to all of you. Now let's look at the financial report for the first quarter of fiscal year 2025. Product sales reached 48.6 million euros and increased by 51.2% versus the first quarter of the prior year. The Kiara sales reached 27.5 million euros, 65.5% above last year, and the year-over-year growth is driven by a strong increase in sales to U.S. military, but also into the travel channel. In addition, the first quarter includes higher sales related to stock replenishment in indirect markets.
Speaker Change: Pick a virus with that.
Speaker Change: I would like to hand over to Peter to provide us with the financial report.
Peter Buhler: Thomas and good morning, or good afternoon to all of you.
Speaker Change: Now, let's look at the financial report for the first quarter of fiscal year 2025.
Speaker Change: Productivity reached $48 6 million and increased by 51, 2% versus the first quarter of the prior year.
Speaker Change: The Kyoto sales reached $727 5 million euros, 65, 5% above last year and the year over year growth was driven by a strong increase in sales to U S military but also into the travel channels.
Speaker Change: In addition to first quarter includes higher sales related to stock replenishment and indirect markets.
Peter Buhler: As you may recall, the first quarter of 2024 had been adversely impacted by supply constraints. Ducorral sales grew by 9.4% and reached 12.3 million euros. The increase in Ducorral sales is primarily driven by a shipment of 1.1 million euros to the French island, Mayotte. Ixchic sales reached €3 million in the first quarter of 2025, compared to €200,000 in the first quarter of last year. xChick was first launched in the United States in quarter one of 2024 and the increase in sales is related to the continuous ramp-up of sales in the United States and the launch in additional territories mainly in France and Canada.
Speaker Change: As you May recall, the first quarter of 2024 have been adversely impacted by supply to supply constraints.
Speaker Change: Two cross sales grew by nine 4% and reached $12 3 million euros. The increase into cross sales is primarily driven by shipment of $1 1 billion euros to the French islands.
Speaker Change: <unk> sales reached 3 million euros in the first quarter of 2025 compared to 200000 viewers in the first quarter of last year.
Speaker Change: <unk> was first launched in the United States in quarter, one of 2024 and the increase in sales is related to the continued ramp up of sales in the United States at the launch in additional territories, mainly in France and Canada.
Peter Buhler: In the first quarter of 2025, we received an order for 40,000 doses of Xtrick to respond to the chikungunya outbreak on La Reunion. The significant majority of these doses were shipped early April and hand sales will be recorded in the second quarter. Third-party products increased by 41% to €5.8 million, compared to €4.1 million in the first quarter of last year. As mentioned previously, we expect third-party product sales to decrease over time, and this year-over-year increase for Q1 is primarily due to supply constraints faced by our third-party partners in Q1 of last year. Over time, we expect a continuous reduction of our third-party business to have a positive impact on the company's gross market.
Speaker Change: In the first quarter of 2025, we received an order for 40000 doses of <unk> to respond to the <unk> outbreak on the Haynesville.
Speaker Change: The significant majority of these doses were shipped early April and hence sales will be recorded in the second quarter.
Speaker Change: Third party products increased by 41% to $5 8 million euros compared to $4 1 million euros in the first quarter of last year as.
Speaker Change: As mentioned previously we expect third party product sales to decrease over time and this year over year increase for Q1, primarily due to supply constraints faced by our third party.
Speaker Change: Partners in Q1 of last year.
Speaker Change: Overtime, we expect the continued reduction of our third party business to have a positive impact of the company's gross margin.
Peter Buhler: Foreign currency effects have no material impact on the euro year's sales performance.
Speaker Change: First foreign currency effects had no material impact on the year over year sales performance now.
Peter Buhler: I'm moving on to the income statement. Total revenues reached €49.2 million versus €32.8 million in the first three months of 2024. Cost of goods and services increased marginally versus prior year, despite the significant increase in sales. Gross margin on commercial products, excluding eggsheck, amounted to 62.7% compared to 43.9% in the first quarter of 2024. The significant improvement in gross margin is primarily due to better manufacturing performance, with fewer batch failures and inventory adjustments. Ixiara's cross-margin reached 72.6%, which is significantly better than the 52% of last year and even exceeds pre-COVID levels. Ducroix's gross margin reached 52.2% compared to 40% to below 40% in the first quarter of last year.
Speaker Change: Moving onto the income statement.
Speaker Change: Total revenues reached $49 2 million euros versus $32 8 million euros in the first three months of 2024.
Speaker Change: Cost of goods and services increased marginally versus prior year. Despite the significant increase in sales gross margin on commercial products, including <unk> amounted to 62, 7% compared to 43, 9% in the first quarter of 2024.
Speaker Change: The significant improvement in gross margin is primarily due to better manufacturing performance with fewer batch failures and inventory adjustments.
Speaker Change: Right.
Speaker Change: <unk> gross margin reached 72, 6%, which is significantly better than the 52% of last year and even exceeds pre COVID-19 levels.
Speaker Change: <unk> gross margin reached 52, 2% compared to 40% to below 40% in the first quarter of last year.
Peter Buhler: Research and development expense increased by around 2 million euros to 15 million euros driven by costs related to our new Shigella program following the start of our collaboration with Limatec Biologics in the fourth quarter of last year. Marketing and distribution expense in the first quarter reached 10.4 million euros compared to 11.3 million euros in the prior year. The decrease is mainly related to lower advertising and promotion expenses. The general and administrative costs were reduced to 9 million euros, compared to 11.7 million in the prior year. The decrease is related to a lower spend on recruiting, lower insurance costs, and savings in professional services.
Speaker Change: Research and development expense increased by around 2 million to 50 million euros, driven by cost related to our new Shigella program. Following the start of our collaboration with <unk> biologics into fourth quarter of last year.
Speaker Change: Marketing and distribution expense in the first quarter reached $10 4 million euros compared to $11 3 million euros in the prior year. The decrease is mainly related to lower advertising and promotion expense.
Speaker Change: General and administrative costs were reduced to 9 million euros.
Speaker Change: Compared to $11 7 million in the press the decrease is related to a lower spend on recruiting lower insurance cost and savings in professional services.
Speaker Change: Yeah.
Peter Buhler: The operating loss of the first quarter of 2025 is reported as minus 6 million euros, compared to an operating profit of 68.2 million euros in the first quarter of the prior year. The first quarter of 2024, we sold the priority review voucher obtained upon approval of the Chikungunya vaccine Xtrick in the United States. This resulted in a non-recurring revenue of 90.8 million euros. Net finance and income tax expense is reported at 3.3 million euros, compared to 9.3 million euros in the prior year. The lower expense is mainly related to a foreign exchange gain of 3.7 million euros due to the development of the US dollar versus euro exchange rate and the related balance sheet revaluation.
Speaker Change: The operating loss of the first quarter 2025 as reported is minus 6 million euros.
Speaker Change: Compared to an operating profit of $68 2 million euros in the first quarter of the prior year the.
Speaker Change: The first quarter of 2024, we sold the priority review voucher obtained upon approval of chikungunya vaccine <unk> in United States. This resulted in a nonrecurring revenue of $90 8 million.
Speaker Change: <unk> net finance and income tax expense is reported at $3 3 million euros compared to $9 3 million in the prior year, the lower expenses, mainly related to a foreign exchange gain of $3 7 million euros due to the development of the U S dollar versus euro exchange rate and the related balance sheet revaluation.
Speaker Change: With this the loss for the first quarter of fiscal 2025 reached $9 2 million.
Peter Buhler: With this, the loss for the first quarter of fiscal 2025 reached 9.2 million euros compared to a profit of 58.9 million euros in the prior year. EBDA is slightly negative, while last year it was positive, driven by the sale of the priority review value.
Speaker Change: Compared to profit of $58 9 million in the prior year.
Speaker Change: EBITDA is slightly negative while last year was positive driven by the sale of the priority review voucher.
Peter Buhler: Before we move to the guidance, a word on cash. As mentioned by Thomas at the beginning of the call, total cash and cash equivalents at the end of March were €153 million compared to €168 million at the end of prior fiscal year. In the first quarter of 2025, we significantly reduced the cash used in operations compared to the prior year from 28.4 million euros to 8.1 million euros, mainly driven by higher sales and good cost control.
Speaker Change: Before we move to the guidance I would've cash.
Speaker Change: As mentioned by Thomas at the beginning of the call total cash and cash equivalents at the end of March were 153 million euros.
Speaker Change: Compared to 168 million euros at the end of the prior fiscal year.
Speaker Change: In the first quarter of 2025, we significantly reduced our cash use in operations compared to the prior year from $28 4 million to $8 1 million.
Speaker Change: Mainly driven by higher sales and cost of good cost control.
Peter Buhler: In addition, as mentioned at the beginning of the call and as stated in our press release, in April we issued new shares for a value of 14.2 million euros through our Add to the Market program based on a reverse inquiry from Novo Holdings. Through this transaction, plus additional shares acquired in the open market, Novo is now one of our top shareholders.
Speaker Change: In addition, as mentioned at the beginning of the call.
Speaker Change: As stated in our press release in April we issued new shares for a value of $14 2 billion euros through our asset market program based on the reverse inquiry from Novo holdings to this transaction plus additional shares acquired in the open market. Nobody is now one of our top shareholders.
Peter Buhler: Now moving to slide 22 to review our guidance for fiscal year 2025. The guidance has not changed compared to the full year 2024 earnings call. We reiterate our product sales guidance of 170 to 180 million euros for the fiscal year and total revenues of 180 to 190 million euros. Total R&D expenses are expected between 90 and 100 million euros, partially offset by grant funding and R&D tax credits. As demonstrated in the first quarter, we are on track to reduce our operational cash burn by 50% on a full-year basis with the goal of being able to reach key inflection points with our existing capital.
Speaker Change: Now moving to slide 22 to review our guidance for fiscal year 2025.
Speaker Change: The guidance is unchanged compared to the full year 2024 earnings call. We reiterate our productive guidance of 170 to 180 million euros for the fiscal year and total revenues of 180 to 190 million euros.
Speaker Change: Total R&D expense are expected between 90, and 100 million euros, partially offset by grant funding and R&D tax credits.
Speaker Change: As demonstrated in the first quarter, we are on track to reduce our operational cash flow by 50% on a full year basis with the goal of being able to reach key inflection points with our existing cash.
Peter Buhler: In the midterm, we continue to focus on gross margin.
Speaker Change: In the midterm, we continue to focus on gross margin, we see a path to potential sustained profitability from 2027 based on a successful Lyme disease vaccine approval and commercialization.
Peter Buhler: We see a path to potential sustained profitability from 2027 based on a successful Lyme disease vaccine approval and commercialization.
Thomas Lingelbach: This concludes the finance section of this call, and I would like to hand back to Thomas to discuss our major growth drivers. Thank you so much, Peter, for this comprehensive financial report. Turning to page 24 of the presentation, looking a little bit into our expected growth drivers for 2025 and beyond. Of course, it's all about LIME for the time being, and therefore, you know, we are very much looking forward to the results of VLA-15 and hopefully its success, which, as Peter pointed out, has the potential for sustained profitability of P&L. Han, approval and commercialization, of course, driven by the substantial milestones and royalties kicking in towards the latter part of 2027, according to current timelines and expectations.
Speaker Change: This concludes the finance section of this call and I would like to hand back to Thomas to discuss our major growth drivers. Thank you very much Peter for this comprehensive financial report.
Thomas Lingelbach: Turning to page 24 of the presentation looks.
Thomas Lingelbach: Looking a little bit into our expected growth drivers for 2025.
Thomas Lingelbach: And beyond.
Thomas Lingelbach: Of course, it's all about line.
Thomas Lingelbach: For the time being and.
Thomas Lingelbach: Therefore, we are very much looking forward to the.
Thomas Lingelbach: The results of BLA 15.
Thomas Lingelbach: And hopefully it.
Thomas Lingelbach: Success.
Thomas Lingelbach: Which as Peter pointed out has the potential for sustained profitability.
Speaker Change: Upon approval and commercialization of cost <unk>.
Speaker Change: Driven by the substantial milestones and royalties kicking in towards the latter part of 2027, according to current timeline and expectation.
Thomas Lingelbach: When we look at the commercial business, we have shown that we have been able to optimize and grow our commercial business and we expect in the near term continued growth for both of the existing older brands like Xearo and Ducoran, but also expect Xigig to gain further global traction. When we look at the future pipeline, we expect really value creation through new pipeline programs and ongoing programs that we have already in the pipeline, including Shigella and Sika. And our goal, as communicated previously, is to have a next phase three program ready, post-successful introduction of the language.
Speaker Change: When we look at the commercial business, we have shown that we have been able to optimize and growth grow our commercial business and we expect in the near term continued growth for both of the existing older brands like <unk> and <unk>, but also.
Speaker Change: <unk> <unk> seek to gain further global traction.
Speaker Change: When we look at the future pipeline, we expect really value creation through new pipeline programs and.
Speaker Change: Ongoing programs that we have already in the pipeline, including CLR and pick up and our goal as communicated previously is perhaps a next phase III program ready.
Speaker Change: The successful introduction of the line vaccine.
Thomas Lingelbach: And with that, we see overall a really good prospect of our business with, of course, major growth drivers around LIME, but also major growth expected from our commercial business and upside from future or existing clinical and preclinical R&D efforts.
Speaker Change: And with that we see overall, a really good prospect of our business.
Speaker Change: With of course major growth drivers around <unk>, but also major growth expected from our commercial business and upside from future or existing.
Speaker Change: Clinical and preclinical R&D assets.
Operator: With that, we would like to conclude our presentation and hand back to the operator to take your questions. Thank you. Dear participants, as a reminder, if you wish to ask a question, please press star 11 on your telephone keypad and wait for your name to be announced. To withdraw a question, please press star 11 again. Please stand by while we compile the Q&A roll study. This will take a few moments.
Speaker Change: With that we would like to conclude our presentation and hand back to the operator to take your questions.
Speaker Change: Thank you Dan participants as a reminder, if you wish to ask a question. Please press star one one on the telephone keypad and makes my name to be announced to withdraw your question. Please press star one again.
Speaker Change: Mr. Bob will compile the Q&A narrow studies will take a few moments.
Speaker Change: Yes.
Maurice Raycroft: And now we're going to take our first question and it comes to the line of Maru Raycroft from Jeffreys. Your line is open, please ask your question. Hi, congrats on the progress and thanks for taking my questions.
Speaker Change: And now we're going to tackle the first question.
Marvel Raycroft: And this comes from the line of Marvel Raycroft from Jefferies. Your line is open. Please ask your question.
Marvel Raycroft: Hi, Congrats on the progress and thanks for taking my questions.
Thomas Lingelbach: I'll ask a quick one on Ixtchik first, and then one on Lyme. I guess for Ixtchik, just wondering what are next steps regarding the label? Wondering if you've heard back from the FDA regarding the label extension application for adolescents that was submitted a couple of months ago? And then what are next steps regarding potential need to add new language?
Marvel Raycroft: Ask a quick one on <unk> first and then went online I guess for extra week. Just wondering what are next steps regarding the label wondering if you've heard back from the FDA regarding the label extension application for adolescence.
Marvel Raycroft: <unk> submitted a couple of months ago, and then what are next steps regarding potential need to add more language safety.
Thomas Lingelbach: Yeah, thanks for your question, Maurice. So I start with the last one first. The review with the FDA is still ongoing. So, we have submitted, as you rightly pointed out, and we are waiting for their reply and hopefully soon the adoption of the label to include the 12 and above. Yeah, the current situation and next steps. At this stage, we have seen changes to the recommendation. You know that we are absolutely committed to the highest standards of safety, so the investigations are ongoing. We know that all of that has occurred in frail, older individuals. We have strongly recommended and continue to do so that healthcare providers apply individualized clinical judgment when determining the appropriateness of x-checks for elderly, frail patients.
Maury: Yes, Thanks for your question Maury.
Speaker Change: So I'll start with the last one first the review with the FDA is still ongoing.
Speaker Change: So we have submitted as you rightly pointed out and we are waiting for their reply and hopefully soon.
Speaker Change: The adoption of the <unk>.
Speaker Change: The label to include CEO trough in the box.
Speaker Change: Yes.
Speaker Change: The current situation and next steps.
Speaker Change: At this stage, we are seeing changes to the recommendation that we are.
Speaker Change: Absolutely committed to the highest standards of safety. So the investigations are ongoing.
Speaker Change: We know that all of that has occurred.
Speaker Change: Current and frail older individuals.
Speaker Change: We have strongly recommend it and continue to do so that healthcare provider supply individuals individualized clinical judgment when determining the appropriateness of exchange.
Speaker Change: <unk>.
Speaker Change: <unk> patients and we are supporting the regulatory authorities as much as we can.
Thomas Lingelbach: And we are supporting the regulatory authorities as much as we can on evaluating those cases and will review also whether certain additional precautions or contraindications in specific population groups may be warranted.
Speaker Change: On evaluating those.
Speaker Change: Those cases.
Speaker Change: <unk>.
Speaker Change: And we'll review also whether certain additional precautions all contra indications in specific population groups may be warranted.
Maurice Raycroft: Got it. Okay, and it makes sense.
Speaker Change: Got it Okay and then it makes sense and then for the Phase III <unk> study.
Thomas Lingelbach: And then for the Phase III Lyme study, can you remind me what the p-value threshold is for the primary endpoint of confirmed Lyme cases? And when considering GMT from historical studies, how are you setting expectations for the bar and what antibody titer you will need to achieve to get sufficient... So, unfortunately, I can't disclose the p-value for the Phase 3 study, but it is sufficiently powered according to the expectations and according to the, I would say, epi studies and disease burden evaluations, which both of them got published by Pfizer. and I think that's basically what we can say.
Speaker Change: Can you remind me what the P value threshold is for the primary endpoint of confirmed cases and when considering GMT from historical studies, how are you setting expectations for the bar on what antibody titer, you will need to achieve.
Speaker Change: To get sufficient protection.
Speaker Change: So unfortunately, I can't disclose the P value for the Florida for the Phase three study but.
Speaker Change: Patiently powered.
Speaker Change: According to the expectations and.
Speaker Change: And according to the.
Speaker Change: I would say <unk> studies and disease burden.
Evaluations.
Speaker Change: Both of them got.
Speaker Change: By Pfizer.
Speaker Change: And I think that basically what we can say I would like to point your attention to.
Thomas Lingelbach: I would like to point your attention to a publication, a joint publication, that we also referenced by Pfizer and Valneva, where you know I would say a potential protective immunological threshold has been, you know, hypothesized, I would say. I think we discussed in length in the past, Maury, that it is very difficult at this point in time. There has never been an immunological correlate for Lyme. And, of course, essays are very different. I mean, and we can, of course, send you again the link to the respective publication. Okay, yeah, that sounds good. That would be helpful.
Speaker Change: Application that joint application.
Speaker Change: That we also referenced by Pfizer and <unk>.
Speaker Change: I would say.
Speaker Change: 10 shows protective immunological threshold has been.
Speaker Change: Hypothesized I would say.
Murray: I think we discussed in length in the past Murray that it is very difficult.
Murray: At this point in time, there has never been.
Murray: And immunological correlate.
Speaker Change: Pauline and of course as states are very different.
Murray: I mean.
Murray: We can of course.
Murray: Thank you again.
Murray: Links to the respective applications.
Murray: Okay.
Murray: It sounds good that would be helpful. Okay. Thanks for taking my questions I'll hop back in the queue.
Maurice Raycroft: Okay, thanks for taking my questions. I'll have back. Thank you.
Murray: Thank you.
Rajan Sharma: Now we're going to take our next question. And it comes from Rajan Sharma from Goldman Sachs. Your line is open, please ask your question. Hi, thanks for taking my question. So, just one on Lyme actually. So, I think you're due $143 million in milestones from Pfizer as an initial milestone.
Murray: Now we're going to take our next question.
Speaker Change: And this comes from the line of <unk> Sharma from Goldman Sachs. Your line is open. Please ask your question.
Sharma: Hi, Thanks for taking my question. So just one online actually so I think to $143 million in milestones from Faiza.
Sharma: As an initial milestone I was wondering is that part of that BG with a potential positive phase III or is that related specifically to approvals whether that's in the U S or elsewhere and then secondly, I was just wondering if you could just comment on tariff switches.
Peter Buhler: I was wondering, would part of that be due with a potential positive phase three, or is that related specifically to approvals, whether that's in the US or elsewhere? And then secondly, I was just wondering if you could just comment on tariffs, which is obviously a focus in the sector at the minute. It'd be helpful just to get your perspectives on potential impact for Valneva. Could you just help us understand your manufacturing footprint and any potential mitigations you may have? Thank you.
Sharma: Obviously, if I because in the sector at the minute be helpful. Just to get your perspective on potential impactful maybe.
Sharma: Could you just help us understand your manufacturing footprint and any potential mitigation you may have thank you.
Peter Buhler: Yeah, hey Rajan, it's Peter. Thanks for the questions. So yes, you're absolutely right. We will, you know, there is a milestone of $143 million that Pfizer would pay us upon first commercialization. So it's not at the end of phase three. It's, there are basically three triggers for that are three parts of the $143 million. There is a first commercial phase in the U.S., first commercial phase in Europe, and ACIP opinion. And all three events are supposed to happen in 2027.
Sharma: Yeah, Hey, Ron it's Peter Thanks for the questions.
Sharma: Yes, Youre absolutely right.
Ron: We will.
Ron: There is a milestone of $143 million.
Ron: The adviser would pay us upon first commercialization. So it is not at the end of phase III.
Ron: There are basically three triggers put are those three parts of the $143 million. There is our first commercial sales in the U S. First commercial sales in Europe and <unk> opinion.
Ron: And all three events are.
Ron: Opposed to happen in 2027 basically.
Peter Buhler: On tariffs, and just to add maybe that there will be another 100 million commercial milestones afterwards based on cumulative sales thresholds and royalty rates of between 14 and 22 percent, just to remind everybody. On tariffs, it's obviously something we're closely following. I think right now it's difficult to express an opinion on it because nothing has been defined in terms of tariffs. So, too many unknowns. We are, of course, looking at, you know, potential mitigation strategy or initiatives.
Ron: On tariffs.
Just to add maybe that there is another.
Ron: There will be another 100 million commercial milestones afterwards based on sales thresholds cumulative sales thresholds and royalty rates of between 14, and 22% just to remind everybody.
Ron: Tariffs.
Ron: Obviously, something we are closely following I think right now it's difficult to to express an opinion on it because.
Ron: Nothing has been defined in terms of tariffs.
Ron: So too many unknowns.
Ron: We are of course looking at potential mitigation strategies or initiatives.
Peter Buhler: To your question on our manufacturing footprint, so our vaccines are basically all manufactured in Europe. So, drug substance for XDR and XTREC is manufactured in Scotland. And then field finishing happens in Germany. And as far as Tucoa is concerned, it's all produced in Sweden. And the IP is also in Europe. Okay, thank you.
Ron: To your question on our on our manufacturing footprint. So our vaccines are basically all manufactured in Europe, So drug substance for external district manufactured in Scotland.
Ron:
Ron: And then Phil finishing happens in Germany.
Ron: As far as to growth concern.
Ron: It's all produced in Sweden at the Ips also.
Ron: In Europe.
Speaker Change: Okay. Thank you.
Amil Divan: Thank you. Now we're going to take our next question. And it comes to land of Amil Divan from Guggenheim Securities. Your line is open. Please ask your question. Great, thanks for taking my questions. Maybe a couple on the financial side. So one, the sales this quarter are quite a bit higher. You know, to maintain your. So I'm just trying to get a sense of the nuances there, maybe relevant. right now.
Ron: Thank you.
Ron: Now we're going to take our next question.
Speaker Change: And it comes from the line of annuity Wang from Guggenheim Securities. Your line is open. Please ask your question.
Annuity Wang: Great. Thanks for taking my questions, maybe a couple on the financial side to one.
Speaker Change: Sales this quarter quite a bit higher than consensus.
Speaker Change: And your full year guidance. So I'm, just trying to get a sense of the nuances there maybe relative to what you see from a consensus estimates right now.
Speaker Change: Just one in terms of the sequencing of the Dod's sales that drove the first quarter for <unk>.
Peter Buhler: just one in terms of sequencing of the DOD sales that drove through the first quarter for CRO. not be too optimistic on that, wait through the rest of the year, or is there maybe some icky chicks or conservatives? Second question, just one. Grossmarginside. back to this pre-pandemic. Hicks are one of the key drivers. there was a shift in the uptake of that vaccine.
Speaker Change: Our old Navy is that a reason not to be too optimistic on that.
Speaker Change: The rest of the year or is there maybe some sort of conservatism built in given that.
Speaker Change: On a label updates that are coming on that front and then the second question just more on that.
Speaker Change: Gross margin side, you've talked about kind of getting back to these pre pandemic levels I think ex chicks are one of the key drivers there.
Speaker Change: If there was a shift in sort of uptake of that.
Speaker Change: That vaccine given some of that.
Speaker Change: And your label safety questions.
Speaker Change: Comfortable getting to the pre pandemic levels gross margins, even again of your mix.
Speaker Change: Maybe shifts a little bit.
Speaker Change: Yeah.
Peter Buhler: Yeah, thanks for the question. So, starting with sales, yes, absolutely, our first quarter revenues are above the consensus. I think it was expected by us, and as I said in the call, so we did see strong growth in particular in Ixiaro on both travel and also DoD. But as I mentioned, you know, last year was very heavily impacted by restricted supply. That was resolved in April of last year. So, you will see this year slightly different phasing, which is also why we do not see right now any change to our guidance. So, first quarter for us was in line with what we had anticipated.
Speaker Change: Yes.
Speaker Change: Thanks for the question so starting with sales.
Speaker Change: Yes, absolutely our first quarter revenues are above above the consensus.
Speaker Change: I think.
Speaker Change: It was expected by us and as I said in the call. So we did see strong growth in particular in <unk> when both travel and also Jody.
Speaker Change: As I mentioned last year was very heavily impacted by.
Speaker Change: By restricted supply.
Speaker Change: That would result in April of last year. So you will see this year slightly different phasing, which is also why we do not see right now any change to <unk>.
Speaker Change: Our guidance so first quarter for US was in line with what we had at <unk>.
Speaker Change: <unk>.
Peter Buhler: As you know, on sales to the Department of Defense, we have not published the number, but as you saw, we signed a new contract and our supply is ongoing according to plan, and it has also increased versus prior year. In terms of cross-margin, you know, we said in the past that we expect X-Jig to, over time, to yield a better cross-margin than the other products. I think that, you know, we're still looking at, we're still considering this, of course. This has not changed. I think overall, Q1 cross-margin was very good. And you're right, we did say in the past we expect to reach a pre-pandemic level.
Speaker Change: As you know on sales to the department of defense. So we have not published.
Speaker Change: The number but as you saw we signed a new contract and we as a no surprise ongoing according to plan and this has indeed.
Speaker Change: He has also increased versus versus prior year.
Speaker Change: In terms of cross margin, we said in the past that we expect <unk> to over time to yield a better gross margin than the other products I think that we're still looking at we're still considering this of course.
Speaker Change: This has not changed.
Speaker Change: I think overall Q1, while gross margin was very good and Youre right. We did say in the past we expect to to reach a pre pandemic level. Although we have not defined fiscal 2025, we have not guided on gross margin for 2025, but of course were very well pleased to see where we were in Q1.
Peter Buhler: Although we have not defined this for 2025, we have not added a cross-margin for 2025. But of course, we're very, very pleased to see where we were in Q1. OK.
Speaker Change: Okay. Thank you.
Samir Devani: Thank you. Now we're going to take our next question. And it comes a line of Samir Devani from RxSecurities. Your line is open, please ask a question. Hi guys, thanks for taking my questions and congrats on a good quarter. Have you now fulfilled the Mayonet Order? Were they not very on the mayonnaise order?
Speaker Change: Thank you.
Speaker Change: Now we're going to take our next question.
Speaker Change: And it comes from the line of Sandy of Gabon from Securities. Your line is open. Please ask your question.
Speaker Change: Hi, guys. Thanks for taking my questions and congrats on a good quarter.
Speaker Change: Yeah.
Speaker Change: Happy now fulfilled the Mira that's owed to us.
Speaker Change: In this quarter.
Speaker Change: Okay.
Speaker Change: I think the learning you're all well.
Speaker Change: The <unk> order.
Thomas Lingelbach: or the Mayotte, yes, so that was the two chorale, yes, that was actually fulfilled in the first quarter. and then just on the La Reunion order. Can you help us in terms of thinking how we should phase this in terms of our modelling? Is it going to lead to a... a reasonable spike in the next quarter and then... fall away in Q3. Yes, so as we said, we supplied a small number of doses at the end of Q1, and the remaining part will be supplied in Q2.
Speaker Change: Yes, so that was the two corral, yes that was actually fulfilled in the first quarter.
Speaker Change: Fine and then just on the la reunion or data and can you help us in terms of thinking how we should face in terms of our modeling for <unk> is it going to lead to.
Speaker Change: A reasonable to spike in the next quarter, and then sort of fall away in Q3.
Speaker Change: Yes.
Speaker Change: So.
Speaker Change: As we've said we supplied a small number of doses at the end of Q1 and the remaining part will be supplied in Q2.
Thomas Lingelbach: or is, was already supplied in Q2, actually. And then finally, just on... on the mechanism for Ixchic and its being alive. I'm just wondering, Thomas, if you could comment on... Has this made you reconsider the sort of dose? potential adverse events you're seeing. It's of course a good question. So we don't see at this point in time any unexpected safety profile in younger adults. or even adolescents. So, at this point in time, we have not reconsidered the dose for the phase 3 infant study. that we had previously announced.
Speaker Change: Or is was already supplied in Q2 I should say.
Speaker Change: Uh huh.
Speaker Change: Okay, and then finally just on.
Speaker Change: Just on the mechanism for X chicken, it's being alive.
Thomas Lingelbach: And I'm just wondering Thomas if you could comment on it.
Thomas Lingelbach: Has this made you reconsider the sort of dice the EMA ease in the PDR.
Thomas Lingelbach: Pediatric studies in light of the <unk>.
Thomas Lingelbach: Potential adverse events you are seeing in the elderly.
Thomas Lingelbach: It is of course good question. So we don't see at this point in time.
Thomas Lingelbach: Any unexpected.
Thomas Lingelbach: Safety profile in.
Thomas Lingelbach: Younger adults.
Thomas Lingelbach: Or even adolescents.
Thomas Lingelbach: So the at this point in time, we have not reconsider D.
Thomas Lingelbach: The dose for the phase III study.
Thomas Lingelbach: Debt that we had previously announced.
Thomas Lingelbach: But as I said at this point in time.
Samir Devani: But, as I said, at this point in time, So that's all I can say for now. Okay, that's great, thanks. Thank you.
Thomas Lingelbach: So that's all I can say for.
Thomas Lingelbach: For now.
Thomas Lingelbach: Okay, that's great thanks very much.
Thomas Lingelbach: Thank you.
Thomas Lingelbach: Now we'll proceed with our next question.
Suzanne van Voorthuizen: Now we'll proceed with our next question. And the question comes from the line of Suzanne Van Voorthuizen from Van Laatschot Kampen. Your line is open. Please ask your question. Hello, this is Samir Lam for Suzanne. Thank you for taking our questions.
Speaker Change: And the question comes from the line of Susan Levine Hoisin from Bonnie <unk> with Kempen. Your line is open. Please ask your question.
Speaker Change: Hello. This is Samuel onshore Suzanne Thank you for taking our questions.
Suzanne van Voorthuizen: For the Lyme phase three program and the last tick season now starting, can you provide some color on the infection rate so far in this study? And is this monitored and in line with the company's expectations? and secondly with the study consisting of two sequential cohorts of subjects. Is the first cohort receiving a second booster this season already? And will you report data on this too at the year-end readout?
Speaker Change: For the line Phase III program and the last tick season now starting can you provide some color on the infection rates. So far in this study.
Speaker Change: And is this monitored and in line with the company's expectations.
Speaker Change: And secondly, with the study consisting of two sequential cohorts of subjects.
Speaker Change: As the first cohort receiving a second boost during the season already and will you report data on this too at the year end read out.
Thomas Lingelbach: And then lastly, regarding the latest news that came from vaccine policymakers, could you comment which elements may or may not affect your vaccine business? And do you see particular risks or opportunities there? So many questions, so thank you for that. So I would say we have not, yes, we are, of course, monitoring on an ongoing basis the overall Lyme cases during the study. We are and will not comment on those, other than we have seen the overall profile over the past couple of years being pretty consistent in terms of number of Lyme cases. And we see at this point in time, no concerns.
Speaker Change: And then lastly regarding the latest news that came from vaccine policymakers could you comment which elements may or may not affect your vaccine business.
Speaker Change: And do you see particular risks or opportunities there.
Speaker Change: So many questions. So thank you for that so I would say we have not yet we are of course monitoring the.
Speaker Change: On an ongoing basis.
Speaker Change: Overall in our live cases during the study.
Speaker Change: And well not.
Speaker Change: Comment on those.
Speaker Change: Other than we have seen.
Speaker Change: The overall profile over the past couple of years.
Be pretty could be pretty consistent in terms of.
Speaker Change: A number of <unk> cases.
Speaker Change: We see at this point in time no.
Speaker Change: Concerns.
Thomas Lingelbach: With regards to the study cohort the answer is no. With regards to the other activities that you were mentioning, namely you know impact on the business, I mean at this point in time probably no one is able to really say what all this political you know dynamic in the United States mean with regards to any of the vaccines on the market or in development? And I think we should probably not speculate about that. And will it have an impact? Probably yes, probably not. So I think we have to wait until, you know, certain, you know, things become more defined and turn into real, you know, requirements of politics.
Speaker Change: With regards to the study cohort the answer is no.
Speaker Change: With regard to the.
Speaker Change: The other activities that you were mentioning.
Speaker Change: Namely impact on the business I mean at this point in time, probably no one is able to really say.
Speaker Change: What all this political die.
Speaker Change: Dynamics.
Speaker Change: In the United States mean with.
Speaker Change: With regards to any of the vaccines on the market or in development and.
Speaker Change: And I think we.
Speaker Change: We should probably not speculate about that.
Speaker Change: And will it have an impact probably yes, probably not.
Speaker Change: So I think we have to wait until <unk>.
Speaker Change: Certain things become more defined and in turn into REO.
Speaker Change: Requirements of policies.
Speaker Change: Excuse me and no further questions.
Suzanne van Voorthuizen: Excuse me, any further questions? Thank you very much. Thank you.
Speaker Change: Thank you very much.
Speaker Change: Thank you.
Speaker Change: Yeah.
Oscar Hafen Lamm: Now we're going to take our next question. And it comes to the line of Oscar Hafen Lamm from Brian Garnier & Co. Your line is open, please ask your question. Thank you for taking my questions. So the first one on Xero, relative to Q4 last year, sales were roughly similar. So we're just wondering if there were any seasonality effects seen during this first quarter? And then maybe how do you forecast the growth of the asset for the remaining of the year? So on the Ixtiaro, like I said, the impact is more quarter over quarter. I don't think there is any particular seasonality impact in Q1, except, as I mentioned also, particularly in one of our indirect markets, there's probably some stocking effect, but in the overall picture, I would not say it's absolutely material.
Speaker Change: Now we're going to take our next question.
Speaker Change: And it comes from the line of Oscar Cabrera from Bryan Garnier <unk> co. Your line is open. Please ask your question.
Speaker Change: Okay.
Oscar Cabrera: Thank you for taking my questions.
Speaker Change: First one on euro.
Speaker Change: Relative to Q4 last year sales of Ruckus sooner. So I was just wondering if there were any seasonality effects seen during this first quarter.
Speaker Change: And then maybe how you forecast suggest that for the remaining of the year.
Speaker Change: Okay.
Speaker Change: So when the euro like I said it.
Speaker Change: The impact is more quarter over quarter.
Speaker Change: I don't think there is any particular seasonality impact in Q1.
Speaker Change: Except as I mentioned also particularly in one of our indirect markets, there's probably some stocking effect, but in the overall picture I would not say, it's absolutely material in them.
Peter Buhler: And I'm sorry, I didn't get the second question. Can you maybe repeat that one? Yeah, just how do you forecast the growth of Xero for the remaining of the year? Oh, yeah. So we have not guided specifically on Xero, but what we did say is we expect Xero to grow double-digit CAGR, which we would expect still for this year's double-digit growth, but we have not guided specifically on a number for Xero.
Speaker Change: Sorry, I didn't get the second question can you repeat that one.
Speaker Change: Yes, just how did you forecast the growth of each euro for the remainder of the year.
Speaker Change: Oh, yeah. So we have not guided specifically on the Onyx Euro, but what we did say is we we expect <unk> to continue to grow at double digit CAGR, which which we would expect so for this unit double digit growth, but we have not guidance specifically.
On the oil number for CLO.
Peter Buhler: Okay, thanks.
Speaker Change: Okay. Thanks, and then maybe quickly a second question this time on the <unk>.
Thomas Lingelbach: And maybe quickly a second question, this time on xChick. I was wondering if, you know, following the updated recommendation from the French HAS, there could be a potential impact related to the order book of vaccines that were ordered for the outbreak in La Réunion. We have, at this point in time, confirmed the 40,000-dose order, and we delivered the 40,000-dose order and all the rest.
Speaker Change: I was wondering if following the updated recommendation from the French H, yes.
Speaker Change: That could be a potential impact related to the order book of vaccines that were ordered for the breaking now.
Speaker Change: Okay.
Speaker Change: We have at this point in time confirmed the 40000 dose ordering we deliberate to 40000 dose order and all the rest of their disease.
Thomas Lingelbach: Okay, thank you. Thank you.
Speaker Change: Okay. Thank you.
Speaker Change: Thank you.
Operator: Dear participants, as a reminder, if you wish to ask a question, please press star 11 on your telephone keypad. Just give us a moment.
Speaker Change: Yeah participants as a reminder, if you wish to ask a question. Please press star one one on the telephone keypad.
Speaker Change: Yes give us amendments and the question comes from the line of Simon shows from <unk>. Your line is open. Please ask your question.
Salmon Shores: And the question comes to Lan of Salmon Shores from First Berlin. Your line is open, please ask your question. Yes, good afternoon. Thanks for taking my questions. I've got three.
Simon Shows: Yes. Good afternoon, thanks for taking my questions I've got three.
Simon Shows: First of all I was wondering if you could give us some color on the idle capacity costs.
Salmon Shores: First of all, I was wondering if you could give us some color on the idle capacity. and your efforts to reduce the...
Simon Shows: On your efforts to reduce fees.
Peter Buhler: And secondly, on the Xero gross margin, which was 73% in Q1, do you think the gross margin on Xero is sustainable at this level?
Simon Shows: Secondly, on <unk> gross margin, which was 73% in Q1.
Simon Shows: I mean do you think the gross margin on CRE sustainable at this level.
Peter Buhler: And on the Ducarole gross margin, do you expect that to be able to get that close to the 60% over? Yes, so let me start with the gross margin questions. So on XCR, we do think that Q1 is probably not representative what it will be for the full year. We do expect an improvement, of course, versus prior year. But I think most of 70% I think is probably not what we will see for the full year. I think. on the On the corral, you know, we haven't guided on the gross margin, but I think the Q1 gross margin is probably roughly representative.
Simon Shows: On the <unk> gross margin do you expect that to be able to get that closer to 60%.
Simon Shows: Overtime.
Simon Shows: Thanks.
Simon Shows: Okay.
Speaker Change: Yes, So let me let me start with the gross margin questions.
Speaker Change: So on <unk>, we do think that Q quarter, Q1 was probably not representative who it will be for the full year, we do expect an improvement of course versus prior year.
Speaker Change: I think north of 70% I think it's probably not what we will see for the full year.
Speaker Change: I think.
Speaker Change: Okay.
Speaker Change: On the <unk>.
Speaker Change: On the <unk>.
Speaker Change: Onto Carl.
Speaker Change:
Speaker Change: No we have I haven't we haven't guided on the gross margin, but I think the Q1 gross margin is probably roughly representative.
Peter Buhler: On the idle cost, so for the first quarter, I would say it was probably roughly around 2 million euros. And so this is primarily related, of course, one, you know, because we have, we have, you know, large capacity, but also because some of the, especially the new manufacturing sites in Scotland, we are in progress of transferring over production. So over time, we will see a reduction that idle cost. Okay, thanks very much. Thank you.
Speaker Change: On the on the idle cost so so for the first quarter.
Speaker Change: I would say it was probably roughly one 2 million euros.
Speaker Change: And.
Speaker Change: So this is this is primarily related of course, one because we have we have.
Speaker Change: Large capacity, but also because some of the.
Speaker Change: Especially as new manufacturing sites in Scotland, we are in progress of transferring over.
Speaker Change: Production. So over time, we will see a reduction that idle costs of course.
Speaker Change: Okay. Thanks very much.
Speaker Change: Thank you.
Operator: Now we're going to take our next question. Just give us a moment. My apologies. Yes, because we stand by.
Speaker Change: Now we're going to take our next question.
Speaker Change: Yes.
Speaker Change: Jessica This amendment.
Speaker Change: Okay.
Speaker Change: My apologies.
Speaker Change: Okay.
Speaker Change: Okay.
Speaker Change: Yes, operator.
Speaker Change: Okay.
Operator: Excuse me, Suzanne, I know that you would like to ask a question. If you don't mind, please, can you press star 11 again? and John Lennon. Thank you.
Speaker Change: Excuse me Susan I know that you would like to ask a question. If you don't mind. Please can you press star one again.
Speaker Change: [laughter].
Speaker Change: Dear speakers there are no further questions for today I would now like to hand, the conference over toward the management team for any closing remarks.
Operator: Dear speakers, there are no further questions for today.
Thomas Lingelbach: I would now like to hand the conference over to the management team for any closing remarks.
Thomas Lingelbach: Thank you so much for your attention today, good questions and as usual, and your interest in following the company and closely, and we are looking forward to staying closely in touch while we are focusing on our execution this year to build strategic value for the future. Thank you so much.
Speaker Change: Thank you so much for your attention today, good questions and as usual and.
Speaker Change: Your interest in following the company and closely and we are looking forward to staying closely in touch while we are focusing on our execution this year to build strategic value for the future. Thank you so much.
Operator: This concludes today's conference call. Thank you for participating. You now may all disconnect. Have a nice day.
Speaker Change: This concludes today's conference call. Thank you for participating you know Mike all disconnect have a nice day.
Speaker Change: [music].
Speaker Change: Okay.
Speaker Change: [music].
Speaker Change: Yes.
Speaker Change: [music].
Operator: Thank you for watching!