Valneva SE (VALN) 2024 Q4 法說會逐字稿

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 report section on our Investor website.

謝謝。您好，感謝您加入我們討論 Valneva 2024 年全年業績和公司最新動態。我很高興今天歡迎您的到來。除了我們的新聞稿和分析師介紹外，您還可以在我們投資者網站的財務報告部分找到我們今天早些時候發布的截至 2024 年 12 月 31 日的 12 個月的綜合財務業績。

I'm joined today by Valneva's 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 2024. There will be an analyst Q&A session at the conclusion of the prepared remarks.

今天與我一起參加的是 Valneva 的首席執行官 Thomas Lingelbach；以及首席財務官 Peter Buhler，他將概述並更新我們的業務以及 2024 年的主要財務業績。在準備好的發言結束後，將舉行分析師問答環節。

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.

在我們開始之前，我想提醒聽眾，在本次演講中，我們將做出前瞻性陳述，這些陳述受制於某些風險和不確定性，可能導致實際結果與這些前瞻性陳述表達或暗示的結果有重大差異。您可以在我們定期向美國證券交易委員會和法國市場管理局提交的文件中找到有關這些風險和不確定性的更多信息，這些文件列在我們公司的網站上。

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 security laws. With that, it's my pleasure to introduce Thomas to begin today's presentation.

請注意，今天的簡報包含截至 2025 年 3 月 20 日提供的信息，除非適用的安全法要求，否則 Valneva 不承擔修改或更新前瞻性聲明的義務。我很高興介紹托馬斯開始今天的演講。

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 EUR160 million aligned with our 2024 guidance.

非常感謝，喬希。祝大家有美好的一天。是的，瓦爾涅娃在 2024 年又度過了成功的一年。這在很大程度上要歸功於我們內部團隊和律師合夥人的奉獻精神和技能。回顧今年的主要亮點，我們實現了目標兩位數的同比銷售成長，銷售額超過 1.6 億歐元，與我們的 2024 年指引一致。

We managed to have a very solid cash position at year end, close to EUR170 million with a significantly lower operating cash burn, and of course, all augmented by our successful placement of almost EUR60 million and the sale of our priority review voucher. And Peter is going to provide more details, of course, on all the financial performance indicators.

我們在年底的現金狀況非常穩固，接近 1.7 億歐元，且營運現金消耗顯著​​降低，當然，這一切都得益於我們成功配售近 6000 萬歐元並出售優先審查券。當然，彼得將提供有關所有財務績效指標的更多詳細資訊。

We had a very strong regulatory execution with three additional IXCHIQ approvals and a very significant number of upcoming label extensions around IXCHIQ. And of course, we achieved one of our strategic objectives to augment our pipeline, with a leading Phase 2 Shigella program.

我們的監管執行力非常強，獲得了三項額外 IXCHIQ 批准，並且即將推出大量有關 IXCHIQ 的標籤擴展。當然，我們透過領先的第二階段志賀氏菌計畫實現了擴大我們產品線的策略目標之一。

When we really look at what have we achieved and what are we expecting for 2025, this is all shown on page 5 of the presentation. As I said, substantial clinical and regulatory progress, as well as financial strengths, really the headlines for 2024. When we look at 2025 ahead, we expect multiple data readouts. We expect product approvals. We expect label extensions.

當我們真正審視我們已經取得的成就以及對 2025 年的期望時，這些都在簡報的第 5 頁上得到了展示。正如我所說，實質的臨床和監管進展以及財務實力才是 2024 年的頭條新聞。當我們展望2025年時，我們期待多個數據讀數。我們期待產品獲得批准。我們期待標籤擴展。

So when we look at this a little bit more in detail, so we expanded access to IXCHIQ. We have launches underway in Canada, Europe, and the United Kingdom, and we entered into a new Asian partnership for key endemic markets, and especially the low medium income countries are very important for this product.

因此，當我們更詳細地研究這個問題時，我們擴大了對 IXCHIQ 的存取權。我們已在加拿大、歐洲和英國推出該產品，並針對主要地方市場建立了新的亞洲合作夥伴關係，特別是中低收入國家對該產品非常重要。

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 2 booster results that we reported.

我們報告了支持將 IXCHIQ 標籤延長至青春期的進一步關鍵臨床發現。我們透過這款產品再次明確了它的產品差異化，主要是在抗體持久性方面。我們已經透過 2024 年報告的其他關鍵新聞流和結果確認了 VLA 產品概況，主要是我們報告的第 2 階段加強劑結果。

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 activities.

正如我之前提到的，我們擁有強大的財務狀況，這使我們能夠繼續進行研發投資。我們擁有穩健的現金，收入持續以兩位數成長。我們還獲得了額外的撥款，用於支持我們的主要 IXCHIQ 活動。

Looking ahead, we see, of course, the transformative potential for the Lyme vaccine candidate VLA15, which is right now in the Phase 3 study. We are on track for the study for -- and first data readout expected by the end or at the end of the year. We have -- this will then result in regulatory filings anticipated for 2026, and hopefully, if everything goes well, first approvals in 2027.

展望未來，我們當然看到了萊姆病候選疫苗 VLA15 的變革潛力，目前正處於第 3 階段研究。我們的研究進展順利，預計在今年年底或年末獲得首批數據。我們已經—這將導致預計在 2026 年提交監管文件，如果一切進展順利，希望在 2027 年獲得首次批准。

So we have further expanded and will further expand access to IXCHIQ. We expect the 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, and of course, we are still waiting for quite a number of national recommendation, vaccination recommendation outside of the United States, which hopefully will support the uptake of that vaccine in the respective markets.

因此，我們已經進一步擴大了 IXCHIQ 的存取權限，並且還將進一步擴大。我們期待該產品在巴西獲得批准，巴西將是該產品的第一個本土市場。我已經提到了主要市場的青少年標籤擴展，當然，我們仍在等待相當多的國家推薦、美國以外的疫苗接種建議，希望這些建議能夠支持相應市場對該疫苗的採用。

We have further meaningful clinical milestones that we anticipate for 2025. The results from the Phase 2 studies for Shigella, but also the Phase 1 results for our novel Zika vaccine candidate.

我們預計 2025 年將取得更多有意義的臨床里程碑。這是志賀氏菌第 2 期研究的結果，也是我們新型寨卡疫苗候選藥物第 1 期研究的結果。

What are the key growth drivers for 2025 and beyond? Of course, the most important one, VLA15, our Lyme vaccine candidate. And 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 for 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.

2025 年及以後的主要成長動力是什麼？當然，最重要的是VLA15，我們的萊姆病疫苗候選藥物。我們已經多次明確表示，如果成功，即成功的數據、成功的監管批准、成功的商業化，該產品將有可能推動 Valneva 實現持續盈利，這得益於里程碑付款和特許權使用費，預計將在 2027 年下半年從成功案例中開始。同時，我們將繼續增加商業收入；當然，在短期內，IXIARO 和 DUKORAL 將繼續保持成長軌跡，而 IXCHIQ 的進一步成長將獲得越來越多的全球關注。

When we look at the future pipeline value, it's, of course, Shigella and Zika that are the next clinical assets in the pipeline. And our goal, as articulated in the past, is to have a next Phase 3 program ready to go into Phase 3 post-Lyme success.

當我們考慮未來的管道價值時，志賀氏菌和寨卡病毒當然是管道中的下一個臨床資產。如同過去所闡述的，我們的目標是準備好下一個第三階段計劃，以成功進入萊姆病後第三階段。

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. And in Europe, given that there is not a very comprehensive reporting system, there are definitely confirmed cases of about 130,000.

當我們稍微研究一下萊姆病候選藥物時，再次回顧萊姆病的背景，萊姆病代表著一種重大的醫療需求，因此也代表著市場機會。目前尚無可用於預防人類萊姆病的疫苗，而且每年的疾病負擔大幅上升。美國疾病管制與預防中心報告稱，美國有近 50 萬例。而在歐洲，鑑於沒有很完善的通報體系，確診個案肯定有13萬左右。

When we look a little bit into the clinical manifestation -- and I think this explains also the severity of Lyme disease -- 10% to 30% of people develop really severe clinical manifestations including Lyme carditis, neuroborreliosis, or Lyme arthritis. 5% to 10% of those remain with persistent symptoms, and those continue to have persistent really over years. So therefore, this is really a major issue and therefore a preventative solution would have a huge health economic benefit.

當我們稍微研究一下臨床表現時——我認為這也解釋了萊姆病的嚴重程度——10% 到 30% 的人會出現非常嚴重的臨床表現，包括萊姆心肌炎、神經性疏螺旋體病或萊姆關節炎。其中 5% 至 10% 的患者會留下持續性症狀，而這些症狀會持續存在多年。因此，這確實是一個重大問題，預防性解決方案將帶來巨大的健康經濟效益。

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 one billion at peak.

當我們觀察生活在高風險地區和萊姆病風險地區的人們時，我們發現美國約有 8,000 萬人生活在特定的萊姆病流行地區，歐洲約有 2 億人生活在特定的萊姆病流行地區。因此，我們目前與輝瑞達成的指導意見是，我們預計市場規模在高峰期將超過 10 億美元。

So we are currently in the middle of -- oh, well, the latter part of the Phase 3 study called VALOR. You know that this Phase 3 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. The -- we reported last year in our joint press release the completion of the primary vaccination series. And we have still for the second cohort the booster vaccination to be done.

所以我們目前正處於——哦，嗯，第三階段研究的後期，稱為 VALOR。您知道這項第三階段的研究已經跨越了三個蜱蟲季節。我們目前正處於第三個蜱蟲季節，或即將進入 2025 年蜱蟲季節。我們去年在聯合新聞稿中報導了初級疫苗接種系列的完成。我們也需要為第二批患者進行加強疫苗接種。

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, 1:1 randomized vaccine against placebo, 2:1 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 3 plus 1 vaccination.

提醒一下，我們的研究參與者大約有 9,000 名，年齡都超過五歲。該研究是一項安慰劑對照隨機研究，疫苗與安慰劑以 1:1 隨機分配，北美與歐洲以 2:1 隨機分配。研究的主要終點是相應的初級系列接種和加強接種後，即所謂的 3 加 1 疫苗接種後的萊姆病確診病例率。

And secondary endpoints include, amongst others, the Lyme disease cases after the primary series, and there are a whole bunch of other, secondary endpoints that we have been discussing in the past. So all in all, we need to see, of course, the right level of cases and the right level of efficacy, and all of that will be shown once we have the final data readout for the prevention of the disease here, which we anticipate towards -- at the end of 2025.

次要終點包括主要係列之後的萊姆病病例等，以及我們過去討論過的一大堆其他次要終點。總而言之，我們當然需要看到正確的病例水平和正確的療效水平，所有這些都將在我們獲得預防疾病的最終數據讀數後顯示出來，我們預計這將在 2025 年底完成。

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% zero response. And we have seen a sustained zero response at that level up to now after three years. We have an antibody persistence study that is going to monitor the persistence to up to 10 years.

當我們研究基孔肯雅病時，這再次提醒大家，我們相信我們的產品是高度差異化的疫苗。這是第一個獲得許可的針對基孔肯雅病的疫苗。僅需一劑即可提供強烈且持久的免疫反應。我們的回應率接近 100%。三年過去了，迄今為止，我們看到這一水準的回應持續為零。我們有一項抗體持久性研究，將監測長達 10 年的持久性。

So we expect that we're going to see a very high level of persistence for a long time. And it's also important that we have seen a similar level of zero response in all age groups tested thus far -- so meaning adolescents, 18 to 64 years of age, and 65 plus. And as I said, it is a true one-shot vaccine.

因此，我們預計我們將會在很長一段時間內看到非常高水準的持久性。同樣重要的是，到目前為止，我們在所有接受測試的年齡組中都看到了類似的零反應水平——這意味著青少年、18 至 64 歲以及 65 歲以上的人。正如我所說，這是一種真正的一次性疫苗。

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 actually is 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.

我們有許多與 IXCHIQ 相關的關鍵研發活動。它們都專注於擴大使用範圍、標籤擴展或驗證性研究，以支援產品在現實生活中的實際有效性。我在一開始就提到，該計畫得到了CEPI提供的超過4000萬美元的新資助，延續了我們與CEPI現有的非常成功的合作夥伴關係。

We have the post-marketing effectiveness study, the Phase 4 study to confirm the effectiveness following the licensure process around the so-called accelerated approval. It's 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. So this forms the package around our Phase 4 activities.

我們進行了上市後有效性研究，即第 4 階段研究，以確認所謂加速批准的許可程序之後的有效性。這是一項我們將在巴西進行的觀察性有效性研究。我們將在流行國家的成年人中進行實用的隨機對照有效性安全性研究，並在巴西進行前瞻性安全隊列研究和實踐監測。所以這構成了我們第四階段活動的整體安排。

When we look at label extension to expand access to the vaccine for all age groups, of course, we have the Phase 3 randomized controlled study in adolescents aged 12 to 17 years of age, and we reported positive data up to month 12 already. So this is an ongoing regulatory process right now. And then we expect to enter into a Phase 3 study for children below 11 years of age, and we anticipate to start the study in the last quarter this year, pending, of course, all positive results, and 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.

當我們考慮延長標籤期限以擴大所有年齡層獲得疫苗的機會時，當然，我們對 12 至 17 歲的青少年進行了第三階段隨機對照研究，並且已經報告了截至第 12 個月的積極數據。因此，這是一個正在進行的監管過程。然後，我們預計將進入針對 11 歲以下兒童的第三階段研究，我們預計將在今年最後一個季度開始這項研究，當然，這取決於所有積極的結果，而這些結果在很大程度上已經報告。當我們查看產品概況時，我已經提到了正在進行的持久性研究，以及我們在 36 個月後報告的最後一個數據點。

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. The -- it got exclusively licensed from our partner LimmaTech. It includes the four most common pathogenic Shigella bacteria serotypes, and LimmaTech in the past reported positive Phase 1/2 clinical data.

當我們研究志賀氏菌時，我們引入的計畫是世界上臨床最先進的四價志賀氏菌候選疫苗，稱為 S4V2。它獲得了我們合作夥伴 LimmaTech 的獨家授權。它包括四種最常見的致病志賀氏菌血清型，LimmaTech 過去曾報告了積極的 1/2 期臨床數據。

With -- 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 $0.5 billion 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, so a major unmet medical need.

該計畫獲得了 FDA 快速通道認證。我們在研發日期間就已經解釋過，我們預計志賀氏菌的市場機會每年將超過 5 億美元。該產品的目標市場當然是中低收入國家，特別是中低收入國家的兒童，因為在這些國家，腹瀉是導致致命性腹瀉病的第二大病因，每年估計有 1.65 億例病例和 60 萬人死亡，因此存在巨大的未滿足的醫療需求。

Therefore, it got also prioritized by the World Health Organization. And 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 2 CHIM study, and that is currently ongoing. And in parallel, we're going to run a Phase 2 pediatric study. The start of this Phase 2 pediatric immunogenicity study is imminent. Both studies are being conducted by LimmaTech. And we assume, all further R&D, CMC regulatory activities from LimmaTech in the course of the coming months. So we are in a transition process to take over the lead on all of that.

因此，它也得到了世界衛生組織的優先重視。當然，我們也有像基孔肯雅病或日本腦炎這樣的旅行者和軍隊病例。當我們審視目前的開發計劃時，我們基本上處於第二階段 CHIM 研究，而該研究目前正在進行中。同時，我們將進行第二階段兒科研究。這個第二階段兒科免疫原性研究即將開始。這兩項研究均由 LimmaTech 進行。我們預計，LimmaTech 將在未來幾個月內開展所有進一步的研發和 CMC 監管活動。因此，我們正處於一個過渡過程中，以接管所有這些工作的領導權。

When we look at the Zika virus candidate called VLA1601, we expect the Phase 1 results there by the end of this year. It is a novel active and inactivated whole-virus vaccine candidate. We are leveraging the platform that we developed for our COVID vaccine called VLA2001. So it's -- 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.

當我們研究寨卡病毒候選藥物 VLA1601 時，我們預計第一階段的結果將在今年年底前公佈。它是一種新型活性和滅活全病毒候選疫苗。我們正在利用為 COVID 疫苗開發的平台 VLA2001。所以，我們在這裡測試雙重佐劑和大規模生產平台，當然，這對疫苗來說是必要的，例如針對寨卡病毒的疫苗。

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, and we see more and more Zika outbreaks coming back. And again, there is currently no vaccine or specific treatment available. It is a PRV-eligible disease, and there is a potential significant funding from public institutions.

我的意思是，我們都清楚地記得，寨卡病毒感染的破壞力相當大——小頭畸形、新生兒嚴重腦缺陷、成人格林-巴利綜合徵，我想，所有這些都在我們的記憶中，而且我們看到越來越多的寨卡病毒疫情捲土重來。而且，目前尚無疫苗或特效治療方法。這是一種 PRV 可治癒的疾病，並且可能會得到公共機構的大量資助。

We have articulated previously that we -- going to execute this Phase 1 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, but 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.

我們之前已經明確表示我們將執行第一階段的研究。我們將研究整體的免疫學特徵，包括抗體持久性。然後，我們將進一步研究獲得潛在許可的進一步途徑，但這也一定取決於我們當時對醫療需求、市場潛力和非稀釋性外部融資機會的看法。

With that, I would like to hand over to Peter.

現在，我想把麥克風交給彼得。

Thank you, Thomas, and 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 EUR163.3 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.

謝謝你，托馬斯，祝大家早安或下午好。接下來進行財務審查，首先從投影片 20 上的頂行細節開始。總產品銷售額達到 1.633 億歐元，符合我們的預期，比 2023 年成長 13%。若不計入 2023 年新冠疫苗銷售額，產品銷售額年增 18%。

IXIARO sales reached EUR94.1 million compared to EUR73.5 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 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 US Department of Defense.

IXIARO 的銷售額達到 9,410 萬歐元，而 2023 年為 7,350 萬歐元，成長了 28%。對旅客的銷售額年增了 19%，由於美國國防部選擇根據 2023 年 9 月的合約購買更多劑量，對美國軍方的銷售額也實現了強勁增長。提醒一下，2025 年 1 月，我們宣布與美國國防部簽訂新的一年合約。

DUKORAL's sales reached EUR32.3 million compared to EUR29.8 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 were improved availability of products through stock replenishments. IXCHIQ was launched in 2024 in the United States, and at the end of the year in Canada and France as we recognize initial sales for the financial year 2024 of EUR3.7 million.

DUKORAL 的銷售額達到 3,230 萬歐元，而上年的銷售額為 2,980 萬歐元，成長了 8%。這一成長的主要動力來自加拿大以及間接市場，即透過庫存補充來提高產品的供應。IXCHIQ 於 2024 年在美國推出，並於年底在加拿大和法國推出，我們確認 2024 財年的初始銷售額為 370 萬歐元。

Finally, third-party sales decreased year over year by EUR2.5 million to EUR33.2 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.

最後，由於上半年第三方供應限制，第三方銷售額年減 250 萬歐元至 3,320 萬歐元。正如過去所討論的，我們預計，由於我們專注於專有產品，這些第三方銷售在未來將繼續下降。第三方產品的減少將支持我們提高整體毛利率的目標。

Moving on to slide 21, looking at the P&L. Other revenues decreased from EUR9.1 million to EUR6.3 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.

前往第 21 張投影片，查看損益表。其他收入從 910 萬歐元減少至 630 萬歐元。下降主要與我們與 CEPI 和布坦坦在基孔肯雅病方面的合作收入減少有關。2023 年，其他收入還包括與我們的 COVID-19 疫苗計劃相關的一些剩餘收入。

Looking at expenses, we reduced our cost of goods by EUR2.4 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.

從費用來看，我們將商品成本減少了 240 萬歐元，商品成本和服務成本都有所下降。除IXCHIQ以外的商業產品整體毛利率達到50.6%，而2023年為46%。這項改進主要與更好的製造性能有關，包括我們蘇格蘭製造工廠的產量提高。

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 reached 38.7% compared to 42.4% in the prior year.

正如先前的收益電話會議中所提到的，我們的毛利率受到蘇格蘭和瑞典新製造工廠的閒置成本的不利影響。IXIARO 的毛利率達到 61%，而 2023 年為 52.3%。DUKORAL的毛利率直接低於IXIARO，為38.7%，而上年度為42.4%。

Third-party sales reached a gross margin of 32.8% and extra cost of goods were EUR7.2 million exceeding sales driven by manufacturing overhead. Research and development expenses increased from EUR59.9 million in 2023 to EUR74.1 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 by our new in-license Phase 2 vaccine candidates for Shigella.

第三方銷售的毛利率達到32.8%，額外的商品成本超過了製造費用推動的銷售額720萬歐元。研發費用從 2023 年的 5,990 萬歐元增加到 2024 年的 7,410 萬歐元。24% 的成長符合我們的預期，得益於 IXIARO 和 IXCHIQ 生產技術轉移到我們位於蘇格蘭的新工廠，以及我們新的許可內志賀氏菌第 2 階段候選疫苗。

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 4 activities.

此外，我們也增加了對臨床前活動的投資。隨著我們進行進一步的臨床研究（特別是在兒科領域），並開始為強制性的第 4 階段活動做準備，我們對基孔肯雅疫苗的研發投資逐年保持穩定。

In 2024, we strengthened our R&D team in line with our strategy to continue focusing on innovation. Marketing and distribution expense are reported at EUR52.4 million compared to EUR48.8 million in 2023. This increase is primarily due to higher staff cost as we strengthen our commercial organization to support our sales growth, including the launch of IXCHIQ.

2024年，我們依照持續專注於創新的策略，加強了研發團隊。據報道，行銷和分銷費用為 5,240 萬歐元，而 2023 年為 4,880 萬歐元。這一成長主要是由於我們加強商業組織以支持銷售成長（包括推出 IXCHIQ）導致的員工成本增加。

G&A expenses decreased from EUR47.8 million in 2023 to EUR42.8 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 the 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 EUR90.8 million.

一般及行政開支從 2023 年的 4,780 萬歐元減少至 2024 年的 4,280 萬歐元。這一下降不僅與外部支出減少有關，也與我們的 G&A 組織的結構變化有關。2024年，瓦爾涅娃出售了經美國IXCHIQ批准獲得的優先審查券。該代金券的售價為 1.03 億美元，扣除與出售代金券相關的費用並折算成歐元後，淨收益為 9,080 萬歐元。

Other income and expense remain stable versus prior year at EUR20.7 million and mainly consist of grants as well as tax credits related to R&D activities in Austria and France. In 2024, Valneva reported operating profit of EUR20.7 million compared with an operating loss of EUR82.1 million in the prior year.

其他收入和支出與上年相比保持穩定，為 2,070 萬歐元，主要包括與奧地利和法國研發活動相關的補助金和稅收抵免。2024 年，Valneva 報告營業利潤為 2,070 萬歐元，而上一年的營業虧損為 8,210 萬歐元。

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 EUR12.2 million while the adjusted EBITDA is reported at plus EUR32.9 million.

2024年的營業利潤主要來自於出售優先審查券相關的非經常性收入。扣除財務費用和所得稅後，Valneva 當期虧損達到負 1,220 萬歐元，而調整後的 EBITDA 則為正 3,290 萬歐元。

Now moving on to the financial outlook. In 2025, we expect total product sales to reach EUR170 million to EUR180 million and total revenues to EUR180 million to EUR190 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.

現在來討論財務前景。2025年，我們預期產品總銷售額將達到1.7億至1.8億歐元，總收入將達1.8億至1.9億歐元。我們預期產品銷售額的成長主要來自於 IXCHIQ 銷售額的成長，這主要得益於美國的推動，同時也得益於向其他新地區的擴張。

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 EUR90 million and EUR100 million as we continue to advance our clinical and preclinical assets. Ease of 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.

我們預計 IXIARO 和 DUKORAL 將繼續成長，而我們假設第三方（如前所述）將繼續大幅下降。隨著我們繼續推進臨床和臨床前資產，我們預計研發投資將達到 9,000 萬至 1 億歐元。外部補助資金以及與研發相關的稅收抵免為研發投資提供了便利，這些資金將記錄在其他收入中。

As mentioned by Thomas, we report a solid cash basis at the end of 2024 with $168 million in cash and cash equivalents, and we expect to decrease our operational cash burden by more than 50% from over EUR60 million in 2024 to around EUR30 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 3 post-Lyme data, and we will look for additional non-dilutive funding for our clinical programs.

正如托馬斯所說，我們報告稱，到 2024 年底，我們的現金基礎將保持穩健，現金和現金等價物為 1.68 億美元，我們預計，我們的營運現金負擔將減少 50% 以上，從 2024 年的 6000 多萬歐元降至 2025 年的 3000 萬歐元左右。我們將繼續謹慎管理現金，以獲得足夠的資金來達到關鍵的轉折點。我們將繼續增加商業收入並專注於策略性研發投資。我們的目標是讓一個臨床計畫進入萊姆病後數據的第 3 階段，並且我們將為我們的臨床計畫尋求額外的非稀釋性資金。

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 (technical difficulty) successful Lyme disease vaccine approval and commercialization, we have the opportunity to become sustainably profitable.

正如過去所提到的，隨著我們專注於專有產品並完成將技術轉移到蘇格蘭的新製造基地，我們預計將繼續提高毛利率。從（技術難度）萊姆病疫苗成功核准和商業化，我們有機會實現持續獲利。

With that, I hand to call back to Thomas to look at our future value drivers.

因此，我決定回電給湯瑪斯，討論我們未來的價值驅動因素。

Many thanks, Peter, for this comprehensive financial report for the full year 2024. Yeah, 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 important asset for the company. And 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.

非常感謝 Peter 提供的 2024 年全年綜合財務報告。是的，讓我再提醒你一次，我們真正看到的是 2025 年及 2025 年以後的成長動力。這是關於萊姆病的。正如我們在本次演示中提到的那樣，這對該公司來說無疑是一項非常重要的資產。預計首次公佈的數據將在今年年底前公佈，這當然將對公司未來的發展和前景產生巨大的影響。

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. And hence, the overall commercial business already this year is expected to be cash generative, and we'll continue to provide cash that we can reinvest in R&D. And 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.

我們的商業業務在過去幾年表現十分出色，我們認為這種勢頭還會持續下去。正如彼得所提到的，第三方產品銷售下降主要是因為我們與[BN]的商業化合作關係將會結束。而更關注我們的專有疫苗將大幅提高成本利潤。因此，預計今年的整體商業業務將產生現金，我們將繼續提供可再投資於研發的現金。我們擁有非常好的研發資產，我們希望能夠進一步發展。我們預計今年將會有一些有意義的臨床數據，特別是有關志賀氏菌和寨卡病毒的數據。

With that, I would like to hand back to the operator to take your questions.

說完這些，我想把麥克風交還給接線員來回答你們的問題。

(Operator Instructions) Suzanne Voorthuizen, Van Lanschot Kempen.

（操作員說明）Suzanne Voorthuizen、Van Lanschot Kempen。

Hi, this is Suzanne from Kempen. Thanks for taking my question. Peter, can you elaborate a bit on the cash burn guidance that that is going down by over 50%? What are the main drivers behind this? And with that, can you also give some context to the R&D expenses going up for the coming year?

你好，我是來自肯彭的蘇珊娜 (Suzanne)。感謝您回答我的問題。彼得，能否詳細說明現金消耗預期，即下降 50% 以上？這背後的主要驅動因素是什麼？另外，能否介紹一下明年研發費用增加的情況？

And then 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 ACIP, but on the other hand, he also specifically mentioned his experience with Lyme. Can you elaborate on this, please? Thank you.

然後還有一個問題要問托馬斯，更多的是關於疫苗情緒的問題，您認為羅伯特甘迺迪現在在政府中的角色會帶來什麼風險或機會？我們看到 CDC 和 ACIP 實施了一些變化，但另一方面，他也特別提到了他對萊姆病的經歷。能詳細說明一下嗎？謝謝。

Yeah, so I can start with the cash. Hey, Suzanne, by the way, yeah, thanks for the question. I will start with your question on cash. So I think there are various reasons why, and you saw we also the -- of course, with the sales growth, that will contribute. But also, I think we will focus on cost containment in 2025.

是的，所以我可以從現金開始。嘿，蘇珊娜，順便說一句，是的，謝謝你的提問。我先從有關現金的問題開始。所以我認為原因有很多，而且你也看到了，當然，隨著銷售的成長，這也會有所貢獻。但同時我認為我們將在 2025 年專注於成本控制。

Also, we will look at -- we will work on our working capital, clearly, but also, 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. So we will -- in 2025, we expect to have the exceptional year where we'll actually collect two years' worth of R&D tax credits. So all these are reasons why we actually see -- we'll see a much lower cash burn. And of course, as Thomas mentioned also, the commercial business returning to profitability will, of course, help our cash.

此外，我們也會考慮——顯然，我們會努力提高我們的營運資金，但我們也有一些措施。例如，隨著 COVID 計劃的結束，研發稅收抵免的收取需要更長的時間。因此，我們預計 2025 年將是一個特殊年份，我們將實際收取相當於兩年的研發稅收抵免。所以，所有這些都是我們實際看到的現金消耗將大大降低的原因。當然，正如托馬斯所提到的，商業業務恢復獲利當然會對我們的現金有所幫助。

Does it answer your question, Suzanne?

這回答了你的問題嗎，蘇珊娜？

Yes, for sure. But maybe in R&D going up, can you also elaborate on that?

是的，當然。但也許在研發方面有所進步，可以詳細說明一下嗎？

Yeah, so R&D going up. I mean, a very significant contribution, of course, to that is the chikungunya Phase 4 trial, the mandatory trials that we need to do under the approval we have in the US. So that is really going to -- these costs are really going to ramp up in 2025. And then, 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.

是的，研發正在增加。我的意思是，當然，對此做出非常重要貢獻的是基孔肯雅熱第四階段試驗，這是我們在美國批准下必須進行的強制性試驗。所以這些成本在 2025 年確實會增加。當然，我們也正在加速推進其餘的研發項目，同時我們的新志賀氏菌計畫也不斷增加研發活動。

Good. So -- and it is worth mentioning, Suzanne, that the -- we will have a -- the Phase 4 program will also be augmented by the Phase 3 initiation in pediatrics, which is also mandatory. The mandatory post-life licensure activity, all that peaks a little bit in the latter part of this year. This is why you see this relatively high R&D cost. But as Peter said, this is the potential offset through the CEPI grant as well as the R&D tax credits that Peter mentioned.

好的。所以 — — 值得一提的是，蘇珊娜，— — 我們將有一個 — — 第 4 階段計劃，也將通過兒科的第 3 階段啟動得到增強，這也是強制性的。強制性的退休後執照活動都在今年下半年達到高峰。這就是為什麼研發成本相對較高的原因。但正如彼得所說，這是透過 CEPI 資助以及彼得提到的研發稅收抵免來實現的潛在抵消。

On RFK, well, you gave us, of course, the question that we are receiving all the time. So 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 gotten -- getting delayed, necessary things that were supposed to be discussed at ACIP could not be discussed. So we need to really evaluate the impact. We need to see how this is going to go, and develop further going forward.

關於羅伯特甘迺迪 (RFK)，嗯，你當然給了我們一個我們一直在收到的問題。因此首先，我們的立場是不要猜測。我認為仔細監視局勢非常重要。當然，所有疫苗公司都擔心 ACIP 會被推遲，原本應該在 ACIP 上討論的必要事項無法討論。所以我們需要真正評估其影響。我們需要觀察事情將如何發展，並進一步向前發展。

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 economic analysis for those vaccines are 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. So we hope that this is going to come very soon.

就我們目前在市面上銷售的疫苗來說，大部分都是自費疫苗。我想說，他們目前沒有受到有關疫苗接種的嚴厲批評。他們瞄準的是醫療需求尚未被滿足的領域。這些疫苗的健康經濟分析對萊姆病非常有利。情況是，ACIP——ACIP 議程草案已將組建萊姆病工作組列入議程。我們希望這能夠很快實現。

And then the -- our view and you and I had this discussion before, my personal view is science will prevail. And so therefore, if there was an efficacious and safe vaccine against the devastating disease like Lyme disease, why should it not be used and given to people who can benefit most of it?

然後──我們的觀點和你我之前討論過的一樣，我個人的觀點是科學將佔上風。因此，如果有一種針對萊姆病這種毀滅性疾病的有效且安全的疫苗，為什麼不將它用於最能從中受益的人呢？

Got it. Thank you very much.

知道了。非常感謝。

Samir Devani, RX Securities Limited.

Samir Devani，RX 證券有限公司。

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.

大家好，感謝你們回答我的問題。讓我先問一些數字問題。您能否確認今年年初是否對 IXIARO 和 DUKORAL 進行了價格上漲？我想這是第一個問題。

And then I guess the only other one on the numbers is -- maybe two on the numbers. There was an intangible spend up to end of September about EUR10 million, and it seems to have gone down to EUR2.5 million in the cash flow. I was just wondering what happened in the last quarter to do that.

然後我猜數字上唯一的另一個是——也許是數字上的兩個。截至 9 月底的無形支出約為 1,000 萬歐元，而現金流似乎已降至 250 萬歐元。我只是想知道上個季度發生了什麼。

And you mentioned about the R&D tax credits that you're expecting. Could you just maybe quantify that for us? Thanks very much.

您提到了您預期的研發稅收抵免。您能為我們量化一下嗎？非常感謝。

So I start with the first part of your question. Hi, Samir, by the way. So we had no material price increases in 2024 for any of our products. So you have almost a like-for-like volume comparison. I'm sure that was your question.

所以我從你的問題的第一部分開始。順便說一句，你好，薩米爾。因此，2024 年我們的任何產品價格均不會大幅上漲。因此，您幾乎可以進行同類的銷售比較。我確信這是你的問題。

Actually, Thomas, it was about 2025 rather than 2020 -- what is -- at the beginning of the year, you've taken it --

事實上，托馬斯，這是關於 2025 年而不是 2020 年——今年年初，你已經接受了--

No, it is 2025. It's already coming -- this is what I meant, yeah. So basically, nothing at this point in time. And then Peter, to your -- to the other part of the question?

不，是 2025 年。它已經到來了——是的，這就是我的意思。所以基本上，目前還沒有任何事情。然後彼得，對於你──問題的另一部分？

Yes, so, your question on intangible, Samir. So that was basically an upfront payment we had made to -- for the in licensing of the Shigella program. And 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 2 right now, we actually moved out of the intangible. So that's why this --

是的，所以，你的問題是關於無形的，薩米爾。所以這基本上是我們為獲得志賀氏菌計劃的許可而支付的預付款。由於我們的合作夥伴 LimmaTech 正在執行部分研發工作，因此我們引入了部分——基本上，他們目前為第二階段貢獻的成本，我們實際上已經擺脫了無形資產。這就是為什麼--

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?

好的，有道理。是的，好的，有道理。然後就談談您提到的研發稅收抵免，彼得。您能告訴我們這個數量是多少嗎？

Well, yeah, we do not give guidance on the R&D tax credits. But when you look at our 2024 financial statements, you will see that out of the EUR20 million that you see in other income, about half of it is R&D tax credit and the other half is grants. So that gives you a rough idea of what the tax credit it was that we collected in 2024. But as I said, for '25, we have not given the detailed guidance.

嗯，是的，我們沒有提供有關研發稅收抵免的指導。但是，當您查看我們的 2024 年財務報表時，您會發現，在其他收入中的 2000 萬歐元中，大約一半是研發稅收抵免，另一半是補助金。這樣您就可以大致了解我們在 2024 年徵收的稅收抵免額。但正如我所說，對於’25，我們還沒有給出詳細的指導。

Okay. And then just maybe if I can sneak one final one and just on the application for approval of IXCHIQ in Brazil. Is there any update as to when we might see that? Thanks very much.

好的。然後也許我可以偷偷說最後一個問題，是關於巴西 IXCHIQ 的批准申請。關於我們何時可以看到這一情況，有任何最新消息嗎？非常感謝。

Yeah, so on Brazil, we are -- you know that we had anticipated the approval in Brazil in the first quarter. The -- we have been seeing some delays on the process. And basically, we have not received any further list of questions, so that -- which means, the review process is very close to its end.

是的，關於巴西，我們——你知道，我們預計巴西將在第一季獲得批准。我們發現流程出現了一些延遲。基本上，我們還沒有收到任何進一步的問題清單，所以——這意味著，審查過程已接近結束。

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 we'll combine then with the Phase 4 requirements, which is necessary to start in the rainy season. So which means we have a bit of buffer, and therefore, we hope that that we're going to get the approval very soon.

我的意思是，我們的合作夥伴布坦坦目前正在努力推動 ANVISA。所有其他步驟都已成功完成，例如批准前檢查等等。您知道批准——也有一個延遲。目前，批准尚未進入關鍵階段。我們需要這項批准才能啟動我們預期的試點疫苗接種計劃，然後我們將把它與雨季開始的第四階段的要求結合起來。這意味著我們有一點緩衝，因此，我們希望很快就能得到批准。

Right, thanks very much.

好的，非常感謝。

You're welcome.

不客氣。

Rajan Sharma, Goldman Sachs.

高盛的拉詹夏爾馬 (Rajan Sharma)。

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 that was supposed to be a vote on your competitors' chikungunya vaccine, as well, I believe?

你好，謝謝你回答我的問題。這只是與 IXCHIQ 相關，也許只是跟進之前的政策問題。您是否認為，鑑於 2 月 ACIP 會議也應該是對您競爭對手的 Chikungunya 疫苗進行投票，因此，延後會議實際上對您近期有益？

And then 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.

其次，再跟進 IXCHIQ。您能談談目前看到的市場動態嗎？感謝現在還相對較早。但是就您所創造的收入和疫苗的吸引力而言，根據您所看到的情況，這些收入來自哪裡？謝謝。

Let me start with the latter part because I cannot -- there's not a lot I can say to the first part of your question. But let's talk a little bit about IXCHIQ dynamic. So first of all, we are absolutely convinced that the [CHIQ] 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.

讓我先回答後半部分，因為我不能——對於你問題的第一部分我沒有太多可以說的。但我們來稍微討論一下 IXCHIQ 動態。因此首先，我們絕對相信[CHIQ]市場將隨著時間的推移而發展。我們過去討論過這個問題。我們最初對於成長有點過於樂觀，但我們絕對相信這款產品將帶來良好的商業機會。

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.

這是為什麼？因為基孔肯雅病是一種嚴重的疾病。我們看到的疫情越多，臨床表現越多，我們就越能說明——基孔肯雅病不僅僅是一種類似流感症狀的疾病，而且還會帶來相當嚴重的健康損害，有些損害會持續很長時間。

And what we see right now is that there is more and more disease awareness. So there is the -- 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.

我們現在看到的是，人們對疾病的認識越來越強。所以，我們以及我們的競爭對手所做的所有投資都確實在推動人們對基孔肯雅病的普遍了解。除此之外，我們還看到了疫情的爆發。我的意思是，大家都注意到了，目前留尼旺島的疫情相當嚴重，一週內就增加了 2,000 多例。

We have published health economic analysis in a very renowned journal, which also shows that the health economic situation for chikungunya vaccination is very favorable. So all in all, to tell you that there is clearly a growing awareness. The growing awareness comes with growing demand, and we see, of course, substantial prospects in the low-medium income countries.

我們在一份非常著名的期刊上發表了衛生經濟分析，這也顯示基孔肯雅疫苗接種的衛生經濟狀況非常有利。總而言之，我可以告訴你們，人們的認識顯然不斷增強。認識的不斷提高帶來了需求的不斷增長，當然，我們看到了中低收入國家的巨大前景。

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 drug substance to them this year. In the United States, we are still waiting for the MMWR and you heard Suzanne's question up at the beginning. I mean, there were still many things that were supposed to be discussed at ACRP. We have been -- this delay of MMWR does not help access to the retail channels. So 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 UK.

我們的兩位合作夥伴都已表達了對各自產品上市年份相當大的初始需求，實際上是明年，但我們今年就會向他們提供藥物成分。在美國，我們仍在等待 MMWR，您在開始時就聽到了 Suzanne 的問題。我的意思是，還有很多事情需要在 ACRP 上討論。我們一直認為 MMWR 的延遲無助於進入零售通路。因此，希望所有問題都能盡快解決，並推動普及。我們在歐洲看到的初步情況是，到目前為止，我們已經在法國和加拿大推出了該產品。我們將要在英國推出。

The initial signs look good. And you -- and 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. And then from there, we have to see how it's further going to develop.

初步跡像看起來不錯。而且您——以及每個人都可以根據我們的指導以及我們所說的第三方產品的下滑以及 IXIARO 和 DUKORAL 的增長，計算出我們對今年 IXCHIQ 銷售額的假設。然後從那裡，我們必須看看它將如何進一步發展。

I think this is all I can say at this point in time about the IXCHIQ dynamic and the market dynamic around chikungunya.

我想這就是我目前能說的有關 IXCHIQ 動態以及基孔肯雅病市場動態的全部內容。

Oscar Haffen Lamm, Bryan, Garnier.

奧斯卡哈芬拉姆、布萊恩、卡尼爾。

Oscar here from BG. I believe most of my questions have been taken, 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 to Phase 2. And then what -- when would you expect the Phase 2 to start and your estimated cost on that one. Thank you.

我是來自 BG 的奧斯卡。我相信我的大部分問題都已經被回答了，但也許是關於寨卡病毒的問題。我很好奇您對流行病學的發展有何看法，以及這最終將如何影響該計劃進入第二階段的潛在延續。然後—您預計第二階段何時開始，以及您預計的成本是多少。謝謝。

You're talking about Shigella Phase 2?

您說的是志賀氏菌第 2 階段嗎？

The Zika Phase 2.

寨卡病毒第二階段。

The Zika Phase 2. Now on the -- so basically, on the Zika -- at this moment in time, we are with Zika in the Phase 1, as you know. We have a first data readout expected by the end of the year. This will then -- followed by an antibody persistence period. We want to really understand antibody persistence since this has been an issue in the past.

寨卡病毒第二階段。現在，基本上，關於寨卡病毒，正如你們所知，目前我們正處於寨卡病毒的第一階段。我們預計在今年年底前獲得首批數據讀數。接下來是抗體持續期。我們希望真正了解抗體的持久性，因為這在過去一直是一個問題。

And basically then, we will take it from there and talk to the authorities about the clinical development pathway. And I would say the earliest we could start a Phase 2 study if we decided to progress into Phase 2 would probably be at the end of 2026, early 2027, so this is the current time horizon.

基本上，我們將從那裡開始並與當局討論臨床發展途徑。我想說，如果我們決定進入第二階段，我們最早可以開始第二階段的研究，可能是在 2026 年底或 2027 年初，所以這是目前的時間範圍。

Got it. Thank you.

知道了。謝謝。

Vamil Divan, Guggenheim Securities.

瓦米爾·迪萬，古根漢證券公司。

Great, thanks for hosting the call and taking my question. So 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 re-looked at. I'm wondering just kind of given all the dynamics when you think is an appropriate time for us to expect that to be announced.

太好了，感謝您主持電話會議並回答我的問題。所以有幾個——我很抱歉我錯過了這一點，但在 IXCHIQ 上，只是——你之前談到了你的中期指導以及重新審視。我只是想知道，考慮到所有的動態，您認為什麼時候是我們期待宣布這一消息的適當時間。

And then 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 catalyst page for this year. I know you guys think it's coming, so I'm just trying to clarify. Do you expect the data this -- like 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.

其次關於萊姆病，我知道輝瑞公司——正如您在這裡提到的，假設數據呈陽性，輝瑞公司計劃在明年提交申請。我只是想弄清楚數據讀取的具體時間，因為輝瑞實際上並沒有將其列為今年催化劑頁面上的關鍵事件。我知道你們都認為它會發生，所以我只是想澄清一下。您預計這些數據會在今年底公佈嗎？或者您認為實際數據可能會在明年公佈，我們應該如何看待這個問題？謝謝。

So, well, yeah, thanks for the questions. So on IXCHIQ, yeah, 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 that 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.

是的，謝謝您的提問。所以關於 IXCHIQ，是的，我們過去確實給了中期指導。我們之前確實說過，我們可能必須修改這一點，事實上，我們認為我們必須修改它，因為您看到銷售額的成長低於我們的預期。我們仍然相信該產品的潛力，我們仍然認為我們在銷售水平方面給出的指導是可以實現的，但肯定需要更長的時間。

And as we said, we need a few more data points. The 2025 started, right? We just have two months now where we have more data points. And we're launching a new territory, so I think we need -- we still need a bit of time to really confirm by when we will get to the critical number but -- and this is also why we have not decided to give a new midterm guidance at this stage. We will -- we may, in the future, come back and give more indication, but it just requires a little bit more time.

正如我們所說，我們需要更多的數據點。2025年就開始了，對吧？我們目前有兩個月的時間可以獲得更多的數據點。而且我們正在開拓一個新的領域，所以我認為我們需要——我們仍然需要一些時間來真正確認何時能夠達到關鍵數字，但——這也是為什麼我們現階段還沒有決定給出新的中期指導。我們將來可能會回來並給出更多跡象，但這需要一點時間。

Thomas, on the timing of the data readout for Lyme?

湯瑪斯，萊姆病的資料讀取時間是怎麼樣的？

Yeah, so I mentioned at the beginning of the call and throughout the presentation that we are expecting 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 tick season.

是的，我在通話開始時以及整個演示過程中都提到，我們預計在 2025 年底首次讀取數據。隨後也將進行進一步分析，並在 2026 年初進一步讀取次要終點資料。我們先前曾在聯合新聞稿中表示，輝瑞將在 2026 年提交監管文件，並希望能夠及時將產品推向市場，以便人們在 2028 年蜱蟲季節從中受益。

Okay, all right, thank you.

好的，好的，謝謝你。

You're more than welcome.

不用客氣。

(Operator Instructions) Maurice Raycroft, Jefferies.

（操作員指示）莫里斯·雷克羅夫特（Maurice Raycroft），傑富瑞（Jefferies）。

I was just going to -- I'll ask one on chikungunya. So 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.

我正要——我要問一個關於基孔肯雅病的問題。因此，由於 Bavarian Nordic 最近獲得了批准，也許您可以談論這一點，以及您計劃如何利用您的先發優勢並加速在 2025 年的發布。我還想知道您是否仍預計 CDC 將在今年 7 月左右發布 MMWR，以及我們應該如何看待這一點。

So basically, so 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. So we have to see really how this is going to evolve. But yes, our internal planning is still assuming that we're going to get MMWR this year.

所以基本上，首先，我們現在非常謹慎地預測 MMWR、CDC、ACIP 流程的任何時間表，因為現實表明我們在這裡存在很大的未知數。所以我們必須真正觀察事情會如何發展。但是的，我們的內部計劃仍然假設我們今年將獲得 MMWR。

When it comes to Bavarian, of course, I mean, you know what I said in the past. We're not going to talk about competitive products, and their dynamic and what it will do or not do. I mean, 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. And I think the more we see there really work around further increasing the awareness of the disease, the better it is.

當談到巴伐利亞時，當然，我的意思是，你知道我過去說過什麼。我們不會談論競爭產品、它們的動態以及它們會做什麼或不會做什麼。我的意思是，我相信大家有很強的呼聲，因為我曾多次提到，對於基孔肯雅氏症來說，疾病意識是關鍵。我認為，我們越能看到真正努力進一步提高人們對這種疾病的認識，效果就越好。

Understood, that makes sense. And also, 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.

明白了，這很有道理。此外，我只是想看看您是否還有關於接種 IXCHIQ 疫苗後住院的受試者的其他觀點可以分享，以及您對即將召開的 ACIP 會議的討論中可能出現的一些情景或期望是什麼。

Yeah, so 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, [shock] CDC, as well as FDA. We don't want to speculate, and we don't want to say anything right now about how they conclude on the causality.

是的，所以我認為我們在這裡看到的是一個正常的過程。病例是根據 VAERS 系統報告的。目前正在評估這些病例與疫苗接種之間的因果關係。我們已經向 ACIP、CDC 以及 FDA 提供了所有必要的資訊。我們不想猜測，現在我們也不想評論他們如何得出因果關係的結論。

We have, of course, our own opinion around that, but let the process prevail. So -- and I think we take it from there, whatever the outcome is going to be.

當然，我們對此有自己的看法，但讓我們遵循流程。所以 — — 我認為無論結果如何，我們都會從那裡開始。

Makes sense. Okay, thanks for taking my questions.

有道理。好的，感謝您回答我的問題。

More than welcome, Maurice.

非常歡迎，莫里斯。

(Operator Instructions) There are no further questions for today. I would now like to hand the conference over to the management team for any closing remarks.

（操作員指示）今天沒有其他問題。現在，我想將會議交給管理團隊，以便他們作結束語。

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 with -- for -- into a great 2025, knowing, of course, that 2025 is a traditional year for the company as we are moving towards Lyme data, which will be very critical for the further strategic development of the company. And as such, we are looking forward to some very interesting further readouts this year as mentioned. And 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.

是的，非常感謝您今天的出席。像往常一樣，非常感謝您提出的精彩問題。我們滿懷信心地展望未來。我們展望偉大的 2025 年，當然，我們也知道，2025 年對公司來說是一個傳統的年份，因為我們正在邁向萊姆數據，這對公司的進一步策略發展至關重要。因此，如同前面所提到的，我們期待今年能有更多非常有趣的成果。再次感謝您的關注。非常感謝您對公司的關注和支持，並祝福您今天剩餘的時間一切順利。謝謝。