Valneva SE (VALN) 2024 Q3 法說會逐字稿

Thank you and hello for joining us to discuss the financial results for the first nine months, 2024 and a 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 nine months ended. September 30th, 2024, which were published earlier today available within the financial reports section of our investor website.

感謝您和我們一起討論 2024 年前 9 個月的財務表現和公司最新動態。我很高興今天歡迎您。除了我們的新聞稿和分析師演示之外，您還可以找到我們截至九個月的綜合財務表現。2024 年 9 月 30 日，今天稍早在我們投資者網站的財務報告部分發布。

I'm joined today by Valneva's CEO, Thomas Lingelbach and our CFO, Peter Buhler who will provide an overview and update on our business as well as our financial results. 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.

今天，Valneva 的執行長 Thomas Lingelbach 和我們的財務長 Peter Buhler 將與我一起，他們將概述和更新我們的業務以及財務業績。在準備好的發言結束後將舉行分析師問答環節。在開始之前，我想提醒聽眾，在本次演示中，我們將做出前瞻性陳述，這些陳述受到某些風險和不確定性的影響，可能導致實際結果與這些前瞻性陳述所明示或暗示的結果存在重大差異。

You can find additional information about these risks and uncertainties in our periodic filings with the Securities and Exchange Commission and with the French Market Authority which are listed on our company website. Please note that today's presentation includes information provided as of today, November 7th, 2024, and Valneva undertakes no obligation to revise or update forward-looking statements, except as required by applicable securities laws. With that, it's my pleasure to introduce Thomas to begin today's presentation.

您可以在我們公司網站上列出的我們向美國證券交易委員會和法國市場管理局定期提交的文件中找到有關這些風險和不確定性的更多資訊。請注意，今天的簡報包含截至今天（2024 年 11 月 7 日）提供的信息，Valneva 不承擔修改或更新前瞻性陳述的義務，除非適用的證券法要求。我很高興介紹托馬斯開始今天的演講。

Thank you, Josh. It's a pleasure to welcome you all to today's call. Yeah, what are the highlights for the first nine months, 2024. Overall, the company's performance is in line with our guidance. When we look at product sales which landed at a bit more than EUR110 million at the end of the nine-month period.

謝謝你，喬許。很高興歡迎大家參加今天的電話會議。是的，2024 年前九個月有哪些亮點？整體而言，公司的業績符合我們的指引。當我們觀察九個月期末的產品銷售額時，其銷售額略高於 1.1 億歐元。

And given the slow uptake of IXCHIQ in the US market, we have narrowed our guidance to 160 to 170. And Peter will provide more details on that with a cash position of more than EUR150 million we consider the company well financed. And when we look at the R&D, we had a very strong R&D execution year-to-date.

鑑於 IXCHIQ 在美國市場的吸收緩慢，我們將指導範圍縮小至 160 至 170。Peter 將提供更多詳細信息，我們認為該公司的現金狀況超過 1.5 億歐元，資金充足。當我們審視研發時，我們今年迄今擁有非常強大的研發執行力。

Of course, most importantly with Lyme going 100% according to plan chik adolescence data that came in as expected, and on time, pediatric and persistence data for chik as well. And we presented our long-term R&D strategy at the Investor Day in New York recently. We continued to perform strongly on our scientific positioning but also on the partnering front, many very interesting publications in renowned journals like, The Lancet our partnership with CEPI supporting Chik Development and more recently, the partnership with Limma Tech on a very exciting Shigella program.

當然，最重要的是，根據按預期提供的計劃 chik 青春期數據，以及按時獲得的 chik 兒科和持久性數據，萊姆病將 100% 發生。我們最近在紐約的投資者日上介紹了我們的長期研發策略。我們繼續在科學定位方面表現強勁，而且在合作方面也表現出色，在著名期刊《柳葉刀》上發表了許多非常有趣的文章，我們與CEPI 合作支持Chik 開發，最近又與Limma Tech 合作開展了一個非常令人興奮的志賀氏菌計畫。

Turning to page 5 of the presentation and looking a little bit into the mid-term of the company, it is fair to say, and Peter noted this in his quote today's press release that we are approaching next year, really a turning point in Valneva's evolution.

翻到簡報的第 5 頁，稍微回顧一下公司的中期業績，可以公平地說，Peter 在今天的新聞稿中指出了這一點，我們即將迎來明年，這確實是 Valneva 的一個轉折點進化。

We are targeting sustained profitability from 2027 onwards, driven by success of the Lyme Disease vaccine program is successful and approved, of course. As mentioned, we are on track in with regards to the phase 3 study and regulatory filings in 2026 the first approval initial phase in 2027 which then would immediately trigger, the development milestone payments and hopefully then later the royalties and the sales milestones. Of course, in the short term, our focus is besides on R&D execution to focus on growing our commercial sales.

我們的目標是從 2027 年起實現持續盈利，這得益於萊姆病疫苗計劃的成功和批准。如前所述，我們正在按計劃進行2026 年的第3 階段研究和監管備案，2027 年的第一個批准初始階段，然後將立即觸發開發里程碑付款，並希望隨後觸發特許權使用費和銷售里程碑。當然，短期內，我們的重點除了研發執行之外，也專注於成長我們的商業銷售。

Despite of the slow uptake of IXCHIQ in the US market, we remain confident in the long-term IXCHIQ prospects. I believe it's a great product and we of course, will carefully review the uptake in the coming months especially since we will see of the developments in the US, but also in Canada, first European countries and we will have a better understanding about the demand from existing and expected future LMIC partners where Chikungunya is endemic.

儘管 IXCHIQ 在美國市場的吸收緩慢，但我們對 IXCHIQ 的長期前景仍然充滿信心。我相信這是一款很棒的產品，我們當然會在未來幾個月仔細檢視其使用情況，特別是因為我們將看到美國、加拿大、歐洲國家的發展，我們將對需求有更好的了解來自基孔肯雅熱流行的現有和預期未來中低收入國家合作夥伴。

We expect that our commercial business overall with improved margins would generate cash again from 2025 onwards. And this will be achieved by a combination of top line grows but also efficiencies on the bottom line. And of course, we will continue building for the future by advancing an attractive and differentiated R&D pipeline. Just by way of reminder what we discussed also at the R&D of investor day.

我們預計，從 2025 年起，我們的商業業務整體利潤率有所提高，將再次產生現金。這將透過營收成長和獲利效率的結合來實現。當然，我們將透過推進有吸引力且差異化的研發管道來繼續建立未來。只是提醒一下我們在投資者日的研發中也討論過的內容。

We have on the one hand side, the mandatory R&D primarily focused around chik development Phase 4 and Phase 3 pediatric, which is financially supported through the CEPI grant. We would like to advance our programs around Shigella and [ZIKA] programs are supported by risk mitigated, development strategies and [sas allow] an efficient capital allocation based on very defined progress data points. And as announced, we expect next clinical entries mainly from our own proprietary preclinical pipeline post licensure in 2027.

一方面，我們的強制性研發主要集中在 chik 開發第 4 階段和第 3 階段兒科，這是透過 CEPI 撥款提供財政支持的。我們希望圍繞志賀氏菌推進我們的計劃，[ZIKA] 計劃得到風險緩解、發展策略和 [SAS 允許] 基於非常明確的進度數據點的有效資本分配的支持。正如所宣布的，我們預計下一個臨床項目主要來自我們自己專有的臨床前管道，將於 2027 年獲得許可。

All of that is reflected in our pipeline slide. We believe that we have besides very unique commercial assets, very interesting and very coherent pipeline, all the way from preclinical to late-stage clinical development, all targets that you see here, all programs that you see here are very unique. In every single program, we are either most advanced, hence first in class, best in class or only in class at all. And this makes us proud to contribute to a world in which home, no one will die or suffer from a vaccine preventable disease.

所有這些都反映在我們的管道幻燈片中。我們相信，除了非常獨特的商業資產之外，我們還擁有非常有趣且非常連貫的管道，從臨床前到後期臨床開發，您在這裡看到的所有目標，您在這裡看到的所有項目都是非常獨特的。在每一個專案中，我們要么是最先進的，因此是班上第一，班上最好的，或者只是班上的。這讓我們自豪地為世界做出貢獻，在這個世界上，家裡沒有人會死亡或患有疫苗可預防的疾病。

Turning over to Lyme, I think the most important thing to note is that we updated on page 9 a little bit, the say the medical need and related market opportunity. This is a slide that you saw as part of the Investor Day. By way of reminder, there's no vaccine currently available to prevent Lyme disease in humans. You see the annual burden of disease, and these are the most recent numbers for the US and Europe. Acknowledging of course, that European numbers are probably significantly underreported.

轉向萊姆，我認為最重要的是要注意的是我們在第 9 頁上進行了一些更新，其中提到了醫療需求和相關的市場機會。這是您在投資者日看到的幻燈片。提醒一下，目前還沒有疫苗可以預防人類萊姆病。你可以看到每年的疾病負擔，這些是美國和歐洲的最新數據。當然，要承認歐洲的數字可能被嚴重低估。

Equally true for the US, but probably not at the same scale. You know, 10% to 30% of cases develop severe manifestations, you know, be carditis, neuroborreliosis, arthritis and you have about another 5% to 10% on the persistent symptoms. And those cases continue to have persistent symptoms following even treatment.

美國也是如此，但規模可能不同。你知道，10% 到 30% 的病例會出現嚴重的症狀，例如心臟炎、神經疏螺旋體病、關節炎，另外大約 5% 到 10% 的病例會出現持續症狀。這些病例即使經過治療，症狀仍持續存在。

And this then turns also in a commercial opportunity if you think about the fact that more than 80 million US citizens live in areas which are considered endemic. And according to CDC delta areas with internet rates about above 4.5% of land cases annually. And in Europe, even more than 200 million people. So therefore, we are very confident in our estimation of more than a billion in terms of a potential vaccine market.

如果你考慮到超過 8000 萬美國公民生活在被認為是流行病的地區這一事實，那麼這也變成了一個商業機會。根據 CDC 的數據，三角洲地區每年的網路普及率約佔陸地案件的 4.5% 以上。而在歐洲，甚至超過2億人。因此，我們對潛在疫苗市場超過10億的估計非常有信心。

I don't need to go again into all the features of our very unique and differentiated Lyme Disease program. I think the key updates here are that, of course, we have fully recruited the Phase 2, when it comes to primary vaccination, we are still, you know, one last round of booster vaccinations ahead of the 2025 seasons to go before we can have the first readout at the end of next year. And we are absolutely on track for the phase trial we tried conclusions.

我不需要再次討論我們非常獨特和差異化的萊姆病計劃的所有特徵。我認為這裡的關鍵更新是，當然，我們已經完全招募了第二階段，當談到初級疫苗接種時，我們仍然是，你知道，在2025 年季節之前進行最後一輪加強疫苗接種，然後我們才能進行明年年底會有第一個讀數。我們絕對步入了階段試驗的正軌，我們嘗試了結論。

And of course, we mentioned already in prior calls and Peter will we emphasize that, that we have completed our cost contributions to the development activities with our partner Pfizer in the first half of this year, which of course has a very positive effect on our cash burn. And we recently reported the two year antibody persistence and put the results in line with our expectations.

當然，我們在之前的電話會議中已經提到過，彼得是否會強調，我們已經在今年上半年完成了與合作夥伴輝瑞一起開發活動的成本貢獻，這當然對我們產生了非常積極的影響。錢。我們最近報告了兩年的抗體持久性，結果符合我們的預期。

Slide 11 shows that the Valor study design close to 10,000 people, 1 to 1 randomized against Placebo, 2 to 1 North America versus EU. Please remember, primary end point rate of confirmed Lyme disease cases after two consecutive tick seasons. And when you look at at the charts below, you see the green syringes versus the black syringe and the black syringe is exactly the last outstanding vaccination, you know, activity that is needed. Before then, the primary efficacy readout is expected towards the tail end of 2025.

投影片 11 顯示，Valor 研究設計了近 10,000 人，以 1 比 1 的比例隨機對照安慰劑，以 2 比 1 的比例隨機對照北美和歐盟。請記住，連續兩個蜱季後萊姆病確診病例的主要終點率。當您查看下面的圖表時，您會看到綠色注射器與黑色注射器，而黑色注射器正是最後一個未完成的疫苗接種，您知道，需要進行的活動。在此之前，預計在 2025 年底公佈主要療效數據。

So overall, as mentioned, very pleased with the collaboration, very pleased with the program and very confident in the program and it's read out and basically everything on track for the end of next year. Turn Chikungunya our famous product, IXCHIQ the world's first and only Chikungunya vaccine. Today, it builds on key differentiators. It has shown a very strong and a very persistent immune response with only one dose.

總的來說，正如前面提到的，我們對合作非常滿意，對這個計劃非常滿意，對這個計劃非常有信心，它已經宣讀完畢，基本上一切都在明年年底按計劃進行。我們的著名產品 IXCHIQ 成為世界上第一個也是唯一一個基孔肯雅疫苗。如今，它建立在關鍵的差異化優勢之上。僅一劑就顯示出非常強烈且非常持久的免疫反應。

And here is where this product differentiates including the fact that we have also shown very strong immunity in elderly. Which just by way of reminder is the main target population for this vaccine according to the ACIP recommendation.

這就是該產品的與眾不同之處，包括我們在老年人中也表現出了非常強的免疫力。提醒一下，根據 ACIP 的建議，這是該疫苗的主要目標族群。

And that's basically the status on the product profile when we look a little bit into all the milestones that we have achieved. Everything is focused on expanding access to IXCHIQ globally. Our Phase 3 adolescent trial for strong and even the safety and profile up to six months. Those submissions for label extension have either been already done or close to be done.

當我們稍微了解我們已經實現的所有里程碑時，這基本上就是產品簡介的狀態。一切都集中在擴大全球範圍內對 IXCHIQ 的存取。我們的 3 期青少年試驗具有強大的穩定性和長達六個月的安全性。標籤延期的提交工作要么已經完成，要么即將完成。

We have published long term antibody assistance results up to 24 months already. And please remember this study is going on for up to 10 years. So, our objective is to monitor antibody assistance to up to 10 years.

我們已經發布了長達 24 個月的長期抗體援助結果。請記住，這項研究將持續長達 10 年。因此，我們的目標是監測長達 10 年的抗體援助。

We have achieved also already first days in Canada where we had a very recently, a very nice launch. And we are preparing to launch in France as the first European country. Other upcoming and near-term catalysts include the expected approval for IXCHIQ in Brazil and the UK.

我們在加拿大也已經取得了第一天的成績，最近我們在那裡進行了一次非常好的發布。我們正準備在法國作為第一個歐洲國家推出。其他即將到來和近期的催化劑包括 IXCHIQ 在巴西和英國的預期批准。

I mentioned already the label extension activities for which we are really expecting then labels to be updated next year. We are very close to report the three-year antibody persistence results, hopefully still this side of Christmas but could come also very early next year depending on how fast we're going to be on all the readouts.

我已經提到了我們真正期望明年更新標籤的標籤擴展活動。我們非常接近報告三年抗體持久性結果，希望仍然在聖誕節期間，但也可能在明年初公佈，具體取決於我們讀取所有讀數的速度。

And then the Phase 2 pediatric trial top line results, same thing either very late this year or very early next year. And we are still working on getting into a partnership for Asia and to augment our existing LMIC partner network that currently consists out of Butantan for Latin America, primarily with a strong partner for Asia.

然後是第二階段兒科試驗的頂線結果，今年稍後或明年初也是同樣的結果。我們仍在努力建立亞洲合作夥伴關係，並擴大我們現有的中低收入國家合作夥伴網絡，目前由拉丁美洲的布坦坦組成，主要是亞洲的強大合作夥伴。

And there are of course major upcoming and future opportunities to capture and drive greater penetration. This is the first point is focused on the US. So, we are still waiting for the MMWR publication, and we expect this to drive primarily retail growth in the US. It's one of the key expected growth drivers to get to an acceptable and promising growth trajectory for the United States.

當然，即將到來和未來還有重大機會來捕捉和推動更大的滲透率。這是第一點是針對美國的。因此，我們仍在等待 MMWR 的發布，我們預計這將主要推動美國零售業的成長。這是美國實現可接受且有希望的成長軌蹟的關鍵預期成長動力之一。

And then of course, with the launches in Europe and the expansions in Canada, we expect major growth drivers for next year. We also expect additional ACIP and European recommendations. There are already some countries in Europe that have based recommendations, Austria being one example. We further expect travel software protocol updates. I mentioned already the label updates to for exchange which includes always antibody persistence, but also the age range.

當然，隨著在歐洲的推出和在加拿大的擴張，我們預計明年將成為主要的成長動力。我們也期待更多 ACIP 和歐洲建議。歐洲已經有一些國家提出了基於建議的建議，奧地利就是一個例子。我們進一步期待旅行軟體協議的更新。我已經提到了標籤更新以進行交換，其中包括始終抗體持久性，以及年齡範圍。

The LMIC approvals, the additional partnerships and our continuous discussions with the US Department of Defense. All those key opportunities will drive access and penetration and hence safe cross.

LMIC 的批准、額外的合作夥伴關係以及我們與美國國防部的持續討論。所有這些關鍵機會將推動進入和滲透，從而推動安全交叉。

When we look at the Shigella program as mentioned at the beginning, it is the world's most clinically advanced tetravalent Shigella vaccine today. And we have exclusively partnered this program with Lima Tech Biologics. It's a tetravalent bioconjugate vaccine with the potential to cover up to 85% of the shigellosis infections. And that's a very important one given that shigella is really a life-threatening disease.

當我們看開頭提到的志賀氏菌計畫時，它是當今世界上臨床最先進的四價志賀氏菌疫苗。我們與 Lima Tech Biologics 獨家合作了這個項目。它是一種四價生物結合疫苗，有可能涵蓋高達 85% 的志賀氏菌感染。鑑於志賀氏菌確實是一種危及生命的疾病，這一點非常重要。

The global market is expected to exceed half a billion annually and this number has been substantiated through an independent market assessment conducted by LEK with key segments including travellers, military, but also endemic countries. And I think that's a very important segment for this vaccine, especially Children in LMIC countries where shigellosis is the second leading cause of fatal diarrhea.

全球市場預計每年將超過 5 億，這一數字已透過 LEK 進行的獨立市場評估得到證實，評估的關鍵群體包括旅行者、軍隊以及流行國家。我認為這對這種疫苗來說是一個非常重要的部分，特別是中低收入國家的兒童，志賀氏菌病是致命性腹瀉的第二大原因。

And we see up to, estimated 165 million cases and more than 600,000 deaths annually. Therefore, Shigella has also been identified as a priority vaccine by WHO. When we look at the development execution and the upcoming milestones, the very close to initiate the Phase 2 CHIM study alongside with the pediatric study under Phase 2 protocol. Those two studies will be conducted by Lima Tech and innovation is still expected this side of Christmas.

我們估計每年有 1.65 億例和超過 60 萬人死亡。因此志賀氏菌也被世界衛生組織認定為優先疫苗。當我們審視開發執行情況和即將到來的里程碑時，我們發現第二階段 CHIM 研究以及第二階段協議下的兒科研究已經非常接近啟動。這兩項研究將由利馬科技公司進行，預計聖誕節期間仍將有創新。

And Valneva is already in the transition to assume full accountability and responsibility be it on the R&D, C MC regulatory side of things. So, we are working hand in hand with the market right now. We are very grateful to our colleagues at Lima Tech for the very smooth and very constructive collaboration and transition. We reported recently that this program achieved FDA fast track designation.

Valneva 已經開始轉型，承擔研發、C MC 監管方面的全部責任和責任。因此，我們現在正在與市場攜手合作。我們非常感謝利馬科技的同事們進行了非常順利且富有建設性的合作和過渡。我們最近報道說，該專案獲得了 FDA 快速通道指定。

When we look a little bit into the development plan for this program, and I mentioned a couple of times that this is a very interesting risk mitigated clinical development strategy supported by multiple catalysts and decision points. On the way towards licensure, this Phase 2 first CHIM study that I mentioned is a CHIM study where we challenge against a sonnei is about to start, you know, imminently. Then it would be followed by a second phase to study where we're going to challenge with flexneri 2a in this case.

當我們稍微研究這個專案的開發計畫時，我多次提到這是一個非常有趣的風險緩解臨床開發策略，由多個催化劑和決策點支持。在獲得許可的過程中，我提到的第二階段第一個 CHIM 研究是一項 CHIM 研究，我們對 sonnei 的挑戰即將開始，你知道，即將開始。接下來是第二階段，研究在這種情況下我們將用福萊納 2a 挑戰什麼。

And those two controlled human infection models would give us a very interesting prospect on the expected potential efficacy of this vaccine. While at the same time, we run immunogenicity studies in Children in LMIC. And you see the bar here that choose Phase 2 Global Health, which is the immunity study in Children that I was talking about earlier, which will then be followed by a small bridging study in European or US Children before we go into a large-scale Phase 3 study in LMICs for Children.

這兩種受控的人類感染模型將為我們提供關於這種疫苗的預期潛在功效的非常有趣的前景。同時，我們對中低收入國家的兒童進行免疫原性研究。你可以看到這裡選擇第二階段全球健康的欄，這是我之前談到的兒童免疫研究，然後將在歐洲或美國兒童中進行小型橋接研究，然後再進行大規模研究中低收入國家兒童的第3 期研究。

And on the adult side, you see in right, that we expect licensure by challenge, meaning controlled human infection model flanked with safety and immunogenicity study to ensure the necessary safety database. And all of that if successful and if executed on time. And according to plan, first approvals could be expected in the 2030-31 horizon.

在成人方面，如右圖所示，我們期望透過挑戰獲得許可，這意味著受控的人類感染模型，同時進行安全性和免疫原性研究，以確保必要的安全資料庫。所有這一切如果成功並且按時執行的話。根據計劃，預計將在 2030-31 年獲得首次批准。

Couple of key results from the LEK study when it comes to the total vaccine market for a potential Shigella vaccine. And here you see the three segments that I mentioned before, we have looked at recommendation, acceptance and vaccination. And you see that the typical waterfall model that we apply for other travel vaccines.

LEK 研究的幾個關鍵結果涉及潛在志賀氏菌疫苗的整個疫苗市場。在這裡你可以看到我之前提到的三個部分，我們研究了建議、接受和疫苗接種。您會看到我們應用於其他旅行疫苗的典型瀑布模型。

And here, you see that, we see a very substantial segment also only about 23% of the total, estimated market probably in this area than Children in endemic. And representing around 76% and then military a certain portion. And that's the current hypothesis that we have when it comes to the market opportunity for this vaccine. And again, pointing to the travel opportunity here, we estimate that the market is dominated by the United States with 80 to 85 million coming from the US alone.

在這裡，你可以看到，我們看到一個非常大的細分市場也只佔總數的 23% 左右，估計這個領域的市場可能比兒童流行。約佔76%，然後是軍事部分。這就是我們目前對於這種疫苗的市場機會的假設。再次，針對這裡的旅遊機會，我們估計該市場由美國主導，光是美國就有 8,000 至 8,500 萬人。

Yeah, with that, I would like to draw your attention on our Zika virus vaccine candidate. You may recall that this is a candidate we call it internally VLA1601 which is an optimized second-generation vaccine candidate against the Zika virus. And we are well in the Phase 1, and we are currently executing the study according to plan.

是的，我想提請您注意我們的寨卡病毒候選疫苗。您可能還記得，這是我們內部稱為 VLA1601 的候選疫苗，它是針對寨卡病毒的優化的第二代候選疫苗。我們正處於第一階段，目前正在按計劃進行研究。

This is a very interesting candidate because we fully comply with one of the desired target product profiles that were published by WHO it leverages an existing platform that we have, namely a platform that we originally developed for CRO but then substantially enhanced and scaled up for our COVID vaccine development. So, it's a like for like process that we apply here. So therefore, it is also suited for large scale manufacturing.

這是一個非常有趣的候選者，因為我們完全符合世界衛生組織發布的期望目標產品概況之一，它利用了我們現有的平台，即我們最初為CRO 開發的平台，但後來為我們的產品進行了大幅增強和擴展。因此，我們在這裡應用的是類似的流程。因此，它也適合大規模製造。

And you know, Zika is coming back. It maybe the simple message here. And we all remember that Zika infections especially in pregnancy can have very devastating effects. And there are no vaccines or specific treatments available to our knowledge. We are currently probably the only company with an active clinical development program at this stage. The Zika vaccine development or the disease area is PRV eligible. And we know that there are currently many public institutions looking into potential funding mechanisms.

你知道，茲卡病毒正在捲土重來。這可能是這裡的簡單訊息。我們都記得寨卡病毒感染，尤其是在懷孕期間，可能會產生非常破壞性的影響。據我們所知，還沒有可用的疫苗或具體治療方法。我們目前可能是現階段唯一一家擁有積極臨床開發計畫的公司。寨卡疫苗開發或疾病地區符合 PRV 資格。我們知道，目前有許多公共機構正在研究潛在的融資機制。

We expect in the first half next year to have Phase 1 results, but also a better insight with regards to market opportunities, potential access strategies but also some decisions on potential external and non diluted funding. So, in a nutshell overall, we are very confident in not only our you know, commercial business, but also and its prospects, but also, and most importantly on our R&D pipeline and its prospects and its major catalysts specifically line at the end of next year. And with this business update, I would like to hand over to Peter to provide you with the financial report.

我們預計明年上半年將獲得第一階段的結果，同時也對市場機會、潛在的進入策略以及有關潛在外部和非稀釋資金的一些決定有更好的了解。因此，總而言之，我們不僅對我們的商業業務及其前景充滿信心，而且最重要的是對我們的研發管道及其前景及其主要催化劑特別是在年底明年。在本次業務更新中，我想請 Peter 向您提供財務報告。

Thank you, Thomas and good morning and good afternoon to all of you. So, moving to the financials of the first nine months of 2024 product sales reached EUR112.5 million and on a comparable basis, grew 12% over prior year including last year's sales of the COVID 19 vaccine sales increased by 6%. The impact of currency fluctuation on a year-on-year basis is neglectable.

謝謝你，托馬斯，祝大家早安，下午好。因此，轉向 2024 年前 9 個月的財務數據，產品銷售額達到 1.125 億歐元，在可比基礎上比上年增長 12%，其中去年的 COVID 19 疫苗銷售額增長了 6%。匯率波動對年比的影響可忽略不計。

Total IXIARO sales reached EUR66 million and increased 31% over prior year. The strong year, over year growth was driven by double digit year over year growth rates in both the travel segment and US military Dukoral sales increased year over year by 6% and reached EUR22.3 million in the first nine months of 2024. In the third quarter, Dukoral sales grew by 85% as discussed in our half year results release. We had limited to Dukoral related marketing investment at the beginning of the year as we anticipated supply constraints in our manufacturing facility in Sweden due to regulatory inspections.

IXIARO 總銷售額達到 6,600 萬歐元，比上年增長 31%。強勁的同比增長得益於旅遊領域兩位數的同比增長率，以及美國軍用 Dukoral 銷售額同比增長 6%，2024 年前 9 個月達到 2,230 萬歐元。正如我們在半年業績發布中討論的那樣，第三季度 Dukoral 銷售額增長了 85%。今年年初，我們對 Dukoral 相關的行銷投資進行了限制，因為我們預計瑞典的製造工廠將因監管檢查而出現供應限制。

In terms of our ongoing launch of our new Chikungunya vaccine IXCHIQ, we report sales of EUR1.8 million by September 30th in the United States.

關於我們正在推出的新型基孔肯雅疫苗 IXCHIQ，我們報告稱，截至 9 月 30 日，在美國的銷售額為 180 萬歐元。

The ACIP recommendation for IXCHIQ was adopted by the CDC in March this year. And as Thomas mentioned, we are still awaiting the MMWR publication. In line with our expectations, third party products declined by minus 23% year over year to reach EUR29.1 million primarily as a result of supply constraints.

ACIP 對 IXCHIQ 的建議於今年 3 月被 CDC 採納。正如托馬斯所提到的，我們仍在等待 MMWR 的發布。與我們的預期一致，主要由於供應限制，第三方產品年減-23%，達到 2,910 萬歐元。

Moving on to the income statement, total revenues reached EUR116.6 million versus EUR111.8 million in the first nine months of 2023. Looking at expense, we observe a decrease in cost of goods and services from EUR74.8 million in the first nine months of 2023 to EUR71.3 million. in the current year, IXIARO gross margin reached 58.8% of IXIARO product sales compared to 47.2% one year ago.

來看損益表，總收入達到 1.166 億歐元，而 2023 年前 9 個月的總收入為 1.118 億歐元。從費用來看，我們觀察到商品和服務成本從 2023 年前 9 個月的 7,480 萬歐元下降至 7,130 萬歐元。今年，IXIARO 毛利率達到 IXIARO 產品銷售額的 58.8%，而一年前為 47.2%。

DUKORAL generated a gross margin of 34.8%. While third party products yielded a gross margin of 32%. The total gross margin excluding IXCHIQ reached 48.6% compared to 43.7% in the first nine months of 2023 and 47.7% at the end of June. It is important to note that the total gross margin is also adversely affected by IXCHIQ related overhead costs as well as idle costs related to our new manufacturing site.

DUKORAL 的毛利率為 34.8%。而第三方產品的毛利率為32%。不包括 IXCHIQ 的總毛利率達到 48.6%，而 2023 年前 9 個月為 43.7%，6 月底為 47.7%。值得注意的是，總毛利率也受到 IXCHIQ 相關管理費用以及與我們新生產基地相關的閒置成本的不利影響。

Research and development expense increased from EUR42.2 million in in the first nine months of 2023 to EUR48.6 million in the current fiscal year. That increase mainly relates to tech transfer costs for the transfer of our IXIARO and the IXCHIQ manufacturing operations to our new Almeida site in Scotland.

研發費用從 2023 年前 9 個月的 4,220 萬歐元增加到本財年的 4,860 萬歐元。這一成長主要與將我們的 IXIARO 和 IXCHIQ 製造業務轉移到我們位於蘇格蘭的新阿爾梅達工廠的技術轉移成本有關。

In addition, our preclinical spend marginally increased over the prior year. Marketing and distribution expense increased year over year by approximately 5% to reach EUR35.7 million. The increase is related to the launch cost related to our IXCHIQ vaccine that also include higher people costs. As we expanded our commercial team G&A expense decreased by 7% year over year to reach EUR32.6 million.

此外，我們的臨床前支出比前一年略有增加。行銷和分銷費用年增約 5%，達到 3,570 萬歐元。這一增長與我們的 IXCHIQ 疫苗相關的上市成本有關，其中還包括更高的人力成本。隨著我們商業團隊的擴大，一般管理費用年減 7%，達到 3,260 萬歐元。

The sale of the PRV generated an income of EUR90.8 million while other income reached EUR14.9 million versus EUR17 million in the prior year. Other income primarily consists of grant income and R&D tax credit. Operating profit is reported at EUR34.2 million versus an operating loss of minus EUR57.2 million in the prior year. Adjusted EBITDA improves from minus EUR46 million to positive EBITDA of EUR48.6 million.

PRV 的銷售產生了 9,080 萬歐元的收入，而其他收入則達到 1,490 萬歐元，而前一年為 1,700 萬歐元。其他收入主要包括補助收入和研發稅收抵免。據報告，營業利潤為 3,420 萬歐元，而上一年的營業虧損為負 5,720 萬歐元。調整後 EBITDA 從負 4,600 萬歐元增至正 4,860 萬歐元。

As mentioned at the beginning of the presentation, our cash position at September 30th is reported at EUR156.3 million and it is worth highlighting that our cash use in operating activities decreased significantly from EUR136 million in the first nine months of 2023 to EUR76.7 million in the current fiscal year.

正如簡報開頭所提到的，我們截至9 月30 日的現金部位為1.563 億歐元，值得強調的是，我們經營活動的現金使用量從2023 年前9 個月的1.36 億歐元大幅下降至76.7歐元本財年達 100 萬元。

Now moving to slide 26 during our investor day in New York, we provided a view on travelers' data, traveling to japanese encephalitis or Chikungunya endemic regions.

現在轉到紐約投資者日期間的幻燈片 26，我們提供了前往日本腦炎或基孔肯雅熱流行地區的旅客資料視圖。

The information on this slide is based on IATA data from August 2024. As the graph illustrates, we see the number of travelers to Chikungunya endemic countries in 2024 is anticipated to be above the pre COVID period while travelers to JE endemic countries are still slightly lower. More importantly, the forecast data shows the number of travelers are expected to grow significantly over the coming years with an anticipated growth of 22% for travels to Chikungunya countries by 2030 nearly 30% for JE endemic countries.

本投影片中的資訊是根據 2024 年 8 月的 IATA 資料。如圖所示，我們看到 2024 年前往基孔肯雅熱流行國家的旅客人數預計將高於新冠疫情之前的水平，而前往乙腦流行國家的旅客人數仍略低。更重要的是，預測數據顯示，未來幾年，前往基孔肯雅熱國家的旅遊人數預計將大幅增長，預計到2030 年前往基孔肯雅熱國家的旅遊人數將增長22%，而前往乙腦流行國家的旅遊人數將成長近30%。

With this let's move to slide 27, to look at our guidance for the current fiscal year and the outlook beyond. For the current fiscal year, we narrow our product sales guidance to EUR160 to EUR170 million and total revenue guidance to EUR170 to EUR180 million. Other income including the proceeds from the PRV is expected to reach between EUR100 and EUR110 million and the R&D expense are expected between EUR65 and EUR75 million.

接下來，讓我們轉到投影片 27，看看我們對本財年的指導以及未來的前景。對於本財年，我們將產品銷售指引縮小至 1.6 至 1.7 億歐元，總收入指引縮小至 170 至 1.8 億歐元。包括 PRV 收益在內的其他收入預計將達到 1 億至 1.1 億歐元，研發費用預計將在 6,500 至 7,500 萬歐元之間。

In the midterm, we continue to expect growth from IXIARO and to DUKORAL, as for the IXCHIQ sales expectations, we will review our midterm [gains] in the coming months, taking into account the sales trend in the United States and early signals from the sales ramp up in Canada and [first] EU countries with this I hand back the call back to Thomas for the news flow.

中期，我們繼續預期 IXIARO 和 DUKORAL 的成長，至於 IXCHIQ 的銷售預期，我們將在未來幾個月回顧我們的中期[收益]，同時考慮美國的銷售趨勢和來自美國的早期訊號。個]歐盟國家的銷售量上升，我將電話轉回給托馬斯以了解新聞動態。

Thank you so much Peter. Yeah, wrapping up with the summary of our key upcoming catalysts and news flow. On Chikungunya, we have the upcoming potential approvals by Anvisa for Brazil and MHRA for the UK.

非常感謝彼得。是的，我們總結了即將到來的關鍵催化劑和新聞流。關於基孔肯雅熱，巴西的 Anvisa 和英國的 MHRA 即將獲得批准。

As mentioned, the 36-month antibody persistence data for IXCHIQ and the initiation of the Phase 4 clinical program for which we have now port alignment on its final detailed design and execution considerations. For the Lyme Disease vaccine, the final booster routing as mentioned earlier, mid 2025 latest to be completed in line with the Lyme seasonality.

如前所述，IXCHIQ 的 36 個月抗體持久性數據以及 4 期臨床計劃的啟動，我們現在已對其最終詳細設計和執行考慮因素進行了端口調整。對於萊姆病疫苗，如前所述，最後的加強接種路線最遲將於 2025 年中期根據萊姆病季節性完成。

Then you know, of course, we have the continuous monitoring for Lyme disease cases, and we will conclude on all of that towards the end of 2025 which then will enable submissions to the regulatory agencies in 2026. Of course, up to positive Phase 3 data. The initiation of the two phase two studies for Shigella vaccine still this side of Christmas.

當然，我們對萊姆病病例進行持續監測，我們將在 2025 年底前得出所有結論，然後在 2026 年向監管機構提交報告。當然，直到積極的第三階段數據。志賀氏菌疫苗的兩項第二階段研究仍在聖誕節期間啟動。

And the report of the Phase 1 data for our second generation Zika vaccine in the first half of next year. And one thing that we didn't talk about, but I would like to re-emphasize here is we continue to see a very good uptake of the IXIARO in the DoD. We expect the [RFP] to for the next contract to be issued imminently. And with that, of course, a new contract with the DoD in the next six months. I would say, yeah, and with that, let me draw your attention on also the near mid-term value drivers.

還有明年上半年我們第二代寨卡疫苗一期數據的報告。我們沒有談論但我想在這裡再次強調的一件事是，我們繼續看到 IXIARO 在國防部中得到了很好的採用。我們預計 [RFP] 將立即發布下一份合約。當然，接下來的六個月內還會與國防部簽訂新合約。我想說，是的，接下來，讓我提請您注意近期的中期價值驅動因素。

I think the most important one is certainly VLA15 Valor Lyme disease. It's the major catalyst for Valneva.It is probably the most important or likely the most important upside that we see for Valneva in the short to midterm. And on the back offline, we expect this company to retransition into the stained profitability initially coming from the early milestones that we expect in 2027 and then followed by the royalties.

我認為最重要的肯定是 VLA15 Valor 萊姆病。它是 Valneva 的主要催化劑。在線下方面，我們預計該公司將重新轉變為盈利能力受損的狀態，最初來自我們預計 2027 年的早期里程碑，然後是特許權使用費。

And of course, with that, the entire value proposition of our neighbour is expected to change in the near term, the commercial revenue growth with a strong focus not only on our existing brands, but also on IXCHIQ where I would like to reiterate that despite of a slow uptake in the US this year, we some (technical difficulty) prospects for this vaccine across all the different markets, mainly North America, Europe and LMRC countries.

當然，這樣一來，我們鄰居的整個價值主張預計會在短期內發生變化，商業收入的增長不僅集中在我們現有的品牌上，而且還集中在 IXCHIQ 上，我想重申，儘管鑑於今年在美國的緩慢採用，我們對這種疫苗在所有不同市場（主要是北美、歐洲和LMRC 國家）的一些（技術難度）前景進行了展望。

And we are absolutely excited and thrilled about the potential of our future pipeline programs including Shigella. But also, Zika and the programs that we have currently in preclinical development that are expected to enter the clinic upon successful line execution and approval in 2027. And with that, I would like to conclude our report and hand back to the operator to take your questions.

我們對包括志賀氏菌在內的未來管道項目的潛力感到非常興奮和興奮。而且，寨卡病毒和我們目前處於臨床前開發階段的專案預計將在 2027 年成功生產線執行和批准後進入臨床。至此，我想結束我們的報告並交回給接線員回答您的問題。

(Operator Instruction)

（操作員說明）

Maurice Raycroft. Jefferies.

莫里斯·雷克羅夫特。傑弗里斯.

Hi, good morning. Congrats on the progress and thanks for taking my questions. Maybe first one, I'll just start with IXIARO, you mentioned expectations for new orders in 2025. And you're seeing good uptake with DoD. Is there anything more you can say about that including where the orders could be coming from and what the amounts could look like for next year.

嗨，早安。恭喜您的進展，並感謝您提出我的問題。也許第一個，我將從 IXIARO 開始，您提到了對 2025 年新訂單的期望。您會看到國防部的良好採用。您還有什麼可以說的嗎，包括訂單可能來自哪裡以及明年的金額可能是多少。

So basically, on IXIARO Maurice, you know that when we exclude the one year where the military built additional stock, which was I think 2019, all the other years with the DoD has been pretty stable and when you calculate, in some years, we gave details of the military and other years, we did not. But you know that overall, there has that you can calculate the demand of it, give or take 200,000 doses. And then it depends a little bit on the supply demand pattern because sometimes they keep higher stocks and lower stocks.

所以基本上，在IXIARO Maurice 上，你知道，當我們排除軍方增加庫存的一年（我認為是2019 年）時，國防部的所有其他年份都相當穩定，當你計算時，在某些年份，我們提供了軍事和其他年份的詳細信息，我們沒有。但你知道，總體而言，你可以計算它的需求量，給予或服用200,000劑。然後，這在一定程度上取決於供需模式，因為有時他們會保持較高的庫存和較低的庫存。

And I think at this point in time, you know, noting, of course, that a new government may have different views in terms of you know, military personnel stationed in Southeast Asia. But at this point in time and given that it is a mandatory vaccine for those parts of the troupe, we expect this overall demand to be pretty stable at that level and we expect that the RFP that will be for the next kind of request will also point in this direction. So, that, that's our expectation right now on IXIARO and the DoD.

我認為在這個時候，你知道，當然，新政府可能對駐紮在東南亞的軍事人員有不同的看法。但目前，鑑於它是劇團這些部分的強制性疫苗，我們預計總體需求將在該水平上相當穩定，並且我們預計針對下一種請求的 RFP 也將在該水平上保持穩定。這就是我們現在對 IXIARO 和國防部的期望。

And of course, we are in very active dialogue with the DoD on Chikungunya as well. So, you've seen that they issued a preliminary recommendation for IXCHIQ. But we are not yet at the point where they have decided whom to vaccinate, when to vaccinate. And that's something that we certainly expect to come next year.

當然，我們也正在與國防部就基孔肯雅熱問題進行非常積極的對話。您已經看到他們發布了針對 IXCHIQ 的初步建議。但我們還沒有決定要為誰接種疫苗、何時接種疫苗。我們當然希望明年會出現這種情況。

Got it. That's helpful and maybe a question related to IXCHIQ, I'm just wondering if you have a better sense of when the MMWR publication update could occur and if you can remind how the publication will be leveraged with payers and stakeholders and how that could translate for the opportunity.

知道了。這很有幫助，也許是一個與IXCHIQ 相關的問題，我只是想知道您是否對MMWR 出版物更新何時會發生有更好的了解，以及您是否可以提醒如何利用該出版物與付款人和利益相關者以及如何將其轉化為機會。

Yeah, so we expect the MMWR release is something where I think timing wise, we don't feel comfortable making any promise we had hoped to see this already months ago. You know, there is when you look historically for other vaccines, how long it took, sometimes it was very fast, sometimes it took a long time.

是的，所以我們預計 MMWR 的發布是我認為時機明智的事情，我們不願意做出任何我們幾個月前希望看到的承諾。你知道，當你歷史上尋找其他疫苗時，需要多長時間，有時非常快，有時需要很長時間。

We certainly expect the MMWR released to be the major driver to allow us accessing the retail channel in the US. And we expect and this is one of the big learnings probably for us. We certainly see that retail becomes more and more important in the US. And, especially given the very high cost that, someone would need to pay in two other channels.

我們當然預計 MMWR 的發布將成為我們進入美國零售通路的主要推動力。我們期望這可能是我們最大的收穫之一。我們當然看到零售業在美國變得越來越重要。而且，特別是考慮到成本非常高，有人需要透過其他兩個管道支付。

And, therefore, you know, this is one of the identified key drivers amongst, of course, a few others, that we have identified more.

因此，您知道，這是我們已經確定的更多關鍵驅動因素之一。

Got it. And is that something you think could happen in 2025 the publication coming out?

知道了。您認為 2025 年該出版物出版時可能會發生這種情況嗎？

So, I think, I mean, we said earlier in one of the prior calls and I, and if I recall correctly, even in New York, we said that we expected by year end. But as I said, you know, it's a little bit out of our control. There is nothing we can do about it. And, but it's certainly one of the pieces. Let's say one of the missing pieces that we are still looking for.

所以，我想，我的意思是，我們在之前的一次電話會議中說過，如果我沒記錯的話，即使在紐約，我們也說過我們預計到年底。但正如我所說，你知道，這有點超出我們的控制範圍。我們對此無能為力。而且，但這肯定是其中之一。比方說我們仍在尋找的缺失部分之一。

Understood. Okay, thanks for taking my questions off back in the queue.

明白了。好的，感謝您將我的問題重新放到隊列中。

Suzanne van Voorthuizen, Van Lanschot Kempen.

蘇珊娜·範·沃爾特赫伊森，範·蘭肖特·肯彭。

Hello. This is [Chiara Montironi]. I'm on behalf of Susan. Thanks a lot for taking my question and congratulations for the update. I had one question on the IXCHIQ, I was wondering if you could give me a more color on why the sales have not grown in Q3 compared to Q2. And what will explain that after reporting positive trends on other commercial metrics?

你好。這是[基亞拉·蒙蒂羅尼]。我代表蘇珊。非常感謝您提出我的問題並祝賀我的更新。我有一個關於 IXCHIQ 的問題，我想知道您是否能為我提供更多信息，解釋為什麼第三季度的銷售額與第二季度相比沒有增長。在報告了其他商業指標的正面趨勢之後，該如何解釋這一點？

Yeah, it's a good question. So, basically, partially it has to do with what we have in the channel right now. And so, what is actually the product that we have really shipped and sold to distributors.

是的，這是一個好問題。所以，基本上，部分與我們目前頻道中的內容有關。那麼，我們真正運送並銷售給分銷商的產品到底是什麼？

And this one component to it, the second part is that we are really not seeing at this moment in time. Let's say the uptake that we, let's say we didn't see the uptake at the end of the third quarter. I think we are now at the end of November. The situation has certainly improved. And so, we are confident that we are now going into a better cross trajectory.

其中一個組成部分，第二部分是我們目前確實沒有看到。假設我們在第三季末沒有看到吸收率。我想我們現在已經是十一月底了。情況確實有所改善。因此，我們相信我們現在正在進入一個更好的交叉軌跡。

But there are many elements that we are need to monitor very, very carefully. And and it's, as I said, a couple of times, it's a bit too early at this point in time to really draw conclusions on all of that. So, we have given ourselves until the mid of the year in order to ensure that we get to the right level of understanding.

但有很多因素我們需要非常非常仔細地監控。正如我所說的，有好幾次，現在就對所有這些真正下結論還為時過早。因此，我們已經在今年年中之前完成了任務，以確保我們達到正確的理解水平。

Okay, thank you so much. So, basically, you will give guidance, let's say in six months or more because.

好的，非常感謝。所以，基本上，你會提供指導，比如說在六個月或更長時間內，因為。

I think, yeah, and so basically what I, what in other words, we have said, you know, we have given a mid-term outlook of anticipated 100 million product sale for IXCHIQ three years after launch. We have you know, the prelaunch period right now on the initial launch period ongoing in Canada, we expect to launch in France, and we have we will gain very good understanding about the LMIC demand in the first quarter of next year.

我想，是的，所以基本上我，換句話說，我們已經說過，我們已經給出了 IXCHIQ 推出三年後預期產品銷售量為 1 億份的中期展望。我們知道，目前在加拿大正在進行初始啟動階段的預啟動階段，我們預計將在法國啟動，我們將在明年第一季對中低收入國家的需求有充分的了解。

So, this will help us to better understand the, let's say the mid midterm prospect of this vaccine and whether our hypothesis on the S curve and you may recall that we discussed the S curve and that all travel vaccine sales uptakes in the history have followed a certain S curve. But we have of course, taken certain these assumptions on this escrow progression, whether they hold still true or whether we need to update our midterm guidance. At the same time, it is very clear that we continue to see the and to see no reason to update or change the long-term prospect of the product.

因此，這將幫助我們更好地了解這種疫苗的中期前景，以及我們對 S 曲線的假設是否正確，您可能還記得我們討論過 S 曲線以及歷史上所有旅行疫苗銷售情況都遵循的情況一定的S曲線。但我們當然對這一託管進程採取了某些假設，無論它們是否仍然正確，或者我們是否需要更新我們的中期指導。同時，很明顯，我們繼續認為沒有理由更新或改變產品的長期前景。

Okay. Got it. Thank you so much.

好的。知道了。太感謝了。

You're more than welcome.

非常歡迎您。

Ed White, H.C. Wainwright.

懷特，H.C.溫賴特。

Hi, thanks for taking my questions. I didn't hear any update on VLA 2112 for Epstein Barr virus. I was just wondering if you can give us an update of where you are in development there and your thoughts moving forward.

您好，感謝您回答我的問題。我沒有聽到有關 Epstein Barr 病毒的 VLA 2112 的任何更新。我只是想知道您是否可以向我們介紹您的最新發展以及您的未來想法。

Yeah, so good question. I mean, we provided an update on our EBB activities at the Investor Day in New York. It's our leading program in Preclinical today. We are currently evaluating in vivo in vitro different antigen compositions.

是的，很好的問題。我的意思是，我們在紐約投資者日提供了 EBB 活動的最新資訊。這是我們今天臨床前的領先項目。我們目前正在體內體外評估不同的抗原組合物。

And we are expecting to conclude on the, let's say the lead vaccine design next year based on all those experiments with the objective to really build what we call a differentiated EBB vaccine. We hope to learn also from others because there are a couple of data readouts expected from other companies working on EBB with either a more you know, traditional GP 350 approach but also an approach that includes another antigen.

我們預計明年將基於所有這些實驗得出主導疫苗設計，其目標是真正建立我們所謂的差異化 EBB 疫苗。我們也希望向其他人學習，因為預計其他從事 EBB 的公司會使用您更了解的傳統 GP 350 方法以及包含另一種抗原的方法來讀取一些數據。

And so, all of that is working according to plan and going according to plan with our expected clinical entry as we suggested or as we presented in 2027 of course, you know, there's always a point for us to accelerate clinical entry. So, we would like to be ready for clinical entry probably towards the latter part of 2026 mid to end 2026 and then decide, you know, subject to capital capacity at the time when actually to start the clinic entry.

因此，所有這一切都在按計劃進行，並按照我們建議的或我們在 2027 年提出的預期臨床進入計劃進行，當然，你知道，我們總是有一個加速臨床進入的點。因此，我們希望可能在 2026 年下半年到 2026 年底為臨床進入做好準備，然後根據實際開始臨床進入時的資本能力來決定。

Okay. Thank you. And, and perhaps a question for Peter, you had mentioned that R&D expenses were up due to the transfer cost to Scotland. I'm just wondering if, these transfer costs will continue into the fourth quarter and into 2025 or if they're behind us now.

好的。謝謝。而且，也許是彼得的一個問題，你提到研發費用因為轉移到蘇格蘭的成本而增加。我只是想知道這些轉移成本是否會持續到第四季和 2025 年，或者現在是否已經過去了。

Yeah, this will still continue into 2025 and then basically end early '26. So, we will first transfer the IXIARO over to Almeta and then followed by IXCHIQ.

是的，這仍將持續到 2025 年，然後基本上在 26 年初結束。因此，我們將首先將 IXIARO 轉移到 Almeta，然後再轉移 IXCHIQ。

Okay. Thanks for taking my questions.

好的。感謝您回答我的問題。

Rajan Sharma, Goldman Sachs.

拉詹·夏爾馬，高盛。

Hi, thanks for taking my question. I've got a couple of one on margins and one on IXCHIQ just on IXCHIQ I know you've kind of discussed it a little bit on the call, but could you just kind of help us understand what's changed from the Capital Markets Day in October when you sort of reiterated that midterm guidance? Has there anything kind of materially changed since then or is it just kind of your latest view on trends particularly in the US.

您好，感謝您提出我的問題。我有幾篇關於利潤率的文章，一篇關於IXCHIQ 的文章，就在IXCHIQ 上我知道您在電話會議上對此進行了一些討論，但是您能否幫助我們了解自2017 年資本市場日以來發生了什麼變化？從那時起有什麼實質的變化嗎？

And then maybe one for Peter on gross margins. Could you just discuss those idle costs that you highlighted and how that evolves through this year and into next year? And to what extent that kind of continues to be a factor on margins. And then you, I think you said around 59% gross margin on IXIARO. Do you think that remains stable from here? Thank you.

然後也許是彼得的毛利率問題。您能否討論一下您強調的那些閒置成本以及今年和明年的閒置成本如何演變？這種情況在多大程度上仍然是利潤率的因素。然後你，我想你說 IXIARO 的毛利率大約是 59%。您認為從這裡開始保持穩定嗎？謝謝。

So let me start with the first question on the IXCHIQ prospects. I would say at this point in time, we are, as I reported or as people are also presented at the investor day, we have, we are monitoring month to month. The certain performance indicators that could be predictive for uptake and this includes, you know, order, this includes reorder. But we were expecting, I would say a deeper you know, uptake towards the latter part of the year as compared to what we are seeing right now.

那麼，讓我從關於 IXCHIQ 前景的第一個問題開始。我想說，在這個時候，正如我所報導的那樣，或者人們也在投資者日上介紹的那樣，我們正在每月進行監控。某些績效指標可以預測採用率，這包括訂單，包括重新訂購。但我們預計，與我們現在所看到的相比，今年下半年的吸收率會更高。

And that's probably, and this is indicative, this is not definitive. And therefore, we have, you know, kind of said at this point in time, the uptake is slower than anticipated. And that's why we have to continue monitoring the situation throughout the first half of next year. And then only then we will have an informed basis and can take an informed decision as to whether our midterm expectation from this product is still right at about 100 million or not.

這很可能，而且這是指示性的，這不是決定性的。因此，我們現在可以說，吸收速度比預期慢。這就是為什麼我們必須在明年上半年繼續監測局勢。只有這樣，我們才會有一個知情的基礎，才能做出明智的決定，我們對該產品的中期預期是否仍然在 1 億左右。

And as I mentioned during the call earlier, we have, you know, the Canada launch that very recently started. We have Europe getting on stream with France as the identified and prioritized for the country. And and we should not underestimate the significant demand that we are expecting from LMIC countries for which we have at this point in time, some visibility but still a rather limited visibility. And all of that is expected to help us taking an informed decision on midterm guidance for the product around mid-next year.

正如我之前在電話中提到的，我們最近才剛開始在加拿大推出。我們讓歐洲與法國一起啟動，作為該國的確定和優先事項。我們不應該低估我們對中低收入國家的巨大需求，我們目前對這些國家有一定的了解，但仍然相當有限。所有這些預計將幫助我們在明年中期左右對該產品的中期指導做出明智的決定。

And so, to your question on gross margin, Rajan. So, first on the IXIARO gross margin. So, when you look at our half year results, and you look at our Q3 result. Now, our year over year, our full year gross margin for IXIARO improved by more than 1% points which shows you the direction this goes into.

那麼，對於你關於毛利率的問題，Rajan。首先是 IXIARO 的毛利率。因此，當您查看我們的半年業績時，您會看到我們第三季的業績。現在，與去年同期相比，IXIARO 的全年毛利率提高了 1% 以上，這向您展示了這一趨勢的發展方向。

So, we gradually improve the margin every quarter and we continue this trend to we expect this trend to continue. As you know we experienced some issues with in manufacturing and we lost a batch in Q1 but we will and so this is now behind us. And what we also see is actually yield is increasing compared to what we saw in prior years.

因此，我們每季都逐漸提高利潤率，我們將繼續這種趨勢，我們預計這種趨勢將持續下去。如你所知，我們在製造方面遇到了一些問題，我們在第一季損失了一批，但我們會的，所以現在這已經過去了。我們也看到，與前幾年相比，產量實際上正在增​​加。

When we go to idle cost, you know, we have our new beautiful manufacturing site in Scotland where, as we just said before, we're gradually transferring over now manufacturing first of IXIARO and then followed by IXCHIQ and so, we do see idle costs going down or down over the time. Of course, as we transfer over to the new site.

當我們談到閒置成本時，你知道，我們在蘇格蘭擁有美麗的新製造基地，正如我們之前所說，我們正在逐步轉移現在的製造，首先是IXIARO，然後是IXCHIQ，因此，我們確實看到閒置成本成本隨著時間的推移而下降或下降。當然，當我們轉移到新站點時。

Yeah, and it may be to add on and complement what Peter just said we are and this goes back to a question that raised earlier. So, we expect all those transfer activities and transition activities to continue well over the course of 2025. And then when we come into 2026, we will have a situation where everything will be in our brand-new large-scale manufacturing facility.

是的，這可能是對彼得剛才所說的我們的補充和補充，這又回到了先前提出的問題。因此，我們預計所有這些轉移活動和過渡活動將在 2025 年繼續下去。然後當我們進入 2026 年時，我們將看到一切都將在我們全新的大型製造工廠中。

And basically, the old facility will not be needed anymore at that point in time. And that's a unique opportunity for us because then we have, we are really set also from a manufacturing standpoint for the long-term future. And in a setting that allows even the cross margin to further improve.

基本上，到那時就不再需要舊設施了。這對我們來說是一個獨特的機會，因為那時我們也從製造的角度真正為長期的未來做好了準備。並且在允許全倉保證金進一步改善的環境中。

Okay. Thank you. And maybe Peter if I could just follow up on the on the one point on IXIARO, so it sounds like you expect kind of continued growth margin increase from here. Is that fair? And in that case, is it likely to be linear?

好的。謝謝。也許彼得，如果我可以跟進 IXIARO 的一個問題，所以聽起來您預計從這裡開始會持續的成長率成長。這樣公平嗎？在這種情況下，它可能是線性的嗎？

Well, you know, it will increase whether it be totally linear. I can't comment, of course, but like we said, in the past, we expect the IXIARO margin to continue to improve and over time to get back to where we were pre COVID.

嗯，你知道，無論是完全線性的，它都會增加。當然，我無法發表評論，但正如我們所說，過去我們預計 IXIARO 利潤率將繼續提高，並隨著時間的推移恢復到新冠疫情爆發前的水平。

All right, thank you very much.

好的，非常感謝。

Samir Devani, Rx security.

Samir Devani，Rx 安全。

Hi guys. Thanks for taking my questions. I think I just got a couple on the numbers. I think you mentioned that you're hoping that the commercial business will be cash generative next year and I guess I'm trying to understand how much of your G&A spend is attributable to the commercial business. So, maybe if you can give us a bit of color on that. And then the second question is just on, you've outlined the plan for the Shigella development and Phase 3 starting in 2027. I was just wondering if you could let us know how much is the cost of that Phase 3 development program? Thanks very much.

嗨，大家好。感謝您回答我的問題。我想我剛剛得到了一些數字。我想您提到您希望商業業務明年能夠產生現金，我想我正在嘗試了解您的一般管理支出有多少來自商業業務。所以，也許你能給我們一些關於這一點的資訊。接下來是第二個問題，您概述了從 2027 年開始的志賀氏菌開發和第三階段的計劃。我只是想知道您能否告訴我們第三階段開發計劃的成本是多少？非常感謝。

Yeah. So let me take the question on commercial business, cash on trip and then the G&A cost. So, you know, we try to keep it relatively simple. And the way we look at our G&A cost is we allocate about 40% onto to commercial. And that's how we determine the profitability there. And then second question to you.

是的。那麼讓我來回答關於商業業務、旅行現金以及一般行政費用的問題。所以，你知道，我們盡量保持相對簡單。我們看待 G&A 成本的方式是，我們將大約 40% 分配給商業成本。這就是我們確定獲利能力的方式。然後問你第二個問題。

You asked a question about if I understood you correctly, you are talking about the entire Phase 3 program for Shigella. Correct? So, both of all the three programs [address] together. Is this what you had in mind?

你問了一個問題，我是否理解正確，你正在談論志賀氏菌的整個第三階段計劃。正確的？因此，所有三個程式都[地址]在一起。這就是你的想法嗎？

That's right to, I guess I'm asking in the context of you've indicated sustainable profitability from 2027. So, in light of that, I guess.

我想我是在您表示從 2027 年開始實現可持續盈利的背景下問的，這是正確的。所以，鑑於此，我想。

Absolutely. So now if we look at the so what is our current working hypothesis? Our current working hypothesis is that we will have the two, Phase 3 or a phase 3 CHIM study, a Phase 3, immunogenicity and safety study. And we will have a Phase 3 feed defy study in infants.

絕對地。那麼現在如果我們看看我們目前的工作假設是什麼？我們目前的工作假設是，我們將進行兩項第 3 期或第 3 期 CHIM 研究，第 3 期免疫原性和安全性研究。我們將對嬰兒進行第三階段的飼料抗拒研究。

So, whether they will be initiated all three in parallel, whether there will be a sequence where they, whether there will be a staggered approach. It all will depend on the, I would say the situation coming out of the Phase 2 CHIM studies. The further assumption that we are currently taking is that the Phase 3 study in the field efficacy study in infants will be fully funded by a public institution.

因此，它們是否會並行啟動所有三個，是否會有一個順序，是否會有一個交錯的方法。我想說，這一切都取決於第二階段 CHIM 研究的情況。我們目前採取的進一步假設是，嬰兒現場療效研究的第三階段研究將由公共機構全額資助。

And so that we will as [Baliva] pay for the respective Phase 3 studies, we have at this point in time, a rough ballpark estimate. But since we have not agreed the detailed trial design with the authorities, I do not feel comfortable giving a number at this point in time. What I can assure you is we will manage and stagger all of those activities in a way that we are fully committing and and reconfirming that in the success case of life, this company will be sustainably profitable from 2027 onwards.

因此，我們將作為 [Baliva] 支付相應的第 3 階段研究費用，我們目前有一個粗略的估計。但由於我們尚未與當局就詳細的試驗設計達成一致，因此我不願意在此時給出一個數字。我可以向您保證的是，我們將以我們完全承諾的方式管理和錯開所有這些活動，並再次確認，在成功的案例中，該公司將從 2027 年起持續盈利。

Okay. That's great. Thanks very much.

好的。那太棒了。非常感謝。

There are no further questions. So, I'll hand back for closing remarks.

沒有其他問題了。那麼，我將作結束語。

Thank you so much for your great questions as usual. Thank you for your time. Thank you for following us and we wish you all a wonderful remainder of the day. Bye.

非常感謝您像往常一樣提出的好問題。感謝您抽出時間。感謝您關注我們，祝您有個愉快的一天。再見。