Valneva SE (VALN) 2024 Q2 法說會逐字稿

Hello and thank you for joining us to discuss Valneva's first half 2024 results and corporate update. It's my pleasure to welcome you today.

您好，感謝您加入我們討論 Valneva 2024 年上半年業績和公司動態。我很高興今天歡迎您。

In addition to our press release and analyst presentation, you can find our consolidated financial results for the six months ended June 30, 2024, which were published earlier today, available within the Financial Reports section on our Investor website.

除了我們的新聞稿和分析師簡報之外，您還可以在我們的投資者網站的財務報告部分找到今天早些時候發布的截至 2024 年 6 月 30 日的六個月的綜合財務業績。

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 key financial results for the first half. There will be an analyst Q&A session at the conclusion of the prepared remarks.

今天，Valneva 的執行長 Thomas Lingelbach 也加入了我的行列。我們的財務長彼得·布勒 (Peter Buhler) 將概述和更新我們的業務以及上半年的主要財務業績。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 will be making forward-looking statements which are subject to certain risks and uncertainties that could cause the actual results to differ materially from those expressed or implied by these forward-looking statements. You can find additional information about these risks and uncertainties in our periodic filings with the Securities and Exchange Commission and with the French market authority, which are listed on our company website. Please note that today's presentation includes information provided as of today, August 13, 2024, and Valneva undertakes no obligation to revise or update forward-looking statements except as required by applicable securities laws.

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。您可以在我們向美國證券交易委員會和法國市場管理局提交的定期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。請注意，今天的簡報包含截至今天（2024 年 8 月 13 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。

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

我很高興介紹托馬斯開始今天的演講。

Thank you, Josh. Good day, everyone. It's a pleasure to present to you, together with my colleagues, the great achievements that we have been able to deliver on in the first half this year, most notably in R&D and strategic development.

謝謝你，喬許。大家好。很高興與我的同事們一起向大家介紹我們今年上半年的巨大成就，尤其是在研發和策略發展方面。

Peter will develop the financials more in detail, but product sales of EUR68.3 million included first recognized sales for IXCHIQ and we're overall in line with our anticipated supply and sales phasing. And hence we have reiterated our set of full year financial guidances. The successful sale of our priority review voucher and the deferral of our loan reimbursement in the first quarter allowed us to maintain a solid cash position and now that we completed [some works] for the Lyme disease program, we anticipate a significantly lower cash burn towards the latter part of the year.

Peter 將更詳細地制定財務數據，但 6,830 萬歐元的產品銷售額包括 IXCHIQ 的首次確認銷售額，我們總體上符合我們預期的供應和銷售階段。因此，我們重申了我們的全年財務指引。我們的優先審查憑證的成功銷售以及第一季貸款償還的延遲使我們能夠保持穩固的現金狀況，現在我們完成了萊姆病計劃的[一些工作]，我們預計現金消耗將大大減少今年下半年。

We achieved major things in R&D, as I mentioned at the beginning and the first one, of course, the new Shigella vaccine. Most recently, we entered into a strategic partnership to accelerate the development of the world's most advanced tetravalent Shigella vaccine.

我們在研發方面取得了重大成就，正如我在開頭提到的，第一個當然是新的志賀氏菌疫苗。最近，我們建立了戰略合作夥伴關係，以加速世界上最先進的四價志賀氏菌疫苗的開發。

Additional IXCHIQ approvals in Canada and Europe were obtained even slightly ahead of them planning which allows us to launch in first markets in the last quarter of this year and we have pending approvals in the UK and Brazil. We are very grateful that we have been able to extend our partnership with CEPI, who awarded us a new more than EUR40 million grant to support product access, post-marketing and label extension trials for IXCHIQ.

在加拿大和歐洲獲得了額外的 IXCHIQ 批准，甚至比計劃提前了一點，這使我們能夠在今年最後一個季度在首批市場推出，並且我們在英國和巴西也有待批准。我們非常感謝能夠擴大與 CEPI 的合作關係，CEPI 授予我們超過 4000 萬歐元的新撥款，用於支持 IXCHIQ 的產品准入、上市後和標籤延伸試驗。

We reported positive Phase 3 IXCHIQ data in adolescents, which will all be used to support our label extension submissions in the second half of this year. We also published two-year antibody persistence data in Lancet, which are also expected to support further label extensions. And as you know, this study is going on for roughly five years.

我們報告了青少年中 IXCHIQ 3 期的積極數據，這些數據將全部用於支持我們在今年下半年提交的標籤擴展申請。我們也在《柳葉刀》上發表了兩年的抗體持久性數據，預計這些數據也將支持進一步的標籤擴展。如您所知，這項研究持續了大約五年。

We completed the enrollment in Phase 2 study of IXCHIQ in children 1 to 11 years of age. Completed the primary vaccination in our Phase 3 VALOR study for Lyme disease. And hence, we are fully on track for the first readout at the end of 2025. And as you know and as reported already at the last quarter, we initiated the Phase 1 for our second-generation Zika vaccine candidate with data expected in the first half of this year.

我們完成了 IXCHIQ 1 至 11 歲兒童 2 期研究的入組。完成了萊姆病 3 期 VALOR 研究的初次疫苗接種。因此，我們完全預計在 2025 年底首次公佈結果。如您所知，正如上個季度已經報導的那樣，我們啟動了第二代寨卡候選疫苗的第一階段，預計數據將在今年上半年公佈。

Let me draw your attention to page number 6 of the presentation, which is a recap of Valneva's strategy. You know that our aim is to become a globally recognized vaccine company, in line with our vision contributing to a world where no one dies or suffers from a vaccine-preventable disease. Our strategy is based on three pillars.

讓我提請您注意簡報的第 6 頁，該頁回顧了 Valneva 的策略。您知道，我們的目標是成為一家全球認可的疫苗公司，這符合我們的願景，為一個沒有人死亡或患有疫苗可預防疾病的世界做出貢獻。我們的策略基於三個支柱。

On the one hand side, Driving Commercial Growth. Here, we see clearly IXCHIQ and the possibility to unlock the IXCHIQ value by building awareness and market. Capitalizing on the bundling effect with existing travel pass business and expanding globally, reaching more LMIC territories via strategic partnerships. And this commercial business is expected to become cash flow positive from 2025 onwards.

一方面，推動商業成長。在這裡，我們清楚地看到了 IXCHIQ 以及透過建立知名度和市場來釋放 IXCHIQ 價值的可能性。利用與現有旅遊通行證業務的捆綁效應並在全球擴張，透過策略合作夥伴關係涵蓋更多中低收入國家地區。該商業業務預計從 2025 年起將實現正現金流。

The second pillar is our R&D. And here, we would really like to capture R&D upside and provide upside to our investors by leveraging our proven R&D engine and existing strategic partnerships. We continue to focus on vaccines that can make a difference, as you know, technology-agnostic, striving for first only of best-in-class solutions and execute efficiently to general meaningful clinical catalysts. The new example, Shigella is a vaccine where we expect Phase 3 to enter once Lyme hopefully will be successful.

第二個支柱是我們的研發。在這裡，我們非常希望利用我們經過驗證的研發引擎和現有的策略合作夥伴關係，抓住研發優勢，並為我們的投資者提供優勢。如您所知，我們繼續專注於能夠發揮作用的疫苗，與技術無關，力爭成為一流的解決方案中的第一個，並有效地執行以產生普遍有意義的臨床催化劑。新的例子是志賀氏菌疫苗，我們預期一旦萊姆病有望成功，疫苗將進入第三階段。

The third pillar is really the maximization of our integrated biotech model. You know we are one of the very few pure play vaccine companies that have a fully integrated model from research to sales and we build on continuing value from R&D and commercial execution. Of course, we support the timely Lyme approvals. And on the back of that, we may achieve sustained profitability with potential VLA15 commercial revenues from our partner, Pfizer.

第三個支柱其實是我們綜合生物技術模型的最大化。您知道，我們是極少數擁有從研究到銷售的完全整合模式的純疫苗公司之一，我們建立在研發和商業執行的持續價值之上。當然，我們支持及時批准萊姆病。在此基礎上，我們可能會透過來自合作夥伴輝瑞的潛在 VLA15 商業收入實現持續獲利。

When you look at our pipeline, you see that the introduction of the Shigella program through the strategic alliance with LimmaTech has helped us really to build a very coherent pipeline with strong and advanced clinical candidates. Of course, with Lyme as the number one in our pipeline and clearly the most attractive value player, then chikungunya with ongoing clinical activity, speed Phase 3, speed Phase 2 pediatric, speed Phase 3 adolescent and also Phase 1b with Shigella, which I'm going to develop more in detail, but with a first Phase 2 CHIM study, Controlled Human Infection Model, and pediatric studies to begin in the second half of this year. And then with Zika, which could be a very nice plug-and-play within our existing travel vaccine portfolio. And as reported in the past, our key focus areas in preclinical are circled around EBV and various enteric disease programs.

當您查看我們的管道時，您會發現透過與 LimmaTech 的策略聯盟引入志賀氏菌計畫確實幫助我們建立了一個具有強大且先進的臨床候選者的非常連貫的管道。當然，萊姆病是我們管道中的第一名，顯然是最具吸引力的價值參與者，然後基孔肯雅病正在進行臨床活動，速度第3階段，速度第2階段兒科，速度第3階段青少年以及志賀氏菌第1b階段，我'我將進行更詳細的研究，但第一個 2 期 CHIM 研究、受控人類感染模型和兒科研究將於今年下半年開始。然後是寨卡病毒，這可能是我們現有的旅遊疫苗產品組合中非常好的即插即用型疫苗。正如過去所報導的那樣，我們臨床前的重點關注領域圍繞著 EBV 和各種腸道疾病項目。

When we look at IXCHIQ, the world's first and only chikungunya vaccine licensed today, we have really a very unique product here. We expect to benefit by being first to market and we believe we have a differentiated and competitive product characterized by very strong and durable immunological response following a single injection. And very importantly, we have shown that there is no difference in immunogenicity between younger and older adults. The vaccine has been generally well tolerated amongst the more than 3,500 adults and more than 700 adolescents evaluated for safety thus far.

當我們看到今天獲得許可的世界上第一個也是唯一一個基孔肯雅疫苗 IXCHIQ 時，我們確實擁有一個非常獨特的產品。我們希望透過率先進入市場而受益，我們相信我們擁有差異化和有競爭力的產品，其特點是單次注射後非常強和持久的免疫反應。非常重要的是，我們已經證明年輕人和老年人之間的免疫原性沒有差異。迄今為止，已對 3,500 多名成年人和 700 多名青少年進行了安全性評估，該疫苗總體耐受性良好。

When we look at the US launch success and where we are right now, we made some recent achievements. We launched the unbranded traveler campaign to build consumer awareness, the DHA, IHD adopted the CDC recommendations and published the chikungunya virus and vaccine guidances, and we are continuously growing our customer base, distributors and customers reordering IXCHIQ already.

當我們審視美國的發射成功以及我們目前所處的位置時，我們最近取得了一些成就。我們發起了無品牌旅行者活動以提高消費者意識，DHA、IHD 採納了CDC 的建議並發布了基孔肯雅病毒和疫苗指南，我們正在不斷擴大我們的客戶群、分銷商和已經重新訂購IXCHIQ的客戶。

What's coming up? Of course, this is a quite challenging endeavor because we are talking about a brand-new disease, brand-new vaccine. So we are investing significantly in building awareness, building recommendations, building adoption. And as next steps, we see really the publication of this chikungunya vaccine recommendations in MMWR, which is still pending, continue working with CDC to raise awareness of global threats, including recent significant cases in Brazil and the ACIP is expected to discuss guidelines for endemic island regions, i.e., Puerto Rico and the review is planned for October this year with a vote in February 2025.

即將發生什麼事？當然，這是一項相當具有挑戰性的工作，因為我們談論的是一種全新的疾病、全新的疫苗。因此，我們在提高意識、建立建議和提高採用方面進行了大量投資。作為下一步，我們確實在MMWR 中看到了基孔肯雅疫苗建議的發布，該建議仍在等待中，繼續與CDC 合作，提高對全球威脅的認識，包括最近在巴西發生的重大病例，ACIP 預計將討論地方性流行病的指導方針波多黎各等島嶼地區計劃於今年 10 月進行審查，並於 2025 年 2 月進行投票。

And when we look at the territory expansion, you see already on slide 11 that we have many boxes ticked. US done, of course, label extension for adolescents, pediatric, but also antibody persistence is coming up. Canada, we got the approval. Also there, label extensions will follow.

當我們查看領土擴張時，您已經在幻燈片 11 中看到我們勾選了許多方塊。當然，美國已經完成了針對青少年、兒科的標籤擴展，而且抗體持久性也即將推出。加拿大，我們得到了批准。此外，標籤擴展也將隨之而來。

In Europe, everything so far achieved according to plan, slightly ahead of plan. As I said, MHRA approval still outstanding for the UK and then also here as next steps post licensure label extension submissions. We have the Brazilian licensure process ongoing, and we are targeting additional markets with established travelers' markets, but also additional LMIC territories, including on the basis of WHO prequalification.

在歐洲，到目前為止一切都按計劃實現，略高於計劃。正如我所說，英國 MHRA 的批准仍然懸而未決，這裡也是提交許可標籤延期後的下一步。我們正在進行巴西許可程序，我們的目標是其他市場，包括已建立的旅行者市場，以及其他中低收入國家地區，包括在世界衛生組織資格預審的基礎上。

When we look at the ongoing clinical activities, which, as I mentioned at the beginning are supported by the new more than $40 million CEPI grant, we have the post-marketing effectiveness study, Phase 1b, which are in reality two studies, one observational effectiveness study in participants greater than 12 years of age in Brazil and so-called pragmatic randomized controlled effectiveness and safety study in adults in an endemic country with roughly 20,000 people.

當我們審視正在進行的臨床活動時，正如我在一開始提到的，這些活動得到了超過4000 萬美元的CEPI 新撥款的支持，我們有上市後有效性研究，即1b 期，這實際上是兩項研究，一項是觀察性研究在巴西針對 12 歲以上參與者進行的有效性研究，以及在大約 20,000 人的流行國家針對成年人進行的所謂實用隨機對照有效性和安全性研究。

The label extensions I mentioned already, we completed the Phase 3 successfully for adolescents and the Phase 2 for children 1 to 11 years of age is already fully enrolled. The ongoing antibody persistence and long-term safety study in adults is a very important study because it will further substantiate our hypothesis that this vaccine after a single shot will protect at least for five years. And then we have another study that we have been working on in potentially immunocompromised adults.

我已經提到的標籤擴展，我們成功完成了針對青少年的第 3 階段，針對 1 至 11 歲兒童的第 2 階段已經完全註冊。正在進行的成人抗體持久性和長期安全性研究是一項非常重要的研究，因為它將進一步證實我們的假設，即這種疫苗在單次注射後可以保護至少五年。然後我們還有另一項研究，我們一直在針對可能免疫功能低下的成年人進行研究。

When we look at Lyme, as I said, we consider Lyme the single largest value driver in Valneva. It's the only Lyme disease program in advanced clinical development today. You have heard it many, many times, but it's a multivalent recombinant protein-based vaccine covering the six most prevalent serotypes of Lyme neuroborreliosis in the Northern Hemisphere. It's based on an established mode of action out to surface protein A and antibodies able to basically kill the spherocytes of the tick. And the single largest achievement in the first half of this year has been the completion of the primary vaccination enrollment, great achievement by the joint teams at Pfizer and Valneva.

正如我所說，當我們關注萊姆時，我們認為萊姆是瓦爾內瓦最大的單一價值驅動因素。這是當今唯一處於高級臨床開發階段的萊姆病計畫。您已經聽過很多次了，但它是一種基於多價重組蛋白的疫苗，涵蓋北半球萊姆神經疏螺旋體病六種最受歡迎的血清型。它基於表面蛋白 A 和抗體的既定作用模式，能夠基本上殺死蜱的球形紅血球。今年上半年最大的成就是完成了初級疫苗接種工作，這是輝瑞和 Valneva 聯合團隊的巨大成就。

You remember that we have estimated the market to be above EUR1 billion in sales. And as you also know, Valneva will be eligible for upfront and milestone payments up to more than $400 million, of which we received thus far $165 million. There is a tiered royalty model in place, subject to sales levels in between 14% and 22%.

您還記得我們估計市場銷售額將超過 10 億歐元。如您所知，Valneva 將有資格獲得高達 4 億多美元的預付款和里程碑付款，其中我們迄今為止已收到 1.65 億美元。有一個分層的特許權使用費模型，受 14% 至 22% 之間的銷售水準影響。

There are a couple of key important milestones coming up. We completed our cost contribution to the Lyme program in the first half of this year, as I mentioned during my introduction, and we expect the two-year antibody persistence and booster results in the third quarter this year. Just by way of reminder, this is immunogenicity data post-second booster, so it will give us an indication about the necessity for annual boostering. And of course, with all of that, we are on track for the Phase 3 readout at the end of 2025 with regulatory filings expected in 2026.

有幾個重要的里程碑即將到來。正如我在介紹中提到的，我們在今年上半年完成了對萊姆病計畫的成本貢獻，我們預計在今年第三季獲得兩年的抗體持久性和加強結果。提醒一下，這是第二次加強後的免疫原性數據，因此它將向我們表明每年加強的必要性。當然，儘管如此，我們仍有望在 2025 年底完成第 3 階段的發布，預計將於 2026 年提交監管文件。

Page number 15 shows again the overall -- the study design of the Phase 3 efficacy study, which is a placebo-controlled randomized study, 1:1 randomized against placebo, 2:1 North America versus the European side. And the primary endpoint is the rate of concerned Lyme disease cases after two consecutive tick seasons meaning primary immunization plus first booster with a secondary endpoint including the efficacy after the first Lyme season, meaning after the completion of the primary series. So overall, we are very excited about the progress around Lyme and we are very grateful to our partner, Pfizer, that we will be able to manage the study according to our guidance and plan.

第15頁再次顯示了總體情況－3期功效研究的研究設計，這是一項安慰劑對照隨機研究，1:1隨機對照安慰劑，2:1北美對照歐洲一側。主要終點是連續兩個蜱蟲季節後相關萊姆病病例的比率，即初次免疫加第一次加強免疫，次要終點包括第一個萊姆病季節後（即完成主要係列後）的療效。總的來說，我們對萊姆病的進展感到非常興奮，我們非常感謝我們的合作夥伴輝瑞，我們將能夠根據我們的指導和計劃來管理這項研究。

When we look at Shigella, as I mentioned during my introduction, it is a wonderful opportunity that we have generated here through the strategic partnership with LimmaTech. The product candidate is called S4V, and it is really a unique opportunity to develop a first-in-class vaccine for a life-threatening disease. It is the most advanced tetravalent Shigella program in the world. It's based on the so-called bioconjugation technology and has the potential to cover up to 85% of the Shigella infections.

當我們關注志賀氏菌時，正如我在介紹中提到的，這是我們透過與 LimmaTech 的策略合作夥伴關係創造的絕佳機會。該候選產品名為 S4V，這確實是開發針對危及生命的疾病的一流疫苗的獨特機會。這是世界上最先進的四價志賀氏菌計畫。它基於所謂的生物結合技術，有可能涵蓋高達 85% 的志賀氏菌感染。

The license that we have entered into as part of our strategic partnership with LimmaTech is a global one. And the vaccine candidate is, as I said, 4-valent covering the most pathogenic Shigella bacteria serotypes. LimmaTech already reported positive Phase 1/2 clinical data, including robust immunogenicity and favorable safety and tolerability data.

作為與 LimmaTech 策略合作夥伴關係的一部分，我們簽訂的許可是全球性的。正如我所說，候選疫苗是四價疫苗，涵蓋了最具致病性的志賀氏菌血清型。LimmaTech 已經報告了積極的 1/2 期臨床數據，包括強大的免疫原性以及良好的安全性和耐受性數據。

We estimate the market opportunity for Shigella vaccine to exceed $0.5 billion annually. And it's a wonderful plug-and-play because we are seeing here a very similar commercial footprint, namely travelers and military from high-income countries, but LMICs as well and here specifically children living in endemic countries. It is the second leading cause of fatal diarrheal disease, up to estimated more than 150 million cases and more than 600,000 deaths are attributed annually to Shigella. And therefore, it has been identified as a priority vaccine by WHO.

我們估計志賀氏菌疫苗的市場機會將每年超過 5 億美元。這是一個很棒的即插即用，因為我們在這裡看到了非常相似的商業足跡，即來自高收入國家的旅行者和軍隊，但也包括中低收入國家，特別是生活在流行國家的兒童。它是致命性腹瀉的第二大原因，估計每年有超過 1.5 億例和超過 60 萬人死亡是由志賀氏菌引起的。因此，它被世界衛生組織確定為優先疫苗。

In terms of upcoming milestones, I mentioned at the very beginning of this call, we will soon start the first Phase 2 CHIM study. CHIM means Controlled Human Infection Model, so it's a human challenge study in the US in adults and a Phase 2 pediatric study in LMIC. Both will be led and conducted by LimmaTech before then Valneva will take over further activities. We will start already working on a couple of things immediately, like CMC and regulatory activities. And of course, given the exclusive global license nature, we will be responsible for worldwide commercialization if approved.

就即將到來的里程碑而言，我在本次電話會議一開始就提到，我們很快就會開始第一個第二階段 CHIM 研究。CHIM 的意思是受控人類感染模型，因此它是在美國針對成人進行的人體挑戰研究，也是在中低收入國家進行的 2 期兒科研究。兩者都將由 LimmaTech 領導和實施，然後 Valneva 將接管進一步的活動。我們將立即開始處理一些事情，例如 CMC 和監管活動。當然，鑑於全球獨家許可性質，如果獲得批准，我們將負責全球商業化。

The page number 18 shows the overall key terms of the strategic partnership with LimmaTech. And here, you see basically how the partnership works. So LimmaTech receives an upfront payment, is eligible for future milestone and royalty payments. The upfront payment is EUR10 million. And all the further development, regulatory and sales-based milestones will go up to EUR40 million. There's a low-double-digit royalty on net sales in the travel segment and additional payments and single-digit royalties based on commercialization in LIMCs.

第 18 頁顯示了與 LimmaTech 策略合作夥伴關係的整體關鍵條款。在這裡，您基本上可以看到合作夥伴關係是如何運作的。因此 LimmaTech 收到預付款，有資格獲得未來的里程碑付款和特許權使用費。預付款為1000萬歐元。所有進一步的開發、監管和銷售里程碑將高達 4000 萬歐元。旅遊領域的淨銷售額有兩位數的低特許權使用費，以及基於低收入國家商業化的額外付款和個位數特許權使用費。

As I mentioned, it's a true partnership. So we collaborate through the Phase 2. LimmaTech conducts the first Phase 2 human challenge study, which is a challenge with sonnei, serotype and the pediatric immunogenicity study. Then Valneva will take the lead and initiate a second Phase 2 CHIM study against the second serotype, namely flexneri 2a.

正如我所提到的，這是一種真正的夥伴關係。所以我們在第二階段進行合作。LimmaTech 進行了第一個 2 期人類挑戰研究，這是一項針對 Sonnei、血清型和兒科免疫原性研究的挑戰。然後，Valneva 將主導針對第二种血清型（即福氏 2a）啟動第二個 2 期 CHIM 研究。

And of course, LimmaTech and Valneva have already started working on tech transfer and the IND will be transferred to Valneva once all Phase 2 studies are fully enrolled. And then Valneva will lead and manage all future development activities. So overall, we are really excited about this fantastic opportunity. You may recall that augmenting our R&D pipeline has always been one of our strategic objectives. And therefore, we are thrilled that we found an opportunity for a potential first-in-class vaccine for a life-threatening disease, so fully in line with our mission and vision.

當然，LimmaTech 和 Valneva 已經開始進行技術轉讓，一旦所有 2 期研究全部完成， IND 將轉移到 Valneva。然後 Valneva 將領導和管理所有未來的開發活動。總的來說，我們對這個絕佳的機會感到非常興奮。您可能還記得，擴大我們的研發管道一直是我們的策略目標之一。因此，我們很高興找到了一個機會，可以開發出一種針對危及生命的疾病的潛在一流疫苗，這完全符合我們的使命和願景。

So when we talk a little bit about Zika, you know that we started a Phase 1 study with our so-called optimized second-generation vaccine candidate, VLA1601. It should, in reality, call it VLA1601 2 because it's the second-generation adjuvanted inactivated whole-virus. We are leveraging here the platform that we originally developed for IXIARO, then further optimized for our COVID vaccine VLA2001 and upscale. So we use a like-for-like technological approach here.

因此，當我們談論寨卡病毒時，您知道我們已經開始使用所謂的最佳化第二代候選疫苗 VLA1601 進行第一階段研究。實際上，它應該稱為 VLA1601 2，因為它是第二代佐劑滅活全病毒。我們在這裡利用最初為 IXIARO 開發的平台，然後針對我們的新冠疫苗 VLA2001 和高端疫苗進一步優化。因此，我們在這裡使用類似的技術方法。

And as you know, the Zika virus is coming back. It's reemerging. And it's another mosquito-transmitted disease with devastating clinical effects. And there are no vaccines or specific treatments available. It's also worth noting that Zika is PRV-eligible. And many different organizations are currently discussing potential funding mechanisms around Zika. In terms of upcoming milestones, of course, we are currently executing the Phase 1 study and subject to data, we will then consider the future development strategy in the first half of next year.

如您所知，茲卡病毒正在捲土重來。它又重新出現了。這是另一種由蚊子傳播的疾病，具有毀滅性的臨床影響。並且沒有可用的疫苗或特定治療方法。還值得注意的是，寨卡病毒符合 PRV 資格。許多不同的組織目前正在討論圍繞寨卡病毒的潛在融資機制。當然，就即將到來的里程碑而言，我們目前正在進行第一階段研究，根據數據，我們將在明年上半年考慮未來的發展策略。

With this remarkable progress on our R&D and strategic development front, we come to the financials. And it's a pleasure to hand over to Peter.

隨著我們在研發和策略發展方面取得的顯著進展，我們開始關注財務狀況。很高興將工作交給彼得。

Thank you, Thomas, and good morning and good afternoon to all of you. Product sales for the first half year reached EUR68.3 million and on a comparable basis grew 7% over prior year. Including last year's sales of the COVID-19 vaccine, sales declined by minus 2%. The impact of currency fluctuations is neglectable.

謝謝你，托馬斯，祝大家早安，下午好。上半年產品銷售額達6,830萬歐元，較去年同期成長7%。包括去年的 COVID-19 疫苗銷售額在內，銷售額下降了-2%。貨幣波動的影響可忽略不計。

Total IXIARO sales reached EUR41.9 million and increased by 38% over the prior year. The strong year-over-year growth was primarily driven by sales to US military that were low in the first half of 2023. IXIARO sales into the travel market also delivered growth over the first half year despite supply constraints experienced during the first quarter. IXIARO supply constraints were fully resolved in the second quarter.

IXIARO 總銷售額達到 4,190 萬歐元，比上一年增長 38%。強勁的年成長主要是由於 2023 年上半年對美國軍方的銷售量較低。儘管第一季出現供應緊張，但 IXIARO 旅遊市場的銷售額在上半年也實現了成長。IXIARO 的供應限制在第二季得到了徹底解決。

DUKORAL sales declined year-over-year by minus 13% and reached EUR14.9 million in the first half of 2024. The decrease is mainly related to reduced marketing investments as our new manufacturing site in Sweden underwent regulatory evaluation and approval.

2024 年上半年，DUKORAL 銷售額年減 -13%，達 1,490 萬歐元。這項減少主要與我們在瑞典的新生產基地經過監管評估和批准而減少的行銷投資有關。

In terms of our ongoing launch of our new chikungunya vaccine IXCHIQ, report sales of EUR1 million by June 30 in the United States. As a reminder, the ACIP recommendation for IXCHIQ was adopted by the CDC in March of this year. In line with our expectations, third-party products declined by minus 37% year-over-year to reach EUR10.5 million as a result of supply constraints.

關於我們正在推出的新型基孔肯雅疫苗 IXCHIQ，報告稱截至 6 月 30 日在美國的銷售額將達到 100 萬歐元。提醒一下，ACIP 對 IXCHIQ 的建議已於今年 3 月被 CDC 採納。與我們的預期一致，由於供應限制，第三方產品年減-37%，達到 1,050 萬歐元。

Moving on to the income statement. Total revenues reached EUR70.8 million versus EUR73.7 million in the first half year of 2023. The decrease of 4% is driven by, as already mentioned, last year's revenue related to COVID-19 vaccine and lower revenues recognized from R&D collaborations as well as our prior year revenues related to the divestiture of our clinical trial material manufacturing site in Sweden.

繼續看損益表。總收入達 7,080 萬歐元，而 2023 年上半年為 7,370 萬歐元。如前所述，下降 4% 的原因是去年與 COVID-19 疫苗相關的收入、研發合作確認的收入下降以及我們上一年與剝離瑞典臨床試驗材料生產基地相關的收入。

Looking at expenses, we observed a significant decrease in cost of goods and services from EUR53.8 million in the first half of 2023 to EUR45.6 million in the current first half year. IXIARO gross margin reached 57.5% of IXIARO product sales compared to 40.2% in the first half of 2023. In the prior year, the IXIARO gross margin was adversely impacted by batch write-offs. DUKORAL generated a gross margin of 34.8%, while third-party products yielded a gross margin below 30%.

從支出來看，我們發現商品和服務成本大幅下降，從 2023 年上半年的 5,380 萬歐元降至目前上半年的 4,560 萬歐元。IXIARO 毛利率佔 IXIARO 產品銷售額的 57.5%，而 2023 年上半年為 40.2%。去年，IXIARO 毛利率受到批量沖銷的不利影響。DUKORAL 的毛利率為 34.8%，而第三方產品的毛利率則低於 30%。

The total gross margin, excluding IXCHIQ, grew to 47.7% from 40% in the first half year of 2023. However, the total gross margin is also adversely affected by IXCHIQ-related overhead costs as well as idle costs related to our new manufacturing sites. In the second half of the year, we expect further gross margin improvements as supply shortages have been resolved.

不包括 IXCHIQ 的總毛利率從 2023 年上半年的 40% 成長至 47.7%。然而，總毛利率也受到 IXCHIQ 相關間接費用以及與我們新生產基地相關的閒置成本的不利影響。下半年，隨著供應短缺問題得到解決，我們預計毛利率將進一步改善。

Research and development expenses increased from EUR26 million in the first half of 2023 to EUR29.7 million in the first half of fiscal year 2023. That increase mainly related to tech transfer costs for the transfer of our IXIARO and IXCHIQ manufacturing operations to our new Almeida site in Scotland, as well as higher R&D spend for IXCHIQ as we continue to execute ongoing studies.

研發費用從2023年上半年的2,600萬歐元增加到2023財年上半年的2,970萬歐元。這一成長主要與我們將 IXIARO 和 IXCHIQ 製造業務轉移到蘇格蘭阿爾梅達新工廠的技術轉移成本有關，以及隨著我們繼續進行正在進行的研究，IXCHIQ 的研發支出增加。

Marketing and distribution expense increased by approximately 15% to reach EUR23.2 million. The increase is related to increased launch costs related to our IXCHIQ vaccine that also include higher people costs as we expanded our commercial team. G&A expense were reported at EUR22.8 million and remained stable year-over-year.

行銷和分銷費用增加約 15%，達到 2,320 萬歐元。這一成長與我們的 IXCHIQ 疫苗相關的上市成本增加有關，其中還包括隨著我們擴大商業團隊而增加的人員成本。G&A 費用為 2,280 萬歐元，較去年同期保持穩定。

The sale of the PRV generated net other income of EUR90.8 million, which contributed to an operating profit of EUR46.7 million versus an operating loss of negative EUR35 million in the prior year. Adjusted EBITDA improved from minus EUR28 million to positive EBITDA of EUR56 million.

PRV 的出售產生了 9,080 萬歐元的其他淨收入，帶來了 4,670 萬歐元的營業利潤，而上一年的營業虧損為負 3,500 萬歐元。調整後 EBITDA 從負 2,800 萬歐元增至正 EBITDA 5,600 萬歐元。

Now moving to slide 25. As discussed during our full year 2023 earnings release, we expect revenues to double by the time Lyme is launched. The main driver of this anticipated sales growth is, of course, the addition of sales derived from our IXCHIQ vaccine, but also expected continuous growth of IXIARO.

現在轉到投影片 25。正如我們在 2023 年全年收益發布中所討論的，我們預計萊姆推出時收入將翻倍。當然，這項預期銷售成長的主要驅動力是來自我們的 IXCHIQ 疫苗的銷售增加，但也預期 IXIARO 的持續成長。

Next slide, please. We confirm our guidance for fiscal year 2024 with product sales of EUR160 million to EUR180 million, other income of EUR100 million to EUR110 million and R&D expense of EUR60 million to EUR75 million. It is to be noted that the addition of the Shigella program does not change our R&D expense guidance for the year. As we completed our contribution to the budgeted Lyme Phase 3 trial, we expect a significantly lower cash burn in the second part of the year. We also confirm our midterm guidance, including double-digit CAGR growth of IXIARO over the next three years and IXCHIQ sales exceeding EUR100 million in year three of launch.

請下一張投影片。我們確認 2024 財年的指導，產品銷售額為 1.6 億歐元至 1.8 億歐元，其他收入為 1 億歐元至 1.1 億歐元，研發費用為 6,000 萬歐元至 7,500 萬歐元。值得注意的是，志賀氏菌計畫的增加並不會改變我們今年的研發費用指引。隨著我們完成對萊姆病第三階段試驗的預算貢獻，我們預計今年下半年的現金消耗將顯著減少。我們也確認了我們的中期指導，包括 IXIARO 在未來三年內實現兩位數的複合年增長率，以及 IXCHIQ 在推出的第三年銷售額超過 1 億歐元。

With that, I hand the call back to Thomas.

說完，我把電話轉回給湯瑪斯。

Thank you so much, Peter. Yes, let me conclude our presentation with slide 28. I mentioned all the key news flow items during my update on the individual programs and activities, but this is the summary of what we have still to expect. On chik, the upcoming potential approvals in Brazil and the UK The submission for label extensions related to adolescents, antibody persistence data and the initiation of the Phase 1b clinical activities.

非常感謝你，彼得。是的，讓我用幻燈片 28 來結束我們的簡報。我在更新各個計劃和活動時提到了所有關鍵的新聞流項目，但這是我們仍然期望的摘要。同時，巴西和英國即將提交與青少年相關的標籤擴展、抗體持久性數據和 1b 期臨床活動的啟動。

Lyme, of course, a very important data set in the third quarter with the Phase 2 two-year antibody persistence and booster results. Then, of course, we hope that we will be on time to complete also all booster vaccinations ahead of the tick season 2025. And then the primary data readout at the end of 2025. It says here, study completion, it's not study completion because, of course, study continues for a longer time. But this is the primary endpoint readout and secondary endpoint read out.

當然，萊姆病第三季的一個非常重要的數據集是第二階段兩年抗體持久性和加強結果。當然，我們希望能夠在 2025 年蜱蟲季節之前按時完成所有加強疫苗接種。然後是 2025 年底的主要數據讀出。這裡說的是學習完成，這不是學習完成，因為當然，學習持續的時間更長。但這是主要終點讀數和次要終點讀數。

Then the additional news flow around the Department of Defense, we expect a new supply contract for IXIARO in the last quarter this year. And now with the newly augmented program, the initiation of the Phase 2 studies, both the first CHIM study as well as the pediatric immunogenicity study in LMIC. And then looking a little bit into the earlier part of next year, the Phase 1 data for our second-generation Zika vaccine.

然後，圍繞國防部的更多消息傳出，我們預計 IXIARO 將在今年最後一個季度簽訂新的供應合約。現在，隨著新增強的計劃的啟動，第 2 期研究，包括第一個 CHIM 研究以及中低收入國家 (LMIC) 的兒科免疫原性研究。然後來看看明年早些時候我們第二代寨卡疫苗的第一階段數據。

This concludes the presentation, and I would like to hand back to the operator to take your questions.

演講到此結束，我想將問題交還給接線員。

(Operator Instructions) Suzanne van Voorthuizen, Van Lanschot Kempen.

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

Maybe to start off on the IXCHIQ launch. Now with many approvals in the bucket in your first full quarter of sales in, can you walk us through which markets IXCHIQ is available today to the end customer? And can you expand on which territories you expect to be the most important contributors to sales in the future? And yes, providing the path to your guidance of over EUR100 million within three years. And then I have a follow-up.

或許可以從 IXCHIQ 的發布開始。現在，您在第一個完整季度的銷售中獲得了許多批准，您能否向我們介紹 IXCHIQ 今天向最終客戶提供哪些市場？您能否擴展您預計哪些領域將成為未來銷售最重要的貢獻者？是的，為您在三年內獲得超過 1 億歐元的指導提供了途徑。然後我有一個後續行動。

Good. Okay, Suzanne. Let me start off by the -- so basically, right now, the vaccine is only available in the United States. We got the approvals in Canada and Europe, as you know, slightly ahead of our own expectation. You may recall that we originally said we would launch ex-US at the very beginning of 2025. We hope that we are now in a position to launch in selected European countries and Canada already in the fourth quarter. So all the preparatory activities are ongoing.

好的。好的，蘇珊娜。首先，基本上，目前該疫苗僅在美國上市。如您所知，我們在加拿大和歐洲獲得了批准，略高於我們自己的預期。您可能還記得，我們​​最初表示將在 2025 年初在美國以外地區推出。我們希望我們現在能夠在第四季度在選定的歐洲國家和加拿大推出。因此，所有準備活動正在進行中。

You know that there's a lot to be done post-approval, country-specific, and this is currently in the make. So to manage expectations, we expect, of course, sales to be very moderate in the ex-US countries in the fourth quarter because it will be a launch in the fourth quarter. We have not yet finally decided where we are going to launch first in Europe. But this is currently under evaluation.

您知道，批准後還有很多工作要做，針對具體國家/地區，目前正在製定中。因此，為了管理預期，我們當然預計第四季度在美國以外國家的銷售將非常溫和，因為它將在第四季度推出。我們尚未最終決定在歐洲首先在哪裡推出。但這目前正在評估中。

And there are, of course, the typical key travel vaccination countries in Europe. And there are also countries in Europe which have a higher base awareness around chikungunya than others. All of that is currently under consideration. And hopefully, we will be able to communicate around that very soon.

當然，還有歐洲典型的主要旅行疫苗接種國家。歐洲也有一些國家對基孔肯雅熱的基礎認知度高於其他國家。所有這些目前都在考慮之中。希望我們能夠很快就這個問題進行溝通。

When we talk about the sales expectation, we are still very confident about the overall market size and the growth projection that we gave, the midterm growth projection that we gave for IXCHIQ. It is a bit too early to say how it's really going to play out.

當我們談論銷售預期時，我們對整體市場規模和我們給出的成長預測，即我們為 IXCHIQ 給出的中期成長預測仍然非常有信心。現在說它到底會如何發展還為時過早。

You may recall, we discussed in the past, all travel vaccines in the past have shown an S curve at the beginning. And so we have to see at which point we're really going to see the speed increase. As I mentioned during the presentation, we have still a couple of things outstanding in the United States, MMWR being one, for example, very critical in order to facilitate the IXCHIQ growth from a US perspective. And then, of course, all the respective recommendations for the ex-US countries and then the introduction in the LMS.

大家可能還記得，我們​​過去討論過，過去所有的旅行疫苗一開始都是呈現S曲線的。所以我們必須看看什麼時候我們才能真正看到速度的提高。正如我在演講中提到的，我們在美國仍有一些懸而未決的事情，例如，從美國的角度來看，為了促進 IXCHIQ 的成長，MMWR 是非常關鍵的。當然，還有針對美國以外國家/地區的所有相應建議，然後在 LMS 中介紹。

Got it. That's very helpful. And then my second question online. I wanted to follow up regarding the Phase 2 two-year antibody persistence data that is expected in the next quarter or in this quarter, actually. Can you clarify what data sets we're expecting here? This is a second booster compared to no second booster? Or yes, can you remind us what you expect basically?

知道了。這非常有幫助。然後是我在網路上的第二個問題。實際上，我想跟進預計在下個季度或本季的第二階段兩年抗體持久性數據。您能澄清一下我們在這裡期望什麼數據集嗎？與沒有第二個助推器相比，這是第二個助推器？或者是的，您能提醒我們您的基本期望是什麼嗎？

Basically, it's the same as we reported after the first booster. So basically you have the vaccination schedule 026. Then you have one year later, we measured the immunological response pre- and post-booster. And you may recall that after the first booster, we saw a very, very significant anamnestic response, so the immunological response post the first booster was by a substantial factor higher than the immunogenicity after priming.

基本上，這與我們在第一個助推器之後報告的情況相同。所以基本上你就有了疫苗接種計劃 026。一年後，我們測量了加強劑前後的免疫反應。您可能還記得，在第一次加強接種後，我們看到了非常非常顯著的記憶反應，因此第一次加強接種後的免疫反應比啟動後的免疫原性高出很多倍。

Now we're going to look at the same situation one year later, so which means month 30, which is the second booster, so the immunogenicity data pre-booster and then month 31, the immunogenicity data post the second booster. And here, we will see how the immunological responses look like. We haven't seen the data yet, so it's hard to tell. But as you know, our current working hypothesis is that the Lyme vaccine will require an annual booster shot. And of course, this immunogenicity data will give you a very good hint around this.

現在我們將在一年後查看相同的情況，這意味著第30 個月，即第二次加強劑，因此免疫原性數據是加強劑前的，然後是第31 個月，即第二次加強劑後的免疫原性數據。在這裡，我們將看到免疫反應是什麼樣的。我們還沒有看到數據，所以很難說。但如您所知，我們目前的工作假設是萊姆病疫苗需要每年加強注射。當然，這些免疫原性數據將為您提供很好的提示。

And then allow me to squeeze in one more online. Can you remind us on the Phase 2 data and the Phase 3 setup, how you expect the immunogenicity to translate into the primary endpoint of presenting cases? And appreciating efficacy rates vary across different types of diseases that are presented by vaccines, what efficacy percentage do you think is good for marketing of Lyme vaccine?

然後讓我在網路上再擠一張。您能否提醒我們有關 2 期數據和 3 期設置的信息，您預計免疫原性如何轉化為病例的主要終點？不同類型的疫苗所呈現的有效率也不同，您認為多少有效率百分比對萊姆病疫苗的營銷有利？

These are two very complex and very challenging questions. So let me start with the first one. I mean, unfortunately, there is nothing like an immunologic it correlates at this point in time. But as we reported in the past, we see the immunological results definitely in line with what prior vaccines have shown also there is no direct comparability possible because of different assays, different vaccine constructs, but we feel confident also based on all the published animal data that our immune responses are definitely in line with or even better than what has been shown in the past.

這是兩個非常複雜且非常具有挑戰性的問題。那麼讓我從第一個開始。我的意思是，不幸的是，目前還沒有什麼比免疫學更相關的東西。但正如我們過去所報導的那樣，我們看到的免疫學結果絕對與先前的疫苗所顯示的結果一致，而且由於不同的測定、不同的疫苗結構，也不存在直接可比性，但基於所有已發表的動物數據，我們也充滿信心我們的免疫反應肯定與過去所顯示的一致甚至更好。

I think the other part on the prevention of the disease, we have discussed this a couple of times. We are in the efficacy study. We are measuring Lyme disease cases. Hence, we are measuring against the clinical endpoint. So rates of confirmed Lyme cases in the vaccine group as compared to the placebo group. I mean, what is good, what is the bad efficacy result. I would say any result that would give a strong recommendation, I would consider a success. Don't push me for a percentage number. I'm not allowed to say so.

我認為關於預防疾病的另一部分，我們已經討論過幾次了。我們正在進行功效研究。我們正在測量萊姆病病例。因此，我們正在根據臨床終點進行衡量。因此，與安慰劑組相比，疫苗組中萊姆病確診病例的比率。我的意思是，什麼是好的功效，什麼是不好的功效結果。我想說，任何能給予強烈推薦的結果，我都會認為是成功的。別催我要百分比數字。我不被允許這樣說。

Evan Wang, Guggenheim Securities.

艾文王，古根漢證券。

Two from me. First on IXCHIQ. Could you provide an update on some of the launch metrics in the US? Just any additional commentary you can provide on the degree of how access and reimbursement progress is going, what we're seeing in terms of some of the initial restocking and active accounts you have?

我的兩個。首先是 IXCHIQ。您能否提供美國一些發布指標的最新資訊？您可以就訪問和報銷進展的程度提供任何額外的評論嗎？

And then on Shigella, appreciate -- or happy to see that licensure. Can you just talk about some of the upcoming trials you have planned? I know I guess, first, with the LimmaTech reported S4V results, when will we see that full data either in publication or in medical conference? And then with your planned Phase 2 immunogenesis study, can you remind us maybe how should we think about that trial design relative to the results that we saw from Kenya?

然後對於志賀氏菌，欣賞或高興地看到該許可。您能談談您計劃的一些即將進行的試驗嗎？我知道我猜，首先，根據 LimmaTech 報告的 S4V 結果，我們什麼時候才能在出版品或醫學會議上看到完整的數據？然後，根據您計劃的第二階段免疫發生研究，您能否提醒我們，相對於我們在肯亞看到的結果，我們應該如何考慮該試驗設計？

So many questions, hopefully, are able to capture these. So I think on IXCHIQ, we are really seeing, as you rightly pointed out that we are having customers reordering IXCHIQ, which is good because it means that slowly, slowly the vaccine is being taken up. I think we -- it's a bit too early to really talk about this in detail.

這麼多的問題，希望能夠抓住這些。因此，我認為在 IXCHIQ 上，我們確實看到了，正如您正確指出的那樣，我們正在讓客戶重新訂購 IXCHIQ，這很好，因為這意味著疫苗正在慢慢地被採用。我認為我們——現在真正詳細討論這個問題還為時過早。

I think we have continued to grow the awareness of chikungunya and IXCHIQ amongst HCPs, who also started to engage with customers. We have now sold dosage across each of our sales channels, including a growing number of reorders, as I mentioned earlier, is the number of customer accounts we are engaging with is growing as well.

我認為我們不斷提高 HCP 中對基孔肯雅熱和 IXCHIQ 的認識，他們也開始與客戶互動。我們現在已經在每個銷售管道銷售了劑量，包括越來越多的重新訂購，正如我之前提到的，我們與之合作的客戶帳戶數量也在增加。

Additionally, we continue to see travelers proactively asking about chik, which is a fantastic achievement already right now. And access and coverage of IXCHIQ continues to improve. We had approximately 25% coverage last quarter and now it's over 50%. And I think this is really an important step forward. And as I said, there are a couple of things still outstanding and there are some gating factors worth noting, including the fact that the ACIP recommendations for chikungunya has still not been published in the MMWR, which is important for driving further reimbursement and prescribing of the vaccine by HCPs. So that's a little bit where we are on the IXCHIQ front.

此外，我們繼續看到旅行者主動詢問 chik，這已經是一項了不起的成就。IXCHIQ 的存取和覆蓋範圍不斷改善。上個季度我們的覆蓋率約為 25%，現在已超過 50%。我認為這確實是向前邁出的重要一步。正如我所說，有一些事情仍然懸而未決，還有一些值得注意的限制因素，包括 ACIP 針對基孔肯雅熱的建議尚未在 MMWR 中發表，這對於推動進一步報銷和開具處方非常重要由HCP 接種疫苗。這就是我們在 IXCHIQ 方面的一些情況。

When it comes to Shigella, I mean, we are, at this point in time, so I'll start with the latter part of your question. I think the LimmaTech team is preparing for respective application of their data pre-deal, meaning the Phase 1/2 study. I don't have the details, but you can easily reach out and ask them directly.

說到志賀氏菌，我的意思是，我們現在是這樣，所以我將從你問題的後半部分開始。我認為 LimmaTech 團隊正在準備其資料預交易的各自應用，即 1/2 期研究。我不知道詳細信息，但您可以輕鬆地直接聯繫他們並詢問他們。

Then when it comes to the development plan going forward, at this point in time, we have clearly presented with the deal that we expect the two Phase 2 human challenge studies, so the CHIM studies against the two most relevant serotypes. The next steps in parallel to the immunogenicity study and safety study in peds in LMIC.

然後，談到未來的開發計劃，此時，我們已經明確提出了我們期望進行兩項 2 期人類挑戰研究的協議，因此 CHIM 針對兩種最相關的血清型進行研究。下一步將與中低收入國家兒童的免疫原性研究和安全性研究並行。

And then from there, we have, of course, the first development plan, but we would like to get further validation through the regulatory agencies and therefore, we hope that we will have a more precise potential development plan to licensure at our planned Investor Day in October this year and this is where we plan to present this development plan in detail.

然後，我們當然有了第一個開發計劃，但我們希望透過監管機構得到進一步的驗證，因此，我們希望我們能有一個更精確的潛在開發計劃，以便在計劃的投資者日獲得許可今年10月，我們計劃在這裡詳細介紹這個發展計劃。

Oscar Haffen Lamm, Bryan Garnier.

奧斯卡·哈芬·拉姆，布萊恩·卡尼爾。

So regarding IXCHIQ, I understand that the current focus and guidance is basically based on the travelers markets. And I was just wondering if we could also expect in the near future some major contracts kick in, similar to what happened to IXIARO years back?

所以關於IXCHIQ，我理解目前的重點和指導基本上是基於旅行者市場。我只是想知道我們是否也可以預期在不久的將來會簽訂一些主要合同，類似於幾年前 IXIARO 發生的情況？

Yes. So I think that's an excellent question. And quite frankly speaking, we are not yet entirely clear how the US Military process is going to work, but most likely not in the same way we used to have it with IXIARO because the military is not doing those kind of contracts anymore. But definitely, the military part and you saw that we had already a good achievement in that DHA department -- the Defense Health Agency adopted the CDC recommendations, which is already a great achievement. And therefore, we expect the US Military to become a major customer for IXCHIQ in the United States.

是的。所以我認為這是一個很好的問題。坦白說，我們還不完全清楚美國軍方的流程將如何運作，但很可能不會像我們過去與 IXIARO 的方式一樣，因為軍方不再簽訂此類合約。但毫無疑問，在軍事部分，你看到我們在 DHA 部門已經取得了很好的成就——國防衛生局採納了 CDC 的建議，這已經是一項偉大的成就。因此，我們預期美國軍方將成為 IXCHIQ 在美國的主要客戶。

Rajan Sharma, Goldman Sachs.

拉詹·夏爾馬，高盛。

So firstly, just on DUKORAL. I just wanted to clarify the regulatory approvals that you're waiting for. Are they now resolved, so we should expect kind of normal supply of DUKORAL and normal marketing in the second half of the year? And I guess just related to that, do you expect DUKORAL to grow in 2024, given I think sales are down 13% year-to-date? And then I just have a follow-up on IXCHIQ too.

首先，就 DUKORAL 而言。我只是想澄清一下您正在等待的監管批准。現在問題解決了嗎？我想與此相關的是，鑑於我認為今年迄今為止的銷售額下降了 13%，您預計 DUKORAL 會在 2024 年實現增長嗎？然後我也對 IXCHIQ 進行了跟進。

Yes. Maybe I'll take the first part, and then I hand over to Peter to talk a little bit more about DUKORAL performance. Just to avoid misunderstanding here. We had some phasing issues around DUKORAL sales because we were waiting for the approval of the new fill/finish site in Sweden. We built a new field finish site in Sweden as part of our COVID endeavor.

是的。也許我會先講第一部分，然後我會交給 Peter 來詳細討論一下 DUKORAL 的表現。這裡只是為了避免誤解。我們在 DUKORAL 銷售方面遇到了一些階段性問題，因為我們正在等待瑞典新填充/加工場地的批准。作為應對新冠肺炎疫情努力的一部分，我們在瑞典建立了一個新的現場完工場地。

And we replaced the old filling site with this brand-new filling site and this required certain regulatory approvals in all the markets where DUKORAL has been licensed. Therefore, we were also cautiously investing in marketing, sales, and everything around that and we had some phasing issues associated with the sales of DUKORAL. That's just what we are not expecting anything anymore. We got all approvals. Everything is clear. And this will lead us to the full year.

我們用這個全新的填充場地取代了舊的填充場地，這需要在 DUKORAL 已獲得許可的所有市場獲得一定的監管批准。因此，我們也在行銷、銷售以及與之相關的一切方面進行了謹慎的投資，並且我們遇到了一些與 DUKORAL 銷售相關的分階段問題。這正是我們不再期待的事。我們得到了所有批准。一切都清楚了。這將引領我們進入全年。

Peter, you want to say something about this?

彼得，你想對此說些什麼嗎？

So with pleasure, Thomas. So just to remind you, in Q1, DUKORAL did grow, right? And we did say in the past, we do expect DUKORAL to continue to grow year-over-year. We haven't provided a specific number, but this has not changed given the H1 results. So we do expect growth and to grow up.

很高興，湯瑪斯。所以提醒您，在第一季度，DUKORAL 確實有所成長，對嗎？我們過去確實說過，我們確實預期 DUKORAL 將繼續逐年成長。我們沒有提供具體數字，但考慮到上半年的結果，這個數字並沒有改變。所以我們確實期望成長和成長。

Okay. That's clear. And then just going back to IXCHIQ. Just wondering if you could provide a sense of how many doses have been administered to date or kind of how much of that revenue number that you've reported is stocking?

好的。很清楚。然後回到 IXCHIQ。只是想知道您是否可以提供迄今為止已經註射了多少劑量的信息，或者您報告的收入數字中有多少是庫存？

Peter, do we have the number on that? I don't think we can --

彼得，我們有電話號碼嗎？我認為我們不能--

So Rajan, so basically the way we account for IXCHIQ for now is we really account for on a sell-through basis. So we only account when sales are happened -- are made to the retailer or to the provider, which means there is little to no stock in the channel. So we do not book as we ship into distributors. We chose that just to avoid potential returns.

Rajan，基本上我們目前對 IXCHIQ 的核算方式是根據銷售量進行核算。因此，我們只在銷售發生時進行會計——銷售給零售商或供應商，這意味著通路中幾乎沒有庫存。因此，我們在向經銷商發貨時不會進行預訂。我們選擇這樣做只是為了避免潛在的回報。

(Operator Instructions) Maurice Raycroft, Jefferies.

（操作員說明）Maurice Raycroft，Jefferies。

Congrats on the progress. For IXCHIQ, I'm wondering if you can talk about any unique strategy for what you're doing during this time to gain advantage or insulate your launch ahead of potential competitor entry? And as a follow-up to an earlier question, do you have any insight into whether Department of Defense would want to contract for one or two chik vaccines? Or how will that work?

祝賀取得的進展。對於 IXCHIQ，我想知道您是否可以談談您在這段時間所做的任何獨特策略，以在潛在競爭對手進入之前獲得優勢或隔離您的發布？作為先前問題的後續問題，您是否了解國防部是否願意簽訂一種或兩種 Chik 疫苗的合約？或者說這將如何運作？

Yes. Well, I mean, that's a good one. I would say, first of all, when it comes to the military, I mean, you will appreciate that this is a different disease than Japanese encephalitis. So it's very difficult to draw a direct comparison. So our goal is to ensure that military has full access to the IXCHIQ vaccine and that they are stocking in preparation for outbreaks.

是的。嗯，我的意思是，這是一件好事。我想說，首先，當談到軍隊時，我的意思是，你會意識到這是一種與日本腦炎不同的疾病。所以很難進行直接比較。因此，我們的目標是確保軍隊能夠充分獲得 IXCHIQ 疫苗，並進行儲備以應對疫情爆發。

In addition, and as I reported earlier, they are evaluating the data and current outback to determine if it fits in their protocol, the way IXIARO does right now. And therefore, we believe that we could play a very important first-mover here, a first-mover advantage. So difficult to say at this point in time. But I would say there's a good chance that we could really play a first-mover game here with the US Military for sure.

此外，正如我之前報導的那樣，他們正在評估數據和當前內陸地區，以確定它是否符合他們的協議，就像 IXIARO 目前所做的那樣。因此，我們相信我們可以在這裡發揮非常重要的先發優勢，即先發優勢。目前很難說。但我想說，我們確實很有可能與美國軍方進行先發制人的遊戲。

Got it. Understood. And anything else you're doing commercially for IXCHIQ just to help insulate your launch ahead of competitor entry? And then I have one follow-up.

知道了。明白了。您還為 IXCHIQ 進行了哪些其他商業活動，以幫助您在競爭對手進入之前避免發布產品？然後我有一個後續行動。

Yes. I think nothing on top of what I reported earlier. I think for us, the most important thing is that we get the label extensions done so that we have a product that is licensed for everyone above 12 years of age. We want to make sure that we get the antibody persistence data into the label, that at least the ones that we have reported on thus far.

是的。我認為沒有什麼比我之前報道的更重要的了。我認為對我們來說，最重要的是完成標籤擴展，以便我們擁有適用於 12 歲以上所有人的產品。我們希望確保將抗體持久性數據寫入標籤，至少是我們迄今為止報告的數據。

These are all major potential competitive advantages. And that's what we are currently aiming for and this is what we are doing in addition to what I reported earlier on the commercial front and building awareness and getting it into the channel and working with HCPs and so on and forth.

這些都是主要的潛在競爭優勢。這就是我們目前的目標，除了我之前在商業方面報導的內容之外，這也是我們正在做的事情，建立意識並將其納入管道並與 HCP 合作等等。

Got it. Makes sense. And for the IXIARO Department of Defense contract in fourth quarter of this year, can you remind me if you're saying what the amount or range of that contract you're expecting?

知道了。有道理。對於今年第四季度的 IXIARO 國防部合同，如果您說的是您期望的合約金額或範圍，您能否提醒我？

Peter, I'm not sure what we reported in the past, well --

彼得，我不確定我們過去報道過什麼，好吧--

And it's ongoing discussion. So right now, Maurice, we don't know. I think generally speaking, what we saw last year is that the Department of Defense compared to what the contract in 2019, they're building less stock. So we would -- my best guess right now would be at a similar level than what we had last year. But again, it's early discussions.

並且它正在持續討論。所以現在，莫里斯，我們不知道。我認為總的來說，我們去年看到的是，與 2019 年的合約相比，國防部正在建造更少的庫存。因此，我現在最好的猜測是，我們的水平將與去年相似。但同樣，這只是早期討論。

Samir Devani, RX Securities.

Samir Devani，RX 證券。

It's just a quick follow-up on IXIARO. I was wondering if you could just give us a breakdown of what you're seeing from a travel sales perspective versus military sales perspective in terms of growth rates?

這只是 IXIARO 的快速跟進。我想知道您是否可以向我們詳細介紹一下您從旅行銷售角度與軍事銷售角度所看到的成長率？

Peter?

彼得？

Yes. Thanks, Samir. Well, we have not disclosed the details between military and travel. As we said, both segments are growing. Travel sales, we have a relatively small growth. So the majority of the year-over-year growth is really coming from US Military, where, as I said during the call last year in the first half year of 2023, we had very, very low sales. And this year, it was much more substantial, but we have not disclosed the exact data.

是的。謝謝，薩米爾。嗯，我們還沒有透露軍事和旅行之間的細節。正如我們所說，這兩個細分市場都在成長。旅遊銷售方面，我們有相對較小的成長。因此，大部分同比成長實際上來自美國軍方，正如我在去年 2023 年上半年的電話會議中所說，我們的銷售額非常非常低。而今年，這個數字要大得多，但我們還沒有透露確切的數據。

Thank you. As there are no further questions, I would like to hand back to Thomas Lingelbach for any closing remarks.

謝謝。由於沒有其他問題，我想請托馬斯·林格爾巴赫發表結束語。

Thanks a lot for your questions. As you have seen, the first half year, especially on the R&D and strategic development front has been quite remarkable and we see really great growth opportunities for Valneva, including that we have reiterated that we see a pathway to sustained profitability upon successful licensure and commercialization of the Lyme vaccine. And therefore, thanks to all of you. Thanks to all shareholders, employees, partners and I wish you a very good remainder of the day.

非常感謝您的提問。正如您所看到的，上半年，特別是在研發和策略發展方面，表現相當出色，我們看到了Valneva 的巨大增長機會，包括我們重申，我們看到了在成功獲得許可和商業化後實現持續盈利的途徑萊姆病疫苗。因此，感謝你們所有人。感謝所有股東、員工、夥伴，祝福你們今天過得愉快。

Thank you.

謝謝。

This concludes today's conference call. Thank you for participating. You may now disconnect. Speakers, please stand by.

今天的電話會議到此結束。感謝您的參與。您現在可以斷開連線。發言者請稍候。