Valneva SE (VALN) 2026 Q1 法說會逐字稿

Good day and thank you for standing by. Valneva presents its first quarter 2026 financial results. (Operator Instructions) Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Joshua Drumm, Vice President, Global Investor Relations. Please go ahead.

各位好，感謝您耐心等候。Valneva 將公布其 2026 年第一季財務結果。(接線員指示) 請注意，今天的電話會議將被錄音。現在我想把會議交給今天的講者：全球投資人關係副總裁 Joshua Drumm。請開始。

Hello, and thank you for joining us to discuss Valneva's financial results for the first quarter 2026 and corporate update. It's my pleasure to welcome you today. In addition to our press release and analyst presentation, you can find our consolidated financial results for the three months ended March 31, 2026, which were published earlier today available within the Financial Reports section on our Investor website. 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.

各位好，感謝您加入我們，一同討論 Valneva 2026 年第一季財務結果與公司最新進展。很高興今天歡迎各位。除新聞稿與分析師簡報外，您也可在我們投資人網站的「財務報告」專區，查閱今日稍早發布之截至 2026 年 3 月 31 日止三個月的合併財務結果。今天與我一同出席的有 Valneva 執行長 Thomas Lingelbach，以及財務長 Peter Buhler；他們將就我們的業務與財務結果提供概覽與最新說明。在預備發言結束後，將安排分析師問答環節。

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 actual results to differ materially from those expressed or implied by these forward-looking statements. You can find additional information about these risk 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, May 13, 2026, and Valneva undertakes no obligation to revise or update forward-looking statements, except as required by applicable securities laws.

在開始之前，我想提醒各位，本次簡報將包含前瞻性陳述；此類陳述受若干風險與不確定性影響，可能導致實際結果與這些前瞻性陳述所明示或暗示者存在重大差異。關於上述風險與不確定性的更多資訊，請參閱我們向美國證券交易委員會以及法國市場主管機關提交的定期申報文件；相關文件已列示於公司網站。另請注意，本次簡報所含資訊截至今日（2026 年 5 月 13 日）；除非適用證券法另有要求，Valneva 不承擔修訂或更新任何前瞻性陳述之義務。

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

接下來，我很高興介紹 Thomas 開始今天的簡報。

Thank you, Josh. Good day, everyone. Yes, our first quarter was certainly dominated by the Lyme Phase III readout. With the strong efficacy observed, the first prespecified statistical criteria not met, but the second one met, Pfizer is planning for submissions to regulatory authorities. On financials, we reported a top line of approximately EUR30 million.

謝謝你，Josh。各位好。是的，我們第一季的重點無疑是萊姆病第三期試驗的讀出結果。在觀察到強勁療效的情況下，第一項預先指定的統計標準未達成，但第二項達成；Pfizer 正規劃向監管機關提交申請。就財務而言，我們報告的營收約為 3,000 萬歐元。

A year-on-year, quarter-to-quarter comparison is, however, with regards to this first quarter, not really meaningful because of various factors, including a different business setup, supply phasings, one-off effects on the expense side, all of that will be elaborated by Peter during his respective financial report.

然而，就本第一季而言，以年對年、季對季來比較其實不太具意義，原因包括多項因素：例如不同的業務架構、供應時點的差異、費用端的一次性影響等；Peter 將在其財務報告中進一步說明。

Given the level of uncertainty around Lyme, our strong focus is on cash containment and management. We reported a strong cash position, which excludes the proceeds from the recent financing, more than EUR100 million total cash at the end of the first quarter and launched a comprehensive program to reduce our operating expenses, which also includes a reduction of global workforce by approximately 10% to 15% and aims to result in a significant 25% to 35% reduction in our operating expenses as compared to last year.

鑑於萊姆病項目仍存在不確定性，我們的重點放在現金控管與管理。我們報告了強勁的現金部位（不含近期融資所得款項）：第一季末總現金超過 1 億歐元；並啟動一項全面性計畫以降低營運費用，其中也包括全球人力約 10% 至 15% 的縮減，目標是使營運費用相較去年顯著降低 25% 至 35%。

With that, let me turn to our programs and to our key business activities. I reported already about the statistical miss and the fact that the second prespecified statistical criteria met the lower bound. Overall, the efficacy, as you can see on the slide, is above 70%, which is really strong. The vaccine was well tolerated. There were no safety concerns identified at the time of analysis. The reason for all of that is that we have observed fewer-than-anticipated Lyme disease cases that were accrued over the study period.

接下來我將談談我們的研發計畫與主要業務活動。我先前已提到統計未達標，以及第二項預先指定的統計標準達到其下限。整體而言，如投影片所示，療效超過 70%，表現非常強勁。疫苗耐受性良好。在分析時點未發現任何安全性疑慮。造成上述結果的原因在於：我們在研究期間累積到的萊姆病病例數低於原先預期。

Given, however, the clinically meaningful efficacy and the fact that the 95% confidence interval lower bound was above 20 in the second prespecified analysis, Pfizer is confident in the vaccine's potential and hence, as mentioned earlier, is planning submissions to regulatory authorities. Lyme represents a major medical need and hence market opportunity. There is no vaccine currently available to prevent Lyme disease in humans. And we see a continuous rise of the annual burden of disease. We have here in this slide, reported the numbers of people who live in high-risk areas of Lyme disease, almost 90 million in North America, more than 200 million in Europe and an annual disease burden of a reported 500,000 cases in the US, more than 100,000 in Europe.

然而，鑑於具臨床意義的療效，以及在第二項預先指定分析中 95% 信賴區間下限高於 20，Pfizer 對該疫苗的潛力具信心，因此如先前所述，正規劃向監管機關提交申請。萊姆病代表一項重大的醫療需求，因此也具市場機會。目前尚無可用於預防人類萊姆病的疫苗。我們也看到每年疾病負擔持續上升。在這張投影片中，我們列示居住於萊姆病高風險地區的人口：北美近 9,000 萬人、歐洲超過 2 億人；每年通報的疾病負擔為美國 50 萬例以上、歐洲超過 10 萬例。

Also, we all acknowledge that those reported numbers are probably heavily underreported. Clinically, Lyme comes with different clinical manifestations. 10% to 30% of the individuals develop either carditis, neuroporosis or arthritis. And some, namely 5% to 10% of the cases continue to have persistent symptoms even following treatment. As such, we see VLA15 or LB6V using the Pfizer terminology as a compelling opportunity in a highly underserved market. It is the only Lyme disease vaccine candidate in such a stage of development in nearly 30 years. It's highly differentiated.

此外，我們都認同這些通報數字很可能嚴重低估。在臨床上，萊姆病有不同的臨床表現：10% 至 30% 的患者會出現心肌炎、神經硼螺旋體病或關節炎。另有部分患者（約 5% 至 10%）即使接受治療後仍持續出現症狀。因此，我們認為 VLA15（或依 Pfizer 用語稱 LB6V）是在高度未被滿足的市場中一項極具吸引力的機會。這是近 30 年來唯一進入此一研發階段的萊姆病疫苗候選產品。其差異化程度很高。

We built on a proven mode of action, but with a broad coverage addressing all the prevalent serotypes prevalent on both sides of the Atlantic. It is a modern state-of-the-art recombinant protein-based subunit vaccine. We tested individuals in the study aged 5 years and above. And as I mentioned, we continue seeing a growing disease burden across high-risk areas, and some of you have recently seen, again, articles in this regards. There is, of course, a strong strategic fit with Pfizer's existing business and franchise.

我們建立在已被驗證的作用機制之上，同時提供廣泛涵蓋，可涵蓋大西洋兩岸所有主要流行的血清型。這是一款現代、最先進的重組蛋白次單元疫苗。我們在研究中測試了 5 歲及以上的受試者。如我所提，我們持續看到高風險地區的疾病負擔增加；各位近期也可能再次看到相關報導。當然，這也與 Pfizer 既有業務與產品線具有高度策略契合度。

And overall, we really see a prophylactic solution as the solution of choice for this disease. As such, we remain confident. We remain confident in the prospect of this vaccine to ultimately make its way to patients or to people who are in need of it.

整體而言，我們確實認為預防性解決方案是對抗此疾病的首選。因此，我們仍然有信心。我們仍對這款疫苗最終能提供給患者、或有需要的人群抱持信心。

Turning over to Chikungunya. Our IXCHIQ product is continuing its path through different R&D activities besides limited commercial sales in travel. The overall market evolution, market development and access in emerging markets and low medium-income countries is, however, quite remarkable and is progressing quite nicely. We have a very significant pilot vaccination campaign ongoing in Brazil. The vaccine is being given to adults 18 to 59 years of age. And the objective is to reach a 20% to 40% coverage within this target population across various municipalities in Brazil.

接著談屈公病。我們的 IXCHIQ 產品除在旅遊市場進行有限的商業銷售外，也持續推進不同的研發活動。然而，整體市場演變、市場開發，以及在新興市場與中低收入國家的可近性進展相當顯著，且推進得相當順利。我們在巴西正進行一項規模很大的試點接種活動。疫苗施打對象為 18 至 59 歲成人。目標是在巴西多個市鎮的此一目標族群中達到 20% 至 40% 的覆蓋率。

We have already vaccinated more than 30,000 people to date, and we are aiming for much more than 100,000 overall. There is also additional work ongoing to prepare for post-marketing effectiveness in Brazil and in other jurisdictions. Currently, we are focusing on creating a strong safety database with our study 406, which is well advanced and is nearing completion of the enrollment. We are working on ensuring greater access to this vaccine in endemic countries. We have a project ongoing to expand the network of manufacturing and distribution partners in those countries, and we are making good progress.

截至目前我們已為超過 30,000 人接種，並以總計超過 100,000 人為目標。此外，也正進行其他工作，以為巴西及其他司法管轄區的上市後有效性研究做準備。目前我們聚焦於透過第 406 號研究建立強健的安全性資料庫；該研究進展良好，且即將完成受試者收案。我們也致力於確保此疫苗在流行國家的更大可近性。我們正推動一項專案，以擴大這些國家的製造與配送合作夥伴網絡，並已取得良好進展。

We reported very recently through our different social media channels that the locally produced Chikungunya vaccine by Butantan called Butantan-chik achieved licensure in Brazil. This has been a major, major achievement in the endeavor that is supported by CEPI and for which we are grateful on advancing this vaccine and advancing access into countries and for countries who can really benefit from it.

我們近期透過不同的社群媒體管道報告：由 Butantan 在地生產、名為 Butantan-chik 的屈公病疫苗已在巴西取得上市許可。這是 CEPI 支持之努力中的一項重大、重大的里程碑；我們也對其在推進此疫苗、並提升各國（尤其是能真正受益的國家）可近性方面所做的貢獻深表感謝。

A few words on Shigella and our shigellosis program. It is certainly one of the most advanced, if not the most advanced tetravalent vaccine candidate against shigellosis. We are targeting the four most common pathogenic Shigella bacteria. And previously, our partner, LimmaTech reported positive initial Phase I/II data. We have currently two studies ongoing, one in children in Africa and the other one is an immunogenicity and pilot efficacy study, so-called controlled human infection model.

關於志賀氏菌（Shigella）以及我們的志賀氏菌病（shigellosis）計畫，簡要說幾點。這無疑是最先進的志賀氏菌病四價疫苗候選之一，甚至可能是最先進的。我們鎖定四種最常見的致病性志賀氏菌。先前，我們的合作夥伴 LimmaTech 已公布正向的第一期/第二期初步數據。目前我們有兩項研究正在進行中，一項是在非洲的兒童族群，另一項是免疫原性與初步療效研究，即所謂的受控人體感染模型。

For both, we are expecting the first readouts or the readouts over the summer. And then as we discussed and reported previously, we will decide on next development steps for this program and for this program addressing a global market that is expected north of 0.5 billion annually.

兩項研究我們都預期在夏季取得首次讀出或相關讀出結果。接著，如同我們先前討論並已報告的，我們將決定此計畫的下一步開發方向；而此計畫所面向的全球市場，預估每年規模可超過 5 億。

Given the severity of shigellosis, especially that it's the fact that it is the second leading cause of fatal diarrhea in children. And it, therefore, has been prioritized by WHO and other funding institutions. So overall, a lot going on, on our key R&D and business activities.

鑑於志賀氏菌病的嚴重性，尤其是它是兒童致命性腹瀉的第二大原因。因此，世界衛生組織（WHO）及其他資助機構已將其列為優先項目。總體而言，我們在關鍵研發與業務活動上都有許多進展。

And with that, I would like to hand over to Peter to provide us with the financial report.

接下來，我想把時間交給 Peter，請他為我們提供財務報告。

Thank you, Thomas. Yes. So looking at the financial report for the first quarter of fiscal year 2026. Product sales reached EUR30.5 million compared to EUR48.6 million one year ago. IXIARO sales were EUR20.2 million compared to EUR27.5 million in the first quarter of 2025.

謝謝你，Thomas。是的。那麼來看 2026 財政年度第一季的財務報告。產品銷售額達到 3,050 萬歐元，較一年前的 4,860 萬歐元下降。IXIARO 銷售額為 2,020 萬歐元，較 2025 年第一季的 2,750 萬歐元下降。

The year-over-year decline is primarily a result of a difference in the phasing of scheduled deliveries to the US Department of Defense. Deliveries in the first quarter of 2026 has continued under the current contract signed in January 2025.

年對年下滑主要是因為對美國國防部（US Department of Defense）排程交付的時點不同所致。2026 年第一季的交付仍依據 2025 年 1 月簽署的現行合約持續進行。

DUKORAL sales reached EUR8.6 million compared to EUR12.3 million in the first quarter of last year. The prior year included one-off sales related to the supply of doses to Mayotte following a local color outbreak. In addition, DUKORAL sales in the first quarter were adversely impacted by the change in our distribution partner for certain EU countries, mainly Germany, which represent a substantial travelers market. This change took effect from January 1 and included the transfer of residual inventories, which in the case of DUKORAL was sufficient to satisfy the demand for the current first quarter. We expect new product deliveries to resume in the second quarter of 2026.

DUKORAL 銷售額達到 860 萬歐元，較去年第一季的 1,230 萬歐元下降。前一年包含一次性銷售，係因應馬約特（Mayotte）當地霍亂疫情而供應劑量。此外，第一季 DUKORAL 銷售亦受到我們在部分歐盟國家（主要是德國）更換經銷夥伴的負面影響；德國代表相當可觀的旅遊者市場。此變更自 1 月 1 日起生效，並包含移轉剩餘庫存；就 DUKORAL 而言，該庫存足以滿足本季第一季的需求。我們預期新的產品交付將於 2026 年第二季恢復。

IXCHIQ sales reached EUR1.6 million compared to EUR3 million in the first quarter of 2025, which have benefited from first shipment of doses to French islander la Reynie in response to a major outbreak as well as from travel sales in the United States. Third-party products were reduced to EUR100,000 compared to EUR5.8 million in last year's first quarter, and this decline reflects the intentional wind down of third-party product distribution to increase the focus on our proprietary products.

IXCHIQ 銷售額達到 160 萬歐元，較 2025 年第一季的 300 萬歐元下降；2025 年第一季受惠於因應重大疫情而首次向法國島嶼拉雷尼（la Reynie）出貨劑量，以及美國的旅遊市場銷售。第三方產品降至 10 萬歐元，較去年第一季的 580 萬歐元大幅下降；此下滑反映我們有意逐步結束第三方產品經銷，以提高對自有產品的聚焦。

Now moving on to the income statement. We reported total revenues of EUR30.9 million versus EUR49.2 million in the first three months of 2025. Other revenues remained largely unchanged year-over-year. Cost of goods and services were EUR26.2 million versus EUR21.3 million in the prior year. The increased cost of goods despite lower sales were a result of several factors.

接著看損益表。我們報告總營收為 3,090 萬歐元，對比 2025 年前三個月的 4,920 萬歐元。其他收入年對年大致持平。銷貨及服務成本為 2,620 萬歐元，對比前一年的 2,130 萬歐元。儘管銷售較低，銷貨成本仍上升，原因有數項。

Idle costs increased compared to one year ago following the completion of the manufacturing transfer to the new Almeida facility. The costs related to failed batches and inventory provisions in addition to onerous contracts related to IXCHIQ significantly exceeded the cost observed in the first quarter of the prior year.

在完成製造移轉至新的 Almeida 廠後，相較一年前，閒置成本增加。與失敗批次與存貨提列相關的成本，以及與 IXCHIQ 相關的不利合約（onerous contracts）成本，均顯著高於前一年第一季所觀察到的水準。

Additionally, cost of goods in the first quarter of last year were particularly low due to positive impacts related to standard cost adjustments. In the first quarter of 2026, the gross margin on commercial product sales, excluding IXCHIQ, was 45.2% compared to 62.7% for the three months ended March 31, 2025, or approximately 50% for the full year of 2025. IXIARO's gross margin reached 50.8% compared to 72.6% in the first quarter of 2025, and the decline was driven by higher manufacturing costs following the transfer of production to the Almeida facility, increased batch write-offs and lower overhead absorption due to lower sales. In addition, as already mentioned, last year's first quarter had a significant positive impact related to standard cost revaluation.

此外，去年第一季的銷貨成本特別低，係因標準成本調整帶來的正面影響。在 2026 年第一季，商業產品銷售（不含 IXCHIQ）的毛利率為 45.2%，相較於截至 2025 年 3 月 31 日止三個月的 62.7%，或 2025 全年的約 50%。IXIARO 的毛利率為 50.8%，相較 2025 年第一季的 72.6%；下滑主要由於生產移轉至 Almeida 廠後製造成本較高、批次報廢增加，以及因銷售較低導致間接費用吸收不足。另外，如先前所提，去年第一季亦受惠於標準成本重估帶來的顯著正面影響。

For the full year of 2025, IXIARO gross margin reached 59.6%. The gross margin of IXCHIQ was negative, impacted by cancellation fees related to external manufacturing commitments following lower-than-anticipated sales. Additionally, cost of goods include idle capacity costs and costs not allocated to products of EUR5 million. We expect gross margin to normalize and improve following one-off effects in the first quarter of 2026.

2025 全年 IXIARO 毛利率為 59.6%。IXCHIQ 的毛利率為負，主要受外部製造承諾在銷售低於預期後所產生的取消費用影響。此外，銷貨成本亦包含 500 萬歐元的閒置產能成本及未分攤至產品的成本。我們預期在 2026 年第一季的一次性影響消退後，毛利率將回歸正常並改善。

Research and development expense for the first quarter remained stable year-over-year at EUR15.2 million, mainly representing investments into IXCHIQ and Shigella, as well as our preclinical EBV project. Marketing and distribution expenses in the first quarter reached EUR7 million compared to EUR10.4 million in the prior year. The decrease is mainly related to lower spend on IXCHIQ, in particularly in the United States. General and administrative costs decreased to EUR8.2 million compared to EUR9 million in the prior year. The decrease is related to lower people costs as well as savings in professional services.

第一季研發費用年對年維持穩定，為 1,520 萬歐元，主要為對 IXCHIQ 與志賀氏菌計畫的投資，以及我們的臨床前 EBV 專案。第一季行銷與通路費用為 700 萬歐元，較前一年的 1,040 萬歐元下降。下降主要與 IXCHIQ 支出降低有關，尤其是在美國。一般與行政費用降至 820 萬歐元，較前一年的 900 萬歐元下降。下降原因為人員成本降低以及專業服務費用節省。

The operating loss for the first quarter of 2026 is reported at minus EUR23.7 million, driven by lower sales and gross margin. Net finance and income tax expense is reported at EUR8.4 million compared to EUR3.3 million in the prior year. The increased expense is driven by a foreign exchange loss of EUR3 million compared to foreign exchange gain of EUR3.7 million in the prior year. With this, the loss of the first quarter of fiscal year 2026 reached EUR32.1 million compared to EUR9.2 million in the prior year.

2026 年第一季營業損失為負 2,370 萬歐元，主要由較低的銷售與毛利率所致。淨財務費用與所得稅費用為 840 萬歐元，較前一年的 330 萬歐元增加。費用增加主要由於匯兌損失 300 萬歐元，而前一年為匯兌收益 370 萬歐元。因此，2026 財政年度第一季虧損達 3,210 萬歐元，較前一年的 920 萬歐元擴大。

A word on cash. As mentioned at the beginning of this presentation, total cash and cash equivalents at the end of March were EUR105 million compared to EUR110 million at the end of the prior year fiscal year. In the first quarter of 2025, we continued to reduce the cash used in operations compared to the prior year. Cash at the end of March does not yet include initial proceeds from our successful reserved offering completed in April 2026.

再談一下現金。如本簡報一開始所提，3 月底的現金及約當現金總額為 1.05 億歐元，較上一財政年度年底的 1.10 億歐元下降。在 2025 年第一季，我們持續降低營運所使用的現金，相較前一年有所改善。3 月底的現金尚未包含我們於 2026 年 4 月成功完成的保留發行（reserved offering）之初始募集款項。

Now moving to the next slide to review our guidance for the fiscal year. In light of emerging adverse trends in travel vaccine uptakes across our key markets, driven by geopolitical factors, we adjust our product sales guidance to EUR135 million to EUR150 million for the fiscal year 2026 and total revenues to EUR145 million to EUR160 million. In April 2026, we initiated a restructuring plan to streamline our business operations and focus our resources on key projects. As a result, we plan a global workforce reduction between 10% and 15% and expect an overall reduction in our operating expense of about 25% to 35% compared to the level of 2025. This concludes the finance section of this call, and I would like to hand back to Thomas.

接著看下一張投影片，回顧我們對本財政年度的指引。鑑於在我們主要市場中，旅遊疫苗接種量出現由地緣政治因素驅動的新興不利趨勢，我們將 2026 財政年度產品銷售指引調整為 1.35 億至 1.50 億歐元，總營收調整為 1.45 億至 1.60 億歐元。2026 年 4 月，我們啟動重整計畫，以精簡營運並將資源聚焦於關鍵專案。因此，我們規劃全球人力縮減 10% 至 15%，並預期相較 2025 年水準，整體營運費用將降低約 25% 至 35%。以上為本次電話會議的財務部分，接下來我想把時間交還給 Thomas。

Thank you so much, Peter. We have to conclude our presentation, talking a little bit about the future. Of course, and as I mentioned during the introduction, and Peter reiterated this during the financial report, while we are living through the period of uncertainty regarding the Lyme vaccine candidate, we will, of course, do everything to focus on our base business to make sure that we advance the key strategic project and activities and that we contain cash to the maximum level possible.

非常感謝你，Peter。我們必須結束今天的簡報，並稍微談談未來。當然，正如我在開場時提到、Peter 也在財務報告中再次強調的，在我們正處於萊姆病疫苗候選案不確定性的期間，我們當然會盡一切努力聚焦於我們的核心業務，以確保推進關鍵策略專案與各項活動，並在最大可能的程度上控管現金支出。

However, we plan for Lyme success. And we plan for a successful outcome of the Lyme process that will be run by Pfizer with the respective regulatory authorities. And if successful, it would offer for Valneva very significant strategic growth opportunities.

然而，我們仍以萊姆病的成功為規劃前提。我們也規劃萊姆病專案在 Pfizer 與相關監管機關推進下能取得成功結果。若成功，將為 Valneva 帶來非常重大的策略性成長機會。

In such a case, we want to leverage our core strength in vaccine development because this is where we believe we will be able to deliver greater long-term value. Our focus will be to build scale in the R&D pipeline post VLA15 and post successful approval and commercialization. We'll do this by a combination of organic and inorganic, meaning strategic growth in the pipeline. We clearly would like to expand and extend beyond our initial investment thesis when we created the company, namely vector-borne diseases. And you have seen that some of our preclinical activities, especially EBV and also the enteric disease focus point already in this direction.

在這種情況下，我們希望運用我們在疫苗開發上的核心優勢，因為我們相信這將使我們能夠創造更大的長期價值。我們的重點將是在 VLA15 之後、以及在成功獲准與商業化之後，擴大研發（R&D）產品線的規模。我們將透過有機與無機的方式來達成，也就是在產品線上進行策略性成長。我們顯然希望擴展並超越公司成立時的初始投資論點，也就是媒介傳播疾病。你們也看到我們的一些臨床前活動，特別是 EBV，以及腸道疾病的聚焦方向，已經朝這個方向前進。

And of course, we will continue, as we have done last year, and we will do so this year again to optimize our business operations, be it on the commercial, but also be it on the manufacturing and supply side, all to generate as much cash with the commercial business as possible. With this, I would like to conclude our update and give back to the operator to take your questions.

當然，我們將持續如同去年所做的、並且今年也會再次這麼做，去優化我們的營運，不論是在商業端，或是在製造與供應端，目的都是要讓商業業務盡可能產生最多現金。在此，我想結束我們的最新進度，並把時間交還給主持人來進行提問。

Maury Raycroft, Jefferies.

Maury Raycroft，Jefferies。

I'll ask a couple on the Lyme program. I know there's a degree of uncertainty there. But wondering if there's any perspective you can provide on the status of Pfizer's pre-BLA meeting request with FDA and whether a meeting date has been scheduled and potentially what timing for that meeting to look like?

我想就萊姆病專案問幾個問題。我知道這裡存在一定程度的不確定性。但想請問你們是否能就 Pfizer 向 FDA 提出 pre-BLA 會議申請的狀態提供一些觀點，以及是否已排定會議日期，並可能就該會議的時間點提供一些指引？

Hi, Maury, thank you for the question. Pfizer are preparing for respective meetings. More we cannot state and say at this point in time, unfortunately.

嗨，Maury，謝謝你的問題。Pfizer 正在準備相關會議。很遺憾，目前我們無法再多做說明。

Okay. Understood. And wondering if you can help us understand how Pfizer plans to present the totality of clinical evidence to FDA, including cases that were adjudicated out and whether there's been any discussion around reevaluating outcomes under less restrictive clinical criteria. We've discussed how you guys have used a stringent definition. And so, wondering if there's any perspective on that.

好的。了解。另外想請你們協助我們理解，Pfizer 計畫如何向 FDA 呈現臨床證據的整體性，包括那些被裁定排除的病例，以及是否曾討論在較不嚴格的臨床標準下重新評估結果。我們討論過你們採用了相當嚴格的定義。因此想請問是否能分享一些看法。

Maury, unfortunately, I can't comment to that.

Maury，很抱歉，這部分我無法評論。

Understood. Okay. And maybe one other quick clarification question. Once Pfizer has the BLA meeting scheduled, they have the BLA meeting. Do you know if there will be a disclosure around the BLA acceptance or how logistics could work going forward?

了解。好的。再一個很快的釐清問題。一旦 Pfizer 排定 BLA 會議並完成該會議後，你們是否知道未來是否會揭露 BLA 受理（acceptance）的資訊，或後續流程在作業上會如何進行？

Our current hypothesis is that file acceptance will be disclosed.

我們目前的假設是，送件受理將會對外揭露。

Suzanne van, Kempen.

Suzanne van，Kempen。

This is Romy on for Suzanne. The first is on IXIARO growth dynamics. So I was wondering if the decline we saw for Q1 of this year was solely driven by phasing with the US DoD? Or was there also contributions from the private travel markets? And then a follow-up there. For the full year '26 guidance adjustment, is this primarily based on your thinking of the general travel dynamics expected this year?

我是代替 Suzanne 的 Romy。第一個問題是關於 IXIARO 的成長動能。我想請問，今年第一季我們看到的下滑是否完全是由於與美國國防部（US DoD）的出貨時點（phasing）所致？還是私人旅遊市場也有影響？接著一個追問。針對 2026 全年指引下修，主要是基於你們對今年整體旅遊動態的預期嗎？

So let me take the question first and then possibly Peter can complement. So I think as we said during our report, there is a -- it's a combination of various factors. And certainly, the major contributing factor, as reported by Peter, has to do with phasing of supplies to the DoD, our single largest customer for IXIARO. The supply schedule and the phasing is different year-over-year, and it's very hard to predict the exact supply schedule. And that makes always this quarter-to-quarter comparisons really difficult.

我先回答這個問題，之後 Peter 也許可以補充。我想如同我們在報告中所說，這是——多項因素的組合。而且，正如 Peter 所報告的，主要的影響因素與對 DoD 的供貨時點安排有關；DoD 是 IXIARO 的單一最大客戶。供貨排程與出貨時點每年都不同，而且很難精準預測實際供貨排程。這也使得季度對季度的比較一直都非常困難。

There is, however, also a contributing point around reduced travel. And Peter presented very clearly that this is the root cause for -- and the major cause for why we have been taking a prudent stand and revised the guidance down by EUR10 million.

不過，也有一個因素是旅遊減少所帶來的影響。而 Peter 也非常清楚地說明，這是——也是我們採取審慎立場並將指引下修 1,000 萬歐元的根本原因與主要原因。

It is not that we see already a huge impact in quarter one. But what we are observing is really a reduced level of travel into the geographies which are very important for our travel vaccines. And this is also supported by airline data, and we see this trend emerging. So the -- and that's, I think, all we can say with regards to the dynamic of IXIARO and Peter, please jump in if you want to add anything.

並不是說我們在第一季就已經看到很大的影響。但我們觀察到的是，前往對我們旅遊疫苗非常重要的地區之旅遊量確實下降。航空公司數據也支持這點，我們看到這個趨勢正在浮現。所以——我想，關於 IXIARO 的動態，我們能說的大概就這些；Peter，如果你想補充請加入。

Yes. I think the only other thing to add is to a lesser extent than these shipments to US military, there is this impact on the indirect markets with the shifting of distributor, where we see a slight impact, not as much as on DUKORAL, but we see a little impact also on IXIARO, but this is more just technically in the switchover from -- to a new partner, right?

是的。我想另外可以補充的是，除了對美軍的出貨之外，還有一個較小程度的影響來自間接市場的經銷商更換；我們看到些微影響，雖然不像 DUKORAL 那麼明顯，但在 IXIARO 上也有一點影響。不過這更多只是技術性因素，因為從——轉換到新的合作夥伴的過渡期，對吧？

Vamil Divan, Guggenheim Partners.

Vamil Divan，Guggenheim Partners。

So maybe a couple more on the Lyme front, and I appreciate you may not be able to answer all these fully right now. But one, I'm curious when we would actually -- when you think the full data would be released for us to review it in totality. Second, I'm wondering, are there other examples you can point us to with vaccines where there's been the situation where the prespecified or first primary endpoint of the trial was not met in terms of the confidence interval and the vaccine is still approved? Or are there any sort of comps that you can point us to, to give confidence on this still getting through? And then just on the event rate, I'm curious if you can comment on the event rate being lower than what you saw or what you expected?

我想再就萊姆病多問幾個問題，也理解你們現在可能無法完整回答。第一，我想知道我們實際上何時能——你們認為完整數據何時會公布，讓我們能全面檢視。第二，我想請問是否有其他疫苗案例可供參考：在試驗的預先指定或第一主要終點（primary endpoint）在信賴區間上未達標，但疫苗仍獲核准？或是否有任何可比案例（comps）能提供一些信心，讓我們相信仍可能通過？另外關於事件率（event rate），我想請問你們是否能評論事件率低於你們看到的或預期的情況？

And does that in any way sort of impact what you think in terms of the commercial opportunity for this vaccines or the interest in the amount of events that are happening in the community? Is there any change to your views based on what you saw in terms of how many people acquiring the disease during the trial?

這是否會在任何程度上影響你們對該疫苗商業機會的看法，或對社區中事件發生數量的關注？基於你們在試驗期間看到的感染人數，你們對於社區中有多少人罹病的看法是否有所改變？

Yes. So let me start from the back to the front here a little bit. So yes, I mean, as we reported in the press release, the total end, meaning the total number of reported and adjudicated cases was certainly lower than anticipated, which resulted in this wide spread confidence interval lower and upper. We don't necessarily see this with regards to what is happening in the high-risk areas of Lyme. And this is certainly something that we will need to look into and Pfizer are certainly doing that as we speak.

是的。我先從後往前回答一下。是的，正如我們在新聞稿中所報告的，總體而言，也就是通報並完成裁定（adjudicated）的病例總數，確實低於預期，這也導致信賴區間上下限的跨度很大。就萊姆病高風險地區的實際情況而言，我們不一定認為這反映了那裡正在發生的狀況。這當然是我們需要進一步研究的事項，而 Pfizer 目前也正在進行相關分析。

With regards to other vaccines, there are a few reports and publications that were made in two different channels, including social media, analyst reports where people focus on situations that may have been not similar, but probably comparable. I mean there were reports around a flu vaccine called Fluad. There were reports around one of the RSV vaccines.

關於其他疫苗，確實有一些報告與出版物透過兩個不同管道發布，包括社群媒體、分析師報告；其中人們聚焦的情況可能不完全相同，但大概具有可比性。我的意思是，曾有一些報告提到一款名為 Fluad 的流感疫苗。也有一些報告提到其中一款 RSV 疫苗。

There were also references made to the immunobridging in the pneumo development areas. We don't think that -- I mean, all of that is certainly probably indicative. But by the end of the day, I don't think that there is something that one can really compare like-for-like.

另外也有人提到在肺炎球菌（pneumo）開發領域的免疫橋接（immunobridging）。我們不認為——我的意思是，這些當然可能具有一定指標性。但歸根結底，我不認為真的存在可以完全一對一類比的對照。

In the world of vaccine development, you need to really review whether the results are clinically meaningful, and this is certainly the case. And then it's a review of the totality of clinical evidence and data that will certainly be facilitated by Pfizer in the best possible and optimal way. To your question about where and when will the data in totality be presented? Pfizer stated that they will present the full data set at a forthcoming conference. To my knowledge, it has not yet been confirmed which one this is going to be.

在疫苗開發的世界裡，你必須真正檢視結果是否具有臨床意義，而這確實是本案的情況。接著就是對全部臨床證據與數據的整體性審查，而輝瑞將以最佳且最優的方式來促成這件事。回到你關於何時、在哪裡會完整呈現全部數據的問題：輝瑞表示他們將在即將舉行的一場會議上公布完整數據集。就我所知，目前尚未確認會是哪一場會議。

Damien Choplain, Stifel.

Damien Choplain，Stifel。

I have a couple of question on the restructuring plan. So can you elaborate on how the savings will phase through the year? And how should we think about the split of savings between R&D and SG&A? And the last one, when do you anticipate achieving full payback from the program?

我有幾個關於重整計畫的問題。你們能否進一步說明節省金額在年度內會如何逐步體現？以及我們應該如何看待研發（R&D）與銷售、一般及行政費用（SG&A）之間的節省分配？最後一個問題：你們預期何時能從該計畫達到完全回收（full payback）？

Yes. Thanks for the question, Damien. So in terms of timing, as we -- a lot of the redundancy we're looking at -- when we look at people costs, a lot of the redundancy we're looking at are in Austria, and there's a clear legal process. So actually, this will continue for a while. And then, of course, similar to other European countries, there will be notice periods.

是的。謝謝你的問題，Damien。就時程而言，當我們——我們正在評估的許多冗員——如果看人事成本，我們評估的許多冗員是在奧地利，而那裡有明確的法律程序。所以實際上，這會持續一段時間。然後，當然，和其他歐洲國家類似，會有通知期（notice periods）。

So the full payback will certainly only be next year on that. We initiated the process now with the Austrian authorities, and I think information to staff will occur approximately in a month from now. I think when it comes to external spend, this is actually initiated now, and we will -- we are -- we do expect a significant savings for the remainder of 2026 and then, of course, carried over into 2027.

因此，完全回收肯定要到明年才會實現。我們現在已與奧地利主管機關啟動流程，我認為大約一個月後會向員工進行通知。至於外部支出（external spend），這其實已經開始啟動，我們——我們確實預期在 2026 年剩餘期間會有顯著節省，當然也會延續到 2027 年。

And between R&D and SG&A, sorry, most of the savings we would expect in R&D as opposed to -- if you compare to 2025, right? In sales and marketing, it's going to be more or less cosmetic in line with kind of the adjustments we did to the top line. And then in G&A, it's in a way a continuation of savings we've already seen in 2025 versus prior year, and we will continue to add on some savings, but it's not going to be as substantial as in R&D, of course.

至於研發與 SG&A 之間的分配，抱歉，若以 2025 年作比較，對吧？我們預期大部分節省會出現在研發，而不是——在銷售與行銷方面，基本上會比較偏表面（cosmetic），大致與我們對營收端所做的調整一致。而在一般及行政（G&A）方面，某種程度上是延續我們在 2025 年相較前一年已看到的節省，我們會再增加一些節省，但當然不會像研發那麼顯著。

Rajan Sharma, Goldman Sachs.

Rajan Sharma，高盛（Goldman Sachs）。

I've got a couple of questions. And sorry to labor the point on the Pfizer part, but I was just wondering what level of insight do you actually have into Pfizer's FDA discussions? Is it essentially the same as everybody else in the market where you get the update when Pfizer discloses it? And then I had a couple of financial questions, which I can follow up with.

我有幾個問題。也抱歉一直追問輝瑞的部分，但我想了解的是，你們對輝瑞與 FDA 討論的實際掌握程度到什麼程度？你們基本上是否和市場上其他人一樣，都是等輝瑞披露後才得到更新？另外我還有幾個財務問題，之後也可以再追問。

So we are not actively involved in the preparations or discussions in between Pfizer and regulatory authorities. But we have a process to be informed through existing steering structures at different time points than as compared to the market.

我們並未積極參與輝瑞與監管機關之間的準備工作或討論。但我們有一套流程，會透過既有的指導／治理架構（steering structures），在不同時間點獲得資訊，相較於市場會更早一些。

Okay. Got it. And then a couple on the financials. So Peter, I think -- well, you guided to normalized gross margin for 2026. Could you just help us understand what a normalized gross margin is for Valneva and what the impact of idle capacity costs might be?

好的。了解。接著有幾個關於財務的問題。Peter，我想——嗯，你們對 2026 年給了「常態化毛利率」（normalized gross margin）的指引。你能否協助我們理解，對 Valneva 而言什麼是常態化毛利率，以及閒置產能成本（idle capacity costs）可能帶來的影響？

In 2025, you had EUR10 million of idle capacity costs, and you've reported EUR5 million already in first quarter of '26. I think at full year results, you mentioned that idle capacity costs in '26 will be similar to 2025. So is that still the case? And then secondly, just on the outlook for revenues. Can you just help us understand or reassure that there's no further downside there?

在 2025 年，你們有 1,000 萬歐元的閒置產能成本，而你們在 2026 年第一季已經認列了 500 萬歐元。我記得在全年業績時，你們提到 2026 年的閒置產能成本會與 2025 年相近。所以現在仍然是這樣嗎？其次，關於營收展望：你能否協助我們理解，或讓我們放心，這裡不會再有進一步下行風險？

Looking at the midpoint of your new guidance range, that's about implies around a 12% decline versus 25%. In Q1 '26, you've seen a 26% decline. And I think third-party products will trend down. And it sounds like the travel market slowdown that you mentioned was not fully realized in Q1. So yes, could you just help us understand those dynamics and provide some reassurance that there's not further downside there?

看你們新指引區間的中位數，意味著相較 25 年大約下滑 12%。但在 2026 年第一季，你們看到的是 26% 的下滑。而且我認為第三方產品會呈下降趨勢。同時你們提到的旅遊市場放緩，聽起來在第一季尚未完全反映。所以，是的，你能否協助我們理解這些動態，並提供一些保證，確認不會再有進一步下行？

Yes. Thank you, Rajan. So on gross margin, normalized gross margin, so -- and it's, of course, it's work in progress in a way, but we would expect that we probably get close to where we were for the full year 2025 for the rest of the year. In terms of idle capacity, it is a bit higher than last year. It's not the full EUR5 million.

是的。謝謝你，Rajan。關於毛利率、常態化毛利率——當然，某種程度上這仍在進行中（work in progress），但我們預期今年剩餘期間大概會接近 2025 全年的水準。至於閒置產能，它確實比去年高一些。但不是完整的 500 萬歐元。

So we said the EUR5 million is idle plus some unallocated costs. So most of the EUR5 million is is idle, and it is higher than last year just because we transitioned over to Almeida and then now you're fully utilizing the Almeida facility, which increased part of the idle capacity because of the pure size of this manufacturing site.

我們說的 500 萬歐元是閒置加上一些未分攤成本（unallocated costs）。所以這 500 萬歐元中的大部分是閒置，而且比去年高，原因是我們轉移到 Almeida，現在你已經在充分利用 Almeida 廠房；由於這個製造基地的純粹規模，閒置產能的部分因此增加。

When it comes to revenues, I mean, we think we have a realistic guidance now, the range we gave, EUR130 million to EUR150 million. Where we will land in this range, we can't say, of course. That's why we gave the range. But right now, we feel comfortable that it's appropriate. What happens for the remainder of the year in terms of geopolitical situation, we can, of course, not give any guarantee.

至於營收，我們認為目前的指引是務實的，我們給的區間是 1.3 億到 1.5 億歐元。我們當然無法說最終會落在哪個位置。這也是我們給區間的原因。但就目前而言，我們覺得這是合適的。至於今年剩餘期間地緣政治情勢會如何發展，我們當然無法做任何保證。

I mean if the overall situation in -- especially in the Middle East gets worse and the travel market gets affected, we cannot exclude it will have an impact. But as from where we stand today, we think it's a realistic assumption, the range.

我的意思是，如果整體情勢——尤其是中東——進一步惡化，並影響旅遊市場，我們不能排除會帶來影響。但以我們今天所處的位置來看，我們認為這個區間是合理的假設。

Brandon Folkes, H.C. Wainwright.

Brandon Folkes，H.C. Wainwright。

Just changing gears here a little bit and focusing on the Shigella Phase II readout, what are you looking for in this readout? How will you assess the go-forward decision? And has that part changed given the focus on OpEx reduction? And then maybe just looking a bit further out on this, if you were to commercialize that product, would you be selling to the same call points as DUKAROL? Can you just talk about the commercial synergies of a Shigella and cholera product?

稍微換個話題，聚焦在志賀氏菌（Shigella）第二期（Phase II）結果讀出，你們在這次讀出中主要在看什麼？你們將如何評估是否繼續推進的決策？在目前聚焦降低營運費用（OpEx）的情況下，這部分是否有所改變？另外再往後看一點，如果你們要將該產品商業化，你們會賣給與 DUKAROL 相同的客戶接觸點（call points）嗎？你能否談談志賀氏菌與霍亂產品在商業上的協同效益？

Thank you so much. Glad that we are able to talk a little bit about Shigella for a change. Yes. So first of all, the thing that we really like about this program is that through the controlled human infection model that is currently run at John Hopkins, we will get pilot efficacy. We are challenging people with one strain, namely the Shigella sonnei strain.

非常感謝。很高興我們能夠換個話題，稍微談談志賀氏菌（Shigella）。是的。首先，我們非常喜歡這個計畫的一點是，透過目前在約翰霍普金斯（John Hopkins）進行的受控人體感染模型，我們將獲得初步的有效性資料。我們會用一個菌株來對受試者進行攻毒，也就是志賀氏菌宋內氏菌株（Shigella sonnei）。

And what we hope to see is, a, that the challenge model works, meaning that people above a certain immunological titer are being protected and others not that we see really an effect on placebo versus vaccine in this model. And ideally, the first indication about the immunological threshold that needs to be reached in order to see protection.

我們希望看到的是：第一，攻毒模型能夠運作，也就是免疫學滴度高於某個門檻的人會受到保護，而其他人則不會；並且在這個模型中，我們確實能看到安慰劑組與疫苗組之間的效果差異。理想情況下，也能得到第一個關於需要達到何種免疫學門檻才能看到保護效果的指標。

On the children's side, we hope to see that we see a solid immunogenicity profile, good zero response rates and that we have a first idea about the schedule and whether this two-dose schedule in children will be sufficient or not. So this is what we expect to see from those studies. And then we're going to take -- it's hard to say -- to predict right now what the outcome is going to be.

在兒童方面，我們希望看到穩健的免疫原性特徵、良好的血清轉換率，並且對接種時程有初步概念，以及這個兒童兩劑接種時程是否足夠。這就是我們預期從這些研究中看到的結果。接著我們將會——很難說——目前還很難預測結果會是什麼。

But the good thing is, you have a huge derisking in case of positive data. And therefore, once we see the data, we are currently anticipating that we will need to turn an additional round around optimizing probably dose schedule and so on and so forth and anticipate those things to commence literally next year.

但好處是，如果數據為正面，你就能大幅降低風險。因此，一旦我們看到數據，我們目前預期還需要再進行一輪額外工作，可能是優化劑量、接種時程等等，並預期這些工作將在明年就開始啟動。

I think there is currently no strategic change with regards to the Shigella program in connection with our restructuring activities. I would say there is probably a bit of a different phasing or pace associated with it as compared to previous hypothesis. But strategically and focus-wise, we don't see a real difference.

我認為，就志賀氏菌計畫而言，與我們的重組活動相關，目前沒有任何策略上的改變。我會說，相較於先前的假設，可能在時程安排或推進速度上會有些不同。但在策略與聚焦方向上，我們看不出真正的差異。

Now coming back to your question around commercialization, which is a very good one. Shigella and shigellosis has two key potential markets. By far, the largest medical need and commercial opportunity sits in emerging countries and in low medium-income countries where this is a disease with a huge mortality burden and therefore, a very, very relevant risk benefit and health economical benefit.

回到你關於商業化的問題，這確實是個很好的問題。志賀氏菌與志賀氏菌病（shigellosis）有兩個主要的潛在市場。迄今為止，最大的醫療需求與商業機會在新興國家以及中低收入國家，因為這是一種具有巨大死亡負擔的疾病，因此其風險效益與健康經濟效益都非常、非常顯著。

Here, in the ideal world, one would target step-by-step a multivalent vaccine covering more than just shigellosis. So combination vaccines that could potentially also include ETEC cholera and other components. But as a second step, and I think those combination vaccines in the enteric disease field is -- would certainly represent a huge commercial opportunity. And we see the introduction in those emerging markets as a first step really as a stepping stone.

在理想情況下，會逐步鎖定一種多價疫苗，涵蓋的不僅僅是志賀氏菌病。也就是可能包含 ETEC、霍亂以及其他成分的聯合疫苗。但作為第二步，我認為腸道疾病領域的這類聯合疫苗——無疑將代表一個巨大的商業機會。而我們將在這些新興市場的導入視為第一步，真正作為一個墊腳石。

The second part is travelers. There is a clear need for Shigella vaccine in travelers. Again, in the ideal world, you would have a combination vaccine to create more and more coverage in order to be able to provide a travelers diarrhea vaccine. And in order to present the travelers diarrhea vaccine, you will need to add additional antigens above and beyond even cholera and ETEC. But again, it's a stepwise approach, whether or not Shigella stand-alone will be directly licensed and commercialized in Travelers or whether we're going to focus on combination right away is something that we are exploring.

第二部分是旅遊者。旅遊者對志賀氏菌疫苗有明確需求。同樣地，在理想情況下，你會希望有一種聯合疫苗，以建立更廣的涵蓋範圍，從而能提供一款旅遊者腹瀉疫苗。而要推出旅遊者腹瀉疫苗，你需要在霍亂與 ETEC 之外再加入額外的抗原。但同樣是循序漸進的方式：志賀氏菌單一疫苗是否會直接在旅遊者市場取得許可並商業化，或是我們是否會立即聚焦於聯合疫苗，這是我們正在探索的方向。

And it will be part of our review in connection with the future development plan for Shigella. And please keep in mind that we announced previously that we are working on enteric diseases also in our preclinical arena. We are working on a product covering ETEC vaccine candidate, for example, covering both AT as well as ST. And of course, with that plus our cholera vaccine in hand, we, in a way, set ourselves up for potential combination vaccines in the traveler diarrhea environment.

這也將成為我們在制定志賀氏菌未來開發計畫時審視的一部分。也請記得，我們先前已宣布在臨床前領域也在布局腸道疾病。例如，我們正在開發一個涵蓋 ETEC 的疫苗候選產品，涵蓋 AT 與 ST。當然，結合這個產品以及我們手上的霍亂疫苗，我們在某種程度上已為旅遊者腹瀉場景中的潛在聯合疫苗做好布局。

I hope this answers your question?

希望這回答了你的問題？

Simon Scholes, First Berlin Equity Research.

Simon Scholes，First Berlin Equity Research。

I've just got one question. You wrote in the 2025 20-F that you'd received a letter from the FDA preventing you from using the Almeida facility to produce IXIARO for distribution in the US. I was just wondering if you could outline current measures to mitigate that and also give us some idea as to whether this will impact sales of IXIARO or your capacity to supply the Department of Defense with IXIARO.

我只有一個問題。你們在 2025 年的 20-F 中寫到，你們收到 FDA 的一封信，禁止你們使用 Almeida 廠房生產供應美國市場的 IXIARO。我想請問你們能否概述目前為降低影響所採取的措施，並也請你們說明這是否會影響 IXIARO 的銷售，或你們向國防部供應 IXIARO 的供貨能力。

So first of all, yes, you're right. We received 483 as part of the pre-approval inspection and the complete response letter with regards to the pre-approval supplement of Almeida as an alternative site for IXIARO manufacturing. We have, however, received approvals for the new manufacturing site from all the other regulatory bodies.

首先，是的，你說得沒錯。我們在核准前查廠（pre-approval inspection）中收到 483，並且就將 Almeida 作為 IXIARO 製造替代廠址的核准前補充申請（pre-approval supplement）收到了完整回覆函（complete response letter）。不過，我們已經獲得其他所有監管機構對新製造廠址的核准。

Now we were smart enough to file Almeida as an additional manufacturing site and the existing facility is still active. And I think this is important to note, and we are releasing product out of the previous facility or the existing facility called [Menson] into the US market as we speak. And of course, we are working with the FDA to address their concerns articulated in the 483 and we'll resubmit the pre-approval supplement process as soon as we can.

我們很明智地將 Almeida 以新增製造廠址的方式申報，而既有廠房仍在運作。我認為這點很重要；我們目前正如你所知，仍在把產品從先前的廠房或既有廠房（名為 [Menson]）放行供應到美國市場。當然，我們也正與 FDA 合作，以解決其在 483 中提出的疑慮，並會在可行的最短時間內重新提交核准前補充申請流程。

Okay. So you don't expect any impact from temporary inability to use Almeida on IXIARO sales in the US?

好的。所以你們不預期暫時無法使用 Almeida 會對 IXIARO 在美國的銷售造成任何影響？

Not at this point in time.

目前這個時間點不會。

That was our final question for today. I will now hand the call back to Thomas Lingelbach for closing remarks.

以上是我們今天的最後一個問題。我現在把電話交回給 Thomas Lingelbach 作結語。

Thank you so much for your attendance today. Great questions and for following Valneva. And as we said during the call today, we are looking forward, especially to the next steps in connection with the Lyme vaccine, are confident in the prospect of not only Lyme, but also Valneva. Thanks a lot.

非常感謝各位今天的出席。問題都很精彩，也感謝各位持續關注 Valneva。正如我們今天在電話會議中所說，我們非常期待接下來與萊姆病疫苗相關的下一步，並對不僅是萊姆病項目、也包括 Valneva 的前景充滿信心。非常感謝。

This concludes today's conference call. Thank you for participating. You may now disconnect.

今天的電話會議到此結束。感謝各位參與。您現在可以掛線。