Valneva SE (VALN) 2025 Q3 法說會逐字稿

Hello and thank you for joining us to discuss Valneva's financial results for the first nine months of 2025 and corporated. It's my pleasure to welcome you today. In addition to our press release and analyst presentation, you can find our consolidated financial results for the nine months ended September 30, 2025, which were published earlier today, available within the financial reports section of our investor website.

您好，感謝您參加本次會議，共同探討 Valneva 公司 2025 年前九個月的財務表現及公司整體表現。今天非常榮幸能歡迎各位的到來。除了我們的新聞稿和分析師簡報外，您還可以在我們投資者網站的財務報告部分找到我們截至 2025 年 9 月 30 日的九個月的合併財務業績，該業績已於今天早些時候發布。

I'm joined today by Valneva's CEO, Thomas Lingelbach; and our CFO, Peter Buhler, who will provide an overview and update on our business as well as our key financial results for the first half. There will be an analyst Q&A session at the conclusion of the prepared remarks. Before we begin, I'd like to remind listeners that during this presentation, we will be making forward-looking statements, which are subject to certain risks and uncertainties that could cause actual results to differ materially from those expressed or implied by these forward-looking statements.

今天，Valneva 的執行長 Thomas Lingelbach 和財務長 Peter Buhler 將與我一同出席，他們將概述和更新我們的業務以及上半年的主要財務業績。在發言結束後，將安排分析師問答環節。在開始之前，我想提醒各位聽眾，在本次演講中，我們將做出一些前瞻性陳述，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表達或暗示的結果存在重大差異。

You can find additional information about these risks and uncertainties in our periodic filings with the Securities and Exchange Commission and with the French Market Authority, which are listed on our company website. Please note that today's presentation includes information provided as of today, August 12, 2025, and Valneva undertakes no obligation to revise or update forward- looking statements, except as required by applicable securities laws.

您可以在我們公司網站上列出的定期向美國證券交易委員會和法國市場管理局提交的文件中，找到有關這些風險和不確定性的更多資訊。請注意，今天的簡報包含截至 2025 年 8 月 12 日的信息，除適用證券法要求外，Valneva 不承擔修改或更新前瞻性聲明的義務。

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

接下來，我很榮幸地向大家介紹湯瑪斯，他將開始今天的演講。

Thank you so much, Josh. Good day, everyone. Welcome to our nine-month call.

非常感謝你，喬許。大家好。歡迎參加我們為期九個月的電話會議。

So before, we go into the business highlights and also Peter will provide a very detailed financial report, I would like to start off by providing a couple of key financial management highlights.

因此，在我們深入探討業務亮點之前，彼得也將提供一份非常詳細的財務報告，我想先介紹幾個關鍵的財務管理亮點。

Total revenues, reached, EUR127 million at, the nine month time point, which is this essential growth of almost 9% despite of, some headwinds, be it from a geopolitical perspective, but also from an extric perspective in particular.

截至九個月時，總收入達到 1.27 億歐元，儘管面臨一些不利因素，無論是地緣政治方面還是其他方面，仍然實現了近 9% 的重要成長。

And, we are very glad that we have been able to deliver on that growth, year-to-date. We have also been able to significantly reduce our operating cash burn, which has been one of our key objectives in continuously improving efficiency of our operations. This resulted in a cash position of more than EUR140 million which includes also the net proceeds from different ATM transactions.

而且，我們非常高興今年迄今已經實現了這一成長目標。我們也大幅降低了營運現金消耗，這是我們持續提高營運效率的關鍵目標之一。這使得現金部位超過 1.4 億歐元，其中包括來自不同 ATM 交易的淨收益。

Peter will further detail and most importantly, we successfully completed our debt refinancing, which of course enhances substantially our financial flexibility and we are very glad that we have found in Pharmaon a new partner to support Valneva in the years to come.

Peter 將進一步詳細說明，最重要的是，我們成功完成了債務再融資，這當然大大增強了我們的財務靈活性，我們非常高興找到了 Pharmaon 這家新的合作夥伴，在未來幾年裡為 Valneva 提供支持。

Recapping a little bit, on the first nine months, key business highlights, around Ichic, we responded, to significant, unmet medical needs on the la reunion and Mayotte, the respective outbreaks. We also responded to a cholera outbreak in Mayotte by supplying doses of Tucoral. And we again finalized the new ICAO, US Department of Defense contract, all of that, supporting our mission in targeting unmet medical needs.

簡單回顧一下，在 Ichic 成立的前九個月裡，我們針對留尼汪島和馬約特島疫情爆發期間未得到滿足的重大醫療需求做出了回應，這是其主要業務亮點。我們也向馬約特島提供了杜可樂（Tucoral）來應對霍亂疫情。我們再次敲定了新的國際民航組織和美國國防部合同，所有這些都支持我們滿足未滿足的醫療需求的使命。

On the regulatory and commercial side of things, we secured additional marketing organizations for exchequ in the UK and Brazil, label extensions for adolescents 12 years of age and older in Europe and Canada, and we announced an exclusive vaccine marketing and distribution agreement for Germany with CSL Sequerius replacing Bavarian Nordic, by the end of this year for, the, our established brands, and they already started, distributing, Ichik in Germany.

在監管和商業方面，我們為英國和巴西的 Exchequ 疫苗爭取到了額外的營銷機構，為歐洲和加拿大 12 歲及以上的青少年延長了標籤適用範圍，並且我們宣布與 CSL Sequerius 達成一項獨家疫苗營銷和分銷協議，CSL Sequerius 將取代 Bavarian Nordic，負責我們品牌現有德國的銷售。他們已經開始在德國分銷 Ichik 疫苗。

Of course, on the clinical side, it's all about Lyme, right now, and, we completed, all vaccinations in the Valloa phase 3 study according to plan.

當然，在臨床方面，目前一切都與萊姆病有關，我們已經按計劃完成了 Valloa 3 期研究中的所有疫苗接種。

We also reported further positive safety and immunity, data following the third annual booster as part of our phase 3 follow-up study VLA 15,221.

我們也報告了在第三次年度加強免疫後，作為我們 3 期後續研究 VLA 15,221 的一部分，進一步的積極安全性和免疫力數據。

On, ICC, the vaccine profile, got further substantiated, with the antibody persistence data. Now, after 4 years, still showing the 95% 0 response rate after a single shot, which is the key differentiation. For this, live attenuated single-shot, vaccine, we further reported, immune response in adolescents and positive pediatric safety and immunogenicity data.

ICC，即疫苗特性，透過抗體持久性數據得到了進一步證實。現在，4 年過去了，單次注射後仍然保持 95% 的零反應率，這是關鍵的差異。為此，我們進一步報告了減毒活單劑疫苗在青少年中的免疫反應以及積極的兒科安全性和免疫原性數據。

Last but not least, we also reported, a positive phase one results, from our second generation Zika vaccine candidate VLA 1,601. Going a little bit, into the details of the individual programs, I would like to start off with Lyme. We've been talking a lot about Lyme and we will be talking a lot about Lyme. The Lyme continues representing a major unmet medical need and hence market opportunity. Close to half a million cases every year confirmed in the United States, probably now in Europe.

最後，我們也報告了第二代寨卡疫苗候選藥物 VLA 1,601 的一期臨床試驗的正面結果。接下來，我想稍微深入探討各個項目的細節，先從萊姆病說起。我們一直在談論萊姆病，以後也會繼續談論萊姆病。萊姆病仍代表著尚未滿足的重大醫療需求，因此也蘊含著巨大的市場機會。美國每年確診病例接近50萬例，現在歐洲可能也出現了這種情況。

The same order of magnitude. Also there are limited reporting systems available. You remember that we have about 90 million US citizens living in high-risk areas of Lyme disease and in Europe, more than 200 million.

數量級相同。此外，可用的報告系統也十分有限。您還記得美國約有 9,000 萬公民生活在萊姆病高風險地區，而歐洲則有超過 2 億公民生活在高風險地區嗎？

In those endemic regions. Most importantly, the health economical benefit for a potential vaccination against Lyme disease is considered extremely favorable.

在這些地方性流行地區。最重要的是，萊姆病疫苗的潛在健康經濟效益被認為非常有利。

Why? Because you have very severe manifestations in connection with Lyme disease. 10 to 30% of people develop either carditis, neurobolliosis, arthritis, and 5 to 10% persistent symptoms. Even following treatment with respective antibiotics. By way of reminder around, the phase three study that is currently ongoing, Pfizer reconfirmed, that they're going to submit regulatory applications in the US and Europe in 2026. The Valoa study, has been executed according to plan.

為什麼？因為你患有非常嚴重的萊姆病。 10%到30%的人會發展成心肌炎、神經衰弱、關節炎，5%到10%的人會出現持續性症狀。即使在接受相應抗生素治療後。提醒大家，目前正在進行的第三階段研究，輝瑞公司再次確認，他們將於 2026 年在美國和歐洲提交監管申請。Valoa 研究已按計劃完成。

And, basically, Pfizer guided, for readout in the first half of 2026. And, the study, of course, is now going through its follow-up period, since, the official case count, ended at the end of October, then we run the normal process.

輝瑞預計，相關數據將於 2026 年上半年公佈。當然，這項研究現在正處於後續研究階段，因為官方病例統計在 10 月底結束，然後我們運行正常的流程。

To case adjudications, for, testing activities, database cleanings, and all of that before, the results will be announced, in the first half of next year. Most importantly, the time point for which we expect the product to be launched hasn't changed. It is important for us and ourfizer colleagues that the product can be launched in the autumn of 2027, well ahead of the 2028 peak season.

案件裁決、測試活動、資料庫清理以及之前的所有工作，結果將於明年上半年公佈。最重要的是，我們預期產品上市的時間點不會改變。對我們和輝瑞的同事來說，重要的是該產品能在 2027 年秋季上市，遠早於 2028 年的銷售旺季。

It is important to get really people protected for the tick season 2028. As such, we are very much looking forward to the data, which hopefully are going to be positive and hence provide a pathway for a vaccine that could really address a huge unmet medical need.

為應對 2028 年的蜱蟲季，做好充分的防護措施至關重要。因此，我們非常期待這些數據，希望這些數據是正面的，從而為真正能夠解決巨大未滿足醫療需求的疫苗提供途徑。

Turning to our highly differentiated single-shot chikungunya vaccine, VLA 1,553 or ICHIC, where are we, at this point in time? Of course, we have on the regulatory side, still the situation that, the product is suspended, in the United States. And we are still awaiting, further information from FDA which we haven't received at all, at this moment in time.

就我們高度差異化的單劑基孔肯雅疫苗 VLA 1,553 或 ICHIC 而言，目前我們處於什麼階段？當然，在監管方面，目前的情況是，該產品在美國已被暫停銷售。目前我們仍未收到美國食品藥物管理局（FDA）的進一步資訊。

In all the other countries, we are working, on the basis of updated, prescribing information or, SPCs, and, we are seeing that the product is, being administered, and we are trying to focus potentially on the expansion into LMIC territories, and are working with existing and hopefully future partners in this regard. The most imminent, point now to consider, in this program that is supported by Spi, our post-marketing effectiveness, studies, the Phase 4.

在其他所有國家，我們都根據更新的處方資訊或藥品說明書開展工作，並且我們看到該產品正在被使用，我們正在努力將重點放在可能擴展到低收入和中等收入國家，並在這方面與現有和希望未來的合作夥伴合作。現在最迫切的一點是，在 Spi 支持的這項計劃中，我們的上市後效果研究，即第四階段。

Which are about to commence, with an observational effectiveness study, in Brazil with pragmatic randomized control effectiveness safety studies in adolescents and adults, including elderly, in, various endemic countries, and then later a prospective safety court study, and surveillance in Brazil as well. Of course, I mentioned already the label expansions and, the reports on the positive data, which, we will, further submit, and hopefully, be granted in the different, product labels. We see clearly the product differentiation, for exchick. Which of course is super important for a potential outbreak disease and for people who are planning multiple trips into areas where there is a high risk of a potential outbreak.

這些研究即將開始，首先在巴西進行觀察性有效性研究，然後在各個流行國家的青少年和成人（包括老年人）中進行實用性隨機對照有效性安全性研究，之後還將進行前瞻性安全性法庭研究，並在巴西進行監測。當然，我已經提到了標籤擴展和積極數據的報告，我們將進一步提交這些報告，並希望能夠獲得不同產品標籤的批准。我們清楚地看到了產品差異化，例如 exchick。當然，這對於可能發生的疾病爆發以及計劃多次前往可能爆發疾病的高風險地區的人來說，是非常重要的。

Shigera. You may recall that we, in licensed the vaccine through a partnership with Limaech. The program called S4V2, is the world's most clinically advanced tetravalent Shigella, vaccine candidate.

茂拉。您可能還記得，我們​​透過與 Limaech 的合作獲得了該疫苗的許可。該計畫名為 S4V2，是目前全球臨床進展最快的四價志賀氏菌疫苗候選產品。

It, addresses the four most common, serotypes of the Shigella bacteria. The program, reported earlier, positive 12, clinical data in different age groups.

它針對四種最常見的志賀氏菌血清型。先前報告的該項目在不同年齡組中取得了 12 項積極的臨床數據。

In terms of, medical needs, Shigella represents the second leading cause of fatal diarrhea, and here, especially in infants, below five years of age, the global market, is expected on the one hand side in LMICs, in particular the target population that I just mentioned. But also, it represents significant opportunity for travelers, and military, given the overall medical needs, and, also the diarrheal diseases to be seen in the context of antibiotic resistance.

就醫療需求而言，志賀氏菌是致命腹瀉的第二大原因，尤其是在五歲以下的嬰兒中，全球市場一方面預計在低收入和中等收入國家，特別是我剛才提到的目標人群。但同時，考慮到整體醫療需求，以及在抗生素抗藥性的背景下腹瀉疾病的出現，這也為旅行者和軍隊帶來了重要的機會。

The Shigella development or vaccine development against sugulosis has been identified as a priority by WHO.

世界衛生組織已將志賀氏菌症的研究或疫苗研發列為優先事項。

We have currently a couple of studies ongoing. We have the Phase 2, in infants, for which we expect, results still this year. And we have the phase 2B, controlled human infection model study in adults, where we changed, some of the, data, time points, the clinical design in order to extend the period of immunogenicity where we had the opportunity to optimize those and schedule.

我們目前正在進行幾項研究。我們正在進行第二階段試驗，受試者是嬰兒，預計今年內會公佈結果。我們有針對成年人的 2B 期受控人體感染模型研究，我們改變了一些數據、時間點和臨床設計，以延長免疫原性時期，並有機會優化這些指標和時間表。

And we expect the, pilot efficacy data next year with, immunogenicity data coming in earlier, upon success, and please remember that we have intentionally set up the clinical design and the clinical pathway in a way that the program is highly de-risk from a capital allocation perspective.

我們預計明年將獲得試驗療效數據，免疫原性數據將在成功後更早獲得。請記住，我們特意設計了臨床方案和臨床路徑，以從資本配置的角度來看大大降低該專案的風險。

So based on positive data based on our respective goal decisions, we will assume full accountability for the program, following those two studies which are still sponsored by Limatech. Yeah, with this update on our, operational business and R&D in particular, I would like to hand over to Peter to provide you the financial report for the 9 month period.

因此，基於我們各自目標決策所獲得的正面數據，我們將對該專案承擔全部責任，遵循 Limatech 仍然贊助的這兩項研究。是的，鑑於我們營運業務和研發方面的最新進展，我想把時間交給彼得，讓他為大家提供過去九個月的財務報告。

Thank you, Thomas.

謝謝你，托馬斯。

Product sales reached EUR119.4 million compared to EUR112 million in the nine months of 2024, an increase of 6.2%. Foreign currency fluctuation had an adverse impact of EUR1.3 million.

產品銷售額達到 1.194 億歐元，而 2024 年前九個月為 1.12 億歐元，成長了 6.2%。外匯波動造成了130萬歐元的不利影響。

Xiao sales reached EUR74.3 million increasing 12.5% over the prior year.

Xiao 的銷售額達到 7,430 萬歐元，比上年增長 12.5%。

The year over year growth was driven by sales to the US Department of Defense, as well as increased sales in some European countries.

年比成長主要得益於對美國國防部的銷售，以及在一些歐洲國家的銷售成長。

Foreign currency fluctuation adversely impacted Xiao sales during the first nine months by EUR800,000.

外匯波動對 Xiao 的銷售額在前九個月造成了 80 萬歐元的負面影響。

Torral sales decreased from EUR22.3 million in the first nine months of 2024 to EUR21.5 million in the same period of 2025.

Torral 的銷售額從 2024 年前九個月的 2,230 萬歐元下降到 2025 年同期的 2,150 萬歐元。

Sales were EUR400,000 adversely impacted by foreign currency fluctuation, mainly resulting from a weakening Canadian dollar, and also lower sales to our German partner as we are transitioning from our current distributor to CSL Securities.

受外匯波動（主要是加幣貶值）以及由於我們正在從目前的經銷商過渡到 CSL Securities，導致對德國合作夥伴的銷售額下降，銷售額減少了 40 萬歐元。

Ixtrix sales reached EUR7.6 million compared to EUR1.8 million in the nine months of 2024.

Ixtrix 的銷售額達到 760 萬歐元，而 2024 年前九個月的銷售額為 180 萬歐元。

While exchick sales included the supply of 40,000 doses to combat the major chikungunya outbreak on the French island of La Reunion, the temporary restriction and US license suspension significantly adversely impacted sales in the traveler segment, leading to an adjustment of our sales guidance.

雖然出口銷售額包括供應 40,000 劑疫苗以對抗法國留尼旺島的大規模基孔肯雅疫情，但臨時限制和美國許可證暫停對旅行者市場的銷售產生了重大不利影響，導致我們調整了銷售預期。

Third-party products decreased by 28.5% year-over-year to EUR16.1 million. This decrease is a result of the anticipated discontinuation of certain third-party distribution agreements. As mentioned in our previous calls, we expect third-party product sales over time to account for less than 5% of total product sales.

第三方產品較去年同期下降 28.5%，至 1,610 萬歐元。這一下降是由於預計某些第三方分銷協議將終止所致。正如我們在先前的電話會議中所提到的，我們預計隨著時間的推移，第三方產品銷售額將佔產品總銷售額的不到 5%。

Now moving on to the income statement.

接下來來看損益表。

Total revenues reached EUR127 million versus EUR112.5 million in the first nine months of 2024.

2024 年前九個月的總收入達到 1.27 億歐元，而 2024 年前九個月的總收入為 1.125 億歐元。

The increase of 9% is driven by higher product sales and an increase in other revenues related to revenue recognition from partnerships.

9% 的成長是由產品銷售增加以及與合作關係相關的收入確認所帶來的其他收入增加所推動的。

Looking at expenses, cost of goods and services for the nine months of 2025 reached EUR71.1 million compared to EUR71.3 million during the same period last year.

從支出來看，2025 年前九個月的商品和服務成本達到 7,110 萬歐元，而去年同期為 7,130 萬歐元。

The gross margin on commercial products, excluding exchick reached 57.2% in the first six months of 2025 compared to 48.6% in the prior year.

2025 年上半年，不包括小雞在內的商業產品的毛利率達到 57.2%，而去年同期為 48.6%。

The improvement in gross margin was driven by better manufacturing performance and favorable product mix.

毛利率的提高得益於生產效率的提高和產品組合的最佳化。

The Ciaro gross margin reached 63.2% compared to 58.8% in the first nine months of 24, and Torre generated a gross margin of 52.3% compared to 34.8% in the prior year.

Ciaro 的毛利率從 2024 年前九個月的 58.8% 增長到 63.2%，而 Torre 的毛利率從上一年的 34.8% 增長到 52.3%。

Cost of goods related to exchequ amount to EUR8.6 million and include provisions to recognize lower exchequ demand.

與國庫相關的商品成本為 860 萬歐元，其中包括確認國庫需求減少的準備金。

Cost of goods also include EUR8.2 million of idle capacity costs.

商品成本還包括820萬歐元的閒置產能成本。

Research and development expense increased from EUR48.6 million in the nine months of 2024 to EUR59.7 million in the same period of 2025. That increase is but is driven by costs related to the Shigella vaccine candidate, following the R&D collaboration with Limatech Biologics and costs related to the Ichick phase 4 post-marketing commitments.

2024 年前九個月的研發費用為 4,860 萬歐元，2025 年前九個月的研發費用為 5,970 萬歐元。這一增長是由志賀氏菌疫苗候選藥物相關的成本推動的，這是由於與 Limatech Biologics 的研發合作以及與 Ichick 的 4 期上市後承諾相關的成本所致。

Marketing and distribution expense decreased from EUR35.7 million in the prior year to EUR28.6 million in the nine months of 2025.

行銷和分銷費用從前一年的 3,570 萬歐元減少到 2025 年前九個月的 2,860 萬歐元。

The decrease is related to a planned reduction in advertising and promotion spend related to exchick following the launch in early 2024.

此次減少與計劃在 2024 年初 exchick 上市後減少相關廣告和促銷支出有關。

G&A expense reached EUR29.5 million in the first nine months of 2025 compared to EUR32.6 million in the same period of last year. This decrease is a result of a program to increase operational efficiency across the company that we ran at the end of 2024.

2025 年前九個月的一般及行政費用達到 2,950 萬歐元，而去年同期為 3,260 萬歐元。這一下降是我們在 2024 年底實施的提高公司營運效率計畫的結果。

In the nine months of 2025, Balneva reported an operating loss of EUR53.9 million compared to an operating profit of EUR34.2 million in the prior year.

2025 年前九個月，巴爾內瓦報告營業虧損 5,390 萬歐元，而前一年營業利潤為 3,420 萬歐元。

Last year's operating profit was the result of a sale of a priority re voucher for a total net proceed of EUR90.8 million.

去年的營業利潤來自出售優先再融資憑證，淨收益總計 9,080 萬歐元。

Adjusted EBITDA in the first half of 2025 reached a negative EUR37.7 million compared to a positive impact, and so a positive EBITDA of EUR48.6 million impacted by the sale of the PRE.

2025 年上半年調整後的 EBITDA 為負 3,770 萬歐元，而先前受到正面影響，因此，受 PRE 出售的影響，EBITDA 為正 4,860 萬歐元。

Before moving to the outlook and guidance, a word on cash. As mentioned by Thomas at the beginning of the call, cash at September 30th was reported at EUR143.5 million compared to EUR168.4 million at the end of 2024.

在展望未來和指導意見之前，先談談現金流問題。正如 Thomas 在電話會議開始時所提到的，截至 9 月 30 日，現金餘額為 1.435 億歐元，而 2024 年底的現金餘額為 1.684 億歐元。

The cash at the end of September includes a total of 3 ATM transactions for a value of a total of EUR26 million net of transaction cost.

9 月底的現金包括 3 筆 ATM 交易，總價值為 2,600 萬歐元（扣除交易成本後）。

Cash used in operating activities was reported at EUR28.4 million compared to EUR76.7 million in the first nine months of 2024.

經營活動所用現金為 2,840 萬歐元，而 2024 年前九個月為 7,670 萬歐元。

Now moving to slide 19, we confirm our financial guidance for the fiscal year 2025 with product sales of 155 to EUR170 million and total revenues of 165 to EUR180 million.

現在翻到第 19 張投影片，我們確認 2025 財年的財務指導，產品銷售額為 1.55 億至 1.7 億歐元，總收入為 1.65 億至 1.8 億歐元。

We continue to project R&D expense of 80 to EUR90 million and the R&D expenses will partially be offset by grant funding and an dissipated R&D tax credits.

我們繼續預計研發費用為 8,000 萬至 9,000 萬歐元，研發費用將部分由撥款資助和研發稅收抵免抵消。

As confirmed in the result at the end of September, we expect a significant lower use of cash in operations.

正如9月底的業績報告所證實的那樣，我們預計營運現金使用量將大幅下降。

Cash will remain a key focus in order to ensure sufficient runway to reach key inflection points.

現金流仍將是重點關注領域，以確保有足夠的資金儲備來應對關鍵的轉折點。

In the midterm, we expect continuous growth in our product sales, focused and strategic investments into R&D and continuous improvement in gross margin. We continue to expect Boniva to be sustainably profitable post successful approval and commercialization of the Lyme disease vaccine.

中期來看，我們預期產品銷售額將持續成長，研發投入將更加集中且具策略意義，毛利率也將持續提高。我們仍然預期，在萊姆病疫苗成功核准並實現商業化後，博尼瓦將持續獲利。

With this, I had to call back to.

因此，我不得不回撥電話。

Thomas.

托馬斯。

Thank you so much, Peter.

非常感謝你，彼得。

At this moment, I would like to turn, to our key, growth drivers for the remainder of the year, but also most importantly, beyond the end of 2025.

此時此刻，我想談談我們今年剩餘時間以及更重要的是2025年底以後的關鍵成長驅動因素。

We have built Valeba now on a very solid foundation.

我們已經為Valeba打下了非常堅實的基礎。

And lime is certainly going to be the single largest growth driver for the company in the years to come and the single largest near term catalyst for the company and its shareholders.

而青檸無疑將成為公司未來幾年最大的成長動力，也是公司及其股東近期最大的催化劑。

But also, for people who may benefit from a vaccination against Lyme disease.

但對於可能受益於萊姆病疫苗的人來說，這也是一種選擇。

The BLA 15 success, which is, hopefully expected in the first half of next year, may drive the company upon successful approval and commercialization, into, sustained profitability, driven by substantial milestones and later royalties starting in the latter part of 2027.

BLA 15 的成功（預計在明年上半年實現）可能會推動公司在成功獲批和商業化後持續獲利，這主要得益於 2027 年下半年開始的重大里程碑和後續特許權使用費。

Of course, for this year, and despite of having adjusted our guidance on product sales, we hope that we will be able to continue our growth trajectory for our established brands, Xiao and Tukoral, and we are working hard in, gaining, and regaining global traction on exchic and in particular leveraging. LMIC opportunities and new territories, where a product like exchange with its highly differentiated product profile, could be perfectly suited.

當然，今年儘管我們調整了產品銷售預期，但我們希望能夠繼續保持旗下成熟品牌 Xiao 和 Tukoral 的成長勢頭，我們正在努力爭取和重新獲得 exchic 的全球影響力，尤其是在槓桿作用方面。低收入和中等收入國家（LMIC）的機會和新領域，像交易所這樣具有高度差異化產品特性的產品，可能非常適合這些領域。

There is more, that Van Nieva has to offer in its pipeline, above and beyond Lyme. Also, Lyme is, of course, very dominant and rightly so. We are advancing a number of quite promising internal candidates. We are identifying new opportunities.

除了萊姆病之外，Van Nieva 還有更多產品正在研發中。當然，萊姆病也非常普遍，而且理應如此。我們正在提拔一些非常有前途的內部候選人。我們正在尋找新的機會。

Be it in-house, be it also external potential partnering opportunities, with the aim to really build a coherent, R&D pipeline, with an attractive next phase 3 program upon successful BLA 15 stroke Lyme commercialization, making us really, a leading vaccine biotech in the world. As such, we see substantial growth, substantial upside, and, with that, I would like to hand back to the operator to take your questions.

無論是內部研發，還是外部潛在的合作機會，我們的目標都是真正建立一個連貫的研發管線，並在 BLA 15 中風萊姆病商業化成功後，推出一個有吸引力的下一階段 3 期項目，使我們真正成為世界領先的疫苗生物技術公司。因此，我們看到了巨大的成長潛力，巨大的上漲空間，接下來，我想把時間交還給操作員，讓他回答大家的問題。

(Operator Instructions)

（操作說明）

Vamil Divan, Guggenheim Partners.

瓦米爾·迪萬，古根漢合夥人。

Okay, yeah, thanks, for the call and taking our questions. So maybe just two questions that I could while we wait for the lime date, obviously the big event coming, you mentioned you're waiting to hear from the FDA. Is there any sort of timelines there, any, guidance on when you think you may hear or anything that the FDA is bound by in terms of when they need to respond by?

好的，謝謝您的來電和回答我們的問題。所以，在我們等待最終結果公佈的這段時間裡，我或許可以問兩個問題，顯然，這是一件大事，您提到您正在等待 FDA 的消息。是否有任何時間表，或任何指導意見，說明您認為何時可能會聽到消息，或者FDA在何時需要做出回應方面受到任何約束？

And then Du girl, you mentioned this quarter, there were a couple of factors, I think you said currency and then the distributor shift in Germany. Wondering if you can quantify the impact of the especially and just how you think about sort of you know you're talking about you know growth for that asset going forward how you sort of see that you're recovering the growth.

然後，你提到了這個季度，其中有幾個因素，我想你提到了匯率，還有德國分銷商的變動。我想知道您是否可以量化這種影響，特別是您如何看待這種資產未來的成長，以及您如何看待這種成長的恢復。

Thank you.

謝謝。

Okay, so, let me start off with, the li, line the exchange, question, and, FDA.

好的，那麼，讓我先從 li、line 交易所、問題和 FDA 開始。

So unfortunately, the answer is, there is no predefined process because, a similar process, meaning a suspension, in the same way that it, was done for exchick, without.

所以很遺憾，答案是，沒有預先設定的流程，因為類似的流程，也就是暫停，就像對 exchick 所做的那樣，沒有。

Web packs, etc. Has not been done to our knowledge before. So, actually, there is no precedent. There is also, currently not a procedure to our knowledge, that needs to be followed, from a timing perspective, and as such, we are hoping for a collaborative. Interaction with the FDA, which of course could not have happened due to the government lockdown, for quite a while, but we certainly hope that we will be able to embark with the FDA into a dialogue, still this year.

據我們所知，之前還沒有人做過網頁包之類的事情。所以，實際上，這方面並沒有先例。據我們所知，目前還沒有從時間安排上需要遵循的程序，因此，我們希望能夠進行合作。由於政府的封鎖措施，與美國食品藥物管理局 (FDA) 的互動當然無法進行，但我們當然希望今年能夠與 FDA 展開對話。

I'll let Peter, answer, to your question.

我會讓彼得來回答你的問題。

Yeah, so I think I commented on the currency impact during the call. I think with regards to Germany, we have not disclosed the number and you know we never disclosed numbers on individual countries. What I would say is the third quarter of last year, so particularly strong quarter for Germany, and basically as we are now.

是的，我想我在電話會議中談到了匯率的影響。我認為就德國而言，我們沒有公佈具體數字，而且你也知道，我們從未公佈過個別國家的具體數字。我想說的是去年第三季度，也就是德國表現特別強勁的季度，基本上和我們現在的情況一樣。

Moving to our new distribution partner in Germany, there's just not purchases that are made by the existing one because they, they're using up, of course the stock they have before we then we ship products to the new one. So that's, it's basically technical delay. Now to your question on looking forward, I mean we have not yet provided of course guidance for 2026, but it's safe to assume that we will, continue, we will expect the continued growth of the Dura brand.

由於我們已將產品轉入德國的新分銷合作夥伴，因此現有合作夥伴不會再進行採購，因為他們會先用完庫存，然後再將產品運送給新的合作夥伴。所以，這基本上是技術性延誤。現在回答您關於展望未來的問題，我的意思是，我們當然還沒有提供 2026 年的指導意見，但可以肯定的是，我們將繼續，並期待 Dura 品牌繼續成長。

Maury Raycroft, Jefferies.

莫里‧雷克羅夫特，傑富瑞。

Hi, congrats on the progress and thanks for taking our questions. For the lime Phase 3 readout, Pfizer has to complete three months of safety follow-up after the end of the peak season in October, which implies to us that the readout could come as early as mid 1Q26, just based on the additional time required for database lock and analysis. If the readout happens later into the second quarter of 2026, would that imply that analysis of the results are just taking longer, or what are some of the reasons that could push the timing to later in the second quarter?

您好，恭喜您所取得的進展，感謝您回答我們的問題。對於石灰的 3 期試驗結果，輝瑞必須在 10 月份銷售旺季結束後完成三個月的安全隨訪，這意味著根據數據庫鎖定和分析所需的額外時間，結果最早可能在 2026 年第一季中期公佈。如果結果公佈時間延後到 2026 年第二季末，這是否意味著結果分析需要更長時間，還是有哪些原因導致公佈時間延後到第二季末？

Hi, Maury. Yeah, good question. So basically, Pfizer, are in control of this process. All I can say is we have seen that, Pfizer are taking every single step, in a very professional and at most accelerated way. At the same time, they will not take any regulatory risk, understandably, in the current environment.

你好，莫里。嗯，問得好。所以基本上，輝瑞公司掌控著這個過程。我只能說，我們已經看到，輝瑞公司正在以非常專業、甚至可以說是快速的方式採取每一步行動。同時，在當前環境下，他們自然不會承擔任何監管風險。

And therefore, I'm assuming that they will be as early as possible. I cannot see at this point in time any major, delays compared to the timelines that you have, just alluded to. And of course, I think, my colleagues mentioned this to you during the fireside chat, we are also hoping for, the, an ear as early as possible readout of the top-line data.

因此，我假設他們會儘早行動。就目前而言，我看不出與您剛才提到的時間表相比會有任何重大延誤。當然，我想我的同事們在爐邊談話中也向您提到過這一點，我們也希望儘早獲得初步數據。

Got it. Okay, makes sense. And maybe one other question just for the exchick BLA suspension. Can you comment on what you proposed in your response to FDA as a remedy? And are there some contingency options that you have to, that you have in place that could get this back on track in the United States?

知道了。嗯，有道理。或許還有一個問題，僅針對前BLA停職處。您能否就您在回覆FDA時提出的補救措施做一些說明？那麼，你們是否有一些應急方案，或者已經制定了哪些措施，可以讓美國的情況重回正軌？

So, basically, our response, has solely been focused on the real medical evidence.

所以，基本上，我們的回應完全集中在真實的醫學證據上。

Our response has been focusing on the, individual, case analysis and case assessments both by Vaneva as well as by others, including other regulatory agencies.

我們的因應措施一直著重於對個案進行分析和評估，這些分析和評估既包括 Vaneva 的個案，也包括其他監管機構的個案。

And has been focusing on our reiteration on a positive health economical benefit, so-called positive, risk-benefit ratio as already articulated by CDC and others.

並且一直專注於重申積極的健康經濟效益，即所謂的積極風險收益比，正如美國疾病管制與預防中心和其他機構已經闡述的那樣。

And so basically, we have, already, a phase 4 program ongoing, as and we have a more stringent com vigilance review, ongoing since we saw the SAEs primarily in La Reunion, and this has been the cornerstones in our. Response and clarification vis a vis the FDA.

因此，基本上我們已經啟動了第四階段項目，並且自從我們在留尼旺島主要發現嚴重不良事件以來，我們一直在進行更嚴格的社區警戒審查，這已成為我們工作的基石。針對FDA的回應和澄清。

Got it. Okay. Very helpful. Thanks for answering my questions.

知道了。好的。很有幫助。謝謝你回答我的問題。

More than welcome, Maury.

非常歡迎，莫里。

[Romy O'Connor from VLK].

[VLK 的 Romy O'Connor]

Hi, thanks for taking my questions. Two, if I may. The first one, with this, talk about, possibility of the LA 15, yeah, being maybe, earlier than expected, do you think you're going to be able to launch on time then for the 2027 peak season? And on exchick, I was just wondering how, sales are expected to grow, going forward from here. And what the future drivers are. Thank you.

您好，感謝您回答我的問題。如果可以的話，我想說兩個。首先，考慮到洛杉磯 15 號航展可能會比預期更早開幕，您認為您能夠按時在 2027 年旺季前開幕嗎？至於 exchick，我只是想知道從現在開始，銷售額預計會如何成長。以及未來的駕駛會是什麼樣的人。謝謝。

Yeah, so first of all, on the timeline for VLA 15, so we have, Pfizer reconfirmed, the regulatory submission timeline for next year.

是的，首先，關於 VLA 15 的時間表，輝瑞公司再次確認了明年的監管提交時間表。

The regulatory submission timeline next year is the very pivotal and important underlying hypothesis for a launch in the latter part of 2027.

明年的監理申報時間表是 2027 年下半年產品上市的關鍵和重要前提。

Because, the program is, under, accelerated food pathway, fast track, etc. So all of that, is important in order to meet the timeline. Of a launch in the autumn of 2027 because remember, the vaccine needs three shots for priming. So this means if you want to have people protected for the Lyme season in 2028, you've got to start, vaccinating towards the latter part of 2027. Currently, all timelines communicated by Pfizer, do support that notion and that timeline.

因為該項目屬於加速食品途徑、快速通道等範疇。所以所有這些對於按時完成專案都很重要。預計在 2027 年秋季推出，因為請記住，疫苗需要接種三劑才能產生免疫力。所以這意味著，如果你想讓人們在 2028 年萊姆病流行季得到保護，你必須從 2027 年下半年開始接種疫苗。目前，輝瑞公司公佈的所有時間表都支持這一觀點和時間表。

With regards to, the Ik situation, it's, of course, not an easy question, to answer because, we see, we continue to see, major growth opportunities for exchick, in the travel sector but also in the countries where the CIC virus is endemic.

至於 Ik 的情況，這當然不是一個容易回答的問題，因為我們看到，而且我們繼續看到，exchick 在旅遊業以及 CIC 病毒流行的國家都有巨大的成長機會。

Given that the, single-shot live attenuated approach, has, a particular importance for countries where you have recurrent outbreaks.

鑑於單劑減毒活疫苗接種方法對於反覆爆發疫情的國家來說尤其重要。

And, we are working with many different countries right now in potentially ensuring access, of the vaccine, in those territories. It's a bit too early to talk about the, those territory expansion activities. And what it will really mean in terms of commercial opportunities. We have two existing partners with Bhutanan for Brazil and South America and the Serum Institute of India for Asia, but there are more countries, there are more territories we are currently in dialogue with, and we are trying everything to accelerate market access in those countries, and you know how long it will really take to establish.

目前，我們正在與許多不同的國家合作，以確保這些地區能夠獲得疫苗。現在談論這些領土擴張活動還為時過早。以及這在商業機會方面究竟意味著什麼。我們目前與不丹在巴西和南美洲有兩家合作夥伴，與印度血清研究所在亞洲有兩家合作夥伴，但還有更多國家、更多地區我們正在進行對話，我們正在盡一切努力加快在這些國家的市場准入，你也知道真正建立市場需要多長時間。

Vaccination against chikungunya in the world of travel vaccinations has to be seen. I mean, it's, history has told us that it's not easy to predict, growth trajectory for travel vaccines, and as such, I think we will hopefully be able to provide further guidance, as part of our 20,276, outlook. In the earlier part of next year.

在旅遊疫苗接種領域，基孔肯雅疫苗接種仍有待觀察。我的意思是，歷史告訴我們，旅行疫苗的成長軌跡並不容易預測，因此，我認為我們希望能夠提供進一步的指導，作為我們 20,276 年展望的一部分。明年年初。

Great. Thank you.

偉大的。謝謝。

(Operator Instructions)

（操作說明）

[Theodora Robile] from Goldman Sachs.

來自高盛的西奧多拉·羅比勒。

Hi, thanks for taking my question. Just one from me. So in today's release, you refer to uncertainty around private and public funding opportunities being a consideration and whether you take your Zika vaccine candidate forward. I was just wondering, is there any more detail you can share with us in terms of factors you're weighing up, some sort of level of funding you'd need to see to take the candidate forward? Any further details would be appreciated. Thank you.

您好，感謝您回答我的問題。我只有一個。所以在今天的新聞稿中，您提到私人和公共資金機會的不確定性是您是否推進寨卡疫苗候選藥物的一個考慮因素。我只是想問一下，您能否透露更多細節，例如您正在權衡哪些因素，以及您需要多少資金才能推進候選人的申請？如有任何補充訊息，敬請告知。謝謝。

Yeah, so, we announced already that statement as part of our, ika release, that we, announced two weeks ago, and we only repeated it in today's earnings, release.

是的，我們在兩週前發布的 ika 公告中已經宣布了這一聲明，今天在收益公告中我們只是再次重申了這一點。

The, on the one hand side, we are, super happy with the data that we have generated. We have shown very good, immunogenicity data, and we have shown excellent safety data for, a vaccine that, would, also target, pregnant women, for example. At the same time, there is a significant uncertainty around the potential regulatory pathway to licensure because, it's an outbreak disease. So, a classical placebo-controlled efficacy study would probably not be deemed feasible. At the same time, there are major regulatory headwinds, against accelerated pool pathways at this point in time. And, the major, I would say NGOs, but also, public health agencies have deprioritized, Zika given the epidemiological situation.

一方面，我們對所產生的數據非常滿意。我們已經展示了非常好的免疫原性數據，並且我們已經展示了優秀的安全性數據，該疫苗還可以針對孕婦等人群。同時，由於這是一種爆發性疾病，其潛在的監管許可途徑存在很大的不確定性。因此，進行經典的安慰劑對照療效研究可能被認為是不可行的。同時，目前加速推進資金池路徑面臨巨大的監管阻力。而且，我認為主要的非政府組織以​​及公共衛生機構，鑑於當時的流行病學情勢，已經降低了寨卡病毒的優先順序。

As such, the return on investment, for, further development, is not an obvious one and certainly in the absence of, those clarifications, it would not be prudent to, invest, as V leva stand alone in this program going forward. At the same time, if there was, a substantial, funding, provided by, respective institutions, public, private, we would be very happy to do it, in a similar way, as we developed our chikungunya vaccine, for example, with substantial support by, SP.

因此，進一步發展的投資回報並不明顯，而且在沒有這些澄清的情況下，V leva 單獨參與該計劃的後續投資肯定是不明智的。同時，如果相關機構（公共或私人機構）能夠提供大量資金，我們將非常樂意以類似的方式進行這項工作，就像我們開發基孔肯雅疫苗一樣，例如，我們得到了SP的大力支持。

At this point in time, again, we keep the options open, but we count also on the understanding here that, we need to be mindful of capital allocations and returns on investments, even if there was an exciting, product candidate or there is an exciting product candidate and certainly, an interesting medical opportunity.

目前，我們仍然保留各種選擇，但我們也相信，我們需要注意資本配置和投資回報，即使有一個令人興奮的候選產品，或者確實有一個令人興奮的候選產品，以及一個有趣的醫療機會。

(Operator Instructions)

（操作說明）

We have no further questions at this time. I will now hand back to you for closing remarks.

目前我們沒有其他問題。現在我將發言權交還給各位，請你們作總結發言。

Yes. Thank you everyone for having taken time today. We are very thankful about your support. And again, we are looking forward to delivering. On our expectations for the remainder of the year and then most importantly, to the next big and biggest catalyst for Valeva in its history with li lime data coming in next year. Thanks so much and have a good remainder of the day. Bye-bye.

是的。感謝大家今天抽出時間。我們非常感謝您的支持。我們再次期待著交付。我們對今年剩餘時間的預期，以及最重要的是，明年即將公佈的石灰數據將成為 Valeva 歷史上下一個重大催化劑。非常感謝，祝您今天餘下的時間過得愉快。再見。