Biontech SE (BNTX) 2022 Q2 法說會逐字稿

Welcome to the BioNTech Second Quarter 2022 Update Call. I would like to hand the call over to the Vice President of Investor Relations and Strategy, Sylke Maas. Please go ahead, Sylke.

歡迎來到 BioNTech 2022 年第二季度更新電話會議。我想將這個電話轉給投資者關係和戰略副總裁 Sylke Maas。請繼續，西爾克。

Good morning and good afternoon. Thank you for joining us today to review BioNTech's second quarter '22 clinical and operational progress and financial results. A few housekeeping items before we start. I invite you to view the slides that accompany the webcast and the second quarter 2022 press release, both of which were issued this morning and can be found in the Investors section of our website.

早上好，下午好。感謝您今天加入我們，回顧 BioNTech 的第二季度 '22 臨床和運營進展以及財務業績。在我們開始之前有一些家務。我邀請您查看網絡廣播和 2022 年第二季度新聞稿隨附的幻燈片，這兩份文件均於今天上午發布，可在我們網站的“投資者”部分找到。

As outlined on Slide 2, during today's presentation, we will be making several forward-looking statements. These forward-looking statements include, but are not limited to, our current COVID-19 vaccine revenues, as these include figures that are derived from the preliminary estimates provided by our partners; our estimated financial results for 2022; the continued global demand for our COVID-19 vaccine; our target vaccine production capacity for 2022 and beyond; our ability to supply our COVID-19 vaccine; the planned next steps in our pipeline programs; the timing for enrollment, initiation, completion, reporting of data from our clinical trials; the timing of our ability to obtain and maintain regulatory approval for our product candidates; and other risks described in our filings made with the U.S. Securities and Exchange Commission, including our most recent quarterly report filed today.

如幻燈片 2 所述，在今天的演示中，我們將發表幾項前瞻性陳述。這些前瞻性陳述包括但不限於我們目前的 COVID-19 疫苗收入，因為這些包括來自我們合作夥伴提供的初步估計的數據；我們預計 2022 年的財務業績；全球對我們的 COVID-19 疫苗的持續需求；我們在 2022 年及以後的目標疫苗生產能力；我們提供 COVID-19 疫苗的能力；我們管道計劃中計劃的下一步；註冊、啟動、完成、報告我們臨床試驗數據的時間；我們獲得和維持對我們的產品候選者的監管批准的時間；以及我們向美國證券交易委員會提交的文件中描述的其他風險，包括我們今天提交的最新季度報告。

Actual results could differ from those we currently anticipate. You are, therefore, cautioned not to place undue reliance on any forward-looking statements, which speak only as of today, shared today during this conference call and webcast.

實際結果可能與我們目前的預期不同。因此，請注意不要過分依賴任何前瞻性陳述，這些陳述僅在今天發表，在今天的電話會議和網絡直播中分享。

Also, please note that Slides 3, 4 and 5 provide details and important safety information regarding our COVID-19 vaccine. Finally, you can find the agenda for today's call on Slide 6. It's my pleasure to welcome the members of BioNTech's management team participating in today's call.

另請注意，幻燈片 3、4 和 5 提供了有關我們 COVID-19 疫苗的詳細信息和重要安全信息。最後，您可以在幻燈片 6 上找到今天電話會議的議程。我很高興歡迎 BioNTech 管理團隊的成員參加今天的電話會議。

I'm joined today by our CEO and Co-Founder, Ugur Sahin; Ozlem Tureci, our Chief Medical Officer and Co-Founder; Jens Holstein, our Chief Financial Officer; and Ryan Richardson, our Chief Strategy Officer.

今天，我們的首席執行官兼聯合創始人 Ugur Sahin 加入了我的行列； Ozlem Tureci，我們的首席醫療官兼聯合創始人； Jens Holstein，我們的首席財務官；和我們的首席戰略官 Ryan Richardson。

I would like to turn the call over to Ugur Sahin.

我想把電話轉給 Ugur Sahin。

Thank you, Sylke. Good morning and good afternoon and heartly welcome to all call participants. We appreciate your continued support. Today, it's my pleasure to provide an overview of the key highlights from the second quarter and our objectives for the remainder of the year. Our team will provide further details before we open the call for questions.

謝謝你，西爾克。早上好，下午好，衷心歡迎所有電話參與者。我們感謝您一直以來的支持。今天，我很高興概述第二季度的主要亮點以及我們今年剩餘時間的目標。在我們開始提問之前，我們的團隊將提供更多詳細信息。

We have made significant progress in the second quarter as we continued to advance toward our vision of building our global immunotherapy powerhouse. With our deep expertise in immunology and fully integrated spectrum of translational research, development, manufacturing and commercialization competencies, we are all well positioned for success.

隨著我們繼續朝著建立全球免疫治療強國的願景前進，我們在第二季度取得了重大進展。憑藉我們在免疫學方面的深厚專業知識和全面整合的轉化研究、開發、製造和商業化能力，我們都為成功做好了準備。

We are leveraging a multi-platform strategy built on our innovation engine comprised of various cutting-edge technologies. This of course enables us to advance our differentiated pipeline of novel immunotherapies for multiple waves of innovation.

我們正在利用由各種尖端技術組成的創新引擎構建的多平台戰略。這當然使我們能夠為多波創新推進我們差異化的新型免疫療法管道。

We have earned a position of market leadership with our COVID-19 vaccine. Our goal is to continue to deepen that leadership. We believe that SARS-CoV-2 will be with us for the foreseeable future. It is therefore necessary to evolve our products to address the ever-changing challenges posed by the virus.

我們的 COVID-19 疫苗贏得了市場領導地位。我們的目標是繼續深化這種領導。我們相信，在可預見的未來，SARS-CoV-2 將與我們同在。因此，有必要改進我們的產品以應對病毒帶來的不斷變化的挑戰。

In oncology, we have 18 programs in 23 ongoing clinical trials, including 5 randomized Phase II trials. We intend to advance several of these programs into pivotal studies in the coming years.

在腫瘤學方面，我們在 23 個正在進行的臨床試驗中擁有 18 個項目，其中包括 5 個隨機 II 期試驗。我們打算在未來幾年將其中幾個項目推進到關鍵研究中。

In infectious diseases, we have 1 ongoing Phase I program and more than 10 preclinical programs addressing diseases which represent significant health challenges globally. We expect to bring 4 of these programs into the clinic this or beginning of next year.

在傳染病方面，我們有 1 個正在進行的 I 期項目和 10 多個臨床前項目，以應對代表全球重大健康挑戰的疾病。我們預計今年或明年年初將其中 4 個項目引入臨床。

Our aim is to bring multiple new products in oncology and infectious disease to market over the next 3 to 5 years. We believe that our technology innovation engine has the potential to address a broad set of diseases beyond cancer and infectious disease.

我們的目標是在未來 3 到 5 年內將多種腫瘤學和傳染病新產品推向市場。我們相信，我們的技術創新引擎有潛力解決癌症和傳染病以外的廣泛疾病。

We envision application of our mRNA technology in the treatment of inflammatory, cardiovascular and neurodegenerative diseases and in regenerative medicine. We have several active exploratory programs in these areas that are in the product candidate selection stage. We aim to continuously impact the health of people around the world and thereby create long-term value for our shareholders.

我們設想將我們的 mRNA 技術應用於治療炎症、心血管和神經退行性疾病以及再生醫學。我們在這些領域有幾個積極的探索性計劃，它們正處於產品候選選擇階段。我們的目標是不斷影響世界各地人們的健康，從而為我們的股東創造長期價值。

I will now provide an overview of our accomplishments from the second quarter, starting with the corporate and pipeline updates on Slide 8. Following a better-than-anticipated first quarter, the second quarter of 2022 was in line with our financial expectations. We reported total revenues of EUR 3.2 billion contributing to total revenues of EUR 9.6 billion in the first half of the year.

我現在將概述我們第二季度的成就，從幻燈片 8 上的公司和管道更新開始。繼第一季度好於預期之後，2022 年第二季度符合我們的財務預期。我們報告的總收入為 32 億歐元，其中上半年的總收入為 96 億歐元。

In June, we broke ground and began construction of our first BioNTainer mRNA manufacturing facility on the African continent in Kigali, Rwanda. The site will manufacture a range of mRNA-based vaccines to address the needs of the African Union member states. This potentially includes our COVID-19 vaccine as well as investigational malaria and tuberculosis vaccine candidates that we expect to advance into the clinic in the coming months.

6 月，我們在盧旺達基加利的非洲大陸破土動工並開始建設我們的第一個 BioNTainer mRNA 製造設施。該網站將生產一系列基於 mRNA 的疫苗，以滿足非洲聯盟成員國的需求。這可能包括我們的 COVID-19 疫苗以及我們預計在未來幾個月內進入臨床的研究性瘧疾和結核病候選疫苗。

We have signed a new equal share cost and profit collaboration agreement with Genmab for the joint development of an antibody targeting CD27. This expands our existing strategic collaboration for developing next-generation immune checkpoint modulators. There are several positive developments in our oncology pipeline.

我們與 Genmab 簽署了一項新的成本和利潤均攤合作協議，共同開發針對 CD27 的抗體。這擴大了我們在開發下一代免疫檢查點調節劑方面的現有戰略合作。我們的腫瘤學管道有幾個積極的發展。

Positive data from an investigator-initiated Phase I study of BNT122, our iNeST product candidate partnered with Genentech, were reported at 2022 as committing with encouraging signs of immunogenicity and disease control in patients with resected pancreatic cancers.

我們與基因泰克合作的 iNeST 產品候選者 BNT122 的一項由研究者發起的 I 期研究的陽性數據報告於 2022 年，在切除的胰腺癌患者中出現了令人鼓舞的免疫原性和疾病控制跡象。

We have recently initiated 2 more clinical trials. This includes a Phase I trial of BNT142, our second product built on the RiboMabs platform. We've also dosed the first patient in the first human Phase I trial of our FixVac product candidate, BNT116, in patients with advanced non-small cell lung cancer.

我們最近又啟動了 2 項臨床試驗。這包括 BNT142 的 I 期試驗，這是我們在 RiboMabs 平台上構建的第二個產品。我們還在我們的 FixVac 候選產品 BNT116 的第一個人體 I 期試驗中對晚期非小細胞肺癌患者進行了給藥。

Finally, BNT211, our next-generation CAR-T cell therapy, received an EMA Priority Medicines or PRIME designation for third or later line treatment of testicular cancer. As a result, BNT211 will benefit from early and more frequent interactions with the EMA for the next development phase. The PRIME designation came on the heels of exciting preliminary clinical data from 14 evaluable patients presented at the AACR meeting. We've reported details of the data in our earnings call last quarter.

最後，我們的下一代 CAR-T 細胞療法 BNT211 獲得了 EMA 優先藥物或 PRIME 指定，用於睾丸癌的三線或更高線治療。因此，在下一個開發階段，BNT211 將受益於與 EMA 的早期和更頻繁的交互。在 AACR 會議上提交的 14 名可評估患者的令人興奮的初步臨床數據之後，獲得了 PRIME 稱號。我們在上個季度的財報電話會議中報告了數據的詳細信息。

On Slide 9, we highlight several significant achievements in our COVID-19 vaccine program that further strengthened our market leadership position. We continued to expand our label and have received multiple regulatory approvals for our COVID-19 vaccine in the second quarter.

在幻燈片 9 中，我們強調了我們在 COVID-19 疫苗計劃中取得的幾項重大成就，這些成就進一步鞏固了我們的市場領導地位。我們繼續擴大我們的標籤，並在第二季度獲得了多項 COVID-19 疫苗的監管批准。

We received emergency use authorization for vaccination of children 6 months through 4 years of age. The label now includes a 3-dose series in this age group. We also received emergency use authorization for our third booster in children aged 5 through 11 years old.

我們獲得了 6 個月至 4 歲兒童疫苗接種的緊急使用授權。該標籤現在包括該年齡組的 3 劑系列。我們還獲得了用於 5 至 11 歲兒童的第三個助推器的緊急使用授權。

Recently, our COVID-19 vaccine received full approval in the United States for adolescents, 12 years and older, and we've have submitted for full approval in this age group in several other geographies. With these regulatory approvals, our COVID-19 vaccine has achieved one of the broadest labels among available vaccines.

最近，我們的 COVID-19 疫苗在美國獲得了針對 12 歲及以上青少年的完全批准，我們已經在其他幾個地區提交了該年齡組的完全批准。憑藉這些監管部門的批准，我們的 COVID-19 疫苗已成為可用疫苗中最廣泛的標籤之一。

On the distribution front, at the beginning of July, we have delivered more than 3.6 billion doses to 180 countries and regions since launched in December 2020. The strong global distribution makes us the market leading provider of COVID-19 vaccines. We've recently signed a new agreement with the U.S. government to supply an additional 105 million COVID vaccine doses with an option for the U.S. to purchase up to an additional 195 million doses.

在分銷方面，自 2020 年 12 月推出以來，在 7 月初，我們已向 180 個國家和地區交付了超過 36 億劑疫苗。強大的全球分銷使我們成為市場領先的 COVID-19 疫苗供應商。我們最近與美國政府簽署了一項新協議，將額外提供 1.05 億劑 COVID 疫苗，美國可選擇購買多達 1.95 億劑。

Our 2022 order book now includes approximately 2.5 billion doses. Global health equity is a priority for us, which we are pursuing with a multiprong strategy. This includes our pledge to provide 2 billion doses for low- and middle-income countries by the end of 2022. We are on the track to achieve this goal. As part of our long-term COVID-19 strategy, we aim to develop vaccines that generate a more robust, bold and long-lasting immune response and enable task response to the dynamics of emerging new variants.

我們的 2022 年訂單現在包括大約 25 億劑。全球健康公平是我們的首要任務，我們正在通過多管齊下的戰略來追求這一目標。這包括我們承諾到 2022 年底為低收入和中等收入國家提供 20 億劑疫苗。我們正在實現這一目標。作為我們長期 COVID-19 戰略的一部分，我們的目標是開發能夠產生更強大、更大膽和更持久的免疫反應的疫苗，並能夠對新出現的新變種的動態做出反應。

In our clinical programs, our Omicron BA.1 adapted monovalent and bivalent vaccine candidates demonstrated high immune responses and tolerable safety profile. As part of our relentless development work aimed at addressing COVID-19 variants, we now have regulatory submission for Omicron BA.1 and BA.4/5 adapted bivalent vaccines ongoing worldwide.

在我們的臨床項目中，我們的 Omicron BA.1 適應單價和二價候選疫苗表現出高免疫反應和可耐受的安全性。作為我們旨在解決 COVID-19 變體的不懈開發工作的一部分，我們現在在全球範圍內提交了適用於 Omicron BA.1 和 BA.4/5 的二價疫苗的監管提交。

Our strategy includes multiple next-generation COVID-19 vaccine approaches. This effort is progressing with the initiation of a Phase II trial of BNT162b5, the first of several vaccine candidates designed to optimize and prolong the immune response. BNT162b5 is a bivalent vaccine candidate based on enhanced versions of SARS-CoV-2 ancestral strain and Omicron BA.2 variant spike proteins engineered for broader immunity.

我們的戰略包括多種下一代 COVID-19 疫苗方法。隨著 BNT162b5 II 期試驗的啟動，這項工作正在取得進展，這是旨在優化和延長免疫反應的幾種候選疫苗中的第一種。 BNT162b5 是一種二價候選疫苗，基於 SARS-CoV-2 祖先菌株的增強版本和 Omicron BA.2 變異刺突蛋白，旨在實現更廣泛的免疫。

Slide 10 underscores the critical need to reduce vaccine adaptation timelines to match the speed at which the virus mutates. We have all experienced the rise and fall of multiple COVID-19 variants over the last 2.5 years. Since the emergence of the Omicron lineage, every 2 to 3 months, we've seen a new sublineage. Because SARS-CoV-2 is rapidly changing, it is imperative to establish vaccine development protocols and regulatory pathways that keep up with the pace of virus mutants.

幻燈片 10 強調了縮短疫苗適應時間以匹配病毒變異速度的迫切需要。在過去的 2.5 年中，我們都經歷了多種 COVID-19 變體的興衰。自從 Omicron 譜係出現以來，每 2 到 3 個月，我們就會看到一個新的亞譜系。由於 SARS-CoV-2 正在迅速變化，因此必須建立跟上病毒突變速度的疫苗開發方案和監管途徑。

With the current development path, it generally has taken us 8 months to develop a new variant adapted vaccine and progress its full clinical trial. Discussions with regulators are ongoing to define the most appropriate pathways to leverage current experience and ensure that variant adaptive vaccines can be made available in the future to address newly emerging variants or sublineages in a timely manner. We believe that based on the plethora of generated data is a potential to reduce the existing vaccine adaptation timelines to as little as 3 months.

按照目前的開發路徑，我們一般需要8個月的時間來開發一種新的變種適應疫苗並推進其完整的臨床試驗。與監管機構的討論正在進行中，以確定最合適的途徑來利用當前經驗，並確保將來可以提供變體適應性疫苗，以及時解決新出現的變體或亞系。我們認為，基於大量生成的數據，有可能將現有的疫苗適應時間縮短至 3 個月。

Slide 11. Regulatory bodies around the globe agree that current vaccines require adaptation to the new Omicron strain sublineages. Based on the scientific evidence, including our BA.1 adaptive vaccine clinical data and BA.4/5 preclinical data presented at the FDA Advisory Committee meeting in June, the FDA published guidance recommending the introduction of bivalent booster vaccines incorporating the spike protein from the Omicron BA.4/5 sublineage for the vaccination campaigns this fall.

幻燈片 11. 全球監管機構一致認為，目前的疫苗需要適應新的 Omicron 菌株亞系。基於科學證據，包括我們在 6 月 FDA 諮詢委員會會議上提交的 BA.1 適應性疫苗臨床數據和 BA.4/5 臨床前數據，FDA 發布了指南，建議引入含有來自美國的刺突蛋白的二價加強疫苗。用於今年秋季疫苗接種活動的 Omicron BA.4/5 亞系。

In Europe, we have finalized BA.1 adapted bivalent vaccine submission to EMA, including a comprehensive clinical data package. In addition, we are preparing a rolling submission of preclinical and CMC data for an Omicron BA.4/5 adapted bivalent vaccine to EMA, which we expect to begin submitting this month.

在歐洲，我們已經完成了向 EMA 提交的 BA.1 適應二價疫苗，包括一個全面的臨床數據包。此外，我們正在準備向 EMA 提交 Omicron BA.4/5 適應二價疫苗的臨床前和 CMC 數據滾動提交，我們預計將於本月開始提交。

In parallel, submission of our Omicron-adapted bivalent vaccine data packages is advancing with regulators worldwide. We are preparing for a clinical trial of our Omicron BA.4/5-adapted bivalent vaccine, which is expected to commence in August.

與此同時，我們適應 Omicron 的二價疫苗數據包的提交正在與全球監管機構一起推進。我們正在準備我們的 Omicron BA.4/5 適應二價疫苗的臨床試驗，預計將於 8 月開始。

In anticipation of a launch of the Omicron-adapted bivalent vaccines as early as October 2022, we have started to manufacture both BA.1 and BA.4/5 variant-adapted vaccines. This proactive approach enables us for multiple launch scenarios based on the different regulatory recommendations. We plan to supply both vaccines for the booster campaign this fall.

預計最早將於 2022 年 10 月推出適用於 Omicron 的二價疫苗，我們已開始生產適用於 BA.1 和 BA.4/5 變體的疫苗。這種積極主動的方法使我們能夠根據不同的監管建議進行多種發射場景。我們計劃為今年秋天的加強活動提供兩種疫苗。

I'm proud of our team and the cooperation of our partners. I'm grateful for the hard work that has been continuously delivered to provide vaccines to people around the globe to address this evolving COVID-19 threat.

我為我們的團隊和合作夥伴的合作感到自豪。我感謝為應對這一不斷演變的 COVID-19 威脅而不斷為全球人民提供疫苗而付出的辛勤工作。

With that, I will turn the call over to Ozlem.

有了這個，我會把電話轉給 Ozlem。

Thank you, Ugur. I'm delighted to provide our pipeline updates to date. First, Slide 13. As Ugur mentioned, we shared our most recent data from the clinical trial evaluating safety and immunogenicity of Omicron BA.1-adapted vaccine candidates with the regulators, including the FDA Vaccine Advisory Committee. This slide shows one of our representative data sets: testing of adapted vaccine candidates as a booster dose in vaccinated individuals. One month after administration the fourth dose of the monovalent Omicron BA.1-adapted candidate in triple-vaccinated individuals increased neutralizing geometric mean titers against Omicron BA.1 13.5 and 19.6-fold above pre-booster dose levels.

謝謝你，烏古爾。我很高興提供我們迄今為止的管道更新。首先，幻燈片 13。正如 Ugur 所提到的，我們與包括 FDA 疫苗諮詢委員會在內的監管機構分享了評估 Omicron BA.1 適應疫苗候選者的安全性和免疫原性的臨床試驗的最新數據。這張幻燈片顯示了我們的一個代表性數據集：在接種疫苗的個體中測試適應性候選疫苗作為加強劑量。施用後一個月，在三聯疫苗個體中，第四劑單價 Omicron BA.1 適應候選藥物增加了針對 Omicron BA.1 的中和幾何平均滴度，比加強劑量水平高出 13.5 倍和 19.6 倍。

Booster vaccination with Omicron BA.1-adapted bivalent vaccine candidates at the 30 and 60 microgram doses resulted in a 9.1- and 10.9-fold increase in neutralizing geometric mean titers against Omicron BA.1. This means both monovalent and bivalent Omicron BA.1-adapted vaccine candidates met superiority for the ratio of geometric mean titers and non-inferiority for seroresponses compared to the current vaccine.

用 30 和 60 微克劑量的 Omicron BA.1 適應二價候選疫苗加強接種導致針對 Omicron BA.1 的中和幾何平均滴度增加 9.1 倍和 10.9 倍。這意味著與當前疫苗相比，單價和二價 Omicron BA.1 適應的候選疫苗在幾何平均滴度比和血清反應的非劣效性方面均具有優勢。

The monovalent Omicron-adapted vaccine candidate showed super superiority for the ratio of geometric mean titers. The safety and reactogenicity profile of the Omicron BA.1-adapted vaccine candidates were overall similar to BNT162b2 with similar local reactions and systemic events.

單價 Omicron 適應的候選疫苗在幾何平均滴度比方面顯示出超強的優勢。適應 Omicron BA.1 的候選疫苗的安全性和反應原性概況總體上與 BNT162b2 相似，具有相似的局部反應和全身事件。

Overall, these data provide the proof of concept for Omicron-adapted vaccine candidates, achieving immunogenicity and safety goals and meeting the regulatory requirements for a successful trial. We also tested neutralization activity of the sera generated in this trial against the Omicron BA.4/5 sublineage. These were lower compared to the neutralization activity against Omicron BA.1 for both monovalent and bivalent BA.1-adapted vaccine candidates. This is not surprising given the mutational differences between the spike proteins of these 2 sublineages.

總體而言，這些數據為適應 Omicron 的候選疫苗提供了概念證明，實現了免疫原性和安全性目標，並滿足了成功試驗的監管要求。我們還測試了該試驗中產生的血清對 Omicron BA.4/5 亞系的中和活性。與單價和二價 BA.1 適應疫苗候選者對 Omicron BA.1 的中和活性相比，這些活性較低。鑑於這兩個亞譜系的刺突蛋白之間的突變差異，這並不奇怪。

On Slide 14, the sequences show how Omicron BA.4/5 is distinct from the BA.2 and BA.1 strains. BA.4/5 sublineage is carrying its own unique mutations, including changes in the receptor binding domain, the RBD; and the N-terminal domain, the NTD. The new mutation in the RBD may change its ability to latch on to host cells and evade immunity resulting from exposure to earlier strains. Of note, BA.4/5 are distinct from BA.1 in their N-terminal domain and, in fact, are more closely related to the wild type ancestral strain in that regard.

在幻燈片 14 上，序列顯示了 Omicron BA.4/5 與 BA.2 和 BA.1 菌株的不同之處。 BA.4/5 亞系攜帶其獨特的突變，包括受體結合域 RBD 的變化；和 N 端結構域，NTD。 RBD 中的新突變可能會改變其鎖定宿主細胞和逃避因暴露於早期菌株而產生的免疫力的能力。值得注意的是，BA.4/5 在其 N 端結構域與 BA.1 不同，事實上，在這方面與野生型祖先菌株更密切相關。

Our clinical development program has extended to include BA.4/5-adapted vaccine candidates in addition to BA.1 now. As previously mentioned, for the BA.4/5 candidates, we expect a clinical trial will be initiated in August this year. We, however, already have cross neutralization data in mouse models.

我們的臨床開發計劃現已擴展到除了 BA.1 之外，還包括適應 BA.4/5 的候選疫苗。如前所述，對於 BA.4/5 候選者，我們預計將於今年 8 月啟動臨床試驗。然而，我們已經在小鼠模型中獲得了交叉中和數據。

As shown on Slide 15, Omicron BA.4/5-adapted monovalent and bivalent boosters in mice substantially increased neutralization responses for all Omicron subvariants as well as the wild-type strain. Compared to Omicron BA.1-adapted boosters, both the monovalent Omicron BA.4/5-adapted vaccine as well as the bivalent Omicron BA.4/5-adapted vaccine show strong neutralization of the Omicron sublineages, including the most distinct sublineage BA.1.

如幻燈片 15 所示，小鼠中 Omicron BA.4/5 適應的單價和二價增強劑顯著增加了所有 Omicron 亞變體以及野生型菌株的中和反應。與適應 Omicron BA.1 的加強劑相比，適應 Omicron BA.4/5 的單價疫苗和適應 Omicron BA.4/5 的二價疫苗均顯示出對 Omicron 亞系的強中和作用，包括最獨特的亞系 BA .1。

Based on our previous experience, we consider the cross neutralization data from such mouse models to be predictive for what will be observed in humans. Our extensive clinical experience with variant-adapted vaccines and the broad data base may enable preclinical immunogenicity data and CMC package to be sufficient for future emergency use approvals and authorizations subject to regulatory approval. This may enable a fast regulatory pathway for timely response to emerging variants.

根據我們之前的經驗，我們認為來自此類小鼠模型的交叉中和數據可以預測人類將觀察到的情況。我們在變體適應疫苗方面的豐富臨床經驗和廣泛的數據庫可能使臨床前免疫原性數據和 CMC 包足以滿足未來的緊急使用批准和受監管批准的授權。這可能會為及時響應新出現的變體提供快速的監管途徑。

Now to Slide 16. Our long-term scientific strategy includes exploring multiple next-generation COVID-19 vaccine approaches to achieve a broad and longer lasting immune response and high levels of protection against SARS-CoV-2 as it evolves. We are designing and testing several different constructs that engage multiple effector arms of the immune system, including antibodies and T cells.

現在轉到幻燈片 16。我們的長期科學戰略包括探索多種下一代 COVID-19 疫苗方法，以實現廣泛和更持久的免疫反應，並隨著 SARS-CoV-2 的發展提供高水平的保護。我們正在設計和測試幾種不同的結構，這些結構涉及免疫系統的多個效應臂，包括抗體和 T 細胞。

In July, we and our partner, Pfizer, dosed the first patient in the Phase II study evaluating the safety, tolerability and immunogenicity of BNT162b5, our first next-generation vaccine candidate, to enter the clinic. BNT162b5 is a bivalent vaccine candidate, which includes enhanced SARS-CoV-2 spike antigens of the ancestral strain and the Omicron BA.2 sublineage engineered for increased immunogenicity. BNT162b5 is modified to elicit antibodies that we believe will offer superior protection against infection regardless of the circulating variant. This is accomplished through the introduction of modifications designed to expose more neutralization sensitive epitopes to the immune system.

7 月，我們和我們的合作夥伴輝瑞（Pfizer）在 II 期研究中給第一位患者註射了進入臨床的第一個下一代候選疫苗 BNT162b5 的安全性、耐受性和免疫原性。 BNT162b5 是一種二價候選疫苗，其中包括增強的 SARS-CoV-2 祖先菌株的刺突抗原和 Omicron BA.2 亞系，旨在提高免疫原性。 BNT162b5 被修飾以引發抗體，我們認為無論循環變體如何，這些抗體都能提供卓越的抗感染保護。這是通過引入旨在將更多中和敏感表位暴露於免疫系統的修飾來實現的。

We have also initiated preclinical work on other next-generation vaccine modalities including multi-antigen T cell-enhancing vaccines and potential Pan-SARS-CoV-2 vaccines. We believe that T cell immunity to COVID-19 is important when striving for more durable and broad protection and protection against severe disease caused. We anticipate advancing candidates for both T cell enhancing and Pan-SARS-CoV-2 approaches into the clinic in the second half of 2022.

我們還啟動了其他下一代疫苗模式的臨床前工作，包括多抗原 T 細胞增強疫苗和潛在的 Pan-SARS-CoV-2 疫苗。我們認為，對 COVID-19 的 T 細胞免疫在爭取更持久和更廣泛的保護以及防止引起的嚴重疾病時非常重要。我們預計 T 細胞增強和 Pan-SARS-CoV-2 方法的候選藥物將在 2022 年下半年進入臨床。

We believe that taking this multipronged approach will enable us to achieve our ultimate goal of delivering a Pan-SARS-CoV-2 vaccine with higher and more durable protection and superior (inaudible), helping us to better manage future variants of concern.

我們相信，採取這種多管齊下的方法將使我們能夠實現我們的最終目標，即提供具有更高、更持久保護和優越（聽不清）的 Pan-SARS-CoV-2 疫苗，幫助我們更好地管理未來的關注變體。

Slide 17 highlights our expansive oncology pipeline that is grounded in our multi-modality toolbox and our focused execution over the last years. We have reviewed our oncology pipeline extensively at our Innovation Day in June. However, we had developments since then.

幻燈片 17 突出了我們廣泛的腫瘤學管道，該管道基於我們的多模態工具箱和我們過去幾年的重點執行。我們在 6 月的創新日廣泛審查了我們的腫瘤學管道。然而，我們從那以後有了發展。

We now have a total of 18 clinical product candidates leveraging immune therapeutic modalities that are either targeting tumor sets directly or that are modulating the immune response against the tumor. Our programs have combination potential both within our pipeline and with other approved therapies.

我們現在共有 18 個臨床產品候選者利用免疫治療方式，這些方式要么直接針對腫瘤組，要么調節針對腫瘤的免疫反應。我們的項目在我們的管道內和其他批准的療法中都有組合潛力。

Our product candidates are currently being evaluated in 23 ongoing clinical trials, 5 of which are randomized Phase II trials. We initiated Phase I trials for BNT116, a new program of our FixVac platform; and for BNT142, a second program from our RiboMabs platform. We also have a new preclinical program through our collaboration with our partner, Genmab, BNT313, the CD27 antibody for solid tumors.

我們的候選產品目前正在 23 項正在進行的臨床試驗中進行評估，其中 5 項是隨機 II 期試驗。我們啟動了 BNT116 的 I 期試驗，這是我們 FixVac 平台的一個新程序；對於 BNT142，我們的 RiboMabs 平台的第二個程序。通過與我們的合作夥伴 Genmab、BNT313（實體瘤的 CD27 抗體）合作，我們還制定了一項新的臨床前計劃。

Moving to Slide 18. FixVac leverages our proprietary uridine mRNA backbone for full extralization of intrinsic adjuvanticity of RNA. It encodes cancer-specific shared antigens for intravenous administration using the proprietary RNA/LPX formulation. This is optimized for induction of strong antigen-specific immune responses.

轉到幻燈片 18。FixVac 利用我們專有的尿苷 mRNA 骨架來完全外化 RNA 的內在佐劑性。它使用專有的 RNA/LPX 配方編碼用於靜脈內給藥的癌症特異性共享抗原。這針對誘導強烈的抗原特異性免疫反應進行了優化。

Our FixVac product candidate, BNT116, contains 6 of such tumor-associated antigens, covering up to 100 of patients in all major histological subtypes of non-small cell lung cancer. In July 2020, the first participant was dosed in the first-in-human clinical trial, evaluating the safety, tolerability and preliminary efficacy of BNT116 alone and in combination in patients with advanced or metastasized non-small cell lung cancer.

我們的 FixVac 候選產品 BNT116 包含 6 種此類腫瘤相關抗原，覆蓋了多達 100 名非小細胞肺癌所有主要組織學亞型的患者。 2020年7月，第一位參與者在首次人體臨床試驗中給藥，評估BNT116單獨和聯合用於晚期或轉移性非小細胞肺癌患者的安全性、耐受性和初步療效。

The trial will comprise several cohorts to establish a safe dose for BNT116 monotherapy as well as for BNT116 in combination with cemiplimab, which is Regeneron's Libtayo, in patients who have progressed on prior PD-1 inhibitor treatment and are not -- or are not eligible for chemotherapy. And in combination with docetaxel in patients who have received prior platinum-based chemotherapy.

該試驗將包括幾個隊列，以確定 BNT116 單藥治療的安全劑量以及 BNT116 與再生元的 Libtayo 聯合 cemiplimab 的安全劑量，用於先前 PD-1抑製劑治療取得進展且不符合或不符合條件的患者用於化療。並與多西他賽聯合用於先前接受過鉑類化療的患者。

On Slide 19 now, another first-in-human trials started recently for our second RiboMabs product candidate, BNT142. Our RiboMabs product candidates encode cancer cell targeting antibodies and are based on nucleoside-optimized RNA designed to minimize immunogenicity and to maximize protein expression. Product candidates are formulated using liver-targeting LNPs for intravenous delivery and aim to address the limitations of recombinant antibodies, including complex manufacturing processes.

現在在幻燈片 19 上，我們的第二個 RiboMabs 候選產品 BNT142 最近開始了另一項首次人體試驗。我們的 RiboMabs 候選產品編碼癌細胞靶向抗體，並基於核苷優化的 RNA，旨在最大限度地降低免疫原性並最大限度地提高蛋白質表達。候選產品採用肝臟靶向 LNP 進行靜脈給藥，旨在解決重組抗體的局限性，包括複雜的製造工藝。

The RiboMabs product candidate, BNT142, is a nucleoside-modified RNA that encodes the bispecific T-cell engaging antibody. This antibody targets CD3, the T cell receptor component and Claudin-6, an oncofetal cell surface antigen, found in solid tumors such as testicular and ovarian cancer. The Phase I/II dose escalation trial evaluates the safety and pharmacokinetics of BNT142 in patients with Claudin-6 positive advanced solid tumors.

RiboMabs 候選產品 BNT142 是一種核苷修飾的 RNA，可編碼雙特異性 T 細胞結合抗體。該抗體靶向 CD3（T 細胞受體成分）和 Claudin-6（一種癌胚細胞表面抗原），在實體瘤（如睾丸癌和卵巢癌）中發現。 I/II 期劑量遞增試驗評估了 BNT142 在 Claudin-6 陽性晚期實體瘤患者中的安全性和藥代動力學。

On Slide 20, at the ASCO meeting in June, positive data from an investigator-sponsored Phase I study of autogene cevumeran individualized cancer vaccine partnered with Genentech was reported. The study was conducted by our colleagues at Memorial Sloan Kettering Cancer Center in adjuvant treatment of patients with localized pancreatic adenocarcinoma.

在幻燈片 20 上，在 6 月的 ASCO 會議上，報告了與基因泰克合作的一項由研究者贊助的自體基因 cevumeran 個體化癌症疫苗 I 期研究的陽性數據。該研究由我們在紀念斯隆凱特琳癌症中心的同事進行，用於輔助治療局部胰腺腺癌患者。

After standard-of-care surgery and resection of the tumor, R0, R1 resected patients were treated with 1 dose of atezolizumab. Patients then received 8 doses of our individualized vaccine followed by standard-of-care adjuvant chemotherapy with modified FOLFIRINOX. After 12 weeks of chemotherapy, patients received 1 additional booster vaccination with our individualized vaccine.

在標準護理手術和腫瘤切除後，R0、R1 切除的患者接受 1 劑 atezolizumab 治療。患者隨後接受了 8 劑我們的個體化疫苗，隨後接受了改良 FOLFIRINOX 的標準護理輔助化療。化療 12 週後，患者接受了 1 次額外的加強疫苗接種，接種我們的個體化疫苗。

The 5-year survival rates after resection alone are as low as 10% in pancreatic cancer so that the need for further improving adjuvant treatment of early-stage pancreatic cancer is urgent. We believe our neoantigen vaccines are well suited for the treatment of this low mutation burden tumor, especially in the adjuvant setting.

胰腺癌單純切除術後5年生存率低至10%，亟需進一步完善早期胰腺癌的輔助治療。我們相信我們的新抗原疫苗非常適合治療這種低突變負荷腫瘤，尤其是在輔助治療中。

The main findings in the value of the patients that were, firstly, half of the patients developed high-magnitude immune responses against at least 1 of the targets in their individualized set of neoantigen candidates they were vaccinated with, as in this study, an assay with a high threshold was used to interrogate the immune response of all patients on an individual target basis.

患者價值的主要發現是，首先，一半的患者針對他們接種疫苗的個體化新抗原候選組中的至少一個目標產生了高幅度的免疫反應，如在本研究中，一項測定具有高閾值的用於在個體目標基礎上詢問所有患者的免疫反應。

Lower magnitude vaccine-induced immune responses against further neoantigen targets cannot be excluded. So even though pancreatic cancer is considered a low mutation tumor type with an unfavorable "tumor microenvironment," engineering of an individualized vaccine was shown to be feasible that was capable of mobilizing an adaptive T cell response.

不能排除針對其他新抗原靶點的較低量級疫苗誘導的免疫反應。因此，儘管胰腺癌被認為是具有不利“腫瘤微環境”的低突變腫瘤類型，但個體化疫苗的工程設計被證明是可行的，能夠調動適應性 T 細胞反應。

Second, patients with high magnitude vaccine-induced neoantigen-specific immune responses in this study shown by 2 immune response assays had a higher median recurrence-free survival compared to nonimmune responders, suggesting that the vaccine is conferring clinical benefit. While early, this data is encouraging and has motivated us to plan for a randomized Phase II trial.

其次，與非免疫應答者相比，本研究中具有高度疫苗誘導的新抗原特異性免疫應答的患者通過 2 種免疫應答測定顯示具有更高的中位無復發生存期，這表明疫苗正在賦予臨床益處。雖然早期，但這些數據令人鼓舞，並促使我們計劃進行一項隨機 II 期試驗。

Turning to Slide 21. I'll provide an overview of our strategic collaboration with our esteemed partners from Genmab in which we are developing multiple next-generation immune checkpoint immune modulators, designed to prime and activate antitumor T cell and natural killer cell function.

轉到幻燈片 21。我將概述我們與 Genmab 尊敬的合作夥伴的戰略合作，我們正在開發多種下一代免疫檢查點免疫調節劑，旨在啟動和激活抗腫瘤 T 細胞和自然殺傷細胞功能。

BNT311 is our bispecific antibody, which conditionally co-stimulates 4-1BB while blocking the PD-1, PD-L1 axis. This candidate is being evaluated in 2 ongoing trials including a Phase II trial in refractory or recurrent non-small cell lung cancer and a Phase I/II trial in advanced solid tumors.

BNT311 是我們的雙特異性抗體，它有條件地共刺激 4-1BB，同時阻斷 PD-1、PD-L1 軸。該候選藥物正在兩項正在進行的試驗中進行評估，包括一項針對難治性或複發性非小細胞肺癌的 II 期試驗和一項針對晚期實體瘤的 I/II 期試驗。

BNT312, our second bispecific antibody, being evaluated in advanced solid tumors stimulates the immune system for a combination of dual conditional activation of CD40 on professional antigen presenting cells and 4-1BB on antigen-specific T cells.

BNT312是我們的第二種雙特異性抗體，正在晚期實體瘤中進行評估，它刺激免疫系統結合CD40對專業抗原呈遞細胞和4-1BB對抗原特異性T細胞的雙重條件激活。

We have expanded our collaboration with Genmab through a new agreement in which we will develop BNT313, a monospecific HexaBody targeting CD27 on naive and activated T cells. We are planning to initiate a Phase I/II clinical trial in solid tumors. The first patient is expected to be dosed in the second half of this year.

我們通過一項新協議擴大了與 Genmab 的合作，我們將在其中開發 BNT313，一種針對幼稚和活化 T 細胞上的 CD27 的單特異性 HexaBody。我們正計劃啟動實體瘤的 I/II 期臨床試驗。預計第一名患者將在今年下半年給藥。

With that, I conclude the pipeline update, and we'll now turn over the call to Jens Holstein, our CFO, who will provide the financial update.

至此，我結束了管道更新，我們現在將電話轉給我們的首席財務官 Jens Holstein，他將提供財務更新。

Thank you, Ozlem, and a warm welcome to those of you on the phone. I'll start my section by presenting the key highlights for the second quarter of 2022, which you can find on Slide 23.

謝謝你，Ozlem，並熱烈歡迎電話中的各位。我將通過介紹 2022 年第二季度的主要亮點來開始我的部分，您可以在幻燈片 23 上找到這些亮點。

our total revenues reported for the second quarter of 2022 reached EUR 3.2 billion. Together with the strong first quarter, we outperformed our prior year development as I will show you when taking a look at the year-to-date figures. As a consequence to this top line number, we ended the second quarter with an operating result of EUR 2.2 billion and generated earnings per share on a fully diluted basis of EUR 6.45.

我們報告的 2022 年第二季度總收入達到 32 億歐元。加上強勁的第一季度，我們的表現優於去年的發展，因為我將在查看年初至今的數據時向您展示。由於這一頂線數字，我們在第二季度結束時的經營業績為 22 億歐元，並在完全攤薄的基礎上產生了 6.45 歐元的每股收益。

With respect to the company's financial position, we ended the second quarter of 2022 with EUR 9.3 billion of cash and cash equivalents as well as trade receivables of around EUR 10.4 billion. The trade receivables are mainly derived from our collaboration with Pfizer and mainly remained outstanding due to the contractual settlement of the gross profit share under the collaboration.

關於公司的財務狀況，截至 2022 年第二季度，我們的現金和現金等價物為 93 億歐元，貿易應收賬款約為 104 億歐元。貿易應收款項主要來自我們與輝瑞的合作，主要由於合作下毛利份額的合同結算而仍未結清。

From our outstanding trade receivables as of June 30, we had already collected EUR 5.6 billion in cash as of July 15, improving our cash and, in turn, reducing our trade receivable position subsequent to the end of Q2. By end of July 15, 2022, our cash and cash equivalents were EUR 14.9 billion.

從截至 6 月 30 日的未償還貿易應收賬款中，截至 7 月 15 日，我們已經收取了 56 億歐元的現金，從而改善了我們的現金，進而減少了我們在第二季度末之後的貿易應收賬款頭寸。截至 2022 年 7 月 15 日，我們的現金和現金等價物為 149 億歐元。

Continuing with Slide 24. We recognized approximately EUR 3.2 billion of COVID-19 vaccine revenues during the second quarter and EUR 9.5 billion during the first 6 months of 2022. The half year numbers are fully in line with our expectations and are based on invoice doses in the amount of approximately 1.2 billion.

繼續幻燈片 24。我們在第二季度確認了大約 32 億歐元的 COVID-19 疫苗收入，在 2022 年前 6 個月確認了 95 億歐元。半年的數字完全符合我們的預期，並基於發票劑量金額約為 12 億美元。

We believe the development of the pandemic has been and remains dynamic, causing a rephasing of orders and with this leading to fluctuations in quarterly revenues. Let me give you some more details on our revenue streams. As a reminder, on our COVID-19 vaccine collaborations, territories have been allocated between us, Pfizer and Fosun Pharma based on marketing and distribution rights. Our COVID-19 vaccine revenues included EUR 2 billion for the second quarter and EUR 6.6 billion for the first 6 months of 2022 that are related to our share of gross profit from COVID-19 vaccine sales in the collaboration partners territories.

我們認為，大流行的發展一直並且仍然是動態的，導致訂單重新調整，從而導致季度收入波動。讓我給你一些關於我們收入來源的更多細節。提醒一下，在我們的 COVID-19 疫苗合作中，我們、輝瑞和復星醫藥之間已經根據營銷和分銷權分配了領土。我們的 COVID-19 疫苗收入包括第二季度的 20 億歐元和 2022 年前 6 個月的 66 億歐元，這與我們在合作夥伴地區的 COVID-19 疫苗銷售毛利中所佔的份額有關。

These revenues represent a net figure, meaning that we generate 100% gross profit on those revenues. As we have mentioned in the past and explained in more detail in our financial statements and filings with the SEC, our profit share is to some extent estimated based on preliminary data shared between our collaboration partner, Pfizer, and us.

這些收入代表一個淨數字，這意味著我們從這些收入中產生 100% 的毛利潤。正如我們過去提到並在我們的財務報表和提交給美國證券交易委員會的文件中更詳細解釋的那樣，我們的利潤份額在某種程度上是根據我們的合作夥伴輝瑞公司和我們之間共享的初步數據估算的。

Our COVID-19 vaccine revenues from direct COVID-19 vaccine sales to customers in our territory were EUR 0.6 billion for the second quarter and EUR 1.7 billion for the first 6 months of 2022. Those revenues were significantly driven by the orders that were placed in late 2021 following the emergent Omicron variant. Also included in our COVID-19 vaccine revenues were EUR 0.6 billion for the second quarter and EUR 1.2 billion for the first 6 months of 2022 of revenues from sales to our collaboration partners.

第二季度，我們從直接向境內客戶銷售 COVID-19 疫苗的 COVID-19 疫苗收入為 6 億歐元，2022 年前 6 個月為 17 億歐元。這些收入很大程度上受到了以下訂單的推動在出現 Omicron 變體之後的 2021 年末。我們的 COVID-19 疫苗收入還包括第二季度的 6 億歐元和 2022 年前 6 個月的 12 億歐元來自我們合作夥伴的銷售收入。

I'll be moving to our financial results for the first quarter (sic) [half] of 2022, as shown on Slide 25. Having explained our revenues on the previous slide, let me move to cost of sales that reached approximately EUR 0.8 billion in the second quarter of 2022 compared to EUR 0.9 billion for the comparative prior-year period. For the first 6 months of 2022, the cost of sales reached approximately EUR 2.1 billion compared to EUR 1.1 billion for the comparative prior-year period.

我將轉到我們 2022 年第一季度（原文如此）[half] 的財務業績，如幻燈片 25 所示。在上一張幻燈片中解釋了我們的收入之後，讓我轉到達到約 8 億歐元的銷售成本2022 年第二季度為 9 億歐元，而去年同期為 9 億歐元。 2022 年前 6 個月，銷售成本達到約 21 億歐元，而去年同期為 11 億歐元。

The change in cost of sales resulted mainly from the recognition of costs related to our COVID-19 vaccine revenues in our own territories. This includes the share of gross profit that we owe to our collaboration partner, Pfizer. In addition, cost of sales were impacted by expenses arising from inventory write-offs and expenses for production capacities derived from contracts with contract manufacturing organizations.

銷售成本的變化主要是由於我們承認了與我們在自己領土上的 COVID-19疫苗收入相關的成本。這包括我們欠合作夥伴輝瑞公司的毛利潤份額。此外，銷售成本受到庫存沖銷產生的費用和與合同製造組織的合同產生的生產能力費用的影響。

Research and development expenses reached EUR 399.6 million for the second quarter of 2022 compared to EUR 201.1 million for the comparative period in 2021. For the first 6 months of 2022, research and development expenses amounted to EUR 685.4 million compared to EUR 417.3 million for the comparative prior-year period. The increase was mainly due to the recognizing costs related to the manufacturing of prelaunch Omicron vaccine candidates as research and development expenses in the period incurred as well as an increase in head count.

2022 年第二季度的研發費用達到 3.996 億歐元，而 2021 年同期為 2.011 億歐元。2022 年前 6 個月的研發費用為 6.854 億歐元，而 2021 年同期為 4.173 億歐元比較上年期間。增加的主要原因是在發生期間將與生產預發布 Omicron 候選疫苗相關的成本確認為研發費用以及員工人數的增加。

General and administrative expenses reached EUR 130 million for the second quarter of 2022 compared to EUR 47.8 million for the comparative period in 2021. For the first 6 months of 2022, general and administrative expenses reached EUR 220.8 million compared to EUR 86.7 million for the comparative prior-year period. The increase in G&A was mainly driven by the planned increase in head count and increased expenses for purchased external services.

2022 年第二季度的一般和管理費用達到 1.3 億歐元，而 2021 年可比期間為 4780 萬歐元。2022 年前 6 個月，一般和管理費用達到 2.208 億歐元，而可比期間為 8670 萬歐元上年期間。 G&A 的增加主要是由於計劃中的員工人數增加和購買的外部服務費用增加所致。

Income taxes were accrued with an amount of EUR 0.6 billion for the second quarter of 2022 compared to EUR 1.2 billion for the comparative period in 2021. For the first 6 months of 2022, income taxes were accrued with an amount of EUR 2 billion compared to EUR 1.7 billion for the comparative prior-year period. The derived effective income tax rate for the first 6 months of 2022 was 26.8% and is expected to be around 28% for the full year.

2022 年第二季度應計所得稅為 6 億歐元，而 2021 年可比期間為 12 億歐元。與 2022 年前 6 個月相比，應計所得稅為 20 億歐元去年同期為 17 億歐元。 2022 年前 6 個月的派生有效所得稅率為 26.8%，預計全年約為 28%。

For the second quarter of 2022, net profit reached EUR 1.7 billion compared to EUR 2.8 billion for the comparative period in 2021. For the first 6 months of 2022, net profit reached EUR 5.4 billion compared to EUR 3.9 billion for the comparative prior-year period.

2022 年第二季度，淨利潤達到 17 億歐元，而 2021 年同期為 28 億歐元。2022 年前 6 個月，淨利潤達到 54 億歐元，上年同期為 39 億歐元時期。

Our diluted earnings per share for the second quarter of 2022 amounted to EUR 6.45 compared to EUR 10.77 for the comparative period in 2021. For the first 6 months of 2022, our diluted earnings per share was EUR 20.69 compared to EUR 15.14 in 2021.

我們 2022 年第二季度的攤薄每股收益為 6.45 歐元，而 2021 年同期為 10.77 歐元。2022 年前 6 個月，我們的攤薄每股收益為 20.69 歐元，而 2021 年為 15.14 歐元。

Before turning to the financial guidance, I would like to take a moment to speak about the natural gas supply situation in Europe, as we feel it is a topic to be addressed. We carefully monitor the impact of the natural gas supply situation on our business continuity. According to our most recent information and analysis, commercial mRNA manufacturing in our facility is not expected to be impacted.

在轉向財務指導之前，我想花點時間談談歐洲的天然氣供應情況，因為我們認為這是一個需要解決的話題。我們仔細監控天然氣供應情況對我們業務連續性的影響。根據我們最新的信息和分析，我們工廠的商業 mRNA 生產預計不會受到影響。

We are currently evaluating the impact originating from our partner suppliers and service providers. At this time, it is too early to conclude which impact, if any, may be driven by our partner suppliers and service providers. In addition, we are closely monitoring potential implications for all of our business.

我們目前正在評估來自我們的合作夥伴供應商和服務提供商的影響。目前，要斷定我們的合作夥伴供應商和服務提供商可能會產生何種影響（如果有的話）還為時過早。此外，我們正在密切關注對我們所有業務的潛在影響。

Our R&D and clinical development activities are currently dependent on gas, and we are putting measures in place to mitigate related risks. We are proactively engaging with collaboration partners and governmental authorities to mitigate adverse development from any potential energy shortage in the future.

我們的研發和臨床開發活動目前依賴於氣體，我們正在採取措施降低相關風險。我們正在積極與合作夥伴和政府當局合作，以減輕未來任何潛在能源短缺帶來的不利發展。

Now let's move to Slide 26. We reiterate our outlook for the 2022 financial year. Our very strong start into 2022 financial year, and the results achieved during Q2 confirm that we are on track to achieve our previous financial guidance for the 2022 financial year. As mentioned, we experienced rephasing of orders. We, therefore, expect an uptick in demand in our key markets in the fourth quarter of 2022 related to the Omicron-adapted bivalent vaccine, subject to regulatory approval.

現在讓我們轉到幻燈片 26。我們重申對 2022 財年的展望。我們在 2022 財年的開局非常強勁，並且在第二季度取得的成果證實，我們有望實現我們之前對 2022 財年的財務指導。如前所述，我們經歷了訂單的重新調整。因此，我們預計 2022 年第四季度我們的主要市場對 Omicron 適應二價疫苗的需求將增加，但需獲得監管部門的批准。

Overall, we are confirming our estimated COVID-19 vaccine revenue of approximately EUR 13 billion to EUR 17 billion for the full 2022 financial year and also reiterate our planned expenses and CapEx as well as the estimated annual effect of income tax rate, which we have summarized for you on this slide.

總體而言，我們確認我們在整個 2022 財年估計的 COVID-19 疫苗收入約為 130 億歐元至 170 億歐元，並重申我們的計劃費用和資本支出以及所得稅率的估計年度影響，我們有在這張幻燈片上為您總結。

And with that, I turn the call over to our Chief Strategy Officer, Ryan Richardson, for an update on our outlook for 2022 and concluding remarks. Thank you.

因此，我將電話轉給我們的首席戰略官 Ryan Richardson，以了解我們對 2022 年的展望和總結性發言的最新信息。謝謝你。

Thank you, Jens. Turning to Slide 28. Our COVID-19 vaccine continues to play a major role in addressing the pandemic and the outlook remains strong. As highlighted earlier, we and our partner, Pfizer, have shipped more than 3.6 billion doses of BNT162b2 to more than 180 countries and territories worldwide.

謝謝你，詹斯。轉到幻燈片 28。我們的 COVID-19 疫苗在應對這一流行病方面繼續發揮重要作用，前景依然強勁。如前所述，我們和我們的合作夥伴輝瑞公司已向全球 180 多個國家和地區運送了超過 36 億劑 BNT162b2。

In the first half of the year, we and our partner, Pfizer, believed that we have increased market share in select geographies where we operate and more market share data is reported. In these markets, we estimate that the cumulative share of doses administered increased from approximately 52% in January 2022 to approximately 63% in July. In developed markets, over the same time period, we estimate that our share increased from approximately 59% to 68%.

今年上半年，我們和我們的合作夥伴輝瑞認為，我們在我們經營的特定地區增加了市場份額，並且報告了更多的市場份額數據。在這些市場中，我們估計給藥劑量的累積份額從 2022 年 1 月的約 52% 增加到 7 月的約 63%。在發達市場，在同一時期，我們估計我們的份額從大約 59% 增加到 68%。

Our 2022 site order book stands at approximately 2.5 billion doses. In the second quarter, the United States government agreed to purchase an additional 105 million doses with an option for up to another 195 million doses, bringing the potential total to 300 million doses. Upon delivery of the initial 105 million doses, we and Pfizer will receive USD 3.2 billion.

我們 2022 年的現場訂單約為 25 億劑。在第二季度，美國政府同意再購買 1.05 億劑，並可選擇再購買 1.95 億劑，使潛在總數達到 3 億劑。在交付最初的 1.05 億劑疫苗後，我們和輝瑞將獲得 32 億美元。

We also have an order for more than 650 million doses to be delivered to EC member states this year. We amended the contract to rephase deliveries toward the fourth quarter. This rephasing will not change the total doses expected to be delivered in 2022. With the expected launch of our Omicron variant adaptive vaccines, we anticipate that shipment volumes will increase in the late fall, should we receive regulatory authorization.

我們還有一份訂單，今年將向 EC 成員國交付超過 6.5 億劑疫苗。我們修改了合同，將交付重新安排到第四季度。這種重新調整不會改變預計在 2022 年交付的總劑量。隨著我們的 Omicron 變體適應性疫苗的預期推出，我們預計如果我們獲得監管授權，出貨量將在晚秋增加。

We also continue to prioritize equitable access to our medicines. As shown on Slide 29, we are making substantial progress towards our commitment to provide 2 billion doses of our COVID-19 vaccine to low- and middle-income countries, having shipped over 1.5 billion doses as of July 17, 2022.

我們還繼續優先考慮公平獲得我們的藥物。如幻燈片 29 所示，我們在向低收入和中等收入國家提供 20 億劑 COVID-19 疫苗的承諾方面取得了重大進展，截至 2022 年 7 月 17 日已運送超過 15 億劑。

At the end of June, we also broke ground and started construction of our first BioNTainer site in Kigali, Rwanda. This is the first node in a decentralized manufacturing network of at least 3 sites on the African continent. Additional sites are planned for Senegal and South Africa. Once fully operational, each BioNTainer unit will have the capacity to manufacture up to 50 million doses per year.

6 月底，我們還在盧旺達基加利破土動工並開始建設我們的第一個 BioNTainer 站點。這是非洲大陸至少 3 個站點的分散製造網絡中的第一個節點。計劃在塞內加爾和南非增設站點。一旦全面投入使用，每個 BioNTainer 裝置將有能力每年生產多達 5000 萬劑。

On Slide 30, we highlight select pipeline milestones for the year. We plan to begin testing the immunogenicity and safety of an Omicron BA.4/5 adapted bivalent vaccine in August. We anticipate advancing additional next-generation vaccines into the clinic during the second half of the year and plan to provide further data updates on our expanding COVID-19 vaccine portfolio in the second half.

在幻燈片 30 上，我們突出顯示了當年的選定管道里程碑。我們計劃在 8 月開始測試 Omicron BA.4/5 適應的二價疫苗的免疫原性和安全性。我們預計在下半年將更多的下一代疫苗推向臨床，併計劃在下半年就我們不斷擴大的 COVID-19 疫苗組合提供進一步的數據更新。

Also in the second half of the year, we intend to begin dosing patients with our shingles vaccine, partnered with Pfizer. We also anticipate initiating clinical trials for our herpes simplex 2 virus vaccine, BNT162, in the second half as well as for our tuberculosis and malaria vaccines, BNT164 and 165, respectively, also in the second half of the year or early 2023.

同樣在今年下半年，我們打算與輝瑞合作，開始給患者註射我們的帶狀皰疹疫苗。我們還預計在下半年啟動我們的單純皰疹病毒 2 病毒疫苗 BNT162 以及我們的結核病和瘧疾疫苗 BNT164 和 165 的臨床試驗，也分別在今年下半年或 2023 年初啟動。

Based on encouraging results demonstrated by BNT161, our Pfizer-partnered modified mRNA seasonal influenza vaccine, Pfizer plans to initiate a Phase III clinical trial in the second half of the year. In oncology, and together with our collaboration partner, Genmab, we plan to start a first-in-human Phase I/II clinical trial in the second half for our CD27-targeted antibody, BNT313.

基於 BNT161（我們與輝瑞合作的改良 mRNA 季節性流感疫苗）所展示的令人鼓舞的結果，輝瑞計劃在今年下半年啟動 III 期臨床試驗。在腫瘤學方面，我們計劃與我們的合作夥伴 Genmab 一起，在下半年開始針對我們的 CD27靶向抗體 BNT313進行首次人體 I / II 期臨床試驗。

We also expect to provide data updates later this year for our Claudin-6-positive CAR-T cell candidate, BNT211, which is in trials in multiple solid tumors. We anticipate disclosing data from our ongoing Phase II trial evaluating our iNeST candidate, BNT122, in first-line melanoma in combination with pembrolizumab in the first half of 2023.

我們還希望在今年晚些時候為我們的 Claudin-6 陽性 CAR-T 細胞候選者 BNT211 提供數據更新，該細胞正在多個實體瘤中進行試驗。我們預計將在 2023 年上半年披露我們正在進行的 II 期試驗的數據，該試驗評估我們的 iNeST 候選藥物 BNT122在一線黑色素瘤中與 pembrolizumab 聯合使用。

Concluding on Slide 31, we remain focused on executing against our strategic objectives for the remainder of the year. We are in a strong position to continue our COVID-19 leadership with the potential launch of our first variant adapted vaccines later this fall, alongside the continued development of multiple next-generation product candidates.

在幻燈片 31 上結束，我們將繼續專注於在今年剩餘時間內執行我們的戰略目標。我們有能力繼續我們在 COVID-19 方面的領先地位，可能會在今年秋天晚些時候推出我們的第一個變體適應疫苗，同時繼續開發多個下一代候選產品。

We will also continue to broaden and accelerate our oncology pipeline development with the planned initiation of multiple registrational and first-in-human trials. In infectious disease, beyond COVID-19, we plan to initiate multiple first-in-human vaccine trials by year-end. And we also continue to progress more than 10 preclinical stage mRNA vaccine and precision antibacterial programs.

我們還將繼續擴大和加速我們的腫瘤管道開發，計劃啟動多項註冊和首次人體試驗。在傳染病方面，除了 COVID-19，我們計劃在年底前啟動多項首次人體疫苗試驗。並且我們還在繼續推進10多個臨床前階段的mRNA疫苗和精準抗菌項目。

We expect continued corporate development activity in the second half as well. We are currently evaluating a wide range of opportunities, which could complement and expand both our pipeline and technology toolkit. And we continue to add capability and scale to our organization as we expand our footprint in Europe, United States, Asia and Africa.

我們預計下半年企業發展活動也將繼續。我們目前正在評估廣泛的機會，這些機會可以補充和擴展我們的管道和技術工具包。隨著我們在歐洲、美國、亞洲和非洲的足跡擴大，我們將繼續為我們的組織增加能力和規模。

We are investing in human capital, bringing on the people and expertise needed to further transform our global research and development and commercial organization to support our growing pipeline and long-term vision. We remain as focused as ever on creating true long-term value for patients, shareholders and society.

我們正在投資人力資本，引進所需的人才和專業知識，以進一步轉變我們的全球研發和商業組織，以支持我們不斷增長的管道和長期願景。我們一如既往地專注於為患者、股東和社會創造真正的長期價值。

With that, I would like to thank our shareholders for their continued support and would now open the floor for questions.

藉此，我要感謝我們的股東一直以來的支持，現在請大家提問。

(Operator Instructions) Now we're going to take our first question -- please stand by -- and the first question comes from the line of Matthew Harrison from Morgan Stanley.

（操作員說明）現在我們要回答第一個問題——請稍候——第一個問題來自摩根士丹利的 Matthew Harrison。

Ryan, I guess I just wanted to follow up on one of the comments you made towards the end about size and scope of the opportunities that you're evaluating, how you think about broadly uses of cash here. And should investors be expecting that you would consider deals that are quite sizable? Or should we be thinking much more about smaller bolt-on technology deals?

Ryan，我想我只是想跟進你在最後發表的關於你正在評估的機會的規模和範圍的評論之一，你如何看待這裡廣泛使用的現金。投資者是否應該期望您會考慮規模相當大的交易？還是我們應該更多地考慮較小的附加技術交易？

Yes. Thanks for the question, Matt. So we are looking at a wide range of opportunities. But for the most part, Matt, we're looking really at bolt-on acquisitions and/or strategic partnerships. Our focus is going to continue to be on organic R&D and scaling that up over the coming years. And as we get into more registrational trials with our own pipeline, we think we'll have a better ability, say, over the next 24 months or so, to be able to deploy capital into those pivotal trials that could deliver products for launches over the next 3 to 5 years, as Ugur laid out.

是的。謝謝你的問題，馬特。因此，我們正在尋找廣泛的機會。但在大多數情況下，馬特，我們真正關注的是附加收購和/或戰略合作夥伴關係。我們的重點將繼續放在有機研發上，並在未來幾年擴大規模。隨著我們通過自己的管道進入更多的註冊試驗，我們認為我們將有更好的能力，比如說，在接下來的 24 個月左右，能夠將資金部署到那些可以交付產品以供發布的關鍵試驗中。正如 Ugur 所說，接下來的 3 到 5 年。

So really, it's about complementing that organic strategy, and that includes expanding our pipeline in -- either early or mid-stage pipeline in complementary ways. We're really looking for programs and technologies that synergize with what we're already doing, and that may include extending our RNA platforms into new verticals or new white space or bolstering our cell therapy pipeline.

所以真的，這是關於補充有機戰略，這包括以互補的方式擴大我們的管道——無論是早期還是中期管道。我們真的在尋找與我們已經在做的事情協同工作的程序和技術，這可能包括將我們的 RNA 平台擴展到新的垂直領域或新的空白空間或支持我們的細胞治療管道。

Does that answer your question?

這是否回答你的問題？

It does.

確實如此。

Now we're going to take our next question. And the next question comes from the line of Tazeen Ahmad from Bank of America.

現在我們要回答下一個問題。下一個問題來自美國銀行的 Tazeen Ahmad。

Okay. Ryan, maybe I also want to ask you about some of the comments that you made about deliveries for the rest of the year. So for this quarter, when you mentioned that some deliveries have been pushed out, are you just referring to the portion of deliveries that BioNTech is responsible for or would it also have applied to some of what Pfizer was delivering in the U.S?

好的。 Ryan，也許我還想問你一些關於今年剩餘時間交付的評論。因此，對於本季度，當您提到某些交付已被推遲時，您是指 BioNTech 負責的交付部分，還是它也適用于輝瑞在美國交付的部分產品？

And then same topic, how should we think about your capacity to deliver doses for the rest of the year once you get to full-scale production for the new variants? Basically, do you have a sense of how many doses you'd have capacity to deliver between now and year-end?

然後是同樣的話題，一旦你開始全面生產新的變種，我們應該如何考慮你在今年剩餘時間裡提供劑量的能力？基本上，您是否知道從現在到年底之間您有能力提供多少劑量？

Thank you, Tazeen. I'll start with that and then also ask Jens Holstein to weigh in as well. On your first question with regard to the shift in doses towards the end of the year, that is a -- that does reflect both our and Pfizer's scheduled deliveries. I think namely, it includes the orders for delivery to the European Union. We had announced during the quarter that some of those deliveries would be shifted into the back end of the year. And that's a pretty sizable number of orders. It's actually our largest order for this year and extends into next year.

謝謝你，塔澤恩。我將從這個開始，然後也請 Jens Holstein 參與進來。關於你關於年底劑量變化的第一個問題，這確實反映了我們和輝瑞的預定交付。我認為，它包括交付給歐盟的訂單。我們在本季度宣布，其中一些交付將轉移到年底。這是相當數量的訂單。這實際上是我們今年最大的訂單，並延續到明年。

So that's a big component of the shift to Q4, but we also see that in other markets as well. The U.S. is less about shifting because the orders -- the original contract orders went through April. And then as we mentioned on the call today, we've had an additional order, which we expect will be delivered over the second half of the year, likely heavily weighted in Q4.

所以這是轉向第四季度的一個重要組成部分，但我們在其他市場也看到了這一點。美國不太關心轉移，因為訂單——最初的合同訂單已經過了 4 月份。然後正如我們在今天的電話會議上提到的，我們有一個額外的訂單，我們預計將在今年下半年交付，可能在第四季度佔很大比重。

Maybe before we go to the capacity point, Jens, do you want to add to that?

也許在我們討論容量點之前，Jens，你想補充一下嗎？

Yes. Thank you, Ryan. But you basically gave the answer already. Maybe a bit to add here. I mean we have, of course, in other countries also some delays, specifically if we look at euro -- or not delays, we have some shifts from Q2 in Q4. And Ryan was alluding to this in his speech that we have 650 million doses that we expect to be delivered in the course of this year.

是的。謝謝你，瑞安。但是你基本上已經給出了答案。或許這裡要補充一點。我的意思是，當然，我們在其他國家也有一些延遲，特別是如果我們看一下歐元 - 或者不延遲，我們在第四季度從第二季度發生了一些變化。 Ryan 在他的演講中提到了這一點，我們預計將在今年交付 6.5 億劑疫苗。

I mean all of this, of course, is heavily influenced and we've seen that throughout the year so far by the dynamic of the pandemic and, of course, specifically, how the timing will be for approval from the FDA and from EMA and that will influence the total amount that we are able to deliver to our customers at the end of the day.

當然，我的意思是所有這一切都受到了很大的影響，到目前為止，我們已經看到這一年全年都受到大流行的動態影響，當然，特別是 FDA 和 EMA 批准的時機以及這將影響我們在一天結束時能夠交付給客戶的總量。

So there is -- that's the main reason why we have been cautious in terms of looking at our guidance of EUR 13 billion to EUR 17 billion. I think, overall, if you look at the EUR 9.6 billion that we have reported for the first 6 months, I mean we feel very, very good about it. And just to maybe allude also to what we said in the Q1 call on the basis of 2.4 billion doses, we said we will end up somewhere in the middle of that range.

因此，這就是我們在查看 130 億歐元至 170 億歐元的指導時一直保持謹慎的主要原因。我認為，總的來說，如果你看看我們前 6 個月報告的 96 億歐元，我的意思是我們對此感覺非常非常好。並且也許還暗示了我們在第一季度電話會議中所說的基於 24 億劑的劑量，我們說我們最終將處於該範圍的中間位置。

So -- of course, there are some fluctuations that we have seen already last year when the delivery moved from 1 month into the next month, that can happen over the end of the quarter, over the end of the year as well, of course. So -- and all this, just keeps us with the guidance that we have given to you on EUR 13 billion to EUR 17 billion. But we are overall very optimistic that we will see a good year, 2022.

所以——當然，去年我們已經看到了一些波動，當交付從 1 個月轉移到下個月時，這可能發生在本季度末，當然也可能發生在年末.所以 - 所有這一切，只是讓我們保持在 130 億歐元到 170 億歐元之間為您提供的指導。但總體而言，我們非常樂觀地認為，2022 年將是一個好年頭。

Yes. And Tazeen, on your capacity question, I would just say that, of course, we -- our objective is to deliver the full order book, the full 2.5 billion doses that are scheduled for delivery this year. I think 1 factor that will -- that could impact that would be the timing of the various authorizations that we do expect in the fall for the Omicron variant vaccine. I think we do have to manage inventory.

是的。 Tazeen，關於你的產能問題，我只想說，當然，我們的目標是交付完整的訂單，計劃今年交付的全部 25 億劑。我認為有一個因素——這可能會影響我們在秋季對 Omicron 變體疫苗進行各種授權的時間。我認為我們確實必須管理庫存。

As we've alluded to here on the call, we have produced different vaccines at risk in order to be able to supply readily. We do feel confident that we'll be able to supply to meet demand. But of course, as mentioned, these things are dynamic. The demand is dynamic and we'll be following regulatory authorizations should they occur.

正如我們在電話會議中提到的那樣，我們已經生產了不同的處於風險中的疫苗，以便能夠隨時供應。我們確信我們將能夠滿足需求。但是，當然，如前所述，這些事情是動態的。需求是動態的，如果發生，我們將遵循監管授權。

So we feel good about the position, but there's always a chance, of course, that the planned deliveries will shift as we move throughout the year. And we just have to -- and we've been operating under those assumptions for 1.5 years now and have to continue to do so.

所以我們對這個職位感覺很好，但當然，隨著我們全年的搬遷，計劃的交付總是有可能發生變化。我們只需要 - 我們已經在這些假設下運營了 1.5 年，並且必須繼續這樣做。

Now we're going to take our next question, please stand by. And the next question comes from the line of Daina Graybosch from SVB Securities.

現在我們要回答下一個問題，請稍候。下一個問題來自 SVB 證券的 Daina Graybosch。

I have 1 sort of a 3-parter under fall booster. So we've talked about the EMA and U.S. and whether they want BA.1 versus BA.4/5. Can you give us a breakdown of the rest of the world in your expectations for which of these versions they'll guide to or want?

我在秋季助推器下有 1 種 3-parter。所以我們討論了 EMA 和美國，以及他們是否想要 BA.1 和 BA.4/5。您能否向我們詳細介紹一下世界其他地區您對他們將引導或想要哪些版本的期望？

And the second part is, do you think there'll be enough use of both versions for us to understand the relative vaccine effectiveness as you compare across countries using BA.1 versus the BA.4/5? And finally, is your BA.4/5, does it have spikes from both BA.4/5 or have you selected 1?

第二部分是，當您比較使用 BA.1 和 BA.4/5 的國家/地區時，您認為這兩個版本的使用是否足以讓我們了解疫苗的相對有效性？最後，是你的 BA.4/5，它有來自 BA.4/5 的尖峰還是你選擇了 1？

Daina, this is Ugur. Thanks for the question. So with regard to the BA -- so you are aware that the FDA expects a BA.4/5 vaccine, whereas the EMA appears to be open to both BA.1 as well as BA.4/5. And based on that, we are preparing ourselves to manufacture and supply both vaccine compositions both as a bivalent vaccine.

戴娜，這是烏古爾。謝謝你的問題。所以關於 BA - 所以你知道 FDA 期望 BA.4/5 疫苗，而 EMA 似乎對 BA.1 和 BA.4/5 都開放。在此基礎上，我們正準備生產和供應這兩種疫苗組合物作為二價疫苗。

With regard to the rest of the world, we have to see how the spread of pandemic will continue. Currently, it appears to be that the dominating sublineages are based on BA.2 and BA.4/5 sublineages. And if this continues, we anticipate that the BA.4/5 vaccine, yes, which has higher similarity to the BA.2 lineage, will produce a stronger neutralizing antibody response against both BA.4/5 as well as BA.2.

至於世界其他地區，我們必須看看大流行將如何繼續蔓延。目前，主要的亞系似乎是基於 BA.2 和 BA.4/5 亞系。如果這種情況繼續下去，我們預計與 BA.2 譜系具有更高相似性的 BA.4/5 疫苗將產生針對 BA.4/5 和 BA.2 的更強的中和抗體反應。

There is some evidence from preclinical data that we have generated and, in part, presented already, and there is also evidence from ongoing studies in humans with full infection indicating that BA.2 or BA.4/5 vaccine could have a border neutralization.

有一些來自我們已經產生並且部分已經提供的臨床前數據的證據，還有來自正在進行的完全感染人類研究的證據表明 BA.2 或 BA.4/5 疫苗可能具有邊界中和作用。

And with regard to BA.4/5 spike, you know that BA.4/5 in the original sequence share the same spike sequence and, therefore, we always refer to BA.4/5.

而對於BA.4/5的spike，大家知道原始序列中的BA.4/5共享相同的spike序列，所以我們總是指BA.4/5。

Now we're going to take our next question, please stand by. And the next question comes from the line of Chris Shibutani from Goldman Sachs.

現在我們要回答下一個問題，請稍候。下一個問題來自高盛的 Chris Shibutani。

This is [Stephen] on for Chris. I had 1 on cost of sales. It was noted that this was affected by inventory write-offs. We were just wondering if you could provide some context around these write-offs, maybe quantify the impact? And then -- and related know how we should be thinking about margins on a forward basis?

這是克里斯的[斯蒂芬]。我有 1 的銷售成本。值得注意的是，這受到庫存沖銷的影響。我們只是想知道您是否可以提供有關這些註銷的一些背景信息，也許可以量化影響？然後 - 以及相關人員知道我們應該如何考慮遠期利潤率？

Yes, [Stephen], thanks for the question. So indeed, we have some write-offs in Q2. You will see that in the filing document, we talked about around about EUR 400 million that have impacted negatively our cost figure. If you look -- if you take that out, the gross margin is in the range of what we have seen in previous quarters, despite the fact that the increase in terms of volume that went into low-income countries and middle income countries actually slightly increased in Q2.

是的，[斯蒂芬]，謝謝你的提問。因此，確實，我們在第二季度進行了一些註銷。您會在提交文件中看到，我們談到了大約 4 億歐元，這對我們的成本數據產生了負面影響。如果你看 - 如果你把它拿出來，毛利率在我們在前幾個季度看到的範圍內，儘管進入低收入國家和中等收入國家的數量實際上略有增加第二季度有所增加。

So that is something that we have to swallow in Q2, depending on how much forward it will take, of course, something that this will remain a topic that we have to keep a view on in the quarters, depending on how the pandemic evolves.

所以這是我們必須在第二季度接受的事情，這取決於它將需要多長時間，當然，這仍然是一個我們必須在季度內保持看法的話題，這取決於大流行的演變方式。

Now we're going to take our last question, please stand by. And the last question comes from the line of Zhiqiang Shu from Berenberg.

現在我們要回答最後一個問題，請稍候。最後一個問題來自貝倫貝格的舒志強一行。

I'd like to ask about the next-generation vaccine approaches. In particular, with regard to the T cell enhancing vaccines, for Ugur, can you talk about the advantage of this vaccine? And regarding the Pan-SARS-CoV-2 vaccine, I was wondering if you can talk about the feasibility here? Whether you could -- this vaccine will include multiple strains or -- and including some of the prefusion stability approaches you're taking there?

我想問一下下一代疫苗的方法。特別是關於T細胞增強疫苗，對於Ugur，您能談談這種疫苗的優勢嗎？關於泛SARS-CoV-2疫苗，我想知道你能不能在這裡談談可行性？你是否可以——這種疫苗將包括多種毒株，或者——包括你正在採用的一些融合前穩定性方法？

And as a quick follow-up on BNT122, maybe for Ozlem, in terms of the first-line melanoma. I noticed the data release is shifted to first half of '23. Can you talk about some of the considerations there?

作為對 BNT122 的快速跟進，可能對 Ozlem 而言，就一線黑色素瘤而言。我注意到數據發布轉移到了 23 年上半年。你能談談那裡的一些考慮嗎？

Okay. So I'm happy to take both questions. So first of all, with regard to our strategy for next-generation vaccines. We have a number of ongoing preclinical programs and decided to bring 2 clinical programs into -- 2 preclinical programs into clinical testing. One is related to a next-generation vaccines, aiming to increase the neutralizing antibody titers and broaden the neutralizing antibody titers by modification of the spike protein.

好的。所以我很高興回答這兩個問題。首先，關於我們的下一代疫苗戰略。我們有許多正在進行的臨床前計劃，並決定將 2 個臨床計劃納入 - 2 個臨床前計劃納入臨床測試。一個與下一代疫苗有關，旨在通過修飾刺突蛋白來增加中和抗體滴度並擴大中和抗體滴度。

And the second approach, so this is about strengthening the B-cell response. And the second approach aims for the development of broadly active T cell vaccine. As you know, the spike protein is the target of strong evolution and has a high mutation rate and the concept of a T cell vaccine is to strengthen the cellular immunity against COVID-19.

第二種方法，所以這是關於加強 B 細胞反應。第二種方法旨在開發廣泛活性的 T 細胞疫苗。如您所知，刺突蛋白是強進化的目標，具有高突變率，而 T 細胞疫苗的概念是增強針對 COVID-19 的細胞免疫。

It is now established that cellular immunity has a paramount effect on preventing severe disease. And we see here the opportunity to identify epitopes that are conserved among all SARS-CoV-2 variants. And this is an approach where we will share more information in the coming weeks, how this development would relate to the already existing lean approaches.

現在已經確定，細胞免疫對預防嚴重疾病具有至關重要的作用。我們在這裡看到了識別在所有 SARS-CoV-2 變體中保守的表位的機會。這是一種方法，我們將在未來幾週內分享更多信息，這種發展將如何與現有的精益方法相關聯。

With regard to BNT122, so we shifted readout for the Phase II to next year and the background is here that recruitment of patients into the study was delayed, also related to the pandemic and post-pandemic effects and, therefore, the readout is shifted to 2023.

關於 BNT122，所以我們將第二階段的讀數轉移到明年，背景是，招募患者進入研究被延遲，這也與大流行和大流行後的影響有關，因此，讀數被轉移到2023 年。

There are no further questions. Sylke, over to you.

沒有進一步的問題。西爾克，交給你了。

Thank you. Thank you all for joining us today, and we look forward to speaking with you in the future. Thank you, and stay safe.

謝謝你。感謝大家今天加入我們，我們期待在未來與您交談。謝謝你，並保持安全。

That does conclude our conference for today. Thank you for participating. You may all disconnect. Have a nice day.

這確實結束了我們今天的會議。感謝您的參與。你們都可以斷開連接。祝你今天過得愉快。