Sanofi SA (SNY) 2023 Q2 法說會逐字稿

Good morning, good afternoon, and good evening to everyone. Thank you for joining us to review Sanofi's Second Quarter 2023 Results, followed by a Q&A session. As usual, you can find the slides to this call on the Investors page on our website at sanofi.com.

大家早上好，下午好，晚上好。感謝您與我們一起回顧賽諾菲 2023 年第二季度業績，然後進行問答環節。與往常一樣，您可以在我們網站 sanofi.com 的投資者頁面上找到本次電話會議的幻燈片。

Moving to Slide 3, I would like to remind you that information presented in this call contains forward-looking statements that involve known and unknown risks, uncertainties and other factors that may cause actual results to differ materially. I refer you to our Form 20-F document on file with the SEC and also our Document (foreign language) for a description of these risk factors.

轉向幻燈片 3，我想提醒您，本次電話會議中提供的信息包含前瞻性陳述，這些陳述涉及已知和未知的風險、不確定性和其他可能導致實際結果產生重大差異的因素。我建議您參閱我們在 SEC 備案的 20-F 表文件以及我們的文件（外文），以了解這些風險因素的描述。

With that, please advance to Slide 4. Our speakers on the call today are Paul Hudson, Chief Executive Officer; Dietmar Berger, Global Head of R&D at Interim; the Global Business Unit Heads, Bill Sibold, Thomas Triomphe, Olivier Charmeil and Julie Van Ongevalle; and Jean-Baptiste de Chatillon, the Chief Financial Officer.

接下來，請轉到幻燈片 4。今天電話會議的發言人是首席執行官 Paul Hudson； Dietmar Berger，Interim 全球研發主管；全球業務部門負責人 Bill Sibold、Thomas Triomphe、Olivier Charmeil 和 Julie Van Ongevalle；和首席財務官 Jean-Baptiste de Chatillon。

(Operator Instructions) And with that, I'd like to turn the call over to Paul.

（操作員指示）接下來，我想將電話轉給保羅。

Well, thank you, Eva, and thanks, everyone, for joining our call today. Together with members of the executive team, I'll take you through Sanofi's business and financial performance in the second quarter of 2023.

好的，謝謝你，伊娃，也謝謝大家今天加入我們的電話會議。我將與執行團隊成員一起，帶您了解賽諾菲 2023 年第二季度的業務和財務業績。

Starting with our sales performance on Slide 6. We delivered another quarter of growth in Q2. The Specialty Care and Vaccine as the key drivers. In Specialty Care, sales were up double digit in the quarter, driven mainly by Dupixent, which continues its outstanding growth trajectory. Vaccine sales were up by more than 9%, and we shared with you our excitement for this growing business on our vaccine investor event last month in London.

從幻燈片 6 中的銷售業績開始。我們在第二季度實現了又一個季度的增長。專業護理和疫苗是關鍵驅動因素。在特殊護理領域，本季度銷售額增長了兩位數，主要受到 Dupixent 的推動，該公司繼續保持其出色的增長軌跡。疫苗銷量增長了 9% 以上，我們在上個月於倫敦舉行的疫苗投資者活動中與您分享了我們對這一不斷增長的業務的興奮之情。

The approval of Beyfortus in the U.S. earlier in July and the ACIP meeting taking place next week give us strong confidence to continue to deliver mid- to high single-digit sales growth in vaccines as previously guided. Core assets in General Medicines and Consumer Health care also continued to grow. (inaudible) , our last meaningful LOE in the decade as well as noncore assets in GenMed declined as anticipated.

Beyfortus 於 7 月初在美國獲得批准，以及下週舉行的 ACIP 會議，讓我們有信心繼續按照之前的指導實現疫苗中高個位數銷售增長。普通藥品和消費保健品的核心資產也持續增長。 （聽不清），我們十年來最後一個有意義的 LOE 以及 GenMed 的非核心資產如預期下降。

In summary, based on our solid performance and expected healthy underlying momentum in the second half of 2023, we upgrade our financial guidance for the full year. On the next slide, well, let's have a look at the sales performance in the first half as it looks beyond some impacts from quarterly phasing. Combined, our key growth drivers were up more than 15%, which we believe is a great emerging proof point of our successful portfolio transformation towards innovative medicines.

總而言之，基於我們穩健的業績和預期 2023 年下半年的健康潛在勢頭，我們上調了全年的財務指引。在下一張幻燈片中，我們來看看上半年的銷售業績，因為它超越了季度階段的一些影響。我們的主要增長動力合計增長了 15% 以上，我們相信這是我們向創新藥物成功進行投資組合轉型的一個重要的新證據。

Of note, our stand-alone consumer health care business grew 6% in the first half, while we continue to streamline the CHC product portfolio and divest smaller nonstrategic brands. Now on the next slide, let me take a moment to discuss how we continue to drive shareholder value for our CHC business. Since we embarked on our Play to Win strategy, it has always been our objective to maximize the value of CHC by bringing it back to growth.

值得注意的是，我們的獨立消費者醫療保健業務上半年增長了 6%，同時我們繼續精簡 CHC 產品組合併剝離較小的非戰略品牌。現在，在下一張幻燈片上，讓我花點時間討論我們如何繼續推動 CHC 業務的股東價值。自從我們開始實施 Play to Win 戰略以來，我們的目標始終是通過使其恢復增長來最大化 CHC 的價值。

Julie and the team have successfully executed on their strategic priorities over the last 2 years, and as a result, the business has returned to growth, in line with the market and delivering 8% organic growth annually. At this point, sustaining growth is critical to further drive the value of this attractive business and to further accelerate the strategic execution. In the U.S., the world's largest OTC and VMS market Sanofi CHC has a historically lower revenue base compared to other leading players. The targeted acquisition of Qunol that we announced this morning is addressing the strategic gap in 1 of the fastest-growing VMS categories, and has the potential to unlock the additional value.

Julie 和團隊在過去 2 年裡成功執行了他們的戰略重點，因此，業務恢復了增長，與市場保持一致，每年實現 8% 的有機增長。此時，持續增長對於進一步提升這一有吸引力的業務的價值並進一步加速戰略執行至關重要。在美國，全球最大的 OTC 和 VMS 市場賽諾菲 CHC 與其他領先企業相比，其收入基礎歷來較低。我們今天早上宣布的對 Qunol 的定向收購旨在解決增長最快的 VMS 類別之一的戰略差距，並有可能釋放附加價值。

Julie will tell you more about the acquisition in just a few moments. On capital allocation priorities they will, remain unchanged, focused on investments into science and innovation especially -- sorry, specifically across Specialty Care and Vaccines. Continuing with our biopharma business on Slide 9, we are laser focused on the 3 key launches this year, which -- with each of them representing significant blockbuster potential addressing high unmet needs in large markets. As a reminder, you'll recall that last year, we launched 3 highly innovative products in Specialty Care, which we believe we have a potential of up to EUR 1 billion of peak sales combined.

朱莉稍後將告訴您有關此次收購的更多信息。在資本配置優先事項上，他們將保持不變，特別是對科學和創新的投資——抱歉，特別是在專業護理和疫苗領域。繼續幻燈片 9 上的生物製藥業務，我們重點關註今年的 3 個關鍵產品，其中每一個都代表著巨大的重磅炸彈潛力，可解決大型市場中未滿足的高需求。提醒一下，您可能還記得，去年我們在特殊護理領域推出了 3 款高度創新的產品，我們相信這些產品的峰值銷售額合計可達 10 億歐元。

Those 3 products: Xenpozyme and Enjaymo and Cablivi were above EUR 250 million in sales in aggregate, the first year of their launch. This year, we're launching another 3 innovative products each of them with significant blockbuster potential. We believe ALTUVIIIO, Beyfortus and Tzield together can add up to at least EUR 5 billion in peak sales. The sales of these important products will build over time, and we are very encouraged by the early launch indicators.

這 3 個產品：Xenpozyme、Enjaymo 和 Cablivi 在推出第一年的總銷售額超過 2.5 億歐元。今年，我們將推出另外 3 款創新產品，每款都具有巨大的暢銷潛力。我們相信 ALTUVIIIO、Beyfortus 和 Tzield 的峰值銷售額加起來至少可達 50 億歐元。這些重要產品的銷量將隨著時間的推移而增加，我們對早期推出的指標感到非常鼓舞。

Before I let deep dive deeper into the science behind our recent positive R&D readouts, I would like to take a moment and highlight the extraordinary cadence of positive pipeline catalysts, which we've shared with you during the first half of the year. All these pipeline successes have strengthened our confidence in delivering highly innovative medicines, which have the potential to become significant future growth drivers. We look forward to the PDUFA date for Dupixent in CSU in October this year, potentially adding 300,000 biologic-eligible patients to the broad label of Dupixent.

在深入探討我們最近的積極研發成果背後的科學之前，我想花點時間強調一下我們在今年上半年與您分享的積極管道催化劑的非凡節奏。所有這些管道的成功增強了我們提供高度創新藥物的信心，這些藥物有潛力成為未來重要的增長動力。我們期待今年 10 月 Dupixent 在科羅拉多州立大學的 PDUFA 日期，這可能會為 Dupixent 的廣泛標籤增加 300,000 名符合生物製劑資格的患者。

For Tzield, well, we made it clear when we acquired Provention Bio earlier this year that we based the value of the acquisition on the already approved indication and that any additional indications will be further upside. We now have the results of the Phase III PROTECT study in-house. The study met its primary endpoint of preservation of C-peptide and showed encouraging trend in the clinical secondary endpoints. At the American Diabetes Association Congress in June. Key opinion leaders confirm to us that protecting as much of the beta-cell mass for as long as possible is a critical clinical benefit to patients. We believe that the totality of the data is compelling and look forward to presenting the full data set at the Medical Congress in the second half of this year.

對於 Tzield 來說，我們在今年早些時候收購 Provention Bio 時明確表示，我們的收購價值是基於已經批准的適應症，任何其他適應症都將進一步上漲。我們現在擁有內部 III 期 PROTECT 研究的結果。該研究達到了 C 肽保存的主要終點，並在臨床次要終點方面顯示出令人鼓舞的趨勢。六月在美國糖尿病協會大會上。關鍵意見領袖向我們證實，盡可能長時間地保護盡可能多的 β 細胞群對患者來說至關重要的臨床益處。我們相信數據的整體性令人信服，並期待在今年下半年的醫學大會上展示完整的數據集。

Given the wealth of news and a series of more readouts expected in the coming months, we decided to host an R&D Day on December 7 in New York City to discuss with you these exciting data in much more detail. We want to showcase the progress of our key innovative molecules from our growing pharmaceutical pipeline and further dimensionalize their future commercial potential to help you understand our growth trajectory until the end of the decade.

鑑於未來幾個月將會有大量新聞和一系列更多信息，我們決定於 12 月 7 日在紐約舉辦研發日活動，與您更詳細地討論這些令人興奮的數據。我們希望展示我們不斷增長的製藥管道中關鍵創新分子的進展，並進一步確定其未來的商業潛力，以幫助您了解我們直到本世紀末的增長軌跡。

Now Dietmar, over to you.

現在迪特瑪，交給你了。

Thank you, Paul. Let's take a closer look at some of the recent pipeline successes with our innovative assets across key therapeutic areas. Starting with neurology on Slide 12, let me first focus on multiple sclerosis. MS is a condition that often strikes early in life and creates a high burden on patients, families and payers. Frexalimab, our second-generation investigational anti-CD40-ligand antibody is implicated in the CD40 ligand pathway appearing to be involved in the MS-related inflammatory process. The inhibition of the CD40, CD40-ligand access in the periphery, upstream of T cell interaction with B-cells, dendritic cells and microglia prevents activation of these cells and may block the inflammation that drives MS disease progression.

謝謝你，保羅。讓我們仔細看看我們在關鍵治療領域的創新資產最近取得的一些成功。從幻燈片 12 上的神經病學開始，讓我首先關注多發性硬化症。多發性硬化症是一種經常在生命早期發作的疾病，給患者、家庭和付款人造成沉重負擔。 Frexalimab 是我們的第二代研究性抗 CD40 配體抗體，與 CD40 配體途徑有關，似乎參與了 MS 相關的炎症過程。抑制 CD40、CD40 配體進入外周、T 細胞與 B 細胞、樹突狀細胞和小膠質細胞相互作用的上游，可防止這些細胞的激活，並可能阻止導致 MS 疾病進展的炎症。

We presented exciting Phase II data of Frexalimab in the first CD40-ligand inhibitor randomized controlled study in RMS at a late-breaking session of the 2023 CMSC Annual Meeting. The data highlighted that following 12 weeks of therapy, the number of new gadolinium-enhancing T1 lesions in the MRI was reduced by 89% and 79% in the higher and lower dose treatment arms, respectively, compared with placebo, meeting the study's primary endpoint.

我們在 2023 年 CMSC 年會的最新會議上展示了 Frexalimab 在第一個 RMS 中 CD40 配體抑製劑隨機對照研究中令人興奮的 II 期數據。數據強調，經過 12 週的治療，與安慰劑相比，高劑量治療組和低劑量治療組的 MRI 中新的钆增強 T1 病灶數量分別減少了 89% 和 79%，達到了研究的主要終點。

At week 24, 96% of participants in the higher-dose Frexalimab arm were free of new gadolinium-enhancing T1 lesions. Based on these unprecedented results, we plan to advance Frexalimab into pivotal trials in MS in the first half of next year.

第 24 週時，高劑量 Frexalimab 組中 96% 的參與者沒有出現新的钆增強 T1 病變。基於這些前所未有的結果，我們計劃在明年上半年將 Frexalimab 推進到多發性硬化症的關鍵試驗中。

Turning to immunology. We have recently announced positive Phase IIb data for Amlitelimab in moderate to severe atopic dermatitis. Amlitelimab is a fully human, nondepleting monoclonal antibody that binds to OX40 ligand a key immune regulator. It has the potential to be a first-in-class treatment for a range of immune-mediated diseases and inflammatory disorders, including atopic dermatitis and asthma. Amlitelimab acts more upstream than DUPIXENT in aims to restore immune homeostasis between pro-inflammatory and regulatory T cells. In this dose-ranging Phase IIb study treatment with Amlitelimab resulted in statistically significant improvements in the average Eczema Area and Severity Index or EASI score from baseline at 16 weeks compared to placebo for all 4 subcutaneous doses that were studied. Biomarker results support an effect on both type 2 and non-type 2 pathways.

轉向免疫學。我們最近宣布了 Amlitelimab 治療中度至重度特應性皮炎的 IIb 期積極數據。 Amlitelimab 是一種全人源、非耗盡型單克隆抗體，可與關鍵免疫調節劑 OX40 配體結合。它有潛力成為治療一系列免疫介導的疾病和炎症性疾病（包括特應性皮炎和哮喘）的一流療法。 Amlitelimab 比 DUPIXENT 作用更上游，旨在恢復促炎性 T 細胞和調節性 T 細胞之間的免疫穩態。在這項劑量範圍的 IIb 期研究中，與安慰劑相比，對於所研究的所有 4 種皮下劑量，Amlitelimab 治療導致 16 週時平均濕疹面積和嚴重程度指數或 EASI 評分較基線有統計學顯著改善。生物標誌物結果支持對 2 型和非 2 型途徑都有影響。

Based on these top line data, we are particularly excited by Amlitelimab potential for disease modification and infrequent dosing. And we look forward to sharing the full results later this year. We are preparing for Phase III studies in atopic dermatitis to begin in the first half of next year.

基於這些重要數據，我們對 Amlitelimab 在疾病緩解和不頻繁給藥方面的潛力感到特別興奮。我們期待在今年晚些時候分享完整的結果。我們正在為明年上半年開始的特應性皮炎 III 期研究做準備。

Moving on to my next slide at our investor call during the ATS meeting in May, we highlighted very positive results from some of our early-stage molecules in immunology, including SAR-443765 in asthma. SAR765 is a bispecific Nanobody that targets both IL-13 and TSLP. With its unique 2 binding domains, we see this molecule producing a synergistic effect compared to both anti-TSLP and anti-IL-13 as illustrated on the chart on the right. Its target profile has the potential to become the most potent anti-type 2 agent with coverage of non-type 2 patients as well.

轉到 5 月份 ATS 會議期間投資者電話會議上的下一張幻燈片，我們強調了我們在免疫學方面的一些早期分子的非常積極的結果，包括治療哮喘的 SAR-443765。 SAR765 是一種雙特異性納米抗體，同時靶向 IL-13 和 TSLP。憑藉其獨特的 2 個結合域，我們看到該分子與抗 TSLP 和抗 IL-13 相比產生協同效應，如右圖所示。其靶點概況有潛力成為最有效的抗 2 型藥物，並覆蓋非 2 型患者。

Based on this exciting early data, we plan to initiate the Phase IIb program by the second half of the year. Now on Slide 15, our regulatory and R&D milestones. As Paul highlighted earlier, we made great progress on delivering our pipeline including the landmark barriers results in COPD and the approvals of ALTUVIIIO and Beyfortus in the U.S. to name just a few. As we have moved to the second half of 2023, let me also update you on tolebrutinib. As you know, we currently have 4 Phase III studies ongoing, of which 3 are fully recruited. The tolebrutinib Phase III trials are event driven and powered based on reaching a predefined number of clinical events defined as 6 months confirmed disability worsening or progression.

基於這些令人興奮的早期數據，我們計劃在今年下半年啟動 IIb 期項目。現在在幻燈片 15 上，我們的監管和研發里程碑。正如 Paul 之前強調的那樣，我們在交付產品線方面取得了巨大進展，包括 COPD 方面具有里程碑意義的障礙結果以及 ALTUVIIIO 和 Beyfortus 在美國獲得批准等等。隨著我們進入 2023 年下半年，我還要向您介紹托布替尼的最新情況。如您所知，我們目前正在進行 4 項 III 期研究，其中 3 項已全部招募。 Tolebrutinib III 期試驗是事件驅動的，並基於達到預定數量的臨床事件（定義為 6 個月內確認的殘疾惡化或進展）提供動力。

We use historical data to estimate event rates that led to the original projected time lines. As far as the readouts of the trials GEMINI 1 and 2 in RMS are concerned, the current actual event rate, of course, at a pace that makes us confident that the readout will occur in the middle of next year. In addition, based likewise on event rate analysis, we now expect the results of the non-relapsing SPMS trial called Hercules earlier than expected, also in the middle of 2024. Importantly, we remain on track for our planned submission time line of tolebrutinib in 2024, as previously stated. But now with the added opportunity to file both RMS and SPMS together for a more complete data package. Concerning the ongoing partial U.S. clinical hold on the recruitment of new patients for the PERSEUS study, we are actively working to better understand the tolebrutinib safety profile and (inaudible) communication with the FDA regarding this work.

我們使用歷史數據來估計導致原始預計時間線的事件發生率。就 RMS 中 GEMINI 1 和 2 試驗的讀數而言，當前的實際事件發生率當然使我們相信讀數將在明年年中進行。此外，同樣基於事件率分析，我們現在預計名為 Hercules 的非複發性 SPMS 試驗的結果將比預期更早，也就是 2024 年中期。重要的是，我們仍按計劃提交託布替尼的時間線如前所述，2024 年。但現在有更多機會將 RMS 和 SPMS 一起歸檔以獲得更完整的數據包。鑑於美國臨床部分正在暫停 PERSEUS 研究新患者的招募，我們正在積極努力更好地了解托布替尼的安全概況，並就這項工作與 FDA 進行（聽不清）溝通。

We will update you once we have meaningful new information. And on my last slide, let me finish with a topic that to my heart and aims at the inclusion of communities that are historically underrepresented in the development of pharmaceutical innovation. We have embarked on a major journey to design and conduct clinical trials with clearly defined diversity goals, which are representative of disease population demographics. Sanofi's efforts in R&D strive to have these communities represented in our clinical trial programs as much as possible.

一旦我們獲得有意義的新信息，我們會及時通知您。在我的最後一張幻燈片上，讓我以一個我內心深處的主題來結束，該主題旨在包容歷史上在製藥創新發展中代表性不足的社區。我們已經踏上了設計和開展具有明確多樣性目標的臨床試驗的重要旅程，這些目標代表了疾病人口統計數據。賽諾菲在研發方面的努力致力於讓這些社區盡可能多地參與我們的臨床試驗項目。

It is our responsibility as a leading biopharmaceutical company to recognize any difference in the safety and efficacy of our drugs and vaccines that may exist between different populations of people. We will continue to address as many of these access barriers as possible at the earlier stages of study design to advance toward a world where the research we conduct and the data we generate are more representative of the patients we aim to help.

作為一家領先的生物製藥公司，我們有責任認識到我們的藥物和疫苗的安全性和有效性在不同人群之間可能存在的任何差異。我們將繼續在研究設計的早期階段盡可能多地解決這些准入障礙，以實現我們進行的研究和生成的數據更能代表我們旨在幫助的患者的世界。

And with that, I hand it over to Bill.

說完，我就把它交給了比爾。

Thank you, Dietmar Now looking at Specialty Care, where we delivered yet another strong quarter with solid double-digit growth despite the anticipated impact from generics on Aubagio in the U.S., which started in the second half of March. Dupixent performance was excellent in the quarter with demand-driven growth across all approved indications and geographies. In rare diseases, our Fabry and Pompe franchises reported near double-digit growth in the second quarter with Nexviazyme as 1 of the key contributors. We are very pleased with the launch of the Nexviazyme in the U.S. and ex U.S. markets, where we continue to successfully drive switches to Nexviazyme as the next standard of care in Pompe disease with an established efficacy and safety profile.

謝謝你，Dietmar 現在看看 Specialty Care，儘管從 3 月下半月開始，美國 Aubagio 仿製藥預計會受到影響，但我們仍實現了另一個強勁的季度，實現了兩位數的穩健增長。 Dupixent 在本季度的表現非常出色，所有批准的適應症和地區均實現了需求驅動的增長。在罕見疾病方面，我們的 Fabry 和 Pompe 特許經營權在第二季度報告了接近兩位數的增長，其中 Nexviazyme 是主要貢獻者之一。我們對 Nexviazyme 在美國和美國以外市場的推出感到非常高興，我們繼續成功推動轉向 Nexviazyme 作為龐貝病的下一個護理標準，並具有既定的功效和安全性。

Now moving to my next slide. DUPIXENT sales were up 34%, reaching almost EUR 2.6 billion in a single quarter. As highlighted on the slide, the brand drove continuous robust growth in both the U.S. and ex U.S. geographies, roughly 6 years after the initial launch of Dupixent in AD in the U.S. We remain very excited about the outlook for the brand's outstanding commercial success, and expect to cross the EUR 10 billion mark this year.

現在轉到下一張幻燈片。 DUPIXENT 銷售額增長 34%，單季度達到近 26 億歐元。正如幻燈片中所強調的，自 Dupixent 在美國首次推出大約 6 年後，該品牌在美國和美國以外地區持續強勁增長。我們對該品牌出色的商業成功前景仍然感到非常興奮，並且預計今年將突破 100 億歐元大關。

Our key 2023 regulatory milestones are on track and provide additional sources of significant future growth. For example, we talked to you about the filing and upcoming PDUFA date for DUPIXENT and CSU which is a significant opportunity for expansion into a large population of 300,000 patients in the U.S. alone. Outside the U.S., we continue to roll out the rollout of additional approved indications in additional patient populations in key markets such as Japan and China.

我們的 2023 年關鍵監管里程碑已步入正軌，並為未來的顯著增長提供了額外的來源。例如，我們與您討論了 DUPIXENT 和 CSU 的申請和即將到來的 PDUFA 日期，這是向僅在美國就擴展到 300,000 名患者的龐大人群提供的一個重要機會。在美國之外，我們繼續在日本和中國等主要市場的更多患者群體中推出更多已批准的適應症。

Moving to Slide 20. Let's take a closer look at the impressive performance of DUPIXENT over time. The brand continues to grow its leadership as the #1 NBRx across all specialties in the U.S. market. In dermatology, Dupixent is the gold standard in AD across all age groups. Our strong execution of launches has been recognized by Spirit's global insights. The report highlights DUPIXENT and prurigo nodularis as the #1 recent dermatology launch based on dermatologist familiarity and user base 3 months after launch. PN has further strengthened our position with dermatologists, reinforcing DUPIXENT's strong efficacy, including on itch across multiple inflammatory skin diseases. With the positive experiences in AD down to the age of 6 months and approval in prurigo nodularis, dermatologists continue to build their strong confidence and familiarity with the brand.

轉到幻燈片 20。讓我們仔細看看 DUPIXENT 隨著時間的推移令人印象深刻的性能。該品牌作為美國市場所有專業產品中排名第一的 NBRx 的領導地位不斷增強。在皮膚科領域，Dupixent 是所有年齡段 AD 治療的黃金標準。 Spirit 的全球洞察力認可了我們強大的產品發布執行力。該報告強調 DUPIXENT 和結節性癢疹是基於皮膚科醫生的熟悉度和發布後 3 個月後的用戶群而成為近期排名第一的皮膚科產品。 PN 進一步鞏固了我們在皮膚科醫生中的地位，增強了 DUPIXENT 的強大功效，包括針對多種炎症性皮膚病的瘙癢功效。憑藉在 AD 領域直至 6 個月齡的積極經驗以及結節性癢疹的批准，皮膚科醫生繼續建立對該品牌的強烈信心和熟悉度。

In respiratory, Dupixent continues to demonstrate its leadership position in the U.S. asthma market. Holding the #1 NBRx share in respiratory biologics for the last 3 quarters among pulmonologists and allergists combined. As you know, advanced therapy penetration is an important marker of both potential and success in these markets. The penetration data on this slide will remind you of the very significant growth potential, which remains in AD and asthma, for approved therapies, and we are more confident than ever that Dupixent will continue to take the largest share.

在呼吸領域，Dupixent 繼續展現其在美國哮喘市場的領導地位。過去三個季度，在肺科醫生和過敏科醫生中，NBRx 在呼吸生物製劑領域的份額合計排名第一。如您所知，先進療法的滲透率是這些市場潛力和成功的重要標誌。這張幻燈片上的滲透率數據將提醒您，對於已批准的治療方法，AD 和哮喘領域仍然存在非常顯著的增長潛力，我們比以往任何時候都更有信心 Dupixent 將繼續佔據最大份額。

Now on my next slide, let's switch to ALTUVIIIO, another exciting launch in specialty care. As Paul mentioned earlier, we are on track to unlock the full potential of this important new therapy in hemophilia A. We are already seeing very encouraging early launch indicators and strong momentum going into Q3. ALTUVIIIO is capturing an increasing share of switches and has quickly positioned itself as the factor of choice capturing over 70% of all switches to factor products with over 250 patients already prescribed ALTUVIIIO in the U.S. While still early in the launch, switches are mostly coming from heme A competitor products including approximately 10% of switches from Hemlibra. We believe this positive trend will continue as more patients gain first-hand experience with the benefits high sustained factor levels in the normal to near normal range.

現在，在我的下一張幻燈片上，讓我們切換到 ALTUVIIIO，這是專業護理領域另一項激動人心的產品。正如 Paul 之前提到的，我們有望釋放這種重要的 A 型血友病新療法的全部潛力。我們已經看到非常令人鼓舞的早期啟動指標和進入第三季度的強勁勢頭。 ALTUVIIIO 正在佔據越來越多的轉換份額，並迅速將自己定位為首選因子，佔所有轉換因子產品的 70% 以上，在美國已有超過 250 名患者已開出 ALTUVIIIO 處方。雖然仍處於推出初期，但轉換大部分來自heme A 競爭對手產品包括 Hemlibra 約 10% 的開關。我們相信，隨著越來越多的患者獲得正常至接近正常範圍內高持續因子水平的第一手經驗，這種積極趨勢將持續下去。

Commercially, we are making fast progress as well. Over 80% of our priority accounts who represent the majority of volume share in the heme A market have already prescribed the product. And from a market access perspective, we have received very favorable feedback from payers. Granting coverage aligned with label and no step edits for more than 150 million lives. Importantly, we have implemented a robust patient support program, including reimbursement education and a 30-day free trial program to help accelerate patients starting Altuviiio while their insurance coverage is verified.

在商業上，我們也取得了快速進展。我們超過 80% 的優先客戶（代表血紅素 A 市場的大部分銷量份額）已經開了該產品的處方。從市場准入的角度來看，我們收到了付款人非常有利的反饋。為超過 1.5 億人的生活提供與標籤一致的覆蓋範圍，且無需任何步驟編輯。重要的是，我們實施了強大的患者支持計劃，包括報銷教育和 30 天免費試用計劃，以幫助患者在保險範圍得到驗證的同時加速開始使用 Altuviiio。

With this, I'm handing it over to Thomas.

有了這個，我就把它交給托馬斯了。

Thank you, Bill. In the second quarter, vaccine sales were up 9%, driven by PPH performance. With strong Pentaxim sales in China and the Hexaxim introduction in new public markets in our rest of the world region. PPH also benefited from favorable phasing. As I highlighted before, in the U.S., VAXELIS continues to expand and gain market share from pentavalent vaccines and these sales are not booked in the Sanofi top line.

謝謝你，比爾。在 PPH 業績的推動下，第二季度疫苗銷售額增長了 9%。 Pentaxim 在中國的銷售強勁，並且 Hexaxim 在我們世界其他地區的新公開市場上推出。 PPH 也受益於有利的階段性。正如我之前強調的，在美國，VAXELIS 繼續擴大五價疫苗的市場份額並獲得市場份額，這些銷售額並未計入賽諾菲的營收。

Meningitis, Travel and Endemic franchise decreased by minus 6% due to the divestment of Japanese Encephalitis vaccine last year. Excluding JEV sales, the [franchise] performance was stable, signaling that Travel and Endemic vaccinations are back to their pre-pandemic level. Of note, in Q2, we recorded an additional EUR 59 million sales linked to the remaining European shipments of our COVID-19 booster interesting data.

由於去年日本腦炎疫苗的撤資，腦膜炎、旅遊和地方病特許經營權下降了-6%。不包括乙腦疫苗銷售，[特許經營]表現穩定，表明旅行和地方性疫苗接種已恢復到大流行前的水平。值得注意的是，在第二季度，我們額外記錄了 5900 萬歐元的銷售額，這與我們的 COVID-19 助推器的剩餘歐洲發貨量相關。

It's noteworthy that during the Spring Booster campaign in the U.K., about half of the COVID-19 doses used where Sanofi boosters. Overall, Vaccines (inaudible) delivered a very strong first half performance with plus 12% growth. Moving now to flu on Slide 23. We do expect to achieve in 2023, the same record sales of last year at constant exchange rate, thanks to the recognized quality of our differentiated intense portfolio. From a phasing perspective, we currently anticipate an H2 flu sales split between Q3 and Q4 of 2/3 to 1/3. The expansion in Europe of Efluelda, high dose influenza vaccine gaining market share versus standard vaccine will be a primary driver as well as the conversion from trivalent to quadrivalent vaccines all over the world.

值得注意的是，在英國春季加強疫苗接種活動期間，大約一半的 COVID-19 劑量使用了賽諾菲加強疫苗。總體而言，疫苗（聽不清）上半年表現非常強勁，增長了 12%。現在轉向幻燈片 23 上的流感。我們確實預計在 2023 年實現按固定匯率計算與去年相同的銷售記錄，這要歸功於我們差異化密集產品組合的公認質量。從分階段的角度來看，我們目前預計第三季度和第四季度的 H2 流感銷售額比例為 2/3 至 1/3。 Efluelda（高劑量流感疫苗相對於標準疫苗獲得的市場份額）在歐洲的擴張將是主要推動力，也是全球疫苗從三價向四價轉變的主要推動力。

In parallel, we continue to observe relatively low vaccination rates due to post-pandemic vaccination fatting and some price erosion in the standards market due to ample supply. But overall, the elderly demographics remains very positive. And based on historical data, we generally expect a rebound in flu vaccination rates in the coming years, similar to what was observed after the H1 and (inaudible).

與此同時，我們繼續觀察到由於大流行後疫苗接種肥厚導致的疫苗接種率相對較低，以及由於供應充足而導致標準市場價格下降。但總體而言，老年人口統計數據仍然非常樂觀。根據歷史數據，我們普遍預計未來幾年流感疫苗接種率將出現反彈，類似於上半年和（聽不清）之後觀察到的情況。

And on my last slide, I'd really like to underscore that we are advancing our new vaccine candidates and reported rich flow of data from our pipeline in the first half of the year. Following strong Phase I/II data, our PCV21 candidate SP0202, is expected to enter Phase III in H1 2024. Ambitions to be the first pediatric vaccines with more than 20 serotypes and has clear blockbuster potential. Similarly, we plan to initiate in H1 2024, the Phase III of SP0125, our RSV toddler candidate designed to protect citral entering their second RSV season. Most importantly, we are fully on track to launch Beyfortus [infants] to protect babies going through their first RSV season and to relieve parents and the health care systems from the heavy burden of RSV disease.

在我的最後一張幻燈片上，我真的想強調，我們正在推進我們的新候選疫苗，並報告了今年上半年來自我們管道的豐富數據流。繼強勁的 I/II 期數據之後，我們的 PCV21 候選藥物 SP0202 預計將在 2024 年上半年進入 III 期。我們的目標是成為第一個擁有 20 多种血清型的兒科疫苗，並具有明顯的重磅炸彈潛力。同樣，我們計劃在 2024 年上半年啟動 SP0125 的第三階段，這是我們的 RSV 幼兒候選藥物，旨在保護進入第二個 RSV 季節的檸檬醛。最重要的是，我們完全有望推出 Beyfortus [嬰兒]，以保護嬰兒度過第一個 RSV 季節，並減輕父母和醫療保健系統因 RSV 疾病造成的沉重負擔。

In the U.S., Beyfortus was approved on July 17 for the prevention of RSV lower respiratory tract disease in infants. Building up on this key milestone an ag ACIP meeting is now set for early next week on August 3 to discuss nirsevimab use for the coming season with both a recommendation vote and vaccines for children program inclusion boat scheduled. Momentum is also very strong in Europe with medical agencies in France and Spain, having published broad infant recommendation for Beyfortus. And where specific budgets have been set to ensure Beyfortus coverage for the 2023 RSV season.

在美國，Beyfortus 於 7 月 17 日獲得批准，用於預防嬰兒 RSV 下呼吸道疾病。在此關鍵里程碑的基礎上，ag ACIP 會議定於下周初於 8 月 3 日舉行，討論下個季節的 nirsevimab 使用情況，並安排推薦投票和兒童疫苗計劃納入計劃。歐洲的勢頭也非常強勁，法國和西班牙的醫療機構已經發布了 Beyfortus 的廣泛嬰兒推薦。並製定了具體預算以確保 Beyfortus 覆蓋 2023 年 RSV 季節。

With this, I hand the call over to Olivier.

說完，我把電話轉給了奧利維爾。

Thank you, Thomas. GenMed sales in the second quarter were EUR 3.1 billion. Our core assets grew 2.4%, driven by double-digit growth of Toujeo and Rezurock partially offset by lower sales of Lovenox due to competition and the absence of COVID-19-related demand compared to the same period last year. Toujeo Q2 sales grew by 15%, driven by solid volume growth, mainly in the rest of the world markets, including China, which we consider to be a key market for this product going forward.

謝謝你，托馬斯。 GenMed 第二季度銷售額為 31 億歐元。我們的核心資產增長了 2.4%，這得益於 Toujeo 和 Rezurock 兩位數增長的推動，部分抵消了 Lovenox 銷售額因競爭和與去年同期相比缺乏 COVID-19 相關需求而下降的影響。在銷量穩健增長的推動下，Toujeo 第二季度銷售額增長了 15%，主要是在世界其他市場，包括中國，我們認為中國是該產品未來的關鍵市場。

As Europe continues to grow in the U.S. based on an increased number of patients and a larger pool of prescribing specialists. Sales of non-core assets decreased mainly due to launches, which continue to be impacted by unfavorable U.S. channel mix and a related true-up adjustment in the second quarter. In addition, sales in China were lower to VBP implementation in May last year. In summary, we confirm our full year 2023 objective and expect GenMed sales to decline at a low single-digit rate compared to last year.

隨著歐洲在美國的持續增長，患者數量的增加和處方專家隊伍的擴大。非核心資產銷售下降主要是由於新產品的推出，這繼續受到不利的美國渠道組合和第二季度相關調整的影響。此外，中國的銷售額低於去年 5 月實施 VBP 的水平。總之，我們確認了 2023 年全年目標，並預計 GenMed 銷售額與去年相比將以較低的個位數下降。

Turning now to Tzield. Payers have responded favorably with more than 200 million lives in the U.S. now covered, and we are encouraged by the number of enrollments into our patient support program. Improved family support and a shorter time between enrollment and infusion are expected to further drive positive outcomes for at-risk individuals and accelerate the uptake of this innovative therapy. At the same time, scientific organization, patient groups and policymakers have started to highlight the need to screen for type 1 diabetes proactively. Importantly, at this year's American Diabetes Association meeting, the ADA updated its guidelines to now include a recommendation for Tzield as a therapy for delaying the onset of Stage 3 autoimmune type 1D in Stage 2 patients.

現在轉向齊爾德。付款人對此反應良好，目前已覆蓋美國超過 2 億人的生命，我們的患者支持計劃的註冊人數令我們感到鼓舞。家庭支持的改善以及入組和輸注之間時間的縮短預計將進一步為高危人群帶來積極的結果，並加速這種創新療法的採用。與此同時，科學組織、患者團體和政策制定者已開始強調主動篩查 1 型糖尿病的必要性。重要的是，在今年的美國糖尿病協會會議上，ADA 更新了其指南，現在建議將 Tzield 作為延緩 2 期患者 3 期自身免疫 1D 型發病的治療方法。

With this, I'm handing it over to Julie.

有了這個，我就把它交給朱莉了。

Thank you, Oliver. Sanofi CHC sales in the second quarter were up 0.7%, negatively impacted by the inventory phasing related to the upgrade of our ERP system in the U.S. and Brazil, as I showed last quarter. While the market continues to grow at a dynamic pace, driven by price and mix, digested wellness in cough and cold categories continued to perform strongly with double-digit growth. And when looking at the first half sales performance, I'm glad to highlight that all categories reported growth, except for pain care, which was down versus the exceptional COVID-related demand last year.

謝謝你，奧利弗。正如我上季度所展示的，賽諾菲 CHC 第二季度銷售額增長了 0.7%，受到美國和巴西 ERP 系統升級相關庫存階段的負面影響。儘管在價格和產品組合的推動下，市場繼續以動態的速度增長，但咳嗽和感冒類別的消化健康產品繼續表現強勁，實現了兩位數的增長。在查看上半年的銷售業績時，我很高興地強調，除疼痛護理外，所有類別均出現增長，與去年與新冠相關的特殊需求相比，疼痛護理有所下降。

Sales of others were down 13.4% in Q2 as we continue to streamline our portfolio and divest smaller nonstrategic brands. In the past 3 years, we have successfully simplified our brand portfolio and have halved our number of brands. And over the last 2 months alone, we completed 1 divestment in Europe and signed a second in Japan.

隨著我們繼續精簡產品組合併剝離較小的非戰略品牌，其他品牌的銷售額在第二季度下降了 13.4%。在過去的三年裡，我們成功地簡化了我們的品牌組合，並將品牌數量減少了一半。僅在過去兩個月，我們就在歐洲完成了一項撤資，並在日本簽署了第二項撤資協議。

Excluding divestments, our organic growth was almost 2% in Q2 and 7.5% in the first half. In parallel, we're regularly assessing growth opportunities to strengthen and scale our portfolio of brands and geographic footprint. As Paul introduced earlier, I'm very happy to present to you our acquisition of Qunol. Once the acquisition closes, Qunol will allow us to participate in the VMS category, 1 of the biggest and fastest-growing categories in the world's largest market, which is the U.S.

不包括撤資，我們第二季度的有機增長近 2%，上半年有機增長 7.5%。與此同時，我們定期評估增長機會，以加強和擴大我們的品牌組合和地理足跡。正如 Paul 之前介紹的那樣，我很高興向您介紹我們對 Qunol 的收購。收購完成後，Qunol 將允許我們參與 VMS 類別，這是全球最大市場（美國）最大且增長最快的類別之一。

Qunol is focused on healthy aging, 1 of the most dynamic segments within GMS and is the #1 brand in the U.S. of CoQ10 for Hearts health as well as the #1 brand of Turmeric for Joint health. With a strong science-backed product portfolio, Qunol enjoys above category brand loyalty and has delivered double-digit sales growth due to its premium positioning. Qunol will be joining Sanofi CHC top 5 brands in sales. Integrating this brand into our existing U.S. commercial infrastructure will enable us to unlock future value within the healthy aging segment.

Qunol 專注於健康老齡化，這是 GMS 中最具活力的細分市場之一，是用於心臟健康的輔酶 Q10 的美國第一品牌以及用於關節健康的薑黃的第一品牌。憑藉強大的科學支持的產品組合，Qunol 享有高於類別的品牌忠誠度，並因其高端定位而實現了兩位數的銷售增長。 Qunol 將躋身賽諾菲 CHC 銷量前 5 名品牌之列。將該品牌融入我們現有的美國商業基礎設施將使我們能夠在健康老齡化領域釋放未來價值。

Continuing on our ambition in North America, I'm also extremely happy to announce that Sanofi CHC U.S. and Canada were recently granted the B Corp certification. As you may know, B Corp is recognized to be a gold standard among ESG certifications and awarded to companies who have achieved verified high social and environmental standards. This certification will help us to continuously progress and is fully aligned with our ambitious sustainability strategy, which is focused on better self-care and goes hand-in-hand with health care communities and a health care finance.

繼續我們在北美的雄心壯志，我也非常高興地宣布，賽諾菲 CHC 美國和加拿大最近獲得了共益企業認證。如您所知，共益企業 (B Corp) 被公認為 ESG 認證中的黃金標準，並授予那些已達到經過驗證的高社會和環境標準的公司。該認證將幫助我們不斷進步，並完全符合我們雄心勃勃的可持續發展戰略，該戰略專注於更好的自我保健，並與醫療保健社區和醫療保健金融齊頭並進。

This achievement also enables us to further connect our brands with consumers. As we know that despite high inflation, 66% of Americans and 80% of young Americans, aged between 18 and 34 are willing to pay more for sustainable products. We also have seen net products marketed as sustainable, grew 2x faster than those that were not. We are the first large health care company to be B Corp certified in North America, and I hope many others will follow.

這一成就也使我們能夠進一步連接我們的品牌與消費者。眾所周知，儘管通貨膨脹率很高，但 66% 的美國人和 80% 的 18 歲至 34 歲的美國年輕人願意為可持續產品支付更多費用。我們還發現，以可持續方式銷售的淨產品的增長速度是非可持續產品的兩倍。我們是北美第一家獲得共益企業認證的大型醫療保健公司，我希望其他許多公司也能效仿。

With this, I'm handing it over to Jean-Baptiste, our CFO.

至此，我將把它交給我們的首席財務官讓-巴蒂斯特 (Jean-Baptiste)。

Thank you very much, Julia. And well done, both for Qunol and the B Corp notification is really great. On Slide 31, before taking the P&L perspective, let me highlight the underlying sales performance in H1 by separating out some of the special current drivers. We reported sales of EUR 19.7 billion in the first half of '22. When taking out sales loss due to product divestments or (inaudible) LOE and EAP carve-out, the base becomes just under EUR 19 billion. From there, we added almost EUR 1.7 billion in H1 this year, a growth rate of 8.9% at constant exchange rate. Dupixent across its multiple indication is a key contributor, but I'm also encouraged to see that the recent launches in Specialty Care, plus REZUROCK in GenMed are starting to play a more significant role.

非常感謝你，朱莉婭。幹得好，對於 Qunol 和共益企業來說，通知都非常棒。在幻燈片 31 上，在考慮損益表之前，讓我通過分離出一些特殊的當前驅動因素來強調上半年的基本銷售業績。我們報告 22 年上半年銷售額為 197 億歐元。如果扣除因產品撤資或（聽不清）LOE 和 EAP 剝離而造成的銷售損失，基數將接近 190 億歐元。在此基礎上，今年上半年我們增加了近 17 億歐元，按固定匯率計算增長率為 8.9%。 Dupixent 在其多種適應症中是一個關鍵貢獻者，但我也很高興看到最近在 Specialty Care 領域的推出，加上 GenMed 領域的 REZUROCK 開始發揮更重要的作用。

Vaccines remain strong on sales were additionally supported by COVID vaccine sales this year. And in totality, we are offsetting the decline in the U.S. glargine business.

疫苗銷售依然強勁，這還得益於今年新冠疫苗銷售的支持。總的來說，我們正在抵消美國甘精胰島素業務的下滑。

On Slide 32 when we look at the Q2 group P&L, we see again a slight improvement in gross margin due to favorable specialty care product mix, efficiency gains in manufacturing and supply and COVID vaccine contracts. This was partially offset by generic competition for Aubagio and lower net pricing of Lantus in the U.S. R&D expenses were up slightly driven by the growing vaccines pipeline. Pharma R&D spending was lower in Q2 due to a high base effect as several mid- to late-stage oncology trials were still in progress in the same period last year.

在幻燈片 32 中，當我們查看第二季度集團損益表時，我們再次看到毛利率略有改善，這得益於有利的專業護理產品組合、製造和供應效率的提高以及新冠疫苗合同。這被 Aubagio 的仿製藥競爭和來得時在美國的淨定價較低所部分抵消。研發費用因疫苗管道不斷增長而略有上升。由於基數效應較高，去年同期幾項中後期腫瘤學試驗仍在進行中，因此第二季度的製藥研發支出較低。

BOI grew 6.6% to EUR 2.7 billion this quarter, and it included higher capital gains related to portfolio streamlining compared to the same period last year. More importantly, we continue to benefit from the increased share of profit that is paid by Regeneron towards development cost of the antibody alliance.

本季度 BOI 增長 6.6%，達到 27 億歐元，與去年同期相比，其中包括與投資組合精簡相關的更高資本收益。更重要的是，我們繼續受益於再生元為抗體聯盟的開發成本支付的利潤份額的增加。

In Q3 this year, there will be an inverse effect as in Q3 2022, we recorded a true-up related to Q2 2022 development balance. On Slide 33, let me briefly comment on the CHC P&L. As already signaled in Q1, we expected a softer quarter. This was mainly due to the inventory built in the 2 largest markets in anticipation of an important software switch linked to ordering and billing. As anticipated, G&A also continued to grow because of further implementation of the stand-alone organization.

今年第三季度，將會產生相反的影響，因為在 2022 年第三季度，我們記錄了與 2022 年第二季度發展平衡相關的調整。在幻燈片 33 上，讓我簡要評論一下 CHC 損益表。正如第一季度已經表明的那樣，我們預計季度會更加疲軟。這主要是由於預計與訂購和計費相關的重要軟件切換而在兩個最大市場建立了庫存。正如預期的那樣，由於獨立組織的進一步實施，G&A 也繼續增長。

This year's Q2 was also supported by a meaningful capital gain linked to product divestment. To summarize, we finished the first half growing EPS, again, almost double digit. This was supported by a strong underlying sales performance when excluding Aubagio. The improvement in profitability was further supported by COVID vaccines-related sales and revenues, capital gains phasing on last year's amended antibody alliance, but more an offset our investments in launches on the CHC standalone organization.

今年第二季度還得到了與產品撤資相關的有意義的資本收益的支持。總而言之，我們上半年的每股收益再次實現了幾乎兩位數的增長。排除 Aubagio 後強勁的基本銷售業績支撐了這一點。盈利能力的改善得到了與新冠疫苗相關的銷售和收入、去年修訂後的抗體聯盟的資本收益的進一步支持，但更多地抵消了我們在 CHC 獨立組織上的投資。

Let's move to the outlook. On Slide 36, we are recapping the H2 business outlook. Dupixent is expected to continue its strong performance, thanks to its many indications and also the still low biologics penetration, especially in atopic dermatitis. We assume high rate of generic erosion for Aubagio with the product also going low in Europe in Q4. Flu sales in the northern hemisphere are expected to be similar to prior year level, and then GenMed sales decline is expected to decelerate. We also expect significant contribution from our 3 innovative launches this year, mainly ALTUVIIIO and Beyfortus, which combined could be over EUR 400 million in sales in H2 based on our plans.

讓我們轉向展望。在幻燈片 36 上，我們回顧了下半年的業務前景。由於其多種適應症以及生物製劑滲透率仍然較低，尤其是在特應性皮炎方面，Dupixent 預計將繼續其強勁表現。我們假設 Aubagio 的仿製藥侵蝕率很高，該產品第四季度在歐洲的價格也較低。北半球的流感銷售額預計將與去年水平相似，然後 GenMed 銷售額的下降預計將放緩。我們還預計今年的 3 款創新產品將做出重大貢獻，主要是 ALTUVIIIO 和 Beyfortus，根據我們的計劃，下半年銷售額合計可能超過 4 億歐元。

On the P&L side, we expect our last COVID vaccine revenues of approximately EUR 400 million in H2 to be reported in the other revenues line. Capital gains in the second half will be most likely lower than in H1 and could reach around EUR 200 million. This brings me to my final slide, the full year outlook.

在損益表方面，我們預計下半年的新冠疫苗收入約為 4 億歐元，將在其他收入項目中報告。下半年的資本收益很可能會低於上半年，並可能達到 2 億歐元左右。這就是我的最後一張幻燈片，即全年展望。

Based on our retain business performance in the first half on our COVID-19 revenues, we are raising guidance and expect now EPS to grow mid-single digit at constant exchange rate. We continue to experience headwinds from currency, approximately minus 6.5% to minus 7.5% for full year based on July average exchange rate.

根據我們上半年在 COVID-19 收入方面的保留業務表現，我們正在提高指導，並預計每股收益現在將按固定匯率計算實現中個位數增長。我們繼續面臨貨幣方面的阻力，根據 7 月平均匯率，全年匯率約為 -6.5% 至 -7.5%。

Let's now move to Q&A.

現在讓我們進入問答環節。

We will now open the call to your questions. (Operator Instructions)

我們現在將開始電話詢問您的問題。 （操作員說明）

The first question will be with Emily Field from Barclays.

第一個問題將由巴克萊銀行的艾米麗·菲爾德提出。

I'll just ask 2. On the first one, we've been getting a lot of questions about how a potential competitor entrant in atopic dermatitis could influence Dupixent, particularly from a pricing perspective. I was just wondering if you could provide some thoughts there and sort of your share expectations moving into the back half of the year? And then also just on flu, what impact are you expecting vaccine fatigue to have on volumes for 2023? And then just any other color you can provide there would be great.

我只想問 2。關於第一個問題，我們收到了很多關於特應性皮炎領域的潛在競爭對手如何影響 Dupixent 的問題，特別是從定價角度來看。我只是想知道您是否可以提供一些想法以及您對下半年的份額期望？另外，就流感而言，您預計疫苗疲勞會對 2023 年的產量產生什麼影響？然後你能提供的任何其他顏色都會很棒。

Thank you, Emily. Bill, pricing.

謝謝你，艾米麗。賬單，定價。

Well, look, thanks for the question, first of all, Emily. And we're excited about the quarter that we've had. We're excited about the future, and we're excited about the competition coming actually. I think it helps us grow the market. I think 1 of the key things that you have to remember that the future growth is partially driven by bio penetration. And when we have more products there, it helps drive that bio penetration. Now the other side of that is that the best profile wins.

嗯，聽著，首先謝謝你的提問，艾米麗。我們對這個季度感到興奮。我們對未來感到興奮，對競爭的實際到來感到興奮。我認為這有助於我們擴大市場。我認為你必須記住的關鍵事情之一是，未來的增長部分是由生物滲透推動的。當我們在那裡擁有更多產品時，它有助於推動生物滲透。現在，另一方面是最好的配置文件獲勝。

And we have the best profile. I think anything you look at that's coming in the pipeline is either incomplete or just inadequate to compete with what Dupixent has already shown in well over 500,000 patients already globally. So I think anyone coming in has a tough time competing just against the best profile, as I said in the remarks, the gold standard. However, it is a competitive market. And whenever you have a competitive market over time, there's always some impact on price. But we've taken all the competition, the new indications, everything into consideration, and it's all considered in our strong growth that we expect for the future.

我們擁有最好的個人資料。我認為你所看到的任何即將推出的產品要么不完整，要么不足以與 Dupixent 已經在全球超過 500,000 名患者中展示的效果相競爭。因此，我認為任何進來的人都很難與最好的形象競爭，正如我在評論中所說的，黃金標準。然而，這是一個競爭激烈的市場。隨著時間的推移，只要市場競爭激烈，價格總會受到一些影響。但我們已經考慮了所有的競爭、新的適應症以及一切因素，並且這些都被考慮到了我們對未來的強勁增長預期中。

Thanks, Bill, and very well said. There is -- people forget we already have a lot of competition, and they're doing a really great job and maintaining the right price and the right balance. So thanks, Bill.

謝謝，比爾，說得很好。人們忘記了我們已經有很多競爭，而他們做得非常出色並保持了合適的價格和適當的平衡。所以謝謝，比爾。

Thomas, over to you. Volumes for flu.

托馬斯，交給你了。流感的捲。

As a segue, talking about competitive fields where we have a great product. I think flu is a very good example. Thanks for your question, Emily. It's difficult to quantify what's going to be in volume, the vaccine (inaudible) impact. But traditionally, you know that we are not communicating specifically a number of fluid doses in terms of volumes but rather on flu sales. Why? Because we are differentiating our portfolio and that's the strategy that has been successful for many years. We focus on products that provide protection beyond to and that's why we are able to really move the market to super product and to a superior here.

接下來，談談我們擁有出色產品的競爭領域。我認為流感就是一個很好的例子。謝謝你的提問，艾米麗。很難量化疫苗（聽不清）的影響。但傳統上，您知道我們並不是根據體積來具體傳達液體劑量的數量，而是根據流感銷量來傳達。為什麼？因為我們正在使我們的產品組合脫穎而出，這是多年來一直成功的策略。我們專注於提供超越的保護的產品，這就是為什麼我們能夠真正將市場推向超級產品和高級產品。

That's why in a competitive field, we are doing very well. And of course, we remain totally ready to take any opportunity in the market. We do very well. It's a changing market and should the (inaudible) will be ready to move forward.

這就是為什麼在競爭激烈的領域，我們做得很好。當然，我們仍然完全準備好抓住市場上的任何機會。我們做得很好。這是一個不斷變化的市場，（聽不清）應該準備好向前發展。

Thank you. Thank you, Thomas.

謝謝。謝謝你，托馬斯。

Next question is from Richard Vosser from JPMorgan.

下一個問題來自摩根大通的理查德·沃瑟。

Just 1 more on DUPIXENT just on the quarter. The growth rate in the U.S. fell a bit more in line with the TRx growth. So -- is that -- the mix is now stabilizing in terms of Medicaid and commercial patients? Or is there a little bit more price pressure or a rebate adjustment just some idea of what's going on in the quarter? And then secondly, on the CD40 ligand, efficacy clearly looks pretty good. How differentiated is this? Could this be on safety, convenience, just versus some of the high efficacy products that are clearly taking over the market in MS?

本季度 DUPIXENT 上僅新增 1 個。美國的增長率與 TRx 的增長更加一致。那麼，醫療補助和商業患者的混合現在正在穩定嗎？或者是否有更多的價格壓力或回扣調整隻是對本季度發生的情況的一些了解？其次，對於 CD40 配體，效果顯然看起來相當不錯。這有何差異化？與明顯佔領多發性硬化症市場的一些高效產品相比，這是否是因為安全性、便利性？

Okay. So maybe, Bill, just to show on, just to cover that off.

好的。所以也許，比爾，只是為了炫耀，只是為了掩蓋這一點。

Yes, sure. Thanks, Richard. So the U.S., it's 70% commercial, right? And that's been incredibly stable over time. Look, if you're looking at the quarter versus Q1, gross net unchanged and versus last year, there is some additional contracting and rebating built in there but it's all anticipated. And as I said, we've taken this into consideration for the future growth that we expect.

是的，當然。謝謝，理查德。那麼美國 70% 是商業化的，對嗎？隨著時間的推移，這種情況一直非常穩定。看，如果你看一下本季度與第一季度的比較，總淨值不變以及與去年相比，其中存在一些額外的合同和回扣，但這都是預期的。正如我所說，我們已經將這一點考慮到了我們預期的未來增長。

Thank you, Bill. And maybe Dietmar, CD4ligand and how it will be differentiated.

謝謝你，比爾。也許還有 Dietmar、CD4ligand 以及它將如何區分。

Richard, thank you for the question. I mean, obviously, there are different medicines available right in MS. The data that we've presented at the MS conference at the MS centers conference actually, we feel is unprecedented, right? When we look at the -- when we look at the efficacy, when we look at the reduction in the gadolinium-enhancing lesions, especially the 96% reduction, that really provides a lot of potential benefit for patients. On the positive side as well, when we look at the safety profile that we've also presented at the same conference.

理查德，謝謝你的提問。我的意思是，顯然，針對多發性硬化症有不同的藥物可供選擇。實際上，我們在 MS 中心會議上的 MS 會議上提供的數據，我們感覺是前所未有的，對嗎？當我們觀察療效時，當我們觀察钆增強病變的減少，尤其是 96% 的減少時，這確實為患者提供了很多潛在的益處。從積極的一面來看，當我們查看我們也在同一次會議上提出的安全概況時。

It actually looks very, very well tolerable. So we feel we have both on the safety and the efficacy side. a really important new product, a really important new option for patients. It's a new mechanism you know that patients do develop resistance, do we develop progression to the currently available mechanisms and bringing this new mechanism with this profile to patients will be a real benefit. So really looking forward to that.

實際上看起來非常非常可以忍受。所以我們覺得我們在安全性和有效性方面都有。一個非常重要的新產品，對於患者來說一個非常重要的新選擇。您知道，這是一種新機制，患者確實會產生耐藥性，我們是否會向當前可用的機制發展，並將這種具有這種特徵的新機制帶給患者將是真正的好處。所以真的很期待。

Thanks, Dietmar. I was about to that actually, that patients still progress, even with standard of care. And we know there's always enthusiasm for a different level of efficacy with the right balance on safety and this will be first and best-in-class. So I think it's pretty exciting for us the data certainly supports that at this point. Next question?

謝謝，迪特瑪。實際上，我想說的是，即使採用標準護理，患者仍然會取得進步。我們知道，人們總是熱衷於不同水平的功效與安全性的適當平衡，這將是一流的。所以我認為這對我們來說非常令人興奮，目前的數據肯定支持這一點。下一個問題？

Next question is from Peter Welford from Jefferies.

下一個問題來自 Jefferies 的 Peter Welford。

I've got 2. Firstly, on before. I wonder if you could just talk a little bit about ahead of the ACIP meeting. Your thoughts on the pricing that you'll disclose to -- and also how we should think about for the ACIP what a positive, I guess, recommendation and vote looks like. And I say that just because there was some confusion, I guess, after the meeting for the adult vaccines as to the implications of it. So I wonder if you could just set up your selling as the sort of debates that would be and what a positive outcome looks like from your perspective. Then if I could just go back to the CD40-ligand. Just curious, could you talk a little bit about what the Phase III plan is going to be in that study in terms of -- does a Phase III trial now in that setting, do you have to look at CD20s as the comparator -- or what sort of comparison arms can you use in a study like that now for ethical grounds.

我有2。首先，之前。我想知道您是否可以在 ACIP 會議之前談談一些情況。您對將要披露的定價的想法，以及我們應該如何考慮 ACIP 的積極建議和投票是什麼樣的。我這麼說只是因為，我想，在成人疫苗會議之後，對其影響存在一些困惑。所以我想知道你是否可以將你的銷售設置為那種辯論，以及從你的角度來看積極的結果是什麼樣的。那麼我是否可以回到 CD40 配體。只是好奇，您能談談該研究中的 III 期計劃是什麼嗎？現在在這種情況下進行 III 期試驗，您是否必須將 CD20 視為比較器，或者出於道德原因，您可以在現在這樣的研究中使用什麼樣的比較手段。

Thank you, Peter. Maybe Beyfortus right around the corner Thomas.

謝謝你，彼得。也許 Beyfortus 就在拐角處，托馬斯。

Yes, right around the corner, as you know, very well, registered July 17, ACIP next week, August. We are very excited and confident about the forthcoming recommendation and the voting. Why? I think I want to explain that there has been great work with the ACIP over the past few weeks, and we've been really reassured by the ACIP recognition of the burden of RSV disease for all infants. So a clear recommendation for all infants is critical and will be successful in my view, to ensure equitable access across the population, which is a very important part to look at when it comes to prevention. So during ACIP meetings in the past, key stakeholders have clearly expressed their interest in ensuring that broad and equitable access and therefore, that gives us confidence. Similarly, we expect inclusion into the VFC program because this decision is critical, again, to ensure equitable access for all infants. So moving forward with confidence about ACIP.

是的，就在拐角處，如您所知，很好，7 月 17 日註冊，ACIP 下週，即 8 月。我們對即將到來的推薦和投票感到非常興奮和充滿信心。為什麼？我想我想解釋一下，過去幾週 ACIP 開展了出色的工作，ACIP 認識到 RSV 疾病對所有嬰兒造成的負擔，這讓我們感到非常放心。因此，針對所有嬰兒的明確建議至關重要，在我看來，這將是成功的，以確保所有人都能公平地獲得服務，這是預防方面需要考慮的一個非常重要的部分。因此，在過去的 ACIP 會議上，主要利益相關者明確表達了他們對確保廣泛和公平的准入的興趣，因此，這給了我們信心。同樣，我們希望將其納入 VFC 計劃，因為這一決定對於確保所有嬰兒的公平機會至關重要。因此，我們對 ACIP 充滿信心，繼續前進。

Thomas am I right in saying that we're the only preventative RSV on the agenda at.

托馬斯，我說得對，我們是議程上唯一的預防性RSV。

We are, absolutely. And the second part of the question, sorry, Peter, was on price. Very similar to what we said in the past, we want to mature -- and that's very much linked to the ACIP recommendation. So both go together. If there is a broad ACIP recommendation, we want to ensure there is equitable access for this product to everyone.

我們絕對是。抱歉，彼得，問題的第二部分是關於價格。與我們過去所說的非常相似，我們想要成熟——這與 ACIP 的建議密切相關。所以兩者走到一起。如果有廣泛的 ACIP 建議，我們希望確保每個人都能公平地使用該產品。

And therefore, it will be a premium innovative vaccine price well aligned with what was discussed in terms of pricing during the previous ACIP meetings.

因此，這將是一個優質的創新疫苗價格，與之前 ACIP 會議上討論的定價完全一致。

Thank you, Thomas. Deitmar Peter had some ideas on how you should run the Phase III for the CD40 ligand. So over to you.

謝謝你，托馬斯。 Deitmar Peter 對於如何運行 CD40 配體的 III 期有一些想法。那麼就交給你了。

No, thank you for the question, Peter. I mean we're obviously looking at what the right studies are. We will communicate as soon as we really taken those decisions and have discussed them also with regulatory authorities.

不，謝謝你的提問，彼得。我的意思是，我們顯然正在研究什麼是正確的研究。一旦我們真正做出這些決定並與監管機構進行討論，我們將立即進行溝通。

Let me just point out that this is an important new mechanism. And looking at the role that CD40 plays, now as we have a molecule that has that right safety and benefit ratio, right? We will really look at what are the right studies across the spectrum of MS, right? So there's definitely broad potential for the medicine. And I also want to highlight that CD40 ligand is implied across a variety of diseases, right? So this is a major opportunity for us, not only in neurology, but more broadly really in inflammatory diseases.

我想指出的是，這是一個重要的新機制。看看 CD40 所扮演的角色，現在我們有了一種具有正確安全性和效益比的分子，對嗎？我們將真正研究跨 MS 範圍的正確研究有哪些，對嗎？因此，這種藥物肯定具有廣泛的潛力。我還想強調的是，CD40 配體存在於多種疾病中，對吧？因此，這對我們來說是一個重大機遇，不僅在神經學領域，而且在更廣泛的炎症性疾病領域。

Thank you, Dietmar.

謝謝你，迪特瑪。

Next question is from Seamus Fernandez from Guggenheim.

下一個問題來自古根海姆的謝默斯·費爾南德斯。

So just a follow-up on Bay Fortis and sort of the growth expectations based on the ACIP recommendation and the opportunity in hospitals. Just hoping to understand the trajectory of growth. I think historically, for pediatric vaccines, we've seen a substantial uptake perhaps even approaching peak penetration within 3 to 4 years. So just trying to get a better understanding of your thoughts on the trajectory of growth there?

因此，這只是 Bay Fortis 的後續行動，以及基於 ACIP 建議和醫院機會的增長預期。只是希望了解成長的軌跡。我認為，從歷史上看，對於兒科疫苗，我們已經看到了大量的使用，甚至可能在 3 到 4 年內達到峰值滲透率。那麼只是想更好地了解您對那裡的增長軌蹟的想法嗎？

And then Separately, on Amlitelimab, just trying to get a better understanding. You're speaking about a broad mechanism of action, longer-acting potential as well as competitive efficacy results in that patient population in atopic dermatitis. Just trying to get a better understanding of how long a duration you're looking at, and also differentiation from other OX40 targeted agents that you've discussed outside of this, where safety of targeting the ligand was viewed to be a potential advantage.

然後單獨討論 Amlitelimab，只是想更好地了解。您談論的是特應性皮炎患者群體的廣泛作用機制、長效潛力以及競爭性療效結果。只是想更好地了解您所關注的持續時間，以及與您在此之外討論的其他 OX40 靶向藥物的區別，其中靶向配體的安全性被認為是一個潛在優勢。

Okay. Thank you, Seamus. Thank you for raising the expectations for Thomas on the (inaudible). So Thomas, I'm interested in the shape of the curve, too. So maybe you can answer that.

好的。謝謝你，西莫。感謝您提高對托馬斯的期望（聽不清）。托馬斯，我也對曲線的形狀感興趣。所以也許你可以回答這個問題。

Thank you, Seamus. Now the important thing, first, we're really ready to launch. And again, you will know that it's the first time ever there will be a broad preventive measure to avoid RSV and Bronchiolitis in new borns. So very exciting, obviously, now when it comes to the curve of that launch, a bit early to say, SMEs. We're first going to get the ACIP recommendation.

謝謝你，西莫。現在重要的是，首先，我們真的準備好發布了。再說一遍，您會知道這是有史以​​來第一次採取廣泛的預防措施來避免新生兒感染呼吸道合胞病毒和細支氣管炎。顯然，現在談到推出的曲線時，非常令人興奮，對於中小企業來說，現在說還為時過早。我們首先要獲得 ACIP 的建議。

Those 2 votes as per the previous question from Peter are obviously very important. If we go for an equitable and broad access, which we count on, I believe that it will take, as always, of vaccines a few years to reach (inaudible). It tends to be a steady, progressive ramp-up over a certain number of years. So again, we are talking here altogether about a EUR 2.5 billion market, and we believe there is no asset like before in this market. So we are confident about our trajectory for blockbuster.

Peter 之前提出的問題中的那兩票顯然非常重要。如果我們尋求公平和廣泛的獲取機會（我們所指望的），我相信一如既往，疫苗將需要幾年的時間才能實現（聽不清）。它往往是在一定年限內穩定、漸進的增長。再說一次，我們在這裡談論的是一個 25 億歐元的市場，我們相信這個市場中不存在像以前那樣的資產。因此，我們對我們的重磅炸彈之路充滿信心。

Good. Well said. Dietmar on amlitelimab, some questions about differentiation against between OX40 ligand and maybe an OX40 and then maybe some suggestion about interval?

好的。說得好。 Dietmar 關於 amlitelimab，關於 OX40 配體和 OX40 之間差異的一些問題，然後可能是一些關於間隔的建議？

Yes. Yes. The I mean obviously, we have not communicated the full data yet. They will be at a conference later this year. But even if you look at, if you step back and look at the mechanism, when you look at the data that we have communicated up to now, there is clear differentiation, first of all, from how is the molecule designed. It is the OX40 ligand, right? It doesn't OX40. It's a nondepleting monoclonal antibody, whereas others that are actually depleting and in that sense, then can lead to, for example, autoimmune phenomena, which we have not seen in the studies that we've communicated.

是的。是的。我的意思顯然是，我們還沒有傳達完整的數據。他們將於今年晚些時候參加一次會議。但即使你看，如果你退後一步看看機制，當你看我們迄今為止傳達的數據時，就會發現明顯的區別，首先是分子是如何設計的。它是 OX40 配體，對嗎？不是OX40。它是一種非消耗性單克隆抗體，而其他實際上正在消耗的單克隆抗體，從這個意義上說，可能會導致例如自身免疫現象，這是我們在我們所傳達的研究中沒有看到的。

So far. OX40 ligand, the OX40, OX40-Ligand axis, again is broadly implicated in different types of diseases in immunology and in inflammatory disorders, but it actually acts more upstream, right, as I said before. So it really gets to that homeostasis between pro-inflammatory and regulatory T cells.

迄今為止。 OX40 配體，即 OX40、OX40-配體軸，再次廣泛涉及免疫學中不同類型的疾病和炎症性疾病，但它實際上在上游發揮作用，對吧，正如我之前所說。因此，它確實實現了促炎性 T 細胞和調節性 T 細胞之間的穩態。

And you get that specifically when you hit the ligand, not so much when you hit OX40 itself, and that really gets to this distinction between do you see our immune phenomenon, do you get the right benefit risk, et cetera, et cetera. What we're also really interested in, and what we were -- what we're looking forward to further discuss then is, by targeting OX40, can you actually also lead to a reset of the immune system somewhat? Do you have an extended effect, which I think is really important with this medicine.

當你擊中配體時，你會得到這一點，而當你擊中 OX40 本身時，你會得到這一點，這確實涉及到你是否看到我們的免疫現象、你是否獲得正確的受益風險等等之間的區別。我們真正感興趣的是，我們期待進一步討論的是，通過針對 OX40，實際上還能在某種程度上導致免疫系統的重置嗎？你有延長效果嗎，我認為這對於這種藥來說非常重要。

And then how often do you have to dose? And I think you're going well beyond with this, well beyond, like, for example, 4- to 8-weekly application then. So I think there's a lot of really positive potential characteristics to this molecule, and we are very much looking forward to share the full data set later during this year.

那麼您需要多久服藥一次？我認為你已經遠遠超出了這一點，遠遠超出了，例如，每週 4 到 8 次申請。所以我認為這個分子有很多真正積極的潛在特徵，我們非常期待在今年晚些時候分享完整的數據集。

And maybe later this year, get also to give more specifics on interval, for example, which could be a significant opportunity, we'll find out. I don't want to miss the sort of last bit on -- we have a readout coming on the OX40 ligand TNF in HS. And I think that's also a little bit of something that could be a new standard. Of course, we don't know. But I think we're trying to do something that's not been done before.

也許今年晚些時候，我們還會提供更多關於間隔的細節，例如，這可能是一個重要的機會，我們會發現。我不想錯過最後一點——我們有 HS 中 OX40 配體 TNF 的讀數。我認為這也可以成為一個新標準。當然，我們不知道。但我認為我們正在嘗試做一些以前從未做過的事情。

It's part of our (inaudible) platform.

它是我們（聽不清）平台的一部分。

Yes. Exactly exactly.

是的。完全正確。

Next question is from Peter Verdult from Citi.

下一個問題來自花旗銀行的 Peter Verdult。

Peter also 2 questions. On Tzield, I don't know whether this question is for Paul or Olivier or Bill, physician feedback on the drug is pretty impressive in the current indication. So just can I push you on any further launch metrics, number of patients on treatment number of sites that you've got open in the U.S. to offer this 14-day infusion treatment.

彼得也有2個問題。關於 Tzield，我不知道這個問題是針對 Paul、Olivier 還是 Bill，在目前的適應症中，醫生對該藥物的反饋相當令人印象深刻。因此，我可以向您介紹任何進一步的啟動指標、接受治療的患者數量以及您在美國開設的提供 14 天輸液治療的站點數量。

And then Paul, on PROTECT, I mean, the primary endpoint was positive in recently diagnosed patients, but it was only a numerically trend -- numerical trend on time and range and interesting us. I'm just trying to work out sort of over and above that $2 billion peak sales. Is that proposition still intact without those secondary end points. And then Bill, I apologize, I'm going to come back to Dupixent only because it's probably near term, going to be an area of focus. I mean a lot of people talk about rebating and price, but I'm just more interested in just Dupixent today in the U.S., what is the split between commercial and Part D.

然後保羅，關於保護，我的意思是，最近診斷的患者的主要終點是積極的，但這只是一個數字趨勢——時間和範圍上的數字趨勢，這讓我們很感興趣。我只是想算出 20 億美元峰值銷售額之上的數字。如果沒有那些次要終點，這個命題是否仍然完好無損？然後 Bill，我很抱歉，我會回到 Dupixent 只是因為它可能是近期的一個焦點領域。我的意思是很多人都在談論回扣和價格，但我只是對今天在美國的 Dupixent 更感興趣，商業版和 D 部分之間的區別是什麼。

I'm just trying to work out -- we all know that Dupixent is going to be a huge drug based on where penetration is today in the current indications and the label expansion plans you've got -- but what we -- we need to balance that with potential short-term volume pressures in terms of your competitor -- the only thing they can do is do a very aggressive bridge program. So commercial patients, high deductible plans, would that create some sort of short-term volume pressure on the Dupixent franchise. So we can explore that a little bit in a little detail, that would be great.

我只是想弄清楚——我們都知道 Dupixent 將成為一種巨大的藥物，基於目前的適應症和標籤擴展計劃的滲透情況——但我們——我們需要什麼為了平衡這一點與競爭對手潛在的短期銷量壓力——他們唯一能做的就是製定一個非常積極的過渡計劃。因此，商業患者、高免賠額計劃會給 Dupixent 特許經營權造成某種短期銷量壓力。所以我們可以稍微詳細地探討一下，那就太好了。

Okay. So 2 questions, it became 3. So thank you, Peter. So Olivier, any more color you want to add on Tzield launch?

好的。所以 2 個問題，變成了 3 個問題。所以謝謝你，彼得。那麼 Olivier，您想在 Tzield 的發布中添加更多顏色嗎？

Yes. Peter, I think you said it right. The interest around Tzield with our customers with the opinion leaders has surpassed our expectation. Some of us are just back from San Diego. And we have been very impressed by the excitement within the type 1 diabetes community. We are, of course, very happy with the recent update of the ADA guidelines that we were not expecting so early. We know that, of course, we still have a lot of work to do, and we took the product beginning of May, and we are getting structured we need to work, and we had it in mind from the beginning of course, on the screening programs in order to make sure that they are consistent.

是的。彼得，我認為你說得對。我們的客戶和意見領袖對 Tzield 的興趣超出了我們的預期。我們中的一些人剛從聖地亞哥回來。 1 型糖尿病界的興奮給我們留下了深刻的印象。當然，我們對 ADA 指南最近的更新感到非常高興，這是我們沒有預料到的這麼早。我們知道，當然，我們還有很多工作要做，我們從五月初就開始使用該產品，我們正在構建我們需要工作的結構，當然，我們從一開始就考慮到了這一點篩選程序以確保它們的一致性。

There are a lot of initiatives that are emerging, both in the U.S. but also outside of the U.S. In the past, there was no, of course, a limited interest to screen, but it's clear that since the registration of amlitelimab, the interest of screening has increased dramatically and even some countries are going to go in the direction of systematic maybe [more] screening in the upcoming years.

無論是在美國還是在美國以外，都出現了許多舉措。在過去，當然，篩選的興趣有限，但很明顯，自從 amlitelimab 註冊以來，篩查數量急劇增加，甚至一些國家將在未來幾年朝著系統化、或許[更多]篩查的方向發展。

We'll need to work, of course, in order to make sure that there is a limited time line between the intent to prescribe a amlitelimab. So we are conscious that it's a slow burn, but we are, of course, very excited and very impressed, of course, by the positive feedback on the -- from KOL. Continuous rollout in terms of education, in terms of understanding the different stages of type 1 diabetes, Stage 2, Stage 3, that is not always fully understand -- understood.

當然，我們需要努力，以確保在開出 amlitelimab 的意圖之間有一個有限的時間線。因此，我們意識到這是一個緩慢的過程，但當然，我們對來自 KOL 的積極反饋感到非常興奮和印象深刻。在教育方面、在了解 1 型糖尿病的不同階段、第 2 階段、第 3 階段方面不斷推出，但並不總是完全理解——理解。

So we will provide you more detail during the call in the next quarter. What I can say about PROTECT is that we have a positive trial with a strong result on primary endpoint of preservation of C-peptide. With KOL, firming at ADA at protecting beta cell mass for as long, of course, is a clinical benefit. So more to come in the upcoming weeks. But for the time being, very impressed by the initial feedback of the type 1 diabetes community and KOL.

因此，我們將在下個季度的電話會議中向您提供更多詳細信息。關於 PROTECT，我能說的是，我們進行了一項積極的試驗，在 C 肽保存的主要終點方面取得了強有力的結果。當然，對於 KOL，在 ADA 中長期保護 β 細胞群是一種臨床益處。未來幾週還會有更多內容。但就目前而言，1 型糖尿病社區和 KOL 的初步反饋給我留下了深刻的印象。

I think Dietmar has something maybe about time and range or some of the nuances.

我認為迪特瑪可能有一些關於時間和範圍或一些細微差別的東西。

Yes. Peter, I think this is really important, right, to discuss this because when you step back, we are really blazing new trails with this program. How long have we waited to have a medicine available for patients with type 1 diabetes, right? And the initial data delay on the delay of onset, we're already unprecedented. And now having positive data in the setting of early intervention is another really important data set. And very clear data on the primary endpoint that's important. The study is positive.

是的。彼得，我認為討論這個問題非常重要，對吧，因為當你退後一步時，我們真的正在通過這個項目開闢新的道路。我們等了多久才找到一種治療 1 型糖尿病患者的藥物，對嗎？而最初的數據延遲對發病的延遲，我們已經是前所未有的了。現在，在早期干預方面擁有積極的數據是另一個非常重要的數據集。關於主要終點的非常清晰的數據非常重要。這項研究是積極的。

The secondary end points describe more the clinical benefit. And when you look at time and range, when you look at insulin use, that's really what gets people excited. We've had discussions at the ADA meeting, very, very positive feedback as you have heard yourself, right? So when we look at the totality of data, this is a very convincing package, and we're really looking forward to discussing those data further.

次要終點更多地描述了臨床益處。當你觀察時間和範圍，當你觀察胰島素的使用時，這確實讓人們感到興奮。我們在 ADA 會議上進行了討論，得到了非常非常積極的反饋，正如您自己聽到的那樣，對嗎？因此，當我們查看全部數據時，這是一個非常令人信服的數據包，我們真的很期待進一步討論這些數據。

Thanks, Dietmar. I think both summed it up very well. We said when we took this asset that we had some work to do in terms of building the infrastructure and helping support patients. So I think that's going to be a journey for us, but a positive 1 given the scale of the unmet need and the lack of competition through the rest of the decade. I think Olivier said it really well. I think we've all been very pleasantly surprised by the demand and what that can mean. It's very early days, but I think it's really great to see so many centers wanting to get started. Bill, the Dupixent question.

謝謝，迪特瑪。我認為兩位都總結得很好。我們說，當我們獲得這項資產時，我們在建設基礎設施和幫助支持患者方面還有一些工作要做。因此，我認為這對我們來說將是一段旅程，但考慮到未來十年未滿足的需求規模和缺乏競爭，這是一個積極的旅程。我覺得奧利維爾說得很好。我認為我們都對這種需求及其含義感到非常驚喜。現在還為時尚早，但我認為看到這麼多中心想要開始真是太好了。比爾，Dupixent 問題。

Thanks, Peter. So just specifically, it's 70%, 70 percent commercial in the U.S. And that's -- I'll remind you now that we have 5 indications in the U.S. also multiple age ranges. And I think the thing to take into consideration here is as you look ahead and just where we are today are kind of 2 key numbers: Atopic dermatitis [Biopen] is 12%; asthma Biopen is 22%, and we have 3 other indications beyond that and other indications coming. You've heard me say it now for a bunch of years that we are kind of at the beginning still in many ways we are at the beginning. We're at the beginning of the new indications, new age groups, new geographies. So I think there's still a lot ahead of Dupixent. We're really excited about it. You've heard me describe it as a rocket ship, it's a rocket ship.

謝謝，彼得。具體來說，它在美國有 70%、70% 的商業化——我現在提醒您，我們在美國有 5 個適應症，也有多個年齡段。我認為這裡需要考慮的是，當你展望未來時，我們今天所處的位置有兩個關鍵數字：特應性皮炎 [Biopen] 為 12%；哮喘 Biopen 為 22%，除此之外我們還有 3 個其他適應症，並且還有其他適應症即將推出。多年來你一直聽我說過，我們還處於起步階段，但在很多方面我們仍處於起步階段。我們正處於新適應症、新年齡段、新地域的開端。所以我認為 Dupixent 的發展還有很長的路要走。我們對此感到非常興奮。你聽過我把它描述為一艘火箭飛船，它是一艘火箭飛船。

Thank you, Bill. I mean I understand, particularly when people have been over-interpreting the immunology marketplace through Q1 and Q2 in other disease areas that there's a heightened level of questioning, but you have to understand we already have competition in both AD and as -- as Bill said, we have 3 more indications where first and only pretty much. And then we have this low penetration as Bill said, the market opportunity is so vast and frankly, because so many patients are suffering, let's not forget that. So we have so much work to do on that, there's such a pull. So we really are still only at the beginning, and I think people have to really understand it that way. And it's exciting, a 33% growth. I think it was Q2 on a medicine of this size. I think -- and for us to be talking in these terms is really established to be involved in it. Okay. The next question.

謝謝你，比爾。我的意思是，我理解，特別是當人們在其他疾病領域通過第一季度和第二季度過度解釋免疫學市場時，質疑程度更高，但你必須明白，我們在 AD 和 AS 領域已經存在競爭——正如 Bill 所說說，我們還有另外 3 個跡象，其中第一個也是唯一一個差不多。然後，正如比爾所說，我們的滲透率很低，坦率地說，市場機會是如此巨大，因為有這麼多患者正在受苦，我們不要忘記這一點。所以我們在這方面還有很多工作要做，有很大的動力。所以我們確實還處於起步階段，我認為人們必須真正這樣理解它。 33% 的增長令人興奮。我認為這種規模的藥物是第二季度。我認為——對於我們來說，用這些術語進行討論確實是為了參與其中。好的。下一個問題。

Next question is from Thibault Boutherin from Morgan Stanley.

下一個問題來自摩根士丹利的 Thibault Boutherin。

I just have 2, please. The first 1 on the -- on U.S. insulins and launches. You highlighted the step-down in sales this quarter for U.S. launches due to net price decline. Was there a specific negative cost late adjustment in the quarter or any other one-off negative one-off? Or should we consider that the sales this quarter in the U.S. for launches is a good proxy for what to expect in the future? And then the second question on the COVID-19 one-off revenues. Can you confirm that these revenues are relating to agreements previously made with European countries? Your slide indicates that you will book them the revenues in other revenues. What margin should we assume on these revenues? Is it just a usual vaccines gross margin? And so just a quick follow-up on that. Should we expect that these revenues will not persist beyond 2023?

我只有2個，拜託。第一個關於——美國胰島素和上市。您強調了由於淨價下降，本季度美國產品的銷售量下降。本季度是否存在特定的負成本後期調整或任何其他一次性負一次性調整？或者我們是否應該考慮本季度在美國的上市銷售可以很好地反映未來的預期？然後是關於 COVID-19 一次性收入的第二個問題。您能否確認這些收入與之前與歐洲國家達成的協議有關？您的幻燈片表明您將把這些收入記入其他收入中。我們應該對這些收入假設多少利潤？這只是普通疫苗的毛利率嗎？對此進行快速跟進。我們是否應該預期這些收入不會持續到 2023 年之後？

Okay. So JB will come to you on COVID-19 one-offs. And Thomas, you put your hand up if you want to add something, Olivier insulin.

好的。因此，JB 將在 COVID-19 期間臨時來找您。托馬斯，如果你想添加一些東西，請舉手，奧利維爾胰島素。

Yes. So Thibault, thank you for your question. Yes, there was some gross to net elements in the Q2. So the Q2 is not a good proxy for the end of the year. you could use as a good proxy, more of first half decline, which is a little bit above 55%. Even if we think that we are going better in the second part of the year, we are in a declining market, a large industry to 4% and of course, you know that the volumes are holding pretty well. Our market share has been pretty stable on the (inaudible) market, 33% to 34%, very consistent across the last 5 or 6 quarters. But of course, more sales in the channels that IV discounted 340B and, of course, Medicare coverage gap. So overall, you should expect a much better second part of the year on Lantus in the U.S.

是的。蒂博，謝謝你的提問。是的，第二季度有一些總淨值。因此，第二季度並不是年底的良好指標。你可以用上半年下降幅度更大的數據作為一個很好的指標，略高於 55%。即使我們認為今年下半年會更好，但我們正處於一個不斷下滑的市場，一個下降到 4% 的大行業，當然，你知道銷量保持得很好。我們的市場份額在（聽不清）市場上相當穩定，為 33% 至 34%，在過去 5 或 6 個季度中非常穩定。但當然，IV 折扣 340B 的渠道銷售更多，當然還有醫療保險覆蓋範圍的差距。因此，總體而言，您應該期待今年下半年來得時在美國的表現要好得多。

Thank you, Olivier. It's -- I touched on it in my presentation about the sort of transformation of the portfolio we're on. The team has done exceptionally well with Lantus. But it very much were the Lantus company for a very long time. And as we transition our portfolio and our pipeline Dupixent beyond it gets (inaudible) a good example of that. We're becoming a new company in a new portfolio. And I think it shouldn't be lost as we move from 1 horse to the other, which is pretty much what our job is to do is to make that successful transition. I think the team, Olivier's team did a really outstanding job on that. So JB, COVID.

謝謝你，奧利維爾。我在關於我們正在進行的投資組合轉型的演講中談到了這一點。該團隊在來得時的表現非常出色。但在很長一段時間內，它一直是來得時公司。當我們轉變我們的產品組合和管道時，Dupixent 就得到了（聽不清）一個很好的例子。我們正在成為一家擁有新投資組合的新公司。我認為當我們從一匹馬轉向另一匹馬時，它不應該丟失，這幾乎就是我們要做的工作就是成功過渡。我認為奧利維爾的團隊在這方面做得非常出色。所以 JB，新冠病毒。

Yes. COVID revenues, I confirm that [50] -- [EUR 500 million] will be booking other revenues. And as a proxy, you can take the average gross margin of vaccine applied to that as it is normal.

是的。 COVID 收入，我確認 [50] - [5 億歐元] 將記入其他收入。作為代理，您可以採用疫苗的平均毛利率，因為這是正常的。

And maybe the only thing I will add is that Thibault no, we don't expect 2024 similar revenues. So we expect it to be real one-off in '23.

也許我唯一要補充的是，蒂博不，我們預計 2024 年不會有類似的收入。所以我們預計這將是 23 年真正的一次性事件。

Next question is from Graham Parry from BofA.

下一個問題來自美國銀行的 Graham Parry。

So first 1 is just on your guidance for launch products for a Beyfotus (inaudible) of EUR 400 million in the second half. I think consensus sales for those is around [EUR 275 million] the moment. So just where are you more optimistic there? Is this -- are you anticipating a a faster launch of Beyfortus than the 150-ish that (inaudible) is forecasting at the moment or or an acceleration in Altuviiio, for example? And then secondly, on the T-cell PROTECT study, you sort of seem to have shied away from saying whether you think you can file or not. So just to be clear, do you intend to take this data to regulators? And is it your expectation at the moment that to file in that indication you may need more data or a new trial looking at insulin use and time in target glucose range?

因此，第 1 條只是關於下半年推出價值 4 億歐元的 Beyfotus（聽不清）產品的指導。我認為目前這些產品的共識銷售額約為 [2.75 億歐元]。那麼你對哪些方面比較樂觀呢？這是 - 您是否預計 Beyfortus 的發布速度會比目前預測的 150 左右（聽不清）更快，或者是 Altuviiio 的加速發布？其次，在 T 細胞保護研究中，你似乎迴避說你是否認為你可以提交。需要澄清的是，您打算將這些數據提交給監管機構嗎？您目前的期望是，要提交該指示，您可能需要更多數據或一項新的試驗來觀察胰島素的使用和目標血糖範圍內的時間？

Graham, thank you very much. The difference, I think, between what you're having consensus and what we put out there for the launches. Firstly, to remind you that -- we wanted to give some type of number to give you a sense of how quickly we're transforming the portfolio. I mentioned that a moment or 2 ago. I think perhaps 1 of the biggest gaps versus consensus on Beyfortus. And I think we can really close some of that with the end market performance.

格雷厄姆，非常感謝你。我認為，你們達成的共識與我們為發布所發布的內容之間存在差異。首先，提醒您——我們想提供某種類型的數字，讓您了解我們改變投資組合的速度。我一兩分鐘前就提到過這一點。我認為這可能是 Beyfortus 與共識之間最大的差距之一。我認為我們確實可以通過終端市場的表現來解決其中的一些問題。

Especially after a recommendation.

尤其是在推薦之後。

If we get the recommendation next week, I think back to your original question about shape have launch, I think we'd expect to do certainly spread or close to consensus -- sorry, better than consensus on Beyfortus. I don't know whether -- I mean, Olivier has already touched on Tzield. I don't know whether we'll come back to protect in a moment. But Bill, do you want to add anything other than you've already said on Altuviiio, I mean.

如果我們下週得到建議，我想回到你關於形狀發布的最初問題，我認為我們肯定會傳播或接近共識——抱歉，比 Beyfortus 的共識更好。我不知道——我的意思是，奧利維爾是否已經談到了齊菲爾德。不知道一會兒我們是否會回來保護。但是比爾，我的意思是，除了你已經在 Altuviiio 上說過的內容之外，你還想補充什麼嗎？

No, look, it's early days, but it is a great product, and it really has the potential to redefine what is possible for hemophilia A patients because it does get their factor level to normal or near normal. So that takes some time for the community to digest, if you will. But out of the gates, I think we're really strong and really excited. This is kind of the factor and there's been a lot of questions about does it start to make gains with other competitors, nonfactors, for instance.

不，看，現在還處於早期階段，但它是一個很棒的產品，它確實有潛力重新定義 A 型血友病患者的可能性，因為它確實使他們的因子水平恢復正常或接近正常。因此，如果您願意的話，社區需要一些時間來消化。但走出大門，我認為我們真的很強大並且非常興奮。這是一種因素，並且存在很多問題，例如它是否開始與其他競爭對手（例如非因素）一起獲得收益。

And as I said, about 10% of the switches are coming from Hemlibra. And it's not a question of frequency. And I think some of our competitors may make that comment or have. It depends if patients want what is possible from a factor level. And ultimately, why don't they deserve the same right to be closer to non-hemophilia patients. So we think it's going to take some time for the market to get used to having that possibility and reimagine what's possible. So very excited about that launch.

正如我所說，大約 10% 的開關來自 Hemlibra。這不是頻率的問題。我認為我們的一些競爭對手可能會發表或已經發表過這樣的評論。這取決於患者是否想要從某個因素水平上得到可能的結果。最終，為什麼他們不應該享有同樣的權利來更接近非血友病患者。因此，我們認為市場需要一些時間來適應這種可能性並重新想像可能發生的事情。對於這次發布非常興奮。

And Dietmar, anything on the filing?

迪特瑪，文件中有什麼內容嗎？

Yes. I mean the -- again, stepping back for a second, right? You have a positive study. You have preservation of beta cell mass, which is really important for this disease. You have secondary endpoints that show a positive trend that really show that there's clinical benefit. We talked about time in range. We talked about insulin use. And keep in mind, this is on top of continuous glucose monitoring. So this is on top of the best available therapy that these patients can have these days, right? They have the continuous glucose monitor on 1 arm and the insulin pump on the other arm and they're treating themselves continuously, which means showing additional benefit on top of that is really important right for patients. And I'm looking forward to discussing these data with regulators to say it very clearly.

是的。我的意思是——再退一步，對吧？你有一個積極的學習。 β細胞質量得到保存，這對於這種疾病非常重要。您的次要終點顯示出積極的趨勢，真正表明存在臨床益處。我們討論了範圍內的時間。我們討論了胰島素的使用。請記住，這是連續血糖監測的基礎。所以這是這些患者目前可以接受的最佳療法的基礎，對吧？他們的一隻手臂上有連續血糖監測儀，另一隻手臂上有胰島素泵，他們不斷地自我治療，這意味著除此之外顯示額外的好處對患者來說非常重要。我期待著與監管機構討論這些數據，以便說得非常清楚。

Yes. I mean we are spending some time looking at the data because I think you've said it very well. These patients were effectively very well managed. So to show the difference was always a high bar, but there are differences. And I think we hope to get to that point where we can do that. I just want to go back just quickly. I mentioned upfront that -- last year, we see very important medicines, but smaller potentials, Xenpozyme, Enjaymo and Cablivi.

是的。我的意思是我們正在花一些時間查看數據，因為我認為你說得很好。這些患者得到了有效的良好管理。因此，顯示差異始終是一個很高的標準，但差異是存在的。我認為我們希望能夠做到這一點。我只想快點回去。我之前提到過，去年，我們看到了非常重要的藥物，但潛力較小，例如 Xenpozyme、Enjaymo 和 Cablivi。

This year, Altuviiio, Beyfortus and Tzield, much bigger potential. And as we keep getting into the launch sequence here, we'll be getting to the Amlitelimabs and big indications like Dupixent (inaudible). You're seeing the order of magnitude as the pipeline matures, become much more significant, and that's our role is to deliver that and to show how that cuts off the things that have been declining for a number of years. And that -- again, that transition is management responsibility. We're really happy about how that's trending so far. Maybe take another question? We have time.

今年，Altuiiio、Beyfortus 和 Tzield 的潛力更大。當我們繼續進入這裡的發布序列時，我們將討論 Amlitelimabs 和 Dupixent（聽不清）等重大適應症。隨著管道的成熟，您會看到其數量級變得更加重要，而我們的作用就是實現這一點，並展示如何消除多年來一直在下降的東西。再說一次，這種轉變是管理層的責任。我們對迄今為止的趨勢感到非常高興。也許再問一個問題？我們有時間。

The next question is from David Risinger from Leerink.

下一個問題來自 Leerink 的 David Risinger。

I have 2 questions, Paul, please. First, so just to follow-on on what you just mentioned. Could you discuss the opportunity for accelerating sales growth prospects following the annualization of AUBAGIO generic impacts in 2024? And second, could you comment on the outcome of your discussions with the FDA regarding a potential early filing of Dupi for COPD?

保羅，我有兩個問題。首先，繼續您剛才提到的內容。您能否討論一下 2024 年 AUBAGIO 仿製藥影響年化後加速銷售增長前景的機會？其次，您能否評論一下您與 FDA 就 Dupi 治療 COPD 的潛在早期申請進行討論的結果？

Okay. Thank you, David. Thank you for pointing out that AUBAGIO is our last meaningful LOE of the decade. So anniversarying that is going to be quite important for us -- it's been -- it's a great medicine and it's been given a lot to the company, but it's our last meaningful LOE not sure about the suggestions for growth next year on the back of that, J.B., do you want to make a comment?

好的。謝謝你，大衛。感謝您指出 AUBAGIO 是我們這十年來最後一個有意義的 LOE。因此，週年紀念對我們來說非常重要——它一直是——這是一劑良藥，為公司提供了很多幫助，但這是我們最後一次有意義的 LOE，不確定明年的增長建議J.B.，你想發表評論嗎？

Well, what we see when you look at what we published at Q1, looking at having drugs really blockbuster to launch post ['26] going to the (inaudible) of Dupixent. We are really looking at the growth profile by having 3 to 5 drugs and [2 billion to 5 billion] potential sales. So it's really when you take this potential for growth, of course, we are aiming at growth. and that's what we want to deliver. Don't forget that our underlying growth right now is quite impressive already and which gives us a great opportunity to deliver. Just if you look at H1 2023. When you take just our growth drivers, Dupixent Specialty Care products and when you take the core assets of GenMed on the vaccine sales, it's 15.3% just in H1 2023. And I was also showing when you take out the divestments on the LOE of AUBAGIO and ERP carve-out we are already enjoying a great growth. We want to stimulate that. We want to be a growth company. Yes, and that's what we do every day.

好吧，當你看看我們在第一季度發布的內容時，我們看到的是，在 ['26] 後（聽不清）Dupixent 推出真正重磅炸彈的藥物。我們確實通過 3 到 5 種藥物和 [20 億到 50 億] 潛在銷售額來關注增長情況。所以，當你利用這種增長潛力時，我們的目標當然是增長。這就是我們想要提供的。不要忘記，我們目前的潛在增長已經相當令人印象深刻，這為我們提供了實現目標的絕佳機會。如果你看看 2023 年上半年。當你只考慮我們的增長動力 Dupixent 特種護理產品時，當你考慮 GenMed 在疫苗銷售方面的核心資產時，2023 年上半年它的增長率為 15.3%。當你考慮憑藉 AUBAGIO LOE 的撤資和 ERP 的剝離，我們已經享受到了巨大的增長。我們想要刺激這一點。我們希望成為一家成長型公司。是的，這就是我們每天所做的。

Thank you, JB. It's quite an important point, and we did put it in the deck for that reason that come into this Q&A to start for transition. But we want to make quite clear that 15-plus percent, we recognize that it's taking off things that coming to the end of their journey. But the reality is that's a big number. Well, we're not suggesting what it is for next year, you can see where our ambition lies with accelerating the underlying to get it to something that we would hope to compete with the best in the industry. So that's what we think. -- Do COPD filing, Dietmar, anything you want to.

謝謝你，傑比。這是非常重要的一點，我們確實將其放入了本次問答中以開始過渡的原因。但我們想明確表示，超過 15% 的人，我們認識到，這正在推動即將結束旅程的事情。但現實是這個數字很大。好吧，我們並不是在暗示明年會發生什麼，你可以看到我們的雄心在於加速基礎工作，使其達到我們希望與行業中最好的公司競爭的水平。這就是我們的想法。 ——做慢性阻塞性肺病（COPD）歸檔，Dietmar，任何你想做的事。

David, thank you. For the question. I would love to tell you more, but we're still ahead of those discussions, right? But let me again also just briefly step back here because I think the Boreas data in COPD are very important for patients, for us, for the community. What we've seen there is efficacy with a well known safety profile, it's just and will just be an entire change, right, in how these patients are treated. So I think -- it's very important that we have those discussions with regulatory authorities, the unmet medical needs for patients with COPD is very high. So it's the third most important reason for death on a global basis. And we are coming back from the ATS meeting from the American Thoracic Society Meeting, right, where we had the discussion of the data where we presented the data very positive feedback from the community and the leader. So we are very much looking forward to have those discussions with the regulatory authorities.

大衛，謝謝你。對於這個問題。我很想告訴你更多信息，但我們仍然領先於這些討論，對吧？但讓我再次簡單地回到這裡，因為我認為 Boreas 在慢性阻塞性肺病方面的數據對於患者、我們、社區都非常重要。我們所看到的療效和眾所周知的安全性，這將是對這些患者治療方式的徹底改變，對吧。所以我認為，我們與監管機構進行討論非常重要，慢性阻塞性肺病患者未得到滿足的醫療需求非常高。因此，這是全球第三大死亡原因。我們剛從美國胸科學會會議的 ATS 會議回來，右圖，我們在會上討論了數據，並提出了來自社區和領導者的非常積極的反饋。因此，我們非常期待與監管機構進行這些討論。

Okay. Yes. And just to keep me clear. Since Q1 update, I think you've touched on this a little bit. We're still ahead of any significant regulatory conversation. So nothing has changed for us on that. So we remain very enthusiastic. I think it's just worth is saying. And I think it takes a bit of course, in Q2, we have the chance to be at ATS and meet a lot of opinion leaders. And this is very exciting. Let's be honest. The unmet needs of the advanced therapy. So you should know that we will bring off best forward in that regulatory interaction. Okay.

好的。是的。只是為了讓我清楚。自第一季度更新以來，我認為您已經觸及了這一點。我們仍然領先於任何重大的監管對話。所以我們在這方面沒有任何改變。所以我們仍然非常熱情。我認為這是值得說的。我認為這當然需要一點時間，在第二季度，我們有機會參加 ATS 並會見很多意見領袖。這非常令人興奮。說實話。先進療法的未滿足需求。所以你應該知道我們將在監管互動中取得最好的進展。好的。

Next question is from Gary Steventon from Exane BNP.

下一個問題來自 Exane BNP 的 Gary Steventon。

Firstly, just on the guidance. I guess how should we think about your ability to continue to ramp up investment in R&D and behind new launches over the near-term commentary on growth and the contribution for the new launch is pretty encouraging. So I'm just wondering kind of how close or not you might be to a point where it's more difficult to reinvest that near-term growth given that the extra COVID vaccine revenue seems to have supported the guidance upgrade?

首先，只是指導。我想我們應該如何考慮你們繼續增加研發投資和新產品推出的能力，因為近期對增長的評論和對新產品的貢獻是相當令人鼓舞的。因此，我只是想知道，考慮到額外的新冠疫苗收入似乎支持了指導意見的升級，您可能有多接近對近期增長進行再投資的程度？

And then secondly, just on consumer actually and the strategic priorities here. I mean you've slimmed down the number of brands improved growth. We've got the divisional P&L and today's deal helps to strengthen that U.S. presence. So other than making progress on OTC switches, and I think an update there would also be very much appreciated. What do you see really as the next steps for consumer on that road map? And then just quickly, you mentioned the new deal being a top 5 products, so you need further quantification there would also be helpful.

其次，關於消費者的實際情況和戰略重點。我的意思是，你減少了品牌數量，提高了增長。我們已經獲得了部門損益表，今天的交易有助於加強我們在美國的業務。因此，除了在 OTC 開關方面取得進展之外，我認為我們也將非常感謝那裡的更新。您認為消費者在該路線圖上的下一步行動是什麼？然後很快，您提到新交易是排名前 5 的產品，因此您需要進一步量化，這也會有所幫助。

Okay, Gary. Thank you, JB. How are you threading the needle.

好的，加里。謝謝你，傑比。怎麼穿針啊。

Well, we've been studying it for a while. And each time we have this challenge to to do new arbitrage to do 1 in 1 out to improve permanently our growth profile in our pipeline. And as you hear me say often, we still have a lot to do in our transformation on the cost base is still presenting a lot of opportunities. Some are are longer to deliver. We are doing a deep work with all our M&S manufacturing and supply team to improve some basics. And we know also that we will have some trade-offs within our own portfolio because that's a story that we are in to build the growth. We need to thread that needle. We reinvest in R&D. That's why we are here.

嗯，我們已經研究了一段時間了。每次我們都會面臨新的套利挑戰，進行一對一的套利，以永久改善我們管道中的增長狀況。正如你經常聽到我說的那樣，我們在轉型中還有很多工作要做，成本基礎仍然存在很多機會。有些交付時間較長。我們正在與所有瑪莎百貨製造和供應團隊進行深入合作，以改進一些基礎知識。我們還知道，我們將在自己的投資組合中進行一些權衡，因為這是我們要實現增長的故事。我們需要穿針。我們對研發進行再投資。這就是我們在這裡的原因。

Yes. Maybe I also could just add there is with the management team that we do a lot of great work on reallocating or adding -- giving back to the bottom line. I think we're now working transversely on other sort of structural or systemic opportunities to try and free up more resources. And I think we have a good plan, and I think there's some confidence in the team to be able to do that. Nothing nothing too crazy, but definitely enough to be able to make sure we don't miss a value creation opportunity. Julie, a whole host of things viewed to answer ranging from -- don't forget the switches, maybe make a comment about the top 5? And what sort of -- what's the next big moment for you and the team?

是的。也許我還可以補充一點，我們的管理團隊在重新分配或增加方面做了很多出色的工作——回饋底線。我認為我們現在正在橫向研究其他類型的結構性或系統性機會，以嘗試釋放更多資源。我認為我們有一個很好的計劃，而且我認為團隊有信心能夠做到這一點。沒什麼太瘋狂的，但絕對足以確保我們不會錯過價值創造的機會。朱莉，要回答的問題有很多——不要忘記開關，也許可以對前 5 個問題發表評論？對你和團隊來說，下一個重要時刻是什麼？

First of all, Gary, thank you so much for the question because this quarter is a big moment for -- and I think overall, what I can say is that our ultimate goal is to maximize the value creation of CHC. And what we've been doing in the past 2 years, we really focus on our existing portfolio divesting for pruning and divesting a part of a double downing on the brands that we believe had the most pose potential. And today, we are ready to welcome a new brand that is helping us to really fill 1 of our strategic gaps and strengthen our geographic footprint. And that's really what we want to continue to do, obviously, is to everything that will drive max value creation for CHC.

首先，Gary，非常感謝你提出這個問題，因為本季度是一個重要時刻——我認為總的來說，我能說的是，我們的最終目標是最大化 CHC 的價值創造。在過去的兩年裡，我們一直在做的事情是，我們真正專注於現有的投資組合剝離，以進行修剪，並剝離我們認為最具潛力的品牌的部分雙重打擊。今天，我們準備好迎接一個新品牌，它正在幫助我們真正填補我們的戰略空白並加強我們的地理足跡。顯然，這正是我們真正想要繼續做的事情，就是推動 CHC 創造最大價值的一切。

On Qunol specifically, again, high-quality assets, strong science in a very special healthy aging segment and what already enjoys high cancer -- I mean, brand loyalty. Top 5 brand means that, again, it has a brand that still has a lot of potential also in the future because it has a premium positioning and also because of its in its category, but also because of its model and that we believe there's opportunities potentially for other chronic diseases.

具體到 Qunol，再次強調，高質量的資產、非常特殊的健康老齡化領域的強大科學，以及已經享有很高的癌症——我的意思是，品牌忠誠度。前 5 名品牌再次意味著它擁有一個在未來仍然具有很大潛力的品牌，因為它具有高端定位，也因為它在其類別中，而且還因為它的模型，並且我們相信有機會可能會導致其他慢性疾病。

So a lot of -- obviously, looking forward to welcome the brand at closing and to expand it. Then on switches, there is nothing new. Obviously, we continue to work with the FDA on the approval of the switches, and we're advancing on the execution of the -- on their strategy to get the clinical hold, including the generation of the necessary data. And I hope that we'll have more information by the end of the year.

顯然，很多人都期待在關閉時歡迎該品牌並擴大其規模。然後在交換機上，就沒有什麼新的了。顯然，我們將繼續與 FDA 合作批准這些轉換，並且我們正在推進他們獲得臨床控制的策略的執行，包括生成必要的數據。我希望我們能在今年年底之前獲得更多信息。

Yes. So that's part of our next steps. Of course, we would like to unlock the value of those switches and it's still on. We will work on it on -- apart from that, we have not departed from what we said in December '19, we want to grow consumer health. We want to maximize the value. We want really to give some management teams the maximum opportunity to grow this value. So that's where we are.

是的。這是我們下一步的一部分。當然，我們希望釋放這些開關的價值，而且它仍然處於打開狀態。我們將繼續努力——除此之外，我們並沒有背離我們在 19 年 12 月所說的，我們希望促進消費者健康。我們希望價值最大化。我們確實希望為一些管理團隊提供最大的機會來發展這一價值。這就是我們現在的情況。

Okay. Thank you. Thank you, JP.

好的。謝謝。謝謝你，JP。

Last question from Jo Walton from Credit Suisse.

最後一個問題來自瑞士信貸銀行的喬·沃爾頓。

Apologies for that. I just have 2 questions, please. I noticed that Dietmar isn't on the Executive Committee just looking at the -- on your website. I wonder if you could tell us when you're going to be in a position to announce a new permanent head of R&D? And could I just ask related another R&D-related question. It's a couple of years now since you bought Tidal IP for the targeted delivery CAR-T, certain cell types? I wonder this area still looks to be facing real challenges. Is it still an area of focus for you? Can you tell us when we may hear next steps on it please?

對此表示歉意。我只有 2 個問題。我注意到迪特瑪不在執行委員會中，只是在看你們網站上的內容。我想知道您是否可以告訴我們您何時能夠宣布新的常任研發主管？我可以問另一個與研發相關的問題嗎？距離您購買 Tidal IP 用於靶向遞送 CAR-T（某些細胞類型）已經有幾年了？我想知道這個領域看起來仍然面臨著真正的挑戰。它仍然是您關注的領域嗎？您能告訴我們什麼時候可以聽到後續措施嗎？

Okay. Joe, thank you. As with all internal announcements, we'll communicate them when we communicate them. So thank you for the update there. Dietmar Tidal, I think the question was.

好的。喬，謝謝你。與所有內部公告一樣，我們會在溝通時進行溝通。謝謝您的更新。 Dietmar Tidal，我想問題是。

Yes, Tidal. That is a very interesting program within our oncology research at this point in time. It is the approach to use mRNA-based therapeutics to generate CAR T cells in vivo basically, give the mRNA and generate the CAR T cells within the patient, which could be entirely disruptive as you know, Joe, right, for the CAR T cell space. We are progressing that program is moving forward. We'll give an update once we can. But let me just tell you that this is part of our broader genomic medicines unit and our genomic medicines initiatives that we have and also synergies that we realized with our mRNA center of excellence. And our first product from this genomic medicines unit is actually coming into the clinic this year. It's not a title program, but it's really showing you that progress that we're making on the genomic medicine side.

是的，潮汐。目前，這是我們腫瘤學研究中一個非常有趣的項目。這是一種使用基於 mRNA 的療法在體內生成 CAR T 細胞的方法，基本上是在患者體內提供 mRNA 並生成 CAR T 細胞，正如你所知，喬，對，這對於 CAR T 細胞來說可能是完全破壞性的空間。我們正在取得進展，該計劃正在向前推進。我們會盡快更新。但我只想告訴您，這是我們更廣泛的基因組藥物部門和我們擁有的基因組藥物計劃的一部分，也是我們與 mRNA 卓越中心實現的協同效應的一部分。我們基因組藥物部門的第一個產品實際上將於今年進入臨床。這不是一個標題項目，但它確實向您展示了我們在基因組醫學方面取得的進展。

And so far, the program is actually moving forward very well in the research area, and I'm looking forward to bring that closer to the clinic.

到目前為止，該項目實際上在研究領域進展順利，我期待著將其更接近臨床。

Yes. So thank you. Maybe just a last couple of comments. As we said up front, it's a solid quarter. We've given an upgrade to the guidance. We've advanced the pipeline. We are reallocating resources to R&D and growth opportunities. I think this is the work that needs to be done, and I think we're really happy with the progress that we're making. Of course, we expect to see an even better performance in summer as we get through the rest of the year, but time will tell. But we're -- no, we're very excited about the progress we're making in the company. So thank you to everybody for dialing in and making time for asking questions, and we look forward to reconnecting the next available opportunity. And hopefully, many of you just made a note for December 7 New York City. I think that will be a good day. in. Thank you very much.

是的。所以謝謝。也許只是最後幾條評論。正如我們前面所說，這是一個穩定的季度。我們對指南進行了升級。我們已經推進了管道。我們正在將資源重新分配給研發和增長機會。我認為這是需要完成的工作，而且我認為我們對所取得的進展感到非常滿意。當然，我們預計在今年剩餘的時間裡，我們會在夏季看到更好的表現，但時間會證明一切。但我們——不，我們對公司取得的進展感到非常興奮。因此，感謝大家撥通電話並抽出時間提問，我們期待著下一個可用的機會重新聯繫。希望你們中的許多人剛剛為 12 月 7 日紐約市做了記錄。我想那將是美好的一天。非常感謝。