Novartis AG (NVS) 2018 Q3 法說會逐字稿

Good morning, and good afternoon, and welcome to the Novartis Q3 2018 Results Release Conference Call and Live Audio Webcast.

早上好，下午好，歡迎來到諾華 2018 年第三季度業績發布電話會議和現場音頻網絡廣播。

(Operator Instructions) And the conference is being recorded.

（操作員說明）會議正在錄製中。

(Operator Instructions) A recording of the conference call, including the Q&A session, will be available on our website shortly after the call ends.

（操作員說明）電話會議的錄音，包括問答環節，將在電話會議結束後不久在我們的網站上提供。

(Operator Instructions)

（操作員說明）

With that, I would like to hand over to Mr. Samir Shah, Global Head of Investor Relations.

就此，我想請投資者關係全球主管 Samir Shah 先生髮言。

Please go ahead, sir..

請繼續，先生..

Thank you very much, and good morning, and good afternoon, everybody.

非常感謝大家，早上好，下午好。

Before we start, I just wanted to read to you the safe harbor statements.

在我們開始之前，我只想向您宣讀安全港聲明。

The information presented today contains forward-looking statements and involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements.

今天提供的信息包含前瞻性陳述，涉及已知和未知的風險、不確定性和其他因素，這些因素可能導致實際結果與此類陳述明示或暗示的任何未來結果、業績或成就存在重大差異。

Please refer to the company's Form 20-F on file with the U.S. Securities and Exchange Commission for a description of some of these factors.

請參閱公司在美國證券交易委員會備案的 20-F 表格，了解其中一些因素的說明。

In addition, just wanted to point out that the information presented in respect of the proposed Endocyte transaction may be deemed to be solicitation material.

此外，只是想指出，就擬議的 Endocyte 交易提供的信息可能被視為招標材料。

In connection with the proposed Endocyte transaction, Novartis and Endocyte intend to file relevant materials with the U.S. SEC.

關於擬議的 Endocyte 交易，諾華和 Endocyte 打算向美國證券交易委員會提交相關材料。

We urge you to read these materials, including a proxy statement of Endocyte and all other relevant documents filed with the SEC when such documents become available and which will be available for free.

我們敦促您閱讀這些材料，包括 Endocyte 的代理聲明以及在這些文件可用時向 SEC 提交的所有其他相關文件，這些文件將免費提供。

The proposed Endocyte transaction has not been completed, and there can be no guarantee that the proposed Endocyte transaction will be completed or that it will be completed as currently proposed or at any particular time.

擬議的 Endocyte 交易尚未完成，不能保證擬議的 Endocyte 交易將完成或將按當前提議或在任何特定時間完成。

And with that, I'll now hand across to Vas.

有了這個，我現在將交給 Vas。

Thank you, Samir, and thanks, everyone, for joining today's conference call.

謝謝薩米爾，也感謝大家參加今天的電話會議。

We're really pleased with our performance in quarter 3, where we continued our journey to be a leading focused medicines company powered by breakthrough innovation and data and digital technologies.

我們對第三季度的業績感到非常滿意，我們繼續努力成為一家領先的專注於突破性創新、數據和數字技術的醫藥公司。

When you go to Slide 4, you can see that our group performance was strong, with sales growing 6% in constant currency and core operating income up 9% in constant currency.

當你轉到幻燈片 4 時，你會看到我們的集團表現強勁，銷售額按固定匯率計算增長 6%，核心營業收入按固定匯率計算增長 9%。

Harry will go through the numbers in a bit more detail.

Harry 將更詳細地分析這些數字。

We're also quite pleased with our innovation milestones in the quarter.

我們也對本季度的創新里程碑感到非常滿意。

And I'll go through these in the upfront section.

我將在前面部分介紹這些內容。

But with the AVXS-101 filing in U.S., Europe and Japan, BAF312 filed in U.S. and Europe, the approval of KYMRIAH in multiple geographies and the proposed acquisition of Endocyte, I think we're also demonstrating we have the innovation power and the innovation momentum to continue to drive growth well into the future.

但是隨著美國、歐洲和日本的 AVXS-101 申請、美國和歐洲的 BAF312 申請、KYMRIAH 在多個地區的批准以及對 Endocyte 的擬議收購，我認為我們也證明了我們擁有創新能力和創新能力繼續推動未來增長的勢頭。

So if you go to Slide 5, when you look at the underlying drivers for that strong performance, you can see that COSENTYX and ENTRESTO continue to perform well.

因此，如果您轉到幻燈片 5，當您查看這種強勁表現的潛在驅動因素時，您會發現 COSENTYX 和 ENTRESTO 繼續表現良好。

I'll go into each of those in a bit more detail.

我將更詳細地介紹每一個。

But I also wanted to point out our Oncology growth drivers are tracking extremely well: PROMACTA, TAFINLAR and MEKINIST as well as JAKAVI.

但我還想指出，我們的腫瘤學增長驅動力跟踪得非常好：PROMACTA、TAFINLAR 和 MEKINIST 以及 JAKAVI。

And I'll say a bit more about LUTATHERA.

我會多說一點 LUTATHERA。

It's become a bright -- I think a real bright point for us as we now see this as a potential blockbuster medicine.

它已經成為一個亮點——我認為這對我們來說是一個真正的亮點，因為我們現在將其視為一種潛在的重磅藥物。

And I'll show you a bit more data about where we see LUTATHERA trending right now.

我將向您展示更多關於 LUTATHERA 目前流行趨勢的數據。

Then when you move to the next slide and you look at COSENTYX, I think as we've hopefully now shown, it's really established as the leading differentiated IL-17A inhibitor and had an outstanding performance in the quarter.

然後，當您轉到下一張幻燈片並查看 COSENTYX 時，我認為正如我們現在希望展示的那樣，它確實已確立為領先的差異化 IL-17A 抑製劑，並且在本季度表現出色。

You can see the 37% growth, really strong momentum by Paul and his team across all indications and geographies.

你可以看到 37% 的增長，這是 Paul 和他的團隊在所有適應症和地區的強勁勢頭。

Importantly, we surpassed HUMIRA in TRx in psoriatic arthritis in the United States.

重要的是，我們在美國的銀屑病關節炎治療 TRx 方面超過了 HUMIRA。

And then we have recent 5-year data, which similar to what we've shown in psoriasis, showed that in PsA and in AS, we showed sustained benefit complementing our long-term data, as I said, in psoriasis.

然後我們有最近 5 年的數據，類似於我們在牛皮癬中顯示的數據，表明在 PsA 和 AS 中，我們顯示出持續的益處補充我們在牛皮癬中的長期數據。

I think that really builds out the profile of COSENTYX as the leading IL-17A inhibitor, on the one hand, in psoriasis, and then in rheumatology, really being unique in the mechanistic approach it has to treating the underlying joint disease that are really prominent in these 2 conditions.

我認為這確實確立了 COSENTYX 作為領先的 IL-17A 抑製劑的形象，一方面，在銀屑病中，然後在風濕病學中，在治療真正突出的潛在關節疾病的機制方法上確實是獨一無二的在這2個條件下。

Going a little bit deeper on psoriasis on Slide 7. You can see that we continue to gain market share in psoriasis in a very competitive market.

在幻燈片 7 上更深入地了解銀屑病。您可以看到，我們在競爭激烈的市場中繼續獲得銀屑病的市場份額。

I think Paul could say more about this.

我認為保羅可以就此說更多。

And there's a few reasons for this.

這有幾個原因。

One, we continue to believe that within the physician mindset and the payer mindset, there are 2 classes here they're thinking about in terms of the new drugs, IL-17A and IL-12/23.

第一，我們仍然相信，在醫生的心態和付款人的心態中，他們在新藥 IL-17A 和 IL-12/23 方面正在考慮兩類。

We are the leading IL-17A with some really important unique datasets, including that we can treat multiple manifestations of psoriatic disease, including scalp, nail, palmoplantar and joint involvement.

我們是領先的 IL-17A，擁有一些非常重要的獨特數據集，包括我們可以治療銀屑病的多種表現，包括頭皮、指甲、掌蹠和關節受累。

And 2/3 of patients have those additional sources of the disease.

2/3 的患者有這些額外的疾病來源。

And then on top of that, when you look at our real-world evidence datasets we've been putting out into the community, they consistently confirm the safety and efficacy benefits of COSENTYX.

然後最重要的是，當您查看我們一直向社區提供的真實世界證據數據集時，它們始終證實了 COSENTYX 的安全性和有效性優勢。

So we're quite pleased and really looking for COSENTYX to continue its strong trajectory into the coming years.

因此，我們非常高興並且真的希望 COSENTYX 在未來幾年繼續保持強勁的發展軌跡。

Then moving to Slide 8. ENTRESTO as well had a very strong performance in the quarter, doubling versus Q3 in 2017.

然後轉到幻燈片 8。 ENTRESTO 在本季度也有非常強勁的表現，與 2017 年第三季度相比翻了一番。

You can see both U.S. and ex U.S. sales were nicely up.

你可以看到美國和美國以外的銷售額都很好。

I think importantly here, we're starting to roll out datasets from trials that we began in 2015 to really build out the profile of ENTRESTO.

我認為在這裡重要的是，我們開始推出 2015 年開始的試驗數據集，以真正建立 ENTRESTO 的概況。

Both TRANSITION and PIONEER taken together will hopefully enable us to really show that ENTRESTO can be used in the hospital setting.

將 TRANSITION 和 PIONEER 結合在一起有望使我們能夠真正證明 ENTRESTO 可以在醫院環境中使用。

The TRANSITION study has already read out and the PIONEER study will be something we'll be presenting as a late-breaker at AHA in November.

TRANSITION 研究已經宣讀完畢，而 PIONEER 研究將是我們將在 11 月的 AHA 上作為晚期突破者展示的內容。

That will enable us to ensure that patients are getting ENTRESTO at the right time in the hospitals.

這將使我們能夠確保患者在醫院的正確時間獲得 ENTRESTO。

In addition, the PARAGON study continues as planned following the interim analysis that we talked about earlier this year with the results expected in mid-2019.

此外，PARAGON 研究在我們今年早些時候談到的中期分析之後按計劃繼續進行，預計在 2019 年年中得出結果。

I would also note the PARADISE study, which is in pre-heart failure, post-MI patients, is also enrolling according to plan.

我還要指出，針對心力衰竭前、心肌梗死後患者的 PARADISE 研究也在按計劃招募。

So overall, the ENTRESTO picture looking strong, and we continue to see solid momentum around the world with this medicine.

所以總的來說，ENTRESTO 的前景看起來很強勁，我們繼續看到這種藥物在世界範圍內的強勁勢頭。

I mentioned LUTATHERA, and I wanted to show on Slide 9 the kind of really explosive performance we're seeing now in LUTATHERA.

我提到了 LUTATHERA，我想在幻燈片 9 上展示我們現在在 LUTATHERA 中看到的那種真正爆炸性的性能。

It's off to a strong start in the U.S. You can see here number of doses per quarter.

它在美國開局良好。您可以在此處查看每季度的劑量數。

And this trend is really, I think, very encouraging.

我認為，這種趨勢確實非常令人鼓舞。

And we're -- now we're starting to roll out the medicine in Europe.

我們——現在我們開始在歐洲推出這種藥物。

In the U.S., we have 85 centers that are actively prescribing.

在美國，我們有 85 個中心在積極開處方。

We have 70% coverage of the relevant lives.

我們對相關生活的覆蓋率為 70%。

And in the U.K. now, we have 18 centers actively prescribing.

現在在英國，我們有 18 個中心在積極開藥。

And I think seeing the strength of the performance in LUTATHERA, feeling now that it's a potential blockbuster medicine, seeing this outperform our deal case is part of the rationale when we come to the Endocyte deal for the confidence we had in taking the step to acquire Endocyte.

我認為，看到 LUTATHERA 的表現實力，現在感覺它是一種潛在的重磅炸彈藥物，看到它優於我們的交易案例是我們進行 Endocyte 交易的部分理由，因為我們有信心採取步驟收購內細胞。

And I'll talk more about that in a few slides.

我將在幾張幻燈片中詳細討論這一點。

Now moving to Sandoz on Slide 10.

現在轉到幻燈片 10 上的 Sandoz。

I think, as you know, Sandoz continues to perform well in a difficult environment both in the U.S. but also around the world.

我認為，如您所知，山德士在美國乃至全球的艱難環境中繼續表現良好。

When you look at Q3 2018 performance, the U.S. impact continued of the industry-wide pricing pressure.

當您查看 2018 年第三季度的業績時，美國對全行業定價壓力的影響仍在繼續。

But we were able to grow sales ex U.S. at 2%.

但我們能夠以 2% 的速度增長美國以外的銷售額。

And importantly, our biosimilars portfolio is growing at 21%.

重要的是，我們的生物仿製藥組合正以 21% 的速度增長。

And when you think about how we're going to drive Sandoz moving forward, a lot of it is about executing a strategy of transformation and shifting the focus to complex generics and biosimilars.

當你考慮我們將如何推動 Sandoz 向前發展時，很多都是關於執行轉型戰略並將重點轉移到復雜的仿製藥和生物仿製藥上。

We're well on our way to do that in the United States.

在美國，我們正在努力做到這一點。

We announced that our planned sale of the core Gx business to Aurobindo.

我們宣布計劃將核心 Gx 業務出售給 Aurobindo。

And then we're also expanding rapidly in biosimilars in Europe.

然後我們也在歐洲迅速擴大生物仿製藥。

And Richard can speak more about that.

理查德可以談論更多。

But both Rixathon and ERELZI are performing well.

但 Rixathon 和 ERELZI 都表現良好。

We have the approval for our adalimumab biosimilar and our infliximab biosimilar.

我們的阿達木單抗生物仿製藥和英夫利昔單抗生物仿製藥獲得了批准。

And I would note that we are now in the market with our adalimumab biosimilars in 4 countries.

我要指出的是，我們現在在 4 個國家/地區投放我們的阿達木單抗生物仿製藥。

And we have a positive CHMP opinion for pegfilgrastim, which should enable a launch, we hope, in Q4, assuming approval.

我們對 pegfilgrastim 有積極的 CHMP 意見，如果獲得批准，我們希望它能夠在第四季度推出。

So overall, I think Sandoz is on the right track.

所以總的來說，我認為山德士走在正確的軌道上。

Challenging environment, but I think we're taking the steps necessary to put the division in a place where it can succeed.

充滿挑戰的環境，但我認為我們正在採取必要的步驟，使該部門能夠取得成功。

And moving to Slide 11.

並移動到幻燈片 11。

Alcon continues its strong sales growth.

愛爾康繼續保持強勁的銷售增長。

And I think that's really the key point of the Alcon story.

我認為這確實是愛爾康故事的關鍵點。

We need to keep generating that strong sales growth across segments, and we did that in the quarter.

我們需要在各個細分市場保持強勁的銷售增長，我們在本季度做到了這一點。

You can see 7% sales growth in Surgical, 3% sales growth in Vision Care.

您可以看到外科手術的銷售額增長了 7%，視力保健的銷售額增長了 3%。

Core operating income grew 1%.

核心營業收入增長 1%。

And we had always known that the margin story for Alcon this year was going to be a little bit choppy coming out of the trough 2017 margin.

我們一直都知道，今年愛爾康的利潤率故事在 2017 年的低谷之後會有點波動。

David Endicott is here.

大衛·恩迪科特來了。

And he can provide more perspective.

他可以提供更多的視角。

But when you look at the year-to-date performance in Alcon, we have core operating income growing at 14%.

但是，當您查看愛爾康年初至今的業績時，我們的核心營業收入增長了 14%。

The core ROS at 18.6%.

核心 ROS 為 18.6%。

So business is on the right direction and is continuing its trajectory as we've stated.

因此，業務正朝著正確的方向發展，並且正如我們所說的那樣繼續其發展軌跡。

And we remain confident, as Harry can discuss further, in the overall trajectory of the margins.

正如 Harry 可以進一步討論的那樣，我們對利潤率的總體軌跡仍然充滿信心。

Now when you go to Slide 12, just to say a word in the quarter, we had a number of key data readouts and regulatory milestones.

現在，當你轉到幻燈片 12 時，只在本季度說一句話，我們有許多關鍵數據讀數和監管里程碑。

And I don't want to go through all of these, but a few I wanted to highlight on this slide.

我不想詳細介紹所有這些，但我想在這張幻燈片上強調一些。

I will talk about AVXS-101 and Endocyte specifically.

我會具體談談AVXS-101和Endocyte。

But I did want to note that BAF312 was filed in SPMS in both U.S. and Europe.

但我確實想指出，BAF312 已在美國和歐洲的 SPMS 中提交。

We will be presenting the BYL719 study results at the presidents' presentation in ESMO over the weekend.

我們將在周末的 ESMO 總統演講中展示 BYL719 研究結果。

And we'll be holding an investor call around that, so everybody can understand better that data.

我們將就此召開投資者電話會議，以便每個人都能更好地理解這些數據。

And importantly, driving our in-line brands really across the various brands, whether it's GILENYA, KISQALI, Aimovig, Taf/Mek, we continue to generate data to support these important growth drivers at the company.

重要的是，無論是 GILENYA 、 KISQALI 、 Aimovig 、 Taf / Mek ，我們真正推動我們的在線品牌真正跨越各種品牌，我們繼續生成數據以支持公司的這些重要增長動力。

Now before moving off this slide, I wanted to give an update on ACZ885.

在離開這張幻燈片之前，我想介紹一下 ACZ885 的最新情況。

Yesterday, we received a complete response letter from the FDA regarding the filing in cardiovascular disease.

昨天，我們收到了 FDA 關於心血管疾病備案的完整回复函。

As we had said last year, we were focused all along on trying to get the hsCRP responder group as the primary driver in the label so that we could make sure the relevant patient population would get treated and there would be appropriate access to the medicine.

正如我們去年所說，我們一直專注於讓 hsCRP 應答者群體成為標籤中的主要驅動因素，以便我們能夠確保相關患者群體得到治療，並且能夠適當地獲得藥物。

We presented our case to the FDA.

我們向 FDA 提交了我們的案例。

The FDA has asked additional questions and has requested additional data with respect to the responder population.

FDA 提出了更多問題，並要求提供有關響應者人群的更多數據。

And we're evaluating now what would be the appropriate next steps.

我們現在正在評估下一步的適當步驟。

I would want to highlight that we continue on track with our ACZ885 studies in lung cancer, where we're enrolling studies in adjuvant lung, first-line metastatic lung and second-line metastatic lung.

我想強調的是，我們繼續推進 ACZ885 肺癌研究，我們正在招募輔助肺、一線轉移性肺和二線轉移性肺的研究。

And we're on track for readouts of those studies between 2020 and 2022.

我們正按計劃在 2020 年至 2022 年期間公佈這些研究。

So moving to Slide 13 and diving a bit more on AveXis.

所以轉到幻燈片 13 並深入了解 AveXis。

And there's been a lot of discussion, I think, given the competitive dynamics in SMA around the AVXS-101 program.

鑑於 SMA 圍繞 AVXS-101 計劃的競爭動態，我認為已經進行了很多討論。

So I wanted to again level set everyone on the extraordinary result that you see with this medicine in SMA Type 1. I think whether you look at the videos that are posted by the NIH Director or if you look at other testimonials for patients, this is a simply extraordinary medicine, where you have patients who would otherwise be expected to die, many of them out now beyond 4 years of age developing normally.

所以我想再次讓大家了解這種藥物在 1 型 SMA 中所見的非凡效果。我想無論你是看 NIH 主任發布的視頻還是看其他患者的推薦，這都是一種簡單非凡的藥物，你的病人本來會死，其中許多人現在已經超過 4 歲，發育正常。

So I think a few key points to highlight here.

所以我認為這裡要強調幾個關鍵點。

First, when you look at the baseline study characteristics, this was a severe population.

首先，當您查看基線研究特徵時，這是一個嚴重的人群。

And I think whenever you're looking at results in SMA, it's important to look at the baseline study population because there's a lot of variability in the baseline characteristics of these patients.

而且我認為，每當您查看 SMA 的結果時，查看基線研究人群很重要，因為這些患者的基線特徵存在很大差異。

When you look at the efficacy, we had 100% of patients alive and without need for permanent ventilatory support.

當您查看療效時，我們有 100% 的患者存活並且不需要永久通氣支持。

And then if you could imagine a parent wanting to treat their infant, they're certainly not going to want to take the risk that there's some percentage of patients that die with respect to a given therapy.

然後，如果您可以想像一位父母想要治療他們的嬰兒，他們肯定不會願意冒一定比例的患者因特定治療而死亡的風險。

So we're -- we believe this is quite material and quite important when you look at treating infants for a devastating disease.

所以我們——我們相信，當你考慮治療嬰兒的毀滅性疾病時，這是非常重要的。

We had 9 out of 10 achieve a CHOP INTEND score of greater than 40 at 8 months, 11 out of 12 greater than 50 during the 24-month study and 11 out of 12 achieving at sitting unassisted during the 24-month study.

在 8 個月時，10 人中有 9 人的 CHOP INTEND 分數超過 40，在 24 個月的研究中，12 人中有 11 人超過 50，在 24 個月的研究中，12 人中有 11 人在獨立坐姿時取得了成績。

And when you look actually at the CHOP INTEND scores, we're getting patients in the relevant period of time where you can measure CHOP INTEND into the high 50s or low 60s for their CHOP INTEND scores.

當您實際查看 CHOP INTEND 分數時，我們會讓患者處於相關時間段，您可以將 CHOP INTEND 測量到 CHOP INTEND 分數的高 50 分或低 60 分。

CHOP INTEND is less relevant after the first year of life.

CHOP INTEND 在一歲之後就不那麼重要了。

But I think that shows you not only the efficacy benefit from a mortality standpoint but also the functional benefit you get with these patients.

但我認為這不僅向您展示了從死亡率角度來看的療效優勢，還向您展示了這些患者獲得的功能優勢。

Strong durability, we continue to achieve major milestones with this therapy out beyond 4 years for the patients.

強大的耐久性，我們繼續通過這種療法為患者實現超過 4 年的重要里程碑。

We've been able to track 2 years in the reported data.

我們已經能夠在報告的數據中追踪 2 年。

I think again I'd want to highlight that those patients who we've disclosed in previous congresses that are tracked for even longer than 2 years, only a portion of them have received other therapies.

我想再次強調，我們在之前的大會上披露的跟踪時間甚至超過 2 年的患者中，只有一部分接受了其他療法。

There's also a portion that have received no other therapies and continue to do extremely well.

還有一部分沒有接受其他治療，並且繼續表現得非常好。

When you think about that mechanistically, we know that motor neurons don't divide.

當你從機械上考慮這個問題時，我們知道運動神經元不會分裂。

You have your maximal motor neurons as an infant.

您在嬰兒時期擁有最大的運動神經元。

When you receive an IV gene therapy, you would expect all of the -- most of the motor neurons, we hope, and perhaps all of the motor neurons to have the appropriate gene inserted.

當你接受 IV 基因治療時，你會期望所有 - 我們希望大多數運動神經元，也許所有運動神經元都插入了適當的基因。

So the mechanistic rationale for waning of effect is not there in our view.

因此，我們認為不存在影響減弱的機械原理。

Now there could be other things that happen as we do longer-term follow-up.

現在，隨著我們進行長期跟進，可能還會發生其他事情。

But I think it's important that we stick to the science and stick to the data when you're looking at these kinds of medicine.

但我認為，當你研究這些藥物時，我們堅持科學並堅持數據是很重要的。

Lastly, I would point out on the right-hand side, when you look at the speed of response, the speed of response is quite striking with respect to AVXS-101 and other relevant therapies.

最後，我要在右側指出，當您查看響應速度時，AVXS-101和其他相關療法的響應速度非常驚人。

I think that will be important for SMA Type 2, 3. And I'll talk a little bit more about where we are in those studies in a moment.

我認為這對於 SMA 類型 2、3 很重要。稍後我將詳細討論我們在這些研究中所處的位置。

So moving to the next slide.

轉到下一張幻燈片。

When you look at SMA Type 1, we have successfully filed now in U.S., Europe, in Japan, all ahead of schedule for SMA Type 1 with AVXS-101.

當您查看 1 類 SMA 時，我們現在已經在美國、歐洲、日本成功提交了帶有 AVXS-101 的 1 類 SMA 的計劃。

We have a potential approval, we believe, in the U.S. in the first half of 2019.

我們相信，我們有可能在 2019 年上半年在美國獲得批准。

We do have a Breakthrough Therapy Designation there.

我們確實在那裡獲得了突破性治療指定。

In the EU, we have -- we believe the approval is mid-2019.

在歐盟，我們有——我們相信批准是在 2019 年年中。

We do have PRIME designation in the EU.

我們在歐盟確實擁有 PRIME 稱號。

And we initiated submission in Japan in mid-September.

我們於 9 月中旬在日本開始提交。

We anticipate the completion by year-end of the full file.

我們預計在年底前完成完整文件。

And again, we expect approval in the first half, given that we have Sakigake designation, one of the first medicines to receive this designation in Japan.

同樣，鑑於我們擁有 Sakigake 指定，我們預計在上半年獲得批准，這是日本首批獲得該指定的藥物之一。

So we're quite pleased with the progress in SMA Type 1, a truly transformational foundational therapy for these patients.

因此，我們對 1 型 SMA 的進展感到非常高興，這是對這些患者真正具有變革性的基礎療法。

Now on Slide 15, give you a little bit of an update on where we are on the trials because I know there have been some questions and some misinformation regarding this.

現在在幻燈片 15 上，向您提供一些關於我們在試驗中所處位置的最新信息，因為我知道對此存在一些問題和一些錯誤信息。

When you look at where we are, the START study, which is the long-term follow-up for the SMA Type 1 patients, we have 12 patients enrolled.

當你看看我們在哪裡時，START 研究是對 SMA 1 型患者的長期隨訪，我們有 12 名患者入組。

When you look at the STR1VE study, which is the single IV dose confirmation study, patient enrollment is complete.

當您查看 STR1VE 研究時，這是單次 IV 劑量確認研究，患者登記已完成。

When you look at the STR1VE EU study, we have 6 patients enrolled and patients enrolling very well.

當您查看 STR1VE EU 研究時，我們有 6 名患者入組，而且入組情況非常好。

We expect to complete enrollment shortly.

我們預計很快就能完成註冊。

When you look at the SMA Type 2, Type 2, 3 study with intrathecal dosing, patient enrollment is complete.

當您查看帶有鞘內給藥的 SMA 2 型、2 型、3 型研究時，患者登記已完成。

And when you look at the presymptomatic SMA studies, which are being conducted under the rubric of newborn screening, we have 6 patients enrolled and we're seeing very heavy demand for that study as well.

當您查看在新生兒篩查項目下進行的症狀前 SMA 研究時，我們有 6 名患者入組，我們也看到對該研究的需求非常大。

So altogether, clinical program is on track to continue to expand beyond SMA 1 into 2, 3 and then eventually into newborn screening.

因此，總的來說，臨床計劃有望繼續從 SMA 1 擴展到 2、3，然後最終擴展到新生兒篩查。

So going to Slide 16.

轉到幻燈片 16。

I want to say a word now about a few slides about Endocyte, the acquisition we announced earlier today, which really builds on the earlier acquisition we've made with Advanced Accelerator Applications.

我現在想談談關於 Endocyte 的幾張幻燈片，這是我們今天早些時候宣布的收購，它實際上是建立在我們對 Advanced Accelerator Applications 進行的早期收購的基礎上的。

As I've tried to articulate to all of you, we're on a journey to focus our company as a medicines company.

正如我試圖向大家闡明的那樣，我們正在努力將公司定位為一家醫藥公司。

And within being a medicines company, along with our appropriate diversification in therapeutic areas, to build leadership in 3 platforms, which we believe are advanced therapy platforms that will drive differential growth: cell therapy, we have KYMRIAH and then building beyond that; gene therapy, we acquired AveXis and are building on our portfolio there; and finally, in radiopharmaceuticals or radioligand therapy in this case.

作為一家醫藥公司，隨著我們在治療領域的適當多樣化，在 3 個平台上建立領導地位，我們認為這些平台是先進的治療平台，將推動差異化增長：細胞療法，我們有 KYMRIAH，然後再構建；基因治療，我們收購了 AveXis 並在那裡建立我們的產品組合；最後，在這種情況下，在放射性藥物或放射性配體治療中。

Now when you look at the specific assets that we have here in Endocyte, which we would plan to bring into our Advanced Accelerator operations, prostate cancer is expected to be an $11 billion market globally in 2024.

現在，當您查看我們在 Endocyte 中擁有的特定資產時，我們計劃將其納入我們的 Advanced Accelerator 業務，預計到 2024 年全球前列腺癌市場將達到 110 億美元。

This medicine is expected to provide an additional treatment option for prostate cancer.

該藥物有望為前列腺癌提供額外的治療選擇。

And I'll talk more about that because I think there is some misunderstanding in some of the notes I've seen over the course of today as to what exactly we are treating here versus other therapies that are on the market.

我會更多地談論這一點，因為我認為我在今天看到的一些筆記中存在一些誤解，即我們在這裡治療的究竟是什麼，而不是市場上的其他療法。

This is a first-to-market potential product in a PSMA radioligand therapy.

這是 PSMA 放射配體療法中第一個上市的潛在產品。

The enrollment of Phase III has been initiated and is on track.

三期招生工作已經啟動，正在推進中。

FDA feedback, which we reviewed, is very clear that radiographic PFS can be used as the endpoint, which should enable a relatively rapid, we believe, timeline for the Phase III study.

我們審查的 FDA 反饋非常明確，放射學 PFS 可以用作終點，我們相信，這應該能夠相對快速地完成 III 期研究的時間表。

It's a significantly derisked profile when you look at the Lancet paper that's been published on the strong Phase II data.

當您查看發表在強大的 II 期數據上的《柳葉刀》論文時，這是一個顯著降低風險的概況。

There's extensive preclinical data as well as various other investigator-initiated study data that we've reviewed, which gives us confidence in the overall profile of the medicine.

我們審查了廣泛的臨床前數據以及各種其他研究者發起的研究數據，這使我們對藥物的整體概況充滿信心。

Now importantly, this expands our nuclear medicines platform.

現在重要的是，這擴展了我們的核醫學平台。

Following the launch of LUTATHERA, it gives us a second radioligand therapy.

LUTATHERA 推出後，它為我們提供了第二種放射配體療法。

It allows us to eventually move this PSMA-617 therapy into earlier lines of therapy.

它使我們最終能夠將這種 PSMA-617 療法轉移到更早的療法中。

And then we have opportunities to expand the platform in the future.

然後我們有機會在未來擴展這個平台。

One thing not noted in this slide, this also would enable us to have new manufacturing capabilities that we would then apply to our radioligand portfolio in the future.

這張幻燈片中沒有提到的一件事是，這也將使我們擁有新的製造能力，我們將在未來將其應用於我們的放射性配體產品組合。

So when you go to Slide 17, what exactly do we talk about here?

所以當你轉到第 17 張幻燈片時，我們在這裡到底在談論什麼？

And this is, I think, a very important point, and I hope investors will take a moment.

我認為這是非常重要的一點，我希望投資者能花點時間。

This is a therapy, as is the case with LUTATHERA, where we link a radioactive particle to a ligand.

這是一種療法，就像 LUTATHERA 的情況一樣，我們將放射性粒子連接到配體。

And this ligand has high specificity for a given tumor cell type.

並且這種配體對給定的腫瘤細胞類型具有高度特異性。

And in that way, we can target the radiation directly to the relevant cancer.

這樣，我們就可以將放射線直接瞄準相關癌症。

So it's a very targeted approach.

所以這是一個非常有針對性的方法。

We do that with neuroendocrine tumors.

我們用神經內分泌腫瘤來做。

And here, we do it with PSMA in prostate cancer.

在這裡，我們用 PSMA 治療前列腺癌。

This high-affinity targeting allows us to really manage -- I think improve the efficacy and also manage the safety profile.

這種高親和力的目標使我們能夠真正管理——我認為提高療效並管理安全性。

Now other therapies available in the market are simply infusions of radium that are actually just used for bone metastases, not for metastatic prostate cancer.

現在市場上的其他療法只是簡單地輸注鐳，實際上只用於骨轉移，而不是轉移性前列腺癌。

So as you look at your benchmarks for what are the appropriate sales potential, please ensure you're using relevant benchmarks when you do this.

因此，當您查看合適的銷售潛力的基準時，請確保您在執行此操作時使用相關基準。

Now once this is bound -- the particles are bound together, they get internalized, and you would expect that the cancers then ultimately respond.

現在一旦結合——粒子結合在一起，它們就會被內化，你會期望癌症最終會做出反應。

And that's a response that we've seen.

這是我們已經看到的回應。

Now when you look at the data on Slide 18, you can see here in the Phase II study, we had a strong PSA response, which we think is a relative measure.

現在，當您查看幻燈片 18 上的數據時，您可以在此處的 II 期研究中看到，我們有強烈的 PSA 反應，我們認為這是一個相對的衡量標準。

You can see on the left-hand side, we had a solid trend in these patients, who had failed multiple lines of therapy in PFS as well as in overall survival.

您可以在左側看到，我們在這些患者中有一個堅實的趨勢，這些患者在 PFS 和總生存期方面的多線治療都失敗了。

And we've seen similar data from other smaller study sets and in IITs as well.

我們也從其他較小的研究集和 IIT 中看到了類似的數據。

So when you go to the next slide, you can see our -- the Phase III VISION trial, which is currently enrolling, takes the 2:1 randomization, takes patients with metastatic prostate cancer, they have to have a positive PSMA scan and then have had a prior taxane or a prior novel androgen access drug.

所以當你翻到下一張幻燈片時，你可以看到我們的 III 期 VISION 試驗，目前正在招募中，採用 2:1 隨機化，接受轉移性前列腺癌患者，他們必須進行 PSMA 掃描呈陽性，然後之前使用過紫杉烷類藥物或使用過新型雄激素藥物。

And after that, then they're randomized into either the PSMA drug or to best supportive care and then we'll see.

在那之後，然後他們被隨機分配到 PSMA 藥物或最佳支持治療，然後我們會看到。

We have 750 patients, enrollment initiated.

我們有 750 名患者，已開始登記。

And as I said, FDA has agreed to the endpoints on both primary and secondary.

正如我所說，FDA 已經同意主要和次要的終點。

So when you go to Slide 20, you can see that some of the deal characteristics.

所以當你轉到幻燈片 20 時，你可以看到一些交易特徵。

We're certainly happy to answer any questions, but I think it's relatively straightforward.

我們當然很樂意回答任何問題，但我認為這相對簡單。

We fund it through cash.

我們通過現金為其提供資金。

We don't expect dilution with respect to this deal.

我們預計這筆交易不會稀釋。

We expect it to start contributing to group sales in 2021.

我們預計它將在 2021 年開始為集團銷售額做出貢獻。

Our overall financial expectations is the medicine has a blockbuster potential.

我們的總體財務預期是該藥物具有重磅炸彈的潛力。

And if we are able to get into earlier lines of therapy, we can have even higher sales potential with this medicine, which would generate an attractive IRR to the company.

如果我們能夠進入更早的治療線，我們可以通過這種藥物獲得更高的銷售潛力，這將為公司帶來有吸引力的 IRR。

And of course, all of this is subject to the appropriate approvals from Endocyte shareholders and the relevant regulatory agencies.

當然，所有這一切都需要得到 Endocyte 股東和相關監管機構的適當批准。

So if you go to Slide 21, the expected next steps for the deal.

因此，如果您轉到幻燈片 21，交易的預期後續步驟。

Of course, we'll continue to generate the data and provide additional information as it becomes available.

當然，我們將繼續生成數據並在可用時提供更多信息。

We have filed a proxy statement -- we will file the proxy statement with the SEC.

我們已經提交了委託書——我們將向美國證券交易委員會提交委託書。

And we are hopeful to have closing in first half 2019, subject to the various considerations.

我們希望在 2019 年上半年關閉，但要考慮到各種因素。

So moving to Slide 22, last slide before I'll turn it over to Harry.

轉到幻燈片 22，最後一張幻燈片，然後我將它交給 Harry。

We are going to hold an R&D and investor update on November 5. We'll have a deep dive on AVXS-101.

我們將於 11 月 5 日舉行研發和投資者更新。我們將深入探討 AVXS-101。

We'll have some of the key scientists there, so investors can speak to the team directly on where we are in that program.

我們將有一些關鍵科學家在那裡，因此投資者可以直接與團隊討論我們在該計劃中的位置。

And then we'll have a number of other detailed updates on a range of programs.

然後我們將對一系列計劃進行其他一些詳細更新。

A few that I would want to call out that are beyond what we traditionally talk about, QAW039, our CRTh2 antagonist for severe asthma, where we may now start to move toward study readout.

我想指出的一些超出了我們傳統上談論的內容，QAW039，我們用於嚴重哮喘的 CRTh2 拮抗劑，我們現在可以開始進行研究讀出。

We really want to make sure everyone understands that -- what we believe substantial potential is for this medicine.

我們真的想確保每個人都明白這一點——我們認為這種藥物具有巨大的潛力。

We will go through our multiple sclerosis portfolio, BAF, ofatumumab as well as the status with respect to GILENYA.

我們將了解我們的多發性硬化症產品組合、BAF、ofatumumab 以及 GILENYA 的狀態。

We'll provide you all the RTH258 2-year data and continue to demonstrate the profile of that medicine as well as provide an update on the Oncology late-stage portfolio, building off of the BYL presentation we will make this weekend and provide an update to you early next week.

我們將為您提供所有 RTH258 2 年數據，並繼續展示該藥物的概況，並提供腫瘤後期產品組合的更新，以我們將在本週末進行的 BYL 演示為基礎並提供更新下周初給你。

So overall, I think a really strong performance.

所以總的來說，我認為表現非常強勁。

And I'll hand it over to Harry to give you some more perspective from a financial standpoint.

我會把它交給哈利，從財務的角度給你更多的觀點。

Thank you, Vas.

謝謝你，瓦斯。

Good morning, good afternoon, everyone.

大家早上好，下午好。

So as usual, my comments refer to growth rates in constant currencies, unless otherwise noted.

因此，與往常一樣，除非另有說明，否則我的評論指的是固定匯率的增長率。

So on Slide 24, you see the summary of our quarter 3 and year-to-date performance.

因此，在幻燈片 24 上，您可以看到我們第 3 季度和年初至今業績的摘要。

We continued to deliver good growth with quarter 3 sales up plus 6% and year-to-date sales up plus 5%.

我們繼續實現良好增長，第三季度銷售額增長 6%，年初至今銷售額增長 5%。

This performance drove accretive bottom line growth as well.

這一業績也推動了利潤增長。

So core operating income was up 9% in the quarter and 7% year-to-date.

因此，本季度核心營業收入增長了 9%，年初至今增長了 7%。

As you can see, free cash flow grew plus 10% the first 9 months to USD 8.8 billion, driven by this very strong operating performance.

如您所見，在這種非常強勁的經營業績的推動下，自由現金流在前 9 個月增長了 10%，達到 88 億美元。

Year-to-date operating income grew 3%, driven by the quarter 3 operating income declining 13% as we recognized charges for ongoing restructuring programs and the impairment of Alcon's CyPass.

年初至今的營業收入增長了 3%，這是受第三季度營業收入下降 13% 的推動，因為我們確認了正在進行的重組計劃的費用和 Alcon 的 CyPass 減值。

Turning to Slide 25.

轉到幻燈片 25。

We see here the quarter 3 and year-to-date core margins of the group at each division.

我們在這裡看到該集團每個部門的第三季度和年初至今的核心利潤率。

Strong sales uptake in Innovative Medicines drove margin expansion for the division and the group.

創新藥物的強勁銷售增長推動了該部門和集團的利潤率增長。

Innovative Medicines margin was up plus 2.1% points in the quarter, bringing year-to-date margin up 1.1% to 32.4% of sales.

創新藥物的利潤率在本季度上升了 2.1%，使年初至今的利潤率上升了 1.1%，達到銷售額的 32.4%。

Group margins improved by 0.8% points in the quarter and plus 0.5% points year-to-date, driving the margin to 27% of sales.

本季度集團利潤率提高了 0.8 個百分點，年初至今提高了 0.5 個百分點，使利潤率達到銷售額的 27%。

Slide 26.

幻燈片 26。

I wanted to have a quick view on the Alcon sales and margin progression over the past few years based on September year-to-date numbers for each of the years.

我想根據每年 9 月年初至今的數據，快速了解愛爾康過去幾年的銷售額和利潤率進展情況。

As you can see, investments in 2016 and 2017 were necessary to stabilize and then grow again the top line.

如您所見，2016 年和 2017 年的投資對於穩定並再次增長收入是必要的。

In 2018, the strong sales growth is driving margin expansion.

2018 年，強勁的銷售增長推動了利潤率的擴張。

Year-to-date core margin improved by over 1 point to 18.6% of sales as compared to a trough margin year in 2017.

與 2017 年的低谷年度相比，年初至今的核心利潤率提高了 1 個百分點以上，達到銷售額的 18.6%。

We have always said we expect some quarterly fluctuations in the margin for Alcon.

我們一直說我們預計愛爾康的利潤率會出現一些季度波動。

And David Endicott clearly can give you some further flavor on that.

David Endicott 顯然可以為您提供更多信息。

In quarter 1 2018, the spending was lower.

2018 年第一季度，支出較低。

And in quarter 3 2018, Alcon increased investments behind some key brands.

2018 年第三季度，愛爾康增加了對一些主要品牌的投資。

In quarter 4, typically margins are lower each year compared to the full year margin due to increases in equipment sales as hospitals finalize their purchases before year-end.

在第 4 季度，通常每年的利潤率都低於全年利潤率，這是由於醫院在年底前完成採購導致設備銷售增加。

Hence, it's always important to look year-to-date and full year numbers.

因此，查看年初至今和全年的數字始終很重要。

Clearly, we expect 2018 full year core margin to be up versus 2017 full year and then full year margin growth in each of the following years.

顯然，我們預計 2018 年全年核心利潤率將高於 2017 年全年，然後在接下來的每一年實現全年利潤率增長。

Importantly, mid- to long term, Alcon remains committed and on track to achieve margins in line with the medical devices industry, i.e.

重要的是，從中長期來看，愛爾康仍然致力於並有望實現與醫療器械行業一致的利潤率，即

in the range of low to mid-20s.

在 20 多歲到 20 多歲之間。

The margin expansion is expected to be driven by continued strong top line growth, improved gross margin and cost leverage.

預計利潤率的增長將受到持續強勁的收入增長、毛利率和成本槓桿的改善的推動。

On Slide 27, just back to the guidance.

在幻燈片 27 上，回到指南。

We are increasing our group sales guidance to grow mid-single digits, so at the higher end of what we said before, given our year-to-date 5% sales growth.

考慮到我們年初至今 5% 的銷售增長，我們正在增加我們的集團銷售指導以增長中等個位數，因此在我們之前所說的較高端。

And we expect that to continue at a nice level in quarter 4. This is driven by strong performance of the Innovative Medicines division, where we also can revise up the full year guidance to grow in the mid- to high single-digit range.

我們預計第 4 季度將繼續保持在一個不錯的水平。這是由創新藥物部門的強勁表現推動的，我們還可以修改全年指導以在中高個位數範圍內增長。

This guidance includes, also when you look at the core operating income, we reconfirm our core operating income guidance as issued in January, expect it to grow in the range of mid- to high single-digit.

該指南還包括，當您查看核心營業收入時，我們再次確認 1 月份發布的核心營業收入指南，預計它將在中高個位數範圍內增長。

And as I mentioned earlier, also in the year, the guidance includes AveXis R&D and prelaunch investments.

正如我之前提到的，同樣在這一年，該指南包括 AveXis 研發和啟動前投資。

And as you see, this guidance is also very consistent with our year-to-date performance, where we grew sales plus 5% and core operating income plus 7%.

如您所見，這一指引也與我們年初至今的業績非常一致，我們的銷售額增長了 5%，核心營業收入增長了 7%。

On Slide 28, just a quick update on the expected currency impact, assuming mid-October rates would hold for the future.

在幻燈片 28 上，只是對預期貨幣影響的快速更新，假設 10 月中旬的利率將在未來保持不變。

On full year of 2018, the currency impact is expected to be flat on both sales and core operating income.

2018 年全年，貨幣對銷售額和核心營業收入的影響預計持平。

As you can see here, the strengthening U.S. dollar has a negative impact on half 2, offsetting the positive impacts we have seen in half 1. Should currencies stay at the current level throughout 2019, we see a negative effect of minus 2% on sales and minus 3% to minus 4% on core operating income for full year 2019 results.

正如您在此處看到的那樣，美元走強對 half 2 產生了負面影響，抵消了我們在 half 1 中看到的積極影響。如果貨幣在整個 2019 年保持在當前水平，我們將看到對銷售額產生負 2% 的負面影響2019 年全年業績的核心營業收入下降 3% 至 -4%。

Please, as always, pay close attention to this as you build your models.

請一如既往地在構建模型時密切注意這一點。

And as most of you know, we are always updating the expected currency impact each month on our website.

正如你們大多數人所知，我們每個月都會在我們的網站上更新預期的貨幣影響。

And with that, I turn back to Vas.

然後，我回到 Vas。

Thank you, Harry.

謝謝你，哈利。

So when you go to Slide 30, I think, reiterating what we've already told you, we delivered strong accretive growth in the quarter and pleased with our momentum there.

因此，當你轉到幻燈片 30 時，我想，重申我們已經告訴過你的內容，我們在本季度實現了強勁的增長，並對我們在那裡的勢頭感到滿意。

And we continue on track to our stated goals with respect to margin expansion and top line growth.

我們將繼續朝著既定的利潤增長和收入增長目標邁進。

The innovation momentum is continuing in the company.

公司的創新勢頭正在持續。

We progressed our advanced therapy platform strategy with the agreement to acquire Endocyte.

我們通過收購 Endocyte 的協議推進了我們先進的治療平台戰略。

And we're on track to deliver our full year guidance.

我們正按計劃提供全年指導。

So with that, we can open up the line for questions.

因此，我們可以打開問題熱線。

(Operator Instructions) We have the first question in the line.

（操作員說明）我們有第一個問題。

It's from the line of Graham Parry from Bank of America Merrill Lynch.

它來自美國銀行美林證券公司的 Graham Parry。

So firstly, on COSENTYX, can you just give us an update on your contracting into 2019?

那麼首先，在 COSENTYX 上，您能否向我們介紹一下您在 2019 年簽訂合同的最新情況？

And have you seen less rebating needed to attain first-line positions?

您是否看到獲得一線職位所需的回扣更少？

Or is ILUMYA and kind of the prospect of risankizumab launch next year skewing that contracting at all?

或者 ILUMYA 和 risankizumab 明年推出的前景是否完全扭曲了這種收縮？

Secondly, on your SMA franchise, could you just give a best guess on timing of filing in Type 2, 3?

其次，關於您的 SMA 特許經營權，您能否就第 2 類和第 3 類申請的時間給出一個最佳猜測？

Can you file 2020 on the back of the strong data?

2020年能否在強勁數據的支撐下入檔？

And also at WMS, there was some data on branaplam, which seemed to show worse CHOP INTEND scores than we see with the Roche oral agent or AVXS-101, but there was dose reduction and discontinuation of the trial temporarily.

同樣在 WMS，有一些關於 branaplam 的數據，它的 CHOP INTEND 評分似乎比我們在羅氏口服藥物或 AVXS-101 上看到的更差，但暫時減少了劑量並停止了試驗。

So perhaps, if you could just help us understand how you think that data compares to the other agents in development and in the market and where it fits in your overall strategy going forward.

所以也許，如果你能幫助我們了解你認為數據與開發和市場中的其他代理相比如何，以及它在你未來的整體戰略中的位置。

Third is biosimilar RITUXAN.

第三個是生物類似藥 RITUXAN。

Could you explain when you expect to refile and why you haven't refiled that yet?

你能解釋一下你預計什麼時候重新提交以及為什麼你還沒有重新提交嗎？

And last one, just an update on AFINITOR.

最後一個，只是 AFINITOR 的更新。

Looking at court dockets, it looks like you settled most of the litigations and IPRs there.

查看法庭記錄，您似乎在那裡解決了大部分訴訟和知識產權。

Could we see some protection there beyond your prior March 2020 guidance?

我們能否在您之前的 2020 年 3 月指南之外看到一些保護？

Thank you, Graham.

謝謝你，格雷厄姆。

So first, on COSENTYX contracting, Paul?

那麼首先，關於 COSENTYX 合同，保羅？

So Graham, thank you for the question.

格雷厄姆，謝謝你提出這個問題。

Yes, I mean, it's too early to announce where we stand for '19.

是的，我的意思是，現在宣布我們對 19 年的立場還為時過早。

But the conversation has progressed as we would have hoped through the summer.

但整個夏天，談話都像我們希望的那樣取得了進展。

There is definitely a more interesting dynamic for us, a positive dynamic because we're significantly larger asset than we were this time last year when we went into this, so we have more leverage.

對我們來說肯定有一個更有趣的動態，一個積極的動態，因為我們的資產比去年這個時候的資產要大得多，所以我們有更多的槓桿作用。

We're also very pleased with how we got pickup in volume in first line.

我們也對我們如何在第一線獲得銷量感到非常滿意。

So we'll be open-minded and [hopeful] as you'd expect as we go into '19.

因此，當我們進入 19 年時，我們將像您所期望的那樣保持開放和 [充滿希望]。

But I'm very comfortable with the outlook for us as we transition into next year.

但隨著我們過渡到明年，我對我們的前景感到非常滿意。

So with respect to SMA, I'll just quickly confirm on AVXS Type 2 -- 101 Type 2, 3 our current stated filing objective is in 2020.

因此，關於 SMA，我將快速確認 AVXS Type 2 -- 101 Type 2, 3 我們目前規定的申請目標是在 2020 年。

Now with respect to branaplam LMI, I'll turn it over to John.

現在關於 branaplam LMI，我將把它交給約翰。

Yes, I didn't -- can you repeat the question regarding LMI?

是的，我沒有——你能重複一下關於 LMI 的問題嗎？

John, it was regarding the -- our overall plans with respect to LMI in our portfolio.

約翰，這是關於我們投資組合中 LMI 的總體計劃。

Yes, we continue to advance LMI according to our original plans.

是的，我們繼續按照我們原來的計劃推進LMI。

We look at exploring opportunities in terms of combinations with our AVXS-101.

我們著眼於探索與我們的 AVXS-101 組合的機會。

So our current plans are to continue to explore our opportunities moving forward in this space.

因此，我們目前的計劃是繼續探索我們在這個領域向前發展的機會。

And I think, Graham, on LMI, I mean, we had some early studies, right, that I think were disclosed at WMS.

我認為，格雷厄姆，在 LMI 上，我的意思是，我們有一些早期的研究，對的，我認為這些研究是在 WMS 上披露的。

But we feel good about the overall profile.

但我們對整體情況感覺良好。

I would say that our hope is that gene therapy will be foundational.

我想說的是，我們希望基因療法成為基礎。

And I think the question of whether or not supplementation will be required at all is something that clinical trials will ultimately have to determine.

而且我認為是否需要補充劑的問題最終必須由臨床試驗來確定。

But orals will certainly have a role for patients who have antibodies at baseline or patients who have maternal antibodies prior to being able to get a foundational gene therapy is how we sort of overall see this space evolving.

但對於在基線時有抗體的患者或在能夠獲得基礎基因治療之前有母體抗體的患者，口服肯定會發揮作用，這是我們總體上看待這個空間演變的方式。

Now with respect to biosimilar RITUXAN, Richard?

現在關於生物仿製藥 RITUXAN，Richard？

Thanks for the question.

謝謝你的問題。

So obviously, we've been working closely with the FDA and have discussions on a path forward for our rituximab.

很明顯，我們一直在與 FDA 密切合作，並就我們的利妥昔單抗的前進道路進行討論。

We are currently awaiting their written feedback just to clarify the next steps.

我們目前正在等待他們的書面反饋，以明確後續步驟。

And once we'll have -- we have that, we'll come back to you and let you know.

一旦我們有了——我們有了那個，我們就會回來告訴你。

And then finally, with respect to AFINITOR, Liz?

最後，關於 AFINITOR，Liz？

Sure.

當然。

It's Liz Barrett with Oncology.

我是腫瘤科的 Liz Barrett。

AFINITOR, we do expect generic competition in Europe in the beginning of 2019 and then limited generic competition the end of 2019 in the U.S. And beyond that, we really just can't give any other information.

AFINITOR，我們確實預計 2019 年初歐洲將出現仿製藥競爭，然後在 2019 年底在美國進行有限的仿製藥競爭。除此之外，我們真的無法提供任何其他信息。

The next question comes from the line of Andrew Baum from Citigroup.

下一個問題來自花旗集團的安德魯鮑姆。

A couple of questions.

幾個問題。

Given the appointment of a new Chief Legal Counsel and given your focus on upgrading the standards which Novartis holds its compliance, I would imagine you'd be seeking to close out the numerous ongoing investigations, particularly in the U.S. with the Diovan (inaudible) general.

鑑於任命了一位新的首席法律顧問，並且鑑於您專注於提升諾華公司遵守的標準，我想您會尋求結束眾多正在進行的調查，特別是在美國與 Diovan（聽不清）將軍.

Could you give us some indications of what kind of timing we might expect in order to reaching closure here?

你能給我們一些指示，說明我們可能期望什麼樣的時間在這裡結束嗎？

And if you've got anything you feel you can add at all on financial settlements, I'd be interested, but I understand that may be challenging.

如果您覺得可以在財務結算方面添加任何內容，我會很感興趣，但我知道這可能具有挑戰性。

Second, in relation to Cigna, which was obviously lighter than, I think, The Street was looking for, for in the quarter, could you break down exactly why that was?

其次，關於 Cigna，我認為它明顯比華爾街正在尋找的要輕，因為在本季度，你能詳細說明為什麼會這樣嗎？

Was it discontinuation as a function of the data?

是否因數據而停產？

Was it increased rebating or prioritization or other factors?

是增加回扣或優先次序或其他因素？

That'd be helpful.

那會很有幫助。

Thank you, Andrew.

謝謝你，安德魯。

So with respect to the first question, we're pleased that we have Klaus Moosmayer joining us Chief Ethics and Risk Officer from Siemens.

因此，關於第一個問題，我們很高興克勞斯·穆斯邁爾 (Klaus Moosmayer) 加入我們，擔任西門子的首席道德與風險官。

He has deep expertise in managing global organizations and really elevating their capabilities on ethics, risk and compliance.

他在管理全球組織和真正提升他們在道德、風險和合規方面的能力方面擁有深厚的專業知識。

And of course, we are thrilled that Shannon Klinger, our Chief Legal Counsel, as well now being elevated up on the team.

當然，我們很高興我們的首席法律顧問 Shannon Klinger 現在也在團隊中得到提拔。

So I think, overall, we have the right team in place.

所以我認為，總的來說，我們擁有合適的團隊。

Now in terms of the various litigations around the world, I can't provide, I think, specific details.

現在就世界各地的各種訴訟而言，我想不能提供具體的細節。

What I would say is we are looking to try to accelerate closing these matters so that we can move forward, given the new culture at the company, which is one that, on the one hand, wants to be much more empowered and curious for our people and on the other hand, wants to have an uncompromising approach with respect to integrity, ethics.

我想說的是，鑑於公司的新文化，我們正在努力加快解決這些問題，以便我們能夠向前邁進，一方面，這種文化希望對我們的公司擁有更多的權力和好奇心。人們，另一方面，希望在誠信和道德方面採取不妥協的態度。

And so I think once we have better clarity on any of those matters, we'll give you information.

因此，我認為一旦我們對這些問題中的任何一個有了更好的了解，我們就會向您提供信息。

But certainly, my aspiration is to try to close off these matters, so the company can move ahead in its new strategy and new direction.

但可以肯定的是，我的願望是設法解決這些問題，這樣公司才能朝著新戰略和新方向前進。

Now with respect to Cigna, Liz?

現在關於 Cigna，Liz？

Yes.

是的。

Actually, there were several factors that contributed to the Cigna decline.

實際上，有幾個因素導致了 Cigna 的下滑。

I think it's really important, first, to note that we actually had growth in markets except for the U.S. and the emerging growth markets.

我認為首先要注意的是，我們實際上在美國和新興增長市場以外的市場都有增長，這一點非常重要。

The emerging growth markets is really a phasing, so the majority of the decline is in the U.S. There were 3 factors that contributed to that.

新興增長市場確實是一個階段性的，所以大部分下降發生在美國。有 3 個因素造成了這種情況。

One is actually there was a reduction in inventory.

一個是實際上庫存減少了。

So that was about half of the decline in the U.S. And then to your point, it was around the TFR.

所以這大約是美國下降的一半。然後就你的觀點而言，它是在 TFR 附近。

I think the great news for patients that we delivered at ASCO and presented was around patients' ability to come off drug.

我認為我們在 ASCO 上交付並展示的對患者來說的好消息是圍繞患者戒毒的能力。

And I think that's something that both physicians and patients are excited about.

我認為這是醫生和患者都感到興奮的事情。

But as patients come off, we didn't replenish the funnel at the same rate.

但是當病人離開時，我們沒有以同樣的速度補充漏斗。

And so we've seen some of that.

所以我們已經看到了其中的一些。

And then the third factor is really around competitive pressure in the market and what we've done.

然後第三個因素實際上是圍繞市場競爭壓力和我們所做的事情。

And I think the most important thing is, in reaction to that, we've -- we're really refining our messages to focus on efficacy, both in first line and in second line because you've also seen an increase in imatinib generic.

而且我認為最重要的是，作為對此的反應，我們真的在改進我們的信息以關註一線和二線的療效，因為你也看到了伊馬替尼仿製藥的增加.

So we want to focus our message in those failures beyond imatinib.

因此，我們希望將我們的信息集中在伊馬替尼以外的那些失敗上。

So I do think that we feel like it will -- the decline will stabilize and we will return to growth in 2019.

所以我確實認為我們覺得它會 - 下降將穩定下來，我們將在 2019 年恢復增長。

So it's not something we expect to continue.

所以這不是我們期望繼續的事情。

The next question comes from the line of Matthew Weston from Crédit Suisse.

下一個問題來自 Crédit Suisse 的 Matthew Weston。

Three questions, if I can, please.

三個問題，如果可以的話，請。

The first on AveXis launch dynamics, Vas.

AveXis 發布動態的第一個，Vas。

Clearly, you've set out the timeline that points to the middle of next year.

顯然，您已經制定了指向明年年中的時間表。

Can you give us some comfort around the manufacturing supply that should be available at launch if you were to see 3 global approvals?

如果您要看到 3 項全球批准，您能否讓我們了解一下應該在發佈時提供的製造供應？

And also given expectations for launch timing as drugs sometimes go awry, can you give us your view as to how you see the rollout?

並且考慮到藥物有時會出現問題而對發佈時間的期望，您能否告訴我們您對推出的看法？

Is there a strong bolus that you expect will very rapidly get rolled out?

是否有您預計會很快推出的強力推注？

Obviously, something where reimbursement dynamics and really the first gene therapy out there means the uptake will be slower.

顯然，報銷動態和真正的第一個基因療法意味著吸收會更慢。

Secondly, on VOTRIENT, another drug in Oncology where we saw a slowdown in 3Q.

其次，關於 VOTRIENT，另一種腫瘤藥物，我們在第三季度看到了放緩。

Liz, I would be interested in whether there was anything specific behind that dynamic.

Liz，我想知道這種動態背後是否有任何具體內容。

And then finally, Vas, on Endocyte, the one thing that slightly surprised us, the deal is structured as a merger rather than as a tender, which often suggests there are competition concerns.

最後，Vas，在 Endocyte 上，讓我們略感意外的是，這筆交易的結構是合併而不是招標，這通常表明存在競爭問題。

And so it's whether or not you're prepared to comment as to whether or not you expect competition commission scrutiny and whether that's around their CAR-T platform or whether that's around the lutetium platform and how you see that playing out.

因此，您是否準備好評論您是否期望競爭委員會進行審查，以及是否圍繞他們的 CAR-T 平台，或者是否圍繞镥平台，以及您如何看待這種情況。

Great.

偉大的。

Thanks, Matthew.

謝謝，馬修。

So first, on AVXS-101 supply and then the global rollout, I'll hand it to Paul.

因此，首先，關於 AVXS-101 的供應和全球推廣，我將把它交給保羅。

Paul?

保羅？

Yes, so it has been a great pleasure to get the AveXis team in more detail.

是的，所以很高興能更詳細地了解 AveXis 團隊。

And one of the real impressive things beyond the science has been their commitment to world-class manufacturing and on a significant scale.

除了科學之外，真正令人印象深刻的事情之一是他們致力於世界級的大規模製造。

And as we got deeper into being credible partners of them, it's quite clear that we can match with the IV and SMA 1 whatever the demand may be.

隨著我們越來越成為他們可靠的合作夥伴，很明顯，無論需求是什麼，我們都可以與 IV 和 SMA 1 相匹配。

So we're comfortable there.

所以我們在那裡很舒服。

In terms of rollout, really it will be -- we've gone for the breakthroughs in all 3 jurisdictions, as Vas said.

正如 Vas 所說，就推出而言，確實如此——我們已經在所有 3 個司法管轄區取得了突破。

And as they go online, we'll be there to match the demand.

當他們上線時，我們將在那裡滿足需求。

And as for boluses, I think you mentioned, whilst there is a little bit of a bolus, I am sure we again are ready to treat whatever presents and supported by physician and payer.

至於丸劑，我想你提到過，雖然有一點丸劑，但我相信我們再次準備好治療任何礼物並得到醫生和付款人的支持。

And then I would note as well, as we get further along with AVXS, it's important to note that the intrathecal dose is significantly lower than the IV dose.

然後我還要指出，隨著我們與 AVXS 的進一步發展，重要的是要注意鞘內劑量明顯低於靜脈注射劑量。

And then supply considerations become much more -- much less central.

然後供應考慮變得更加重要 - 更不重要。

Now with respect to VOTRIENT, Liz?

現在關於 VOTRIENT，Liz？

With respect to VOTRIENT, we're actually where we expected to be at this time.

關於 VOTRIENT，我們實際上處於我們預期的位置。

I think it's important to note that the dynamics of what's happening in RCC, particularly in the first-line treatment with the approval of the I-O/I-O in May and as well as the impending data that's coming at ESMO around the I-O/TKI data.

我認為重要的是要注意 RCC 正在發生的動態，特別是在 5 月份 I-O/I-O 批准的一線治療中，以及 ESMO 即將發布的 I-O/TKI 數據周圍的數據。

So I think it's fair to say that in the U.S. and Europe, we expect to continue to see some declines, which is exactly what we projected.

所以我認為可以公平地說，在美國和歐洲，我們預計會繼續出現一些下降，這正是我們的預期。

I think it's also important to note that we are seeing very strong growth in Latin America, Japan and emerging growth markets and recently received reimbursement in China.

我認為同樣重要的是要注意我們在拉丁美洲、日本和新興增長市場看到非常強勁的增長，並且最近在中國收到了報銷。

So we actually have some growth markets offsetting the decline that we are seeing in U.S. and Europe.

因此，我們實際上有一些增長市場抵消了我們在美國和歐洲看到的下滑。

But it is showing strong growth in other markets.

但它在其他市場顯示出強勁的增長。

And then lastly, with respect to Endocyte and the structure of the deal, Harry?

最後，關於 Endocyte 和交易結構，Harry？

Thank you, Matthew.

謝謝你，馬修。

So there are no specific concerns here, just the structure that both parties agreed upon to do a one-step merger versus a tender offer.

所以這裡沒有具體的問題，只是雙方同意進行一步合併與要約收購的結構。

So nothing specifically to read into that.

所以沒有什麼特別需要了解的。

The next question comes from the line of Tim Anderson from Wolfe Research.

下一個問題來自 Wolfe Research 的 Tim Anderson。

On COSENTYX, second-biggest drug now, competitive area and we've got the J&J ECLIPSE trial close to report out fairly soon head-to-head versus your drug.

在 COSENTYX 上，現在是第二大藥物，競爭領域，我們已經完成了強生 ECLIPSE 試驗，很快就會與您的藥物進行正面交鋒。

Can you talk about how J&J as the sponsor of that trial may have optimized that trial to increase the odds that it hits and also your expectations on the odds that it will be a positive trial?

您能否談談強生作為該試驗的讚助商如何優化該試驗以增加它命中的機率以及您對它成為陽性試驗的機率的期望？

If it does happen, what's going to be Novartis' talking points in defense of COSENTYX?

如果它真的發生了，諾華公司在為 COSENTYX 辯護時的談話要點是什麼？

And are you going to say it won't have any real commercial impact on the product?

你會說它不會對產品產生任何真正的商業影響嗎？

And then the second question, just to clarify on formulary positioning for COSENTYX, you guys kind of got beat up earlier in the year when you rebated -- you changed the rebate structure in COSENTYX to try to get out of the rebate trap on first-line psoriasis.

然後是第二個問題，只是為了澄清 COSENTYX 的處方定位，你們在今年早些時候的回扣時有點被打敗了——你們改變了 COSENTYX 的回扣結構，試圖首先擺脫回扣陷阱——行牛皮癬。

Has that had success in moving you up into first-line access?

這是否成功地將您提升到一線訪問？

And what do you expect on that particular front in terms of access restrictions in 2019?

就 2019 年的訪問限製而言，您對這一特定方面有何期望？

Yes, I think for both of those, ECLIPSE and the formulary situation, to Paul.

是的，我認為對於 Paul 來說，ECLIPSE 和公式情況。

Paul?

保羅？

So thank you for the question.

謝謝你的提問。

When you sit down with dermatologists in the clinic, clear is clear.

當您在診所與皮膚科醫生坐下來時，一切都清楚了。

And this debate about my [posse] is bigger than your posse is a little bit less relevant.

這場關於我的 [團隊] 的辯論比你的團隊大一點點就不那麼重要了。

Now it matters to patient outcome.

現在它對患者的結果很重要。

And of course, the study may read out, you would expect, a well-organized competitor to pick its moments to be able to make sure that they had some differentiation.

當然，您可能會期望這項研究表明，一個組織良好的競爭對手會選擇合適的時機來確保他們有一些差異化。

Our confidence in not worrying too much about the outcome is because we think it will be mainly a campaign or marketing message.

我們有信心不會過分擔心結果，因為我們認為這將主要是一項競選或營銷信息。

Maybe the larger the dataset may be able to tell us more about that medicine.

也許更大的數據集可能能夠告訴我們更多關於該藥物的信息。

More importantly, I think it's worth evaluating the ARROW study, the more mechanistic study, that we have in play.

更重要的是，我認為值得評估我們正在進行的 ARROW 研究，這是一項更機械化的研究。

Because the real unanswered questions in dermatology are about the extra manifestations.

因為皮膚病學中真正懸而未決的問題是關於額外的表現。

I think in one of our backup slides, you can see under that, that we care greatly about advancing the understanding -- Slide 33, accelerating the understanding and advancing the understanding for the dermatology community.

我想在我們的一張備份幻燈片中，您可以在下面看到，我們非常關心促進理解——幻燈片 33，加速理解並促進皮膚病學界的理解。

And 2/3 of these patients have other complications where predominantly IL-17A is the driver.

這些患者中有 2/3 有其他並發症，其中主要是 IL-17A 是驅動因素。

So you have to recognize that the real news will be ARROW.

所以你必須認識到真正的新聞將是 ARROW。

Yes, there will be some marketing impact, I'm sure, of ECLIPSE, depending on how it reads out, but we're comfortable with that.

是的，我敢肯定，ECLIPSE 會產生一些營銷影響，具體取決於它的讀出方式，但我們對此感到滿意。

As for the rebating and for looking -- let's look back first at the last 2 years that we've said that we will be thoughtful about our rebates in COSENTYX and that we'll trade access enough to grow volume faster than the additional rebate and run a successful business.

至於回扣和尋找——讓我們首先回顧一下過去 2 年，我們說過我們將對 COSENTYX 的回扣進行深思熟慮，並且我們將進行足夠的交易，以比額外回扣更快地增加交易量，並且經營成功的企業。

I think we've proven clearly that we've done that and very pleased, by the way, with our Q3 performance.

我認為我們已經清楚地證明我們已經做到了，順便說一下，我們對第三季度的表現非常滿意。

We don't dig deeper and share data on the first-line setting, but it's performed exactly as we hoped it would do.

我們沒有深入挖掘並分享一線設置的數據，但它的表現完全符合我們的預期。

And it sets us up very nicely for '19.

它為 19 年做好了準備。

I said in an answer to a question earlier, I think from Graham, that we have got ourselves set up very nicely for '19.

我之前在回答一個問題時說，我認為來自格雷厄姆，我們已經為 19 年做好了很好的準備。

Whilst we haven't advertised what we've achieved, we're confident with the position and the strategies deployed in the last couple of years.

雖然我們沒有公佈我們取得的成就，但我們對過去幾年的地位和部署的戰略充滿信心。

Next question comes from the line of Richard Vosser from JPMorgan.

下一個問題來自摩根大通的 Richard Vosser。

Richard Vosser, JPMorgan.

理查德·沃瑟，摩根大通。

Just a question on the Endocyte deal, first of all.

首先，只是關於內細胞交易的問題。

Just, first of all, can you give us some help in terms of the proportion of prostate cancer patients that express their PSMA protein on them?

只是，首先，您能否就前列腺癌患者在其身上表達 PSMA 蛋白的比例提供一些幫助？

And also thinking about the initial indication that you're doing the Phase III trial, and it looks like it might be [post] taxane.

還要考慮你正在進行 III 期試驗的初步跡象，看起來它可能是 [後] 紫杉烷。

So does that mean you have to fail Taxotere first?

那麼這是否意味著您必須首先讓 Taxotere 失敗？

Just some thoughts on the positioning there.

只是對那裡的定位有一些想法。

And perhaps you could give us an idea of whether the royalty payments still stand to AVX post the transaction and [of those] stand.

或許你可以告訴我們特許權使用費是否仍然適用於 AVX 發布交易和 [of those] 立場。

And also on the manufacturing, you talked about that being important.

在製造方面，您也談到了這一點很重要。

Perhaps you could update us and think about the capacity that it brings along with that.

或許您可以更新我們的情況並考慮它帶來的能力。

And second area, just thinking about the CRL on generic Advair, perhaps you could update us there.

第二個方面，只是考慮通用 Advair 上的 CRL，也許你可以在那裡更新我們。

And final question on Alcon.

關於愛爾康的最後一個問題。

You've helpfully given us a 2023 time frame for margins in Alcon to hit the low to mid-20s.

您為我們提供了 2023 年的時間框架，使愛爾康的利潤率達到 20 年代中期的低水平，這對我們很有幫助。

But perhaps you could give us an idea of the pace of that improvement in margins.

但也許你可以讓我們了解一下利潤率提高的速度。

Great.

偉大的。

Thank you, Richard.

謝謝你，理查德。

So first question on just the overall landscape for prostate cancer PSMA, et cetera, Liz?

那麼第一個問題是關於前列腺癌 PSMA 等的整體情況，Liz？

Yes, sure.

是的，當然。

There are about 70% to 80% of patients express PSMA.

約有70%～80%的患者表達PSMA。

To answer your question directly, yes, in the trial that we have shown you, you do have to fail at least one taxane.

要直接回答您的問題，是的，在我們向您展示的試驗中，您必須至少使一種紫杉烷不合格。

It doesn't have to be Taxotere, but it has to be one taxane.

它不一定是泰索帝，但它必須是一種紫杉烷。

And I think our goal is in the future to move it earlier into the treatment paradigm, so we will begin to think about that post close.

而且我認為我們的目標是在未來將其更早地轉移到治療範式中，因此我們將開始考慮關閉後。

And as far as -- I don't think we're commenting as far as the royalty is concerned at this point.

至於——我不認為我們在這一點上就特許權使用費發表評論。

And then lastly, around the manufacturing, there's different types of manufacturing.

最後，圍繞製造業，有不同類型的製造業。

There's direct and indirect.

有直接的和間接的。

And the method that they have is really just giving us the capability of being able to generate less waste and have a more purified therapy.

他們擁有的方法實際上只是讓我們能夠產生更少的廢物並獲得更純淨的療法。

So we're looking at how we leverage that technology and that expertise over to AAA.

因此，我們正在研究如何將這項技術和專業知識用於 AAA。

And I think from that perspective, that sort of answers the question on what we think is the benefit of the manufacturing.

我認為從這個角度來看，這回答了我們認為製造業的好處是什麼的問題。

They are currently using a CRO, so I think that our ability post close to look at the total manufacturing and see the best way forward, we'll look at that post close.

他們目前正在使用 CRO，所以我認為我們有能力在關閉後查看整個製造並看到最好的前進方向，我們將在關閉後查看。

And it's certainly our aspiration to drive that synergy, given the capability we have within AAA to reach patients eventually all around the world through our supply chain.

鑑於我們在 AAA 內部有能力通過我們的供應鏈最終接觸到世界各地的患者，我們當然希望推動這種協同作用。

Next, the CRL on generic Advair, Richard?

接下來，通用 Advair 的 CRL，Richard？

Thanks for the question.

謝謝你的問題。

So to reiterate what we said on the previous earnings call, we've had good discussions and communications with the FDA.

因此，為了重申我們在之前的財報電話會議上所說的話，我們與 FDA 進行了良好的討論和溝通。

We believe we understand what is necessary to get Advair -- generic Advair to the market.

我們相信我們了解將 Advair——通用 Advair 推向市場的必要條件。

And we stick with the timeline as we communicated earlier, where we see this coming to the market at the back end of next year.

我們堅持我們之前溝通的時間表，我們看到它在明年年底進入市場。

Great.

偉大的。

And then with respect to the pace of Alcon margin improvement, David?

然後關於愛爾康利潤率提高的速度，大衛？

Yes just to start with saying that the 2017 is -- sorry, just starting with 2017, obviously, the trough year, '18 will be up, '19 will be up on that.

是的，首先要說 2017 年是——抱歉，從 2017 年開始，顯然是低谷年，'18 年將會上升，'19 年將會上升。

We haven't really commented on the pace, but we intend to have our Capital Markets Day in November.

我們還沒有真正評論步伐，但我們打算在 11 月舉辦我們的資本市場日。

And December, we'll have an opportunity to take you through the margin progression, how we see that.

12 月，我們將有機會向您介紹保證金進展情況，我們是如何看待的。

It obviously moves a great deal on our products like our ATI wells, our manufacturing productivity and then leveraging our cost structure.

它顯然對我們的產品有很大的影響，比如我們的 ATI 油井、我們的製造生產力，然後利用我們的成本結構。

So we feel good about where we're going long-term.

因此，我們對我們的長期發展方向感到滿意。

Next question comes from the line of David Evans from Kepler Cheuvreux.

下一個問題來自 Kepler Cheuvreux 的 David Evans。

It's David Evans from Kepler Cheuvreux.

我是 Kepler Cheuvreux 的 David Evans。

Just on Lutathera, the initial launch, as you pointed out, has been excellent.

正如您所指出的，就在 Lutathera 上，最初的發布非常出色。

It's been faster than I think probably most people would have modeled.

它比我認為可能大多數人建模的速度要快。

Could you just possibly give us a little bit more of a view on the shape of the launch?

你能不能給我們更多關於發射形狀的看法？

And how you expect that to look?

你希望它看起來如何？

Are there any kind of sticking points in terms of getting access to centers and training centers up?

在進入中心和培訓中心方面是否存在任何障礙？

Or should we expect it as a typical fast linear pharma oncology launch in the U.S.?

或者我們是否應該將其視為美國典型的快速線性腫瘤藥物上市？

And equally, Europe, I would imagine should be a lot slower.

同樣，我認為歐洲應該慢得多。

Is that fair?

這公平嗎？

So on Lutathera launch, Liz?

那麼在 Lutathera 推出時，Liz？

Yes, sure.

是的，當然。

I think you said it appropriately.

我覺得你說的很恰當。

I think we are seeing what would you normally see it in a traditional pharma launch.

我認為我們看到的是您通常會在傳統製藥發布會上看到的情況。

And I think that we were very pleasantly pleased with that.

我認為我們對此感到非常愉快。

We have over 85 centers in the United States, as Vas showed earlier.

正如 Vas 早些時候展示的那樣，我們在美國有超過 85 個中心。

And we expect that to continue to -- we don't -- we would -- I would say you could look at it like you would a traditional model.

我們希望它繼續 - 我們不會 - 我們會 - 我會說你可以像傳統模型一樣看待它。

And I think in Europe, you're correct, that we do expect a slower uptake at the centers.

我認為在歐洲，你是對的，我們確實預計中心的吸收速度會較慢。

It is really important to note that it could take up to a year for a center to really understand and be prepared to offer this therapy.

真正重要的是要注意，一個中心可能需要長達一年的時間才能真正理解並準備好提供這種療法。

So I think the team is doing a phenomenal job.

所以我認為團隊做得非常出色。

We're also just starting to see reimbursement in Europe.

我們也剛剛開始看到歐洲的報銷。

So while we do expect it to be slower than the U.S. So I think -- than the U.S. so I think the majority of the revenue going forward in the next -- over the next period will be -- will mainly be coming from the U.S., but we're really pleased with the uptick so far.

因此，雖然我們確實預計它會比美國慢，但我認為——比美國慢，所以我認為未來的大部分收入——在下一個時期——將主要來自美國。 ，但我們對目前的增長感到非常滿意。

And also Liz's team's plan is to get this global over time as well.

Liz 團隊的計劃也是隨著時間的推移使其全球化。

Your next question comes from the line of Florent Cespedes from Societe Generale.

您的下一個問題來自法國興業銀行的 Florent Cespedes 系列。

Three quick ones.

三個快速的。

First, on Afinitor, could you give us more color on why the product declined in Q3 versus the slight growth in H1?

首先，關於 Afinitor，您能否詳細說明為什麼該產品在第三季度下降，而上半年略有增長？

Is it due to the fact that we're approaching the end of its patent life?

是因為我們即將結束其專利壽命嗎？

Second question on canakinumab, could you give us -- could you share with us a little bit more regarding the requirements from the FDA.

關於 canakinumab 的第二個問題，你能否給我們 - 你能否與我們分享更多有關 FDA 要求的信息。

Is there a new large outcome trial needed in cardio for the future of this product in cardio?

對於該產品在有氧運動中的未來，是否需要在有氧運動中進行新的大型結果試驗？

Or could you provide the data, more information to the FDA based on the trials available so far?

或者您能否根據目前可用的試驗向 FDA 提供數據和更多信息？

And last question, for Richard on Sandoz.

最後一個問題，關於 Sandoz 的 Richard。

Europe looks a bit soft this quarter after a 7% growth in H1.

在上半年增長 7% 之後，歐洲本季度看起來有點疲軟。

There is only 1% growth in Q3.

第三季度僅增長 1%。

Is there any reason behind that?

這背後有什麼原因嗎？

Thanks, Florent.

謝謝，弗洛倫特。

Liz on Afinitor.

Liz 在 Afinitor 上。

Yes, Afinitor is really driven by the CDK market and in breast -- our breast cancer market, so that's what is driving that, the performance there.

是的，Afinitor 確實受到 CDK 市場和乳腺癌——我們的乳腺癌市場的推動，所以這就是推動它的動力，那裡的表現。

As you see in the United States since the CDK market has actually penetrated more.

正如你在美國看到的那樣，CDK 市場實際上滲透得更多。

We saw a leveling off of Afinitor.

我們看到 Afinitor 趨於平穩。

But now that you're seeing the increase of penetration of CDK in Europe and other markets and you're seeing a subsequent decline in Afinitor.

但現在你看到 CDK 在歐洲和其他市場的滲透率增加，而 Afinitor 隨後下降。

So we expect the same dynamic to likely happen as the CDK market begins to penetrate in earlier lines in those markets as well.

因此，我們預計隨著 CDK 市場也開始滲透到這些市場的早期產品線中，同樣的動態可能會發生。

And then, John, with respect to the canakinumab CRL?

然後，John，關於 canakinumab CRL？

Yes, regarding the canakinumab CRL, as we saw from the CANTOS trial, we knew that the patients who achieved HSCRP less than 2 received the most benefit.

是的，關於 canakinumab CRL，正如我們從 CANTOS 試驗中看到的那樣，我們知道 HSCRP 低於 2 的患者獲益最大。

And as we continue, we had discussions, and we received the CRL yesterday.

隨著我們的繼續，我們進行了討論，昨天我們收到了 CRL。

And we're continuing to explore additional information based on the information that we received from the FDA.

我們將繼續根據我們從 FDA 收到的信息探索更多信息。

And we'll have further understanding as we move forward.

隨著我們的前進，我們將有進一步的了解。

Yes.

是的。

So we'll provide updates on that as we go.

因此，我們將隨時提供更新。

And then Richard, on the EU generics?

然後理查德，關於歐盟仿製藥？

Yes, thanks for the question, Florent.

是的，謝謝你的提問，Florent。

So, yes, there was a softening of the performance in the European business and let me sort of outline what drove that.

所以，是的，歐洲業務的表現有所疲軟，讓我概述一下是什麼推動了這一點。

So firstly, it's worth noting that we did launch -- our bio launches that we had in quarter 3 last year.

所以首先，值得注意的是我們確實推出了——我們去年第三季度推出的生物產品。

So the prior year was a pretty big year for us with the launches of Erelzi and Rixathon.

因此，隨著 Erelzi 和 Rixathon 的推出，前一年對我們來說是非常重要的一年。

And then on the retail side, you're aware that we withdrew valsartan and so that had an impact on us as well as some seasonal buying patterns, which are constantly varying across quarters and some [years] And so we felt the impact of that.

然後在零售方面，您知道我們撤回了纈沙坦，因此這對我們以及一些季節性購買模式產生了影響，這些模式在各個季度和某些 [年份] 中不斷變化，因此我們感受到了這種影響.

Now -- so I remain confident about the European business as it performed well and going forward, obviously, we have a number of launches coming up in the near term.

現在 - 所以我仍然對歐洲業務充滿信心，因為它表現良好並展望未來，顯然，我們在短期內推出了許多產品。

This week, we launched adalimumab into Europe in a number of markets, as Vas mentioned, as well as we're optimistic about for a drafting committee Europe business pretty soon as well as infliximab.

本週，正如 Vas 提到的那樣，我們在多個市場向歐洲推出了阿達木單抗，我們對歐洲起草委員會的業務以及英夫利昔單抗持樂觀態度。

So I hope that answers your question, Florent.

所以我希望這能回答你的問題，Florent。

Your next question comes from the line of Steve Scala from Cowen.

你的下一個問題來自 Cowen 的 Steve Scala。

Several questions.

幾個問題。

KYMRIAH in follicular lymphoma, the filing has been delayed.

KYMRIAH 在濾泡性淋巴瘤中的應用已被推遲。

The company previously has said manufacturing issues would not delay filings.

該公司此前曾表示，製造問題不會延遲申請。

Is there a change in that?

這有什麼變化嗎？

Secondly, Paul, you previously have said thousands of type 1 patients would want AVXS-101 upon launch, which implies multibillion dollars in revenue in 2019, fueled by, as you have said previously, time is neurons.

其次，Paul，您之前曾說過，數以千計的 1 型患者在 AVXS-101 上市後會想要 AVXS-101，這意味著 2019 年的收入將達到數十億美元，正如您之前所說，時間就是神經元。

The answer to Matthew's question was a bit more muted than that very positive portrayal in the past, and I'm wondering if you could amplify.

Matthew 的問題的答案比過去非常積極的描述要溫和一些，我想知道你是否可以放大。

And then lastly for Richard, biosimilar HUMIRA in the EU.

最後是理查德，歐盟的生物仿製藥 HUMIRA。

What do you think the slope of adoption will be?

您認為採用的斜率是多少？

For instance, can biosimilars get 25% molecule share in the first year or more?

例如，生物仿製藥能否在第一年或更長時間內獲得 25% 的分子份額？

So I think first on KYMRIAH, Liz?

所以我首先想到 KYMRIAH，Liz？

No, in KYMRIAH where we currently are manufacturing, we've just announced a slowdown on trials, but we have not noticed any ending of a trial or expecting that we will -- that we would delay any trial because of the manufacturing.

不，在我們目前正在製造的 KYMRIAH 中，我們剛剛宣布試驗放緩，但我們沒有註意到試驗的任何結束或期望我們會——我們會因為製造而推遲任何試驗。

So I think that's the only thing we want to add at this point.

所以我認為這是我們目前唯一想添加的內容。

So I mean, our aspiration is to keep FL as well as the other B-cell [enhanced] cancers on track with respect to KYMRIAH.

所以我的意思是，我們的願望是讓 FL 以及其他 B 細胞 [增強型] 癌症在 KYMRIAH 方面走上正軌。

Paul, on Type 1 SMAs?

保羅，關於 1 型 SMA？

So, Steven, sorry, if I was somewhat muted, that wasn't my intention, I was trying to respond to the manufacturing question which I'm comfortable with.

所以，史蒂文，抱歉，如果我有點沉默，那不是我的本意，我只是想回答我覺得舒服的製造問題。

The SMA community is desperate for a gene therapy.

SMA 社區迫切需要一種基因療法。

We do believe it's going to be foundational across all SMA types.

我們相信它將成為所有 SMA 類型的基礎。

Our first indication will be in newborns, and we expect to have a significant demand for that patient population.

我們的第一個適應症是新生兒，我們預計該患者群體會有很大的需求。

And we will be ready to match that demand.

我們將準備好滿足這一需求。

I should have perhaps mentioned earlier about our North Carolina manufacturing site that we made a big investment in to triple our capacity.

關於我們在北卡羅來納州的製造基地，我或許應該早點提到我們進行了大量投資以將我們的產能提高三倍。

So we're preparing very well for whatever is there.

所以我們正在為那裡的一切做好準備。

And we do hope that there is a significant number of patients as much for the patients as for the business.

我們確實希望有大量的患者和企業一樣多。

Thank you, Paul.

謝謝你，保羅。

And biosimilars HUMIRA, Richard?

和生物仿製藥修美樂，理查德？

Yes, thanks for the question.

是的，謝謝你的提問。

So to answer your question about so what market share penetration there will be.

因此，要回答您關於市場份額滲透率的問題。

I think it's an interesting question, and what I would say if you look at it historically, every biosimilar that comes to the market in Europe, I think changes the adoption and moves it upwards.

我認為這是一個有趣的問題，如果你從歷史上看，我想說的是，每一種進入歐洲市場的生物仿製藥，我認為都會改變採用率並將其向上移動。

And we saw that obviously last year with rituximab coming to the market, and you see that penetration levels there.

我們很明顯地看到去年利妥昔單抗進入市場，你可以看到那裡的滲透水平。

So -- and we've also got obviously a few competitors coming to the market with us.

所以——我們顯然也有一些競爭對手和我們一起進入市場。

I think that drives me to be optimistic about the biosimilar penetration over the first year.

我認為這促使我對第一年的生物仿製藥滲透持樂觀態度。

I also stand with that, I won't get too specific about numbers, but I do feel the European market is ready for this and most definitely the health authorities need to be looking at opportunities to save money, so very positive.

我也支持這一點，我不會對數字說得太具體，但我確實覺得歐洲市場已經為此做好了準備，而且衛生當局肯定需要尋找省錢的機會，所以非常積極。

Your next question comes from the line of Eric Le Berrigaud from Bryan Garnier.

您的下一個問題來自 Bryan Garnier 的 Eric Le Berrigaud。

Three questions, please.

請教三個問題。

The first one related to margins in pharma and Sandoz.

第一個與製藥和 Sandoz 的利潤率有關。

And the way sales to other segments and other revenues are contributing to the margin increase in the quarter.

對其他部門的銷售和其他收入的方式為本季度的利潤率增長做出了貢獻。

Could you maybe at least for innovative medicine, while it contributed more than 100 basis points out of the 190, explain what is behind especially the sharp increase in other revenues and also if sales to other segments, if there's been any shift from Corporate into the various divisions?

你能不能至少為創新醫學貢獻了 190 個基點中的 100 個基點，解釋一下背後的原因，尤其是其他收入的急劇增長，以及是否向其他部門銷售，是否有任何從公司轉移到各個部門？

Because it looks like there is a double-digit increase where there is a significant decrease in Corporate.

因為它看起來有兩位數的增長，而企業卻顯著下降。

And second point on Lutathera, perhaps, again, 3 questions.

關於 Lutathera 的第二點，也許又是 3 個問題。

First to understand how is it used, and whether it's very late in lines, like second, third line.

首先了解它是如何使用的，以及它是否在行中很晚，例如二，三行。

Mainly second, why it has no impact on Sandostatin, as I guess it's a relief to Sandostatin.

主要是其次，為什麼它對 Sandostatin 沒有影響，因為我猜這是對 Sandostatin 的一種緩解。

And then maybe to remind us what your plans are to move it in earlier lines in the future.

然後可能會提醒我們您計劃在未來將其移動到較早的線路中。

And third, on Sandoz Europe.

第三，山德士歐洲。

Again, just to understand how the trajectory of the biosimilars could be in year 2. Because we can understand that now rituximab, for instance, in Europe is getting into the second year.

再次，只是為了了解生物仿製藥在第二年的發展軌跡。因為我們可以理解，例如，現在歐洲的利妥昔單抗正在進入第二年。

So how does it look like?

那麼它看起來怎麼樣呢？

Are you able to increase volume?

你能增加音量嗎？

Are you facing significant price decrease?

您是否面臨大幅降價？

Are you keeping your market share?

你在保持你的市場份額嗎？

Because we see the brand names still going down, but if it looks more flat for the biosimilar, then probably there is some explanation behind it.

因為我們看到品牌名稱仍在下降，但如果生物仿製藥看起來更平淡，那麼背後可能有一些解釋。

First on other revenues, Harry?

首先是其他收入，Harry？

Yes, so on the other revenues, as you mentioned, mainly driven by Innovative Medicines.

是的，正如您提到的，其他收入主要由創新藥物推動。

This is basically profit split and royalties behind Aimovig and XOLAIR.

這基本上是 Aimovig 和 XOLAIR 背後的利潤分配和版稅。

So from that standpoint kind of -- and margin averaged true-up from the profit split where we have marked in best efforts in the SG&A line and then some true-up and limited royalties on other revenues as well as XOLAIR royalties from U.S. profit split.

因此，從這個角度來看，我們在 SG&A 系列中做出了最大努力，然後對其他收入的一些調整和有限的特許權使用費以及來自美國利潤分配的 XOLAIR 特許權使用費進行了平均利潤分配.

So that's the main part driving the other revenues up.

所以這是推動其他收入增長的主要部分。

There's no change in the structure of how we maybe work with corporate and respective divisions.

我們與公司和各自部門合作的方式結構沒有變化。

We have seen -- you may have seen this in the Corporate line, that vaccines IP-related royalties have come down significantly and therefore increase in the Corporate costs line and core Corporate expenses.

我們已經看到——您可能已經在公司業務中看到了這一點，與疫苗知識產權相關的特許權使用費已大幅下降，因此公司成本線和核心公司費用增加。

Thank you, Harry.

謝謝你，哈利。

On Lutathera, Liz?

在 Lutathera 上，Liz？

Yes, sure.

是的，當然。

Lutathera is indicated for second line in neuroendocrine tumors and that's where our growth is.

Lutathera 適用於神經內分泌腫瘤的二線治療，而這正是我們的成長所在。

And as traditionally seen and typically seen in this market, obviously some of the patients initially have been through even more than 2 lines.

正如傳統上看到的和在這個市場上通常看到的那樣，顯然一些患者最初已經經歷了超過 2 條線。

So we've seen the later line, but we do expect to become standard of care in second line.

所以我們已經看到了後線，但我們確實希望成為二線護理的標準。

We -- there you haven't seen any impact on Sandostatin because there's a couple of things happened with the dynamics of Lutathera.

我們——你沒有看到對 Sandostatin 有任何影響，因為 Lutathera 的動態發生了幾件事。

One, you do have to come off of Sandostatin temporarily, but the trials were done, followed by Sandostatin.

第一，你必須暫時停用善寧，但試驗已經完成，然後是善寧。

So once the Lutathera treatment is complete, the patients go back on to kind of Sandostatin.

因此，一旦 Lutathera 治療完成，患者就會重新使用善寧。

And I think that we believe that Sandostatin will continue to be first-line standard of care, but we are considering looking in and investigating Lutathera in earlier lines of therapy.

我認為我們相信 Sandostatin 將繼續作為一線標準治療，但我們正在考慮在早期治療中尋找和研究 Lutathera。

And lastly, Sandoz biosimilars Europe, Richard?

最後，山德士歐洲生物仿製藥公司，理查德？

Yes, thank you for the question.

是的，謝謝你的提問。

So to answer your question is sort of a how you think -- how we should think about the growth rate?

所以回答你的問題有點像你的想法——我們應該如何考慮增長率？

So first, I'd like to sort of point that obviously for the quarter, we had a 21% growth rate in biosimilars.

所以首先，我想指出一點，顯然在本季度，我們的生物仿製藥增長率為 21%。

Now of that, the base business, which we sort of call the non-launch business in Europe, also performed very well.

現在，我們在歐洲稱之為非發射業務的基礎業務也表現非常好。

And we continue to see good uptake on both rituximab as well as etanercept.

我們繼續看到利妥昔單抗和依那西普的良好吸收。

As we move forward, I still think there's good opportunity to continue to keep growing these products.

隨著我們的前進，我仍然認為有很好的機會繼續發展這些產品。

Obviously, the biosimilar penetration hasn't maxed out, but at the same time, we do see some fighting back of the originator and that generally is in the form of prices.

顯然，生物仿製藥的滲透率還沒有達到頂峰，但與此同時，我們確實看到了原研者的一些反擊，而且通常以價格的形式出現。

So that gives some variability.

所以這給出了一些可變性。

But we still see these as growth brands as we move into next year.

但在我們進入明年時，我們仍然將這些視為增長品牌。

So I hope that answers your question.

所以我希望這能回答你的問題。

Your next question comes from the line of Michael Leuchten from UBS.

你的下一個問題來自瑞銀的 Michael Leuchten。

Two questions, please.

請教兩個問題。

One on Aimovig.

一個在 Aimovig。

For patients that are coming off the free drug program, I wondered if you had any data to show what happens to those as they are all converted on to commercial, is there any leakage, any color would be helpful, if not early days.

對於即將結束免費藥物計劃的患者，我想知道您是否有任何數據可以顯示這些患者在全部轉換為商業藥物時會發生什麼，是否有任何洩漏，任何顏色都會有所幫助，如果不是早期的話。

And a question on Alcon.

還有一個關於愛爾康的問題。

Given the CyPass withdrawal, I was wondering how you measure the potential impact on Alcon surgical given that the business has spent a lot of time rebuilding trust with the physician communities, social community.

考慮到 CyPass 退出，我想知道您如何衡量對 Alcon Surgical 的潛在影響，因為該公司已經花了很多時間重建與醫生社區、社會社區的信任。

Is there any way you can quantify touch points?

有什麼方法可以量化接觸點？

Any color that would damage for the business, if any.

任何會損害業務的顏色（如果有）。

Thank you, Michael.

謝謝你，邁克爾。

Paul, on Aimovig.

保羅，在 Aimovig。

So firstly, we're delighted with the uptake of Aimovig in the U.S. And indeed it reads across very nicely to what we think will happen in Europe that is rolling reimbursement in Europe, the unprecedented demand bodes well for the choices made.

因此，首先，我們對 Aimovig 在美國的採用感到高興。事實上，它很好地解讀了我們認為歐洲將發生的事情，即歐洲的滾動報銷，前所未有的需求預示著做出的選擇是好的。

As for -- we're not sharing data yet for the conversion.

至於——我們還沒有為轉換共享數據。

I think you'll appreciate clearly that our objective earlier on in the launch was to give physicians and patients the earliest opportunity to use the medicine unencumbered, find out if they're a responder and just how great a responder.

我想你會清楚地意識到，我們在發布初期的目標是讓醫生和患者儘早有機會不受阻礙地使用藥物，看看他們是否是一個反應者，以及反應者有多好。

And that's proven out to be exactly as we thought with the significant uptake.

事實證明，這與我們所想的完全一樣，並得到了顯著的接受。

It's also worth mentioning as well because as we get through the end of the year and into next year and we start talking about -- or our partner will start talking about the U.S. dollar sales, that we are running both a hub, at the high touch with neurologists and the retail approach.

同樣值得一提的是，隨著我們度過今年年底和明年，我們開始談論 - 或者我們的合作夥伴將開始談論美元銷售額，我們正在運行一個樞紐，處於高位接觸神經科醫生和零售方法。

So we feel that we'll be unique in offering both channels to get drug to patients.

所以我們覺得我們在提供兩種渠道為患者提供藥物方面將是獨一無二的。

So we feel good about how we're going to convert and when we're going to convert, but I'm not going to share that data right now.

因此，我們對如何轉換以及何時轉換感到滿意，但我現在不打算分享這些數據。

Thank you, Paul.

謝謝你，保羅。

And on CyPass situation, David?

關於 CyPass 的情況，大衛？

Yes, on CyPass, probably the best way to think about the impact is long-term relationship with the surgeons.

是的，在 CyPass 上，考慮影響的最佳方式可能是與外科醫生的長期關係。

I think we feel really good about what we did around how we handled this.

我認為我們對我們處理這件事的方式感到非常滿意。

It was done with a lot of scientific advice from folks we know well, but also in conjunction with the agencies.

它是在我們熟悉的人的大量科學建議下完成的，同時也與這些機構一起完成。

We've exposed all the data at ESCRS.

我們已經在 ESCRS 公開了所有數據。

We'll show it again at AAO.

我們將在 AAO 再次展示它。

We made it available to people on our website.

我們在我們的網站上向人們提供了它。

And obviously, the -- we continue to work with the agencies around the world to do the next thing we can to see what we can do around the product, long term.

顯然，我們將繼續與世界各地的機構合作，做我們能做的下一步，看看我們能圍繞產品做些什麼，長期來看。

The important part of this is the Surgical business grew 7% in the quarter.

其中重要的部分是外科手術業務在本季度增長了 7%。

It also continues to benefit from a lot of our ATI well push, which I think kind of is your best metric on how we're doing with the surgeons.

它還繼續受益於我們對 ATI 的大量推動，我認為這是衡量我們如何與外科醫生合作的最佳指標。

I think surgeons appreciated our proactive and assertive response to the signals we saw.

我認為外科醫生很欣賞我們對我們看到的信號的積極主動和自信的反應。

Thank you, David.

謝謝你，大衛。

Thank you, Michael.

謝謝你，邁克爾。

Your next question comes from the line of Kerry Holford from BNP Paribas.

你的下一個問題來自法國巴黎銀行的 Kerry Holford。

Just 2 questions left for me.

只剩下 2 個問題留給我。

KYMRIAH, just interested to get your view on the sales ramp.

KYMRIAH，只是想了解您對銷售量的看法。

So far, has that delivered -- how has that delivered versus your internal expectations?

到目前為止，是否已交付 - 與您的內部期望相比，交付情況如何？

Are you comfortable with the current consensus forecasts for over $200 million next year?

您對明年超過 2 億美元的當前共識預測感到滿意嗎？

And also, just to understand why you've taken on board a third-party manufacturing on this asset in China with Cellular Biomedicine Group?

而且，只是為了了解您為什麼與 Cellular Biomedicine Group 一起在中國進行該資產的第三方製造？

Is that to supply the local market only?

是不是只供應本地市場？

And then on Gilenya, just following the positive IPR ruling last July, just can you remind us of the next steps here in terms of time line?

然後關於 Gilenya，就在去年 7 月對知識產權作出積極裁決之後，您能否提醒我們在時間表方面的後續步驟？

Thanks, Kerry.

謝謝，克里。

KYMRIAH, Liz?

KYMRIAH，麗茲？

Sure.

當然。

Thanks for the questions.

感謝您的提問。

On KYMRIAH, where we are today, to be honest with you, we're actually above our expectations given the manufacturing challenges that we've had.

在我們今天所處的 KYMRIAH 上，老實說，考慮到我們遇到的製造挑戰，我們實際上超出了我們的預期。

I think that's actually a response to physicians really being excited about the opportunity to bring KYMRIAH to their patients.

我認為這實際上是對醫生真正對將 KYMRIAH 帶給患者的機會感到興奮的回應。

So it's hard to tell where we would be if we didn't have the challenges, but I think that what we've seen is that centers have continued to order KYMRIAH despite this and because they really think it's important for their patients to get KYMRIAH.

所以很難說如果我們沒有挑戰我們會在哪裡，但我認為我們所看到的是，儘管如此，中心仍然繼續訂購 KYMRIAH，因為他們真的認為讓他們的病人獲得 KYMRIAH 很重要.

So we've been able -- the good news is we've actually been able to deliver the therapy to the most -- to most of the patients.

所以我們已經能夠 - 好消息是我們實際上已經能夠為大多數患者提供治療。

So we're really pleased to be able to bring this therapy to patients.

所以我們真的很高興能夠將這種療法帶給患者。

On China, as you say, it's because we do need to have manufacturing in China based on China law, and we also expect that they'll be able to assist us in gaining access to patient population in China.

關於中國，正如你所說，這是因為我們確實需要根據中國法律在中國進行製造，我們也希望他們能夠幫助我們接觸中國的患者群體。

So I think what you've seen over the last few months is we've expanded our footprint for cell therapy manufacturing around the world.

所以我想你在過去幾個月裡看到的是我們已經擴大了我們在全球細胞治療製造領域的足跡。

I think that shows that we're committed to providing access to this important medicine around the world.

我認為這表明我們致力於在全世界提供獲得這種重要藥物的機會。

Maybe I'll just add on Kymriah.

也許我會添加 Kymriah。

When you look longer term, and we really see this as a long-term play, and we are quite confident in the profile of the medicine, which is why we invested in resolving the manufacturing issue in the U.S. We announced a deal with Cell for Cure in France.

當你從長遠來看，我們真的認為這是一個長期的遊戲，我們對藥物的概況非常有信心，這就是為什麼我們投資解決美國的製造問題。我們宣布與 Cell 達成協議在法國治療。

We announced we'll be building a facility here in Switzerland.

我們宣布我們將在瑞士建立一個設施。

We announced the China facility to really give us the global supply chain that we need.

我們宣佈在中國設立工廠是為了真正為我們提供所需的全球供應鏈。

And the reason we do that, as Liz points out, is KYMRIAH has a pretty unique profile we're learning.

正如 Liz 指出的那樣，我們這樣做的原因是 KYMRIAH 具有我們正在學習的非常獨特的配置文件。

It's a profile that hits the sweet spot between strong efficacy and solid safety, can be used in the outpatient setting.

這是一個在強大的功效和可靠的安全性之間達到最佳平衡點的配置文件，可用於門診環境。

And when you think longer term about this evolution of this space, it's really going to be about moving to earlier lines of therapy, where the T cells are less exhausted and you can generate stronger responses.

當你從長遠考慮這個領域的這種演變時，它真的會轉向更早的治療線，在那裡 T 細胞不那麼疲憊，你可以產生更強的反應。

And you want to a very safe profile medicine in order to be able to do that.

為了能夠做到這一點，您需要一種非常安全的藥物。

So our aspiration with this is to get across B-cell [NEH] cancers, get into earlier lines, have global manufacturing scale and be able then to really make this into a significant medicine for Novartis.

因此，我們的願望是跨越 B 細胞 [NEH] 癌症，進入早期生產線，擁有全球製造規模，然後能夠真正將其變成諾華的重要藥物。

Now with respect to the Gilenya IPR, there's no new updates from what we've told, I think, you in the last quarter.

現在關於 Gilenya IPR，我們在上個季度告訴你的內容沒有新的更新。

We have filed the lawsuits against the relevant parties.

我們已對相關方提起訴訟。

We're waiting now the next steps with respect to the various court cases and what these various parties might do.

我們現在正在等待有關各種法庭案件以及這些各方可能採取的措施的後續步驟。

As soon as we have any further updates, of course, we'll keep you all aware.

一旦我們有任何進一步的更新，當然，我們會讓你們都知道。

The next question comes from the line of Seamus Fernandez from Guggenheim Securities.

下一個問題來自古根海姆證券公司的 Seamus Fernandez。

Just a couple here.

這裡只有一對。

I don't know if anybody asked any questions on Aimovig yet, but just interested to know a little bit of how we should be thinking about the evolution of gross to net and pricing in this area.

我不知道是否有人問過關於 Aimovig 的任何問題，但只是想知道一點我們應該如何考慮這一領域的毛收入到淨收入的演變和定價。

Obviously, we're seeing some spectacular uptake of the products, but there's speculation and awareness that a lot of free drug is obviously entering the market because payers have not really supported yet.

顯然，我們看到了一些驚人的產品吸收，但有人猜測和意識到許多免費藥物顯然正在進入市場，因為付款人尚未真正支持。

So just wondering how Aimovig is going to evolve in terms of gross-to-net pricing in the U.S. and how you feel, once that occurs, how the market is likely to shift in terms of the uptake.

所以只是想知道 Aimovig 在美國的毛淨定價方面將如何演變，以及你的感受，一旦發生，市場在吸收方面可能會發生怎樣的變化。

And then the second question is actually on QAW.

然後第二個問題實際上是關於QAW 的。

I noticed that the first 2 trials that Novartis has reading out for QAW are on FEV1.

我注意到 Novartis 為 QAW 讀取的前 2 個試驗是在 FEV1 上。

The benefits that we've seen on FEV1 so far have been somewhat limited with the antibodies.

到目前為止，我們在 FEV1 上看到的好處在某種程度上受到了抗體的限制。

Just trying to understand how your team has actually managed to -- or is managing those trials for success, given what we've seen on the FEV1 endpoint in that -- in the high-eosinophil type area.

考慮到我們在 FEV1 端點上看到的情況，只是想了解您的團隊實際上是如何在高嗜酸性粒細胞類型區域成功地成功進行這些試驗的。

Thank you, Seamus.

謝謝你，西默斯。

So on Aimovig, Paul?

那麼關於 Aimovig，保羅？

Yes, I think, clearly, I'm not going to comment on the gross to net.

是的，我想，很明顯，我不會對毛淨值發表評論。

And in fact, just to be clear, Amgen take the lead on that decision ultimately in the U.S. I don't think we should get confused about free drug and trialing with what that means ultimately for gross to net.

事實上，需要明確的是，Amgen 最終在美國帶頭做出了這一決定。我認為我們不應該對免費藥物感到困惑，也不要對這最終意味著毛利和淨額的試驗感到困惑。

Again we were launching several months ahead of competition that were coming and taking [fast].

我們再次在即將到來的競爭[快速]之前推出幾個月。

Again, we wanted to make sure patients got to try it.

同樣，我們希望確保患者能夠嘗試。

It wasn't about coverage or commercial insurance, it was about trial.

這與承保範圍或商業保險無關，而是與審判有關。

And you'll have also seen, as recently as yesterday, an update from Express Scripts about the fact that we are already part of their plan.

就在昨天，您還會看到來自 Express Scripts 的更新，內容是我們已經參與了他們的計劃。

It wasn't just recently.

不僅僅是最近。

It was from the beginning.

這是從一開始。

So we know over time that the volume has to be converted to commercial patients.

因此，隨著時間的推移，我們知道必須將數量轉換為商業患者。

And we feel again very confident in how to do that, and we have the plans in place to do it.

我們再次對如何做到這一點充滿信心，並且我們已經制定了計劃。

So I probably wouldn't have much to add.

所以我可能沒有太多要補充的。

I think that's all for me.

我想這就是我的全部。

And John, the QAV -- QAW pivotals.

還有約翰，QAV -- QAW 的關鍵人物。

Yes, thanks for the question, Steven on -- regarding what we saw in Phase II, as you know, fevipiprant, or QAWs, are the only DP2 antagonist to show improvement in FEV1, asthma control and reduction in sputum eosinophils, and we have our ongoing Phase IIIs, which are LUSTRE-1 and LUSTRE-2.

是的，謝謝你的問題，史蒂文繼續——關於我們在第二階段看到的情況，如你所知，非維普蘭或 QAW 是唯一顯示 FEV1 改善、哮喘控制和痰嗜酸性粒細胞減少的 DP2 拮抗劑，我們有我們正在進行的第三階段，即 LUSTRE-1 和 LUSTRE-2。

We expect to see results in the second quarter of next year.

我們預計將在明年第二季度看到結果。

And we have that currently powered at greater than 90%, 40% relative risk reduction in the rate of moderate to severe asthma exacerbation.

我們目前有超過 90% 的動力，中度至重度哮喘發作的相對風險降低了 40%。

So we're looking forward to seeing the results in the exacerbations for next year.

因此，我們期待看到明年惡化的結果。

Just to be clear, where we try to position QAW is really ahead of the monoclonal antibodies.

需要明確的是，我們試圖將 QAW 定位在單克隆抗體之前。

And we know we need to show exacerbation reductions that will enable that to happen, but our absolute aspiration is the struggle to demonstrate it can be used before biologics and also then be used in children where we also have a program to ensure that there's pediatric dosing available over time so that we can really cover the space of severe eosinophilic asthma.

我們知道我們需要證明可以減少惡化以實現這一點，但我們的絕對願望是努力證明它可以在生物製劑之前使用，然後也可以用於兒童，我們也有一個計劃來確保有兒科劑量隨著時間的推移，我們可以真正覆蓋重度嗜酸性哮喘的空間。

Your next question comes from the line of [Maria Tamyemye] from PRIME Avenue.

你的下一個問題來自 PRIME Avenue 的 [Maria Tamyemye]。

Maria from Prime Time Avenue.

黃金時段大道的瑪麗亞。

Just a few points of clarification left really.

只剩下幾點澄清了。

One is following up on Kerry's question on KYMRIAH.

一個是跟進克里關於 KYMRIAH 的問題。

I mean how should we think long term about pay aways to third parties?

我的意思是我們應該如何長期考慮支付給第三方的費用？

In terms of China, should we think of your partner as more of a glorified CMO or someone who gets meaningful royalties or something potentially even approaching a profit split?

就中國而言，我們是否應該將您的合作夥伴更多地視為一位光榮的 CMO 或獲得有意義的特許權使用費或什至可能接近利潤分割的人？

And as we look into the really long term and think about KYMRIAH potentially being a mega blockbuster, what sort of royalty rate pay way should we assume for the various regions?

當我們著眼於真正的長期並考慮 KYMRIAH 可能成為一個超級大片時，我們應該為各個地區假設什麼樣的版稅率支付方式？

Also, a couple of questions on the Endocyte deal, please.

另外，請問幾個關於 Endocyte 交易的問題。

But first is in terms of the positioning, I understand that it's going to be much broader than the way your pharmaceutical is currently going into prostate cancer.

但首先是在定位方面，我知道它會比你的藥物目前進入前列腺癌的方式更廣泛。

But ultimately, in that bone met space, is my understanding correct that you would still be competing because you wouldn't be giving 2 radiopharmaceuticals, one treating just the bone mass and one treating effectively the bone met plus something else?

但最終，在那個骨相遇空間，我的理解是否正確，你仍然會參加比賽，因為你不會給予 2 種放射性藥物，一種只治療骨量，另一種有效治療骨相遇加上其他東西？

And then the second question on that is also, I mean given the somewhat checkered history of radiopharmaceuticals in prostate cancer, would you say that you don't expect any similar problems for your product because it's much more of Endocyte product because it's much more targeted?

然後第二個問題也是，我的意思是考慮到放射性藥物治療前列腺癌的歷史有些曲折，你會說你不認為你的產品有任何類似的問題，因為它更多的是 Endocyte 產品，因為它更有針對性？

Or are there any particular learnings for your own clinical programs, in particular, any tumor settings or patient segments that you won't go after?

或者您自己的臨床項目是否有任何特別的學習，特別是您不會追求的任何腫瘤設置或患者細分？

And then just a small point of clarification on AVXS-101.

然後只是對 AVXS-101 的一點澄清。

So, Vas, you earlier commented that gene therapy is likely to be foundational.

所以，Vas，你之前評論說基因療法可能是基礎療法。

Were you saying that you expect orals to show lesser efficacy in the vast majority of patients and therefore the gene therapies should remain or should become standard of care for the foreseeable future?

您是說您預計口服藥物對絕大多數患者的療效較差，因此在可預見的未來基因療法應該保留或應該成為標準治療？

Or was that comment really just related to the pent-up demand on the bolus patients and you're effectively saying that you think if you look at the cumulative commercial opportunity longer term, most of that will have gone to the gene therapies before the orals actually hit the market?

或者，該評論真的只是與推注患者被壓抑的需求有關，你實際上是在說，如果你從長遠來看累積的商業機會，其中大部分將在口服之前用於基因治療真的打市場了嗎？

So first, on KYMRIAH global, Liz?

那麼首先，在 KYMRIAH global 上，Liz？

Yes, sure.

是的，當然。

I mean, I think the way that you should like at it is that we're committed, as Vas explained, to bringing this important therapy around the world.

我的意思是，我認為您應該喜歡的方式是，正如 Vas 解釋的那樣，我們致力於將這種重要療法帶到世界各地。

I don't think that there's any additional royalty or other things that we have to think about beyond what we already know.

我認為除了我們已經知道的之外，我們不需要考慮任何額外的版稅或其他事情。

On the CVNG and partnership in China, I think we look at it very much as a partnership.

關於 CVNG 和在中國的合作夥伴關係，我認為我們非常重視它的合作夥伴關係。

They will be manufacturing for us, and they will also work with us to gain access there, but it's -- we're not expecting any type of profit share there.

他們將為我們製造，他們也將與我們合作以獲得那裡的准入權，但它 - 我們不期望在那裡獲得任何類型的利潤份額。

So I think that pretty much answers that question.

所以我認為這幾乎可以回答這個問題。

It's really important, again as Vas said before, to understand that we're in the long game with cell therapy and particularly with KYMRIAH.

正如 Vas 之前所說，了解我們在細胞療法，尤其是 KYMRIAH 的長期遊戲中，這一點非常重要。

And we've seen and we feel like our -- the key stakeholders are physicians and patients are excited about KYMRIAH, and we actually continuously get requests from around the world to have access to this medicine.

我們已經看到並且感覺我們的 - 主要利益相關者是醫生和患者對 KYMRIAH 感到興奮，而且我們實際上不斷收到來自世界各地的請求以獲得這種藥物。

So it's important that we do it but we also do it in the right way.

因此，我們這樣做很重要，但我們也以正確的方式進行。

And we're planning to do that.

我們正計劃這樣做。

Moving to the prostate and to Endocyte, I do think there's again a little bit of a misunderstanding.

談到前列腺和內細胞，我確實認為又存在一點誤解。

This therapy is for all patients to treat prostate cancer.

這種療法適用於所有治療前列腺癌的患者。

I think that's the most -- the clearest way that I can explain it.

我認為這是我能解釋的最——最清晰的方式。

It's not to treat a side effect or any other part of prostate cancer, it's to treat prostate cancer.

它不是治療副作用或前列腺癌的任何其他部分，而是治療前列腺癌。

And what's happening in prostate cancer, I think it's really important to think about the evolution of what's happened in prostate cancer.

前列腺癌正在發生的事情，我認為思考前列腺癌發生的事情的演變非常重要。

With antiandrogen therapies, particularly the novel antiandrogen therapies, are moving into the non-metastatic settings.

隨著抗雄激素療法，特別是新型抗雄激素療法，正在進入非轉移性環境。

So you're seeing the need for more therapies in the metastatic setting.

所以你看到在轉移性環境中需要更多的治療方法。

And so we see that this will be an important medicine for all prostate patients with PSMA, which as I said -- that I noted before, it's about 70% to 80% of the patient population.

因此，我們看到這將成為所有患有 PSMA 的前列腺患者的重要藥物，正如我之前所說——我之前指出，它大約佔患者人數的 70% 到 80%。

I think we demonstrated with -- through the launch of Lutathera, and that we can bring this important therapy to patients, and that physicians and centers and nuclear medicine physicians are interested in and excited about bringing these types of therapies to patients.

我認為我們通過 Lutathera 的推出證明了這一點，並且我們可以將這種重要的療法帶給患者，並且醫生和中心以及核醫學醫師對將這些類型的療法帶給患者感興趣並感到興奮。

So I think we feel very good about the prospects for the prostate cancer area.

所以我認為我們對前列腺癌領域的前景感到非常樂觀。

It's a large market, and these patients are in need of additional therapy.

這是一個很大的市場，這些患者需要額外的治療。

Can I just clarify -- sorry, can I just clarify on that point because I thought that the vast majority of metastatic patients, the first metastases that develop or the main metastases are at the bone met.

我能否澄清一下——抱歉，我能否澄清一下這一點，因為我認為絕大多數轉移性患者，首先發生的轉移或主要轉移發生在骨骼上。

So are you basically expecting to be as good on bone met as other therapies, but have the broader application?

那麼，您是否基本上期望與其他療法一樣改善骨質疏鬆，但有更廣泛的應用？

Or would you see that separately...

或者你會單獨看到...

Let me try one more time, Maria.

讓我再試一次，瑪麗亞。

So when you think about radiopharmaceuticals as traditionally conceived, you're infusing a radioactive compound, systemically IV, and those radioactive compounds have certain affinities.

因此，當您按照傳統方式考慮放射性藥物時，您正在輸註一種放射性化合物，全身靜脈注射，而這些放射性化合物具有一定的親和力。

So radium has infinity in places where there is calcium.

所以鐳在有鈣的地方有無窮大。

So a radium builds up in the bone.

因此，鐳會在骨骼中積聚。

But you have systemic side effects.

但是你有全身性的副作用。

And you don't have a very targeted approach to all of where you find the relevant cancer because this is really infusing a radioactive agent.

而且你沒有一個非常有針對性的方法來處理你發現相關癌症的所有地方，因為這實際上是在註入放射性物質。

Radioligand therapy, which is what we do with Advanced Accelerator Applications and what we do here with Endocyte, links a scientifically well-understood ligand that's specific to a specific cancer that links to a radioactive particle through conjugation chemistry.

放射配體療法，這是我們在 Advanced Accelerator Applications 中所做的，也是我們在這裡在 Endocyte 中所做的，將科學上充分理解的配體連接起來，該配體特定於特定癌症，通過共軛化學連接到放射性粒子。

In the case of prostate cancer, there is a well-understood antigen called prostate-specific membrane antigen, PSMA, which is used as a diagnostic and ultimately used for treating the cancer.

就前列腺癌而言，有一種廣為人知的抗原，稱為前列腺特異性膜抗原 PSMA，可用作診斷並最終用於治療癌症。

So what our aspiration is, based on all the science that we understand, is that these PSMAs are overexpressed on prostate cancer cells.

因此，基於我們了解的所有科學知識，我們的願望是這些 PSMA 在前列腺癌細胞上過度表達。

So wherever you find prostate cancer in the body, you will be able to treat with radioligand therapy as that conceived by endocyte.

因此，無論您在體內發現前列腺癌，都可以像內細胞治療一樣使用放射配體療法進行治療。

So our expectation is we will be able to work well in bone met, but more importantly, we will work well for anywhere in the body that you find prostate cancer.

所以我們的期望是我們將能夠很好地治療骨質疏鬆症，但更重要的是，我們會很好地治療身體任何發現前列腺癌的部位。

And then we hope to create overall survival benefits and progression-free survival benefits in the indication of prostate cancer.

然後我們希望在前列腺癌的適應症中創造總體生存效益和無進展生存效益。

And then on AVSX-101 as a foundational therapy, really what I -- what we believe, and we have to ultimately generate the data to show this in SMA2, 3. But on SMA1, we've clearly shown this is the foundational therapy, potentially lifelong, clear and compelling efficacy -- remarkable efficacy.

然後將 AVSX-101 作為基礎療法，真的是我 - 我們所相信的，我們必須最終生成數據以在 SMA2、3 中顯示這一點。但在 SMA1 上，我們已經清楚地表明這是基礎療法，潛在的終生、明確和令人信服的功效——卓越的功效。

And so far, what we've seen over the patients beyond 4-year consistent effect.

到目前為止，我們在患者身上看到的效果超過 4 年。

Now in SMN2, 3, we have the studies running mechanistically, we believe correcting the SMN1 gene fundamentally is want you want to do here.

現在在 SMN2、3 中，我們有機械地運行研究，我們相信從根本上糾正 SMN1 基因是你想要在這裡做的。

And that's what we're trying to do with this and that should enable the speed of action and the hopeful clinical benefit that you want to see in SMA Type 2, 3. Now we need to show that, but then we believe gene therapy would become foundational in those patients as well.

這就是我們正在嘗試做的事情，這應該能夠加快行動速度，並帶來希望在 SMA 2 型和 3 型中看到的臨床益處。現在我們需要證明這一點，但我們相信基因療法會也成為這些患者的基礎。

I mean, we always have to remind ourselves here that this is an absolutely terrible disease.

我的意思是，我們必須始終在這裡提醒自己，這是一種絕對可怕的疾病。

You meet patients who have this disease, if you meet their patients, this is an absolutely devastating condition.

你遇到患有這種疾病的患者，如果你遇到他們的患者，這絕對是一種毀滅性的疾病。

So having benefits that are quick, saving what motor neurons are available still in the body, enabling function has a huge, huge impact.

因此，獲得快速的好處，節省體內仍然可用的運動神經元，啟用功能具有巨大的影響。

So when we look at this from a distance and start to say, "well, these things look all very similar.

所以當我們從遠處看這個並開始說，“好吧，這些東西看起來都很相似。

" Actually, these differences matter massively to the patients involved.

“實際上，這些差異對所涉及的患者非常重要。

And so I think that's what we believe will ultimately carry the day, with respect to onetime gene therapy for these patients.

因此，我認為這就是我們相信最終會取得成功的原因，即針對這些患者的一次性基因治療。

The question comes from the line of Keyur Parekh from Goldman Sachs.

這個問題來自高盛的Keyur Parekh。

I have 2 questions, please.

我有 2 個問題，請。

The first one, Paul or Vas, how would you categorize the recent pricing comments from J&J on kind of the inflammation market?

第一個，Paul 或 Vas，您如何對強生最近對炎症市場的定價評論進行分類？

And secondly, just more broadly on the pricing team.

其次，更廣泛地涉及定價團隊。

Kind of -- can you talk a bit about what are you seeing as it relates to kind of the IL-17 biomarket and kind of then on the migraine side, where obviously we saw headlines from Express yesterday choosing to leave off certain products of that category.

有點——你能談談你所看到的與 IL-17 生物市場和偏頭痛相關的東西嗎，顯然我們昨天看到 Express 的頭條新聞選擇放棄某些產品類別。

Just calling you to describe for us what you're seeing in that market.

只是打電話給您描述一下您在那個市場上看到的情況。

And then secondly, as I look at your early-stage clinical trials, it seems like you've got a bunch of assets now forward looking at NASH.

其次，當我看你們的早期臨床試驗時，你們現在似乎有很多資產可以展望 NASH。

How would you categorize your interest in that space?

您如何歸類您對該領域的興趣？

And then conversely, what's quite unique is not a lot of I/O assets on your early-stage clinical trial.

然後相反，非常獨特的是早期臨床試驗中沒有很多 I/O 資產。

Is that now a deprioritized area from your perspective?

從你的角度來看，那現在是一個被取消優先考慮的領域嗎？

Or are they just kind of further along?

還是他們只是走得更遠？

So with respect to pricing in IL-17 and CGRP, Paul, any comments you'd want to make?

那麼關於 IL-17 和 CGRP 的定價，保羅，你想發表什麼意見？

I'm not aware of any comments that have been made externally.

我不知道有任何外部評論。

I think just a couple of observations.

我想只是一些觀察。

We work very hard at affordability and to make sure that those that need the medicine get the medicine.

我們非常努力地提高負擔能力，並確保那些需要藥物的人得到藥物。

I think that's where our priority is, and I think we have been showing to be skillful in our work with payers and PBMs alike.

我認為這是我們的首要任務，我認為我們在與付款人和 PBM 等方面的合作中表現得非常熟練。

So I'd perhaps have nothing more to add than that.

所以我可能沒有什麼要補充的了。

Yes, on NASH, we have a lead compound called LJN452 tropifexor which is a FXR agonist synthetic, which we believe has a best-in-class profile.

是的，在 NASH 上，我們有一種名為 LJN452 tropifexor 的先導化合物，它是一種 FXR 激動劑合成物，我們認為它具有一流的特性。

We have completed 2 steps of the Phase IIb studies.

我們已經完成了 IIb 期研究的兩個步驟。

We're now in a final dose escalation.

我們現在正在進行最後的劑量遞增。

We believe because of the profile of the product, we can avoid pruritus, we can avoid LDL elevations and get the dose -- effective dose much higher than other established therapies.

我們相信，由於產品的特點，我們可以避免瘙癢，我們可以避免低密度脂蛋白升高，並獲得比其他既定療法高得多的有效劑量。

Given that we have that product, we've announced collaborations with a few external parties on combinations as well as our own deal with -- for amikacin from Conatus where you have a combination trial ongoing as well as rights to some of their compounds.

鑑於我們擁有該產品，我們已經宣布與一些外部方就組合以及我們自己的交易進行合作 - 對於來自 Conatus 的阿米卡星，您正在進行組合試驗以及對他們的一些化合物的權利。

We also have an alliance with Allergan to do a combination trial there.

我們還與 Allergan 結盟，在那裡進行聯合試驗。

Our belief is in having that lynchpin molecule for -- in having the FXR will enable us to hopefully combine with multiple other agents.

我們的信念是擁有關鍵分子 - 擁有 FXR 將使我們有希望與多種其他藥物結合。

We play a long game here.

我們在這裡玩了一場漫長的比賽。

We know there's many other companies in Phase III.

我們知道第三階段還有許多其他公司。

We think understanding the underlying biology and then having the real best-in-class agent is the way forward in NASH, so stay tuned as we get more results.

我們認為了解基礎生物學然後擁有真正一流的代理是 NASH 的前進方向，敬請期待我們獲得更多結果。

With respect to I/O, I wouldn't say there's a change in strategy.

關於 I/O，我不會說策略發生了變化。

What I'd say is, we, in observing the external environment have held I/Os or I/Os is to a very high standard.

我要說的是，我們在觀察外部環境時已經持有 I/O 或 I/O 是一個非常高的標準。

And we want to ensure that we see either single-agent activity or a situation where we're confident that the activity we see can be attributed to our I/O compound.

我們希望確保我們看到的是單一代理活動，或者是我們確信我們看到的活動可以歸因於我們的 I/O 化合物的情況。

I would note with, canakinumab, we have a pretty large Phase III I/O program that is validated based on studies and analysis of a 10,000-patient study published in The New England Journal of Medicine, where we're in adjuvant lung cancer first line and second line lung cancer.

我要指出的是，canakinumab，我們有一個相當大的 III 期 I/O 計劃，該計劃基於對發表在《新英格蘭醫學雜誌》上的 10,000 名患者的研究和分析進行了驗證，我們首先在輔助肺癌中進行研究一線和二線肺癌。

We of course, are also in part T-cell therapies.

當然，我們也參與了部分 T 細胞療法。

We continue our work across the full range of I/O assets that we brought in.

我們將繼續我們引入的所有 I/O 資產的工作。

I think by last count, we have either tied or leading number of I/O assets that are in the early-stage clinic.

我認為根據最後的統計，我們在早期臨床階段的 I/O 資產數量持平或領先。

But from my perspective, we want to hold them to a high bar.

但從我的角度來看，我們希望將它們保持在一個高標准上。

We want to really ensure we see single-agent activity.

我們想要真正確保我們看到單一代理活動。

And then in combination, really be sure that the additional agent is giving a benefit so that we're really creating value for patients and for the health care system.

然後結合起來，真正確保額外的代理人帶來好處，這樣我們才能真正為患者和醫療保健系統創造價值。

So I think that's the last question.

所以我認為這是最後一個問題。

I appreciate everyone joining the call, and of course, appreciate your interest.

感謝大家加入電話會議，當然也感謝您的關注。

And investing -- all of you who invest in our company, we appreciate your support.

投資——所有投資我們公司的人，我們感謝你們的支持。

So thank you again, and have a great day.

再次感謝你，祝你有美好的一天。

Thank you for joining today's call.

感謝您參加今天的電話會議。

You may now disconnect your handset.

您現在可以斷開聽筒。