Novartis AG (NVS) 2018 Q2 法說會逐字稿

Good morning, and good afternoon, and welcome to the Novartis Q2 2018 Results Release Conference Call and Live Audio Webcast.

早上好，下午好，歡迎來到諾華 2018 年第二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, and good afternoon, everybody.

謝謝，大家下午好。

And thank you for joining us for the Novartis Q2 earnings call.

感謝您加入我們的諾華第二季度財報電話會議。

Before we start, I just want to read the safe harbor statement.

在我們開始之前，我只想閱讀安全港聲明。

The information presented today contains forward-looking statements that involve known and unknown risks, uncertainties and other factors.

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。

These may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements.

這些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 us at the Securities and Exchange Commission for a description of some of these factors.

請參閱我們在美國證券交易委員會存檔的公司 20-F 表格，了解其中一些因素的說明。

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

然後，我將交給 Vas。

Thank you, Samir, and thanks, everyone, for joining today.

謝謝 Samir，也謝謝大家今天的加入。

With me today in Basel, I have Shannon Klinger, our Legal Counsel; Liz Barrett, our CEO of Novartis Oncology; Richard Francis, CEO of Sandoz; John Tsai, our new Head of Global Drug Development and Chief Medical Officer; Paul Hudson, CEO of Novartis Pharmaceuticals.

今天在巴塞爾，我有我們的法律顧問 Shannon Klinger； Liz Barrett，我們的 Novartis Oncology 首席執行官；山德士首席執行官理查德·弗朗西斯；我們新的全球藥物開發主管兼首席醫療官 John Tsai；諾華製藥公司首席執行官保羅哈德森。

We have Mike Ball, the Chairman-designate for Alcon.

我們有 Alcon 的候任主席 Mike Ball。

And I'm also proud to welcome David Endicott, the new CEO of Alcon; and Harry Kirsch, our CFO.

我也很自豪地歡迎愛爾康公司新任首席執行官大衛·恩迪科特 (David Endicott)；和我們的首席財務官 Harry Kirsch。

So what I'd like to do today is give you an overview of the results as well as some of the data and some of the other highlights we have for the quarter.

所以我今天想做的是向您概述結果以及我們本季度的一些數據和其他一些亮點。

I'll turn it over to Harry for a financial review and then we'll try to move quickly to Q&A.

我會將其轉交給 Harry 進行財務審查，然後我們將嘗試快速進行問答。

So moving to Slide 4. This quarter and really for the whole first half of this year, we were continuing our transformation into a focused medicines company.

轉到幻燈片 4。本季度乃至今年整個上半年，我們都在繼續轉型為一家專注於醫藥的公司。

When you go back to 2014, pre the transformation, we really had a mixed business, more of a health care conglomerate.

當你回到 2014 年，在轉型之前，我們確實擁有混合業務，更像是一家醫療保健集團。

And now with the actions we've taken over the first half of the year, we've really shifted the company post the proposed Alcon spinoff to a 100% medicines company.

現在，通過我們在今年上半年採取的行動，我們確實將擬議中的愛爾康分拆後的公司轉變為一家 100% 的醫藥公司。

When you look at it, we completed the divestment of the GSK OTC stake.

當你看的時候，我們完成了 GSK OTC 股權的剝離。

We proposed the 100% spinoff of Alcon.

我們提議 100% 剝離愛爾康。

We're prioritizing our therapeutic areas as well within Innovative Medicines, including a move out of infectious disease research.

我們正在優先考慮我們的治療領域以及創新藥物，包括退出傳染病研究。

And we've also made, I think, important strategic moves, completing the acquisition of AAA, completing the acquisition of AveXis and starting to bring in more platform therapies around gene therapy, like Luxturna.

我認為，我們還採取了重要的戰略舉措，完成了對 AAA 的收購，完成了對 AveXis 的收購，並開始引入更多圍繞基因治療的平台療法，比如 Luxturna。

So moving to Slide 5. In addition to the strategic progress we've made in the first half, I'm also pleased with our operational performance.

轉到幻燈片 5。除了我們在上半年取得的戰略進展外，我還對我們的運營表現感到滿意。

As you saw in the quarter, we had solid growth with operating leverage.

正如您在本季度看到的那樣，我們在運營槓桿方面實現了穩健增長。

Sales were up 5% and core operating income was up 7% in constant currencies.

按固定匯率計算，銷售額增長 5%，核心營業收入增長 7%。

You can see strong performance across Innovative Medicines and Alcon.

您可以看到 Innovative Medicines 和 Alcon 的強勁表現。

And Sandoz was a mixed story, with strong performance outside the U.S. and a continued challenging environment in the U.S.

Sandoz 的情況好壞參半，在美國以外的市場表現強勁，而美國的環境依然充滿挑戰。

So moving to Slide 6. In Innovative Medicines, we had very good performance across our key growth brands.

轉到幻燈片 6。在創新藥物方面，我們在主要增長品牌中表現非常出色。

Cosentyx came in at $701 million and Entresto at $239 million.

Cosentyx 的收入為 7.01 億美元，Entresto 的收入為 2.39 億美元。

And in the subsequent slides, I'll walk through some of the key highlights for many of these brands.

在隨後的幻燈片中，我將介紹其中許多品牌的一些主要亮點。

But taken together, you can see that we're delivering on our recent launches as well as our key growth drivers across the portfolio.

但總的來說，您可以看到我們正在兌現我們最近推出的產品以及我們整個產品組合的主要增長動力。

So moving to Slide 7. Cosentyx, our leading IL-17A inhibitor, showed strong growth in Q2 with plus 40% in constant currencies.

轉到幻燈片 7。我們領先的 IL-17A 抑製劑 Cosentyx 在第二季度表現出強勁增長，按固定匯率計算增長了 40%。

When you look at the real drivers of that performance, it's been driven by demand and enhanced access.

當您查看該性能的真正驅動因素時，它是由需求和增強的訪問驅動的。

Paul can comment more about it in the Q&A, but in particular, TRx growth was up 81% versus prior year.

Paul 可以在問答中對此發表更多評論，但特別是，TRx 增長比上一年增長了 81%。

I also think we're seeing now that the, what we've described in the past that within psoriasis, you're seeing a bifurcation of the market into the IL-17A inhibitors and the IL-12/23.

我還認為我們現在看到的是，我們過去在銀屑病中所描述的，你看到市場分為 IL-17A 抑製劑和 IL-12/23。

And we are the leading IL-17A inhibitor.

我們是領先的 IL-17A 抑製劑。

And we're seeing continued growth in rheumatology, where recent clinical data, I think, has only further solidified that IL-17A is the mechanism of choice in ankylosing spondylitis and therefore, enabling us to grow in the medium to long term in rheumatology.

我們看到風濕病學的持續增長，我認為最近的臨床數據進一步證實了 IL-17A 是強直性脊柱炎的首選機制，因此，使我們能夠在風濕病學中長期發展。

So moving to Slide 8. Entresto, which, of course, is the standard of care now in heart failure, saw sales more than double in the second quarter to $239 million.

所以轉到幻燈片 8。 Entresto，當然，現在是治療心力衰竭的標準藥物，第二季度的銷售額增長了一倍以上，達到 2.39 億美元。

Underlying demand remained strong in the U.S. But we also had solid ex U.S. sales and are continuing to see important access decisions around the world in places like China as well as in Europe.

美國的潛在需求依然強勁，但我們在美國以外的銷售也很強勁，並且繼續在中國和歐洲等地看到世界各地的重要准入決定。

And the news flow supporting Entresto's momentum is really ramping up now, with CHAMP-HF showing improvements in quality of life.

支持 Entresto 勢頭的新聞流現在確實在增加，CHAMP-HF 顯示生活質量有所改善。

And we know the quality-of-life story is very important to physicians and Entresto patients.

我們知道生活質量故事對醫生和 Entresto 患者非常重要。

We will have the PARAGON interim analysis in Q3 with the completion of the trial in 2019.

隨著 2019 年試驗的完成，我們將在第三季度進行 PARAGON 中期分析。

And we'll have a number of Phase IV studies reading out over the course of the coming quarters to further create news flow and support the overall profile of Entresto.

我們將在接下來的幾個季度中朗讀一些 IV 期研究，以進一步創造新聞流並支持 Entresto 的整體形象。

So moving to Slide 9. We also had an important launch in the quarter with Aimovig, our first-in-class migraine prevention drug, with our partners at Amgen.

因此轉到幻燈片 9。我們還在本季度與我們在 Amgen 的合作夥伴一起推出了我們一流的偏頭痛預防藥物 Aimovig 的重要發布。

And it's off to a strong start in the U.S. We really see unprecedented demand for this product, which really reflects the strong unmet need for migraine patients for a better preventative therapy.

它在美國開局良好。我們確實看到了對該產品前所未有的需求，這確實反映了偏頭痛患者對更好的預防性治療的強烈未滿足需求。

And we believe this bodes well for Europe.

我們相信這對歐洲來說是個好兆頭。

Paul can answer more detailed questions on how the launch is going, but you did see we had the CHMP positive opinion in May with an approval expected in Q3.

Paul 可以回答有關發布進展情況的更詳細問題，但您確實看到我們在 5 月份收到了 CHMP 的積極意見，預計在第三季度獲得批准。

And importantly, we had an Australia registration in July, and we've already received approval as well as Switzerland.

重要的是，我們在 7 月份進行了澳大利亞註冊，我們已經獲得了瑞士的批准。

So globally as well, Aimovig is starting to ramp up.

因此，在全球範圍內，Aimovig 也開始加速發展。

Now moving to Slide 10.

現在轉到幻燈片 10。

In Oncology, we saw continued growth with our growth drivers Promacta/Revolade, Mekinist and Tafinlar and Jakavi.

在腫瘤學方面，我們看到了我們的增長動力 Promacta/Revolade、Mekinist 和 Tafinlar 以及 Jakavi 的持續增長。

This is consistent with what we've seen in prior quarters.

這與我們在前幾個季度看到的情況一致。

In particular, we received FDA approval in adjuvant melanoma for Taf/Mek, which we think will be important for us to continue to drive this brand, particularly given the competition that, of course, has come up in the class.

特別是，我們獲得了 FDA 批准用於 Taf / Mek 輔助黑色素瘤，我們認為這對我們繼續推動這個品牌很重要，特別是考慮到競爭當然已經出現在課堂上。

We think treating patients earlier in the adjuvant setting will enable us to continue to drive Mekinist and Tafinlar.

我們認為在輔助環境中更早地治療患者將使我們能夠繼續推動 Mekinist 和 Tafinlar。

We also have a triplet study that will read out next year with our PDR001 anti-PD-1 antibody.

我們還有一項三重研究，明年將使用我們的 PDR001 抗 PD-1 抗體進行宣讀。

So taken together, these brands are doing well.

所以綜合來看，這些品牌表現不錯。

And I think Liz and the team are doing a great job driving these around the world.

而且我認為 Liz 和團隊在推動全球範圍內的這些方面做得很好。

On Slide 11, you see an update on our Oncology launches.

在幻燈片 11 上，您會看到我們腫瘤學發布的更新。

In Kisqali, we have now launched in many countries across Europe and are starting to see some momentum build outside the United States.

在 Kisqali，我們現在已經在歐洲許多國家推出，並開始看到美國以外的一些勢頭。

In the U.S., we're refining our messages and continuing to work on how best to position Kisqali.

在美國，我們正在完善我們的信息並繼續研究如何最好地定位 Kisqali。

And I think a real key moment for us will be the approval of MONALEESA-3 and MONALEESA-7 data, which will enable us to have a full label for physicians to then fully consider Kisqali's benefits and overall profile.

我認為對我們來說真正的關鍵時刻將是 MONALEESA-3 和 MONALEESA-7 數據的批准，這將使我們能夠為醫生提供完整的標籤，然後充分考慮 Kisqali 的益處和整體概況。

And that will enable us to really fully understand the trajectory of the medicine into the future.

這將使我們能夠真正充分了解醫學在未來的發展軌跡。

Now with Kymriah, we had Q2 sales of $16 million.

現在有了 Kymriah，我們第二季度的銷售額為 1600 萬美元。

The pediatric ALL launch is going well.

兒科 ALL 的推出進展順利。

We received FDA approval in DLBCL as well as positive opinions on CHMP in both indications.

我們在 DLBCL 中獲得了 FDA 批准，並在這兩個適應症中獲得了對 CHMP 的積極意見。

I'd say it's early days and we've always said this is going to be a 5-year journey with Kymriah to really get it to be the globally successful brand we want it to be.

我想說現在還為時尚早，我們一直說這將是與 Kymriah 的 5 年旅程，以真正讓它成為我們希望它成為的全球成功品牌。

On manufacturing, we have seen some variability in our product specifications.

在製造方面，我們發現產品規格存在一些差異。

This is something we're looking at now in DLBCL to make sure that we can continue to ramp up the demand.

這是我們現在正在 DLBCL 中尋找的東西，以確保我們能夠繼續增加需求。

But we feel confident in the overall longer-term outlook for Kymriah.

但我們對 Kymriah 的整體長期前景充滿信心。

Now with respect to Lutathera.

現在關於 Lutathera。

This is a brand we're very excited about.

這是一個讓我們非常興奮的品牌。

We've seen very strong performance in the United States, both for the Netspot diagnostic as well as for the Lutathera therapeutic.

我們在美國看到了非常強勁的表現，無論是 Netspot 診斷還是 Lutathera 治療。

It's certainly exceeding our expectations.

這肯定超出了我們的預期。

We're seeing a very fast ramp.

我們看到一個非常快的斜坡。

And so that's something we'll keep an eye on and continue to keep you updated on.

因此，我們會密切關注這一點，並繼續讓您了解最新情況。

But I think it's already showing the AAA acquisition is starting to reap benefits for our Oncology portfolio.

但我認為這已經表明 AAA 收購開始為我們的腫瘤產品組合帶來好處。

And we look forward to bringing forward additional radionuclide therapies using the same platform in the future.

我們期待在未來使用同一平台推出更多的放射性核素療法。

Now moving to Slide 12.

現在轉到幻燈片 12。

Both Sandoz and Alcon continued in line with their recent trends.

Sandoz 和 Alcon 繼續保持其最近的趨勢。

As I mentioned, Sandoz net sales were down 2%, primarily impacted by U.S. price erosion.

正如我所提到的，Sandoz 的淨銷售額下降了 2%，主要受美國價格下跌的影響。

Ex U.S. sales grew 5% in constant currencies.

按固定匯率計算，除美國以外的銷售額增長了 5%。

And importantly, our global Biopharmaceutical sales continued their momentum.

重要的是，我們的全球生物製藥銷售繼續保持增長勢頭。

We're continuing to work through some of the regulatory setbacks we had in the U.S. But overall, we feel like our Biopharmaceuticals momentum is where it needs to be, particularly given the high interest of U.S. policymakers in biosimilars.

我們正在繼續努力克服我們在美國遇到的一些監管挫折。但總的來說，我們認為我們的生物製藥勢頭正處於需要的位置，特別是考慮到美國決策者對生物仿製藥的高度興趣。

In Alcon, we continued our strong growth momentum, with net sales up 5% and core operating income up 14%.

在愛爾康，我們繼續保持強勁的增長勢頭，淨銷售額增長 5%，核心營業收入增長 14%。

Mike, David and the team are doing a great job continuing to drive very strong growth in Surgical as well as to manage in Vision Care as we wait for our next wave of Vision Care innovations to kick in.

Mike、David 和團隊在繼續推動外科領域的強勁增長以及管理視力保健方面做得非常出色，因為我們正在等待下一波視力保健創新浪潮的到來。

Now moving to Slide 13.

現在轉到幻燈片 13。

We're advancing our pipeline of potential blockbuster launches.

我們正在推進我們的潛在重磅發布管道。

And we've already made good progress in 2018, advancing the 3 medicines that you see listed.

我們在 2018 年已經取得了良好的進展，推進了您看到的 3 種藥物上市。

And we're preparing now for up to 10 additional blockbuster launches over the coming 2 years.

我們現在正準備在未來 2 年內推出多達 10 部重磅炸彈。

We were very pleased by the external recognition from Evaluate Pharma, which really, as you know, aggregates across a range of different forecasts.

我們對 Evaluate Pharma 的外部認可感到非常高興，正如您所知，它確實匯總了一系列不同的預測。

And in that evaluation, we were the #1 company in value creation between 2018 and 2024 with our existing pipeline, as well as #1 in value creation from advanced therapies with AVXS as well as Kymriah.

在該評估中，我們在 2018 年至 2024 年期間憑藉我們現有的管道在價值創造方面排名第一，在 AVXS 和 Kymriah 先進療法的價值創造方面排名第一。

So we feel like the pipeline is where it needs to be and we're really preparing now to launch these medicines well.

所以我們覺得管道就在它需要的地方，我們現在真的在準備好推出這些藥物。

Moving to Slide 14.

轉到幻燈片 14。

Two projects that I wanted to highlight are BAF and AVXS.

我想強調的兩個項目是 BAF 和 AVXS。

BAF312, siponimod, is the first and only drug that's shown to reduce disability progression in a true SPMS population, as you all know, in the EXPAND study.

正如眾所周知，在 EXPAND 研究中，BAF312 siponimod 是第一個也是唯一一個在真正的 SPMS 人群中被證明可以減少殘疾進展的藥物。

We have done quite a bit of work to really explain to regulators as well as to the physician community that this impact was independent of relapses.

我們已經做了很多工作來真正向監管機構和醫生社區解釋這種影響與復發無關。

So when you look at the left-hand side of this chart, you can see some of the analyses that we've done, which consistently show independent of relapse that you have an effect on disability progression in these patients.

因此，當您查看此圖表的左側時，您可以看到我們所做的一些分析，這些分析始終表明，與復發無關，您對這些患者的殘疾進展有影響。

And then on the right-hand side, the other element of our discussions has been really showing the quality-of-life benefit.

然後在右側，我們討論的另一個要素確實顯示了生活質量的好處。

This is cognitive processing speed, a data we recently presented.

這是認知處理速度，我們最近提供的數據。

And you can see over time, clear improvements in patients treated with siponimod versus those receiving placebo.

隨著時間的推移，您可以看到接受辛尼莫德治療的患者與接受安慰劑的患者相比有明顯改善。

Importantly, the SPMS submission was completed in Q2 2018.

重要的是，SPMS 提交於 2018 年第二季度完成。

We are awaiting file acceptance.

我們正在等待文件接受。

We did confirm earlier today that we have used our prior -- one of our priority review vouchers with BAF.

我們今天早些時候確實確認我們已經使用了我們之前的 - 我們的 BAF 優先審查憑證之一。

And we anticipate, assuming regulatory approval that happen on time in early 2019 in the U.S. And also post our discussions with the European regulators, we will move forward with an SPMS submission in Europe, which we expect to make in Q3 2018 with a potential approval in Q4 2019.

我們預計，假設 2019 年初在美國按時獲得監管批准，並發布我們與歐洲監管機構的討論，我們將在歐洲推進 SPMS 提交，我們預計將在 2018 年第三季度提交並獲得潛在批准2019 年第四季度。

So moving to Slide 15 and AVXS-101, our breakthrough therapy for patients with pediatric SMA Type 1. We can now confirm our U.S. regulatory submission in half 2 2018.

現在轉到幻燈片 15 和 AVXS-101，這是我們針對 1 型兒科 SMA 患者的突破性療法。我們現在可以確認我們在 2018 年下半年提交的美國監管申請。

And earlier today, I put a little bit more clarity on that to Q3 2018.

今天早些時候，我對 2018 年第三季度的情況做了更明確的說明。

We have a discussion with FDA, a pre-BLA meeting in which we confirmed the commercial product as comparable to the product used in the Phase I trial.

我們與 FDA 進行了討論，這是一次 BLA 前會議，我們在會上確認商業產品與 I 期試驗中使用的產品具有可比性。

In addition, that our Phase I trial data is sufficient to form the basis of the SBLA -- the BLA submission and we'll also provide clinical data from this Phase III STR1VE data as part of the submission during the submission.

此外，我們的 I 期試驗數據足以構成 SBLA 的基礎——BLA 提交，我們還將在提交期間提供來自該 III 期 STR1VE 數據的臨床數據作為提交的一部分。

And overall, this integrated review of the safety findings was supportive of moving ahead with the filing.

總的來說，這種對安全調查結果的綜合審查支持推進備案。

So this is very positive news and enables us now to advance this towards submission.

所以這是一個非常積極的消息，使我們現在能夠將其推進到提交。

Another important element that happened in HHS policy circle is newborn screening for SMA is now officially recognized by the U.S. and HHS for inclusion in the recommended screening panels at the state level.

HHS 政策圈發生的另一個重要因素是新生兒 SMA 篩查現在得到美國和 HHS 的正式認可，被列入州級推薦的篩查小組。

And I'll explain a little bit more why that's an important part of the longer-term story for AVXS-101 in a moment.

稍後我將解釋為什麼這是 AVXS-101 長期故事的重要組成部分。

But first, on Slide 16, I wanted to just go through some of the data, just to clarify, given the other data that's out in the marketplace.

但首先，在幻燈片 16 上，我只想瀏覽一些數據，只是為了澄清，考慮到市場上的其他數據。

We really believe the data we have now confirm AVXS-101 could be the foundational gene replacement therapy for SMA Type 1, because it has rapid onset, sustained efficacy and that you see those effects regardless of the severity of treatment.

我們真的相信我們現在確認的數據 AVXS-101可能是 1 型 SMA 的基礎基因替代療法，因為它起效快，療效持久，而且無論治療的嚴重程度如何，您都能看到這些效果。

This is the Phase I study.

這是第一階段的研究。

You can see on the left-hand side of the chart that shortly after the infusion of AVXS-101, you can see rapid increases in the CHOP INTEND score, which is the measure that is used now across trials for this disease.

您可以在圖表的左側看到，在輸注 AVXS-101 後不久，您可以看到 CHOP INTEND 評分迅速增加，這是目前在該疾病的試驗中使用的衡量標準。

You can also see that the scores for the CHOP INTEND get into the 50, 60 range.

您還可以看到 CHOP INTEND 的分數進入 50、60 範圍。

A perfect score is 64 on this test.

該測試的滿分是 64 分。

And you can also see the dashed line on the chart, which is, at least to our eyes, given all the caveats of cross-trial comparisons, where we've seen the oral therapies typically enable children to get to.

你還可以看到圖表上的虛線，至少在我們看來，考慮到交叉試驗比較的所有警告，我們已經看到口服療法通常可以讓兒童到達那裡。

So you can see a highly efficacious therapy at a single infusion that can be given to patients with really profound results.

因此，您可以在一次輸液中看到一種非常有效的療法，可以給患者帶來真正深遠的效果。

Importantly as well is we've really focused on some of the specific quality-of-life benefits.

同樣重要的是，我們真正關注了一些特定的生活質量福利。

When you think about the ability to swallow, only 4 of 12 patients were able to swallow safely in this study.

當您考慮吞嚥能力時，在這項研究中，12 名患者中只有 4 名能夠安全吞嚥。

And 11 of 12 now are swallowing safely for oral feeding at month 24.

現在，12 名嬰兒中有 11 名在 24 個月時可以安全吞嚥以進行經口餵養。

And we continue to see improvements in these children as well over time.

隨著時間的推移，我們繼續看到這些孩子的進步。

So very striking data from AVXS-101.

來自 AVXS-101 的非常驚人的數據。

We're not stopping with this study, of course.

當然，我們不會停止這項研究。

On Slide 17, you can see that we are expanding across, first, SMA Type 1. The START study already has 12 patients enrolled.

在幻燈片 17 上，您可以看到我們首先擴展到 1 型 SMA。START 研究已經有 12 名患者入組。

This is the confirmatory study in Type 1 SMA.

這是 1 型 SMA 的驗證性研究。

The STR1VE study has been initiated.

STR1VE 研究已經啟動。

This is a single IV dose and patient enrollment is complete.

這是單次 IV 劑量，患者登記已完成。

You can also see that we are -- have initiated now the STR1VE EU study, which will form the basis of our EU filing.

您還可以看到，我們現在已經啟動了 STR1VE 歐盟研究，這將構成我們提交歐盟文件的基礎。

We're moving into SMA Type 2. We've started in Q1 2018 the SMA Type 2 with intrathecal dosing.

我們正在進入 2 型 SMA。我們已於 2018 年第一季度開始使用鞘內給藥的 2 型 SMA。

And then as I mentioned earlier, the importance of newborn screening, we are also now advancing the study in presymptomatic SMA.

然後正如我之前提到的，新生兒篩查的重要性，我們現在也在推進症狀前 SMA 的研究。

So these are children identified in newborn screening, genetically identified of having SMA, who then can be treated with gene therapy and at least potentially, could have a life in which they never even know that they have SMA, which would then really enable us to potentially eliminate a disease.

因此，這些兒童在新生兒篩查中被識別出來，從基因上被識別出患有 SMA，然後他們可以接受基因治療，至少有可能，他們可能會過上一種他們甚至不知道自己患有 SMA 的生活，這將真正使我們能夠可能消除一種疾病。

And that's something we're working towards as well.

這也是我們正在努力的方向。

And that trial was initiated in Q2.

該試驗是在第二季度啟動的。

So taken together on Slide 18, AVXS-101 is ready for launch in 2019.

因此，在幻燈片 18 中，AVXS-101 已準備好在 2019 年推出。

We're on track from a regulatory standpoint, EU submission in '19.

從監管的角度來看，我們正在走上正軌，歐盟在 19 年提交了文件。

And we also have Japan pre-submission in Q3 2018.

我們還在 2018 年第三季度進行了日本預提交。

I would highlight in the U.S., that we have orphan designation; we have Breakthrough Therapy designation; in EU, we have PRIME designation; and in Japan, we have Sakigake designation, all showing how advanced and remarkable this therapy is.

我要強調的是，在美國，我們有孤兒稱號；我們有突破性療法稱號；在歐盟，我們擁有 PRIME 稱號；在日本，我們有Sakigake的稱號，都顯示了這種療法的先進性和卓越性。

Clinical readouts are along the lines I just said.

臨床讀數與我剛才所說的一致。

And importantly, our manufacturing scaleup, our commercial scaleup, is already underway in the facility in Chicago.

重要的是，我們的製造規模，我們的商業規模，已經在芝加哥的工廠進行。

And we've now started work on a 170,000-square-foot facility in Durham, North Carolina, which would be fully operational in 2020.

我們現在已經開始在北卡羅來納州達勒姆建設一個 170,000 平方英尺的設施，該設施將於 2020 年全面投入運營。

So with that, I'll hand it over to Harry.

因此，我將把它交給哈利。

Yes, thank you, Vas.

是的，謝謝你，瓦斯。

Good morning, and good afternoon, everyone.

大家早上好，下午好。

So let's start on the financials on Slide #20.

因此，讓我們從幻燈片 #20 的財務數據開始。

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

和往常一樣，除非另有說明，否則我的評論指的是固定匯率的增長率。

So as Vas mentioned, we delivered solid performance in the second quarter, with net sales of $13.2 billion, growing 5% in constant currency, driven by Cosentyx, Entresto, Oncology and Alcon.

正如 Vas 提到的那樣，在 Cosentyx、Entresto、Oncology 和 Alcon 的推動下，我們在第二季度取得了穩健的業績，淨銷售額為 132 億美元，按固定匯率計算增長了 5%。

Core operating income was $3.5 billion, growing 7%, with margin improvement as higher sales and improved gross margin more than offset growth investments.

核心營業收入為 35 億美元，增長 7%，利潤率有所提高，因為銷售額的增加和毛利率的提高抵消了增長投資的影響。

Free cash flow grew 10% in U.S. dollars to $3.6 billion, driven by strong operating results.

在強勁的經營業績的推動下，以美元計算的自由現金流增長了 10%，達到 36 億美元。

Now the net income number you see here obviously benefited from the sale of our stake in the GSK OTC joint venture.

現在你在這裡看到的淨收入數字顯然受益於我們出售 GSK OTC 合資企業的股份。

We recognized a $5.7 billion net gain on completion of this transaction, increasing the group net income to $7.8 billion this quarter.

我們在完成此項交易後確認了 57 億美元的淨收益，使本季度集團淨收入增加到 78 億美元。

Slide 21 shows quarter 2 2018 core EPS of $1.29, growing 4%.

幻燈片 21 顯示 2018 年第二季度核心每股收益為 1.29 美元，增長 4%。

I just want to highlight here again that from the 1st of April 2018, we stopped recognizing core net income from the OTC joint venture and associated companies.

我只想在這裡再次強調，從 2018 年 4 月 1 日起，我們停止確認 OTC 合資企業和聯營公司的核心淨收入。

As you can see from the slide, in quarter 2 2017, OTC joint venture core net income contributed $0.04 to core EPS.

從幻燈片中可以看出，2017 年第二季度，場外交易合資企業核心淨收入為核心每股收益貢獻了 0.04 美元。

So if you would take out the OTC joint venture core net income from Q2 last year, Q2 this year, core EPS would have grown about 7% in constant currency and 9% in U.S. dollars, so very much in line with the core operating income growth.

因此，如果你將去年第二季度的 OTC 合資企業核心淨收入剔除，今年第二季度，核心每股收益按固定匯率計算將增長約 7%，按美元計算將增長 9%，這與核心營業收入非常吻合生長。

On Slide 22, we see the quarter 2 core margins of the group in each of the divisions.

在幻燈片 22 上，我們看到了該集團在每個部門的第二季度核心利潤率。

Overall, the group core operating margin was 26.9% in quarter 2, which is up 0.5 point in constant currency versus prior year.

總體而言，第二季度集團核心營業利潤率為 26.9%，按固定匯率計算較上年同期上升 0.5 個百分點。

This was driven by the strong performance of the Innovative Medicines division and Alcon.

這是由創新藥物部門和愛爾康的強勁表現推動的。

The Innovative Medicines division core margin increased to 32.2% of sales.

創新藥物部門的核心利潤率增至銷售額的 32.2%。

This is mainly driven by continued uptake of Cosentyx and Entresto as well as manufacturing productivity gains.

這主要是由於 Cosentyx 和 Entresto 的持續採用以及製造業生產率的提高。

On Slide 23, just want to reconfirm our full year group guidance.

在幻燈片 23 上，只想再次確認我們的全年小組指導。

Group sales are expected to grow low to mid-single digit.

集團銷售額預計將增長到中低個位數。

Of course, now assuming continued good momentum, including the launches, growth could be -- sales growth could be at the upper end of the range for the full year.

當然，現在假設持續良好的勢頭，包括發布，增長可能是 - 銷售增長可能處於全年範圍的上限。

Group core operating income is expected to grow mid- to high single digit, driven by the sales performance and productivity programs, partly offset by growth investments and the AveXis development efforts.

在銷售業績和生產力計劃的推動下，預計集團核心營業收入將增長中高個位數，部分被增長投資和 AveXis 開發工作所抵消。

Now by division, we reconfirm the Innovative Medicines guidance of mid-single-digit growth.

現在按部門劃分，我們再次確認中個位數增長的創新藥物指導。

For Sandoz, reflecting the first half year performance, the sales guidance was revised downwards to low single-digit decline.

對於 Sandoz，反映了上半年的業績，銷售指引被下調至較低的個位數跌幅。

And we are revising Alcon guidance upwards to mid-single-digit growth, again following strong sales growth in the first half.

在上半年強勁的銷售增長之後，我們再次將愛爾康的業績預期上調至中個位數增長。

And with that, I turn it back to Vas.

然後，我把它轉回 Vas。

Great.

偉大的。

Thank you, Harry.

謝謝你，哈利。

So moving to Slide 25.

所以轉到幻燈片 25。

Just in conclusion, we're continuing our transformation to a focused medicines company, and we're pleased with the progress we're making on that front.

總之，我們正在繼續向一家專注於醫藥的公司轉型，我們對我們在這方面取得的進展感到滿意。

We delivered a solid operational performance in the quarter, advanced our pipeline, including our potential blockbuster launches.

我們在本季度提供了穩健的運營業績，推進了我們的管道，包括我們潛在的重磅炸彈發布。

And as Harry just mentioned, we are on track for our full year guidance.

正如 Harry 剛才提到的，我們正在按計劃實現全年指導。

So what that, I think we can open the line for questions.

那麼，我認為我們可以打開問題熱線。

So operator?

那麼運營商？

(Operator Instructions) The first question is from the line of Jo Walton from Crédit Suisse.

（操作員說明）第一個問題來自 Crédit Suisse 的 Jo Walton。

I've got 3 quick ones, please.

我有 3 個快速的，拜託。

You mentioned with Kymriah that you were having some issues with product specification.

你和 Kymriah 提到你在產品規格方面遇到了一些問題。

Could you just tell us what in practice that means?

你能告訴我們這在實踐中意味著什麼嗎？

Does it mean that your people are asking you to produce product, but you are saying, "No, we can't at the moment until we understand what the situation"?

這是否意味著您的員工要求您生產產品，但您說“不，我們現在不能，直到我們了解情況”？

So effectively, this is actually delaying the growth of Kymriah.

如此有效，這實際上延遲了 Kymriah 的成長。

Secondly, on Cosentyx, I wonder if you could just tell us a little bit more about any patient assistance programs that you're effectively through, not needing, a little bit more on the access side of things there, because we're still seeing that your sales growth is materially less than your prescription growth, so there does still seem to be some effective price decline there.

其次，在 Cosentyx 上，我想知道你是否可以告訴我們更多關於你有效地通過的任何患者援助計劃，而不是需要更多關於那裡事情的訪問方面的信息，因為我們仍然看到您的銷售增長大大低於處方增長，因此那裡似乎仍然存在一些有效價格下降。

And finally, I wonder if you could just tell us a little bit more about how we should be thinking about the recent Gilenya IPR patent decision.

最後，我想知道你是否可以告訴我們更多關於我們應該如何考慮最近的 Gilenya IPR 專利決定。

Effectively, on the face of it, that suggests that, that product could have a much, much longer patent.

實際上，從表面上看，這表明該產品可以擁有更長、更長的專利。

But of course, formulation patents aren't as strong.

但當然，配方專利並不那麼強大。

So if you could just guide us as to how we should be thinking about that, please.

所以，如果你能指導我們應該如何考慮這個問題，請多多指教。

So thank you for the questions on Kymriah.

感謝您提出有關 Kymriah 的問題。

I'll hand it to Liz.

我會把它交給LZ。

Thanks for the question.

謝謝你的問題。

I think the most important thing to let you know is that the variability that we've seen in the commercial specifications, which isn't unusual with a new therapy as you launch into a new target patient population, is that we have still been able to deliver final product to the majority of patients.

我認為讓您知道的最重要的事情是我們在商業規格中看到的可變性，當您向新的目標患者群體推出新療法時，這並不罕見，我們仍然能夠將最終產品交付給廣大患者。

It's really more of a specification.

它實際上更像是一個規範。

And we're working directly with the FDA on trying to solve the issue as well as looking at new ways to improve our output to meet more commercial specification on Kymriah.

我們正在與 FDA 直接合作，試圖解決這個問題，並尋找新的方法來提高我們的產量以滿足 Kymriah 的更多商業規範。

So I think the most important thing to us is that we're able to deliver the therapy to the patients who need them.

所以我認為對我們來說最重要的是我們能夠為需要的患者提供治療。

Thank you, Liz.

謝謝你，麗茲。

On Cosentyx, Paul?

在 Cosentyx 上，保羅？

Thanks, Jo, for the Cosentyx question.

喬，謝謝 Cosentyx 的問題。

Nothing new on patient access.

患者訪問沒有什麼新鮮事。

We continue to run at a sort of low rate in terms of those that get it.

就那些獲得它的人而言，我們繼續以一種低利率運行。

You probably noticed our value per TRx improved actually in Q2 over Q1 and was closer to what we had in Q4.

您可能注意到我們在第二季度的每 TRx 價值實際上比第一季度有所提高，並且更接近我們在第四季度的價值。

With pricing stable and rebates stable, we hope that will be maintained through the rest of the year.

隨著價格穩定和回扣穩定，我們希望在今年餘下的時間裡保持這種狀態。

The comment about volume or TRx growth and the dollar.

關於交易量或 TRx 增長和美元的評論。

So for the quarter, we were 33% up in dollars versus the same period last year, but 65% up in TRx, if you normalize the removal of the free drug programs that we had in last year.

因此，對於本季度，我們的美元與去年同期相比增長了 33%，但 TRx 增長了 65%，如果你將取消我們去年的免費藥物計劃正常化的話。

It's exactly where we expected to be.

這正是我們預期的地方。

We're very pleased with where we are as we go through Q2.

我們對第二季度的現狀感到非常滿意。

Remember, the enhanced position we took in the first-line setting in Q1 plays out throughout the whole of the year.

請記住，我們在第一季度在一線設置中的增強地位貫穿全年。

So you make an adjustment in Q1.

所以你在第一季度做出調整。

You know this, I think, already.

我想你已經知道了。

But then you gather momentum on volume.

但是隨後您會在交易量上獲得動力。

So we're exactly where we said we would be.

所以我們正是我們說的那樣。

I'm looking forward to the remainder of the year.

我很期待今年剩下的時間。

And I think it's probably worth reiterating that we're very committed to delivering on consensus, which we feel is, particularly after Q2, is well within reach.

而且我認為可能值得重申的是，我們非常致力於達成共識，我們認為，特別是在第二季度之後，這是可以實現的。

Great.

偉大的。

Thank you, Paul.

謝謝你，保羅。

And on Gilenya, the guidance we've given is that the composition of matter patent goes off in Q3 of next year, as you all are well aware.

在 Gilenya 上，我們給出的指導是，物質專利的組成將在明年第三季度結束，你們都知道。

The dosing patent that was recently held up in the IPR process goes off in 2027.

最近在 IPR 過程中擱置的劑量專利將於 2027 年到期。

We believe strongly to defend our IP.

我們堅信捍衛我們的知識產權。

And we have taken action to defend our IP against the generic companies that intend or have at least stated they intend to launch versus Gilenya next year.

我們已經採取行動來保護我們的知識產權免受那些打算或至少表示他們打算明年推出 Gilenya 的仿製藥公司的侵害。

And that's as much as we can say on this topic at this moment in time.

這就是我們此刻就此主題所能說的全部內容。

I think we could realistically provide more updates mid-next year.

我認為我們實際上可以在明年年中提供更多更新。

But until that point in time, this is what we know.

但直到那個時間點，這就是我們所知道的。

And all I can say is we are vigorously defending our patents that have been now upheld at the IPR.

我能說的是，我們正在大力捍衛我們現在在 IPR 得到維護的專利。

The next question is from the line of Richard Vosser from JPMorgan.

下一個問題來自摩根大通的 Richard Vosser。

Three, please.

三，請。

Firstly, on Gleevec, could you talk about the trends you're seeing rest of world and how we should think about the growth in emerging markets and the potential declines in the EU?

首先，關於格列衛，您能否談談您看到的世界其他地區的趨勢以及我們應該如何考慮新興市場的增長和歐盟的潛在衰退？

What are the relative magnitudes of the movements in those 2 discrete geographies?

這兩個獨立的地理區域的相對幅度是多少？

Second question on Afinitor, some -- a pretty much substantial pickup in Afinitor for 2 quarters in the U.S. Perhaps you could talk about where the growth is coming from and how sustainable it is?

關於 Afinitor 的第二個問題，一些 - Afinitor 在美國的兩個季度有相當大的回升。也許你可以談談增長的來源以及它的可持續性？

And then finally, one question on Alcon, obviously very strong implantables growth.

最後，關於愛爾康的一個問題，植入式產品的增長顯然非常強勁。

Perhaps you could give us some more detail on the breakdown of the contribution from CyPass and normal IOLs and AT-IOLs to the growth of implantables?

或許您可以向我們提供更多關於 CyPass 和普通 IOL 以及 AT-IOL 對植入物增長的貢獻的詳細信息？

Thanks, Richard.

謝謝，理查德。

I'll hand it to Liz for Gleevec and Afinitor.

我會把它交給 Liz 以獲得 Gleevec 和 Afinitor。

Yes, on Gleevec, I think the way to think about it is that in the U.S. and Europe, we are continuing to see declines as you would expect to see in both of those markets.

是的，關於格列衛，我認為考慮它的方式是在美國和歐洲，我們將繼續看到您在這兩個市場中所期望看到的下降。

And we are seeing growth, as you state, in a lot of our emerging markets.

正如您所說，我們在許多新興市場都看到了增長。

And at the same time, the -- it's good to know that China, we received approval for reimbursement of Gleevec in China.

與此同時，很高興知道中國，我們在中國獲得了格列衛報銷的批准。

So we're seeing some growth of Gleevec there.

所以我們在那裡看到了格列衛的一些增長。

So I think that's all I can really say on what we expect to see on the growth of Gleevec or how we expect Gleevec to play out.

所以我認為這就是我真正能說的關於我們期望看到格列衛的增長或我們期望格列衛如何發揮作用的全部內容。

I think the most important thing with Afinitor is a few things.

我認為 Afinitor 最重要的是幾件事。

Is one, is we're starting to see some -- where we saw decline originally in the U.S. based off of the CDK class, you're starting to see now as those progress, you're starting to see that decline level off.

是一個，我們開始看到一些 - 我們最初在美國看到基於 CDK 類的下降，你現在開始看到這些進展，你開始看到下降趨於平穩。

And then we also received -- we have approvals and growth in emerging markets with Afinitor.

然後我們還收到了——我們在 Afinitor 的新興市場獲得了批准和增長。

And then we have a small indication for TSC.

然後我們對 TSC 有一個小的指示。

And we're actually seeing some nice growth in that area.

我們實際上在該領域看到了一些不錯的增長。

So that's really driving the Afinitor.

所以這真的推動了 Afinitor。

Great.

偉大的。

And David, on implantables?

大衛，關於植入物？

Yes, thanks for the question.

是的，謝謝你的提問。

On the Surgical business, we had a good quarter.

在外科業務方面，我們有一個很好的季度。

The multifocal implantables grew slightly, mostly built off our Clareon AutonoMe launches in Europe and kind of the stability in emerging markets.

多焦點植入物略有增長，主要是基於我們在歐洲推出的 Clareon AutonoMe 以及新興市場的穩定性。

The mix went favorable to AT-IOLs, where we showed really strong growth, PanOptix leading that as we move that around the world, but also ReSTOR ACTIVEFOCUS in the U.S. The CyPass piece is obviously an exciting market for us.

這種組合對 AT-IOLs 有利，我們在那裡顯示出非常強勁的增長，PanOptix 在我們將其轉移到世界各地時處於領先地位，但在美國也有 ReSTOR ACTIVEFOCUS。CyPass 產品顯然對我們來說是一個令人興奮的市場。

We're continuing to train physicians.

我們正在繼續培訓醫生。

We trained up to 1,000 so far.

到目前為止，我們培訓了多達 1,000 人。

We intend to train another 1,000 by year-end.

我們打算在年底前再培訓 1,000 人。

We're excited about what's going on there.

我們對那裡發生的事情感到興奮。

And we were fortunate also to roll out the CyPass Ultra System.

我們也很幸運推出了 CyPass Ultra 系統。

So I think we've got good momentum on CyPass, kind of as expected.

所以我認為我們在 CyPass 上取得了良好的勢頭，有點像預期的那樣。

The next question is from the line of Michael Leuchten from UBS.

下一個問題來自瑞銀的 Michael Leuchten。

It's Michael from UBS.

我是瑞銀的邁克爾。

One question for Harry and one for Richard, please.

請一個問題給 Harry，一個給 Richard。

Harry, Q1, you were very clear that in Q2, you were looking for a slower growth than the company was able to deliver.

哈里，Q1，你很清楚在第二季度，你正在尋找比公司能夠實現的更慢的增長。

So outside the drivers that you outlined, was there anything else that actually allowed you to come in significantly ahead the predicted low to mid-single-digit EBIT growth that you had sort of proposed for Q2?

因此，除了您概述的驅動因素之外，還有什麼其他因素實際上可以讓您顯著領先於您為第二季度提出的預測的中低個位數 EBIT 增長？

And then on Sandoz, we're seeing a sequential worsening of the -- at least at the EBIT performance, especially if I take out the reversal of the litigation provision.

然後在 Sandoz 上，我們看到連續惡化 - 至少在 EBIT 表現方面，特別是如果我取消訴訟條款的逆轉。

Is that still a scenario where you think a pruning of the portfolio is enough, as you outlined at the Capital Markets Day, to reposition the company?

正如您在資本市場日概述的那樣，您認為削減投資組合是否仍然足以重新定位公司？

Or is there a slide now in the U.S., where maybe more drastic measures are needed?

還是美國現在出現下滑，可能需要採取更嚴厲的措施？

And also, if I could tack one on, on Cosentyx, Paul, you said in Q1, there was some low inventory levels.

而且，如果我能在 Cosentyx 上加上一個，保羅，你在第一季度說，庫存水平有些低。

Has there been a rebuild of inventory that contributed in Q2?

是否有對第二季度做出貢獻的庫存重建？

Or is it a clean number?

或者它是一個乾淨的數字？

Thank you, Michael.

謝謝你，邁克爾。

So first, Harry, on the outlook?

那麼首先，Harry，關於前景？

Yes, Michael, thanks for the question.

是的，邁克爾，謝謝你的提問。

So I would say, overall across our portfolio, we had a slightly better growth momentum.

所以我想說，總體而言，在我們的投資組合中，我們的增長勢頭略好一些。

Also, our productivity efforts in manufacturing paced up very nicely.

此外，我們在製造業的生產力方面的努力進展非常順利。

On the other hand, of course, we also have to offset the AveXis piece.

另一方面，當然，我們也要抵消AveXis這塊。

That's why good sales momentum, a bit better quarter 2 core operating income, that allows us also to stay then the core operating income guidance for the year as AveXis comes in.

這就是為什麼良好的銷售勢頭，更好的第二季度核心營業收入，這使我們也能夠在 AveXis 進入時保持當年的核心營業收入指導。

Thanks, Michael -- thanks, Harry.

謝謝，邁克爾——謝謝，哈利。

On Sandoz?

在山德士？

Thanks for the question, Michael.

謝謝你的問題，邁克爾。

So the way we think about (inaudible) on sales or EBITDA as you talk about it, is obviously, we are seeing a decline in the U.S. of 17% for this quarter, and as Vas pointed out, growth in the rest of the world.

因此，當你談論它時，我們考慮（聽不清）銷售額或 EBITDA 的方式顯然是，我們看到本季度美國下降了 17%，正如 Vas 指出的那樣，世界其他地區的增長.

So within that decline, we've already started and done some significant pruning and we continue to do that.

因此，在這種下降中，我們已經開始並進行了一些重大的修剪，我們將繼續這樣做。

With the biosimilars coming into our portfolio more and more across the world and into the U.S., we see our portfolio shifting.

隨著越來越多的生物仿製藥在世界各地和美國進入我們的產品組合，我們看到我們的產品組合正在發生變化。

Now that's leading us to have a better gross margin.

現在這導致我們有更好的毛利率。

And as you know, our gross margin has improved now, I think, for 6 or 7 quarters on the trot.

如您所知，我認為我們的毛利率已經連續 6 或 7 個季度有所提高。

So I think the strategy is playing out.

所以我認為這個策略正在發揮作用。

I do believe we're going to be in a position to start growing margins again.

我確實相信我們將能夠再次開始增加利潤率。

But we obviously have to manage our portfolio through this downturn in the U.S., which we are doing.

但我們顯然必須在美國經濟低迷期間管理我們的投資組合，我們正在這樣做。

And we will come out of that.

我們會走出困境。

But we have to be realistic about the time that's going to take.

但我們必須對將要花費的時間持現實態度。

Great.

偉大的。

Thank you, Richard.

謝謝你，理查德。

And Paul, on Cosentyx?

保羅，在 Cosentyx 上？

And so Michael, thanks for the question.

邁克爾，謝謝你提出這個問題。

Yes, there was an inventory effect in Q1.

是的，第一季度存在庫存效應。

But actually, in Q2, it didn't bounce right back.

但實際上，在第二季度，它並沒有立即反彈。

So our days on hand remained very low against the historical data.

因此，與歷史數據相比，我們手頭的天數仍然很低。

So what we know from that is pretty much the entire kickup in demand is literally that, just demand.

因此，我們從中了解到的幾乎是整個需求的增長實際上就是需求。

So hence, why we're very pleased with the underlying performance and what it means or could mean for the rest of the year.

因此，為什麼我們對基本表現及其對今年剩餘時間的意義或可能意味著什麼感到非常滿意。

The next question is from the line of Andrew Baum from Citi.

下一個問題來自花旗銀行的 Andrew Baum。

Three questions, if I may.

三個問題，如果可以的話。

First, could you address your move to decline to take price increases, following Pfizer's lead?

首先，你能談談你在輝瑞公司的帶領下拒絕接受提價的舉動嗎？

And more broadly, if you could share with us your expectations for movement following the announcement of the blueprint in terms of shifting away from the rebate structure?

更廣泛地說，您是否可以與我們分享您對藍圖公佈後在擺脫退稅結構方面的行動的期望？

Second, for John, Novartis has an enviable portfolio of immuno-oncology assets in combination.

其次，對於約翰而言，諾華擁有令人羨慕的免疫腫瘤學資產組合。

You must have some significant data from some of those trials in-house.

您必須從其中一些內部試驗中獲得一些重要數據。

Could you give us some indication of when we may expect early indication of data, both safety and efficacy, from some of those combinations beyond the LAG-3, which I think is the only one I've seen presented publicly?

您能否給我們一些指示，說明我們何時可以從 LAG-3 以外的某些組合中獲得安全性和有效性的早期指示，我認為這是我見過的唯一公開展示的組合？

And then finally, in the wake of the generic valsartan withdrawal from some of your generic competitors, should we anticipate any uptick in brand Diovan as positioned (inaudible) patients?

最後，在你們的一些仿製藥競爭對手撤回仿製藥纈沙坦之後，我們是否應該預期代文品牌作為定位（聽不清）患者的任何增長？

Thank you, Andrew.

謝謝你，安德魯。

So first, on the topic of price increases, we looked in June at the overall situation, the blueprint coming out, and made the decision prior to some of the recent events that we were going to withdraw any further price increases and make a commitment internally that we're not going to take any further price increases for the remainder of 2018.

所以首先在漲價這個話題上，我們6月份看的是大局，藍圖出來了，在最近的一些事情發生之前，我們就決定不再漲價，內部做出承諾。我們不會在 2018 年剩餘時間內進一步提價。

We thought that was prudent, given the dynamic environment that we're currently in, a lot of discussions around how to shape policy.

考慮到我們目前所處的動態環境，我們認為這是謹慎的做法，圍繞如何制定政策進行了大量討論。

And of course, our net prices overall are flat to declining in the U.S., in any case.

當然，無論如何，我們在美國的淨價格總體持平或下降。

So we think this was a prudent approach, given the dynamic environment.

因此，鑑於動態環境，我們認為這是一種謹慎的方法。

I think given the various discussions on the blueprint and the various levers, we are supportive as a company on reforming Part B, reforming 340B, enabling broader and faster access to biosimilars, reforming the rebate structures and how rebating works in the United States.

我認為，鑑於對藍圖和各種槓桿的各種討論，作為一家公司，我們支持改革 B 部分、改革 340B、更廣泛和更快地獲得生物仿製藥、改革退稅結構以及退稅在美國的運作方式。

But I think there's going to have to be a lot of discussion, of course, and a lot of input I'm sure the administration is going to receive before actually being able to enact any changes.

但我認為，當然，必須進行大量討論，並且我確信在實際能夠實施任何更改之前，政府將收到大量意見。

So what we plan to do is watch how this evolves over the remainder of this year and then chart a course going forward for 2019, 2019 moving ahead.

因此，我們計劃做的是觀察今年剩餘時間的發展情況，然後製定 2019 年的前進路線，2019 年繼續前進。

And I'm certainly fully engaged in trying to be involved in the discussions at the pharma level as well as in D.C. generally.

而且我當然完全致力於參與製藥層面的討論以及整個華盛頓特區的討論。

So on IO, John, your perspectives?

那麼關於 IO，約翰，你的觀點是什麼？

Yes, just a couple of things there, a couple of things.

是的，那裡只有幾件事，幾件事。

Thanks for the question, Andrew.

謝謝你的問題，安德魯。

Just regarding our approach for IO therapy as well as some of the products in Oncology that we have in our portfolio.

關於我們的 IO 治療方法以及我們產品組合中的一些腫瘤學產品。

First, in our portfolio, as you know, we have BYL719, which is a planned indication in combination with fulvestrant for postmenopausal hormone-positive HER2- advanced breast cancer in patients with PI3 kinase mutations.

首先，如您所知，在我們的產品組合中，我們有 BYL719，這是與氟維司群聯合治療 PI3 激酶突變患者絕經後激素陽性 HER2 晚期乳腺癌的計劃適應症。

That's something that we're looking forward to getting the results on before the end of the year.

這是我們期待在年底前獲得結果的事情。

In addition, I know Liz had mentioned earlier in terms of our filing with the FDA and Kisqali and getting results from the MONALEESA-3 and -7 results from the FDA, we're hoping to hear back fairly soon on that filing as well as starting the trial on adjuvant breast cancer in Kisqali.

此外，我知道 Liz 早些時候提到過我們向 FDA 和 Kisqali 提交的文件以及從 FDA 獲得 MONALEESA-3 和 -7 結果的結果，我們希望很快能收到關於該文件的回復以及在 Kisqali 開始輔助乳腺癌試驗。

And in addition, as we look forward, we also have the INC280 single Phase II study that's underway in non-small cell lung cancer.

此外，正如我們所期待的，我們還有正在進行的針對非小細胞肺癌的 INC280 單一 II 期研究。

That's currently in our portfolio.

這目前在我們的投資組合中。

And maybe I'll step in, Andrew, just on the IO portfolio.

安德魯，也許我會介入 IO 投資組合。

I mean, John's only been here for a few weeks.

我的意思是，約翰才來這裡幾個星期。

So just -- we're, on the immuno-oncology portfolio specifically, we are, of course, continuing to hold ourselves to a high standard, looking for single-agent activity.

所以 - 我們，特別是在免疫腫瘤學產品組合上，我們當然會繼續保持高標準，尋找單一代理活動。

Or if it's in combination, we need to see something pretty incredible to really want to take it forward, unless we're sure of a single-agent effect.

或者如果它是組合的，我們需要看到一些非常令人難以置信的東西才能真正想要推進它，除非我們確定單一代理效應。

We are seeing some promising things on 1 or 2 of the compounds.

我們在 1 種或 2 種化合物上看到了一些有前途的東西。

But it's still very early.

但現在還很早。

The most promising opportunity we have right now, as I mentioned, is the triplet Mek/Taf, PDR001, which is now in a pivotal study, which we expect to read out next year.

正如我所提到的，我們現在擁有的最有前途的機會是三聯體 Mek/Taf，PDR001，它現在正處於一項關鍵研究中，我們預計將在明年宣讀。

I think we'll probably have additional updates in the back half of this year on some of the other single agents and to see whether or not they're active enough to then take into further clinical trials.

我認為我們可能會在今年下半年對其他一些單一藥物進行額外的更新，看看它們是否足夠活躍，然後進行進一步的臨床試驗。

But I think the overall sentiment I want to say is we're holding ourselves to a high bar.

但我認為我想表達的總體情緒是我們正在堅持一個高標準。

We want to see single-agent activity or quite significant combination activity before we take it forward.

在我們推進之前，我們希望看到單一代理活動或相當重要的組合活動。

Anything you want to add, Liz?

LZ，你有什麼要補充的嗎？

No, I think just the fact that some of the early data, we will start to see, I think, in 2019.

不，我認為只是一些早期數據的事實，我認為我們將在 2019 年開始看到。

Some of the other IO combos, I think we'll see more coming out in 2019 around some of our earlier compounds.

一些其他的 IO 組合，我認為我們會在 2019 年看到更多圍繞我們早期的化合物出現。

And then valsartan, Paul?

然後是纈沙坦，保羅？

So Andrew, thanks.

所以安德魯，謝謝。

I think if I've got this and understand this correctly, so there's almost no negative impact on branded Diovan, it's worth saying that.

我想如果我明白了這一點並正確理解了這一點，那麼對品牌 Diovan 幾乎沒有負面影響，那麼值得一提。

Secondly, there could be an opportunity, depending on where the patients, sort of viewed depending on the geography, way too early to tell.

其次，可能有機會，取決於患者所在的位置，根據地理位置進行觀察，現在判斷還為時過早。

I think it might be worth adding that we are prepared to meet an unexpected increase in demand if that was to occur.

我認為可能值得補充的是，如果發生這種情況，我們已準備好應對需求的意外增長。

And maybe just as a sidebar, it's also worth clarifying that this has absolutely no impact on Entresto at any point in any process.

也許只是作為側邊欄，還值得澄清的是，這在任何過程中的任何時候都對 Entresto 絕對沒有影響。

So we are confident in how we go forward in preparation with Diovan and indeed with Entresto for the rest of the year.

因此，我們對如何與 Diovan 以及 Entresto 一起為今年餘下的時間做準備充滿信心。

The next question is from the line of Florent Cespedes from Societe Generale.

下一個問題來自法國興業銀行的 Florent Cespedes。

Three quick ones.

三個快速的。

First, for Harry, on Pharma margin, could you give us more color on what is behind the much better-than-expected performance of the Pharma margin this quarter?

首先，對於 Harry，關於製藥利潤率，您能否給我們更多關於本季度製藥利潤率好於預期的表現背後的原因？

And maybe, Vas, if you could give us your thought, knowing that as Gilenya should benefit from a potential additional exclusivity, so any update on your goal in terms of margin expansion for the Pharma division?

也許，Vas，如果你能告訴我們你的想法，知道 Gilenya 應該從潛在的額外排他性中受益，那麼你在製藥部門利潤擴張方面的目標有什麼更新嗎？

Second question for Paul, on Entresto, the performance ex U.S. is extremely good.

保羅的第二個問題，關於 Entresto，美國以外的表現非常好。

Is it because of a stronger penetration in Europe?

是因為在歐洲的滲透力更強嗎？

Or is it more a geographical expansion?

還是更像是地域擴張？

And if there is a stronger penetration in Europe, is there anything you could learn from the European performance that you could use in the U.S.?

如果歐洲的滲透率更高，您是否可以從歐洲的表現中學到什麼可以在美國使用？

And my last question is on research for John.

我的最後一個問題是關於約翰的研究。

QGE031, this product is entering Phase III.

QGE031，該產品進入III期。

Could you share with us why you are quite confident that this product could work in chronic urticaria, knowing that this product failed in asthma?

您能否與我們分享為什麼知道該產品對哮喘無效，您仍然非常有信心該產品可用於慢性蕁麻疹？

And how could you position and differentiate this product versus Xolair?

您如何定位和區分該產品與 Xolair？

As far as I understand, it's a kind of follow-up of Xolair.

據我了解，這是 Xolair 的一種後續產品。

Thanks, Florent.

謝謝，弗洛倫特。

First, on the margin, Harry?

首先，在邊際上，哈利？

Yes, Florent, thank you.

是的，弗洛倫特，謝謝你。

It's really down to 3 key points, as I mentioned actually in my earlier discussion.

正如我在之前的討論中提到的那樣，它實際上歸結為 3 個關鍵點。

But just let me give you a little bit more flavor.

但是讓我給你多一點味道。

As you can imagine, the uptake of Cosentyx, the significant uptake of Cosentyx and of Entresto is happening at a very high gross margin and so very high incremental margin, as a lot of the marketing and sales is already -- or most of it is already in place.

正如你可以想像的那樣，Cosentyx 的採用，Cosentyx 和 Entresto 的大量採用正在以非常高的毛利率和非常高的增量利潤率發生，因為很多營銷和銷售已經 - 或者其中大部分是已經到位。

So significant margin contributions, especially from those 2 key growth products.

如此顯著的利潤貢獻，尤其是來自這兩個主要增長產品。

And then now we see the manufacturing footprint initiative that we talked about a couple of years ago really gaining momentum.

然後現在我們看到我們幾年前談到的製造足跡計劃真正獲得動力。

As you know, we talked about a 4-year program, with $1 billion-plus by 2020.

如您所知，我們討論了一個為期 4 年的計劃，到 2020 年將超過 10 億美元。

We are now in the middle of that program and see significant gains from it.

我們現在正處於該計劃的中間，並從中看到了顯著的收益。

The first couple of years, as you would expect in manufacturing and supply chain, it is a bit slower, but then it gains more momentum.

前幾年，正如您在製造和供應鏈中所期望的那樣，它有點慢，但隨後獲得了更多動力。

So our technical operation teams do a fantastic job here, together with the business.

因此，我們的技術運營團隊與業務一起在這裡做得非常出色。

And we get very nice manufacturing gross margin pickup as well.

我們也獲得了非常好的製造業毛利率回升。

And then just on the impact of Gilenya, LOE changes on our margin, I mean, we've said and I think we've reiterated at meet the management, our goal is to get our Innovative Medicines margins into the mid-30s, in line with the overall competitive space.

然後就 Gilenya 的影響而言，LOE 改變了我們的利潤率，我的意思是，我們已經說過，我認為我們在與管理層會面時重申過，我們的目標是將我們的創新藥物利潤率提高到 30 年代中期，符合整體競爭空間。

And that remains our goal.

這仍然是我們的目標。

We don't change -- we're not changing that at this point in time until we have more certainty on the Gilenya outlook.

我們不會改變——在我們對 Gilenya 前景有更多確定性之前，我們不會在這個時間點改變這一點。

We believe it would be premature, given that there's still many steps in the process now that still have to happen for Gilenya LOE to be further extended.

我們認為現在還為時過早，因為要進一步延長 Gilenya LOE，現在仍有許多步驟需要完成。

Entresto, ex U.S., Paul?

Entresto，前美國，保羅？

So thanks, Florent.

所以謝謝，弗洛倫特。

In some ways, Europe has benefited from the learnings of the U.S. coming online.

在某些方面，歐洲受益於美國上網的經驗。

We're almost 100% up in the U.S. from last year and 150% up in Europe.

我們在美國比去年增長了近 100%，在歐洲增長了 150%。

China coming online as well, Q2 sales, around about $6 million.

中國也即將上線，第二季度銷售額約為 600 萬美元。

So we're gaining momentum.

所以我們正在獲得動力。

In answer to your question about penetration and new markets, yes, there's a few new markets to come.

在回答你關於滲透率和新市場的問題時，是的，有一些新市場即將到來。

We hope to update you on France in Q3 positively.

我們希望在第三季度積極向您介紹法國的最新情況。

But we're very pleased with the learnings that get shared globally and regularly.

但我們對在全球範圍內定期分享的經驗感到非常高興。

And the overall performance of more than doubling the sales is a direct result of shared learnings, new markets and real excellent discipline.

銷售額翻了一番以上的整體業績是共享學習、新市場和真正優秀紀律的直接結果。

Final point maybe just to add, we've got the news flows upcoming later this year.

最後一點可能只是補充一點，我們已經在今年晚些時候發布了新聞。

TRANSITION, hopefully to start early initiation and then we just keep rolling forward on news flow.

TRANSITION，希望儘早啟動，然後我們就繼續推進新聞流。

So sharing the best practice, bringing the news flow.

所以分享最佳實踐，帶來新聞流。

Thank you, Paul.

謝謝你，保羅。

And then John, on QGE?

然後約翰，在 QGE 上？

Thanks, Florent, for the question.

謝謝弗洛倫特提出的問題。

QGE, and many people would know this as ligelizumab, is a high-affinity anti-IgE that forms complexes with the free IgE.

QGE，許多人將其稱為 ligelizumab，是一種高親和力抗 IgE，可與游離 IgE 形成複合物。

We believe that there's differences in the pathophysiology between asthma and CSU.

我們認為哮喘和 CSU 在病理生理學上存在差異。

And that pathophysiology is distinct in these 2 different disease states.

在這兩種不同的疾病狀態中，病理生理學是不同的。

We recently did share some results in May that showed the improved efficacy versus Xolair in patients who are inadequately controlled and these patients who have chronic spontaneous urticaria.

我們最近確實在 5 月份分享了一些結果，這些結果顯示，在控制不佳的患者和患有慢性自發性蕁麻疹的患者中，與 Xolair 相比，療效有所提高。

So we believe that this would be a path forward in terms of ligelizumab.

因此，我們相信這將是 ligelizumab 的一條前進道路。

I might add as well.

我也可以補充。

That would allow us to have access to the U.S. market as well fully in CSU with QGE.

這將使我們能夠通過 QGE 進入美國市場，並完全進入 CSU。

The next question is from the line of Steve Scala calling from Cowen.

下一個問題來自 Cowen 的 Steve Scala 電話。

I have 3 questions.

我有 3 個問題。

First, how will the manufacturing issues with Kymriah impact Kymriah trials to move up into earlier lines of therapy and development of the BCMA CAR program?

首先，Kymriah 的製造問題將如何影響 Kymriah 試驗進入早期治療線和 BCMA CAR 計劃的開發？

So that's the first question.

這是第一個問題。

Second is back on Cosentyx.

其次是回到 Cosentyx。

Is the second quarter performance a full manifestation of the efforts to enhance access?

二季度的業績是否是加強准入力度的充分體現？

Or is that still a work in progress, so future quarters will be even better?

還是這項工作仍在進行中，所以未來的季度會更好？

And then lastly, for Harry, just to clarify, did you say that group sales will be at the upper end of the low to mid-single-digit range?

最後，Harry，澄清一下，你是說集團銷售額將處於中低個位數範圍的上端嗎？

It makes sense, given the H1 strength, but that being the case, why not raise that range now?

考慮到 H1 強度，這是有道理的，但既然如此，為什麼不現在提高該範圍呢？

Thanks, Steve.

謝謝，史蒂夫。

So first, on Kymriah trials, Liz?

那麼首先，關於 Kymriah 試驗，Liz？

Yes, I think the easy answer is that no, we don't expect there to be any changes to clinical trials of Kymriah in the earlier setting or at this point, the BCMA, so.

是的，我認為簡單的答案是不，我們不希望 Kymriah 的臨床試驗在早期設置或此時 BCMA 中有任何變化，所以。

Thank you, Liz.

謝謝你，麗茲。

On Cosentyx, Paul?

在 Cosentyx 上，保羅？

Well, it's sort of both, I guess.

好吧，我想兩者兼而有之。

I mean, we -- you take the opportunity to have the enhanced access in Q1 and you see a benefit in Q2 for sure.

我的意思是，我們——您藉此機會在第一季度獲得了增強的訪問權限，您肯定會在第二季度看到好處。

But when you take the access, it affects the whole book of business at the beginning of the year.

但是當你訪問時，它會影響年初的整個業務。

So you have to build volume throughout the remainder of the year, so very much like our position going into Q2.

因此，您必須在今年餘下的時間裡增加銷量，這與我們進入第二季度的立場非常相似。

And as long as we keep doing what we're doing and building the volume, we should see a continued improved performance.

只要我們繼續做我們正在做的事情並增加音量，我們應該會看到持續改進的性能。

Let me just add again that we're very committed to consensus for the year.

讓我再次補充一點，我們非常致力於在今年達成共識。

So it would imply that we do continue to do that.

所以這意味著我們確實會繼續這樣做。

Thanks, Paul.

謝謝，保羅。

And on guidance, Harry?

在指導下，哈利？

Yes, so the first quarter was 4%, second quarter, 5%.

是的，所以第一季度是 4%，第二季度是 5%。

As you mentioned, around 5% on the first half.

正如您所提到的，上半年約為 5%。

We expect continued good momentum.

我們預計將繼續保持良好勢頭。

So you may see us raise the guide in the quarter 3. Besides, it's a little bit too early now.

所以你可能會看到我們在第 3 季度提高了指南。此外，現在還為時過早。

But I'm quite confident we'll be at the upper end of the guidance on sales.

但我非常有信心我們將處於銷售指導的上限。

The next question is from the line of Michael Leacock calling from MainFirst.

下一個問題來自 MainFirst 的 Michael Leacock。

Just briefly on Sandoz, if I may, and for Richard.

如果可以的話，我只是簡單介紹一下 Sandoz，還有理查德。

Biosimilars seemed to have settled into a sort of steady trend.

生物仿製藥似乎已經形成了一種穩定的趨勢。

Do you think this will continue?

你認為這會持續下去嗎？

Or do you see an inflection point?

或者你看到拐點了嗎？

And if so, when?

如果是這樣，什麼時候？

I see that some guidance was removed by the FDA recently on some biosimilar analysis.

我看到 FDA 最近刪除了一些關於某些生物仿製藥分析的指南。

I think it was statistics.

我認為這是統計數據。

What do you read into that?

你讀到什麼？

Does that make it easy or more difficult in general?

總的來說，這會使它變得容易還是更困難？

And what about any refiling of Rituxan?

那麼 Rituxan 的任何再填充呢？

And then thirdly, have you applied for any interchangeability with any of your biosimilars?

第三，您是否申請了與您的任何生物仿製藥的互換性？

And if you were to apply for interchangeable, could you still get the biosimilar designation if you sort of fall short of the interchangeable hurdle?

如果你要申請可互換，如果你沒有達到可互換的障礙，你還能獲得生物仿製藥的稱號嗎？

Or would you need to put in a new application?

還是需要重新申請？

Richard, on all 3 questions?

理查德，關於所有 3 個問題？

Thanks for the questions.

感謝您的提問。

So let me start with the growth rate.

所以讓我從增長率開始。

Obviously, we had a 34% growth in biosimilars in quarter 2, which we're very pleased with.

顯然，我們在第二季度的生物仿製藥增長了 34%，我們對此感到非常滿意。

And as you say, that's a steady trend.

正如你所說，這是一個穩定的趨勢。

But I think that's a high trend.

但我認為這是一個高趨勢。

So I think that's one where, as you think about our portfolio, we have portfolios that we're launching with Rixathon and Erelzi and other ones that are mature being in the market and other ones that are starting to potentially get competition.

所以我認為，當你考慮我們的產品組合時，我們擁有與 Rixathon 和 Erelzi 一起推出的產品組合，以及市場上成熟的其他產品和其他可能開始競爭的產品。

So I think we have to think about that when we're looking at our growth rate.

所以我認為我們在查看增長率時必須考慮到這一點。

I think -- I wouldn't really talk about inflections, I'd continue to talk about just solid growth of the biosimilars.

我認為——我不會真正談論變化，我會繼續談論生物仿製藥的穩健增長。

That will be seen by acceleration and sometimes lower numbers based on when products come to the market and when competitors come to the market.

根據產品何時進入市場以及競爭對手何時進入市場，可以通過加速和有時較低的數字來看出這一點。

So I hope that helps sort of think about that going forward.

所以我希望這有助於思考未來的發展。

With regard to the FDA guidance, I mean, I think generally, if I step back, I would say all the guidance, all the discussions, all the comments coming out of the FDA, I think, are extremely positive towards their approach to biosimilars.

關於 FDA 指南，我的意思是，我認為一般來說，如果我退後一步，我會說所有指南、所有討論、所有來自 FDA 的評論，我認為，對他們的生物仿製藥方法非常積極.

When it comes to some of the recent communication, I think it's been comments, I don't think they've actually changed policy yet.

關於最近的一些交流，我認為是評論，我認為他們還沒有真正改變政策。

So we're looking to see actually what they do around some of the things they've been mentioning.

所以我們希望看到他們圍繞他們一直提到的一些事情做了什麼。

It sounds very positive.

聽起來很積極。

So I think the second part of that question was that, does that impact Rixathon and our rituximab filing in any way?

所以我認為這個問題的第二部分是，這是否會以任何方式影響 Rixathon 和我們的利妥昔單抗申請？

What I'd say is it's very too early to say.

我要說的是現在說還為時過早。

We still have to meet with the FDA.

我們仍然需要與 FDA 會面。

Once we meet with the FDA, we'll have a far better understanding of that.

一旦我們與 FDA 會面，我們就會對此有更好的了解。

And then moving on, I think, to your final question around interchangeability.

然後繼續，我想，你關於互換性的最後一個問題。

Once again, there's just a lot of commentary and narrative coming out of the FDA, all positive, about potentially making interchangeability something which is easier for potentially people to show or potentially less of a barrier, depends how you interpret it.

再一次，FDA 發表了很多評論和敘述，都是積極的，關於可能使可互換性成為可能讓人們更容易展示或可能減少障礙的東西，這取決於你如何解釋它。

All in all, I think these are all very positive statements.

總而言之，我認為這些都是非常積極的說法。

But nothing has been documented or finalized.

但沒有任何記錄或最終確定。

So I feel very cautious about giving any sort of strong opinion, apart from it seems to be heading in the right direction towards, I think, more (inaudible) about the market really starting to become positive and open up towards biosimilars.

所以我對給出任何強烈的意見都非常謹慎，除了它似乎正朝著正確的方向前進，我認為，更多（聽不清）關於市場真正開始變得積極並向生物仿製藥開放。

The next question is from the line of Tim Race from Deutsche Bank.

下一個問題來自德意志銀行的 Tim Race。

First question, very quick.

第一個問題，很快。

What was the milestone income in Innovative Medicines in other revenue?

其他收入中創新藥物的里程碑收入是多少？

So if you could just explain what that was for?

所以，如果你能解釋一下那是乾什麼用的？

And then just perhaps just explain a little bit, maybe I'm being thick, but in terms of Kymriah, the manufacturing issue in the U.S. Is that actually limiting how many patients can go on the product at present?

然後也許只是解釋一下，也許我太厚了，但就 Kymriah 而言，美國的製造問題是否真的限制了目前可以使用該產品的患者數量？

And what is the actual issue?

實際問題是什麼？

And then second, in Europe, you've sort of out-licensed the manufacturing of -- or you've got a partner for the manufacturing with Cell for Cure?

其次，在歐洲，你已經獲得了一些製造許可——或者你有一個製造合作夥伴與 Cell for Cure 合作？

What is that?

那是什麼？

Is that a temporary agreement before you put up your own infrastructure there?

這是你在那裡建立自己的基礎設施之前的臨時協議嗎？

Or is that a permanent agreement?

或者這是一個永久的協議？

And what does that signal about your expectations for ex U.S. sales?

這表明您對美國以外銷售的預期是什麼？

So on the first question on milestone income, Harry?

那麼關於里程碑收入的第一個問題，Harry？

Yes, that was basically a minor amount from a prior product divestment, which had a few other time-barred basically milestone payments.

是的，這基本上是之前產品撤資的一小部分，之前的產品撤資還有一些其他時間限制的基本上里程碑式的付款。

So not significant, but still in the core results.

所以並不重要，但仍然是核心結果。

Thanks, Harry.

謝謝，哈利。

And then on the 2 questions on Kymriah, Liz?

然後關於 Kymriah 的 2 個問題，Liz？

So on Kymriah, I guess the easiest way to explain it is really cell variability.

所以在 Kymriah 上，我想最簡單的解釋方法就是細胞變異性。

And so after manufacturing, you have a percentage of cells that are viable.

所以在製造之後，你有一定比例的活細胞。

And so what we have in our commercial label, and this is what's really important, commercial label is slightly more stringent than what was in our clinical study.

因此，我們的商業標籤中有什麼，這才是真正重要的，商業標籤比我們的臨床研究中的要嚴格一些。

So what happens is some of them are out of spec because they're not at the same level.

所以發生的事情是其中一些不符合規格，因為它們不在同一級別。

We have -- we are working very closely with the FDA and so it's hard -- and we actually have a perspective of what we think it is.

我們已經 - 我們正在與 FDA 密切合作，所以這很困難 - 我們實際上對我們的想法有一個看法。

But at the same time, we're not sure, so we wouldn't want to speculate right now.

但與此同時，我們不確定，所以我們現在不想推測。

I think the most important thing is that we are continuing with pediatric and young adult ALL and being able -- not seeing the same level of variability there.

我認為最重要的是，我們正在繼續研究兒科和年輕成人 ALL，並且能夠——看不到相同水平的變異性。

It's really around DLBCL and again, our ability to bring the therapy to the patients at the end of the day, because through mechanisms that we have of being able to provide those therapies back to patients in the majority of the cases.

這真的是圍繞 DLBCL，而且我們在一天結束時將治療帶給患者的能力，因為在大多數情況下，通過我們能夠將這些治療提供給患者的機制。

I think that's the most important thing.

我認為這是最重要的事情。

The other thing I will note is when you think about long-term manufacturing, we have a lot that we're doing around building long-term manufacturing and capacity, working on improvement, continuous improvement of our processes.

我要注意的另一件事是，當你考慮長期製造時，我們正在圍繞建立長期製造和能力、致力於改進、持續改進我們的流程做很多事情。

So we see, as Vas talked about earlier, we're here in the long game in cell therapy and believe that we ultimately will be able to provide product and therapy to patients around the world, which is what -- which is ultimately what we want to do.

所以我們看到，正如 Vas 之前談到的，我們在細胞治療的長期遊戲中在這裡，並且相信我們最終將能夠為世界各地的患者提供產品和治療，這就是 - 這就是我們的最終目標想做。

And just to add to Liz's comments, just on the ex U.S. front, we have a facility in Leipzig, Germany, which is used in the clinical trials, which will also be used in the commercial manufacturing.

補充 Liz 的評論，就在美國前線，我們在德國萊比錫有一個設施，用於臨床試驗，也將用於商業製造。

We also announced last week that we'll be opening a facility in Paris with our partner, Cell for Cure, to ensure we have adequate capacity fully for ex U.S. markets.

我們上週還宣布，我們將與我們的合作夥伴 Cell for Cure 在巴黎開設一家工廠，以確保我們有足夠的能力完全滿足美國以外市場的需求。

And we're also exploring additional capacity in Asia, which we hope to provide an update on at the appropriate time.

我們還在探索亞洲的額外容量，我們希望在適當的時候提供最新信息。

The next question is from the line of Naresh Chouhan from New Street.

下一個問題來自 New Street 的 Naresh Chouhan。

A couple of questions.

幾個問題。

Firstly, on Tasigna, it's the ex U.S. growth rate is slowing quite materially, are there certain countries where generic Gleevec is now being used on a more wholesale basis instead of Tasigna?

首先，在 Tasigna 上，美國以外的增長率正在大幅放緩，是否有某些國家/地區現在更多地批發使用仿製藥 Gleevec 而不是 Tasigna？

How should we be thinking about Tasigna ex U.S.?

我們應該如何看待來自美國的 Tasigna？

That would be helpful.

那會很有幫助。

And then secondly, on the Sandoz gross margin, the margin was very strong despite significant price cuts.

其次，在 Sandoz 的毛利率方面，儘管大幅降價，但利潤率非常高。

Is it fair to assume that biosimilars are driving the majority of that 190 basis point improvement?

假設生物仿製藥推動了 190 個基點的大部分改進，這是否公平？

Or have you exited some unprofitable products and that's driving some of the favorable product mix as well?

還是您退出了一些無利可圖的產品，這也推動了一些有利的產品組合？

So first, on Tasigna, Liz?

首先，在 Tasigna，Liz？

Yes.

是的。

So on Tasigna, that what you were seeing in Europe this quarter was really around phasing in Germany.

因此，在 Tasigna 上，您本季度在歐洲看到的實際上是在德國分階段進行的。

And the other thing is we presented data at ASCO around treatment-free intervals.

另一件事是我們在 ASCO 上展示了無治療間隔的數據。

And so we expected to see a slight dropoff due to that.

因此，我們預計會因此出現輕微下降。

But what we are seeing is actually some nice share, new product share increase because of that new data.

但我們看到的實際上是一些不錯的份額，由於新數據，新產品份額有所增加。

So I think the way I would think about Tasigna is, yes, you do continue to have patients moving to generic Gleevec.

所以我認為我對 Tasigna 的看法是，是的，你確實繼續讓患者轉向通用格列衛。

But at the same time, I think we see a very stable performance of Tasigna really around the world with some growth markets.

但與此同時，我認為我們看到 Tasigna 在全球範圍內的一些增長市場中表現非常穩定。

And in and out, some up, some down, but at the end of the day, a fairly stable market.

進進出出，有的上漲，有的下跌，但歸根結底，市場相當穩定。

Thanks.

謝謝。

And Sandoz gross margin, Richard?

山德士的毛利率，理查德？

Thanks for the question.

謝謝你的問題。

So what is driving the gross margin?

那麼是什麼推動了毛利率？

Well, I think it's a number of factors.

好吧，我認為這是多種因素。

Obviously, the biosimilar growth rates are definitely helping at 34%.

顯然，生物仿製藥的增長率達到了 34%，這無疑是有幫助的。

That's becoming a good and significant business.

這正在成為一項良好而重要的業務。

But we've also got other factors, as Harry mentioned, productivity improvements and NTO.

但我們還有其他因素，正如 Harry 提到的那樣，生產力提高和 NTO。

The plan is starting to come through.

該計劃開始實施。

And that's obviously helping us there as well.

這顯然也在幫助我們。

And then 2 other factors, as we focus, and we've been focusing the last 3 years geographically on the countries which we know will drive profitable growth, with the right portfolio.

然後是我們關注的其他 2 個因素，過去 3 年我們一直在地理上關注我們知道將通過正確的投資組合推動盈利增長的國家。

We've been doing that.

我們一直在這樣做。

And then finally, we've obviously been continuously pruning our portfolio to make sure we take out the products which we don't see as growth drivers going forward.

最後，我們顯然一直在不斷修剪我們的產品組合，以確保我們剔除我們認為不會成為未來增長動力的產品。

The next question is from Kerry Holford from BNP Paribas.

下一個問題來自法國巴黎銀行的 Kerry Holford。

Three questions, please.

請教三個問題。

Firstly, on AVXS-101, so on the slides, you mentioned manufacturing.

首先，關於 AVXS-101，所以在幻燈片上，你提到了製造。

And as I understand it, you're manufacturing today from one facility, but a new facility should come online in 2020.

據我了解，您今天在一個工廠進行製造，但新工廠應該會在 2020 年上線。

So my question here is, is there any risk you're supply-constrained during the first year of launch?

所以我的問題是，在發布的第一年，你們是否存在供應受限的風險？

How should we think about the sales ramp in that initial year before that new facility comes online?

在新設施上線之前的第一年，我們應該如何考慮銷售增長？

LIK066, I see the decision has been made to discontinue that product.

LIK066，我看到已經決定停止該產品。

Can you tell us why?

你能告訴我們為什麼嗎？

What did you see in the Phase III data that has led you to that conclusion?

您在 III 期數據中看到了什麼導致您得出該結論？

And also, can you confirm whether you are continuing with the heart failure study, which I believe continues?

而且，您能否確認您是否繼續進行心力衰竭研究，我認為該研究仍在繼續？

I think that's a Phase II study.

我認為這是一項 II 期研究。

Or are you dropping that project completely?

還是您要完全放棄該項目？

And then lastly, a quick one on Gilenya.

最後，快速介紹一下 Gilenya。

Following the approval of the pediatric dose, the 0.25 mg dose, can you confirm when you expect to launch that dose in the U.S.?

在兒科劑量 0.25 mg 劑量獲得批准後，您能否確認預計何時在美國推出該劑量？

So on AVXS-101, Paul?

那麼關於 AVXS-101，保羅？

So we're not anticipating any supply constraints at all.

因此，我們根本沒有預料到任何供應限制。

If you look at what we should get an approval, it would be IV.

如果你看看我們應該獲得什麼批准，那就是 IV。

And for the patients that will benefit most, the young infants, that is we'll be right -- well-positioned in terms of supply.

對於最受益的患者，即年幼的嬰兒，我們是對的——在供應方面處於有利地位。

As we bring on IT in 2020, then the much bigger patient populations, of course, materialize, too and we'll be well-positioned for that.

當我們在 2020 年引入 IT 時，當然，更大的患者群體也會實現，我們將為此做好準備。

So not expecting any supply constraints.

所以不要期待任何供應限制。

On LIK, I'll just take that one.

在 LIK 上，我就拿那個。

So we ran a study in obesity.

所以我們進行了一項關於肥胖的研究。

And what we ultimately saw in the study, which we'll, of course, present at an upcoming congress and ultimately publish, was a reduction in weight loss, but not a reduction, we believe, that was significant enough to warrant further development.

我們最終在這項研究中看到的是，我們當然會在即將召開的大會上展示並最終發表這項研究，它是減重的減少，但我們認為減重的幅度不足以保證進一步的發展。

So with that now, we're reevaluating how we might take an SGLT1, 2 forward in heart failure.

因此，現在，我們正在重新評估我們如何在心力衰竭中採用 SGLT1、2。

And I think we can provide an update once we've made that decision.

我認為我們可以在做出決定後提供更新。

And then lastly, on the launch of Gilenya pediatric, Paul?

最後，關於 Gilenya 兒科產品的推出，保羅？

Yes, we launched the low dose for pediatrics on May 11.

是的，我們於 5 月 11 日推出了用於兒科的低劑量。

And we expect it to make a very small percentage of the overall, but it is already available.

我們預計它只佔整體的很小一部分，但它已經可用了。

It's from the line of Marietta Miemietz from Primavenue.

它來自 Primavenue 的 Marietta Miemietz 系列。

I have one financial question on Sandoz and then a couple product questions, please.

我有一個關於 Sandoz 的財務問題，然後是幾個產品問題。

On the Sandoz guidance downgrade, I just wanted to check, is that entirely due to greater-than-expected pricing pressure in the U.S.?

關於 Sandoz 指導下調，我只是想檢查一下，這是否完全是由於美國的定價壓力大於預期？

Or are you actually also slightly more negative for Glatopa and/or your other Biopharmaceutical products than you were at the beginning of the year?

或者，與年初相比，您對 Glatopa 和/或您的其他生物製藥產品的負面情緒實際上是否也略有增加？

And in that context, following on from Michael's question, am I right in assuming that your marketed biosimilars in Europe have not actually had any material growth sequentially, i.e., Q2 over Q1, and that they're likely to stagnate for the foreseeable future due to your capacity constraint?

在這種情況下，繼邁克爾的問題之後，我是否正確地假設您在歐洲上市的生物仿製藥實際上沒有連續出現任何實質性增長，即第二季度超過第一季度，並且它們可能會在可預見的未來停滯不前到你的能力限制？

So I'm not talking about new launches or the U.S., but really just about the in-market products in Europe.

所以我不是在談論新產品或美國，而是在談論歐洲市場上的產品。

And then the product questions, on canakinumab, please, with the cardiology opportunity around the corner, can you just give us an update on your thinking around patient stratification?

然後是關於 canakinumab 的產品問題，隨著心髒病學機會的臨近，您能否向我們介紹一下您對患者分層的最新想法？

Do you expect first-dose response to remain the best patient stratification tool for the foreseeable future?

在可預見的未來，您是否期望首劑反應仍是最好的患者分層工具？

And have you had any feedback from regulators and payers, how they think about that?

你有沒有從監管機構和付款人那裡得到任何反饋，他們對此有何看法？

And then a question on nazartinib, please.

請再問一個關於 nazartinib 的問題。

Why was the Phase III study in first-line lung cancer withdrawn?

肺癌一線治療III期研究為何撤回？

Was that mainly recruitment issues?

那主要是招聘問題嗎？

Or were there any other reasons?

還是有其他原因？

And how does that affect the compound's prospect as a combination partner for your other assets, such as INC280 and PDR001, if it's never going to be approved on a stand-alone basis?

如果永遠不會在獨立的基礎上獲得批准，這將如何影響化合物作為您其他資產（例如 INC280 和 PDR001）的組合合作夥伴的前景？

Great.

偉大的。

So first, on Sandoz, Richard, both on the guidance and the biosimilars?

那麼首先，關於 Sandoz，Richard，關於指南和生物仿製藥？

Okay.

好的。

Thank you for the question.

感謝你的提問。

So as Harry pointed out, we are revising the guidance down.

因此，正如 Harry 指出的那樣，我們正在向下修訂指南。

But to be very clear, this does not reflect any changes in the fundamentals we believe in the business.

但非常明確的是，這並不反映我們對業務的基本面有任何改變。

But it takes into account some factors which we are now aware of.

但它考慮了我們現在知道的一些因素。

One is obviously we have a Rixathon delay in the U.S. Two, the 40-milligram launch and ramp-up has been slow and the market is under more pricing pressure than anticipated.

一是顯然我們在美國有一個 Rixathon 延遲。二是 40 毫克的推出和增加一直很緩慢，市場承受的定價壓力比預期的要大。

And also, there's been significant destocking in Russia in the first half of the year.

此外，今年上半年俄羅斯的庫存大幅減少。

So those are the factors.

所以這些就是因素。

Going into your question around biosimilars in Europe, I hope I have understood it correctly, but if not, please tell me.

關於歐洲生物仿製藥的問題，我希望我理解正確，但如果不正確，請告訴我。

So we're seeing biosimilar growth both in the U.S. and in EU.

因此，我們看到美國和歐盟的生物仿製藥都在增長。

And we're seeing strong growth in the EU, both from our base business that we've already got there, but also the launches, which continue to perform well.

我們在歐盟看到了強勁的增長，無論是我們已經在那裡的基礎業務，還是繼續表現良好的新產品。

And we continue to roll out Rixathon and Erelzi in new markets.

我們繼續在新市場推出 Rixathon 和 Erelzi。

And within the markets they are in, they continue to gain market share and perform well.

在他們所在的市場中，他們繼續獲得市場份額並表現良好。

So we're seeing good momentum and good growth in Europe of our biosimilar business.

因此，我們在歐洲看到了我們生物仿製藥業務的良好勢頭和良好增長。

So I hope those both answer your question.

所以我希望他們都能回答你的問題。

Okay.

好的。

Is that on a year-over-year basis?

這是按年計算的嗎？

Because I mean, just basically looking at your numbers, the 10% growth that we're talking about for the biosimilars, the 10% growth you talk about in Europe, and the biosimilars numbers, unless I get the currency completely wrong, just suggests that there was not really much growth in the European biosimilars between Q1 and Q2.

因為我的意思是，基本上只是看你的數字，我們談論的生物仿製藥的 10% 增長，你在歐洲談論的 10% 的增長，以及生物仿製藥的數字，除非我完全弄錯了貨幣，只是建議第一季度和第二季度之間歐洲生物仿製藥的增長並不多。

So I was just trying to see if that is correct, if it's due to capacity constraints and if that's going to stay.

所以我只是想看看這是否正確，是否是由於容量限制以及是否會繼續存在。

Yes.

是的。

No, once again, reiterating that we do have good growth quarter-on-quarter in Europe.

不，再次重申我們在歐洲確實有良好的季度環比增長。

And maybe to answer the capacity, where we launch our products, both Rixathon and Erelzi, we launch them with the mindset that we can actually supply those markets and be competitive and grow market share.

也許為了回答容量問題，在我們推出 Rixathon 和 Erelzi 產品的地方，我們推出它們的心態是我們可以實際供應這些市場並具有競爭力並增加市場份額。

So if we think about how we launch, where we launch but where we have launched, we can actually supply the market and grow and become competitive.

因此，如果我們考慮我們如何推出，我們在哪裡推出以及我們已經推出的地方，我們實際上可以供應市場並發展並變得具有競爭力。

In Germany, we are #1 now with Rixathon.

在德國，我們現在是 Rixathon 的第一名。

We have overtaken the other biosimilar competitor, so we are market leader and continue to grow.

我們已經超越了其他生物仿製藥競爭對手，因此我們是市場領導者並繼續增長。

And we continue to grow Erelzi in market share in every market we've launched it.

我們繼續擴大 Erelzi 在我們推出的每個市場的市場份額。

So I think the message I'm giving here, the performance of biosimilars in Europe is growing quarter-on-quarter.

所以我認為我在這裡要傳達的信息是，歐洲生物仿製藥的業績正在逐季增長。

Now obviously, things can change on that, as and when competitors come into the market or where we see pricing degradation suddenly happen.

很明顯，當競爭對手進入市場或我們看到價格突然下降時，情況可能會發生變化。

But right now, we feel very confident in how we're performing.

但現在，我們對自己的表現非常有信心。

So on EGFR now, and then I'll cover canakinumab.

所以現在在 EGFR 上，然後我將介紹 canakinumab。

But on EGFR, Liz?

但是關於 EGFR，Liz？

Yes, on EGFR, we decided to rethink the strategy, given Tagrisso and the approval of Tagrisso as standard of care and what was the best way to differentiate.

是的，在 EGFR 上，我們決定重新考慮該策略，考慮到 Tagrisso 和 Tagrisso 作為護理標準的批准以及什麼是差異化的最佳方式。

And so what we really thought it was important to stop the single-agent study.

所以我們真正認為停止單一代理研究很重要。

And right now, we're looking and waiting on data with combination and we'll rethink the strategy of how we launch EGF in the future.

而現在，我們正在尋找和等待結合的數據，我們將重新考慮我們未來如何推出 EGF 的戰略。

And lastly, on canakinumab.

最後，關於 canakinumab。

On canakinumab, just first taking a step back, we have the file in with the FDA in cardiovascular risk reduction.

關於 canakinumab，先退後一步，我們向 FDA 提交了降低心血管風險的文件。

We also have started the adjuvant study or are in the midst of starting the second-line study in lung cancer and as well ultimately, a first-line study.

我們也已經開始了輔助研究，或者正在開始肺癌的二線研究，最終也是一線研究。

So we'll have 3 studies ongoing.

所以我們將進行 3 項研究。

And then maybe to Andrew's earlier question on IO, that's clearly a place now we're making a significant step forward in taking forward canakinumab, based on the data we presented in the New England Journal on canakinumab's oncology effect.

然後也許對於 Andrew 之前關於 IO 的問題，根據我們在新英格蘭雜誌上提供的關於 canakinumab 的腫瘤學效果的數據，這顯然是我們在推進 canakinumab 方面向前邁出的重要一步。

But the effect of cardiovascular disease, all of our discussions that Paul and his team have had with payers and as well as physicians clearly indicates we need a very clear indication statement that demonstrates we could target a patient subpopulation that would reflect the estimated relative risk reduction of 24% for CVRR in the subpopulation of the patients who had a CRP response after the first dose.

但是心血管疾病的影響，保羅和他的團隊與付款人以及醫生進行的所有討論都清楚地表明我們需要一個非常明確的適應症聲明來證明我們可以針對一個患者亞群來反映估計的相對風險降低在首次給藥後有 CRP 反應的患者亞群中，CVRR 為 24%。

We are taking that forward to the FDA.

我們正在將其提交給 FDA。

We are currently continuing discussions with the FDA in terms of what they would find ultimately appropriate in the label.

我們目前正在繼續與 FDA 就他們認為最終適合標籤的內容進行討論。

But that's going to really determine our approach on canakinumab.

但這將真正決定我們對 canakinumab 的方法。

If we don't get the label we need to be successful, then we'll have to rethink our strategy with the product in cardiovascular disease.

如果我們沒有獲得成功所需的標籤，那麼我們將不得不重新考慮我們的心血管疾病產品戰略。

It's from the line of Keyur Parekh from Goldman Sachs.

它來自 Goldman Sachs 的 Keyur Parekh 系列。

Two on Sandoz and then one on AveXis, please.

請在 Sandoz 上使用兩個，然後在 AveXis 上使用一個。

On Sandoz, can you just help us think about what was the actual price impact decline you saw on the U.S. business?

關於 Sandoz，您能幫我們想想您看到的美國業務的實際價格下降影響是什麼嗎？

So clearly, it's 9% globally, but just give us some magnitude of how much of it was in the U.S. and if there's any particular categories where that pressure was higher than in other parts of the business?

很明顯，它在全球範圍內是 9%，但請告訴我們其中有多少在美國，以及是否有任何特定類別的壓力高於業務的其他部分？

And then secondly, again on Sandoz, kind of any thoughts on, we believe, kind of Mylan's priced Copaxone at 60% list price discount?

然後其次，再次關於 Sandoz，我們相信，關於 Mylan 以 60% 標價折扣定價的 Copaxone，有什麼想法嗎？

How do you think that market evolves over the next couple of years?

您認為未來幾年該市場將如何發展？

And where do you think biosimilar pricing for the U.S. goes as we go through 2019?

您認為 2019 年美國的生物仿製藥定價將走向何方？

And then on AveXis, clearly, you're coming close to filing, given the debate in the U.S. around high-priced medicines.

然後在 AveXis 上，很明顯，鑑於美國圍繞高價藥品的爭論，你即將提交申請。

Vas, any thoughts from your perspective on how -- what might be considered a reasonable price for this medicine?

Vas，從你的角度來看，你有什麼想法——這種藥的合理價格是多少？

So the first 2 questions on Sandoz, Richard?

那麼關於 Sandoz 的前兩個問題，理查德？

Yes, thanks for the question.

是的，謝謝你的提問。

We don't actually call out the actual prices, declines we see across the different regions.

我們實際上並沒有說出實際價格，而是我們在不同地區看到的價格下降。

We just give the global price decline.

我們只是給出全球價格下跌。

I would say what you're seeing in the market generally is a continued price decline.

我會說你在市場上看到的一般是價格持續下跌。

I do think we see this as slightly lower than in previous years, but not dramatically.

我確實認為我們認為這比往年略低，但幅度不大。

So I still see this as a challenging market.

所以我仍然認為這是一個充滿挑戰的市場。

With regard to the other pricing question around Mylan and the 40 milligrams of Copaxone, I don't really want to comment on what they've done.

關於 Mylan 和 40 毫克 Copaxone 的其他定價問題，我真的不想評論他們所做的事情。

I think obviously, that's something for them to talk about.

我認為很明顯，這是他們可以談論的事情。

I would say that we've been in the Copaxone market with our 20 milligrams for nearly 3 years.

我會說我們以 20 毫克的劑量進入 Copaxone 市場將近 3 年。

So we're well aware of the changes in prices and the different tactics that people use.

所以我們很清楚價格的變化和人們使用的不同策略。

And I think we've proven with the 20 milligrams, we're pretty good at navigating that.

而且我認為我們已經證明了 20 毫克，我們非常擅長駕馭它。

That said, obviously, we have a competitive situation here where pricing is playing into that.

就是說，很明顯，我們在這里處於競爭激烈的局面，定價正在發揮作用。

And we've got to be mindful of that.

我們必須注意這一點。

And as I said with regard to the guidance, that has put pressure on that opportunity for us.

正如我在指導方面所說的那樣，這給我們的機會帶來了壓力。

And we've got to see how that plays out.

我們必須看看結果如何。

Great.

偉大的。

So then on pricing for AVXS, Paul?

那麼關於 AVXS 的定價，保羅？

It's too early to talk about pricing in general.

現在談論定價還為時過早。

I mean, just to remind everybody, we're trying to strike the right value proposition for payer, patients and health systems alike.

我的意思是，只是提醒大家，我們正在努力為付款人、患者和醫療系統制定正確的價值主張。

I think it is worth just reminding people of what the existing costs are to have them in mind for perspective.

我認為值得提醒人們現有的成本是多少，以便讓他們牢記在心。

The current treatment option is over $2 million over a 5-year period.

目前的治療方案在 5 年期間超過 200 萬美元。

And the cost of not treating at all is also significant, depending on where you are.

根本不治療的成本也很高，具體取決於您所在的位置。

It can be between $1 million and $2 million over 5 years for supportive care.

5 年內用於支持治療的費用可能在 100 萬到 200 萬美元之間。

Clearly, it's way too early for us, but just to let you know the current sort of perspectives that are in the market.

顯然，這對我們來說還為時過早，但只是為了讓您了解市場上當前的各種觀點。

The last question is from Emmanuel Papadakis from Barclays.

最後一個問題來自巴克萊銀行的 Emmanuel Papadakis。

A couple, maybe one on BAF312.

一對，也許是 BAF312 上的一個。

You've now filed with a priority review voucher, not sure if you had any further discussions with the FDA, but any thoughts on the precise label wording there would be extremely helpful, in terms of an update.

您現在已經提交了優先審查憑證，不確定您是否與 FDA 進行了任何進一步的討論，但就更新而言，任何關於精確標籤措辭的想法都會非常有幫助。

Are you still expecting or hoping for an explicit SPMS indication?

您是否仍然期待或希望獲得明確的 SPMS 指示？

Second one is on Promacta.

第二個是在 Promacta 上。

It seems to have been one of the greater successes from the original GSK transaction.

這似乎是最初的 GSK 交易取得的更大成功之一。

What are you doing differently there?

你在那裡做什麼不同？

And how sustainable is that growth we're seeing in the ITP indication?

我們在 ITP 指標中看到的這種增長的可持續性如何？

And then maybe a quick follow-up on Sandoz.

然後可能會快速跟進 Sandoz。

Just if you could revisit for us Advair, substitutable Advair, filing time lines in the U.S., that would be very helpful.

如果您可以為我們重新訪問 Advair，可替代的 Advair，在美國提交時間線，那將非常有幫助。

Great.

偉大的。

Thanks, Emmanuel.

謝謝，伊曼紐爾。

On BAF312, just to remind everyone, the EXPAND study, which we completed, was the first study ever conducted in a secondary progressive MS population.

在 BAF312 上，提醒大家，我們完成的 EXPAND 研究是有史以來第一項在繼發性進展型 MS 人群中進行的研究。

You had patients with relatively high EDSS scores, older patients, at least relatively for an MS population, so a very unique study population, that in the past, we've shown is very distinct than any other study population that's been studied in the past in relapsing MS studies.

你有 EDSS 評分相對較高的患者，年齡較大的患者，至少相對於 MS 人群而言，所以這是一個非常獨特的研究人群，在過去，我們已經證明它與過去研究過的任何其他研究人群截然不同在復發性 MS 研究中。

So our goal with the U.S. FDA is to reflect that unique study population, and so in effect, to get as close as we can to a secondary progressive MS population.

因此，我們與美國 FDA 的目標是反映該獨特的研究人群，因此實際上盡可能接近二級進展 MS 人群。

Now we'll ultimately have to have the label negotiations with the FDA to get the precise wording and see how FDA would like to characterize "secondary progressive MS," primarily because it's not a straightforward diagnosis.

現在，我們最終必須與 FDA 就標籤進行談判以獲得準確的措辭，並了解 FDA 希望如何描述“繼發性進展型 MS”，主要是因為這不是一個簡單的診斷。

There's multiple components in how you ultimately identify a secondary progressive MS patient.

您最終如何識別繼發性進展性 MS 患者有多個組成部分。

But our goal is to very clearly delineate that BAF312 is for this unique patient population studied in the EXPAND study.

但我們的目標是非常清楚地描述 BAF312 適用於 EXPAND 研究中研究的這一獨特患者群體。

In Europe, it's more straightforward, at least relatively speaking.

在歐洲，它更直接，至少相對而言。

And in that case, we will be advancing a file with secondary progressive MS in the proposed labeling.

在那種情況下，我們將在提議的標籤中推進一個帶有二級進步 MS 的文件。

Promacta, Liz?

Promacta，麗茲？

Yes, I think I agree.

是的，我想我同意。

We're very excited about and happy with the performance of Promacta.

我們對 Promacta 的表現感到非常興奮和高興。

We do see that growth continue.

我們確實看到增長仍在繼續。

And we expect that growth to continue.

我們預計這種增長將繼續下去。

And I think it's important, about a year ago, we made a decision to increase our reach and frequency and really, the commercial focus on Promacta.

而且我認為這很重要，大約一年前，我們決定增加我們的覆蓋面和頻率，實際上是對 Promacta 的商業關注。

And we've seen -- as a result of that, we've seen it grow around the world.

我們已經看到 - 因此，我們已經看到它在世界範圍內發展。

So I also think it's really important to note that we still actually have a lot of room of a lot of ITP patients that are not being treated.

所以我也認為非常重要的是要注意我們實際上還有很多未接受治療的 ITP 患者的空間。

And so we think that there's opportunity to continue to improve and increase penetration around the world.

因此，我們認為有機會繼續改善和提高全球滲透率。

So we're happy about it so far.

所以到目前為止我們對此很滿意。

And then Richard, on Advair?

然後理查德，關於 Advair？

Yes, thanks for the question on Advair.

是的，感謝您對 Advair 的提問。

So I think to answer your question, the aim is to be able to be in position to file and launch in the second half of next year.

所以我想回答你的問題，目標是能夠在明年下半年備案和啟動。

So I think as I think we highlighted in the quarter 1 earnings, the aim would be to be able to launch this product around about quarter 4 of next year.

所以我認為，正如我認為我們在第一季度收益中強調的那樣，目標是能夠在明年第四季度左右推出該產品。

Great.

偉大的。

Thank you, Richard.

謝謝你，理查德。

Thanks, Emmanuel.

謝謝，伊曼紐爾。

So thanks, everyone, for joining today's call and your interest in Novartis.

因此，感謝大家參加今天的電話會議以及您對諾華的關注。

And then for the investors on the call, thank you for investing in our company.

然後對於電話會議的投資者，感謝您投資我們公司。

And we'll look forward to catching up with you on the Q3 conference call.

我們期待在第三季度電話會議上與您見面。

Have a great day.

祝你有美好的一天。

Thank you for joining today's conference call.

感謝您參加今天的電話會議。

You may now disconnect your lines.

您現在可以斷開線路。