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Operator
Operator
Good afternoon and welcome to the Novartis Q2 2019 Results Release Conference Call and Live Audio Webcast. (Operator Instructions) And the conference is being recorded. (Operator Instructions) A recording of the conference call, including the Q&A session, will be available on our website shortly after the call ends. (Operator Instructions)
下午好,歡迎來到諾華 2019 年第二季度業績發布電話會議和現場音頻網絡廣播。(操作員說明)會議正在錄製中。(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。(操作員說明)
With that, I would like to hand over to Mr. Samir Shah, Global Head of Investor Relations. Please go ahead, sir.
就此,我想請投資者關係全球主管 Samir Shah 先生髮言。請繼續,先生。
Samir Shah - Global Head of IR
Samir Shah - Global Head of IR
Thank you. Thank you, everybody, for taking the time to listen and participate in our quarter 2 investor call.
謝謝。謝謝大家花時間聽取和參與我們第二季度的投資者電話會議。
Before we start, I'll just read the safe harbor statement. The information presented today contains forward-looking statements that involve known and unknown risks, uncertainties and other factors. These may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. 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.
在我們開始之前,我將閱讀安全港聲明。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。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。
And with that, I'll hand across to Vas.
然後,我將交給 Vas。
Vasant Narasimhan - CEO
Vasant Narasimhan - CEO
Thank you, Samir, and thanks, everyone, for joining today's conference call. In the room with me today I have Harry Kirsch, our CFO; Shannon Klinger, our Chief Legal Officer, Susanne Schaffert, our President of Novartis Oncology; Marie-France Tschudin, our President of Novartis Pharmaceuticals; John Tsai, our Global Head of Drug Development; and Richard Saynor, our new Head of Sandoz.
謝謝薩米爾,也感謝大家參加今天的電話會議。今天與我同在的房間裡有我們的首席財務官 Harry Kirsch;我們的首席法務官 Shannon Klinger,我們的諾華腫瘤學總裁 Susanne Schaffert; Marie-France Tschudin,我們的諾華製藥總裁; John Tsai,我們的全球藥物開發主管;和 Richard Saynor,我們 Sandoz 的新負責人。
So as you saw today in this morning's results, we really had an exceptional Q2 and a strong first half of the year, which we're very pleased with and very pleased to give you further details on over the course of this presentation.
因此,正如您在今天上午的結果中看到的那樣,我們確實有一個出色的第二季度和上半年的強勁表現,我們對此感到非常高興,並且非常高興在本次演示過程中向您提供更多詳細信息。
If we turn to Slide 4, we delivered a strong Q2 with margin expansion and continued to progress our agenda on transformative innovation. When you look at the operational performance, we have plus 8% on sales, plus 20% on core operating income with a margin expansion of 3.2%. And Harry will go through in a bit more detail the numbers as well as some of the pushes and pulls that we see for the first half as well as for the second half. But based on the strong momentum that we've seen, we are increasing our sales and core operating income guidance for the full year, and Harry will go through the specifics of that in a few slides.
如果我們轉向幻燈片 4,我們在第二季度實現了強勁的利潤增長,並繼續推進我們的轉型創新議程。當您查看運營績效時,我們的銷售額增長了 8%,核心運營收入增長了 20%,利潤率增長了 3.2%。哈里將更詳細地介紹我們在上半場和下半場看到的數字以及一些推動和拉動。但基於我們所看到的強勁勢頭,我們正在增加全年的銷售額和核心營業收入指導,Harry 將在幾張幻燈片中詳細介紹這一點。
Importantly, we also advanced our transformative innovation agenda with our pipeline with Zolgensma, Piqray and Mayzent all launched. Xiidra, acquired in July, is now fully integrated and we're getting prepared to re-energize that brand. SEG101 filed with a priority review. And we also had a positive overall survival data in -- with Kisqali in premenopausal women presented at ASCO. So very strong progress on our innovation agenda as well.
重要的是,我們還推出了與 Zolgensma、Piqray 和 Mayzent 的管道,推進了我們的變革性創新議程。Xiidra 於 7 月被收購,現已完全整合,我們正準備為該品牌重新註入活力。SEG101申請優先審評。我們也有一個積極的總體生存數據——在 ASCO 上展示了絕經前婦女的 Kisqali。我們的創新議程也取得了非常大的進展。
So moving to Slide 5. The sales performance is primarily driven by very strong performance in Innovative Medicines. In particular, we are pleased with the performance in our growth drivers. So of course, Entresto and Cosentyx continue their strong momentum, as you can see with the growth rates in Q2 and the first half. Across our Oncology brands as well, very strong growth. Lutathera continuing to perform well. Kisqali beginning to accelerate, Kymriah also with very solid performance. So we saw a broad-based growth across our Innovative Medicines portfolio, which gives us confidence as well for the remainder of this year and going into future years.
所以轉到幻燈片 5。銷售業績主要是由創新藥物的強勁表現推動的。特別是,我們對增長動力的表現感到滿意。因此,當然,Entresto 和 Cosentyx 繼續保持強勁勢頭,正如您在第二季度和上半年的增長率中所看到的那樣。在我們的腫瘤學品牌中,增長也非常強勁。Lutathera 繼續表現良好。Kisqali 開始加速,Kymriah 也有非常穩健的表現。因此,我們看到了我們創新藥物產品組合的廣泛增長,這也讓我們對今年剩餘時間和未來幾年充滿信心。
So moving to Slide 6. When you look at Cosentyx specifically and particularly focusing on the U.S., we were pleased we could continue to grow the brand in a what is increasingly competitive environment. Looking at the U.S. dermatology segment, you can see that for NBRx percent gains of Q2 of 2019 versus Q2 2018, Cosentyx gained 1.5 share points in a very competitive space. So we're very pleased by that strong performance by our U.S. team. When you look at TRxs, we're growing ahead of market at 28% versus the market growth of 10% and with 17% overall growth in NBRx.
所以轉到幻燈片 6。當你特別關注 Cosentyx 並且特別關注美國時,我們很高興我們能夠在競爭日益激烈的環境中繼續發展品牌。看看美國皮膚科,你可以看到,對於 NBRx 2019 年第二季度與 2018 年第二季度相比的百分比增長,Cosentyx 在競爭激烈的領域獲得了 1.5 個份額點。因此,我們對美國團隊的出色表現感到非常高興。當你看 TRxs 時,我們以 28% 的速度領先於市場,而市場增長率為 10%,NBRx 的整體增長率為 17%。
When you go to rheumatology, where again, Cosentyx has truly unique data in psoriatic arthritis and ankylosing spondylitis, you can see our weekly TRxs are now approaching or exceeding Enbrel and HUMIRA. When you think in terms of market growth, we're growing 38% versus a market growth of 14% on TRxs and also have solid NBRx share growth. So when you look across the U.S. business, we are very pleased with how Cosentyx is performing in this competitive environment and we'll look to continue that momentum in the back half.
當你去風濕病學時,Cosentyx 在銀屑病關節炎和強直性脊柱炎方面再次擁有真正獨特的數據,你可以看到我們每週的 TRxs 現在接近或超過 Enbrel 和 HUMIRA。當你考慮市場增長時,我們增長了 38%,而 TRxs 的市場增長為 14%,而且 NBRx 的份額增長也很穩固。因此,當你縱觀美國業務時,我們對 Cosentyx 在這種競爭環境中的表現感到非常滿意,我們將期待在後半段繼續保持這種勢頭。
Turning to Slide 7. I also wanted to highlight that we continue to generate additional data on Cosentyx in the existing indications in psoriasis and rheumatology as we prepare for data we plan to release later this year and in the coming years on new indications. In particular, when you look at psoriatic arthritis, most of these patients have so-called axial manifestations. And Cosentyx has demonstrated in our recent MAXIMIZE study that we could impact these axial manifestations in a significant way. You can see the data here that we recently presented. This further bolsters the case for Cosentyx' use in these rheumatology patients. And I think it's just one example of many as we continue to build out the data set to support Cosentyx' broad use.
轉到幻燈片 7。我還想強調的是,在準備我們計劃在今年晚些時候和未來幾年發布的新適應症數據時,我們將繼續在銀屑病和風濕病學的現有適應症中生成更多關於 Cosentyx 的數據。特別是,當您觀察銀屑病關節炎時,這些患者中的大多數都有所謂的中軸表現。Cosentyx 在我們最近的 MAXIMIZE 研究中證明,我們可以顯著影響這些軸向表現。您可以在此處查看我們最近提供的數據。這進一步支持了 Cosentyx 在這些風濕病患者中的應用。我認為這只是眾多示例中的一個,因為我們將繼續構建數據集以支持 Cosentyx 的廣泛使用。
So moving to Slide 8. When you look at Entresto, we are seeing a really strong performance from Entresto, continued acceleration for this important medicine for heart failure patients. You saw the revenue growth of 81% with solid growth both in the U.S. and in the ex U.S. But importantly, we continue to get strong recommendations from key groups. So on the right-hand side, you can see the European Society of Cardiology heart failure expert consensus now supports Entresto's use in a -- as first-line therapy for patients with HFrEF. This will allow us to continue to accelerate the use of Entresto in the first-line setting, in ambulatory and in the hospital setting. I'll talk a little bit more about the PARAGON data set in a few slides.
所以轉到幻燈片 8。當你看 Entresto 時,我們看到 Entresto 的表現非常強勁,這種用於心力衰竭患者的重要藥物的持續加速。你看到收入增長了 81%,在美國和美國以外的地區都實現了穩健增長。但重要的是,我們繼續得到關鍵群體的強烈推薦。因此,在右側,您可以看到歐洲心髒病學會心力衰竭專家共識現在支持 Entresto 作為 HFrEF 患者的一線治療。這將使我們能夠繼續加速 Entresto 在一線環境、門診和醫院環境中的使用。我將在幾張幻燈片中更多地討論 PARAGON 數據集。
So moving to Slide 9. I'd like to spend a few slides giving you an update on Zolgensma. So we're really pleased with the launch of Zolgensma today. We've seen very strong demand. We're pleased with the launch and access progress we're making. I want to give you a few details as proof points.
所以轉到幻燈片 9。我想用幾張幻燈片向您介紹 Zolgensma 的最新情況。所以我們對今天推出 Zolgensma 感到非常高興。我們看到了非常強勁的需求。我們對正在取得的發布和訪問進展感到滿意。我想給你一些細節作為證據。
First, when you look at the launch, we had an approval on May 24. Within 3 days, we were promoting in the market. Within roughly a week, we had our first commercial policy and product ready to ship. We had our first U.S. patient treated within approximately 2 weeks and we already have had patients treated through the French ATU mechanism outside the United States. In some instances, we've even had patients approved for therapy from the time of receiving the Rx within 24 hours. So that kind of shows you the enthusiasm there is in the SMA community for this medicine.
首先,當您查看發佈時,我們在 5 月 24 日獲得了批准。3 天內,我們在市場上進行了推廣。在大約一周內,我們的第一份商業政策和產品準備就緒。我們在大約 2 週內接受了第一位美國患者的治療,並且我們已經有患者通過美國以外的法國 ATU 機制接受治療。在某些情況下,我們甚至讓患者在收到 Rx 後 24 小時內獲准接受治療。因此,這向您展示了 SMA 社區對這種藥物的熱情。
Now for some of the details, the first thing I want to highlight is even in the absence of medical policies or specific approvals, we are able to use medical exceptions to manage many of these patients getting through the process. And that's the primary route right now we're doing when we don't have a policy in place. But we're having best-in-class, we believe, progress on getting medical policies in place.
現在對於一些細節,我想強調的第一件事是即使沒有醫療政策或具體批准,我們也能夠使用醫療例外來管理這些患者中的許多人通過這個過程。當我們沒有適當的政策時,這是我們現在正在做的主要路線。但我們相信,我們在製定醫療政策方面取得了一流的進展。
Over 20 commercial plans, representing 40% of commercial lives, and 4 Medicaid plans have policies on coverage already. Not all of these have been posted on external websites. The majority of these policies are in line or close to the label. The common limitations we're seeing are with patients with 4 SMN2 copies, which is about 10% of the overall SMN2 prevalent population in this age group; and some limitations with combination use with nusinersen. When you look at the approval rates we're seeing so far, patients going through the Novartis hub, almost all patients going through our hub have been approved thus far when appropriate steps -- after appropriate steps have been taken. We have very high approval rates for the on-label patients either via policy or medical exception, as I said. And I think the other important thing to note is we've had a wide range of the patients already approved, including patients from age 1 to 23 months, weights up to 12 kilograms, 2 and 3 SMN2 copy numbers, treatment-naïve as well as those previously treated by the currently approved product.
超過 20 個商業計劃(佔商業生命的 40%)和 4 個醫療補助計劃已經有保險政策。並非所有這些都已發佈在外部網站上。這些政策中的大多數符合或接近標籤。我們看到的常見限制是具有 4 個 SMN2 拷貝的患者,約佔該年齡組 SMN2 總體流行人群的 10%;以及與 nusinersen 聯合使用的一些限制。當你看看我們到目前為止看到的批准率時,通過諾華中心的患者,到目前為止,幾乎所有通過我們中心的患者都在採取適當的步驟後獲得批准——在採取適當的步驟之後。正如我所說,我們通過政策或醫療例外對標籤上的患者有非常高的批准率。我認為另一件需要注意的重要事情是,我們已經批准了範圍廣泛的患者,包括年齡從 1 到 23 個月、體重不超過 12 公斤、2 和 3 個 SMN2 拷貝數、未接受過治療的患者與那些以前被當前批准的產品處理過的一樣。
In terms of contracting, to get any of the special contract terms that we've been promoting, we have 17 commercial plans representing 40% of commercial lives having already signed a letter of intent on contracting terms. And we continue to try to progress across the relevant insurance community. So strong progress already, and just with the first few weeks after launching this medicine.
在合同方面,為了獲得我們一直在推廣的任何特殊合同條款,我們有 17 個商業計劃代表 40% 的商業生活已經簽署了合同條款意向書。我們將繼續努力在相關保險界取得進步。已經取得如此巨大的進步,而且就在推出這種藥物後的前幾週。
So if you go to Slide 10 and you look at the news flow we have for the second half, we are planning to initiate discussions with the U.S. FDA on intrathecal dosing for the older populations based on our STRONG study. We are on track to have EU and Japan approval by Q4 2019. And we plan to have other country filings initiated in Q3 for our broad global rollout of the medicine. Later on this year, we'll show the data -- updates on data from SPR1NT, STRONG and STR1VE at various medical congresses, as you can see, over the course of the fall.
因此,如果您轉到幻燈片 10 並查看我們下半年的新聞流,我們計劃根據我們的 STRONG 研究與美國 FDA 就老年人群的鞘內給藥展開討論。我們有望在 2019 年第四季度獲得歐盟和日本的批准。我們計劃在第三季度啟動其他國家/地區的備案,以便我們在全球範圍內廣泛推廣該藥物。今年晚些時候,我們將展示數據——如您所見,整個秋季在各種醫學大會上來自 SPR1NT、STRONG 和 STR1VE 的數據更新。
So moving to Slide 11. One piece of data I wanted to highlight from our recent presentations at AAN is Zolgensma's performance in presymptomatic patients, where patients are achieving age-appropriate motor milestones. Just to remind you, SPR1NT is our presymptomatic study. It's a study that has patients with both 2 copies and 3 copies of the SMN1 gene. Patients were presymptomatic.
所以轉到幻燈片 11。我想從我們最近在 AAN 上的演講中強調的一項數據是 Zolgensma 在症狀前患者中的表現,患者正在實現與年齡相適應的運動里程碑。提醒您,SPR1NT 是我們的症狀前研究。這是一項針對具有 2 個和 3 個 SMN1 基因拷貝的患者的研究。患者是無症狀的。
And what you can see on the right-hand side is the progress these patients are making versus the WHO windows of normal achievement. So you can see the patients in green boxes are patients who are sitting without support that have 2 copies of the SMN2 gene. You can see patients standing with assistance, and you can see how these patients are now progressing. And we're looking forward to providing you an update to show, we hope, that we can get these patients to progress normally after treatment early in their life after being identified by newborn screening or in the early months of their life. So very exciting data presented at AAN already on presymptomatic patients and more updates to come in the fall.
您可以在右側看到的是這些患者取得的進展與 WHO 正常成就窗口的對比。所以你可以看到綠框裡的病人是沒有支撐就坐著的病人,他們有 2 個 SMN2 基因拷貝。你可以看到病人在幫助下站著,你可以看到這些病人現在的進展情況。我們期待著為您提供更新,以表明我們希望,我們可以讓這些患者在通過新生兒篩查確診後或在生命的最初幾個月內在生命早期接受治療後正常進展。在 AAN 上已經展示了關於症狀前患者的非常令人興奮的數據,並將在秋季推出更多更新。
So now moving to Piqray on Slide 12. Piqray received FDA approval on May 24. CHMP opinion is expected in the second half of this year. We're pleased with the progress we're already making with payers, covering over 80% of the target population in terms of the engagement we already had. We're also seeing good uptake of the PIK3CA mutation testing, which was really our focus for this year to really ensure high testing rates so that we can drive the launch for the years to come. The NCCN guidelines currently recommend PIK3CA mutation testing, and we've also entered into an agreement with Foundation Medicine to develop plasma and tissue testing.
現在轉到幻燈片 12 上的 Piqray。Piqray 於 5 月 24 日獲得 FDA 批准。預計 CHMP 將於今年下半年發表意見。我們對我們已經與付款人取得的進展感到滿意,就我們已經擁有的參與而言,覆蓋了超過 80% 的目標人群。我們還看到 PIK3CA 突變測試得到了很好的採用,這確實是我們今年的重點,以真正確保高測試率,以便我們能夠推動未來幾年的發布。NCCN 指南目前推薦 PIK3CA 突變檢測,我們還與 Foundation Medicine 達成協議以開發血漿和組織檢測。
We're also pleased that we're now able to confirm we'll be exploring Piqray in other tumor types in the second half of 2019. We'll have trial starts for HER2-positive advanced breast cancer as well as triple-negative breast cancer. And then based on data we already have in house, we will be moving to late-stage studies in first half of 2020 in head and neck and ovarian cancers.
我們也很高興我們現在能夠確認我們將在 2019 年下半年在其他腫瘤類型中探索 Piqray。我們將開始對 HER2 陽性晚期乳腺癌和三陰性乳腺癌進行試驗。然後根據我們已有的內部數據,我們將在 2020 年上半年進行頭頸癌和卵巢癌的後期研究。
So on Slide 13, we move to Mayzent. Now in Mayzent, we're also pleased with the progress we've made. This was a year where we wanted to focus on educating the patient -- physician community, making sure we had strong access in place so that we could drive this brand's use in the SPMS setting for the long term. Just to remind you, we had unique clinical data and a supportive label to start with, with the full range of RMS indications, but the only medicine that has SPMS data specifically in its label. And some of the interesting profile elements of the drug, high efficacy, reduces disease progression, no first-dose observation for 70% of the patients.
所以在幻燈片 13 上,我們轉到 Mayzent。現在在 Mayzent,我們也對我們取得的進展感到滿意。這一年,我們希望專注於教育患者——醫生社區,確保我們擁有強大的訪問權限,以便我們能夠長期推動該品牌在 SPMS 環境中的使用。提醒您,我們擁有獨特的臨床數據和支持性標籤,具有全方位的 RMS 適應症,但唯一在其標籤中明確包含 SPMS 數據的藥物。而該藥的一些有趣的概況要素,療效高,可減緩疾病進展,70%的患者無需首劑觀察。
Thus far, our priorities for Mayzent are progressing well. We believe we're the first choice now for active SPMS for health care providers in the United States. We have 90% of neurologists willing to prescribe Mayzent based on the survey data that we see. We currently have 70 million lives with preferred access to Mayzent to date, and we continue to try to grow that access over time. And we're also working to use digital tools to help identify patients who truly are active SPMS patients and would benefit from Mayzent in the long term.
到目前為止,我們對 Mayzent 的優先事項進展順利。我們相信我們現在是美國醫療保健提供者主動 SPMS 的首選。我們有 90% 的神經科醫生願意根據我們看到的調查數據開出 Mayzent 處方。迄今為止,我們目前有 7000 萬人優先使用 Mayzent,並且隨著時間的推移,我們將繼續努力增加這種訪問。我們還在努力使用數字工具來幫助識別真正活躍的 SPMS 患者,並從長遠來看會從 Mayzent 中受益。
So we'll look forward to providing detailed sales data in Q3 for both Zolgensma and Mayzent, but I hope that gives you a sense of where we are in building the foundational building blocks for both of these launches.
因此,我們期待在第三季度提供 Zolgensma 和 Mayzent 的詳細銷售數據,但我希望這能讓您了解我們在為這兩項發布構建基礎構建塊方面所處的位置。
Now turning to ophthalmology. With Beovu, or RTH258, we've, as you know, developed a differentiated medicine that now is on track for launch upon approval later this year. Remind you that HAWK and HARRIER clinical programs demonstrated uncompromised vision, less retinal fluid and fewer injections versus the comparator medicine. We've also launched a pretty expanded clinical program, including a study called TALON, which is a head-to-head study of brolucizumab versus aflibercept in a treat-to-control regimen in kind of an apples-to-apples setting. So we look to continue to provide the data needed to support Beovu's use in a broad range of patients for the long term.
現在轉向眼科。如您所知,通過 Beovu 或 RTH258,我們開發了一種差異化藥物,該藥物有望在今年晚些時候獲得批准後上市。提醒您,與比較藥物相比,HAWK 和 HARRIER 臨床項目展示了不妥協的視力、更少的視網膜液和更少的注射。我們還啟動了一個相當擴展的臨床項目,包括一項名為 TALON 的研究,這是一項在同類對照方案中對 brolucizumab 與 aflibercept 進行的頭對頭研究。因此,我們希望繼續提供支持 Beovu 長期用於廣泛患者所需的數據。
We're prepared for the launch. Approval expected in Q4 '19, CHMP in Q1 2020. We've already seen strong awareness of the clinical data. Both our U.S. and EU operations are preparing, and we plan to be ready for a strong day 1 launch of this medicine.
我們已準備好發布。預計在 19 年第四季度獲得批准,CHMP 在 2020 年第一季度獲得批准。我們已經看到了對臨床數據的強烈認識。我們在美國和歐盟的業務都在準備中,我們計劃為該藥上市的第一天做好準備。
Also in ophthalmology, when you go to Slide 15, our plan is to accelerate Xiidra now that we've brought it fully in house while laying the foundation to maximize its long-term potential. Now just to remind you, dry eye is a significant patient unmet need. It's generally underdiagnosed and undertreated. 34 million patients with dry eye in the U.S. alone. It's estimated only 50% are accurately diagnosed and really only a fraction of that, 10%, is treated with an appropriate medicine.
同樣在眼科領域,當你轉到幻燈片 15 時,我們的計劃是加速 Xiidra,因為我們已經將它完全引入內部,同時為最大限度地發揮其長期潛力奠定了基礎。現在提醒您,乾眼症是患者未滿足的重要需求。它通常未被充分診斷和治療。僅在美國就有 3400 萬乾眼症患者。據估計,只有 50% 的人得到了準確診斷,而實際上只有其中的一小部分,即 10%,得到了適當的藥物治療。
We're well aware that when you look at the TRx data for Xiidra over recent quarters, it has been very flat. We believe this is because of the uncertainty involved as Xiidra's ultimate ownership was not clear. Now that we've brought certainty to the sales organization and the marketing organization, our plan is to reinvest in the medicine. We'll reengage the sales force, focus on share of voice. We have a plan to optimize our medical education with a plan to promote, including a DTC campaign starting in Q4 of '19. Longer term, our plan to maximize Xiidra will depend on our ability to expand access for Part D patients beginning in 2021. So we'll continue to track, continue to push, and we'll look forward to keeping you up to date on our progress with Xiidra.
我們很清楚,當你查看最近幾個季度 Xiidra 的 TRx 數據時,它一直非常平穩。我們認為這是因為 Xiidra 的最終所有權不明確所涉及的不確定性。既然我們已經為銷售組織和營銷組織帶來了確定性,我們的計劃是對藥物進行再投資。我們將重新聘用銷售人員,專注於話語權份額。我們有一個計劃來優化我們的醫學教育,並製定一個推廣計劃,包括從 19 年第四季度開始的 DTC 活動。從長遠來看,我們最大化 Xiidra 的計劃將取決於我們從 2021 年開始擴大對 D 部分患者的訪問的能力。因此,我們將繼續跟踪、繼續推動,我們期待讓您了解我們在 Xiidra 方面的最新進展。
Now lastly on our near-term portfolio, I wanted to give an update on SEG101, crizanlizumab, which has been submitted in both the U.S. and EU. Now just as a reminder, in the world of sickle cell disease, we have therapies which are to treat a sickle-cell pain crisis. There are therapies to prevent a crisis from happening in the first place, such as with SEG101. And then there are of course cell and gene therapies that are looking in certain patients to try to definitively treat the underlying genetic cause of the disease. In the case of SEG101, we're really focused on preventing vaso-occlusive crises, which are the primary reason for hospitalization, the primary cause of pain and long-term sequelae for these patients, including some of the mortality outcomes, and the long-term cost to the system.
最後,關於我們的近期投資組合,我想介紹一下 SEG101 crizanlizumab 的最新情況,該藥物已在美國和歐盟提交。現在提醒一下,在鐮狀細胞病的世界裡,我們有治療鐮狀細胞疼痛危機的療法。有一些療法可以從一開始就防止危機發生,例如 SEG101。然後當然有細胞和基因療法正在尋找某些患者,以試圖明確治療疾病的潛在遺傳原因。在 SEG101 的案例中,我們真正專注於預防血管閉塞性危象,這是住院的主要原因,是這些患者疼痛和長期後遺症的主要原因,包括一些死亡率結果,以及長期- 系統的長期成本。
So as I think you may have seen, we've been granted priority review for SEG101 in the U.S. and we continue to advance our filings around the world. We're also gearing up for a successful launch in the U.S. with a commercial organization in place, access plans in place and an innovative disease awareness campaign that we've launched using digital technology, which we hope will truly mobilize the patient community behind this medicine. As a reminder, there's about 60% of the patients, we would expect within the sickle cell disease population, who have 2 or more vaso-occlusive crises and would be eligible for SEG101.
因此,正如我認為您可能已經看到的那樣,我們已在美國獲得 SEG101 的優先審查權,並且我們將繼續推進我們在全球範圍內的申請。我們還準備在美國成功推出商業組織、訪問計劃以及我們使用數字技術發起的創新疾病意識活動,我們希望這將真正動員患者社區支持這一點藥品。提醒一下,我們預計在鐮狀細胞病人群中,大約有 60% 的患者有 2 次或更多次血管閉塞性危象,並且有資格接受 SEG101。
So moving to Slide 17 and just to say a word -- a few words about upcoming readouts. We have a number of upcoming readouts in Q3, Q4 and Q1. And wanted to highlight a few of these in my closing comments.
所以轉到幻燈片 17,只想說一句話——關於即將到來的讀數的幾句話。我們在第三季度、第四季度和第一季度有一些即將發布的數據。並想在我的結束語中強調其中的一些。
So if you move to Slide 18, I think as many of you are aware, the PARAGON heart failure studies, the first confirmatory trial that's been -- trying to be conducted in preserved ejection fraction -- large-scale study to be conducted in preserved ejection fraction, or heart failure, using a novel endpoint with recurrent heart failure hospitalization. Our next expected milestones for this are results and filing in the second half of 2019. And we also have a shell that's been posted for the ESC late-breaker. I would note we have not seen the data yet for this study. This is really a shell for the late-breaker presentation. The study was intentionally designed to assess Entresto's impact on the burden of disease with these repeat hospitalizations. We believe the study design looking at that primary endpoint, as well as other elements we've learned from past failures in preserved injection heart -- fraction heart failure, will give us the best possible chance of succeeding in a patient population that's never had an approved medicine. So we'll look forward to giving you updates as soon as we can. And hopefully, we'll have positive results to share later this year.
所以如果你轉到幻燈片 18,我想你們中的許多人都知道,PARAGON 心力衰竭研究,這是第一個驗證性試驗——試圖在保留射血分數的情況下進行——將在保留的情況下進行的大規模研究射血分數,或心力衰竭,使用新的端點與復發性心力衰竭住院治療。我們的下一個預期里程碑是 2019 年下半年的結果和備案。我們還有一個為 ESC late-breaker 發布的 shell。我會注意到我們還沒有看到這項研究的數據。這實際上是一個 late-breaker 演示文稿的外殼。該研究旨在評估 Entresto 對這些重複住院的疾病負擔的影響。我批准的藥物。因此,我們期待盡快為您提供更新。希望我們能在今年晚些時候分享積極的成果。
So moving to Slide 19, I also wanted to say a word about ofatumumab, which is our -- a subcutaneous B-cell depletion agent targeting the CD20 target to provide -- which has the potential to provide access to high-efficacy B-cell therapy for a broad RMS patient population. We believe taking a medicine that is highly efficacious, moving it subcutaneous to give patients full flexibility, the potential to avoid having to go regularly in for a lengthy intravenous infusion process, will be welcomed by providers and by patients and could potentially allow the more broad use of B-cell depleting agents in RMS.
轉到幻燈片 19,我還想談談奧法木單抗,這是我們提供的一種針對 CD20 靶標的皮下 B 細胞耗竭劑,它有可能提供高效 B 細胞廣泛的 RMS 患者群體的治療。我們相信,採用一種高效的藥物,將其轉移到皮下以給予患者充分的靈活性,避免必須定期進行長時間的靜脈輸注過程的可能性,將受到提供者和患者的歡迎,並可能允許更廣泛的應用在 RMS 中使用 B 細胞耗竭劑。
I also wanted to remind the group -- of the data profile that we have for ofatumumab, where we know that with the loading dose we've taken into the Phase III program, 60 milligrams Q12 dosing to start, we've seen very rapid B-cell depletion, and you can see that in the attached graph. Then what we expect is with monthly dosing, we can maintain that B-cell depletion and hopefully avoid some of the rebound that you might see in drugs that are dosed less frequently, especially towards the end of the therapy timing. So we wouldn't want to see that rebound, so we believe monthly dosing will hopefully keep those B cells down.
我還想提醒小組——我們擁有的 ofatumumab 數據概況,我們知道在 III 期計劃中我們採用的負荷劑量,60 毫克 Q12 劑量開始,我們已經看到非常快B 細胞耗竭,您可以在附圖中看到這一點。然後我們期望每月給藥,我們可以維持 B 細胞耗竭,並希望避免您可能在給藥頻率較低的藥物中看到的一些反彈,尤其是在治療時間結束時。所以我們不希望看到這種反彈,所以我們相信每月給藥有望使這些 B 細胞下降。
On the flip side, we know that when we stop therapy, the B-cell repletion will happen in case safety signals are seen. So we think it could be a positive both from an efficacy and a safety standpoint. And ultimately of course, the data will tell us. So we'll look forward to provide that data to you later this year and hopefully bring something to patients that's flexible, self-administered and provides an approved overall profile.
另一方面,我們知道當我們停止治療時,如果看到安全信號,B 細胞就會充滿。因此,我們認為從功效和安全的角度來看,這可能是積極的。當然,最終,數據會告訴我們。因此,我們期待在今年晚些時候向您提供這些數據,並希望為患者帶來一些靈活、自我管理並提供經批准的整體概況的東西。
So moving to Slide 20. Now I just want to say a word as well about fevipiprant, our oral DP2 agent to tackle severe asthma. Just a reminder, on the left-hand side, our goal here is to address the so-called treatment gap in severe asthma. We know that there are 3.4 million patients, in GINA 3 moderate patients, who are on inhaled therapies. But these patients -- many of these patients progress and need something beyond their inhaled therapeutics. Well, we know there's only 120,000 patients on biologics, which leaves a significant gap of 3 million patients either with high EOs or all-comers that need a better option to enable them to be in control of their asthma before potentially needing a biologic or perhaps in lieu of a biologic.
所以轉到幻燈片 20。現在我只想說說 fevipiprant,我們用於治療嚴重哮喘的口服 DP2 藥物。提醒一下,在左側,我們的目標是解決所謂的嚴重哮喘治療差距。我們知道有 340 萬患者,在 GINA 中有 3 名中度患者接受吸入治療。但是這些患者——這些患者中的許多人正在進步並且需要一些超出他們吸入療法的東西。好吧,我們知道只有 120,000 名患者使用生物製劑,這就留下了 300 萬患者的顯著差距,這些患者要么是高 EO 要么是所有患者都需要更好的選擇,以便在可能需要生物製劑或可能需要生物製劑之前控制他們的哮喘代替生物製品。
We have a sizable Phase III program of 5 separate studies. LUSTER 1 and 2 looks at exacerbations. We have an endpoint there that tries to put us in line with the exacerbation reduction seen with biologics. We have ZEAL 1 and 2 that target lung function. And then we have the SPIRIT trial that's looking at safety. So we'll look forward to providing you additional data. ZEAL 1 and 2, we would expect the data release in Q4, and LUSTER 1 and 2 in Q1 of 2020.
我們有一個由 5 項獨立研究組成的相當大的 III 期項目。LUSTER 1 和 2 著眼於惡化。我們在那裡有一個終點,試圖讓我們與生物製劑的惡化減少保持一致。我們有針對肺功能的 ZEAL 1 和 2。然後我們進行了關注安全性的 SPIRIT 試驗。因此,我們期待為您提供更多數據。ZEAL 1 和 2,我們預計將在 2020 年第 4 季度發布數據,而 LUSTER 1 和 2 將在 2020 年第 1 季度發布。
So lastly, I wanted to just introduce -- we have here in the room Marie-France Tschudin, who's been appointed President of Novartis Pharmaceuticals. She's of course a member of our Executive Committee. We're thrilled to have her. She's had 25 years of experience in pharma and biotech, including a lengthy period at Celgene. Most importantly for us, she's a purpose-driven leader who lives the culture we're trying to build at the company every day: Our unbossed, inspired, curious culture. She joined us in 2017, has held a few different roles. And we'll look forward to supporting her with great success here at Novartis Pharmaceuticals.
所以最後,我想介紹一下——我們在場的 Marie-France Tschudin,她被任命為諾華製藥公司的總裁。她當然是我們執行委員會的成員。我們很高興有她。她在製藥和生物技術領域擁有 25 年的經驗,包括在 Celgene 的長期工作。對我們來說最重要的是,她是一位以目標為導向的領導者,她每天都在踐行我們在公司努力打造的文化:我們不受約束、充滿靈感、充滿好奇的文化。她於 2017 年加入我們,擔任過幾個不同的角色。我們期待著支持她在諾華製藥取得巨大成功。
So thank you very much. And I'll hand it over to Harry for some more details on the financials.
非常感謝。我會把它交給 Harry,了解有關財務的更多細節。
Harry Kirsch - CFO
Harry Kirsch - CFO
Thank you, Vas. Good morning and good afternoon, everyone. My comments refer to the continued operations results, and growth rates are in constant currencies unless otherwise noted.
謝謝你,瓦斯。大家早上好,下午好。我的評論指的是持續經營業績,除非另有說明,否則增長率均以固定匯率計算。
So Slide 23 shows a summary of our quarter 2 and first half continuing operations performance. In quarter 2, sales grew 8% mainly driven by continued momentum of Cosentyx and Entresto and our Oncology growth drivers, including Lutathera, Taf/Mek, Promacta, Kisqali and Kymriah.
所以幻燈片 23 顯示了我們第二季度和上半年持續經營業績的總結。第二季度,銷售額增長 8%,主要受 Cosentyx 和 Entresto 的持續增長勢頭以及我們的腫瘤學增長驅動因素(包括 Lutathera、Taf/Mek、Promacta、Kisqali 和 Kymriah)的推動。
Core operating income and core EPS both grew 20%, mainly driven by higher sales and productivity, partly offset by growth investments. On free cash flow, we had $3.6 billion, up 11% in U.S. dollars, mainly driven by the strong operating performance and the divestment proceeds from the sale of our Klybeck site here in Basel. These positive cash flows were partly offset by OTC joint venture dividends which we received for the last time in quarter 2 2018.
核心營業收入和核心每股收益均增長 20%,主要受銷售額和生產力提高的推動,部分被增長投資所抵消。在自由現金流方面,我們有 36 億美元,按美元計算增長 11%,這主要是由於強勁的經營業績和出售我們在巴塞爾的 Klybeck 場地的撤資收益。這些正現金流部分被我們在 2018 年第二季度最後一次收到的 OTC 合資企業股息所抵消。
Net income in the quarter for continuing operations was $2.1 billion and $4 billion in the first half. The slide you see here, this reported net income numbers versus prior year is due to the $5.7 billion OTC joint venture divestment gain we recorded in quarter 2 of last year.
本季度持續經營淨收入為 21 億美元,上半年為 40 億美元。你在這裡看到的幻燈片,這個報告的淨收入數字與去年相比是由於我們在去年第二季度記錄的 57 億美元的 OTC 合資企業撤資收益。
On Slide 24, you see the quarter 2 core margin by division. Continuing operations, margin improved by about 3 percent points in the quarter and the first half, driven by Innovative Medicines division. The Innovative Medicines' strong sales leverage and productivity were the key drivers of the margin expansion. While there was sales growing 9%, we are expanding margin while still increasing investments in our key growth drivers and pre-launches.
在幻燈片 24 上,您可以看到按部門劃分的第 2 季度核心利潤率。在創新藥物部門的推動下,本季度和上半年的持續運營利潤率提高了約 3 個百分點。Innovative Medicines 強大的銷售槓桿和生產力是利潤率擴張的主要驅動力。雖然銷售額增長了 9%,但我們正在擴大利潤率,同時仍在增加對關鍵增長驅動因素和預發布的投資。
There were also a couple of favorable onetime items this quarter in the IM core margin. Pre-launch inventory provision releases after the regulatory approvals of Zolgensma and Piqray contributed about 1 margin point. The continued Diovan and Exforge growth due to generics valsartan supply shortages contributed about 0.5 margin point. So the total Innovative Medicines margin improved 370 basis points to 35.4% of sales. If we exclude the onetime effects described earlier, the Innovative Medicines margin would have been around 34% of sales.
本季度 IM 核心利潤率也有一些有利的一次性項目。在 Zolgensma 和 Piqray 的監管批准後發布的上市前庫存撥備貢獻了約 1 個利潤點。由於仿製藥纈沙坦供應短缺,Diovan 和 Exforge 的持續增長貢獻了約 0.5 個利潤點。因此,創新藥物的總利潤率提高了 370 個基點,達到銷售額的 35.4%。如果我們排除前面描述的一次性影響,創新藥物的利潤率將約為銷售額的 34%。
Sandoz improved by 140 basis points, the margin. And this was driven by sales growth, positive product, geographic mix, productivity and cost discipline as we continue the Sandoz transformation.
Sandoz 利潤率提高了 140 個基點。隨著我們繼續 Sandoz 轉型,這是由銷售增長、積極的產品、地理組合、生產力和成本紀律推動的。
On to Slide 25. So in light of this very strong first half performance, we are revising upwards our 2019 full year guidance. For the new focus medicines company: Net sales are revised upwards, expected to grow mid- to high single digit; core operating income revised upwards, expected to grow low double-digit to mid-teens. And from a divisional perspective, we revised Innovative Medicines sales guide upwards to grow mid- to high single digit. And the Sandoz sales guidance is also revised upwards to broadly in line to a low single-digit growth.
轉到幻燈片 25。因此,鑑於上半年的強勁表現,我們正在上調 2019 年全年指引。新焦點醫藥:淨銷售額上調,預計增長中高個位數;核心營業收入向上修正,預計將以兩位數的低位增長至十幾歲左右。從部門的角度來看,我們向上修訂了創新藥物銷售指南,以實現中高個位數增長。山德士的銷售指引也向上修正,大致符合低個位數增長。
We now also expect, just a word on the tax rate, our full year core tax rate to be in line with what you see on the half 1 core tax rate of 16.4%. The increase both versus the previous year as well as versus our original 16% is driven by some profit mix changes.
我們現在還預計,就稅率而言,我們的全年核心稅率將與您在上半年 16.4% 的核心稅率上看到的一致。與上一年相比以及與我們最初的 16% 相比的增長是由一些利潤組合變化推動的。
On Slide 26, I want to talk through some of the dynamics for the first and expected dynamics for the second half of 2019. Clearly, the half 1 performance was very strong with core operating income growing 19%. This was mainly driven by the continued sales momentum of our growth drivers as well as ongoing productivity programs. We, of course, expect these to continue in the second half.
在幻燈片 26 上,我想談談 2019 年下半年上半年和預期動態的一些動態。顯然,上半年的業績非常強勁,核心營業收入增長了 19%。這主要是由於我們增長動力的持續銷售勢頭以及正在進行的生產力計劃。當然,我們預計這些將在下半年繼續。
In the first half, we also benefited, as mentioned earlier, from valsartan competitor supply shortages which resulted in double-digit growth for Diovan and Exforge. Recall that this supply issue and Diovan-Exforge growth started in quarter 3 of 2018 and may stop at any time. Hence, also in quarter 3, we begin to lap the growth in the base from this valsartan situation.
上半年,如前所述,我們還受益於纈沙坦競爭對手的供應短缺,這導致 Diovan 和 Exforge 實現了兩位數的增長。回想一下,這個供應問題和 Diovan-Exforge 的增長始於 2018 年第 3 季度,並可能隨時停止。因此,同樣在第 3 季度,我們開始從這種纈沙坦情況中獲得基數增長。
As we look at the second half, we are expecting potential increased generics headwinds, particularly on AFINITOR, Exjade and some older ophtha brands. Furthermore, we continue to monitor generic activities on Sandostatin LAR. Now as discussed on the quarter 1 call, we were expecting these generic headwinds earlier in the year, basically in quarter 2. There is of course a potential that we continue to see less generic headwinds than expected also in quarter 3. In that case, if that situation would come up, I would assume that we end the year 2019 at the higher end of our full year core operating income guidance, but it's a bit too early to tell. And I'm sure we will discuss this topic again at the quarter 3 call.
展望下半年,我們預計仿製藥的逆風可能會增加,尤其是 AFINITOR、Exjade 和一些較老的眼科品牌。此外,我們繼續監測 Sandostatin LAR 的通用活動。正如在第一季度電話會議上所討論的那樣,我們預計今年早些時候會出現這些通用逆風,基本上是在第二季度。當然,我們在第三季度也有可能繼續看到比預期更少的通用逆風。在這種情況下,如果出現這種情況,我會假設我們將在 2019 年結束時達到全年核心營業收入指引的較高端,但現在下結論還為時過早。我相信我們會在第 3 季度的電話會議上再次討論這個話題。
On Slide 27, you see how currencies would impact our results. If mid-July rates prevail for the remainder of 2019, the full year impact on sales would be negative 3%, and on core operating income, would be a negative 4%. And as you know, every month, we update the expected currency impact on our website.
在幻燈片 27 上,您可以看到貨幣將如何影響我們的結果。如果 7 月中旬的利率在 2019 年剩餘時間內占主導地位,全年對銷售額的影響將為負 3%,對核心營業收入的影響將為負 4%。如您所知,我們每個月都會在網站上更新預期的貨幣影響。
And with that, I hand back to Vas.
就這樣,我交還給 Vas。
Vasant Narasimhan - CEO
Vasant Narasimhan - CEO
Thank you, Harry.
謝謝你,哈利。
(technical difficulty)
(技術難度)
And so in conclusion, a very strong first half to 2019. And when you take a step back over the last 18 months of the company, we've been able to do over $60 billion of transactions to transform the company. We've set 5 priorities in place to truly drive performance, starting with culture and innovation. And it's starting to pay off, we believe: Strong sales and margin expansion, double-digit core operating income growth, the innovation pipeline is really kicking in, catalyst-rich second half. And we'll look forward to continue to keep you updated in the second half of the year.
總而言之,到 2019 年上半年非常強勁。當你回顧過去 18 個月的公司時,我們已經能夠進行超過 600 億美元的交易來改造公司。我們已經確定了 5 個優先事項來真正推動績效,從文化和創新開始。我們相信它開始得到回報:強勁的銷售和利潤率擴張,兩位數的核心營業收入增長,創新管道真正開始,下半年催化劑豐富。我們期待在下半年繼續為您提供最新信息。
So with that, I'll open it up for questions.
因此,我將打開它提問。
Operator
Operator
(Operator Instructions) Your first question comes from the line of Graham Parry of Bank of America.
(操作員說明)您的第一個問題來自美國銀行的 Graham Parry。
Graham Glyn Charles Parry - MD and Head of Healthcare Equity Research
Graham Glyn Charles Parry - MD and Head of Healthcare Equity Research
So the first one's on Zolgensma and the $100 million inventory expectations for a quarter or perhaps the second half of the year. Just trying to get a feel for what sort of inventory you would have built prior to launch.
因此,第一個是關於 Zolgensma 的,以及一個季度或下半年的 1 億美元庫存預期。只是想了解一下您在發布之前會建立什麼樣的庫存。
Secondly, on label expansion with the SPR1NT data, could you give us some time lines of when you expect to meet with FDA? And whether you think a 2H filing on the back of that still remains possible? And similar for the STRONG data on the intrathecal filing as well.
其次,關於 SPR1NT 數據的標籤擴展,您能否給我們一些您預計何時會見 FDA 的時間表?您是否認為在此基礎上提交 2H 文件仍然可行?與鞘內歸檔的 STRONG 數據類似。
And then thirdly on both PARAGON and the ofatumumab data, you submitted both for medical conferences. You flagged that you don't have the data in house yet on PARAGON. But would you issue a headlined press release on the data when it comes? Or do we have to wait for ESC? And a similar question for ofatumumab, ASCLEPIOS has data submitted for ECTRIMS, and do you have data in house there? Or should we expect a headline press release somewhat imminently?
第三,關於 PARAGON 和 ofatumumab 的數據,你們都提交給了醫學會議。您在 PARAGON 上標記說您還沒有內部數據。但是,當數據出現時,你會發布一份帶標題的新聞稿嗎?還是必須等ESC?還有一個關於 ofatumumab 的類似問題,ASCLEPIOS 已經為 ECTRIMS 提交了數據,你們那裡有數據嗎?還是我們應該期待即將發布的頭條新聞稿?
And final on Gilenya, just can you give us an update on where you are with your Mylan declaratory judgement and preliminary injunction? And whether the API win that you had, do you think, strengthens your hand in settlement negotiations with generics now?
最後關於 Gilenya,您能否向我們介紹一下您對 Mylan 宣告性判決和初步禁令的最新進展?你認為你贏得的 API 是否會加強你現在與仿製藥的和解談判?
Vasant Narasimhan - CEO
Vasant Narasimhan - CEO
Thanks, Graham. So on the Zolgensma $100 million provision. Harry?
謝謝,格雷厄姆。所以在 Zolgensma 上有 1 億美元的準備金。哈利?
Harry Kirsch - CFO
Harry Kirsch - CFO
Yes. Thank you, Graham, for the question. So we basically -- from an IFRS standpoint, we basically expense or write-down immediately any production of product that is not yet approved. It happens on every product. And then once approval is there, the inventory basically gets written up and there's inventory provision release. Now in this quarter, we got 2 products approved, Zolgensma and Piqray, and therefore had roughly $100 million north inventory provision release in OIE, where you see it.
是的。謝謝格雷厄姆提出的問題。所以我們基本上 - 從 IFRS 的角度來看,我們基本上會立即支出或減記任何尚未批准的產品生產。它發生在每個產品上。然後一旦獲得批准,庫存基本上就會被記錄下來,庫存準備金就會發放。現在在本季度,我們獲得了 2 種產品的批准,Zolgensma 和 Piqray,因此在 OIE 中釋放了大約 1 億美元的北方庫存撥備,你可以看到。
That -- now that happened last time, I think -- usually, this happens and you don't even notice as much, it's smaller numbers. Last time this was a large number was 7 years back with Entresto approval. But it's normal practice. And basically, that presents on these products what has been produced over the -- since -- on AveXis since we acquired. And is of course also showing that production is going extremely well. And we are ready to supply many, many patients with it.
那——我認為上次發生過——通常情況下,這種情況發生了,你甚至沒有註意到那麼多,它是較小的數字。上一次這是一個很大的數字是 7 年前獲得 Entresto 批准的。但這是正常的做法。基本上,這些產品展示了自我們收購以來在 AveXis 上生產的產品。當然也表明生產進行得非常順利。我們準備好為很多很多患者提供它。
Vasant Narasimhan - CEO
Vasant Narasimhan - CEO
And does not necessarily indicate anything about sales expectations. I think that's it.
並且不一定表示有關銷售預期的任何信息。我想就是這樣。
Harry Kirsch - CFO
Harry Kirsch - CFO
No. I mean, I would not -- first of all, we were -- of course, this is a product that has long shelf life. So -- and production of course is important, and we want to make sure that we are ready to supply any sales scenario.
不。我的意思是,我不會——首先,我們是——當然,這是一種保質期很長的產品。所以 - 生產當然很重要,我們希望確保我們準備好提供任何銷售方案。
Vasant Narasimhan - CEO
Vasant Narasimhan - CEO
Yes. And I would say also on Zolgensma production, it's going well. We have, in addition to our Chicago, North Carolina facility, acquired a facility in Colorado. This year, we'll have ample capacity up to 1,000 patients plus. And then we'll plan to expand capacity there going forward.
是的。我還要說 Zolgensma 的生產,進展順利。除了我們在北卡羅來納州芝加哥的工廠外,我們還在科羅拉多州收購了一家工廠。今年,我們將有足夠的容量容納 1,000 名以上的患者。然後我們將計劃在未來擴大產能。
Now with respect to the SPR1NT and STRONG studies. So SPR1NT is now technically covered by our existing label, the treatment of patients in the presymptomatic phase. So we would plan to present updates on that data, per the slide, I think, at WMS. And -- but it wouldn't affect our filing.
現在關於 SPR1NT 和 STRONG 研究。所以 SPR1NT 現在在技術上被我們現有的標籤所涵蓋,即症狀前階段患者的治療。因此,我認為,我們將計劃在 WMS 上根據幻燈片展示該數據的更新。並且 - 但它不會影響我們的備案。
Now with respect to STRONG, our plan is to go to the FDA in Q3 and hopefully come to an agreement on a filing strategy. If there was agreement, we would aspire to file before the end of this year.
現在關於 STRONG,我們的計劃是在第三季度去 FDA 並希望就申請策略達成協議。如果達成協議,我們希望在今年年底前提交申請。
Now moving to PARAGON and ofa, John?
現在轉到 PARAGON 和 ofa,約翰?
John Tsai - Head of Global Drug Development & Chief Medical Officer
John Tsai - Head of Global Drug Development & Chief Medical Officer
Yes, Graham, thanks for the question. And we have very rich second half of the year with data readouts, in Entresto, for PARAGON, ofatumumab as well as fevi. As Vas said earlier, we don't have any of the data in hand. We're obviously very excited about seeing the data in the very near future. We're going to look at these case by case and evaluate whether we will issue press releases moving forward. But what I will say is that we've had to submit some of the abstracts, for example, for Entresto and for PARAGON to the ESC so that we could hold the late-breaking session at ESC. So moving forward, we'll be looking forward and evaluating these case-by-case basis.
是的,格雷厄姆,謝謝你的提問。我們在下半年有非常豐富的數據讀數,在 Entresto 中,用於 PARAGON 、 ofatumumab 和 fevi 。正如 Vas 之前所說,我們手頭沒有任何數據。我們顯然對在不久的將來看到這些數據感到非常興奮。我們將逐案研究這些情況,並評估我們是否會發布新聞稿。但我要說的是,我們必須向 ESC 提交一些摘要,例如 Entresto 和 PARAGON 的摘要,這樣我們才能在 ESC 舉行最新的會議。因此,展望未來,我們將期待並逐案評估這些情況。
Vasant Narasimhan - CEO
Vasant Narasimhan - CEO
Yes. And lastly on Gilenya, we do not expect any launch of a generic Gilenya in 2019. And this is in part because, as you know, Novartis was granted a motion for preliminary injunction which prohibits any generic manufacturers in that case from launching Gilenya until the decision on the patent, which at the earliest would be in March 2020. So we do -- we expect a potential appeal decision in early 2020. But right now, our focus is on vigorously defending the dosage patent and protecting Gilenya for as long as possible.
是的。最後,關於 Gilenya,我們預計 2019 年不會推出任何通用 Gilenya。這在一定程度上是因為,如您所知,諾華獲得了一項初步禁令動議,該動議禁止該案中的任何仿製藥製造商在專利決定之前推出 Gilenya,最早是在 2020 年 3 月。所以我們這樣做了——我們預計可能會在 2020 年初做出上訴決定。但現在,我們的重點是大力捍衛劑量專利並儘可能長時間地保護 Gilenya。
Operator
Operator
Your next question comes from the line of Tim Anderson from Wolfe Research.
您的下一個問題來自 Wolfe Research 的 Tim Anderson。
Timothy Minton Anderson - MD of Equity Research
Timothy Minton Anderson - MD of Equity Research
In my opinion, the 2 most important readouts for Novartis through the rest of the year are PARAGON-HF and the QAW trials. And there's reasons to be cautious with both of those. With PARAGON, no one's succeeded yet in getting a label for HFpEF. And then for QAW, there's been lots of prior failed attempts with that class of drugs. So of those 2 programs, if you had to pick 1 with the higher odds of success on delivering Phase III results that are positive, which would it be?
在我看來,在今年餘下的時間裡,諾華最重要的兩項數據是 PARAGON-HF 和 QAW 試驗。並且有理由對這兩者保持謹慎。使用 PARAGON,還沒有人成功獲得 HFpEF 標籤。然後對於 QAW,之前有很多嘗試使用這類藥物的失敗案例。那麼,在這 2 個項目中,如果你必須選擇 1 個成功機率更高的 III 期陽性結果,你會選哪個?
And then second question is on Cosentyx. About a year ago or so, you guys had kind of repriced the brand in the U.S. to try to get more first-line biologic usage in psoriasis ahead of [KNS]. And I'm wondering how that has evolved and played out. And if you can just talk about that evolution of your first-line biologic usage due to that repricing strategy.
然後第二個問題是關於 Cosentyx 的。大約一年前,你們在美國對該品牌進行了某種重新定價,試圖在 [KNS] 之前獲得更多的銀屑病一線生物製劑使用。我想知道它是如何演變和發揮作用的。如果你能談談由於重新定價策略而導致的一線生物藥物使用的演變。
Vasant Narasimhan - CEO
Vasant Narasimhan - CEO
Thanks, Tim. Well, I'll let John go on his pick and maybe I'll think about my pick. Go ahead, John.
謝謝,蒂姆。好吧,我會讓約翰繼續他的選擇,也許我會考慮我的選擇。去吧,約翰。
John Tsai - Head of Global Drug Development & Chief Medical Officer
John Tsai - Head of Global Drug Development & Chief Medical Officer
Thanks, Tim. If I had to pick one versus the other, I would say there was a differential of about 0.01% difference, perhaps, if I had to differentiate between the 2. But this is my own personal, subjective opinion, which is I would say PARAGON perhaps has a 0.01% chance higher likelihood of success.
謝謝,蒂姆。如果我必須選擇一個與另一個,我會說有大約 0.01% 的差異,如果我必須區分這兩個。但這是我個人的主觀意見,我會說 PARAGON可能有 0.01% 的機會成功。
As you know, there's been numerous trials that have failed in heart failure with preserved ejection fraction. And currently, there is no treatment for this population of patients. We've learned from some of the trials that have been conducted in the past and we've actually incorporated those learnings into our trial for PARAGON. So success in PARAGON really is based on what we have for a primary endpoint: Combination of CV mortality with hospitalizations, whether that would be first-time hospitalizations or recurrent hospitalizations. So we're excited about it and we're looking forward to seeing those results.
如您所知,有許多針對射血分數保留的心力衰竭的試驗均以失敗告終。目前,還沒有針對這部分患者的治療方法。我們從過去進行的一些試驗中吸取了教訓,實際上我們已經將這些經驗融入到我們對 PARAGON 的試驗中。因此,PARAGON 的成功實際上是基於我們對主要終點的了解:CV 死亡率與住院的結合,無論是首次住院還是複發住院。所以我們對此感到興奮,我們期待看到這些結果。
Now in terms of fevi, I wouldn't say it's a lower likelihood of success. It's just I think that asthma is such an unmet -- a significant unmet medical need. And currently, we have the biologics, and there's really no oral treatments beyond your current inhalers. So we have a very extensive and comprehensive clinical program that we call VIBRANT with close to 5,000 patients. But if I had to pick 1 of the 2, it might be slightly higher, but it would almost be on -- par on par. So I'll defer to Vas to see if he has any other comments.
現在就 fevi 而言,我不會說成功的可能性較低。我只是認為哮喘是一個未被滿足的——一個重要的未被滿足的醫療需求。目前,我們擁有生物製劑,除了您當前的吸入器之外,確實沒有口服治療方法。所以我們有一個非常廣泛和全面的臨床項目,我們稱之為 VIBRANT,有近 5,000 名患者。但如果我必須從 2 個中選擇 1 個,它可能會稍微高一些,但它幾乎是 - 同等水平。所以我會聽取 Vas 的意見,看看他是否有任何其他意見。
Vasant Narasimhan - CEO
Vasant Narasimhan - CEO
No, I mean, the only thing I'd add on QAW at fevipiprant is just to remind that the key insight here was to shift the DP2s into more severe patient populations. So we saw a positive result in Phase II presented at ERS a few years ago in patients with high eosinophils. But the class had been explored in the past, but had been explored in GINA 3 or less, so far less severe patients. And so we believe that with the profile of the medicine, its good penetration of the relevant tissues as well as the eosinophil reductions we saw in the Phase II study, that's what really gave us confidence.
不,我的意思是,我唯一要在 fevipiprant 上添加的 QAW 只是提醒這裡的關鍵見解是將 DP2 轉移到更嚴重的患者人群中。因此,我們在幾年前的 ERS 上看到了針對高嗜酸性粒細胞患者的 II 期試驗的陽性結果。但該類過去曾探索過,但曾在 GINA 3 或以下、較不嚴重的患者中探索過。因此,我們相信,憑藉藥物的特性、它對相關組織的良好滲透以及我們在 II 期研究中看到的嗜酸性粒細胞減少,這才是真正給我們信心的原因。
In terms of Cosentyx in first-line biologic use in the U.S., Marie-France?
就 Cosentyx 在美國的一線生物製劑用途而言,Marie-France?
Marie-France Tschudin - President of Novartis Pharmaceuticals
Marie-France Tschudin - President of Novartis Pharmaceuticals
So first of all, it's great to be back. It's a great time to be back in pharma. What I would say is that the performance for Cosentyx has played out as expected after last year's access wins, so we're very happy with that. We do remain confident that we will maintain our #1 or #2 position in our major markets.
所以首先,很高興能回來。現在是重返製藥業的好時機。我要說的是,在去年的訪問勝利之後,Cosentyx 的表現達到了預期,所以我們對此感到非常高興。我們仍然有信心在我們的主要市場保持我們的第一或第二位置。
We see very strong underlying demand, and that is because of Cosentyx' unique profile that does address manifestations beyond skin. We also believe we've got the most robust data, and that will continue. We're also presenting further data later this year, for example PREVENT in non-radiographic axial SpA. We're very confident in the future of Cosentyx in both derm and womb indications.
我們看到非常強勁的潛在需求,這是因為 Cosentyx 的獨特配置確實解決了皮膚以外的表現。我們還相信我們擁有最可靠的數據,而且這種情況將繼續下去。我們還將在今年晚些時候提供更多數據,例如 PREVENT 在非射線照相中軸 SpA 中的應用。我們對 Cosentyx 在皮膚和子宮適應症方面的未來充滿信心。
Vasant Narasimhan - CEO
Vasant Narasimhan - CEO
Maybe if I would just add on the first line, we believe that it was the right strategy to get to the first line because I think the data supported it, but also from a payer perspective, it put us in a strong position. I know there's a lot of focus on the entrants, some of the new entrants coming in. And I think at least what Q2 showed is we were able to hold our own on formulary positioning thus far, and that's going to have to be our focus going forward, to ensure we keep growing share and beating the market in the years to come. But we're on it, and we believe we remain -- continue to believe that first-line usage, and -- keeping it in the first line is critical.
也許如果我只想在第一行添加,我們認為進入第一行是正確的策略,因為我認為數據支持它,而且從付款人的角度來看,它使我們處於有利地位。我知道很多人都關注進入者,一些新進入者。而且我認為至少第二季度表明我們能夠在處方定位上保持自己的地位,這將成為我們未來的重點,以確保我們在未來幾年繼續增長份額並擊敗市場。但我們正在努力,我們相信我們仍然 - 繼續相信一線使用,並且 - 將其保持在一線是至關重要的。
Operator
Operator
The next question comes from the line of Keyur Parekh of Goldman Sachs.
下一個問題來自高盛的 Keyur Parekh。
Keyur Parekh - Equity Analyst
Keyur Parekh - Equity Analyst
Two questions, please, the first one for Vas and then for Harry. Vas, you described the launch for Zolgensma as being very strong and good demand. Can you give us some sense for how many patients have you actually treated so far? Is it kind of single digit? Is it double digits? How should we think about that?
有兩個問題,第一個給 Vas,然後給 Harry。Vas,您將 Zolgensma 的推出描述為非常強勁和良好的需求。您能告訴我們到目前為止您實際治療了多少患者嗎?它是個位數嗎?是兩位數嗎?我們應該如何考慮?
And then secondly, Harry, kind of in your remarks about the differences between the first half and the second half, you alluded to the fact that if there was going to be lower generic impact than you expect, you would get to the higher end of the range you have just issued. Given you've delivered 19% core operating income growth in the first half, it would be difficult mathematically for you to get to anywhere other than the midpoint of the range, even if you were to get a lot of generic competition given the guidance you've given on AFINITOR. So what would it take for you to go above the range? And why isn't that more likely?
其次,哈利,在你關於上半場和下半場之間差異的評論中,你提到了這樣一個事實,即如果一般影響比你預期的要低,你會達到更高端您剛剛發布的範圍。鑑於上半年您的核心營業收入增長了 19%,從數學上講,您很難達到範圍中點以外的任何地方,即使您在指導下獲得了很多仿製藥競爭在 AFINITOR 上給出。那麼,您需要什麼才能超出範圍?為什麼這不是更有可能呢?
Vasant Narasimhan - CEO
Vasant Narasimhan - CEO
Thanks, Keyur. So first on Zolgensma, we're not going to give any specific numbers. But what I would say is we're seeing strong demand in terms of Rxs coming into the hub, which is I think the first marker we were looking for and that steady week-on-week, and that's what we wanted to see and is in line with our plan. We're seeing good conversion of those Rxs through the system, whether it's in Medicaid or in private payers, ultimately into approvals either through the medical exception process or getting policies in place and then ultimately shipping the medicine and getting the patients treated, which is when we ultimately recognize sales.
謝謝,基爾。所以首先在 Zolgensma 上,我們不會給出任何具體數字。但我要說的是,我們看到 Rxs 進入中心的強勁需求,我認為這是我們正在尋找的第一個標記,並且每週都保持穩定,這就是我們想要看到的,並且是符合我們的計劃。我們通過系統看到這些 Rxs 的良好轉換,無論是在醫療補助計劃還是私人支付者中,最終通過醫療例外程序或製定政策獲得批准,然後最終運送藥物並讓患者接受治療,這是當我們最終確認銷售額時。
So we're looking at all 3. We have a great team on it. I think I personally am involved in many elements of this. So I think when we say it's on plan, I think it's exactly what we mean. It's where we wanted it to be. We have a lot of work to do, but we're happy with where we are.
所以我們正在考慮所有 3 個。我們有一個很棒的團隊。我想我個人參與其中的許多因素。所以我認為當我們說它在計劃中時,我認為這正是我們的意思。這是我們想要的地方。我們有很多工作要做,但我們對自己的現狀感到滿意。
Now with respect to the second half, Harry?
現在關於下半場,Harry?
Harry Kirsch - CFO
Harry Kirsch - CFO
Yes, Keyur. We have great momentum, no question. So the first half has been great. And we do expect that the key growth drivers continue to do well, productivity programs to continue to go slightly -- or ahead of expectations.
是的,基爾。毫無疑問,我們勢頭強勁。所以上半場表現很好。我們確實預計,主要的增長動力將繼續表現良好,生產力計劃將繼續略有進展——或超出預期。
The generic impact, we start seeing some. There is [Zaflar] coming in a couple of European countries, so we expect a bit higher generic impact. We see early signs. Of course, we will rigorously defend all of our products, but that starts a bit. And of course, the inventory provision release, will not to this magnitude happen again.
一般影響,我們開始看到一些。[Zaflar] 進入了幾個歐洲國家,因此我們預計通用影響會更高一些。我們看到了早期跡象。當然,我們會嚴格捍衛我們所有的產品,但這有點開始。當然,存貨撥備的釋放,不會再次發生到這種程度。
The second impact -- I don't want to talk down second half year, but we saw the acceleration of our sales momentum in the second half of last year. And also when you compare half 2 margins last year versus half 1, already an increase off the margins last year. So we have also a bit of a base effect, but we expect continued good performance and just mainly the generics, in addition to some of these base effects, basically is the unknown.
第二個影響——我不想談論下半年,但我們看到去年下半年我們的銷售勢頭在加速。而且,當您將去年的一半 2 利潤率與一半 1 的利潤率進行比較時,去年的利潤率已經有所增加。所以我們也有一些基礎效應,但我們期望持續良好的性能,主要是仿製藥,除了其中一些基礎效應,基本上是未知的。
Operator
Operator
Your next question comes from the line of Andrew Baum of Citi.
你的下一個問題來自花旗銀行的 Andrew Baum。
Andrew Simon Baum - Global Head of Healthcare Research and MD
Andrew Simon Baum - Global Head of Healthcare Research and MD
First question is I note that you provisioned $700 million in relation to the DOJ case related to Diovan. Given your Chief Legal Counsel is on the call, perhaps you might care to talk to any anticipated changes to your corporate integrity agreement in terms of the addition of any onerous impact for your marketing activities going forward?
第一個問題是,我注意到您為 DOJ 與 Diovan 相關的案件撥備了 7 億美元。鑑於您的首席法律顧問正在接聽電話,也許您可能想談談您的公司誠信協議的任何預期變化,以增加對您未來營銷活動的任何繁重影響?
Second, on Zolgensma, historically, Novartis has provided guidance for full year for the newly launched product. I think Entresto and Cosentyx. I wonder whether you might care to do so in this case.
其次,在 Zolgensma 上,從歷史上看,諾華(Novartis)公司為新推出的產品提供了全年的指導。我認為是 Entresto 和 Cosentyx。我想知道在這種情況下您是否願意這樣做。
And then finally, I know you're not exposed to government plan anywhere near as much as some of your peers, but I also remember, Vas, you enthusiastically embraced the proposed rebate reforms being for patients and by inference for the industry. Now that's no longer in place, I'd be interested to hear your thoughts on how you assess the risks for U.S. reimbursement and pricing given the pressures from both sides of the aisle.
最後,我知道你不像你的一些同行那樣接觸政府計劃,但我也記得,瓦斯,你熱情地接受了針對患者和推論行業的擬議退稅改革。現在已經不存在了,我很想听聽您對如何評估美國報銷和定價風險的想法,因為來自過道雙方的壓力。
Vasant Narasimhan - CEO
Vasant Narasimhan - CEO
Thanks, Andrew. So first on the provision, I'll answer the question. We've taken the legal provision of about $700 million related to the Southern District case. We've taken the provision in the context of the ongoing settlement discussion, and I think you can understand we can't comment further as the discussions are ongoing. And once we have a further update, we'll of course provide it, but I don't want to pre-speak against those negotiations. With respect to providing full year guidance, I can't recall what we did when, but I think with Zolgensma, we're focused on getting the fundamentals in place, getting a very strong launch and getting as many patients as possible in the just, call it, the prevalent pool, patients who are not new newly diagnosed and trying to get all of the patients that are newly diagnosed if we can. So we're not going to give any guidance. But anyway, you'll see it all in Q3, and I got to say we feel really good about where we are, we feel good about the trajectory we're seeing thus far.
謝謝,安德魯。所以首先關於條款,我會回答這個問題。我們已經採取了與南區案件相關的約 7 億美元的法律條款。我們在正在進行的和解討論中採用了該條款,我想你可以理解我們無法進一步評論,因為討論正在進行中。一旦我們有進一步的更新,我們當然會提供它,但我不想預先反對這些談判。關於提供全年指導,我不記得我們什麼時候做了什麼,但我認為對於 Zolgensma,我們專注於讓基本面到位,獲得非常強大的發布並在剛剛的時間內獲得盡可能多的患者,稱之為普遍池,不是新診斷的患者,如果可以的話,我們試圖讓所有新診斷的患者。所以我們不會提供任何指導。但無論如何,你會在第三季度看到這一切,我不得不說我們對我們所處的位置感覺非常好,我們對迄今為止看到的軌跡感覺很好。
Lastly, with respect to U.S. government policy. Certainly, the environment is very fluid. You can imagine we need to stay very close to it. Very difficult for us to predict between the executive branch and between the various proposals between the committees and the Senate, which ones will ultimately prevail or if they come in the end to full legislative vote. So hard to comment on specifics. Also hard to comment on specifics because we haven't actually seen on paper any of the proposed legislation, proposed rules or proposed bills.
最後,關於美國政府的政策。當然,環境非常多變。你可以想像我們需要非常接近它。我們很難預測行政部門之間以及委員會和參議院之間的各種提案之間,哪些提案最終會佔上風,或者它們最終是否會獲得立法機構的全面投票。很難對細節發表評論。也很難對細節發表評論,因為我們實際上還沒有在紙面上看到任何擬議的立法、擬議的規則或擬議的法案。
In broad strokes, we, as a company, remain supportive of many of the reforms, whether that's around transparency, whether that's around some of the elements addressed by the CREATES Act, enabling stronger access to biosimilars, reforming Part B, thinking about the patient caps in Part D, all of these things are things that we're open and supportive of. But until we see something concretely on paper, it's difficult to say and difficult to really determine how any of this will progress. So we look forward with you to get more updates as the year progresses. I would want to highlight that we are very low exposure relative to our peer group, and we are -- amongst the leaders ex U.S. in the world in medicines, depending on how you look at it #1 in Europe and amongst the leaders around the world. In the U.S., we're low exposed to these government programs relative to our peers. So that also, I think, creates a positive relative situation for us.
概括地說,作為一家公司,我們仍然支持許多改革,無論是圍繞透明度,還是圍繞 CREATES 法案所涉及的一些要素,加強對生物仿製藥的獲取,改革 B 部分,考慮患者D 部分的上限,所有這些都是我們開放和支持的事情。但在我們在紙面上看到具體的東西之前,很難說,也很難真正確定這將如何發展。因此,隨著時間的推移,我們期待與您一起獲得更多更新。我想強調的是,相對於我們的同行群體,我們的曝光率非常低,而且我們是——除美國外,在世界醫藥領域處於領先地位,這取決於你如何看待它在歐洲和全球領先地位中排名第一世界。在美國,與同行相比,我們對這些政府計劃的接觸程度較低。因此,我認為,這也為我們創造了一個積極的相對局面。
Operator
Operator
Your next question comes from the line of Peter Welford from Jefferies.
你的下一個問題來自 Jefferies 的 Peter Welford。
Peter James Welford - Senior Equity Analyst
Peter James Welford - Senior Equity Analyst
Just got a few quick ones. Firstly just for Harry, on the margins. We all know obviously the Innovative Medicines margin long-term gain basically goes to around mid-30%. Just curious as to whether or not we should think of that now as being conservative or should we think that to be likely to be hit sooner?
剛得到幾個快速的。首先只是為了哈利,在邊緣。眾所周知,創新藥物的利潤率長期收益基本上達到 30% 左右。只是好奇我們現在是否應該認為這是保守的,還是我們應該認為它可能會更快受到打擊?
I guess I'm asking is it likely potentially you start back to see the conservative number where you can likely go ahead of that? Or is it more likely that, that mid-30% will just be achieved before the initial 2022 guidance.
我想我是在問你是否有可能重新開始查看保守數字,你可能會領先於此?或者更有可能的是,在 2022 年最初的指導方針之前達到 30% 的中期。
Just secondly then, on Piqray, you mentioned that the sales for Zolgensma and Mayzent could be disclosed in the third quarter, but there is no mention of Piqray. Should we be taking that, I guess, to mean that Piqray with the companion diagnostic is going to take longer for sales to build? Or should we also anticipate some further visibility on Piqray during the quarter?
其次,在 Piqray 上,你提到 Zolgensma 和 Mayzent 的銷售額可以在第三季度披露,但沒有提到 Piqray。我想,我們是否應該認為這意味著帶有伴隨診斷的 Piqray 需要更長的時間才能建立銷售?或者我們是否也應該期待在本季度對 Piqray 有更多的了解?
Vasant Narasimhan - CEO
Vasant Narasimhan - CEO
So, on the margin, Harry?
那麼,在邊際上,哈利?
Harry Kirsch - CFO
Harry Kirsch - CFO
Peter, so as we all know, quarterly margins are also a bit volatile. So for example, last year, in quarter 3 we had a 34% margin. We entered the year at 32%, and we made good progress in 2017, 31%, last year, 32%. Now if you take a bit of the onetimers out, the first half, we are in the range of 33% to 34%. So good progress. Now could we achieve on a full year basis a bit earlier, we have to see. The big 2 or 3 big components, I would say, that will determine that. One, is the Gilenya defense. That is, of course, a big piece. We are confident, but of course, when we gave the mid-30 guidance it was not part of it. So that would certainly be helpful and potential upside. If it holds longer than that, then we will do everything that it would, but too early to update our guidance. And the other element is, of course, how the launches are doing, and we have many of them. Good, good progress overall, and I think what I'm highly confident about is how our productivity efforts are progressing. That's fully in our own control, and was part of our, I would say, overdelivery in the first half already. But of course, the first 2 elements I described we have to see how it develops over the next quarters.
彼得,眾所周知,季度利潤率也有點波動。例如,去年第三季度我們的利潤率為 34%。我們以 32% 的速度進入了這一年,我們在 2017 年取得了良好的進展,31%,去年,32%。現在,如果你去掉一些一次性的,上半年,我們在 33% 到 34% 的範圍內。這麼好的進展。現在我們能否提前一點實現全年目標,我們必須拭目以待。我會說,2 或 3 個大的組成部分將決定這一點。一,是 Gilenya 防守。那當然是一大塊。我們有信心,但當然,當我們給出 30 年代中期的指導時,它並不是其中的一部分。所以這肯定會有幫助和潛在的好處。如果它持續的時間比這更長,那麼我們將盡其所能,但更新我們的指南還為時過早。當然,另一個因素是發布的情況,我們有很多。好,總體上取得了良好的進展,我認為我非常有信心的是我們的生產力工作是如何取得進展的。這完全在我們自己的控制之下,而且我想說,我們已經在上半年超額交付了。但當然,我描述的前兩個要素我們必須看看它在接下來的幾個季度中如何發展。
Vasant Narasimhan - CEO
Vasant Narasimhan - CEO
And then on Piqray?
然後在 Piqray 上?
Susanne Schaffert - President of Novartis Oncology
Susanne Schaffert - President of Novartis Oncology
Peter, as Mayzent and Zolgensma, there's no difference in terms of the disclosure for Piqray. As Vas said, we're off to a very solid start. As you know, Piqray is approved together with a companion diagnostic for PIK3CA mutation testing from Qiagen and both of that is already included in the NCCN guidance. We are engaging these payers, covering 80% of the target population. And as you -- as we emphasized last time, obviously focus is on testing because that's the condition for Piqray treating, and we have to say that testing is going up, and we expect this to continue.
Peter,作為 Mayzent 和 Zolgensma,在 Piqray 的披露方面沒有區別。正如 Vas 所說,我們的開端非常穩固。如您所知,Piqray 與 Qiagen 的 PIK3CA 突變測試伴隨診斷一起獲得批准,並且兩者都已包含在 NCCN 指南中。我們正在吸引這些支付者,覆蓋 80% 的目標人群。正如你——正如我們上次強調的那樣,顯然重點是測試,因為這是 Piqray 治療的條件,我們不得不說測試正在上升,我們希望這種情況繼續下去。
Operator
Operator
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。
Stephen Michael Scala - MD & Senior Research Analyst
Stephen Michael Scala - MD & Senior Research Analyst
I have a few. First, on Zolgensma. Based on the strong reception in the market, it would seem an average of 5 to 10 patients could be put on the drug per week in Q3. Would you like to take this opportunity to suggest that that expectation is too aggressive, too conservative or are you unsure? All of your comments on the call so far have been plural, patients, Rxs, plans, contracts. So based on what you've said it would seem like that would be a good range.
我有幾個。首先,關於 Zolgensma。基於市場的強烈反應,似乎在第三季度平均每周可以有 5 到 10 名患者使用該藥物。您是否想藉此機會表明這種期望過於激進、過於保守或者您不確定?到目前為止,您對電話的所有評論都是複數、患者、Rxs、計劃、合同。所以根據你所說的,這似乎是一個很好的範圍。
Second, if PARAGON is a clear success or a clear failure, wouldn't you have to issue a top line release before ESC? So no top front line release implies fuzzy data at ESC? And then lastly, what are some reasons why Mayzent cannot duplicate Gilenya's first year sales, which were nearly $0.5 billion given a superior profile and label?
其次,如果 PARAGON 明顯成功或明顯失敗,您是否必須在 ESC 之前發布頂線版本?所以沒有頂級前線發布意味著 ESC 的數據模糊?最後,為什麼 Mayzent 不能複制 Gilenya 第一年的銷售額,即近 5 億美元的卓越形象和標籤,有哪些原因?
Vasant Narasimhan - CEO
Vasant Narasimhan - CEO
Thank you, Steve. Always well-phrased questions from Steve. On Zolgensma, unfortunately, I cannot provide specifics on patients per week. I think what we would say is we are in the plurals range on all of the things you mentioned, and so we continue to see very solid uptake, and we are seeing that uptake every week. And so I think it's been positive. Every week, in terms of patients, every week in terms of plan, plans in terms of policies, every week as well in terms of contracting. So good momentum, and we look forward to sharing details in quarter 3. In terms of the PARAGON top line release, John?
謝謝你,史蒂夫。史蒂夫總是提出措辭恰當的問題。不幸的是,在 Zolgensma 上,我無法提供每週患者的具體情況。我想我們要說的是,我們在你提到的所有事情上都處於復數範圍內,因此我們繼續看到非常穩固的吸收,而且我們每週都會看到這種吸收。所以我認為這是積極的。每週,就患者而言,每週就計劃而言,計劃就政策而言,每週以及合同方面。如此良好的勢頭,我們期待在第 3 季度分享細節。就 PARAGON 頂線發布而言,約翰?
John Tsai - Head of Global Drug Development & Chief Medical Officer
John Tsai - Head of Global Drug Development & Chief Medical Officer
Yes. Thanks, Steve. As I have had a chance to look at various clinical trials, especially the large ones in cardiovascular clinicals, we've seen that results are sometimes difficult to interpret because it takes longer for us to either look at subgroups or sometimes there are secondary endpoints that we need to understand. So it will be great if it were clear and it will be great if it were clearly positive. Then I think that would be a very easy decision for us to move forward. But obviously, it really depends on the results that we see, and we do have some secondary endpoints as well as some sub-studies so we'll have to await what those are.
是的。謝謝,史蒂夫。由於我有機會查看各種臨床試驗,尤其是心血管臨床中的大型試驗,我們發現結果有時難以解釋,因為我們需要更長的時間來查看亞組,或者有時存在次要終點我們需要了解。所以,如果它是明確的,那就太好了,如果它是明確積極的,那就太好了。然後我認為這將是我們前進的一個非常容易的決定。但顯然,這真的取決於我們看到的結果,我們確實有一些次要終點和一些子研究,所以我們必須等待它們是什麼。
Vasant Narasimhan - CEO
Vasant Narasimhan - CEO
And then lastly on Mayzent. Marie-France, you want to just take that?
最後是 Mayzent。Marie-France,你想接受嗎?
Marie-France Tschudin - President of Novartis Pharmaceuticals
Marie-France Tschudin - President of Novartis Pharmaceuticals
Sure Vas, thanks. So the first thing I would say is that the physicians haven't identified patients so far with SPMS because there has been no medicine in the marketplace. So as we've said before, this year is all about education. I can give you some data on where we are with the launch. As you know, it is the only product proven to delay the stability in active SPMS patients. The awareness is high. We've got more than 90% of neurologists willing to prescribe. Even in my own personal conversations with physicians, there is a lot of appreciation for the EXPAND data. They need a treatment for this patient population. We've also seen a lot of progress in access. Over 70 million lives with preferred access, but we really need to focus on patient identification, creating a sense of urgency. At the end, we are very confident on the long-term potential of Mayzent, but this year is all about education.
當然瓦斯,謝謝。所以我要說的第一件事是,到目前為止,醫生還沒有發現患有 SPMS 的患者,因為市場上還沒有藥物。所以正如我們之前所說,今年是關於教育的一年。我可以給你一些關於我們在發射方面的數據。如您所知,它是唯一被證明可以延遲活動性 SPMS 患者的穩定性的產品。意識很高。我們有超過 90% 的神經科醫生願意開處方。即使在我個人與醫生的談話中,也有很多人對 EXPAND 數據表示讚賞。他們需要為這個患者群體提供治療。我們在訪問方面也看到了很大的進步。超過 7000 萬人生活在首選通道中,但我們確實需要關注患者識別,從而產生緊迫感。最後,我們對 Mayzent 的長期潛力非常有信心,但今年的重點是教育。
Operator
Operator
The next question comes 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 系列。
Florent Cespedes - Senior Equity Analyst
Florent Cespedes - Senior Equity Analyst
Three quick ones. First on Entresto, what is behind the sequential acceleration of the sales mainly in Europe, is it the guidelines that were new recommendations? I'm just wondering what could be the trigger to see such acceleration on the U.S. market?
三個快速的。首先在 Entresto 上,主要在歐洲的銷售連續加速的背後是什麼,是新建議的指導方針嗎?我只是想知道是什麼觸發了美國市場出現這種加速?
Second question on Beovu. Could you give us more color on your U.S. commercial operations as your competitors are quite strong and well established there. And if you have maybe some flexibility to even further expand your U.S. operations on ophthalmology?
關於 Beovu 的第二個問題。您能否給我們更多關於您在美國的商業運營的顏色,因為您的競爭對手非常強大並且在那裡根深蒂固。如果您有一些靈活性可以進一步擴大您在美國的眼科業務?
My last question is on Sandoz. So the division growth is back into positive territories. Do you see some improvement in some areas? Or is there any base effect? And is this better performance sustainable?
我的最後一個問題是關於 Sandoz 的。因此,部門增長回到了積極的領域。您是否看到某些方面有所改善?或者有沒有底效應?這種更好的表現是否可持續?
Vasant Narasimhan - CEO
Vasant Narasimhan - CEO
All right. First, on Entresto acceleration, Marie-France.
好的。首先,關於 Entresto 加速,Marie-France。
Marie-France Tschudin - President of Novartis Pharmaceuticals
Marie-France Tschudin - President of Novartis Pharmaceuticals
So we see very strong momentum overall, and this is really due to underlying demand. Obviously, the PIONEER data has opened up a new patient segment for us in the in-hospital initiation. We're very confident with the momentum we're seeing across geographies, not only in Europe and in the U.S., but I can also say that China is off to a good start. Obviously, the ESC Heart Failure Association consensus paper that positions us in first-line on new onset in decompensated patients has been very, very useful for us and a real endorsement of the product. We are confident Entresto is becoming standard of care across the board, so we'll continue to see strong momentum, as I said, worldwide.
所以我們看到整體勢頭非常強勁,這實際上是由於潛在需求。很顯然,PIONEER數據為我們在院內啟動開闢了一個新的患者細分市場。我們對我們在各個地區看到的勢頭非常有信心,不僅在歐洲和美國,而且我也可以說中國有了一個良好的開端。顯然,ESC 心力衰竭協會共識文件將我們置於失代償患者新發的第一線,這對我們非常非常有用,也是對該產品的真正認可。我們相信 Entresto 正在成為全面的護理標準,因此正如我所說,我們將繼續在全球範圍內看到強勁的勢頭。
Vasant Narasimhan - CEO
Vasant Narasimhan - CEO
Thank you. Lastly, on Beovu, we are having a really strong commercial team. We've been able to attract some excellent talent with deep experience in retinal disease and launching retinal medicines. We have a sales force fully deployed and ready. We have an excellent MSL team that's been out now for some time educating physicians on the data. We have good plans in place with respect to contracting, particularly given how the medicine is given in a buy-and-bill model. We've been working a lot on our patient hub to ensure that we are ready to go and make it seamless and easy for physicians to get patients on to the medicine. So we've got all, I think, the elements in place ready to go. Also, ex U.S. as well, we're gearing up well for the RTH -- of the Beovu launch. So overall, we feel like we're in a good place. I would say that for all of our launches, we have an executive-level review with our leadership team and deep ownership at the executive team level to make sure that we're doing the best we can to get all the details right on these upcoming launches.
謝謝。最後,在 Beovu 上,我們擁有一支非常強大的商業團隊。我們已經能夠吸引一些在視網膜疾病和推出視網膜藥物方面具有豐富經驗的優秀人才。我們有一支全面部署並準備就緒的銷售隊伍。我們有一個優秀的 MSL 團隊,現在已經有一段時間了,他們在數據方面對醫生進行培訓。我們在合同方面製定了良好的計劃,特別是考慮到藥物是如何在購買和賬單模式中提供的。我們一直在我們的患者中心做了大量工作,以確保我們準備就緒,讓醫生能夠無縫、輕鬆地讓患者接受藥物治療。所以我認為,我們已經準備好了所有的元素。此外,除美國外,我們也在為 Beovu 發布的 RTH 做好準備。所以總的來說,我們覺得我們處在一個好地方。我想說的是,對於我們所有的發布,我們都與我們的領導團隊進行了執行級別的審查,並在執行團隊級別進行了深入的所有權,以確保我們正在盡我們最大的努力來獲得這些即將推出的所有細節。發射。
The next question? Sandoz. Sandoz growth. Yes, of course. So Sandoz, we're pleased with the Q2 performance. When you look at it, it was primarily driven by strong performance outside the U.S. A mix of mostly strong biosimilars performance, but also I would say our core generics business with some recent launches such as fulvestrant and a few others continues to overall do well. So we're very proud with how Sandoz is performing ex U.S. Within the U.S., our team continues to work hard on what is a challenging environment. If you take out onetime -- certain onetime effects, you will see that in the U.S. the base business continues to have declines in the mid-teens consistent with what we've seen in past quarters. So we haven't seen yet the stabilization in that core GX business in the U.S. I think for U.S. -- in the U.S., the key will be our upcoming launches, which we hope will be a pegfilgrastim potentially as well are our inhaled generics as well as some of the injectable launches we have upcoming. And if those go well, we hope to also have the U.S. contribute. So going forward, we feel comfortable raising the guidance to in line to low single-digit based on that momentum that we're seeing really outside the U.S.
下一個問題?山德士。山德士的成長。是的當然。所以 Sandoz,我們對第二季度的表現感到滿意。當你看它時,它主要是由美國以外的強勁表現推動的。主要是生物仿製藥表現強勁的組合,但我也想說我們的核心仿製藥業務以及最近推出的一些產品,如氟維司群和其他一些產品,總體上繼續表現良好。因此,我們對 Sandoz 在美國以外的表現感到非常自豪。在美國,我們的團隊繼續努力應對充滿挑戰的環境。如果你去掉一次性 - 某些一次性影響,你會看到在美國,基礎業務在十幾歲中期繼續下降,這與我們在過去幾個季度看到的情況一致。所以我們還沒有看到美國核心 GX 業務的穩定。我認為對於美國 - 在美國,關鍵將是我們即將推出的產品,我們希望它可能成為 pegfilgrastim 以及我們的吸入仿製藥以及我們即將推出的一些可注射產品。如果進展順利,我們希望美國也能做出貢獻。因此,展望未來,根據我們在美國以外真正看到的勢頭,我們很樂意將指導提高到低個位數。
Operator
Operator
Your next question comes from the line of Jo Walton from Credit Suisse.
你的下一個問題來自瑞士信貸的 Jo Walton。
Jo Walton - MD
Jo Walton - MD
Just a few quick ones, please. Harry, you said that you were looking at sandostatin LAR generics in Europe. I wonder if you could tell us which countries the product has been approved in and what you expect the timeline for that to be moving into perhaps bigger, more important countries and potentially into the U.S.
請簡單介紹幾句。Harry,你說過你在歐洲研究善寧 LAR 仿製藥。我想知道您是否可以告訴我們該產品已在哪些國家/地區獲得批准,以及您希望該產品進入更大、更重要的國家並可能進入美國的時間表是什麼。
On the Gilenya situation, could you tell us whether you're still accruing for royalties to Mitsubishi Tanabe? Their changing guidance earlier this year suggest that they're not being paid since February. So is that an extra benefit that this product is now even more profitable for you?
關於 Gilenya 的情況,您能否告訴我們您是否仍在為 Mitsubishi Tanabe 收取版稅?他們今年早些時候不斷變化的指引表明,他們自 2 月以來就沒有得到報酬。那麼,這個產品現在對您來說更有利可圖,這是額外的好處嗎?
On Zolgensma, I wonder if you could just tell us a little bit about how you're progressing ex U.S. You say that you have treated somebody in France. But when do you think we'll actually be able to see paying customers outside of the U.S.? And finally, for Harry, you mentioned the tax rate going up because of the mix effect for -- to over 16%. Does that mix effect keep going? Should we now be looking at something above 15% for medium-term tax rate?
關於 Zolgensma,我想知道你是否可以告訴我們一些你在美國前的進展情況。你說你在法國治療過一個人。但是你認為我們什麼時候才能真正看到美國以外的付費客戶?最後,對於 Harry,你提到由於混合效應,稅率上升到超過 16%。這種混合效應會繼續嗎?我們現在應該考慮將中期稅率提高到 15% 以上嗎?
Vasant Narasimhan - CEO
Vasant Narasimhan - CEO
So on sandostatin, Susanne?
蘇珊娜,關於善寧?
Susanne Schaffert - President of Novartis Oncology
Susanne Schaffert - President of Novartis Oncology
So sandostatin, let me share the facts that we have. There is one generic company that has recently received marketing authorization in the EU via decentralized procedure, and they now start getting national ratifications for their local marketing authorization. We know that there are several countries where they already achieved that like U.K., Denmark, Germany. And we see some first limited commercial activities. On the U.S., we are closely monitoring the situation, and we will keep you updated of information, in case we have.
所以善寧,讓我分享我們所擁有的事實。有一家仿製藥公司最近通過分散程序在歐盟獲得了營銷授權,他們現在開始獲得國家批准其當地營銷授權。我們知道有幾個國家已經做到了這一點,例如英國、丹麥和德國。我們看到了一些最初的有限商業活動。在美國,我們正在密切關注局勢,如果有的話,我們會及時通知您。
Vasant Narasimhan - CEO
Vasant Narasimhan - CEO
I think one reminder on sandostatin is it's a unique medicine, the setting it's given in. And so I think when you think about when and if generics start to come in, one generic starts to come, you will really have to model your erosion curves similar to what you see with biologics and with very limited competition and that's what our expectation at the moment in all geographies.
我認為關於善寧的一個提醒是它是一種獨特的藥物,它的使用環境。所以我認為當你考慮何時以及如果仿製藥開始出現時,一個仿製藥開始出現,你真的必須模擬你的侵蝕曲線,類似於你在生物製劑中看到的,並且競爭非常有限,這就是我們的期望所有地區的時刻。
Next on Gilenya, Mitsubishi, Harry?
接下來是 Gilenya、Mitsubishi、Harry?
Harry Kirsch - CFO
Harry Kirsch - CFO
All I can say, I don't know where some of the statements come from, but we are still paying and accruing royalties for Gilenya to Mitsubishi Tanabe and according -- in accordance to the contractual terms and agreement with them. So we keep paying, and we keep accruing.
我只能說,我不知道某些聲明的來源,但我們仍在根據合同條款和與他們達成的協議,向 Mitsubishi Tanabe 支付和累積 Gilenya 的版稅。所以我們一直在付出,我們一直在積累。
Vasant Narasimhan - CEO
Vasant Narasimhan - CEO
And then in terms of Zolgensma ex U.S., first, to clarify, the patients we referenced from the French ATU or from the named patient program are fully paid patients. So these are not -- these are paid patients by the -- either by self or by the relevant government, in the case of France. In terms of when we would expect approval as I said, in the presentation, we're targeting approval before the end of this year. I think for planning assumption you should assume Q4 of this year is when we expect to get European Commission okay and be able to launch the medicine.
然後就美國前的 Zolgensma 而言,首先要澄清的是,我們從法國 ATU 或指定患者計劃中引用的患者是全額付費患者。因此,就法國而言,這些不是由自己或相關政府支付給患者的費用。正如我在演示文稿中所說,就我們預計何時獲得批准而言,我們的目標是在今年年底之前獲得批准。我認為對於規劃假設,你應該假設今年第四季度是我們期望歐盟委員會同意並能夠推出藥物的時候。
In terms of tax rate, Harry?
就稅率而言,哈利?
Harry Kirsch - CFO
Harry Kirsch - CFO
Thank you for the question on tax rate, Jo. Because often it's a complex topic and sometimes overlooked topic. It's also hard to forecast, so we had a slight increase from 16% to 16.4%. That's where we are quite confident the tax rate will be for this year. First of all, a couple of developments. As you know, the Swiss tax reform got approved on -- for us here in the Basel city, cantonal level and federal level which is excellent because that gives us a very good planning security in a very large part of our operations. We have a huge substance as you know in Switzerland with our 10,000+ associates, many manufacturing sites as well as R&D and our headquarters, many of them are here. So very positive development there that takes away uncertainty. That's great. And we have overall a very attractive tax rate. Now of course, the tax environment is getting -- since years more and more difficult, we have been able to maintain an attractive tax rate. And I also expect that we continue to maintain attractive tax rate probably midterm in the range between 16% and 17.5%. To be more precise than that, we usually do year by year, but I expect that over the years we continue to have a very attractive tax rate.
喬,謝謝你提出關於稅率的問題。因為它通常是一個複雜的話題,有時甚至是被忽視的話題。這也很難預測,所以我們從 16% 略微增加到 16.4%。這就是我們對今年的稅率很有信心的地方。首先,有幾個發展。如您所知,瑞士稅制改革獲得批准——對我們在巴塞爾市、州一級和聯邦一級來說,這非常好,因為這為我們的大部分業務提供了非常好的規劃保障。正如您所知,我們在瑞士擁有龐大的實體,擁有 10,000 多名員工、許多製造基地以及研發中心和我們的總部,其中許多都在這裡。那裡非常積極的發展消除了不確定性。那太棒了。總體而言,我們的稅率非常有吸引力。當然,現在稅收環境正在變得越來越困難——多年來,我們一直能夠保持有吸引力的稅率。而且我還預計我們將繼續保持有吸引力的稅率,中期可能在 16% 到 17.5% 之間。更準確地說,我們通常每年都這樣做,但我預計多年來我們的稅率將繼續保持非常有吸引力。
Operator
Operator
Your next question comes from the line of Seamus Fernandez from Guggenheim.
你的下一個問題來自古根海姆的 Seamus Fernandez。
Seamus Christopher Fernandez - Senior Analyst of Global Pharmaceuticals
Seamus Christopher Fernandez - Senior Analyst of Global Pharmaceuticals
So just a couple here. Can you guys talk a little bit about Cosentyx and the direction and performance there? Just looks like you were coming in somewhat below in the U.S. relative to script trends. Just wanted to get a better sense of how the mix of impacts there were coming in, whether it be inventory effects, price, direct price negotiations impacts relative to formulary access or perhaps just a doughnut-hole impact.
所以這裡只有一對。你們能談談 Cosentyx 以及那裡的方向和表現嗎?就劇本趨勢而言,您在美國的表現似乎稍遜一籌。只是想更好地了解影響的組合是如何產生的,無論是庫存影響、價格、直接價格談判影響與處方准入相關,還是可能只是甜甜圈影響。
The second question, just wanted to get a general sense of the performance of your HUMIRA generic or biosimilar, and I assume presumably most of that performance came in European markets. Can you just give us a general qualitative sense, if you can't give us the exact sales? Just trying to get a sense of how the penetration is going for that product.
第二個問題,只是想大致了解您的 HUMIRA 仿製藥或生物仿製藥的性能,我假設大部分性能來自歐洲市場。如果你不能給我們確切的銷售額,你能給我們一個大概的定性意義嗎?只是想了解該產品的滲透情況。
And then the last question, in terms of the expectations for PARAGON, John, you mentioned that there are always things with regard to large clinical studies like this that we have to be careful about and think about. Maybe could you just give us a general sense of what you would characterize. Is that a clean win? How would you characterize a clean win? And then what are some of the aspects that you think kind of complicate an evaluation of a large study like PARAGON, whether it be the different regional dynamics that we've seen become an issue in a number of studies or other factors?
然後是最後一個問題,關於對 PARAGON 的期望,約翰,你提到像這樣的大型臨床研究總是有一些我們必須小心和思考的事情。也許你能給我們一個關於你要描述的東西的大致概念嗎?這是一場乾淨的勝利嗎?您如何描述乾淨利落的勝利?然後,您認為哪些方面使對像 PARAGON 這樣的大型研究的評估變得複雜,無論是我們已經看到的不同區域動態成為許多研究中的一個問題還是其他因素?
Vasant Narasimhan - CEO
Vasant Narasimhan - CEO
First, on Cosentyx. I'll just quickly take that one. In terms of what we saw, there was a small difference in terms of sales versus script trends. That's was primarily driven by small bit of inventory. Mostly, it's RDs which were just related to formulary access. In general, right now, we're seeing sales volume trend with Rx scripts and there is nothing that we would say as important to flag with respect to Cosentyx momentum in the U.S. across indications. With respect to adalimumab in Europe, I think as you know there are number of generic entrants who have come to market in adalimumab, which means that it's, of course, a competitive marketplace. We have, to our experience, seen solid uptake of the adalimumab biosimilars, whether through tenders or in other ways. When you look at our add-up penetration in Europe overall versus the originator it is around 22%. We estimate we are ranked #3 amongst biosimilars players. That's probably the best data we can get. We are very proud of our performance, particularly in rituximab, where we face less competition, as well as in etanercept which is, I think, a more favorable situation for us relative to the competition.
首先,在 Cosentyx 上。我很快就拿那個。就我們所看到的而言,銷售趨勢與腳本趨勢之間存在細微差別。這主要是由少量庫存驅動的。大多數情況下,它是與處方集訪問相關的 RD。總的來說,現在,我們看到 Rx 腳本的銷售量趨勢,我們認為沒有什麼重要的是要標記美國的 Cosentyx 勢頭。關於歐洲的阿達木單抗,我想正如你所知,有許多仿製藥進入市場的阿達木單抗,這意味著它當然是一個競爭激烈的市場。根據我們的經驗,無論是通過招標還是其他方式,我們都看到了阿達木單抗生物仿製藥的穩步增長。當您查看我們在歐洲的總滲透率與發起者的總滲透率時,它約為 22%。我們估計我們在生物仿製藥廠商中排名第三。這可能是我們可以獲得的最佳數據。我們為我們的表現感到非常自豪,特別是在我們面臨較少競爭的利妥昔單抗以及依那西普方面,我認為相對於競爭對我們來說是一個更有利的情況。
With respect to PARAGON endpoints, John.
關於 PARAGON 端點,約翰。
John Tsai - Head of Global Drug Development & Chief Medical Officer
John Tsai - Head of Global Drug Development & Chief Medical Officer
Thanks, Seamus, for the question regarding PARAGON. As you know, as I said earlier, the success would be really based on the primary endpoint, and the primary endpoint being CV mortality and hospitalization. What we know about heart failure with preserved ejection fraction is that the burden really is around hospitalizations and rehospitalizations for these patients. So for us, what we think would be success really is dependent on this hospitalizations or sometimes the subsequent readmission into the hospital. So that's something that we're looking at very closely and knowing that this is a significant burden for that population of patients.
感謝 Seamus 提出有關 PARAGON 的問題。如您所知,正如我之前所說,成功實際上取決於主要終點,而主要終點是 CV 死亡率和住院率。我們對射血分數保留的心力衰竭的了解是,負擔實際上是這些患者的住院和再住院治療。所以對我們來說,我們認為成功實際上取決於這次住院或有時隨後再次入院。所以這是我們正在密切關注的事情,並且知道這對那部分患者來說是一個沉重的負擔。
Now regarding your second part of the question on what are some of the things we're looking at for perhaps secondary endpoints or sub-studies, and you had specifically mentioned are there regional differences. We have looked at some of the previous studies, looking at regional recruitment, particularly in the Eastern European countries, and we think we've factored that into our study. We have less than 5% from Russia and Georgia where -- in one of the previous studies, where there were some questions around that. We think we've taken that into consideration. But thinking about some of the other perhaps sub-studies we're looking at, we do have a cognitive sub-study looking at cognitive impacts. What I will say is that as we look at the overall adverse event reporting, we haven't seen and as well as the patient experience from spontaneous reports because Entresto is being used. We've not seen any signals in the current spontaneous adverse eventing -- events. But obviously, we need to see the results of the cognitive sub-study to be able to tell for sure. So these are some of the things that we take into consideration for the trial.
現在關於你的問題的第二部分,關於我們正在尋找的可能是次要終點或子研究的一些東西,你特別提到是否存在區域差異。我們研究了之前的一些研究,著眼於區域招聘,尤其是在東歐國家,我們認為我們已經將其納入我們的研究。我們只有不到 5% 來自俄羅斯和格魯吉亞——在之前的一項研究中,那裡存在一些問題。我們認為我們已經考慮到了這一點。但是考慮到我們正在研究的其他一些子研究,我們確實有一個認知子研究著眼於認知影響。我要說的是,當我們查看總體不良事件報告時,我們還沒有看到以及自發報告中的患者體驗,因為正在使用 Entresto。在當前的自發不良事件中,我們沒有看到任何信號。但顯然,我們需要查看認知子研究的結果才能確定。所以這些是我們在試驗中考慮的一些事情。
Vasant Narasimhan - CEO
Vasant Narasimhan - CEO
I think overall, with PARAGON, I think the key thing to remember as we get to the final study is we looked very closely at past history, we studied very closely how the past studies were conducted, we tried to manage as best we could, we tried to also ensure we use repeat hospitalization for the composite endpoint along with CV death for the composite primary endpoint. And then we tried to also leverage our Phase II study, which showed both significant decreases in NT-pro-BNP as well as atrial remodeling. So all of that taken together makes us feel like we've conducted the study in the best possible way to give us a chance of success. But then in the end, the science will ultimately tell us.
我認為總的來說,對於 PARAGON,我認為在我們進行最終研究時要記住的關鍵是我們非常仔細地研究了過去的歷史,我們非常仔細地研究了過去的研究是如何進行的,我們盡力做到最好,我們還試圖確保我們對複合終點使用重複住院治療,同時對複合主要終點使用 CV 死亡。然後我們還嘗試利用我們的 II 期研究,該研究顯示 NT-pro-BNP 和心房重構均顯著下降。所以所有這些加在一起讓我們覺得我們已經以最好的方式進行了研究,給了我們成功的機會。但最終,科學最終會告訴我們。
Operator
Operator
Your next question comes from the line of Richard Parkes from Deutsche Bank.
你的下一個問題來自德意志銀行的 Richard Parkes。
Richard J. Parkes - Director
Richard J. Parkes - Director
This is Richard Parkes from Deutsche Bank. First question on gross margin within Innovative Medicines. I think you previously said that the flat year-on-year gross margin for the full year would be a good guide, but you had a very strong second quarter, and I just wondered how we should think about that. Whether there's anything specific in Q2 gross margin and should the new launches be a positive to gross margin, offsetting maybe some of the impact from the generic launches? So that's the first question.
我是德意志銀行的理查德·帕克斯。關於創新藥物毛利率的第一個問題。我想你之前說過全年毛利率持平將是一個很好的指導,但你的第二季度非常強勁,我只是想知道我們應該如何考慮這一點。Q2 毛利率是否有任何具體情況,新產品是否應該對毛利率產生積極影響,抵消仿製藥的部分影響?這是第一個問題。
The second question is on Lutathera. I think sequential quarter-on-quarter growth slowed a bit. So I just wonder if there were any special effects there and whether you could discuss the longer-term growth prospects for that franchise?
第二個問題是關於 Lutathera。我認為環比增長有所放緩。所以我只是想知道那裡是否有任何特殊效果,您是否可以討論該特許經營權的長期增長前景?
Vasant Narasimhan - CEO
Vasant Narasimhan - CEO
So first on gross margins, Harry?
那麼首先是毛利率,Harry?
Harry Kirsch - CFO
Harry Kirsch - CFO
Gross margins is a bit hard to predict. As you know, our gross margin started to increase quite significantly driven by the productivity programs and favorable mix in the second half of last year. So whilst I continue to see good gross margins for the second half from the improvement versus prior year second half is expected to not be as much. Now a lot depends on the product mix, as you know, depends on -- some of the products with higher cost of goods progressing versus the ones that have either no royalty burden and very high gross margins. So hard to predict, but I think it just hopefully helps a bit with the modeling that probably was prior year half 2 I would not assume such a significant improvement.
毛利率有點難以預測。如您所知,在去年下半年的生產力計劃和有利組合的推動下,我們的毛利率開始顯著增長。因此,雖然我繼續看到下半年毛利率與去年同期相比有所改善,但預計下半年不會那麼多。正如你所知,現在很大程度上取決於產品組合——一些產品成本較高的產品與那些沒有特許權使用費負擔和非常高毛利率的產品相比。很難預測,但我認為它只是希望對可能是前半年的建模有所幫助 2 我不認為會有如此顯著的改進。
Vasant Narasimhan - CEO
Vasant Narasimhan - CEO
I just want to add, I mean, our overall transformation of our manufacturing is progressing really, really nicely, whether you look at our improvements in yield and improvement in production performance in our facilities, the optimization of our planned footprint around the world, the use of new technologies, we have set out to really transform our manufacturing engine as a company. I think you're seeing now the impact of all of that work in the gross margin. Susanne, on Lutathera.
我只想補充一點,我的意思是,我們的製造業整體轉型進展得非常非常好,無論你看看我們在產量和設施生產性能方面的改進,我們在全球計劃的足蹟的優化,使用新技術,我們已經著手真正轉變我們公司的製造引擎。我想你現在看到了所有這些工作對毛利率的影響。蘇珊娜,在 Lutathera。
Susanne Schaffert - President of Novartis Oncology
Susanne Schaffert - President of Novartis Oncology
On Lutathera, we had another strong quarter reaching $109 million, and the majority of sales are still coming from the U.S. And you're right when you said that growth rates in the U.S. slightly declined in Q2, and the main reason is really that major Tier 1 centers have now worked through their prevalence pool, really patient on the waiting list that were mostly in late-line. So what we're focusing now on is really positioning Lutathera as the preferred second-line treatment and we expect really further continued growth. We remain very confident on Lutathera, and we also expect now sales coming in from ex U.S. We make nice progress in receiving reimbursement approvals, recently got approval for reimbursement in Spain and Italy. We got also regulatory approval in Switzerland and in Israel. So we remain very, very confident with Lutathera that it has potential for blockbuster sales, and we'll continue to grow strongly.
在 Lutathera 上,我們有另一個強勁的季度,達到 1.09 億美元,大部分銷售額仍然來自美國。當你說美國的增長率在第二季度略有下降時,你是對的,主要原因確實是一級中心現在已經完成了他們的患病率池,在等待名單上真的很耐心,這些名單大多排在後期。因此,我們現在關注的是真正將 Lutathera 定位為首選的二線治療藥物,我們期待真正的進一步持續增長。我們對 Lutathera 仍然非常有信心,我們現在也預計來自美國以外的銷售額。我們在獲得報銷批准方面取得了很好的進展,最近在西班牙和意大利獲得了報銷批准。我們還獲得了瑞士和以色列的監管批准。因此,我們對 Lutathera 仍然非常、非常有信心,它有潛力成為重磅炸彈,我們將繼續強勁增長。
Operator
Operator
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 - Senior Analyst
Richard Vosser - Senior Analyst
I have one question on China and the impact from the 4 plus 7 tenders, please. Just thinking about I think Gleevec is mentioned and there's been some tenders there but maybe thinking about the impact on Diovan and Exforge. How should we think about that? And maybe if I can ask 1 second question, just on SEG101. How are you expecting that to be used? You see it being used primarily in patients who have had a vaso-occlusive crisis? Or how should we think about that?
我有一個關於中國的問題,以及 4 加 7 招標的影響。只是想一想,我認為 Gleevec 被提及並且那裡有一些招標,但可能會考慮對 Diovan 和 Exforge 的影響。我們應該如何考慮?也許我可以問 1 第二個問題,就在 SEG101 上。您希望如何使用它?您認為它主要用於發生血管閉塞危象的患者嗎?或者我們應該如何考慮?
Vasant Narasimhan - CEO
Vasant Narasimhan - CEO
Thank you, Richard. So on China, in general, we are focused very much on our launch medicines. We are focused on moving out of the historical established medicines business given the number of recent approvals we have had, we have had double-digit approval, double-digit reimbursement. Entresto is doing well. Cosentyx is off to a strong start, our new oncology medicines are off to a strong start. So our focus is very much on driving the new launches. We do expect in due course these tenders to impact our legacy established medicines business, primarily Gleevec and valsartan-containing medicines. To date, these tenders have not started at a significant scale on those specific medicines for a variety of reasons. So at the moment, it's not a significant impact. Even when it comes, we expect that our launches should more than offset the impact of the 4 plus 7 tenders. That's very much our focus on strategy. We also believe the government is doing the right thing in shifting resources from these older medicines and focusing on new innovation that actually fits Novartis' strategy quite well. With respect to SEG101, Susanne.
謝謝你,理查德。所以在中國,總的來說,我們非常關注我們的上市藥物。考慮到我們最近獲得的批准數量,我們專注於退出歷史悠久的藥品業務,我們獲得了兩位數的批准,兩位數的報銷。Entresto 表現不錯。Cosentyx 開局良好,我們的新腫瘤藥物開局良好。因此,我們的重點非常放在推動新產品的發布上。我們確實希望這些招標會在適當的時候影響我們傳統的成熟藥品業務,主要是格列衛和含纈沙坦的藥品。迄今為止,由於各種原因,這些特定藥物的招標尚未大規模啟動。所以目前來說,影響不大。即使它來了,我們預計我們的發射應該超過抵消 4 加 7 招標的影響。這是我們非常關注的戰略。我們還認為,政府正在做正確的事情,將資源從這些老藥上轉移,並專注於實際上非常適合諾華戰略的新創新。關於 SEG101,Susanne。
Susanne Schaffert - President of Novartis Oncology
Susanne Schaffert - President of Novartis Oncology
In terms of positioning, what we would expect really SEG101 has impressive effect on prevention and reduction of VOCs. We could show in our data that we could reduce VOCs by 50%, and that's how we would expect it to position. So patient population is probably the patients with 2 or more VOCs per year, which is around 60% of the total patient population.
從定位上來說,SEG101在VOCs防治和減排方面的效果可想而知。我們可以在我們的數據中顯示我們可以將 VOC 減少 50%,這就是我們期望它定位的方式。所以患者人群可能是每年有 2 個或更多 VOCs 的患者,大約佔患者總數的 60%。
Operator
Operator
Your next question comes from the line of Michael Leacock from MainFirst.
您的下一個問題來自 MainFirst 的 Michael Leacock。
Michael Richard Leacock - Director
Michael Richard Leacock - Director
Two very quick questions. On Entresto, any update in terms of reimbursements timing in China? And you mentioned on Xiidra that there was a lack of progress owing to uncertainty of its ownership. Could the same apply to Aimovig?
兩個非常快速的問題。關於 Entresto,中國的報銷時間有任何更新嗎?你在 Xiidra 上提到由於其所有權的不確定性而缺乏進展。這同樣適用於 Aimovig 嗎?
Vasant Narasimhan - CEO
Vasant Narasimhan - CEO
So I'll start with Xiidra and then come back on Entresto. So right now, with respect to Aimovig, we think there's clarity in the sales force. And we've been working together with Amgen to ensure that any of our legal disputes do not impact the focus of the sales force in the United States. I would also say we're pleased even though it has not come up yet on the call. We are pleased with the uptake of Aimovig outside the United States. It's been very positive overall, and we continue to drive that. With respect to Entresto, we're working through now reimbursement at the regional level and are focused very much on getting an NRDL listing nationally for Entresto. We hope to achieve that in one of the upcoming cycles. We do have a number of regions where Entresto is already now on the listing at the regional level, but the goal very much remains to get on the national NRDL schedule in the coming cycles.
所以我將從 Xiidra 開始,然後再回到 Entresto。所以現在,關於 Aimovig,我們認為銷售人員很清楚。我們一直在與 Amgen 合作,以確保我們的任何法律糾紛都不會影響美國銷售團隊的工作重點。我還要說我們很高興,即使它還沒有出現在電話會議上。我們很高興 Aimovig 在美國以外的地區得到採用。總體而言,這是非常積極的,我們將繼續推動這一點。關於 Entresto,我們現在正在通過區域層面的報銷工作,並且非常專注於為 Entresto 在全國范圍內獲得 NRDL 列表。我們希望在即將到來的周期之一中實現這一目標。我們確實有一些地區 Entresto 現在已經在地區一級上市,但目標仍然是在未來週期內進入國家 NRDL 時間表。
Operator
Operator
The next question comes from the line of Naresh Chouhan from Intrinsic Health.
下一個問題來自 Intrinsic Health 的 Naresh Chouhan。
Naresh Chouhan - Founder
Naresh Chouhan - Founder
Just on Mayzent, could you update us how you're doing with setting up and implementing the CYP screening? And is that adding to the inertia amongst doctors to, you kind of mentioned trying to instill some urgency in doctors. Is this kind of adding to the inertia in prescribing or switching patients to Mayzent? Just quickly, if I can, Entresto ex U.S. was very strong, just some insight to that would be helpful.
關於 Mayzent,您能否向我們介紹一下您在設置和實施 CYP 篩選方面的進展情況?這是否增加了醫生的惰性,你提到試圖向醫生灌輸一些緊迫感。這種情況是否會增加患者開處方或轉用 Mayzent 的惰性?很快,如果可以的話,Entresto ex U.S. 非常強大,只是對此有一些了解會有所幫助。
Vasant Narasimhan - CEO
Vasant Narasimhan - CEO
So on Mayzent, Marie-France.
所以在 Mayzent,Marie-France。
Marie-France Tschudin - President of Novartis Pharmaceuticals
Marie-France Tschudin - President of Novartis Pharmaceuticals
So in Mayzent, we are using a hub system that does manage the start forms, the benefits of verification and genotyping as well as the other lab data and then ultimately the delivery of the product. What we do see is that the numbers in the hub are encouraging, but it is a 60-day onboarding plus 1 month free, so it's about 90 days. So we are now working to try and accelerate that, but our initial feedback is very positive on how that's looking.
因此,在 Mayzent,我們正在使用一個中心系統來管理啟動表格、驗證和基因分型的好處以及其他實驗室數據,然後最終交付產品。我們看到的是中心的數字令人鼓舞,但這是 60 天的入職培訓加上 1 個月的免費試用期,所以大約是 90 天。因此,我們現在正在努力嘗試加速這一進程,但我們的初步反饋對它的外觀非常積極。
Vasant Narasimhan - CEO
Vasant Narasimhan - CEO
And then with respect to Entresto ex U.S. acceleration, Marie-France will be the right person to ask. She oversaw Entresto
然後關於 Entresto ex U.S.加速,Marie-France 將是合適的人選。她監督了 Entresto
Marie-France Tschudin - President of Novartis Pharmaceuticals
Marie-France Tschudin - President of Novartis Pharmaceuticals
Yes. As I mentioned before in the call, I think just the momentum is really strong all over and the PIONEER data has just really boosted the in-hospital initiation, which has really changed the dynamics. And so overall, we've seen great performance in Europe. We've seen great performance in the U.S. We were starting to see very encouraging performance in China, and I just believe that momentum will continue as we go forward and we establish Entresto as standard of care.
是的。正如我之前在電話中提到的那樣,我認為整個勢頭真的很強勁,而 PIONEER 數據確實促進了住院啟動,這確實改變了動態。總的來說,我們在歐洲看到了出色的表現。我們在美國看到了很好的表現。我們開始在中國看到非常令人鼓舞的表現,我只是相信隨著我們前進的勢頭將繼續下去,我們將 Entresto 確立為護理標準。
Operator
Operator
Your next question comes from the line of Kerry Holford from Exane BNP Paribas.
您的下一個問題來自 Exane BNP Paribas 的 Kerry Holford。
Kerry Ann Holford - Analyst
Kerry Ann Holford - Analyst
Kerry Holford from Exane. A final one from me on the Xiidra. I noticed on the slide in your pack and you highlighted, Vas, that you're not expecting significant Part D access expansion until 2021. I wonder if you can just talk through why that couldn't come earlier beginning of next year and so you essentially saying that really we should expect limited growth in Xiidra in 2020 will be primarily dependent on that commercial plan patient only?
來自 Exane 的 Kerry Holford。我在 Xiidra 上的最後一個。Vas,我在你的資料包中的幻燈片上註意到你強調說,你預計到 2021 年才會有顯著的 D 部分訪問擴展。我想知道你是否可以談談為什麼不能在明年初早些時候實現,所以你基本上是說我們真的應該預計 2020 年 Xiidra 的有限增長將主要取決於商業計劃患者?
Vasant Narasimhan - CEO
Vasant Narasimhan - CEO
Thank you, Kerry. Marie-France, on Xiidra.
謝謝你,克里。Marie-France,在 Xiidra 上。
Marie-France Tschudin - President of Novartis Pharmaceuticals
Marie-France Tschudin - President of Novartis Pharmaceuticals
So first of all, let me just say that we're really excited to add Xiidra to our portfolio. We think it's a great complement to our front-of-the-eye business, and it does bridge to our pipeline. Xiidra has got a really strong clinical profile. It's really the only product proven to reduce signs and symptoms. Vas already mentioned the medical need and how underdiagnosed dry eye disease is. Currently, we see 1.6 million prescriptions in a market that's 34 million. What I can say to you is that we've done excellent commercial coverage and expanding to Part D will happen over 2021 because we're pretty much locked in for 2020. However, we do believe that there is a lot of room to grow. It is -- dry eye disease is promotionally sensitive. We're starting a DTC campaign in Q4. We think it's a strong strategic fit, and there's clear blockbuster potential for us in the U.S. alone.
所以首先,我只想說我們很高興將 Xiidra 添加到我們的產品組合中。我們認為這是對我們眼前業務的一個很好的補充,它確實是我們管道的橋樑。Xiidra 的臨床表現非常出色。它確實是唯一被證明可以減少體徵和症狀的產品。Vas 已經提到了醫療需求以及乾眼病診斷不足的情況。目前,我們在 3400 萬的市場中看到 160 萬張處方。我可以告訴你的是,我們已經完成了出色的商業報導,並且將在 2021 年擴展到 D 部分,因為我們幾乎已經鎖定了 2020 年。但是,我們確實相信有很大的增長空間。它是——乾眼症會增加敏感度。我們將在第四季度開始 DTC 活動。我們認為這是一個強有力的戰略契合,而且僅在美國就有明顯的重磅炸彈潛力。
Vasant Narasimhan - CEO
Vasant Narasimhan - CEO
I think if you go back in time and you look at the early quarters when there was a heavy focus on Xiidra, you saw the strong performance of this medicine. So we want to rekindle that fire.
我認為,如果你回到過去,看看早期重點關注 Xiidra 的季度,你就會看到這種藥物的強勁表現。所以我們想重新點燃那把火。
Operator
Operator
Your next question comes from the line of Laura Sutcliffe from UBS.
你的下一個問題來自瑞銀的 Laura Sutcliffe。
Laura Sutcliffe - Equity Research Analyst
Laura Sutcliffe - Equity Research Analyst
Just on Zolgensma and specifically on your Medicaid book of business. We know the reimbursement in Medicaid is going to take much longer than in the commercial setting. But I was just wondering if you could tell us whether your views on access and uptake in the Medicaid environment have evolved at all over the last few weeks since you've got approval?
就在 Zolgensma 上,特別是在您的 Medicaid 業務簿上。我們知道 Medicaid 的報銷時間比商業環境要長得多。但我只是想知道,您是否可以告訴我們,自您獲得批准以來,您對 Medicaid 環境中的訪問和接受的看法在過去幾週內是否有任何變化?
Vasant Narasimhan - CEO
Vasant Narasimhan - CEO
Yes on Zolgensma and Medicaid, we have 4 policies now already up on Zolgensma and Medicaid, which I think is very encouraging. I would say in terms of medical exception requests thus far in Medicaid that Novartis at least are managing through our hub, we've also seen positive responses from Medicaid states. Our first patient actually was a Medicaid patient. And so when you look at those narratives in general, patients are able to navigate Medicaid's with medical exception. So that gives us encouragement that even in the time that it will take us to get the medical policies fully set up, we can still work through the system and get patients treated given the demand from the parents, the children, their providers. We feel generally optimistic. We love to accelerate getting those policies in place, and our teams are working hard to do that. But as you rightly point out, it will be longer in Medicaid versus in the private insurance segment.
是的,關於 Zolgensma 和 Medicaid,我們現在已經制定了 4 項關於 Zolgensma 和 Medicaid 的政策,我認為這非常令人鼓舞。我想說的是,到目前為止,就醫療補助計劃中的醫療例外請求而言,諾華至少正在通過我們的中心進行管理,我們也看到了醫療補助計劃各州的積極回應。我們的第一位患者實際上是一名醫療補助患者。因此,當您總體上看這些敘述時,患者能夠在醫療例外情況下瀏覽醫療補助計劃。因此,這給了我們鼓勵,即使在我們需要完全制定醫療政策的時候,我們仍然可以通過系統工作,並根據父母、孩子和他們的提供者的需求讓病人得到治療。我們普遍感到樂觀。我們樂於加快制定這些政策,我們的團隊正在努力做到這一點。但正如您正確指出的那樣,與私人保險部門相比,醫療補助計劃的時間會更長。
Operator
Operator
The next question comes from the line of Mani Foroohar from SVB Leerink.
下一個問題來自 SVB Leerink 的 Mani Foroohar。
Mani Foroohar - MD of Genetic Medicines & Senior Research Analyst
Mani Foroohar - MD of Genetic Medicines & Senior Research Analyst
A quick question on Zolgensma. You talked about the attractive launch metrics you've seen thus far. When we think about modeling in future quarters, how should we think about time from dosage to realizing reimbursement in the U.S. versus global markets where you're going to be launching? Do you expect that to be relatively swift? Or should we expect the payment over time dynamics you are talking about to come into play as you launch in U.S. across different markets?
關於 Zolgensma 的一個快速問題。您談到了迄今為止您所看到的有吸引力的發布指標。當我們考慮未來幾個季度的建模時,我們應該如何考慮從劑量到在美國與您將要推出的全球市場實現報銷的時間?你認為這會相對迅速嗎?或者我們是否應該期待您正在談論的隨著時間的推移支付動態在您在美國不同市場推出時發揮作用?
Vasant Narasimhan - CEO
Vasant Narasimhan - CEO
So with respect to the payment over time, it's important to know we're doing this through a third-party. So actually, what we do is we recognize revenue immediately and then take a provision for our estimate of whether or not we would need to have any sort of rebate at some time over the period that we ultimately contract for. So you shouldn't model any lag. As Harry guided last time, it's really revenue recognition at the time of dosing. Today, because it's very early days, we don't have any plans currently using these kinds of models though we continue to work with clients in terms of contracting. It will be a similar situation we expect outside the United States as far as we can tell. Once we get those launches moving, we'll of course keep you updated if you need to shift your modeling at all for ex U.S. patients.
因此,關於隨著時間的推移付款,重要的是要知道我們是通過第三方這樣做的。所以實際上,我們所做的是立即確認收入,然後為我們估計在我們最終簽訂合同的期間內的某個時間是否需要任何形式的回扣做出準備。所以你不應該模擬任何滯後。正如 Harry 上次指導的那樣,這實際上是在給藥時確認收入。今天,因為還很早,我們目前沒有任何計劃使用這些類型的模型,儘管我們繼續在合同方面與客戶合作。據我們所知,這將是我們預計美國以外的類似情況。一旦我們啟動了這些發布,如果您需要為前美國患者完全改變模型,我們當然會及時通知您最新情況。
Operator
Operator
The next question comes from the line of David Maris from Wells Fargo.
下一個問題來自 Wells Fargo 的 David Maris。
David William Maris - Senior Analyst
David William Maris - Senior Analyst
Just a question. One of the proposals being floated is reference pricing. If you could just address in broad strokes what the average selling price difference of your lead products or the bulk of your pharma products are U.S. versus Europe or the developed markets that they're thinking about benchmarking to?
就一個問題。提出的建議之一是參考定價。如果你能粗略地解決你的主要產品或你的大部分醫藥產品的平均售價差異是美國與歐洲或他們正在考慮基準的發達市場?
Vasant Narasimhan - CEO
Vasant Narasimhan - CEO
Yes. When you look at the proposals, in our experience it would be a very limited exposure in Part B, we don't have many Part B medicines. I can't really give you a specific answer on Part B, probably better to ask some of our competitors on Part B. With respect to Part D, our analysis suggests that when you take into account rebates, other government subsidies and things that we give patient assistance programs, free drug et cetera, that our net pricing for our major medicines within Part D really -- at least, recently launched medicines in Part D approach those what we see in top European countries, so we really don't see a significant gap in Part D. I know from an industry-wide perspective, there's certainly a high variability within Part B, and I think that's where the focus has been.
是的。當您查看這些提案時,根據我們的經驗,B 部分的曝光量非常有限,我們沒有很多 B 部分藥物。關於 B 部分,我真的不能給你一個具體的答案,可能最好問問我們在 B 部分的一些競爭對手。關於 D 部分,我們的分析表明,當你考慮回扣、其他政府補貼和我們提供患者援助計劃,免費藥物等等,我們在 D 部分中對主要藥物的淨定價確實 - 至少,最近在 D 部分推出的藥物接近我們在歐洲頂級國家看到的那些,所以我們真的看不到D 部分存在重大差距。我知道,從整個行業的角度來看,B 部分肯定存在很大差異,我認為這就是重點所在。
Thank you for the questions. And I think we have time for one last question before we finish the call. So last question, please.
謝謝你的問題。我想我們在結束電話會議之前有時間回答最後一個問題。最後一個問題,請。
Operator
Operator
Last question comes from the line of Emmanuel Papadakis from Barclays.
最後一個問題來自巴克萊銀行的 Emmanuel Papadakis。
Emmanuel Douglas Papadakis - MD & Head of European Pharmaceuticals Research
Emmanuel Douglas Papadakis - MD & Head of European Pharmaceuticals Research
I'll try and keep it to one semi-brief question. It was to Harry Kirsch and perhaps about a little bit on margins. You talked about potentially getting a bit early to that mid-30s target. You didn't mention the possibility of us actually getting through that target and beyond. And in particular R&D, I mean, it's been perhaps one of the areas where you most actively talked in the past about something you can internally control in terms of reduction. You're already at the 20%. To what extent in the world of big data could you take it below that figure?
我將嘗試將其保留為一個半簡短的問題。這是給哈里·基爾希的,也許還有一點利潤。你談到可能會提前一點實現 30 年代中期的目標。您沒有提到我們實際上有可能實現該目標並超越目標。特別是研發,我的意思是,它可能是您過去最積極談論的領域之一,您可以在減少方面進行內部控制。你已經達到了 20%。在大數據世界中,您可以在多大程度上低於該數字?
Vasant Narasimhan - CEO
Vasant Narasimhan - CEO
Thanks for the question, Emmanuel. In general, for the company, we're trying to make the company as productive as possible. So our goal, of course, is not to stop in one specific number but certainly focus on areas where we can become as efficient and as competitive with anyone in our industry and if relevant in areas like business services or procurement competitive with anyone in any industry. Right now, our goal is to get to the 30 -- mid-30s in -- by 2022. If we get there on a full year basis sooner, then of course we'll give you updated perspective on where we want to head next on margins. But I certainly want to set the expectations, our aspirations are to be as productive as possible.
謝謝你的問題,伊曼紐爾。總的來說,對於公司而言,我們正在努力使公司盡可能高效。因此,我們的目標當然不是停留在一個特定的數字上,而是肯定會專注於我們可以變得與我們行業中的任何人一樣高效和具有競爭力的領域,如果與商業服務或採購等領域相關,則可以與任何行業中的任何人競爭.現在,我們的目標是到 2022 年達到 30 歲——30 歲中期。如果我們在全年基礎上更早到達那裡,那麼我們當然會給你更新的觀點,讓你知道我們下一步想在利潤率上取得什麼進展。但我當然想設定期望,我們的願望是盡可能多產。
Now with respect to R&D, we don't view R&D as the key lever to achieve this. R&D is fundamental to the company. We always wanted to get to that 20% range; we're there now. But we don't use R&D as our driver for margin improvement. What we want to do is ensure we fund every good program, and we do that and we ensure that -- and if we need to, of course, increase our R&D levels in order to fund excellent projects, we'll do that. In the medium and longer term, if data science, digital technologies can help us transform not only our manufacturing and business services and sales areas, we hope that also will transform R&D. We hope that actually gives us capacity to do more programs, and we can continue to be at 20% and even do more programs to grow the company.
現在關於研發,我們不認為研發是實現這一目標的關鍵槓桿。研發是公司的根本。我們一直想達到 20% 的範圍;我們現在在那裡。但我們不會將研發作為提高利潤率的驅動力。我們想要做的是確保我們為每一個好的項目提供資金,我們做到了,我們確保——當然,如果我們需要提高我們的研發水平以資助優秀的項目,我們會這樣做。從中長期來看,如果數據科學、數字技術不僅可以幫助我們改變我們的製造、商業服務和銷售領域,我們希望也能改變研發。我們希望這實際上給了我們做更多項目的能力,我們可以繼續保持 20%,甚至做更多的項目來發展公司。
So that's -- I think that's it for today's call. Thank you again for investing in Novartis, for your interest in Novartis. We look forward to delivering a strong second half of the year. We appreciate your interest in the company, and we wish you a great summer. Thank you.
這就是 - 我認為今天的電話會議就是這樣。再次感謝您投資諾華,感謝您對諾華的關注。我們期待在今年下半年表現強勁。我們感謝您對公司的興趣,並祝您度過一個美好的夏天。謝謝。
Operator
Operator
That does conclude our conference for today. Thank you for participating. You may all disconnect.
我們今天的會議到此結束。感謝您的參與。你們都可以斷開連接。