諾和諾德 (NVO) 2025 Q2 法說會逐字稿

內容摘要

  1. 摘要
    • Q2 上半年營收成長 18%,營業利益成長 29%,但若排除去年一次性減損與今年 M&A、Catalent 成本,實際營業利益成長約 20%
    • 下修全年指引:銷售成長預期調整為 8-14%,營業利益成長 10-16%,主因美國市場 GLP-1 產品銷量低於預期
    • 市場反應:公司強調近期 Wegovy 處方數(NBRx)已止跌回升,並持續與監管機構合作打擊非法仿製藥與 API 進口
  2. 成長動能 & 風險
    • 成長動能:
      • 美國與國際市場(特別是英國、新興市場、APEC)雙位數成長,APEC 肥胖業務成長 361%
      • GLP-1 類糖尿病藥物與肥胖治療產品為主要成長引擎,肥胖業務上半年成長 58%
      • 新產品線推進,包括口服 Semaglutide(預計 2026 年美國上市)、MASH(脂肪肝)新適應症即將啟動
      • 稀有疾病事業群恢復成長,年增 15%,並有新藥申請與正面審查意見
    • 風險:
      • 美國市場非法仿製藥與 API 進口(主要來自中國)持續影響正品銷量,短期內難以完全解決
      • 中國糖尿病市場僅成長 6%,主要因市場結構變化,非競爭壓力
      • 2025-2026 年部分產品將面臨專利到期與仿製藥競爭,特別是在加拿大與其他市場
      • GLP-1 類藥物在美國糖尿病市場成長放緩,滲透率已達 30%,未來增速趨緩
  3. 核心 KPI / 事業群
    • 全球服務患者數:超過 4,500 萬人,年增 300 萬人
    • 美國區營收成長 17%,國際營運(IO)成長 19%
    • GLP-1 糖尿病產品銷售成長 10%,肥胖治療產品銷售成長 58%
    • 稀有疾病事業群銷售成長 15%
    • 中國區營收成長 6%,APEC 肥胖業務成長 361%
  4. 財務預測
    • 2024 全年營收成長預估 8-14%
    • 2024 全年營業利益成長預估 10-16%
    • CapEx 維持不變,全年預計高於上半年,2024-2025 年接近高峰,之後將逐步回落
  5. 法人 Q&A
    • Q: Orforglipron(競品)最新臨床數據與 Novo 口服 Semaglutide 相比有何看法?市場分群策略是否改變?
      A: Novo 口服 Semaglutide 17% 體重減輕優於 Orforglipron 12%,且安全性更佳,對美國上市充滿信心。市場分群策略不變,預期口服市場將顯著成長,且能覆蓋更多未進入治療的患者。
    • Q: 美國非法仿製藥(compounding)問題何時能改善?是否已啟動 ITC 投訴?
      A: 目前尚未見到明顯改善,正與 FDA 積極溝通,所有法律選項都在考慮中,但無法透露具體訴訟進度。
    • Q: 產能利用率與未來價格競爭策略?專利到期後會否降價保市佔?
      A: 產能持續擴張,三個 Catalent 廠已投產,將積極捍衛市場份額。未來會根據競爭與成本結構調整價格策略。
    • Q: 口服 GLP-1 價格帶會否明顯低於注射劑型?
      A: 不會急於降價,會根據價值與可及性平衡,並觀察現金自費(cash channel)與訂閱制等新型態定價模式。
    • Q: Rebelsus(口服 Semaglutide)在糖尿病市場表現不佳,為何對口服肥胖藥物有信心?
      A: 糖尿病市場口服藥物選擇多,Rebelsus 劑量效力不及注射劑;但肥胖市場目前僅有注射劑,口服劑型將大幅提升接受度,且新產品效力與注射劑相當。

完整原文

使用警語:中文譯文來源為 Google 翻譯,僅供參考,實際內容請以英文原文為主

  • Operator

    Operator

  • So you get okay, right, welcome everybody. I'm James Quigley, European farmer here at the Goldman Sachs. It's my pleasure to welcome you to the second quarter results presentation. Today we've got, Karsten Knudsen, the CFO, also joined by, Martin Lange, Executive Vice President, Chief Scientific Officer. We say more, head of, operation, and the head.

    所以你明白了,對,歡迎大家。我是詹姆斯‧奎格利 (James Quigley),高盛的歐洲農民。我很高興歡迎您參加第二季業績報告會。今天我們邀請到了財務長 Karsten Knudsen,還有執行副總裁兼首席科學官 Martin Lange。我們更多說的是,主管,操作,頭部。

  • (inaudible)

    (聽不清楚)

  • Karsten Munk Knudsen - Chief Financial Officer, Executive Vice President

    Karsten Munk Knudsen - Chief Financial Officer, Executive Vice President

  • Thank you, James and welcome to the Q2 results meeting here in London, the lunch meeting. Thank you all for coming and thank you to the ones listening in online. So. So we have a good team here. So again, we have Martin Lange in his first day as CSO of News. So congratulations to you, Martin on you on that one.

    謝謝詹姆斯,歡迎參加在倫敦舉行的第二季業績會議和午餐會議。感謝大家的到來,也感謝線上收聽的各位。所以。所以我們這裡有一支優秀的團隊。再一次,這是馬丁·蘭格 (Martin Lange) 擔任新聞部首席策略官的第一天。所以,馬丁,祝賀你。

  • I think a good timing of becoming CSO. We'll talk more about that later. And then Dave Moore from the US known person, so President of our US business and Ludwig from running commercial strategy and our portfolio planning.

    我認為現在是擔任 CSO 的好時機。我們稍後會詳細討論這一點。然後是來自美國的知名人士戴夫·摩爾 (Dave Moore),他是我們美國業務的總裁,還有路德維希 (Ludwig),他負責商業策略和投資組合規劃。

  • So, we have, we're going to go through our results briefly and then we're going to host the Q&A session moderated by Jacob Martin Rode, Head of Investor Relations. So as always, then there will be forward-looking statements discussed today and forward-looking statements, they are associated with the risks and assumptions. Unfortunately, that's also what we saw last week with our downgrade because we made some assumptions that unfortunately they didn't fully pan through and that's why we had to downgrade our outlook for the year that I'm sure we'll come back to.

    因此,我們將簡要介紹我們的結果,然後我們將舉辦由投資者關係主管 Jacob Martin Rode 主持的問答環節。因此,與往常一樣,今天討論的前瞻性陳述和前瞻性陳述將會與風險和假設相關。不幸的是,這也是我們上週下調評級時看到的情況,因為我們做出了一些假設,但不幸的是這些假設並沒有完全實現,這就是為什麼我們不得不下調今年的展望,我相信我們會再次下調。

  • So, talking about the results in in the first half of the year in in through our strategic aspirations, I'd say we are. We continue to expand our patient reach, and I think this is really the core of New Nors, driving change for patients suffering from serious chronic disease, progressive diseases within diabetes and obesity.

    因此,從我們的戰略願望來談論上半年的成果,我想說我們確實做到了。我們將繼續擴大患者覆蓋範圍,我認為這才是「新規範」的核心,推動患有嚴重慢性病、糖尿病和肥胖症等漸進性疾病的患者的改變。

  • And now we're serving more than 45 million patients. We added more than 3 million patients compared to a year ago. So it speaks to the scaling of our business and also the future prospects of what we're, what we are operating under.

    現在我們為超過 4500 萬名患者提供服務。與一年前相比,我們增加了300多萬名患者。因此,它說明了我們業務的規模以及我們營運的未來前景。

  • On the commercial side, my colleagues will come into it and the same for R&D and financials. We deliver 18% top line growth at exchange rates in in in the first half of the year and 29% operating profit growth in the first half.

    在商業方面,我的同事會參與其中,研發和財務方面也是如此。以匯率計算,我們上半年的營業收入成長了 18%,營業利潤成長了 29%。

  • Operating profit impacted by an impairment in the first half of last year and then some additional cost due to M&A and Catalan this year. So Netnet operating profit on the line is closer to the 20% growth, but still very healthy operating profit growth. And in terms of cash flow generation, that's of course a key premise for the company. We generated almost $34 billion in free cash flow despite investing $28 billion in CapEx in the first half of the year, and we returned also more or less our full free cash flow to shareholders here in the first half of the year. So a disciplined approach on capital allocation.

    營業利潤受到去年上半年減損以及今年併購和加泰隆尼亞業務產生的一些額外成本的影響。因此,Netnet 的線上營業利潤接近 20% 的成長,但營業利潤成長仍然非常健康。就現金流產生而言,這當然是公司的關鍵前提。儘管上半年我們投資了 280 億美元的資本支出,但我們仍產生了近 340 億美元的自由現金流,並且上半年我們也向股東返還了幾乎全部的自由現金流。因此,資本配置應採取嚴謹的方法。

  • Then I hand it over to Ludo for commercial updates.

    然後我將其交給 Ludo 進行商業更新。

  • Ludovic Helfgott - Executive Vice President - Rare Disease

    Ludovic Helfgott - Executive Vice President - Rare Disease

  • Very quickly.

    非常快。

  • From a sales perspective, the region in the US actually grew 17% in the first part of the year, and the IO grew 19%, which is an overall 18% growth for in the first half of the year. If you look at the IO in particular, really double-digit growth on UK and emerging markets and APEC and the 6% in China, I'm sure we might come back to that at a later stage from Therapeutic perspective, you can clearly grow an 18% overall growth logically.

    從銷售角度來看,今年上半年美國地區實際上成長了 17%,IO 地區成長了 19%,因此上半年整體成長了 18%。如果你特別關注 IO,英國和新興市場以及亞太經合組織確實實現了兩位數的成長,而中國則成長了 6%,我相信我們可能會在稍後從治療角度回到這一點,從邏輯上講,你顯然可以實現 18% 的整體成長率。

  • GLP-1 diabetes plus 10%, the obesity care 58%, and the rare disease actually back to growth with a 15% growth rate across the board and of course with day we can a bit more into that I guess at some point.

    GLP-1 糖尿病成長 10%,肥胖症照護成長 58%,罕見疾病實際上恢復成長,全線成長率為 15%,當然,我想,隨著時間的推移,我們可以在某個時候對此進行更深入的研究。

  • If you look from an IO perspective, the international operations growth to 19% driven by the GLP-1 diabetes and obesity care. You had this overall GLP-1 diabetes care cells growth, 10%, I said. With double digits in and emerging market and APEC and this decrease in China which is driven by the market itself. It's not a competition issue. It's actually a market expansion discussion we might want to talk about that at a later stage.

    如果從IO的角度來看,在GLP-1糖尿病和肥胖症護理的推動下,國際業務成長至19%。我說過,總體而言,GLP-1 糖尿病護理細胞增加了 10%。新興市場和亞太經合組織的成長均達到兩位數,而中國的下降是由市場本身推動的。這不是一個競爭問題。這實際上是一個市場擴張的討論,我們可能想在稍後階段討論這個問題。

  • On the obesity side in IO, a growth of 125% versus last semester in 2024. [UC] 64% emerging market 157. And then 361% for APEC China is growing a lot, but of course out of a small base, so mathematically it doesn't make much sense, but really a healthy growth on obesity care in sales and growth for the first 6 months in (inaudible).

    在印度,肥胖問題將比 2024 年上學期增加 125%。 [UC] 64% 新興市場 157。亞太經合組織中國市場 361% 的成長幅度很大,但當然基數很小,所以從數學上講沒有多大意義,但肥胖護理產品在前 6 個月的銷售額和成長確實健康成長。(聽不清楚)。

  • And then over to you David from the US. Thanks.

    接下來是來自美國的戴維 (David)。謝謝。

  • David Moore - Executive Vice President - Corporate Development

    David Moore - Executive Vice President - Corporate Development

  • So, when we think about the obesity market in the US, everyone knows we're in a competitive environment. We're a competitive environment with Lili. We'll talk a little bit about that. We're also in a competitive environment with fake, cheaper alternative of our medicine that's being imported by China, which we are keenly focused on, putting an end to that, so we go back to competing in the branded obesity market.

    因此,當我們考慮美國的肥胖市場時,每個人都知道我們處於一個競爭激烈的環境中。我們和 Lili 處在一個競爭環境。我們將稍微討論一下這個。我們也處在一個競爭激烈的環境中,中國進口的假冒、廉價的藥品替代品層出不窮,我們對此高度重視,力求杜絕這種現象,因此我們重新回到品牌肥胖症市場的競爭中。

  • So, if you think about the dynamics in the branded market this is what we typically see when you have the lead, the first mover position, another product comes in, it's an easier position to be in to go to the doctor and saw to my product, start new patients on my product. By the way, I experienced the same thing when I launched Ozempic versus Trulicity, and it works, and that's the dynamic that we had.

    因此,如果你考慮品牌市場的動態,這就是我們通常看到的情況,當你擁有領先地位,先發優勢時,另一種產品進入市場,你更容易去看醫生,看到我的產品,開始用我的產品治療新患者。順便說一句,當我推出 Ozempic 與 Trulicity 時,我也經歷了同樣的事情,而且它有效,這就是我們所擁有的動態。

  • And what we learned in the beginning of the year, I took this job over in January. There was a shift last year just in terms of messaging. Actually makes sense. You have select data, it's compelling, it's meaningful clinical data, real world outcomes, and you switch the message to be beyond weight. That was actually the name of the campaign, Treat Beyond the Weight.

    根據我們在年初學到的知識,我在一月接手了這項工作。去年,訊息傳遞方面發生了轉變。確實有道理。您擁有精選數據,這些數據令人信服,是有意義的臨床數據、真實世界的結果,並且您將資訊轉換為超越重量的意義。這實際上是該活動的名稱,即「超越體重,善待他人」。

  • What we learned is a little premature to do that. There probably will be a time to do that, and there's a meaningful discussion to have around comorbidities, but there's two players in the game, and it's still about weight loss.

    我們認識到這樣做還為時過早。可能將來會有這樣做的時候,並且會圍繞合併症進行有意義的討論,但遊戲中有兩個玩家,而且仍然與減肥有關。

  • That's the primary reason for prescribing is around weight loss. It's what patients are looking for, it's what doctors are looking for. We changed that message in June to go back to driving the weight loss competitive message. We have real world data that is head-to-head versus Seretide and Samagnotide.

    開處方的主要原因是為了減肥。這是病人所尋求的,也是醫生所尋求的。我們在六月改變了這個訊息,重新開始推動減肥競賽訊息。我們擁有與 Seretide 和 Samagnotide 進行正面對比的真實世界數據。

  • We have some magnitude data where we follow patients for 2 years and we see the average weight loss is 20%. Actually just got updated to 21% because we continue to follow these patients in the We Go Together campaign. That's starting to resonate again. We're starting to see the impact of having that weight loss message. Once we solidify that competitively, then you move on to the other elements, right? And you have a discussion about the other aspects.

    我們有一些對患者進行兩年追蹤調查的大量數據,我們發現平均體重減輕了 20%。實際上剛剛更新到 21%,因為我們在「我們一起走」活動中繼續追蹤這些患者。這又開始引起共鳴了。我們開始看到減肥訊息的影響。一旦我們在競爭上鞏固了這一點,我們就會轉向其他元素,對嗎?而你們也討論了其他方面。

  • And so, what we're starting to see is a shift in MBRX's. MBRX is our sign of health. It's the leading indicator, how's your brand doing? And from about May of 2024, April, May 2024 to May of 2025, the NBRX's of, we were going down. That's a bad indicator of your health of your brand. We're still growing. The market's growing, you can see there's growth, but the MBRX's were going down. In May, that has stopped. And we're starting to see growth.

    因此,我們開始看到 MBRX 的轉變。MBRX 是我們健康的標誌。這是領先指標,你的品牌表現如何?從 2024 年 5 月、2024 年 4 月、5 月到 2025 年 5 月,NBRX 一直在下降。這表示您的品牌健康狀況不佳。我們仍在成長。市場正在成長,你可以看到成長,但 MBRX 卻在下降。五月份,這種情況已經停止。我們開始看到成長。

  • We're seeing growth with Wegovy competitively, especially versus devices. Nationally, NBRX [awagobi] device passed that bound device. And that is in part due to CVS conversion, but that's not all of it. It's also that we're seeing growth outside of the CVS conversion. So we will continue in this competitive dynamic. We now have an opportunity to go out and talk about a difference in CVOT outcomes.

    我們看到 Wegovy 的競爭力正在成長,尤其是與設備相比。在全國範圍內,NBRX[awagobi]設備超過了此綁定設備。這部分是由於 CVS 的轉換,但這並不是全部。我們也看到了 CVS 轉換以外的成長。因此,我們將繼續保持這種競爭態勢。我們現在有機會出去談論 CVOT 結果的差異。

  • Once again, we saw outcomes last week with the surpass data, and our reps are armed to go in and say that this is not a class effect. It's very easy to walk in and say, we have a little bit better data, and by the way, it's a class effect. They'll all be the same. It is not. They're not the same. 12% is not 26%. So that's a conversation with Omics. It's also a conversation with Wegovy. Moving forward in weeks, we'll launch MASH.

    再一次,我們上週看到了超越數據的結果,我們的代表可以肯定地說,這不是階級效應。我們很容易走進去說,我們有更好的數據,順便說一句,這是一種階級效應。它們都是一樣的。它不是。它們不一樣。 12% 不是 26%。這就是與 Omics 的對話。這也是與Wegovy的對話。幾週後,我們將推出 MASH。

  • MASH is a primary indication, one that entire companies have been built upon, and we have an opportunity to go out and differentiate and go further in terms of that strength of the label and go out and start selling in the mash market. We have a dedicated sales force, small. We've hired about 130 people. They'll call on hepatologists and GI.

    MASH 是一個主要指標,整個公司都是以此為基礎建立起來的,我們有機會走出去,在標籤優勢方面脫穎而出,走得更遠,並開始在麥芽漿市場上銷售。我們擁有一支專門的銷售隊伍,規模不大。我們已僱用了約 130 名員工。他們會請肝病專家和胃腸病專家來。

  • There's only about 300 hepatologists in the US and we'll focus on about 15,000 gastroenterologists and our obesity sales reps will be armed with the MAS launch. Remember, it's about 80% overlap with obesity, 40% overlap with type 2 diabetes. We're not waving any victory flags. We've got a long way to go, but this is a growth story. It's an expansion of the obesity market story. And in the beginning of the year we'll be launching oral Sema for obesity, and we'll come back to that in a little bit.

    美國祇有大約 300 名肝病專家,而我們將重點放在大約 15,000 名胃腸病專家,我們的肥胖症銷售代表將配備 MAS 產品。請記住,它與肥胖症有大約 80% 的重疊,與第 2 型糖尿病有 40% 的重疊。我們不會揮舞任何勝利旗幟。我們還有很長的路要走,但這是一個成長的故事。這是肥胖市場故事的擴展。今年年初,我們將推出針對肥胖症的口服藥物 Sema,稍後我們會再討論這個問題。

  • Over to you, Mark.

    交給你了,馬克。

  • Martin Holst Lange - Executive Vice President

    Martin Holst Lange - Executive Vice President

  • Thank you very much.

    非常感謝。

  • And with Dave here, obviously, as you all remember, we filed all smuggle site for peace in the US earlier this year. We expect to see an approval of that filing at the towards the end of this year with a strong US launch, starting 2026.

    戴夫在這裡,顯然,大家都記得,我們今年早些時候在美國為和平申請了所有走私網站。我們預計該產品申請將在今年底獲得批准,並於 2026 年開始在美國強勢推出。

  • Just to remind you of the data, with all the magnetic and obesity, we saw a 16% weight loss, almost 17% weight loss with the safety and solubility profile that we already know very well from Sema subcutaneously. So, we're actually able to achieve the same weight loss, the same safety and ability orally as we do. That's very strong. And again, 17% weight loss, we think that is going to be unsurpassed or unsurpassed for a long period of time. In addition to that, and this is a potential.

    只是為了提醒您數據,考慮到所有的磁性和肥胖,我們看到體重減輕了 16%,幾乎減輕了 17%,並且我們已經非常了解 Sema 皮下注射的安全性和溶解度概況。因此,我們實際上能夠透過口服達到相同的減肥效果、相同的安全性和能力。這非常強大。再次強調,17% 的減重效果,我們認為這將是無人能及的,或者在很長一段時間內都無法被超越的。除此之外,這也是一種潛力。

  • We aim to have the comorbidity benefits in the label starting with the maze benefits that we know well from subcutaneous cement. So, a really exciting offering in the space to be launched in the US by David and his team early 2020.

    我們的目標是從我們熟知的皮下水泥迷宮益處開始,在標籤中體現合併症益處。因此,David 和他的團隊將於 2020 年初在美國推出該領域的真正令人興奮的產品。

  • In the IT space, obviously you know our focus on diabetes and obesity. We also have other therapy areas and we see progress and activities across the board. Obviously in the diabetes space it's going to be very exciting to see what [calma can do in reimagin free], i.e., glycemic control and weight loss in patients with type 2 diabetes for.

    在 IT 領域,您顯然知道我們關注的是糖尿病和肥胖。我們還有其他治療領域,我們看到了全面的進展和活動。顯然,在糖尿病領域,看到 Calma 在 Reimagin Free 中能發揮什麼作用,為 2 型糖尿病患者控制血糖和減輕體重,將會非常令人興奮。

  • It's going to be very interesting to see the phase 2 data for [amiretin] also in the diabetes.

    觀察 [amiretin] 在糖尿病治療中的第 2 階段數據將會非常有趣。

  • In the space we continue to progress. We aim to have a 7.2 mg EU submission already here in Q3. We aim to see the Read of our triple agonist and importantly, we'll initiate the [Caguan side] and phase 3 program also later this year.

    在太空中我們不斷進步。我們的目標是在第三季獲得 7.2 毫克的歐盟提交。我們的目標是看到三重激動劑的療效,重要的是,我們將在今年稍後啟動 [Caguan 方面] 和第 3 階段計劃。

  • That's going to be incredibly exciting in the diabetes and obesity space. I would be remiss Ludovic is no longer so interested in rare disease, but I still have to mention US approval and positive CHFP opinion for Elmo and imminent regulatory filing of my mate. And then obviously in other disease areas we closed down selfurin, not because it was a bad offering. It was just not better than the.

    這對於糖尿病和肥胖症領域來說將會非常令人興奮。如果 Ludovic 不再對罕見疾病感興趣,那我就太疏忽大意了,但我仍然必須提到美國對 Elmo 的批准和 CHFP 的積極評價,以及我的伙伴即將提交的監管文件。顯然,在其他疾病領域,我們關閉了 Selfurin,並不是因為它的產品不好。它只是沒有比它更好。

  • And as you know right now, we have at least in the [facepa] the strongest data in MASH, and as they've mentioned, we expect regulatory approval for that in the US within a couple of months. Finally, obviously, the rotator, I have to remind you, we see that as high risk, high reward. But the readout will come towards the end of the year in Q4 and obviously going to be exciting. And with that back to you. Guys, right.

    正如您現在所知,我們至少在 [facepa] MASH 中擁有最強大的數據,正如他們所提到的,我們預計美國監管部門將在幾個月內批准該藥物。最後,顯然,我必須提醒你,我們認為旋轉器具有高風險和高回報。但數據將在年底第四季公佈,顯然這將是令人興奮的。並將其返回給您。夥計們,對的。

  • Karsten Munk Knudsen - Chief Financial Officer, Executive Vice President

    Karsten Munk Knudsen - Chief Financial Officer, Executive Vice President

  • Thank You, Martin. Then on Outlook which we announced last week, so we lowered our outlook link to predominantly a lower volume growth in the US compared to what we expected back at our Q1 release. So lower volume outlook for Simic and Vigo.

    謝謝你,馬丁。然後,就我們上週發布的展望而言,我們下調了展望,主要是因為與我們在第一季發佈時預期的相比,美國的交易量增長較低。因此西米克和維戈的銷售前景較低。

  • They was just touching on that we do see positive signs on VigoI now over the last last few weeks and data points.

    他們只是提到,過去幾週我們確實看到了 VigoI 的正面跡象和數據點。

  • So sales growth outlook now 8 to 14% for the full year and operating profit 10 to 16% for the full year. Currencies updated based on July 31st, so it's like tweak compared to last week, so now 3.5 points lower respectively, mainly linked to the US dollar.

    因此,預計全年銷售額將成長 8% 至 14%,全年營業利潤成長 10% 至 16%。貨幣根據 7 月 31 日更新,因此與上週相比有所調整,現在分別下降了 3.5 點,主要與美元掛鉤。

  • And the corresponding adjustment to net finances linked to the hedging of our core currencies. CapEx unchanged while free cash flow is reduced to between $35billion and $45 billion Danish krona mainly as a function of the low US outlook amplified by the gross to net payment term in that model. So that's really what drives the cash flow delta compared to the Q1 guidance.

    以及與我們的核心貨幣對沖相關的淨財務的相應調整。資本支出保持不變,而自由現金流減少至 350 億至 450 億丹麥克朗之間,這主要是因為該模型中總付款期限與淨付款期限放大了美國的低前景。因此,與第一季指引相比,這才是真正推動現金流差異的因素。

  • There are a few comments around the cash flow in the second half of the year versus what we realized in the first half of the year, and the simple explanation is really twofold. One is higher cap expense in the second half of the year compared to the first half of the year, and the second reason is that on account tax payments mainly in Denmark is back and loaded into the second half of the year compared to the first half of the year. Adjusting for that, it's way more normalized in terms of cash flow generation across the year.

    關於下半年現金流與上半年現金流的對比,有一些評論,簡單的解釋實際上有兩個面向。一是下半年的資本支出比上半年高,二是主要在丹麥的應稅額回流到下半年,而不是上半年。經過調整後,全年現金流的產生就更正常化了。

  • So that covers the financial outlook and now we're ready to move to Q&A. Thank you.

    這涵蓋了財務前景,現在我們準備進入問答環節。謝謝。

  • Operator

    Operator

  • (Operator Instructions)

    (操作員指示)

  • Unidentified_15

    Unidentified_15

  • So a quick question, Martin on Orthoglyphone phase 3 data from the tame one has just been released. So the placebo adjusted weight loss of around 11.5% at 72 weeks, 24% vomiting, 10% discontinuations at the highest dose. So what is your view on the products relative to Wagovi and to all some 25 mg? And then Dave and then Ludwig you had a good slide in the back of the presentation yesterday on the segmentation of the market.

    所以我有一個快速的問題,馬丁,關於剛剛發布的馴服的 Orthoglyphone 第三階段數據。因此,安慰劑調整後,72 週時體重減輕約 11.5%,嘔吐發生率為 24%,最高劑量時停藥率為 10%。那麼您對 Wagovi 以及所有 25 毫克產品有何看法?然後是戴夫和路德維希,你們昨天在演示的後面有一張關於市場細分的精彩幻燈片。

  • Does this data change how you think the competition will develop in those segments?

    這些數據是否會改變您對這些領域競爭發展方式的看法?

  • Thank you.

    謝謝。

  • Martin Holst Lange - Executive Vice President

    Martin Holst Lange - Executive Vice President

  • So I I think the numbers speak for themselves. If we were to compare 17% weight loss to 12% weight loss, withdrawal rate due to adverse event on the highest dose of 10% versus 7% overall withdrawal rate on the highest dose 25%, which was I think 18 for 25 mg. It speaks for itself. It appears that and again it's an indirect comparison.

    所以我認為數字說明了一切。如果我們將體重減輕 17% 與體重減輕 12% 進行比較,最高劑量因不良事件導致的停藥率為 10%,而最高劑量的總體停藥率為 7%,即 25 毫克的停藥率為 18%。其意義不言而喻。看起來,這又是一個間接的比較。

  • There is a substantial difference in weight loss potential, but also in the safety soability profile between the two offerings. At the same time, we can scale all the magnesite and therefore I think we, it's fair to say we're super excited about launching that product in a competitive space.

    兩種產品的減肥潛力以及安全性都存在很大差異。同時,我們可以擴大所有菱鎂礦的規模,因此我認為,可以說我們非常高興在競爭激烈的領域推出產品。

  • David Moore - Executive Vice President - Corporate Development

    David Moore - Executive Vice President - Corporate Development

  • We're really excited to launch this. This is a good old fashioned no no launch where we have a competitive, compelling profile. The reason we decided to move forward with this launch, regardless of Orfo was because we had a product with meaningful weight loss with a known compound and familiarity and safety in millions of people using this worldwide in addition to The broadest label. That's the reason we decided to bring it forward.

    我們非常高興推出這個產品。這是典型的「不准發布」活動,我們擁有競爭力和引人注目的形象。我們決定繼續推出這款產品,而不考慮 Orfo,是因為我們擁有一款具有顯著減肥功效的產品,其成分已知,並且全球數百萬用戶都熟悉且安全,此外還擁有最廣泛的標籤。這就是我們決定提前實施這項計劃的原因。

  • We know what 16-17% weight loss means, and I think what we're really excited about is this sort of segments of the market that are not motivated to go and seek treatment today, either because of the way they see their disease, or they're not motivated to go and seek a medicine that would require an injection. There is another segment of people out there living with obesity. That are very interested in an oral daily GOP one, and we're going to, treat it that way in a, in an unconstrained, type of launch in the US.

    我們知道 16-17% 的減肥意味著什麼,我認為我們真正感到興奮的是這類市場現在沒有動力去尋求治療,要么是因為他們看待疾病的方式,要么是他們沒有動力去尋求需要注射的藥物。還有一部分人患有肥胖症。他們對共和黨的每日口頭報告非常感興趣,我們將在美國以一種不受約束的方式推出它。

  • Ludovic Helfgott - Executive Vice President - Rare Disease

    Ludovic Helfgott - Executive Vice President - Rare Disease

  • And if you take a step back, the whole idea that we shared, which is this idea that you don't have one single population of people patients with obesity, but actually sub segments of them can only be reinforced by that view. We don't believe that if anything, we believe that the share of the oral market will actually grow significantly given the quality of what you have here efficacy wise and including with the cardiovascular benefits we can really bang that into the profile.

    如果你退一步來看,我們所分享的整個想法,即你不只有一個肥胖患者群體,而是實際上有其中的細分群體,這種觀點只能得到強化。我們不相信,如果有的話,我們相信口服市場的份額實際上會大幅增長,考慮到你們的產品的品質、功效以及心血管益處,我們真的可以把它納入到概況中。

  • And that will be very helpful to start unlocking all these groups of segments that are today not really already getting to the obesity market, but we'll get there, and we start to have quite precise ideas of who these groups could be. So, in other words, we believe in the overall part of the market. We believe that the EP is actually has the potential to be best in class there right now, given the data that we saw this morning, and we have a trust that we can really do a super launch in the US.

    這將非常有助於開始解鎖所有這些目前尚未真正進入肥胖市場的群體,但我們將進入這個市場,並開始對這些群體可能是誰有相當精確的了解。所以,換句話說,我們相信市場的整體部分。我們相信,根據我們今天早上看到的數據,EP 實際上有潛力成為目前最好的產品,我們相信我們真的可以在美國實現超級發布。

  • David Moore - Executive Vice President - Corporate Development

    David Moore - Executive Vice President - Corporate Development

  • I mean, we're going to team up pretty well as we start putting these things together. You can already imagine the type of BTC is, I'm thinking about. I'm a pretty simple sales and marketing guy.

    我的意思是,當我們開始把這些東西放在一起時,我們將會很好地合作。你已經可以想像我正在思考的 BTC 的類型了。我是一個非常簡單的銷售和行銷人員。

  • When you can say your product is better, things usually happen in the marketplace, and at least from what we've seen in the first-generation sort of oral small molecule, taking the lead from our CSL, we made a good move in terms of thinking about oral Sama for obesity, and it was a good call.

    當你可以說你的產品更好時,市場上通常會有更好的表現,至少從我們在第一代口服小分子藥物中看到的情況來看,在 CSL 的帶動下,我們在考慮使用口服 Sama 治療肥胖症方面做出了正確的舉措,這是一個很好的決定。

  • Ludovic Helfgott - Executive Vice President - Rare Disease

    Ludovic Helfgott - Executive Vice President - Rare Disease

  • Building on that and to finish up your question, it's not only good for the oral market, it's also good because you're increasingly seeing that the patients will have a journey towards obesity. They might start with an oral get to injectable. They start with injectable, get to an oral. So it's not just the subgroup themselves you're opening, it's actually the full lifetime value of a patient. You can actually multiply by having several different offerings of high quality, which is the one we believe we are bringing to patients today. So it's a double whammy in a sense.

    基於此並回答您的問題,這不僅對口服市場有利,而且因為您越來越多地看到患者會走向肥胖。他們可能會從口服開始,然後注射。他們從注射開始,然後口服。因此,您開設的不僅僅是子組本身,實際上還有患者的整個生命週期價值。實際上,您可以透過提供幾種不同的高品質產品來實現倍增,而這正是我們相信我們今天為患者提供的。從某種意義上來說,這是雙重打擊。

  • Operator

    Operator

  • Brilliant. Wonderful. Let's move to the front table here, people first, and then we'll go to Simon Baker afterwards.

    傑出的。精彩的。我們先到前面的桌子,各位先發言,然後我們再去找西蒙·貝克。

  • Unidentified_15

    Unidentified_15

  • Thank you. Actually, just, a clarification from Martin on, single chamber. I think you mentioned yesterday the need to run a clinical equivalent study. Can you just, help us a bit with the timeline when you think you we can start this study, how long it would take, what does the submission process look like for this type of study and I guess I mean the reason I ask this question is just to sort of compare the timeline for [Kinse] single chamber with [amicin subcu] because if they get close, how do you think of one that with the other.

    謝謝。實際上,馬丁只是對單室問題進行了澄清。我想您昨天提到了進行臨床等效研究的必要性。您能否幫助我們制定時間表,您認為我們什麼時候可以開始這項研究,需要多長時間,這種類型的研究的提交流程是怎樣的,我想我問這個問題的原因只是為了比較一下 [Kinse] 單室與 [amicin subcu] 的時間表,因為如果它們接近,您如何看待其中一個與另一個。

  • Martin Holst Lange - Executive Vice President

    Martin Holst Lange - Executive Vice President

  • Maybe you do on the timelines afterwards and Ludo you can do on [Microin] versus [Kakasema].

    也許你會在之後的時間線上做,你可以在[Microin]上做Ludo,對戰[卡卡塞馬]。

  • David Moore - Executive Vice President - Corporate Development

    David Moore - Executive Vice President - Corporate Development

  • So, absolutely, and obviously we see a benefit in terms of supply flexibility to have the single chamber. I do want to call out we are scaling to to have a very strong launch with the dual chamber device, but it will give us that flexibility. It's an upside if we can do it, and I had to do the clinical equivalent study. It's going to be smaller and shorter than what you would conventionally think with a phase 3 study, so we just had to show similar weight loss and trajectory weight loss and similar soil profile.

    因此,我們絕對且明顯地看到了單室在供應彈性方面的優勢。我確實想說,我們正在擴大規模,以便透過雙房設備實現非常強勁的推出,但它將為我們提供靈活性。如果我們能做到的話,那將是一件好事,而且我必須進行臨床等效研究。它將比你傳統上認為的第三階段研究的規模更小、更短,所以我們只需要展示類似的重量減輕和軌跡重量減輕以及類似的土壤概況。

  • We intend to initiate the study around the turn of the year, and I won't go further into the timeline.

    我們打算在今年年初啟動這項研究,我不會進一步透露時間表。

  • Martin Holst Lange - Executive Vice President

    Martin Holst Lange - Executive Vice President

  • And having multiple treatments in the market.

    且市面上有多種治療方法。

  • Ludovic Helfgott - Executive Vice President - Rare Disease

    Ludovic Helfgott - Executive Vice President - Rare Disease

  • I think the whole question is bringing the diversity to the different patient populations and we really believe in the value and efficacy and safety profile of [emmicritin]. By the way, we have the injectable, we have the oral as well, which is not the case for, you're offering to the patients a portfolio of options that are really based on helping them adapting the treatments to what they really need and the associated comorbidities because for me what's really interesting beyond the format is the kind of programs we're designing and I'm sure that Martin will come to that later on, but the idea is to replicate from a scientific perspective the diversity of patients that you find in the market and enriching the AMACE program as an example with sub-studies of subs and subpopulations on which we're going to study the very specific needed end points the sleep apnea, osteoarthritis, we talked to other benefits that will enrich the program with.

    我認為整個問題是為不同的患者群體帶來多樣性,我們真的相信它的價值、功效和安全性[艾米克林]。順便說一句,我們有註射劑,也有口服劑,但事實並非如此,您為患者提供的是一系列選擇,這些選擇實際上是為了幫助他們根據實際需要和相關合併症調整治療方法,因為對我來說,除了形式之外,真正有趣的是我們正在設計的項目類型,我相信馬丁的亞群計劃,我們將在這些亞群和亞群上研究非常具體的必要終點,如睡眠呼吸中止症、骨關節炎,我們還討論了可以豐富該計劃的其他好處。

  • So, for me it's not just a formal discussion, it's the ability to answer the weight first because we won't do the same mistake twice weight first and then the comorbidities that are associated with the various populations we're targeting.

    因此,對我來說,這不僅僅是一個正式的討論,而是能夠首先回答體重問題,因為我們不會犯同樣的錯誤兩次,首先是體重,然後是與我們所針對的不同人群相關的合併症。

  • Martin Holst Lange - Executive Vice President

    Martin Holst Lange - Executive Vice President

  • Very good, thanks a lot. Let's go to Simon then and onwards to Harry afterwards.

    非常好,非常感謝。我們先去找西蒙,然後再去找哈利。

  • Simon Baker - Analyst

    Simon Baker - Analyst

  • Thank you, Simon Baker from Rothschild and Co. Redburn. Let's go back to the market as it stands today. You are seeing, encouraging upticks in MBRX, but you've still got the problem of compounding which you said is pretty much unchanged.

    謝謝你,羅斯柴爾德雷德伯恩公司的西蒙貝克。讓我們回顧一下今天的市場現況。您看到 MBRX 出現了令人鼓舞的上漲,但您仍然面臨複合問題,您說這個問題幾乎沒有改變。

  • So, can you give us some sort of help in thinking what is a reasonable time frame over which to expect that to change? I know it's a difficult thing to ask, but if things go as planned, would we expect this to be meaningfully low in 26 or 27? How long do you, or indeed 25, how long would it take to have an impact there? And related to that, It doesn't look like you've filed a section 337 complaint with the International Trade Commission to block infringing API coming into the state. Is that true? And if not, do you plan to do so? And if so, when?

    那麼,您能否幫助我們思考一下,預計這種變化的合理時間範圍是多大?我知道這個問題很難回答,但如果一切按計劃進行,我們是否預計這個數字在 26 或 27 年會顯著降低?您需要多長時間,或者實際上是 25,需要多長時間才能在那裡產生影響?與此相關,您似乎並沒有向國際貿易委員會提交第 337 條投訴來阻止侵權 API 進入該州。這是真的嗎?如果沒有,您打算這樣做嗎?如果是的話,什麼時候?

  • David Moore - Executive Vice President - Corporate Development

    David Moore - Executive Vice President - Corporate Development

  • Yeah, I may let Karsten answer kind of any legal action or comments but let me focus on US and enforcement right now.

    是的,我可能會讓卡斯滕回答任何法律訴訟或評論,但現在讓我集中討論美國和執法問題。

  • We have not seen a meaningful change in the compounding in the US after May 22nd, which is when compounding became illegal again, except for rare circumstances. Which is a grace period after being removed from the drug shortage list. We have seen some change in the dynamics in terms of moving from 503B to 503A, kind of the who is compounding, and kind of moving towards a more mass personalization versus just, mass production and compounding.

    5 月 22 日之後,除了極少數情況外,我們並未看到美國的複利制度發生重大變化,因為自那時起,複利制度再次變得非法。這是從藥品短缺名單中移除後的寬限期。我們已經看到從 503B 到 503A 的動態變化,有點像誰在復合,並且有點朝著更大規模的個性化而不是大規模生產和復合的方向發展。

  • We haven't seen a change on where it's coming from, Simon. We track it, we see it, most of it coming in from China, largely from plants that are not approved. Certainly, the methodology is not approved in terms of the way that they're producing synthetic API, fake synthetic, and the way that it's coming into the country.

    西蒙,我們還沒有看到它的來源改變。我們追蹤它,我們看到它大部分來自中國,主要來自未經批准的工廠。當然,就他們生產合成 API、假合成 API 的方式以及這些 API 進入該國的方式而言,這種方法是未經批准的。

  • And it's been coming in in containers that is not for human use for research purposes only, right? That is where we're in active dialogue right now with FDA and we're having meaningful dialogue. You can imagine we've been having conversations for a couple of years, right? Since we were put on the shortage list and we saw this compounding, that dialogue has changed to be productive, to be responsive. I don't, I can't put a date like in terms of when we're going to see something. We do have expectations. We do have timelines we discuss with them unless it's going to escalate on our end to further action.

    而且它是裝在不供人類使用、僅用於研究目的的容器中運來的,對嗎?這就是我們目前正在與 FDA 進行積極對話並且有意義的對話。你可以想像我們已經交談了好幾年了,對吧?自從我們被列入短缺名單並看到這種情況加劇以來,對話變得更加富有成效,更加積極。我不知道,我無法確定我們什麼時候會看到某樣東西。我們確實有期望。我們確實與他們討論過時間表,除非我們採取進一步行動。

  • In terms of how fast does it go away, it's a little bit difficult to say.

    至於它消失的速度有多快,這有點難說。

  • The most important thing for us is to get enforcement and to stop the fake API from coming in, then we can go into our next order of execution and in combating, this and bringing it back to the, what is the rule letter of the law, and it's for rare circumstances. It's not, launching a dose that's not even approved in the mass marketing way, and that's what we're really focused on stopping.

    對我們來說,最重要的是採取執法行動,阻止假冒 API 流入,然後我們才能進入下一階段的執行和打擊,並將其帶回法律的規則條文中,這是針對罕見情況的。我們真正要阻止的並不是以大規模行銷的方式推出尚未獲得批准的劑量。

  • Karsten Munk Knudsen - Chief Financial Officer, Executive Vice President

    Karsten Munk Knudsen - Chief Financial Officer, Executive Vice President

  • Yeah, so, and just covering, the second part of the question around ITC, that's correct. I would say that building on Dave's comments that all options are on the table.

    是的,所以,這只是有關 ITC 問題的第二部分,是正確的。我想說,根據戴夫的評論,所有選擇都在考慮範圍內。

  • So now, we're, the commercial messaging. And the public affairs angle to it, the regulator dialogue, and of course the litigation pathway on several avenues. So we have, we are all in on both capabilities, advisors, etc. So I have all options on the table and then we find the best way forward and for obvious reasons we cannot comment on yet nondisclosed litigations.

    所以現在,我們是在傳遞商業訊息。還有公共事務角度、監管機構對話,當然還有幾種途徑的訴訟途徑。所以,我們全心投入雙方的能力、顧問等面向。所以我把所有的選擇都擺在桌面上,然後我們找到最好的前進方式,出於顯而易見的原因,我們不能對尚未披露的訴訟發表評論。

  • Simon Baker - Analyst

    Simon Baker - Analyst

  • Very good, thanks.

    非常好,謝謝。

  • Operator

    Operator

  • Let's move to Harry, UBS

    讓我們轉向瑞銀的 Harry

  • Unidentified_16

    Unidentified_16

  • Thank you, Harry Susten from UBS. I just want to touch on capacity. So, you've previously guided to cast and capacity coming more on stream in 2026, and clearly, you've been ramping up your CapEx since around 2023, so we should expect that to further add to that. Combine that with cells having disappointed this year, what are we looking like in terms of capacity utilization going into next year? And then what does that mean in terms of looking to compete maybe more aggressively on price to try and boost volumes and maybe to just wrap into that you've obviously got the loss of exclusivity of [semmer] in a number of markets next year. Will you look to compete on price in those markets with generics?

    謝謝瑞銀的 Harry Susten。我只想談容量。因此,您之前曾預測 2026 年將有更多演員和產能投入使用,而且顯然,您從 2023 年左右就開始增加資本支出,因此我們應該預期這會進一步增加。再加上今年電池表現令人失望,明年的產能利用率會如何?那麼,從尋求更積極地在價格上競爭以試圖提高銷售的角度來看,這意味著什麼?也許只是因為明年你顯然會在多個市場上失去 [semmer] 的獨家經營權。您會考慮在這些市場上與仿製藥進行價格競爭嗎?

  • Thank you.

    謝謝。

  • Karsten Munk Knudsen - Chief Financial Officer, Executive Vice President

    Karsten Munk Knudsen - Chief Financial Officer, Executive Vice President

  • Yeah, absolutely on capacity, so clearly ramping capacity and we see very good progress on the different programs and I can I can inform you that that now all three [catalan] sites are [producingg] so that builds of course a lot of resilience in our system. And then our cat plan, of course, yields a lot of extra capacity for the company. And that's back to my introductory comment about how much we're scaling. So, we're scaling more than 3 million patients just compared to a year ago.

    是的,絕對是產能問題,所以產能明顯在提升,我們看到不同項目都取得了很好的進展,我可以告訴你,現在所有三個 [加泰羅尼亞] 站點都在 [生產],這當然會增強我們系統的彈性。當然,我們的 Cat 計劃為公司帶來了大量額外產能。這又回到了我之前關於我們擴展規模的介紹評論。因此,與一年前相比,我們的患者人數已超過 300 萬人。

  • So, enabling that future scaling, then we believe that the CapEx program also in light of the significant unmet need in our portfolio is spot on what we have to do in terms of the CapEx program and competition and competitive competitiveness. I would say that clearly we're going for defending our space in this market and we're going to defend volumes and with our productivity, our unit costs, and our manufacturing footprints, we're going to fight for our space.

    因此,為了實現未來的擴展,我們相信,考慮到我們投資組合中尚未滿足的大量需求,資本支出計畫正是我們在資本支出計畫、競爭和競爭力方面必須做的事情。我想說的是,我們顯然要捍衛我們在這個市場中的空間,我們要捍衛產量,我們要憑藉我們的生產力、我們的單位成本和我們的製造足跡,為我們的空間而戰。

  • Operator

    Operator

  • Great, thanks. Thanks, Scott. Let's move here to to Pete.

    太好了,謝謝。謝謝,斯科特。讓我們移步到皮特這裡。

  • Peter Verdult - Analyst

    Peter Verdult - Analyst

  • Thanks, BNP, just one question, you talked about the market segmenting. What about, price segmentation? I realize you're not going to talk about pricing in detail, but high level, it's pretty obvious. You're talking about all 25 being we go being in a pill, so I think everyone in the room would think, apparently pricing to where we are today.

    謝謝,法國巴黎銀行,只有一個問題,您談到了市場區隔。那麼,價格細分怎麼樣?我知道您不會詳細談論定價問題,但從高層次來看,這是非常明顯的。你說的是,我們將把所有 25 種藥物都放入藥丸中,所以我想房間裡的每個人都會認為,顯然定價是我們今天所處的位置。

  • You've got a competitor who had rave reviews about or data and diabetes at ADA and have now produced data that is clearly not to that side like. So, in terms of base case expectations, when you think about that oral GLP one segment of the market, are you assuming base case that it's a much lower price segment versus the injectable market?

    您的競爭對手曾對 ADA 的數據和糖尿病給予高度評價,但現在他們提供的數據顯然不符合您的期望。那麼,就基本預期而言,當您考慮口服 GLP 市場的一部分時,您是否假設基本情況是它的價格部分比注射劑市場低得多?

  • Thank you.

    謝謝。

  • Martin Holst Lange - Executive Vice President

    Martin Holst Lange - Executive Vice President

  • Do you want that one.

    你想要那個嗎?

  • David Moore - Executive Vice President - Corporate Development

    David Moore - Executive Vice President - Corporate Development

  • Dave? Yeah, happy to, yeah, not guiding, of course, on any pricing strategy, right? And.

    戴夫?是的,很高興,是的,當然不會指導任何定價策略,對嗎?和。

  • We're not in a in a hurry to raise the price down in this category, right? When it take compounding aside, it's still largely to manufacturers, and I think there's, a shared view of really balancing the value and access.

    我們並不急於降低這個類別的價格,對嗎?拋開複合不談,這主要還是針對製造商,我認為,大家對真正平衡價值和獲取管道有著共同的看法。

  • As you said, it is sema, in a pill, and we certainly want to protect that, ratio of value to access.

    正如你所說,它是藥丸中的 sema,我們當然希望保護它的價值與獲取的比率。

  • There is, of course, segments of the population that open up as price goes down, and we're learning from that in the cash channel, we're learning from that and what we see in telehealth and partnerships, and that's just something that, we're going to continue to watch and and get smart about it.

    當然,隨著價格下降,一部分人會敞開心扉,我們正在從現金管道中學習,我們正在從遠距醫療和合作夥伴關係中學習,這就是我們將繼續觀察並了解的事情。

  • Ludovic Helfgott - Executive Vice President - Rare Disease

    Ludovic Helfgott - Executive Vice President - Rare Disease

  • On that side we're looking at the price as a price 0.1 off and it's actually not the way the market is reacting. The people are looking at longer view at subscriptions that we can see in some of the direct channels. So it's actually much more again a lifetime value of a patient throughout.

    在那方面,我們認為價格有 0.1 的折扣,但這實際上並不是市場的反應方式。人們對一些直接管道中訂閱業務的關注度越來越高。因此,這實際上意味著患者一生的價值。

  • The journey of initiation and the maintenance that needs to be taken into account. And that's why the one-off doesn't really matter. What matters is if you discount back what you're going to get from a pricing perspective month after month in the whole journey.

    啟動過程和需要考慮的維護。這就是為什麼一次性的事情並不重要。重要的是,您是否從整個旅程中逐月從定價角度折扣您將獲得的收益。

  • And that's what actually what we're experimenting as we speak, more than just having a one single price point. That's the thing, it's important. It's also important to make sure that from a cash perspective, we have to preserve a certain consistency, as you can imagine, between all the various channels we have. Otherwise, it's becoming messy, and you have arbitral that we don't want to create.

    這就是我們現在正在嘗試的,而不僅僅是一個單一的價格點。就是這樣,這很重要。同樣重要的是,從現金角度來看,我們必須在我們擁有的所有不同管道之間保持一定的一致性,正如您所想像的那樣。否則,情況就會變得混亂,而且你還會面臨我們不想創造的仲裁。

  • Martin Holst Lange - Executive Vice President

    Martin Holst Lange - Executive Vice President

  • Thanks Ludo, thanks Dave.

    謝謝 Ludo,謝謝 Dave。

  • Then we have Richard Vosser hiding in the corner.

    然後我們看到理查德·沃瑟躲在角落。

  • Richard Vosser - Analyst

    Richard Vosser - Analyst

  • Just have one question. Just stay time globally. How's that evolving and how do you think stay time will evolve in different channels like oral? I can imagine. That with the clip on data, maybe the day time would be rather short.

    只有一個問題。只需在全球範圍內停留時間。這是如何發展的?您認為在口語等不同管道中停留時間將如何發展?我可以想像。透過剪輯數據,也許白天的時間會相當短。

  • But do you think payers will use that to step through in the US market, but just different stay times, different market segments, and how's it evolving now?

    但是您是否認為付款人會利用它來進入美國市場,但只是不同的停留時間,不同的細分市場,現在情況如何?

  • Ludovic Helfgott - Executive Vice President - Rare Disease

    Ludovic Helfgott - Executive Vice President - Rare Disease

  • Absolutely, and I think it's very interesting what you're saying. You're right. I think it's going to be by group of patients. We know that right now it's around 7 months if I'm not mistaken, on we go more years, several years on a.

    絕對如此,我認為你所說的話非常有趣。你說得對。我認為這將是由一組患者決定的。我們知道,如果沒記錯的話,現在大約是 7 個月,接下來還要幾年,幾年。

  • We believe that some of these patients also based on the pricing structure of subscription, etc. Might actually have a longer stay time. We might also have patients that are very active for 789 months, and then they will pause and start again. So I think it's going to be very difficult to have one single weighted average stay time that is meaningful for the variety of patterns and behaviors we're seeing.

    我們相信,其中一些患者也可能會根據訂閱等定價結構而擁有更長的住院時間。我們也可能有一些患者在 789 個月內非常活躍,然後他們會暫停並重新開始。因此,我認為,對於我們所看到的各種模式和行為,很難有一個有意義的單一加權平均停留時間。

  • This being said, everything we're doing is to extend time. And we're doing and I'm sure that you comment on that, we're launching a lot of initiatives to make sure that the longer you stay, the longer you see the benefits. And if you think about what we saw with Surpass, in the data, which you now see that all the [Gants] are not the same, that the CV benefits gained on the long run. All this actually pleads for longer stay time for the patients. That's true for as much as. So, we're doing a lot to extend it, but I think that the average will be less and less meaningful.

    話雖如此,我們所做的一切都是為了延長時間。我們正在這樣做,我相信您也會對此發表評論,我們正在推出許多舉措,以確保您停留的時間越長,就能越早看到好處。如果你想想我們在 Surpass 中看到的情況,從數據中你會發現,所有的 [Gants] 都是不一樣的,從長遠來看,CV 會帶來好處。這一切其實都在懇求病人能夠有更長的住院時間。這對於大多數情況都是正確的。因此,我們正在做很多工作來擴展它,但我認為平均值將越來越沒有意義。

  • Martin Holst Lange - Executive Vice President

    Martin Holst Lange - Executive Vice President

  • Thank you, Ludo. Then we'll move here in the middle.

    謝謝你,魯多。然後我們就移到中間這裡。

  • Callum Morris - Analyst

    Callum Morris - Analyst

  • Thanks Callum Morris, Berenberg. I just had another question on pricing. Obviously in the cash channel we've seen a lower penetration for Wagovi than anticipated, and obviously we've talked about lots of factors for that. But how much do you think that is also to do with price competition with Lili and is Empe coming through into that channel in H2 this year? Do you expect to go in a lower price point than what you've got with Goy at the moment? Thank you.

    感謝 Callum Morris、Berenberg。我剛剛還有另一個關於定價的問題。顯然,在現金管道中,我們發現 Wagovi 的滲透率低於預期,而且顯然我們已經討論了許多造成這種情況的因素。但是您認為這與與 Lili 的價格競爭有多少關係? Empe 是否會在今年下半年進入該頻道?您是否期望價格會比目前 Goy 的價格更低?謝謝。

  • David Moore - Executive Vice President - Corporate Development

    David Moore - Executive Vice President - Corporate Development

  • In terms of, the dynamics of our cash channel, right? I mean Lily started about a year before we did in terms of having Lili Direct and then vials. We have an interest to continue to expand that and we will, and you'll see more efforts and initiatives in order for us to expand that cash channel with partners, with NovoCare Pharmacy, right, and other intermediaries. Because we think that it that market is opening up, right, and the sort of consumerism of obesity, it's clear and it's apparent.

    就我們的現金管道的動態而言,對嗎?我的意思是,就 Lili Direct 和小瓶而言,Lily 比我們早一年就開始使用。我們有興趣繼續擴大這一範圍,並且您將看到我們做出更多努力和舉措,以便與合作夥伴、NovoCare Pharmacy 和其他中介機構一起擴大這一現金管道。因為我們認為市場正在開放,對吧,肥胖的消費主義是清晰而明顯的。

  • And we intend to participate in that. We'll have a portfolio of offerings, right, in that cash channel. I think we compete well on price. Right now with Lili, I don't think there's a meaningful difference that I can glean from the research. It's a different story right in compounding and what dynamic exists there and why all of our efforts are on the table, as Cart mentioned, to curtail that.

    我們打算參與其中。我們將在該現金管道中提供一系列產品。我認為我們在價格上有很好的競爭力。目前,對於莉莉,我認為我無法從研究中發現任何有意義的差異。在複合方面,情況就完全不同了,那裡存在著什麼樣的動態,以及為什麼我們所有的努力都是為了減少這種情況,正如卡特所提到的。

  • With respect to Ozempic coming into the cash channel, no specific comments that we would make, but you could probably understand why we would not want those prices to be meaningfully different as Olympic, does participate in the obesity market, even if not by design.

    關於 Ozempic 進入現金管道,我們不會發表任何具體評論,但您可能理解為什麼我們不希望這些價格有太大差異,因為奧林匹克確實參與了肥胖市場,即使不是有意為之。

  • Martin Holst Lange - Executive Vice President

    Martin Holst Lange - Executive Vice President

  • Good. Let's move over here to Yihan.

    好的。讓我們轉到 Yihan 這裡。

  • Yihan Li - Equity Analyst

    Yihan Li - Equity Analyst

  • Hi, Yihan Li, Barclays.

    你好,我是巴克萊銀行的李一涵。

  • Thank you for taking our questions. So I think we have one, compounding market size because you mentioned currently you still have like 1 million people on the compounding, and we are just wondering like how confident you are in terms of the projecting of the size of the company market, like how bigger or smaller it could be because we previously heard from him that they were saying there are around like 1.5 million people on personalized therapy and continues to grow every day.

    感謝您回答我們的問題。所以我認為我們有一個複合市場規模,因為您提到目前您仍然有 100 萬人在復合,我們只是想知道您對公司市場規模的預測有多大或多小,因為我們之前聽他說過,他們說大約有 150 萬人接受個性化治療,並且每天都在增長。

  • And of course, we know it's not all on GRP ones, but yeah, it's just like curious, is it possible like the marketing market could be bigger. And also like, just wondering in terms of your revised guidance, anything you could share like that is attributable to this persistence of the company market.

    當然,我們知道這並不全是 GRP 的問題,但是的,只是很好奇,行銷市場是否有可能變得更大。另外,我只是想知道,就您修改後的指導方針而言,您可以分享的任何內容都歸因於公司市場的持續性。

  • Thank you.

    謝謝。

  • Karsten Munk Knudsen - Chief Financial Officer, Executive Vice President

    Karsten Munk Knudsen - Chief Financial Officer, Executive Vice President

  • You want to go first, David, (inaudible) and assumptions.

    大衛,你想先說(聽不清楚)和假設。

  • David Moore - Executive Vice President - Corporate Development

    David Moore - Executive Vice President - Corporate Development

  • Yeah, I'm happy to start. I think the level of precision right that we can get in terms of this fake market which runs through medical spas, aesthetic clinics, places like [KHs] that are public companies, is certainly not as accurate as we can with our own longitudinal data. And IQVIA, right, even though I think IQVIA was broke this week with MBRX, it's just not as precise. We do it through market research. We do qualitative, we do quantitative, larger studies, and it gives us a good feel in terms of the amount of prescribing that's happening, the number of patients that are on, and our triangulation of that, currently.

    是的,我很高興開始。我認為,對於醫療水療中心、美容診所以及像 [KHs] 這樣的上市公司這樣的虛假市場,我們所能獲得的精確度肯定不如我們利用自己的縱向數據獲得的精確度。還有 IQVIA,對,儘管我認為 IQVIA 本週憑藉 MBRX 取得了突破,但它並不那麼精確。我們透過市場調查來做到這一點。我們進行了定性、定量和更大規模的研究,這讓我們對目前的處方數量、患者數量以及我們對此的三角測量有了很好的了解。

  • We still believe it's 30% of the market around 1 million patients. Of course, there's different stay times, people coming on and off and switching, but that's the, as precise as we're able to get at this point.

    我們仍然相信它佔據了約 100 萬名患者的 30% 的市場份額。當然,停留時間會有所不同,人們會來來往往,也會輪流值班,但這就是我們目前能夠得到的最精確的資訊。

  • Karsten Munk Knudsen - Chief Financial Officer, Executive Vice President

    Karsten Munk Knudsen - Chief Financial Officer, Executive Vice President

  • Yeah, and on our outlook for the year, we have not included any oxide from compounding in our guidance for the year. So even if there were some positive signals, say, from regulators in the coming weeks or months, it's not baked in. And one of the reasons, or the key reason is really that there would be a lag effect before inventories are wound down and everything is stopping, so this would be a benefit 26 and 27.

    是的,在我們對今年的展望中,我們沒有將任何化合物氧化物納入今年的指導中。因此,即使監管機構在未來幾週或幾個月發出一些正面訊號,也還未落實。其中一個原因,或者說關鍵原因實際上是在庫存減少和一切停止之前會有滯後效應,所以這將是好處 26 和 27。

  • Yihan Li - Equity Analyst

    Yihan Li - Equity Analyst

  • Very clear.

    非常清楚。

  • Thank. You.

    感謝。你。

  • Let's move to Michael, the next one.

    讓我們轉到下一個人邁克爾。

  • Thank you. Michael Jeffries, Carson question for you. No we used to guide for the next year with Q3 a long time ago, and there's quite a few balls in the air for 2026, whether this is a samic trajectory or a launch cost space. Do you think you'd be in a position to offer a view on 2026, or would you want to with the Q3 results?

    謝謝。麥可·傑弗里斯,卡森問你一個問題。不,我們很久以前就用 Q3 來指導下一年度的工作,而對於 2026 年來說,還有很多事情要做,無論是相同的軌跡還是發射成本空間。您認為您可以對 2026 年做出展望嗎?或者您想根據第三季的業績做出展望嗎?

  • Karsten Munk Knudsen - Chief Financial Officer, Executive Vice President

    Karsten Munk Knudsen - Chief Financial Officer, Executive Vice President

  • Well, so I can only talk generally about 2026 because as we're only guiding our full year results.

    好吧,我只能泛泛地談論一下 2026 年,因為我們只是在指導我們的全年業績。

  • I believe in the market space we're in now, that's the appropriate point in time, to be guiding for 26. The starting point is really the notion of unmet needs and the ramp of patients as I spoke to before, with more than 3 million patients year on year. So that's of course our key focus to continue to drive that. Then we're focused on launching a obesity in the US. So of course that's a key priority. My mate is also getting closer.

    我相信,在我們現在所處的市場空間中,這是指導 26 的適當時間點。出發點實際上是未滿足的需求和患者數量的增加,正如我之前提到的,每年都有超過 300 萬名患者。因此,這當然是我們繼續推動這目標的重點。然後我們專注於在美國開展肥胖症防治工作。所以這當然是首要任務。我的伴侶也越來越親近了。

  • It may not be a big positive in 206, but it's still getting closer and then you say in terms of there's been some discussion. So at the call I was saying. What we're looking into when we take everything we know today in terms of timelines and price points, etc.

    在 206 中這可能不是一個很大的利好,但它仍然越來越接近,然後你會說就有一些討論而言。我在電話裡是這麼說的。當我們把今天所知道的一切,包括時間表、價格點等,都考慮進去時,我們會研究什麼?

  • And then it's a low single digit impact to top line growth next year. So these are some of the key building blocks that we're looking into but very focused on driving growth.

    這對明年的營收成長將產生較低的個位數影響。這些是我們正在研究的一些關鍵基石,但我們主要關注的是推動成長。

  • Thank you.

    謝謝。

  • Martin Holst Lange - Executive Vice President

    Martin Holst Lange - Executive Vice President

  • Thank you. Let's move back to Michael for next one.

    謝謝。讓我們回到邁克爾進行下一個話題。

  • Unidentified_18

    Unidentified_18

  • Thank you very much. My question on healthcare tourism. So next year, Canada will have generics. So, there's going to be generics flooding into the market and sandals were in the FT yesterday or the day before, talking about, 60 to 70% discounts to this price.

    非常感謝。我的問題是關於醫療旅遊。因此明年加拿大將有仿製藥。因此,仿製藥將會大量湧入市場,昨天或前天,《金融時報》就報道過,仿製藥的價格將比現在低 60% 到 70%。

  • So how do you assess the risk of either generic Semaglutide generic Ozempic coming down from Canada through into the US, or more so if there is branded as epic, branded Wegovy, in the US that could also potentially where patients go over and get prescriptions and then come back and potentially, create a market that way. So, what are the defenses that Novo has to guard against that?

    那麼,您如何評估仿製藥 Semaglutide 和仿製藥 Ozempic 從加拿大進入美國的風險,或者更確切地說,如果在美國有以 Epic 為品牌的 Wegovy,患者可能會去那裡開處方,然後回來,並可能以這種方式創造一個市場。那麼,Novo 需要採取哪些防禦措施來防範這種情況呢?

  • David Moore - Executive Vice President - Corporate Development

    David Moore - Executive Vice President - Corporate Development

  • Well, yeah, I mean, I think we can do that, of course, probably build on it, there's not a legal mechanism for generic product to enter into the United States that's not approved, right? And then you could say, well, that's what we said about compounding, but there's not an incentive for Canada or companies operating in Canada for to allow that to happen. If you're talking about border states and crossing the line with your car, I mean that happens today, right?

    嗯,是的,我的意思是,我認為我們可以做到這一點,當然,可能在此基礎上再接再厲,沒有合法機制允許未經批准的仿製藥產品進入美國,對嗎?然後你可能會說,好吧,這就是我們所說的複合,但加拿大或在加拿大運營的公司沒有動力允許這種情況發生。如果您談論的是邊境州和駕車越過邊界,我的意思是今天就會發生這種事,對嗎?

  • I think what we have to be really clear about is, the legal activities that we can take and we can enforce and be prepared for, when there is generics that are approved around the world and make it clear really what our response is here in the US to stop it.

    我認為我們必須真正清楚的是,當仿製藥在世界各地獲得批准時,我們可以採取、可以執行和準備的法律行動,並明確我們在美國採取什麼反應來阻止它。

  • Karsten Munk Knudsen - Chief Financial Officer, Executive Vice President

    Karsten Munk Knudsen - Chief Financial Officer, Executive Vice President

  • Yeah, not a lot more to add. So, it's part of, the building block I gave for Outlook there that is erosion in Canada. So, it is going to happen in Canada and then of course our legal and regulatory teams, they're looking at defending our US businesses in this context from inappropriate parallel.

    是的,沒什麼好補充的。所以,這是我為《展望》提供的關於加拿大侵蝕問題的基石的一部分。所以,這將在加拿大發生,當然我們的法律和監管團隊正在考慮在這種背景下保護我們的美國業務免受不適當的平行影響。

  • Indeed, thanks a lot. Let's move back to Pete before coming to the mid table afterwards.

    確實,非常感謝。讓我們先回到皮特,然後再來到中間的桌子。

  • Peter Verdult - Analyst

    Peter Verdult - Analyst

  • Yeah, Pete from BNP. Karsten, just to follow on from yesterday's question on CapEx, I know you've been very clear, low double digit, but you are spending an inordinate amount this year at $10 billion. And let's be fair, if you ask everyone around the room what no revenue is going to be in 3 or 4 years, there's going to be a wide range of expectations. So can I just ask the question differently?

    是的,英國國家銀行的 Pete。卡斯滕,剛才問了昨天關於資本支出的問題,我知道您說得很清楚,是低兩位數,但今年您的支出過高,達到了 100 億美元。公平地說,如果你問房間裡的每個人,三、四年後收入會是多少,他們會有各種各樣的預期。那我可以用不同的方式來提問嗎?

  • When will the bulk, when can you start to get more towards normalized CapEx in terms of, not having to spend $10 billion a year? So can I just push you a little bit more on that?

    什麼時候才能開始更多地實現正常化的資本支出,而不必每年花費 100 億美元?那我可以就此再給你多一點提示嗎?

  • Karsten Munk Knudsen - Chief Financial Officer, Executive Vice President

    Karsten Munk Knudsen - Chief Financial Officer, Executive Vice President

  • Yeah, you are always welcome to push on your questions, Pete. So, the short version is we're very close to the peak, whether it's, this year or next year, but we're very close to the peak and then you should see our absolute levels to be coming down from there.

    是的,皮特,我們隨時歡迎你提出你的問題。因此,簡而言之,我們非常接近峰值,無論是今年還是明年,但我們非常接近峰值,然後你應該會看到我們的絕對水平從那裡下降。

  • Martin Holst Lange - Executive Vice President

    Martin Holst Lange - Executive Vice President

  • Good.

    好的。

  • Then we move to to Simon and, yeah, start with Simon.

    然後我們轉到西蒙,是的,從西蒙開始。

  • Simon Baker - Analyst

    Simon Baker - Analyst

  • Thank you for taking the second one.

    感謝您參加第二個。

  • Just want to go back to a comment you made yesterday about [rebelsus]. You said you're, adjusting, de-emphasizing the commercial focus on [rebelsus].

    我只想回顧一下你昨天發表的關於[叛逆者]。你說你正在調整,不再強調商業重點[叛逆者]。

  • That prompted a client to ask, well, we have a, an oral version of an injectable drug, and they're de-emphasizing commercialization efforts on it because it's not performing particularly well.

    這促使客戶問道,嗯,我們有一種注射藥物的口服版本,並且由於其效果不是特別好,他們不再強調對它的商業化努力。

  • Why would obesity be any different? Now I'm sure there are lots of reasons why, but can you just say why we should not extrapolate from the lobo's experience towards the obesity. I'm happy to from a commercial perspective, Martin and may have some too.

    為什麼肥胖會有所不同?現在我確信有很多原因,但你能說一下為什麼我們不應該根據狼的經驗推斷肥胖的原因嗎?我很高興從商業角度來看,馬丁可能也有一些。

  • Karsten Munk Knudsen - Chief Financial Officer, Executive Vice President

    Karsten Munk Knudsen - Chief Financial Officer, Executive Vice President

  • They're very different in terms of what we've seen, what we've learned about rebels and the diabetes market. And the place that it takes up in terms of a place in therapy, is wildly different than obesity. In diabetes, all of the medicines that a patient was on as they sequenced through and their disease progressed were orals, and they were all oral medicines, right?

    就我們所見、所了解的叛逆者和糖尿病市場而言,他們有很大不同。就治療而言,它所佔據的地位與肥胖症截然不同。對於糖尿病,患者在病情進展過程中服用的所有藥物都是口服藥,對嗎?

  • Right up through SGLT2s and the meaningful difference in clinicians was, changing that to the injectable, right, which came in the form of Trulicity of it and it didn't have that same sort of level of, an upgrade if you will, and the way it was viewed in type 2 diabetes. Conversely, when we think about oral, we do research and have conversations with oral. It's just the opposite. There's only injectables, right.

    直到 SGLT2 出現,臨床醫生的重大區別在於,將其改為注射劑,對吧,注射劑的形式是 Trulicity,它沒有達到同等水平,如果你願意的話,這是一種升級,以及它在 2 型糖尿病中被看待的方式。相反,當我們考慮口語時,我們會進行研究並與口語進行對話。事實恰恰相反。只有註射劑,對的。

  • And now there's the promise and the openness of, I could have a GLP-1 and a pill, I could have we go in a pill, and it's viewed it's viewed very differently in terms of what that unlocks, and what the potential is. And I think, on the company side.

    現在,我們有了希望和開放性,我可以將 GLP-1 與藥丸一起使用,也可以將藥丸用於治療,而人們對其能帶來什麼以及其潛力的看法則截然不同。我認為,從公司方面來說。

  • It's more we see more opportunity, more growth, more potential, right in and go, and then or go, than we have seen with rebels and make those choices.

    與叛逆者相比,我們看到了更多的機會、更多的成長、更多的潛力,我們可以選擇繼續前進,也可以選擇離開,並做出那些選擇。

  • Anything from you Martin.

    馬丁,您有什麼事嗎?

  • Martin Holst Lange - Executive Vice President

    Martin Holst Lange - Executive Vice President

  • I fully agree on sort of the preference dynamics, but there is also the fact that with the doses that we have for rebels, the efficacy is not comparable to that of the subcutaneous in the diabetes.

    我完全同意這種偏好動態,但事實是,我們為叛亂分子提供的劑量,其療效與糖尿病患者的皮下注射劑量無法相比。

  • But in the space we've exactly designed 25 mg of waltz of to match what we can do with the subcutaneous.

    但在空間上,我們精確設計了 25 毫克的華爾滋來匹配我們可以用皮下做的事情。

  • So I think from from the clinical perspective that just gives freedom for the patients to choose.

    因此我認為從臨床角度來看這只是給予病人選擇的自由。

  • Ludovic Helfgott - Executive Vice President - Rare Disease

    Ludovic Helfgott - Executive Vice President - Rare Disease

  • If you summarize, you also have a brand name difference. That's one, you have the efficacy versus the injectable. Again, the oral VOV and the injectable are broadly in line in the efficacy and (inaudible).

    如果你總結一下,你也會發現品牌名稱的差異。一方面,它具有註射劑所不具備的功效。再次,口服 VOV 和注射劑的療效大致相同,且(聽不清楚)。

  • And then you have the fact that we also need to remember that rebels were launched at the moment where we started to have to make some tough decisions between injectables and orals, which means that in many places where rebels could actually have been successful, even in diabetes options we had to pull back because we had to dedicate. Some API to the injectable form, which means that the launch of [Reversos per se] is for me not a good predictor of what an oral irrespective of everything you said what an oral could be, it's been stop and go and, in the markets, where actually we could launch Spain as an example, we actually did pretty well.

    然後,我們還需要記住,叛亂分子是在我們開始必須在註射劑和口服劑之間做出一些艱難決定的時候發起的,這意味著在許多叛亂分子實際上可以取得成功的領域,即使在糖尿病治療方面,我們也不得不退縮,因為我們必須全身心投入。有些 API 是注射劑型,這意味著 [Reversos 本身] 的推出對我來說並不能很好地預測口服藥物的效果,不管你怎麼說口服藥物的效果,它一直處於走走停停的狀態,在市場上,實際上我們可以推出西班牙作為例子,我們實際上做得很好。

  • So, I wouldn't use the rebels as a proxy for the normal behavior in the oil market for the reasons that I just mentioned.

    因此,基於我剛才提到的原因,我不會將叛軍的行為視為石油市場正常行為的代表。

  • It's great. Thanks. Let's move to Harry and then we'll go to Tbo afterwards.

    這很棒。謝謝。我們先去 Harry,再去 Tbo。

  • Unidentified_16

    Unidentified_16

  • Brilliant, thank you, Harry Seton from UBS again. If I could go back to compounding, and you talked about working with the FDA to TRY and limit some of the API coming into the US. Obviously since the new administration's come into into power, we've seen some flux at the FDA. Would you say that given your conversations with the FDA that they are acting at the speed that you'd want them to, or would you say that disruption is also Adding to the delay in getting this compounding situation sorted.

    太棒了,再次感謝瑞銀的 Harry Seton。如果我可以回到複合領域,您談到與 FDA 合作嘗試限制一些 API 進入美國。顯然,自從新政府上台以來,我們看到 FDA 發生了一些變化。根據您與 FDA 的對話,您是否認為他們的行動速度符合您的期望,或者您是否認為這種幹擾也加劇了解決這一複雜情況的延遲。

  • David Moore - Executive Vice President - Corporate Development

    David Moore - Executive Vice President - Corporate Development

  • Yeah, thank you for that, Harry.

    是的,謝謝你,哈利。

  • My answer is I would like it to be faster, but that is true regardless of how fast they move given what we're experiencing right now, right? We haven't seen, there's been a noticeable, disruption in the conversations or the speed because of that, not by any means.

    我的回答是,我希望它能更快,但考慮到我們現在所經歷的情況,無論它們移動得多快,這都是事實,對嗎?我們還沒有看到,對話或速度有任何明顯的中斷,絕對沒有。

  • And the support that we're getting around Congress is also moving with speed. I mean just last week we had 80 congressional leaders send a letter to FDA saying this has to stop, and we know that there have been live conversations with some of those leaders with the leadership, as well as legal leadership at FDA and they've assured us that this is a top priority.

    我們在國會獲得的支持也在快速成長。我的意思是,就在上週,我們有 80 名國會領導人致函 FDA,表示這種行為必須停止,而且我們知道,他們已經與其中一些領導人以及 FDA 的領導層和法律領導層進行了現場對話,他們向我們保證,這是首要任務。

  • Good, only in the last 10 minutes.

    很好,只剩最後10分鐘了。

  • Unidentified_16

    Unidentified_16

  • Thank you. Dave, if you could, just, touch on the slowdown of the GLP one market, diabetes market in the US, if you could sort of come back on the key reasons, behind the general market slowdowns for GP1 diabetes. Are you experiencing any sort of access or reimbursement restrictions, as the category become more costly for payers, or is it just that the penetration rates are peaking, and the market gets a bit more saturated than than before?

    謝謝。戴夫,如果您可以談談 GLP 一號市場、美國糖尿病市場的放緩,您能否再談談 GP1 糖尿病市場整體放緩背後的主要原因。隨著該類別對付款人來說變得更加昂貴,您是否遇到任何形式的訪問或報銷限制,或者只是滲透率達到頂峰,市場比以前更加飽和?

  • David Moore - Executive Vice President - Corporate Development

    David Moore - Executive Vice President - Corporate Development

  • Yeah, thank you for that.

    是的,謝謝你。

  • As we discussed last quarter, right, we are seeing a slowdown. In terms of the growth for GOP 1 diabetes, it's still growth, right? I think it's in the neighborhood of 15% 1st half of the year. I think there is still room for growth in the diabetes market. It's slower than what we've seen before, right? So yes, there's more patients, that have been on the GOP-1.

    正如我們上個季度所討論的,我們正在看到經濟放緩。就 GOP 1 糖尿病的增長而言,它仍在增長,對嗎?我認為今年上半年的成長率大約在 15% 左右。我認為糖尿病市場仍有成長空間。它比我們以前見過的要慢,對嗎?是的,有更多的患者接受 GOP-1 治療。

  • I think we're in the 30% range in the US, very different, in the rest of the world, of those that have been on a GOP 1 for diabetes. And we're also seeing, this changeover, if you will, from our supply situation where the GOP 1 diabetes market participated in the obesity market, not by plan, right, but we saw those fluctuations, right now we have that sort of smoothing in terms of what the real sort of growth potential looks like as demand, has subsided and or sorry, supply issues have subsided. And we're seeing, in that range, there's still room for growth. I think if we compare that.

    我認為在美國我們處於 30% 的範圍內,與世界其他地區使用 GOP 1 治療糖尿病的人數相比有很大不同。我們也看到了這種轉變,如果你願意的話,從我們的供應情況來看,GOP 1 糖尿病市場參與了肥胖症市場,這不是按計劃進行的,但我們看到了這些波動,現在我們在實際增長潛力方面有這種平滑,因為需求已經消退,或者抱歉,供應問題已經消退。我們看到,在這個範圍內仍有成長空間。我想如果我們比較一下。

  • You know that is the area where we see, a lot more potential for growth in the future for GOP 1.

    你知道,我們看到共和黨在未來有很大的成長潛力。

  • Absolutely. Let's move back to Vosser.

    絕對地。讓我們回到沃瑟。

  • Richard Vosser - Analyst

    Richard Vosser - Analyst

  • Hi, thanks Richard Vosser, JP Morgan. Just on [amoretin] and the phase 2 diabetes data that you're going to get in the second half or 4th quarter, what do you hope to learn from that trial in terms of the doses, dosing, and, the, titration, to inform on the phase 3.

    你好,謝謝摩根大通的理查沃瑟。僅就 [amoretin] 和您將在下半年或第四季度獲得的第 2 階段糖尿病數據而言,您希望從該試驗中了解到有關劑量、給藥和滴定方面的哪些信息,以便為第 3 階段提供信息。

  • Martin Holst Lange - Executive Vice President

    Martin Holst Lange - Executive Vice President

  • It's a really good question, as we've always try to acknowledge the fact that at least for the 1 biology, the ED94 good glycemic control versus weight loss is different and that has led to different doses, actual doses between diabetes and obesity. We see others do it in a different way, which also makes it sometimes a little bit difficult to see full dose response on the clinical doses. That that being said, we need to understand fully.

    這是一個非常好的問題,因為我們一直試圖承認這樣一個事實,至少對於 1 個生物學而言,ED94 良好的血糖控制與減肥是不同的,這導致了糖尿病和肥胖症之間的劑量、實際劑量不同。我們看到其他人以不同的方式進行治療,這也使得有時很難看到臨床劑量的全部劑量反應。話雖如此,我們需要充分理解。

  • What does [Ment] priority do to these dynamics? We need more data to fully understand that.

    [Ment] 優先順序對這些動態有什麼影響?我們需要更多數據來充分理解這一點。

  • And specifically on the titration, obviously based on everything that we know and here we can also include redefine 1 and 2. I don't expect to learn so much on [citration], but the actual doses we need to get right for diabetes versus obesity evaluating, are we going for the same doses or are we going for a differentiated (inaudible).

    特別是在滴定方面,顯然基於我們所知道的一切,在這裡我們還可以包括重新定義 1 和 2。我並不指望在[citration]方面學到太多,但為了評估糖尿病和肥胖症,我們需要獲得正確的實際劑量,我們是採用相同的劑量,還是採用差異化的劑量(聽不清楚)。

  • Operator

    Operator

  • Thank you, Martin. And before asking Karsten to wrap up, let's go for a final question. Would you might like.

    謝謝你,馬丁。在讓卡斯滕結束之前,我們先來問最後一個問題。你可能願意。

  • Thank you. Follow up to that, Martin, on a meretan dosing into phase three. I guess one question coming out of the old data today is like how well can one actually model PKPD when compounds change and structures change. You've decided to move into phase 3 quite quickly with the [McCree], and are you still confident with the dose selection and do you have flexibility to maybe change that is needed in phase 3?

    謝謝。馬丁,接下來,我們將進入第三階段的 meretan 劑量治療。我想今天從舊數據中得出的一個問題是,當化合物和結構發生變化時,人們實際上能多好地模擬 PKPD。您已決定很快進入 [McCree] 第 3 階段,您對劑量選擇是否仍然有信心,並且是否有靈活性來根據第 3 階段的需要進行更改?

  • Karsten Munk Knudsen - Chief Financial Officer, Executive Vice President

    Karsten Munk Knudsen - Chief Financial Officer, Executive Vice President

  • So, the actual doses, of course, we can change and the dot, sorry, the dose escalation ranges can also be changed and it's actually by design a little bit.

    因此,我們當然可以改變實際劑量,而且劑量遞增範圍也可以改變,這實際上有點設計上的。

  • The flexible approach, some patients will benefit from titrating every 4 weeks between the individual doorsteps. Some will actually be recommended if they lose weight very fast or if they experience gastrointestinal side effects to do every 8 weeks.

    採用靈活的方法,一些患者將受益於每 4 週進行一次個別門階之間的滴定。實際上,如果某些人減肥速度很快或出現胃腸道副作用,他們會被建議每 8 週進行一次。

  • And what we have learned so far again combining everything that we know from [amrein] but also from redefined 1 and 2 giving us confidence that we picked the right doses and we are also confident on the dose titration and the steps that that will require.

    到目前為止,我們所學到的知識再次結合了我們從 [amrein] 以及重新定義的 1 和 2 中了解到的所有知識,讓我們有信心選擇了正確的劑量,並且我們對劑量滴定和所需的步驟也充滿信心。

  • Again we can adapt. I don't think that's going to be relevant and obviously as we've also talked to, we've had really good dialogues with leaders who also think about these dynamics so.

    我們又可以適應。我認為這不會有任何關聯,而且顯然,正如我們所談論的,我們與同樣考慮這些動態的領導人進行了非常好的對話。

  • At the end of the day, we will have to wait and see, but at this point in time, we are happy with the doses and the dosteps that we've chosen.

    最終,我們將不得不拭目以待,但目前,我們對所選的劑量和劑量步驟感到滿意。

  • Operator

    Operator

  • Good before giving it a remarks, thank you to everyone tuning in online as well as showing up in the room and reach out to the relations in case of follow ups.

    很好,在發表評論之前,感謝在線收聽的所有人以及來到會議室並與相關人員聯繫以進行後續跟進的所有人。

  • Karsten Munk Knudsen - Chief Financial Officer, Executive Vice President

    Karsten Munk Knudsen - Chief Financial Officer, Executive Vice President

  • Thank you and thank you all for attending. I think we actually covered a lot of ground at this lunch meeting. I think it's. That that we're driving growth for the long term. We spoke about our pipeline, Ereinkroce, also obesity, competitive profiles.

    謝謝大家,也謝謝大家的出席。我認為我們在這次午餐會議上實際上討論了很多內容。我認為是的。我們正在推動長期成長。我們討論了我們的管道、Ereinkroce、肥胖症、競爭力概況。

  • We spoke about all the measures we're taking in the US to get back to stronger growth. We have the portfolio, we have the leadership, so now it's really about executing on what we have. What we didn't talk a lot about was international operations within re it's 90% of the unmet needs on a global scale.

    我們談到了美國為恢復更強勁的成長而採取的所有措施。我們擁有投資組合,擁有領導力,所以現在真正需要做的就是執行我們所擁有的。我們很少談論的是國際業務,因為全球範圍內 90% 的需求尚未得到滿足。

  • So just a reminder, 19% growth in the first half and a very consistent portfolio-like approach in terms of driving growth in a very big area with sizable unmet needs and a portfolio that's only started to really roll into those markets with low penetration rates both in diabetes and [Ngovi]. So, this is really the name of the game driving growth not only through the end of this year but also into the years to come.

    需要提醒的是,上半年增長了 19%,並且採取了非常一致的投資組合式方法,以推動一個非常大的領域(存在大量未滿足的需求)的增長,而投資組合才剛開始真正進入那些滲透率較低的市場,無論是在糖尿病還是[恩戈維]。因此,這實際上是推動成長的遊戲名稱,不僅在今年年底,而且在未來幾年。

  • Ludovic Helfgott - Executive Vice President - Rare Disease

    Ludovic Helfgott - Executive Vice President - Rare Disease

  • So 1% market share for exactly. So thank you for that.

    所以市佔率正好是 1%。謝謝你。

  • Karsten Munk Knudsen - Chief Financial Officer, Executive Vice President

    Karsten Munk Knudsen - Chief Financial Officer, Executive Vice President

  • Thank you for dialing in and thank you for attending this lunch and thank you to James and Goldman for hosting. Hope to see you next quarter.

    感謝您撥入電話,感謝您參加這次午餐,也感謝詹姆斯和戈德曼的主持。希望下個季度能見到您。

  • Thank you.

    謝謝。

  • Thank you.

    謝謝。