摩根士丹利製藥股票分析師 Thibu Guha 與管理團隊一起主持了諾和諾德 2025 年第一季活動。 Lars Fruergaard 討論了該公司的財務業績,強調了糖尿病和肥胖症治療的成長。
該公司專注於基於創新的成長策略,預計銷售額成長率為 13% 至 21%。他們正在應對美國市場面臨的挑戰,特別是複合挑戰,並強調履行供應義務的重要性。
該公司對擴大產能、開展試驗以及在肥胖領域保持領先地位的計劃充滿信心。
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
Unidentified Participant
Unidentified Participant
Welcome everyone. My name is [Thibu Guha]. I'm a pharma equity analyst at Morgan Stanley. So thanks for joining the Novo first-quarter 2025 event post results. We are delighted to have with us, the management team of Novo Nordisk. So Lars Fruergaard, Karsten Knudsen, Martin Lange, and Mike Doustdar. So thank you very much for joining us.
歡迎大家。我的名字是[蒂布·古哈]。我是摩根士丹利的製藥股票分析師。感謝您參加 Novo 2025 年第一季活動成果發表會。我們很高興能與諾和諾德的管理團隊一起。拉斯·弗魯爾加德、卡斯滕·克努森、馬丁·蘭格和麥克·杜斯特達爾就是這樣。非常感謝您加入我們。
And, so yeah, without further ado, I will hand it to you, Lars. Thank you very much.
是的,不用多說,我就把它交給你了,拉爾斯。非常感謝。
Lars Fruergaard Joergensen - President, Chief Executive Officer
Lars Fruergaard Joergensen - President, Chief Executive Officer
Thank you very much. And thank you for hosting us today. Like we normally do, we'll go through a few slides relative snappily to set the scene and then get into your questions.
非常感謝。感謝您今天的接待。像平常一樣,我們會相對快速地瀏覽幾張投影片來設定場景,然後回答您的問題。
Now, of course, we'll be talking about the future that might turn out to be different than what we preach from here. So please be careful around that. This is the summary slides. I'll not cover it in much detail. We will, through our few slides, talk to commercial performance. We'll talk to the pipeline and our financial guidance for the year.
當然,現在我們要談論的未來可能與我們在這裡所宣揚的有所不同。所以請小心一點。這是摘要幻燈片。我不會詳細介紹它。我們將透過幾張投影片來討論商業表現。我們將討論今年的管道和財務指導。
So firstly, on financial performance, we have seen the reported 18% growth. Well, relatively equally contributing regions, US and international relations. And it's, again, the tier one franchise in diabetes and obesity that's driving the growth. We are proud that we are still an absolute volume leader. We have these slides just to underline how we are scaling.
首先,就財務表現而言,我們看到了報告的 18% 的成長。嗯,貢獻相對均等的地區、美國和國際關係。再次,糖尿病和肥胖症領域的一級特許經營權推動了成長。我們很自豪,我們仍然是絕對的銷售領導者。我們有這些幻燈片只是為了強調我們如何擴展。
And with our big footprint in Mike's part of the world, we have close to two-thirds of all patients on GILD1-based treatments. And you know that we're investing significantly in keeping that, say, leadership position in terms of serving many more patients for the future. So scaling in manufacturing is happening, and we're quite pleased with that. A key topic for this quarter has been the US development in Scripps.
由於我們在 Mike 所在地區的廣泛影響力,近三分之二的患者接受了基於 GILD1 的治療。你知道,我們正在投入大量資金來保持領先地位,以便未來為更多的患者提供服務。製造業正在不斷擴大規模,我們對此感到非常高興。本季的一個關鍵話題是美國在史克里普斯的發展。
And here the slide is. We have seen that we have gone flat in the Scripps. That's something we take very seriously. It is impacted by how compounding has developed for Regovi to a small degree, or simply in the US, to a degree where we now estimate that it is as big as our own business, more than a million patients. You have probably seen the announcements from his day that we have to drop short this list. Hence, it's now illegal to do compounding. We have started a no care pharmacy cash offering.
幻燈片如下。我們已經看到我們在斯克里普斯的進展已經平緩。我們對此非常重視。它受到 Regovi 複合發展的影響,影響程度很小,或者僅在美國,我們現在估計它與我們自己的業務一樣大,超過一百萬患者。您可能已經看到他那個時候發布的公告,說我們必須縮短這個名單。因此,現在進行複合是違法的。我們已經開始提供無人護理藥局現金捐贈。
We are building some partnerships with telehealth providers. And we also will have some benefit from the decision by CVS in terms of focusing on Regovi. So we are taking this very seriously. And we believe that as we progress the year, compounding will be dramatically reduced.
我們正在與一些遠距醫療提供者建立合作關係。CVS 專注於 Regovi 的決定也將為我們帶來一些好處。所以我們對此非常重視。我們相信,隨著時間的推移,複合成長率將大幅下降。
It's really only for individualized patients in rare cases that will be allowed. And we'll work hard to make sure that it's limited to that. And we expect that should lead to a reflection point in the Scripps in the coming second half of the year. And I'm sure we'll get into this in more detail.
事實上,只有在極少數情況下才允許針對個別患者實施該措施。我們將盡力確保其僅限於此。我們預計這將導致史克里普斯在今年下半年出現反思點。我相信我們會更詳細地討論這個問題。
With that, I'll hand over to Mike for some words on IOO.
說完這些,我會把時間交給 Mike,讓他談談 IOO。
Maziar Doustdar - Executive Vice President - International Operations
Maziar Doustdar - Executive Vice President - International Operations
Thanks very much, Lars. Lars showed you how the different regions in international operations have been doing, almost all of them, with very good growth rates. He also mentioned that the growth is really in GLP-1, diabetes GLP-1 and obesity GLP-1. So I've decided to use this slide on focusing on GLP-1.
非常感謝,拉爾斯。拉爾斯向您展示了國際業務各個地區的經營情況,幾乎所有地區的成長率都非常好。他也提到,真正成長的是 GLP-1、糖尿病 GLP-1 和肥胖症 GLP-1。所以我決定用這張投影片來重點介紹 GLP-1。
The 11% GLP-1 diabetes growth that the company showed, 13% of it comes from international operations. And you can see the three products that we have, ozempic, rubellsis, and victosa, and how they are basically delivering their growth rates in each of the four regions we have in international operations.
該公司顯示的11%的GLP-1糖尿病成長率,其中13%來自國際業務。您可以看到我們擁有的三種產品,ozempic、rubellsis 和 victosa,以及它們在我們國際運營的四個地區中基本上如何實現其增長率。
On the other hand, we showed 65% growth rates for the company on obesity GLP-1. And a lion's share of that, 137% of that this quarter, came from international operations on the back of two products, Saxenda, which is slowly going out, and Migovi, which is very quickly replacing and being launched across the market. We came into the year with close to 20 markets having Migovi. As of today, we are very close to 25. And we have plans, of course, to roll out Migovi in many more markets as we go, and the growth rates speak for themselves.
另一方面,我們顯示該公司在肥胖GLP-1方面的成長率為65%。其中,本季的最大份額(137%)來自國際業務,主要得益於兩款產品:Saxenda 正在慢慢退出市場,而 Migovi 正在迅速取代 Saxenda 並在整個市場推出。今年,我們已經有近 20 個市場採用了 Migovi。截至今天,我們已經非常接近 25 歲了。當然,我們計劃在更多市場推出 Migovi,其成長率不言而喻。
Martin Lange - Executive Vice President - Development
Martin Lange - Executive Vice President - Development
And thank you very much. So as you all know, we've reported on REDEFINE 1. That created a lot of attention, and also on REDEFINE 2 in type 2 diabetes. Just as a reminder, we saw a very, very strong weight loss in REDEFINE 1, 23% weight loss. Comparable to that of Migovi, i.e. we get a lot more weight loss, but with the same safety and solid ability profile. Same thing in type 2 diabetes. But it's also important to point out that we're taking some learnings from those trials. Chiefly, that they were too brief. We did not accrue the full weight loss potential. We do believe that there is maybe more weight loss potential for Kaggle 7. And therefore, we've extended REDEFINE 4. And we have initiated, or will initiate in this quarter, REDEFINE 11.
非常感謝。大家知道,我們已經報道了REDEFINE 1。這引起了廣泛關注,REDEFINE 2 在第 2 型糖尿病中的應用也受到了廣泛關注。提醒一下,我們看到 REDEFINE 1 的減重效果非常顯著,減重了 23%。與 Migovi 相比,我們減輕了更多的體重,但具有相同的安全性和可靠的能力。2 型糖尿病也是同樣的情況。但同樣需要指出的是,我們從這些試驗中學到了一些教訓。主要是因為它們太簡短了。我們沒有發揮出全部的減肥潛力。我們確實相信 Kaggle 7 可能還有更大的減重潛力。因此,我們擴展了 REDEFINE 4。我們已經啟動,或將在本季度啟動REDEFINE 11。
Taking the learnings of doing a longer trial but also focusing on how to re-titrate if titration has been stopped. With that, and with these initiatives, we do believe that we will see the fuller weight loss potential of Kaggle 7. And obviously, given the duration of REDEFINE 3, that is basically, by design, already built in. Very exciting still for us. We do see a lot of merit in, obviously, Kaggle 7, but also the broader ambulance biology. I'll come back to that.
吸取長期試驗的經驗教訓,同時也關注如果滴定停止,如何重新滴定。有了這些以及這些舉措,我們確實相信我們將看到 Kaggle 7 更充分的減肥潛力。顯然,考慮到 REDEFINE 3 的持續時間,這基本上是按照設計內建的。對我們來說仍然非常令人興奮。顯然,我們確實看到了 Kaggle 7 的許多優點,同時也看到了更廣泛的救護車生物學的優點。我稍後會再談這個問題。
Both phymocretins, but also for Kaggle 7 in more depth. Each with their different traits. But the potential offering of Kaggle 7 is obviously unsurpassed weight loss, with a very strong safety and solubility profile, and with the comorbidity benefits that we know, and at least I love from somatic side, IECB benefits, soon to be liver benefits. Maybe benefits on cognitive function. And obviously, in the diabetes space, also kidney benefits.
既有phymocretins,也有針對Kaggle 7的更深入的研究。每個人都有不同的特質。但 Kaggle 7 的潛在優勢顯然是無與倫比的減肥效果,具有非常強的安全性和溶解度,以及我們所知的合併症益處,至少從軀體方面來說我喜歡它,IECB 益處,很快就會有肝臟益處。可能對認知功能有益。顯然,在糖尿病領域,腎臟也有益處。
Also, magnetite is something that we have been talking about for some time. Obviously, there's a lot of talk in the town about anything all GLP-1 analog. Just to remind you, with also magnetite, we see with 25 milligrams for obesity, 17% weight loss. That is a really, really strong weight loss in this space. With, again, a safety and solubility profile that is not only well-known and acceptable to patients, but also established in a very, very large database.
此外,磁鐵礦也是我們討論過一段時間的東西。顯然,人們對 GLP-1 類似物有很多討論。只要提醒您,使用磁鐵礦,我們發現肥胖症患者攝取 25 毫克磁鐵礦可減輕 17% 的體重。這在這個領域確實是一個非常強勁的減重趨勢。再次強調,其安全性和溶解度特性不僅為患者所熟知和接受,而且還在非常大的資料庫中建立。
In that, we also have seen the biomarkers for comorbidities. For example, waist circumference. For example, lowering in risk of inflammation. For example, also lowering in blood pressure and lipids. And that basically means that we have a reasonable aspiration of getting the benefits from the select trial, but maybe also other trials into the also magnetite for obesity. Again, a very strong offering with unsurpassed efficacy in the oral space, being the first all GLP-1 for the treatment of obesity. Very well-established safety and solubility profile, and potential for CV and other benefits in the label.
在那裡,我們也看到了合併症的生物標記。例如腰圍。例如降低發炎風險。例如降低血壓和血脂。這基本上意味著我們有合理的願望從選擇性試驗中獲得益處,但也許其他試驗也能對肥胖症產生影響。再次,這是一款非常強大的產品,在口腔領域具有無與倫比的功效,是第一個用於治療肥胖症的全 GLP-1 藥物。非常完善的安全性和溶解度特性,以及標籤中 CV 和其他益處的潛力。
I can speak a lot to this slide. The short messages, we see progress across all our therapy areas in our Phase 1, 2, 3, actually Phase 4 pipelines. In diabetes, in obesity, in cardiovascular, in liver disease, in actually also kidney disease, but certainly also in rat disease. A lot of important things have and will happen for the duration of 2025.
我可以針對這張投影片講很多內容。簡短的消息是,我們看到我們在第 1、2、3 階段以及實際上是第 4 階段的所有治療領域都取得了進展。在糖尿病、肥胖、心血管疾病、肝病、腎臟疾病,當然還有大鼠疾病。2025 年期間將會發生很多重要的事情。
I think most interestingly for today is probably to dwell a little bit on our obesity pipeline. We believe it to be strong, and deep, and very competitive. Building a pipeline that caters to different patient needs across the obesity spectrum. From our perspective, it's naive to think that obesity is one disease. Many patients with different patient needs. Just to give an example, if you have reasonably low BMI, let's say 30 to 35, no comorbidities, we are building categorically inside, currently taking that into Phase 3 to cater to that.
我認為今天最有趣的事情可能是稍微討論一下我們的肥胖問題。我們相信它是強大的、有深度的、非常有競爭力。建立一條滿足不同肥胖症患者需求的管道。從我們的角度來看,認為肥胖是一種疾病是天真的。許多患者有不同的患者需求。舉個例子,如果你的 BMI 相當低,比如說 30 到 35,沒有合併症,我們正在進行內部分類構建,目前正在將其納入第 3 階段以滿足這一需求。
If you have a need for maybe a slightly bigger weight loss and focus on comorbidities, it's where we're going. If you have bigger weight loss needs, it's going to be categorically similar. It's going to be a metrician. And it's going to be our current internal triagonist.
如果您需要稍微減輕一點體重並關注合併症,這就是我們要去的地方。如果您有更大的減肥需求,那麼情況將會非常相似。它將成為一名計量學家。它將成為我們當前的內在三角主角。
But we've also just done an acquisition for an external triagonist being a GLP-1 flu-scanned GRT. And we've also acquired a small molecule with a non-ingredient-based motivation. So in the obesity space, a lot of exciting stuff coming in. And obviously, also our research pipeline that we are not disclosing, continuously feeding into that, not only looking at weight loss, but also at quality of weight loss and comorbidities.
但我們也剛完成了一項外部三角試驗的收購,即 GLP-1 流感掃描 GRT。我們還獲得了一種非基於成分的小分子。因此,在肥胖領域,出現了很多令人興奮的事情。顯然,我們也沒有公開我們的研究管道,但我們仍在持續不斷地研究,不僅關注減肥,還關注減肥的品質和合併症。
So with that, over to you, Karsten.
那麼,就交給你了,卡斯滕。
Karsten Munk Knudsen - Chief Financial Officer, Executive Vice President
Karsten Munk Knudsen - Chief Financial Officer, Executive Vice President
Thank you, Martin. Then we move to outlook. So we're continuing an innovation-based growth strategy, delivering 18% growth in the first quarter on back of significant growth in the preceding years. And the guidance here that we updated here in connection with the first quarter is a sales growth now of between 13% and 21%. It's slower than three months ago.
謝謝你,馬丁。然後我們轉向展望。因此,我們將繼續推行基於創新的成長策略,在前幾年顯著成長的基礎上,第一季實現了 18% 的成長。我們在此更新的第一季預測是銷售額成長率將在 13% 至 21% 之間。比三個月前慢了。
And that's really a function of the slower start to the year, linked to especially compounding in the US, impacting the COVID. And this outlook is also based on an acceleration of scripts in the US in the second half of the year, based on a number of tactics we're deploying. And I'm sure we'll come back to that in further detail during the session.
這其實是由於今年開局較慢,尤其與美國經濟的複合成長有關,對新冠疫情產生了影響。這一前景也基於下半年美國劇本的加速發展,以及我們正在部署的一系列策略。我相信我們會在會議期間進一步討論這個問題。
Operating profit also lowered compared to three months ago. But it's important to note that the lowering of top line is partially being offset by tighter resource allocation. So very diligent in terms of how we resource the company. Still driving growth, but of course, gearing the company vis-a-vis the growth that we're seeing. Currencies have moved against the company, with the US dollar being down from DKK7.17 in three months ago to DKK6.56 now. This year, we have full hedge on the US dollar. So on the net profit, we hedged on that. And that's what you see in net financials.
與三個月前相比,營業利潤也有所下降。但值得注意的是,營收的下降部分被資源配置的收緊所抵銷。因此,我們在為公司提供資源方面非常勤勉。仍在推動成長,但當然,公司也要適應我們所看到的成長。貨幣走勢對該公司不利,美元兌丹麥克朗從三個月前的7.17跌至現在的6.56。今年我們對美元進行了全面對沖。因此,對於淨利潤,我們對此進行了對沖。這就是您在淨財務中看到的。
And then finally, cash flow down compared to three months ago. Still very cash generative as a business. And the reason we're lowering is, of course, a function of the lower top line outlook, and then the gearing that is in the US cross-net model that further amplifies on free cash flow. So that's the outlook for 2025, continued growth.
最後,與三個月前相比,現金流有所下降。作為一家企業,其現金創造能力仍然很強。當然,我們降低利率的原因是由於營業收入前景較低,而且美國跨網路模型中的槓桿進一步放大了自由現金流。這就是 2025 年的前景,持續成長。
And with that, we're ready to move to Jacob and Q&A.
好了,我們現在準備好進入 Jacob 的問答環節。
Jacob Rode - Head of Investor Relations
Jacob Rode - Head of Investor Relations
Thank you, Karsten. Thank you, Tim. That concludes the first part of the session, and we'll move into Q&A. We'll do one question per person, please. And we'll start with our host today, Thibu from Morgan Stanley.
謝謝你,卡斯滕。謝謝你,提姆。會議的第一部分到此結束,我們將進入問答環節。請向每個人提問一個問題。我們今天的主持人是來自摩根士丹利的 Thibu。
Unidentified Participant
Unidentified Participant
Thank you very much. So the question is on the CVS agreement with CVS. So just if you could confirm if there is any timeline associated with the exclusivity, and also just if you picked in an improvement in the opt-in rate on this formulary within your guidance.
非常感謝。所以問題在於 CVS 與 CVS 的協定。因此,如果您可以確認是否有與排他性相關的時間表,並且如果您在指導範圍內選擇了此處方集的選擇加入率的提高。
Jacob Rode - Head of Investor Relations
Jacob Rode - Head of Investor Relations
Yeah. Thank you, Thibaut. I think it goes to you, Lars.
是的。謝謝你,蒂博。我想這該由你決定,拉爾斯。
Lars Fruergaard Joergensen - President, Chief Executive Officer
Lars Fruergaard Joergensen - President, Chief Executive Officer
Yeah, thank you. So we have a longstanding good relationship with CVS. And based on that, we have made an agreement with them that we will bring also our cash offering into the pharmacy chain. So really focused on giving more access. We have not bid on an exclusive contract. So the rates we have provided, you can assume that it's similar for co-preferred and exclusive access. Nevertheless, CVS has decided to go with Wegovy.
是的,謝謝。因此我們與 CVS 保持著長期良好的關係。基於此,我們與他們達成協議,我們也將把現金捐贈帶入藥局連鎖店。因此真正專注於提供更多的存取權限。我們尚未競標獨家合約。因此,對於我們提供的費率,您可以假設共同優先訪問和獨家訪問的費率是相似的。儘管如此,CVS 還是決定與 Wegovy 合作。
And I think it's linked to, obviously, the profile of Wegovy, the real-world experience in the weight loss it delivers, and also the additional benefits. And I know personally that they're keenly interested in MeSH. And you have a big overlap in patient populations when you look at MeSH obesity. So there's real unmet need. So it's actually a very, very, say, inexpensive way to get access to MeSH coverage, assuming we get this on label in the second half. So it's a really good deal for them. And for a payer, it works very well to focus on this product.
我認為這顯然與 Wegovy 的形象、其減肥的實際經驗以及其他好處有關。我個人知道他們對 MeSH 非常感興趣。當您查看 MeSH 肥胖症時,您會發現患者群體有很大的重疊。因此確實存在著未滿足的需求。因此,這實際上是一種非常非常便宜的獲取 MeSH 覆蓋範圍的方法,假設我們在下半年獲得標籤。所以這對他們來說確實是一筆好交易。對於付款人來說,專注於該產品非常有效。
So there are a lot of scares about, say, price competition, et cetera. It's not going to be initiated because of exclusivity, because we will not make that. And I doubt our competitors will do that as well. But we will see that in a managed way, pricing will come down over time, as we've seen in all other categories. And that is unlocking larger volumes. So it still unlocks growth. And I think that's a very good outlook and a very good model for us. Thank you.
因此,人們對價格競爭等問題有許多擔憂。它不會因為排他性而被啟動,因為我們不會這樣做。我懷疑我們的競爭對手也會這樣做。但我們會看到,在可控的範圍內,價格會隨著時間的推移而下降,就像我們在所有其他類別中看到的那樣。這就意味著要釋放更大的容量。因此它仍能促進成長。我認為這對我們來說是一個非常好的前景和非常好的模式。謝謝。
Thank you, Lars. Very clear. Then we move to Emily.
謝謝你,拉爾斯。非常清楚。然後我們轉向艾米麗。
Emily Field - Analyst
Emily Field - Analyst
Hi. Thanks. Emily Fields from Barclays. Reading through the comments from yesterday's call, it does seem that you are, and with the launch of NovoCare and that you're expecting sort of the cash paid portion of what we're going to increase in the second half. However, we've obviously seen a lot of consumer-focused companies warn about consumer softness in the US with the economic situation there. So within your revised guidance range, are you anticipating any consumer softness? Or if you could just provide context to how you're thinking about what will still be a relatively expensive out-of-pocket product?
你好。謝謝。巴克萊銀行的 Emily Fields。透過閱讀昨天電話會議的評論,您似乎確實如此,隨著 NovoCare 的推出,您預計我們下半年的現金支付部分將會增加。然而,我們顯然已經看到許多以消費者為中心的公司警告稱,鑑於美國的經濟形勢,該國的消費市場將變得疲軟。那麼,在您修改後的指導範圍內,您是否預期會出現消費者疲軟的情況?或者您可以提供一些背景信息,說明您認為什麼仍然是相對昂貴的自付費用產品?
Jacob Rode - Head of Investor Relations
Jacob Rode - Head of Investor Relations
Thanks, Emily. I think that goes to you, Karsten.
謝謝,艾米麗。我想這跟你有關,卡斯滕。
Karsten Munk Knudsen - Chief Financial Officer, Executive Vice President
Karsten Munk Knudsen - Chief Financial Officer, Executive Vice President
Yeah. So as I also said at the call, estimating the cash channel for us linked to compounding and telehealth agreement stands on a number of assumptions. So the way we've been, a number of assumptions and somewhat limited data quality. So that's what we've built into our guidance.
是的。因此,正如我在電話會議上所說的那樣,估計與複合和遠距醫療協議相關的現金管道是基於許多假設。因此,我們一直以來的做法是,做出一些假設,並且數據品質有一定的限制。這就是我們在指導中所考慮的。
And the way we've done it is basically triangulate from different aspects. One is the amount of people we currently estimate is on compounded product today, especially bulk compounded products, how many will switch to branded, and hence get into the cash channel as one element.
我們這樣做的方式基本上是從不同方面進行三角測量。其中一個因素是,我們目前估計目前使用複合產品(尤其是大宗複合產品)的人數,有多少人會轉向品牌產品,從而進入現金管道。
And then whatever data we otherwise can see in terms of cash channel penetration and telehealth impact. So based on that, we've made an estimate on what is realistic in our view to put into our guidance on we go, we cash channel throughout the year, especially the second half of this year.
然後,我們可以看到現金管道滲透率和遠距醫療影響方面的任何數據。因此,基於此,我們對我們認為可以納入全年現金管道指導的現實情況進行了估算,特別是今年下半年。
Jacob Rode - Head of Investor Relations
Jacob Rode - Head of Investor Relations
Thank you, Carsten. Then we go to Sachin.
謝謝你,卡斯滕。然後我們去找薩欽。
Sachin Jain - Analyst
Sachin Jain - Analyst
Hi there. I wonder if you could just try and put some guardrails around what you mean for real launch for Oral-Sema. And the reason I ask the question is you frame the oral segment of the market as a minority. So it's a real launch in that context, which would be different from, I guess, the competitors' commentary, which assumes oral segments are a lot bigger. So I'm just going to give you two potentials. One, that you have disclosed some inventory. Would you give any color on that? Or B, any commentary related to consensus next year, which is DKK3 billion.
你好呀。我想知道您是否可以嘗試對 Oral-Sema 的真正發佈設定一些限制。我之所以問這個問題,是因為您將口腔市場劃分為少數群體。因此,在這種背景下,這是一次真正的發布,我想這與競爭對手的評論有所不同,競爭對手的評論認為口服市場要大得多。所以我只想給你兩個可能性。第一,你們已經揭露了一些庫存。你能解釋一下嗎?或 B,任何與明年共識相關的評論,即 30 億丹麥克朗。
Jacob Rode - Head of Investor Relations
Jacob Rode - Head of Investor Relations
Thank you, Sachin. I think it goes to you, Lars, in the real launch.
謝謝你,薩欽。我認為在真正的發布會上你會獲勝,拉爾斯。
Lars Fruergaard Joergensen - President, Chief Executive Officer
Lars Fruergaard Joergensen - President, Chief Executive Officer
I can talk to the launch, and maybe others can chip in. I don't think you're going to get any guidance on sales. But Martin described the profile. So I think we have a potential winning profile in terms of efficacy. And in any new category, you have to relate to safety. And I think it's rare to have a launch where you have as much safety as you have on this, and not least when you have to go up against small molecules that clear in different ways than this product.
我可以和發表會談談,也許其他人也可以參與。我認為你不會得到任何有關銷售的指導。但馬丁描述了概況。因此我認為從功效來說我們具有獲勝的潛力。在任何新類別中,您都必須考慮安全性。我認為,很少有產品能像這款產品一樣安全,尤其是當你必須對抗以不同於該產品的方式清除的小分子時。
So I think from the get-go, a very, very strong profile. Then you also know we've been building API capacity. And we actually have a dedicated US supply chain for this. So we have API in North Carolina. And typically, when we install new capacities, it's defined for a certain output. And then we optimize that over time. This optimization is going really well. So on an out point of view, we are encouraged.
所以我認為從一開始,我們就擁有非常非常強大的形象。那你也知道我們一直在建立 API 容量。事實上,我們為此設立了專門的美國供應鏈。所以我們在北卡羅來納州有 API。通常,當我們安裝新容量時,它是針對特定的輸出定義的。然後我們隨著時間的推移對其進行優化。這次優化進展非常順利。因此從外部角度來看,我們感到鼓舞。
And then, of course, we also have different formulation technology generations that also creates more, say, output. So when we say we can go into a full launch, that means that we believe we have the products to be able to do that. We will not get into, say, sizing the all opportunity. We think there is going to be a large injectable segment. When we ask patients, physicians who are already on weekly injection therapy, that is seen as very convenient. But we also know that there are many who prefer a tablet-based oil treatment. So we feel really good about the opportunity we have and the ability to launch and supply the market.
當然,我們也有不同世代的配方技術,它們也能創造更多的產量。因此,當我們說我們可以全面推出該產品時,這意味著我們相信我們擁有能夠做到這一點的產品。我們不會去衡量所有的機會。我們認為注射劑市場將會非常龐大。當我們詢問已經接受每週注射治療的患者和醫生時,這被認為非常方便。但我們也知道,很多人更喜歡採用以藥片為基礎的油療法。因此,我們對自己擁有的機會以及推出和供應市場的能力感到非常滿意。
And then I think there will be interesting considerations about the go-to-market model. Do we use the known classical, say, contracting PVM insurance or do you go with the channel we have built, or do you do both? So we will not disclose all the taxes around that. But I think it's a really great opportunity. And I think we have all the elements from supply, commercial, go-to-market channels to make that an exciting opportunity for us.
然後我認為對於市場進入模式將會有一些有趣的考慮。我們是否使用已知的經典方法,例如簽訂 PVM 保險,或者您是否採用我們已經建立的管道,或者您是否兩者兼而有之?因此我們不會透露與此相關的所有稅收。但我認為這確實是一個絕佳的機會。我認為我們擁有供應、商業、市場通路等所有要素,這對我們來說是一個令人興奮的機會。
Jacob Rode - Head of Investor Relations
Jacob Rode - Head of Investor Relations
Thank you. Very good. Last but not least, we have [Naresh] up here.
謝謝。非常好。最後但同樣重要的是,我們有[Naresh]在這裡。
Unidentified Participant
Unidentified Participant
Yeah. Thanks. Just a question on duration of treatment on compounded drugs. What data do you have on that, and how should we think about that? And is there a better proxy, XUS, where you've got an out-of-pocket market? How do you think about duration of treatment for that subset of patients?
是的。謝謝。這只是關於複方藥物治療持續時間的一個問題。您對此有什麼數據?我們該如何看待這個問題?有沒有更好的代理,XUS,你有一個自付費用市場?您認為該類患者的治療持續時間是如何的?
Jacob Rode - Head of Investor Relations
Jacob Rode - Head of Investor Relations
That goes to you, Karsten.
這都歸功於你,卡斯滕。
Karsten Munk Knudsen - Chief Financial Officer, Executive Vice President
Karsten Munk Knudsen - Chief Financial Officer, Executive Vice President
Yeah. So again, not super good data on compounded. It's really market research with all the caveats on market research. So I would say that the indications we have is that the average stay time is shorter than the seven months we've been talking to on Vigobe in the compounded segment. So that's the starting point.
是的。所以,再說一遍,複合數據並不是特別好。這實際上是市場研究,但包含市場研究的所有註意事項。因此我想說,我們得到的跡像是,平均停留時間比我們在複合細分市場中談論的 Vigobe 的七個月要短。這就是起點。
What I would say, that's an average across all the different shapes and forms of compounded approaches. What we are also hearing is when we have some of the different telehealth service providers that are selling compounded today, it's important to note that their business is to wrap a service around the product and a subscription model. So they have a lot of incentive to keep people on product and basically make a 12-month agreement at a lower price point than a two-month agreement.
我想說的是,這是所有不同形狀和形式的複合方法的平均值。我們也聽說,當我們今天有一些不同的遠距醫療服務提供者在銷售複合藥物時,重要的是要注意,他們的業務是圍繞產品和訂閱模式提供服務。因此,他們有很大的動力讓人們繼續使用產品,並且基本上以比兩個月協議更低的價格簽訂 12 個月的協議。
So I think there's some opportunity in telehealth with the subscription model, both in terms of pricing accordingly, but also the patient services and reminders to patients. So like here in the UK, we have a collaboration with EMATS where there are weekly notifications around, did you take your Vigobe injection, et cetera.
因此,我認為訂閱模式在遠距醫療方面存在一些機會,不僅在相應的定價方面,而且在病患服務和提醒方面。就像在英國一樣,我們與 EMATS 有合作,每週都會發送通知,詢問您是否注射了 Vigobe 等等。
So I think that service to patients should help on stay time. And it goes hand-in-hand with the telehealth providers incentives as well. So I think that's as specific as we can be on it based on data.
所以我認為對病人的服務應該有助於延長住院時間。它也與遠距醫療提供者的激勵措施相輔相成。所以我認為,根據數據,我們能夠對此做出盡可能具體的說明。
Jacob Rode - Head of Investor Relations
Jacob Rode - Head of Investor Relations
Very good. Thanks. Then we'll move to Simon Baker, here in the front.
非常好。謝謝。然後我們請前面的西蒙·貝克發言。
Simon Baker - Analyst
Simon Baker - Analyst
Thanks so much. A sort of bigger picture question, but it comes from the crux of it, about the whole supply-demand dynamic here. That last year, this was clearly a supply-constrained market. Is that still the case? It feels like, from the feedback we get from clients, this is more demand-constrained. But could that simply be that it is supply-constrained, it's just the compounds have been supplying half your market and that's going to go away?
非常感謝。這是一個更大的問題,但它源自於問題的核心,即整個供需動態。去年,這顯然是一個供應受限的市場。現在還是這樣嗎?從我們從客戶那裡得到的回饋來看,這似乎更受到需求的限制。但這可能只是因為供應受限,只是化合物已經供應了一半的市場,而這種情況將會消失嗎?
And thinking about both demand and your ability to increase supply, how does the CVS deal fit into that? I mean, presumably, they must be confident, you must be confident that you can supply all that they need, because obviously an outage would not be helpful there. So just really give us a feel for how the market looks now, because the trend from last year, the scripts, these moving parts is not absolutely clear. So any insights would be really helpful.
考慮到需求和增加供應的能力,CVS 交易如何適應這種情況?我的意思是,他們大概必須有信心,你必須有信心提供他們所需的一切,因為顯然停電對他們沒有幫助。所以請讓我們真正感受到現在的市場狀況,因為去年的趨勢、腳本、這些活動部分還不是完全清晰。因此任何見解都會非常有幫助。
Jacob Rode - Head of Investor Relations
Jacob Rode - Head of Investor Relations
And of course, Jukard as well, then Lars, you can build on if anything afterwards.
當然,還有 Jukard,然後是 Lars,如果之後還有什麼可以繼續的話,你們可以繼續發展。
Karsten Munk Knudsen - Chief Financial Officer, Executive Vice President
Karsten Munk Knudsen - Chief Financial Officer, Executive Vice President
Yeah. So in terms of supply-demand, and for those of you who read our quarterly announcements very carefully, then you'll see the wording around supply and supply constraints has been toned down significantly. And if you compare to just three months ago, where we said across markets and products with supply constraints, now we're talking about certain markets and certain products. So that is just a clear signal that at a global scale, the supply-demand balance has changed significantly.
是的。因此,就供需而言,對於仔細閱讀我們季度公告的人來說,您會發現有關供應和供應限制的措辭已經大大淡化。如果與三個月前相比,我們當時討論的是跨市場和產品的供應限制,而現在我們討論的是某些市場和某些產品。這是一個明確的訊號,顯示全球範圍內的供需平衡已經發生了重大變化。
So I wouldn't say that we're totally out of constraints across all markets and all products, but it's much, much better. You see that also as a function of significantly more Vigovi launches in IO and more in the plan, which is also baked into our guidance, promotional efforts for SimPIC at a global scale. So that's kind of the macro picture on supply-demand. In the US, we're fully supplied for our GF1 portfolio. So the high inventories and, of course, ready to service our obligations vis-a-vis the CVS agreement.
因此,我不會說我們在所有市場和所有產品上都完全擺脫了限制,但情況已經好得多了。您還會看到,這也是 IO 中 Vigovi 推出的更多功能以及計劃中的更多功能,這些功能也融入了我們在全球範圍內對 SimPIC 的指導和推廣工作中。這就是供需的宏觀狀況。在美國,我們的 GF1 產品組合供應充足。因此,庫存充足,當然,我們也準備好履行 CVS 協議規定的義務。
And clearly, we don't want to get into a drug shortage situation again, neither vis-a-vis CVS or similar launch come next year. Then that leads to the second part of your question. Is it then demand constraint? And that links into what we've been communicating this quarter, that the market has actually accelerated super nicely in terms of total volumes. At a global scale, if you take branded products, the obesity market has more than doubled compared to a year ago. So I think that's, and it doubled the year before also. So the market expansion and demand, I'd say, data proves that we're penetrating as the market is expanding as it should.
顯然,我們不想再次陷入藥品短缺的局面,無論是針對 CVS 還是明年推出的類似產品。那麼這就引出了你問題的第二部分。那麼這是需求約束嗎?這與我們本季所傳達的訊息相聯繫,即市場總量實際上已經加速成長。從全球來看,如果以品牌產品為例,肥胖症市場比一年前成長了一倍以上。所以我認為,這個數字比前一年也翻了一番。因此,我想說,市場擴張和需求數據證明我們正在滲透,因為市場正在以應有的方式擴張。
And in the US, if you take compounding and then say, in obesity, compounding is one third of the market, then you actually get to a really attractive market expansion also in the US. Unfortunately for us, it's based on compounders expanding in the cash channel. And that's why it's so important for us to get the cash channel built, both with NovoCare and partners in telehealth to service on the patient activation. So that's kind of the all supply-demand picture.
在美國,如果你採用複合法,然後說,在肥胖症領域,複合法佔了市場的三分之一,那麼你實際上也在美國獲得了真正有吸引力的市場擴張。不幸的是,它是基於複合企業在現金管道的擴張。這就是為什麼建立現金管道對我們來說如此重要,包括與 NovoCare 和遠距醫療合作夥伴合作為患者活化提供服務。這就是整個供需情況。
Jacob Rode - Head of Investor Relations
Jacob Rode - Head of Investor Relations
Thank you, Carsten. Let's do it a bit differently. So are there any questions to either R&D or IO? James, smart man.
謝謝你,卡斯滕。讓我們做點不同的事情。那麼對於研發部門或 IO 來說還有什麼問題嗎?詹姆斯,聰明人。
James Quigley - Analyst
James Quigley - Analyst
Thank you, James, for the Goldman Sachs. My question for IO is on Mugobi China. And I've got a quick one as well for Carsten. But on Mugobi China, it's a very strong quarter. It's only the third quarter of the launch. But is this the start of a trend? Or should we expect it to continue to be volatile on a quarterly basis?
詹姆斯,謝謝你,高盛。我對 IO 的問題是關於 Mugobi China 的。我也為卡斯滕準備了一個簡短的答案。但對於 Mugobi 中國來說,這是一個非常強勁的季度。現在才剛發佈到第三季。但這是一種趨勢的開始嗎?或者我們應該預期它會繼續按季度波動?
And do you have any other information about potential launch of semiglutide generics in the regions with the upcoming patent expiring in 26? So any competitive intelligence on China, Canada, Brazil, Mexico, those ones that are going there? And a quick other one for Carsten. All semiglutide, 25 milligram. The timing of the potential approval seems like it's six months. Have you used the PRV? Did you buy it? And is there an expense coming in the second quarter?
您是否有關於在 26 年專利即將到期的地區推出西米魯肽仿製藥的其他資訊?那麼,有沒有關於中國、加拿大、巴西、墨西哥等國家的競爭情報呢?還有一個簡短的關於卡斯滕 (Carsten) 的問題。全部是西米魯肽,25毫克。潛在批准的時間似乎是六個月。您使用過 PRV 嗎?你買了嗎?第二季有支出嗎?
Maziar Doustdar - Executive Vice President - International Operations
Maziar Doustdar - Executive Vice President - International Operations
So on China and Mugobi, I would say we foresee a fantastic year throughout the upcoming three quarters. There's always in our part of the world in China and emerging markets quarterly fluctuations. It could be one quarter, a little bit better or worse.
因此,對於中國和穆戈比而言,我想說,我們預見未來三個季度將是輝煌的一年。在我們這個地區,中國和新興市場總是存在季度波動。這可能是個季度,稍微好一點或差一點。
But I would say we have incredibly high ambition for China's Mugobi, not just this year, but beyond. And you should foresee good numbers coming out of that. In the context of LOEs and other players, there are, to the best of my knowledge, five, six players right now that are trying to make semiglutide for post-LOE. And we are watching them very seriously.
但我想說,我們對中國的穆戈比抱持著非常高的期望,不僅是今年,而且是以後。你應該可以預見到最終會有好的結果。在 LOE 和其他參與者的背景下,據我所知,目前有五、六名參與者正在嘗試為 LOE 後製造塞米魯肽。我們正在非常認真地關注著他們。
Having said that, I would say that they would need to have a certain amount of volume before they become a viable threat. And there has to be a number of them also in the market that gives the government and everyone else confidence that collectively they will be able to, again, capture a large number of patients. Our success with Ozempic historically, and now, of course, with Mugobi on the back of getting many, many more patients month by month, is one of our best tools we can have to protect the business for longer.
話雖如此,我想說,他們需要達到一定的數量才能成為可行的威脅。而市場上也必須有一定數量的這類公司,讓政府和其他所有人都有信心,他們將能夠再次吸引大量患者。我們過去在 Ozempic 上取得的成功,當然還有現在 Mugobi 上取得的成功,都讓我們每月獲得越來越多的患者,這是我們能夠長期保護業務的最佳工具之一。
Brand recognition, I've spoken to that in the past, should not be underestimated. A place like China really cares about brands. And historically, we have been seeing that has helped us with many of our products that actually do not have patents in China, but we have leadership. And that gives us confidence and the hope going forward.
我過去曾說過,品牌認知度不容小覷。像中國這樣的地方確實很注重品牌。從歷史上看,這對我們幫助很大,我們的許多產品實際上在中國並沒有專利,但我們卻擁有領導地位。這給了我們前進的信心和希望。
And then, of course, as we are ramping up, our economy of scale is at a very different level as many of these players. So we also will be able to discuss with the government when the time comes on volumes and prices, perhaps in a position of strength compared to many other players. So those are, I would say, what gives me confidence. And you also mentioned Mexico and some of the other players.
當然,隨著我們業務的不斷擴大,我們的規模經濟與許多參與者處於非常不同的水平。因此,到時候我們也能與政府討論產量和價格問題,與許多其他參與者相比,我們可能處於優勢地位。所以我想說,這些就是給我信心的東西。您還提到了墨西哥和其他一些參與者。
I would say, to a large extent, the same thing. We just launched Mugobi in Mexico, actually, last month, going incredibly well. And Mexico was supposed to go LOE next year, 2026, and our legal and regulatory team have done a phenomenal job. And just more recently, we have heard that that LOE is now postponed by an additional year. So we are very happy about that. So it gives us more time to follow on the bit of a strategy that we're doing in China.
我想說,在很大程度上,是同一件事。實際上,我們上個月剛在墨西哥推出了 Mugobi,進展非常順利。墨西哥原定於明年(2026年)實現 LOE,我們的法律和監管團隊做得非常出色。就在最近,我們聽說 LOE 現已延後一年。所以我們對此感到非常高興。因此,我們有更多時間實施我們在中國實施的策略。
Jacob Rode - Head of Investor Relations
Jacob Rode - Head of Investor Relations
Thank you, Mike. And abiding to the rule of one question at first, and I'll take the liberty to move to [Jess] in the corner.
謝謝你,麥克。首先遵守一個問題的規則,然後我會擅自轉向角落的 [Jess]。
Unidentified Participant
Unidentified Participant
Can I do a question and a clarification? A clarification on that 7.4 months of duration. Is the mean different from median or mode? That would really help to understand if you're seeing churn early.
我可以提出一個問題並澄清一下嗎?對 7.4 個月期限作出澄清。平均值與中位數或眾數不同嗎?這確實有助於您了解早期是否出現了客戶流失。
The question is, if you indulge me with, you've got about, say, 3 million or so patients in the US on Mugobi, right? Not Mugobi, all the brands, right, across, including compounders. And the 90 million, potentially, of these patients, let's say a third of them have access with the access you have. We, in theory, are scratching the surface of a very large market, right? Your penetration rates are quite low. I'm quite puzzled.
問題是,如果您允許我這樣說的話,那麼在美國大約有 300 萬左右的患者使用 Mugobi,對嗎?不是 Mugobi,而是所有品牌,對的,包括複合材料。在這些潛在的 9000 萬名患者中,假設其中三分之一的人能夠獲得與您一樣的治療機會。從理論上講,我們只是觸及了一個非常大的市場的表面,對嗎?你們的滲透率相當低。我非常困惑。
You've had, Lily, two quarters of destocking. Your growth got impaired by compounders in the first quarter when we are scratching the surface of a very large market. All the sell-side brokers, like me, have built their models proclaiming the market is 120, 150, 200, I don't know. Everyone has a big number. But does this make you stop in your tracks and ask the question, is there any other rate-limiting step in realizing that market size, which might, because, I mean, if the market is that large, why compounders matter at this low level of penetration? I'm unable to get my head around it, so I'm very curious on how you would think about the problem.
莉莉,你已經經歷了兩個季度的去庫存化。當我們在第一季觸及一個非常大的市場的表面時,你們的成長就受到了複合因素的損害。所有賣方經紀人,像我一樣,都建立了他們的模型,宣稱市場是 120、150、200,我不知道。每個人都有一個大數字。但這是否會讓你停下腳步並提出一個問題,在實現這一市場規模的過程中是否還有其他限速步驟,這可能是因為,我的意思是,如果市場如此之大,為什麼複合材料在如此低的滲透水平下仍然重要?我無法理解這一點,所以我非常好奇您會如何看待這個問題。
Jacob Rode - Head of Investor Relations
Jacob Rode - Head of Investor Relations
Thanks a lot for this. And do you have one penetration to you, Lars?
非常感謝。拉爾斯,你有什麼見解嗎?
Lars Fruergaard Joergensen - President, Chief Executive Officer
Lars Fruergaard Joergensen - President, Chief Executive Officer
I think it's a great question. So I think it started with the classical market structure with PBMs, insurance companies, and ultimately, let's say, at last, employers paying. And it started with, you know, opting in and relatively easy access, cost starts growing, and then a lot of friction is put in and it becomes difficult to get access. So I think in totality, the stack of players have not succeeded in actually unlocking the value of treating obesity because there is actually a tremendous health benefit.
我認為這是一個很好的問題。所以我認為它始於傳統的市場結構,包括 PBM、保險公司,最後,也就是雇主支付。你知道,一開始是選擇加入並相對容易訪問,但後來成本開始增長,然後出現很多摩擦,訪問變得困難。因此我認為,總體而言,各方尚未真正挖掘出治療肥胖症的價值,因為這實際上具有巨大的健康益處。
So there was data out recently from Aaron about when you do obesity treatment, there's a cost year one, but actually you start saving costs already from year two. So we haven't fully gotten to the perfect transaction model in untanking that. So when we build a cash model, of course, right now serving individual patients with telehealth, but it's also building the opportunity to actually engage with large payers.
因此,Aaron 最近發布的數據顯示,當你進行肥胖症治療時,第一年會產生成本,但實際上從第二年開始就已經開始節省成本了。所以我們還沒有完全找到解決這個問題的完美交易模型。因此,當我們建立現金模型時,當然,現在為個人患者提供遠距醫療服務,但它也在創造與大付款人實際接觸的機會。
So if you take a payer that has a large number of employees, you are self-insured. If you have long tenure among your employees, you will be accumulating all the costs from the comorbidities associated with obesity. You get the lower work attendance from those who are sick. So actually, there's a very robust financials in actually helping them understand their own data and how to actually go about it.
因此,如果您選擇擁有大量員工的付款人,那麼您就是自我保險。如果您的員工任職時間較長,那麼您將累積與肥胖相關的合併症的所有成本。生病的人出勤率較低。因此,實際上,在幫助他們了解自己的數據以及如何實際處理這些數據方面,有著非常強大的財務實力。
You can say in European healthcare systems, you have a lot of experience in how do you sanction rational use of medicines based on health technologies. But in the US it's like, I have a right to access and there's no discrimination so far. I'm not advocating for discrimination, but we need to understand and meet your patient needs and what's the value of doing that.
您可以說,在歐洲醫療保健體系中,您在如何根據衛生技術批准合理使用藥物方面擁有豐富的經驗。但在美國,我有權訪問,到目前為止沒有任何歧視。我並不是提倡歧視,但我們需要了解並滿足患者的需求以及這樣做的價值。
And I think this will be coming as more models are built and that will also put pressure on the existing, say, chain in actually coming up with that solution to payers. So I think this will happen over the relative short term. I think we'll see that will unlock a lot and then you'll have the cash channels so more channels being opened up and access will increase. Anything to add, Karsten?
我認為,隨著更多模型的建立,這種情況將會發生,這也將對現有的連鎖店施加壓力,迫使他們真正為付款人提供解決方案。所以我認為這將在相對較短的時間內發生。我認為我們會看到這將解鎖很多東西,然後你就會有現金管道,因此更多的管道被開放,訪問量也會增加。還有什麼要補充的嗎,卡斯滕?
Karsten Munk Knudsen - Chief Financial Officer, Executive Vice President
Karsten Munk Knudsen - Chief Financial Officer, Executive Vice President
Yeah, just building on Lars' comments because clearly obesity is our top priority because we have a super strong portfolio and very significant unmet need on a global basis. So this is the key or the biggest growth opportunity for the company. So when we look at rate limiting factors and we can have that discussion for all markets, including China where I was just a few weeks ago, but in the U.S. you can look at it as initially the rate limiting factor was supply.
是的,只是基於拉爾斯的評論,因為肥胖顯然是我們的首要任務,因為我們擁有超強大的產品組合和全球範圍內非常大的未滿足需求。所以這對公司來說是關鍵的或最大的成長機會。因此,當我們研究限制利率的因素時,我們可以針對所有市場進行討論,包括我幾週前去過的中國,但在美國,你可以將其視為最初的限制利率的因素是供應。
Then as I said before, we've moved out of supply as a rate limiting factor. Then the next step is how is the system a rate limiting factor? And when you look at the old healthcare system, then in terms of prescribers, today we have around 80,000 GPs that are prescribing Vigovi in the U.S. And if you compare that to the number of scripts, then there's significant more capacity in the system. So it's not the healthcare system in terms of prescribers and scripts and fulfillment that's a rate limiting factor. Then you say, what is then the rate limiting factor?
然後,正如我之前所說,我們已經不再提供限速因素。那麼下一步是系統如何成為速率限制因素?當您回顧舊的醫療保健系統時,就處方者而言,今天我們在美國有大約 80,000 名全科醫生開立 Vigovi 處方。如果您將其與處方數量進行比較,那麼該系統的容量就會大大增加。因此,限制速度的因素並不是處方人員、處方和履行情況方面的醫療保健系統。那麼您會說,速率限制因素是什麼?
And there I would say in terms of capacity in the system, financial capacity in the system, then of course there's things has to fit together in the financial capacity. And that's why Lars is talking about access and payers managing that in the appropriate way. And that's why the cash channel is so important that we built that because that's also part of building capacity in the oral system because that moves it out in the out-of-pocket setting and hence less pressure on insurance companies.
我想說的是,就係統容量、系統財務容量而言,當然所有事情都必須與財務容量相符。這就是為什麼拉爾斯談論訪問和付款人以適當的方式管理它。這就是為什麼現金管道如此重要,以至於我們要建立它,因為這也是口腔系統能力建設的一部分,因為它將費用轉移到自付費用環境中,從而減輕了保險公司的壓力。
And then the last piece is on patient activation. So because obesity is a different type of patient activation compared to other disease areas. And again, their telehealth providers play a different role than in other disease areas. So that's how we're looking about the rate limiting factors across the different pieces of the system.
最後一部分是關於患者活化。與其他疾病領域相比,肥胖是一種不同類型的患者活化。而且,他們的遠距醫療提供者扮演的角色與其他疾病領域不同。這就是我們如何看待系統不同部分的速率限制因素。
Jacob Rode - Head of Investor Relations
Jacob Rode - Head of Investor Relations
Thank you, Carsten. Thank you, Lars. Let's move to Peter Verdult .
謝謝你,卡斯滕。謝謝你,拉爾斯。讓我們轉到 Peter Verdult。
Peter Verdult - Analyst
Peter Verdult - Analyst
Thanks, Pete Vidal, BNP. Just one question for Carsten. Rather than asking you to comment on every deal you sign or comment on every permutation that President Trump might not enact, can we come at it from a different angle, which is when we followed you around the world in the last few years, the messaging has been, look, 10% to 15% price mix headwinds on the portfolio in the US is a good proxy for us to use. Does that still stand or, Anthony, I know you're not gonna quantify and say what it is now, but does that still stand or should we just be assuming a step up going forward given everything that's going on? Thanks.
謝謝,法國國家銀行的 Pete Vidal。只想問卡斯滕一個問題。我們不是要求您對簽署的每一項協議或川普總統可能不會頒布的每一項安排都發表評論,而是可以從不同的角度來看待這個問題,也就是,當我們在過去幾年裡跟隨您在世界各地時,得到的信息是,看,美國投資組合 10% 到 15% 的價格組合逆風是我們可以採用的一個很好的指標。這種說法是否仍然成立?或者,安東尼,我知道你不會量化並說出現在的情況,但這種說法是否仍然成立?或者,考慮到正在發生的一切,我們是否應該假設未來會有所進步?謝謝。
Karsten Munk Knudsen - Chief Financial Officer, Executive Vice President
Karsten Munk Knudsen - Chief Financial Officer, Executive Vice President
Yeah, thanks, Pete, for that question. I'd say for the 10 to 15% is an asymptic or diabetes comment and there are no changes to that one. Of course, it's forward-looking, so now we are in RA and we're in the middle of the process, so we don't know how that works out, but based on what we know today, that still stands.
是的,謝謝你,Pete,提出這個問題。我想說 10% 到 15% 是一個漸近或糖尿病的評論,對此沒有任何改變。當然,這是前瞻性的,所以現在我們處於 RA 中,我們正處於這個過程的中間,所以我們不知道它會如何發展,但根據我們今天所知道的,它仍然成立。
Yeah, and multiple permutations from there, but I would say it's important to note that a lot of the administration and the communication there in terms of different healthcare impacts, we've been commenting on tariffs, but in terms of pricing, the main focus is on government channels, whether it's Medicare, Medicaid, or even VA, and for the COVID that we've been discussing a lot today, the COVID is not present in Medicare and hence has much less exposure to different pricing mechanisms introduced by the administration than other disease categories.
是的,從那裡開始會有多種排列組合,但我想說,重要的是要注意,很多政府部門和溝通部門就不同的醫療保健影響進行了討論,我們一直在評論關稅,但在定價方面,主要關注的是政府渠道,無論是醫療保險、醫療補助,還是退伍軍人事務部,而對於我們今天小得多的新冠肺炎,肺炎,肺炎,肺炎,因此對政府的醫療類別。
Jacob Rode - Head of Investor Relations
Jacob Rode - Head of Investor Relations
Perfect, thank you, Klaas. Now let's move to David Evans.
太好了,謝謝你,克拉斯。現在我們來談談大衛·埃文斯。
David Evans - Analyst
David Evans - Analyst
Thanks. David Evans from Kepler. So just going back, sorry, to the question on access and what's holding back from on, I mean, there are roughly half US overweight patients do normally have insurance coverage, but what is actually making some of those go to the compounding channel?
謝謝。開普勒的戴維·埃文斯。所以,抱歉,回到關於獲取途徑的問題以及阻礙因素,我的意思是,大約有一半的美國超重患者通常都有保險覆蓋,但實際上是什麼讓其中一些人進入了複合渠道?
What actual steps are, I mean, I assume it's the insurance companies just making it really, really difficult for these patients to actually get on the brand, even if they normally have coverage. Could you just talk us through, I mean, what are they doing? Is it just a delay for the patient to get on drug? Are they motivated to go to compounding products because it's quicker or easier? Or if you could just give us a little more detail on that.
實際步驟是什麼?我的意思是,我認為保險公司讓這些患者很難真正使用該品牌,即使他們通常有保險。您能簡單跟我們講講他們在做什麼嗎?這是否只是為了延遲患者服藥?他們是否有動力去使用複合產品,因為它更快或更容易?或者您可以提供一些有關此問題的更多細節?
Jacob Rode - Head of Investor Relations
Jacob Rode - Head of Investor Relations
Thanks. Klaas, do you want to go for that one?
謝謝。克拉斯,你想去那個嗎?
Karsten Munk Knudsen - Chief Financial Officer, Executive Vice President
Karsten Munk Knudsen - Chief Financial Officer, Executive Vice President
Yeah, the simple question to that is, and it pretty much links to a behavioral theory that people move to the places with least friction. And here, simplicity and ease of access, that has really been a play for compounders and telehealth.
是的,這個問題很簡單,它與一種行為理論密切相關,即人們會去摩擦最少的地方。而在這裡,簡單和易於訪問,對於複合材料和遠距醫療來說確實發揮了作用。
Lars Fruergaard Joergensen - President, Chief Executive Officer
Lars Fruergaard Joergensen - President, Chief Executive Officer
Lars, I can just add a perspective that if you have a disease like obesity, where say half of your population or more have that condition, just intellectually it does make sense to cover that based on insurance, because insurance is something about treating the few and having the many say contribute to it.
拉爾斯,我可以補充一個觀點,如果你患有肥胖症之類的疾病,假設有一半或更多的人口患有這種疾病,那麼從理智上講,通過保險來覆蓋這種疾病是有意義的,因為保險的本質是治療少數人,讓多數人為此做出貢獻。
So I think we need to get to a different state where we actually look at very large populations need to have treatment. And how do you get to get the model to work accordingly? And the current model is not designed to accommodate obesity. So just a thought on insurance and obesity.
所以我認為我們需要進入一個不同的狀態,真正關注需要治療的大量人群。那麼如何讓模型正常運作呢?而目前的模型並不是為適應肥胖而設計的。這只是關於保險和肥胖的一些想法。
Jacob Rode - Head of Investor Relations
Jacob Rode - Head of Investor Relations
Thank you, Lars. Let's try with either IO or R&D again. [Manuel]?
謝謝你,拉爾斯。讓我們再次嘗試 IO 或 R&D。[曼努埃爾]?
Unidentified Participant
Unidentified Participant
I'll take an R&D one. Martin, give us an update on the co-formulation progress of Kegel-Semmer and its importance to scaling up supply for that asset, since you seem to have mentioned supply a few times in recent updates, and then maybe a follow on the importance of REDEFINE for and REIMAGINE for, and your confidence in showing superiority on weight loss in the former HPO and see the latter. Thank you.
我要選擇一個研發的。馬丁,請向我們介紹 Kegel-Semmer 聯合配方的進展情況及其對擴大該資產供應的重要性,因為您似乎在最近的更新中多次提到了供應,然後也許可以談談 REDEFINE 和 REIMAGINE 的重要性,以及您對在前一種 HPO 中展示減肥並觀察後者的信心。謝謝。
Martin Lange - Executive Vice President - Development
Martin Lange - Executive Vice President - Development
So on co-formulation, ongoing studies, obviously having to show equivalence to both on the pharmacokinetics, but also on the clinical equivalence, I have no insights into the results. For us, it's an exploratory measure that will obviously add to our flexibility in the supply chain if we succeed, but we're currently aiming to scale the dual-chamber device to be able to cater to a full Kegel-Semmer launch. So that's our base case and that's our plan.
因此,對於聯合配方、正在進行的研究,顯然必須證明藥物動力學和臨床等效性的等效性,我對結果沒有任何見解。對我們來說,這是一項探索性措施,如果成功,顯然會增加我們供應鏈的靈活性,但我們目前的目標是擴大雙腔設備的規模,以滿足凱格爾-塞默爾 (Kegel-Semmer) 的全面推出。這就是我們的基本情況和計劃。
On REDEFINE for and REIMAGINE for, as you know, studies designed to test for non-inferiority first and then superiority. So again, the base case and an upside, and in the wake of REDEFINE one, we do believe that the biology speaks to it. The question is whether it's the extension of, for example, REDEFINE four has been timely to really accrue the full weight loss. That remains to be seen. So I'm fairly confident on the non-inferiority and we'll have to see on the superiority. I think if we really want to look at the full weight loss potential of Kegel-Semmer, we have to wait for a dedicated prospect to have started like a REDEFINE 11, which will be ready at time of launch.
關於 REDEFINE 和 REIMAGINE,如您所知,研究旨在首先測試非劣效性,然後再測試優效性。因此,再次強調,這是一個基本情況,也是一個上行趨勢,在 REDEFINE 之後,我們確實相信生物學可以解釋這一點。問題是,REDEFINE four 的擴展是否及時,是否能真正達到完全的減肥效果。這還有待觀察。因此,我對非劣效性相當有信心,我們必須看看其優越性。我認為,如果我們真的想了解 Kegel-Semmer 減肥法的全部減肥潛力,我們必須等待專門的潛在客戶開始使用,例如 REDEFINE 11,它將在發佈時準備就緒。
Jacob Rode - Head of Investor Relations
Jacob Rode - Head of Investor Relations
Thank you, Martin. And then we move to Harry from UBS.
謝謝你,馬丁。然後我們轉到瑞銀的哈利。
Harry Sephton - Analyst
Harry Sephton - Analyst
Brilliant. Thank you very much. Maybe one on IO. So previously you've talked about the fact that you have two different brands for Smagletite as a potential advantage in IO to access the cash paying channel for Wigovi versus Lily just with Manjaro.
傑出的。非常感謝。也許 IO 上有一個。所以之前您談到過,Smagletite 有兩個不同的品牌,這在 IO 中具有潛在優勢,可以透過 Manjaro 訪問 Wigovi 和 Lily 的現金支付管道。
Just once again, an update there as to whether you're seeing the benefits of specifically targeting cash pay channels where Lily might not be able to if they've got one product that has to be reimbursed and therefore only reimbursed for diabetes or obesity. Thank you.
再次,我想更新一下,您是否看到了專門針對現金支付管道的好處,如果 Lily 有一種需要報銷的產品,並且只能報銷糖尿病或肥胖症,那麼他們可能無法做到這一點。謝謝。
Maziar Doustdar - Executive Vice President - International Operations
Maziar Doustdar - Executive Vice President - International Operations
Yeah. So definitely we see a huge advantage on having gone for the two brand strategy in international operations. We have around 6 million patients on Ozempic today in IO and we have 1.1 million on Wigovi. So 7 million patients. It would be very, very difficult. And of course, Lily's numbers are much, much smaller than that to have done that with a single brand.
是的。因此,我們確實看到在國際營運中採用雙品牌策略具有巨大優勢。目前,印度約有 600 萬名患者使用 Ozempic,110 萬名患者使用 Wigovi。所以有700萬患者。這會非常非常困難。當然,Lily 的銷量比單一品牌的銷量小得多。
As you can see, Lily was not and has not been able to get reimbursement in the diabetes area to accommodate those patients and for us as a company that takes diabetes incredibly serious, we wanted to make sure that we are there not just for the obesity patients, but also for diabetics one. So our strategy has fit us and the purpose that we have with both diabetes and obesity very, very well.
正如您所看到的,Lily 過去和現在都無法獲得糖尿病領域的報銷來容納這些患者,而對於我們作為一家非常重視糖尿病的公司來說,我們希望確保我們不僅為肥胖患者提供服務,也為糖尿病患者提供服務。所以我們的策略非常適合我們以及我們對抗糖尿病和肥胖的目標。
And I would say you also see that, of course, that has because one product is reimbursed often and the other one has been allowing us to play with the pricing in a way that would have not been possible, of course, if it was all under a single brand. So the answer is yeah.
我想說,您也看到了,這是因為一種產品經常獲得報銷,而另一種產品則允許我們以某種方式操縱定價,當然,如果所有產品都屬於單一品牌,這是不可能的。所以答案是肯定的。
Jacob Rode - Head of Investor Relations
Jacob Rode - Head of Investor Relations
Thank you, Mike. Emily again.
謝謝你,麥克。又是艾米麗。
Emily Field - Analyst
Emily Field - Analyst
Hi, Emily Fields from Barclays. I have another R&D question just for Martin. For the monotherapy co-gurlantide trial that you're starting later this year, if you could give some thoughts on just how many doses you're thinking of exploring and how far beyond 2.4 you may go.
你好,我是巴克萊銀行的 Emily Fields。我還有一個研發問題想問馬丁。對於您今年稍後開始的單藥治療 co-gurlantide 試驗,您能否談談您打算探索多少劑量以及可以超出 2.4 多少劑量。
Martin Lange - Executive Vice President - Development
Martin Lange - Executive Vice President - Development
It's a really good question. As you know, we've already done and reported on Phase two for co-gurlantide where we tested higher doses than the 2.4. And in that setting, we didn't see a lot of added weight loss. So 2.4 appears to be the optimal dose. Doesn't mean that we'll not test an additional dose level in Phase 3, really looking towards maximizing the weight loss.
這確實是一個好問題。如您所知,我們已經完成並報告了 co-gurlantide 的第二階段研究,其中我們測試的劑量高於 2.4。在那種環境下,我們並沒有看到體重減輕很多。因此 2.4 似乎是最佳劑量。這並不意味著我們不會在第 3 階段測試額外的劑量水平,而是真正希望最大限度地減輕體重。
But I think already going back to what I spoke to before, having an asset that gives a 12, 13, 14% weight loss with a safety and tolerability profile will fit very nicely into the portfolio that we're building so that we can cater to the full need of the patients.
但我認為回到我之前所說的內容,擁有一種能夠減輕 12%、13%、14% 體重且具有安全性和耐受性的資產將非常適合我們正在建立的產品組合,以便我們能夠滿足患者的全部需求。
Jacob Rode - Head of Investor Relations
Jacob Rode - Head of Investor Relations
Perfect, Martin. We have time for two more questions. I think that was the first one.
完美,馬丁。我們還有時間回答另外兩個問題。我認為那是第一個。
Sachin Jain - Analyst
Sachin Jain - Analyst
Hi there. Can I take another question on the cash channel given you talked about the importance of it. So do you have any idea as to what percentage of the 100 million addressable patients in the US can afford your Novacare price? And where do you sit on potentially coming back to a syringe and vial cheaper strategy which doesn't have read-through to reimburse channels?
你好呀。既然您談到了現金管道的重要性,我可以回答另一個有關現金管道的問題嗎?那麼,您是否知道美國 1 億可尋址患者中有多少比例能夠負擔 Novacare 的價格?並且,您如何看待可能重新採用注射器和小瓶這種沒有讀取報銷管道的更便宜的策略?
And I might just take one R&D for Martin. You talked about oral non-ingredient GLP-1. Does that preclude a later stage BD asset in oral that could be an ex-US asset given oral stem is predominantly focused on the US?
我可能只會為馬丁進行一項研發。您談到了口服非成分 GLP-1。鑑於口腔領域主要集中在美國,這是否排除了口腔領域後期 BD 資產可能成為美國以外的資產?
Jacob Rode - Head of Investor Relations
Jacob Rode - Head of Investor Relations
Question on cash channel to you, Karsten.
卡斯滕,請問您關於現金管道的問題。
Karsten Munk Knudsen - Chief Financial Officer, Executive Vice President
Karsten Munk Knudsen - Chief Financial Officer, Executive Vice President
Yeah, so the starting point is where are we today in terms of the cash channel. And as we've said, we've just begun. So we're in the low single digits with the Novacare as share of our total scripts. If you look at competition, based on the market data, we see that in the high teens of cash out of total. So that speaks to the potential in where we are today in the cash channel.
是的,所以起點是我們今天的現金管道處於什麼位置。正如我們所說,我們才剛剛開始。因此,Novacare 在我們全部處方中所佔的比例處於較低的個位數。如果你觀察一下競爭狀況,根據市場數據,我們會發現現金佔總現金的比例高達百分之十幾。這說明了我們目前在現金管道中的潛力。
So as a forward-looking statement, I do believe that the cash channel has the potential to constitute a very significant share of the total market. So approaching the 50% or even more in the medium to long-term. Exactly what price point that will end up being, that's of course something we'll be looking at as we mature the channel and penetrate other channels. So all we do believe that the cash channel is a key channel for the markets.
因此,作為前瞻性聲明,我確實相信現金管道有潛力佔據整個市場的巨大份額。因此從中長期來看,這一比例將接近 50% 甚至更高。最終的價格點究竟是多少,這當然是我們在通路成熟和滲透其他管道時會考慮的事情。因此,我們始終相信現金通路是市場的關鍵管道。
Price sensitivity, I don't want to come too detailed on today in terms of how many can access the 499 out of the 100 million, 110 million with obesity. But based on the numbers I just gave, there'll be a very nice potential already with the 499. Sorry? Sorry, it's a while. Sorry, it's a while, sorry. Of course, we're looking at different product presentation options as we announced today. Not that it's a cash play necessarily, but we submitted the FlexTouch PDS290 to the FDA. So hopefully we'll have an approval for that for the Google this year.
價格敏感性,今天我不想太詳細地談論 1 億人中有多少人可以接觸到 4.99 億肥胖者,即 1.1 億肥胖者。但根據我剛才給出的數字,499 已經具有非常好的潛力。對不起?抱歉,稍等片刻。抱歉,等了好久了,抱歉。當然,正如我們今天宣布的那樣,我們正在研究不同的產品展示選項。這不一定是一場現金遊戲,但我們已將 FlexTouch PDS290 提交給 FDA。因此,我們希望今年谷歌能夠批准這項計劃。
And of course, we're also evaluating other product presentations for the US and globally as we move forward. Simply to, given the, as Lars was talking to, the size of the market, one billion people with obesity globally, this market will be served in different segments, whether it's cargolentide, oil, or injectables. But then of course there'll also be different product presentations to penetrate the market in different countries, et cetera, and price points.
當然,隨著我們不斷前進,我們也在評估針對美國和全球的其他產品展示。簡單地說,正如拉爾斯所說的那樣,考慮到市場的規模,全球有 10 億肥胖人口,這個市場將分為不同的部分,無論是卡可倫肽、油還是注射劑。但當然也會有不同的產品展示來滲透不同國家等的市場,以及價格點。
Jacob Rode - Head of Investor Relations
Jacob Rode - Head of Investor Relations
Thank you, Carsten. And let's move for the final question, which is Simon Baker. One question per person. So we'll move to Simon Baker.
謝謝你,卡斯滕。讓我們進入最後一個問題,提問者是西蒙貝克。每人一個問題。因此我們將轉向西蒙·貝克。
Simon Baker - Analyst
Simon Baker - Analyst
Thank you. I was gonna sneak a second one, but that's me told, so I won't. Just going back to the impact of the compounders. They've had a surprisingly significant impact from a standing start operating in the shadows.
謝謝。我本來想偷偷地吃第二個,但是這是我的吩咐,所以我不會吃。回到複合材料的影響。他們從一開始就在暗中活動,但卻產生了令人驚訝的重大影響。
I'm just wondering, has this changed your view on what happens at the end of the curve in 32, in terms of the ability of, dare I say, proper generic manufacturers to supply the market? Because these compounders, one works the numbers out, they've managed to source 25 kilos or so of Smagitide from Lord knows where. How has that, how has their performance now changed your view, if at all, of what the proper players can do at loss of exclusivity? Thank you.
我只是想知道,這是否改變了您對 32 號曲線末端發生的情況的看法,就合適的仿製藥製造商供應市場的能力而言?因為這些合成劑製造商,透過計算,他們設法從天知道的地方採購了 25 公斤左右的 Smagitide。他們的表現如何改變了你對合適的球員在失去獨家經營權後能做什麼的看法?謝謝。
Jacob Rode - Head of Investor Relations
Jacob Rode - Head of Investor Relations
Thanks, Simon. Lars, I'll give it to you.
謝謝,西蒙。拉斯,我會把它給你。
Lars Fruergaard Joergensen - President, Chief Executive Officer
Lars Fruergaard Joergensen - President, Chief Executive Officer
I think you need to consider a level playing field. And when we built, for instance, an API facility, we spent half the time constructing it and the rest of the time validating it and built the quality around it to document that it's precisely the same product that comes out every time as what was in the file.
我認為你需要考慮公平的競爭環境。例如,當我們建立 API 設施時,我們花費一半的時間來建造它,其餘的時間用於驗證它並圍繞它構建質量,以證明每次生產出的產品都與文件中的產品完全相同。
And when we test the currently compounded products out in the market, those contain a lot of impurities. Some of them even contain banned substances that are banned for use in drugs. And we have seen safety incidents being reported, even deaths linked to it. So if you asked these companies to comply with ordinary GMP rules, there would be SIP supply.
當我們測試目前市面上的複合產品時,發現它們含有許多雜質。有些甚至含有藥物中禁止使用的違禁物質。我們已經看到了安全事故的報道,甚至還有與之相關的死亡事件。因此,如果你要求這些公司遵守普通的 GMP 規則,那麼就會有 SIP 供應。
So just to put it in perspective. So you can do a lot of say tricks short term, but you have to be able to withstand the scrutiny of FDA and inspections, not only of the API, but also to finish. And we have a number of cases where quite serious inspection reports has been filed and even FDA, sorry, FBI closing down facilities. So you have to factor in what is needed to be a reliable, high quality supplier.
所以,只是為了客觀地看待它。因此,你可以在短期內做很多技巧,但你必須能夠經受住 FDA 的審查和檢查,不僅是 API 的審查,還要完成。我們有許多案例,其中提交了相當嚴重的檢查報告,甚至 FDA,對不起,FBI 也關閉了相關設施。因此,您必須考慮如何才能成為可靠、高品質的供應商。
Jacob Rode - Head of Investor Relations
Jacob Rode - Head of Investor Relations
Perfect. Thank you, Lars. Thank you, Simon. Before giving it to you, I'll ask for final remarks. A big thank you for the quarter turn-up and for all the good questions. So Lars, final remarks from you.
完美的。謝謝你,拉爾斯。謝謝你,西蒙。在把它交給你之前,我想請你做最後的評論。非常感謝您在本季度的出席以及提出的所有好問題。那麼 Lars,請聽我最後說幾句。
Lars Fruergaard Joergensen - President, Chief Executive Officer
Lars Fruergaard Joergensen - President, Chief Executive Officer
Yeah. Thank you, Jakob. So thank you all for coming. We acknowledge that it's been a turbulent period and I hope it comes across that we have, I think, a relative clear field for what we need to execute on in terms of continuously scaling capacity, executing the trials, coming back strongly with Cacosema and I think a leadership opportunity in the all GF1 obesity category.
是的。謝謝你,雅各。感謝大家的到來。我們承認這是一個動蕩的時期,我希望大家能夠看到,我們在持續擴大產能、開展試驗、憑藉 Cacosema 強勢回歸以及在所有 GF1 肥胖類別中佔據領導地位方面,對我們需要執行的事情有一個相對清晰的認識。
And then the commercial efforts that's needed both to make sure there's preference for our products and what is needed to close down compounding to really sustain an attractive growth profile and bring innovation to patients around the world. So on that, we are quite optimistic and clear on what we have to do. So thank you very much.
然後,我們需要進行商業努力,既要確保我們的產品受到青睞,又要關閉複合業務,以真正維持有吸引力的成長前景,並為世界各地的患者帶來創新。因此,我們對此非常樂觀,並且清楚自己要做什麼。非常感謝。