諾和諾德 (NVO) 2024 Q2 法說會逐字稿

(audio in progress) (Operator Instructions) Please be advised that today's conference is being recorded. I would now like to hand the conference over to your first speaker today, Jacob Rode, Head of Investor Relations. Please go ahead, sir.

（音訊正在進行中）（操作員指示）請注意，今天的會議正在錄製中。現在我想將會議交給今天的第一位發言人，投資者關係主管雅各布·羅德 (Jacob Rode)。請繼續，先生。

Thank you. Welcome to this Novo Nordisk earnings call for the first six months of 204. My name is Jacob Martin Wiborg Rode, and I'm the Head of Investor Relations at Novo Nordisk.

謝謝。歡迎參加諾和諾德 204 年前六個月的財報電話會議。

With me today, I have CEO of Novo Nordisk, Lars Fruergaard Jørgensen; Executive Vice President and Head of Commercial Strategy and Corporate Affairs, Camilla Sylvest; Executive Vice President and Head of North America Operations, Doug Langa; Executive Vice President and Head of Development, Martin Holst Lange; and finally, Chief Financial Officer, Karsten Munk Knudsen. All speakers will be available for the Q&A session.

今天和我在一起的還有諾和諾德 (Novo Nordisk) 執行長 Lars Fruergaard Jårgensen；執行副總裁兼商業策略與企業事務主管 Camilla Sylvest；執行副總裁兼北美營運主管 Doug Langa；執行副總裁兼開發主管 Martin Holst Lange；最後是財務長 Karsten Munk Knudsen。所有演講者都將參加問答環節。

Today's announcement and the slides for this call are available on our website, novonordisk.com. Please note that this call is being webcasted live, and a recording will be made available on our website as well. The call is scheduled to last one hour. Please turn to the next slide.

今天的公告和本次電話會議的幻燈片可在我們的網站 novonordisk.com 上取得。請注意，本次電話會議正在進行網路直播，錄音也將在我們的網站上提供。通話預計可持續一小時。請翻到下一張投影片。

The presentation is structured as outlined on slide 2. Please note that all sales and operating profit growth statements will be at constant exchange rates, unless otherwise specified. Please turn to the next slide.

此簡報的結構如投影片 2 所示。請翻到下一張投影片。

We need to advise you that this call will contain forward-looking statements. These are subject to risks and uncertainties that could cause actual results to differ materially from expectations. For further information on the risk factors, please see the company announcement for the first six months of 2024, as well as the slides prepared for this presentation.

我們需要告知您，本次電話會議將包含前瞻性陳述。這些都存在風險和不確定性，可能導致實際結果與預期有重大差異。有關風險因素的更多信息，請參閱公司 2024 年前六個月的公告以及為本次演示準備的幻燈片。

With that, over to you, Lars, for an update on our strategic aspirations.

現在，拉斯，請您了解我們策略願景的最新情況。

Thank you, Jacob. Please turn to next slide. In the first six months, we delivered 25% sales growth and 19% operating profit growth, both at constant exchange rates. The operating profit growth was impacted by the impairment loss related to ocedurenone.

謝謝你，雅各。請翻到下一張投影片。前六個月，我們的銷售額成長了 25%，營業利潤成長了 19%（以固定匯率計算）。營業利潤成長受到與奧塞酮相關的減損損失的影響。

I'd like to start this call by going through the performance highlights across our strategic aspirations before handing over the word to my colleagues. Starting with our focus on purpose and sustainability, we are now serving more than 42 million patients with our diabetes and obesity treatments.

在將發言權交給我的同事之前，我想先回顧一下我們策略願景的績效亮點。從我們對目標和永續性的關注開始，我們現在正在為超過 4,200 萬名患者提供糖尿病和肥胖治療。

Our total carbon emissions rose by 31%, as compared to the first six months of 2023. This was primarily driven by our increased investments in capital expenditure to meet the high demand for our products.

與 2023 年前六個月相比，我們的總碳排放量增加了 31%。

To uphold our commitment to being a sustainable employer, we expanded the number of women in senior leadership positions to 41%, compared to 40% in the first six months of 2023. Across all leadership positions, 46% are held by women.

為了履行我們成為永續雇主的承諾，我們將擔任高階領導職位的女性人數增加到 41%，而 2023 年前六個月為 40%。

Within R&D, we had a number of exciting readouts this quarter, including the positive Mim8 Phase 3 results. Martin will come back to this and our overall R&D milestones later. The quarterly sales growth reflects solid commercial execution across both operating units. The performance in the first six months has enabled us to raise our outlook for the full year.

在研發方面，本季我們獲得了許多令人興奮的結果，包括 Mim8 第 3 階段的正面結果。馬丁稍後將回到這一點以及我們的整體研發里程碑。季度銷售成長反映了兩個營運部門穩健的商業執行力。前六個月的表現使我們提高了全年的預期。

Camilla and Doug will go through the details later. Karsten will go through the financials. But I'm very pleased with our performance in the first six months of 2024. With that, I'll give the word to Camilla for an update on commercial execution.

卡米拉和道格稍後將詳細討論細節。卡斯滕將檢查財務狀況。但我對 2024 年前六個月的表現非常滿意。

Thank you, Lars, and please turn to the next slide. In the first six months of 2024, our total sales increased by 25% at constant exchange rates. The sales growth was driven by both operating units, with North America operations growing 36% and international operations growing 11%.

謝謝拉爾斯，請翻到下一張投影片。 2024 年前 6 個月，以固定匯率計算，我們的總銷售額成長了 25%。銷售成長由兩個營運部門推動，其中北美業務成長 36%，國際業務成長 11%。

In the US, sales growth was positively impacted by gross-to-net sales adjustments related to prior years. Our GLP-1 sales increased in diabetes by 32%, driven by North America operations growing 39% and international operations growing 20%.

在美國，銷售成長受到與往年相關的總銷售額與淨銷售額調整的正面影響。在北美業務成長 39% 和國際業務成長 20% 的推動下，我們的糖尿病 GLP-1 銷售額成長了 32%。

Insulin sales increased by 10%, driven by North America operations growing 36% and international operations growing 3%. Obesity care sales increased 37%, driven by North America growing 35% and international operations growing 47%.

在北美業務成長 36% 和國際業務成長 3% 的推動下，胰島素銷售額成長了 10%。在北美成長 35% 和國際業務成長 47% 的推動下，肥胖護理銷售額成長 37%。

In international operations, we continue to roll out Wegovy gradually with volume cap launches to balance supply and demand. In both geographies, growth was driven by Wegovy, partly offset by declining Saxenda sales as the market is moving towards once-weekly treatments, where disease sales decreased by 3%.

在國際業務中，我們繼續逐步推出 Wegovy，並推出數量上限以平衡供需。在這兩個地區，成長均由 Wegovy 推動，但部分被 Saxenda 銷售額下降所抵消，因為市場正在轉向每週一次的治療，其中疾病銷售額下降了 3%。

Please turn to the next slide. With 25% sales growth in diabetes care, we are growing faster than the total diabetes market. As a result, our global diabetes value market share increased to 34.1%. This is above our strategic aspiration of reaching one-third of the global diabetes value market in 2025. The increase reflects market share gains in both North America operations and international operations.

請翻到下一張投影片。糖尿病照護領域的銷售額成長了 25%，我們的成長速度超過了整個糖尿病市場。因此，我們的全球糖尿病價值市佔率增至 34.1%。這超出了我們到 2025 年達到全球糖尿病價值市場三分之一的戰略願望。

Please turn to the next slide. In international operations, diabetes care sales increased by 11% in the first six months of 2024, which was primarily driven by GLP-1 sales going 20%. Novo Nordisk is the market leader in international operations with a GLP-1 value market share of 69%.

請翻到下一張投影片。在國際業務中，糖尿病護理銷售額在 2024 年前 6 個月增長了 11%，這主要是由 GLP-1 銷售額增長 20% 推動的。諾和諾德是國際業務的市場領導者，其 GLP-1 價值市場佔有率為 69%。

Ozempic continues its GLP-1 market leadership, with 46.6% market share. We're also pleased to see Rybelsus increasing its market share to more than 16%, driven by solid uptake across geographies. And with that, I will hand over to Doug.

Ozempic 繼續保持其 GLP-1 市場領先地位，佔據 46.6% 的市場份額。我們也很高興看到 Rybelsus 在各個地區的強勁應用的推動下，其市場份額增加至 16% 以上。接下來，我會把工作交給道格。

Thank you, Camilla. Please turn to the next slide. Sales in North America is driven by market share gains and healthy prescription volume growth of the GLP-1 class above 10% in the second quarter this year, compared to the second quarter last year.

謝謝你，卡米拉。請翻到下一張投影片。與去年第二季相比，今年第二季 GLP-1 類藥物的市佔率成長和處方量健康成長超過 10%，推動了北美的銷售。

Sales of GLP-1 diabetes care products in the US increased by 42% at constant exchange rates. The sales increase was mainly driven by continued uptake of Ozempic. Measured on total prescriptions, Novo Nordisk expanded its market leadership, now with around 56% market share. Note that the sales growth of Ozempic was negatively impacted by periodic supply constraints in the beginning of the year.

以固定匯率計算，GLP-1 糖尿病照護產品在美國的銷售額成長了 42%。銷售額成長主要得益於 Ozempic 的持續吸收。以總處方量衡量，諾和諾德擴大了其市場領導地位，目前市佔率約為 56%。請注意，Ozempic 的銷售成長受到年初週期性供應限制的負面影響。

Please go to the next slide. To safeguard continuity of care for Wegovy, we reduced the supply of the lower dose strengths in May of 2023, which continued throughout the remainder of last year. In the beginning of this year, we gradually started increasing the supply of the lower dose strengths.

請轉到下一張投影片。為了保障 Wegovy 照護的連續性，我們在 2023 年 5 月減少了較低劑量劑量的供應，這種情況在去年剩餘時間一直持續。今年年初，我們逐漸開始增加低劑量規格的供應。

And I am pleased to see that this has been reflected in prescriptions. And we are now seeing more than double the number of prescriptions in the market compared to the beginning of the year. Further, while demand is still expected to exceed supply, we grow more confident in our ability to supply. We will continue to dynamically manage supply, but only the initiation dose strength of 0.25 milligrams.

我很高興看到這已反映在處方中。我們現在看到市場上的處方數量比年初增加了一倍以上。此外，儘管預計需求仍將超過供應，但我們對供應能力越來越有信心。我們將繼續動態管理供應，但初始劑量強度僅為 0.25 毫克。

Wegovy still has broad market access, with coverage for more than 50 million people with obesity. And importantly, around 10 million vulnerable people with obesity now have access to Wegovy through channels such as Medicaid, which is now available in more than 20 states.

Wegovy 仍擁有廣泛的市場准入，涵蓋超過 5,000 萬肥胖者。重要的是，大約 1000 萬肥胖弱勢群體現在可以透過醫療補助等管道獲得 Wegovy，該服務現已在 20 多個州提供。

Ultimately, our focus is to reach more patients living with obesity. And as volumes go up, prices will come down. In the first six months of 2024, sales growth was driven by increased volumes, partially countered by lower realized prices. Next slide, please.

最終，我們的重點是惠及更多肥胖患者。隨著銷量的增加，價格將會下降。 2024 年頭 6 個月，銷量成長是由銷量增加推動的，但實際價格下降部分抵消了銷量成長。請下一張投影片。

Our rare disease sales decreased by 3%. Sales in international operations declined by 14%. This was partly offset by a 13% sales increase in North America operations, reflecting the Sogroya launch and positive gross-to-net adjustments related to prior years in the US.

我們的罕見疾病銷售額下降了 3%。國際業務銷售額下降 14%。這被北美業務 13% 的銷售額成長所部分抵消，這反映了 Sogroya 的推出以及與前幾年在美國相關的積極毛淨調整。

Rare blood disorder sales decreased by 2%, driven by lower NovoSeven and haemophilia A sales. This was partially countered by increased haemophilia B sales. Rare endocrine disorder sales decreased by 8%. We are working on re-establishing full supply capacity of rare endocrine disorder products following a reduction of manufacturing output.

由於 NovoSeven 和血友病 A 銷售額下降，稀有血液疾病銷售額下降了 2%。 B 型血友病銷售量的增加部分抵消了這一影響。罕見內分泌疾病銷售額下降8%。在製造業產量減少後，我們正在努力重建罕見內分泌失調產品的全面供應能力。

Now over to you, Martin, for an update on R&D.

馬丁，現在請您了解研發方面的最新情況。

Thank you, Doug. Please turn to the next slide. I'm very pleased to share the results of the FRONTIER 2 Phase 3 trial with Mim8, which we provided headline results for back in May. The full data set was also disclosed at the ISTH in June.

謝謝你，道格。請翻到下一張投影片。我很高興與 Mim8 分享 FRONTIER 2 第 3 階段試驗的結果，我們早在 5 月就提供了該試驗的主要結果。完整的數據集也在 6 月的 ISTH 上披露。

Before I walk you through the results, I would like to briefly remind you of the innovative clinical trial design. FRONTIER 2 was a pivotal Phase 3 26-week, open-label, randomized, controlled, and multi-armed trial. The trial investigated the efficacy and safety of once-weekly and once-monthly subcutaneous Mim8 versus no previous prophylaxis treatment or on-demand treatment, and versus prior coagulation factor prophylaxis treatment.

在向您介紹結果之前，我想先簡單提醒您創新的臨床試驗設計。 FRONTIER 2 是一項關鍵的 3 期 26 週、開放標籤、隨機、對照和多臂試驗。該試驗研究了每週一次和每月一次皮下注射 Mim8 與既往未進行預防性治療或按需治療，以及與既往凝血因子預防性治療相比的有效性和安全性。

254 people aged 12 years and older with haemophilia A with or without inhibitors were included in the trial. The co-primary endpoint was mean annualized bleeding rate for treated bleeds for both once-weekly and once-monthly Mim8 versus on-demand treatment and versus prior coagulation factor prophylaxis treatment.

該試驗納入了 254 名 12 歲及以上患有 A 型血友病（有或沒有抑制劑）的患者。共同主要終點是每週一次和每月一次 Mim8 與按需治療和先前凝血因子預防治療的治療出血的平均年化出血率。

Please turn to the next slide. Overall, in FRONTIER 2, Mim8 has demonstrated superiority of Mim8 prophylaxis with both weekly and monthly dosing. In the on-demand treatment population, Mim8 demonstrated superior reductions of 97% and 99% in estimated mean annualized bleeding rate for once-weekly and once-monthly treatment, respectively. This was compared to those receiving continued on-demand treatment.

請翻到下一張投影片。總體而言，在 FRONTIER 2 中，Mim8 透過每周和每月給藥證明了 Mim8 預防的優越性。在按需治療族群中，Mim8 表現出每週一次和每月一次治療的估計平均年化出血率分別降低了 97% 和 99%。這是與那些接受持續按需治療的人進行比較的。

In the intra-patient comparison, in people with prior coagulation factor prophylaxis, Mim8 demonstrated superior reductions of 48% and 43% in estimated mean annual bleeding rates for once-weekly and once-monthly treatment, respectively.

在患者內部比較中，在先前接受過凝血因子預防的患者中，每週一次和每月一次治療的 Mim8 估計平均年出血率分別顯著降低了 48% 和 43%。

Of note, in the population with prior on-demand treatment, 86% and 95% of people receiving once-weekly and once-monthly Mim8 treatment, respectively, experienced zero treated bleeds. In the population with prior coagulation factor prophylaxis, 66% and 65% of people receiving once-weekly and once-monthly Mim8, respectively, had zero bleeds.

值得注意的是，在先前接受過按需治療的人群中，接受每週一次和每月一次 Mim8 治療的人分別有 86% 和 95% 的治療出血次數為零。在先前接受凝血因子預防的人群中，每週一次和每月一次 Mim8 治療的人群分別有 66% 和 65% 的患者出血次數為零。

In the trial, Mim8 appeared to have a safe and well-tolerated profile with no thromboembolic events observed and no evidence of neutralizing anti-Mim8 antibodies. Further, only 5% to 12% of patients experienced injection site reactions across all five treatment arms.

在試驗中，Mim8 似乎具有安全且耐受性良好的特徵，沒有觀察到血栓栓塞事件，也沒有中和抗 Mim8 抗體的證據。此外，在所有五個治療組中，只有 5% 至 12% 的患者經歷過注射部位反應。

In conclusion, we're very excited about the FRONTIER 2 results. Given the differing needs of people living with haemophilia A, a once-weekly or a once-monthly dosing provides optionality and flexibility for people living with haemophilia A with and without inhibitors. We now expect to file for first regulatory approval of Mim8 during the first half of 2025.

總之，我們對 FRONTIER 2 的結果感到非常興奮。鑑於 A 型血友病患者的不同需求，每週一次或每月一次的給藥方式為有或沒有抑制劑的 A 型血友病患者提供了選擇和靈活性。我們現在預計將在 2025 年上半年提交 Mim8 的首次監管批准。

Next slide, please. Turning to diabetes, I would also like to share the results from the COMBINE 1 trial, which investigated the use of once-weekly IcoSema, a combination of once-weekly insulin icodec and once-weekly semaglutide in people with type 2 diabetes.

請下一張投影片。談到糖尿病，我還想分享COMBINE 1 試驗的結果，該試驗研究了每週一次的IcoSema（每週一次的icodec 胰島素和每週一次的索馬魯肽的組合）在2 型糖尿病患者中的使用情況。

The objective of the 52-week trial was to assess the efficacy and safety of switching to once-weekly IcoSema compared to once-weekly insulin icodec alone in people with type 2 diabetes inadequately controlled on a daily basal insulin with or without oral anti-diabetic drugs.

這項為期52 週的試驗的目的是評估對於每日基礎胰島素聯合或不聯合口服抗糖尿病藥物控制不佳的2 型糖尿病患者，轉為每週一次IcoSema 與每週一次單獨使用icodec 相比的有效性和安全性藥物。

The trial achieved its primary endpoint with IcoSema demonstrating superiority in reducing A1c at week 52 with once-weekly IcoSema compared with insulin icodec. From an overall HbA1C baseline of 8.2%, IcoSema achieved an estimated reduction in A1c of 1.6 percentage points compared to 0.9 percentage points for insulin icodec.

該試驗透過 IcoSema 達到了主要終點，證明與胰島素 icodec 相比，每週一次的 IcoSema 在第 52 週降低 A1c 方面具有優越性。從 8.2% 的整體 HbA1C 基線來看，IcoSema 預計 A1c 降低了 1.6 個百分點，而胰島素 icodec 則降低了 0.9 個百分點。

People in the trial had a baseline body weight of 48 -- sorry -- 84.5 kilograms. Treatment with IcoSema achieved a superior change in body weight, with a weight loss of 3.7 kilograms compared with a 1.9 kilograms weight gain with insulin icodec. The estimated treatment difference was 5.6 kilograms.

參加試驗的人的基線體重是 48 公斤（抱歉，是 84.5 公斤）。 IcoSema 治療實現了體重顯著變化，體重減輕了 3.7 公斤，而胰島素 icodec 則增加了 1.9 公斤體重。估計治療差異為 5.6 公斤。

In the trial, the rate of clinically significant or severe hypoglycemia was statistically significantly lower with IcoSema at 0.14 events per patient years of exposure versus 0.63 events per patient year of exposure with once-weekly insulin icodec.

在試驗中，IcoSema 的臨床顯著或嚴重低血糖發生率在統計學上顯著降低，每位患者暴露年發生 0.14 次事件，而每週一次的胰島素 icodec 則為每患者年暴露 0.63 次事件。

In the trial, once-weekly IcoSema appeared to have a safe and well-tolerated profile. Now that the third and last pivotal Phase 3 trial is completed, we expect to file for regulatory approval of IcoSema during the second half of 2024.

在試驗中，每週一次的 IcoSema 似乎具有安全性和良好的耐受性。現在第三個也是最後一個關鍵的 3 期試驗已經完成，我們預計將在 2024 年下半年提交 IcoSema 的監管批准。

Next slide, please. Now, I would like to highlight some of the additional exciting R&D news, including trial readouts and initiations anticipated for the rest of the year. Within diabetes, insulin icodec under the brand name of Awiqli has been approved in multiple countries.

請下一張投影片。現在，我想重點介紹一些其他令人興奮的研發新聞，包括預計在今年剩餘時間進行的試驗讀數和啟動。在糖尿病領域，Awiqli 品牌的胰島素 icodec 已在多個國家獲得批准。

In the US, however, we're disappointed to have received a complete response letter from the FDA for insulin icodec. The letter outlined requests related to the manufacturing process, and the type 2 -- sorry -- the type 1 diabetes indication before the application review could be completed. We're evaluating the content of the CRL, and we'll work closely with the FDA to fulfill the requests. We do not expect to be able to fulfill the request during 2024.

然而，在美國，我們對收到 FDA 對胰島素 icodec 的完整回覆函感到失望。這封信概述了與製造過程相關的請求，以及在完成申請審查之前的 2 型（抱歉）1 型糖尿病適應症。我們正在評估 CRL 的內容，並將與 FDA 密切合作來滿足要求。我們預計 2024 年將無法滿足該請求。

In the first half of this year, the FLOW data were submitted as a label expansion application to the FDA in the US and to the European regulatory authorities. Submissions to regulatory authorities in Japan and China are expected in the second half of 2024.

今年上半年，FLOW數據作為標籤擴展申請向美國FDA和歐洲監管機構提交。預計將於 2024 年下半年向日本和中國的監管機構提交申請。

Additionally, in the second half of this year, we are expected to see the readout of the STRIDE outcomes trial with Ozempic 1.0 milligram in peripheral artery disease. Further, we also expect readout of the SOUL cardiovascular outcomes trial with Rybelsus14 milligrams.

此外，今年下半年，我們預計將看到 Ozempic 1.0 毫克治療週邊動脈疾病的 STRIDE 結果試驗結果。此外，我們也預期讀取 Rybelsus14 毫克的 SOUL 心血管結果試驗結果。

Both trials are expected to further strengthen the comprehensive cardiometabolic evidence that we have for semaglutide. Also in the second half of the year, we look forward to initiate a Phase 2 study for amycretin, demonstrating our commitment to continuously raising the innovation behind diabetes.

兩項試驗預計將進一步加強我們對索馬魯肽的全面心臟代謝證據。同樣在今年下半年，我們期待啟動香蜜素的 2 期研究，以表明我們致力於不斷提高糖尿病背後的創新能力。

Moving to obesity care, in the second quarter, we successfully completed the OASIS 4 trial. OASIS 4 investigated once-daily semaglutide 25 milligram for weight management in adults with obesity or overweight, with one or more comorbidities.

轉向肥胖護理，第二季我們成功完成了 OASIS 4 試驗。 OASIS 4 研究了每日一次 25 毫克索馬魯肽對患有一種或多種合併症的肥胖或超重成人的體重管理作用。

The trial achieved its primary endpoint with oral semaglutide 25 milligram, demonstrating superiority compared to placebo with respect to change in body weight. From a baseline body weight of 105.9 kilograms, oral semaglutide 25 milligram achieved a 13.6% reduction compared to 2.2% reduction with placebo.

該試驗透過口服 25 毫克索馬魯肽達到了主要終點，證明了與安慰劑相比在體重變化方面的優越性。從基線體重 105.9 公斤開始，口服 25 毫克司馬魯肽可減輕 13.6%，而安慰劑則可減輕 2.2%。

The global launch of oral semaglutide 25 milligram is contingent on portfolio prioritization and manufacturing capacity. Four weeks ago, we received regulatory approval for the treatment of obesity or overweight in China.

口服索馬魯肽 25 毫克的全球上市取決於產品組合的優先順序和生產能力。四個星期前，我們在中國獲得了治療肥胖或超重的監管部門批准。

And in the EU, the EMA adopted a positive opinion for an update of the Wegovy label to reflect data from the SELECT trial. The SELECT cardiovascular outcomes trial demonstrated that Wegovy statistically significantly reduced the risk of major adverse cardiovascular events by 20% compared to placebo.

在歐盟，EMA 對更新 Wegovy 標籤以反映 SELECT 試驗的數據採取了積極意見。 SELECT 心血管結果試驗表明，與安慰劑相比，Wegovy 在統計上顯著降低了主要不良心血管事件的風險 20%。

The label update will also include SELECT data showing a numerical risk reduction in cardiovascular death by 15%, a significant risk reduction of death from any cause by 19%, as well as a significant risk reduction of 18% in heart failure composite endpoints.

標籤更新還將包括 SELECT 數據，顯示心血管死亡的數字風險降低 15%，全因死亡風險顯著降低 19%，心臟衰竭複合終點風險顯著降低 18%。

Last on Wegovy, based on interactions with the FDA, we decided to withdraw the results from the STEP HFpEF trials for regulatory review in the US and EU to further substantiate the likelihood of getting heart endpoints into the label update.

最後，在 Wegovy 上，根據與 FDA 的互動，我們決定撤回 STEP HFpEF 試驗的結果，以供美國和歐盟的監管審查，以進一步證實將心臟終點納入標籤更新的可能性。

We now expect to resubmit the file in the beginning of 2025, with additional relevant data. We remain excited about the potential of semaglutide 2.4 milligram in this population, given the data that we've seen from the two completed STEP HFpEF trials.

我們現在預計在 2025 年初重新提交該文件以及其他相關數據。鑑於我們從兩項已完成的 STEP HFpEF 試驗中看到的數據，我們對 2.4 毫克索馬魯肽在這一人群中的潛力仍然感到興奮。

Looking ahead, we are, in the second half, expecting Phase 2 results for monlunabant, as well as Phase 3 results for the STEP UP trial with semaglutide 7.2 milligram around the turn of the year. Lastly, we anticipate first Phase 3 results for REDEFINE 1 with CagriSema in obesity. With all of this activity, we're confident with the progress we're making towards developing superior treatment solutions for people with obesity.

展望未來，我們預計下半年將獲得 monlunabant 的 2 期結果，以及 7.2 毫克 semaglutide 的 STEP UP 試驗的 3 期結果。最後，我們預期 REDEFINE 1 與 CagriSema 治療肥胖症的第一個 3 期結果。透過所有這些活動，我們對為肥胖症患者開發優質治療解決方案所取得的進展充滿信心。

Within cardiovascular and emerging therapy areas, we, in June 2024, announced that the CLARION-CKD Phase 3 trial involving ocedurenone, was terminated. This was based on an interim analysis performed by an independent monitoring committee that concluded that the trial met the pre-specified futility criteria, meaning that the trial, unfortunately, did not meet its primary endpoint.

在心血管和新興治療領域，我們在 2024 年 6 月宣布終止涉及 ocedurenone 的 CLARION-CKD 3 期試驗。這是基於獨立監測委員會進行的中期分析，該分析得出的結論是，該試驗符合預先指定的無效標準，這意味著該試驗不幸的是沒有達到其主要終點。

We've initiated a randomized and placebo-controlled Phase 3 cardiovascular outcomes trial called the ARTEMIS. The trial will assess the efficacy and safety of ziltivekimab 15 milligram in acute myocardial infarction. Lastly, we look much forward to the Phase 3 readout of the ESSENCE trial investigating semaglutide 2.4 milligram in MASH.

我們啟動了一項名為 ARTEMIS 的隨機安慰劑對照 3 期心血管結果試驗。本試驗將評估 ziltivekimab 15 毫克治療急性心肌梗塞的療效和安全性。最後，我們非常期待調查 MASH 中 2.4 毫克索馬魯肽的 ESSENCE 試驗的第 3 期結果。

With that, over to you, Karsten.

就這樣，交給你了，卡斯滕。

Thank you, Martin. Please turn to the next slide. In the first six months of 2024, our sales grew by 24% in Danish kroner and 25% at constant exchange rates, driven by both operating units. In the US, sales growth was positively impacted by gross-to-net sales adjustments related to prior years.

謝謝你，馬丁。請翻到下一張投影片。 2024 年頭 6 個月，在兩個營運部門的推動下，我們的銷售額（以丹麥克朗計算）成長了 24%，以固定匯率計算成長了 25%。在美國，銷售成長受到與往年相關的總銷售額與淨銷售額調整的正面影響。

The gross margin decreased to 84.9% compared to 85.1% in 2023. The decline is mainly driven by increased costs related to ongoing capacity expansions. This is partially countered by a positive price impact from gross-to-net adjustments related to prior years in the US, in addition to positive product mix reflecting increased sales of GLP-1-based treatments.

毛利率從 2023 年的 85.1% 下降至 84.9%。這在一定程度上被美國前幾年毛淨值調整帶來的正面價格影響所抵消，此外積極的產品組合反映了基於​​ GLP-1 的治療藥物銷售的增加。

Sales and distribution costs increased by 5% in Danish kroner and by 6% at constant exchange rates. The increase in sales and distribution costs is impacted by adjustments to legal provisions in the second quarter of 2023.

以丹麥克朗計算的銷售和分銷成本增加了 5%，以固定匯率計算則增加了 6%。銷售和分銷成本的增加受到 2023 年第二季法律規定調整的影響。

In North America operations, the cost increase is mainly driven by promotional activities related to Wegovy, while in international operations, the increase is mainly related to promotional activities for Rybelsus, as well as obesity care market development activities.

在北美業務中，成本增加主要由Wegovy相關的促銷活動推動，而在國際業務中，成本增加主要與Rybelsus的促銷活動以及肥胖護理市場開發活動有關。

Research and development costs increased by 79% measured in Danish kroner and by 78% at constant exchange rates. The increase in cost is mainly driven by increased late-stage clinical trial activity and increased early research activities, as well as the impairment related to ocedurenone of DKK5.7 billion and other impairments of intangible assets.

以丹麥克朗計算的研發成本增加了 79%，以固定匯率計算則增加了 78%。成本增加主要是由於後期臨床試驗活動增加和早期研究活動增加，以及與奧塞酮相關的 57 億丹麥克朗減損和其他無形資產減損所致。

Administration costs increased by 8% measured both in Danish kroner and constant exchange rates. Operating profit increased by 18% measured in Danish kroner and by 19% at constant exchange rates. Operating profit is impacted by the impairment loss related to ocedurenone of DKK5.7 billion.

以丹麥克朗和固定匯率計算的管理成本增加了 8%。以丹麥克朗計算的營業利潤成長了 18%，以固定匯率計算則成長了 19%。營業利潤受到與 ocedurenone 相關的 57 億丹麥克朗減損損失的影響。

Net financial items showed a net loss of DKK530 million compared to a net gain of DKK96 million last year, mainly reflecting hedging losses on the US dollar. The effective tax rate was 20.6% in the first six months of 2024 compared to 19.9% in the first six months of 2023. Net profit increased by 16%, and diluted earnings per share increased by 17% to DKK10.17. Net profit is negatively impacted by the DKK5.7 billion impairment of ocedurenone.

淨金融項目顯示淨虧損 5.3 億丹麥克朗，而去年則為淨收益 9,600 萬丹麥克朗，主要反映了美元對沖損失。 2024 年前六個月的有效稅率為 20.6%，而 2023 年前六個月的有效稅率為 19.9%。淨利受到 ocedurenone 57 億丹麥克朗減損的負面影響。

Free cash flow realized in first half of 2024 was DKK41.3 billion compared to DKK45.5 billion in the first six months of 2023. The lower free cash flow reflects increasing capital expenditure as well as acquisition of intangible assets. This is partially countered by net cash generated from operating activities. The impairment of the intangible asset of ocedurenone of DKK5.7 billion has no impact on free cash flow.

2024 年上半年實現的自由現金流為 413 億丹麥克朗，而 2023 年前六個月為 455 億丹麥克朗。經營活動產生的淨現金部分抵銷了這一影響。 ocedurenone 57億丹麥克朗無形資產減損對自由現金流沒有影響。

Capital expenditure for property, plant, and equipment was DKK18.9 billion compared to DKK10.6 billion in 2023. This was primarily driven by investments in additional capacity for API production and fill-finish capacity for both current and future injectable and oral products. Please go to the next slide.

物業、廠房和設備的資本支出為189 億丹麥克朗，而2023 年為106 億丹麥克朗。 。請轉到下一張投影片。

A key priority for Novo Nordisk is to ensure attractive allocation of capital to shareholders. For 2023, the total dividend per share increased 51.6% to DKK9.40. For 2024, the Board of Directors has decided to pay out an interim dividend of DKK3.50 per share, which will be paid out in August of this year. We have returned more than KDD38 billion to shareholders through dividends and share buybacks in the first six months of 2024.

諾和諾德的首要任務是確保向股東提供有吸引力的資本配置。 2023 年，每股股息總額成長 51.6%，達到 9.40 丹麥克朗。董事會決定派發2024年每股3.50丹麥克朗的中期股息，將於今年8月發放。 2024 年前六個月，我們透過股利和股票回購向股東返還了超過 380 億第納爾。

Our ongoing repurchase program for the full year amounts to up to DKK20 billion, a reduction from DKK30 billion allocated last year. This allocation aligns with our strategic capital allocation strategy for Novo Nordisk. We prioritize investing in internal growth opportunities, returning capital to shareholders through dividends, and business development activities.

我們全年正在進行的回購計畫金額高達 200 億丹麥克朗，比去年分配的 300 億丹麥克朗減少。這項分配符合我們對諾和諾德的策略資本分配策略。我們優先投資內部成長機會、透過股利和業務發展活動向股東返還資本。

Finally, we look towards share buyback program as a flexible measure contingent on the first three priorities to distribute excess cash. We continued the growth momentum in 2024 and have raised our sales growth outlook to between 22% and 28% at constant exchange rates.

最後，我們將股票回購計畫視為一項靈活的措施，具體取決於分配多餘現金的前三個優先事項。我們在 2024 年繼續保持成長勢頭，並將按固定匯率計算的銷售成長預期上調至 22% 至 28%。

The updated sales outlook at constant exchange rates reflects higher full-year expectations for both operating units. The guidance reflects expectations for sales growth in both North America operations and international operations, mainly driven by volume growth of GLP-1-based treatments for obesity and diabetes care.

以固定匯率計算的最新銷售前景反映了兩個營運部門更高的全年預期。該指引反映了對北美業務和國際業務銷售成長的預期，這主要是由基於 GLP-1 的肥胖和糖尿病護理療法的銷售成長所推動的。

With the expectation of continued volume growth and capacity limitations at some manufacturing sites, the outlook also reflects expected continued periodic supply constraints and related drug shortage notifications across a number of products and geographies. Novo Nordisk is investing in internal and external capacity to increase supply both short and long term.

由於預計一些生產基地的銷售將持續成長且產能有限，該前景也反映了預計持續的周期性供應限制以及多個產品和地區的相關藥品短缺通知。諾和諾德正在投資內部和外部產能，以增加短期和長期供應。

Operating profit growth outlook is now expected to be between 20% and 28% at constant exchange rates. The updated expectation reflects the impairment loss reflected to ocedurenone communicated in June of negative 6 percentage points.

以固定匯率計算，營業利潤成長前景目前預計在 20% 至 28% 之間。更新後的預期反映了 6 月傳達的 ocedurenone 反映的減損損失為負 6 個百分點。

Excluding this impact, we now expect a positive 4-percentage-point increase on operating profit growth expectations for the full year. This is driven by the updated increased sales outlook compared to previous expectations. Capital expenditure is still expected to be around DKK45 billion in 2024, reflecting expansion of the global supply chain.

排除此影響，我們現在預計全年營業利潤成長預期將成長 4 個百分點。這是由於與先前的預期相比更新後的銷售前景增加所致。預計 2024 年資本支出仍約為 450 億丹麥克朗，反映了全球供應鏈的擴張。

Free cash flow is now expected to be between DKK59 billion and DKK69 billion, reflecting the sales growth, a favorable impact from rebates in the US countered by investments in capital expenditure. The updated cash flow expectation mainly reflects the increased sales growth outlook.

目前，自由現金流預計在 590 億丹麥克朗至 690 億丹麥克朗之間，反映了銷售成長、美國回扣的有利影響以及資本支出投資的抵銷。更新後的現金流量預期主要反映了銷售成長前景的上調。

Income under the 340B program has been partially recognized. One ruling from the US Court of Appeals for the Seventh Circuit remains pending and along with the DC Circuit ruling, may be subject to further discretionary appellate review before the US Supreme Court.

340B 計劃下的收入已部分確認。美國第七巡迴上訴法院的一項裁決仍懸而未決，與華盛頓特區巡迴法院的裁決一起，可能需要接受美國最高法院進一步的酌情上訴審查。

Depending on the outcome of any subsequent rulings and appeals in these matters, there may be a material impact on Novo's financial position, net sales, and cash flow. Financial impacts related to and following the expected closing of the Catalent transaction have not been included in the financial guidance.

根據這些事項的任何後續裁決和上訴的結果，可能會對 Novo 的財務狀況、淨銷售額和現金流產生重大影響。與康泰倫特交易預期結束相關的財務影響尚未包含在財務指南中。

That covers the outlook for 2024. Now back to you, Lars.

這涵蓋了 2024 年的展望。

Thank you, Karsten. Please turn to the final slides. We're very pleased with the sales growth in the first six months of 2024. The growth is driven by increasing demand for our GLP-1-based diabetes and obesity treatments. And we're serving more patients than ever before.

謝謝你，卡斯滕。請翻到最後的幻燈片。我們對 2024 年前六個月的銷售成長感到非常滿意。我們正在為比以往更多的患者提供服務。

Within R&D, we're very pleased with the first Phase 3 trial results with Mim8 and its potential for people living with haemophilia, as well as the recommendation for a label extension for cardiovascular risk reduction for Wegovy in the EU.

在研發方面，我們對 Mim8 的第一個 3 期試驗結果及其對血友病患者的潛力以及在歐盟延長 Wegovy 降低心血管風險標籤的建議感到非常滿意。

With that, I'd like to hand over the word to Jacob.

說到這裡，我想把話交給雅各。

Thank you, Lars. Next slide, please. With that, we're now ready for the Q&A, where I kindly ask all participants to limit her or himself to one or maximum two questions, including sub-questions.

謝謝你，拉爾斯。請下一張投影片。這樣，我們現在就可以進行問答了，我懇請所有參與者將自己限制在一個或最多兩個問題上，包括子問題。

Operator, we're now ready to take the first question.

接線員，我們現在準備回答第一個問題。

Emily Field, Barclays.

艾米麗·菲爾德，巴克萊銀行。

Hi. Thanks for taking my questions, one on Wegovy pricing and one on Wegovy supply. The first question on pricing.

你好。感謝您回答我的問題，一個關於 Wegovy 定價，一個關於 Wegovy 供應。第一個問題關於定價。

In terms of the gross-to-net and US widening from 1Q to 2Q, can you help us understand the moving parts here? Is there a component of seasonality? How much due to competition or how much due to channel mix, as you talked about more penetrating into the Medicaid channel and you can now sell to the select population in Medicare.

就毛淨值和美國從第一季到第二季的擴大而言，您能幫助我們了解這裡的變化部分嗎？是否存在季節性因素？有多少是由於競爭，有多少是由於管道混合，正如您談到更多地滲透到醫療補助管道，您現在可以向醫療保險中的特定人群銷售。

And then, secondly, on supply, it's great to see the 0.5 and 1 mg doses of Wegovy coming off the FDA drug shortage list, although it does seem like you're voluntarily keeping the 0.25 dosage capped in order to limit new patients. Do you expect this cap to continue throughout the rest of the year? Or could it be lifted before the end of 2024? Thank you.

其次，在供應方面，很高興看到 0.5 毫克和 1 毫克劑量的 Wegovy 從 FDA 藥物短缺清單中消失，儘管看起來你們確實自願保持 0.25 劑量上限以限制新患者。您預計這項上限會在今年剩餘時間內持續下去嗎？或是可以在2024年底前取消嗎？謝謝。

Thank you, Emily, for those questions. For the first question, I'll hand it over to Lars on overall pricing dynamics before turning it to Doug on US-specific dynamics pricing-wise and also on the supply situation. Lars?

謝謝艾米麗提出這些問題。對於第一個問題，我將把整體定價動態交給 Lars，然後交給 Doug，討論美國特定的定價動態以及供應情況。拉爾斯？

Yeah. Thank you. Emily, thank you. So I would say, overall, the current market structure is one where we really compete and secure success based on ability to supply. So it's not one where, say, classical commercial tactics is dominating.

是的。謝謝。艾米麗，謝謝你。所以我想說，總體而言，目前的市場結構是我們真正競爭並根據供應能力確保成功的市場結構。因此，這並不是傳統商業策略占主導地位的領域。

And you should see, I would say, our commercial strategies in that perspective. You allude to the channel mix, and we also just said in our brief that we are now expanding access in Medicaid. So we have 20 states adopting Wegovy in Medicaid.

我想說，你應該從這個角度來看我們的商業策略。您提到了通路組合，我們剛剛在簡報中也說過，我們現在正在擴大醫療補助的覆蓋範圍。因此，我們有 20 個州在醫療補助中採用了 Wegovy。

Of course, with that, expansion, as we know, from all drug categories, when you move into some of these channels, it comes at a lower, say, net price in these channels, which then has no impact. But I would say we are encouraged with a stable competitive dynamics. And our focus is really on securing supply to make sure that we can serve as many patients as possible more than other, say, tougher commercial tactics.

當然，據我們所知，隨著所有藥品類別的擴張，當你進入其中一些管道時，這些管道的淨價會較低，這不會產生任何影響。但我想說的是，我們受到穩定的競爭動力的鼓舞。我們的重點實際上是確保供應，以確保我們能夠為盡可能多的患者提供比其他更嚴格的商業策略更多的服務。

Thank you, Lars. And with that, I'll hand over to you, Doug, on the US specifics as well as on the supply situation.

謝謝你，拉爾斯。接下來，道格，我將向你介紹美國的具體情況以及供應。

Yeah. Thanks, Lars, and thanks for the question, Emily. So overall, I'd start with -- we're pleased with the Wegovy performance, whether you look at the NBRx moving from roughly 5,000 new branded prescriptions at the beginning of the year to 35,000 currently or the TRx, which moved from 100,000 beginning of the year to roughly 200,000 or doubling.

是的。謝謝拉爾斯，也謝謝艾蜜莉的提問。總的來說，我首先對 Wegovy 的表現感到滿意，無論是 NBRx 從年初的大約 5,000 個新品牌處方增加到目前的 35,000 個，還是 TRx（從年初的 100,000 個）今年增加到大約200,000 人或翻倍。

We're pleased with that. We're serving more patients than ever before, as Lars mentioned earlier. And market access continues to be robust.

我們對此感到滿意。正如拉爾斯之前提到的，我們為比以往更多的患者提供服務。市場准入仍然強勁。

As I had mentioned, there's over 50 million people with obesity and importantly, around 10 million vulnerable patients that have access via Medicaid in around 20 states. So that's robust, and we're pleased with that.

正如我所提到的，有超過 5000 萬肥胖者，重要的是，大約 20 個州有大約 1000 萬弱勢患者可以透過醫療補助獲得醫療補助。所以這很強大，我們對此感到滿意。

And in doing that, we're seeing that almost or above 80% of the patients are paying $25 or less. And that is our ambition. Our goal is to grow market access. And it's fair to assume as volume goes up, prices will come down. And we have seen lower Wegovy prices in the first half.

在此過程中，我們發現幾乎或超過 80% 的患者支付的費用為 25 美元或更少。這就是我們的雄心。我們的目標是擴大市場准入。可以公平地假設，隨著數量的增加，價格將會下降。上半年我們看到 Wegovy 價格較低。

I don't want to get into specifics there, but it is in line with expectations. But our focus remains in building even stronger access for AOM treatments across all channels. And again, I'd say that we are pleased with the overall performance, and we're serving more patients than ever before.

我不想透露具體細節，但它符合預期。但我們的重點仍然是在所有管道上建立更強大的 AOM 治療管道。我再說一遍，我們對整體表現感到滿意，我們為比以往更多的患者提供服務。

Thank you so much, Doug. And finally, also on the lower dose strength of Wegovy. Any update there?

非常感謝你，道格。最後，還有 Wegovy 的較低劑量強度。有更新嗎？

Yeah. And so we don't believe that the 0.25 -- that was a choice we made. Again, as we've said consistently, quarter after quarter, continuity of care is incredibly important to us and maybe what separates us.

是的。所以我們不相信 0.25——這是我們所做的選擇。再一次，正如我們一季又一季地一貫所說的那樣，持續的護理對我們來說非常重要，也許也是我們與眾不同的原因。

We think it's really important that patients are able to titrate through the appropriate doses. So we'll continue to dynamically manage that. But we're also confident in the levels that we see with all the other dose strengths. So you shouldn't anticipate that 0.25 changing throughout this year, to the question.

我們認為患者能夠透過適當的劑量進行滴定非常重要。因此，我們將繼續動態管理這一點。但我們對所有其他劑量強度的水平也充滿信心。因此，對於這個問題，您不應預期 0.25 在今年會發生變化。

Thank you, Doug, and thank you, Emily. We are now ready to take the next question, please.

謝謝你，道格，謝謝你，艾蜜莉。我們現在準備好回答下一個問題。

Louise Chen, Cantor.

路易絲·陳，康托爾。

Hi, thanks for taking my question here. So first one I have was just on monlunabant. I wanted to see what type of efficacy and safety you expect to see or want to see to move forward with this product?

您好，感謝您在這裡提出我的問題。所以我的第一個藥物就是服用 monlunabant。我想了解您希望看到或希望看到什麼類型的功效和安全性來推進產品？

And then second question was just on ESSENCE. Out of the 1,200 patients enrolled in the Phase 3 study, how many patients are expected to be part of the F2, F3 biopsy readout? Thank you.

第二個問題是關於 ESSENCE 的。在 3 期研究的 1,200 名患者中，預計有多少患者將成為 F2、F3 活檢讀數的一部分？謝謝。

Thank you, Louise, for those two questions. I'll hand both of them to you, Martin, first on monlunabant expectations, as well as on patients enrolled in ESSENCE.

謝謝你，路易絲，提出這兩個問題。馬丁，我將把這兩個問題交給您，首先是關於 monlunabant 的期望，以及參加 ESSENCE 的患者。

Yeah, absolutely. So we continue to be excited about the potential for monlunabant. We don't have a lot of news yet. We expect the readout from the dedicated obesity trial in Q3 of this year and from the diabetes kidney disease trial at the end of this year.

是的，絕對是。因此，我們繼續對 monlunabant 的潛力感到興奮。我們還沒有太多消息。我們預計今年第三季的專門肥胖試驗和今年年底的糖尿病腎病變試驗將公佈結果。

Based on our modeling, we expect around a 15% weight loss. And obviously, our focus is on demonstrating that, together with an attractive safety profile. But we don't have a lot of news at this point. We have waited a couple of months before that.

根據我們的模型，我們預計體重會減輕 15% 左右。顯然，我們的重點是證明這一點以及有吸引力的安全性。但目前我們還沒有太多消息。在此之前我們已經等了幾個月了。

On the ESSENCE trial, you'll probably recall, we sort of have a two-tier trials. The first proportion of the trial includes 800 patients, which will serve as the regulatory submission. We'll see the readout of those 800 patients this year.

在 ESSENCE 試驗中，您可能還記得，我們​​有兩層試驗。第一部分試驗包括 800 名患者，這將作為監管提交。今年我們將看到這 800 名患者的結果。

They will all have liver biopsies, and they'll be in the F2, F3 categories. We then go to the full 1,200 patients for a heart outcomes proportion of the trial. It will basically also be patients who had liver biopsies and be in the F2 to F3 categories. But first step is to see the regulatory readout, which we will receive at the end -- towards the end of the year.

他們都會進行肝臟活檢，並且屬於 F2、F3 類別。然後，我們對全部 1,200 名患者進行了試驗，以了解其心臟結果比例。基本上也是進行了肝臟切片檢查且屬於 F2 至 F3 類別的患者。但第一步是查看監管數據，我們將在年底收到該數據。

Thank you, Martin, and thank you, Louise. We are now ready to take the next question, please.

謝謝你，馬丁，謝謝你，路易絲。我們現在準備好回答下一個問題。

Evan Seigerman, BMO Capital Markets.

Evan Seigerman，BMO 資本市場。

Hi, guys. Thank you so much for taking my questions and for all the color on the call today. A few for me. Just on the Catalent transaction, maybe just walk us through kind of the update there.

嗨，大家好。非常感謝您回答我的問題，並感謝您今天在電話會議上的所有演講。給我幾個。就 Catalent 交易而言，也許只是向我們介紹那裡的更新情況。

And more specifically, as you think about building out capacity, what are the levers can you pull to kind of get your supply of incretins up to meet demand? I know that was a key theme on the call today. And then maybe you can kind of walk us through some of the expectations for the CB1 inverse agonist data that's coming later in the third quarter. Thank you so much.

更具體地說，當您考慮擴大產能時，您可以採取哪些手段來增加腸促胰島素的供應以滿足需求？我知道這是今天電話會議的關鍵主題。然後也許您可以向我們介紹一下對第三季稍後發布的 CB1 反向激動劑數據的一些預期。太感謝了。

Thank you, Evan, for those two questions. Firstly, to Karsten on Catalent and overall supply chain strategy.

謝謝埃文提出這兩個問題。首先，Karsten 介紹了 Catalent 和整體供應鏈策略。

Yeah. Thanks, Evan, for this question and good to connect. So on Catalent, it is still our expectation that the transaction closes towards the end of 2024. We're in active dialogue with the different regulators in terms of antitrust reviews. So -- but reiterate closing towards the end of the year.

是的。謝謝埃文提出這個問題，很高興與您聯繫。因此，對於 Catalent，我們仍然預計交易將於 2024 年底完成。所以——但重申在年底前關閉。

And with Catalent, we're significantly expanding our fill-finish network with the three additional sites on top of the sites we already have up and running and by the way, also are expanding. So our overall supply chain strategy is really one of scaling our API facilities in Kalundborg on the peptide side and in Hillerød, Denmark, on the antibodies side, linked to our pipeline progression and then scaling our Finnish sites on a global scale to be able to accommodate significantly many more patients than we've been able to do so historically.

透過康泰倫特，我們正在顯著擴展我們的填充網絡，在我們已經建立和運行的站點之上增加了三個站點，順便說一句，我們也在擴展。因此，我們的整體供應鏈策略實際上是擴大我們在卡倫堡的勝肽方面和在丹麥希勒德的抗體方面的API 設施，與我們的管道進展相關聯，然後在全球範圍內擴大我們的芬蘭工廠能夠容納比我們歷史上多得多的患者。

And that ties into our overall corporate strategy of being able to reach many, many more patients than we've ever done before, linked to the unmet need in the cardiometabolic space.

這與我們的整體企業策略相關，即能夠接觸到比以往更多的患者，與心臟代謝領域未滿足的需求相關。

Thank you, Karsten. And secondly, on monlunabant expectations again for Martin?

謝謝你，卡斯滕。其次，關於馬丁再次蒙魯納班特的期望？

Yeah. So again, not a lot of news. We're expecting two data readouts: one from obesity, one for diabetes later this year. That will be exciting. Our focus will, obviously, be on the efficacy in terms of the weight loss.

是的。話又說回來，新聞不多。我們預計將在今年稍後公佈兩項數據：一項來自肥胖，一項來自糖尿病。那將是令人興奮的。顯然，我們的重點將放在減肥方面的功效。

Our current modeling is suggesting at least a 15% weight loss. That will be an attractive oral monotherapy in and of itself, but also with the potential of being combined with semaglutide. But these are early days. These are model data, and we'll see the stronger readouts in Q3 and Q4 of this year.

我們目前的模型顯示體重至少減輕 15%。這本身就是一種有吸引力的口服單一療法，而且還具有與索馬魯肽聯合使用的潛力。但現在還處於早期階段。這些是模型數據，我們將在今年第三季和第四季看到更強的讀數。

Thank you, Martin, and thank you, Evan. We are ready to take the next question, please.

謝謝你，馬丁，謝謝你，埃文。我們準備好回答下一個問題了。

Sachin Jain, Bank of America.

薩欽‧賈恩 (Sachin Jain)，美國銀行。

Thank you for taking my questions. Two, please. Firstly, a big picture one for Karsten, just on guidance. Midpoint, I believe, implies underlying acceleration in 2H relative to the underlying growth in the first half. Given there's a lot of moving parts, I wonder if you could just talk through some of the key drivers, pushes and pulls, particularly around Wegovy and Ozempic.

感謝您回答我的問題。請兩位。首先，卡斯滕有一個大局觀，只是作為指導。我認為，中點意味著相對於上半年的基本成長而言，下半年的潛在加速。鑑於有很多活動部件，我想知道您是否可以談談一些關鍵的驅動因素、推動力和拉力，特別是圍繞 Wegovy 和 Ozempic。

And then the second question is to try and get a bit more color, Doug, Karsten, Lars, on the Wegovy price around the commentary, as volumes go up, price comes down. If you would give us some sense of magnitude of price pressure short and midterm.

然後第二個問題是嘗試在評論周圍獲得更多關於 Wegovy 價格的色彩，Doug、Karsten、Lars，隨著銷量的增加，價格會下降。請讓我們了解短期和中期價格壓力的大小。

So I'm going to frame the question like this. You've loosely commented to around 10% price pressure per year for Ozempic. Should we think about Wegovy as more or less on that? And can you give any specific color on 2H trends relative to 1H? Thank you.

所以我將這樣提出這個問題。您曾寬鬆地評論過 Ozempic 每年約 10% 的價格壓力。我們應該或多或少地考慮一下 Wegovy 嗎？您能否給出相對於 1H 的 2H 趨勢的具體顏色？謝謝。

Thank you, Sachin. For the first one on guidance building blocks, I'll hand that to you, Karsten.

謝謝你，薩欽。對於第一個關於指導構建塊的內容，我將把它交給你，卡斯滕。

Yeah. Thank you for that question, Sachin. And as noted in our release, then we are upgrading our top-line guidance by a couple of points and narrowing the guidance range also. So really supporting the fact that we are off to a really strong start in this year and see strong trends both commercially as well as supply chain-wise. So that's the backdrop for our increase in guidance.

是的。謝謝你提出這個問題，薩欽。正如我們的新聞稿中所指出的，我們將我們的頂線指導提高了幾個點，並縮小了指導範圍。因此，我們確實支持了這樣一個事實：我們今年有了一個非常強勁的開局，並且看到了商業和供應鏈方面的強勁趨勢。這就是我們增加指導的背景。

And then to the second-half acceleration part of your question, yes, that is correct. And you could say the 25% growth we have in the first half of this year benefits from the rebate adjustments we've been talking to related to the US, both in the first quarter and in the second quarter, as well as to an easier comparator linked to the phasing of rebates in 2023.

然後是你問題的後半部分加速部分，是的，這是正確的。你可以說，我們今年上半年 25% 的成長得益於我們一直在談論的與美國相關的退稅調整，無論是第一季度還是第二季度，以及更容易的比較器與2023 年分階段回扣相關。

So we delivered 25% with both a tailwind and an easy comparator. And then delivering that for the full year clearly entails an acceleration into the second half in terms of growth despite the fact that the comparator is tougher linked to the rebate phasing of last year.

因此，我們在順風順水和簡單比較的情況下交付了 25%。然後，儘管比較器與去年的分階段回扣聯繫更加嚴格，但全年實現這一目標顯然需要下半年的成長加速。

And that acceleration is really a function of continued trends of what you're seeing already in the marketplace today in terms of the Wegovy penetration in the US, where we doubled the number of scripts from the beginning of the year until now, weekly scripts, also an acceleration in terms of Wegovy sales in international operations and the continuation of Ozempic performance into the second half. So underlying clear line acceleration during the second half compared to the first half.

這種加速實際上是當今市場上 Wegovy 在美國的滲透率持續趨勢的結果，從年初到現在，我們的腳本數量增加了一倍，每週腳本， Wegovy 國際業務銷售加速，Ozempic 業績延續到下半年。因此，與上半場相比，下半場有明顯的加速。

Thank you, Karsten. And secondly, on overall pricing dynamics, Lars?

謝謝你，卡斯滕。其次，關於整體定價動態，拉斯？

Yeah. So thanks, Sachin. So we prefer not to get into a very detailed comments on pricing because that turns into a quarter-over-quarter storyline then. So -- but I would like to say, underlying what I mentioned in my opening that -- and also, as Karsten just alluded to -- this is a marketplace where we compete on bringing, say, volumes to the market.

是的。謝謝，薩欽。因此，我們不想對定價進行非常詳細的評論，因為這會變成一個季度環比的故事情節。所以，但我想說，根據我在開場白中提到的內容，而且正如卡斯滕剛才提到的那樣，這是一個我們競爭的市場，比如說，為市場帶來銷售。

So it's not one where we feel that we are into, say, price competition. Having said that, there are different segments of the market. And we feel that it's relevant to also be present in the segments where we had the most vulnerable patients, and they are typically served by Medicaid.

因此，我們並不覺得自己陷入了價格競爭。話雖如此，市場有不同的細分市場。我們認為，在我們擁有最脆弱患者的細分市場中也存在相關性，並且他們通常由醫療補助服務提供服務。

So we have now, as we mentioned, 20 states having adopted to Wegovy. And we all know that for any product, when you go into Medicaid, it comes at somewhat lower price point. So that should be factored in.

正如我們所提到的，我們現在有 20 個州採用了 Wegovy。我們都知道，對於任何產品，當您進入醫療補助時，它的價格都會較低。所以應該考慮到這一點。

So it's a stable competitive setting. And it's really, for us, about scaling the volumes to deliver on the demand -- sorry -- on the access we have delivered. And we can see the demand is there. So it's about scaling to meet the demand, I would say, more than any other tactics, so to say.

所以這是一個穩定的競爭環境。對我們來說，這實際上是關於擴展數量以根據需求提供服務——抱歉——根據我們提供的訪問權限。我們可以看到需求是存在的。因此，我想說，這比任何其他策略更重要的是透過擴展來滿足需求。

And as Karsten just mentioned, we have the capacity to scale and accelerate, serving many more patients in the second half. And I think that's, I think, the encouraging part of our release here that we upgrade to do that against a somewhat tougher comparator in the second half of the year. So I think there's a sign of strong momentum and also execution from a supply chain point of view. Thank you.

正如卡斯滕剛才提到的，我們有能力擴大規模並加速發展，在下半年為更多患者提供服務。我認為，我認為，這是我們在這裡發布的令人鼓舞的部分，我們升級了這一點，以對抗今年下半年更嚴格的比較器。因此，我認為從供應鏈的角度來看，存在著強勁勢頭和執行力的跡象。謝謝。

Last question, just as a clarification then, where are you with Medicaid penetration? Should we expect a major uptick in 2H relative to 1H?

最後一個問題，作為澄清，您的醫療補助滲透率如何？我們是否應該預期 2H 相對於 1H 會有大幅上漲？

So I don't have detailed insight into that, and I'm not sure we can comment specifically on that.

所以我對此沒有詳細的了解，我不確定我們是否可以對此發表具體評論。

So if I can give one data point. So we have Medicaid coverage into the tune of 20 states. How exactly the volumes are going to fall out in the second half between Medicaid and commercial, of course, is very speculative. But we have actually a very strong Medicaid-based access of 20 states and around 10 million people with obesity covered that way around.

那如果我可以提供一個數據點。因此，我們的醫療補助涵蓋了 20 個州。當然，下半年醫療補助和商業的銷售量究竟會如何下降，目前還很難確定。但實際上，我們在 20 個州擁有非常強大的基於醫療補助的服務，並涵蓋了大約 1000 萬肥胖症患者。

Thank you, Lars. Thank you, Karsten, and thank you, Sachin. And with that, we are ready for the next set of questions, please.

謝謝你，拉爾斯。謝謝你，卡斯滕，謝謝你，薩欽。至此，我們準備好回答下一組問題了。

Richard Vosser, JPMorgan.

理查沃瑟，摩根大通。

Hi, thanks for taking my question. Maybe one on Wegovy in the US as well. Based on the new patients -- I know you've said that your 35,000 scripts a week, you'll limit those starter doses.

您好，感謝您提出我的問題。也許美國的 Wegovy 上也有一個。根據新患者的情況，我知道您說過每週 35,000 個腳本，您將限制這些起始劑量。

But based on the new patients, you've already accrued and that level of patients and your knowledge of pull-through of patients to higher doses. How do you see the TRx developing? You've obviously doubled in the first half. But some idea of how that could develop, I think, would be helpful for people.

但基於新患者，您已經累積了一定程度的患者以及您對患者接受更高劑量的了解。您如何看待 TRx 的發展？上半場你顯然已經翻倍了。但我認為，關於如何發展的一些想法會對人們有所幫助。

And I suppose the question is, at what point do you expect TRx to exceed scripts from Ozempic on a weekly basis? And then one other question just on Ozempic ex-US supply. I think you alluded to that that could improve in the second half.

我想問題是，您預計 TRx 每週會在什麼時候超過 Ozempic 的腳本？然後還有一個關於 Ozempic 的美國前供應的問題。我想你提到了下半場可能會有所改善。

But just when can you anticipate supply being resolved there so that we can expect strong growth in the second half? When can we expect strong growth for Ozempic to resume in IO? Thanks very much.

但您何時才能預期那裡的供應得到解決，以便我們可以期待下半年的強勁成長？我們何時可以預期 Ozempic 在 IO 領域恢復強勁成長？非常感謝。

Thank you, Richard. On the first one, in terms of the strong TRx trends in the US, I'll hand it over to you, Doug.

謝謝你，理查。第一個，關於美國強勁的 TRx 趨勢，我將把它交給你，Doug。

Yeah. Thank you, Richard. And let me just clarify. We're not precisely limiting to 35,000. We're dynamically managing that because, again, critically important to us is patient continuity of care.

是的。謝謝你，理查。讓我澄清一下。我們並沒有嚴格限制為 35,000。我們正在動態管理這一點，因為對我們來說至關重要的是患者護理的連續性。

So that is the starting dose, as you know. And so that's the one we will manage. It's not to limit, and so you may see fluctuations in that. What I would anticipate is a steady consistent TRx trend. I don't want to get into where that may go or where that may cross Ozempic.

如您所知，這就是起始劑量。這就是我們要管理的。這不是限制，因此您可能會看到其中的波動。我預期 TRx 趨勢會穩定一致。我不想討論它可能會去往何處或可能會穿越臭氧層。

Again, we're pleased with the performance. As Karsten and both -- Lars alluded to, we've more than doubled that from the beginning of the year to currently. We're seeing strong NBRx, and we're serving more patients. So I don't want to get into predictions of when they'll cross.

我們再次對錶現感到滿意。正如卡斯滕和拉斯提到的那樣，從年初到現在，我們的數量增加了一倍以上。我們看到 NBRx 表現強勁，並且正在為更多患者提供服務。所以我不想預測它們何時會交叉。

Thank you, Doug. And on the gradual supply scaling, over to you, Karsten.

謝謝你，道格。至於逐步擴大供應規模，就交給你了，卡斯滕。

Yeah. So talking about ex-US and scaling there. Then first of all, I'd just like to allude to the performance in international operations where Rybelsus are or semaglutide is doing really well in the first half, growing DKK0.66. So actually contributing as much as Ozempic in international operations.

是的。所以談論美國以外的地區並在那裡擴展。首先，我想提一下國際業務的表現，Rybelsus 或索馬魯肽上半年表現非常好，成長了 0.66 丹麥克朗。因此，實際上在國際業務中的貢獻與 Ozempic 一樣多。

And then looking at IO between the first half and second half, then clearly, our ambition and what's implied in guidance is an acceleration from the 11% we delivered in the first half. And that acceleration will come from the sema franchise.

然後看看上半年和下半年之間的 IO，很明顯，我們的雄心和指導中暗示的內容是比我們上半年交付的 11% 有所加速。這種加速將來自 sema 特許經營權。

But as you see, we have now launched in 12 markets with Wegovy in international operations. So clearly, you should also expect to see some pickup there, driving higher growth in the second half in IO.

但正如您所看到的，我們現在已經在 12 個市場推出了 Wegovy 的國際業務。顯然，您也應該期待看到一些回升，推動下半年 IO 的更高成長。

Thank you, Karsten, and thank you, Richard, for those two questions. We are now ready to take the next set of questions, please.

謝謝你，卡斯滕，謝謝你，理查德，提出這兩個問題。我們現在準備好回答下一組問題。

Peter Verdult, Citigroup.

花旗集團的彼得‧維爾杜特。

Thank you. Peter Verdult, Citi. Two questions. Doug, just to be obligatory, any latest data or intel in terms of average duration of use on Wegovy? And then, secondly, Karsten, on the 340B, when we last spoke, my understanding was Novo has been very conservative in revenue recognition from the 340B, leaving risks very much to the upside.

謝謝。彼得‧韋爾杜，花旗銀行。兩個問題。 Doug，請問有關於 Wegovy 平均使用時間的最新數據或情報嗎？其次，Karsten，關於 340B，當我們上次交談時，我的理解是 Novo 在 340B 的收入確認方面非常保守，從而將風險留給了很大的上行空間。

And I think when we last discussed this, and I wrote on this, should the rulings go your way, there could be quite a material uplift to earnings, I think, to the tune of 5%. So can I just check in with you whether that is still the case, or have you any updated thoughts there? Thank you.

我認為，當我們上次討論這個問題時，我也寫過這一點，如果裁決按你的意願進行，我認為盈利可能會大幅提升，達到 5%。那麼我可以向您諮詢情況是否仍然如此，或者您有什麼最新的想法嗎？謝謝。

Thank you, Pete. On the first one on Wegovy stay time, I'll give that to you, Doug.

謝謝你，皮特。在 Wegovy 上的第一個停留時間，我會把它交給你，道格。

Yeah. Thanks, Pete, for the questions. So in the US, we're still seeing around six months, and that's given the periodic supply constraints. And we have to work through that.

是的。謝謝皮特提出的問題。因此，在美國，考慮到週期性的供應限制，我們仍然會看到大約六個月的時間。我們必須解決這個問題。

But I would tell you this, we are confident that, over time, the stay time will improve more towards 12 months and beyond, which would reflect the clinical profile of the product and what we saw in some of the clinical trials. So still around six months, we're working through that. More to come as we see more stability in supply over time.

但我想告訴你的是，我們相信，隨著時間的推移，停留時間將進一步改善，接近12 個月甚至更長，這將反映該產品的臨床概況以及我們在一些臨床試驗中看到的情況。我們正在努力解決這個問題，還有大約六個月的時間。隨著時間的推移，我們看到供應更加穩定，還會有更多的事情發生。

Thank you, Doug. And over to Karsten on 340B.

謝謝你，道格。然後搭乘 340B 前往卡斯滕。

Yeah. Thanks, Pete, for that comment. And first of all, I'd just like to refer also to our company announcement and the update on 340B that we included on the legal matters there.

是的。謝謝皮特的評論。首先，我還想提及我們公司的公告以及我們在其中包含的有關法律事務的 340B 更新。

And I would say the only new item compared to when we discussed in connection with Q1 is that there's one additional ruling that has come out in this case complex which is a DC circuit ruling, which ruled similarly to the ruling we had in our case. So all supporting our case, but we still have one key ruling outstanding in the Seventh Circuit.

我想說，與我們討論第一季度時相比，唯一的新內容是，在這個複雜的案件中出現了一項額外的裁決，即直流電路裁決，其裁決與我們在本案中的裁決類似。因此，所有人都支持我們的案子，但第七巡迴法院仍有一項關鍵裁決懸而未決。

And then as to our accounting, I don't remember us discussing it being conservative. I remember I was discussing it being prudent and aligned to the accounting standards of revenue recognition, where revenue recognition has to be highly probable in order to book it as revenue.

至於我們的會計，我不記得我們討論過它是保守的。我記得我正在討論它是否謹慎並符合收入確認的會計標準，其中收入確認必須具有很高的可能性才能將其記為收入。

So that's how we do it. And -- but we also call out that there is a scenario that could have a material impact on our financial position. And that's what we called out in our announcement. And then let's see how the Seventh Circuit rules and what level of appeals we'll be looking at in the coming months. It could be any day that could be news, but I don't know anything further as of today.

我們就是這樣做的。而且 - 但我們也指出，有一種情況可能會對我們的財務狀況產生重大影響。這就是我們在公告中所呼籲的。然後讓我們看看第七巡迴法院如何裁決，以及我們在未來幾個月內將考慮什麼程度的上訴。任何一天都可能成為新聞，但截至今天我不知道任何進一步的消息。

Thank you.

謝謝。

Thank you, Karsten, and thank you, Pete, as well. We're now ready to take the next, please.

謝謝你，卡斯滕，也謝謝你，皮特。我們現在準備好接受下一個了，請。

James Quigley, Goldman Sachs.

詹姆斯‧奎格利，高盛。

Great. Thank you for taking my questions. I've got two, please. So firstly, on some of the obesity portfolio considerations, you've got a number of obesity readouts in the second half of the year. But how are you thinking of the relative positioning and weight loss expectations for STEP UP, so the 7.2 milligrams sema and obviously, CagriSema as well.

偉大的。感謝您回答我的問題。我有兩個，拜託。首先，就一些肥胖組合的考量而言，今年下半年你會得到一些肥胖數據。但您如何看待 STEP UP 的相對定位和減肥預期，即 7.2 毫克 sema，顯然還有 CagriSema。

Will it be an either/or approach from a commercial perspective, or will it be purely data dependent? And could sema 7.2 milligrams potentially be more desirable given the known CV benefits from sema across all the trials we've seen. And we haven't necessarily seen that with cagri yet.

從商業角度來看，這會是一種非此即彼的方法，還是純粹依賴數據？考慮到我們所見的所有試驗中 sema 的已知 CV 益處，sema 7.2 毫克是否可能更理想。我們還沒有在 cagri 上看到過這一點。

And then the second question on oral therapy. So obviously, there's been some early competitor data that's been on the market recently. But in terms of your oral offering, so OASIS 4, how would you characterize the competitiveness of the data you've seen so far for the 25-milligram dose? And how are you thinking about positioning in the market or even a market fit approach on the launch?

然後是關於口腔治療的第二個問題。顯然，最近市場上出現了一些早期競爭對手的數據。但就您的口服產品而言，即 OASIS 4，您如何描述您迄今為止所看到的 25 毫克劑量數據的競爭力？您如何考慮市場定位，甚至是發佈時的市場契合方法？

And then maybe also related to that one, the oral SNAC technology, can you remind us where you are in terms of the latest generations? And at what point you'll be able to have a peptide-based oral with the SNAC technology that could be as convenient as a typical small molecule? Thank you.

然後也許也與口服 SNAC 技術有關，您能提醒我們您在最新一代方面處於什麼位置嗎？什麼時候您將能夠使用 SNAC 技術獲得像典型小分子一樣方便的基於勝肽的口服藥物？謝謝。

Thank you, James. I think I counted a little bit more than two questions there. But first, over to Camilla on the overall obesity portfolio. And after that, we'll turn to Martin on the SNAC enhancer.

謝謝你，詹姆斯。我想我算了一下，問題多於兩個。但首先，讓卡蜜拉談談整體肥胖問題。之後，我們將向 Martin 求助有關 SNAC 增強劑的問題。

Yeah. Thanks a lot. First of all, I'd just like to say that we are very encouraged about the progression of our pipeline in obesity. And of course, we look forward to the readouts that we are having in the second half of this year.

是的。多謝。首先，我想說，我們對肥胖領域的進展感到非常鼓舞。當然，我們期待今年下半年的數據。

It's going to be exciting second half from a number of Phase 3 readouts that we have both in oral and also in the injectable space. And I think let's await those readouts. And then later on, of course, when we get closer to launches, we can talk about positioning and how we are going to commercially utilize the strong pipeline that we have.

從我們在口服和注射領域獲得的許多第三階段讀數來看，下半場將是令人興奮的。我想讓我們等待這些讀數。當然，稍後，當我們接近發佈時，我們可以討論定位以及我們將如何在商業上利用我們擁有的強大管道。

Thanks a lot, Camilla. And over to you, Martin, on SNAC.

非常感謝，卡米拉。馬丁，SNAC 的話題就交給你了。

Yeah. So specifically, in the clinical space, we've been testing obviously generation 1, 2 and 3, as you know. And in the research space, we continue to evolve this. It goes without saying, we'll not take any new generation into the clinic unless we see a potential for a step change in terms of bioavailability. And this is an ongoing journey and an ongoing effort for us.

是的。具體而言，如您所知，在臨床領域，我們顯然一直在測試第一代、第二代和第三代。在研究領域，我們不斷發展這一點。不言而喻，除非我們看到生物利用度方面有可能發生重大變化，否則我們不會將任何新一代產品帶入臨床。對我們來說，這是一個持續的旅程和持續的努力。

With respect to the dosing restrictions, we actually don't see them as limitations. But I also have to say we don't see a potential of removing those limitations anytime soon.

關於劑量限制，我們實際上並不認為它們是限制。但我也不得不說，我們認為短期內沒有可能消除這些限制。

Thank you, Martin.

謝謝你，馬丁。

And just a reminder in the company announcement, James, you will also see the approval of EMA of the new doses related to oral semaglutide/Rybelsus in the EU.

James，在公司公告中提醒您，您還將看到 EMA 批准與歐盟口服索馬魯肽/Rybelsus 相關的新劑量。

Thanks a lot, Martin, and thanks a lot, James. We're now ready for the next set of questions.

非常感謝，馬丁，非常感謝，詹姆斯。我們現在準備好回答下一組問題。

Emmanuel Papadakis, Deutsche Bank.

伊曼紐爾‧帕帕達基斯，德意志銀行。

Thank you for taking the question. Maybe a question on sema ahead of potential inclusion in 2027 IRA price negotiation. Perhaps, you could just enlighten us as to what magnitude of price cut you've assumed in your midterm planning and your latest perspectives on potential impact in the commercial channel from reduced pricing in Medicare.

感謝您提出問題。也許是在 2027 年 IRA 價格談判可能包含先前關於 sema 的問題。也許，您可以告訴我們您在中期計劃中假設的降價幅度是多少，以及您對醫療保險定價降低對商業管道潛在影響的最新看法。

And then on CagriSema, ahead of the first REDEFINE results, just talk to us a little bit about your device capacity for the dual chamber pen device at launch. Would that be enough to switch a significant proportion of patients from sema to CagriSema over that 2026, '27 timeframe? Or indeed, is there any reason why you wouldn't expect the majority of patients to start switching over? Thank you.

然後在 CagriSema 上，在第一個 REDEFINE 結果之前，請與我們談談您在發佈時雙室筆設備的設備容量。這是否足以在 2026 年、27 年的時間範圍內將很大一部分患者從 sema 轉為 CagriSema？或者事實上，您有任何理由不希望大多數患者開始轉換？謝謝。

Thank you, Emmanuel. The first one on the IRA and the latest there, that goes to you, Doug.

謝謝你，伊曼紐。愛爾蘭共和軍 (IRA) 上的第一份和最新一份，都交給你了，道格。

Yeah. Thanks, Emmanuel, for the question. Maybe as a starting point, I'd like to say that we fundamentally disagree with the principles of price setting. It hurts innovation. It potentially creates higher out-of-pocket costs for seniors and less choice. So that's not good.

是的。謝謝伊曼紐爾提出這個問題。也許作為一個起點，我想說我們從根本上不同意定價原則。這會傷害創新。這可能會為老年人帶來更高的自付費用和更少的選擇。所以這不好。

What I would say is that we're not going to comment on price. But we've worked through the first negotiations on NovoLog and Fiasp. And as you know, that's a minor part of our business. So we expect limited impact there.

我想說的是我們不會對價格發表評論。但我們已經完成了 NovoLog 和 Fiasp 的首次談判。如您所知，這只是我們業務的一小部分。因此，我們預計那裡的影響有限。

And then I would say, as it relates to a read-through to semaglutide, it's just way too early. This has been a new process for both us and the government. We're learning a lot. I'm sure they learned a lot. But I don't want to speculate on what that may mean for semaglutide read-through.

然後我想說，因為它涉及索馬魯肽的通讀，所以現在還為時過早。這對我們和政府來說都是一個新的過程。我們學到了很多。我確信他們學到了很多。但我不想推測這對索馬魯肽通讀可能意味著什麼。

Thank you, Doug. And for the second question on CagriSema capacity, over to you, Karsten.

謝謝你，道格。關於 CagriSema 容量的第二個問題，交給你了，Karsten。

Yeah. Hi, Emmanuel, thank you for the question. For CagriSema and supply chain strategy, then, of course, we learned a lot from Wegovy. And we are full speed in terms of scaling our capacities linked to CagriSema.

是的。嗨，伊曼紐爾，謝謝你的提問。對於 CagriSema 和供應鏈策略，我們當然從 Wegovy 學到了很多。我們正在全速擴展與 CagriSema 相關的產能。

It is a dual-chamber device, so scalability is different compared to multi-use devices that we have in other parts of our portfolio. But we are rapidly scaling the CagriSema device. We are exploring a co-formulation also to improve scalability.

它是雙室設備，因此可擴展性與我們產品組合其他部分中的多用途設備不同。但我們正在快速擴展 CagriSema 設備。我們正在探索一種複合配方，以提高可擴展性。

It's not without risk, and that's why I say we're exploring the opportunity to do so. And then, bear in mind, behind CagriSema in our pipeline, we have amycretin in a subcutaneous version, which we'll report out in the first quarter of next year, which is another offering together with the STEP UP.

這並非沒有風險，這就是為什麼我說我們正在探索這樣做的機會。然後，請記住，在我們的管道中的 CagriSema 背後，我們有皮下版本的阿黴素，我們將在明年第一季報告，這是與 STEP UP 一起提供的另一項產品。

And then as my last comment, I would say, given the clinical profile of semaglutide, we believe that we will be selling semaglutide for many, many years to come. And we are building the infrastructure to compete on that at a global scale for many years to come.

然後，作為我最後的評論，我想說，鑑於索馬魯肽的臨床概況，我們相信我們將在未來許多年銷售索馬魯肽。我們正在建設基礎設施，以便在未來的許多年裡在全球範圍內進行競爭。

Thank you, Karsten, and also thanks for your questions. With that, we are ready for the next set of questions, please.

謝謝你，卡斯滕，也謝謝你的提問。這樣，我們就準備好回答下一組問題了。

Simon Baker, Redburn Atlantic.

西蒙貝克，雷德本大西洋月刊。

Thank you for taking my questions. Two, if I may. Firstly, going back to the obesity pipeline, you announced that you terminated the development of the once-monthly injectable GLP/GIP due to portfolio considerations. I wonder if you could elaborate on that and also update us on your appetite for a monthly injectable obesity treatment.

感謝您回答我的問題。如果可以的話，兩個。首先，回到肥胖產品線，出於投資組合的考慮，你們宣布終止每月注射一次的 GLP/GIP 的開發。我想知道您是否可以詳細說明這一點，並向我們介紹您對每月注射肥胖治療的興趣。

And then a question on icodec in the US. Given the complete response letter and leaving aside the questions on manufacturing, is a type 1 carve-out from the application a possible solution to expediting this? Because I assume that one mustn't just think about icodec, but also IcoSema, which is potentially the bigger opportunity and obviously held up by this. Any thoughts on that would be much appreciated. Thank you.

然後是關於美國icodec的問題。考慮到完整的回覆信並拋開製造方面的問題，從申請中剔除類型 1 是否是加快這一進程的可能解決方案？因為我認為人們不能只考慮 icodec，還要考慮 IcoSema，這可能是更大的機會，顯然因此而受到阻礙。任何對此的想法將不勝感激。謝謝。

Thank you, Simon. Both of those go to you, Martin. Firstly, on the once-monthly GLP-1/GIP and secondly, on icodec.

謝謝你，西蒙。這兩件事都歸你所有，馬丁。首先是每月一次的 GLP-1/GIP，其次是 icodec。

Yeah. Absolutely. So I just want to reiterate, I think we all along stated that the once-monthly GLP-1/GIP study that we conducted was an exploratory study, more assessing the concept of a once-monthly technology than the actual GLP-1/GIP component.

是的。絕對地。所以我想重申一下，我想我們一直都說我們進行的每月一次的GLP-1/GIP 研究是一項探索性研究，更多的是評估每月一次的技術概念，而不是實際的GLP- 1/GIP成分。

It was exploratory. And while we definitely can use the data, the current profile was not something that we would take into further clinical development. So basically, we still have this focus. We do see once-monthly as convenience more than anything else.

這是探索性的。雖然我們肯定可以使用這些數據，但我們不會將目前的情況用於進一步的臨床開發。所以基本上我們還是有這個重點的。我們確實認為每月一次比其他任何事情都更方便。

Our primary focus is efficacy and safety. And as we already discussed there, we have a very competitive pipeline and portfolio. But we will maintain this focus with either the next generation of this technology or alternative technologies.

我們的首要關注點是功效和安全性。正如我們已經討論過的那樣，我們擁有非常有競爭力的產品線和產品組合。但我們將透過下一代技術或替代技術來保持這一重點。

Specifically on icodec, we are in ongoing dialogue with the FDA, so I don't want to speculate too much. But obviously, part of this is a potential carve-out of the type 1 diabetes. You should not see this impact the IcoSema dialogue.

特別是在 icodec 方面，我們正在與 FDA 進行持續對話，所以我不想做出太多猜測。但顯然，部分原因是可能排除第 1 型糖尿病。您不應該看到這對 IcoSema 對話的影響。

Thank you so much.

太感謝了。

Thank you, Martin. And also thank you, Simon, for those two questions. Then we have time for one final set of questions, please.

謝謝你，馬丁。西蒙，也謝謝你提出這兩個問題。然後我們有時間回答最後一組問題。

Mark Purcell, Morgan Stanley. Please go ahead.

馬克‧珀塞爾，摩根士丹利。請繼續。

Yeah, thank you very much for taking my questions. Wegovy heart failure, could you help us understand the additional data you're looking to file and whether you're going for a CV death and heart failure endpoints, sort of heart endpoints in terms of a claim from the studies?

是的，非常感謝您回答我的問題。 Wegovy 心臟衰竭，您能否幫助我們了解您想要提交的額外數據，以及您是否打算尋求心血管死亡和心臟衰竭終點，即研究聲稱的心臟終點？

I guess, the pooled analysis of the STEP HFpEF programs showed a strong 69% risk reduction in CV death and heart failure events. But there's significant numbers of patients in SELECT and FLOW, which I guess could be relevant. So an understanding of what you're aiming to achieve there would be great, thank you.

我猜想，STEP HFpEF 計畫的總結分析顯示，心血管死亡和心臟衰竭事件的風險大幅降低了 69%。但 SELECT 和 FLOW 中有大量患者，我想這可能是相關的。因此，了解您的目標是很好的，謝謝。

And then the second one, just as a follow-up to INV-202, could you help us understand, Martin, how INV-347 differs compared to INV-202 in terms of PK and CNS distribution and selectivity of the CB1 versus CB2 receptors? Just trying to understand whether this could actually leapfrog monlunabant into Phase 3.

然後第二個，就像 INV-202 的後續產品一樣，馬丁，您能幫助我們了解 INV-347 與 INV-202 相比，在 PK 和 CNS 分佈以及 CB1 與 CB2 受體的選擇性方面有何不同？只是想了解這是否真的可以跳過 monlunabant 進入第三階段。

Thank you, Mark. And both of those to you, Martin. Firstly, semaglutide in HFpEF, and secondly, within Inversago, the INV-347.

謝謝你，馬克。馬丁，這兩件事都給你。首先是 HFpEF 中的索馬魯肽，其次是 Inversago 中的 INV-347。

Yeah, thank you very much, Mark, for those questions. First of all, on HFpEF, as you recall, we conducted two dedicated HFpEF trials in patients with established HFpEF, one in diabetes and one in patients without diabetes but with obesity.

是的，非常感謝馬克提出這些問題。首先，關於 HFpEF，正如您所記得的，我們在已確診 HFpEF 的患者中進行了兩項專門的 HFpEF 試驗，一項針對糖尿病患者，另一項針對非糖尿病但患有肥胖症的患者。

When we do the meta-analysis of the two trials, we see a 69% decrease in risk of CV death or hospitalization for heart failure, so absolutely very strong data and something that has encouraged us a lot. This was also why the FDA granted us breakthrough designation.

當我們對這兩項試驗進行薈萃分析時，我們發現心血管死亡或因心臟衰竭住院的風險降低了 69%，因此絕對是非常有力的數據，這讓我們深受鼓舞。這也是 FDA 授予我們突破性頭銜的原因。

As we discussed last quarter, we had fairly few events in these two reasonably small studies. And through our dialogue with the FDA, it was very clear that if we could sort of increase the volume of events to further substantiate this, the likelihood of getting heart endpoints into the US label would increase.

正如我們上季所討論的，在這兩項規模相當小的研究中，我們的事件相當少。透過我們與 FDA 的對話，很明顯，如果我們能夠增加事件數量以進一步證實這一點，那麼將心臟終點納入美國標籤的可能性就會增加。

Given that we have had and will have some strong readouts in the not-so-distant future, it was a reasonably easy decision to say we can accept a small delay and then increase our likelihood of getting heart endpoints into the label as compared to the more functional test. So we saw that as a really good bargain.

考慮到我們已經並將在不遠的將來獲得一些強大的讀數，我們可以接受一個小的延遲，然後增加我們將心臟終點納入標籤的可能性，這是一個相當容易的決定。所以我們認為這是一筆非常划算的交易。

On monlunabant, second generation is still early days. There is a potential for a longer half-life. So a potential for less frequent than once-daily dosing, which is obviously attractive. And further, a potential for even less brain penetration, again, we are quite confident with the safety profile of monlunabant.

關於蒙魯那班，第二代仍處於早期階段。半衰期可能更長。因此，給藥頻率可能低於每日一次，這顯然很有吸引力。此外，由於大腦滲透的潛力甚至更小，我們對 monlunabant 的安全性非常有信心。

But again, if second generation could have an even lower likelihood of potential adverse events, that would be attractive. I don't think you will see anything surpass our progress of monlunabant. We see this as a really, really strong lifecycle management opportunity.

但同樣，如果第二代發生潛在不良事件的可能性更低，那將會很有吸引力。我認為您不會看到任何超越我們蒙魯那班的進展的東西。我們認為這是一個非常非常強大的生命週期管理機會。

Thank you, Martin. Thank you, Mark, and thank you to everyone else who have asked questions during the session. This concludes the Q&A session. Thanks a lot for participating, and feel free to contact Investor Relations regarding any follow-up questions you might have.

謝謝你，馬丁。謝謝馬克，也感謝在會議期間提出問題的所有其他人。問答環節到此結束。非常感謝您的參與，如有任何後續問題，請隨時聯繫投資者關係部。

Before we close the call, I'd like to hand it over to you, Lars, for any final remarks.

在我們結束通話之前，拉斯，我想請您發表最後的意見。

Thank you, Jacob. I hope it comes across that we are pleased with the momentum in our business, in particular, our GLP-1 business in diabetes and obesity, not least the strong growth for Wegovy script trends in the US, which is refueling the upgrade we have communicated today, which also means that our supply is on track in being able to serve more patients, both short and longer term.

謝謝你，雅各。我希望大家對我們的業務勢頭感到滿意，特別是我們在糖尿病和肥胖方面的 GLP-1 業務，尤其是美國 Wegovy 腳本趨勢的強勁增長，這正在推動我們所傳達的升級今天，這也意味著我們的供應已步入正軌，能夠為更多短期和長期患者提供服務。

We're also excited about our pipeline, the news we have announced recently, but also what we have coming up later in the year. So with that, thank you also from my side for your questions and attention today. With that, we close the call. Thank you.

我們也對我們的管道、我們最近宣布的消息以及我們今年稍後發布的消息感到興奮。因此，我也感謝你們今天提出的問題和關注。至此，我們結束通話。謝謝。

Thank you. This concludes today's conference call. Thank you for participating. You may now disconnect.

謝謝。今天的電話會議到此結束。感謝您的參與。您現在可以斷開連線。