諾和諾德 (NVO) 2024 Q1 法說會逐字稿

Good day, and thank you for standing by. Welcome to the Q1 2024 Novo Nordisk AS Earnings Conference Call. (Operator Instructions) Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Daniel Bohsen, CVP, Investor Relations. Please go ahead, sir.

美好的一天，感謝您的支持。歡迎參加諾和諾德 2024 年第一季財報電話會議。 （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演講者、投資者關係首席副總裁丹尼爾·博森 (Daniel Bohsen)。請繼續，先生。

Thank you. Welcome to this Novo Nordisk Earnings call for the first 3 months of 2024. My name is Daniel Muusmann Bohsen, and I'm the Head of Investor Relations at Novo Nordisk. 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.

謝謝。歡迎參加諾和諾德 2024 年前 3 個月的收益電話會議。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 1 hour.

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。通話預計為期 1 小時。

Please turn to the next slide. 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.

請翻到下一張投影片。此簡報的結構如投影片 2 所示。

Please turn to the next slide. 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 3 months of 2024 and the slides prepared for this presentation.

請翻到下一張投影片。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 2024 年前 3 個月的公司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，拉斯向您介紹我們戰略願景的最新情況。

Thank you, Daniel. Please turn to the next slide. In the first three months, we have delivered 24% sales growth and 30% operating profit growth. Furthermore, we have raised the outlook for the full year. I would like to start this call by going through the performance highlights across our strategic aspirations before handing over the word to my colleagues.

謝謝你，丹尼爾。請翻到下一張投影片。前三個月，我們的銷售額成長了 24%，營業利潤成長了 30%。此外，我們也上調了全年展望。在向我的同事傳達訊息之前，我想先回顧一下我們策略願景的績效亮點。

Starting with our focus on purpose and sustainability, we are now serving almost 42 million patients with our diabetes and obesity treatments. Our total carbon emission rose by 32% as compared to the first quarter of 2023. This was primarily driven by our increased investments in capital expenditure to meet the high demand for our products.

從我們對目標和永續性的關注開始，我們現在正在為近 4,200 萬名患者提供糖尿病和肥胖治療。與 2023 年第一季相比，我們的碳排放總量增加了 32%。

Compared to the first quarter of 2019, carbon emissions from operations and transportation decreased by 31%. To uphold our commitment to being a sustainable employer, we expanded the number of women in senior leadership positions to 41%, compared with 39% in the first quarter of 2023.

與2019年第一季相比，營運和運輸的碳排放量下降了31%。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 年第一季為 39%。

Within R&D, we are pleased with the successful completion of the FLOW Kidney Outcomes Trial and the approval of the Wegovy label expansion in the U.S. based on the Select Cardiovascular Outcomes Trial. Martin will come back to this and our overall R&D milestones later.

在研發方面，我們對 FLOW 腎臟結果試驗的成功完成以及基於精選心血管結果試驗的 Wegovy 標籤擴展在美國獲得批准感到高興。馬丁稍後將回到這一點以及我們的整體研發里程碑。

We also announced the agreement to acquire 3 fill-finish sites from Novo Holdings in connection with a transaction where Novo Holdings has agreed to acquire Catalent. This is expected to enable us to reach many more people living with serious chronic diseases.

我們也宣布同意從 Novo Holdings 收購 3 個填充加工場地，該交易與 Novo Holdings 同意收購 Catalent 的交易有關。預計這將使我們能夠惠及更多患有嚴重慢性疾病的人。

The quarterly sales growth reflects solid commercial execution across operating units. Both operating units contributed to sales growth driven by demand for our GLP-1 treatments for both diabetes and obesity. Camilla and Doug will go through the details per therapy area later. Karsten will go through the financials, but I'm very pleased with the performance so far this year.

季度銷售成長反映了各營運部門穩健的商業執行力。由於對糖尿病和肥胖症 GLP-1 治療的需求推動，這兩個營運部門都對銷售成長做出了貢獻。卡米拉和道格稍後將詳細介紹每個治療領域的詳細資訊。卡斯滕將檢查財務狀況，但我對今年迄今為止的表現非常滿意。

Now I would like to hand the word over to Camilla who will give us an update on the commercial execution.

現在我想把這個消息交給卡米拉，她將為我們提供商業執行的最新資訊。

Thank you. Lars. Please turn to the next slide. In the first three months of 2024, our total sales increased by 24%. The sales growth was driven by both operating units with North America operations growing 35% and international operations growing 11%. In the US, sales growth was positively impacted by gross to net sales adjustments related to prior years. Our GLP-1 sales in diabetes increased 32% driven by North America operations growing 37% and international operations growing 22%.

謝謝。拉斯.請翻到下一張投影片。 2024年前三個月，我們的總銷售額成長了24%。銷售成長由兩個營運部門推動，其中北美業務成長 35%，國際業務成長 11%。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 37% 和國際業務成長 22% 的推動下，我們在糖尿病領域的 GLP-1 銷售額成長了 32%。

Insulin sales increased by 9% driven by North America operations growing 23% and international operations growing 5%. Obesity Care sales increased 42% driven by North America operations growing 44% and international operations growing 35%.

在北美業務成長 23% 和國際業務成長 5% 的推動下，胰島素銷售額成長了 9%。在北美業務成長 44% 和國際業務成長 35% 的推動下，肥胖護理銷售額成長了 42%。

In both geographies, growth was driven by Wegovy, partly offset by declining Saxenda sales. Doug will talk more about North America obesity performance, but in IO Wegovy sales exceeded DKK 1 billion in the quarter. We continue to roll out Wegovy in a sustainable manner with volume-capped launches to balance supply and demand. Rare disease sales decreased by 3%, which Doug will also speak more to later.

在這兩個地區，成長均由 Wegovy 推動，但部分被 Saxenda 銷售下降所抵消。 Doug 將更多地談論北美肥胖表現，但 IO Wegovy 本季銷售額超過 10 億丹麥克朗。我們繼續以可持續的方式推出 Wegovy，並透過數量上限來平衡供需。罕見疾病銷售額下降了 3%，Doug 稍後也會詳細談到這一點。

Please turn to the next slide. With 24% 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%, which 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 24%，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場份額增至 34%，高於我們到 2025 年達到全球糖尿病價值市場三分之一的戰略願望。

In international operations, please turn to the next slide. In international operations, Diabetes Care sales increased by 12% in the first three months of 2024, which was primarily driven by GLP-1 sales growing 22%. Novo Nordisk is the market leader in international operations with a GLP-1 value market share of around 70%. Ozempic continues its GLP-1 market leadership with 47.2% market share. We are also pleased to see Rybelsus increasing its market share to around 15%, driven by solid uptake across geographies.

在國際營運中，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 年前三個月增長了 12%，這主要是由 GLP-1 銷售額增長 22% 推動的。諾和諾德是國際業務領域的市場領導者，其 GLP-1 價值市場佔有率約為 70%。 Ozempic 以 47.2% 的市佔率繼續保持其 GLP-1 市場領先地位。我們也很高興看到 Rybelsus 在跨地區的強勁應用的推動下，其市場份額增加至 15% 左右。

And with that, I will hand over the word to Doug.

接下來，我將把這個字交給道格。

Thank you, Camilla. Please turn to the next slide. Sales in North America is driven by healthy prescription volume growth of the GLP-1 class of around 15% in the first quarter of 2024, compared to the first quarter of 2023. Novo Nordisk is taking market share, meaning we are growing more than the market, fueled by our strategic GLP-1 brands of Ozempic and Rybelsus.

謝謝你，卡米拉。請翻到下一張投影片。與2023 年第一季相比，2024 年第一季GLP-1 類藥物的處方量健康成長約15%，推動了北美的銷售。超過了市場，由我們的策略 GLP-1 品牌 Ozempic 和 Rybelsus 推動。

Measured on total prescriptions, Novo Nordisk continues to be the market leader with around 56% market share. Sales growth of Ozempic was negatively impacted by periodic supply constraints in the beginning of the first quarter.

以總處方量衡量，諾和諾德繼續保持市場領先地位，佔據約 56% 的市場。第一季初，Ozempic 的銷售成長受到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 release of 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。為了確保 Wegovy 護理的連續性，我們在 2023 年 5 月減少了較低劑量規格的釋放，這一情況在去年剩餘時間裡一直持續著。今年年初，我們逐漸開始增加低劑量規格的供應。

I am pleased to see that this has been reflected in prescriptions, and we are now seeing more than 27,000 new-to-brand prescriptions and approaching the peak total prescriptions seen last year. Wegovy still has broad market access with more than 50 million covered lives. Importantly, around 10 million vulnerable patients have access to Wegovy via Medicaid in more than 15 states.

我很高興看到這已反映在處方中，我們現在看到超過 27,000 個新品牌處方，接近去年的總處方數高峰。 Wegovy 仍然擁有廣闊的市場准入，覆蓋超過 5000 萬人的生活。重要的是，超過 15 個州的約 1000 萬弱勢患者可以透過醫療補助獲得 Wegovy。

Following an expanding market access and our focus on reaching more patients, Wegovy net prices declined in the first quarter. While we continue to gradually increase the overall supply throughout the rest of 2024, our primary focus remains on ensuring continuity of care for patients who have already initiated treatment.

隨著市場准入的擴大以及我們專注於覆蓋更多患者，Wegovy 淨價在第一季有所下降。雖然我們在 2024 年剩餘時間內繼續逐步增加整體供應量，但我們的主要重點仍然是確保為已經開始治療的患者提供連續性照護。

Next slide, please. Our rare disease sales decreased by 3%. Sales in international operations declined by 18%. This was partly offset by a 20% sales increase in North America operations, reflecting the launch of Sogroya and positive gross to net adjustments related to prior years in the US.

請下一張投影片。我們的罕見疾病銷售額下降了 3%。國際業務銷售額下降 18%。這部分被北美業務 20% 的銷售額成長所抵消，這反映了 Sogroya 的推出以及與前幾年相關的美國毛淨值調整。

Sales of rare blood disorders decreased by 4%, driven by NovoSeven and hemophilia A products, partly countered by increased hemophilia B sales. Sales of rare endocrine disorder products increased by 1%. We are working on reestablishing full supply of rare endocrine disorder products, following a reduction of manufacturing output in 2022 and 2023.

在 NovoSeven 和血友病 A 產品的推動下，罕見血液疾病的銷售額下降了 4%，但血友病 B 銷售額的增加部分抵消了這種影響。罕見內分泌失調產品銷售額成長1%。在 2022 年和 2023 年製造業產量減少後，我們正在努力重建罕見內分泌失調產品的全面供應。

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

現在，馬丁向您介紹研發方面的最新情況。

Thank you, Doug. Please turn to the next slide. In March, we announced that the FDA has approved a label expansion for Wegovy with the indication of reducing risk of major adverse cardiovascular events, abbreviated MACE. MACE includes cardiovascular death, non-fatal heart attack, and non-fatal stroke in adults with either obesity -- sorry, overweight or obesity and established cardiovascular disease.

謝謝你，道格。請翻到下一張投影片。今年 3 月，我們宣布 FDA 已批准 Wegovy 的標籤擴展，顯示可降低主要不良心血管事件（縮寫為 MACE）的風險。 MACE 包括患有肥胖（抱歉，超重或肥胖並患有心血管疾病）的成年人的心血管死亡、非致命性心臟病和非致命性中風。

The approval is based on the SELECT Cardiovascular Outcomes Trial, which demonstrated for the primary endpoint that Semaglutide 2.4 milligram reduced the risk of MACE by 20% compared to placebo when added to standard of care.

此次批准基於 SELECT 心血管結果試驗，該試驗的主要終點表明，當添加到標準治療中時，與安慰劑相比，索馬魯肽 2.4 毫克可將 MACE 風險降低 20%。

In addition to the cardiovascular indication, the label also is updated to include that risk reduction in MACE was achieved regardless of baseline age, sex, race, ethnicity, body mass index, and level of renal function impairment. Cardiovascular death superiority was not confirmed and thus the testing hierarchy was stopped.

除了心血管適應症外，該標籤還進行了更新，包括無論基線年齡、性別、種族、民族、體重指數和腎功能損害程度如何，均實現了 MACE 風險降低。心血管死亡優勢尚未得到證實，因此停止了測試等級。

However, the label update does include data on the numerical risk reduction in cardiovascular death by 15% and a statistically significant risk reduction of death from any cause by 19%, both compared to placebo.

然而，標籤更新確實包含了與安慰劑相比，心血管死亡風險數字降低 15% 以及全因死亡風險顯著降低 19% 的數據。

In the clinical pharmacological section, the label now also describes that the exact mechanism of cardiovascular risk reduction has not been established, reflecting that the beneficial CV effects of Semaglutide is not associated with weight loss alone.

在臨床藥理學部分，標籤現在也描述了降低心血管風險的確切機制尚未確定，這反映出索馬魯肽的有益心血管作用與減肥無關。

The approval of the Wegovy label expansion for the indication of reducing MACE in the U.S. an important milestone for people living with obesity and cardiovascular disease. The select data demonstrates that Semaglutide 2.4 milligram has the potential to prolong lives by addressing some of the leading causes of preventable death by, for example, reducing the risk of cardiovascular events.

在美國批准 Wegovy 標籤擴展用於減少 MACE 的適應症，對於肥胖和心血管疾病患者來說是一個重要的里程碑。選定的數據表明，索馬魯肽 2.4 毫克有可能透過解決一些可預防死亡的主要原因（例如降低心血管事件的風險）來延長生命。

Next slide, please. In March of 2024, Novo Nordisk acquired Cardior Pharmaceuticals. The agreement includes Cardior’s lead compound, CDR132L, currently in Phase II clinical development for treatment of heart failure. CDR132L is a synthetic antisense oligonucleotide and is a disease modifying therapy designed to halt or partially reverse cellular pathology in the heart by targeting microRNA-132.

請下一張投影片。 2024年3月，諾和諾德收購了Cardior Pharmaceuticals。該協議包括 Cardior 的先導化合物 CDR132L，目前正處於治療心臟衰竭的 II 期臨床開發階段。 CDR132L 是一種合成的反義寡核苷酸，是一種疾病修飾療法，旨在透過靶向 microRNA-132 來阻止或部分逆轉心臟的細胞病理。

With its distinct mode of action, CDR132L has the potential to become a first-in-class therapy for long-lasting improvements of heart function. A second Phase II trial is planned and will investigate CDR132L in a broader chronic heart failure population with left ventricular hypertrophy. This acquisition is in line with our strategic aspiration of establishing a presence in cardiovascular disease and emerging therapy areas.

憑藉其獨特的作用模式，CDR132L 有潛力成為持久改善心臟功能的一流療法。第二項 II 期試驗已計劃進行，將在更廣泛的伴有左心室肥厚的慢性心臟衰竭人群中研究 CDR132L。此次收購符合我們在心血管疾病和新興治療領域建立業務的策略性意願。

Next slide please. As we shift our focus to the upcoming R&D milestones, there are many exciting approvals, trial initiations and trial completions to watch out for. Allow me to go through a few key milestones from the first quarter of 2024 and touch upon a few upcoming highlights later in 2024.

請下一張投影片。當我們將注意力轉向即將到來的研發里程碑時，有許多令人興奮的批准、試驗啟動和試驗完成值得關注。請容許我回顧一下 2024 年第一季以來的幾個關鍵里程碑，並談談 2024 年晚些時候即將到來的一些亮點。

Within diabetes, Insulin Icodec under the brand name of Awiqli was recommended for approval for the treatment of diabetes by the European Regulatory Authorities. We anticipate a final decision from the European Commission within a couple of months, making an exciting milestone for the world's first once weekly basal insulin.

在糖尿病領域，Awiqli品牌的胰島素Icodec被歐洲監管機構推薦批准用於治療糖尿病。我們預計歐盟委員會將在幾個月內做出最終決定，為世界上第一個每週一次的基礎胰島素創造一個令人興奮的里程碑。

Of note, an FDA advisory committee meeting for Insulin Icodec has been announced to discuss the new drug application. The meeting will focus on the risk benefit profile of Icodec in the treatment of Type 1 diabetes and is scheduled for May 2024 in due time prior to the action date in July. Awiqli is currently approved in both Canada and Switzerland.

值得注意的是，FDA 已宣布召開胰島素 Icodec 顧問委員會會議來討論新藥申請。會議將重點討論 Icodec 治療第 1 型糖尿病的風險效益概況，並定於 2024 年 5 月在 7 月行動日期之前的適當時間舉行。 Awiqli 目前已在加拿大和瑞士獲得批准。

Further, diabetes combined to a Phase III trial for IcoSema was successfully completed. The primary endpoint was met with IcoSema demonstrating superior reduction in A1c compared to once weekly Semaglutide 1.0 milligram in people with Type 2 diabetes inadequately controlled on GLP-1 treatment and in need of treatment intensification.

此外，糖尿病合併 IcoSema 的 III 期試驗已成功完成。與每週一次的索馬魯肽 1.0 毫克相比，IcoSema 達到了主要終點，表明對於 GLP-1 治療未得到充分控制且需要強化治療的 2 型糖尿病患者，A1c 具有更好的降低作用。

From an overall A1c baseline of 8%, once weekly IcoSema achieved an estimated reduction in A1c of 1.35 percentage points compared to 0.9 percentage points for Semaglutide 1.0 mg. IcoSema appeared to have a safe and well tolerated profile and shows the potential to set a new benchmark for once weekly treatment of Type 2 diabetes. We expect results from COMBINE 1 in the second quarter of 2024.

從 8% 的整體 A1c 基線來看，每週一次 IcoSema 預計 A1c 降低了 1.35 個百分點，而索馬魯肽 1.0 mg 則降低了 0.9 個百分點。 IcoSema 似乎具有安全且耐受性良好的特點，並顯示出有可能為每週一次的 2 型糖尿病治療設定新基準。我們預計 COMBINE 1 的結果將在 2024 年第二季公佈。

Also on diabetes, we have successfully completed the FLOW Kidney Outcomes Trial with once weekly injectable Semaglutide 1.0 milligram. The trial achieved its primary endpoint by demonstrating a statistically significant and superior reduction in kidney disease progression as well as cardiovascular and kidney death by 24% for people treated with 1.0 mg compared to placebo.

同樣在糖尿病方面，我們也成功完成了每週注射一次 1.0 毫克索馬魯肽的 FLOW 腎臟結果試驗。該試驗實現了其主要終點，證明與安慰劑相比，接受 1.0 mg 治療的患者在腎臟疾病進展以及心血管和腎臟死亡方面具有統計學顯著性和顯著的降低 24%。

In March, the FLOW data was submitted as a label expansion application to the U.S. FDA. Submission to the European regulatory authorities is expected in the second half of 2024. The FLOW results will be shared at the European Renal Association Congress later this month.

3月，FLOW數據作為標籤擴展申請提交給美國FDA。預計將於 2024 年下半年向歐洲監管機構提交。

We have also successfully completed an exploratory Phase II trial with higher doses of once weekly subcutaneous Semaglutide. The trial investigated efficacy and tolerability of 8 mg and 16 mg Semaglutide in people with Type 2 diabetes.

我們也成功完成了一項探索性 II 期試驗，每週皮下注射一次較高劑量的索馬魯肽。該試驗研究了 8 毫克和 16 毫克索馬魯肽對第 2 型糖尿病患者的療效和耐受性。

In the trial, dose response on weight loss was observed and the higher doses of Semaglutide appeared to have a safe and well tolerated profile in line with previous Semaglutide trials. Semaglutide in higher doses in diabetes are now being evaluated for further clinical development.

在試驗中，觀察到了體重減輕的劑量反應，並且與先前的索馬魯肽試驗一致，較高劑量的索馬魯肽似乎具有安全性和良好的耐受性。目前正在評估較高劑量的索馬魯肽治療糖尿病的效果，以進行進一步的臨床開發。

Moving to obesity care, in the first quarter we have already covered the Wegovy label expansion for approval for cardiovascular risk reduction in the US. In the first quarter, the STEP-HFpEF trials were submitted to the U.S. FDA and granted priority review. The FDA also announced that an advisory committee is to be convened in the second half of 2024 to discuss the application.

轉向肥胖護理，第一季我們已經涵蓋了 Wegovy 標籤擴展，以在美國獲得降低心血管風險的批准。第一季度，STEP-HFpEF試驗已提交美國FDA並獲得優先審查。 FDA 也宣布將於 2024 年下半年召開諮詢委員會來討論該申請。

In rare disease, we are excited about the expected readout of Mim8 Phase III in the second quarter of 2024. Mim8 is a novel, next generation, Factor VIIIa Mimetic Bispecific Antibody with potential for improved patient outcomes and reduced patient burden in treatment of people with hemophilia A.

在罕見疾病方面，我們對 2024 年第二季 Mim8 III 期試驗的預期結果感到興奮。病A.

Looking ahead to the second half of 2024, there are several events of note within diabetes. This includes the readouts of STRIDE and the SOUL trials, as well as Phase II for monlunabant and the initiation of Phase II trials for Amycretin.

展望 2024 年下半年，糖尿病領域有幾件值得注意的事件。這包括 STRIDE 和 SOUL 試驗的結果，以及 monlunabant 的 II 期試驗和 Amycretin II 期試驗的啟動。

Within obesity, we look forward to the readout of the first pivotal trial in CagriSema. Lastly, within cardiovascular and emerging therapy areas, we look forward to the readout of the Phase III ESSENCE trial within MACE.

在肥胖方面，我們期待 CagriSema 的第一個關鍵試驗的結果。最後，在心血管和新興治療領域，我們期待 MACE 內 III 期 ESSENCE 試驗的結果。

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 Q1 2024, our sales grew by 22% in Danish kroner and 24% at constant exchange rates, driven by both operating units. In the U.S., sales growth was positively impacted by gross to net sales adjustments related to prior year.

謝謝你，馬丁。請翻到下一張投影片。 2024 年第一季度，在兩個營運部門的推動下，我們的銷售額以丹麥克朗計算增長了 22%，以固定匯率計算增長了 24%。在美國，銷售成長受到與前一年相關的總銷售額與淨銷售額調整的正面影響。

The gross margin increased to 84.8% compared to 84.7% in Q1 2023, reflecting a positive price impact due to gross to net sales adjustments in the U.S. a positive product mix due to increased sales of GLP-1-based products. This is partially countered costs related to ongoing capacity expansions and a negative currency impact.

毛利率從 2023 年第一季的 84.7% 增至 84.8%，反映出美國毛利率與淨銷售額調整帶來的正面價格影響，以及基於 GLP-1 的產品銷售增加所帶來的正面產品組合。這部分抵消了與持續產能擴張和負面貨幣影響相關的成本。

Sales and distribution costs increased by 7% in Danish kroner and by 8% at constant exchange rates around 20% as percentage of sales. In North America, operations costs are driven by promotional activities related to Wegovy, and in international operations, the increase is related to promotional activities for Rybelsus as well as Obesity Care market development activities.

以丹麥克朗計算的銷售和分銷成本增加了 7%，以固定匯率計算則增加了 8%，佔銷售額的百分比約為 20%。在北美，營運成本由與 Wegovy 相關的促銷活動所驅動，而在國際營運中，成長則與 Rybelsus 的促銷活動以及肥胖照護市場開發活動有關。

Research and development costs increased by 28% measured both in Danish kroner and at constant exchange rates, amounting to around 13% of sales. Cost increases reflect late-stage clinical trial activity and increased early research activities compared to Q1 2023.

以丹麥克朗和固定匯率計算的研發成本增加了 28%，約佔銷售額的 13%。與 2023 年第一季相比，成本增加反映了後期臨床試驗活動和早期研究活動的增加。

Administration costs increased by 8% measured in Danish kroner and by 9% at constant exchange rates. Operating profit increased by 27% measured in Danish kroner and by 30% at constant exchange rates, reflecting the sales growth.

以丹麥克朗計算的管理成本增加了 8%，以固定匯率計算則增加了 9%。以丹麥克朗計算的營業利潤成長了 27%，以固定匯率計算則成長了 30%，反映了銷售額的成長。

Net financial items showed a net gain of DKK 72 million compared to a net loss of DKK 270 million last year. The effective tax rate was 20.4% in the first three months of 2024 compared to 19.9% in the first three months of 2023. Net profit increased by 28% and diluted earnings per share increased by 29% to DKK 5.68.

淨財務項目顯示淨收益為 7,200 萬丹麥克朗，去年淨虧損為 2.7 億丹麥克朗。 2024 年頭三個月的有效稅率為 20.4%，而 2023 年頭三個月的有效稅率為 19.9%。 淨利潤增長 28%，稀釋每股收益增長 29%，達到 5.68 丹麥克朗。

Free cash flow realized in the first quarter of 2024 was DKK 5 billion compared with DKK 24.8 billion in the first three months of 2023. The lower free cash flow reflects phasing of rebates related to lower U.S. growth sales in the first quarter of 2024 compared to the fourth quarter of 2023. This is combined with reduced insulin list prices, higher taxes paid and increasing capital expenditure towards additional manufacturing capacity. This is partially countered by increased net profit.

2024 年第一季實現的自由現金流為50 億丹麥克朗，而2023 年前三個月為248 億丹麥克朗。回饋。淨利潤的增加部分抵消了這一影響。

Capital expenditure for property, plant and equipment was DKK 8.5 billion compared with DKK 4.7 billion in 2023, primarily reflecting investments in additional capacity for API production and fill-finish capacity for both current and future injectable and oral products.

物業、廠房和設備的資本支出為 85 億丹麥克朗，而 2023 年為 47 億丹麥克朗，主要反映了對現有和未來注射劑和口服產品的 API 生產和填充能力的額外投資。

In February 2024, we announced an agreement to acquire 3 fill-finish sites from Novo Holdings in connection with a transaction where Novo Holdings has agreed to acquire Catalent a Global Contract Development and Manufacturing Organization. The fulfillment of various customary closing conditions is progressing and Novo Nordisk still expects that the acquisition will be completed towards the end of 2024.

2024 年 2 月，我們宣布達成協議，從 Novo Holdings 收購 3 個填充加工場地，該交易與 Novo Holdings 同意收購全球合約開發和製造組織 Catalent 的交易有關。各種慣例成交條件的履行正在取得進展，諾和諾德仍預計收購將於 2024 年底完成。

Please go to the next slide. We continued the growth momentum in 2024 and has increased our sales growth to between 19% and 27% at constant exchange rates. This is based on several assumptions as described in the company announcements. Of note, the updated sales outlook at constant exchange rates reflect gross to net sales adjustment related to prior years in the U.S. in the first quarter.

請轉到下一張投影片。 2024 年，我們持續維持成長勢頭，以固定匯率計算，銷售額成長至 19% 至 27%。這是基於公司公告中描述的幾個假設。值得注意的是，以固定匯率計算的最新銷售前景反映了美國第一季與往年相關的總銷售額與淨銷售額的調整。

The guidance reflects expectations for sales growth in both North American operations and international operations, mainly driven by volume growth of GLP-1 based treatments for obesity and Diabetes Care.

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 的肥胖治療和糖尿病護理銷售成長所推動的。

With the expectation of continued volume growth and capacity limitations, 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 for both short and long term.

由於預計銷售量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，以增加短期和長期的供應。

Operating profit growth is now expected to be between 22% and 30% at constant exchange rates. The increased expectation for operating profit growth is reflecting the increased sales outlook, partially countered by an expected loss on other operating income and expenses.

以固定匯率計算，目前預計營業利潤成長在 22% 至 30% 之間。對營業利潤成長的預期提高反映了銷售前景的提高，但其他營業收入和支出的預期損失部分抵消了這一影響。

Capital expenditure is still expected to be around DKK 45 billion in 2024, reflecting the expansion of the supply chain, including the previously communicated expansions of manufacturing facilities in Denmark and France.

預計 2024 年資本支出仍約為 450 億丹麥克朗，反映了供應鏈的擴張，包括先前通報的丹麥和法國製造設施的擴張。

The free cash flow is now expected to be between DKK 57 billion and DKK 67 billion. The updated cash flow expectation reflects changes to gross to net sales estimates and related cash flow impacts, as well as business development activities, including the planned acquisition of Cardior.

目前自由現金流預計在 570 億丹麥克朗至 670 億丹麥克朗之間。更新後的現金流量預期反映了總銷售額與淨銷售額估計的變化和相關現金流量影響，以及業務發展活動，包括計畫收購 Cardior。

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 slide. We are pleased with the sales growth in the first three months of 2024, driven by increased demand for our GLP-1 based diabetes and obesity treatments. More patients benefit from our innovative treatments and the agreement to acquire the 3 Catalent manufacturing sites will enable us to serve significantly more people living with diabetes and obesity in the future.

謝謝你，卡斯滕。請翻到最後一張投影片。由於對我們基於 GLP-1 的糖尿病和肥胖治療的需求增加，我們對 2024 年前三個月的銷售成長感到滿意。更多患者受益於我們的創新療法，而收購康泰倫特 3 個生產基地的協議將使我們能夠在未來為更多的糖尿病和肥胖患者提供服務。

Within R&D we are pleased with the positive results from the Kidney Outcomes Trial with SELECT and the label expansion for cardiovascular disease risk reduction for Wegovy in the US.

在研發方面，我們對 SELECT 腎臟結果試驗的積極結果以及 Wegovy 在美國降低心血管疾病風險的標籤擴展感到滿意。

With that, back to Daniel.

說到這裡，回到丹尼爾。

Thank you, Lars. Next slide please. With that, we are now ready for the Q&A session. (Operator Instructions) Operator, we are now ready to take the first question.

謝謝你，拉爾斯。請下一張投影片。這樣，我們現在就可以開始問答環節了。 （操作員指示）操作員，我們現在準備回答第一個問題。

(Operator Instructions) We will now go to your first question. And your first question comes from the line of Michael Nedelcovych from TD Cowen.

（操作員說明）我們現在回答您的第一個問題。你的第一個問題來自 TD Cowen 的 Michael Nedelcovych。

Thank you for the questions. I have two. The first is on the guidance range. In every year going back to 2017, the guidance range has been between 3% and 6% and often narrowed in the first quarter. The fact that this year's guidance range spans 8% is understandable given supply uncertainties, but one might have imagined that management might have some additional clarity by now and possibly have narrowed the range. Of course, this implies risk both to the downside and to the upside, but it's hard to interpret persistent uncertainty as a good thing. So, to what specifically do you attribute that uncertainty?

謝謝你的提問。我有兩個。第一個是指導範圍。自 2017 年以來，每年指導區間都在 3% 至 6% 之間，並且往往在第一季收窄。考慮到供應的不確定性，今年的指導範圍跨越 8% 這一事實是可以理解的，但人們可能會想像管理層現在可能已經有了一些額外的明確性，並且可能已經縮小了範圍。當然，這意味著下行風險和上行風險，但很難將持續的不確定性解釋為一件好事。那麼，您將這種不確定性具體歸因於什麼？

And then my second question has to do with high dose injectable Semaglutide. As you noted, the Phase II trial incorporated a 16 milligram dose, which we understood to be a dose intended to find a weight loss plateau in order to make sure no efficacy was being left on the table. You note that the weight loss was dose responsive, but did you find that plateau? And can you give us any sense how much additional weight loss was gained at 8 milligrams and 16 milligrams of Semaglutide?

我的第二個問題與高劑量注射索馬魯肽有關。正如您所指出的，II 期試驗採用了 16 毫克劑量，我們認為該劑量旨在找到減肥平台，以確保不會留下任何功效。您注意到體重減輕是劑量反應性的，但是您是否發現了這個平台期？您能否告訴我們服用 8 毫克和 16 毫克索馬魯肽後體重額外減輕了多少？

And you also noted that higher doses are now being evaluated for further clinical development, but of course Phase III trials at a 7.2 milligram dose are already nearing completion, so are you contemplating additional trials at even higher doses?

您還指出，現在正在評估更高的劑量以進行進一步的臨床開發，但當然，7.2 毫克劑量的 III 期試驗已經接近完成，所以您是否正在考慮進行更高劑量的額外試驗？

Thank you for the questions, Mike, and thanks for being up early in the morning. Karsten, the first one, guidance range for you. And afterwards you, Martin, on the Sema max trial.

麥克，謝謝你提出的問題，也謝謝你一大早起床。卡斯滕，第一個，為您提供指導範圍。之後，馬丁，您將參加 Sema max 試驗。

Good morning, Michael. So, thank you for looking up our historic ranges, and of course we do that also when we are assessing. I think it's important to note that as we've seen over the past year or 2, then the run rate we have in terms of very high growth level and volatility has caused us to be a little bit more cautious in terms of guidance ranges. Also linked to the very strict regulations we have here as a listed company in Denmark around how to navigate that.

早上好，麥可。所以，感謝您查找我們的歷史範圍，當然我們在評估時也會這樣做。我認為值得注意的是，正如我們在過去一兩年所看到的那樣，我們在非常高的成長水準和波動性方面的運作率導致我們在指導範圍方面更加謹慎。這也與我們作為丹麥上市公司在如何應對這一問題方面製定的非常嚴格的規定有關。

So, I would say there is no additional signals to the guidance range for the first quarter. We are on our base plan in terms of running our business, and there are no major changes to risks, either I would say favorably or negatively. We are on track, and we like what we see.

因此，我想說第一季的指導範圍沒有其他訊號。我們的業務運營符合我們的基本計劃，風險沒有重大變化，無論是有利還是不利。我們走在正軌上，我們喜歡我們所看到的。

Thank you, Karsten. Martin, over to you.

謝謝你，卡斯滕。馬丁，交給你了。

Yes, thank you very much for the question. So, I will not comment on the actual data. So we'll disclose them at a later time point. So, vis-a-vis the actual weight loss observed, that will be disclosed later on. I specifically talked about diabetes when we talked about evaluating further development. You are absolutely right, in obesity we're currently conducting a Phase III trial, and what we can say at this point is that the data that we've seen from diabetes are securing that we remain confident also on higher doses in the obesity space.

是的，非常感謝你的提問。所以，我不會對實際數據發表評論。因此，我們將在稍後的時間點披露它們。因此，相對於觀察到的實際體重減輕，這將在稍後披露。當我們談論評估進一步發展時，我特別談到了糖尿病。你說得完全正確，在肥胖方面，我們目前正在進行一項 III 期試驗，此時我們可以說的是，我們從糖尿病中看到的數據確保我們對肥胖領域的更高劑​​量仍然充滿信心。

Thank you, Martin, and thank you, Mike, for the questions. We are ready for the next question, please.

謝謝馬丁，也謝謝麥克提出的問題。我們已經準備好回答下一個問題了。

I will now go to the next questions. And your next question comes from the line of Richard Vosser from JPMorgan. Please go ahead.

我現在將討論下一個問題。您的下一個問題來自摩根大通的理查德·沃瑟（Richard Vosser）。請繼續。

Two, please. First one, just on supply progression in the U.S. and ex-U.S. for Wegovy and Ozempic. I mean, we've seen very good uptake of the starter doses in the U.S. with a substantial ramp. Should we anticipate a continued gradual ramp of those doses throughout this year? Is that how we should think about it? Just some more color there on supply, and particularly also U.S., I think it was quite weak this quarter. Can that be turned around, particularly in China and some other areas?

請兩位。第一個是關於美國和美國以外地區的供應進展。對於 Wegovy 和 Ozempic。我的意思是，我們已經看到美國對起始劑量的吸收非常好，而且增長幅度很大。我們是否應該預期今年這些劑量將持續逐步增加？我們該這樣思考嗎？只是供應上有更多顏色，尤其是美國，我認為本季供應相當疲軟。這種情況能否扭轉，特別是在中國和其他一些地區？

Then just second question on Mim8. Lots of discussion by this, including some of your competitors going into new administration profiles for their products. Perhaps you could remind us a little bit more detail, Martin, of the target product profile, so we can put those, is that into perspective with the tweaks that Hemlibra were making when we see them.

接下來是關於 Mim8 的第二個問題。對此進行了大量討論，包括您的一些競爭對手為其產品製定了新的管理配置。馬丁，也許你可以提醒我們更多關於目標產品概況的細節，這樣我們就可以將這些內容與 Hemlibra 在我們看到它們時所做的調整結合起來。

Thank you, Richard. So Karsten, you start with supply, and we'll then go to Martin again like before.

謝謝你，理查。所以卡斯滕，你從供應開始，然後我們會像以前一樣再次去找馬丁。

Yes. So on supply and specifically on Wegovy. Then its pleasure to report that from a starting point around 5,000 NBRx weekly in the U.S. on Wegovy, entering this year, now we're in excess of 25,000. So more than 5x compared to where we started this year.

是的。關於供應，特別是 Wegovy。然後我很高興地向您報告，從最初在美國 Wegovy 上每週處理 5,000 個 NBRx 開始，進入今年，現在我們已經超過 25,000 個。與我們今年開始的水平相比，增長了 5 倍以上。

And clearly, that is a sign of supply chain operating and running, and building inventories and supplying the market, because our strategy is to supply starter doses to patients who should then be able to titrate up through the dose regime. So on that front, you should see that as confidence in scaling.

顯然，這是供應鏈運作和運作、建立庫存和供應市場的標誌，因為我們的策略是向患者提供起始劑量，然後患者應該能夠透過劑量方案進行滴定。因此，在這方面，您應該將其視為對擴展的信心。

We're not guiding for the full year specifically on NBRx. I think generally speaking, guiding on NBRx is a tricky discipline. But I would say that implicitly in our guidance for the full year, when you look at the midpoint compared to first quarter performance, then that uptake or that acceleration in growth is driven by continued Wegovy expansion in the U.S., and there you should see look at TRx ramp over the year, but also continued launches in – volume capital launches in IO. So, Wegovy is key to growth acceleration for the remainder of the year.

我們不會專門針對 NBRx 提供全年指導。我認為一般來說，NBRx 的指導是一個棘手的學科。但我想說的是，我們對全年的指導中隱含著這一點，當您查看與第一季業績相比的中點時，那麼這種吸收或增長的加速是由Wegovy 在美國的持續擴張推動的，您應該看到 TRx 一年的成長，而且還繼續在 IO 中進行大量資本發行。因此，Wegovy 是今年剩餘時間加速成長的關鍵。

Thank you, Karsten. Martin, on Mim8.

謝謝你，卡斯滕。馬丁，Mim8。

Yes. Thanks very much, Richard. And you're absolutely right. We are only a few weeks away from the readout of Mim8. So, that's going to be exciting. What our target profile is reflecting is obviously, as we discussed and also passed the efficacy, primary endpoint is annual bleeding rate and looking at the median, if you expect more than 50% of people having no bleeds, the ABR will be 0. So, we have to look at the proportion of patients with no bleeds throughout a year, and that's where we will see Mim8 potentially having a very competitive profile.

是的。非常感謝，理查德。你是完全正確的。距離 Mim8 的發布只剩幾週了。所以，這將是令人興奮的。我們的目標概況所反映的顯然是，正如我們討論並通過的功效一樣，主要終點是年出血率，查看中位數，如果您預計超過 50% 的人沒有出血，則 ABR 將為 0。必須查看一年中沒有出血的患者比例，這就是我們將看到Mim8 可能具有非常有競爭力的特徵的地方。

We expect to see an attractive safety profile. And then we expect to be able to demonstrate that Mim8, regardless of dose, will have a true monthly profile, which obviously gives a great convenience benefit for patients. At the same time, Mim8 will be delivered in an easy to use, very intuitive device, and with an injection volume that is pain free. So, potential upsides on efficacy, good safety profile, and a clear convenience and injection pain upside.

我們期望看到有吸引力的安全狀況。然後我們期望能夠證明 Mim8，無論劑量如何，都將具有真實的每月概況，這顯然為患者帶來了極大的便利。同時，Mim8 將以易於使用、非常直覺的設備形式提供，且注射量無痛。因此，潛在的功效優勢、良好的安全性以及明顯的便利性和注射疼痛優勢。

Thank you, Martin. Thank you, Richard, for the question. We are ready to take the next question, please.

謝謝你，馬丁。謝謝理查提出這個問題。我們準備好回答下一個問題了。

Your next question comes from the line of Louise Chen from Cantor. Please go ahead.

您的下一個問題來自 Cantor 的 Louise Chen。請繼續。

I just wanted to ask you for SELECT, has the approval actually helped you gain better coverage of Semaglutide with your peers? And then secondly, on your ESSENCE NASH data, we've received a lot of questions on that. I'm curious what you feel would be a good outcome to give you confidence that you have a commercially competitive drug. And prior, you had said it was end of the year for readout, but now it’s, we’ll you said it's coming out in second half of '24. I don't know if there was an acceleration in the timeline.

我只是想問您的 SELECT，批准實際上是否幫助您在同行中更好地了解索馬魯肽？其次，關於您的 ESSENCE NASH 數據，我們收到了許多相關問題。我很好奇你認為什麼是一個好的結果，可以讓你相信你擁有一種具有商業競爭力的藥物。之前，您曾說過要在今年年底公佈，但現在，我們會說它將在 24 年下半年發布。不知道時間軸是否有加速。

Thank you, Louise. Doug, SELECT and the implications for the U.S. market.

謝謝你，路易絲。 Doug，SELECT 及其對美國市場的影響。

Yes. Thank you, Louise. And maybe as a starting point, it's probably good to remind you that currently we have over 50 million people that we're covering living with obesity. Now, there's still room to grow, and certainly that's our ambition, but we're pleased with the level of access today.

是的。謝謝你，路易絲。也許作為一個起點，最好提醒您，目前我們正在覆蓋超過 5000 萬人患有肥胖症。現在，仍有成長的空間，這當然是我們的雄心，但我們對今天的訪問水平感到滿意。

And again, I think it's also important that, as you know, in March, Wegovy was the label was expanded based on the SELECT data trial, and to become the only, I repeat the only AOM with proven CV benefit. So, we've already seen an impact of the label update with CMS allowing for reimbursement in Medicare Part D for AOMs with a CV indication. So we're pleased with that.

再說一遍，我認為同樣重要的是，正如您所知，3 月份，Wegovy 的標籤基於 SELECT 數據試驗進行了擴展，並成為唯一的，我重複一遍，唯一具有經過驗證的 CV 益處的 AOM。因此，我們已經看到了 CMS 標籤更新的影響，允許在 Medicare D 部分中對具有 CV 適應症的 AOM 進行報銷。所以我們對此感到滿意。

Now, there's still some work to do with planned sponsors on the exact criteria of reimbursement, and so we think the uptake will be gradual, a couple million today. But overall, we're pleased with the level of access, and we think we're going to take advantage of SELECT moving forward.

現在，計劃中的贊助商仍需要就報銷的確切標準進行一些工作，因此我們認為吸收將是漸進的，今天是數百萬。但總的來說，我們對訪問級別感到滿意，我們認為我們將利用 SELECT 繼續前進。

Thank you, Doug. Martin, on NASH.

謝謝你，道格。馬丁，關於 NASH。

Yes. Thank you very much. So as a reminder, the ESSENCE trial is in two parts. First, 800 patients treated for 72 weeks, which will be the regulatory trial. Here, the primary endpoint is liver biopsy assessment of steatosis and fibrosis. What we hope to see is basically what we saw in our pretty large Phase II trial, where we saw a significant and clinically relevant improvement in steatosis and also clinically relevant improvement in fibrosis.

是的。非常感謝。提醒一下，ESSENCE 試驗分為兩個部分。首先，800 名患者接受為期 72 週的治療，這將是監管試驗。在這裡，主要終點是脂肪變性和纖維化的肝臟活檢評估。我們希望看到的基本上是我們在相當大的 II 期試驗中看到的，在該試驗中，我們看到了脂肪變性的顯著且臨床相關的改善以及纖維化的臨床相關改善。

If we see the same level in Phase III, we would be looking at a very attractive profile. This is also what allowed the FDA to grant us breakthrough designation based on the Phase II data. And then in addition, we are extending the study to an additional couple of hundred patients where we will continue treatment to look for heart outcomes. So basically, both liver-related and also cardiovascular heart outcomes, also to cater to the broader, both clinical as well as payer discussions.

如果我們在第三階段看到相同的水平，我們將看到一個非常有吸引力的概況。這也是 FDA 根據 II 期數據授予我們突破性稱號的原因。此外，我們還將這項研究擴展到另外數百名患者，我們將繼續治療以觀察心臟結果。因此，基本上，肝臟相關的和心血管心臟的結果，也是為了滿足更廣泛的臨床和付款人討論。

Thank you, Martin. We are now ready for the next question.

謝謝你，馬丁。我們現在準備好回答下一個問題。

We will now go to the next question. And your next question comes from the line of Evan Seigerman from BMO Capital Markets. Please go ahead.

我們現在進入下一個問題。您的下一個問題來自 BMO 資本市場的 Evan Seigerman。請繼續。

Congrats on all the progress. Can you walk me through some of the expected pricing dynamics for Wegovy in the United States? And I'm asking this in the context of, why are you necessarily giving price given that, supply is constrained and the demand is so high? Maybe walk me through how you're thinking about how this will evolve over the next few quarters?

祝賀所有的進展。您能否向我介紹一下 Wegovy 在美國的一些預期定價動態？我問這個問題的背景是，鑑於供應有限而需求如此之高，為什麼你們一定要給價格？也許請告訴我您如何思考未來幾季將如何發展？

Thank you, Evan. So Lars, will you give that a go?

謝謝你，埃文。那麼拉斯，你願意嘗試嗎？

Yes. So thank you for that question. So we strongly believe in the value of our GLP-1 products, and we just spoke about some of the very nice outcome data we have achieved. So we have a situation where we are gradually increasing access to more and more, say, channels of the market, which comes some of those with a lower price. It's really a sign of us reaching more and more patients and also some of the more vulnerable patients that's impacting the pricing dynamics.

是的。謝謝你提出這個問題。因此，我們堅信 GLP-1 產品的價值，我們剛剛談到了我們所獲得的一些非常好的結果數據。因此，我們面臨的情況是，我們正在逐漸增加進入越來越多的市場管道，其中一些管道的價格較低。這確實是一個跡象，表明我們接觸到越來越多的患者，以及一些影響定價動態的更脆弱的患者。

We see an overall stable competitive environment. And with the volume opportunity we have at hand, that significantly outweighs what we see in terms of lower price points in some of these additional channels. So strong belief in the value of our products, but also a wish to treat more and more patients, and some of those come at a slightly lower price point than what we launched at, so to say.

我們看到整體穩定的競爭環境。考慮到我們手頭上的銷售機會，這遠遠超過了我們在其中一些額外管道中看到的較低價格點。我們對我們產品的價值有著如此強烈的信念，但也希望能夠治療越來越多的患者，可以說，其中一些產品的價格比我們推出的價格略低。

Thank you, Lars. Thank you, Evan, for the question. We're ready for the next question.

謝謝你，拉爾斯。謝謝你，埃文，提出這個問題。我們準備好回答下一個問題了。

And your next question comes from the line of Sachin Jain from Bank of America. Please go ahead.

您的下一個問題來自美國銀行的 Sachin Jain。請繼續。

Sachin Jain, Bank of America. Two for Martin, if I may. Firstly, back on Mim8 and the zero bleed rate you referenced Martin. I think at the CMD you referenced a 70% zero bleed rate post hoc analysis. I think Hemlibra's got about a 50% zero bleeds on the label, but Roche quotes 80% to 90% in real life. So given the sort of various benchmarks, just what zero bleed rate for you as an absolute number confirms a superior profile versus Hemlibra for the caveat of cross trial comparisons?

薩欽‧賈恩 (Sachin Jain)，美國銀行。如果可以的話，給馬丁兩個。首先，回到 Mim8 和您提到的 Martin 的零出血率。我認為在 CMD 上您提到了 70% 零流失率事後分析。我認為 Hemlibra 的標籤上有大約 50% 的零出血率，但羅氏在現實生活中引用了 80% 到 90% 的零出血率。因此，考慮到各種基準，對於交叉試驗比較而言，您的零出血率作為絕對數字是多少才能確認優於 Hemlibra 的配置？

The second question is on Amycretin. Maybe I misunderstood and perhaps I didn't hear your commentary correctly. You've referenced a Phase II start towards the end of this year. From the CMD, I thought you were awaiting a sub cut date early next year and the diabetes data next year before potential Phase III start. Did I misunderstand at the CMD or has something changed since then?

第二個問題是關於阿黴素的。也許我誤解了，也許我沒有正確地聽到你的評論。您提到了今年年底啟動的第二階段。從 CMD 來看，我以為你們正在等待明年初的分切日期以及明年潛在的 III 期開始之前的糖尿病數據。我對 CMD 是否有誤解，或此後發生了什麼變化？

So thank you, Sachin, two for you, Martin, first, on Mim8 and then on Amycretin timeline.

所以謝謝你，Sachin，謝謝你，Martin，首先是在 Mim8，然後是在 Amycretin 時間線上。

Yes. Thank you very much, Sachin. So first of all on Mim8, obviously I can only compare the regulatory data and what is in the label. I think you are right. What we've seen so far in our clinical trials is slightly in excess of 70% of patients with no bleeds, which obviously if that is also confirmed in Phase III, will be a very competitive profile. So this is what we're looking for and then again, you have to compare like-to-like for the regulatory studies.

是的。非常感謝你，薩欽。所以首先在Mim8上，顯然我只能比較監理資料和標籤上的內容。我想你是對的。到目前為止，我們在臨床試驗中看到略超過 70% 的患者沒有出血，顯然，如果這一點也在 III 期試驗中得到證實，這將是一個非常有競爭力的情況。因此，這就是我們正在尋找的東西，而且您必須對監管研究進行同類比較。

On Amycretin, I don't think you misunderstood anything. We for better or worse had to focus from a regulatory perspective on obesity and diabetes as two distinct entities. And for obesity we are currently in the process of finalizing the subcutaneous Phase I and then we'll look at how to further progress Amycretin in obesity. For type 2 diabetes, we are currently in the process of conducting a Phase II study to understand the potential of Amycretin in type 2 diabetes.

關於阿黴素，我認為你沒有誤解任何事情。無論好壞，我們都必須從監管角度關注肥胖和糖尿病作為兩個不同的實體。對於肥胖症，我們目前正在完成皮下第一階段的工作，然後我們將研究如何進一步推進 Amycretin 在肥胖症方面的進展。對於第 2 型糖尿病，我們目前正在進行一項 II 期研究，以了解香蜜素在第 2 型糖尿病中的潛力。

Thank you, Martin. Thank you, Sachin. We are ready for the next question.

謝謝你，馬丁。謝謝你，薩欽。我們準備好回答下一個問題了。

And your next question comes from the line of Peter Verdult, Citi.

您的下一個問題來自花旗集團的 Peter Verdult。

Peter Verdult here from Citi. Just two questions. Favorite topics for you both, supply and pricing. Sorry to test your patience, but starting with Karsten, you've consistently stated that scaling supply is management's number one priority. With that in mind, can we peak it a bit more beyond 2024? When we think about you opening the taps and quadrupling starter doses for Wegovy, is that a nod to supply capacity in 2025 being a multiple of 2024? I realize I'm pushing my luck here, but some sense would be helpful.

來自花旗銀行的 Peter Verdult。只有兩個問題。你們倆最喜歡的話題是供應和定價。很抱歉考驗您的耐心，但從卡斯滕開始，您一直表示擴大供應規模是管理階層的首要任務。考慮到這一點，我們能否在 2024 年之後達到高峰？當我們想到您打開水龍頭並將 Wegovy 的起始劑量增加四倍時，這是否意味著 2025 年的供應能力是 2024 年的倍數？我意識到我在這裡碰碰運氣，但一些理智會有所幫助。

And then just for Lars or Camilla, I mean we're seeing with FLOW and SELECT and HFpEF, the data support increasing use of Sema continues to grow, but we are also now seeing the backlash, [politically] in the U.S. Danish authorities wanting to step out of Ozempic after SGLT-2. They are lowering the price of Ozempic 30% in Denmark.

然後，就 Lars 或 Camilla 而言，我的意思是，我們看到 FLOW、SELECT 和 HFpEF 的數據支持 Sema 的使用不斷增長，但我們現在也看到了美國丹麥當局 [政治上] 的強烈反對SGLT-2後退出Ozempic。他們將丹麥 Ozempic 的價格降低了 30%。

So the question is, just a sort of follow on from the previous one. I'm not interested in pricing for the next few quarters, but how do you think about just the dynamics going forward as people try and manage their budgets? I mean, the demand is clearly there. It's a case where we should expect a step-up in pricing erosion, but put simply, the volume opportunity is so great that any pricing concerns get fully offset. I just want to understand how you are thinking about that dynamic.

所以問題是，這只是前一個問題的延續。我對未來幾季的定價不感興趣，但您如何看待人們嘗試管理預算時的動態？我的意思是，需求顯然是存在的。在這種情況下，我們應該預期價格侵蝕會加劇，但簡而言之，銷售機會如此之大，以至於任何定價擔憂都可以完全抵消。我只是想了解您如何看待這種動態。

Thanks, Pete. So first Karsten, Pete's pushing his luck on supply in the coming years?

謝謝，皮特。那麼首先是卡斯滕，皮特在未來幾年的供應上碰運氣？

Yes. So guiding for supply in 2025 at the Q1 call 2024 I think is stretching it a bit. So let me give you a couple of boundaries. So from a fill-finish point of view, then we continue to scale the single-dose platform that we have launched in the U.S. So that is ongoing and something we're driving each and every day. So of course, we'll continue to scale that.

是的。因此，我認為 2024 年第一季電話會議上對 2025 年供應的指導有點誇張。所以讓我給你一些界線。因此，從填充完成的角度來看，我們將繼續擴大我們在美國推出的單劑量平台的規模。當然，我們將繼續擴大規模。

And then on top of that, which we're also out saying today, that as of now we have launched in nine countries beyond the U.S, Wegovy. So the ramp up ex-U.S. will also be taking pace over this year, but also into next year. So net-net, yes, there will be a good ramp into 2025. The exact amount and factors and all that, we'll have to get back to you on that one at a later point in time.

最重要的是，我們今天也宣布，到目前為止，我們已經在美國以外的九個國家推出了 Wegovy。因此，美國以外地區的成長也將在今年加快步伐，而且還會進入明年。所以，是的，到 2025 年將會有一個良好的增長。

Thank you, Karsten. Lars?

謝謝你，卡斯滕。拉爾斯？

Yes. Thanks Pete for the question on how we see the pricing dynamics. I would say when we launched semaglutide, both in type 2 diabetes and in obesity, it was into an established price point in the market. And we launched at a similar pricing as prior generations, despite the fact of a significantly better clinical profile. And obviously, that was an attractive value proposition, and that has led to significant volume growth because of the benefits.

是的。感謝皮特提出我們如何看待定價動態的問題。我想說的是，當我們在第 2 型糖尿病和肥胖症領域推出索馬魯肽時，它已經進入了市場的既定價格點。儘管臨床情況明顯較好，但我們的推出價格與前幾代產品相似。顯然，這是一個有吸引力的價值主張，並且由於其好處而導致銷量顯著增長。

And right now, we have a situation where you can say both, that volume is to some degree putting strains on healthcare systems. But at the same time, we are just starting to unfold the full value of patients being on this treatment. And these same healthcare systems are significantly burdened by chronic diseases, and many of them linked to the exact diseases we're treating here. So I think I'm optimistic about how we can communicate the value to the healthcare systems of these interventions. I'm very optimistic about the underlying, say, willingness among both patients and physicians to use these medicines.

現在，我們面臨的情況可以說是兩種說法，即數量在某種程度上給醫療保健系統帶來了壓力。但同時，我們才剛開始展現接受這種治療的患者的全部價值。這些醫療保健系統承受著慢性疾病的沉重負擔，其中許多疾病與我們在這裡治療的確切疾病有關。因此，我認為我對如何向醫療保健系統傳達這些幹預措施的價值持樂觀態度。我對患者和醫生使用這些藥物的潛在意願非常樂觀。

And then of course, we see very different markets. In the U.S. we see typically year-over-year slight erosion in net price. In other markets it's more of a stable nature, and you have sometimes one-offs. So in that overall equation, I'm actually very confident that we can manage to articulate the value of medicines at a price point that's also understood by the healthcare systems, and with the continued volume opportunity, this turns into a very attractive commercial model.

當然，我們看到了非常不同的市場。在美國，我們通常會看到淨價比去年同期略有下降。在其他市場，情況更加穩定，有時會出現一次性情況。因此，在整個方程式中，我實際上非常有信心，我們可以設法以醫療保健系統也可以理解的價格點闡明藥品的價值，並且隨著持續的銷售機會，這將變成一個非常有吸引力的商業模式。

Thank you, Lars, and thanks Pete for the questions. We are ready for the next question.

謝謝拉爾斯，也謝謝皮特提出的問題。我們準備好回答下一個問題了。

And your next question comes from the line of Simon Baker from Redburn. Please go ahead.

你的下一個問題來自 Redburn 的 Simon Baker。請繼續。

Firstly, another one on pricing, if I may. Lars, you indicated that the pricing impact that you've seen in Q1 is effectively channel mix. I just wondered if you could confirm that and apportion the amount of pricing that is down to channel mix and how much is down to pricing reductions within specific channels.

首先，如果可以的話，再講一個關於定價的問題。 Lars，您表示您在第一季看到的定價影響實際上是通路組合。我只是想知道您是否可以確認這一點，並分配通路組合的定價量以及特定通路內定價降低的量。

And then the second question on a completely different subject. I just wonder if you could give us any commentary on the FTC's recent challenge to Orange Book patent listing, of which you were one of the named companies. Any idea on the timeline over which this will play out?

然後是關於完全不同主題的第二個問題。我只是想知道您是否可以就聯邦貿易委員會最近對橙皮書專利清單提出的挑戰發表評論，您是其中被點名的公司之一。您對這件事的時間表有什麼想法嗎？

Good. Thank you, Simon. So Karsten, I think I'll give both of them to you. The first, the pricing in Q1, then the second, the FTC challenge of patents.

好的。謝謝你，西蒙。所以卡斯滕，我想我會把它們都給你。第一個是第一季的定價，第二個是聯邦貿易委員會對專利的挑戰。

Yes, Simon, thanks for these questions. So as we've been saying earlier on, one should always be careful of over-interpreting pricing in individual quarters, so to be more specific. Then on Ozempic, like-for-like, we do see continued reduction in the price. And then yes, we have some growth to net benefit in the first quarter, but over the full year, you should like-for-like see a net price reduction for Ozempic in the U.S. And the same goes for Wegovy, back to the volume opportunity, but net-net, given increasing volume and competition, net pricing like-for-like will be down in the U.S.

是的，西蒙，謝謝你提出這些問題。因此，正如我們之前所說，人們應該始終小心，不要過度解釋各個季度的定價，因此更具體地說。然後，在 Ozempic 上，我們確實看到價格持續下降。然後，是的，我們第一季的淨收益有所增長，但在全年中，您應該會看到 Ozempic 在美國的淨價格下降。的增加，美國的淨定價將下降。

And then as to the FTC letter on patents, I believe that was the question.

至於聯邦貿易委員會關於專利的信函，我認為這就是問題所在。

That was the question. Yes.

這就是問題所在。是的。

So, the FTC question on the patents, it's important to note, first of all the patents in question are related to Ozempic, Victoza and Saxenda, but we're talking about device patents first of all, and we're talking about patents that are valid and granted by the U.S. Patent Office.

因此，對於 FTC 關於專利的問題，需要注意的是，首先，所涉及的專利與 Ozempic、Victoza 和 Saxenda 相關，但我們首先討論的是設備專利，而且我們討論的是有效並由美國專利局授予。

The question is all about whether they should be listed in the Orange Book or not. And of course, when we listed the patents, we carefully assessed whether we are following the appropriate protocol per FDA and sought guidance and feedback on that. So, all we believe that what we have done is appropriate, but of course, we'll follow the regulations as issued by the FDA.

問題在於它們是否應該被列入橙皮書。當然，當我們列出專利時，我們仔細評估了我們是否遵循 FDA 的適當協議，並尋求相關指導和回饋。所以，我們認為我們所做的都是適當的，但當然，我們會遵守 FDA 發布的規定。

Thank you, Karsten. Thank you, Simon. And we are ready for the next question, please.

謝謝你，卡斯滕。謝謝你，西蒙。我們已經準備好回答下一個問題了。

And your next question comes from the line of Florent Cespedes from Bernstein.

你的下一個問題來自伯恩斯坦的弗洛倫特·塞斯佩德斯。

Two quick ones. First, on obesity in Europe, could you give us an update on the situation in Europe for Wegovy and the discussions with the payers if they are waiting for a select data pool on the labels? So some color on this front would be great.

兩個快的。首先，關於歐洲的肥胖問題，您能否向我們介紹一下 Wegovy 在歐洲的最新情況以及與正在等待標籤上精選數據池的付款人的討論情況？所以前面的一些顏色會很棒。

My second question for Karsten, on sales and distribution, could you give us some color on how you see this line going forward as it was much lower than expected this quarter, but at least related to the fact that you have less promotion efforts. So some colors would be great.

我向卡斯滕提出的第二個問題是關於銷售和分銷的，您能否給我們一些關於您如何看待這條線的進展的信息，因為它比本季度的預期要低得多，但至少與您的促銷力道較少有關。所以有些顏色會很棒。

Thank you, Florent. Camilla, the first question to you, Wegovy outside the U.S.?

謝謝你，弗洛倫特。卡米拉，第一個問題是，Wegovy 在美國境外嗎？

Yes. And you also asked specifically about whether they are waiting for SELECT. Of course, we are initially waiting for the regulatory decision on the SELECT which we expect in the second half of this year. Having said that, there is, of course, a keen interest in this set of data. But already now, we do have reimbursement in a number of countries outside the U.S. So U.K., Scotland, Canada -- sorry, Japan and also Switzerland. So we are seeing a very positive interest in Wegovy and, of course, also in the SELECT data that shows a strong cost effectiveness.

是的。而且您也特別詢問了他們是否正在等待 SELECT。當然，我們最初正在等待有關 SELECT 的監管決定，預計將在今年下半年做出。話雖如此，大家當然對這組數據抱持著濃厚的興趣。但現在，我們確實在美國以外的許多國家提供了報銷服務，例如英國、蘇格蘭、加拿大——對不起，還有日本和瑞士。因此，我們看到人們對 Wegovy 非常感興趣，當然，對 SELECT 數據也表現出強大的成本效益。

Thank you, Camilla. Karsten, on S&D cost development?

謝謝你，卡米拉。 Karsten，關於 S&D 成本開發？

Commercial investments. Yes. So coming back to our recent Capital Markets Day and our strategic resource allocation, then what I was discussing there was our intent to allocate substantial resources towards innovation, i.e., R&D. So having an increasing R&D ratio, i.e., investments that are growing faster than sales, and our commercial investments growing at a slower pace than sales, and that is exactly what you are seeing this quarter and also what you should expect to be seeing this year, that commercial investments are growing slower than sales.

商業投資。是的。回到我們最近的資本市場日和我們的策略資源分配，我當時討論的是我們打算將大量資源分配給創新，即研發。因此，研發比率不斷增加，即投資成長速度快於銷售成長速度，而我們的商業投資成長速度慢於銷售成長速度，這正是您在本季看到的情況，也是您今年應該看到的情況，商業投資的成長速度慢於銷售的成長速度。

We have the majority of our commercial infrastructure in place across our therapeutic categories. So what we are pursuing are really targeted investments. I would say a lot of focus on obesity market development and building the obesity market. And then we also have some early investments in some of our newer therapy areas, so building some infrastructure on the cardiovascular side. So that are really the main focus areas on commercial investments.

我們在治療類別中擁有大部分商業基礎設施。所以我們追求的是真正的定向投資。我想說的是，我們非常關注肥胖市場的發展和肥胖市場的建設。然後我們也在一些較新的治療領域進行了一些早期投資，因此在心血管方面建立了一些基礎設施。因此，這確實是商業投資的主要關注領域。

And we are ready for the next question, please.

我們已經準備好回答下一個問題了。

Your next question comes from the line of Mark Purcell from Morgan Stanley. Please go ahead.

您的下一個問題來自摩根士丹利的馬克·珀塞爾。請繼續。

I have two. The first one is just going back to the Wegovy U.S. starting dose. The pace of growth at the moment seems to be increasing a bit. It is about 10% week-over-week, now up to 33,000, 0.25 milligram doses per week. Should we assume that this sort of increase will continue to be steady or is there going to be a slowdown in that 10% growth week-over-week? And your confidence in converting to the high doses would be helpful.

我有兩個。第一個是回到 W​​egovy 美國的起始劑量。目前的成長速度似乎有所加快。每週增加約 10%，目前已達到每週 33,000 劑，即 0.25 毫克劑量。我們是否應該假設這種成長將繼續穩定，還是每週 10% 的成長速度會放緩？您對轉換為高劑量的信心會有所幫助。

And then the second question is on the CagriSema dual chamber device. I wonder if you could help us understand some of the properties of this device in terms of whether it is connected and the importance in terms of patient compliance potentially from it being a connected device, the launch preparedness and any indications of the co-formulation of CagriSema. What does that mean for the dual chamber device?

第二個問題是關於 CagriSema 雙室裝置。我想知道您是否可以幫助我們了解該設備的一些屬性，例如它是否已連接，以及患者依從性的重要性，可能是因為它是一個連接的設備，啟動準備以及聯合配製的任何跡象卡格里塞瑪。這對於雙室裝置意味著什麼？

Good. So, the first question, over to you, Doug, for the commercial dynamics right now with Wegovy in the U.S.

好的。所以，第一個問題就交給你了，Doug，關於 Wegovy 目前在美國的商業動態。

Yes. Thanks, Mark. I mean we're certainly pleased with the last couple of weeks of NBRx. As I stated in the beginning, over 27,000 and reaching all-time high with TRx. But remember, as I've talked about quarter-over-quarter, our key focus remains the safeguarding of patient continuity of care and we manage that supply dynamically to do that. So we're going to continue to gradually scale efforts and we're going to do that throughout the remainder of this year. And certainly we're happy and pleased with what we're seeing now and we're very pleased with SELECT and what we're going to be able to do moving forward.

是的。謝謝，馬克。我的意思是，我們對 NBRx 過去幾週的表現當然感到滿意。正如我在開頭所說，TRx 的數量超過 27,000 並達到歷史新高。但請記住，正如我所說的季度環比，我們的重點仍然是保障患者護理的連續性，並且我們動態管理供應來做到這一點。因此，我們將繼續逐步擴大努力，並將在今年剩餘時間內這樣做。當然，我們對現在所看到的一切感到高興和滿意，我們對 SELECT 以及我們未來將能夠做的事情感到非常滿意。

Good. Thank you, Doug. Martin, CagriSema device and connectivity.

好的。謝謝你，道格。 Martin，CagriSema 設備和連接。

Yes. So, very briefly, the CagriSema device, as you say it is a dual chamber device as the two drugs can currently not be co-formulated. And it's a single dose device, very simple to use, so basically you should compare that to the device of Wegovy. Currently no connectivity embedded in that device.

是的。因此，非常簡單地說，CagriSema 裝置，正如您所說，它是一個雙室裝置，因為兩種藥物目前無法共同配製。它是單劑量設備，使用起來非常簡單，所以基本上您應該將其與 Wegovy 的設備進行比較。目前該設備中沒有嵌入連接。

On the question on co-formulation, obviously with a dual chamber device, that's not our normal platform. The co-formulation will allow us more flexibility and that we can then deliver CagriSema in more versions. One could potentially be in flex touch thereby from a supply perspective, allowing us more flexibility.

關於聯合配方的問題，顯然使用雙室裝置，這不是我們的正常平台。聯合配方將為我們提供更大的靈活性，然後我們可以提供更多版本的 CagriSema。從供應的角度來看，人們可能會採取靈活的方式，從而使我們具有更大的靈活性。

Thank you, Martin. Thanks for the question. We're ready for the next.

謝謝你，馬丁。謝謝你的提問。我們已經準備好迎接下一個。

And your question comes from the line of Harry Sephton from UBS.

你的問題來自瑞銀集團的 Harry Sephton。

Two, please. So, on the first question is whether you saw any material impact to your first quarter volumes in the U.S. from the cyber-attack on UnitedHealth's Change Payments platform that may have restricted some patients' access to co-pay support and as a result could have contributed to some weakness on volumes beyond just the supply constraints.

請兩位。因此，第一季度是，聯合健康集團零錢支付平台遭受的網路攻擊是否對美國第一季的業務量產生了重大影響，這可能限制了一些患者獲得共同支付支持，從而可能導致除了供應限制之外，還導致銷量出現一些疲軟。

And then my second question is, you've talked about the fact that the ex-U.S. obesity market could be predominantly self-pay in the future. How do you view the potential opportunity for the U.S. market to move more towards self-pay and what are your ambitions there?

我的第二個問題是，你談到了前美國的事實。未來肥胖市場可能主要是自付費用。您如何看待美國市場更多地走向自費的潛在機會？

Thank you, Harry. Doug, two, for you. First on cyber-attack impact -- potential impact in the first quarter? And then second, do you see a self-pay market in the U.S.?

謝謝你，哈利。道格，兩個，給你。首先是網路攻擊的影響——第一季的潛在影響？其次，您認為美國有自費市場嗎？

Yes. Thanks, Mark. Excuse me, thanks, Harry. Nothing material. It doesn't explain the volumes. Just maybe give you a little context there. Again, remember, speaking to Ozempic, we saw a 50% -- over 50% growth rate in the quarter.

是的。謝謝，馬克。對不起，謝謝，哈利。沒什麼實質的。它沒有解釋卷。也許只是給你一些背景資訊。再次請記住，在與 Ozempic 交談時，我們看到本季成長率為 50%——超過 50%。

We continue to gain market share, which is important, and we're clearly the market share leader. But we did see some impacts in the quarter. Periodic supply constraints, and they were primarily in the early part of the year. Remember, we have a larger base. Last year, the volume growth was 50%, and we do see some continuation of utilization management. So those would be more in line with what impacted some of the volumes.

我們繼續獲得市場份額，這很重要，而且我們顯然是市場份額的領導者。但我們確實在本季看到了一些影響。週期性的供應限制，主要是在今年稍早。請記住，我們有更大的基礎。去年，銷量成長了 50%，我們確實看到了利用率管理的一些延續。因此，這些將更符合影響某些數量的因素。

In terms of self-pay, the way I would characterize that is we're always looking at opportunities to bring more patients to our products, and that could be an option. So we evaluate everything moving forward.

就自付費用而言，我的特點是我們一直在尋找機會讓更多患者使用我們的產品，這可能是一種選擇。所以我們評估未來的一切。

Thank you, Doug. And specifically also the cyber-attack did you see any impact from that in the first quarter?

謝謝你，道格。特別是網路攻擊，您認為第一季有什麼影響嗎？

Yes. Nothing material, and that wouldn't explain the volumes.

是的。沒有任何實質內容，這也無法解釋這些卷。

Thank you, Doug, and thank you Harry. We're ready for the next question.

謝謝你，道格，也謝謝你哈利。我們準備好回答下一個問題了。

And your next question is from Richard Parkes. Please go ahead.

你的下一個問題來自理查·帕克斯。請繼續。

So yes, just two questions. Firstly, on Monlunabant, the Phase II data, I'm just wondering if there's going to be anything you can generate from that Phase II trial to give some comfort on the risk of psychiatric side effects, given the class, i.e. any data on confirmation the drug doesn’'t cross the blood-brain barrier to a material degree or should we just expect standard sort of Phase II read out.

所以是的，只有兩個問題。首先，關於Monlunabant 的第二階段數據，我只是想知道是否可以從該第二階段試驗中得出任何東西，以便在考慮到類別（即任何確認數據）的情況下，對精神副作用的風險給予一些安慰該藥物不會在實質程度上穿過血腦屏障，或者我們應該只期待標準的 II 期讀數。

And then secondly, just sort of playing out the devil's advocate on the commentary around value to healthcare systems from Wegovy, obviously some of the arguments for that are based on stay time in the select study of 3.5 years, but what we're seeing in the real world at the moment is less than 12 months in terms of median duration. So for the payers' perspective, there's a risk that they get all of the upfront costs without generating savings if they can't keep patients on drugs. So I'm just wondering, is that a pushback that you often get and how you address that in your discussions with payers?

其次，Wegovy 對醫療保健系統價值的評論有點唱反調，顯然，其中一些論點是基於 3.5 年精選研究中的停留時間，但我們在就中位持續時間而言，目前現實世界還不到12 個月。因此，從付款人的角度來看，如果他們不能讓患者繼續服用藥物，他們就有可能獲得所有的前期費用，但無法節省開支。所以我只是想知道，這是您經常遇到的阻力嗎？

Thank you, Richard. So Martin, first one to you, and Lars I'll give the second one to you.

謝謝你，理查。馬丁，第一個給你，拉爾斯，我會把第二個給你。

Yes. Thank you very much. So I think you are right. We're quite excited about Monlunabant and the potential, because we've seen potential for substantial weight loss with a scalable oral, and that is of course very exciting, however, we have to rule out potential safety issues.

是的。非常感謝。所以我認為你是對的。我們對 Monlunabant 及其潛力感到非常興奮，因為我們已經看到了透過可擴展的口服藥物顯著減輕體重的潛力，這當然非常令人興奮，但是，我們必須排除潛在的安全問題。

The ongoing Phase II trial will give us a good read out on the efficacy and it will also give us a reasonable read out of the safety profile of Monlunabant. However, to fully derisk this, we intend to investigate this as we already announced in a somewhat larger study, to secure that both obviously, our efficacy, but certainly also our safety assessment of this is right. So you'll get a good first read out from the ongoing Phase II trial, but you'll see even more from the next.

正在進行的 II 期試驗將使我們對療效有一個很好的了解，也將使我們對 Monlunabant 的安全性有合理的了解。然而，為了完全消除這種風險，我們打算對此進行調查，正如我們已經在一項更大的研究中宣布的那樣，以確保我們的功效和安全性評估顯然是正確的。因此，您將從正在進行的第二階段試驗中獲得良好的第一讀數，但您將從下一個試驗中看到更多。

Yes. Thank you. So a fair challenge on the stay time. It's still early days. We are pleased with the stay time we see. But I think it's also fair to say that we have not had a sustainable market presence to really be able to tell what will the stay time be. And I think it's also dynamic situation in terms of understanding what is obesity and what's the value of treating obesity.

是的。謝謝。因此，對停留時間的公平挑戰。現在還為時過早。我們對所看到的停留時間感到滿意。但我認為公平地說，我們還沒有永續的市場存在，無法真正判斷停留時間是多少。我認為，在理解什麼是肥胖以及治療肥胖的價值方面，這也是一個動態的情況。

So we believe over time that we will see, say, enough patients getting to a durable weight loss that will also translate into real health benefits. But of course, it takes time to establish those data, and we have simply not been in the market long enough to document that. So -- but I think it will be possible to do that.

因此，我們相信，隨著時間的推移，我們將看到足夠的患者實現持久的體重減輕，這也將轉化為真正的健康益處。但當然，建立這些數據需要時間，而我們進入市場的時間還不夠長，無法記錄這一點。所以——但我認為這是有可能做到的。

Thank you, Lars. Thank you Richard for the questions. We have time for one final brief question.

謝謝你，拉爾斯。謝謝理查德提出的問題。我們還有時間問最後一個簡短的問題。

And your final question comes from the line of Michael Novod from Nordea. Please go ahead.

你的最後一個問題來自 Nordea 的 Michael Novod。請繼續。

Michael from Nordea. So going back to the CMS guidance and some of the access you are getting. Can you comment on how many of the insurance companies are following CMS guidance and also in that connection, how do you see then the potential progress for the TROA Act in the U.S.? Could something happen in 2024 or 2025?

來自北歐聯合銀行的邁克爾.那麼回到 CMS 指南和您獲得的一些存取權限。您能否評論一下有多少保險公司正在遵循 CMS 指導？ 2024 年或 2025 年會發生什麼事嗎？

Thank you, Michael. Doug, over to you for the last answer.

謝謝你，麥可。道格，最後的答案就交給你了。

Thank you, Michael. So we're seeing a couple million, you could say around 4 million lives today that we're seeing as a result of the impact of the label update with CMS allowing for reimbursement in Medicare Part D. Again, this is going to be gradual, right. There's still some work to do as I mentioned earlier with planned sponsors to the exact criteria of reimbursement. So it's going to be gradual, but we certainly see this as a very positive step in the right direction and it's certainly encouraging.

謝謝你，麥可。因此，由於 CMS 標籤更新允許在 Medicare D 部分中進行報銷，我們今天看到了數百萬人，可以說大約 400 萬人的生命。正如我之前提到的，對於計劃中的贊助商來說，要達到確切的報銷標準，還有一些工作要做。所以這將是漸進的，但我們當然認為這是朝著正確方向邁出的非常積極的一步，而且肯定令人鼓舞。

Now as far as TROA, again as I've said, many quarters, I'm not going to get into the predicting game, but again we think it's just a matter of time. Certainly there's support on both sides. So we still think it's just a matter of time. So we're positive. I just -- I can't give you an indication as to when, but we're hard at work there as well.

現在就 TROA 而言，正如我所說，很多個季度，我不會進入預測遊戲，但我們再次認為這只是時間問題。當然，雙方都有支持。所以我們仍然認為這只是時間問題。所以我們持正面態度。我只是——我無法告訴你具體時間，但我們也在努力工作。

Thank you, Doug. Thank you, Michael. And this concludes the Q&A session for this earnings call. Thank you for participating, and please feel free to contact Investor Relations, as always, regarding any follow-up questions you might have. Before we close the call, I would like to hand over to you, Lars, for the final remarks.

謝謝你，道格。謝謝你，麥可。本次財報電話會議的問答環節到此結束。感謝您的參與，如果您有任何後續問題，請一如既往地隨時聯繫投資者關係部。在我們結束通話之前，拉斯，我想請您做最後的發言。

Yes. Thank you, Daniel, and thank you all for joining us today. So I hope it comes across that we're very pleased with the momentum of our business right now as evidenced by the sales performance in the first 3 months and at least the development in script for both Ozempic and Wegovy in the U.S., really proving that we are on track of scaling supplies here during the year. But also our commitment to scale supplies significantly for the coming years to treat even more patients. We're also excited about our pipeline progress and what we have coming up in terms of Mim8 and CagriSema.

是的。謝謝丹尼爾，也謝謝大家今天加入我們。因此，我希望大家對我們目前的業務勢頭感到非常滿意，前 3 個月的銷售業績以及至少 Ozempic 和 Wegovy 在美國的劇本開發就證明了這一點，真正證明了這一點我們正在努力在今年擴大這裡的供應。我們也承諾在未來幾年大幅擴大供應規模，以治療更多患者。我們也對我們的管道進展以及我們在 Mim8 和 CagriSema 方面的進展感到興奮。

And on a final note, I'd like to thank you Daniel. This was the last quarter with you at [Helmuth] as IR Head. Thank you for your leadership and best of luck with your continued career onwards. With this we close the call. Thank you all.

最後，我要感謝丹尼爾。這是您在 [Helmuth] 擔任 IR 主管的最後一個季度。感謝您的領導，祝福您職涯繼續順利。這樣我們就結束通話了。謝謝你們。

Thank you. This concludes today's conference call. Thanks 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。