諾和諾德 (NVO) 2021 Q3 法說會逐字稿

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  • Operator

    Operator

  • Welcome to the Q3 2021 Novo Nordisk A/S earnings conference call. (Operator Instructions) Today I'm pleased to present Lars Fruergaard Jorgensen, CEO. Please go ahead with your meeting.

    歡迎參加諾和諾德公司2021年第三季財報電話會議。 (操作員指示)今天,我很高興邀請執行長Lars Fruergaard Jorgensen出席。請繼續您的會議。

  • Lars Fruergaard Jorgensen - President, CEO & Member of Management Board

    Lars Fruergaard Jorgensen - President, CEO & Member of Management Board

  • Thank you very much. Welcome to this Novo Nordisk call regarding our earnings for the first 9 months of 2021 and outlook for the year. This call follows the early announcement of the high-level results and raised guidance published on Friday last week. I'm Lars Fruergaard Jorgensen, the CEO of Novo Nordisk. With me today I have Chief Financial Officer, Karsten Munk Knudsen; Executive Vice President and Head of Commercial Strategy and Corporate Affairs, Camilla Sylvest; Executive Vice President and Head of North America Operations, Doug Langa; and finally, Executive Vice President and Head of Development, Martin Holst Lange. All presenters will be available for the Q&A session. Today's earnings release and the slides for this call are made available on our website novonordisk.com.

    非常感謝!歡迎參加諾和諾德公司電話會議,討論我們2021年前9個月的業績及全年展望。本次電話會議是在上週五提前公佈了業績展望並上調後召開的。我是諾和諾德公司執行長Lars Fruergaard Jorgensen。今天與我一起出席的嘉賓有:財務長Karsten Munk Knudsen;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;以及執行副總裁兼開發主管Martin Holst Lange。所有演講嘉賓都將出席問答環節。今天的業績報告和本次電話會議的幻燈片可在我們的網站novonordisk.com上取得。

  • Please note that this call is being webcasted live and a recording will be made available on Novo Nordisk website. The call is scheduled to last for 1 hour. Please turn to the next slide.

    請注意,本次電話會議將進行網路直播,錄音將在諾和諾德網站上發布。會議預計持續1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. The Q&A session will begin in about 25 minutes.

    簡報的結構如投影片2所示。請注意,除非另有說明,所有銷售額和營業利潤成長報表均以固定匯率計算。問答環節將於約25分鐘後開始。

  • Please turn to Slide 3. As always, I need to advise you that this conference call will contain forward-looking statements. Such forward-looking statements are subject to risk and uncertainty that could cause actual results to differ materially from expectations. For further information on the risk factors, including the uncertainties around COVID-19, please see the company announcement for the first 9 months of 2021 and the slide prepared for this presentation. Please turn to the next slide.

    請翻到幻燈片3。像往常一樣,我需要提醒您,本次電話會議將包含前瞻性陳述。此類前瞻性陳述受風險和不確定性的影響,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,包括圍繞COVID-19的不確定性,請參閱公司2021年前9個月的公告以及為本次演示準備的幻燈片。請翻到下一張投影片。

  • In the first 9 months of 2021, Novo Nordisk has progressed on all 4 dimensions of our strategic aspirations. I would like to highlight a few today. Within purpose and sustainability, we have expanded the Changing Diabetes in Children program. It now includes 3 additional countries, Indonesia, Pakistan and Peru, to reach the total of 18 countries included in the program. This will support our aspiration of reaching 100,000 children and young people living with Type 1 diabetes in low-resource settings by 2030. Today, the program is providing free care to 30,000 children, adolescents in low- and middle-income countries.

    2021年前9個月,諾和諾德在戰略願景的四個維度中都取得了進展。今天,我想重點介紹其中幾個方面。在目標和永續性方面,我們擴展了「改變兒童糖尿病」計畫。該計畫現已新增印尼、巴基斯坦和秘魯三個國家,覆蓋國家總數達18個。這將支持我們實現2030年惠及資源匱乏地區10萬名1型糖尿病兒童和青少年的願景。目前,該計畫正在為中低收入國家的3萬名兒童和青少年提供免費醫療服務。

  • Within our Circular for Zero strategy, we are excited that Novo Nordisk has received an award at the Climate Week in New York City. The award was given for our work in accelerating the global transition to 100% renewable energy. Martin will come back to key milestones within R&D. But I would like to briefly share my perspectives.

    在我們的「循環零排放」策略框架下,我們很高興看到諾和諾德在紐約氣候週上榮獲獎項。該獎項旨在表彰我們為加速全球對100%再生能源轉型所做的貢獻。 Martin 稍後會回顧研發領域的關鍵里程碑。我想簡單分享一下我的觀點。

  • With initiation of 2 Phase III programs within Obesity and other serious chronic diseases, we now have ongoing late-stage clinical trials within all of our therapy areas. The Phase III initiation with Ziltivekimab demonstrated our ability to successfully integrate the late-stage assets we acquired from Corvidia Therapeutics in 2020 into our internal clinical development programs. For commercial execution, we have progressed on all 3 strategic aspirations, specifically for obesity care. The initial U.S. demand for Wegovy has significantly exceeded our expectations and underscore the high unmet need for people living with obesity. Camilla and Doug will elaborate further on Obesity and provide details on our other therapeutic areas later.

    隨著肥胖症和其他嚴重慢性疾病領域兩個III期計畫的啟動,我們目前在所有治療領域都有正在進行的後期臨床試驗。 Ziltivekimab的III期啟動證明了我們能夠成功地將2020年從Corvidia Therapeutics收購的後期資產整合到我們的內部臨床開發項目中。在商業化執行方面,我們在所有三個策略目標上都取得了進展,尤其是在肥胖治療領域。美國對Wegovy的初始需求大大超出了我們的預期,這也凸顯了肥胖患者的巨大未滿足需求。 Camilla和Doug稍後將進一步闡述肥胖症領域,並詳細介紹我們其他治療領域。

  • Lastly, leaving financials to Karsten, we are pleased with the sales growth of 13% and operating profit growth of 12% in the first 9 months to 2021, both measured in constant exchange rates. With that, I'll give the word to Camilla for an update on commercial exclusion.

    最後,財務方面就交給卡斯滕了,我們對2021年前9個月的銷售額增長13%和營業利潤增長12%感到滿意,這兩項數據均以固定匯率計算。接下來,我會通知卡蜜拉,告知她關於商業豁免的最新情況。

  • Camilla Sylvest - Executive VP, Head of Commercial Strategy & Corporate Affairs and Member of the Management Board

    Camilla Sylvest - Executive VP, Head of Commercial Strategy & Corporate Affairs and Member of the Management Board

  • Thank you, Lars. And please turn to Slide 5. In the first 9 months of 2021, our total sales increased by 13%. The sales increase was driven by both operating units with international operations growing 13% and North America operations also growing by 13%. GLP-1 sales increased 30%, driven by North America growing 24% and international operations growing 47%. Insulin sales increased by 2%, driven by 6% growth in international operations, partially offset by an 8% sales decline in North America operations. The U.S. insulin sales declined by 9%, driven by a decline in volume and realized prices. The latter driven by channel and payer mix as well as rebate enhancements.

    謝謝,Lars。請翻到投影片5。2021年前9個月,我們的總銷售額成長了13%。銷售額的成長是由兩個營運部門共同推動的,其中國際業務成長了13%,北美業務也成長了13%。 GLP-1銷售額成長了30%,其中北美業務成長了24%,國際業務成長了47%。胰島素銷售額成長了2%,其中國際業務成長了6%,但北美業務銷售額下降了8%,部分抵消了這一成長。美國胰島素銷售額下降了9%,原因是銷售量和實際價格下降。實際價格下降的驅動因素是通路和付款人組合以及返利的提高。

  • Obesity care sales grew 49% overall. In international operations, Saxenda sales grew 51%. And in North America operations Obesity care sales grew 48%. In the U.S., Obesity care sales grew 49%, driven by both Saxenda and Wegovy. Biopharm sales increased by 4%, driven by North America operations growing 6% and international operations growing by 3%.

    肥胖護理產品銷售額整體成長49%。 Saxenda在國際業務的銷售額成長了51%。北美業務中,肥胖護理產品銷售額成長了48%。在美國,肥胖護理產品銷售額成長了49%,主要得益於Saxenda和Wegovy的推動。生物製藥銷售額成長了4%,其中北美業務成長了6%,國際業務成長了3%。

  • Please turn to Slide 6. In line with our strategic aspiration of reaching 1/3 of the diabetes value market by 2025, our sales growth of 13% is faster than the overall diabetes market. And hence we have improved our market share by 0.7 percentage points to 29.9%. This increase reflects GLP-1 growth of 30% and market share gains in both operating units. Currently Ozempic has been launched in 67 countries and Rybelsus in 23 countries.

    請翻到幻燈片6。為了實現我們在2025年佔據糖尿病市場三分之一份額的策略目標,我們13%的銷售額成長率高於整體糖尿病市場。因此,我們的市佔率提升了0.7個百分點,達到29.9%。這一成長反映了GLP-1銷售額30%的成長以及兩個營運部門市佔率的提升。目前,Ozempic已在67個國家上市,Rybelsus已在23個國家上市。

  • Please turn to Slide 7. In international operations, diabetes care sales increased by 14% in the first 9 months of 2021, driven by all geographies and therapy areas. GLP-1 sales increased by 47% in the first 9 months of 2021. Novo Nordisk remains the market leader in international operations with a GLP-1 market share of 57.5%, reflecting an increase of 4.7 percentage points compared to 1 year ago. This is driven by share gains across geographies and overall GLP-1 share growth in international operations of 73.6%.

    請翻到幻燈片7。在國際業務方面,2021年前9個月,糖尿病護理產品銷售額成長了14%,這得益於所有地區和治療領域的成長。 GLP-1銷售額在2021年前9個月成長了47%。諾和諾德繼續保持國際業務的市場領先地位,GLP-1市佔率為57.5%,較一年前成長了4.7個百分點。這得益於各地區市場份額的成長以及國際業務中GLP-1整體市佔率73.6%的成長。

  • Please turn to the next slide. Biopharm sales grew by 4% in the first 9 months of 2021. This was driven by 6% sales growth in North America operations and 3% sales growth in international operations. Rare blood disorders grew by 7%, driven by uptake of our launch products Esperoct and Refixia, as well as NovoSeven and Novoeight. Specifically Hemophilia A products grew by 23%, Hemophilia B sales by 26% and NovoSeven by 2%. rare endocrine disorder sales were flat. The unchanged sales reflect international operations increasing by 6%, offset by North America operation decreasing by 10%.

    請翻到下一張投影片。 2021年前9個月,生物製藥銷售額成長了4%。這得益於北美業務6%的銷售額成長和國際業務3%的銷售額成長。罕見血液疾病銷售額成長了7%,這得益於我們上市產品Esperoct和Refixia以及NovoSeven和Novoeight的市場接受度。其中,血友病A產品成長了23%,血友病B產品成長了26%,NovoSeven產品成長了2%。罕見內分泌疾病銷售量持平。銷售額持平反映了國際業務6%的成長,但北美業務下降了10%。

  • And now over to Doug for an update on U.S. GLP-1 and Obesity care.

    現在請 Doug 介紹美國 GLP-1 和肥胖症護理的最新情況。

  • Douglas J. Langa - Executive VP, Head of North America Operations & Member of Management Board

    Douglas J. Langa - Executive VP, Head of North America Operations & Member of Management Board

  • Thank you, Camilla. Please turn to the next slide. The U.S. GLP-1 volume market growth is around 30%, comparing Q3 of 2021 to Q3 of 2020, driven by once weekly injectable GLP-1s as well as Rybelsus. Novo Nordisk new-to-brand market share leadership is now 63.7%, driven by continued uptake of Ozempic and Rybelsus. Additionally, Ozempic remains the NBRx market share leader within the injectable GLP-1s. And measured on total scripts, Novo Nordisk remains the market leader with more than 50% market share. Please turn to the next slide.

    謝謝,卡米拉。請翻到下一張投影片。美國GLP-1市場銷售成長約30%,與2020年第三季相比,成長主要得益於每週一次注射型GLP-1以及Rybelsus。諾和諾德在新品牌市場的領先地位目前達到63.7%,這得益於Ozempic和Rybelsus的持續成長。此外,Ozempic仍是注射型GLP-1中NBRx市場佔有率的領導者。以處方總量計算,諾和諾德仍是市場領導者,市佔率超過50%。請翻到下一張投影片。

  • In the U.S., Rybelsus' total prescription trajectory continues to steadily increase, now above 40,000 prescriptions per week. Since mid-May, our sales force has been fully back out in the field. And Rybelsus was the second largest contributor to growth for Novo Nordisk in the first 9 months of 2021. And if you look at the U.S. specifically, Rybelsus accounted for 36% of the growth in the first 9 months of 2021. Furthermore, leading indicators such as prescriber breadth, HCP awareness, and sourcing from outside the GLP-1 class remain encouraging.

    在美國,Rybelsus 的總處方量持續穩定成長,目前每週處方量超過 4 萬張。自 5 月中旬以來,我們的銷售團隊已全面復工。 Rybelsus 是諾和諾德 2021 年前 9 個月成長的第二大貢獻者。具體來看美國市場,Rybelsus 在 2021 年前 9 個月貢獻了 36% 的成長。此外,處方醫生覆蓋率、HCP 認知度以及 GLP-1 類藥物以外的採購等領先指標仍然令人鼓舞。

  • Importantly, we are confident in the product and its long-term potential. Don't forget that the -- that within the pioneer program Rybelsus demonstrated itself as the most efficacious OAD on the market as measured on A1C and weight. Now outside of the U.S., Rybelsus now has been launched in 22 countries with 1 key market being Japan where Rybelsus has reached a 0.9% modern OAD value market share.

    重要的是,我們對該產品及其長期潛力充滿信心。別忘了,在先鋒計畫期間,Rybelsus 就已證明其是市場上最有效的口服降血糖藥 (OAD),其療效以糖化血紅蛋白 (A1C) 和體重為衡量標準。目前,Rybelsus 已在美國以外的 22 個國家/地區上市,其中一個主要市場是日本,Rybelsus 在日本的現代 OAD 市場佔有率已達 0.9%。

  • While underlining parameters are on track, it should still be noted that Japan was in a third COVID-19 lockdown until the end of September, which has made it difficult for patients and sales forces alike to reach doctors. Please go to the next slide.

    雖然強調的參數已步入正軌,但仍需注意的是,日本在9月底前處於第三次新冠疫情封鎖狀態,這使得患者和銷售人員都難以聯繫到醫生。請翻到下一張投影片。

  • Globally Obesity care sales increased 49% with 48% growth in North American operations and 51% in international operations. As Lars mentioned earlier, the U.S. launch of Wegovy has significantly exceeded our expectations, underlining the high-met need for people with obesity. This has put the supply chain under pressure and patients may temporarily experience a delay in getting prescriptions filled throughout 2021.

    全球肥胖護理銷售額成長49%,其中北美業務成長48%,國際業務成長51%。正如Lars先前提到的,Wegovy在美國的上市顯著超出了我們的預期,凸顯了肥胖患者亟需滿足的醫療需求。這給供應鏈帶來了壓力,患者在2021年全年可能會暫時遇到處方藥延遲的情況。

  • We continue gradual increase in supply and expect to be able to meet demand in early 2022, of course depending upon demand. The initial feedback from patients and prescribers continues to be encouraging. 19 weeks after launch Wegovy has already surpassed Saxenda weekly script levels, reaching around 17,000 scripts per week. More than 70% of Wegovy prescriptions are new to the anti-obesity medication class. Thereby Wegovy is expanding the branded anti-obesity market.

    我們將繼續逐步增加供應,預計在2022年初能夠滿足需求,當然具體情況取決於需求。患者和處方醫生的初步回饋仍然令人鼓舞。 Wegovy上市19週後,每週處方量已超過Saxenda,達到約1.7萬份。超過70%的Wegovy處方是新開的減肥藥。 Wegovy正在拓展品牌減肥藥市場。

  • Market access has progressed since launch. And 3 national payers have now unblocked Wegovy from their national formulary. We are excited to share that commercial formulary access is now around 60% for Wegovy compared to around 80% for Saxenda. Outside the U.S., Wegovy has been submitted for regulatory review in Japan. And we expect a decision from EU authorities before year's end.

    自上市以來,市場准入取得了進展。目前,已有三家國家級付款機構將 Wegovy 從其國家處方集中解禁。我們很高興地宣布,Wegovy 的商業處方集准入率目前約為 60%,而 Saxenda 約為 80%。在美國以外,Wegovy 已提交日本監管部門審核。我們預計歐盟監管機構將在年底前做出決定。

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

    現在輪到你了,馬丁,來介紹研發的最新狀況。

  • Martin Holst Lange - Executive VP, Head of Development & Member of the Management Board

    Martin Holst Lange - Executive VP, Head of Development & Member of the Management Board

  • Thank you, Doug. In line with our COVID strategy to strengthen treatment options in Obesity and addressing an identified unmet need, we have initiated the first of 3 trials in the global Phase IIIa OASIS program, which has planned to enroll approximately 1,000 patients in total. The 68-week OASIS 1 trial will investigate the efficacy and safety once daily oral semaglutide 50 milligrams in 660 people with obesity, all overweight together with co-morbidities. Our expectation is to achieve an efficacy and safety profile similar to that of Wegovy.

    謝謝你,Doug。為了配合我們加強肥胖症治療方案的新冠疫情策略,並解決已發現的未滿足需求,我們已啟動全球IIIa期OASIS計畫三項試驗中的首項,該計畫共入組約1,000名患者。這項為期68週的OASIS 1期試驗將評估每日一次口服50毫克司美格魯肽(semaglutide)對660名肥胖症患者(所有患者均超重並伴有合併症)的療效和安全性。我們期望達到與Wegovy相似的療效和安全性。

  • Within other serious chronic diseases, we are taking an important step to establish a standard lone presence within cardiovascular disease, specifically within Atherosclerotic Cardiovascular Disease or ASCVD. A significant residual unmet need remains despite the availability of many treatments. Therefore in September of 21 we initiated the Phase III cardiovascular outcome trial called ZUES with the CVD asset that we have named Ziltivekimab, which we acquired from Corvidia in -- back in 2020. In brief, Ziltivekimab is a monoclonal antibody directed against IL-6, and is aimed to address the residual inflammation in patients with ASCVD as well as chronic kidney disease.

    在其他嚴重慢性疾病領域,我們正在邁出重要一步,在心血管疾病,特別是動脈粥狀硬化性心血管疾病 (ASCVD) 領域建立標準的單藥治療方案。儘管目前已有多種治療方法,但仍有大量未滿足的醫療需求。因此,我們在2021年9月啟動了名為ZUES的III期心血管結局試驗,試驗對像是我們於2020年從Corvidia收購的名為Ziltivekimab的心血管疾病藥物。簡而言之,Ziltivekimab是一種針對IL-6的單株抗體,旨在治療ASCVD和慢性腎臟病患者的殘留發炎。

  • The trial will assess the efficacy and safety of subcutaneous Ziltivekimab 15 milligram in around 6,200 patients with established ASCVD, chronic kidney disease and systemic inflammation. This will be an event-driven trial, which is expected to complete in 2025. As we previously discussed and as Lars also alluded to, with the initiation of these 2 Phase III programs in the third quarter, we now have ongoing Phase IIIa clinical programs within all of our therapy areas. Please turn to the next slide.

    該試驗將評估皮下注射Ziltivekimab 15毫克對約6,200例確診ASCVD、慢性腎臟病和全身性發炎患者的療效和安全性。這將是一項事件驅動型試驗,預計2025年完成。正如我們之前討論過的,以及Lars也提到的,隨著這兩個III期計畫的啟動,我們目前在所有治療領域都有正在進行的IIIa期臨床計畫。請翻到下一張投影片。

  • Now turning through the high-level R&D milestones, we start with the third quarter of '21. Within diabetes, we completed a Phase I trial with glucose-sensitive insulin called NN1845. In the trial, the asset appeared to have a safe and well-tolerated profile, and demonstrated proof of principle of glucose-sensitive properties. We're currently evaluating further development of glucose-sensitive insulin to optimize the pharmacokinetic properties of this acid. It goes without saying that this is an area that requires multiple short-term goal, and we are actively exploring these in our research areas.

    現在回顧一下高水準研發里程碑,從2021年第三季開始。在糖尿病領域,我們完成了葡萄糖敏感型胰島素NN1845的I期臨床試驗。試驗結果顯示,該藥物安全且耐受性良好,並已證明其具有葡萄糖敏感特性。我們目前正在評估進一步開發葡萄糖敏感型胰島素,以優化該酸的藥物動力學特性。毋庸置疑,這是一個需要設定多個短期目標的領域,我們正在積極探索這些目標,並致力於研究。

  • Within other serious chronic diseases, as we have just discussed in, we initiated Phase III cardiovascular outcome trial for Ziltivekimab. Within NASH we completed a Phase II trial in Q3, investigating the efficacy and safety of Semaglutide 2.4 milligram in people with NASH F4 cirrhosis. While the trial demonstrated significant and clinically relevant reductions in the level of fibrosis, it did not manage to demonstrate an effect of Semaglutide in the primary endpoint of fibrosis in this population. Semaglutide appeared to have a safe and well-tolerated profile.

    在其他嚴重慢性疾病領域,正如我們剛才討論的那樣,我們啟動了Ziltivekimab的III期心血管結局試驗。在NASH領域,我們已於第三季完成了一項II期試驗,旨在評估2.4毫克Semaglutide對NASH F4肝硬化患者的療效和安全性。雖然該試驗顯示Semaglutide顯著降低了纖維化程度,且具有臨床意義,但未能證明Semaglutide對此族群纖維化這一主要終點的療效。 Semaglutide似乎具有安全性和良好的耐受性。

  • A consequence of these results, we have decided that Semaglutide will be further developed for F4 cirrhosis patients as part of combination therapy only. To this effect, 2 combination trials have been initiated within NASH F4. One, as previously mentioned in collaboration with Gilead and one in combination with our internal assets. It's important to mention, and as previously discussed in Q2, that Semaglutide in monotherapy appears to be a very effective and potentially interesting treatment for patients with NASH F2 and F3. And this is currently being investigated in Phase III under an FDA breakthrough designation.

    基於這些結果,我們決定將索馬魯肽進一步開髮用於F4肝硬化患者的合併治療。為此,我們已啟動兩項NASH F4聯合治療試驗。一項如前所述,是與吉利德合作進行的,另一項與我們的內部資產聯合進行。值得一提的是,如第二季所述,索馬魯肽單藥治療似乎對NASH F2和F3患者非常有效,且具有潛在的治療潛力。目前,該藥物正在根據FDA突破性療法認定進行III期臨床試驗。

  • Towards the turn of the year we expect an opinion from the EU on Semaglutide 2.4 milligram in obesity and Ozempic 2.0 milligram in diabetes. Within Biopharm, we expect results from the Phase III program for somapacitan in children, as well as results from cohorts of the ongoing combined Phase I/II trial with Mim8.

    我們預期歐盟將在年底前就Semaglutide 2.4毫克用於治療肥胖症和Ozempic 2.0毫克用於治療糖尿病給予意見。在Biopharm,我們期待獲得兒童Somapacitan III期臨床試驗的結果,以及正在進行的與Mim8聯合進行的I/II期臨床試驗隊列的結果。

  • As planned, we will initiate baseline for the Phase III program with Mim8 in Q4 in at-risk, while still awaiting the full results from the Phase I/II trial. This aligns with the innovative and fast as well as ambitious clinical development program that we have previously talked about for Mim8. In the first half of '22 we expect Phase IIIa results for insulin Icodec in diabetes, as well as for Concizumab and the full resource for Mim8 in Biopharm. We also expect to see the initiation of the Phase III program for cagrisema in Obesity.

    按照計劃,我們將在第四季度啟動 Mim8 在高風險族群的 III 期臨床試驗基線,同時仍在等待 I/II 期試驗的完整結果。這與我們之前談到的 Mim8 創新、快速且雄心勃勃的臨床開發計劃相一致。我們預計在 2022 年上半年獲得胰島素 Icodec 治療糖尿病的 IIIa 期結果,以及 Concizumab 治療糖尿病的 IIIa 期結果,並全面投入 Biopharm 的 Mim8 研發資源。我們也預計將啟動針對肥胖症的 cagrisema 治療的 III 期臨床試驗。

  • With that, over to you, Karsten.

    現在,輪到你了,卡斯滕。

  • Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board

    Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board

  • Thank you, Martin. Please turn to Slide 14.

    謝謝馬丁。請翻到第14張投影片。

  • In the first 9 months of 2021, sales grew by 8% in Danish krone and by 13% at constant exchange rates. The gross margin declined to 83% compared to 83.8% in 2020. The decline reflects a negative currency impact of 0.5 percentage points, lower realized prices in the U.S. and amortization of intangible assets related to the acquisition of Emisphere Technologies in 2020. These are countered by a positive product mix, driven by increased GLP-1 sales and productivity improvements, in line with the strategic aspiration of driving operational efficiencies.

    2021年前9個月,銷售額以丹麥克朗計算成長8%,以固定匯率計算成長13%。毛利率從2020年的83.8%降至83%。毛利率下降反映了0.5個百分點的匯率負面影響、美國市場實際價格下降以及2020年收購Emisphere Technologies相關的無形資產攤銷。但正面的產品組合抵消了這些影響,這得益於GLP-1銷售額的成長和生產效率的提升,符合提升營運效率的策略目標。

  • Sales and distribution costs increased by 10% in Danish krone and 14% at constant exchange rates. The increase is driven by investments in our key strategic priorities, most notably launch activities and promotional spend for Rybelsus and Ozempic as well as market development activities for Obesity and investments in the U.S. launch of Wegovy.

    銷售和分銷成本以丹麥克朗計算成長了10%,以固定匯率計算成長了14%。成長主要源自於我們對關鍵策略重點的投資,尤其是Rybelsus和Ozempic的上市活動和推廣支出,以及針對肥胖症的市場開發活動,以及對Wegovy在美國上市的投資。

  • Research and development costs increased by 11% in Danish krone and 13% at constant exchange rates. The increase is driven by pipeline expansion and diversification, including progression of the pipeline within cardiovascular diseases and NASH. Administration costs increased by 4% in Danish krone and 6% at constant exchange rates, impacted by a low spend in the first 9 months of 2020 due to COVID 19. Operating profit increased by 5% in Danish krone and by 12% at constant exchange rates. It was positively impacted by the amortization of the priority review voucher for Wegovy in the U.S. in the third quarter of 2020.

    研發成本以丹麥克朗計算成長11%,以固定匯率計算成長13%。成長主要源自於產品線的拓展和多樣化,包括心血管疾病和非酒精性脂肪性肝炎(NASH)領域產品線的進展。管理成本以丹麥克朗計算成長4%,以固定匯率計算成長6%,主要受2020年前9個月新冠疫情導致支出減少的影響。營業利益以丹麥克朗計算成長5%,以固定匯率計算成長12%。 2020年第三季度,美國Wegovy優先審評券的攤銷對其產生了正面影響。

  • The negative currency impact on operating profit is partly offset by around DKK 1 billion in hedging gains under net financial items. This compares to a loss of around DKK 1.8 billion in the first 9 months of 2020. The gains on hedge currencies primarily related to the U.S. dollar. Net profit increased by 12% and diluted earnings per share increased by 14% to DKK 15.98. Free cash flow was DKK 52.3 billion compared to DKK 41.6 billion in 2020. The increase reflects the higher net profit, timing of rebates in the U.S. and favorable impact from changes in working capital.

    貨幣對營業利潤的負面影響被淨財務項目項下約10億丹麥克朗的對沖收益部分抵銷。相較之下,2020年前9個月的虧損約為18億丹麥克朗。對沖貨幣的收益主要與美元有關。淨利成長12%,稀釋每股收益成長14%,達15.98丹麥克朗。自由現金流為523億丹麥克朗,2020年為416億丹麥克朗。這一增長反映了更高的淨利潤、美國返利時機以及營運資本變化的有利影響。

  • Further, it is positively impacted by lower intangible investments related to the acquisition of Corvidia Therapeutics impact in 2020. Next slide, please.

    此外,2020 年收購 Corvidia Therapeutics 相關的無形投資減少也對其產生了正面影響。請看下一張投影片。

  • We now expect 2021 sales growth to be between 12% and 15% at constant exchange rates. The raised guidance is based on the performance seen in the first 9 months of the year and reflects expectations for continued sales growth in both international operations and North America operations. The updated outlook reflects higher-than-expected Ozempic market share gains, GLP-1 market growth and Obesity care sales, all mainly in the U.S. It also reflects intensifying competition within both diabetes care and Biopharm.

    我們目前預計,以固定匯率計算,2021 年銷售額成長將在 12% 至 15% 之間。此次上調的業績指引是基於今年前 9 個月的業績表現,反映了對國際業務和北美業務持續成長的預期。更新後的展望反映了 Ozempic 市場份額增長、GLP-1 市場增長以及肥胖護理銷售額高於預期,這些主要在美國市場。這也反映了糖尿病照護和生物製藥領域日益激烈的競爭。

  • Finally, continued pricing pressure within diabetes care, especially in the U.S. is expected to negatively impact sales developments. Operating profit is now expected to grow between 12% and 15%, reflecting the sales growth outlook and continued investments in current and future growth drivers. This includes the continued rollout of Ozempic and Rybelsus, the launch of Wegovy and associated market development activities. Furthermore, additional resources are being allocated to both early and late-stage R&D pipeline activities.

    最後,糖尿病照護領域持續的定價壓力,尤其是在美國,預計將對銷售發展產生負面影響。目前預計營業利潤將成長12%至15%,這反映了銷售成長前景以及對當前和未來成長動力的持續投資。這包括Ozempic和Rybelsus的持續推廣、Wegovy的上市以及相關的市場開發活動。此外,公司正在為早期和後期研發管線活動分配更多資源。

  • Given the current exchange rates, most notably a strengthening of the U.S. dollar, we expect a less negative currency impact for the full year compared to 3 months ago. Consequently, our reported sales and operating profit growth is now expected to be 3 and 4 percentage points lower than at constant exchange rates respectively.

    鑑於當前匯率情勢,尤其是美元走強,我們預期全年的匯率負面影響將較三個月前減弱。因此,我們報告的銷售額和營業利潤增幅預計將分別比以固定匯率計算的成長率低3個百分點和4個百分點。

  • For 2021, financial items are now expected to be a gain of around DKK 0.3 billion, mainly reflecting gains associated with foreign exchange hedging contracts. Capital expenditure is now expected to be around DKK 7 billion in 2021. Lastly, free cash flow has increased by DKK 5 billion and now expected to be between EUR 44 billion and DKK 49 billion. This reflects a favorable impact from higher sales and net profit expectations, timing of U.S. rebates in the U.S. and lower capital expenditure. Based on the increased expectations for cash flow generation in '21, the Board of Directors has approved an expansion of the 2021 share repurchase program by DKK 2 billion to DKK 20 billion.

    2021年,財務項目預計獲利約3億丹麥克朗,主要反映與外匯對沖合約相關的收益。 2021年資本支出預計約70億丹麥克朗。此外,自由現金流增加了50億丹麥克朗,預計在440億歐元至490億丹麥克朗之間。這反映了銷售額和淨利潤預期的提高、美國退稅時機的調整以及資本支出的降低所帶來的有利影響。基於2021年現金流產生預期的提高,董事會已批准將2021年股票回購計畫的規模擴大20億丹麥克朗,達到200億丹麥克朗。

  • That concludes the outlook for '21. Now back to you, Lars, for final remarks.

    以上就是21年展望的總結。現在回到拉爾斯,請你做最後的總結。

  • Lars Fruergaard Jorgensen - President, CEO & Member of Management Board

    Lars Fruergaard Jorgensen - President, CEO & Member of Management Board

  • Thank you, Karsten. Please turn to the final slide.

    謝謝卡斯滕。請翻到最後一張投影片。

  • We are very pleased with the sales growth in the first 9 months of 2021. Sales growth was driven by all geographical areas within international operations as well as North America operations and by all therapy areas. In particular, the sales growth was driven by an accelerated growth of our portfolio of GLP-1 treatments for diabetes and Obesity care.

    我們對2021年前9個月的銷售成長感到非常滿意。銷售成長主要得益於國際業務、北美業務以及所有治療領域的成長。尤其值得一提的是,我們用於糖尿病和肥胖症治療的GLP-1產品組合的加速成長推動了銷售成長。

  • The strong financial performance in the first 9 months of 2021 has enabled us to raise our outlook for the full year. From an R&D perspective, the 2 Phase III program initiations within Obesity and other serious chronic diseases highlights that we continue to expand our late-stage clinical pipeline.

    2021年前9個月的強勁財務表現使我們得以上調全年業績預期。從研發角度來看,肥胖症和其他嚴重慢性疾病領域兩個III期計畫的啟動,凸顯了我們持續拓展後期臨床研發管線的決心。

  • With that, we're now ready for the Q&A where I kindly ask all participants to limit her or himself to 1 or maximum 2 questions. Operator, we're now ready to take the first set of questions, please.

    好了,現在我們進入問答環節,請各位與會者盡量只提問1個問題,最多提問2個。接線員,我們現在可以開始回答第一組問題了。

  • Operator

    Operator

  • (Operator Instructions) Our first question is from Wimal Kapadia of Bernstein.

    (操作員指示)我們的第一個問題來自伯恩斯坦的 Wimal Kapadia。

  • Wimal Kapadia - Research Analyst

    Wimal Kapadia - Research Analyst

  • Wimal Kapadia from Bernstein. So can I just first ask a little bit more about '21 guidance and the implications heading into '22. So the top end of the sales range for '21 suggests the potential 4Q sales growth of over 20%. So can you just first discuss the dynamics that could potentially get us to that level of sales growth in the quarter? And then tied to that, what are the implications for this level of growth heading into '22. And outside of the 340 befit which annualizes, and possibly VBP, are there any other reasons why underlying growth should not be stronger next year given the Wegovy supply constraints that will be resolved. And I'll leave it there.

    伯恩斯坦的Wimal Kapadia。首先,我可以問一下關於2021年業績指引以及對2022年的影響嗎? 2021年銷售額預期上限預示著第四季銷售額成長可能超過20%。您能否先討論哪些因素可能會讓我們在本季達到這一銷售成長水準?然後,與此相關的是,這個成長水準對2022年的影響是什麼?除了340%的年化收益以及可能的VBP之外,考慮到韋戈維亞的供應限制即將解決,還有其他原因導致明年的潛在成長不會更強勁嗎?我就不多說了。

  • Lars Fruergaard Jorgensen - President, CEO & Member of Management Board

    Lars Fruergaard Jorgensen - President, CEO & Member of Management Board

  • Thank you, Wimal. And Karsten, while not guiding for '22 yet, can you talk a bit to lending this year and some of the building blocks for how to look at growth for next year?

    謝謝,Wimal。 Karsten,雖然您還沒有為2022年做出預測,但您能否談談今年的貸款情況,以及如何展望明年成長的一些基本要素?

  • Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board

    Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board

  • Yes. Absolutely. Thank you, Wimal for that set of questions. So first, looking at 2021, as you saw then we delivered 13% sales growth in the first 9 months. And mathematically of course it's hard to move the needle with only 1 quarter to go. So as a starting point, I think you should anchor yourself in the 13% and then look at the run rate we delivered in the third quarter, benefiting from the GLP-1 acceleration as well as the Obesity performance. So for '21, I think the starting point is more around the midpoint of our guidance range being around 13.5%. The reason why we choose to go with a slightly broader-than-normal guidance range is basically the volatility we've seen in our business over the past few years as well as also the volatility linked to the Obesity business. So that's basically the reason for the guidance range. But the starting point would be the midpoint of the range. Then moving into 2022.

    是的,完全正確。感謝 Wimal 提出的這一系列問題。首先,展望 2021 年,如您所見,我們在前 9 個月實現了 13% 的銷售額成長。當然,從數學角度來看,在僅剩一個季度的情況下,很難取得突破。因此,作為起點,我認為您應該將目標定在 13% 上,然後看看我們第三季度的業績,這得益於 GLP-1 的加速以及肥胖業務的良好表現。因此,對於 2021 年,我認為起點應該在我們指導區間的中點附近,即 13.5% 左右。我們之所以選擇略高於正常水平的指導區間,主要是因為過去幾年我們業務的波動性,以及與肥胖業務相關的波動性。所以,這基本上就是我們設定指導區間的原因。但起點應該是區間的中點。然後是 2022 年。

  • Then from a strategic point of view, we are pursuing a growth-focused strategy. And when you look at the growth rate for Novo Nordisk as a company, we are clearly outpacing the industry potentially close to double up in terms of top line growth compared to the industry at large. So clearly growth is a top priority for us as a company. 2021 was an exceptional year for us in terms of growth rates. Everything has pretty much gone well. So really a highly successful year to start on. And we do continue to pursue growth into 2022 at a very attractive level, driven by our GLP-1 business as well as our Obesity franchise. In terms of puts and takes, I would though caution you in terms of a couple of specific aspects. First of all, we are currently getting closer to a conclusion on the volume-based procurement tender situation in China.

    從策略角度來看,我們奉行以成長為中心的策略。諾和諾德的成長率明顯高於產業平均水平,我們的營收成長可能接近產業平均的兩倍。因此,成長顯然是我們公司的首要任務。就成長率而言,2021年對我們來說是非凡的一年。一切進展順利,這確實是一個非常成功的開局之年。在GLP-1業務和肥胖症業務的推動下,我們將繼續在2022年實現極具吸引力的成長。不過,關於利弊,我想提醒大家注意幾個具體方面。首先,我們目前在中國的批量採購招標情況即將得出結論。

  • We have not yet received the final bidding documents, but we expect to receive them shortly. And with insulin in China constituting to the tune of 9% of group sales, then this tender situation, we do expect to have a significant negative impact on our group sales in 2022 as 1 piece. Secondly, what we do benefit from in '21 is the 340B distribution policy change we did in the U.S. market, where we basically restricted distribution under the 340B program to covered entities. There we are getting a benefit. And as we've said in prior quarters, and there are no changes to that this quarter, then we're getting a benefit. It's less than 3% of U.S. sales, but I'm just reminding you that even 3% of U.S. sales is 1.5% of group sales. So with that in the base, we would not get that growth benefit in 2022. And then finally, what we're benefiting from now is also an acceleration in the GLP-1 market in diabetes in the U.S., but also outside the U.S. we've seen in Q3, as you heard, to the tune of 30% volume market growth in the GLP-1 segment. That acceleration and looking at some of the more weekly trends, we do expect that acceleration to slow down and getting back to a more normalized growth level in the whole GLP-1 market when we get into 2022. So you have to adjust for those factors. But needless to say, we do continue to push for attractive growth for our shareholders.

    我們尚未收到最終招標文件,但預計很快就會收到。鑑於中國胰島素市場佔集團銷售額的9%,我們預期此次招標將對我們2022年的集團銷售額產生重大負面影響。其次,我們在2021年受益的是我們在美國市場實施的340B分銷政策變更,該政策基本上將340B計劃下的分銷限制在受保實體範圍內。這讓我們受益匪淺。正如我們在前幾個季度所說,本季沒有變化,所以我們確實受益匪淺。這不到美國銷售額的3%,但我要提醒大家,即使是美國銷售額的3%,也只佔集團銷售額的1.5%。因此,以此為基礎,我們在2022年將無法獲得成長效益。最後,我們現在受益的是美國糖尿病GLP-1市場的加速成長,以及美國以外市場的成長。正如您所聽到的,我們在第三季度看到GLP-1細分市場的銷量成長了30%。從這種加速成長以及一些每週趨勢來看,我們確實預計,到2022年,整個GLP-1市場的成長速度將會放緩,並恢復到更正常的成長水平。所以你必須根據這些因素進行調整。但毋庸置疑,我們將繼續為股東爭取具有吸引力的增幅。

  • Lars Fruergaard Jorgensen - President, CEO & Member of Management Board

    Lars Fruergaard Jorgensen - President, CEO & Member of Management Board

  • Strong growth for a couple of factors to begin for the short term.

    短期內,有幾個因素將開始強勁成長。

  • Operator

    Operator

  • Our next question is from Peter Verdult of Citigroup.

    我們的下一個問題來自花旗集團的 Peter Verdult。

  • Peter Verdult - MD

    Peter Verdult - MD

  • Peter Verdult of Citi. 2 questions. Firstly, just Camilla or Doug, appreciate the update and comments on reimbursement access. Just 1 clarification. Should we still be thinking that when it comes to Wegovy prescriptions, 50% are reimbursed versus -- and 50% are effectively given away as part of the Novo assistance programs. I wanted to make sure whether that's the right way of thinking about it going forward. And then secondly, for Lars and Karsten, just the -- any comments you're willing to give realizing that things are subject to change. But on the drug pricing amendments announced overnight in the U.S. they've enacted and the donut hole discount is removed. That looks like a big win for Novo, but more pragmatic long-term would be mandatory price cuts for semaglutide before the IP expires. So realize nothing is set in stone. I realize you're not going to speculate. But I don't think you'll be remiss of me not to ask you for some initial thoughts on those developments.

    花旗銀行的Peter Verdult,有兩個問題。首先,Camilla或Doug,感謝您關於報銷管道的更新和評論。我只想澄清一點。我們是否仍然認為,在Wegovy的處方中,50%可以報銷,而50%實際上是作為Novo援助計劃的一部分免費贈送的?我想確認一下,這種想法是否是正確的。其次,Lars和Karsten,請問您有什麼意見嗎?請理解,情況可能會有所變化。但就美國隔夜宣布的藥品定價修正案而言,他們已經實施,取消了「甜甜圈洞」折扣。這看起來對Novo來說是一個巨大的勝利,但更務實的長期方案是在智慧財產權到期前強制降低司美格魯肽的價格。所以,要知道,一切都不是一成不變的。我知道您不會進行任何猜測。但我認為如果我不詢問您對這些發展的一些初步想法,您就不會失信於我。

  • Lars Fruergaard Jorgensen - President, CEO & Member of Management Board

    Lars Fruergaard Jorgensen - President, CEO & Member of Management Board

  • Thanks, Peter, for those questions. Doug initially on, say, the book of business in the U.S. on Wegovy, and then I'll cover the drug price reform afterward.

    謝謝彼得的提問。道格首先會講一下Wegovy在美國的業務狀況,之後我會講一下藥品價格改革。

  • Douglas J. Langa - Executive VP, Head of North America Operations & Member of Management Board

    Douglas J. Langa - Executive VP, Head of North America Operations & Member of Management Board

  • Yes. Thanks, Peter, for the question. So overall, progress has been made. And we're happy with the progress with the overall commercial formulary access for Wegovy. And broadly speaking, we're looking at 40% to 60%, 40% coverage, 60% not covered.

    是的。彼得,謝謝你的提問。總的來說,我們取得了進展。我們對Wegovy商業處方集取得的整體進展感到滿意。整體而言,我們預期覆蓋率將達到40%到60%,其中40%為有效覆蓋,60%為無效覆蓋。

  • Lars Fruergaard Jorgensen - President, CEO & Member of Management Board

    Lars Fruergaard Jorgensen - President, CEO & Member of Management Board

  • Good. And you alluded a bit to it, Peter, yourself that it's difficult to speculate about the U.S. health care reform. Just noting over the past couple of weeks I think a rhetoric has been going forth and back. So we would like to have, say, the final text before we start assessing the impact on us. Having said that though, we strongly welcome anything that help the patient's out-of-pocket situation because the complexity of the system ends up with a lot of patients struggling. As you know, we -- a couple of years back put some affordability programs in play to take some of that pain away, and there was also a cost to that. So anything that can smoothen out the system and help patients better is obviously good for the patient, but I think it's also going to be pretty good for our business. But we need to see the final text before we comment on that. So hopefully when we talk a quarter from now, there's more clarity on that.

    很好。彼得,你自己也提到了一點,美國醫改很難預測。我注意到過去幾週,各種說法一直在反覆。所以,我們希望在開始評估對我們的影響之前,能先看到最終文本。話雖如此,我們仍然強烈歡迎任何有助於緩解患者自付費用壓力的措施,因為醫療體系的複雜性最終導致許多患者陷入困境。如你所知,幾年前我們實施了一些可負擔性項目,以減輕患者的負擔,但這也需要付出一些代價。所以,任何能夠理順醫療體系、更好地幫助患者的措施顯然對患者有利,但我認為這對我們的業務也大有裨益。但我們需要先看到最終文本,然後再對此發表評論。希望我們在一個季度後討論時,能對此有更清晰的認識。

  • Operator

    Operator

  • Our next question is from Simon Baker of Redburn.

    我們的下一個問題來自雷德伯恩的西蒙貝克。

  • Simon P. Baker - Head of Pharmaceutical Research

    Simon P. Baker - Head of Pharmaceutical Research

  • Two, if I may, please. Firstly, on Biopharma, the quarter did look a little weaker than consensus was expecting. You did allude to Chinese destocking impacting hemophilia. I just wonder if there were any other factors you would highlight maybe given the exposure to the tender market in Biopharma, any timing of tenders that were different to what you were expecting? And then secondly, on Capex. I see you just trimmed the CapEx guidance slightly for '21. I just wonder if you could give us any color on that and any implications for the CapEx outlook going forward into '22 and beyond?

    請問二。首先,生物製藥方面,本季的表現確實略弱於市場普遍預期。您確實提到了中國去庫存化對血友病治療的影響。考慮到生物製藥行業的招標市場,您是否還有其他因素可以強調?例如,招標時間是否與您的預期不同?其次,關於資本支出。我看到您剛剛略微下調了2021年的資本支出預期。您能否就此提供一些信息,以及這對2022年及以後的資本支出前景有何影響?

  • Lars Fruergaard Jorgensen - President, CEO & Member of Management Board

    Lars Fruergaard Jorgensen - President, CEO & Member of Management Board

  • Thank you, Simon. So 2 questions to you, Karsten. Firstly, on the Biopharm performance in the third quarter, not lower than what we saw in the beginning of the year. And then CapEx also a bit lower compared to what we have seen before. Any perspectives on that?

    謝謝西蒙。卡斯滕,我有兩個問題想問您。首先,生物製藥部門第三季的業績表現並不低於年初的水準。其次,資本支出也比以往略低。您對此有何看法?

  • Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board

    Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board

  • Yes. Thank you, Simon, for that set of questions. And starting out with Biopharma, I'd just like to remind you that the Biopharm business is a more volatile business than the rest of our businesses in diabetes. So kind of awe-interpreting on the quarters is dangerous on Biopharm. So you should more be looking at biopharm on a year-to-date basis, growing some 4%, which we're actually very, very satisfied with. To give you a little bit of flavor on the quarter though, I'd say, we did have some changes in shipment timing on the hemophilia side in international operations impacting the quarter. And in the U.S., we did have some minor adjustments to rebate estimates that impacted our growth hormone franchise. So again, the more kind of informative measure would be our year-to-date performance, which we're very satisfied with. As to CapEx, it's a slight fine-tuning. That's nothing substantive around it. It's -- the adjustment is basically linked to phasing of the execution of our cash burn on our ongoing CapEx programs. So there are no delays or anything in our programs. It's purely, you would say, exact timing on cash flow. Nothing more than that.

    是的。 Simon,謝謝你的提問。首先從生物製藥開始,我想提醒你,生物製藥業務比我們糖尿病領域的其他業務波動更大。所以,對生物製藥的季度業績過於樂觀是危​​險的。所以,你應該更專注於生物製藥業務的年初至今情況,它成長了約4%,我們對此非常非常滿意。不過,為了讓你對本季的情況有個大致的了解,我想說,我們在血友病藥物的國際業務中,發貨時間確實發生了一些變化,這對本季度產生了影響。在美國,我們對回扣估算進行了一些小幅調整,這影響了我們的生長激素業務。所以,更具參考價值的指標應該是我們年初至今的業績,我們對此非常滿意。至於資本支出,這只是一個輕微的微調,並沒有什麼實質的改變。調整基本上與我們正在進行的資本支出項目現金消耗的分階段執行有關。因此,我們的專案沒有任何延遲或其他問題。這純粹是,你會說,對現金流的精確計時。僅此而已。

  • Lars Fruergaard Jorgensen - President, CEO & Member of Management Board

    Lars Fruergaard Jorgensen - President, CEO & Member of Management Board

  • Thank you, Karsten. And on CapEx, it's clear that with the momentum we see right now, we are probably going to spend more money compared to less money on CapEx because it's a really, really strong growth. And obviously we need to make sure we have capacity to support that.

    謝謝,卡斯滕。關於資本支出,很明顯,以我們目前的勢頭來看,我們在資本支出上的支出可能會增加,而不是減少,因為這是一個非常非常強勁的成長。顯然,我們需要確保我們有能力支持這一點。

  • Operator

    Operator

  • Our next question is from Michael Leuchten of UBS.

    我們的下一個問題來自瑞銀的 Michael Leuchten。

  • Michael Leuchten - Co-Head of Pharmaceuticals Research of Equity Research

    Michael Leuchten - Co-Head of Pharmaceuticals Research of Equity Research

  • It's Michael Leuchten from UBS. 2 questions, please. One, Karsten, just going back to the guidance, the implied OpEx growth in the fourth quarter is pretty punchy. And certainly, as the year has progressed, you seem to sort of have walked up the OpEx phasing into the business as the top line outlook has improved as well. In the fourth quarter, where is that incremental investment going? And what implications does that have as a run rate as we think about 2022, if you could? And a question for Doug. Looking at the value of the volume of Rybelsus, it looks like it stepped up. I presume that's the co-pay card rolling off. If that's the case, timing is interesting here, if Rybelsus really is the product that longer-term is sort of meant to carry the torch, why would you pull the co-pay program at this point in time, if that's indeed what is driving the value of the volume?

    我是瑞銀的麥可‧洛伊希滕 (Michael Leuchten)。請問兩個問題。第一,卡斯滕,回到業績指引上,第四季隱含的營運支出成長相當強勁。當然,隨著今年的進展,隨著營收前景的改善,你們似乎已經逐步提高了營運支出。在第四季度,這些增量投資將流向何處?如果可以的話,這對我們設想的2022年的運行率有何影響?還有一個問題問道格。從 Rybelsus 的銷量來看,它似乎有所增長。我猜是因為自付費用卡的推出。如果是這樣的話,時機就很有趣了。如果 Rybelsus 真的是長期目標產品,那麼如果自付費用卡確實是銷售成長的驅動因素,那麼為什麼你們會在這個時候取消自付費用卡呢?

  • Operator

    Operator

  • Ladies and gentlemen, please hold. We're experiencing some technical difficulties.

    女士們,先生們,請稍候。我們遇到了一些技術問題。

  • (technical difficulty)

    (技術難度)

  • Operator

    Operator

  • Ladies and gentlemen, thank you for your patience. We have now reconnected. Our question was from Michael Leuchten of UBS.

    女士們,先生們,感謝各位的耐心等待。我們現在已經接通。我們的問題來自瑞銀的Michael Leuchten。

  • Lars Fruergaard Jorgensen - President, CEO & Member of Management Board

    Lars Fruergaard Jorgensen - President, CEO & Member of Management Board

  • So Michael, I'm not sure when the technology went down. So did you hear Karsten's answer? And did you hear Doug's answer?

    邁克爾,我不確定科技什麼時候失效了。你聽到卡斯滕的回答了嗎?你聽到道格的回答了嗎?

  • Michael Leuchten - Co-Head of Pharmaceuticals Research of Equity Research

    Michael Leuchten - Co-Head of Pharmaceuticals Research of Equity Research

  • No, sorry, it cut off entirely before that.

    不,抱歉,它在那之前就完全切斷了。

  • Lars Fruergaard Jorgensen - President, CEO & Member of Management Board

    Lars Fruergaard Jorgensen - President, CEO & Member of Management Board

  • Okay. So let's try again. So the first question was on guidance for OpEx growth in fourth quarter. So Karsten, if you can talk to that. And then secondly, Doug will talk to how we see Rybelsus launch and also how we look at co-pays, et cetera.

    好的。我們再問一次。第一個問題是關於第四季度營運支出成長的預期。 Karsten,您能談談這個問題嗎?其次,Doug 會談談我們如何看待 Rybelsus 的發布,以及我們如何看待共付額等等。

  • Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board

    Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board

  • Yes, absolutely. Thanks, Michael, for that set of questions and apologies for technical glitch. So when you look at the OpEx into the fourth quarter, it's of course the same principle we're applying for our resource allocation. And just the main nuts and bolts is basically we continue to invest in R&D. Where we are now exceeding 35,000 annualized patients on clinical trials. So all-time high in global development. So continued increasing investments in R&D, which of course you should expect into 2022 also. And in our commercial investments in S&D, we are continuing to invest in growing and expanding our GLP-1 business in diabetes as well as market development as well as we go with launch activities in Obesity. So the same principles applies. And in terms of run rate into fourth quarter. I don't see it as too dissimilar from the run rate we've seen thus far this year. And then, of course, you shouldn't technically do your forecast, as I know you know, based on 1 quarter into next year. But it's the same principles that we're rolling into next year. So aggressive growth investments in commercial and expansion into a broader and more diversified pipeline in R&D.

    是的,完全正確。 Michael,謝謝你的提問,也對技術故障表示歉意。所以,當你觀察第四季的營運支出時,我們當然會遵循同樣的資源配置原則。主要的核心是我們繼續在研發方面投入。目前,我們每年參與臨床試驗的患者數超過3.5萬,創下了全球研發領域的新高。因此,我們繼續加大研發投入,當然也應該持續到2022年。在研發的商業投資方面,我們將持續投資於GLP-1在糖尿病領域的業務成長與拓展,以及市場開發,同時我們也正在推動肥胖症領域的上市活動。所以,同樣的原則也適用。至於第四季的運行率,我認為它與今年迄今為止的運行率並沒有太大差異。當然,從技術上講,你不應該基於明年第一季的情況來做預測,我知道這一點。但我們明年仍將遵循同樣的原則。我們將在商業領域進行積極的成長投資,並拓展更廣泛、更多樣化的研發管道。

  • Lars Fruergaard Jorgensen - President, CEO & Member of Management Board

    Lars Fruergaard Jorgensen - President, CEO & Member of Management Board

  • Thank you, Karsten. Doug, on Rybelsus' performance in the U.S.

    謝謝你,Karsten。 Doug,關於 Rybelsus 在美國的表現。

  • Douglas J. Langa - Executive VP, Head of North America Operations & Member of Management Board

    Douglas J. Langa - Executive VP, Head of North America Operations & Member of Management Board

  • Again, Michael, thank you again for that question. Overall, we do consider it still a very successful launch for Rybelsus overall. And despite some of the lockdowns that we've experienced with COVID-19 last year into this year, as I mentioned, the field force is back in since mid-May. We still consider it a successful launch. Are we where we want to be? Well, again, based on what I said earlier, we can't forget that through the pioneer program Rybelsus demonstrated itself as the most efficacious OAD in the market. So we're still very bullish on the long-term aspect of what Rybelsus can do. And we have a lot of leading indicators which help us be encouraged with this, whether it's -- again, if you look at the growth overall, as we said it was the second biggest growth driver for the company, 36% of the growth in the U.S., we delivered over 180% growth. But maybe more importantly, other leading indicators such as breadth and depth, brand awareness, brand preference, we're still seeing over 80% of the business come out of the GLP-1 category outside of the GLP-1 category. Other things like we're doing 40,000 prescriptions per week. And again, we have a significant number of writers, over 45,000. So these are all indicators that we're still very bullish on what we can do over the long haul.

    邁克爾,再次感謝您的提問。總的來說,我們認為 Rybelsus 的發布仍然非常成功。儘管去年和今年我們經歷了一些新冠疫情的封鎖,但正如我所提到的,第一線員工自 5 月中旬以來就已恢復工作。我們仍然認為這是一次成功的發布。我們達到預期目標了嗎?嗯,再次強調,基於我之前所說的,我們不能忘記,透過先鋒項目,Rybelsus 證明了自己是市場上最有效的處方藥 (OAD)。因此,我們仍然非常看好 Rybelsus 的長期發展。我們有很多領先指標可以讓我們對此感到鼓舞,無論是——再說一次,如果你看一下整體成長情況,正如我們所說,它是公司的第二大成長動力,占美國成長的 36%,我們實現了超過 180% 的成長。但或許更重要的是,其他領先指標,例如廣度和深度、品牌知名度、品牌偏好度,我們仍然看到超過80%的業務來自GLP-1類別以外的產品。此外,我們每週開出的處方數量達到4萬張。此外,我們擁有數量可觀的處方撰寫員,超過4.5萬名。這些都表明,我們仍然對長期發展充滿信心。

  • Operator

    Operator

  • Our next question is from Emmanuel Papadakis from Deutsche Bank.

    下一個問題來自德意志銀行的 Emmanuel Papadakis。

  • Emmanuel Douglas Papadakis - Research Analyst

    Emmanuel Douglas Papadakis - Research Analyst

  • Maybe I could just come back on Wegovy, the 40-60, sounds like it's I guess, you could say, deteriorated, if anything, in Q2 as there is more subsidized products out there. How is that evolving through Q4? When do you expect we'll be at a stage that the copay support is fully rolled off, that likely be by the front end of Q1? And what kind of impact are you expecting that to have on the launch once you've normalized the supply situation? And then just a question on the commercial access. You disclosed the first time 60%. Can you talked to us a little bit about the levels of utilization management within that, are they similar to Saxenda? Are you seeing any significant differences? And how do you expect those to evolve into '22 as well?

    我可以再說說 Wegovy 的 40-60 倍劑量方案,聽起來它在第二季度的情況有所惡化,因為市面上有更多補貼產品。第四季的情況會如何發展?您預計什麼時候能完全取消共付額支持,可能是在第一季末?一旦供應情況正常化,您預計這會對產品上市產生什麼樣的影響?然後是關於商業化准入的問題。您第一次披露的是 60%。能否談談其中的利用率管理水準?它們與 Saxenda 相似嗎?您發現有什麼顯著差異嗎?您預計這些因素在 2022 年會如何發展?

  • Lars Fruergaard Jorgensen - President, CEO & Member of Management Board

    Lars Fruergaard Jorgensen - President, CEO & Member of Management Board

  • Thank you, Emmanuel. Let me try to address the Wegovy. So our strategic priorities have been to really mobilize patients to seek care, to get physicians to prescribe antiobesity medicine and get payers to reimburse Wegovy. And you shouldn't get too deep into short-term commercial tactics in how we do that and make that a proxy for the future because the fact that we have had this bridging program has indeed helped us to mobilize patients and get physicians to prescribe it. And the clinical profile of Wegovy has attracted a lot of attention from the payer. So now we have the 3 big PBMs supporting it.

    謝謝Emmanuel。我來談談Wegovy。我們的策略重點一直是真正動員患者就醫,讓醫生開出減肥藥,並讓支付方報銷Wegovy的費用。你不應該過度關注我們如何做到這一點的短期商業策略,也不應該將其作為未來的參考,因為我們設立的這個銜接計畫確實幫助我們動員了患者,並讓醫生開出處方。 Wegovy的臨床表現也引起了支付者的廣泛關注。所以現在我們有三大藥品福利管理公司(PBM)支持它。

  • And then you can say, as launch progresses we can gradually start considering a different promotional mix. After 6 months, you can, for instance, do DTC in the U.S., which you cannot do in the beginning. So there you need to use a copay or the bridging program to gain patient experience. So we are quite agile in how we look at this promotional mix and short-term book of business, whether it's on commercial covered patients or its 3 patients, doesn't really matter for us. It's about getting this market and the brand going. And from everything we can see, we are succeeding in doing that. So Doug, a few more perspectives on how the commercial access works.

    然後,隨著產品發布的推進,我們可以逐步開始考慮不同的推廣組合。例如,6個月後,你就可以在美國開展直接面向消費者(DTC)的銷售模式,而這在初期是無法實現的。因此,你需要使用共付額或橋接方案來累積病患體驗。因此,我們能夠靈活地調整推廣組合和短期業務,無論是商業覆蓋的患者或3位患者,對我們來說都無關緊要。關鍵在於讓這個市場和品牌繼續發展。從目前的情況來看,我們正在成功做到這一點。 Doug,我想再談談關於商業管道如何運作的一些觀點。

  • Douglas J. Langa - Executive VP, Head of North America Operations & Member of Management Board

    Douglas J. Langa - Executive VP, Head of North America Operations & Member of Management Board

  • Yes. So just to answer, Emmanuel, the very specific question you had. It is very similar to utilization management to Saxenda. And importantly, there's no step-through. So that's important. And then overall, again, as I mentioned earlier, we have 60% overall formulary access, and that's progressing nicely. The team is also doing a really nice job in terms of the opting component with employers. I can't get any specifics there, but again, that's progressing nicely. Remember, this is still not considered a standard listed product, formulary products. So we have some work to do there. But the team is working hard. And as Lars mentioned, we have all 3 major PBMs on board. That's a really good sign. And we have partnerships with several of them in weight management programs, which is also another very good sign. So overall, I think progress is being made.

    是的。 Emmanuel,我來回答你剛才那個非常具體的問題。它與Saxenda的利用率管理非常相似。而且重要的是,它沒有逐步執行的步驟。這一點很重要。總的來說,正如我之前提到的,我們擁有60%的處方藥存取權限,而且進展順利。團隊在與雇主的選擇環節也做得很好。我無法提供任何具體信息,但總的來說,進展順利。請記住,這仍然不被視為標準上市產品,即處方藥產品。所以我們在這方面還有一些工作要做。但團隊正在努力。正如Lars所提到的,我們已經與三大藥品福利管理公司(PBM)達成了合作。這是一個非常好的跡象。我們與其中幾家公司在體重管理專案方面建立了合作關係,這也是另一個非常好的跡象。所以總的來說,我認為我們正在取得進展。

  • Operator

    Operator

  • Our next question is from Steve Scala of Cowen.

    我們的下一個問題來自 Cowen 的 Steve Scala。

  • Stephen Michael Scala - MD & Senior Research Analyst

    Stephen Michael Scala - MD & Senior Research Analyst

  • You noted that you expect Wegovy's supply to meet demand in early 2022. What level of demand does this imply based on your expected supply? So for instance, is it closer to 2x more, 10x more or 25x more? And then secondly, similar question to ones that have already been asked, but a little different version, what percent of the U.S. population can access full coverage of Wegovy today? And what might that percent be at the beginning of 2022?

    您提到,預計 Wegovy 的供應量將在 2022 年初滿足需求。根據您預期的供應量,這意味著什麼程度的需求?例如,是接近 2 倍、10 倍還是 25 倍?其次,與先前的問題類似,但略有不同:目前有多少比例的美國人口可以完全享受 Wegovy 的服務?到 2022 年初,這個比例會是多少?

  • Lars Fruergaard Jorgensen - President, CEO & Member of Management Board

    Lars Fruergaard Jorgensen - President, CEO & Member of Management Board

  • So thank you, Steve. So we have our own forecast in how we model demand. And unfortunately, we're not in a position to be able to share that. But we believe that based on how we understand the market, the flow of patients that we can match that demand. But of course, we have been surprised initially here. So we do not know much more than you do in terms of what the real demand will be, but we feel comfortable that we can help the patients in need of antiobesity medicine. And Doug, on the second question in terms of which percentage of the U.S. population is within reach.

    謝謝你,史蒂夫。我們對需求模型有自己的預測。很遺憾,我們無法分享這些資訊。但我們相信,基於我們對市場的了解和對患者流量的了解,我們可以滿足這項需求。當然,我們一開始也感到很驚訝。所以,我們對實際需求的了解並不比你多,但我們相信我們能夠幫助那些需要減肥藥的患者。道格,關於第二個問題,美國有多少比例的人口可以負擔得起。

  • Douglas J. Langa - Executive VP, Head of North America Operations & Member of Management Board

    Douglas J. Langa - Executive VP, Head of North America Operations & Member of Management Board

  • Yes. Thanks for the question, Steve. In any end, it's important to note that we still don't have Medicare coverage, so that takes out a significant portion of the population. We're working really hard, and we hope to, at some point, whether it's through the Treat and Reduce Obesity Act or some policy change and other policy change to open up that because as a company we certainly think that seniors in the U.S. should have access to antiobesity medications. I mean that's clear. Today, again, so if you just take a look at the commercial access and where we are, we think around 16 million to 20 million people -- patients living with obesity have access. And again, our aim is to get that much more like other products, standard list of products. So our aim is to get much higher, and that's going to take some work. But today, around 16 million to 20 million people today.

    是的。謝謝你的提問,史蒂夫。無論如何,需要注意的是,我們仍然沒有醫療保險覆蓋,這意味著很大一部分人口無法獲得醫療保險。我們正在努力,希望最終能夠透過《治療和減少肥胖法案》或其他政策變化來開放這一覆蓋範圍,因為作為一家公司,我們當然認為美國的老年人應該能夠獲得減肥藥物。這一點很清楚。今天,如果你看一下商業管道以及我們目前的狀況,我們認為大約有1600萬到2000萬肥胖患者可以獲得這些藥物。我們的目標是讓這些藥物更像其他產品,成為標準產品清單。所以我們的目標是更高,這需要一些努力。但今天,大約有1600萬到2000萬人可以獲得這些藥物。

  • Lars Fruergaard Jorgensen - President, CEO & Member of Management Board

    Lars Fruergaard Jorgensen - President, CEO & Member of Management Board

  • Thank you, Doug, and (inaudible).

    謝謝你,道格,還有(聽不清楚)。

  • Operator

    Operator

  • Our next question is from Carsten Lønborg of SEB.

    我們的下一個問題來自 SEB 的 Carsten Lønborg。

  • Carsten Lønborg Madsen - Research Analyst

    Carsten Lønborg Madsen - Research Analyst

  • I have a couple of questions here to Martin, I guess. The OASIS program for Alzheimer's in Obesity, you have 3 trials in this program in total. 1 China patients, 1 Japanese patients, 1 with European and North American patients combined. Is this a sign that you only need 1 trial to get this product approved in the U.S. with the North American patients? Or can you leverage something else on top of this? And then for sema in Alzheimer's, I know it's not so long ago since you actually initiated the Phase III trial. But could you maybe share some of the feedback you have had in terms of appetite to get enrolled on this trial in the Alzheimer's community?

    我想問馬丁​​幾個問題。你們的OASIS肥胖症阿茲海默症計畫總共有3項試驗,1項針對中國患者,1項針對日本患者,1項針對歐洲和北美患者的聯合試驗。這是否意味著你們只需要進行1項試驗就能讓該產品在美國獲得北美患者的批准?或者你們可以在此基礎上採取其他措施嗎?然後,關於阿茲海默症的sema,我知道你們啟動III期試驗的時間並不長。能否請您分享一下,你們收到的回饋,看看是否有人希望在阿茲海默症患者族群中參與這項試驗?

  • Lars Fruergaard Jorgensen - President, CEO & Member of Management Board

    Lars Fruergaard Jorgensen - President, CEO & Member of Management Board

  • Thank you, Karsten. Over to you, Martin, first on OASIS trial design, number of trials needed, et cetera.

    謝謝你,Karsten。 Martin,首先請你談談OASIS試驗的設計、所需的試驗數量等等。

  • Martin Holst Lange - Executive VP, Head of Development & Member of the Management Board

    Martin Holst Lange - Executive VP, Head of Development & Member of the Management Board

  • Yes, absolutely. So as you mentioned, on OASIS, it's a fairly SLIM program, 1,000 patients in total, which obviously also indicates that we have agreed with regulatory authorities that we need to bridge based on the data that we already have on Semaglutide. And we are in a good position that we're both on subcutaneous and oral and also on the different doses, now also on oral have a lot of data with which we can bridge to satisfy the regulatory requirements. On the Alzheimer's trial, it's still early days. As you can probably imagine, we are screening a great number of patients, but the screening period in and of itself is 3 months. So at this point in time, what we see is that the sites that are opening up and running actually screening and recruiting to the level where we would expect them to be or a little bit above.

    是的,絕對可以。正如您所提到的,OASIS 是一個規模相當小的項目,總共只有 1,000 名患者,這顯然也表明我們已經與監管機構達成一致,需要基於我們現有的 Semaglutide 數據進行銜接。我們目前處於有利地位,無論是皮下注射還是口服,以及不同劑量,現在口服方面也累積了大量數據,我們可以利用這些數據來滿足監管要求。阿茲海默症試驗目前仍處於早期階段。您可能可以想像,我們正在篩檢大量患者,但篩檢期本身只有 3 個月。因此,目前我們看到的是,正在開放和運行的站點的篩選和招募實際上已經達到了我們預期的水平,甚至略高於預期。

  • Operator

    Operator

  • Our next question is from Martin Parkhøi of Danske Bank.

    下一個問題來自丹麥銀行的 Martin Parkhøi。

  • Martin Parkhøi - Senior Equity Analyst

    Martin Parkhøi - Senior Equity Analyst

  • Martin Parkhøi of Danske Bank, also 2 questions. First for Lars, you were quoted on various news medias about China that you expect this to be a onetime effect with a potentially significant haircut to pricing. But how do you state now that it will only be a onetime effect, for example, going into -- right, you're seeing 35% growth in your insulin, long-acting insulin franchise in China. Do you feel comfortable that after a big price cut then you can continue on this journey with Tresiba in China? Or isn't that the risk that this could be a controlled tender market? And then second question, I think, will be for Doug. Just on -- again, on Wegovy and (inaudible) in U.S. You say 60% are on it for free, but you also call it, of course, it's called the bridge card because you're making a bridge onto these patients, hopefully you should get coverage. But I also know that some are able to get the drug even though they don't fit into that category. But how many of these 60% will actually have coverage when their 6-month period are in?

    丹斯克銀行的馬丁·帕克海(Martin Parkhøi)也有兩個問題。首先,關於拉爾斯(Lars),各種關於中國的新聞媒體都引用了您的言論,您預計這只是一次性影響,並且可能會大幅降低價格。但是,您現在如何斷言這只是一次性影響?例如,您看到您的胰島素,以及長效胰島素在中國的特許經營權增加了35%。您是否覺得在大幅降價之後,您還能繼續在中國推進Tresiba的研發?或者說,這是否意味著這是一個受控的招標市場?第二個問題,我想是問道格的。關於-再次強調,關於Wegovy和(聽不清楚)在美國的情況。您說60%的患者可以免費使用,但您也稱之為“過橋卡”,因為您為這些患者搭建了一座橋樑,希望您能夠獲得醫療保險。但我也知道,有些人即使不屬於這個類別,也能獲得這種藥物。但是,在這 60% 的人中,有多少人在 6 個月的期限內能夠真正獲得保障?

  • Lars Fruergaard Jorgensen - President, CEO & Member of Management Board

    Lars Fruergaard Jorgensen - President, CEO & Member of Management Board

  • Thank you, Martin, for those 2 questions. And let me start on China. And obviously I don't know for sure what will happen to China because I'm not in charge of that. But if you look at the whole intention about the [VDP], that was to bring the pricing of drugs in China down to the international level. And there are a number of drug categories. So I feel that it's a rational attempt by the authorities in China to get to the right price level. And then there's a keen interest in bringing innovation to China, accelerated regulatory revenue, et cetera. And of course, if it turns into a very hostile pricing environment, I don't think the authorities are creating attractive market for innovation. So at least for now we feel comfortable about that. And Doug, once again, on Wegovy.

    馬丁,謝謝你回答這兩個問題。我先從中國說起。顯然,我不確定中國的情況會怎樣,因為我不負責這方面。但如果你看看[VDP]的整個意圖,它的目的是將中國的藥品定價降至國際水平。而且藥品種類多。所以我認為這是中國當局為達到合理價格水準所做的合理嘗試。此外,中國也熱衷於將創新藥物引入中國,加速監管收入成長等等。當然,如果定價環境變得非常不利,我認為當局就無法為創新藥物創造一個有吸引力的市場。所以至少目前我們對此感到放心。道格,再次談談Wegovy。

  • Douglas J. Langa - Executive VP, Head of North America Operations & Member of Management Board

    Douglas J. Langa - Executive VP, Head of North America Operations & Member of Management Board

  • Thanks, Martin, for the question. So the intent of any of these early initiations or bridge programs is to build awareness, get initiation of use. We can -- physicians can see results. And again, for us, the bridge program was designed to be screened for people that had coverage. Now again, it's not a perfect system. Based on the demand, it was probably one of our most successful programs that we've launched. So -- but it would -- I don't have -- we don't have the exact specificity to know how many coming off that program would exactly have coverage. But again, the intent was, you start them, and then they would have coverage when they come off of it.

    謝謝馬丁的提問。所以,所有這些早期啟動或過渡計畫的目的都是為了提高認知度,引導人們開始使用。我們醫生可以看到效果。同樣,對我們來說,過渡計畫旨在篩選那些有醫療保險的人。當然,它並非一個完美的系統。從需求來看,這可能是我們推出的最成功的項目之一。所以——但是——我沒有——我們無法確切知道有多少人從這個項目中受益。但同樣,我們的目的是,你開始讓他們使用,然後當他們停止使用時,他們就能獲得醫療保險。

  • Operator

    Operator

  • Our next question is from Jo Walton of Crédit Suisse.

    下一個問題來自瑞士信貸的喬·沃爾頓。

  • Jo Walton - MD

    Jo Walton - MD

  • I've got 2 questions. If we could go back to your confidence in the lack of -- in the fact that the GLP market growth of 30% will ease off next year. I just wonder why that is. Is it just a law of large numbers? Or is it perhaps that particularly for your products you're seeing some extra obesity use with Ozempic, which will presumably disappear next year when Wegovy comes in. So we don't need to be -- we need to be sure that we're not double counting. And secondly, I wonder if you could tell us a little bit about how long people are staying on Ozempic these days. I think the data that we have is that the stay rate on all of the GLPs is still pretty poor, less than 6 months or so for many patients. Have you been able to make some progress there?

    我有兩個問題。我們能否回到您對缺乏信心——GLP市場30%的成長率明年將放緩——的信心問題?我只是想知道這是為什麼。這只是大數定律嗎?或者,特別是對於您的產品,您看到Ozempic在肥胖症方面的應用有所增加,而隨著Wegovy明年上市,這種應用可能會消失。所以我們不需要——我們需要確保我們沒有重複計算。其次,您能否告訴我們目前人們服用Ozempic的時間。我認為我們掌握的數據表明,所有GLP的藥物的服用率仍然很低,許多患者的服用時間不到6個月左右。您在這方面取得了一些進展嗎?

  • Lars Fruergaard Jorgensen - President, CEO & Member of Management Board

    Lars Fruergaard Jorgensen - President, CEO & Member of Management Board

  • Thank you, Jo. Karsten first. Obviously difficult to protect the future GLP-1 marked growth. So can you put a bit more color on your comments that we are right now seeing a higher level than we have seen in the past? And then Camilla can talk to stay time on Ozempic.

    謝謝喬。首先是卡斯滕。顯然,要保護未來GLP-1顯著的成長非常困難。那麼,您能否更詳細地解釋一下您所說的,我們現在看到的水平比過去更高?然後卡米拉可以繼續談談Ozempic的問題。

  • Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board

    Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board

  • Yes. Thanks, Jo, for that question. And of course it's a forward-looking statement. The reason why I pulled it forward was when you look at actual NBRx scripts on a weekly basis, we saw a significant step up, I would say, in June or so if you take the U.S. market data, absolute number of NBRx in the GLP-1 market segment, most notably on Ozempic. After that step up, actually the trend has been fairly similar to what we saw before the step up. So we don't see a continued step up, but more like a normalized growth rate during the third quarter and into the fourth quarter as well.

    是的。 Jo,謝謝你的提問。當然,這是一個前瞻性的陳述。我之所以提前發布,是因為當你每週查看實際的NBRx處方數量時,你會發現,如果以美國市場數據來看,GLP-1市場中NBRx的絕對數量(尤其是Ozempic)在6月份左右出現了顯著的增長。在那次成長之後,趨勢實際上與成長之前相當相似。因此,我們預計不會出現持續的成長,而更像是第三季和第四季的正常化成長率。

  • Lars Fruergaard Jorgensen - President, CEO & Member of Management Board

    Lars Fruergaard Jorgensen - President, CEO & Member of Management Board

  • Thank you, Karsten. Camilla, stay time?

    謝謝你,卡斯滕。卡米拉,還有時間嗎?

  • Camilla Sylvest - Executive VP, Head of Commercial Strategy & Corporate Affairs and Member of the Management Board

    Camilla Sylvest - Executive VP, Head of Commercial Strategy & Corporate Affairs and Member of the Management Board

  • Yes. So on stay time, we actually do have a stay time that from the latest data we have is close to around, roughly speaking, more than 15 months on Ozempic. We do think that this is, in general, just a quite significant stay time, and people are -- we know that we can get 80% of people in good control from our clinical trials. So I think that covers that.

    是的。所以,關於停留時間,根據我們掌握的最新數據,Ozempic 的停留時間確實接近,大致超過 15 個月。我們確實認為,總的來說,這是一個相當長的停留時間,我們知道,透過我們的臨床試驗,80% 的患者病情能夠得到良好的控制。所以我認為這涵蓋了這一點。

  • Lars Fruergaard Jorgensen - President, CEO & Member of Management Board

    Lars Fruergaard Jorgensen - President, CEO & Member of Management Board

  • I think we are homing in on the last set of questions. Perhaps, 2, depending on the length of the answers.

    我想我們最後的問題差不多了。也許是2個,取決於答案的長度。

  • Operator

    Operator

  • Our next question is from Kerry Holford of Berenberg.

    下一個問題來自貝倫貝格的 Kerry Holford。

  • Kerry Ann Holford - Analyst

    Kerry Ann Holford - Analyst

  • Yes, 3 for me, please. Firstly, just going back Wegovy. I would be interested to see what proportion of the 60% of covered lives have the employer opt-in effectively granted. And also to understand whether you're finding any debate in your pricing and (inaudible) negotiations for that obesity outcomes data, how much further do you think you can expand Wegovy access essentially ahead of that readout, I think back end of '23? And then just quickly on Mim8. What's giving you the confidence to move forward to start Phase III this quarter? Have you see that lead out of the Phase I/II.

    是的,請給我3個。首先,回到Wegovy。我很想知道在60%的受保人群中,有多少比例實際上獲得了雇主的選擇。另外,為了了解您在肥胖結果數據的定價和(聽不清楚)談判中是否存在任何爭議,您認為在數據公佈之前,也就是2023年底之前,您認為Wegovy的訪問權限還能擴大到什麼程度?然後快速談談Mim8。是什麼讓您有信心在本季啟動第三階段?您認為第一/第二階段的進展如何?

  • Lars Fruergaard Jorgensen - President, CEO & Member of Management Board

    Lars Fruergaard Jorgensen - President, CEO & Member of Management Board

  • Thank you, Kerry. So Doug, first, a perspective on, as I understood it, in the commercial sector how many employers are opting in.

    謝謝,Kerry。 Doug,首先,我想問一下,據我了解,在商業領域,有多少雇主選擇加入。

  • Douglas J. Langa - Executive VP, Head of North America Operations & Member of Management Board

    Douglas J. Langa - Executive VP, Head of North America Operations & Member of Management Board

  • Yes. So we don't disclose that. But generally speaking, we do have a, I would say, a large number of employers that have opted into where we have coverage today. And our aim is to continue to work. We have a regional account team that's out there every day working hard as well as an employer team. And again, it's an important component to building the overall access and affordability, quite frankly, over the long haul.

    是的,所以我們不會透露這一點。但總的來說,我想說,我們目前涵蓋的地區確實有很多雇主選擇加入我們。我們的目標是繼續努力。我們有一個區域客戶團隊,每天都在努力工作,還有一個雇主團隊。坦白說,從長遠來看,這是建立整體可近性和可負擔性的重要組成部分。

  • Lars Fruergaard Jorgensen - President, CEO & Member of Management Board

    Lars Fruergaard Jorgensen - President, CEO & Member of Management Board

  • And if I just should give a very quick answer to the question on the outcome data and health technology assessments, et cetera. So we actually see that payers today with what Wegovy can deliver, see that there's value in the product. So I don't think we have a situation where we need to see COT data for the case to be intact for weight loss, yes. And Martin, on my Mim8.

    我想快速回答一下關於結果數據和健康技術評估等問題。我們實際上看到,如今Wegovy提供的服務,讓付款人看到了產品的價值。所以我認為,我們不需要看到COT數據就能證明減肥案例的有效性,是的。馬丁,在我的Mim8上。

  • Martin Holst Lange - Executive VP, Head of Development & Member of the Management Board

    Martin Holst Lange - Executive VP, Head of Development & Member of the Management Board

  • Yes. So as you know, we've designed a fairly ambitious development program, where we tried to go from first human dose to basically submission in a matter of 4 years. That requires some assumption, and it requires a little bit of initiating things, including our Phase III trial at risk. We do obviously continuously monitor the different cohorts that read out in the ongoing Phase I/II study. That basically means that we know about the safety of the drug in that space. And we do also have some preliminary efficacy readout in the earlier calls. So far we've seen nothing that would discourage us from going into Phase III, which is why we are continuing to pursue our plan.

    是的。如你所知,我們設計了一個相當雄心勃勃的開發計劃,試圖在4年內從首次人體給藥到基本提交。這需要一些假設,也需要一些啟動工作,包括我們處於風險的III期試驗。我們確實會持續監測正在進行的I/II期研究中不同隊列的受試者。這基本上意味著我們了解該藥物在該領域的安全性。而且,我們在之前的電話會議中也有一些初步的療效數據。到目前為止,我們還沒有發現任何阻礙我們進入III期的因素,這就是我們繼續推進計劃的原因。

  • Lars Fruergaard Jorgensen - President, CEO & Member of Management Board

    Lars Fruergaard Jorgensen - President, CEO & Member of Management Board

  • And we'll take one final set of questions, please.

    我們將回答最後一組問題。

  • Operator

    Operator

  • Our final question will be from Sachin Jain of Bank of America.

    我們的最後一個問題來自美國銀行的 Sachin Jain。

  • Sachin Jain - MD

    Sachin Jain - MD

  • Just a couple of clarification questions, please. As I first go back to Rybelsus, sequential growth in the U.S. to (inaudible) Michael's question, it grew sales 40% versus prescription volumes, 15% sequentially. Just to clarify, do you expect sales to grow ahead of scripts going forward as co-pay programs come off? And secondly, a follow-up on the GLP-1 growth outlook for next year. Noting you have a competitor launch tirzepatide which you've historically said would accelerate in the market. So just to clarify how we think about 22 GLP-1 growth given that new launch, is that normalized market growth for a share loss of a competitor? Or do you think that product accelerates the market?

    請澄清幾個問題。首先,我回到Rybelsus在美國的環比成長,回答Michael的問題。 Rybelsus的處方量較上季增加了40%,較上季成長了15%。請澄清一下,隨著共同支付計畫的取消,您是否預期未來銷售額的成長會超過處方量的成長?其次,請問您關於明年GLP-1成長前景的後續問題。我注意到,您的競爭對手tirzepatide即將上市,您之前曾說過它會加速市場成長。那麼,請澄清一下,考慮到這款新產品的上市,我們如何看待22%的GLP-1成長?這是競爭對手市場佔有率損失導致的正常化市場成長嗎?還是您認為該產品加速了市場成長?

  • Lars Fruergaard Jorgensen - President, CEO & Member of Management Board

    Lars Fruergaard Jorgensen - President, CEO & Member of Management Board

  • Thank you, Sachin. Karsten, can you try to put some color on both questions, both, say, value per script on Rybelsus? And then what more you can give on GLP-1 market outlook.

    謝謝,Sachin。 Karsten,您能否解釋一下這兩個問題,例如Rybelsus的單支處方價值?然後,您還能對GLP-1的市場前景發表什麼看法?

  • Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board

    Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board

  • Yes. So thank you, Sachin, for that set of questions. First of all, on Rybelsus in the U.S. and the delta between scripts and ex-factory and realized ARP. I think the key point is, as we showed in the earlier slide, then we actually have a very, very stable TRx uptake curve in the U.S., and Doug was talking to that. So I think the more meaningful measure on Rybelsus is basically to look at the stability of the TRx curve. And then individual quarters are impacted by -- it could be minor inventory movements either this year or last year, et cetera. So I think I would peel that away and say, look at the TRx trending and look at our year-to-date numbers, that's a more reflective way of looking at Rybelsus. As to GLP-1 market growth, then, yes, what we've seen historically is that the launch is beneficial to the market. But you can say the market has also been benefiting from the Rybelsus launch over the past 1.5 years up to 2 years or so. So that's what I mean with the normalized market growth. So assuming tirzepatide launch mid next year, that of course what we've seen in GLP-1 is that it has been a market expansion strategy on our side and also on the Lilly side. I don't know their strategy, but presumably it would help expand the markets.

    是的。 Sachin,謝謝你提出的這一系列問題。首先,關於Rybelsus在美國的銷售情況,以及處方藥價格與出廠價和已實現ARP之間的差異。我認為關鍵在於,正如我們在之前的幻燈片中所展示的那樣,我們在美國實際上擁有非常非常穩定的TRx吸收曲線,Doug也談到了這一點。所以我認為衡量Rybelsus更有意義的指標基本上是看TRx曲線的穩定性。然後,各個季度可能會受到影響——可能是今年或去年的庫存小幅變動等等。所以,我認為我應該從各個方面來分析,看看TRx趨勢,看看我們今年迄今為止的數據,這是一種更能反映Rybelsus情況的方式。至於GLP-1市場的成長,是的,從歷史上看,我們的產品上市對市場有利。但可以說,過去一年半到兩年左右,市場也受惠於Rybelsus的上市。這就是我所說的正常化市場成長。假設tirzepatide明年年中上市,那麼我們在GLP-1上看到的,對我們和禮來來說,這都是一個市場擴張策略。我不知道他們的策略是什麼,但想必這有助於擴大市場。

  • Lars Fruergaard Jorgensen - President, CEO & Member of Management Board

    Lars Fruergaard Jorgensen - President, CEO & Member of Management Board

  • Let's sneak in one final, absolute final question or set of questions.

    讓我們偷偷地問最後一個、絕對最後一個問題或一組問題。

  • Operator

    Operator

  • Our final question will be from Richard Vosser of JPMorgan.

    我們的最後一個問題來自摩根大通的理查德·沃瑟。

  • Richard Vosser - Senior Analyst

    Richard Vosser - Senior Analyst

  • I'll just do one. And it's just looking at the obesity franchise in a bit more big picture for fourth quarter. So how should we think about the development of that franchise? Do you think you could already see the franchise double relative to fourth quarter '20 given improving Wegovy supply, given what we can see in the script as Wegovy probably doubling in the U.S. and strong continued growth of Saxenda ex-U.S., just your thoughts there.

    我只提一個問題。這只是從更宏觀的角度看待第四季度肥胖症藥物的特許經營權。那麼,我們該如何看待該藥物的發展呢?考慮到Wegovy供應的改善,考慮到我們在劇本中看到的Wegovy在美國可能翻一番,以及Saxenda在美國以外地區持續強勁增長,您是否認為該藥物的銷售額相對於2020年第四季度已經翻了一番?以上只是您的想法。

  • Lars Fruergaard Jorgensen - President, CEO & Member of Management Board

    Lars Fruergaard Jorgensen - President, CEO & Member of Management Board

  • Thank you, Richard. So I can unfortunately not go into guiding on Obesity. But of course, you raise a good point that we see a very, very strong uptake of Wegovy in the U.S., better than anyone, I would say, have anticipated. It's not on -- based on cannibalization of Saxenda, which is holding up nice in the U.S. and we see that Saxenda is accelerating its position outside of the U.S., so very strong growth actually to the same degree as we see in the U.S. in international operations. And we see a number of markets where Obesity is moving being reimbursed because health care systems acknowledge the need for having antiobesity medicine, not least coming out of a pandemic where it's clearly established that living with obesity is a risk factor if you catch COVID-19. So we are very encouraged in terms of the 3 priorities I mentioned, mobilizing physicians to prescribe, mobilizing patients to seek care and also increasingly having payers to acknowledge the need for antiobesity medicine. So I think that holds well for the future growth. And in due time, we will clarify with you what our aspirations are. But for now, it is at least to double it by 2025. And we feel comfortable we can do that. So with that, thank you all for your participation. This concludes our earnings call. And if you have more questions, feel free to reach out to our Investor Relations, and looking forward to meet you sometime soon in the future. Thank you very much. Bye-bye.

    謝謝理查德。很遺憾,我無法就肥胖症領域進行指導。當然,您提出的一個很好的觀點是,我們看到Wegovy在美國市場的應用非常強勁,比我想說的任何人預期的都要好。這並不是基於Saxenda的蠶食效應,Saxenda在美國市場表現良好,而且我們看到Saxenda正在加速其在美國以外地區的市場地位,因此其增長非常強勁,實際上與我們在美國看到的國際業務增長程度相當。我們看到許多肥胖症患者正在進入報銷範圍,因為醫療保健系統承認需要抗肥胖藥物,尤其是在疫情結束後,肥胖是感染COVID-19的風險因素。因此,就我提到的三個優先事項而言,我們感到非常鼓舞:動員醫生開處方,動員患者就醫,以及讓越來越多的支付方認識到抗肥胖藥物的必要性。所以我認為這對未來的成長非常有利。我們會在適當的時候向大家闡明我們的目標。目前,我們的目標至少在2025年達到翻倍。我們有信心可以實現這一目標。謝謝大家的參與。我們的財報電話會議到此結束。如果您還有其他問題,請隨時聯繫我們的投資者關係部門,並期待不久的將來再次與您見面。非常感謝。再見。