禮來公司 (LLY) 2022 Q2 法說會逐字稿

And ladies and gentlemen, thank you for standing by. Welcome to the Lilly Q2 2022 Earnings Conference Call. (Operator Instructions) And as a reminder, your conference is being recorded. I would now like to turn the conference over to your host, Kevin Hern, Vice President of Investor Relations. Please go ahead.

女士們，先生們，謝謝你們的支持。歡迎參加禮來公司 2022 年第二季度收益電話會議。 （操作員說明）作為提醒，您的會議正在錄製中。我現在想將會議轉交給您的主持人，投資者關係副總裁 Kevin Hern。請繼續。

Thank you. Good morning, everyone, and thank you for joining us for Eli Lilly and Company's Q2 2022 Earnings Call. Apologies for the hour delay. We had some technical issues on the AT&T side. So thanks for your patience.

謝謝你。大家早上好，感謝您參加禮來公司的 2022 年第二季度財報電話會議。為延遲一小時道歉。我們在 AT&T 方面遇到了一些技術問題。所以謝謝你的耐心。

I'm Kevin Hern, Vice President of Investor Relations. Joining me on today's call are Dave Ricks, Lilly's Chair and CEO; Anat Ashkenazi, Chief Financial Officer; Dr. Dan Skovronsky, Chief Scientific and Medical Officer; Anne White, President of Lilly Neuroscience; Ilya Yuffa, President of Lilly International; Jake Van Naarden, CEO of Loxo at Lilly; Mike Mason, President of Lilly Diabetes; and Patrik Jonsson, President of Lilly Immunology and Lilly USA. We're also joined by Mike Sprengnether, Kento Ueha and Lauren Zierke of the Investor Relations team; as well as Joe Fletcher, who will be taking over leadership of the IR team this month.

我是投資者關係副總裁 Kevin Hern。和我一起參加今天電話會議的還有禮來公司的董事長兼首席執行官 Dave Ricks； Anat Ashkenazi，首席財務官； Dan Skovronsky 博士，首席科學和醫學官；禮來公司神經科學總裁 Anne White；禮來國際總裁 Ilya Yuffa；禮來公司 Loxo 首席執行官 Jake Van Naarden；禮來糖尿病總裁 Mike Mason；以及禮來免疫學和禮來美國公司總裁 Patrik Jonsson。投資者關係團隊的 Mike Sprengnether、Kento Ueha 和 Lauren Zierke 也加入了我們的行列；以及 Joe Fletcher，他將在本月接任 IR 團隊的領導職務。

During this conference call, we anticipate making projections and forward-looking statements based on our current expectations. Our actual results could differ materially due to several factors, including those listed on Slide 3. Additional information concerning factors that could cause actual results to differ materially is contained in our latest Form 10-K and subsequent Forms 10-Q and 8-K filed with the Securities and Exchange Commission.

在這次電話會議期間，我們預計會根據我們目前的預期做出預測和前瞻性陳述。由於多種因素，我們的實際結果可能存在重大差異，包括幻燈片 3 中列出的因素。有關可能導致實際結果產生重大差異的因素的其他信息包含在我們最新提交的 10-K 表格和後續 10-Q 和 8-K 表格中與證券交易委員會。

The information we provide about our products and pipeline is for the benefit of the investment community. It is not intended to be promotional and is not sufficient for prescribing decisions. As we transition to our prepared remarks, please note that our commentary will focus on non-GAAP financial measures.

我們提供的有關我們的產品和管道的信息是為了投資界的利益。它不是為了促銷，也不足以做出處方決定。當我們過渡到我們準備好的評論時，請注意我們的評論將集中在非公認會計準則財務指標上。

Now I'll turn the call over to Dave.

現在我將把電話轉給戴夫。

Thanks a lot, Kevin. In Q2, we achieved a number of impactful pipeline milestones, including approval and launch of Mounjaro in the U.S., the FDA submission and acceptance of donanemab as well as pirtobrutinib and positive top line results for lebrikizumab and EU and Japan submissions for mirikizumab. This pipeline progress underscores the breadth and depth of our exciting long-term outlook.

非常感謝，凱文。在第二季度，我們實現了許多具有影響力的管道里程碑，包括 Mounjaro 在美國的批准和上市、 FDA 提交和接受 donanemab 以及 pirtobrutinib 以及 lebrikizumab 和歐盟和日本提交的 mirikizumab 的積極頂線結果。這一管道進展突顯了我們令人興奮的長期前景的廣度和深度。

Perhaps the headline story for Lilly this second quarter was the launch of Mounjaro in the U.S., where initial uptake has been strong. We're hearing a great deal of enthusiasm from the field, and we're excited about the potential for this new medicine to provide A1C and weight loss benefits to adults living with type 2 diabetes. We remain focused on gaining broad open access for Mounjaro and expect the full impact of this medicine for patients and our business to be realized over time as that access is achieved.

也許禮來公司第二季度的頭條新聞是 Mounjaro 在美國的推出，最初的吸收率一直很高。我們從該領域聽到了極大的熱情，我們對這種新藥為患有 2 型糖尿病的成年人提供 A1C 和減肥益處的潛力感到興奮。我們仍然專注於為 Mounjaro 獲得廣泛的開放訪問，並期望隨著時間的推移，這種藥物對患者和我們的業務的全面影響能夠實現。

Turning to Q2 financial results and progress on our strategic deliverables, we saw relatively flat top line performance in constant currency as strong volume-driven growth for key products, like Verzenio, Jardiance and Trulicity, was offset by lower prices as well as for Alimta's patent expiry in key markets around the world and last year's sale of Cialis rights in China.

談到第二季度的財務業績和我們的戰略可交付成果的進展，我們看到以固定匯率計算的頂線業績相對持平，因為 Verzenio、Jardiance 和 Trulicity 等關鍵產品的強勁銷量增長被較低的價格以及 Alimta 的專利所抵消全球主要市場的到期以及去年在中國出售 Cialis 的權利。

Volume for this quarter grew a robust 10%. When excluding revenue from Alimta, the sale of Cialis rights in China and COVID-19 antibodies, revenue grew 6% compared to Q2 2021.

本季度的銷量強勁增長了 10%。如果不計來自 Alimta 的收入、Cialis 在中國的權利銷售和 COVID-19 抗體，收入與 2021 年第二季度相比增長了 6%。

In Q2, our newer medicines contributed 18% to volume growth and now account for 67% of our core business revenue, which we believe, together with our robust pipeline, is the most important indicator of the strength and durability of our growth outlook.

在第二季度，我們的新藥為銷量增長貢獻了 18%，現在占我們核心業務收入的 67%，我們認為，這與我們強大的管道一起，是我們增長前景的實力和持久性的最重要指標。

Our non-GAAP gross margin was 79.8% in Q2, an increase of approximately 50 basis points compared to the prior year. Our non-GAAP operating margin was 20.5%, which includes a negative impact of approximately 680 basis points attributed to acquired in-process R&D and development milestone charges.

我們第二季度的非美國通用會計準則毛利率為 79.8%，與去年相比增加了約 50 個基點。我們的非 GAAP 營業利潤率為 20.5%，其中包括約 680 個基點的負面影響，歸因於已獲得的在研研發和開發里程碑費用。

At our investment community meeting in December, we outlined 5 potential new medicines that could launch over the next 2 years, which could serve as catalysts to driving top-tier growth through the decade.

在 12 月的投資界會議上，我們概述了可能在未來 2 年內推出的 5 種潛在新藥，它們可以成為推動十年內頂級增長的催化劑。

There have been important pipeline development since our Q1 earnings call for all 5, including the U.S. approval and launch of Mounjaro in type 2 diabetes and a positive CHMP opinion in the European Union; FDA acceptance and Priority Review designation for donanemab in early symptomatic Alzheimer's disease; FDA acceptance and Priority Review designation for pirtobrutinib in mantle cell lymphoma, for patients previously treated with a BTK inhibitor; submissions for mirikizumab in ulcerative colitis in the EU and in Japan; positive top line 52-week data for lebrikizumab in moderate to severe atopic dermatitis. And we also announced U.S., EU and Japan regulatory approval for Olumiant in alopecia areata.

自從我們對所有 5 家公司的第一季度財報電話會議以來，已經有了重要的管道開發，包括美國批准和推出 Mounjaro 治療 2 型糖尿病以及歐盟對 CHMP 的積極意見； FDA 接受和優先審查指定用於治療早期症狀性阿爾茨海默病的多那奈單抗； FDA 接受和優先審查指定 pirtobrutinib 治療套細胞淋巴瘤，用於先前接受 BTK 抑製劑治療的患者；在歐盟和日本提交用於治療潰瘍性結腸炎的 mirikizumab； lebrikizumab 在中度至重度特應性皮炎中的陽性頂線 52 週數據。我們還宣布美國、歐盟和日本監管機構批准 Olumiant 治療斑禿。

Last month, we announced plans for a $2.1 billion investment in 2 new manufacturing sites here in Indiana to support increasing demand for existing products as well as demand for potential new medicines in our pipeline. This announcement followed Lilly's recent investments in new facilities in Massachusetts, North Carolina and Ireland and will further expand Lilly's manufacturing network for active ingredients and new therapeutic modalities, such as genetic medicines. These investments underscore our confidence in the growth of our portfolio in the company.

上個月，我們宣布計劃在印第安納州的 2 個新生產基地投資 21 億美元，以支持對現有產品不斷增長的需求以及對我們管道中潛在新藥的需求。此前，禮來公司最近在馬薩諸塞州、北卡羅來納州和愛爾蘭投資了新設施，並將進一步擴大禮來公司的活性成分和新治療方式（如基因藥物）的製造網絡。這些投資強調了我們對公司投資組合增長的信心。

Finally, we distributed nearly $900 million in dividends to our shareholders in Q2.

最後，我們在第二季度向股東派發了近 9 億美元的股息。

On Slide 5, you'll see a list of key events since our Q1 earnings call, including several important regulatory clinical and COVID-19 antibody updates. As previously announced in Q2, we entered into an agreement with the U.S. government to supply 150,000 doses of bebtelovimab for approximately $275 million in an ongoing effort to provide COVID-19 treatment options for patients. Doses of bebtelovimab valued at approximately $130 million were shipped in Q2, and the remainder of that order will ship in Q3.

在幻燈片 5 上，您將看到自我們第一季度財報電話會議以來的關鍵事件列表，包括幾個重要的監管臨床和 COVID-19 抗體更新。正如之前在第二季度宣布的那樣，我們與美國政府達成協議，以約 2.75 億美元的價格提供 150,000 劑 bebtelovimab，持續努力為患者提供 COVID-19治療選擇。價值約 1.3 億美元的 bebtelovimab 劑量在第二季度發貨，其餘訂單將在第三季度發貨。

Today, we are announcing that in collaboration with the U.S. government, we intend to begin making bebtelovimab available for purchase by states, hospitals and certain other providers through a sole distributor agreement. This will happen later this month, which is prior to the anticipated depletion of the U.S. government's currently available supply.

今天，我們宣布與美國政府合作，我們打算開始通過獨家經銷商協議讓各州、醫院和某些其他供應商購買 bebtelovimab。這將在本月晚些時候發生，這是在美國政府目前可用供應預期耗盡之前。

As we move from large ad hoc federal government purchases, the sale and distribution of COVID-19 antibodies to a broader set of purchasers, we will now integrate estimated sales into our forward guidance.

隨著我們從聯邦政府的大型臨時採購、COVID-19 抗體的銷售和分銷轉向更廣泛的購買者，我們現在將估計銷售額納入我們的前瞻性指導。

As we have said previously, we don't see COVID-19 antibodies as a major long-term driver of growth for the company. Nevertheless, we will continue to do our part where we can to help fight the COVID-19 pandemic with the last monoclonal antibody treatment standing that neutralizes against the Omicron variant.

正如我們之前所說，我們不認為 COVID-19 抗體是公司長期增長的主要動力。儘管如此，我們將繼續盡我們所能，通過最後一種可以中和 Omicron 變體的單克隆抗體治療來幫助抗擊 COVID-19 大流行。

And now, I'll turn the call over to Anat for a more detailed review of our Q2 results.

現在，我將把電話轉給 Anat，以更詳細地審查我們的第二季度業績。

Thanks, Dave. Slide 6 summarizes...

謝謝，戴夫。幻燈片 6 總結了...

(technical difficulty)

（技術難度）

Just continue, Anat, and we'll see what's happening.

繼續，Anat，我們會看到發生了什麼。

Slide 6 summarizes financial performance in the second quarter of 2022. I'll focus my comments on non-GAAP performance.

幻燈片 6 總結了 2022 年第二季度的財務業績。我將把我的評論集中在非 GAAP 業績上。

We had a few notable items impacting the year-over-year financial comparison. Foreign exchange rates had roughly 300 basis point impact on revenue this quarter as we saw Q2 revenue decline 4% or 1% on a constant currency basis.

我們有一些值得注意的項目影響了同比財務比較。外匯匯率對本季度的收入產生了大約 300 個基點的影響，因為我們看到第二季度的收入在固定貨幣基礎上下降了 4% 或 1%。

In Q2 of 2021, we sold our rights to Cialis in China, resulted in $170 million of onetime revenue impact. And this quarter, we also saw the full impact of the loss of exclusivity for Alimta in Europe and Japan and have started to see the impact of multiple generic entrants in the U.S.

在 2021 年第二季度，我們將我們在中國的權利出售給了 Cialis，產生了 1.7 億美元的一次性收入影響。本季度，我們還看到了 Alimta 在歐洲和日本失去獨家經營權的全面影響，並開始看到多家仿製藥進入美國的影響。

When excluding revenue...

剔除收入時...

(technical difficulty)

（技術難度）

Hopefully, everyone on the call can hear us.

希望通話中的每個人都能聽到我們的聲音。

(technical difficulty)

（技術難度）

Go ahead.

前進。

Okay.

好的。

(technical difficulty)

（技術難度）

I'll continue and hopefully everyone can hear us.

我會繼續，希望每個人都能聽到我們的聲音。

(technical difficulty)

（技術難度）

When excluding revenue from Alimta, the sales of Cialis rights in China in Q2 of last year and COVID antibodies...

剔除力達的收入，去年第二季度西力士在中國的銷售權和新冠病毒抗體...

(technical difficulty)

（技術難度）

Okay. Hopefully, you heard. I will repeat my last sentence. So when excluding revenue from Alimta, the sales of Cialis rights in China in Q2 of last year and COVID antibodies, total revenue grew 6%, highlighting the solid momentum for our core business in the second quarter. We expect that this growth rate will accelerate in the second half of the year.

好的。希望你聽到了。我將重複我的最後一句話。因此，如果剔除力達的收入、去年第二季度西力士在中國的權利銷售和 COVID 抗體，總收入增長了 6%，突顯了我們第二季度核心業務的強勁勢頭。我們預計這一增速將在下半年加速。

Moving on to gross margin as a percent of revenue, increased 50 basis points to 79.8% in Q2 of 2022. This increase in gross margin was primarily driven by product mix and the favorable effect of foreign exchange rates on international inventory sold, partially offset by lower realized prices. Increase in logistics and manufacturing costs due to inflation had a modest negative impact on gross margin in Q2.

毛利率佔收入的百分比在 2022 年第二季度增長了 50 個基點，達到 79.8%。毛利率的增長主要是由產品組合和外匯匯率對國際銷售庫存的有利影響推動的，部分抵消了較低的實際價格。通貨膨脹導致的物流和製造成本增加對第二季度的毛利率產生了適度的負面影響。

Total operating expenses increased 14% this quarter which, as discussed on our Q1 earnings call, are now inclusive of acquired in-process R&D and development milestone charges following guidance from the SEC. Acquired IPR&D and development milestone charges represented nearly 1,200 basis points of the Q2 OpEx growth.

正如我們在第一季度財報電話會議上所討論的，本季度總運營費用增加了 14%，現在包括根據美國證券交易委員會的指導獲得的正在進行的研發和開發里程碑費用。獲得的 IPR&D 和開發里程碑費用佔第二季度運營支出增長的近 1,200 個基點。

Marketing, selling and administrative expenses decreased 4% driven mostly by the favorable impact of foreign exchange rates. R&D expenses increased 8% driven by higher development expenses for late-stage assets, partially offset by lower development expenses for COVID-19 antibodies.

營銷、銷售和行政費用下降 4%，主要受匯率的有利影響。由於後期資產開發費用增加，研發費用增加了 8%，部分被 COVID-19抗體開發費用降低所抵消。

This quarter, we recognized acquired IPR&D and development milestone charges of $440 million or $0.46 of EPS primarily related to a charge associated with the buyout of substantially all future obligations that were contingent upon the development, regulatory and commercial success of our mutant-selective PI3K alpha inhibitor.

本季度，我們確認了 4.4 億美元或每股 0.46 美元的收購 IPR&D 和開發里程碑費用，主要與收購幾乎所有未來義務相關的費用，這些義務取決於我們的突變體選擇性 PI3K alpha 的開發、監管和商業成功抑製劑。

In Q2 2021, acquired IPR&D and development milestone charges were $43 million or $0.04 of EPS. Operating income decreased 32% in Q2 primarily due to higher acquired IPR&D and development milestone charges. Operating income as a percent of revenue was 20.5%, which includes the negative impact of approximately 680 basis points attributed to these charges.

2021 年第二季度，獲得的 IPR&D 和開發里程碑費用為 4300 萬美元或每股收益 0.04 美元。第二季度營業收入下降 32%，主要是由於收購的 IPR&D 和開發里程碑費用增加。營業收入佔收入的百分比為 20.5%，其中包括歸因於這些費用的約 680 個基點的負面影響。

Other income and expense was expense of approximately $13 million this quarter compared with income of $5 million in Q2 of 2021. Our Q2 effective tax rate was 14.2%, a decrease of 10 basis points compared to the same period in 2021. This decrease was driven by favorable tax impacts related to the implementation of a provision of the 2017 Tax Act related to the capitalization of R&D expenses, offset by the tax impact of nondeductible development milestone.

本季度的其他收入和費用支出約為 1300 萬美元，而 2021 年第二季度的收入為 500 萬美元。我們第二季度的有效稅率為 14.2%，與 2021 年同期相比下降了 10 個基點。這一下降是由與實施 2017 年稅法中與研發費用資本化有關的條款相關的有利稅收影響，被不可抵扣的發展里程碑的稅收影響所抵消。

At the bottom line, earnings per share declined 32% this quarter, to $1.25 per share. The most significant driver of the year-over-year decline was the impact of acquired IPR&D and development milestone charges, which had $0.46 negative impact in Q2 of this year compared to $0.04 in Q2 of last year.

歸根結底，本季度每股收益下降 32%，至每股 1.25 美元。同比下降的最重要驅動因素是收購的 IPR&D 和開發里程碑費用的影響，與去年第二季度的 0.04 美元相比，今年第二季度產生了 0.46 美元的負面影響。

On Slide 8, we quantify the effect of price, rate and volume on revenue growth. This quarter, U.S. revenue grew 6%. Excluding revenue from Alimta, which declined significantly due to broad generic entry in May and COVID-19 antibodies, revenue grew 11% in the U.S. This volume-driven growth was led by Trulicity, Verzenio and Jardiance.

在幻燈片 8 中，我們量化了價格、費率和數量對收入增長的影響。本季度，美國收入增長了 6%。不包括 Alimta 的收入（由於 5 月份廣泛的仿製藥進入和 COVID-19抗體而顯著下降），美國的收入增長了 11%。這種由銷量驅動的增長由 Trulicity、Verzenio 和 Jardiance 引領。

We experienced a net price decline of 8% for Q2 driven by lower realized prices for Humalog, Alimta and Forteo due to higher rebated segments making slightly larger portion of the business, higher contracted rates and the list price reduction for Insulin Lispro injection this year. Lower realized prices for Taltz were also a driver due to the impact of changes to estimates for rebates and discounts, largely driven by favorable adjustment in the base period and to a lesser extent, continued pull-through of existing access.

我們在第二季度經歷了 8% 的淨價格下降，原因是 Humalog、Alimta 和 Forteo 的實現價格較低，這是由於較高的回扣部門佔業務的比例略高、合同費率較高以及今年胰島素 Lispro 注射液的標價下調。 Taltz 較低的實際價格也是一個驅動因素，原因是回扣和折扣估計變化的影響，主要是由於基期的有利調整，以及在較小程度上，現有准入的持續拉動。

For the first half of 2022, net price decline in the U.S. was 4%, and we continue to expect mid-single-digit net price decline for the full year.

2022 年上半年，美國淨價跌幅為 4%，我們繼續預計全年淨價將出現中個位數的跌幅。

Moving to Europe. Revenue in Q2 grew 1% in constant currency. Excluding revenue from Alimta, which lost exclusivity in June of 2021, revenue grew 12% in constant currency driven primarily by volume growth for Trulicity, Jardiance, Taltz and Verzenio.

搬到歐洲。以固定匯率計算，第二季度的收入增長了 1%。不包括在 2021 年 6 月失去排他性的 Alimta 的收入，按固定匯率計算，收入增長了 12%，主要受 Trulicity、Jardiance、Taltz 和 Verzenio 銷量增長的推動。

For Japan, Q2 revenue decreased 22% in constant currency as our business there continues to be negatively affected by significant declines in off-patent products, primarily Cymbalta and Alimta, which both faced generic entry beginning June 2021. Key growth products represented 69% of total revenue in Japan and grew 11% in Q2 on a constant currency basis. We continue to expect a return to growth in Japan beginning in 2023.

在日本，按固定匯率計算，第二季度收入下降 22%，因為我們的業務繼續受到非專利產品大幅下降的負面影響，主要是 Cymbalta 和 Alimta，這兩個產品都從 2021 年 6 月開始面臨仿製藥進入。關鍵增長產品佔總銷售額的 69%日本的總收入在第二季度按固定匯率計算增長了 11%。我們繼續預計日本將從 2023 年開始恢復增長。

In China, revenue declined 32% in constant currency driven by the impact of the NRDL formulary access, resulting in lower realized prices, partially offset by increased volume for certain newer products, including Verzenio, Tyvyt, Trulicity and Taltz. We also experienced a price decline for Humalog due to the impact of volume-based procurement. We expect improved access to continue to drive future volume growth, more than offsetting the price decline over time.

在中國，受 NRDL 處方集的影響，按固定匯率計算的收入下降了 32%，導致實際價格下降，部分被某些新產品的銷量增加所抵消，包括 Verzenio、Tyvyt、Trulicity 和 Taltz。由於基於數量的採購的影響，我們還經歷了 Humalog 的價格下跌。我們預計，改善的准入將繼續推動未來的銷量增長，而不僅僅是抵消價格隨時間的下降。

With the latest COVID-19 outbreaks in China and to subsequent protective measures intended to control the spread of the virus, we have seen lower volume than we otherwise would have expected in Q2, particularly for infused products. For Tyvyt, we are also seeing the impact of increased competitive pressures. Revenue in the rest of the world increased 3% in constant currency primarily driven by increased sales of key growth products.

隨著中國最近爆發的 COVID-19 疫情以及隨後旨在控制病毒傳播的保護措施，我們看到第二季度的數量低於我們原本預期的數量，特別是對於輸液產品。對於 Tyvyt，我們也看到了競爭壓力增加的影響。世界其他地區的收入按固定匯率計算增長了 3%，主要是由於關鍵增長產品的銷售增加。

For the full year, we continue to expect mid-single-digit net price decline in each of the U.S., EU and Japan and a double-digit price decline in China, resulting in a worldwide net price decline in the high single digits.

全年，我們繼續預計美國、歐盟和日本各自的淨價格將出現中個位數的下降，而中國的價格將出現兩位數的下降，從而導致全球淨價格出現高個位數的下降。

As shown on Slide 9, our key growth products continue to drive robust worldwide volume growth. These products drove 18 percentage point of volume growth this quarter and continue to underpin our overall performance and outlook.

如幻燈片 9 所示，我們的主要增長產品繼續推動全球銷量強勁增長。這些產品在本季度推動了 18 個百分點的銷量增長，並繼續支撐著我們的整體業績和前景。

Slide 10 further highlights the contribution of our key growth products. This quarter, these brands grew 20% or nearly 24% in constant currency, generating $4.3 billion in sales and making up 67% of our core business revenue. We continue to see further growth opportunities for these products.

幻燈片 10 進一步突出了我們主要增長產品的貢獻。本季度，這些品牌按固定匯率計算增長了 20% 或近 24%，產生了 43 億美元的銷售額，占我們核心業務收入的 67%。我們繼續看到這些產品的進一步增長機會。

For example, we're extremely pleased to see the strong trajectory of Verzenio driven by the edge of an indication, including recent acceleration in new-to-brand share of market. In the injectable incretin market, we see significant opportunity for further class growth as these medicines currently make up only 25% of total prescription in the U.S. branded diabetes market and have the prospect of expanding the market through the earlier usage for glucose control and weight loss in the treatment of type 2 diabetes.

例如，我們非常高興地看到 Verzenio 的強勁發展軌跡受到一個跡象的推動，包括最近新品牌市場份額的加速。在註射型腸促胰島素市場，我們看到了進一步增長的重大機會，因為這些藥物目前僅占美國品牌糖尿病市場總處方的 25%，並有望通過早期用於血糖控制和減肥來擴大市場在治療2型糖尿病。

Trulicity is experiencing accelerated demand in many international markets due to market growth and the limited availability of competitor GLP in select markets. We are working to meet this increased demand, while also implementing actions in select countries to manage growth and minimize patient impact. This outlook for Trulicity is included in our guidance.

由於市場增長和競爭對手 GLP 在特定市場的供應有限，Trulicity 在許多國際市場的需求正在加速增長。我們正在努力滿足這種不斷增長的需求，同時還在選定的國家實施行動以管理增長並最大限度地減少對患者的影響。這種對 Trulicity 的展望包含在我們的指導中。

Lilly is thrilled to have both Trulicity, which has the longest length of therapy of any GLP-1, and Mounjaro, which could offer a step-change in innovation for the treatment of type 2 diabetes and other metabolic indications as options in this class of medicine.

禮來很高興同時擁有 Trulicity（在所有 GLP-1 中具有最長的治療時間）和 Mounjaro（它可以為 2 型糖尿病和其他代謝適應症的治療提供創新的階梯式變化，作為此類藥物的選擇）藥物。

Given the excitement and significant interest with the FDA approval of Mounjaro for type 2 diabetes, I would like to briefly provide an update on what we're seeing and hearing in terms of early launch. After U.S. approval in mid-May, our full-scale launch began in mid-June. Our commercial team is prepared, energized and observing a high level of engagement across channels as we roll out a patient-centric approach to launching Mounjaro for patients with type 2 diabetes.

鑑於 FDA 批准 Mounjaro 用於 2 型糖尿病的興奮和重大興趣，我想簡要介紹一下我們在早期推出方面所見和所聞的最新情況。在 5 月中旬獲得美國批准後，我們的全面發射於 6 月中旬開始。當我們推出以患者為中心的方法為 2 型糖尿病患者推出 Mounjaro 時，我們的商業團隊已做好準備、充滿活力並觀察到跨渠道的高水平參與。

The financial results you see from Mounjaro today reflect significant utilization of samples, where accepted, and co-pay assistance program to get patients off to a strong start. Peer negotiations are progressing as expected, and we're taking a disciplined approach to establish Mounjaro's access and are focused on delivering the same broad open access which we achieved for Trulicity.

您今天從 Mounjaro 看到的財務結果反映了樣本的顯著利用（在被接受的情況下）和共同支付援助計劃，以使患者有一個良好的開端。對等談判正在按預期進行，我們正在採取嚴格的方法來建立 Mounjaro 的訪問權限，並專注於提供與 Trulicity 相同的廣泛開放訪問權限。

As we remain focused on strong execution, we're encouraged by the prescription trends from Mounjaro, including the most recent IQVIA data, showing over 20% share of market for new-to-brand prescriptions in the type 2 diabetes injectable incretin class. We are also pleased to see that total Lilly new-to-brand share in the type 2 diabetes injectable incretin class has grown nearly 12 percentage points since the launch of Mounjaro.

由於我們仍然專注於強有力的執行，我們對 Mounjaro 的處方趨勢感到鼓舞，包括最新的 IQVIA 數據，顯示 2 型糖尿病注射腸促胰島素類新品牌處方的市場份額超過 20%。我們也很高興地看到，自 Mounjaro 推出以來，禮來公司在 2 型糖尿病注射型腸促胰島素類藥物中的新品牌份額增長了近 12 個百分點。

Given the heavy utilization of co-pay cards as we build out access for Mounjaro, prescription trends will likely provide a more accurate measure of launch uptake than net sales over the next few quarters.

鑑於我們在為 Mounjaro 建立訪問權限時大量使用共付卡，處方趨勢可能會比未來幾個季度的淨銷售額提供更準確的衡量啟動吸收率的方法。

We are pleased with the initial uptake of Mounjaro, which is at the high end of our contemplated scenarios. We do not anticipate supply constraint for the U.S. launch of Mounjaro, and we will monitor U.S. uptake to determine the appropriate timing for OUS launches.

我們對 Mounjaro 的初步採用感到滿意，這是我們設想的場景的高端。我們預計 Mounjaro 在美國的發射不會受到供應限制，我們將監測美國的吸收情況以確定 OUS 發射的適當時間。

As a reminder, over the last several years, we have made significant investments to grow global manufacturing capacity to support Mounjaro volume, including our new RTP site in North Carolina, which will come online in 2023.

提醒一下，在過去幾年中，我們進行了大量投資以提高全球製造能力以支持 Mounjaro 的產量，包括我們在北卡羅來納州的新 RTP 站點，該站點將於 2023 年上線。

On Slide 12, we provide an update on capital allocation. For the first half of the year, we invested $4.5 billion to drive our future growth through a combination of R&D expenditures, business development outlays and capital investments. In addition, we returned approximately $1.8 billion to shareholders in dividends and repurchased $1.5 billion in stock.

在幻燈片 12 中，我們提供了資本配置的最新信息。今年上半年，我們投資了 45 億美元，通過研發支出、業務發展支出和資本投資相結合來推動我們的未來增長。此外，我們向股東返還了大約 18 億美元的股息，並回購了 15 億美元的股票。

Our capital allocation priorities remain consistent as we continue to fund our key marketed products and expected new launches, invest in our pipeline, pursue opportunities for external innovation to augment our future growth prospects and return excess capital to shareholders.

我們的資本配置優先事項保持一致，因為我們繼續為我們的主要上市產品和預期的新產品提供資金，投資我們的管道，尋求外部創新機會以擴大我們未來的增長前景並將多餘的資本返還給股東。

Slide 13 is our updated 2022 financial guidance. Our full year revenue outlook is unchanged. It now includes an additional $400 million of headwind from foreign exchange rates, since our previous guidance update, for a total impact of roughly $700 million of FX headwind for the full year compared with our original guidance.

幻燈片 13 是我們更新的 2022 年財務指南。我們的全年收入前景保持不變。自我們之前的指導更新以來，它現在包括額外的 4 億美元的外匯逆風，與我們最初的指導相比，全年的外匯逆風總影響約為 7 億美元。

This incremental headwind is offset by additional forecasted revenue from our COVID-19 antibody, bebtelovimab, which includes $275 million from the U.S. government agreement announced in June of this year as well as estimated revenue from the inception of non-U.S. government distribution that Dave mentioned earlier.

這一增加的逆風被我們的 COVID-19抗體 bebtelovimab 的額外預測收入所抵消，其中包括來自今年 6 月宣布的美國政府協議的 2.75 億美元，以及戴夫提到的非美國政府分銷開始的估計收入早些時候。

As we look ahead, Q3 will mark the first full quarter impact of Alimta U.S. (inaudible). In addition, Q3 of 2021 revenue benefited from Olumiant COVID-19 sales that will provide roughly 2.5 percentage points of headwind to our top line growth in the quarter.

展望未來，第三季度將標誌著力達美國的第一個完整季度影響（聽不清）。此外，2021 年第三季度的收入受益於 Olumiant COVID-19 的銷售，這將為我們本季度的收入增長帶來大約 2.5 個百分點的阻力。

Our outlook for gross margin, SG&A and research and development remains unchanged. While the range is unchanged, SG&A does include additional commercial investments for selected key growth products in the second half of the year.

我們對毛利率、SG&A 和研發的展望保持不變。雖然範圍沒有變化，但 SG&A 確實包括在下半年對選定的關鍵增長產品進行額外的商業投資。

Our guidance now include acquired IPR&D and development milestone charges of approximately $610 million, reflecting total charges in the first half of the year. We have had no material acquired IPR&D or development milestone charges at this point in Q3, and this guidance does not include any impact from potential or pending business development transactions in the second half of the year.

我們現在的指導包括大約 6.1 億美元的收購 IPR&D 和開發里程碑費用，反映了上半年的總費用。在第三季度的這一點上，我們沒有獲得重大的 IPR&D 或開發里程碑費用，並且該指南不包括下半年潛在或未決業務開發交易的任何影響。

GAAP and non-GAAP operating margin decreased 100 basis points to approximately 27% and 29%, respectively, primarily due to the negative impact attributable to foreign exchange rates and acquired IPR&D and development milestone charges to date. Our non-GAAP range for other income and expense remains unchanged.

GAAP 和非 GAAP 營業利潤率分別下降 100 個基點至約 27% 和 29%，主要是由於迄今為止外匯匯率和收購的 IPR&D 和開發里程碑費用的負面影響。我們對其他收入和支出的非公認會計原則範圍保持不變。

On a reported basis, other income and expense is now expected to be expense in the range of $500 million to $600 million, reflecting the impact of net losses on investments in equity securities during the second quarter.

根據報告，其他收入和費用現在預計將在 5 億美元至 6 億美元之間，反映了第二季度淨虧損對股票證券投資的影響。

Our tax rate and EPS in the first half of the year still includes the favorable impact of the provision in the 2017 Tax Act that requires capitalization of research and development expenses for tax purposes. Our financial guidance for the full year assumes this provision will be deferred or repealed by Congress, effective for 2022. If this provision is not deferred or repealed effective this year, then we would expect a reported and non-GAAP tax rate to be approximately 10% to 11%.

我們上半年的稅率和每股收益仍然包括2017年稅法中要求將研發費用資本化以用於稅收目的的規定的有利影響。我們全年的財務指導假設國會推遲或廢除這一規定，自 2022 年起生效。如果今年未推遲或廢除這一規定，那麼我們預計報告的非 GAAP 稅率約為 10 % 到 11%。

Based on these changes, we have lowered our reported EPS guidance by $0.34, to now be in the range of $6.96 to $7.11 per share and lowered our non-GAAP EPS guidance by $0.25, to be in the range of $7.90 to $8.05. The $0.25 reduction in our non-GAAP EPS range is driven entirely by the impact of foreign exchange rates as the impact of EPS of acquired IPR&D and development milestone charges for selected -- and selected products are offset by the impact of additional sales of bebtelovimab.

基於這些變化，我們將報告的每股收益指引下調了 0.34 美元，目前在每股 6.96 美元至 7.11 美元的範圍內，並將我們的非公認會計原則每股收益指引下調了 0.25 美元，至 7.90 美元至 8.05 美元的範圍內。我們的非公認會計原則每股收益範圍減少 0.25 美元完全是由外匯匯率的影響驅動的，因為收購的 IPR&D 和開發里程碑費用對選定產品的每股收益的影響——而選定產品被貝特洛維單抗額外銷售的影響所抵消。

Now I will turn the call over to Dan to highlight our progress in R&D.

現在我將把電話轉給 Dan 來強調我們在研發方面的進展。

Thanks, Anat. Looking across Lilly R&D, I continue to be quite encouraged by the potential we have, to turn cutting-edge science into life-changing medicines for patients. This potential is becoming a reality in the late-stage portfolio, where I'll focus my remarks today. But also, it's becoming more and more evident in our earlier-stage projects, and I look forward to providing updates on some of these assets in future quarters.

謝謝，阿納特。縱觀禮來的研發，我繼續為我們擁有的潛力感到鼓舞，將尖端科學轉化為改變患者生命的藥物。這種潛力正在後期投資組合中成為現實，我今天將重點介紹這一點。而且，它在我們的早期項目中變得越來越明顯，我期待在未來幾個季度提供其中一些資產的更新。

Given updates we provided at ADA in June, including detailed results from SURMOUNT-1, I'll focus today's R&D update on the late-stage progress since our last earnings call more generally.

鑑於我們在 6 月份在 ADA 上提供的更新，包括 SURMOUNT-1 的詳細結果，我將把今天的研發更新重點放在我們上次財報電話會議以來的後期進展上。

Slide 14 shows select pipeline opportunities as of August 1, and Slide 15 shows potential key events for the year. I'll cover both of these slides by therapeutic area.

幻燈片 14 顯示了截至 8 月 1 日的選定管道機會，幻燈片 15 顯示了今年潛在的關鍵事件。我將按治療領域介紹這兩張幻燈片。

Starting with immunology. Along with our partner, Incyte, we're proud that Olumiant has now been approved as a first-in-disease systemic treatment for adults with severe alopecia areata in the U.S., EU and Japan. Alopecia areata is a significant unmet medical need, and we're delighted about what this medicine could mean for people living with this disease.

從免疫學開始。與我們的合作夥伴 Incyte 一起，我們感到自豪的是，Olumiant 現在已被批准為美國、歐盟和日本嚴重斑禿成人患者的首個疾病全身治療。斑禿是一個重要的未滿足的醫療需求，我們很高興這種藥物對患有這種疾病的人意味著什麼。

We also announced top line data from the lebrikizumab Phase III monotherapy maintenance studies in patients with moderate to severe atopic dermatitis, which showed 80% of lebrikizumab responders maintained improvements in skin clearance and disease severity at 52 weeks.

我們還公佈了對中度至重度特應性皮炎患者進行的 lebrikizumab III 期單藥維持研究的一線數據，該研究顯示 80% 的 lebrikizumab 應答者在 52 週時保持皮膚清除和疾病嚴重程度的改善。

Data supported both once every 2-week and once every 4-week maintenance dosing, with consistent and durable responses. We believe the potential for a once every 4-week maintenance dosing regimen could be an important point of differentiation for patients and health care providers.

數據支持每 2 週一次和每 4 週一次的維持給藥，具有一致且持久的響應。我們相信，每 4 週一次的維持給藥方案的潛力可能是患者和醫療保健提供者的重要差異化點。

Lilly is planning submission of lebrikizumab to the FDA in 2022, followed by submissions to other regulatory agencies around the world. Almirall has rights to develop and commercialize lebrikizumab for atopic dermatitis in Europe and is planning for submission to the EMA in 2022.

禮來公司計劃在 2022 年向 FDA 提交 lebrikizumab，然後向世界各地的其他監管機構提交。 Almirall 有權在歐洲開發和商業化用於治療特應性皮炎的 lebrikizumab，併計劃在 2022 年提交給 EMA。

Shifting to mirikizumab. We presented results from the Phase III maintenance study, LUCENT-2, at the DDW meeting. This study showed that for patients who responded to treatment on mirikizumab in the 12-week induction period, 50% of patients who received mirikizumab maintenance therapy achieved clinical remission at 1 year compared to 1/4 of patients randomized to placebo.

轉向mirikizumab。我們在 DDW 會議上展示了 III 期維護研究 LUCENT-2 的結果。這項研究表明，對於在 12 週誘導期內對 mirikizumab 治療有反應的患者，接受 mirikizumab 維持治療的患者中有 50% 在 1 年時達到臨床緩解，而隨機接受安慰劑的患者為 1/4。

In addition to the U.S. regulatory submission of mirikizumab for ulcerative colitis that we announced earlier this year, we have now submitted in the EU and Japan.

除了我們今年早些時候宣布的美國監管機構提交的用於治療潰瘍性結腸炎的 mirikizumab 之外，我們現在已經在歐盟和日本提交了申請。

Also noted here in immunology is a Phase II start for our BTLA agonist antibody in SLE and our new KV1.3 inhibitor shown in Phase I. Our IL-2 conjugate is now listed under its nonproprietary name, Rezpegaldesleukin.

在免疫學中還注意到我們在 SLE 中的 BTLA 激動劑抗體的 II 期啟動和 I 期顯示的新的 KV1.3 抑製劑。我們的 IL-2 偶聯物現在以其非專有名稱 Rezpegaldesleukin 列出。

Moving to diabetes. We're thrilled that Mounjaro is now approved in the U.S. as the first and only GIP and GLP-1 receptor agonist for the treatment of adults with type 2 diabetes. We're pleased to have received a positive CHMP opinion in the European Union, and we're hopeful for full approval by the EMA later this quarter. We presented the exciting detailed results from SURMOUNT-1, evaluating tirzepatide for treatment of weight management and participants with obesity or are overweight at ADA, with simultaneous publication in the New England Journal of Medicine.

轉向糖尿病。我們很高興 Mounjaro 現在在美國被批准為第一個也是唯一一個 GIP 和 GLP-1 受體激動劑，用於治療成人 2 型糖尿病。我們很高興在歐盟收到了積極的 CHMP 意見，我們希望在本季度晚些時候獲得 EMA 的全面批准。我們展示了 SURMOUNT-1 令人興奮的詳細結果，評估了 tirzepatide 治療體重管理和 ADA 肥胖或超重的參與者，同時發表在《新英格蘭醫學雜誌》上。

New data included an exploratory analysis that showed roughly 40% of patients achieved at least 25% weight reduction on the 15-milligram dose compared to less than 1% of patients on placebo. Additionally, we saw meaningful reductions in blood pressure and lipids as well as reduction in fat mass that was nearly 3x greater than that in lean mass. Encouraging data also showed that for those patients who had pre-diabetes at the start of the study, over 95% returned to normal glucose levels. The efficacy, safety and tolerability data in SURMOUNT-1 exceeded our expectations.

新數據包括一項探索性分析，該分析顯示大約 40% 的患者在 15 毫克劑量下體重減輕至少 25%，而安慰劑組中只有不到 1% 的患者體重減輕。此外，我們看到血壓和血脂顯著降低，脂肪量減少了近 3 倍，比瘦體重高出近 3 倍。令人鼓舞的數據還顯示，對於那些在研究開始時患有糖尿病前期的患者，超過 95% 的患者血糖水平恢復正常。 SURMOUNT-1 的療效、安全性和耐受性數據超出了我們的預期。

Based on our existing robust data set for tirzepatide, we have now engaged with the FDA and we'll have a meeting soon to evaluate whether there's a potential path forward to registration for chronic weight management based on SURMOUNT-1, combined with data from the SURPASS program. We'll continue to communicate to investors as there are material updates.

基於我們現有的 tirzepatide 強大數據集，我們現在已經與 FDA 進行了接觸，我們將很快召開會議，以評估是否存在基於 SURMOUNT-1 註冊慢性體重管理的潛在途徑，並結合來自超越計劃。由於有重大更新，我們將繼續與投資者溝通。

We continue to expand our clinical program for tirzepatide, and we have now initiated our Phase III study evaluating tirzepatide for treatment of obstructive sleep apnea. We also have begun a new trial called SURPASS-EARLY, which evaluates the long-term safety and efficacy of tirzepatide compared to standard of care when initiated early in the course of type 2 diabetes.

我們繼續擴大我們的 tirzepatide 臨床項目，我們現在已經啟動了評估 tirzepatide 治療阻塞性睡眠呼吸暫停的 III 期研究。我們還開始了一項名為 SURPASS-EARLY 的新試驗，該試驗與在 2 型糖尿病病程早期啟動的標準治療相比，評估了替西帕肽的長期安全性和有效性。

Later this year, we'll begin [SURMOUNT-5] a head-to-head study comparing weight reduction for tirzepatide versus semaglutide 2.4 milligrams. And finally, later this year, we expect to initiate SURMOUNT-MMO, our Phase III morbidity and mortality in obesity study.

今年晚些時候，我們將開始 [SURMOUNT-5] 一項頭對頭研究，比較 tirzepatide 與 semaglutide 2.4 毫克的減肥效果。最後，今年晚些時候，我們預計將啟動 SURMOUNT-MMO，這是我們在肥胖症中的 III 期發病率和死亡率研究。

Moving to our weekly basal insulin Fc, also known as BIF. We have now initiated our second Phase III trial, QWINT-2, which is evaluating BIF compared to degludec in adults with type 2 diabetes who are starting basal insulin for the first time.

轉向我們每週的基礎胰島素 Fc，也稱為 BIF。我們現在已經啟動了我們的第二個 III 期試驗 QWINT-2，該試驗在首次開始使用基礎胰島素的 2 型糖尿病成人中評估 BIF 與 degludec 的比較。

Our Phase II GGG tri-agonist is now listed under its nonproprietary name, Retatrutide. Also, in this area, 2 assets have now entered Phase I clinical development, our Dual Amylin Calcitonin Receptor Agonist or DACRA and our PNPLA3 sIRNA.

我們的 II 期 GGG 三激動劑現已以其非專利名稱 Retatrutide 上市。此外，在該領域，有 2 項資產現已進入 I 期臨床開發，即我們的雙胰淀素降鈣素受體激動劑或 DACRA 和我們的 PNPLA3 sIRNA。

In oncology, we are announcing today that the FDA has accepted the filing for pirtobrutinib in mantle cell lymphoma for patients previously treated with a BTK inhibitor, with Priority Review designation under an accelerated approval pathway. Improved treatment options are needed for this challenging disease, and we're encouraged that this potential new medicine could be available to patients in early 2023.

在腫瘤學方面，我們今天宣布，FDA 已接受針對先前使用 BTK 抑製劑治療的患者的套細胞淋巴瘤患者的 pirtobrutinib 申請，並在加速批准途徑下指定了優先審查。這種具有挑戰性的疾病需要改進的治療方案，我們感到鼓舞的是，這種潛在的新藥可以在 2023 年初提供給患者。

In early-phase oncology, we've moved our mutant-selective PI3-kinase alpha inhibitor into Phase I development.

在早期腫瘤學中，我們已將我們的突變體選擇性 PI3-激酶 α 抑製劑轉移到 I 期開發中。

And finally, moving to neuroscience. We're also pleased to announce the FDA has accepted the filing for donanemab for the treatment of early symptomatic Alzheimer's disease and is granted Priority Review designation under an accelerated approval pathway.

最後，轉向神經科學。我們也很高興地宣布，FDA 已接受用於治療早期症狀性阿爾茨海默病的多那奈馬的申請，並在加速批准途徑下獲得優先審查指定。

We continue to look forward to the top line results of the Phase III confirmatory study, TRAILBLAZER-ALZ 2, by mid-2023, which, if positive, will form the basis of our application for traditional regulatory approval. You also noticed we're now referring to N3pG4 by its nonproprietary name, Remternetug. We plan to initiate the Phase III program for Remternetug in the coming weeks.

我們繼續期待在 2023 年年中之前的 III 期驗證性研究 TRAILBLAZER-ALZ 2 的一線結果，如果結果為陽性，將成為我們申請傳統監管批准的基礎。您還注意到我們現在使用其非專有名稱 Remternetug 來指代 N3pG4。我們計劃在未來幾週內啟動 Remternetug 的第三階段計劃。

As you can see, Q2 was another productive quarter for pipeline advancement at Lilly. Now I'll turn the call back to Dave for closing remarks.

如您所見，第二季度是禮來公司管道推進的另一個富有成效的季度。現在，我將把電話轉回 Dave 以進行結束髮言。

Thanks, Dan. Before we go to Q&A, let me briefly sum up the progress we have made in the second quarter.

謝謝，丹。在進行問答之前，讓我簡要總結一下我們在第二季度取得的進展。

We're encouraged by the performance of our key growth products, which now represent 67% of our core business. We expect to see this grow over time as we work to launch more innovative medicines, like Mounjaro.

我們對關鍵增長產品的表現感到鼓舞，這些產品現在占我們核心業務的 67%。隨著我們努力推出更多創新藥物，如 Mounjaro，我們預計隨著時間的推移，這種情況會有所增長。

Excluding the impact of acquired IPR&D and development milestone charges, we expect to see operating margin expansion from both revenue growth and driving further efficiencies in our business. We saw significant progress in our pipeline this quarter with the approvals of Mounjaro in type 2 diabetes and Olumiant in alopecia areata.

排除收購的 IPR&D 和開發里程碑費用的影響，我們預計營業利潤率將因收入增長和進一步提高業務效率而擴大。隨著 Mounjaro 獲批治療 2 型糖尿病和 Olumiant 獲批治療斑禿，本季度我們的管道取得了重大進展。

We also saw progress on our next wave of potential growth catalysts, with the FDA acceptance of donanemab as well as pirtobrutinib and positive top line readout for lebrikizumab and additional submissions for mirikizumab.

我們還看到了下一波潛在增長催化劑的進展，FDA 接受了 donanemab 和 pirtobrutinib 以及 lebrikizumab 的正面頂線讀數以及 mirikizumab 的額外提交。

Finally, we returned $900 million to shareholders via the dividend and share repurchases.

最後，我們通過股息和股票回購向股東返還了 9 億美元。

Looking to the future, we are confident in our long-term growth prospects as we are focused on developing groundbreaking therapies in areas of significant unmet need as well as driving exceptional execution for our recently launched medicines so they reach patients who need them.

展望未來，我們對我們的長期增長前景充滿信心，因為我們專注於在重大未滿足需求的領域開發突破性療法，並推動我們最近推出的藥物的卓越執行，以便它們到達需要它們的患者。

Before we close, I would like to comment as well. This is Kevin Hern's last call as head of our IR team. And before I turn the call over to him to moderate the Q&A session, I would just like to thank him on behalf of our shareholders, our Board and of course, our executive team and employees. He's done an outstanding job for the last 4.5 years, strengthening our relationships with The Street as well as being an ambassador to both convey the company's messages to shareholders, but also inform management about shareholder perspectives. We wish him the best in his new assignment, transitioning to a leadership role in our U.S. commercial group.

在我們結束之前，我也想發表評論。這是 Kevin Hern 作為我們 IR 團隊負責人的最後一次電話。在我將電話轉給他主持問答環節之前，我只想代表我們的股東、董事會，當然還有我們的執行團隊和員工感謝他。在過去的 4.5 年裡，他做得非常出色，加強了我們與 The Street 的關係，並作為大使向股東傳達了公司的信息，同時也讓管理層了解股東的觀點。我們祝愿他在新的任務中一切順利，過渡到我們美國商業集團的領導角色。

Now I'll turn the call over to Kevin for his last Q&A session.

現在，我將把電話轉給 Kevin，參加他的最後一次問答環節。

Thanks, Dave. Thanks for the kind words. I will definitely miss this.

謝謝，戴夫。感謝您的客氣話。我一定會想念這個的。

We would like to take questions from as many callers as possible, so please limit your questions to 2 per caller. [Lois], if you can provide the instructions for the Q&A session, and then we're ready for the first caller.

我們希望收到盡可能多的來電者的問題，因此請將您的問題限制在每位來電者 2 個。 [Lois]，如果你能提供問答環節的說明，那麼我們就可以接聽第一個來電者了。

(Operator Instructions) The first question will come from the line of Geoff Meacham from Bank of America.

（操作員說明）第一個問題來自美國銀行的 Geoff Meacham。

I just have 2 quick ones, one on Mounjaro. I know it's pretty early in adoption, but maybe just talk about the source of new starts, meaning are they GLP-naive or experience. And then talk about the expected payer dynamics looking to 2023.

我只有兩個快速的，一個在 Mounjaro。我知道現在採用還很早，但也許只是談論新開始的來源，這意味著他們是 GLP 天真的還是經驗。然後談談到 2023 年的預期付款人動態。

And for Dan, on tirzepatide, I know your regulatory discussions are ongoing in obesity, but do you think you can also use the safety database from diabetes and other indications when you look to kind of NASH, sleep apnea, et cetera?

對於丹，關於 tirzepatide，我知道你們的監管討論正在進行中，但是當您查看 NASH、睡眠呼吸暫停等時，您認為您是否也可以使用糖尿病和其他適應症的安全數據庫？

Thanks, Geoff. We'll start off with Mike on Mounjaro. And then, Dan, if you want to comment on the regulatory for tirzepatide in obesity. Mike?

謝謝，傑夫。我們將從 Mounjaro 上的 Mike 開始。然後，丹，如果你想評論肥胖症中替西帕肽的監管。麥克風？

Yes. Thanks, Geoff. Thanks for the question. What we've seen are -- first of all, we're incredibly excited about the very robust launch we've had with Mounjaro. We're also excited about the source of business that we're seeing. 72% of Mounjaro is coming from new patients into the incretin class. We think that's very important, important for accelerating class growth, and we have seen class growth both at total prescriptions, new-to-brand and NTS accelerate since Mounjaro's launch.

是的。謝謝，傑夫。謝謝你的問題。我們所看到的是——首先，我們對我們與 Mounjaro 進行的非常強大的發布感到非常興奮。我們也對我們所看到的業務來源感到興奮。 72% 的 Mounjaro 來自腸促胰島素類的新患者。我們認為這對於加速類增長非常重要，而且自 Mounjaro 推出以來，我們已經看到總處方、新品牌和 NTS 的類增長都在加速。

Of the 28% of the volume that's coming from switches, only 30% of that is from Trulicity and 70% is from other GLPs. And so, as a result, as Anat indicated in -- earlier, we're actually seeing Lilly incretin share market growing, which is the sign that we -- of a robust solid foundation that we're laying. And so the NBRx have increased our share by -- Lilly's share in the injectable market by 12% and new-to-treatment starts by 10%. So we're very happy we're growing the class and the market share at the same time.

在來自交換機的 28% 的交易量中，只有 30% 來自 Trulicity，70% 來自其他 GLP。因此，正如 Anat 在早些時候指出的那樣，我們實際上看到 Lilly incretin 股票市場在增長，這表明我們正在奠定堅實的基礎。因此，NBRx 使我們的份額增加了——禮來在註射劑市場的份額增加了 12%，新治療開始增加了 10%。所以我們很高興我們同時增加了課程和市場份額。

Your second question around payer dynamics, it's going as expected for us. We're trying to stay very disciplined. I think our focus is to set ourselves up for long-term success, not short-term success. And that's what we're doing. So it's going as expected. So far, we have both commercial and Part D access on Express Scripts, Cigna and Humana formularies.

關於付款人動態的第二個問題，這對我們來說是預期的。我們正努力保持紀律性。我認為我們的重點是讓自己獲得長期成功，而不是短期成功。這就是我們正在做的事情。所以它按預期進行。到目前為止，我們擁有 Express Scripts、Cigna 和 Humana 處方集的商業和 D 部分訪問權限。

Thanks, Mike. Dan?

謝謝，邁克。擔？

Yes. Thanks, Geoff, for the question. You're pointing out that correctly, that we intend to pursue a number of related indications for tirzepatide. Some of them have overlapping patient populations. Most of the indications we pursue have a base of patients that either have obesity as a preexisting and sometimes causative condition, such as obstructive sleep apnea or heart failure in people with obesity. Other indications might be a mix of type 2 diabetes and obesity, representing a large number patients, such as NASH.

是的。謝謝，傑夫，這個問題。您正確地指出，我們打算為 tirzepatide 尋求一些相關的適應症。其中一些具有重疊的患者群體。我們追求的大多數適應症的患者群要么患有肥胖症，要么是預先存在的，有時是病因，例如肥胖症患者的阻塞性睡眠呼吸暫停或心力衰竭。其他適應症可能是 2 型糖尿病和肥胖症的混合，代表大量患者，例如 NASH。

So where applicable safety exposures from similar propositions can be used to support submissions, of course, some of those programs are staggered in time, and so by the time we get efficacy data in those indications, we'll also have quite likely the rest of the SURMOUNT program. But where we are today is quite a large and robust safety database from the entire SURPASS program as well as SURMOUNT.

因此，在類似提議的適用安全風險可用於支持提交的情況下，當然，其中一些程序在時間上是錯開的，所以當我們獲得這些適應症的療效數據時，我們也很可能擁有其餘的SURMOUNT 程序。但是我們今天所處的位置是一個來自整個 SURPASS 計劃以及 SURMOUNT 的龐大而強大的安全數據庫。

The next caller is Chris Schott from JPMorgan.

下一位來電者是摩根大通的 Chris Schott。

Just 2 for me. I guess just on the obesity opportunity. I guess based on the feedback you've been getting on that SURMOUNT data, I guess, is there any change in terms of how you anticipate payers will approach obesity? I guess the heart of the question is do you anticipate we're going to really need to see some of the CV morbidity/mortality data before we can think about broad coverage for obesity medications? Or are you seeing payers potentially more interested in covering these type of products given some of the profile that kind of emerged from that study?

對我來說只有2個。我想只是肥胖的機會。我想根據您對 SURMOUNT 數據的反饋，我想，您預計付款人將如何處理肥胖問題是否有任何變化？我想問題的核心是您是否預計我們真的需要查看一些 CV 發病率/死亡率數據，然後才能考慮廣泛覆蓋肥胖藥物？或者，鑑於該研究中出現的一些概況，您是否看到付款人可能對覆蓋這些類型的產品更感興趣？

My second question was one for Dave, I guess, on just health care reform. I know you love answering these questions. But I guess, as you guys have just been so involved in this process, I would just appreciate your thoughts on the latest bill we're seeing and just kind of the impact you would expect it to have on the industry and maybe really more specifically.

我想我的第二個問題是給戴夫的，只是關於醫療改革。我知道你喜歡回答這些問題。但我想，由於你們剛剛參與了這個過程，我很感激你對我們看到的最新法案的看法，以及你期望它對行業產生的影響，也許更具體地說.

Thanks, Chris. We'll go to Mike first and then -- on obesity, and then Dave for health care reform.

謝謝，克里斯。我們先去找邁克，然後是肥胖問題，然後是戴夫的醫療改革。

Yes, great question. The SURMOUNT-1 data was phenomenal data for patients and physicians who treat obesity. We -- I think there's a combination of effects that will affect employers and the government to increase access for obesity agents. One is the data we produce. And I think, obviously, the first data we're producing is the weight loss as well as the factors like lipids and blood pressure. And the data we produced so far has been stellar. So I think the better data we produce in SURMOUNT-1 through SURMOUNT-4 is just going to help us in the short term.

是的，很好的問題。 SURMOUNT-1 數據對於治療肥胖症的患者和醫生來說是驚人的數據。我們 - 我認為有多種影響會影響雇主和政府增加肥胖代理的機會。一是我們產生的數據。我認為，顯然，我們產生的第一個數據是體重減輕以及血脂和血壓等因素。到目前為止，我們生成的數據非常出色。所以我認為我們在 SURMOUNT-1 到 SURMOUNT-4 中產生的更好的數據只會在短期內幫助我們。

Long-term, we think there's a lot of comorbid conditions associated with obesity, like CV and heart failure and sleep apnea, and the better data that we support there will open up those indications, where -- or highly -- they have a lot of overlap with obesity. And so we're excited about those trials and seeing those data as those trials complete.

從長遠來看，我們認為有很多與肥胖相關的合併症，比如心血管疾病、心力衰竭和睡眠呼吸暫停，我們支持的更好的數據將打開這些適應症，或者說它們有很多與肥胖重疊。因此，我們對這些試驗感到興奮，並在這些試驗完成時看到這些數據。

And then lastly, the more we can drive consumer interest in this, that puts pressure on employers and the government to be able to gain access for this. And so I think we've got strong plans on all 3 fronts, and we're excited about the first data disclosure we've had on obesity. So we're very bullish on the long-term prospects of the obesity market and trizepatide thrown in it.

最後，我們越能推動消費者對此的興趣，就會給雇主和政府施加壓力，讓他們能夠獲得這一點。因此，我認為我們在所有 3 個方面都制定了強有力的計劃，我們對首次披露肥胖數據感到興奮。因此，我們非常看好肥胖市場的長期前景以及其中的trizepatide。

Thanks, Mike. Dave?

謝謝，邁克。戴夫？

Yes, Chris, thanks for the question. I think everybody probably on the call has a good grasp of what's in this package. Difficult to speculate on probabilities, but certainly, a lot higher than a month ago, that something crosses the line. There may be some adjustments to this as they go through that parliamentary process and whatever changes might occur still to come in the Senate and the House.

是的，克里斯，謝謝你的提問。我想可能在電話中的每個人都很好地掌握了這個包中的內容。很難推測概率，但可以肯定的是，比一個月前要高得多，有些事情越界了。在他們通過議會程序時可能會對此進行一些調整，而參議院和眾議院仍可能發生任何變化。

But if -- when we're looking at passes, maybe that's your question. As you know, we've been for the Part D reforms. I think they are good incremental changes, particularly capping annual out-of-pocket and getting rid of the donut hole concept. Unfortunately, they don't improve the concept of pacing patient cost sharing on net pricing, which we're hoping it would.

但是如果——當我們查看傳球時，也許這就是你的問題。如你所知，我們一直支持 D 部分改革。我認為它們是很好的增量變化，特別是限制年度自付費用和擺脫甜甜圈洞的概念。不幸的是，他們並沒有改進在淨定價上調整患者成本分攤的概念，我們希望它會這樣。

But by itself, we would support that. The CPI adjustment is not really an issue. As probably everyone on this call knows, there's already lots of CPI capping that goes on in the commercial marketplace. And with CPI being where it is now as well, I think list prices in the drug business are not nearly as fast as the rest of the economy.

但就其本身而言，我們會支持這一點。 CPI 調整併不是一個真正的問題。可能本次電話會議的每個人都知道，商業市場上已經有很多 CPI 上限。由於 CPI 也處於現在的水平，我認為藥品行業的定價遠不及經濟的其他領域。

But the negotiation piece is a problem. And I think, in the short term, speaking for our company, but probably the industry, it doesn't do much. They don't really start until '26 anyway. But in the midterm, there will be, of course, some products that will have attenuated life cycles. And I think that will cause some headwinds for the industry, and we'll see if any Lilly products get caught up in that.

但談判部分是個問題。而且我認為，在短期內，就我們公司而言，但可能對整個行業而言，它並沒有多大作用。無論如何，他們直到 26 年才真正開始。但在中期，當然會有一些產品的生命週期會縮短。我認為這會給該行業帶來一些不利因素，我們將看看是否有禮來公司的產品被捲入其中。

But probably to me, the most damaging thing about it is it sends a signal to investors and capital allocators like us that small molecules, and particularly small molecules in diseases that require step-wise development like cancer, where we start in stage -- in later stages and work our way to adjuvant or even in some orphan conditions, really aren't wanted and are worth a lot less.

但可能對我來說，它最具破壞性的一點是它向投資者和像我們這樣的資本配置者發出了一個信號，即小分子，尤其是癌症等需要逐步發展的疾病中的小分子，我們從階段開始——在後期階段並以我們的方式工作以達到輔助甚至在某些孤兒條件下，確實不需要並且價值要低得多。

So we'll focus our resources on other areas of innovation. We've got plenty of those and so will the rest of the sector. And I think that's really a miss for the patients that probably want better oral cancer drugs in the future and orphan disease drugs. So I think that's probably not being talked about enough, and I just wanted to emphasize that.

因此，我們將把資源集中在其他創新領域。我們有很多這樣的人，該行業的其他人也將如此。而且我認為對於未來可能想要更好的口腔癌藥物和孤兒病藥物的患者來說，這真的是一個錯過。所以我認為這可能沒有得到足夠的討論，我只是想強調這一點。

The next caller is Seamus Fernandez from Guggenheim.

下一位來電者是來自古根海姆的 Seamus Fernandez。

So just a couple of questions here. Dave, I was just hoping to get a little bit more color on the comment that you made there with regard to orals. How do you see that impacting your efforts to bring forward oral diabetes drugs?

所以這裡只有幾個問題。戴夫，我只是希望對你在口頭上發表的評論有更多的色彩。您如何看待這會影響您推出口服糖尿病藥物的努力？

And is it more a benefit to complex oral therapies that aren't small molecule per se, but perhaps are more peptide-oriented? I know you guys are working on some efforts along those lines. So just interested to know if the legislation would imply that as well. From a small molecule perspective, we see a number of oral GLP-1s seeking to come to market at some point in time.

對於本身不是小分子但可能更以肽為導向的複雜口服療法是否更有好處？我知道你們正在沿著這些方向努力。所以只是想知道立法是否也會暗示這一點。從小分子的角度來看，我們看到許多口服 GLP-1 在某個時間點尋求上市。

And then separately, just on Dan, on the glucagon mechanism, I see GGG listed in 2 Phase II clinical trials, but Mazdutide, your oxyntomodulin product, is listed just in sort of the Phase I in diabetes. Wondering if you guys have officially made this decision to move forward with GGG or if Mazdutide is still potentially in the mix as kind of your next-gen asset in the obesity space.

然後單獨在丹上，關於胰高血糖素機制，我看到 GGG 在 2 個 II 期臨床試驗中列出，但你的胃泌酸調節素產品 Mazdutide 只是在糖尿病 I 期中列出。想知道你們是否已正式做出與 GGG 合作的決定，或者 Mazdutide 是否仍有可能成為肥胖領域的下一代資產。

Thanks, Seamus. We'll go to Dave and then Dan.

謝謝，西莫。我們先去找戴夫，然後找丹。

Yes. Thanks, Seamus. I mean I guess, to put a finer point on it, each project will have to be evaluated one by one. But I think you will probably see, 10 years down the line, fewer small molecule oral products developed in the industry than would have been otherwise the case if this bill passes. Again, that to me is the miss.

是的。謝謝，西莫。我的意思是，我想，為了更好地說明這一點，每個項目都必須一個一個地進行評估。但我想你可能會看到，10 年後，如果該法案獲得通過，該行業開發的小分子口服產品將少於其他情況。再說一次，這對我來說是錯過。

And I think it -- there's still probably quite a bit of advantage in oral small molecules in sort of large primary care indications, especially if, in the case of like GLP, we could accept that weight loss will provide broader benefits for the earlier question about when sort of the belief system tips over and people just accept that chronic weight management is good for health, like reduced blood pressure is good for cardiovascular risk.

而且我認為 - 在大型初級保健適應症中，口服小分子藥物可能仍然具有相當大的優勢，特別是如果像 GLP 這樣的情況，我們可以接受減肥將為前面的問題提供更廣泛的好處關於什麼時候某種信念系統倒塌，人們只是接受慢性體重管理對健康有益，就像降低血壓對心血管風險有益一樣。

And I think those products will be evaluated one by one, and big opportunities, I think, will advance and do well. They will have attenuated life cycle in the government business, and that will have to be factored in, but we'll look at that.

而且我認為這些產品將被逐一評估，我認為巨大的機會將推進並做得很好。它們將縮短政府業務的生命週期，這必須考慮在內，但我們會看看這一點。

What I was referring to is more, I think, in narrower revenue opportunities. It just gets a lot harder. And when, by kind of construct, your new indications can't be compressed forward because of the way we develop drugs in some of these diseases, that's a problem. And I don't think that was well-thought through, and there will be a long-term implication to that.

我認為，我所指的更多是更狹窄的收入機會。它只會變得更加困難。而且，由於我們在某些疾病中開發藥物的方式，您的新適應症不能被壓縮，這是一個問題。我不認為這是經過深思熟慮的，這將產生長期影響。

One other thing I probably should say is this bill raises $300 billion for the federal government off the back of the industry, probably cost the industry at least $0.5 trillion, and only about $50 billion of that, like 10%, is going back to patient benefit support. And I think that's another tenet when we were leading pharma, Lilly, was to make sure whatever came out of the industry went back to patients. That's not happening here, and that needs to be discussed as well.

我可能應該說的另一件事是，這項法案在該行業的支持下為聯邦政府籌集了 3000 億美元，可能使該行業損失了至少 5 萬億美元，而其中只有大約 500 億美元，比如 10%，將回到患者手中福利支持。我認為，當我們領導製藥公司禮來公司時，另一個宗旨是確保從該行業產生的任何東西都回饋給患者。這不是在這裡發生的，這也需要討論。

Thanks, Dave. Dan?

謝謝，戴夫。擔？

Yes. Thanks, Seamus, for the question on glucagon-containing molecules. So we previously said that we have 2 in clinical development, Mazdutide, which is our oxyntomodulin, that's glucagon plus GLP-1, and Retatrutide, which is our GGG, which is glucagon GLP-1 and GIP1. You're right that the GGG molecule is ahead in development, that's in Phase II, and the oxyntomodulin is still in Phase I. I think they're both viable as next-generation weight loss products.

是的。謝謝，Seamus，關於含胰高血糖素分子的問題。所以我們之前說我們有兩個臨床開發，Mazdutide，這是我們的胃泌酸調節素，即胰高血糖素加 GLP-1，和 Retatrutide，這是我們的 GGG，即胰高血糖素 GLP-1 和 GIP1。你說得對，GGG 分子在開發中處於領先地位，即處於 II 期，而胃泌酸調節素仍處於 I 期。我認為它們都可以作為下一代減肥產品。

But to be clear here, it's a very high bar. We're looking for a major step-change above the really remarkable results we saw in SURMOUNT-1. I think they both have that potential, but we're going to need to see more data to know which -- if either goes forward to Phase III.

但要明確的是，這是一個非常高的標準。我們正在尋找比我們在 SURMOUNT-1 中看到的真正顯著結果的重大轉變。我認為他們都有這種潛力，但我們需要看到更多的數據才能知道哪個——如果有一個進入第三階段。

Just like when we were doing Phase II in tirzepatide, which was just a few years ago, we noted that it had to have a step-change to go forward to Phase III. If you hear us talking about when -- our growth of these molecules going to Phase III, it means we saw that kind of a big step-change.

就像幾年前我們在 tirzepatide 進行 II 期時一樣，我們注意到它必須有一個階段性的改變才能進入 III 期。如果你聽到我們談論什麼時候——我們這些分子的生長進入第三階段，這意味著我們看到了這種巨大的進步。

The next caller is Louise Chen with Cantor.

下一位來電者是 Cantor 的 Louise Chen。

So my first question for you was on the obesity product. Do you see any potential read-throughs from Novo's SELECT study to tirzepatide? And have you given any color on how you want to structure your studies on an outcomes basis for VC?

所以我的第一個問題是關於肥胖產品。您是否看到從 Novo 的 SELECT 研究到 tirzepatide 的任何潛在通讀？你有沒有對你想如何根據 VC 的結果來組織你的研究給出任何顏色？

And then secondly, it's been quiet on the Alzheimer's front, but just curious if you have any updated thoughts on the market opportunity for donanemab, especially in front of some of these Phase III trials that will read out at the end of the year.

其次，在阿爾茨海默氏症方面一直很安靜，但只是好奇你是否對 donanemab 的市場機會有任何更新的想法，尤其是在這些 III 期試驗將在今年年底公佈之前。

Thanks, Louise. We'll go to Dan for the question on the SELECT trial and then Anne for the question on Alzheimer's.

謝謝，路易絲。我們將向 Dan 詢問有關 SELECT 試驗的問題，然後向 Anne 詢問有關阿爾茨海默氏症的問題。

Hi, Louise. Thanks for that question. Of course, we always reach for our competitors' success on clinical trials. We want great data so that we can have great drugs to help patients. I think the Novo (inaudible) they have passed the interim analysis, but didn't stop the trial for efficacy is fine. I think there's really pretty significant differences here between tirzepatide and semaglutide that we just have to remember, a different mechanism, a different degree of efficacy on various outcomes, different trial designs, different populations to some extent.

嗨，路易絲。謝謝你的問題。當然，我們總是力爭競爭對手在臨床試驗中取得成功。我們需要大量的數據，這樣我們才能有偉大的藥物來幫助患者。我認為 Novo（聽不清）他們已經通過了中期分析，但沒有因為療效而停止試驗是可以的。我認為 tirzepatide 和 semaglutide 之間確實存在非常顯著的差異，我們只需要記住，不同的機制，對不同結果的不同程度的療效，不同的試驗設計，不同的人群在某種程度上。

So we don't change our design of our SURMOUNT-MMO study. We don't change our thinking about probably success. As Mike said earlier, we're highly confident in this mechanism based on all of the data that we've seen, of course, starting with a quite dramatic weight loss, which should be a benefit on morbidity and mortality from obesity.

所以我們不會改變我們對 SURMOUNT-MMO 研究的設計。我們不會改變對可能成功的想法。正如邁克之前所說，基於我們所看到的所有數據，我們對這種機制非常有信心，當然，首先是相當顯著的體重減輕，這應該有利於肥胖的發病率和死亡率。

But also, all of the cardiovascular indicators that we reported out in that Phase III study, including a very significant drop in blood pressure, that should have a benefit. A drop in LDL, an increase in HDL, a drop in triglycerides, all of that should contribute to cardiovascular outcomes. So we remain excited and confident about our own study going forward.

而且，我們在 III 期研究中報告的所有心血管指標，包括血壓的顯著下降，都應該有好處。低密度脂蛋白的下降、高密度脂蛋白的增加、甘油三酯的下降，所有這些都應該有助於心血管結局。因此，我們對未來的研究仍然感到興奮和自信。

Thanks, Dan. Anne?

謝謝，丹。安妮？

Yes. Louise, thanks for the question on Alzheimer's. So the fact is, bottom line, so we remain convinced about the mid- and long-term opportunity for donanemab and the Alzheimer's portfolio. Our focus right now is obviously on the rapid availability of donanemab for the appropriate patients through the accelerated approval pathway and then reconsideration with Phase III data. And we remain optimistic that with -- particularly with traditional FDA approval, FDA -- or sorry, CMS, would not continue to limit coverage for on-label treatments.

是的。路易絲，謝謝你關於阿爾茨海默氏症的問題。所以事實是，底線，所以我們仍然相信多納奈馬和阿爾茨海默氏症產品組合的中長期機會。我們現在的重點顯然是通過加速批准途徑為合適的患者快速提供多納奈馬，然後重新考慮 III 期數據。我們仍然樂觀地認為——特別是在傳統的 FDA 批准下，FDA——或者對不起，CMS，不會繼續限制標籤治療的覆蓋範圍。

Now obviously, you mentioned competitor readout. So as we've noted on prior calls, there's a chance that we'll see mixed results in some of these readouts due to the differences in the medicines and their trial designs. And as you know well, we have some unique design features in TB2 and a medicine that demonstrates rapid and deep plaque clearance. So we won't be discouraged if others miss their primary endpoints. And so we'll be following that closely, obviously.

現在顯然，您提到了競爭對手的讀數。因此，正如我們在之前的電話會議中所指出的那樣，由於藥物及其試驗設計的差異，我們有可能在其中一些讀數中看到混合結果。如您所知，我們在 TB2 中具有一些獨特的設計特點，以及一種能夠快速深入地清除斑塊的藥物。因此，如果其他人錯過了他們的主要終點，我們不會氣餒。因此，顯然，我們將密切關注這一點。

But in the near term, of course, we have to acknowledge that patient access will be very limited under the current CMS NCD with accelerated approval. But what that does do with the accelerated approval is really enable us to engage quickly with CMS following the -- that Phase III data and hopefully drive reconsideration at that point. And it also allows us to accelerate the traditional approval through a supplemental BLA.

但在短期內，當然，我們必須承認，在當前加速批准的 CMS NCD 下，患者的准入將非常有限。但是，加速批准確實使我們能夠在第三階段數據之後迅速與 CMS 合作，並希望在那時推動重新考慮。它還使我們能夠通過補充 BLA 加速傳統審批。

So what we'll do in the near term, following a potential approval and the accelerated pathway is used at that time to build out the diagnostic ecosystem, to help physicians with the referral process and infusion systems, and so there's quite a bit to do, I think, to get ready for that Phase III data.

因此，我們將在短期內做些什麼，在獲得潛在批准之後，當時使用加速途徑來構建診斷生態系統，幫助醫生進行轉診過程和輸液系統，所以還有很多工作要做，我認為，為第三階段數據做好準備。

The next caller is Terence Flynn from Morgan Stanley.

下一位來電者是摩根士丹利的特倫斯·弗林。

2 for me. I guess, Mike, you talked about aiming for long-term success with Mounjaro from a reimbursement perspective. So can you just maybe define that for us, put a finer point on it? Should we assume that means you're aiming for a net price above Trulicity ultimately over time?

2對我來說。我想，邁克，你談到了從報銷的角度與 Mounjaro 合作取得長期成功。所以你能不能為我們定義一下，把它說得更清楚一點？我們是否應該假設這意味著隨著時間的推移，您的目標是最終淨價高於 Trulicity？

And then as we think about your ability to supply the market here, obviously, launch, you said, at the high end of your expectations, and I think you touched on this a little bit during your comments in terms of confidence in U.S. supply, but how are you thinking about the broader supply dynamics globally? And then remind us your flexibility to increase supply, if needed, over time.

然後，當我們考慮到您在這裡供應市場的能力時，顯然，您說，在您的期望的高端推出，我認為您在評論中談到了這一點，就對美國供應的信心而言，但是您如何看待全球更廣泛的供應動態？然後提醒我們，如果需要，您可以靈活地隨著時間的推移增加供應。

Thanks, Terence. We'll go to Mike for both questions on Mounjaro, both access and price and then just global supply outlook.

謝謝，特倫斯。我們將向 Mike 詢問有關 Mounjaro 的兩個問題，包括准入和價格，然後是全球供應前景。

Okay. Thanks, Terence, for those questions. Long-term, I think our goals there, is obviously to optimize our net price, but also secure broad access, like we have for Trulicity. So those are our 2 goals. Obviously, we don't give specifics on our net price negotiations publicly. But we're pleased with the progress. We're staying disciplined, trying to accelerate access before any new product launch.

好的。謝謝，特倫斯，這些問題。從長遠來看，我認為我們的目標顯然是優化我們的淨價格，但也要確保廣泛的准入，就像我們對 Trulicity 所做的那樣。所以這是我們的兩個目標。顯然，我們不會公開具體說明我們的淨價格談判。但我們對進展感到滿意。我們保持自律，努力在任何新產品發布之前加快訪問速度。

You got to be careful that you're not too aggressive. You get access too early, but you pay too much for it. So we're staying disciplined. We've got a great product with a great profile. Payers are seeing that. But it's a process, and we're going through that process right now.

你必須小心，不要太激進。您太早獲得訪問權限，但您為此付出了太多。所以我們保持紀律。我們有一個很棒的產品和一個很棒的配置文件。付款人看到了這一點。但這是一個過程，我們現在正在經歷這個過程。

From a supply perspective on Mounjaro, as Anat said, we were planning for success. And so we have a lot of different launch scenarios. And we have launch scenarios that consider this level of uptake. As Anat shared, we don't anticipate any supply constraints for the U.S. launch of Mounjaro.

正如 Anat 所說，從 Mounjaro 的供應角度來看，我們正計劃取得成功。所以我們有很多不同的發布場景。我們有考慮到這種吸收水平的啟動方案。正如 Anat 所說，我們預計美國推出 Mounjaro 不會出現任何供應限制。

We -- our manufacturing team has been working around the clock for years to build manufacturing capacity throughout the supply chain. We have a number of sites who make this, and they're optimizing our initial capacity on a daily basis. Also, we have made investments to expand our capacity over the next several years. We have a new [parental] plant at Research Triangle Park in North Carolina, that's coming online in 2023, and another one behind that in Concord, North Carolina.

我們——我們的製造團隊多年來一直在夜以繼日地工作，以在整個供應鏈中建立製造能力。我們有很多網站都在做這個，他們每天都在優化我們的初始容量。此外，我們已進行投資以在未來幾年擴大產能。我們在北卡羅來納州的三角研究園有一個新的 [母體] 工廠，該工廠將於 2023 年上線，另一個位於北卡羅來納州康科德的工廠。

Also, we're building 2 manufacturing facilities to [make back an] agreement for Mounjaro, and those will go -- come on at a later time. So obviously, we're planning for success, and our manufacturing team is working around the clock to get as much supply as possible.

此外，我們正在建造 2 個製造設施，以 [收回] Mounjaro 的協議，這些設施將繼續進行 - 稍後再進行。所以很明顯，我們正在為成功做計劃，我們的製造團隊正在夜以繼日地工作以獲取盡可能多的供應。

Next caller is Tim Anderson with Wolfe Research.

下一位來電者是 Wolfe Research 的 Tim Anderson。

On the outcomes trial for obesity, presumably that's a cardiovascular outcomes trial with MACE as a primary endpoint and if so, what level of benefit? Or will it be [powered to show Novo's is designed] to show 17%?

在肥胖的結局試驗中，大概是一項以 MACE 作為主要終點的心血管結局試驗，如果是這樣，獲益水平如何？或者它會[顯示 Novo 的設計] 顯示 17%？

And then on the head-to-head versus Novo's product in obesity, anything you can say on trial design, specifically primary endpoint, and perhaps, most importantly, the timing of having results?

然後在肥胖症方面與 Novo 的產品正面交鋒，關於試驗設計，特別是主要終點，也許，最重要的是，取得結果的時間，你能說什麼？

Thanks, Tim. We'll go to Dan for the first question on SURMOUNT-MMO and then Mike for the second question on the head-to-head trial with Novo for tirzepatide.

謝謝，蒂姆。我們將向 Dan 提出關於 SURMOUNT-MMO 的第一個問題，然後向 Mike 提出關於與 Novo 進行 tirzepatide 的頭對頭試驗的第二個問題。

Yes. Thanks for the question, Tim. You're raising an interesting point. I think implicit in your question is the observation that there's a lot of health benefits that come from losing weight. Obesity is a risk factor for a number of things, not just the things that are traditionally measured in cardiovascular outcome studies or MACE studies.

是的。謝謝你的問題，蒂姆。你提出了一個有趣的觀點。我認為你的問題中隱含的是觀察到減肥對健康有很多好處。肥胖是許多事情的風險因素，而不僅僅是傳統上在心血管結果研究或 MACE 研究中測量的事情。

So probably also noting, we've called this morbidity/mortality outcomes, MMO, in obesity rather than CVOT. But beyond that, I think we've intentionally not gotten into details on the primary endpoint or the powering assumptions. So that is yet to be disclosed.

因此，可能還需要注意，我們將這種發病率/死亡率結果稱為 MMO，即肥胖而不是 CVOT。但除此之外，我認為我們故意沒有深入了解主要終點或動力假設的細節。所以這還有待披露。

Thanks, Dan. Mike?

謝謝，丹。麥克風？

Yes. On the head-to-head versus sema 2.4-milligram, there's been no head-to-head trials comparing tirzepatide to sema 2.4. So we believed it was a good opportunity to do that to demonstrate tirzepatide's significant weight loss benefits and totality, the benefits it has for patients.

是的。在頭對頭與 sema 2.4 毫克的對比中，沒有將 tirzepatide 與 sema 2.4 進行對比的頭對頭試驗。因此，我們認為這是一個很好的機會來證明 tirzepatide 顯著的減肥益處和整體性，以及它對患者的益處。

Head-to-head studies are the gold standards. Every time we talk to health care professionals, they really value and get a lot out of head-to-head studies. It just really informs their treatment. So we think it's the right thing to do, and we're pleased to do that. It's going to be a head-to-head study, where we're comparing tirzepatide versus sema 2.4 in people that have obesity and overweight with the weight-related comorbidity. Other than that, we'll provide more on the design and the time line at a later date as we get closer to posting it on clinicaltrials.gov.

面對面的研究是黃金標準。每次我們與醫療保健專業人士交談時，他們都非常重視並從面對面的研究中獲益良多。它只是真正告知他們的治療。所以我們認為這是正確的做法，我們很高興這樣做。這將是一項面對面的研究，我們將在肥胖和超重與體重相關合併症的人群中比較 tirzepatide 與 sema 2.4。除此之外，隨著我們越來越接近將其發佈在臨床試驗.gov 上，我們將在以後提供更多關於設計和時間表的信息。

The next caller is Steve Scala from Cowen.

下一位來電者是來自 Cowen 的 Steve Scala。

A couple of questions. First, Lilly mentioned in the prepared remarks a limited availability of competitor GLP-1s in select geographies. Can you be more specific on which geographies and the magnitude of the issue?

幾個問題。首先，禮來在準備好的評論中提到，競爭對手 GLP-1 在特定地區的供應有限。您能否更具體地說明問題的地域和嚴重程度？

And then a question for Dan. You must have been on the receiving end of many calls from DSMBs with interim updates on trials, for example, the trial of Trulicity in cardiovascular outcomes, REWIND. The question is what is the depth of the information exchange between DSMBs and sponsors at that time? For instance, if a study is continuing past an interim look, is the conversation only 3 words, study is continuing? Or is it more extensive? Or does it depend? And if it depends, what does it depend on?

然後是丹的一個問題。您一定已經接到了來自 DSMB 的許多關於試驗臨時更新的電話，例如，心血管結果中的 Trulicity 試驗，REWIND。問題是當時DSMB與讚助商之間的信息交流深度如何？例如，如果一項研究正在繼續進行，那麼對話是否只有 3 個詞，研究是否仍在繼續？還是更廣泛？還是取決於？如果它取決於，它取決於什麼？

It would seem to me, at least, counterproductive for a DSMB not to provide some guidance just from the vantage point of further development of the molecule. So that's my question.

至少在我看來，DSMB 不從分子進一步開發的有利位置提供一些指導會適得其反。所以這就是我的問題。

Thanks, Steve. We're going to go to Ilya for the question on the supply and demand that we're seeing for Trulicity outside the U.S., and then we'll go to Dan for the second question. Ilya?

謝謝，史蒂夫。我們將向 Ilya 提出關於我們在美國以外的 Trulicity 看到的供需問題，然後我們將向 Dan 提出第二個問題。伊利亞？

Yes. Steve, thanks for the question. First, what we've seen is an accelerated demand for Trulicity in many of our international markets. And it's probably 3 sources, that, one, great commercial success. We've been really successful in our diabetes portfolio, in driving the growth and utilization of Trulicity. At the same time, we've seen accelerated market growth.

是的。史蒂夫，謝謝你的問題。首先，我們看到許多國際市場對 Trulicity 的需求正在加速增長。它可能有 3 個來源，一個是巨大的商業成功。在推動 Trulicity 的增長和利用方面，我們的糖尿病產品組合非常成功。與此同時，我們看到市場增長加速。

And we have seen, in some select markets, the amplified demand for Trulicity because semaglutide is not available in full extent in a number of markets, in terms of where we've seen volatility and where that is occurring, and so we're evaluating. The local situation is quite dynamic, and we're ramping up as much as we can to meet this amplified demand. But at the same time, in some of these markets, we're going to have to look at managing some of the growth and making sure we limit any kind of patient impact.

我們已經看到，在一些特定市場，對 Trulicity 的需求擴大，因為在我們看到波動的地方和發生的地方，索馬魯肽在一些市場上沒有完全可用，所以我們正在評估.當地的情況非常動態，我們正在盡可能地增加以滿足這種擴大的需求。但與此同時，在其中一些市場中，我們將不得不考慮管理一些增長並確保我們限制任何類型的患者影響。

Thanks, Ilya. Dan?

謝謝，伊利亞。擔？

Yes. Thanks, Steve. I understand where your question is going, and I probably don't need to weigh in specifically on what others might do or see, but I'll tell you how we run DSMBs and how we think about them generally across the industry.

是的。謝謝，史蒂夫。我了解您的問題在哪裡，我可能不需要具體權衡其他人可能會做什麼或看到什麼，但我會告訴您我們如何運行 DSMB 以及我們如何在整個行業中普遍看待它們。

There's a couple of principles at play here. First, of course, is independence. This is not something run by the sponsor, and I think that's an important consideration for patient safety. We don't see the data they see, and we're not privy to the discussions as a rule.

這裡有幾個原則在起作用。首先，當然是獨立性。這不是由贊助商經營的，我認為這是患者安全的一個重要考慮因素。我們看不到他們看到的數據，而且我們通常不參與討論。

The second is that we do set, for DSMBs, rules in advance by which they should make decisions. Those could be very simple rules, in some cases, like to hit statistical significance with a certain alpha on the primary endpoint, or they could be more complex rules, looking for consistency across secondaries or subpopulations or a higher bar of efficacy on the primary so that you're sure that you have a compelling effect that varies from study to study and sponsor to sponsor, I'm sure.

第二個是我們確實為 DSMB 提前製定了規則，他們應該根據這些規則做出決定。在某些情況下，這些可能是非常簡單的規則，例如在主要終點上達到某個 alpha 的統計顯著性，或者它們可能是更複雜的規則，在次要終點或亞群之間尋找一致性，或者在主要終點上尋找更高的效力標準，因此你確定你有一個引人注目的效果，從研究到研究，贊助商到贊助商，我敢肯定。

The third thing is that the recommendations that DSMBs give back to sponsors are often prespecified. So we'll tell the DSMB, if it meets these criteria, this is what you tell us. And if it doesn't, this is what you tell us. And they usually are, a matter of fact, without color that could compromise the integrity or cause unintentional unblinding of an ongoing study. So I hope that's helpful in understanding how DSMBs work.

第三件事是 DSMB 回饋給贊助商的建議通常是預先指定的。所以我們會告訴 DSMB，如果它符合這些標準，這就是你告訴我們的。如果沒有，這就是你告訴我們的。事實上，它們通常沒有顏色，可能會損害完整性或導致正在進行的研究無意中揭盲。所以我希望這有助於理解 DSMB 的工作原理。

I think at many companies, if there is a surprising recommendation for a DSMB, such as to stop a study, there will often be a process where the sponsor, or 1 or 2 representatives of the sponsor, are unblinded so they can confirm the DSMB conclusion before taking action. But that wouldn't be typical for a simple study, a continuous kind of decision.

我認為在許多公司，如果對 DSMB 提出令人驚訝的建議，例如停止一項研究，通常會有一個過程，即申辦者或申辦者的 1 或 2 名代表不設盲，以便他們確認 DSMB在採取行動之前得出結論。但這對於一項簡單的研究、一種連續的決定來說並不典型。

Next caller is Umer Raffat from Evercore.

下一位來電者是 Evercore 的 Umer Raffat。

Umer? Umer?

烏默爾？烏默爾？

Looks like his line dropped. We'll move to Andrew Baum from Citigroup.

看來他的線掉線了。我們將轉到花旗集團的 Andrew Baum。

A couple of questions. First one, on Mounjaro, you uniquely have labeling requiring a second form of contraception during titration, which (inaudible) doesn't have. The recent Supreme Court overturning Roe v. Wade put increased emphasis on the confidence in terms of risk of pregnancy given the consequences.

幾個問題。第一個，在 Mounjaro 上，您有獨特的標籤，需要在滴定期間使用第二種避孕方式，而（聽不清）沒有。最近最高法院推翻了羅訴韋德案，考慮到後果，更加強調對懷孕風險的信心。

How are you thinking about this, whether it's potentially an Achilles heel for the product, whether through additional pharmacology studies, that could be overturned as the (inaudible) indication rolled through? It does seem, from the FDA review, that there's a real pharmacologic concern rather (inaudible) data here?

您如何看待這一點，它是否可能成為產品的致命弱點，是否通過額外的藥理學研究，隨著（聽不清）指示的推出而被推翻？從 FDA 的審查來看，似乎確實存在藥理學問題，而不是（聽不清）數據？

And then second, on the positive side. In relation to the pirtobrutinib filing, assuming you get approval for mantle cell, I'm assuming that you would therefore get inclusion in the MCN -- NCCN guidelines (inaudible) for CLL. So could you talk to how you think the expedited approval through mantle cell may accelerate your penetration of the CLL market whilst you're waiting for the Phase III trial program to mature?

其次，積極的一面。關於 pirtobrutinib 的申請，假設您獲得了套細胞的批准，我假設您因此會被納入 MCN - CLL 的 NCCN 指南（聽不清）。那麼，在您等待 III 期試驗計劃成熟的同時，您能否談談您認為通過套細胞加速批准可能會加速您對 CLL 市場的滲透？

Thanks, Andrew. We'll go to Mike for the first question on Mounjaro labeling and the social climate, and then we'll go to Jake for the question on pirtobrutinib.

謝謝，安德魯。第一個關於 Mounjaro 標籤和社會氛圍的問題，我們會去找 Mike，然後我們會去找 Jake，問關於 pirtobrutinib 的問題。

Thanks, Andrew. I appreciate the question. Let me just -- you just said everyone. Our label, Mounjaro, advises women using oral contraception to switch to or add to a nonoral, contraception methods for 4 weeks during initiation of the product and then during the dose titration for each dose.

謝謝，安德魯。我很欣賞這個問題。讓我 - 你剛才說每個人。我們的標籤 Mounjaro 建議使用口服避孕藥的女性在開始使用該產品的 4 週內，然後在每次劑量的劑量調整期間，改用或添加非口服避孕方法。

Given the -- so health care professionals are aware of this. Given the profound benefits of Mounjaro, this hasn't impacted at all HCP and consumer interest in Mounjaro. If you look at the data in the marketplace, we have data with IQVIA through July 22, which is just 5 weeks of full promotion. And we've -- and Mounjaro has already reached 20% new brand share of market. So we haven't seen this as an issue at all.

鑑於 - 所以醫療保健專業人員意識到了這一點。鑑於 Mounjaro 的巨大好處，這根本沒有影響 HCP 和消費者對 Mounjaro 的興趣。如果您查看市場上的數據，我們將在 IQVIA 獲得截至 7 月 22 日的數據，這只是全面推廣的 5 週。我們已經 - Mounjaro 已經達到了 20% 的新品牌市場份額。所以我們根本不認為這是一個問題。

As to the future, [we're still] evaluating the issue. I have nothing new to report to investors at this time. But this has not been an issue that has impacted Mounjaro's uptake at all.

至於未來，[我們仍在]評估這個問題。目前我沒有什麼新消息要向投資者報告。但這根本不是影響 Mounjaro 吸收的問題。

Thanks, Mike. Jake?

謝謝，邁克。傑克？

Yes, thanks for the question. So just as a matter of policy, we submit company sponsored guideline requests on -- like consistent with labeling indications that we actually intend to receive or expect to receive. So we'll do that in this setting as well, in the context of BTK-pretreated relapsed/refractory mantle cell lymphoma.

是的，謝謝你的提問。因此，作為一項政策，我們提交公司贊助的指南請求——比如與我們實際打算接收或期望接收的標籤指示一致。所以我們也會在這種情況下，在 BTK 預處理的複發/難治性套細胞淋巴瘤的背景下這樣做。

What that -- from there, the NCCN and other guideline process is completely independent and has no involvement from us whatsoever. To the extent that they choose to do something beyond our labeled indication is really completely out of our hands and hard for me to speculate on. And of course, we'll be promoting the product only on the labeled indication that we receive.

那是什麼——從那裡開始，NCCN 和其他指南流程是完全獨立的，我們沒有任何參與。在某種程度上，他們選擇做超出我們標籤指示的事情真的完全不在我們的掌控之中，我很難推測。當然，我們只會在收到的標籤上宣傳該產品。

The next caller is David Risinger from SVB Securities.

下一位來電者是 SVB 證券公司的 David Risinger。

So my questions relate to Mounjaro, please. First, could you clarify the share gain percentages? So I believe the comment was that Lilly's combined Trulicity and Mounjaro share gained by 12 percentage points. So I wanted to just understand what was the starting point and where is the figure today?

所以我的問題與蒙扎羅有關，請。首先，您能否澄清一下股票收益百分比？所以我相信評論是禮來公司的 Trulicity 和 Mounjaro 的合併份額增加了 12 個百分點。所以我想了解起點是什麼，今天的數字在哪裡？

And then there was also a comment about new-to-treatment starts gaining by 10%. So if you could provide the x to y on that. And then based upon your current view of the very strong U.S. uptake of the product, to what degree is Lilly planning to gate its ex U.S. Mounjaro launches due to the manufacturing supply constraints that you're currently up against?

然後還有關於新治療開始增加 10% 的評論。因此，如果您可以提供 x 到 y 。然後根據您目前對該產品在美國的強勁吸收的看法，由於您目前面臨的製造供應限制，禮來公司計劃在多大程度上限制其前美國 Mounjaro 的推出？

Thanks, David. We'll go to Mike for the questions around share gain and then Ilya for the questions around OUS launch.

謝謝，大衛。我們將向 Mike 詢問有關分享收益的問題，然後向 Ilya 詢問有關 OUS 發布的問題。

Okay. Dave, hey, thanks. I'll give you more context of the percentages that we had earlier on in the call. So what we're looking at is IQVIA data, the beginning of that, by our analysis, is June 3. We had our launch meeting the week after ADA, so the week of June 14. So we have been promoting kind of full-on since then.

好的。戴夫，嘿，謝謝。我會給你更多關於我們之前在電話會議中獲得的百分比的背景信息。因此，我們正在查看的是 IQVIA 數據，根據我們的分析，該數據的開始時間是 6 月 3 日。我們在 ADA 之後的一周舉行了啟動會議，所以在 6 月 14 日那一周。所以我們一直在推廣從那時起。

And so when you compare where we're at today, this is -- we have IQVIA data through July 22, so 5 weeks of promotion. So we're comparing the -- our NBRx volume, our new-to-brand volume, and share at July 22 versus June 13 in the injectable incretin market.

因此，當您比較我們今天所處的位置時，這是 - 我們擁有截至 7 月 22 日的 IQVIA 數據，因此進行了 5 週的推廣。因此，我們正在比較注射腸促胰島素市場在 7 月 22 日和 6 月 13 日的 NBRx 銷量、新品牌銷量和份額。

And so what we've seen since then is that Mounjaro's NBRx share has reached 20.5. We saw Trulicity's NBRx has declined by only 8.4 share points. And so that produces a net gain in the Lilly injectable incretin and NBRx share of 12.2%.

從那時起，我們看到的是 Mounjaro 的 NBRx 份額已達到 20.5。我們看到 Trulicity 的 NBRx 僅下跌了 8.4 個股點。因此，禮來可注射腸促胰島素和 NBRx 的份額淨增加 12.2%。

And then with NTS, same time period, same market, we have a 10% overall Lilly injectable incretin NBRx share gain.

然後使用 NTS，在相同的時間段，相同的市場，我們有 10% 的禮來可注射腸促胰島素 NBRx 整體份額增長。

Thanks, Mike. Ilya?

謝謝，邁克。伊利亞？

Yes, David, thanks for your question on the launch of Mounjaro outside of the U.S. and our thoughts around that. One of the key aspects of how we take a look at launching outside the U.S., it's typical for most product launches across pretty much all therapeutic areas to have some lag to U.S. launches, either through -- because of regulatory approval and process, but also pricing and reimbursement. And it can take up to a year to get reimbursement in a number of markets.

是的，大衛，感謝您就 Mounjaro 在美國以外地區推出的問題以及我們對此的看法。我們如何看待在美國以外推出的關鍵方面之一是，幾乎所有治療領域的大多數產品推出通常都會滯後於美國的推出，這要么是因為監管批准和流程，要么是定價和報銷。在許多市場上獲得報銷可能需要長達一年的時間。

So the volumes in that first year of launch are somewhat limited. We are encouraged by what we're seeing in the U.S. launch of Mounjaro and looking forward to launching Mounjaro outside of the U.S. and leveraging our commercial expertise and strength in diabetes across our markets outside the U.S.

因此，推出的第一年的數量是有限的。我們對在美國推出的 Mounjaro 感到鼓舞，並期待在美國以外推出 Mounjaro，並在美國以外的市場利用我們在糖尿病方面的商業專業知識和實力。

Let me just -- David, just to clarify though because of the way you framed your question. You said we're up against supply constraints. In the case of Mounjaro, as we said today in the prepared text, we don't anticipate supply constraints in the U.S. Of course, before introducing a product in a new market, we want to make sure we could fully initiate new patients and supply. And based on our competitor's actions, it's hard to predict a year from now what we'll need in a given market.

讓我——大衛，只是為了澄清一下，因為你提出問題的方式。你說我們面臨供應限制。就 Mounjaro 而言，正如我們今天在準備好的文本中所說，我們預計美國不會出現供應限制。當然，在將產品引入新市場之前，我們希望確保我們能夠全面啟動新患者和供應.根據我們競爭對手的行為，很難預測一年後我們在特定市場中需要什麼。

So it's not that we don't have supply. It's more the demand picture is unstable. We want to -- we're just cautioning that we want to know that before we initiated a launch sequence. But we've launched in the U.S., and we're committed to that supply. It's not that we have an issue, just to be clear.

所以並不是我們沒有供應。更多的是需求情況不穩定。我們想 - 我們只是警告說我們想在啟動啟動序列之前知道這一點。但我們已經在美國推出，我們致力於供應。這不是我們有問題，只是要清楚。

The next caller is Chris Shibutani from Goldman Sachs.

下一位來電者是高盛的 Chris Shibutani。

2 questions. The first on Mounjaro, thank you for that information about the relative trend as far as where the source of patients were. Narrowing in on the question of what portion were actually switches from Trulicity, that was helpful. Back of the envelope, that sounded like about 10%. Is that about what you expected? And where do you think that this will go? I'm asking, obviously, since we're relatively early stages of this launch.

2個問題。第一個在 Mounjaro，感謝您提供有關患者來源的相對趨勢的信息。縮小關於哪些部分實際上是從 Trulicity 轉換的問題，這很有幫助。信封背面，聽起來大約是 10%。這和你預期的一樣嗎？你認為這會去哪裡？顯然，我在問，因為我們處於此次發布的相對早期階段。

Second question would be about Verzenio, actually to bring up something that seems a little bit less focused upon, but performance has been strong and logically, it would seem to be in the adjuvant setting. But could you speak to what you believe is driving this and what the outlook is for those trends that have thus far been delivering the strong performance there?

第二個問題是關於 Verzenio，實際上是為了提出一些似乎不太關注的問題，但表現一直很強勁，從邏輯上講，它似乎是在輔助環境中。但是，您能否談談您認為推動這一趨勢的因素以及迄今為止在該領域表現強勁的趨勢的前景如何？

Thanks, Chris. We'll go to Mike for the question on Mounjaro, and then Jake for the question on Verzenio.

謝謝，克里斯。我們將向 Mike 詢問有關 Mounjaro 的問題，然後請 Jake 詢問有關 Verzenio 的問題。

Yes, that's a good question. I think we're getting what we expected we thought we would see, more new patients into the class. That's who we talked about with health care professionals, and that's what we're getting. So we're not surprised by that. It's pretty typical of what we would expect with the new GLP launch.

是的，這是個好問題。我認為我們得到了我們所期望的我們認為我們會看到的，更多的新患者進入課堂。這就是我們與醫療保健專業人員談論的人，這就是我們得到的。所以我們對此並不感到驚訝。這是我們對新 GLP 發布所期望的非常典型的情況。

Now what you would expect when you have a new product like Mounjaro, especially with endocrinologists, that they don't always see naive patients. They have a good bolus of patients who are already on GLPs. And so when they -- when we talk to them about Mounjaro, they're excited about the opportunity to actually switch some of the patients who are not performing, are not at goal at the current GLP.

現在，當您擁有像 Mounjaro 這樣的新產品時，您會期待什麼，尤其是內分泌學家，他們並不總是看到天真的患者。他們有大量已經在使用 GLP 的患者。因此，當他們——當我們與他們談論 Mounjaro 時，他們很高興有機會真正改變一些表現不佳的患者，這並不是當前 GLP 的目標。

And so I think, early on, you'll see like a higher percent coming from switches versus naive. And so today, we have 72% that is naive. If you look at Trulicity, that's in like 88%. So what I would expect is that, that percentage coming from naive will grow over time. But I think this is what we would expect at launch, and we're very pleased by both Trulicity and Mounjaro's performance since Mounjaro has launched.

所以我認為，在早期，你會看到來自轉換而不是幼稚的百分比更高。所以今天，我們有 72% 是天真的。如果你看一下 Trulicity，那就是 88%。所以我期望的是，來自天真的百分比會隨著時間的推移而增長。但我認為這是我們在發佈時所期望的，我們對 Trulicity 和 Mounjaro 自 Mounjaro 發布以來的表現感到非常滿意。

Thanks, Mike. Jake?

謝謝，邁克。傑克？

Yes. Thanks for the question on Verzenio. We too are pleased with how this has gone so far this year. I think, to your question on why and where it goes from here, on the why, I think it largely comes down to the clinical data from the monarchE study itself. I think the data are demonstrable, and when physicians and patients see them, they quickly want to integrate the drug into their practice.

是的。感謝您對 Verzenio 提出的問題。我們也對今年到目前為止的進展感到滿意。我認為，對於您關於為什麼以及從這裡開始的原因以及原因的問題，我認為這在很大程度上取決於 monarchE 研究本身的臨床數據。我認為這些數據是可以證明的，當醫生和患者看到這些數據時，他們很快就想將藥物整合到他們的實踐中。

Now in addition to that, and this was something we hoped would see happen, we think we're seeing some share gains in the metastatic setting as well, particularly among physicians who historically used other CDK4/6 inhibitors are gaining experience with Verzenio by utilizing it in the adjuvant setting and then starting to use it in the metastatic setting, where perhaps they hadn't been before. So that was part of what we hoped might happen. I think we're seeing that happen a little bit so far this year.

現在除此之外，這是我們希望看到的事情，我們認為我們在轉移性環境中也看到了一些份額收益，特別是在歷史上使用其他 CDK4/6 抑製劑的醫生正在通過利用 Verzenio 獲得經驗它在輔助環境中，然後開始在轉移環境中使用它，也許他們以前沒有使用過。所以這是我們希望發生的事情的一部分。我認為今年到目前為止我們看到這種情況發生了一點。

That having been said, in terms of where we go from here, I'll just say 2 things. One, we continue to interact with physicians who are still not yet aware of the monarchE data. And so that's, of course, good and bad. It's bad because there are patients who are appropriate for the medicine that should be on it. It's -- but it is opportunity to continue growing in the labeled indication that we have currently.

話雖如此，就我們的出發點而言，我只想說兩件事。第一，我們繼續與尚未了解 monarchE 數據的醫生互動。當然，這有好有壞。這很糟糕，因為有些患者適合服用應該服用的藥物。這是 - 但這是在我們目前擁有的標籤指示中繼續增長的機會。

And on that note, as we've talked about in the past, we're hopeful that we have the opportunity to expand the indication to the enrolled trial population for monarchE, and we're awaiting that analysis of overall survival, as we've talked about in the past. So yes, we're pleased with how it's going. We see plenty of opportunity ahead to continue the momentum.

關於這一點，正如我們過去所談到的，我們希望我們有機會將適應症擴大到 monarchE 的登記試驗人群，我們正在等待對總體生存率的分析，因為我們過去談過。所以，是的，我們對它的進展感到滿意。我們看到未來有很多機會繼續保持這種勢頭。

Next caller is Carter Gould from Barclays.

下一位來電者是 Barclays 的 Carter Gould。

I guess, first off, can you talk about how pronounced the cash pay component was of the early kind of Mounjaro number and then how you expect maybe that to evolve?

我想，首先，你能談談現金支付部分在早期的 Mounjaro 數字中有多顯著，然後你期望它會如何演變？

And then, separately, maybe coming back to the drug pricing question but from a different angle, it would appear that Lilly could be one of the main beneficiaries from lower out-of-pocket costs on that side when you think about sort of improvement in compliance. So can you maybe help frame that impact or maybe think about how compliance today differs in the U.S. versus maybe other markets where those out-of-pocket costs or not -- don't exist?

然後，另外，也許會回到藥品定價問題，但從不同的角度來看，當你考慮到某種程度的改進時，禮來似乎可能是這方面降低自付費用的主要受益者之一。遵守。那麼，您能否幫助構建這種影響，或者考慮一下當今美國的合規性與其他不存在自付費用的市場有何不同？

Thanks, Carter. We'll go to Mike for the first question on Mounjaro and then Dave for the follow-up on the drug pricing reform and the impact.

謝謝，卡特。我們將向 Mike 詢問有關 Mounjaro 的第一個問題，然後向 Dave 詢問有關藥品定價改革及其影響的後續問題。

Hey, Carter, thanks for the question. On the cash pay side, we expect the percent of cash pay to follow our percent access in the marketplace. What we've seen so far, again, I reiterate what I said earlier, that we have both Part D and commercial access for Humana, Express Scripts, on the National Preferred Formulary, and Cigna. If you add that up, that's a little over 20% of the national lives. And so I think that's probably the best estimation of what you probably see with the cash pay.

嘿，卡特，謝謝你的提問。在現金支付方面，我們預計現金支付的百分比將跟隨我們在市場上的訪問百分比。到目前為止，我們再次重申我之前所說的，我們擁有 Humana、Express Scripts、國家首選處方集和 Cigna 的 D 部分和商業訪問權限。如果你把它加起來，那就是國民生活的 20% 多一點。所以我認為這可能是你對現金支付可能看到的最好的估計。

Thanks, Mike. Dave?

謝謝，邁克。戴夫？

Yes. Carter, I think you're pointing out something -- as I mentioned, we would be supportive as a freestanding measure of the Part D reforms that are in this reconciliation package for a bunch of reasons. One, it does, I think, more fairly distribute the burden of the industry to pay for into Part D.

是的。卡特，我認為你指出了一些事情——正如我所提到的，出於一系列原因，我們將支持作為該和解方案中的 D 部分改革的獨立措施。一，我認為，它確實更公平地將行業的負擔分配給了 D 部分。

Today, the way the donut hole math works, if you go back a couple of years, we had a lot of earnings calls, we had to describe that, there's this really disproportionate contribution from the industry inside the donut hole. So commonly used medications, like in diabetes and cardiovascular, have a pretty big hit on that. That gets smoothed out. So now, that -- drugs that hit the catastrophic pay more, and it's more of a balanced contribution, independent of drug type. That's a good thing for companies like Lilly that have more commonly used drugs.

今天，甜甜圈洞數學的運作方式，如果你回到幾年前，我們有很多財報電話，我們不得不描述一下，這個行業在甜甜圈洞內部做出了非常不成比例的貢獻。所以常用的藥物，如糖尿病和心血管藥物，對此有很大的影響。這得到了平滑。所以現在，那些造成災難性後果的藥物付出的代價更高，而且它更像是一種平衡的貢獻，與藥物類型無關。對於像禮來這樣擁有更常用藥物的公司來說，這是一件好事。

The other thing though you're pointing out, and I think this really would affect a product like Verzenio for us primarily, is patients who get thrown into the catastrophic have this uncapped 5% contribution today. And we know that not only do patients discontinue, and you mentioned about compliance rates, which are better in [neuro-oncology] in Europe than U.S., for instance, but I think also, you'll see more initiation because physicians and their families screen themselves out of even qualifying for an appropriate medication for themselves because of financial burden and maybe go to chemotherapy instead of a more targeted therapy.

儘管您要指出的另一件事，我認為這確實會主要影響像 Verzenio 這樣的產品對我們來說，是那些陷入災難的患者今天有這個無上限的 5% 貢獻。而且我們知道，不僅患者停止治療，而且您提到了依從率，例如，歐洲的 [神經腫瘤學] 比美國更好，但我認為，您會看到更多的開始，因為醫生及其家人由於經濟負擔，自己甚至沒有資格獲得適合自己的藥物，並且可能會去化療而不是更有針對性的治療。

So that presents another way in which we can both improve health care in America, but also prospects for medicines that Lilly makes. So those are good things. As I said, on balance, we still don't like it because of the negotiation side, but those are positive elements.

因此，這提供了另一種方式，我們既可以改善美國的醫療保健，也可以改善禮來公司生產的藥物的前景。所以這些都是好事。正如我所說，總的來說，我們仍然不喜歡它，因為談判方面，但這些都是積極的因素。

The next caller is Kerry Holford from Berenberg.

下一位來電者是來自 Berenberg 的 Kerry Holford。

2 questions, please. Firstly, on price, you have clearly cited lower realized prices for a number of drugs this quarter, particularly in the U.S. And I'm wondering if you can speak specifically to how that's evolving in the GLP-1 market? Any particular step-up on Trulicity rebates since the Mounjaro launch?

2個問題，請。首先，在價格方面，您已經明確指出本季度許多藥物的實際價格較低，尤其是在美國。我想知道您能否具體談談 GLP-1 市場的發展情況？自 Mounjaro 推出以來，Trulicity 回扣有什麼特別的提升嗎？

What are your expectations there going forward? This is a trend. There's higher rebates related to channel mix (inaudible) by your competitor (inaudible) yesterday. So interested again in your perspective here. And then a quick question for Anat. When do you anticipate having greater clarity on the possible repeal in the 2017 Tax Act?

您對未來有什麼期望？這是一種趨勢。昨天您的競爭對手（聽不清）與渠道組合（聽不清）相關的回扣更高。對你的觀點再次感興趣。然後是對 Anat 的快速提問。您預計何時會更清楚地了解 2017 年稅法的可能廢除？

Great. Thanks, Kerry. We'll go to Mike for the question on incretin market price trends and then Anat for the question on the tax reform. Mike?

偉大的。謝謝，克里。我們將向 Mike 詢問有關腸促胰島素市場價格趨勢的問題，然後向 Anat 詢問有關稅收改革的問題。麥克風？

Yes. That's a good question. I think, naturally, payers will ask for additional rebates when a new product joins a formulary. So that's part of our discussion on being disciplined and why you don't want to accelerate those discussions too rapidly, and that's a factor into it. So I think net-net, I don't expect any step-changes in GLP pricing as a result of Mounjaro launching, but then is part of the [natural pressure] intention and contract negotiations.

是的。這是個好問題。我認為，當新產品加入處方集時，付款人自然會要求額外的回扣。所以這是我們關於遵守紀律的討論的一部分，以及為什麼你不想過快地加速這些討論，這是其中的一個因素。因此，我認為 net-net，我預計 GLP 定價不會因 Mounjaro 的推出而發生任何階躍變化，但這是 [自然壓力] 意向和合同談判的一部分。

Thanks, Mike. Anat?

謝謝，邁克。阿納特？

So on taxes, what we're seeing is we're seeing broad bipartisan support for appealing that change, of capitalizing R&D expenses, as was evident in the recent Senate letter. This could come. We believe it will come through by the end of this year, most likely, if I had to guess, I would say, towards the end of the year, potentially as part of (inaudible).

因此，在稅收方面，我們看到兩黨廣泛支持呼籲改變，將研發費用資本化，正如最近的參議院信函所示。這可能會到來。我們相信它將在今年年底前實現，如果我不得不猜測的話，我會說，最有可能在年底前實現，可能是（聽不清）的一部分。

The next caller is Mohit Bansal from Wells Fargo.

下一位來電者是富國銀行的 Mohit Bansal。

Maybe one question on the SELECT early study, the prediabetic study. So maybe one for you, Dan. What you really need to show, is how long the trial, and what you need to show in terms of delta versus control, to be -- to prove that it is beneficial in prediabetic patients. And wouldn't oral GLP be a better drug for those patients?

也許是關於 SELECT 早期研究的一個問題，即前驅糖尿病研究。所以也許給你一個，丹。您真正需要展示的是試驗多長時間，以及您需要在 delta 與對照方面展示什麼，以證明它對糖尿病前期患者有益。口服 GLP 對這些患者來說不是更好的藥物嗎？

Thanks, Mohit. So Dan, the question on SURPASS-EARLY, the prediabetes study, and then whether oral GLP would be better there.

謝謝，莫希特。所以丹，關於 SURPASS-EARLY 的問題，前驅糖尿病研究，然後是口服 GLP 是否會更好。

Yes. That's an early diabetes study. But I think you're -- I don't believe we've disclosed the design of the endpoints yet. But I think with respect to diabetes prevention, that's certainly a very interesting area. And there are currently FDA guidance on what's required to show diabetes -- prevention of diabetes, to get that kind of claim. It's a very high bar. And I suspect the field will come to an understanding about which drugs can actually decrease the risk of getting diabetes, to prevent diabetes, before any drug is able to get that indication.

是的。這是一項早期糖尿病研究。但我認為你是——我不相信我們已經披露了端點的設計。但我認為關於糖尿病預防，這當然是一個非常有趣的領域。目前，FDA 有關於顯示糖尿病所需的指南 - 預防糖尿病，以獲得此類聲明。這是一個非常高的標準。而且我懷疑該領域將了解哪些藥物實際上可以降低患糖尿病的風險，以預防糖尿病，在任何藥物能夠獲得該適應症之前。

I think this class of medications, particularly tirzepatide, has great promise in that area. We highlighted the data from SURMOUNT-1, that showed the vast majority, more than 95% of people, who were prediabetic at the beginning of the study had normal glucose levels at the end of the study. That's really promising. Longer-term data, including drug washout data, required to get to that kind of claim.

我認為這類藥物，尤其是替西帕肽，在該領域有很大的前景。我們強調了來自 SURMOUNT-1 的數據，該數據顯示絕大多數（超過 95%）在研究開始時處於糖尿病前期的人在研究結束時血糖水平正常。這真的很有希望。獲得此類索賠所需的長期數據，包括藥物清洗數據。

Yes. Maybe if I can add -- are you done?

是的。也許如果我可以添加 - 你完成了嗎？

Mike? Yes.

麥克風？是的。

Yes, I can add a few comments on that. This study is for people with diabetes, have been diagnosed with diabetes. And we want to test what the impact could be on their progression of diabetes if you put a product like tirzepatide on very early in the course of treatment. And so this will study putting -- starting patients who are naive, are very early in their treatment, versus standard of care.

是的，我可以對此添加一些評論。這項研究是針對已被診斷患有糖尿病的糖尿病患者。我們想測試如果您在治療過程的早期使用像 tirzepatide 這樣的產品，會對他們的糖尿病進展產生什麼影響。因此，這將研究推桿——開始是天真的患者，他們的治療非常早期，而不是標準的護理。

We think weight loss with the benefits of a GLP and GIP and the improvement in beta cell function and insulin sensitivity could have a profound impact of disrupting type 2 diabetes. And so that's what we're testing in the study. It's one that we're very excited about.

我們認為通過 GLP 和 GIP 的益處減輕體重以及改善 β 細胞功能和胰島素敏感性可能會對破壞 2 型糖尿病產生深遠影響。這就是我們在研究中測試的內容。這是我們非常興奮的一個。

And we've already started to see weekly injectables being used earlier than just the injection space as more people understand that a weekly injection through an auto-injector is a good experience. And actually, some consumers prefer orals, but some actually consume -- prefer a weekly injection with an auto-injector, like Mounjaro and Trulicity has.

我們已經開始看到每週注射劑的使用比僅僅注射空間更早，因為越來越多的人明白每週通過自動注射器注射是一種很好的體驗。實際上，一些消費者更喜歡口服，但有些消費者實際上更喜歡使用自動注射器每週注射一次，就像 Mounjaro 和 Trulicity 一樣。

The next caller is Evan Seigerman with BMO Capital Markets.

下一位來電者是 BMO Capital Markets 的 Evan Seigerman。

So as part of the FDA acceptance of your accelerated approval filing for donanemab, have you gotten clarity from the agency if the iADRS scale is acceptable as an acceptable endpoint for full approval? And can you also talk about what you saw with the N3pG4 to move it into Phase III?

因此，作為 FDA 接受您對 donanemab 加速批准申請的一部分，如果 iADRS 量表可以作為完全批准的可接受終點，您是否從該機構獲得了明確說明？您能否也談談您在 N3pG4 中看到的將其移至第三階段的情況？

Thanks, Evan. We'll go to Dan for those.

謝謝，埃文。我們會去找丹。

Yes. Thanks for the 2 Alzheimer's questions. So first one is on the accelerated approval application for donanemab and whether that's an opportunity to gain more insight about acceptability of iADRS, which is our primary endpoint in the Phase III study.

是的。感謝您提出 2 個阿爾茨海默氏症問題。因此，第一個問題是關於 donanemab 的加速批准申請，以及這是否是一個機會來更深入地了解 iADRS 的可接受性，這是我們在 III 期研究中的主要終點。

It may not be an opportunity actually because the accelerated approval is not contingent on an understanding of the cognitive or functional benefits of donanemab, which we saw in the Phase II trial. Instead, the accelerated approval is just simply contingent on a demonstration of lowering amyloid levels. So I'm not sure. We'll get into a deep discussion of that, although clearly, it's relevant in terms of the confirmatory study, TRAILBLAZER-2.

實際上，這可能不是一個機會，因為加速批准並不取決於我們在 II 期試驗中看到的對 donanemab 的認知或功能益處的理解。相反，加速批准只是簡單地取決於降低澱粉樣蛋白水平的證明。所以我不確定。我們將對此進行深入討論，儘管很明顯，它與驗證性研究 TRAILBLAZER-2 相關。

The second question that you raised was with respect to Remternetug, the N3pG4 molecule. This is a next-generation anti-plaque or plaque-removing antibody, designed to attack the same power glutamate residue that donanemab goes after. We've seen robust ability of this molecule to clear plaques in patients. Remember that a liability or a potential liability of donanemab is antidrug antibodies, and so we've also noted that this molecule doesn't have that issue.

您提出的第二個問題是關於 Remternetug，即 N3pG4 分子。這是下一代抗斑塊或去除斑塊的抗體，旨在攻擊與多那奈單抗相同的強力谷氨酸殘基。我們已經看到這種分子清除患者斑塊的強大能力。請記住，donanemab 的一個責任或潛在責任是抗藥抗體，因此我們還注意到這種分子沒有這個問題。

So given the potent robust clearance of plaque, combined with lack of ADAs, we think this is amenable to alternative dosage forms that could be more conveyed to patients. So we'll be looking at that.

因此，鑑於斑塊的強大清除能力，再加上 ADA 的缺乏，我們認為這適用於可以更多地傳達給患者的替代劑型。所以我們會看看那個。

The next caller is Robyn Karnauskas with Truist Securities.

下一位來電者是 Truist Securities 的 Robyn Karnauskas。

Robyn? Okay, perhaps we can move to the next caller?

羅賓？好的，也許我們可以轉到下一個呼叫者？

The next caller is Colin Bristow with UBS.

下一位來電者是瑞銀的 Colin Bristow。

And Kevin, thanks for all the great work. On business development, you have 2 deals announced today. Can you just give us your updated thoughts on the areas of interest, the deal size and then just what your -- what's the feedback you're getting from potential targets on their willingness to transact given the market backdrop?

還有凱文，感謝所有出色的工作。在業務發展方面，您今天宣布了 2 筆交易。您能否就感興趣的領域、交易規模以及您從潛在目標獲得的關於他們在市場背景下交易意願的反饋意見向我們提供最新的想法？

And then secondly, just on donanemab, what's your latest thinking? Or have you had any interactions with CMS with regards to how a single successful Phase III trial would be viewed in the context of reimbursement?

其次，就 donanemab 而言，你最近的想法是什麼？或者您是否與 CMS 就如何在報銷的背景下看待單個成功的 III 期試驗進行過互動？

Thank you, and I'll invite Anat to weigh in on the BD question and then Anne for the donanemab question.

謝謝，我將邀請 Anat 參與 BD 問題，然後邀請 Anne 參與 donanemab 問題。

Thanks. So on the business development side and in terms of areas of interest and what we're seeing in the marketplace, given some recent changes in valuation, our areas of interest remain really unchanged from what we've had in the last several quarters, which is our core therapeutic areas, so looking at potential breakthrough innovations in those areas in different stages of preclinical and clinical development as well as in areas of new modalities, where we talked about expansions that we have in those areas.

謝謝。因此，在業務發展方面，就感興趣的領域和我們在市場上看到的情況而言，鑑於最近估值的一些變化，我們感興趣的領域與過去幾個季度的情況相比仍然沒有變化，這是我們的核心治療領域，因此在臨床前和臨床開發的不同階段以及新模式領域中尋找潛在的突破性創新，我們談到了我們在這些領域的擴展。

We do look at, and what you've seen us do in the last 12, 18 months, is more earlier-stage opportunities, where we can bring things into our pipeline to supplement our existing portfolio and add value as well as innovation in our core areas.

我們確實看到，您在過去 12 個月和 18 個月中看到我們所做的是更多早期階段的機會，我們可以將一些東西納入我們的管道以補充我們現有的產品組合，並在我們的產品組合中增加價值和創新核心領域。

Valuations, while they have changed in the last 6 months or so, has not historically been the rate-limiting factor in terms of pursuing business development opportunities. It's really finding those breakthrough opportunities where we make those investments.

儘管估值在過去 6 個月左右發生了變化，但從歷史上看，估值並不是追求業務發展機會的限速因素。它確實在我們進行這些投資的地方找到了那些突破性的機會。

And you asked about kind of target engagement and whether or not those views have changed, we're looking at, whether we look at a partnership or acquisition, everyone wants to get to value. If the opportunity is there, then we tend to be able to get to a good spot.

您詢問了目標參與的類型，以及這些觀點是否發生了變化，我們正在研究，無論是合作還是收購，每個人都希望獲得價值。如果有機會，那麼我們往往能夠找到一個好地方。

Thanks, Anat. Anne?

謝謝，阿納特。安妮？

Thanks for the question on donanemab. So it's our belief that the data package for donanemab, which includes, obviously, both TRAILBLAZZER-ALZ and ALZ 2, should be sufficient to meet what CMS has described as that high level of evidence in NCD.

感謝您對 donanemab 提出的問題。因此，我們相信 donanemab 的數據包，顯然包括 TRAILBLAZZER-ALZ 和 ALZ 2，應該足以滿足 CMS 所描述的非傳染性疾病的高水平證據。

So the TRAILBLAZER-ALZ study, obviously, was the first disease-modifying Alzheimer's trial to successfully meet its primary endpoint. And if TRAILBLAZZER-ALZ 2 also delivers that direct evidence of clinical benefits, as we expect it would, then we'll engage with CMS to discuss that path quickly and broadly expand access to the treatment.

因此，顯然，TRAILBLAZER-ALZ 研究是第一個成功達到其主要終點的疾病改善阿爾茨海默氏症試驗。如果 TRAILBLAZZER-ALZ 2 也像我們預期的那樣提供臨床益處的直接證據，那麼我們將與 CMS 合作，快速討論該路徑並廣泛擴大治療的可及性。

And we have been engaging with CMS throughout the process, and we'll continue to do so moving forward. And they've shown openness to continue to meet. Obviously, they noted in the NCD the promise of donanemab, and they've shown a great deal of interest in understanding the TRAILBLAZER-2 Phase III program. And so I think we'll have more clarity on the timing of reconsideration, that we're able to share that data with them in mid-'23. They've stated publicly they're committed to rapid reconsideration. But I think we'll have to update you on timing once they have that data in hand, middle of next year, and we discuss next steps with them.

在整個過程中，我們一直在與 CMS 合作，我們將繼續這樣做。他們已經表現出繼續會面的開放態度。顯然，他們在 NCD 中註意到了 donanemab 的前景，並且他們對了解 TRAILBLAZER-2 III 期計劃表現出極大的興趣。因此，我認為我們將更清楚地確定重新考慮的時間，以便我們能夠在 23 年中期與他們分享這些數據。他們公開表示，他們致力於快速重新考慮。但我認為，一旦他們掌握了這些數據，明年年中，我們將不得不更新你的時間，我們將與他們討論下一步。

Thanks, Anne. Colin, thanks for your questions. We've exhausted the queue. Dave, for the close.

謝謝，安妮。科林，謝謝你的提問。我們已經排滿了隊列。戴夫，結束。

Okay. Great. Thanks for joining us today. And I just want to apologize for all the technical challenges on the call. We'll get that cleaned up.

好的。偉大的。感謝您今天加入我們。我只想為電話中的所有技術挑戰道歉。我們會把它清理乾淨。

We do appreciate you participating today and your interest in our company. And please follow up with our IR team, including Joe Fletcher, our new leader, and if you have questions we have not addressed today on the call. Have a great day.

感謝您今天的參與以及您對我們公司的興趣。請跟進我們的 IR 團隊，包括我們的新領導 Joe Fletcher，如果您有我們今天在電話會議上沒有解決的問題。祝你有美好的一天。

Thank you. And ladies and gentlemen, that does conclude our conference for today. Thank you for your participation and for using AT&T Teleconference Service. You may now disconnect.

謝謝你。女士們先生們，今天的會議到此結束。感謝您的參與和使用 AT&T 電話會議服務。您現在可以斷開連接。