施貴寶 (BMY) 2020 Q1 法說會逐字稿

Good day, and welcome to the Bristol-Myers Squibb 2020 First Quarter Results Conference Call. Today's conference is being recorded. At this time, I would like to turn the conference over to Mr. Tim Power, Vice President, Investor Relations. Please go ahead.

美好的一天，歡迎參加百時美施貴寶 2020 年第一季度業績電話會議。今天的會議正在錄製中。現在，我想將會議交給投資者關係副總裁 Tim Power 先生。請繼續。

Thanks, Chloe, and good morning, everyone. Thanks for joining us this morning for our first quarter 2020 earnings call. Joining me this morning with prepared remarks are Giovanni Caforio, our Chairman and Chief Executive Officer; and David Elkins, our Chief Financial Officer. Also participating in today's call for the Q&A session are Chris Boerner, our Chief Commercialization Officer; Nadim Ahmed, President, Hematology; and Samit Hirawat, our Chief Medical Officer and Head of Global Drug Development. As you'll note, we've posted slides at bms.com that you can use to follow along with for David and Giovanni's remarks.

謝謝，克洛伊，大家早上好。感謝您今天早上參加我們的 2020 年第一季度財報電話會議。今天早上與我一起發表準備好的講話的是我們的董事長兼首席執行官喬瓦尼·卡福里奧 (Giovanni Caforio)；和我們的首席財務官大衛埃爾金斯。參加今天的問答環節的還有我們的首席商業化官 Chris Boerner； Nadim Ahmed，血液學總裁；以及我們的首席醫療官兼全球藥物開發主管 Samit Hirawat。您將注意到，我們已在 bms.com 上發布了幻燈片，您可以使用這些幻燈片來了解 David 和 Giovanni 的言論。

But before we get started, I'll read our forward-looking statements. During this call, we'll make statements about the company's future plans and prospects that constitute forward-looking statements. Actual results may differ materially from those indicated by those forward-looking statements as a result of various important factors, including those discussed in the company's SEC filings. These forward-looking statements represent our estimates as of today and should not be relied upon as representing our estimates as of any future date. We specifically disclaim any obligation to update forward-looking statements even if our estimates change. We'll also focus our comments on our non-GAAP financial measures, which are adjusted to exclude certain specified items. Reconciliations of those non-GAAP financial measures to the most comparable GAAP measures are available at bms.com.

但在我們開始之前，我將閱讀我們的前瞻性聲明。在本次電話會議中，我們將就公司的未來計劃和前景發表前瞻性聲明。由於各種重要因素（包括公司提交給美國證券交易委員會的文件中討論的因素），實際結果可能與這些前瞻性陳述所示的結果存在重大差異。這些前瞻性陳述代表了我們截至目前的估計，不應被視為代表我們截至未來任何日期的估計。即使我們的估計發生變化，我們特別不承擔更新前瞻性陳述的義務。我們還將重點關注我們的非公認會計準則財務指標，這些指標經過調整以排除某些特定項目。這些非 GAAP 財務指標與最具可比性的 GAAP 指標的調節表可在 bms.com 上找到。

With that, I'll hand it over to Giovanni.

這樣，我就把它交給喬瓦尼了。

Thank you, Tim, and good morning, everyone. I hope that you and your families are healthy and managing safely through these unprecedented times. The COVID-19 pandemic is profoundly impacting our lives, families and communities. Over the past months, our company has focused on how we can help in the global fight against the virus and effectively continue to supply of our medicines to patients globally, while placing the highest priority on the health and safety of our workforce. I am very proud of how our teams around the world have risen to the challenge.

謝謝蒂姆，大家早上好。我希望您和您的家人身體健康，安全度過這個前所未有的時期。 COVID-19 大流行正在深刻影響我們的生活、家庭和社區。在過去的幾個月裡，我們公司一直專注於如何幫助全球抗擊病毒，並繼續有效地向全球患者供應我們的藥品，同時將員工的健康和安全放在首位。我對我們世界各地的團隊如何迎接挑戰感到非常自豪。

During this pandemic, it has been abundantly clear that the biopharma industry plays a critical role in the prevention and treatment of diseases like COVID-19. Governments, healthcare providers and the public have turned to us to identify and develop diagnostic tests, effective treatments and vaccines to prevent the disease. Deep scientific knowledge, development expertise and manufacturing capabilities are what will ultimately help us prevail, and I've been impressed by the collaboration and speed with which the industry is responding.

在這次大流行期間，非常明顯的是，生物製藥行業在預防和治療 COVID-19 等疾病方面發揮著關鍵作用。政府、醫療保健提供者和公眾已向我們尋求幫助，以識別和開發診斷測試、有效的治療方法和疫苗來預防這種疾病。深厚的科學知識、開發專業知識和製造能力最終將幫助我們取得勝利，行業的協作和響應速度給我留下了深刻的印象。

On Slide 4, let me start with what Bristol-Myers Squibb is doing to support the COVID, the global COVID-19 response efforts focused in 4 key areas: our science, our communities, our patients and our people. On the R&D front, we have identified approximately 1,000 compounds in our discovery library that we are making available to external researchers globally to screen for potential molecules to treat COVID-19. We are evaluating certain medicines in our portfolio that could be included in near-term clinical trial, with a focus on the inflammatory immune response associated with COVID-19.

在幻燈片 4 上，讓我首先介紹百時美施貴寶為支持新冠肺炎所做的工作，全球新冠肺炎 (COVID-19) 應對工作重點關注 4 個關鍵領域：我們的科學、我們的社區、我們的患者和我們的人民。在研發方面，我們在發現庫中鑑定了大約 1,000 種化合物，並將其提供給全球外部研究人員，以篩選治療 COVID-19 的潛在分子。我們正在評估我們產品組合中的某些藥物，這些藥物可能會納入近期臨床試驗，重點關注與 COVID-19 相關的炎症免疫反應。

We are also participating in cross-industry groups, designed to foster collaboration. This includes the Gates Foundation COVID-19 Therapeutics Accelerator, the California Institute for Biomedical Research, the National Institutes of Health, among others. We have also focused our resources on how we can support our communities. The Bristol-Myers Squibb Foundation has provided over 170 grants to human service organizations and patient support groups in over 20 countries around the world in order to address gaps in response to COVID-19. We are providing personal protective equipments to healthcare providers on the front lines in China, Italy and to targeted community hospitals here in the U.S., and very importantly, we have been focused on how to support our patients. We have expanded our existing patient support programs to help eligible unemployed patients in the U.S. who have lost their health insurance due to the pandemic by offering access to any branded Bristol-Myers Squibb medicine for free.

我們還參加旨在促進合作的跨行業團體。其中包括蓋茨基金會 COVID-19 治療加速器、加州生物醫學研究所、美國國立衛生研究院等。我們還將資源集中用於如何支持我們的社區。百時美施貴寶基金會已向全球 20 多個國家的人類服務組織和患者支持團體提供了 170 多筆贈款，以彌補應對 COVID-19 方面的差距。我們正在為中國、意大利的一線醫療保健提供者以及美國的目標社區醫院提供個人防護設備，非常重要的是，我們一直專注於如何支持我們的患者。我們擴大了現有的患者支持計劃，通過免費提供任何百時美施貴寶品牌藥品來幫助因疫情而失去健康保險的美國失業患者。

We are working with healthcare providers in new ways through effective virtual engagements to ensure they have the support they need to treat their patients while minimizing in-person contact and the potential spread of COVID-19. We adjusted our clinical trial operations where needed to ensure the safety of patients, providers and our employees and to avoid stressing the overall healthcare system. All clinical trial activities are planned to resume by the end of the year, where local country restrictions have been lifted. Although the impact on clinical trial time lines is still being evaluated, fully recruited trials are at lower risk of delays.

我們正在通過有效的虛擬互動以新的方式與醫療保健提供者合作，以確保他們獲得治療患者所需的支持，同時最大限度地減少面對面接觸和 COVID-19 的潛在傳播。我們根據需要調整了臨床試驗操作，以確保患者、提供者和員工的安全，並避免給整個醫療保健系統帶來壓力。所有臨床試驗活動計劃在今年年底前恢復，當地國家的限制已取消。儘管對臨床試驗時間線的影響仍在評估中，但完全招募的試驗延遲的風險較低。

I'm incredibly proud of our teams across the globe. First, our essential workers continue to work at our sites to ensure our medicines reach patients who depend on them. I'm proud of their dedication. Most of our people are working from home to keep essential workers safe and to minimize the potential spread of the virus. We are supporting our teams with increased flexibility to ensure they have the time they need to care for those at home. Our employees who are licensed healthcare workers and wish to volunteer to provide medical services to patients during the pandemic are supported with full salary and benefits.

我為我們遍布全球的團隊感到無比自豪。首先，我們的重要工作人員繼續在我們的工作場所工作，以確保我們的藥物能夠到達依賴它們的患者手中。我為他們的奉獻精神感到自豪。我們大多數人都在家工作，以確保重要工作人員的安全並最大程度地減少病毒的潛在傳播。我們正在以更大的靈活性支持我們的團隊，以確保他們有時間照顧家裡的人。我們持有執照的醫護人員並希望在大流行期間自願為患者提供醫療服務的員工將獲得全額工資和福利的支持。

Now turning to the quarter. We had excellent performance financially and from a pipeline perspective. Let me start with the extraordinary pipeline execution in the first quarter on Slide 5. We have continued to deliver very well on all key value drivers. Starting with approvals. In late March, ZEPOSIA was approved in the U.S. for relapsing forms of multiple sclerosis with a best-in-class label, and we also received a positive CHMP opinion recommending approval for ZEPOSIA in Europe. In April, we received FDA approval for Reblozyl in MDS. This is the second indication for this medicine, and we are very encouraged by the opportunity we have with this first and only EMA medicine to treat anemia. Additionally, we just announced a CHMP positive opinion for Reblozyl for both beta thal and MDS in Europe.

現在轉向季度。從財務和渠道的角度來看，我們都取得了出色的業績。讓我從幻燈片 5 中第一季度非凡的管道執行開始。我們繼續在所有關鍵價值驅動因素上表現出色。從批准開始。 3 月下旬，ZEPOSIA 在美國獲得批准用於治療復發型多發性硬化症，並獲得同類最佳標籤，我們還收到了 CHMP 的積極意見，建議在歐洲批准 ZEPOSIA。 4 月，我們獲得 FDA 批准 Reblozyl 治療 MDS。這是該藥物的第二個適應症，我們對有機會使用第一個也是唯一一個治療貧血的 EMA 藥物感到非常鼓舞。此外，我們剛剛宣布 CHMP 對 Reblozyl 在歐洲的 beta thal 和 MDS 給予積極意見。

With respect to submissions and filings, we received a priority review for liso-cel in third-line plus large B-cell lymphoma in the U.S. Now with the PDUFA date extended to November 16. We completed our FDA submission for ide-cel, which is an exciting next step in bringing the first CAR-T candidate to adult patients with multiple myeloma. And we very recently announced that we received a priority review for CC-486 in first-line AML maintenance. And with respect to lung cancer, we received a priority review in the U.S. and CHMP validation in the EU for CheckMate-9LA for Opdivo plus Yervoy plus limited chemo in first-line lung cancer. And we're looking forward to the PDUFA for CheckMate-227 next week.

關於提交和備案，我們在美國收到了 liso-cel 治療三線+大 B 細胞淋巴瘤的優先審評，現在 PDUFA 日期延長至 11 月 16 日。我們完成了 FDA 對 ide-cel 的提交，這下一步是令人興奮的一步，將第一個 CAR-T 候選藥物帶給成年多發性骨髓瘤患者。我們最近宣布，我們在一線 AML 維護中收到了 CC-486 的優先審查。在肺癌方面，我們在美國獲得了優先審評，並在歐盟獲得了 CHMP 驗證，用於 Opdivo 聯合 Yervoy 聯合一線肺癌化療的 CheckMate-9LA。我們期待下週 CheckMate-227 的 PDUFA。

Lastly, from a clinical research perspective, we recently reported positive top line results from 2 positive pivotal Phase III studies in our IO pipeline. CheckMate-9ER, evaluating Opdivo in combination with Cabometyx in first-line RCC and CheckMate-743, where Opdivo plus Yervoy demonstrated survival benefit in first-line mesothelioma. We look forward to working with global health authorities to bring this new combination regimens to patients who are waiting for new treatment options.

最後，從臨床研究的角度來看，我們最近報告了 IO 管道中兩項積極的關鍵 III 期研究的積極頂線結果。 CheckMate-9ER，評估 Opdivo 與 Cabometyx 聯合治療一線 RCC 和 CheckMate-743，其中 Opdivo 加 Yervoy 在一線間皮瘤中顯示出生存獲益。我們期待與全球衛生當局合作，為正在等待新治療方案的患者帶來這種新的聯合療法。

This has been a truly remarkable quarter. All of these exciting accomplishments would not have been possible without the focus and dedication of our global teams.

這是一個真正非凡的季度。如果沒有我們全球團隊的專注和奉獻，所有這些令人興奮的成就都是不可能實現的。

Moving to Slide 6. We've had a very good quarter financially despite the emergence of the pandemic. Our business is strong. In the first quarter, we delivered $10.8 billion in sales. Excluding COVID-related buying patterns, this represents a pro forma underlying growth of 8% versus last year. Our performance was strong across brands and geographies as a result of excellent commercial execution across the board. David will provide more details in his remarks, including the shifts we're seeing in buying patterns for some of our medicines.

轉到幻燈片 6。儘管出現了大流行病，但我們的季度財務狀況非常好。我們的業務很強大。第一季度，我們實現了 108 億美元的銷售額。排除與新冠疫情相關的購買模式，預計基本增長率較去年增長 8%。由於全面出色的商業執行力，我們在各個品牌和地區的表現都很強勁。大衛將在他的講話中提供更多細節，包括我們在某些​​藥物的購買模式方面看到的變化。

Let me now provide more details on how we are managing the business in the current environment. Our supply chain remains intact. We are continuing to manufacture API without disruption, and we have safety stock of raw materials and finished products available. The pandemic has naturally caused some logistic complications, and we are navigating this successfully.

現在讓我提供有關我們如何在當前環境下管理業務的更多詳細信息。我們的供應鏈仍然完好無損。我們正在不間斷地繼續生產原料藥，並且我們有可用的原材料和成品的安全庫存。疫情自然造成了一些後勤方面的複雜情況，我們正在成功應對這一問題。

Our integration work is proceeding well. We continue to build on the hard work from '19 that allowed us to hit the ground running and operate with great efficiencies. We've seen an acceleration in the cultural cohesion of our new company during the work-from-home period as the current environment has brought us together in even greater ways. We are on track to deliver $2.5 billion in synergies by the end of '22.

我們的整合工作進展順利。我們繼續以 19 年以來的辛勤工作為基礎，使我們能夠迅速起步並高效運營。在在家工作期間，我們看到新公司的文化凝聚力得到了加速，因為當前的環境以更大的方式將我們聚集在一起。我們有望在 2022 年底實現 25 億美元的協同效應。

Finally, as we see countries moving to Phase 2 of the pandemic and reopening parts of their economies, our focus has shifted to recovery, and we are accelerating planning for restart of many of our operations. We will do this gradually as conditions evolve while continuing to keep the safety and health of our workforce, our patients and our communities as our highest priorities.

最後，當我們看到各國進入疫情第二階段並重新開放部分經濟時，我們的重點已轉向復甦，並且我們正在加快規劃重啟許多業務。我們將隨著情況的發展逐步做到這一點，同時繼續將我們的員工、患者和社區的安全和健康作為我們的首要任務。

So looking forward, while industry-wide dynamics may create volatility in our business in the short term, and there is significant uncertainty regarding the dynamics of the evolution of the pandemic, we are executing well. We remain well positioned and I'm excited about the potential of the company.

因此，展望未來，雖然整個行業的動態可能會在短期內給我們的業務帶來波動，而且疫情的演變動態存在很大的不確定性，但我們的執行情況良好。我們仍然處於有利地位，我對公司的潛力感到興奮。

With that, I'll hand it over to David to walk you through our financials for this quarter and how we are thinking about our future. David?

接下來，我將把它交給大衛，讓您了解我們本季度的財務狀況以及我們如何思考我們的未來。大衛？

Thank you, Giovanni. Hello, everyone, and thanks again for joining. I hope that you and your families are staying safe and healthy while we operate virtually.

謝謝你，喬瓦尼。大家好，再次感謝您的加入。我希望您和您的家人在我們虛擬運營期間保持安全和健康。

As Giovanni mentioned, I'm extremely pleased with the execution of our teams during these unprecedented times. The benefits of our medicines and the strong commercial execution resulted in exceptional performance in the first quarter.

正如喬瓦尼提到的，我對我們團隊在這個前所未有的時期的執行力感到非常滿意。我們藥品的優勢和強大的商業執行力帶來了第一季度的出色業績。

Turning to Slide 8. We had strong top line performance in the quarter with global sales increasing double digits, growing 13% versus prior year on a pro forma basis. We saw significant strengthening of the dollar in the latter part of March, and though this had a minimal impact in the first quarter, it will be important to keep this in mind as we think about the full year outlook. Additionally, important to note, sales were favorably impacted due to COVID-19-related stocking by approximately $500 million. Excluding the COVID-19 impact, underlying sales performance continued to be strong with 8% growth year-over-year.

轉向幻燈片 8。本季度我們的營收表現強勁，全球銷售額增長了兩位數，預計較上年增長 13%。我們在三月下旬看到美元大幅走強，儘管這對第一季度的影響很小，但在我們考慮全年前景時記住這一點很重要。此外，值得注意的是，由於與 COVID-19 相關的庫存，銷售額受到了約 5 億美元的積極影響。排除 COVID-19 的影響，基本銷售業績繼續強勁，同比增長 8%。

Now let's turn to our key brand performance, starting with Eliquis on Slide 9. Eliquis had another strong quarter, growing 37% year-over-year with sales of $2.6 billion globally, largely driven by strong underlying demand. We also saw significant favorable impact from channel and patient level stocking due to COVID-19 of approximately $350 million, which is expected to reverse over the remainder of the year. Excluding COVID-19 impact, sales growth in the quarter would have been 19%.

現在讓我們轉向我們的關鍵品牌表現，從幻燈片 9 上的 Eliquis 開始。Eliquis 又一個強勁的季度，同比增長 37%，全球銷售額達到 26 億美元，這主要是由強勁的潛在需求推動的。我們還看到，由於 COVID-19，渠道和患者層面的庫存帶來了約 3.5 億美元的顯著有利影響，預計這一影響將在今年剩餘時間內扭轉。排除 COVID-19 的影響，該季度的銷售額增長將為 19%。

As the COVID situation evolves, we'll continue to monitor the impact of customers and patients, including new patient starts. Although we expect some variability quarter to quarter due to the pandemic, we remain confident of Eliquis' growth and outlook, where there's continued momentum to grow considering TRx share of 47% and new-to-brand share of approximately 57%. Looking forward, we continue to expect significant growth driven by Eliquis' increasingly strong position as the #1 product in the expanding NOAC class.

隨著新冠疫情的發展，我們將繼續監測客戶和患者的影響，包括新患者的開始。儘管我們預計由於大流行，季度與季度之間會出現一些變化，但我們對 Eliquis 的增長和前景仍然充滿信心，考慮到 TRx 份額為 47%，新品牌份額為約 57%，該公司仍有持續增長的勢頭。展望未來，我們繼續預計 Eliquis 作為不斷擴大的 NOAC 類別中第一大產品的地位日益增強，將推動該公司的顯著增長。

Now turning to Opdivo on Slide 10. U.S. demand trends are in line with our expectations. As previously communicated, demand is down in the low single digits sequentially. We continue to see stabilization of the second line IO eligibility pool of about 1/3 as well as strengthening of our position in the first-line RCC market, which sets a good foundation for the potential future launch of CheckMate-9ER. Internationally, we saw strong execution continued with sales growth of 12% year-over-year. Opdivo was minimally impacted by COVID-19 in the first quarter with strong shares across all our indications. However, we are aware that COVID-19 has impacted patient access to oncology clinics and infusion centers, which could impact the volumes of infused products in the second quarter. We will continue to monitor these factors.

現在轉向幻燈片 10 上的 Opdivo。美國的需求趨勢符合我們的預期。正如之前所傳達的，需求連續下降至低個位數。我們繼續看到二線 IO 資格池穩定在 1/3 左右，並且我們在一線 RCC 市場的地位得到加強，這為未來可能推出 CheckMate-9ER 奠定了良好的基礎。在國際上，我們繼續保持強勁的執行力，銷售額同比增長 12%。 Opdivo 在第一季度受 COVID-19 的影響最小，在我們的所有適應症中均表現強勁。然而，我們知道，COVID-19 影響了患者進入腫瘤診所和輸液中心的機會，這可能會影響第二季度輸液產品的數量。我們將繼續監測這些因素。

Importantly, as we look forward, we believe Opdivo is well positioned for a return to growth in 2021 with action dates in first-line lung for 227 next week and 9LA later this year as well as the upcoming opportunity for CheckMate-9ER.

重要的是，展望未來，我們相信 Opdivo 已做好準備，將在 2021 年恢復增長，一線肺治療的行動日期為下週 227 例、今年晚些時候的 9LA 以及即將到來的 CheckMate-9ER 機會。

Now moving on to our in-line multiple myeloma portfolio on Slide 11. Revlimid and Pomalyst continue to deliver strong double-digit growth of 14% and 29%, respectively year-over-year. This growth was driven by increased share in treatment duration due to demand for Revlimid and Pomalyst-based triplet therapies. The U.S. impact from COVID-19 was relatively minimal in the first quarter. Outside the U.S., we estimate a favorable 5 to -- sorry, 5 -- $50 million to $100 million COVID-related stocking, mainly for Revlimid. Due to the oral administration of Revlimid and Pomalyst, allowing patients to take their therapy at home and the potential for relapse in myeloma patients if treatment is stopped, we expect less of an impact due to treatment disruption related to the pandemic. We are continuing to monitor new patient starts as well as U.S. changes to buying patterns due to the FDA REMS program relaxation from 28-day to 56-day scripts. Because these products are sold through specialty pharmacies, we do not see the same level of stocking you would see with other chronic oral medications.

現在轉到幻燈片 11 上我們的多發性骨髓瘤產品組合。Revlimid 和 Pomalyst 繼續實現強勁的兩位數增長，同比分別為 14% 和 29%。這一增長是由於對基於 Revlimid 和 Pomalyst 的三聯療法的需求導致治療持續時間份額增加所致。第一季度，COVID-19 對美國的影響相對較小。在美國以外，我們估計與新冠病毒相關的庫存將有 5 至 5 至 5 至 5000 萬至 1 億美元的優惠，主要用於來那度胺 (Revlimid)。由於 Revlimid 和 Pomalyst 為口服給藥，允許患者在家中接受治療，並且如果停止治療，骨髓瘤患者可能會復發，因此我們預計與大流行相關的治療中斷所造成的影響較小。我們正在繼續監測新患者的開始情況以及由於 FDA REMS 計劃從 28 天腳本放寬到 56 天而導致的美國購買模式的變化。由於這些產品是通過專業藥房銷售的，因此我們沒有看到與其他慢性口服藥物相同的庫存水平。

Now let's turn to the strength of the balance sheet and capital allocation on Slide 12. We ended the quarter in a strong liquidity position with approximately $19 billion in cash and marketable securities with our net debt coming down to $28 billion. We generated significant cash flow from operations in the first quarter of nearly $4 billion. The strength of our balance sheet will allow us to execute on our capital allocation priorities, which will continue to be our prioritization of deleveraging and achieving less than 1.5x debt-to-EBITDA ratio by the end of 2023, investing in future innovation through business development and our continued commitment to our dividend. As previously stated, at the close of the Celgene transaction, we entered into a $7 billion ASR agreement, of which 80% retired quickly. The remaining 20% will be completed by the end of the second quarter.

現在讓我們看看幻燈片 12 上的資產負債表和資本配置的實力。本季度結束時，我們的流動性狀況良好，擁有約 190 億美元的現金和有價證券，淨債務降至 280 億美元。第一季度我們的運營產生了近 40 億美元的大量現金流。我們的資產負債表實力將使我們能夠執行資本配置優先事項，這將繼續是我們去槓桿化的優先事項，並在 2023 年底前實現債務與 EBITDA 比率低於 1.5 倍，通過業務投資於未來創新發展以及我們對股息的持續承諾。如前所述，在 Celgene 交易結束時，我們簽訂了價值 70 億美元的 ASR 協議，其中 80% 很快就退役了。剩餘的20%將在第二季度末完成。

While we have a share repurchase authorization, our priority for share repurchase is offsetting stock-based compensation and having completed the ASR, we don't plan any near-term share repurchases in the current environment.

雖然我們擁有股票回購授權，但我們股票回購的首要任務是抵消股票薪酬，並且在完成 ASR 後，我們不計劃在當前環境下進行任何近期股票回購。

Now turning to guidance on Slide 13. We are affirming our 2020 adjusted EPS and updating our revenue range, MS&A, R&D and OI&E line items. We now expect revenue to be between $40 billion and $42 billion, primarily driven by currency swings I just described. We expect MS&A to be between $6.5 billion and $6.7 billion and R&D to be between $9.2 billion and $9.4 billion, reflecting reduced activity through the COVID-19, combined with incremental operational efficiencies. In OI&E, we expect to have reduced interest income driven by lower interest rates.

現在轉向幻燈片 13 的指導。我們確認 2020 年調整後每股收益並更新我們的收入範圍、MS&A、研發和 OI&E 項目。我們現在預計收入將在 400 億美元至 420 億美元之間，這主要是由我剛才描述的貨幣波動推動的。我們預計 MS&A 費用將在 65 億美元至 67 億美元之間，研發費用將在 92 億美元至 94 億美元之間，反映出因 COVID-19 導致的活動減少以及運營效率的提高。在OI&E方面，我們預計利率下降將導致利息收入減少。

Now let me also provide you with some perspective on 2021. We are affirming our non-GAAP 2021 EPS based on positive momentum in the business and the assumptions we have made about the impact of COVID-19. As we mentioned in February, we don't plan to provide continual updates to our 2021 guidance. However, this quarter, in light of the exceptional circumstances associated with COVID-19, we believe it's important to confirm that our view of 2021 is intact. Our guidance reflects what we know today, and we will need to monitor how things evolve.

現在，我還向您提供對 2021 年的一些看法。我們基於業務的積極勢頭以及我們對 COVID-19 影響所做的假設，確認了我們的非 GAAP 2021 年每股收益。正如我們在 2 月份提到的，我們不打算對 2021 年指南進行持續更新。然而，本季度，鑑於與 COVID-19 相關的特殊情況，我們認為有必要確認我們對 2021 年的看法是完整的。我們的指導反映了我們今天所知道的情況，我們需要監控事態的發展。

With that in mind, let me provide you with some color on our guidance framework on Slide 14. Our assumption is that the peak impact of COVID-19 crisis on our business occurs in Q2 2020, with a return to a more stable business environment in Q3 and minimal impact from Q4 2020 onwards. Key factors assumed in our guidance include products that saw significant advanced buying at the end of Q1 will see that inventory work down during the rest of the year, mostly in Q2 and, to a lesser extent, in Q3 and Q4; a reduction in new brand prescriptions and physician-administered product demand during Q2, recovering in Q3 and fully recovered in Q4; and planning to resume all clinical activities by year-end where local and country restrictions have been lifted. These assumptions are based off holding FX and interest rates constant as of mid-April 2020. Our guidance does not include changes to macroeconomic factors that could affect not just our business but the entire industry. Of course, as we move forward, the factors that are more industry-related and company-specific might have an impact on our current view, and we will need to incorporate that in our future analysis. These include persistence of the strength of the U.S. dollar, recovery of demand post Q2 2020 and the evolution of macroeconomic environment. Nevertheless, the fundamentals of the business remain very strong, and we remain disciplined with respect to our management of P&L.

考慮到這一點，讓我為您提供有關幻燈片 14 的指導框架的一些信息。我們的假設是，COVID-19 危機對我們業務的影響峰值出現在 2020 年第二季度，隨後將在 2020 年第二季度恢復到更穩定的商業環境。 2020 年第三季度和第四季度之後的影響最小。我們的指導中假設的關鍵因素包括，在第一季度末出現大量提前購買的產品將導致庫存在今年剩餘時間內下降，主要是在第二季度，在較小程度上是在第三季度和第四季度；第二季度新品牌處方和醫生管理產品需求減少，第三季度恢復，第四季度完全恢復；併計劃在年底前恢復所有當地和國家限制已取消的臨床活動。這些假設基於截至 2020 年 4 月中旬保持外彙和利率不變的情況。我們的指導不包括宏觀經濟因素的變化，這些變化不僅可能影響我們的業務，而且可能影響整個行業。當然，隨著我們的前進，與行業相關和公司特定的因素可能會影響我們當前的觀點，我們需要將其納入未來的分析中。其中包括美元持續走強、2020年第二季度後需求復蘇以及宏觀經濟環境的演變。儘管如此，業務的基本面仍然非常強勁，我們在損益管理方面仍然遵守紀律。

Before we move on to Q&A, I want to reiterate how proud I am of our employees during the world crisis. Our strong first quarter results and our guidance demonstrate resiliency and diversification of our portfolio, and we continue to feel good about the long-term growth and financial flexibility of the business.

在我們進行問答之前，我想重申一下，在世界危機期間，我為我們的員工感到多麼自豪。我們強勁的第一季度業績和指導表明我們的投資組合具有彈性和多元化，我們繼續對業務的長期增長和財務靈活性感到滿意。

I'll now turn it over to Tim and Giovanni to manage the Q&A.

我現在將把它交給蒂姆和喬瓦尼來管理問答。

Thanks, David. Chloe, could we go to the first question, please?

謝謝，大衛。 Chloe，我們可以回答第一個問題嗎？

Absolutely. So the first question comes from Seamus Fernandez from Guggenheim.

絕對地。第一個問題來自古根海姆的謝默斯·費爾南德斯。

So one of the products that we've argued as being missed in the Celgene acquisition is CC-486. I was hoping that the team could talk a little bit about the commercial prospects for 486 and kind of the durability of this asset as you think about it. And then incremental to that, just wondering if you could update us on any data that would be coming outside of ASCO. I believe the EHA abstracts are hitting, frankly, on the same day as the late-breakers will come out on the -- either on the 28th or the 29th. So just hoping to get an update on the rest of the pipeline coming at EHA.

因此，我們認為在 Celgene 收購中錯過的產品之一是 CC-486。我希望團隊能夠談談 486 的商業前景以及該資產的耐用性。然後逐步增加，只是想知道您是否可以向我們更新 ASCO 之外的任何數據。坦率地說，我相信 EHA 摘要會在 28 日或 29 日發布的同一天發布。所以只是希望能得到 EHA 其餘管道的最新信息。

Thank you, Seamus. Thank you very much. This is Giovanni. So we're very pleased with the priority review designation for CC-486. I'll ask Nadim to give you a perspective on the commercial opportunity there, and then Samit can follow up on your questions regarding data in ASCO and beyond. Thanks.

謝謝你，西莫。非常感謝。這是喬瓦尼。因此，我們對 CC-486 的優先審評指定感到非常滿意。我將請 Nadim 向您介紹一下那裡的商業機會，然後 Samit 可以跟進您有關 ASCO 及其他數據的問題。謝謝。

Great. Thanks for the question, Seamus. We remain very excited about CC-486. I think it's important to provide some context. So with AML, it's a very poor prognosis disease, even in the newly diagnosed setting, where you look at 5-year survival rates of around 15% to 25%, depending on the age of patients. And even saying that, most patients do have a complete response, but 80% of those patients will relapse within 18 months. So we're very excited about the fact that CC-486 has delivered a 10-month survival benefit in that setting. So I think that's really important.

偉大的。謝謝你的提問，西莫。我們對 CC-486 仍然非常興奮。我認為提供一些背景信息很重要。因此，對於 AML，它是一種預後非常差的疾病，即使在新診斷的情況下也是如此，根據患者的年齡，5 年生存率約為 15% 至 25%。即便如此，大多數患者確實有完全緩解，但其中 80% 的患者會在 18 個月內復發。因此，我們對 CC-486 在這種情況下提供了 10 個月的生存獲益這一事實感到非常興奮。所以我認為這非常重要。

And as we think about the opportunity, it's about 33,000 patients overall. And then if you think about the relapse rates, you can start to think about the EPI related to the disease. So the fact that we've added 10-month survival benefit, we've doubled the relapse-free survival benefit, I think we're very excited about the commercial potential, not only in terms of impacting those patients' outcomes, but also the opportunity now to establish a maintenance treatment paradigm in AML, which other drugs have tried, and we haven't seen survival benefit, avoiding the maintenance setting. So I think, from our perspective, now having clarity on the PDUFA date, the launch team preparations are going very well indeed, and we remain very excited about the opportunity with CC-486.

當我們考慮這個機會時，總共約有 33,000 名患者。然後，如果您考慮復發率，您可以開始考慮與該疾病相關的 EPI。因此，事實上我們增加了 10 個月的生存獲益，我們將無復發生存獲益增加了一倍，我認為我們對商業潛力感到非常興奮，不僅在影響這些患者的結果方面，而且在現在有機會在 AML 中建立維持治療模式，其他藥物已經嘗試過這種模式，但我們還沒有看到避免維持治療的生存獲益。因此，我認為，從我們的角度來看，現在 PDUFA 日期已經明確，發射團隊的準備工作確實進展順利，我們仍然對 CC-486 的機會感到非常興奮。

And in terms of durability, we feel very good about the position we have, our intellectual property around CC-486. So we're very excited about the opportunity for patients and for the business with CC-486. Maybe I'll turn it over to Samit now.

在耐用性方面，我們對我們所擁有的地位以及我們圍繞 CC-486 的知識產權感到非常滿意。因此，我們對 CC-486 給患者和業務帶來的機會感到非常興奮。也許我現在會把它交給薩米特。

Thank you, Nadim, and thanks, Seamus, for the question. Let me first say what we are looking at when we look at ASCO. As you've seen the titles that have come out, we are certainly looking forward to the very exciting data from 9LA in non-small lung cancer, looking at Opdivo plus Yervoy in limited amount of chemotherapy, along with an update -- with a 3-year update for CheckMate-227.

謝謝納迪姆，也謝謝謝莫斯提出的問題。我先說一下我們看ASCO時看的是什麼。正如您已經看到的標題一樣，我們當然期待 9LA 在非小細胞肺癌方面的非常令人興奮的數據，研究 Opdivo 加 Yervoy 在有限化療中的作用，以及更新 - 與CheckMate-227 的 3 年更新。

In addition to that, from a hematology perspective, more specifically, we're looking forward to the first presentation of data from the KarMMa trial for ide-cel in multiple myeloma. In addition to the Orva-cel data update that will be provided. And very importantly, continuing with the multiple myeloma team, looking at presentation of the data for CC-480. That's the CEL MoD, which is going to be very, very important and exciting.

除此之外，從血液學的角度來看，更具體地說，我們期待首次展示 ide-cel 治療多發性骨髓瘤的 KarMMa 試驗數據。除了將提供的 Orva-cel 數據更新之外。非常重要的是，繼續與多發性骨髓瘤團隊合作，研究 CC-480 數據的呈現。這就是 CEL MoD，它將非常非常重要且令人興奮。

You asked about EHA. EHA will be more of encore presentations following up from ASCO. In addition to that, we're certainly looking at the data sets in terms of the outpatient use of liso-cel as well at EHA. So these are going to be important data sets at ASCO, which we will obviously continue to talk about as we go forward and then follow up if there is anything more to say about EHA thereafter. Thank you.

您詢問了 EHA。 EHA 將更多地是 ASCO 後續的安可演講。除此之外，我們當然也在研究 liso-cel 門診使用情況以及 EHA 的數據集。因此，這些將成為 ASCO 的重要數據集，我們顯然會在前進過程中繼續討論這些數據集，如果此後有任何關於 EHA 的內容要說的話，我們也會跟進。謝謝。

The next question comes from Terence Flynn from Goldman Sachs.

下一個問題來自高盛的特倫斯·弗林。

Great. Maybe this is for Chris. You obviously have a number of ongoing or upcoming launches. And just wondering how you're adapting the commercial strategy here with the possibility that the current environment persists longer than maybe we'd expect. And are you confident that you can achieve your target sales goals for a lot of these new product launches? And then a follow-up question just on liso-cel BLA submission. I was wondering if you can give any more specifics about the FDA request.

偉大的。也許這是給克里斯的。顯然，您有許多正在進行或即將推出的產品。只是想知道您如何調整這裡的商業策略，因為當前環境的持續時間可能比我們預期的要長。您是否有信心能夠實現許多新產品發布的目標銷售目標？然後是關於 liso-cel BLA 提交的後續問題。我想知道您是否可以提供有關 FDA 要求的更多細節。

Thank you, Terence. Let me just start, I'll ask Chris then to comment on your question and Nadim and also then Samit can follow up on liso-cel. We're taking a very clear approach with launches. And obviously, the #1 priority is the health and safety of our employees, of the healthcare professionals. So we don't want to disrupt sort of healthcare systems right now. And so we've taken the position to really maximize early on our remote capabilities in terms of engaging with our customers in order to respect to the challenges of the pandemic. Having said that, while we have global principles, those principles apply differently to different parts of the world, and they also apply differently to different brands because the launch of the new indication for an existing well-established brand is clearly a different strategy versus a totally new medicine. So Chris and Nadim can give you a couple of examples on how those principles we are applying them to our launches and, obviously, the continued support of our portfolio.

謝謝你，特倫斯。讓我開始吧，然後我會請 Chris 對你的問題發表評論，然後 Nadim 和 Samit 可以跟進 liso-cel。我們對發布採取非常明確的方法。顯然，第一要務是我們員工和醫療保健專業人員的健康和安全。所以我們現在不想破壞某種醫療保健系統。因此，我們已經採取立場，在與客戶互動方面儘早真正最大限度地發揮我們的遠程能力，以應對這一流行病的挑戰。話雖如此，雖然我們有全球原則，但這些原則對世界不同地區的適用不同，對不同品牌的適用也不同，因為為現有知名品牌推出新適應症顯然是一種不同的策略。全新的藥物。因此，克里斯和納迪姆可以給您舉幾個例子，說明我們如何將這些原則應用到我們的產品發布中，當然還有對我們產品組合的持續支持。

Yes. So maybe I'll start, Terence. Thanks for the question. So as Giovanni mentioned, we made the decision a number of weeks ago to pull in-personal -- in-person engagement with customers. That said, we have continued both on the medical and commercial side to engage with customers remotely. The good news is that BMS has made significant investments in remote engagement capabilities over the last few years. So the teams have a lot of experience, not just for the last couple of months but for many years in leveraging this technology to engage with customers.

是的。那麼也許我會開始，特倫斯。謝謝你的提問。正如喬瓦尼提到的，我們幾週前就決定與客戶進行面對面的接觸。也就是說，我們繼續在醫療和商業方面與客戶進行遠程互動。好消息是，BMS 在過去幾年中在遠程參與能力方面進行了大量投資。因此，團隊在利用這項技術與客戶互動方面擁有豐富的經驗，不僅是過去幾個月的經驗，而且是多年來的經驗。

And as Giovanni mentioned, we've very much taken the point of view that every launch is going to be viewed as independently, and we'll look at how we're going to engage with customers and how we're going to think about those launches given the specifics. So for example, you'll recall that when ZEPOSIA was approved in late March, we decided to postpone that launch. We did so because at the time, the healthcare system was really just bracing for the impact of COVID, and within the MS community, specifically, we were starting to see a pretty big impact on their ability to operate. Through March, for example, we saw about a 25% decrease in new-to-brand scripts in MS. And we, frankly, didn't feel that the conditions were appropriate to introduce a new medicine without having our commercial and medical team to be able to effectively engage with customers. That said, in recent weeks, we've begun to see the MS market begin to adapt to the current environment. Importantly, physicians are beginning to actively initiate new therapies. They've begun switching patients on therapy. And as a result, we plan to launch ZEPOSIA on June 1.

正如喬瓦尼所提到的，我們非常認為每次發布都將被視為獨立的，我們將考慮如何與客戶互動以及如何考慮鑑於具體情況，這些發布。例如，您會記得，當 ZEPOSIA 在 3 月底獲得批准時，我們決定推遲該發布。我們這樣做是因為當時的醫療保健系統實際上只是在為新冠病毒的影響做好準備，特別是在多發性硬化症社區內，我們開始看到他們的運作能力受到了相當大的影響。例如，整個 3 月份，我們發現 MS 的新品牌腳本減少了約 25%。坦率地說，如果我們的商業和醫療團隊無法有效地與客戶互動，我們認為引入新藥的條件不合適。也就是說，最近幾週，我們開始看到 MS 市場開始適應當前的環境。重要的是，醫生們開始積極啟動新療法。他們已經開始為患者更換治療方案。因此，我們計劃於 6 月 1 日推出 ZEPOSIA。

In terms of preparation, the teams are very well prepared. We've hired a very experienced medical and commercial team that's been fully in place, frankly, before launch, and we've gotten very good feedback on the ZEPOSIA profile. So we're very excited about making that opportunity available. Obviously, initially, that launch will heavily index. And this will be true for first-line lung cancer as well. It will heavily index on remote engagements. Again, we have a lot of experience in leveraging that technology. And then as conditions warrant, we'll be able to dial up in-personal promotion. And ultimately, as we always do, we'll use a mix of both in-person and remote engagement to support those launches. And we have a lot of confidence in the teams across the commercial organization and our ability to execute these launches. Nadim, anything to add?

在準備方面，各隊準備得非常充分。坦率地說，我們聘請了一支經驗豐富的醫療和商業團隊，在發布之前就已經完全就位，並且我們得到了有關 ZEPOSIA 簡介的非常好的反饋。因此，我們非常高興能提供這樣的機會。顯然，最初，該發布將大量索引。對於一線肺癌也是如此。它將大量索引遠程參與。同樣，我們在利用該技術方面擁有豐富的經驗。然後，如果條件允許，我們將能夠進行面對面的晉升。最終，正如我們一貫所做的那樣，我們將結合使用面對面和遠程參與來支持這些發布。我們對整個商業組織的團隊以及我們執行這些發布的能力充滿信心。納迪姆，有什麼要補充的嗎？

Sure. Thanks, Chris. I mean I would just say a couple of things. One, we are very excited about the opportunity to launch 4 first-in-class or best-in-class medicines in the U.S. just this year. And so the launch preparations are going very, very well with the team. Of course, we'll continue to use our deep relationships with hematology experts and hematologists and also our commercial infrastructure. So between Reblozyl, liso-cel, ide-cel, CC-486, that's the potential for 4 launches in the U.S. this year.

當然。謝謝，克里斯。我的意思是我只想說幾件事。第一，我們對今年有機會在美國推出 4 種一流或一流藥物感到非常興奮。因此，團隊的啟動準備工作進展得非常非常順利。當然，我們將繼續利用我們與血液學專家和血液學家的深厚關係以及我們的商業基礎設施。因此，Reblozyl、liso-cel、ide-cel、CC-486 等藥物今年有可能在美國上市 4 款。

And just to give you some flavor, what Chris was saying, we were able to very quickly, with Reblozyl, pivot for the MDS launch from an in-lie situation, which we thought at the beginning of the year, to a virtual launch. And we continue to hear good success stories about the ability to access physicians and customers in general through virtual engagement. So we are very excited about the launches ahead of us. And as Chris said, we've really pivoted to that digital environment and we're finding -- we're gaining good access. So very excited about those launches.

克里斯所說的只是為了讓大家了解一下，我們能夠通過 Reblozyl 很快將 MDS 的發布從我們年初認為的實際情況轉向虛擬發布。我們不斷聽到有關通過虛擬參與接觸醫生和客戶的良好成功故事。因此，我們對即將推出的產品感到非常興奮。正如克里斯所說，我們確實已經轉向數字環境，並且我們發現 - 我們正在獲得良好的訪問權限。對這些產品的發布非常興奮。

And then I'll hand over to Samit for the other part of your question.

然後我將把你問題的另一部分交給薩米特。

Thank you, Nadim and thanks, Terence, for the question. As it relates to liso-cel, as you know, that we have submitted the application, the comprehensive data sets at the end of last year. And the FDA accepted the application for liso-cel and granted a priority review in February of this year. Now it is typical for the FDA to request additional information as they continue their review process. And after the company supplied the information in response to several requests that the FDA has made, FDA has decided with the information they've received constitute a major amendment. And that's why the PDUFA date has been extended by 3 months to the 16th of November now. And we are obviously committed to ensuring this medicine is available to patients as soon as possible, and we continue to meet our CVR milestones.

謝謝納迪姆，也謝謝特倫斯提出的問題。因為它涉及到liso-cel，正如你所知，我們已經在去年年底提交了申請，綜合數據集。 FDA於今年2月接受了liso-cel的申請並給予優先審評。現在，FDA 在繼續審查過程時通常會要求提供更多信息。在該公司根據 FDA 提出的多項要求提供信息後，FDA 決定他們收到的信息構成重大修訂。這就是為什麼 PDUFA 日期已延長 3 個月至 11 月 16 日。我們顯然致力於確保盡快為患者提供這種藥物，並且我們將繼續實現我們的 CVR 里程碑。

Obviously, we're not going to comment on the specifics of our regulatory discussions, but let me just remind that we remain very confident about the data for liso-cel for these patients with non-B cell lymphoma as it is an unmet medical need, and we're truly looking forward to the approval of this therapy towards the end of the year.

顯然，我們不會評論監管討論的具體細節，但我只是提醒一下，我們對 liso-cel 用於這些非 B 細胞淋巴瘤患者的數據仍然非常有信心，因為這是一個未得到滿足的醫療需求，我們真誠地期待這種療法在今年年底獲得批准。

The next question comes from Geoffrey Meacham from Bank of America.

下一個問題來自美國銀行的杰弗裡·米查姆。

I just had a couple -- as a follow-up for David. If the environment normalizes this year, you may see a lower run rate for some of your launches. And so does this affect how you think about 2021 in terms of revenue or cash flow? And are there opportunities for synergies to be realized on an accelerated basis?

我剛剛做了一些——作為大衛的後續。如果今年環境正常化，您可能會發現某些發布的運行率較低。那麼這會影響您對 2021 年收入或現金流的看法嗎？是否有機會加速實現協同效應？

And then, Giovanni, big picture on the beauty front, you talked about your Celgene focus even as you fully integrate Celgene. So just curious whether the COVID-19 environment alter this view, either the priorities on perhaps the size and scope of it?

然後，喬瓦尼，美容方面的大局，您談到了您對 Celgene 的關注，即使您完全整合了 Celgene。所以只是好奇 COVID-19 環境是否會改變這種觀點，或者優先考慮它的規模和範圍？

Thank you, Geoff. Let me ask David to start and give you a perspective on 2020 and '21. It's really what has been reflected in our guidance, and I'll get to your second question immediately after.

謝謝你，傑夫。讓我請 David 首先向您介紹一下 2020 年和 21 年。這確實是我們的指導中所反映的內容，我將立即回答你的第二個問題。

Yes. So thank you for the question. Particularly on guidance, as we're thinking about it, as we said, is right now, we think the inventory data that came through is going to release out mainly in Q2 and for the remainder of the year. As far what we're watching closely is the new patient starts in anticipation that, that recovers in Q3 and back to normal in Q4 and as well as the infusion centers and the volumes returning to normal, and that would continue into 2021.

是的。謝謝你的提問。特別是在指導方面，正如我們所說，我們現在正在考慮這一點，我們認為庫存數據將主要在第二季度和今年剩餘時間發布。據我們密切關注的是，新患者開始預計將在第三季度恢復並在第四季度恢復正常，輸液中心和輸液量也將恢復正常，這種情況將持續到 2021 年。

What I would say is that the underlying performance of the business is very strong in the first quarter. And as you heard about with the product launches, our confidence in those 4 product launches are coming this year as well as the product launches next year. That gives us the confidence in reiterating our guidance for both this year and next year, but we're going to keep a very close eye on the macroeconomic factors that could wind up impacting the entire industry, as I talked about in my remarks.

我想說的是，第一季度該業務的基本表現非常強勁。正如您所聽說的產品發布，我們對今年以及明年的這 4 款產品發布充滿信心。這讓我們有信心重申今年和明年的指導意見，但正如我在講話中談到的那樣，我們將密切關注最終可能影響整個行業的宏觀經濟因素。

As far as the synergies, we're continuing to review those synergies, both internally as well as with our Board. We are really pleased with the progress we've been making on the synergy front. And the progress with our third-party vendors has done very well. And as far as getting the organization in place, the vast majority of our placements of the organization are done. And as far as site selection is concerned, bringing our sites together and that's moving along as planned as well. So we remain confident in delivering the synergy targets that we have.

就協同效應而言，我們將繼續在內部以及與董事會一起審查這些協同效應。我們對協同方面取得的進展感到非常滿意。我們與第三方供應商的合作進展非常順利。就組織到位而言，我們對組織的大部分安置已經完成。就選址而言，將我們的站點整合在一起，這也在按計劃進行。因此，我們對實現我們的協同目標仍然充滿信心。

Thank you, David. So just -- and going back to your question, Geoff. So let me just say, first of all, we are very happy with the progress we've made with the integration of the company and, at the same time, the strength of execution in the company. So on one side, our business continues to perform really well. As you've seen, we've made great progress with the pipeline against all key value drivers. We're executing well. We've made progress. I would say we are progressing really well with synergies as well, and we have tremendous flexibility from a P&L perspective and from a financials perspective.

謝謝你，大衛。那麼，回到你的問題，傑夫。所以我想說，首先，我們對公司整合所取得的進展以及公司的執行力感到非常高興。因此，一方面，我們的業務繼續表現良好。正如您所看到的，我們在針對所有關鍵價值驅動因素的管道方面取得了巨大進展。我們執行得很好。我們已經取得了進展。我想說，我們在協同效應方面也取得了很好的進展，從損益角度和財務角度來看，我們擁有巨大的靈活性。

So going forward, we will continue to be very disciplined in terms of how we think about resource allocation and expenses given evolutions related to the COVID pandemic. Now given our strong position, as David mentioned earlier, we've not really changed our capital allocation strategy. Business development remains the central pillar of our strategy. We are very focused on continuing to bring the new assets and innovation into the company. I expect that to continue to be the case, and it's very possible, in fact, that there are more opportunities available to us going forward. And we are definitely focused on business development as we've always been, so thank you.

因此，展望未來，考慮到與新冠疫情相關的演變，我們將繼續嚴格考慮資源分配和支出。正如大衛之前提到的，鑑於我們的強勢地位，我們並沒有真正改變我們的資本配置策略。業務發展仍然是我們戰略的核心支柱。我們非常專注於繼續為公司帶來新資產和創新。我預計這種情況會繼續下去，事實上，我們未來很可能有更多的機會。我們一如既往地專注於業務發展，所以謝謝。

The next question comes from Chris Schott from JPMorgan.

下一個問題來自摩根大通的克里斯·肖特。

Great. Just 2 for me. The first one, in light of the 9ER study, can you talk about the RCC market and the opportunity you see for Opdivo-Yervoy versus IO-TKI combinations over time and how you see Bristol positioning these 2 different frontline offerings you're going to have as you think about how you're going to position them relative to one another?

偉大的。對我來說只有2個。第一個，根據 9ER 研究，您能否談談 RCC 市場以及您看到的 Opdivo-Yervoy 與 IO-TKI 組合隨著時間的推移的機會，以及您如何看待 Bristol 定位這兩種不同的一線產品當您考慮如何將它們相對於彼此定位時？

My second question was on COVID and drug pricing. I think you mentioned some of these kind of macroeconomic factors, but when you think about high unemployment as well as growing budget deficits from government payers, how do you see that flowing through as we think about net pricing looking out later this year and into 2021? Is it -- a core of the question, do you think it's likely that we're going to see some sort of incremental impact to pricing from what's occurring with COVID right now?

我的第二個問題是關於新冠肺炎和藥品定價。我認為您提到了其中一些宏觀經濟因素，但是當您考慮高失業率以及政府付款人不斷增加的預算赤字時，當我們考慮今年晚些時候和 2021 年的淨定價時，您如何看待這些因素的影響？問題的核心是，您認為我們是否可能會看到目前新冠疫情對定價產生某種增量影響？

Thank you, Chris. Let me start, I'll give you my perspective on pricing, and then I'll ask Chris to comment on 9ER and RCC, it's exciting there.

謝謝你，克里斯。首先，我將向您介紹我對定價的看法，然後我將請 Chris 對 9ER 和 RCC 發表評論，這很令人興奮。

So first of all, I think a lot of -- first of all, I would say, Chris, the issue of drug pricing is one where we've been in dialogue now for a period of time, and we, as an industry and as a company, continue to think that there is a real need to be strategic and think about reforming some of the elements of the pricing system in the U.S. that are creating affordability issues for patients. As you know, we believe there is a real opportunity through rebate reform and other measures that are market-based to address the issue of drug pricing in terms of patient affordability, which is the real issue.

首先，我認為，首先，我想說，克里斯，藥品定價問題是我們已經討論了一段時間的問題，我們作為一個行業和作為一家公司，繼續認為確實需要製定戰略，並考慮改革美國定價體系中的一些要素，這些要素給患者帶來了負擔能力問題。如您所知，我們認為，通過回扣改革和其他基於市場的措施，確實有機會解決患者負擔能力方面的藥品定價問題，這才是真正的問題。

Now with respect to your question, first, it's early days and it is early to say, and it's difficult to speculate on the future. Of course, the focus of many, and I think that was at the center of your question, is what happens in an environment where unemployment is higher and there is a significant impact to the commercial markets. So one way to think about it, if you look at our business, where 60% of our business, approximately in the U.S., in the U.S. -- so of that 60%, about 25% of our business is in the commercial space. And when you look at the dynamics that may play out in the commercial space, I think a lot depends on what happens to patients that may be unemployed and potentially lose coverage. So some of those patients will move to a spouse's insurance plan. Some of those patients may take up COBRA. And obviously, any strategy or policy that makes that more affordable would be -- even more affordable would be beneficial for patients. Some of those patients will be eligible for Medicare. If they're over 65, there may be some shift to government programs like the exchanges or Medicaid, and hopefully, no patients or very few patients loses coverage. So these are all of the dynamics that we're going to be working through. And of course, a lot depends on the shape of the recovery and how long unemployment lasts. But I think these are sort of the macro factors that we'll be looking at together. So with that, I'll ask Chris to give you his perspective about the RCC market and the excitement with 9ER.

關於你的問題，第一，現在說還為時過早，未來很難推測。當然，許多人關注的焦點，我認為這是你問題的核心，是在失業率較高且對商業市場產生重大影響的環境中會發生什麼。因此，從一種角度來看，如果你看看我們的業務，我們 60% 的業務，大約在美國，在美國——所以這 60%，大約 25% 的業務是在商業領域。當你觀察商業領域可能出現的動態時，我認為很大程度上取決於可能失業並可能失去保險的患者會發生什麼。因此，其中一些患者將轉入配偶的保險計劃。其中一些患者可能會接受 COBRA。顯然，任何能讓患者負擔得起的策略或政策都會對患者有利。其中一些患者將有資格享受醫療保險。如果他們超過 65 歲，可能會轉向交換或醫療補助等政府計劃，希望沒有患者或極少數患者失去保險。這些都是我們將要解決的所有動態問題。當然，這在很大程度上取決於復甦的形式以及失業持續多久。但我認為這些是我們將一起考慮的宏觀因素。因此，我將請 Chris 向您介紹一下他對 RCC 市場的看法以及 9ER 帶來的興奮。

Yes. Thanks for the question, Chris. We're very excited about the data that we saw with 9ER. Maybe in answering your question, I'll start with just kind of an update on where we are with Opdivo plus Yervoy today in first-line renal. If you go back year, one of the things that we said when we first started to see the IO-TKI data was that we anticipated that Opdivo plus Yervoy would remain a standard of care in first line, and that's precisely what's happened. And we think that's been driven primarily by the impressive long-term benefits that you've seen with Opdivo plus Yervoy.

是的。謝謝你的提問，克里斯。我們對 9ER 看到的數據感到非常興奮。也許在回答你的問題時，我首先會介紹一下目前 Opdivo 加 Yervoy 在一線腎臟治療中的最新進展。如果你回到一年前，我們第一次開始看到 IO-TKI 數據時所說的一件事是，我們預計 Opdivo 聯合 Yervoy 將仍然是一線治療的標準，而這正是發生的情況。我們認為，這主要是由 Opdivo 加 Yervoy 所帶來的令人印象深刻的長期效益推動的。

We just saw the 42-month OS update at ASCO GU. That OS was about 56% in the ITT population, and that's driven continued strong performance of Opdivo plus Yervoy first line. Market share right now is between 30% and 35% overall. It's on the upper end of that range when you look at the labeled indication that we have in intermediate and poor. We do get some non-promoted use in the favorable population, which is off-label for us, of about 15% Opdivo plus Yervoy use there. And we've also seen that the majority of the use that existing IO plus TKI therapies have gotten in first-line renal has largely be at the expense of TKI monotherapy. So Opdivo plus Yervoy has held up really well, and in fact, we've seen a bit of an uptick in Opdivo plus Yervoy over the last number of months. 9ER, very exciting data. We're very happy to see both the OS and the PFS data that we saw there. Also very encouraged by the safety profile for 9ER.

我們剛剛在 ASCO GU 看到了為期 42 個月的操作系統更新。該 OS 在 ITT 人群中的比例約為 56%，這推動了 Opdivo 和 Yervoy 一線藥物的持續強勁表現。目前整體市場份額在 30% 至 35% 之間。當您查看我們的中等和較差的標籤指示時，它處於該範圍的上限。我們確實在有利人群中進行了一些非推廣使用，這對我們來說是標籤外的，大約 15% 的 Opdivo 加 Yervoy 在那裡使用。我們還發現，現有 IO 聯合 TKI 療法在一線腎臟治療中的大部分使用很大程度上是以 TKI 單一療法為代價的。因此，Opdivo 加 Yervoy 的表現非常好，事實上，我們已經看到 Opdivo 加 Yervoy 在過去幾個月中有所上升。 9ER，非常令人興奮的數據。我們很高興看到我們在那裡看到的操作系統和 PFS 數據。 9ER 的安全狀況也非常令人鼓舞。

In terms of how we're thinking about positioning it, still very early days and we're working through the data. But we think these data compete very well against existing IO-TKI therapies. As a result, we think there's an opportunity to drive share from existing IO-TKI therapies. We also think that there's an opportunity to drive share from TKI monotherapy. In spite of advances in first line renal, TKI monotherapy, is still about 20% to 25% of share, mostly in the favorable population.

就我們如何考慮定位而言，還處於早期階段，我們正在研究數據。但我們認為這些數據與現有 IO-TKI 療法競爭非常激烈。因此，我們認為有機會推動現有 IO-TKI 療法的份額。我們還認為有機會提高 TKI 單一療法的市場份額。儘管一線腎臟治療取得了進展，TKI 單藥治療仍佔約 20% 至 25% 的份額，主要是在有利人群中。

And with respect to favorables, we think there's an opportunity there for us as well since 9ER crossed risk status and included that favorable population. And now once approved, we'll have access to that population promotionally.

至於優惠，我們認為我們也有機會，因為 9ER 跨越了風險狀態並納入了優惠人群。現在，一旦獲得批准，我們就可以向該人群進行促銷。

Importantly and the last thing I would say is that once approved, 9ER really does give us the opportunity to offer patients multiple IO modalities here. We'll have -- we'll be the only company, frankly, to have dual IO but also what we believe will be a best-in-class IO-TKI offering. So very excited about the opportunity that 9ER affords us to help patients and provide another modality to those patients. And I think that there's a nice opportunity.

重要的是，我要說的最後一件事是，一旦獲得批准，9ER 確實讓我們有機會為患者提供多種 IO 模式。坦率地說，我們將成為唯一一家擁有雙 IO 的公司，而且我們相信這將是一流的 IO-TKI 產品。對於 9ER 為我們提供幫助患者並為這些患者提供另一種治療方式的機會，我們感到非常興奮。我認為這是一個很好的機會。

The next question comes from Andrew Baum from Citi.

下一個問題來自花旗銀行的安德魯鮑姆。

Some questions for Samit, please. In terms of the pending 9LA data at ASCO, what is the follow-up of that data for both OSM for PFS? My question is, are physicians going to come out of that presentation and rethink their strategy for first-line non-small cell lung on the back of that data. Is there enough follow-up there?

請向薩米特提出一些問題。就 ASCO 待定的 9LA 數據而言，兩個 OSM for PFS 的數據後續是什麼？我的問題是，醫生們是否會在演講結束後根據這些數據重新思考他們的一線非小細胞肺治療策略。那裡有足夠的後續行動嗎？

Second, in terms of the 9ER trial, could you talk to cabozantinib? I remember that when you ran the Phase II, there was a question about toxicity and I think it should be used in low dose. So given it's a much more promiscuous TTI, should we assume a favorable or comparable tox profile? Anything you could share there would be interesting.

第二，關於9ER試驗，您能談談卡博替尼嗎？我記得你們做二期的時候，有一個關於毒性的問題，我覺得應該低劑量使用。因此，鑑於 TTI 更加混雜，我們是否應該假設一個有利的或可比的毒性特徵？您可以在那里分享的任何內容都會很有趣。

And then finally on TIGIT, or TIGIT. Roche is pushing forward very aggressively with their TIGIT antagonist. Merck, clearly, is interested and active with theirs. Your program seems not to have been very much. Is that a function of resource allocation? Or is it a function of what you're seeing with this particular molecule?

最後是 TIGIT，或者 TIGIT。羅氏正在積極推進他們的 TIGIT 對手。顯然，默克公司對他們的產品很感興趣並且很積極。你的程序好像不是很多。這是資源分配的函數嗎？或者它是你所看到的這個特定分子的函數嗎？

Thank you, Andrew. So Samit, I believe all 3 elements of the questions are for you.

謝謝你，安德魯。所以 Samit，我相信問題的所有 3 個要素都適合您。

Thank you, Andrew, always -- as always, very thoughtful questions and certainly thought provoking.

謝謝你，安德魯，一如既往，非常深思熟慮的問題，當然發人深省。

From a 9LA perspective, certainly, we're looking forward to the first presentation of the data at ASCO, although virtually, but certainly going to be very meaningful. As you recall, we had finished enrollment towards the beginning of last year. So had the first readout of the data, the interim analysis has followed the short. What we will be able to share is follow-on data from that perspective. It's very important, I think, to realize from 9LA perspective, a few things that questions that we will be looking towards the data to answer. One is, as you continue the follow on, and as you continue to follow up, what happens to that OS curve? Does it start to flatten out? Number one.

當然，從 9LA 的角度來看，我們期待在 ASCO 上首次展示數據，雖然是虛擬的，但肯定會非常有意義。正如您所記得的，我們在去年初就完成了招生。因此，在第一次讀出數據後，中期分析就隨之而來。我們將能夠分享的是從這個角度來看的後續數據。我認為，從 9LA 的角度認識到一些我們將尋求數據來回答的問題是非常重要的。一是，當你繼續跟進時，當你繼續跟進時，操作系統曲線會發生什麼？它開始變平嗎？第一。

Number two, what happens to that beginning part of the curve that we saw in CheckMate-227, where we have the early progressors? And how a limited amount of chemotherapy can impact that? I think those are the very important answers that we've been looking for as we look towards the presentation of the 9LA data. We remain excited. I think both of them have to be considered together, the 227 data and the 9LA data in overall management of a patient as we look towards non-small cell lung cancer management as we go forward. So I think that dual IO inhibition becomes very important, along with that shortened duration of chemotherapy for some patients we acquired. I will obviously ask, towards the end, when I finish, that to Chris also to comment from commercial perspective, what that really means.

第二，我們在 CheckMate-227 中看到的曲線的開始部分（其中有早期進展者）發生了什麼？有限的化療量會如何影響這一點？我認為這些是我們在展示 9LA 數據時一直在尋找的非常重要的答案。我們仍然很興奮。我認為在患者的整體管理中，227 數據和 9LA 數據必須一起考慮，因為我們在展望非小細胞肺癌管理的過程中不斷前進。因此，我認為雙重 IO 抑制以及縮短我們獲得的一些患者的化療持續時間變得非常重要。顯然，當我結束時，我會問克里斯也從商業角度評論這到底意味著什麼。

On the 9ER side, as you mentioned, CABOMETYX reviews of the dose of 40 milligrams, and certainly, that is going to be important in terms of management of the safety profile, as we've already said, that overall, what we have seen is generally quite manageable safety profile. As Chris also spoke about, that this provides an opportunity for further use of Opdivo in all the risk categories in combination with CABOMETYX. So certainly, a very exciting news where the trial has met all 3 endpoints or major endpoints that we look at from an overall survival benefit as well as looking at PFS and this constraint in addition to a very well-managed safety profile.

在 9ER 方面，正如您提到的，CABOMETYX 審查了 40 毫克的劑量，當然，這對於安全性管理而言非常重要，正如我們已經說過的，總的來說，我們所看到的通常是相當易於管理的安全狀況。正如 Chris 還談到的那樣，這為在所有風險類別中進一步使用 Opdivo 與 CABOMETYX 組合提供了機會。因此，當然，這是一個非常令人興奮的消息，該試驗達到了所有 3 個終點或主要終點，我們從總體生存獲益以及 PFS 和這一限制以及管理良好的安全性方面考慮這些終點。

And I'll finish off on the TIGIT, and then I'll pass it on to Chris to comment further on both the 9LA as well as 9ER. On the TIGIT perspective, we are looking forward to see the data that Roche will be presenting. Certainly, a very complex mechanism, as you very well know. We have our molecule, which is in Phase I. We continue to evaluate the safety and the overall dose profile for that agent. And certainly, there's no data to be shared yet. But we will certainly learn from what Roche is going to present, and then we'll see if we need to manage differently. Chris, you want to add things?

我將結束 TIGIT，然後將其轉交給 Chris，以進一步評論 9LA 和 9ER。從TIGIT的角度來看，我們期待看到羅氏將呈現的數據。當然，正如你所知道的，這是一個非常複雜的機制。我們已經有了處於第一階段的分子。我們將繼續評估該藥物的安全性和總體劑量分佈。當然，目前還沒有可以共享的數據。但我們肯定會從羅氏將要展示的內容中學習，然後我們會看看是否需要採取不同的管理方式。克里斯，你想添加一些東西嗎？

Sure. I think that Samit hit on most of the points around 9LA. What I would say from a commercial standpoint is, obviously, we've had a lot of discussions with physicians over the last few months about 227 and 9LA. And it's important what Samit said that positions, and we really do think that 227 and 9LA really need to be thought about together. 227, you'll recall that what we showed was about 50% of responders were still responding at 2 years, and we saw this nice flattening of the OS curve. You'll see how that data matures at ASCO in a few weeks. But then the way physicians are thinking about 9LA is very much as complementary to 227 in that they offer the benefit of Opdivo plus Yervoy to patients who don't need chemotherapy, that's 227; and for those patients who potentially do need chemotherapy, and that's where 9LA came in -- comes into play. And I think Samit hit on some of the key things that you want to pay attention to when that data are presented at ASCO in a few weeks.

當然。我認為 Samit 擊中了 9LA 周圍的大部分要點。從商業角度來看，我想說的是，顯然，過去幾個月我們與醫生就 227 和 9LA 進行了很多討論。 Samit 所說的立場很重要，我們確實認為 227 和 9LA 確實需要一起考慮。 227，您會記得我們顯示大約 50% 的響應者在 2 年後仍在響應，並且我們看到 OS 曲線非常平坦。幾週後您將看到 ASCO 的數據如何成熟。但醫生對 9LA 的看法與 227 非常相似，因為他們為不需要化療的患者提供了 Opdivo 加 Yervoy 的益處，即 227；對於那些可能確實需要化療的患者，這就是 9LA 發揮作用的地方。我認為，幾週後在 ASCO 上公佈這些數據時，薩米特談到了一些你需要關注的關鍵問題。

Two other things that I would just keep in mind with respect to Opdivo plus Yervoy in lung. First are about half of the lung cancer treaters have used Opdivo plus Yervoy, either in melanoma or renal. So they're familiar with the benefit that we see with that regimen there. And those physicians account for about 2/3 of total lung cancer patients.

關於 Opdivo 和 Yervoy 在肺部的作用，我要記住另外兩件事。首先，大約一半的肺癌治療者使用 Opdivo 聯合 Yervoy 治療黑色素瘤或腎癌。所以他們熟悉我們在那裡看到的那種療法的好處。而這些醫生約佔肺癌患者總數的2/3。

And then the second thing, not a trivial thing, is that we have a very experienced team with a track record of being able to establish Opdivo plus Yervoy as a standard of care in both of the tumors in which we've been approved with that regimen, and they're incredibly excited and prepared to launch Opdivo plus Yervoy in first-line lung cancer. And we're really looking forward to the PDUFA date for 227 next week.

第二件事，不是一件小事，是我們擁有一支經驗豐富的團隊，他們有能力將 Opdivo 加 Yervoy 作為我們已獲批准的兩種腫瘤的護理標準。他們非常興奮，並準備推出 Opdivo 聯合 Yervoy 治療一線肺癌。我們非常期待下週 227 的 PDUFA 日期。

The next question comes from Tim Anderson from Wolfe Research.

下一個問題來自沃爾夫研究中心的蒂姆·安德森。

A couple of questions, please. Quite a few number of years ago, Bristol narrowed its footprint in emerging markets intentionally to kind of focus on, I think, what it felt was geographies where it had more scale and presence. But with Celgene folded in, you're a much bigger organization, and it kind of makes me wonder what the plan is with emerging markets going forward. I don't even see emerging markets or China mentioned in the press release or in the slide deck. But as we've seen across the industry, geographies like China are very important, especially in the area of oncology. That makes me wonder if there's kind of an untapped revenue stream here and what's the solution if you think there is indeed a problem that you don't have a big enough footprint now given the size of the company.

請教幾個問題。幾年前，布里斯托爾有意縮小其在新興市場的足跡，我認為，它認為重點關注其規模更大、影響力更大的地區。但隨著新基（Celgene）的合併，你是一個更大的組織，這讓我想知道新興市場的未來計劃是什麼。我什至沒有看到新聞稿或幻燈片中提到新興市場或中國。但正如我們在整個行業中看到的那樣，像中國這樣的地區非常重要，尤其是在腫瘤學領域。這讓我想知道這裡是否存在未開發的收入來源，如果您認為確實存在問題，鑑於公司的規模，您現在沒有足夠大的足跡，那麼解決方案是什麼。

And second question is on LAG-3. If I understand that you have pivotal LAG-3 plus Opdivo combination data coming up around year-end in first-line melanoma. That's a program that doesn't seem to get talked about very much. Investor expectations are low. My question is, should those expectations be low. Do you view this as a high-risk program?

第二個問題是關於 LAG-3 的。據我了解，您將在年底左右獲得關於一線黑色素瘤治療的關鍵 LAG-3 加 Opdivo 組合數據。這是一個似乎沒有被太多談論的程序。投資者預期較低。我的問題是，這些期望是否應該降低？您認為這是一個高風險計劃嗎？

Thank you, Tim. Let me just answer your first question, and then I'll ask Samit to give you his perspective on the ongoing LAG-3 program. I think your point is really important. It is a very good question. You are right, that given our focus on oncology and all of the work that we have done over the last few years, we have been focused primarily on, I would say, the developed world. I must say, we have a meaningful presence in developing countries. And when we've seen -- when we look at the development of our oncology business, in particular, we have had significant success actually outside of the U.S. and Europe and major markets, including Central and Eastern Europe and some of the key markets in Latin America. And as you know, recently, with the approval of Opdivo in China. So it is also accurate that now we have a broader portfolio and more opportunities to establish a larger presence outside of the sort of Tier 1 top markets and I'm actually really confident we have the right capabilities there, and we have a strong base to continue to invest internationally. There is a real opportunity, but there is also already a presence of the BMS portfolio that has been successful there. So we'll continue to invest across different geographies and there is an opportunity with a broader portfolio to have an even broader approach with respect to the footprint. Samit?

謝謝你，蒂姆。讓我回答您的第一個問題，然後我將請 Samit 向您介紹他對正在進行的 LAG-3 計劃的看法。我認為你的觀點非常重要。這是一個非常好的問題。你是對的，考慮到我們對腫瘤學的關注以及我們過去幾年所做的所有工作，我想說，我們主要關注的是發達國家。我必須說，我們在發展中國家有著有意義的存在。當我們看到——特別是當我們看到我們的腫瘤業務的發展時，我們實際上在美國和歐洲以及包括中歐和東歐以及一些關鍵市場在內的主要市場之外取得了巨大的成功。拉美。如您所知，最近 Opdivo 在中國獲得批准。因此，現在我們擁有更廣泛的產品組合和更多機會在一級市場之外建立更大的影響力，這也是準確的，我實際上非常有信心我們在那裡擁有合適的能力，並且我們擁有強大的基礎繼續進行國際投資。這是一個真正的機會，但 BMS 產品組合也已經在那裡取得了成功。因此，我們將繼續在不同地區進行投資，並且有機會通過更廣泛的投資組合對足跡採取更廣泛的方法。薩米特？

Thank you, Giovanni. I'll take on the LAG-3 question. So I think first of all, a lot has happened in terms of the drug development part in patients with melanoma. And certainly, BMS played a -- BMS has played a big role in getting the IO therapies there, with both Opdivo and Yervoy. LAG-3 is a new mechanism that we are excited about. From the early Phase I data we have seen and also from a biomarker data perspective, looking at the T-cell exhaustion and how to get the immune system going again. And from that perspective, this is going to be a very important study. The trial is currently enrolling and we're certainly seeing from the investigators perspective, they remain excited, and they continue to enroll patients in the trial. It is on track from an enrollment perspective. We continue to collect the data. We're looking towards the readout towards the end of the year.

謝謝你，喬瓦尼。我將回答 LAG-3 問題。所以我認為首先，在黑色素瘤患者的藥物開發部分發生了很多事情。當然，BMS 在提供 IO 療法（Opdivo 和 Yervoy）方面發揮了重要作用。 LAG-3 是一種令我們興奮的新機制。從我們看到的早期 I 期數據以及生物標誌物數據的角度來看，我們正在研究 T 細胞的耗竭以及如何讓免疫系統再次運轉。從這個角度來看，這將是一項非常重要的研究。該試驗目前正在招募中，我們當然從研究人員的角度看到，他們仍然很興奮，並且他們繼續招募患者參加試驗。從招生的角度來看，它正在步入正軌。我們繼續收集數據。我們期待年底的結果。

And in parallel, we continue to plan life cycle management studies in terms of looking at additional indications that you will hear about as we roll them out towards the end of the year, early next year as well.

與此同時，我們繼續計劃生命週期管理研究，以尋找更多跡象，當我們在年底和明年初推出這些研究時，您會聽到這些跡象。

The next question comes from Matt Phipps from William Blair.

下一個問題來自威廉·布萊爾的馬特·菲普斯。

First, given the current environment and potential trouble accessing infusion clinics, is there any reason to accelerate the development of a subcutaneous nivolumab? I know the trial has been going on there since 2018, looking at that.

首先，考慮到目前的環境和進入輸液診所的潛在困難，是否有理由加速皮下注射納武單抗的開發？我知道自 2018 年以來，該試驗一直在進行，正在研究這一點。

And secondly, for the TYK2 small molecule, just want to confirm if the psoriasis trials are on track to complete for mid-year or this summer and all the physician assessments will be completed. And then, a lot of formulation work ongoing according to clinicaltrials.gov and just wondering if any of that will impact potential filings in the near term if the trials are successful.

其次，對於 TYK2 小分子，只是想確認銀屑病試驗是否有望在年中或今年夏天完成，並且所有醫生評估都將完成。然後，根據 ClinicalTrials.gov 的報導，許多製定工作正在進行中，只是想知道如果試驗成功，這些工作是否會影響近期的潛在申請。

Thank you, Matt. So Samit, I think there is 2 questions on subcu, Opdivo and then the status of the TYK2 program?

謝謝你，馬特。 Samit，我認為有兩個關於 subcu、Opdivo 和 TYK2 計劃狀態的問題？

Absolutely. Thank you. So the only thing I can say about the subcu nivo, that we are currently evaluating that. It is ongoing. I think the acceleration will depend on the outcomes of the first Phase I study that we look towards the dosing and the tolerability and safety, which should be available sometime soon. And then based on that, we will continue to progress further, looking into the further development and bringing it to the patients.

絕對地。謝謝。因此，關於 subcu nivo，我唯一能說的是，我們目前正在對其進行評估。它正在進行中。我認為加速將取決於第一個一期研究的結果，我們期待劑量、耐受性和安全性，這些研究應該很快就會公佈。然後在此基礎上，我們會繼續前進，研究進一步的開發，並將其帶給患者。

For your second question around TYK2, as you recall, the Phase II data was certainly very, very promising. Phase III trials, both 046, 047 completed enrollment. So at this time, we are looking at a follow-up of these patients, collection of the data and screening activities so that we can approach the database lock. There is no reason to believe that there will be any delays. We're looking towards the end of the year for readout of the first study, 046 and first quarter of next year for 047 for the psoriasis program. So those 2 are the updates for TYK2 and subcu nivo. Back to you, Tim.

關於 TYK2 的第二個問題，正如您所記得的那樣，II 期數據肯定非常非常有希望。三期試驗，046、047均完成入組。所以此時，我們正在對這些患者進行隨訪，收集數據並進行篩選活動，以便我們能夠接近數據庫鎖定。沒有理由相信會出現任何延誤。我們預計將於今年年底公佈第一項研究 046 的銀屑病項目，並預計明年第一季度公佈 047 的銀屑病項目。這兩個是 TYK2 和 subcu nivo 的更新。回到你身邊，蒂姆。

Thanks, Samit. And I know we're starting to run close to the end of our normal time, but I think it's maybe time to squeeze in 2 more questions, Chloe. Could we go to the next one?

謝謝，薩米特。我知道我們的正常時間即將結束，但我認為也許是時候再問兩個問題了，克洛伊。我們可以去下一個嗎？

The next question comes from Steve Scala from Cowen.

下一個問題來自 Cowen 的 Steve Scala。

Your comments on the liso-cel PDUFA extension reflected no real concern whatsoever and it's 1 of the 4 new launches you called out for this year. It seems you are completely comfortable with the FDA meeting the regulatory time line. I just want to make sure that, that's the impression you wish to convey to us. And then secondly, it was stated that the COVID-19 could lead to inventory destock and a drop in patient visits to infusion centers in the second quarter as well as beyond that. I'm just curious. What was the decline in these metrics during the month of April?

您對 liso-cel PDUFA 擴展的評論並沒有反映出任何真正的擔憂，它是您今年呼籲推出的 4 個新產品之一。看來您對 FDA 遵守監管時間表完全放心。我只是想確保，這就是您希望傳達給我們的印象。其次，據稱 COVID-19 可能會導致第二季度及之後的庫存減少和輸液中心患者就診量下降。我只是好奇。 4 月份這些指標下降了多少？

Sure. Thank you, Steve. So I think we've already made comments on liso-cel. But I'll ask Samit, if there's anything he wants to add. And then David can give you a perspective about different market dynamics and how we see them impacting the business for the rest of the year.

當然。謝謝你，史蒂夫。所以我認為我們已經對 liso-cel 發表了評論。但我會問薩米特，他是否還有什麼要補充的。然後大衛可以向您介紹不同的市場動態以及我們如何看待它們對今年剩餘時間的業務的影響。

Thank you, Giovanni, and thanks, Steve, for the question. For liso-cel, what have said, that we remain confident in the data. We remain confident in the data that we submitted to the FDA. It is very normal for the FDA to, as they review the file, to ask questions. Certainly, we are looking towards the approval date now in November. During the review process, there may be many more questions that come to us, but that's a very normal process. So I think that's the way to look at it. Obviously, we cannot comment specifically on types of questions or what it relates to from a regulatory point of view. We remain confident, and we are looking forward to bringing this treatment to patients as soon as possible towards the end of this year.

謝謝喬瓦尼，也謝謝史蒂夫提出的問題。對於 liso-cel，正如我們所說的，我們對數據仍然充滿信心。我們對提交給 FDA 的數據仍然充滿信心。 FDA 在審查文件時提出問題是很正常的。當然，我們現在正在等待 11 月份的批准日期。在審核過程中，我們可能會遇到更多問題，但這是一個非常正常的過程。所以我認為這就是看待它的方式。顯然，我們無法從監管的角度具體評論問題類型或問題的相關內容。我們仍然充滿信心，期待在今年年底盡快將這種治療方法帶給患者。

Yes. And just on the question around the stocking that we saw. So as we entered the pandemic situation in February and March, and what we saw was across the -- across the board we saw safety stocks increasing, so we saw wholesalers, making sure they had increased inventory. We also saw that pharmacies had extra safety stock, and then we even saw with patients getting longer scripts, as we talked about, Revlimid was an example growing -- doubling the number of days that they could get.

是的。就我們所看到的有關襪子的問題而言。因此，當我們進入二月和三月的大流行形勢時，我們看到的是全面的——我們看到安全庫存全面增加，所以我們看到批發商確保他們增加了庫存。我們還看到藥房有額外的安全庫存，然後我們甚至看到患者獲得更長的處方，正如我們所討論的，來那度胺（Revlimid）就是一個不斷增長的例子——他們可以獲得的天數增加了一倍。

What we're -- are starting to see is some of that destocking come out. And we anticipate, as I said earlier, that the majority of that will come out in Q2. So of the $500 million that we talked about, a majority of that will come out in Q2, and then we'll see it coming out -- the remainder of that coming out in Q3 and Q4 is what we're anticipating. As far as what we're seeing on the new patient starts, it's early days, what we're seeing there. But we could see some of those newer access declining about 10% to 20% depending upon. And we'll be watching that very closely in the second quarter, and we'll update you on that. And then on the infusion center, similar that we're seeing in that 10% to 20% range as well, fewer patients. But again, that's something that we're going to keep an eye on in the second quarter as well.

我們開始看到一些去庫存的結果。正如我之前所說，我們預計其中大部分將在第二季度出現。因此，在我們談到的 5 億美元中，大部分將在第二季度發放，然後我們將看到它的發放——剩下的部分將在第三季度和第四季度發放，這就是我們的預期。就我們在新患者身上看到的情況而言，現在還處於早期階段。但我們可以看到其中一些較新的訪問量下降了約 10% 到 20%，具體取決於。我們將在第二季度密切關注這一情況，並將向您通報最新情況。然後在輸液中心，與我們在 10% 到 20% 範圍內看到的情況類似，患者數量較少。但同樣，這也是我們在第二季度也將密切關注的事情。

Chris, I don't know if there's anything that you wanted to add to that.

克里斯，我不知道你是否還有什麼要補充的。

I think you've managed to hit on the key points. The only other thing I would say is that the drop that we've seen in patient volume, and particularly in new patient starts, has varied, really, across therapeutic areas. So in the CV space, it's been sort of on the order of 20% to 25% across the OAC class, a lesser extent in oncology in the tumors that we are in. It's been on the order of 5% to 20%. And as David mentioned, that has led to some choppiness, for example, in Opdivo sales in April, which we think is attributable to the new patients -- to the drop in new patient starts. That said, we would expect that, as David had mentioned, that would -- the biggest impact for that would be in the second quarter that would begin to normalize and be back to more normal levels by the third quarter -- by the fourth quarter, and that's what we'll be continuing to monitor.

我認為你已經抓住了關鍵點。我要說的另一件事是，我們所看到的患者數量的下降，特別是新患者開始的下降，在不同的治療領域確實有所不同。因此，在 CV 領域，OAC 類別中的比例約為 20% 至 25%，而在我們所處的腫瘤學領域，比例較小。約為 5% 至 20%。正如 David 提到的，這導致了一些波動，例如 4 月份 Opdivo 的銷售情況，我們認為這歸因於新患者數量——新患者開始數量的下降。也就是說，我們預計，正如大衛所提到的，最大的影響將在第二季度開始正常化，並在第三季度之前恢復到更正常的水平，到第四季度，這就是我們將繼續監控的內容。

The next question comes from Dave Risinger from Morgan Stanley.

下一個問題來自摩根士丹利的戴夫·里辛格。

So congrats on the results and the prospects. I have 2 questions. First, could you just comment on the ozanimod opportunity in ulcerative colitis and the expected timing of Phase III top line results? And then I missed part of the call earlier, so I don't know if you discussed it, but could you also comment on Opdivo adjuvant trial readouts to watch? And maybe you could focus us on the biggest incremental commercial opportunities with respect to those adjuvant trials.

因此，對結果和前景表示祝賀。我有 2 個問題。首先，您能否評論一下 ozanimod 在潰瘍性結腸炎中的機會以及 III 期頂線結果的預期時間？然後我早些時候錯過了部分電話會議，所以我不知道你是否討論過這個問題，但你能否評論一下 Opdivo 輔助試驗的讀數？也許您可以讓我們關注與這些輔助試驗相關的最大增量商業機會。

Thank you, David. So Samit and Chris can address both of your questions.

謝謝你，大衛。所以薩米特和克里斯可以回答你的兩個問題。

Samit, if you want to start with the data on IBD and then I'll pick up on the commercial opportunity and talk about adjuvant.

Samit，如果您想從 IBD 數據開始，然後我將抓住商業機會並討論佐劑。

Sure, absolutely. And then certainly from the data that we're looking forward to for ozanimod as opposed in ulcerative colitis, we're still on track. As you know, the trial had already completed enrollment. And we're looking towards the third quarter of this year for the top line readout. Let me give it back to you for adjuvant time lines and the impact, Chris?

當然，絕對。當然，從我們期待的奧扎莫德治療潰瘍性結腸炎的數據來看，我們仍然走在正軌上。如您所知，試驗已經完成註冊。我們期待今年第三季度的營收數據。讓我把輔助時間線和影響還給你，克里斯？

So just on the commercial opportunity in IBD, what I would say to build on what Samit started with around the data is that with both ulcerative colitis and Crohn's disease, as you may know, these are chronic conditions. They require multiple treatments to manage. And in both of those disease areas, there really is a need for more efficacious drugs with a manageable safety profile.

因此，就 IBD 的商業機會而言，我想說的是，以 Samit 開始的數據為基礎，潰瘍性結腸炎和克羅恩病，正如您所知，這些都是慢性疾病。他們需要多次治療才能控制。在這兩個疾病領域，確實需要更有效且安全性可控的藥物。

In terms of how we think we could play in that space with ozanimod, in the pre-biologics space, I think there's a need for safe, convenient options with efficacy that's on the order of what you see with biologics. That's especially true in Crohn's disease, which lacks any sort of a well-established first-line treatment. And then in the post biologic space, there's really a need for safe options with a different MOA for patients as they develop immunogenicity to biologics.

就我們如何看待奧扎尼莫德在前生物製劑領域的應用而言，我認為需要安全、方便的選擇，其功效與生物製劑的功效相當。對於克羅恩病尤其如此，該病缺乏任何成熟的一線治療方法。然後在後生物製劑領域，隨著患者對生物製劑產生免疫原性，確實需要為患者提供具有不同 MOA 的安全選擇。

And as Samit alluded to, the data are still relatively young. And ultimately, the opportunity that we're going to have is going to be data dependent there. With respect to the adjuvant opportunity, as we've talked about routinely, we're excited about the adjuvant opportunity. It's a space where IO should work, given you have an intact immune system. The data that we've seen so far, both in adjuvant melanoma with Opdivo and Yervoy and some of the early data that we've seen with Opdivo in the neoadjuvant setting where we saw about a 45% pathological response rate look very encouraging. And we think it's the opportunity to have the biggest impact on patients. In terms of those commercial opportunities we've been watching out for, remember, the way to think about it commercially is not only the patients who are treated today, but much like what we saw with the introduction of IO in adjuvant melanoma. You really have an opportunity to improve the treatment rate. So you need to look at both patients who are treated today but also what's the treatment rate. So the ones to keep an eye on would be lung. Lung is an area where, in the U.S., there are about 10,000 patients treated today, but the treatment rate in adjuvant lung is only about 40%. Similarly, we're excited about the opportunities in renal cell and esophageal. Those are also potentially large opportunities. Renal, in particular, the treatment rate in adjuvant is only about 15%. And then obviously, we have ongoing programs in adjuvant melanoma as well.

正如薩米特所提到的，這些數據仍然相對較新。最終，我們將擁有的機會將依賴於數據。關於輔助機會，正如我們經常討論的那樣，我們對輔助機會感到興奮。如果你有完整的免疫系統，那麼這就是 IO 應該發揮作用的地方。到目前為止，我們看到的數據，無論是 Opdivo 和 Yervoy 輔助治療黑色素瘤的數據，還是我們在新輔助治療中使用 Opdivo 看到的一些早期數據，我們看到大約 45% 的病理緩解率，看起來非常令人鼓舞。我們認為這是對患者產生最大影響的機會。就我們一直在關注的商業機會而言，請記住，商業化的思考方式不僅是今天接受治療的患者，而且很像我們在輔助黑色素瘤中引入 IO 所看到的情況。你確實有機會提高治療率。因此，您需要查看今天接受治療的兩名患者以及治療率是多少。因此，需要關注的是肺部。在美國，目前約有 10,000 名患者接受肺部治療，但輔助肺部治療率僅為 40% 左右。同樣，我們對腎細胞和食管中的機會感到興奮。這些也是潛在的巨大機遇。特別是腎臟，輔助治療的治療率只有15%左右。顯然，我們也有針對輔助黑色素瘤的持續項目。

Other programs that are of interest would be gastric, bladder. And the nice thing about the portfolio of adjuvant programs we have is that we've got multiple approaches, and we're also looking at traditional adjuvant as well as neoadjuvant and periadjuvant. So really excited about the opportunity.

其他感興趣的項目是胃、膀胱。我們的輔助治療方案組合的好處在於，我們有多種方法，而且我們也在研究傳統輔助治療以及新輔助治療和圍輔助治療。對於這個機會我真的很興奮。

Thank you. Thanks, Chris. So thanks, everyone, for participating in the call. This was a very strong quarter. I'm very proud of our execution and the resilience of our organization. I look forward to what we will continue to achieve together.

謝謝。謝謝，克里斯。謝謝大家參與這次電話會議。這是一個非常強勁的季度。我對我們的執行力和組織的韌性感到非常自豪。我期待著我們將繼續共同取得的成就。

In closing, it is clear that the pandemic is impacting our lives. It's also shed a light on the potential we have as an industry and as a company to transform the lives of patients through science. We're focused on doing our part in continuing to deliver medicines that our patients are depending on. Thanks, everyone, and our team will continue to be available to answer the rest of your questions. Have a good day. Thank you.

最後，很明顯，這種流行病正在影響我們的生活。它還揭示了我們作為一個行業和一家公司通過科學改變患者生活的潛力。我們致力於儘自己的一份力量，繼續提供患者所依賴的藥物。謝謝大家，我們的團隊將繼續回答您的其餘問題。祝你有美好的一天。謝謝。

This concludes today's call. Thank you for your participation. You may now disconnect.

今天的電話會議到此結束。感謝您的參與。您現在可以斷開連接。