吉利德科學 (GILD) 2022 Q4 法說會逐字稿

Good afternoon. Thank you for attending today's Fourth Quarter and Full Year 2022 Gilead Sciences Earnings Conference Call. My name is Hannah, and I will be your moderator for today's call. (Operator Instructions)

下午好。感謝您參加今天的 Gilead Sciences 2022 年第四季度和全年收益電話會議。我叫漢娜，我將擔任今天電話會議的主持人。 （操作員說明）

I would now like to pass the conference over to our host, Jacquie Ross. Please go ahead.

我現在想將會議轉交給我們的主持人 Jacquie Ross。請繼續。

Thank you, operator, and good afternoon, everyone. Just after market closed today, we issued a press release with earnings results for the fourth quarter and full year 2022. The press release, slides and supplemental data are available on the Investors section of our website at gilead.com.

謝謝接線員，大家下午好。今天收市後，我們發布了一份新聞稿，其中包含第四季度和 2022 年全年的收益結果。新聞稿、幻燈片和補充數據可在我們網站 gilead.com 的投資者部分獲取。

The speakers on today's call will be our Chairman and Chief Executive Officer, Daniel O'Day; our Chief Commercial Officer, Johanna Mercier; our Chief Medical Officer, Merdad Parsey; and our Chief Financial Officer, Andrew Dickinson. After that, we'll open the call to Q&A where the team will be joined by Christi Shaw, the Chief Executive Officer of Kite.

今天電話會議的發言人將是我們的董事長兼首席執行官 Daniel O'Day；我們的首席商務官 Johanna Mercier；我們的首席醫療官 Merdad Parsey；以及我們的首席財務官 Andrew Dickinson。之後，我們將開啟問答環節，Kite 首席執行官克里斯蒂·肖 (Christi Shaw) 將加入團隊。

Before we get started, let me remind you that we will be making forward-looking statements, including those related to Gilead's business, financial condition and results of operations, plans and expectations with respect to products, product candidates, corporate strategy, business and operations, financial projections and the use of capital and 2023 financial guidance, all of which involve certain assumptions, risks and uncertainties that are beyond our control and could cause actual results to differ materially from these statements.

在我們開始之前，讓我提醒您，我們將做出前瞻性陳述，包括與 Gilead 的業務、財務狀況和運營結果、產品計劃和預期、候選產品、公司戰略、業務和運營相關的陳述、財務預測和資本使用以及 2023 年財務指導，所有這些都涉及我們無法控制的某些假設、風險和不確定性，並可能導致實際結果與這些陳述存在重大差異。

A description of these risks can be found in the earnings press release and our latest SEC disclosure documents. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.

這些風險的描述可以在收益新聞稿和我們最新的 SEC 披露文件中找到。所有前瞻性陳述均基於吉利德當前可獲得的信息，吉利德不承擔更新任何此類前瞻性陳述的義務。

Non-GAAP financial measures will be used to help you understand the company's underlying business performance. The GAAP to non-GAAP reconciliations are provided in the earnings press release, in our supplementary data sheet as well as on the Gilead website.

非 GAAP 財務指標將用於幫助您了解公司的基本業務績效。收益新聞稿、我們的補充數據表以及 Gilead 網站上提供了 GAAP 與非 GAAP 對賬。

Now I'll turn the call over to Dan.

現在我會把電話轉給丹。

Thank you, Jacquie, and good afternoon, everyone. We had the opportunity to connect with many of you a few weeks ago in San Francisco, and I'm excited to be able to reconnect now to share our strong fourth quarter and full year results for 2022 in addition to our guidance for 2023. These show the tangible impact of our business transformation, notably the growth trajectory for our HIV portfolio and our fast-growing oncology business.

謝謝你，Jacquie，大家下午好。幾週前，我們有機會在舊金山與你們中的許多人聯繫，我很高興現在能夠重新聯繫，分享我們強勁的第四季度和 2022 年全年業績以及我們對 2023 年的指導。這些顯示我們業務轉型的切實影響，特別是我們的 HIV 產品組合和我們快速增長的腫瘤業務的增長軌跡。

The team will take you through our quarterly results in detail, but I'm very pleased to highlight on Slide 4, the strongest full year growth in our base business in 2015 when growth was driven by the peak of HCV sales. Full year 2022 sales of Biktarvy grew 20% year-over-year to $10.4 billion, exceeding $10 billion for the first time. Excluding Biktarvy, our base business in 2022 grew 8% year-over-year, and I'm pleased to share that our initial 2023 guidance points to base business growth between 4% and 6%.

該團隊將帶您詳細了解我們的季度業績，但我很高興在幻燈片 4 上強調，2015 年我們的基礎業務實現了最強勁的全年增長，當時增長是由 HCV 銷售高峰推動的。 Biktarvy 2022年全年銷售額同比增長20%至104億美元，首次超過100億美元。不包括 Biktarvy，我們 2022 年的基礎業務同比增長 8%，我很高興地與大家分享，我們 2023 年的初步指導表明基礎業務增長在 4% 到 6% 之間。

Andy will share our revenue guidance in detail, but I do want to take this opportunity to recognize the Gilead teams for the progress we made in returning to growth. Thanks to their commitment to improving the health of people and communities around the world, Gilead is now poised to extend its reach to more patients and more challenging diseases and conditions than ever before.

安迪將詳細分享我們的收入指導，但我確實想藉此機會表彰吉利德團隊在恢復增長方面取得的進展。由於他們致力於改善世界各地人民和社區的健康，吉利德現在準備將其覆蓋範圍擴大到比以往任何時候都多的患者和更具挑戰性的疾病和病症。

Beyond our financial results, our clinical progress in 2022 reinforces how far we've come. At the end of the year, Sunlenca received its first approval in the U.S. for heavily treatment-experienced adults with multidrug-resistant HIV infection. This follows the European approval in the third quarter. Sunlenca is the first 6-monthly subcutaneous medicine to be approved and we believe it represents the most exciting innovation in HIV therapeutics in recent years with significant potential across prevention and treatment.

除了我們的財務業績外，我們在 2022 年的臨床進展進一步鞏固了我們取得的成就。年底，Sunlenca 在美國首次獲得批准，用於治療具有多重耐藥性 HIV 感染的大量治療經驗的成年人。這是在第三季度獲得歐洲批准之後。 Sunlenca 是第一個獲得批准的 6 個月一次的皮下注射藥物，我們相信它代表了近年來 HIV 治療領域最令人興奮的創新，在預防和治療方面具有巨大潛力。

We look forward to partnering with the HIV community to increase awareness of Sunlenca and to advancing our portfolio of long-acting options. We are anticipating another potential approval any day now with the upcoming PDUFA date for Trodelvy in pretreated HR-positive/HER2-negative metastatic breast cancer. We also expect to hear from European regulators later this year.

我們期待與 HIV 社區合作，以提高對 Sunlenca 的認識，並推進我們的長效選擇組合。隨著即將到來的 PDUFA 日期，我們預計在任何一天，Trodelvy 可能會再次獲得批准，用於治療 HR 陽性/ HER2 陰性轉移性乳腺癌。我們還希望在今年晚些時候聽到歐洲監管機構的意見。

In the meantime, Trodelvy's commercial momentum is building with full year 2022 sales growth of 79%. In cell therapy, we continue to reinforce our leadership and to execute on plans to broaden availability with Yescarta most recently approved in Japan for second-line relapsed or refractory large B-cell lymphoma.

與此同時，Trodelvy 的商業勢頭正在增強，2022 年全年銷售額將增長 79%。在細胞療法方面，我們繼續加強我們的領導地位並執行計劃以擴大 Yescarta 的可用性，最近在日本批准用於二線復發或難治性大 B 細胞淋巴瘤。

Merdad will talk you through our pipeline updates and key milestones in a few moments. For now, I'll simply note the significant expansion in our clinical programs, which have more than doubled in the last 4 years. We continue to add further programs, including our new preclinical candidate to partner with lenacapavir for our long-acting HIV treatment programs, the new Phase III Oaktree study for our novel oral COVID-19 nucleoside and the 5 Phase III trials that we expect to initiate this year.

Merdad 將在稍後向您介紹我們的管道更新和關鍵里程碑。現在，我只想指出我們臨床項目的顯著擴展，在過去 4 年中翻了一番多。我們繼續增加更多的項目，包括我們新的臨床前候選藥物，與 lenacapavir 合作開展我們的長效 HIV 治療項目，新的 III 期 Oaktree 研究，用於我們的新型口服 COVID-19 核苷，以及我們希望啟動的 5 項 III 期試驗今年。

Before I hand over to Johanna, I want to briefly review the clinical goals we shared with you a year ago. The Gilead and Kite teams have done a terrific job in both delivering as planned and acting with agility in response to changing circumstances. We had an impressive year of disciplined and determined execution in 2022 and fully expect to further strengthen our track record of execution in 2023 and beyond.

在我交給約翰娜之前，我想簡要回顧一下我們一年前與您分享的臨床目標。 Gilead 和 Kite 團隊在按計劃交付和靈活應對不斷變化的環境方面都做得非常出色。我們在 2022 年的執行紀律和堅定執行令人印象深刻，我們完全希望在 2023 年及以後進一步加強我們的執行記錄。

With that, I'll hand over to Johanna for a review of our fourth quarter and full year commercial performance. Johanna?

有了這個，我將交給約翰娜審查我們第四季度和全年的商業業績。約翰娜？

Thanks, Dan, and good afternoon, everyone. Before discussing our commercial results, I want to acknowledge our Gilead team for delivering another outstanding quarter and closing out a very successful year. 2022 was an exceptional year for Gilead, with our virology franchise well positioned to continue its leadership for years to come and significant progress in executing our oncology strategy and bringing new medicines to improve the lives of more patients all around the world.

謝謝，丹，大家下午好。在討論我們的商業業績之前，我想感謝我們的 Gilead 團隊交付了另一個出色的季度並結束了非常成功的一年。 2022 年對吉利德來說是不平凡的一年，我們的病毒學特許經營權處於有利地位，可以在未來幾年繼續保持領先地位，並在執行我們的腫瘤學戰略和帶來新藥以改善全球更多患者的生活方面取得重大進展。

Starting on Slide 7. We had a very strong quarter, delivering a total product sales, excluding Biktarvy, of $6.3 billion, up 9% year-over-year or 12% excluding the impact of FX and the loss of exclusivity of Truvada and Atripla with solid growth in each of our core franchises and growth across all geographies, once again, led by HIV and oncology. Quarter-over-quarter, sales grew 5%, driven by HIV, Trodelvy and cell therapy, partially offset by HCV.

從幻燈片 7 開始。我們有一個非常強勁的季度，產品總銷售額（不包括 Biktarvy）為 63 億美元，同比增長 9% 或 12%，不包括外彙的影響以及失去 Truvada 和 Atripla 的獨家經營權我們的每個核心特許經營權都穩步增長，並且在所有地區都取得了增長，這再次由 HIV 和腫瘤學引領。受 HIV、Trodelvy 和細胞療法的推動，銷售額環比增長 5%，部分被 HCV 抵消。

For the full year, total product sales, excluding Biktarvy, were $23.1 billion, up 8% year-over-year or 11% excluding the impact of FX and the Truvada, Atripla LOE, driven by HIV and oncology. As expected, full year Biktarvy sales were down meaningfully in 2022 compared to 2021. That said, Biktarvy's performance has been more sustainable than we previously expected and it's clear that it continues to play an essential role for hospitalized patients treated for COVID-19. In 2022, Biktarvy delivered $3.9 billion, including $1 billion in the fourth quarter. Overall, full year total product sales of $27 billion was flat compared to 2021 as growth in our base business was offset by the decline in Biktarvy sale.

全年，產品總銷售額（不包括 Biktarvy）為 231 億美元，同比增長 8%，不包括 FX 和 Truvada、Atripla LOE 的影響，受 HIV 和腫瘤學的影響，同比增長 11%。正如預期的那樣，與 2021 年相比，Biktarvy 的全年銷售額在 2022 年大幅下降。也就是說，Biktarvy 的表現比我們之前預期的更具可持續性，而且很明顯，它繼續對接受 COVID-19治療的住院患者發揮重要作用。 2022 年，Biktarvy 交付了 39 億美元，其中第四季度交付了 10 億美元。總體而言，全年產品總銷售額為 270 億美元，與 2021 年持平，因為我們基礎業務的增長被 Biktarvy 銷售額的下降所抵消。

On Slide 8, HIV sales for the fourth quarter were $4.8 billion, up 5% year-over-year, driven by higher demand as well as favorable pricing dynamics. This was offset in part by a smaller than usual inventory build in the fourth quarter, reflecting our early efforts on seasonal inventory management. Sequentially, HIV sales in the fourth quarter were up 6%, primarily driven by favorable pricing and inventory dynamics as well as higher demand. For the full year, HIV sales of $17.2 billion were up 5% year-over-year due to higher demand, primarily related to the continued strength of Biktarvy in addition to channel mix leading to higher average realized price. This was partially offset by inventory dynamics and FX.

在幻燈片 8 中，第四季度的 HIV 銷售額為 48 億美元，同比增長 5%，這得益於更高的需求和有利的定價動態。這部分被第四季度比往常少的庫存增加所抵消，反映了我們早期在季節性庫存管理方面的努力。環比而言，第四季度的 HIV 銷售額增長了 6%，這主要是受有利的定價和庫存動態以及更高的需求推動。全年，由於需求增加，HIV 銷售額為 172 億美元，同比增長 5%，這主要與 Biktarvy 的持續實力以及渠道組合導致平均實現價格上漲有關。這部分被庫存動態和外匯所抵消。

Overall, the HIV treatment market in the fourth quarter grew 1.5% year-over-year in the U.S. and over 2% in Europe. On an annual basis, the market has grown in line with our expectations of 2% to 3%.

總體而言，美國第四季度的艾滋病治療市場同比增長 1.5%，歐洲增長超過 2%。按年計算，市場增長符合我們 2% 至 3% 的預期。

Moving to prevention. The U.S. PrEP market grew 18% year-over-year and 3% sequentially in the fourth quarter of 2022, reflecting growing awareness. Descovy sales for the fourth quarter were $537 million, up 13% year-over-year and 7% sequentially. Notably, despite generics and other entrants, demand for Descovy for PrEP continues to increase, up more than 20% for the full year in addition to maintaining a stable market share of over 40%.

轉向預防。 2022 年第四季度，美國 PrEP 市場同比增長 18%，環比增長 3%，反映出人們的意識不斷增強。 Descovy 第四季度銷售額為 5.37 億美元，同比增長 13%，環比增長 7%。值得注意的是，儘管有仿製藥和其他進入者，但對用於 PrEP 的 Descovy 的需求持續增長，全年增長超過 20%，此外還保持了超過 40% 的穩定市場份額。

With these trends and the TAF IP settlement last year, Descovy position in the growing PrEP market has only strengthened. Overall, this provides a strong foundation as we look to the potential launch of lenacapavir for PrEP as a true long-acting every 6-month regimen in the middle part of the decade.

隨著這些趨勢和去年的 TAF IP 和解，Descovy 在不斷增長的 PrEP 市場中的地位只會得到加強。總的來說，這提供了一個堅實的基礎，因為我們期待在本世紀中期推出用於 PrEP 的來那卡韋作為真正的長效每 6 個月一次的治療方案。

Moving to Trodelvy on Slide 9. Sales for the quarter were $2.9 billion, up 15% year-over-year, primarily driven by higher demand as well as favorable pricing dynamics offset in part by lower channel inventory. Quarter-over-quarter, sales were up 6% similarly driven by higher demand as well as favorable pricing and inventory dynamics. In every quarter since our launch, we've seen Biktarvy continue to gain market share, and the fourth quarter was no exception, getting more than 3 percentage points in share year-over-year.

轉到幻燈片 9 上的 Trodelvy。本季度的銷售額為 29 億美元，同比增長 15%，這主要是由於需求增加以及有利的定價動態部分被較低的渠道庫存所抵消。銷售額環比增長 6%，同樣受到需求增加以及有利的定價和庫存動態的推動。自推出以來的每個季度，我們都看到 Biktarvy 繼續獲得市場份額，第四季度也不例外，份額同比增長超過 3 個百分點。

This continued momentum is a testament to the Biktarvy's differentiated clinical profile, reinforced by the long-term 5-year data we presented last year. Notably, in the U.S., Europe and other major markets, Biktarvy remains the #1 regimen for new starts, in addition to its #1 position in treatment switches across most of the major markets, including the U.S. At the end of 2022, there are almost 1 million people managing their HIV with Biktarvy worldwide.

這種持續的勢頭證明了 Biktarvy 的差異化臨床特徵，我們去年提供的長期 5 年數據進一步證實了這一點。值得注意的是，在美國、歐洲和其他主要市場，除了在包括美國在內的大多數主要市場的治療轉換中排名第一之外，Biktarvy 仍然是新開始治療方案的第一名。到 2022 年底，還有全世界有近 100 萬人使用 Biktarvy 控制他們的 HIV。

Taken all together, this has led Biktarvy for the first time to achieve full year sales of over $10 billion in 2022. Looking ahead, we're confident that Biktarvy will remain the leading medicine for the treatment of HIV in the U.S., Europe and other major markets for years to come.

總而言之，這使得 Biktarvy 在 2022 年首次實現全年銷售額超過 100 億美元。展望未來，我們相信 Biktarvy 仍將是美國、歐洲和其他國家治療 HIV 的領先藥物。未來幾年的主要市場。

Now looking ahead for the first quarter of 2023 for HIV, a few points I just wanted to call out. First, with respect to pricing dynamics, as we enter the new year, we expect the typical first quarter reset in patient co-pay and deductible. As always, these will have an unfavorable impact on average realized price in the first quarter. Second, a reminder that we've historically seen inventory buildup in Q4 that has led to notable drawdown by wholesalers in Q1. While we've implemented new processes to better manage inventory dynamics from the fourth quarter into the first quarter, we continue to expect an inventory drawdown to occur in Q1, albeit at more modest levels compared to prior year.

現在展望 2023 年第一季度的 HIV，我只想指出幾點。首先，關於定價動態，隨著我們進入新的一年，我們預計患者共付額和免賠額將在第一季度進行典型的重置。一如既往，這些將對第一季度的平均實現價格產生不利影響。其次，提醒我們，從歷史上看，第四季度的庫存增加導致批發商在第一季度顯著減少。雖然我們實施了新流程以更好地管理從第四季度到第一季度的庫存動態，但我們仍然預計第一季度會出現庫存縮減，儘管與去年同期相比水平較低。

So with this in mind, we expect HIV sales for the first quarter to decline by low teens sequentially from the fourth quarter. This compares to the 18% sequential decline we reported in the first quarter of 2022.

因此，考慮到這一點，我們預計第一季度的 HIV 銷售額將從第四季度開始連續下降十幾位。相比之下，我們在 2022 年第一季度報告了 18% 的連續下降。

For the full year 2023, I'd like to remind you that some of our HIV performance in '22 was driven by shift in channel mix that had a favorable impact on average realized price, contributing in part to the 5% year-over-year revenue growth we reported in 2022.

對於 2023 年全年，我想提醒您，我們在 22 年的一些 HIV 表現是由渠道組合的轉變推動的，這對平均實現價格產生了有利影響，部分原因是同比增長 5%我們在 2022 年報告的年度收入增長。

We expect channel mix in 2023 to be relatively similar to last year, and therefore, do not expect HIV growth to benefit from changes in average realized price like we saw in 2022. As a result, we continue to expect HIV to grow in 2023, albeit at a modestly lower growth rate than 2022.

我們預計 2023 年的渠道組合將與去年相對相似，因此預計 HIV 增長不會像我們在 2022 年看到的那樣受益於平均實現價格的變化。因此，我們繼續預計 HIV 將在 2023 年增長，儘管增長率略低於 2022 年。

As we think about the future of the HIV market, Gilead is well positioned to provide many people living with HIV and those at risk of HIV with multiple options for care. To that end, we're excited about the recent approvals for Sunlenca in the U.S. and Europe for heavily treatment-experienced adults with multidrug-resistant HIV infection. This first indication represents only 1% to 2% of people living with HIV, there's a huge unmet medical need. These individuals have cycled through multiple antiretroviral regimen and until now have had very few, if any, effective options left available. Sunlenca is now approved in the U.S., U.K. and European markets, and we're working as quickly as possible with regulators and reimbursement bodies to make Sunlenca available in many more countries.

當我們思考 HIV 市場的未來時，吉利德（Gilead）處於有利地位，可以為許多 HIV 感染者和有感染 HIV 風險的人提供多種護理選擇。為此，我們對 Sunlenca 最近在美國和歐洲獲批用於治療具有多重耐藥性 HIV 感染的大量治療經驗的成年人感到興奮。這第一個跡象僅代表 1% 到 2% 的艾滋病病毒感染者，存在巨大的未滿足的醫療需求。這些人已經經歷了多種抗逆轉錄病毒療法的循環，直到現在，幾乎沒有（如果有的話）有效的選擇可供選擇。 Sunlenca 現已在美國、英國和歐洲市場獲得批准，我們正在盡快與監管機構和報銷機構合作，讓 Sunlenca 在更多國家上市。

We believe this first launch of Sunlenca represents a key milestone for Gilead and looking forward in the treatment and potential prevention of HIV. With Sunlenca, a true long-acting regimen is a reality. As awareness and familiarity of Sunlenca's every 6-months subcutaneous administration grow among health care providers, community groups and people living with and at risk of HIV, we believe Sunlenca is well positioned for the future.

我們相信 Sunlenca 的首次推出代表了吉利德（Gilead）的一個重要里程碑，並展望了治療和潛在預防 HIV 的前景。使用 Sunlenca，真正的長效養生法成為現實。隨著醫療保健提供者、社區團體以及艾滋病毒感染者和有感染風險的人對 Sunlenca 每 6 個月皮下給藥的認識和熟悉程度的提高，我們相信 Sunlenca 為未來做好了準備。

Turning to HCV on Slide 10. Sales for the fourth quarter were $439 million, up 12% year-over-year, reflecting timing of Department of Corrections or DOC purchases and favorable pricing dynamics in the U.S.

轉到幻燈片 10 上的 HCV。第四季度銷售額為 4.39 億美元，同比增長 12%，反映了美國懲教部或 DOC 採購的時機以及有利的定價動態。

Quarter-over-quarter, HCV sales were down 16%, primarily due to resolution of a rebate claim in Europe in the third quarter of 2022 that did not repeat as well as other pricing dynamics in the U.S., offset in part by timing of DOC purchases.

HCV 銷售額環比下降 16%，這主要是由於 2022 年第三季度歐洲的一項退稅申請得到解決，但美國的其他定價動態並未重複，部分被 DOC 的時間抵消購買。

Going forward, we continue to expect new starts to decline, but are encouraged that our market share remains over 50% in both U.S. and Europe.

展望未來，我們繼續預計新開工量會下降，但我們對我們在美國和歐洲的市場份額仍超過 50% 感到鼓舞。

Sales of HPV and HDV for the fourth quarter were $255 million, as shown on Slide 11. Sales were down 4% year-over-year and down 3% sequentially, primarily due to lower Vemlidy demand and pricing dynamics outside of the U.S.

如幻燈片 11 所示，第四季度 HPV 和 HDV 的銷售額為 2.55 億美元。銷售額同比下降 4%，環比下降 3%，這主要是由於 Vemlidy 需求下降和美國以外的定價動態。

Moving to Biktarvy on Slide 12. Sales for the fourth quarter were $1 billion with a full year totaling $3.9 billion. It's clear that as the pandemic has evolved, Biktarvy's will in the treatment of COVID-19 has remained unchanged as a key part of the standard of care for hospitalized patients. In fact, Biktarvy is still the only antiviral approved in this setting. And in the U.S., Biktarvy continues to be used in over 50% of hospitalized patients who are being treated for COVID-19. We're excited to continue to work on our oral COVID-19 nucleoside, which Merdad will discuss shortly.

轉到幻燈片 12 上的 Biktarvy。第四季度銷售額為 10 億美元，全年總銷售額為 39 億美元。很明顯，隨著大流行的發展，Biktarvy 在治療 COVID-19 方面的意願保持不變，作為住院患者護理標準的關鍵部分。事實上，Biktarvy 仍然是唯一在這種情況下獲得批准的抗病毒藥物。在美國，超過 50% 的 COVID-19 住院患者繼續使用 Biktarvy。我們很高興繼續研究我們的口服 COVID-19核苷，Merdad 將很快討論。

Moving to oncology and beginning with Trodelvy Slide 13. Sales of $195 million in the fourth quarter grew 65% year-over-year and 8% sequentially. For the full year, Trodelvy sales were $680 million, up 79% year-over-year. As we continue to broaden access to Trodelvy around the world, we're encouraged by the growing demand in existing markets. Trodelvy is now reimbursed across the major European markets. And in the U.S., demand was up 13% quarter-over-quarter. Our growth rate almost doubled from the prior quarter, reflecting the solid contribution of our expanded field force and growing awareness.

轉到腫瘤學，從 Trodelvy Slide 13 開始。第四季度的銷售額為 1.95 億美元，同比增長 65%，環比增長 8%。全年，Trodelvy 的銷售額為 6.8 億美元，同比增長 79%。隨著我們繼續在全球範圍內擴大對 Trodelvy 的訪問，我們對現有市場不斷增長的需求感到鼓舞。 Trodelvy 現已在歐洲主要市場獲得報銷。在美國，需求環比增長 13%。我們的增長率幾乎比上一季度翻了一番，這反映了我們擴大的現場人員和不斷提高的意識的堅實貢獻。

We're also excited by the expected decision from the FDA later this month, which could expand Trodelvy's potentially clinically meaningful benefit into the pretreated HR-positive/HER2-negative metastatic breast cancer setting. We estimate this represents at least 6,000 addressable patients in the U.S., and our U.S. field force has just wrapped up its launch meeting and is energized for the upcoming approval.

我們也對 FDA 本月晚些時候的預期決定感到興奮，這可能會將 Trodelvy 的潛在臨床意義的益處擴展到預處理的 HR 陽性/ HER2 陰性轉移性乳腺癌環境中。我們估計這代表美國至少有 6,000 名可尋址患者，我們的美國現場工作人員剛剛結束了啟動會議，並為即將到來的批准充滿活力。

The opportunity for Trodelvy to benefit patients with pretreated HR-positive/HER2-negative metastatic disease is supported by the recent NCCN Category 1 preferred recommendation for Trodelvy based on the TROPiCS-02 data. Additionally, the European Medicines Agency recently validated our marketing authorization application for Trodelvy in HR-positive/HER2-negative and we look forward to a decision later this year.

最近基於 TROPiCS-02 數據對 Trodelvy 的 NCCN 第 1 類首選推薦支持了 Trodelvy 使接受過治療的 HR 陽性/ HER2 陰性轉移性疾病患者受益的機會。此外，歐洲藥品管理局最近驗證了我們針對 HR 陽性/ HER2 陰性的 Trodelvy 的上市許可申請，我們期待今年晚些時候做出決定。

Now on to Slide 14 and on behalf of Christi and the Kite team, cell therapy sales in the fourth quarter were $419 million, up 75% year-over-year and 5% sequentially. Full year, cell therapy sales were $1.5 billion, up 68% year-over-year. The growth in the fourth quarter and full year were driven by continued uptake of Yescarta in large B-cell lymphoma, notably in the U.S. Growing physician familiarity with Yescarta data and Kite's industry-leading manufacturing continue to be key growth drivers. Yescarta sales was $337 million, up 85% compared to the fourth quarter of 2021 and 6% sequentially.

現在轉到幻燈片 14，代表 Christi 和 Kite 團隊，第四季度細胞療法銷售額為 4.19 億美元，同比增長 75%，環比增長 5%。全年，細胞療法銷售額為 15 億美元，同比增長 68%。第四季度和全年的增長是由 Yescarta 在大 B 細胞淋巴瘤中的持續吸收推動的，特別是在美國。越來越多的醫生對 Yescarta 數據的熟悉和 Kite 行業領先的製造繼續成為主要的增長動力。 Yescarta 的銷售額為 3.37 億美元，與 2021 年第四季度相比增長 85%，環比增長 6%。

We're pleased to see not only strong momentum in second-line LBCL in the U.S. but also continued uptake in third-line LBCL in both the U.S. and across European markets. Yescarta sales were $82 million in the fourth quarter, up 2% quarter-over-quarter with growing volume demand in both mantle cell lymphoma and adult acute lymphoblastic leukemia. Year-over-year, Yescarta sales were up 44%.

我們很高興不僅看到美國二線 LBCL 的強勁勢頭，而且美國和整個歐洲市場的三線 LBCL 也持續增長。 Yescarta 第四季度銷售額為 8200 萬美元，環比增長 2%，原因是套細胞淋巴瘤和成人急性淋巴細胞白血病的需求量不斷增長。 Yescarta 銷售額同比增長 44%。

We're pleased to see the building momentum of CAR T cell therapy as a treatment class with curative potential and Yescarta and Tecartus as the leading cell therapies of choice globally. More patients are getting access due to Kite's industry-leading reliable manufacturing capabilities and the team's expanding footprint of authorized treatment centers around the world.

我們很高興看到 CAR T 細胞療法作為具有治愈潛力的治療類別的發展勢頭，以及 Yescarta 和 Tecartus 成為全球領先的細胞療法選擇。由於 Kite 行業領先的可靠製造能力以及該團隊在全球範圍內不斷擴大的授權治療中心足跡，越來越多的患者獲得了治療。

And just last week, U.K.'s National Institute for Health and Care Excellence, or NICE, recommended Yescarta for routine use in third-line large B-cell lymphoma. This makes Yescarta the first CAR T available for commissioning in England. Approvals and reimbursement into additional indications that are currently available in the U.S., the other markets is expected to continue over the next year.

就在上週，英國國家健康與護理卓越研究所 (NICE) 推薦 Yescarta 常規用於三線大 B 細胞淋巴瘤治療。這使得 Yescarta 成為第一個可在英國投入使用的 CAR T。批准和報銷目前在美國可用的其他適應症，其他市場預計將在明年繼續。

Yescarta was recently approved for second-line LBCL in Japan, which has the potential to be the second largest cell therapy market outside of the U.S., and we look forward to the transfer of the marketing authorization to Gilead and Kite later this year.

Yescarta 最近在日本獲准用於二線 LBCL，日本有潛力成為美國以外的第二大細胞治療市場，我們期待今年晚些時候將營銷授權轉移給 Gilead 和 Kite。

In the interim, although it's still early days, we'll continue to work with our partner, Daiichi Sankyo, to make Yescarta available to approximately 7,000 patients in the second-line plus setting. Kite will begin manufacturing supply for the Japanese market through our El Segundo, California facility.

在此期間，雖然現在還處於早期階段，但我們將繼續與我們的合作夥伴 Daiichi Sankyo 合作，使 Yescarta 可供大約 7,000 名二線以上患者使用。 Kite 將開始通過我們位於加利福尼亞州埃爾塞貢多的工廠為日本市場製造供應。

And with that, I'll hand the call over to Merdad for an update on our pipeline. Merdad?

有了這個，我會把電話轉給 Merdad 來更新我們的管道。梅爾達？

Thanks, Johanna. I'm pleased to be starting 2023 with all the momentum in 2022 behind us. With the positive data readouts for Trodelvy and domvanalimab and the recent approvals for lenacapavir, the team is really excited to progress our programs in 2023 and beyond.

謝謝，約翰娜。我很高興以 2022 年的所有勢頭開始 2023 年。隨著 Trodelvy 和 domvanalimab 的積極數據讀數以及最近對 lenacapavir 的批准，團隊非常高興能夠在 2023 年及以後推進我們的計劃。

Starting with virology on Slide 16 and as I just mentioned, lenacapavir received its first U.S. FDA approval for people living with multidrug-resistant HIV in combination with other antiretrovirals. Marketed as Sunlenca, lenacapavir is the first and only twice yearly subcutaneous HIV treatment, bringing a much needed option for people living with multidrug-resistant HIV that until now have limited alternatives.

從幻燈片 16 的病毒學開始，正如我剛才提到的，lenacapavir 與其他抗逆轉錄病毒藥物聯合使用，首次獲得美國 FDA 批准用於治療多重耐藥 HIV 感染者。 lenacapavir 以 Sunlenca 的名義銷售，是第一個也是唯一一個每年兩次的皮下 HIV 治療藥物，為迄今為止替代品有限的多重耐藥 HIV 感染者提供了急需的選擇。

Combined with the approval from the European Commission, the FDA approval is an important validation while we continue to progress our other lenacapavir-based treatment and prevention programs. For HIV treatment, we currently have 10 partner agents for lenacapavir in various stages of development, including 2 new integrase inhibitors or INSTIs in the pre-IND space. We expect to share data this year from the Phase Ib proof-of-concept study for lenacapavir in 2 broadly neutralizing antibodies, or bnAbs, directed at HIV. And in PrEP, our clinical development of lenacapavir as a monotherapy for HIV prevention continues to progress with 2 trials underway and 2 additional trials expected to achieve FPI in the second half of 2023.

結合歐盟委員會的批准，FDA 的批准是一個重要的驗證，同時我們繼續推進我們其他基於 lenacapavir 的治療和預防計劃。對於 HIV 治療，我們目前有 10 種處於不同開發階段的 lenacapavir 合作夥伴藥物，包括 2 種新的整合酶抑製劑或處於 pre-IND 領域的 INSTI。我們預計今年將分享 lenacapavir 在 2 種針對 HIV 的廣泛中和抗體 (bnAb) 中的 Ib 期概念驗證研究的數據。在 PrEP 中，我們的 lenacapavir 作為 HIV 預防單一療法的臨床開發繼續取得進展，正在進行 2 項試驗，另外 2 項試驗預計將在 2023 年下半年實現 FPI。

Moving to Slide 17. We continue to progress our novel oral nucleoside for COVID-19 GS-5245. Treatments such as Gilead Biktarvy and vaccinations have improved the outlook for patients with COVID-19, but there's still a significant need for effective and convenient oral treatment options.

轉到幻燈片 17。我們繼續開髮用於 COVID-19 GS-5245 的新型口服核苷。 Gilead Biktarvy 和疫苗接種等治療方法改善了 COVID-19 患者的前景，但仍然迫切需要有效且方便的口服治療方案。

We've been working with the FDA and other global regulators to launch a clinical development program that could enable global filings. We've initiated the Phase II BIRCH trial in high-risk patients, defined as unvaccinated patients with 1 or more risk factors, or vaccinated patients with 2 or more risk factors. The Phase III Oaktree trial will evaluate standard risk patients, which includes people aged 12 and older with no CDC-defined risk factors. We expect this trial to enroll its first patient in the U.S. in the first quarter, and we'll share progress when we can, which depends in part on the prevalence of COVID-19 near study sites.

我們一直在與 FDA 和其他全球監管機構合作，啟動一項可以實現全球申報的臨床開發計劃。我們已經在高危患者中啟動了 II 期 BIRCH 試驗，高危患者定義為具有 1 個或多個風險因素的未接種疫苗的患者，或具有 2 個或更多風險因素的已接種疫苗的患者。 III 期 Oaktree 試驗將評估標準風險患者，其中包括沒有 CDC 定義的風險因素的 12 歲及以上人群。我們預計該試驗將在第一季度在美國招募第一名患者，我們將盡可能分享進展情況，這在一定程度上取決於研究地點附近 COVID-19 的流行情況。

Moving to oncology on Slide 18 and starting with Trodelvy. We continue to build on the momentum of our TROPICS-02 data, and we announced the European Medicine Agency's validation of our marketing authorization application for pretreated HR-positive/HER2-negative metastatic breast cancer in early January. As Johanna noted, we expect a regulatory decision of our sBLA in the U.S. later this month, and a decision in Europe in the latter part of the year. Trodelvy has already changed the standard of care for many patients with metastatic TNBC and advanced bladder cancer. And we expect that these regulatory approvals will be an important step forward in bringing this potentially practice-changing therapy to certain HR-positive/HER2-negative metastatic breast cancer patients.

轉到幻燈片 18 上的腫瘤學，從 Trodelvy 開始。我們繼續鞏固 TROPICS-02 數據的勢頭，並於 1 月初宣佈歐洲藥品管理局批准了我們針對預處理的 HR 陽性/ HER2 陰性轉移性乳腺癌的上市許可申請。正如 Johanna 指出的那樣，我們預計本月晚些時候我們的 sBLA 將在美國做出監管決定，並在今年下半年在歐洲做出決定。 Trodelvy 已經改變了許多轉移性 TNBC 和晚期膀胱癌患者的護理標準。我們預計，這些監管批准將是將這種可能改變實踐的療法用於某些 HR 陽性/ HER2 陰性轉移性乳腺癌患者的重要一步。

Moreover, recently presented data demonstrated Trodelvy's PFS and OS benefit was consistent across a range of tumor Trop-2 expression levels. This late-breaking post-hoc analysis presented at the San Antonio Breast Cancer Symposium was consistent with Trodelvy data in metastatic triple-negative breast cancer, where baseline Trop-2 expression was not associated with treatment response.

此外，最近提供的數據表明，Trodelvy 的 PFS 和 OS 益處在一系列腫瘤 Trop-2 表達水平上是一致的。在聖安東尼奧乳腺癌研討會上發表的這項最新的事後分析與轉移性三陰性乳腺癌的 Trodelvy 數據一致，其中基線 Trop-2 表達與治療反應無關。

Moving on to Slide 19. We were pleased to share data from the fourth interim analysis of the ARC-7 trial with our partner, Arcus, in December as presented at the ASCO plenary session. ARC-7 is a randomized Phase II proof-of-concept study that enrolled 150 patients, the largest data set in anti-TIGIT studies released to date with more than 100 patients across the 2 dom containing arms. We are pleased to see both dom containing arms demonstrate clinically meaningful differentiation compared to Zim monotherapy across all efficacy measures evaluated, clearly establishing the addition of dombinilumab improved the clinical responses to anti-PD-1 therapy in this population.

轉到幻燈片 19。我們很高興與我們的合作夥伴 Arcus 分享 ARC-7 試驗的第四次中期分析的數據，該數據於 12 月在 ASCO 全體會議上展示。 ARC-7 是一項隨機的 II 期概念驗證研究，招募了 150 名患者，這是迄今為止發布的抗 TIGIT 研究中最大的數據集，在包含 2 個 dom 的臂中有 100 多名患者。我們很高興地看到，在所有評估的療效指標中，與 Zim 單一療法相比，兩個包含 dom 的臂都顯示出具有臨床意義的差異，清楚地表明添加 dombinilumab 改善了該人群對抗 PD-1 療法的臨床反應。

We are also encouraged by the consistency of the safety data in the dom-containing treatment arms which showed no unexpected safety signals. This is an ongoing trial, and we look forward to sharing updated data at ASCO 2023. While these efficacy and safety data will mature over time, this fourth interim analysis fully supports our joint dom's clinical development program and the importance of interrupting the TIGIT pathway.

我們也對包含 dom 的治療臂中安全數據的一致性感到鼓舞，這些臂沒有顯示出意外的安全信號。這是一項正在進行的試驗，我們期待在 ASCO 2023 上分享更新數據。雖然這些療效和安全性數據將隨著時間的推移而成熟，但第四次中期分析完全支持我們聯合 dom 的臨床開發計劃和中斷 TIGIT 通路的重要性。

Based on the totality of the data seen to date, we're very confident that dom with an Fc silent design has the potential to be differentiated compared to other anti-TIGIT molecules in this space. The ongoing Phase III trials of dom added to anti-PD-1 treatment in non-small cell lung cancer will provide the opportunity to confirm this activity. We're moving very quickly with our partners in both proof-of-concept studies as well as late-stage trials, including the 4 ongoing Phase III trials.

基於迄今為止看到的全部數據，我們非常有信心具有 Fc 沉默設計的 dom 與該領域中的其他抗 TIGIT 分子相比具有差異化的潛力。正在進行的將 dom 添加到非小細胞肺癌的抗 PD-1 治療的 III 期試驗將提供確認該活性的機會。我們正在與我們的合作夥伴一起快速推進概念驗證研究和後期試驗，包括正在進行的 4 項 III 期試驗。

Moving to magrolimab, our anti-CD47 therapeutic on Slide 20. We have 3 ongoing pivotal trials and 6 proof-of-concept studies across 6 solid tumor indications. As we shared last month, the independent data monitoring committee met to review data from the first interim analysis from the ENHANCE study in first-line high-risk MDS. I'm pleased to share that there were no new safety signals, and the study continues unchanged.

轉到 magrolimab，我們在幻燈片 20 上的抗 CD47 療法。我們有 3 項正在進行的關鍵試驗和 6 項概念驗證研究，涉及 6 種實體瘤適應症。正如我們上個月分享的那樣，獨立數據監測委員會開會審查了來自一線高風險 MDS ENHANCE 研究的第一次中期分析的數據。我很高興地告訴大家，沒有新的安全信號，而且研究繼續保持不變。

As a reminder, based on previous discussions with the FDA, we are now pursuing mature OS data for filing. The study is powered for the final OS analysis and Gilead remains blinded to the data to preserve study integrity. We will update you again in the second half of 2023 after the second interim analysis, noting that these interim analyses are event-driven, so timing is provisional.

提醒一下，根據之前與 FDA 的討論，我們現在正在尋求成熟的 OS 數據進行備案。該研究為最終的 OS 分析提供了動力，吉利德（Gilead）仍然對數據不知情，以保持研究的完整性。我們將在第二次中期分析後於 2023 年下半年再次向您更新，請注意這些中期分析是事件驅動的，因此時間是臨時的。

Moving on to Slide 21. And on behalf of Christi and the Kite team, I'm pleased to share details of another strong quarter of clinical progress in our cell therapy programs. At ASH, Kite had more than 25 data presentations, further demonstrating the transformative impact of cell therapies, including 3-year follow-up data from ZUMA-5, showing that 52% of patients with indolent lymphomas treated with Yescarta continue to respond.

轉到幻燈片 21。我很高興代表 Christi 和 Kite 團隊分享我們細胞治療計劃中另一個強勁臨床進展季度的詳細信息。在 ASH 上，Kite 展示了超過 25 個數據，進一步證明了細胞療法的變革性影響，包括來自 ZUMA-5 的 3 年隨訪數據，顯示 52% 的惰性淋巴瘤患者接受 Yescarta 治療後繼續有反應。

Following the compelling ZUMA-12 data on Yescarta in frontline LBCL shared at ASH in 2021, we expect to achieve FPI in our Phase III ZUMA-23 trial in frontline high-risk LBCL in the first half of the year. We are also progressing our Phase II ZUMA-24 outpatient study in second-line LBCL and look forward to sharing interim safety data in the first half of this year. While there is still so much we can explore with the Yescarta and Tecartus, we are also building up the pipeline to ensure that Kite will extend its leadership into new indications and next-generation cell therapy technologies.

繼 2021 年在 ASH 上分享關於 Yescarta 一線 LBCL 的令人信服的 ZUMA-12數據之後，我們預計將在今年上半年在一線高風險 LBCL 的 III 期 ZUMA-23 試驗中實現 FPI 。我們還在推進二線 LBCL 的 II 期 ZUMA-24 門診研究，並期待在今年上半年分享中期安全數據。雖然我們可以通過 Yescarta 和 Tectartus 探索很多東西，但我們也在建立管道，以確保 Kite 將其領導地位擴展到新的適應症和下一代細胞治療技術。

In December, we announced a strategic collaboration with Arcellx for the late-stage clinical product candidate, CART-ddBCMA, which is currently being evaluated for the treatment of multiple myeloma. If approved, together with our industry-leading manufacturing capabilities, we believe we can reliably and consistently deliver much needed therapy to patients.

去年 12 月，我們宣布與 Arcellx 就後期臨床候選產品 CART-ddBCMA 進行戰略合作，該產品目前正在接受治療多發性骨髓瘤的評估。如果獲得批准，再加上我們行業領先的製造能力，我們相信我們能夠可靠且始終如一地為患者提供急需的治療。

Additionally, we announced the pending acquisition of Tmunity Therapeutics, which adds an armored CAR T platform and rapid manufacturing technology to Kite. The Arcellx transaction closed earlier this week, and Tmunity is expected to close later this quarter. Both highlight Kite's continued leadership in cell therapy and our commitment to building a robust and exciting pipeline in cell therapies.

此外，我們還宣布了對 Tmunity Therapeutics 的未決收購，後者為 Kite 添加了裝甲 CAR T 平台和快速製造技術。 Arcellx 交易於本週早些時候結束，Tmunity 預計將在本季度晚些時候結束。兩者都突出了 Kite 在細胞治療領域的持續領導地位以及我們致力於在細胞治療領域建立強大而令人興奮的管道。

Wrapping up on Slide 22. We are sharing the key pipeline milestones that we expect in 2023, which, as you can see, spans FPIs, data readouts, updates and regulatory approvals across oncology and urology. This highlights the progress that Gilead has made on its transformation journey with 59 clinical programs that are well diversified across indications and stage. As the clinical pipeline has grown, our focus on execution has intensified, and we look forward to updating you on our programs as we progress through 2023.

在幻燈片 22 上結束。我們正在分享我們預計在 2023 年的關鍵管道里程碑，如您所見，跨越腫瘤學和泌尿學的 FPI、數據讀出、更新和監管批准。這凸顯了吉利德在其轉型過程中取得的進展，59 個臨床項目在適應症和階段上非常多樣化。隨著臨床管道的發展，我們更加註重執行，我們期待著在 2023 年取得進展時向您更新我們的計劃。

With that, I'll hand the call over to Andy. Andy?

有了這個，我會把電話交給安迪。安迪？

Thank you, Merdad, and good afternoon, everyone. Gilead closed out the year with a strong fourth quarter, driven by Biktarvy, Veklury and oncology. For the full year, our sales, excluding Veklury, grew 8%, which is by far the strongest full year growth rate Gilead has reported since HCV sales peaked in 2015. Of note, and excluding the impact of the Atripla and Truvada LOEs, HIV grew 8% year-over-year, driven by continued strong performance of Biktarvy, which grew 20% from 2021 to $10.4 billion. Biktarvy continues to demonstrate strong potential for further growth in 2023 and beyond. Oncology full year revenues exceeded $2 billion for the first time and grew 71% from 2021.

謝謝 Merdad，大家下午好。吉利德（Gilead）在 Biktarvy 、 Veklury 和腫瘤學的推動下，以強勁的第四季度結束了這一年。全年，我們的銷售額（不包括 Veklury）增長了 8%，這是迄今為止 Gilead 自 2015 年 HCV 銷售額達到頂峰以來報告的最強勁的全年增長率。值得注意的是，不包括 Atripla 和 Truvada LOE、HIV 的影響在 Biktarvy 持續強勁表現的推動下，同比增長 8%，比 2021 年增長 20% 至 104 億美元。 Biktarvy 繼續展示出在 2023 年及以後進一步增長的強大潛力。腫瘤學全年收入首次超過 20 億美元，比 2021 年增長 71%。

Moving to our quarterly results starting on Slide 24. The fourth quarter demonstrated another strong performance across our business. Total product sales, excluding Veklury, grew 9% year-over-year despite an approximately $130 million headwind from FX. If we exclude FX in addition to the impact of HIV LOEs, total underlying sales growth for the fourth quarter was 12% compared with the prior year.

轉到我們從幻燈片 24 開始的季度業績。第四季度展示了我們業務的另一個強勁表現。儘管外匯帶來了約 1.3 億美元的逆風，但不包括 Veklury 在內的產品總銷售額同比增長了 9%。如果除 HIV LOE 的影響外，我們還排除外匯，則第四季度的基礎銷售總額與去年同期相比增長了 12%。

Moving to Slide 25. Veklury was down, as expected, year-over-year although it grew 8% on a sequential basis from the third quarter, highlighting that Veklury will continue to play an important role even as COVID-19 progresses into its endemic phase.

轉到幻燈片 25。正如預期的那樣，Veklury 同比下降，儘管它從第三季度開始環比增長 8%，這表明即使 COVID-19 進入流行期，Veklury 仍將繼續發揮重要作用階段。

Non-GAAP product gross margin was 86.8%, up more than 16 percentage points from last year, primarily due to a $1.25 billion charge related to a legal settlement recorded in COGS in the fourth quarter of 2021.

非 GAAP 產品毛利率為 86.8%，比去年增長超過 16 個百分點，這主要是由於與 2021 年第四季度 COGS 中記錄的法律和解相關的 12.5 億美元費用。

Non-GAAP R&D expenses for the fourth quarter 2022 were $1.5 billion compared to $1.3 billion in the same period in 2021. Higher R&D expenses were driven by timing of clinical investments, mainly in oncology in addition to the impact of inflation on expenses.

2022 年第四季度的非 GAAP 研發費用為 15 億美元，而 2021 年同期為 13 億美元。研發費用增加的原因是臨床投資的時機，主要是腫瘤學投資，以及通貨膨脹對費用的影響。

Fourth quarter acquired IP R&D was $158 million, primarily reflecting the MacroGenics collaboration and the license amendment with Jounce. And lower than prior year due to the $625 million charge related to the exercise of opt-in rights for Arcus assets in the fourth quarter of 2021.

第四季度收購的知識產權研發為 1.58 億美元，主要反映了 MacroGenics 的合作以及與 Jounce 的許可修訂。由於與 2021 年第四季度行使 Arcus 資產的選擇加入權相關的 6.25 億美元費用低於上年同期。

Non-GAAP SG&A was $2 billion, up 23% year-over-year, primarily reflecting a charge of $406 million associated with the termination of the Trodelvy collaboration with Everest Medicines. This $406 million charge includes the $280 million that we agreed to pay Everest to acquire the development and commercial rights to Trodelvy in China and other Asian territories in addition to some other termination-related expenses. Excluding this Everest impact, SG&A was down 2% year-over-year.

非 GAAP SG&A 為 20 億美元，同比增長 23%，主要反映了與終止 Trodelvy 與 Everest Medicines 的合作相關的 4.06 億美元費用。這筆 4.06 億美元的費用包括我們同意支付給 Everest 的 2.8 億美元，用於收購 Trodelvy 在中國和其他亞洲地區的開發和商業權利，以及一些其他與終止相關的費用。排除珠穆朗瑪峰的影響，SG&A 同比下降 2%。

Fourth quarter non-GAAP operating margin was 37%, down sequentially due to the factors referenced earlier, including the $406 million Everest charge and up year-over-year. Excluding the Everest charge, non-GAAP operating margin was 42%.

第四季度非 GAAP 營業利潤率為 37%，由於前面提到的因素（包括 4.06 億美元的 Everest 費用）和同比增長而連續下降。不計 Everest 費用，非 GAAP 營業利潤率為 42%。

Non-GAAP effective tax rate in the fourth quarter was 16.8%, lower than the prior year, driven by discrete tax charges recorded in the fourth quarter of 2021.

受 2021 年第四季度記錄的離散稅費推動，第四季度非美國通用會計準則有效稅率為 16.8%，低於上年同期。

Overall, our non-GAAP diluted earnings per share was $1.67 in the fourth quarter compared to $0.69 in the fourth quarter of 2021. Of note, the Everest contract termination impacted non-GAAP diluted EPS by $0.25 a share. This was not reflected in the guidance we shared back in October.

總體而言，我們第四季度的非 GAAP 攤薄每股收益為 1.67 美元，而 2021 年第四季度為 0.69 美元。值得注意的是，Everest 合同終止對非 GAAP 攤薄每股收益的影響為 0.25 美元。這並未反映在我們 10 月份分享的指南中。

Moving to the full year on Slide 26. Total product sales were $27 billion. Excluding Veklury, total product sales were $23.1 billion, up 8% compared to 2021, primarily driven by Biktarvy and oncology. Excluding around $380 million of FX headwinds and the $350 million impact of the Truvada and Atripla LOEs, total product sales, excluding Veklury, were up 11% as compared to 2021.

轉到幻燈片 26 的全年。產品總銷售額為 270 億美元。不包括 Veklury 在內，產品總銷售額為 231 億美元，比 2021 年增長 8%，主要由 Biktarvy 和腫瘤學推動。排除約 3.8 億美元的外匯不利因素以及 Truvada 和 Atripla LOE 的 3.5 億美元影響，不包括 Veklury 在內的產品總銷售額與 2021 年相比增長了 11%。

I touched on the main P&L impacts in the overview, but will highlight on Slide 27 that our non-GAAP effective tax rate for 2022 was 19.3% and non-GAAP diluted EPS was $7.26 per share compared to $7.18 per share reported in 2021.

我在概述中談到了對損益的主要影響，但將在幻燈片 27 中強調，我們 2022 年的非 GAAP 有效稅率為 19.3%，非 GAAP 稀釋每股收益為 7.26 美元，而 2021 年報告的每股收益為 7.18 美元。

I'll move now to guidance on Slide 28. We recognize that the macro environment continues to be uncertain. Our initial 2023 guidance assumes an overall stable macro environment and relatively stable FX at current rates. While inflation is expected to moderate, our 2023 guidance reflects a full year of higher expenses experienced in 2022 associated with inflation. With that in mind, we expect total product sales in the range of $26 billion to $26.5 billion. For total product sales, excluding Veklury, we expect sales in the range of $24 billion to $24.5 billion, representing growth of 4% to 6% for our base business year-over-year.

我現在轉到幻燈片 28 的指導。我們認識到宏觀環境仍然不確定。我們最初的 2023 年指引假設總體穩定的宏觀環境和以當前匯率計算的相對穩定的外匯。雖然通貨膨脹預計會放緩，但我們的 2023 年指引反映了 2022 年全年與通貨膨脹相關的更高支出。考慮到這一點，我們預計產品總銷售額將在 260 億美元至 265 億美元之間。對於不包括 Veklury 在內的產品總銷售額，我們預計銷售額在 240 億美元至 245 億美元之間，這意味著我們的基礎業務同比增長 4% 至 6%。

And we expect Veklury sales of approximately $2 billion. As always, Veklury sales will continue to track hospitalization rates and will remain highly variable depending on the frequency and severity of surges. Notably, we have seen a decline in hospitalization rates in recent weeks, and we'll continue to monitor the landscape carefully. As a result and similar to last year, we will update you on our Veklury expectations on a quarterly basis.

我們預計 Veklury 的銷售額約為 20 億美元。一如既往，Veklury 的銷售額將繼續跟踪住院率，並將根據激增的頻率和嚴重程度保持高度變化。值得注意的是，最近幾週我們發現住院率有所下降，我們將繼續密切關注形勢。因此，與去年類似，我們將每季度向您更新我們對 Veklury 的預期。

Moving to the rest of the P&L. We expect our non-GAAP product gross margin to be approximately 86%, just slightly below our 2022 results and primarily reflecting the growing contribution from oncology. For non-GAAP operating expenses, we expect R&D to increase by a high single-digit percentage compared to 2022 levels, reflecting our ongoing investment in strategic areas of growth and an increase in activity from later-stage trials.

轉到損益表的其餘部分。我們預計我們的非 GAAP 產品毛利率約為 86%，略低於我們 2022 年的結果，主要反映了腫瘤學的貢獻不斷增長。對於非 GAAP 運營費用，我們預計研發將比 2022 年的水平高個位數增長，這反映了我們對戰略增長領域的持續投資以及後期試驗活動的增加。

As a reminder, we had 8 Phase III trials started in 2022, and we expect to have 23 active Phase III trials by the end of 2023. Looking ahead, we expect R&D growth to moderate although we will step up investments as needed to support promising programs based on clinical data.

提醒一下，我們在 2022 年開始了 8 項 III 期試驗，我們預計到 2023 年底將進行 23 項有效的 III 期試驗。展望未來，我們預計研發增長將放緩，但我們將根據需要加大投資以支持有前景的項目基於臨床數據的程序。

Acquired IP R&D includes previously announced payments for Arcellx, Tmunity and milestone payments for existing collaborations. Consistent with our approach in 2022, we will continue to share our expected acquired IP R&D expenses as we announced additional transactions.

獲得的 IP 研發包括先前宣布的對 Arcellx、Tmunity 的付款以及對現有合作的里程碑付款。與我們 2022 年的做法一致，我們將在宣布額外交易時繼續分擔我們預期獲得的知識產權研發費用。

Finally, we expect SG&A to decrease by a low single-digit percentage compared to 2022. However, this is primarily due to some expenses reported in 2022 that we don't expect to repeat in 2023. If we normalize the 2022 SG&A expense for these items, we expect full year 2023 SG&A expense to increase by a mid-single-digit percentage on a basis of approximately $5.1 billion in 2022. Altogether, we expect our non-GAAP operating income for 2023 to be $11 billion to $11.6 billion. Our non-GAAP effective tax rate is expected to be approximately 20% again this year.

最後，我們預計 SG&A 與 2022 年相比將下降個位數百分比。但這主要是由於 2022 年報告的一些費用我們預計不會在 2023 年重複出現。如果我們將這些 2022 年的 SG&A 費用正常化項目，我們預計 2023 年全年 SG&A 費用將在 2022 年約 51 億美元的基礎上以中等個位數百分比增長。總而言之，我們預計 2023 年的非美國通用會計準則營業收入為 110 億美元至 116 億美元。我們的非 GAAP 有效稅率預計今年將再次達到 20% 左右。

And finally, we expect our non-GAAP diluted EPS to be between $6.60 and $7 for the full year and GAAP diluted EPS to be between $5.30 and $5.70 per share.

最後，我們預計全年非 GAAP 稀釋後每股收益將在 6.60 美元至 7 美元之間，而 GAAP 稀釋後每股收益將在 5.30 美元至 5.70 美元之間。

Moving to capital allocation on Slide 29. Our priorities have not changed. In 2022, we returned over $5 billion to shareholders. This included dividend payments and $1.4 billion in share repurchases. Fourth quarter share repurchases were approximately $800 million.

轉到幻燈片 29 的資本配置。我們的優先事項沒有改變。 2022 年，我們向股東返還了超過 50 億美元。這包括股息支付和 14 億美元的股票回購。第四季度的股票回購約為 8 億美元。

For 2023, we have announced today a 2.7% increase in our quarterly cash dividend to $0.75 per share and remain committed to growing our dividend over time in line with earnings growth. You can also expect to see continued judicious investments in our business, both internally and externally through select partnerships and business development transactions. Finally, we will continue to use share repurchases to offset equity dilution as well as additional repurchases on an opportunistic basis.

對於 2023 年，我們今天宣布將季度現金股息增加 2.7% 至每股 0.75 美元，並繼續致力於隨著收益的增長而增加股息。您還可以期望通過精選的合作夥伴關係和業務發展交易，在內部和外部看到對我們業務的持續明智投資。最後，我們將繼續使用股票回購來抵消股權稀釋以及機會主義的額外回購。

With that, I'll invite the operator to open the call up for questions.

有了這個，我將邀請接線員打開電話提問。

(Operator Instructions) The first question comes from the line of Tyler Van Buren with Cowen.

（操作員說明）第一個問題來自 Tyler Van Buren 和 Cowen 的台詞。

It's great to see yet another impressive quarter of performance from the core business. At the midpoint, guidance assumes 5% year-over-year growth for product sales, excluding Veklury, yet non-GAAP EPS guidance assumes a decline of 6%. So should we expect roughly flat earnings for the next 2 to 3 years as you continue to invest aggressively in the pipeline to set up earnings growth for the second half of the decade? Or is that too conservative? And what levers do you have to increase earnings in the near to mid-term?

很高興看到核心業務又一個令人印象深刻的季度業績。在中點，指導假設產品銷售額同比增長 5%（不包括 Veklury），但非 GAAP 每股收益指導假設下降 6%。那麼，隨著您繼續積極投資管道以實現下半年的收益增長，我們是否應該預計未來 2 到 3 年的收益大致持平？還是太保守了？您有什麼槓桿可以在中短期內增加收益？

Tyler, it's Andy. Thanks for the question. We appreciate it. Look, what we've said and obviously, we don't provide longer-term guidance, but I'll reiterate that the -- as you highlighted, the base business is performing very well. We had another good year with Veklury, but we expect, as you heard in our prepared comments that the COVID-19 market will continue to be dynamic. And again, this year, you saw -- if you look at our EPS, the growth of the base business offset the decline in Veklury despite the increase in expenses.

泰勒，是安迪。謝謝你的問題。我們很感激。看，我們已經說過，很明顯，我們沒有提供長期指導，但我會重申——正如你強調的那樣，基礎業務表現非常好。我們與 Veklury 度過了又一個美好的一年，但正如您在我們準備好的評論中所聽到的那樣，我們預計 COVID-19 市場將繼續充滿活力。再一次，今年，你看到——如果你看一下我們的每股收益，基礎業務的增長抵消了 Veklury 的下降，儘管費用增加了。

Going forward, again, a lot of our shareholders, as you know, focus on non-GAAP EPS, excluding Veklury, based on their assumptions. We expect using kind of that metric for our EPS to grow and for that growth to accelerate over the longer run as our products continue to deliver with additional commercial approvals, expanded indications, new products entering the market, et cetera. So again, I think what you're highlighting is the difficulty of looking through the impact of Veklury. When we look at the base business, we have a lot of confidence in terms of the health of the business and the growth it's going to deliver over time, both on the top line and the bottom line.

展望未來，正如您所知，我們的許多股東再次根據他們的假設關注非 GAAP 每股收益，不包括 Veklury。我們希望使用這種指標來衡量我們的 EPS 增長，並在長期內加速增長，因為我們的產品將繼續提供額外的商業批准、擴大適應症、新產品進入市場等。因此，我認為您再次強調的是很難看清 Veklury 的影響。當我們審視基礎業務時，我們對業務的健康狀況及其隨著時間的推移實現的增長充滿信心，無論是在頂線還是底線。

The next question comes from the line of Geoff Meacham with Bank of America.

下一個問題來自美國銀行的 Geoff Meacham。

I will keep it just to one. When you look at lenacapavir in the U.S., just help us with maybe the expected kind of loss dynamics following the recent approval and just with consideration of the hurdles with regard to payer access. And obviously, you guys had a long history here, but wondering if the environment is different today versus sort of pre-pandemic.

我會把它留給一個。當您在美國查看 lenacapavir 時，請幫助我們了解最近批准後可能出現的預期損失動態，並考慮付款人准入方面的障礙。顯然，你們在這裡有著悠久的歷史，但想知道今天的環境與大流行前是否有所不同。

Thanks, Geoff, for your question. It's Johanna. I think that we're super excited with Sunlenca approval. Do remember, though, it's really for a very specific patient population for the heavily treatment experienced multi-drug-resistant population. And so that's about 1% to 2% of people living without HIV. That's about 5,000 patients or so in the U.S. So just to give you a little bit of a perspective on it.

謝謝杰夫提出你的問題。是約翰娜。我認為我們對 Sunlenca 的批准感到非常興奮。但請記住，它確實適用於非常特殊的患者群體，即經歷過大量治療的多重耐藥人群。因此，大約有 1% 到 2% 的人沒有感染艾滋病毒。在美國大約有 5,000 名患者。所以只是為了讓您對此有一些看法。

The -- that's one piece of the puzzle. So far -- so we just launched. So it's still early days, and we're excited about it. And I think physicians' response has been very strong as well. The -- I think they really see the innovation of having something every 6 months coming in and also the promise of what it could mean in future with prevention indication as well as treatment combination.

- 這是拼圖的一部分。到目前為止 - 所以我們剛剛推出。所以現在還為時尚早，我們對此感到很興奮。我認為醫生的反應也非常強烈。 - 我認為他們真的看到了每 6 個月進行一次的創新，以及它在未來可能意味著預防適應症和治療組合的承諾。

So more to come on that one. I think it's an incredible opportunity for us to gain awareness for Sunlenca, how to use the reimbursement systems. And as to your point about pre-COVID to COVID, I think that actually -- we've really normalized the market. I think we're back on track, when it comes to HIV, both screening, diagnosis, et cetera, and treatment. So we do believe that, that's probably not in play as we go forward in 2023. But again, small revenue, huge unmet medical need and an incredible opportunity for patients to have something to ensure that they don't proceed to more like aids disease versus just saying HIV positive.

所以更多的是關於那個。我認為這對我們來說是一個難得的機會，可以讓我們了解 Sunlenca 以及如何使用報銷系統。至於你關於 COVID 之前到 COVID 的觀點，我認為實際上——我們已經真正使市場正常化。我認為我們回到了正軌，當涉及到 HIV 時，包括篩查、診斷等和治療。因此，我們確實相信，隨著我們在 2023 年前進，這可能不會發揮作用。但同樣，收入微薄、醫療需求巨大且未得到滿足，而且患者有難得的機會獲得一些東西來確保他們不會發展成更像艾滋病的疾病而不是僅僅說 HIV 陽性。

The next one is from Michael Yee at Jefferies.

下一篇來自 Jefferies 的 Michael Yee。

Maybe a question for Merdad. On Trop-2, the competitor AstraZeneca, Daiichi continues to be quite bullish and actually as a Phase III lung cancer study readout and -- the Street is quite bullish on Trop-2. Can you explain your thoughts around your differentiation? Appreciating your study readout, I think, in '24 and what we should appreciate as to how you will compete there or differentiate and maybe its safety, but maybe walk me through that and help us understand Trop-2 for you versus your competitors.

也許是 Merdad 的問題。在 Trop-2 上，競爭對手阿斯利康（AstraZeneca）、Daiichi 仍然非常看好，實際上作為 III 期肺癌研究的讀數——華爾街非常看好 Trop-2。你能解釋一下你對差異化的看法嗎？欣賞你的研究讀數，我認為，在 24 年，我們應該欣賞你將如何在那裡競爭或差異化以及它的安全性，但也許讓我了解一下並幫助我們了解 Trop-2 為你和你的競爭對手。

Yes. Thanks, Michael. This is Merdad. You're absolutely right. We do think that -- there are a couple of things that we think about when we think about differentiation. The first is that we've now been on the market and have several approvals under our belt with Trodelvy. And I think that is an important factor for having now been on the market, an important indications.

是的。謝謝，邁克爾。這是梅爾達。你是絕對正確的。我們確實認為 - 當我們考慮差異化時，我們會考慮幾件事。首先是我們現在已經上市，並通過 Trodelvy 獲得了多項批准。我認為這是現在已經上市的一個重要因素，一個重要的跡象。

To your point, with lung, we will be somewhat behind where our competition is. We do think that the data will have to evolve for us and for them. And I think so far, we have been fortunate to not see ILD in our development program so far. And so we are going to continue advancing our program forward aggressively. We've had a lot of success so far. And I think our plan is to keep going ahead with the differentiated clinical development program so we can get into the broadest population as possible.

就你的觀點而言，有了肺，我們將在一定程度上落後於我們的競爭對手。我們確實認為數據必須為我們和他們而發展。我認為到目前為止，我們很幸運沒有在我們的開發計劃中看到 ILD。因此，我們將繼續積極推進我們的計劃。到目前為止，我們已經取得了很大的成功。而且我認為我們的計劃是繼續推進差異化臨床開發計劃，以便我們能夠進入盡可能廣泛的人群。

The next question is from Do Kim with Piper Sandler.

下一個問題來自 Do Kim 和 Piper Sandler。

Congrats on the quarter. Keeping it on Trodelvy. Merdad, I was hoping if you could provide a little more detail on [asset] 7 in pre-chemo HR-positive/HER2-negative breast cancer that you're initiating later this year. Just what that study design would look like? And how did you come to conclude that this was the next best study for this population?

祝賀這個季度。將其保存在 Trodelvy 上。 Merdad，我希望你能提供更多關於你今年晚些時候開始的化療前 HR 陽性/HER2 陰性乳腺癌的 [資產] 7 的細節。那個研究設計會是什麼樣子？您是如何得出結論認為這是該人群的下一個最佳研究的？

Thanks. That's an excellent question. And I think we haven't really talked about the design yet. In large part, we are working through both with investigators and regulators on what the best approach is going to be in that patient population. We do think that there is an important need in a large population there. And we want to make sure that we navigate that pathway carefully. So I think as we develop that program, as that protocol gets developed, we'll be able to share more detail over time.

謝謝。這是一個很好的問題。而且我認為我們還沒有真正討論過設計。在很大程度上，我們正在與研究人員和監管機構合作，研究針對該患者群體的最佳方法。我們確實認為那裡有大量人口的重要需求。我們希望確保我們謹慎地走這條路。所以我認為，隨著我們開發該程序，隨著該協議的開發，我們將能夠隨著時間的推移分享更多細節。

The next question comes from Colin Bristow with UBS.

下一個問題來自瑞銀的 Colin Bristow。

Congrats on all the progress. Maybe one on TIGIT and dompenanumab. The -- what is it that gives you the confidence that the Fc silent construct is the right approach when -- I think at least the animal data suggest that this may not be preferred. And then as you think about the upcoming study, ARC-7. Could you talk about the frequency of scans tier because this has come up as a point of at least discussion with regards to the comparator trials and the frequency of scans.

祝賀所有的進步。也許一個關於 TIGIT 和多佩那單抗。是什麼讓你相信 Fc 沉默結構是正確的方法，我認為至少動物數據表明這可能不是首選。然後當你想到即將進行的研究時，ARC-7。你能談談掃描層的頻率嗎，因為這至少是關於比較試驗和掃描頻率的討論點。

Sure. This is Merdad again. Excellent question. Thank you for that. We -- in terms of our confidence, I think -- to your point, look, I think there was a lot of debate a couple of years ago. We shared in that debate with what the preclinical data was showing. And as you know the data, they were conflicting preclinical data, including some data that suggested maybe an Fc silent may not work. But -- which is why we ran the studies the way we did and very importantly, why we ran ARC-7. The objective there was really to establish whether an Fc silent would demonstrate a benefit relative to Fc-active molecule.

當然。這又是默達德。很好的問題。謝謝你。我們——就我們的信心而言，我認為——就你的觀點而言，我認為幾年前有很多爭論。我們在那場辯論中分享了臨床前數據所顯示的內容。正如你所知，這些數據是相互矛盾的臨床前數據，包括一些表明 Fc 沉默可能不起作用的數據。但是——這就是為什麼我們按照我們的方式進行研究，非常重要的是，為什麼我們運行 ARC-7。那裡的目標實際上是確定 Fc 沉默是否會證明相對於 Fc 活性分子的益處。

Part of the hypothesis there is what happens in the periphery, and whether depleting effector cells with TIGIT could actually be harmful with an Fc competent molecule relative to an Fc nonmolecule. And our confidence really comes from our ARC-7 data. I think the ARC-7 data really answered that question. We clearly show a benefit when added on to a PD-1. The PFS data exceed our bar for moving forward. And so we really think that we've answered that question in the clinic as to whether the Fc now matters.

部分假設是外圍發生了什麼，以及用 TIGIT 耗盡效應細胞是否實際上對 Fc 感受態分子相對於 Fc 非分子有害。我們的信心真的來自我們的 ARC-7 數據。我認為 ARC-7 數據確實回答了這個問題。當添加到 PD-1 時，我們清楚地顯示出好處。 PFS 數據超出了我們前進的標準。所以我們真的認為我們已經在臨床上回答了關於 Fc 現在是否重要的問題。

The next question is from Chris Schott with JPMorgan.

下一個問題來自摩根大通的 Chris Schott。

Just a question on the COVID business. I know it's volatile, and I know at the same time, the Street doesn't seem to model much of a tail for Veklury or GS-5245 at all in numbers beyond this year. We've got Pfizer's and others, then talking about more sustainable COVID businesses, I guess, off of 2023 level. So just missing your thoughts on just how you're thinking about the business longer term? And is this a meaningful franchise for you over time? Or are you really thinking of this continuing to fade down beyond this year?

只是關於 COVID 業務的問題。我知道它是不穩定的，而且我同時知道，在今年以後的數字上，華爾街似乎根本沒有為 Veklury 或 GS-5245 建模太多尾巴。我們有輝瑞公司和其他公司，然後談論更具可持續性的 COVID 業務，我猜，從 2023 年的水平。那麼只是想念您對如何長期考慮業務的想法？隨著時間的推移，這對你來說是一個有意義的特許經營權嗎？或者你真的認為這種情況會在今年以後繼續消退嗎？

Sure, Chris. It's Johanna. Yes. So definitely, we've changed a little bit. Our position on this one has evolved from 2020 to where we are today obviously. I think we do truly believe that the Veklury business is much more sustainable than we've ever seen before, let alone as we think about kind of where we're going with COVID-19, including the oral that Merdad can speak to.

當然，克里斯。是約翰娜。是的。所以可以肯定的是，我們已經改變了一點。我們在這方面的立場顯然已經從 2020 年發展到今天的位置。我認為我們確實相信 Veklury 業務比我們以前見過的更具可持續性，更不用說我們考慮 COVID-19 的發展方向，包括 Merdad 可以談論的口頭內容。

The one piece that we've seen is -- it's maybe a little bit different than some of the orals that you're referring to is one is Veklury has been part of a commercial model since October of 2020. So we haven't had such big inventory loads at the government level like some others have had. So really, what you see probably 85% to 90% of revenues in 2022 are truly reflecting the demand for Veklury in 2022. And so therefore, coming into 2023, we feel very strongly that Veklury, because it's still the only antiviral indicated at the hospital level at this point in time because of the fact that in many countries around the world, it is the treatment of choice when they decide to treat hospitalized patients.

我們看到的一件作品是——它可能與您提到的一些口述有點不同，其中一件是 Veklury 自 2020 年 10 月以來一直是商業模式的一部分。所以我們還沒有像其他一些人一樣，政府層面的庫存負擔如此之大。所以真的，你看到的 2022 年收入的 85% 到 90% 可能真正反映了 2022 年對 Veklury 的需求。因此，進入 2023 年，我們非常強烈地感受到 Veklury，因為它仍然是目前唯一的抗病毒藥物。在這個時間點醫院級別，因為在世界上許多國家，當他們決定治療住院患者時，它是首選的治療方法。

I think there's really an incredible continuing opportunity for us to ensure that Veklury is accessible to all these patients. And so that's why we think the model is quite sustainable moving forward. I would also just add that our label has broadened over the last year in some. We have a very strong body of evidence, including mortality as well as we have guidelines endorsement with the NIH as well as the WHO. So all of those pieces together actually make for a strong Veklury position in '23, but actually and beyond. And maybe I'll just pass it over to Merdad to talk a little bit to how we're thinking about COVID-19 as a whole with the oral.

我認為我們確實有一個令人難以置信的持續機會來確保所有這些患者都能使用 Veklury。這就是為什麼我們認為該模型非常可持續地向前發展。我還要補充一點，我們的標籤在過去一年中在某些方面有所擴大。我們有非常有力的證據，包括死亡率，而且我們有 NIH 和 WHO 認可的指導方針。因此，所有這些部分加在一起實際上構成了 Veklury 在 23 年的強勢地位，但實際上以及以後。也許我會把它傳遞給 Merdad，談談我們如何通過口頭思考整個 COVID-19。

Yes. Just 2 seconds. I think you're right to point out the uncertainties that we all have and that we've seen with outpatient COVID. And we have a lot of confidence in the mechanism of 5245 given what our expertise in the molecule itself and how well behaved it is. And we are going to push forward and do our best with both the high-risk and standard risk study and the uncertainties in terms of the pandemic will really determine what happens from here. So we will definitely keep you updated as to how that goes from here on out.

是的。只需2秒。我認為你指出我們所有人都存在的不確定性以及我們在門診 COVID 方面看到的不確定性是正確的。考慮到我們在分子本身方面的專業知識以及它的表現如何，我們對 5245 的機制充滿信心。我們將推進並儘最大努力進行高風險和標準風險研究，而大流行方面的不確定性將真正決定接下來會發生什麼。因此，我們一定會讓您了解從現在開始的最新情況。

The next question is from Brian Abrahams with RBC.

下一個問題來自 RBC 的 Brian Abrahams。

Maybe continuing on the COVID theme on 5245, the Oaktree study. Can you talk a little bit more about the assumptions you've made in powering this primary endpoint here for the standard risk patients? And then help us understand how Oaktree and Birch might fit together to support U.S. and ex U.S. approvals across the 2 populations you're studying?

也許繼續 5245 的 COVID 主題，Oaktree 研究。你能多談談你在為標準風險患者提供這個主要終點時所做的假設嗎？然後幫助我們了解 Oaktree 和 Birch 如何結合在一起以支持美國和前美國對您正在研究的兩個人群的批准？

Sure. Very briefly. The -- to your point, one is in the high-risk population, right? So I think that's important. Those are people who have risk factors, whether or not they've been vaccinated and then the standard risk, which is people without risk factors. And those are very different populations. The end points are different in terms of what we're looking for. And the high risk we're going to be looking for the ability to prevent things like hospitalization. And the standard risk, it would be looking for things like symptom improvement.

當然。非常簡短。 - 就您而言，一個人屬於高危人群，對嗎？所以我認為這很重要。這些人有風險因素，無論他們是否接種過疫苗，然後是標準風險，即沒有風險因素的人。這些是非常不同的人群。就我們正在尋找的內容而言，終點是不同的。高風險我們將尋找防止住院等事情的能力。標準風險是尋找症狀改善之類的東西。

And I think -- again, I'll just reiterate that I think the uncertainties in terms of those factors and importantly, the underlying event rate is real. And so we've made a number of assumptions around what that background rate will be. And we've built into the trials, checkpoints to make sure that our assumptions are correct. And we have the ability to modify our program based on what the underlying event rates are. So that sort of helps mitigate the risks and the uncertainties. So we've gone in fairly eyes open to that.

我認為——再次重申，我認為這些因素的不確定性，重要的是，潛在的事件發生率是真實的。因此，我們圍繞背景率做出了一些假設。我們在試驗中建立了檢查點，以確保我們的假設是正確的。我們有能力根據潛在的事件發生率來修改我們的程序。因此，這有助於減輕風險和不確定性。所以我們對此持開放態度。

The next question is from Mohit Bansal with Wells Fargo.

下一個問題來自 Wells Fargo 的 Mohit Bansal。

Congrats on the progress. Maybe if you could comment on your overall market share in HIV space and how it has been progressing. What I want to understand is that is there a scenario where your entire business growth could be better than the market growth as you gain share at this point?

祝賀進步。也許您可以評論一下您在 HIV 領域的整體市場份額以及它的進展情況。我想了解的是，隨著您此時獲得份額，是否存在您的整個業務增長可能優於市場增長的情況？

Sure. Mohit, it's Johanna. I think as we look at HIV as a whole, we're looking at about a 5% year-on-year growth. And of course, that's mostly driven by demand, namely Biktarvy. And so it's probably important to talk about the share there. So our total Gilead share is still in the low 70s, and we've been quite stable at that level. We saw a little bit of the dip when we got the Truvada and Atripla LOEs, and that's the only decline that we've seen there and really held steady, where you see nice growth, of course, is Biktarvy. Our year-on-year growth for Biktarvy is 20% in fifth year post launch. And I think that's the piece of the puzzle that's really driving the overall HIV business in addition, to what's going on in PrEP with Descovy.

當然。莫希特，是約翰娜。我認為，當我們將 HIV 視為一個整體時，我們正在尋找大約 5% 的同比增長。當然，這主要是由需求驅動的，即 Biktarvy。因此，談論那裡的份額可能很重要。所以我們的 Gilead 總份額仍處於 70 年代的低位，我們在這個水平上一直相當穩定。當我們得到 Truvada 和 Atripla LOE 時，我們看到了一點點下降，這是我們在那裡看到的唯一下降，並且真正保持穩定，你看到良好的增長，當然，是 Biktarvy。在推出後的第五年，我們對 Biktarvy 的同比增長率為 20%。我認為，除了 PrEP 與 Descovy 正在發生的事情之外，這也是真正推動整個 HIV 業務的難題。

To your point about the market growth, we've seen market growth around 2% to 3% year-on-year, both in the U.S. as well as in Europe, and we've assumed that we're kind of assuming that for some years to come. And I do think there's still enormous opportunity for continued growth in that market. And one of the main reasons why is there's still an opportunity for increasing treatment rates, so from diagnosis to treatment, but also further penetration in underserved patient populations.

就您關於市場增長的觀點而言，我們已經看到美國和歐洲的市場同比增長約 2% 至 3%，我們假設我們假設未來幾年。我確實認為該市場仍有巨大的持續增長機會。主要原因之一是仍然有機會提高治療率，從診斷到治療，而且還進一步滲透到服務不足的患者群體中。

And so at this point in time, with United Nations goal at 95%, 95%, 95% for testing, treatment and virologic suppression, we're only about 70%, 75%. So if we were to get to those goals, you're looking at over 350,000 more patients into the system. So I think you're absolutely right. I think there's a great opportunity for us to continue to grow Biktarvy and our HIV business at Gilead.

所以在這個時間點，聯合國的目標是 95%、95%、95% 用於檢測、治療和病毒學抑制，而我們只有大約 70%、75%。因此，如果我們要實現這些目標，您將看到超過 350,000 名患者進入該系統。所以我認為你是完全正確的。我認為我們有很好的機會繼續發展 Biktarvy 和我們在吉利德的 HIV 業務。

The next question is from Umer Raffat at Evercore.

下一個問題來自 Evercore 的 Umer Rafat。

I have a question on the model today. I feel like consensus models have a lot of operating leverage in the long-term estimates for Gilead. And don't -- consensus doesn't carry more than low single-digit OpEx growth across SG&A and R&D. So with SG&A growing mid-single digits this year after the onetimers and R&D growing high single digits, I guess, should we assume that given all the collaborations and recent acquisitions that you really do need to be growing R&D meaningfully from current levels? I'm just trying to understand where the OpEx is heading longer term.

我今天有一個關於模型的問題。我覺得共識模型在 Gilead 的長期估計中有很大的運營槓桿。而且不要 - 共識在 SG&A 和 R&D 中的 OpEx 增長不會超過低個位數。因此，隨著 SG&A 在 onetimers 和 R&D 增長高個位數之後今年增長了中等個位數，我想，我們是否應該假設鑑於所有合作和最近的收購，你真的需要從當前水平有意義地增長 R&D？我只是想了解 OpEx 的長期發展方向。

Umer, it's Andy. Thanks for the question. Maybe a couple of things. First, I'd highlight that as you'd expect, we are mindful of expenses and don't expect R&D or SG&A to grow indefinitely. That said, we're going to continue to invest thoughtfully in the pipeline, and you're already seeing, I'd highlight, the tangible benefits of doing that. So that's a really important point. We started on the R&D side. As you know, we started 8 Phase III trials this year. We're going to, as you heard, start at least another 5 in 2023. So we are in an investment cycle.

烏默爾，是安迪。謝謝你的問題。也許有幾件事。首先，我要強調的是，正如您所期望的那樣，我們很注意支出，並且不希望研發或 SG&A 無限期增長。也就是說，我們將繼續對管道進行深思熟慮的投資，你已經看到了，我要強調的是，這樣做的實實在在的好處。所以這是非常重要的一點。我們從研發方面開始。如您所知，我們今年開始了 8 項 III 期試驗。正如你所聽到的，我們將在 2023 年至少再啟動 5 個。所以我們正處於一個投資週期。

Over the longer run -- and maybe one other thing before I kind of talk about the long-run picture to your question. Again, when you benchmark us relative to competitors, as you know, historically, for both SG&A and R&D, we underspent. And it's partly why we didn't have the pipeline that would drive the top quartile sustainable growth that we aspire to, and we think we're on track to achieve today.

從長遠來看——在我談論你的問題的長期前景之前，也許還有另一件事。同樣，當您將我們與競爭對手進行比較時，如您所知，從歷史上看，我們在 SG&A 和 R&D 方面的支出都不足。這在一定程度上是為什麼我們沒有能夠推動我們渴望的最高四分之一可持續增長的管道，我們認為我們今天有望實現這一目標。

So we're going to continue to invest as you've heard and especially in these late Phase III trials that have started. We'll continue to do BD not at the same pace or level that we have over the last 4 or 5 years as we've rebuilt the pipeline. But our percent -- our R&D as a percent of revenue this past year was below industry averages, I think, right around 19%. Same thing is true for SG&A as a percent of revenue.

因此，正如您所聽到的，我們將繼續投資，尤其是在這些已經開始的晚期 III 期試驗中。在重建管道時，我們將繼續以與過去 4 或 5 年不同的速度或水平進行 BD。但我們的百分比——我們的研發在過去一年中佔收入的百分比低於行業平均水平，我認為大約是 19%。 SG&A 佔收入的百分比也是如此。

And even our guide suggests, I think, reasonable spend levels relative to comps. In the longer run, to your point, so we think about things over a longer cycle. We will not -- we do not expect to grow R&D or SG&A above the rate of earnings growth. And there is a lot of leverage in the model we expect over the long run. So we're getting to the point where you're starting to see that play through, especially at the top line. And then over the coming years, we expect that you'll really see that play through on the bottom line as well. So thanks for the question.

我認為，甚至我們的指南也建議相對於補償的合理支出水平。從長遠來看，就您的觀點而言，我們會在更長的周期內考慮事情。我們不會——我們不希望研發或 SG&A 的增長超過盈利增長率。從長遠來看，我們期望該模型具有很大的槓桿作用。所以我們已經到了你開始看到它發揮作用的地步，尤其是在頂線。然後在接下來的幾年裡，我們希望您也能真正看到它在底線發揮作用。所以謝謝你的問題。

The next question is from Olivia Brayer with Cantor Fitzgerald.

下一個問題來自 Olivia Brayer 和 Cantor Fitzgerald。

What's the latest thinking with respect to the regulatory path forward for magrolimab? I guess the question really is, could we see survival data from that ENHANCE interim later this year that's actually mature enough to file on? And is there anything beyond OS benefit that FDA has pointed to for a complete submission package?

關於 magrolimab 的監管路徑的最新想法是什麼？我想真正的問題是，我們能否在今年晚些時候看到 ENHANCE 中期的生存數據，這些數據實際上已經成熟到可以歸檔？除了 FDA 指出的完整提交包的 OS 好處之外，還有什麼嗎？

Olivia, this is Merdad. Yes. I think maybe it's good to step back and just clarify in the sense of how we're approaching interim analysis for our studies. So the pivotal magro study is powered for events at the final analysis. And of course, we run interim analyses, I think, as is norm for the industry to evaluate things like safety. But also we spend a little bit of alpha in case there is a dramatic improvement in the primary endpoint and offer ourselves the opportunity to start early to benefit patients.

奧利維亞，這是梅爾達。是的。我認為也許最好退後一步，只是從我們如何為我們的研究進行中期分析的意義上澄清一下。因此，關鍵的宏觀研究歸根結底是為事件提供動力的。當然，我認為我們會進行中期分析，這是行業評估安全性等事項的規範。但我們也會花一點阿爾法，以防主要終點有顯著改善，並為我們自己提供早期開始造福患者的機會。

So the OS data continue to mature. The next interim this year dependent on events, of course, is not the final analysis. So it really depends on how big the magnitude of improvement is in OS, whether that leads to a stop in the study or an unblinding in the study. Our expectation is that we go to the final OS analysis. Of course, we always hope for an upside surprise at one of the earlier interim analysis. And then in terms of approval, I think we really need to have OS. We initially had hoped that we could get, for example, an accelerated approval with CR rates alone. We think we need to do both now to have both a complete response rate, but primarily be driven -- not primarily be driven, but importantly, have OS data as well in order to support a file.

所以OS數據不斷成熟。明年中期取決於今年的事件，當然，這不是歸根結底。因此，這實際上取決於 OS 的改善幅度有多大，這是否會導致研究停止或研究揭盲。我們的期望是進行最終的操作系統分析。當然，我們總是希望在早期的中期分析中出現意外的上漲。然後在批准方面，我認為我們真的需要有操作系統。例如，我們最初希望僅憑 CR 率就能獲得加速批准。我們認為我們現在需要同時做到這兩點，以獲得完整的響應率，但主要是被驅動——不是主要被驅動，但重要的是，還有操作系統數據以支持文件。

The next question is from Simon Baker with Redburn.

下一個問題來自 Simon Baker 和 Redburn。

(inaudible) and the NICE recommendation. Clearly, that's good from a U.K. perspective, but it's the case that NICE recommendations are closely followed by a much larger range of countries. So I just wondered if this does indeed have a spillover benefit beyond the U.K. for Yescarta. How important this approval is in the U.K.?

（聽不清）和 NICE 的建議。顯然，從英國的角度來看這很好，但 NICE 的建議得到了更多國家的密切關注。所以我只是想知道這是否確實對 Yescarta 產生了英國以外的溢出效應。這項批准在英國有多重要？

Simon, it's Christi. Thank you for the question. So we think it's very important because, first of all, it's the number of patients is still very similar at 450, but the process by which patients get approved, obviously should be much smoother and really giving access to -- this recommendation really helps patients get access much more quickly.

西蒙，我是克里斯蒂。感謝你的提問。所以我們認為這非常重要，因為首先，患者人數仍然非常相似，為 450 人，但患者獲得批准的過程顯然應該更加順利，並且真正允許訪問 - 這個建議確實可以幫助患者更快地獲得訪問權限。

And so to your point, we do think as you see this approval that this hopefully, will have an influence on other countries, just like we saw with reimbursement as we look at the reimbursement of Yescarta in over 20 countries, it was one at a time. And as certain countries starting to improve, we saw the other currencies also do the same. So based on the second-line ZUMA-7 trial as well, that will be our next step too, to continue to provide the data that giving a patient a onetime treatment can really help the health care system and improve patient outcomes. So yes, we're very hopeful that it could have some influence.

因此，就您的觀點而言，我們確實認為，當您看到這項批准時，這有望對其他國家產生影響，就像我們在 20 多個國家/地區查看 Yescarta 的報銷時看到的報銷一樣，它是一個時間。隨著某些國家開始改善，我們看到其他貨幣也在做同樣的事情。因此，基於二線 ZUMA-7 試驗，這也將是我們的下一步，繼續提供數據，證明為患者提供一次性治療可以真正幫助醫療保健系統並改善患者的治療效果。所以是的，我們非常希望它能產生一些影響。

The next question is from Robyn Karnauskas with Truist.

下一個問題來自 Robyn Karnauskas 和 Truist。

This is Nicole on for Robyn. Are you seeing any safety signals in a sense for EVOKE-03 with Trodelvy and pembro. Like are the safety profiles comparable to both populations? And if so, would this hamper uptake in the first line?

這是羅賓的妮可。對於帶有 Trodelvy 和 pembro 的 EVOKE-03，您是否看到任何安全信號？安全概況是否與兩個人群具有可比性？如果是這樣，這會阻礙第一線的採用嗎？

Nicole, this is Merdad. We haven't really disclosed anything on the safety. Those studies have really just gotten underway. So I don't think we have anything to share yet. We'll, of course, be following that to see if anything emerges. Your question is exactly the one that we want to make sure we address as we move forward. But I don't -- we don't have enough data at this point to make a comment one way or the other.

妮可，這是梅爾達。我們還沒有真正透露任何關於安全性的信息。這些研究才剛剛開始。所以我認為我們還沒有什麼可以分享的。當然，我們會繼續關注，看看是否有任何進展。您的問題正是我們要確保在前進過程中解決的問題。但我不知道——我們目前沒有足夠的數據來以一種或另一種方式發表評論。

Our last question will be from Evan Seigerman with BMO.

我們的最後一個問題將來自 BMO 的 Evan Seigerman。

One for Christi. You're annualizing well above $1 billion for cell therapy products. Can you talk about the recent work you've done to expand manufacturing and how you could think that could support further growth this year and beyond?

一個給克里斯蒂。您在細胞治療產品方面的年收入遠高於 10 億美元。您能否談談您最近為擴大製造業所做的工作，以及您認為這將如何支持今年及以後的進一步增長？

Sure. So that was our focus and has been our focus is really on the supply side and being able to ensure that we have the capacity to provide for patients, I think that's what you're seeing is our industry-leading manufacturing piece. And if you look at [TCFO 3] here in California, adding the new site to TCFO 4 in Amsterdam and in TCFO 5 in Maryland, we're really able to leverage that footprint to grow not only in the assets that we have today, but in future pipeline, especially as we look at the partnership we have now with Arcellx in multiple myeloma.

當然。所以這是我們的重點，並且一直是我們的重點真正放在供應方面，並能夠確保我們有能力為患者提供服務，我認為這就是您所看到的我們行業領先的製造產品。如果你看看加利福尼亞州的 [TCFO 3]，將新站點添加到阿姆斯特丹的 TCFO 4 和馬里蘭州的 TCFO 5，我們真的能夠利用這一足跡不僅在我們今天擁有的資產上增長，但在未來的管道中，特別是當我們看到我們現在與 Arcellx 在多發性骨髓瘤方面的合作夥伴關係時。

So we're very confident about our ability to supply and the capacity that we've built today and for tomorrow. And really the next focus for us is we've had some really good gains on our margin improvements. But as we look at our operational -- our optimization of our manufacturing footprint, yes, we need to continue to ensure the capacity, which we feel like we've really done. And now we're able to put a big focus too on the optimization piece, which we've made progress on but we have several levers there to pull as well. So I hope you're hearing from me a big confidence in our ability to deliver for patients from a capacity standpoint.

因此，我們對我們的供應能力以及我們今天和明天建立的能力非常有信心。實際上，我們的下一個重點是我們在提高利潤率方面取得了一些非常好的收益。但是，當我們審視我們的運營——我們對製造足蹟的優化時，是的，我們需要繼續確保產能，我們覺得我們已經做到了。現在我們也能夠將重點放在優化部分，我們已經取得了進展，但我們也有幾個槓桿可以拉動。因此，我希望您從我這裡聽到對我們從能力的角度為患者提供服務的能力的巨大信心。

That concludes today's question-and-answer session. I will now turn the call over to the management team for any closing remarks.

今天的問答環節到此結束。我現在將把電話轉給管理團隊，聽取任何結束語。

Great. This is Dan. I just want to do a couple of things here. First of all, thank you all for joining and your ongoing interest and questions for Gilead. As usual, if we didn't get to all of your questions, please reach out to Investor Relations. As you know, we're very happy to answer those on an ongoing basis.

偉大的。這是丹。我只想在這裡做幾件事。首先，感謝大家的加入以及您對吉利德的持續關注和問題。與往常一樣，如果我們沒有回答您的所有問題，請聯繫投資者關係部。如您所知，我們非常樂意持續回答這些問題。

Now let me just close by emphasizing that Gilead is in a very different place than it was a few years ago, thanks to the work the team has done to transform the company. We're going into 2023 in a very strong position with our current medicines performing well and tremendous growth potential in our neuro therapies as well as those in development.

現在讓我在結束時強調，由於團隊為改造公司所做的工作，吉利德與幾年前相比已經大不相同。我們將以非常有利的地位進入 2023 年，我們目前的藥物表現良好，我們的神經療法和開發中的藥物具有巨大的增長潛力。

So what you can expect to see next is quarter-on-quarter execution and even faster progress and greater impact in the future. Thank you very much for your time today, and we look forward to speaking to you again soon.

所以你接下來可以期待看到的是環比執行，甚至未來更快的進步和更大的影響。非常感謝您今天的時間，我們期待很快再次與您交談。

That concludes today's Fourth Quarter and Full Year 2022 Gilead Sciences Earnings Conference Call. Thank you for your participation.

今天的 Gilead Sciences 2022 年第四季度和全年收益電話會議到此結束。感謝您的參與。